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D006973: Hypertension

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (52)


Name (Synonyms) Correlation
drug3411 Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Wiki 0.30
drug3409 Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Wiki 0.21
drug2277 Nutritional support system (NSS) Wiki 0.21
Name (Synonyms) Correlation
drug3461 Thiazide or Thiazide-like diuretics Wiki 0.21
drug225 Amlodipine 2.5 mg/indapamide 1.25 mg Wiki 0.21
drug248 Angiotensin converting enzyme inhibitor Wiki 0.21
drug2390 PH-combination therapy Wiki 0.21
drug71 ACEI/ARB Wiki 0.21
drug3278 Stress and emotion management Wiki 0.21
drug2732 Quantitative IgG Test Wiki 0.21
drug2135 NO gas Wiki 0.21
drug2391 PH-monotherapy Wiki 0.21
drug1966 Maraviroc + Currently used therapy Wiki 0.21
drug1282 FMD Wiki 0.21
drug1959 Maintenance or reduction of immunosuppression Wiki 0.21
drug3438 The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care: Wiki 0.21
drug3869 echocardiogram 2D Wiki 0.21
drug300 Artemisia Annua Leaf Wiki 0.21
drug64 ABPM Wiki 0.21
drug249 Angiotensin receptor blocker Wiki 0.21
drug4140 telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg Wiki 0.21
drug3780 amlodipine 5 mg/indapamide 2.5 mg Wiki 0.21
drug1712 Intervention-EDI and health coaching Wiki 0.21
drug380 BAY1237592 Wiki 0.21
drug892 Control-EDI Wiki 0.21
drug1301 Favipiravir + Currently used therapy Wiki 0.21
drug936 Covid-19 Rapid Test Kit (RAPG-COV-019) Wiki 0.21
drug3198 Standard Donor Plasma Wiki 0.21
drug1236 Exercise Training Only Wiki 0.21
drug2415 PWV Wiki 0.21
drug950 Curently used therapy for COVID-19 non-critical patients Wiki 0.21
drug3410 Telmisartan 20 mg/amlodipine 2.5 mg . Wiki 0.21
drug224 Amlodipine Wiki 0.21
drug4141 telmisartan 40 mg/indapamide 2.5 mg Wiki 0.21
drug1190 Enhanced Chronic Disease Self-management program Wiki 0.21
drug70 ACEI Wiki 0.21
drug4139 telmisartan 40 mg/amlodipine 5 mg Wiki 0.21
drug2811 Rarefaction Wiki 0.21
drug2232 Non-ACEI/ARB Wiki 0.21
drug712 Calcium Channel Blockers Wiki 0.21
drug1968 Maraviroc+Favipiravir+CT Wiki 0.21
drug374 Açaí palm berry extract - natural product Wiki 0.21
drug1237 Exercise and Cognitive Training Wiki 0.21
drug3412 Telmisartan 20 mg/indapamide 1.25 mg Wiki 0.21
drug1118 ECG Wiki 0.15
drug95 ARB Wiki 0.15
drug68 ACE inhibitor Wiki 0.12
drug804 Clinical data Wiki 0.12
drug895 Convalescent Plasma Wiki 0.08
drug717 Camostat Mesilate Wiki 0.08
drug881 Control Wiki 0.07
drug2505 Placebo Wiki 0.02

Correlated MeSH Terms (29)


Name (Synonyms) Correlation
D006976 Hypertension, Pulmonary NIH 0.32
D001997 Bronchopulmonary Dysplasia NIH 0.21
D008595 Menorrhagia NIH 0.21
Name (Synonyms) Correlation
D006929 Hyperaldosteronism NIH 0.21
D054559 Hyperphosphatemia NIH 0.21
D004314 Down Syndrome NIH 0.21
D000309 Adrenal Insufficiency NIH 0.21
D007008 Hypokalemia NIH 0.21
D014552 Urinary Tract Infections NIH 0.15
D009080 Mucocutaneous Lymph Node Syndrome NIH 0.12
D002908 Chronic Disease NIH 0.12
D005356 Fibromyalgia NIH 0.11
D001289 Attention Deficit Disorder with Hyperactivity NIH 0.11
D006470 Hemorrhage NIH 0.11
D010003 Osteoarthritis, NIH 0.10
D002318 Cardiovascular Diseases NIH 0.08
D051436 Renal Insufficiency, Chronic NIH 0.08
D007674 Kidney Diseases NIH 0.06
D029424 Pulmonary Disease, Chronic Obstructive NIH 0.06
D008173 Lung Diseases, Obstructive NIH 0.06
D020141 Hemostatic Disorders NIH 0.06
D001778 Blood Coagulation Disorders NIH 0.06
D013315 Stress, Psychological NIH 0.04
D004194 Disease NIH 0.03
D013577 Syndrome NIH 0.02
D003141 Communicable Diseases NIH 0.02
D018352 Coronavirus Infections NIH 0.02
D007239 Infection NIH 0.01
D045169 Severe Acute Respiratory Syndrome NIH 0.01

Correlated HPO Terms (12)


Name (Synonyms) Correlation
HP:0000822 Hypertension HPO 0.85
HP:0002092 Pulmonary arterial hypertension HPO 0.37
HP:0002905 Hyperphosphatemia HPO 0.21
Name (Synonyms) Correlation
HP:0002900 Hypokalemia HPO 0.21
HP:0000846 Adrenal insufficiency HPO 0.21
HP:0000132 Menorrhagia HPO 0.21
HP:0000859 Hyperaldosteronism HPO 0.21
HP:0007018 Attention deficit hyperactivity disorder HPO 0.11
HP:0012622 Chronic kidney disease HPO 0.09
HP:0001626 Abnormality of the cardiovascular system HPO 0.08
HP:0000077 Abnormality of the kidney HPO 0.07
HP:0001928 Abnormality of coagulation HPO 0.06

Clinical Trials

Navigate: Correlations   HPO

There are 22 clinical trials


1 A Non-randomized Two Part Multi-Center, Open-label, Single Dose Trial With an Escalation Part in Untreated Pulmonary Arterial Hypertension (PAH) and Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Patients (Part A), Followed by a Parallel Group Part in Untreated and Pre-treated Patients With PAH and CTEPH (Part B) to Investigate the Safety, Tolerability and Pharmacodynamics of Inhaled BAY1237592

In this trial the effects of the inhaled drug BAY1237592 will be studied in patients with high blood pressure affecting the blood vessels in the lungs due to Pulmonary Arterial Hypertension (PAH) and due to Chronic Thromboembolic Pulmonary Hypertension (CTEPH). Pulmonary hypertension is characterized by the elevation of pressure in the pulmonary arteries (PAP) and of the pulmonary vascular resistance (PVR) leading to increased workload of the right chamber of the heart to eject blood against this elevated resistance. The goal of this study is to measure the safety and tolerability of the drug as well as the reduction of the PVR at different doses In Part A patients without specific treatment for PH (untreated patients) will be tested. In Part B patients stably pretreated with specific PH drugs will be studied in combination with the new inhaled drug

NCT03754660
Conditions
  1. Hypertension, Pulmonary
Interventions
  1. Drug: BAY1237592
  2. Drug: PH-monotherapy
  3. Drug: PH-combination therapy
  4. Procedure: NO gas
MeSH:Hypertension, Pulmonary Hypertension
HPO:Hypertension Pulmonary arterial hypertension

Primary Outcomes

Description: PVR = 80* (PAP - PCWP) / CO (dyn·sec·cm-5) PAP = pulmonary arterial pressure PCWP = pulmonary capillary wedge pressure CO = cardiac output

Measure: Peak percent reduction in PVR (Pulmonary vascular resistance) from "baseline 2" for untreated patients

Time: Up to 5 hours post inhalation of BAY1237592 compared to "baseline 2"

Description: PVR = 80* (PAP - PCWP) / CO (dyn·sec·cm-5)

Measure: Peak percent reduction in PVR from "baseline" for pre-treated patients

Time: Up to 5 hours post inhalation of BAY1237592 compared to "baseline"

Secondary Outcomes

Measure: Incidence of treatment-emergent adverse events (TEAEs)

Time: Up to 30 days after treatment
2 Controlling Hypertension Through Education and Coaching in Kidney Disease

Chronic kidney disease (CKD) is a serious and growing public health problem. The purpose of this study is to find out if an educational worksheet, called the Encounter Decision Intervention (EDI), combined with health coaching helps CKD patients improve their blood pressure and other health outcomes. The research team hypothesizes that the intervention group will have greater improvement in CKD outcomes than the control group.

NCT04087798
Conditions
  1. Chronic Kidney Diseases
  2. Chronic Disease
  3. Chronic Kidney Disease, Stage 3 (Moderate)
  4. Chronic Kidney Disease, Stage 4 (Severe)
  5. Chronic Kidney Disease Stage 5
Interventions
  1. Behavioral: Control-EDI
  2. Behavioral: Intervention-EDI and health coaching
MeSH:Kidney Diseases Renal Insufficiency, Chronic Hypertension Chronic Disease
HPO:Abnormality of the kidney Chronic kidney disease Hypertension Nephropathy

Primary Outcomes

Description: Changes in systolic blood pressure between baseline and 12 months will be compared between the intervention group and control group.

Measure: Change in Systolic Blood Pressure between baseline and 12 months

Time: Baseline, 12 months

Secondary Outcomes

Description: Changes in diastolic blood pressure between baseline and 12 months will be compared between the intervention group and control group.

Measure: Change in Diastolic Blood Pressure between baseline and 12 months

Time: Baseline, 12 months

Description: BP will be collected at 4 time points - baseline, 1, 6, 12 months. This will be compared between the intervention group and control group.

Measure: Slope of systolic BP between baseline and 12 months using all available BP values

Time: Baseline up to 12 months

Description: BP will be collected at 4 time points - baseline, 1, 6, 12 months. This will be compared between the intervention group and control group.

Measure: Slope of diastolic BP between baseline and 12 months using all available BP values

Time: Baseline up to 12 months

Description: This is a 28-item questionnaire measuring objective CKD disease knowledge and includes questions about goals, cardiovascular risk, and anti-hypertensive medications. Patients will answer the questions with a yes or no answer and their score will be based on how many responses were correct. This number will be converted to a percentage.

Measure: CKD knowledge measured by the Kidney Knowledge Survey (KiKS)

Time: Baseline up to 12 months

Description: This is a 13-item measure with the answers on a Likert scale of 1 (not at all sure) to 4 (extremely sure). The higher the score the higher the self-efficacy, with a range from 13-52.

Measure: Medication Adherence Self-Efficacy Scale-Revised (MASES-R)

Time: Baseline up to 12 months

Description: This scale is to quantify adherence to pharmacological treatments by means of 8 items. Patients will answer yes or no to these items, where a no response = 1 point and a yes response = 0 points. Levels of adherence are based on the following scores: 3-8 = low adherence; 1-2 = medium adherence; 0 = high adherence.

Measure: Morisky Medication Adherence Scale (MMAS - 8)

Time: Baseline up to 12 months

Description: Length of time provider spends with the patient. This will be compared between the intervention group and control group.

Measure: Visit Time with provider

Time: Enrollment visit (baseline)

Description: Length of time between patient check-in and check-out. This will be compared between the intervention group and control group.

Measure: Total time in clinic

Time: Enrollment visit (baseline)

Description: This contains a 17-item questionnaire in which the participants select scores from 1-7 or does not apply. A number of 1 = not at all and a score of 7 = considered very true, and zero = not applicable.

Measure: Patient Motivation by the Treatment Self-Regulation Questionnaire scale (TSRQ)

Time: Baseline up to 12 months

Description: This is a 15-item questionnaire that assesses the quality of physician to patient communication completed by the patients. There are 5 answers to choose from; poor, fair, good, very good, and excellent. The Score range is 1-5, where 1 means negative perception of communication and 5 means positive perception of communication.

Measure: Satisfaction with CKD care based on Communication Assessment Tool (CAT)

Time: Baseline up to 12 months

Description: This is a 21-item questionnaire that is completed by the patients, and select from the the 4 choices: very strongly agree, strongly agree, agree, and neutral/disagree. Each answer is worth one point on a Likert scale with a higher score meaning more satisfied.

Measure: Satisfaction with CKD care based on Consultation Care Measure (CCM)

Time: Baseline up to 12 months

Description: During health coach phone calls, participants will be asked 37 questions about their perceptions of the health coach program, including how much their participation in CHECK-D helped participants change various behaviors. Participant responses will be used to examine various measures of reliability and validity during the analyses of data acquired though this survey.

Measure: Perceptions of health coaching for the intervention group

Time: Baseline up to 12 months

Description: The EMR will be reviewed to evaluate the patients medication refills for adherence.

Measure: Medication adherence from the electronic medical record (EMR)

Time: Baseline up to 12 months

Description: This is an 8-item scale regarding self-efficacy where each statement is rated on the level of agreement from 1-5. 1 is disagree and 5 is agree.

Measure: Self-efficacy for disease self-management based on The Perceived Kidney/Dialysis Self-Management Scale (PKDSMS)

Time: Baseline up to 12 months

Description: This is a 5-item survey about knowledge and behaviors regarding sodium in the diet.

Measure: Self-reported Blood Pressure-Related Behaviors Survey

Time: Baseline up to 12 months

Description: Provider adoption will be measured by the percentage of enrolled patients whose providers used the EDI with them during their visit. Data will be collected by EMR query and a 1-item question in the patient survey.

Measure: Provider Adoption based on EMR query and patient survey

Time: Baseline

Description: Provider fidelity will be measured by the percentage of enrolled patients in the intervention clinics whose providers entered 1-2 patient specific goals in the EDI. This will be collected through EMR query.

Measure: Provider Fidelity measured by EMR query

Time: Baseline

Description: Provider perception of usefulness will be measured by a survey of 2-3 questions about how useful they thought it was.

Measure: Provider Perception of Usefulness by provider survey

Time: Baseline up to 12 months

Description: Change in Serum Creatinine between baseline and 12-months

Measure: Change in serum creatinine

Time: Baseline, 12 months

Measure: Change in urine protein-creatinine ratio

Time: Baseline, 12 months

Measure: Change in estimated glomerular filtration rate (eGFR)

Time: Baseline, 12 months
3 Prognostic Characteristics Difference Between the Hypertension Patients With and Without ACEI Treatment When Suffered With 2019-nCoV Infection in China

There are currently no clinical studies reporting clinical characteristics difference between the hypertension patients with and without ACEI treatment when suffered with novel coronavirus infection in China.

NCT04272710
Conditions
  1. 2019-nCoV
MeSH:Hypertension
HPO:Hypertension

Primary Outcomes

Description: The percentage of patients admitted to the ICU at any time during the 28 days of onset COVID-19.

Measure: Occupancy rate in the intensive care unit (ICU)

Time: up to 28 days

Description: The number of patients requiring mechanical ventilation.

Measure: Mechanical Ventilation

Time: up to 28 days

Description: The number of patients who died of 2019-nCoV infection.

Measure: Death

Time: up to 28 days

Secondary Outcomes

Description: The number of died 2019-nCoV infected patients from any cause.

Measure: All cause mortality

Time: up to 28 days

Description: Time from onset of symptoms to admitted to the ICU, requiring mechanical ventilation, and death.

Measure: Time from onset of symptoms to main outcome and its components

Time: up to 28 days

Description: Time to Clinical Recovery

Measure: Time to Clinical Recovery

Time: up to 28 days
4 Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs

The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.

NCT04278404
Conditions
  1. Coronavirus Infection (COVID-19)
  2. Pulmonary Arterial Hypertension
  3. Urinary Tract Infections in Children
  4. Hypertension
  5. Pain
  6. Hyperphosphatemia
  7. Primary Hyperaldosteronism
  8. Edema
  9. Hypokalemia
  10. Heart Failure
  11. Hemophilia
  12. Menorrhagia
  13. In
  14. Insomnia
  15. Pneumonia
  16. Skin Infection
  17. Arrythmia
  18. Asthma in Children
  19. Bronchopulmonary Dysplasia
  20. Adrenal Insufficiency
  21. Fibrinolysis; Hemorrhage
  22. Attention Deficit Hyperactivity Disorder
  23. Multisystem Inflammatory Syndrome in Children (MIS-C)
  24. Kawasaki Disease
  25. Coagulation Disorder
  26. Down Syndrome
Interventions
  1. Drug: The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care:
MeSH:Infection Communicable Diseases Urinary Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome Bronchopulmonary Dysplasia Down Syndrome Menorrhagia Hypertension Hemostatic Disorders Mucocutaneous Lymph Node Syndrome Blood Coagulation Disorders Hyperphosphatemia Hypokalemia Adrenal Insufficiency Hyperaldosteronism Disease Syndrome Hemorrhage Attention Deficit Disorder with Hyperactivity
HPO:Abnormality of coagulation Abnormality of the coagulation cascade Adrenal insufficiency Attention deficit hyperactivity disorder Hyperaldosteronism Hyperphosphatemia Hypertension Hypokalemia Menorrhagia Primary hyperaldosteronism

Primary Outcomes

Measure: Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

Measure: Volume of distribution (V) or apparent oral volume of distribution (V/F) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

Measure: Elimination rate constant (ke) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

Measure: Half-life (t1/2) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

Measure: Absorption rate constant (ka) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

Measure: AUC (area under the curve) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

Measure: Maximum concentration (Cmax) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

Measure: Time to achieve maximum concentration (Tmax) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.
5 Hypertension in Patients Hospitalized With COVID-19 in Wuhan, China: A Single-center Retrospective Observational Study

Some studies have shown that the main pathogenesis of patients with covid19 is related to ACE2 receptor. Lung is one of the main organs, and there are many ACE2 receptors in cardiovascular system. ACEI / ARB is the main target of antihypertensive drugs. Previous reports suggested that there were large number of patients with covid19 also suffered from hypertension, suggesting that patients with hypertension may be the susceptible to covid19. Therefore, we try to follow up the patients admitted to Hankou hospital to explore the impact of hypertension and hypertension treatment on the severity and prognosis of patients with covid19, so as to provide new methods for the treatment of patients with covid19 in the future.

NCT04318301
Conditions
  1. COVID-19
  2. Hypertension
MeSH:Hypertension
HPO:Hypertension

Primary Outcomes

Description: mortality in 28-day

Measure: Rate of Death

Time: From date of admission until the date of death from any cause, up to 60 days

Secondary Outcomes

Description: evaluate the severity of pneumonia according to CT scans and clinical manifestation

Measure: the severity of pneumonia

Time: From date of admission until the date of discharge or death from any cause, up to 60 days

Other Outcomes

Description: days from admission to discharge or death

Measure: the length of hospital stay

Time: From date of admission until the date of discharge or death from any cause, up to 60 days
6 The CORONAvirus Disease 2019 Angiotensin Converting Enzyme Inhibitor/Angiotensin Receptor Blocker InvestigatiON (CORONACION) Randomized Clinical Trial

Coronavirus disease 2019 (COVID-19) is a pandemic infection caused by a virus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Because SARS-CoV-2 is known to require the angiotensin-converting enzyme 2 (ACE-2) receptor for uptake into the human body, there have been questions about whether medications that upregulate ACE-2 receptors might increase the risk of infection and subsequent complications. One such group of medications are anti-hypertensives that block the renin-angiotensin system, including both angiotensin converting enzyme inhibitors (ACEi) and angiotensin II receptor blockers (ARB). Both ACEi and ARB are widely used for the treatment of hypertension. Early reports from China and Italy suggest that many of those who die from COVID-19 have a coexisting history of hypertension. Consequently, there have been questions raised as to whether these 2 types of blood pressure medication might increase the risk of death among patients with COVID-19. However, it is well known that the prevalence of hypertension increases linearly with age. Therefore, it is possible that the high prevalence of hypertension and ACEi/ARB use among persons who die from COVID-19 is simply confounded by age (older people are at risk of both a history of hypertension and dying from COVID-19). Whether these commonly prescribed blood pressure medications increase the risk of COVID-19 or not remains unanswered. Statements from professional cardiology societies on both sides of the Atlantic have called for urgent research into this question. Our study aims to randomize patients with primary (essential) hypertension who are already taking ACEi/ARB to either switch to an alternative BP medication or continue with the ACEi/ARB that they have already been prescribed. Adults with compelling indications for ACEi/ARB will not be enrolled.

NCT04330300
Conditions
  1. Hypertension
  2. COVID-19
Interventions
  1. Drug: Thiazide or Thiazide-like diuretics
  2. Drug: Calcium Channel Blockers
  3. Drug: ACE inhibitor
  4. Drug: Angiotensin receptor blocker
MeSH:Coronavirus Infections Hypertension
HPO:Hypertension

Primary Outcomes

Description: Time from randomization to the first occurrence of any of the clinical events above

Measure: Number of Covid-19 positive participants who die, require intubation in ICU, or require hospitalization for non-invasive ventilation (NIV)

Time: 12 months

Secondary Outcomes

Description: Time from randomization to the first occurrence of above

Measure: Number of Covid-19 positive participants who die

Time: 12 months

Description: Time from randomization to the first occurrence of above

Measure: Number of Covid-19 positive participants who require intubation in intensive care unit (ICU)

Time: 12 months

Description: Time from randomization to the first occurrence of above

Measure: Number of Covid-19 positive participants who require hospitalization for non-invasive ventilation (NIV)

Time: 12 months

Description: Time from randomization to the first occurrence of above

Measure: Number of SARS-CoV-2 positive participants

Time: 12 months

Measure: Maximum troponin T value (ng/L) among Covid-19 positive participants who require acute hospitalization

Time: 12 months

Description: Performed in a random sub-sample of the cohort (both study arms)

Measure: 24 hour mean systolic BP (mmHg) on ambulatory BP monitoring

Time: 12 months

Description: Time from randomization to the first occurrence of above

Measure: All-cause mortality

Time: 12 months
7 Phase IV Observational Study to Associate Hypertension and Hypertensinon Treatment to COVID19

Multicentric non-profit observational study, in patients with COVID-19 hospitalized in Italy, conducted through a pseudonymised survey.

NCT04331574
Conditions
  1. COVID-19
  2. Hypertension
  3. Cardiovascular Diseases
MeSH:Hypertension Cardiovascular Diseases
HPO:Abnormality of the cardiovascular system Hypertension

Primary Outcomes

Description: Using anamnestic data collected from the health record of the hospital or of the general practitioner, we will count the number of COVID-19 patients enrolled that were treated with ACE Inhibitors or ARB.

Measure: Numbers of COVID-19 patients enrolled that use ACE inhibitors and/or Angiotensin Receptor Blockers (ARB) as antihypertensive agents

Time: 3 months

Description: This study want to observe whether the assumption of antihypertensive ACE inhibitors or ARB increases the severity of the clinical manifestation of COVID19

Measure: Numbers of COVID-19 patients enrolled with no symptoms, with moderate symptoms or with severe symptoms of pneumoni based on the WHO specification for ARDS that also used ACE inhibitors and/or Angiotensin Receptor Blockers (ARB) as antihypertensive agents

Time: 3 months

Secondary Outcomes

Description: Collecting selected data from the health record and hospital charts of the patients we will assess whether among the recorded parameters there are any that can predict COVID19 prevalence and severity

Measure: Number and type of anthropometric and clinical parameters that associate with COVID19 and COVID-19 severity

Time: 3 months
8 ARB, ACEi, DRi Usage in COVID-19

It is supposed to monitor hypertensive patients who are infected or have clinical manifestations of COVID-19 for 1 month after the onset of the disease. Three groups will be considered: 1. receiving ACE inhibitors 2. receiving ARBs 3. receiving DIR.

NCT04364984
Conditions
  1. Hypertension
  2. COVID-19
Interventions
  1. Drug: Angiotensin converting enzyme inhibitor
MeSH:Hypertension
HPO:Hypertension

Primary Outcomes

Description: BP one week before COVID-19 infection and 3 weeks follow-up after COVID-19 onset

Measure: BP (hypertensive efficacy)

Time: 4 weeks

Secondary Outcomes

Description: features of disease course: number of patients and duration of fever (above 37.2C), duration of cough (days), duration of throat pain (days), headache (days), nausea or vomiting (days), diarrhea (days), myalgia or arthalgia (days), and numder of patients who need hospital and intensive care unit

Measure: COVID-19 course

Time: 3 weeks
9 Prospective Monitoring of Drug Safety and the Occurrence of Complications During Hospitalization in Patients With Cardiovascular Diseases With COVID-19

Hospitalized patients with COVID-19 will be included in the study in centers around Poland. After the hospitalization, a short questionnaire will be completed, including pre-hospitalization diagnoses, pre-hospitalization medications, clinical status on admission, the course, complication and the duration of hospitalization. The questionnaire will be available in paper form and on-line.

NCT04374110
Conditions
  1. COVID
  2. Hypertension
  3. Cardiovascular Diseases
  4. Cardiovascular Risk Factor
Interventions
  1. Other: Clinical data
MeSH:Hypertension Cardiovascular Diseases
HPO:Abnormality of the cardiovascular system Hypertension

Primary Outcomes

Description: Death, myocardial infarction, heart failure, myocarditis, acute renal failure, stroke

Measure: Adverse events

Time: through study completion, an average of 2 weeks

Secondary Outcomes

Description: Number of participants with death, myocardial infarction, heart failure, myocarditis, acute renal failure, stroke analyzed separately for each of the endpoints

Measure: Number of participants with death, myocardial infarction, heart failure, myocarditis, acute renal failure, stroke

Time: through study completion, an average of 2 weeks

Description: Ventilation during hospitalization

Measure: Ventilation during hospitalization

Time: through study completion, an average of 2 weeks

Description: Number of participants with death, myocardial infarction, heart failure, myocarditis, acute renal failure, stroke analyzed separately for each of the endpoints

Measure: Number of participants with death, myocardial infarction, heart failure, myocarditis, acute renal failure, stroke

Time: prolonged follow up, through study completion, an average of one year
10 Association Between Hypertension, Renin-Angiotensin-Aldosterone System Inhibitors and COVID-19

Background. Angiotensing converting enzyme type 2 (ACE2), a key enzyme of the renin-angiotensin-aldosterone system (RAAS), is the receptor of SARS-CoV-2 for cell entry into lungs. Because ACE2 may be modulated by RAAS inhibitors, such as angiotensin converting enzyme inhibitors (ACEi) and angiotensin II receptor blockers (ARBs), there is concern that patients treated with ACEi and ARBs may be at higher risk for COVID-19 infection and severity. Aim. To analyze the associations between COVID-19 and hypertension, and treatments with ACEi and ARBs. Methods. In this retrospective observational study, consecutive patients hospitalized for suspected COVID-19 pneumonia will be divided into 2 groups, whether or not COVID-19 is confirmed. The two groups will be compared for baseline characteristics, mainly prior treatment with ACEi and ARBs, and clinical outcome at 1-month follow-up. The main hypothesis is that ACEi and ARBs, which interact differently with ACE2, may have different relationships with COVID-19 infection or severity.

NCT04374695
Conditions
  1. COVID-19
MeSH:Hypertension
HPO:Hypertension

Primary Outcomes

Description: Prevalence of a previous treatment by angiotensin converting enzyme inhibitors in patients with and without confirmed Covid-19 pneumonia.

Measure: Prior treatment by ACEi

Time: at admission to hospital

Description: Prevalence of a previous treatment by angiotensin II type 1-receptor blockers in patients with and without confirmed Covid-19 pneumonia.

Measure: Prior treatment by ARB

Time: at admission to hospital

Secondary Outcomes

Description: Association between COVID-19 infection status and other baseline characteristics and comorbidities (age, sex, history of hypertension, chronic heart disease, diabetes mellitus, COPD, asthma, obesity, allergies)

Measure: Baseline characteristics and comorbidities

Time: at admission to hospital

Description: Association between previous treatment by ACEi and ARBs and clinical course of COVID-19 (one-month mortality, hospitalization in intensive care unit, duration of hospital stay, early discharge to home)

Measure: Major Clinical Adverse Events

Time: One month follow-up
11 COVID-19 Blood Pressure Endothelium Interaction Study

The current COVID-19 pandemic (caused by the SARS-CoV-2 virus) represents the biggest medical challenge in decades. Whilst COVID-19 mainly affects the lungs it also affects multiple organ systems, including the cardiovascular system. There are documented associations between severity of disease and risk of death and To provide all the information required by review bodies and research information systems, we ask a number of specific questions. This section invites you to give an overview using language comprehensible to lay reviewers and members of the public. Please read the guidance notes for advice on this section. 5 DRAFT Full Set of Project Data IRAS Version 5.13 advancing age, male sex and associated comorbid disease (hypertension, ischaemic heart disease, diabetes, obesity, COPD and cancer). The most common complications include cardiac dysrhythmia, cardiac injury, myocarditis, heart failure, pulmonary embolism and disseminated intravascular coagulation. It is thought that the mechanism of action of the virus involves binding to a host transmembrane enzyme (angiotensin- converting enzyme 2 (ACE2)) to enter some lung, heart and immune cells and cause further damage. While ACE2 is essential for viral invasion, it is unclear if the use of the common antihypertensive drugs ACE inhibitors or angiotensin receptor blockers (ARBs) alter prognosis. This study aims to look closely at the health of the vascular system of patients after being treated in hospital for COVID-19 (confirmed by PCR test) and compare them to patients who had a hospital admission for suspected COVID-19 (negative PCR test) . Information from this study is essential so that clinicians treating patients with high blood pressure understand the impact of the condition and these hypertension medicines in the context of the current COVID-19 pandemic. This will allow doctors to effectively treat and offer advice to patients currently prescribed these medications or who are newly diagnosed with hypertension.

NCT04409847
Conditions
  1. COVID
  2. Hypertension
Interventions
  1. Diagnostic Test: ABPM
  2. Diagnostic Test: ECG
  3. Diagnostic Test: FMD
  4. Diagnostic Test: PWV
  5. Diagnostic Test: Rarefaction
MeSH:Hypertension
HPO:Hypertension

Primary Outcomes

Description: Ambulatory Blood Pressure Monitoring systolic blood pressure

Measure: ABPM systolic blood pressure

Time: 24 hours (all day and night)

Secondary Outcomes

Description: Ambulatory Blood Pressure Monitoring diastolic blood pressure

Measure: 24-hr ABPM DBP

Time: 24 hours (all day and night)

Description: Day Ambulatory Blood Pressure Monitoring systolic blood pressure

Measure: day ABPM SBP

Time: 8am to 8pm

Description: Day Ambulatory Blood Pressure Monitoring diastolic blood pressure

Measure: day ABPM DBP

Time: 8am to 8pm

Description: Night Ambulatory Blood Pressure Monitoring systolic blood pressure

Measure: night ABPM SBP

Time: 8pm to 8am

Description: Night Ambulatory Blood Pressure Monitoring diastolic blood pressure

Measure: night ABPM DBP

Time: 8pm to 8am

Description: The fall in pressure, called the "dip", is defined as the difference between daytime mean systolic pressure and nighttime mean systolic pressure expressed as a percentage of the day value

Measure: dipping status

Time: 24 hours (all day and night)

Description: he morning surge was defined as the difference between the mean systolic blood pressure during the 2 hours after waking and arising minus the mean systolic blood pressure during the hour that included the lowest blood pressure during sleep.

Measure: morning surge

Time: 24 hours (all day and night)

Description: 24 hour Ambulatory Blood Pressure Monitoring heart rate

Measure: 24 hour ABPM HR

Time: 24hr (all day and night)

Description: Day Ambulatory Blood Pressure Monitoring heart rate

Measure: day ABPM HR

Time: 8 am to 8 pm

Description: Night Ambulatory Blood Pressure Monitoring heart rate

Measure: night ABPM HR

Time: 8pm to 8 am
12 Assessing Effectiveness of a Chronic Disease Self-management Program in Faith-based Organizations in Barbados: a Cluster Randomized Trial

In Barbados, levels of hypertension are high (40.7%) and cause of a high proportion of deaths due to cardiovascular diseases. In this study, the Stanford University-led Chronic Disease Self-Management Program (CDSMP) will be modified to form one of the basic components of a three-pronged intervention to improve blood pressure control. Our overall goal is to evaluate the effectiveness of a hypertension self-management program in community-based settings. With the advent of the Coronavirus disease 2019 (COVID-19) we recognize that it may be necessary to adapt the programme to accommodate virtual delivery. Our specific aims are to: 1. Adapt the Stanford (CDSMP) to ensure cultural appropriateness to Barbados. In view of the need to adhere to physical distance guidelines in the era of COVID-19 disease, modifications will be made to enhance virtual delivery while maintaining programme fidelity. We will engage stakeholders in performing modifications related to content, context and mode of delivery of the CDSMP program with the goal of ensuring cultural appropriateness. 2. Determine the clinical effectiveness of CDSMP combined with medication enhancement tools. We will conduct a cluster randomized trial in twelve faith-based organizations(FBOs) in Barbados. We are primarily interested in studying the changes in systolic blood pressure. Secondarily, we will also assess change in weight, medication adherence, dietary behavior and physical activity. 3. Understand the barriers and facilitators to implementation and sustainability of CDSMP plus self-monitoring tools in faith-based organizations. We will assess cost and sustainability of the intervention and qualitatively assess factors associated with barriers and facilitators of implementation in FBOs in Barbados. Impact and novelty: We aim to increase the proportion of patients with controlled hypertension leading to reduced illness and deaths from strokes and heart attacks in particular. Few studies have looked at a blended approach to CDSMP delivery and these will become more necessary in the era of COVID-19. Findings on the factors impacting implementation will be transferable to small island developing states and other predominantly black populations.

NCT04437966
Conditions
  1. Hypertension
Interventions
  1. Behavioral: Enhanced Chronic Disease Self-management program
MeSH:Hypertension Chronic Disease
HPO:Hypertension

Primary Outcomes

Description: We will measure systolic blood pressure before and 6 months after the interventions

Measure: Systolic blood pressure

Time: Six months

Secondary Outcomes

Description: We will measure participants' weight in kilograms before and six months after the intervention

Measure: Mean weight change for intervention and control groups

Time: Six months

Description: Changes in dietary behavior will be monitored by using the Dietary Approaches to Stop Hypertension Accordance Score. Score ranges from 0 to 9. A low score represents a poor diet for hypertension control. The higher the score the more appropriate for hypertension control.

Measure: Level of adherence to the Dietary Approaches to Stop Hypertension (DASH) Diet

Time: Six months

Description: Using the results of the GPAQ median physical activity in MET-minutes per week will be calculated before the intervention as well as six months post intervention

Measure: Assessing physical activity levels using the Global Physical Activity Questionnaire (GPAQ)

Time: Six months

Description: Perceived self-efficacy scores will be calculated using a tool developed by K Lorig(Stanford University School of Medicine) for measuring self-efficacy in chronic disease management programs. Score ranges from 1 to 10. A higher score is better.

Measure: Self-Efficacy for Managing Chronic Diseases 6-item Scale

Time: Six months
13 The Prevalence of Pulmonary Hypertension, With or Without Right Ventricular Loading, in Patients With COVID-19 Who Are Being Treated With a Respirator in the Intensive Care Unit.

The virus infection Covid-19 fills our hospitals and intensive care departments in a very unique way and there is a lack of essential insight into the pathophysiology of the disease. As a result, very specific treatment options are missing. The US Medicines Agency (FDA) has in the last days given a general license for treatment with inhaled nitric oxide (iNO). Inhaled NO in Sweden (and Europe) is approved for the indication of pulmonary hypertension in adults. However, no one has yet described the occurrence of pulmonary hypertension, with or without right ventricular loading, in the Covid-19 patients who become so seriously ill that they need to be treated at an IVA ward. Knowledge of this is, of course, a prerequisite for determining the need for pulmonary artery catheterization (PA catheter, Swan-Ganz catheter) and also to better understand whether iNO treatment or other forms of lung selective vasodilation therapy may be of benefit to this patient group.

NCT04459364
Conditions
  1. Hypertension, Pulmonary
  2. Right Ventricular Overload
  3. COVID
MeSH:Hypertension, Pulmonary Hypertension
HPO:Hypertension Pulmonary arterial hypertension

Primary Outcomes

Description: To determine the prevalence of pulmonary hypertension and right ventricular load in patients with COVID-19 treated in intensive care unit evaluated by routine echocardiography.

Measure: Prevalence

Time: Day 1
14 Association Between Angiotensin Converting Enzyme Inhibitor or Angiotensin Receptor Blocker Use and COVID-19 Severity and Mortality Among US Veterans

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus responsible for COVID-19, enters type II pneumocytes using angiotensin-converting enzyme 2 (ACE2). It is unclear whether ACE inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) increase, decrease, or have no significant effect on ACE2 expression or activity. Therefore, ACEI and ARB may be harmful, beneficial, or have no impact on Coronavirus Disease 2019 severity and mortality. The Specific Aims of this observational study are: (1) Among SARS-CoV-2-positive outpatients, compare all-cause hospitalization and mortality rates between: 1.1 Current users of a range of doses of ACEI/ARB- vs. non- ACEI/ARB-based regimens, and 1.2 Current users of a range of doses of ACEI- vs. ARB-based regimens, and (2) Among those hospitalized for COVID-19, compare all-cause mortality between: 2.1 Current users of a range of doses of ACEI/ARB- vs. non- ACEI/ARB-based regimens, and 2.2 Current users of a range of doses of ACEI- vs. ARB-based regimens.

NCT04467931
Conditions
  1. Hypertension
  2. COVID
Interventions
  1. Drug: ACEI/ARB
  2. Drug: Non-ACEI/ARB
  3. Drug: ACEI
  4. Drug: ARB
MeSH:Hypertension
HPO:Hypertension

Primary Outcomes

Description: For outpatient Veterans with a positive SARS-CoV-2 test (Aims 1.1 and 1.2), the primary outcome is a composite of time to all-cause hospitalization or all-cause mortality.

Measure: All-Cause-Hospitalization or All-Cause Mortality

Time: Through study completion (approximately July 31, 2020).

Description: For Veterans hospitalized with COVID-19 (Aims 2.1 and 2.2), the primary outcome is time to all-cause mortality.

Measure: All-Cause Mortality

Time: Through study completion (approximately July 31, 2020).

Secondary Outcomes

Description: For aims 1 and 2, a secondary outcome will be time to intensive care unit (ICU) admission.

Measure: ICU admission

Time: Through study completion (approximately July 31, 2020).

Description: For aims 1 and 2, a secondary outcome will be duration of hospitalization.

Measure: Duration of hospitalization

Time: Through study completion (approximately July 31, 2020).

Description: For aim 2, a secondary outcome will be time to mechanical ventilation.

Measure: Mechanical ventilation

Time: Through study completion (approximately July 31, 2020).

Description: For aim 2, a secondary outcome will be time to in-hospital dialysis.

Measure: Dialysis

Time: Through study completion (approximately July 31, 2020).

Other Outcomes

Description: Time to gastrointestinal bleed. This will be a negative control outcome.

Measure: Gastrointestinal bleed

Time: Through study completion (approximately July 31, 2020).

Description: Time to urinary tract infection. This will be a negative control outcome.

Measure: Urinary tract infection

Time: Through study completion (approximately July 31, 2020).
15 Stress Echocardiography in Patients Recovery From Mild COVID-19 Illness

With the appearance of the new SARS-COV2 virus, additional challenges are being imposed on the medical community after the resolution of acute COVID-19 illness, resulting in specific pathophysiologic mechanisms that while acutely damage the lung parenchyma might chronically impact the cardiopulmonary system. This study aims to investigate changes after mild COVID-19 illness in echocardiographic indices at rest and stress.

NCT04498299
Conditions
  1. Echocardiography, Stress
  2. COVID-19
  3. Hypertension, Pulmonary
Interventions
  1. Diagnostic Test: echocardiogram 2D
MeSH:Hypertension, Pulmonary Hypertension
HPO:Hypertension Pulmonary arterial hypertension

Primary Outcomes

Description: Left atrium volume index

Measure: • LA volume index

Time: 3 minutes

Description: Left ventricle telediastolic diameter

Measure: • LV telediastolic diameter

Time: 3 minutes

Description: Left ventricle telesystolic diameter

Measure: • LV telesystolic diameter

Time: 3 minutes

Description: Left ventricle posterior wall

Measure: • LV posterior wall

Time: 3 minutes

Description: Right atrium area

Measure: • RA area

Time: 3 minutes

Description: Right ventricle basal dimensión

Measure: • RV basal dimensión

Time: 3 minutes

Description: Right ventricle cavity dimensión

Measure: • RV mid cavity dimension;

Time: 3 minutes

Description: Right ventricle longitudinal dimension

Measure: • RV longitudinal dimension

Time: 3 minutes

Description: Distal, right ventricle outflow tract dimension at the distal or pulmonic valve level

Measure: • Distal, RV outflow tract dimension at the distal or pulmonic valve level

Time: 3 minutes

Description: Proximal right ventricle outflow tract dimension at the proximal subvalvular level

Measure: • Proximal RV outflow tract dimension at the proximal subvalvular level

Time: 3 minutes

Description: • Tricuspid annular plane systolic excursion

Measure: • TAPSE

Time: 3 minutes

Description: Right ventricle free Wall strain

Measure: • RV free Wall strain

Time: 3 minutes

Description: Inferior cava vein PW Doppler

Measure: • Inferior cava vein PW Doppler

Time: 3 minutes

Description: E wave mitral

Measure: • E wave mitral

Time: 3 minutes

Description: A wave mitral

Measure: • A wave mitral

Time: 3 minutes

Description: E wave /A wave mitral

Measure: • E wave /A wave mitral

Time: 3 minutes

Description: E-wave at mitral annulus

Measure: • E-wave at mitral annulus

Time: 3 minutes

Description: E-wave at mitral annulus / A-wave at the mitral annulus

Measure: • E-wave at mitral annulus / A-wave at the mitral annulus

Time: 3 minutes

Description: E wave/ E-wave at the mitral annulus

Measure: • E wave/ E-wave at the mitral annulus

Time: 3 minutes

Description: E tricuspid (E)

Measure: • E tricuspid (E)

Time: 3 minutes

Description: A triuspid (A)

Measure: • A tricuspid (A)

Time: 3 minutes

Description: E/A

Measure: • E/A

Time: 3 minutes

Description: Systolic pulmonary artery pressure

Measure: • Systolic pulmonary artery pressure

Time: 3 minutes

Description: E-wave at the tricuspid annulus

Measure: • E-wave at the tricuspid annulus

Time: 3 minutes

Description: Mean pulmonary artery pressure

Measure: • Mean pulmonary artery pressure

Time: 3 minutes

Description: Stroke volume

Measure: • Stroke volume

Time: 3 minutes

Description: Cardiac output

Measure: • Cardiac output

Time: 3 minutes
16 Effect of a Nutritional Support System to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III

The disease caused by SARS-CoV-2, has derived a pandemic in which its evolution and complications depend on the immune capacity of the host. The virus has been characterized by presenting an inflammatory cascade, increased by the overproduction of proinflammatory cytokines, the decrease in metalloenzymes and also the rapid spread of the virus. There are several lines of treatment, however, nutritional treatment only considered a caloric intake. For this reason, this study will evaluate the evolution of patients with COVID-19 assisted by nutritional support based on supplements such as omega 3, zinc, selenium, vitamin D, glutamine, prebiotics, and foods such as spirulina and the effect of this therapy in reducing complications and comorbidities. Research question: Will the nutritional support system reduce complications in stage III positive COVID-19 patients with comorbidities (type 2 DM, SAH, overweight / obesity with BMI <35), with a better benefit than that achieved with the conventional nutritional treatment ?. Hypothesis: The nutritional support system will reduce the complications of patients with COVID-19 in stage III with comorbidities. General Objective: To determine the effect of the use of a nutritional support system on complications in patients with COVID-19 in stage III with comorbidities. Methodology: A controlled, blinded, randomized clinical trial will be conducted in patients with COVID-19, hospitalized at the ISSEMYM Toluca Arturo Montiel Rojas Medical Center, who meet the inclusion criteria. The evolution of the group of patients receiving the nutritional support system (NSS) and the normal diet implemented by the hospital will be evaluated against the group of patients receiving only the diet, using laboratory and cabinet tests during their hospital stay. Statistical analysis: for independent groups with normal distribution, Student's T will be applied. If the distribution does not meet normality criteria, a Mann Whitney U will be performed; Two-way ANOVA will be applied to monitor the groups over time with normal distribution. If the distribution does not meet normality criteria, a Friedman test will be performed, in both cases post hoc tests will be performed. The results will be analyzed using version 8 of the Graphpad Prism software.

NCT04507867
Conditions
  1. Covid19
  2. Diabetes Mellitus
  3. Hypertension
  4. Obesity
Interventions
  1. Dietary Supplement: Nutritional support system (NSS)
  2. Other: Control
MeSH:Hypertension
HPO:Hypertension

Primary Outcomes

Description: Fraction of oxygen-saturated hemoglobin relative to the patient's total blood hemoglobin, represented as a percentage. Measurement using the pulse oximeter of the multi-parameter vital signs monitor. Measurement units % SpO2.

Measure: Oxygen saturation

Time: 1 minute

Description: Balance between the production of heat by the body and its loss. Measurement using an infrared thermometer. Units of measure degrees centigrade.

Measure: Body temperature

Time: 30 seconds

Description: Force exerted by the blood against the walls of the vessels (arteries) as it is pumped by the heart. Measurement using the multi-parameter vital signs monitor. Units of measurement in mmHg. Obtain systolic and diastolic pressure.

Measure: Blood pressure

Time: 2 minutes

Description: Number of times the heart beats for a certain period of time, measured by the multi-parameter vital signs monitor. Units of measure beats per minute.

Measure: Heart rate

Time: 1 minute

Description: Number of breaths that a living being takes during a certain period of time, Count daily with the patient at rest the number of breaths for one minute each time the chest rises. Measured in breaths per minute.

Measure: Breathing frequency

Time: 1 minute

Description: Disruption of the organic functions of any living being. The existence of the death certificate will be reviewed daily. Categories: dead or alive.

Measure: Death

Time: 10 seconds

Description: Simultaneous knowledge, in the unity of time, of oneself (subject) and of the surrounding world (object), is the reflection of reality. It will be evaluated daily with the glasgow scale. Categories: 1.13-15 points. 2. 9-12 points. 3. 3-8 points.

Measure: Awareness

Time: 2 minutes

Description: Number of days that the patient remains hospitalized. It is reviewed daily if the patient has been discharged. Categories: 1.Hopitalized. 2. Released.

Measure: Hospital stay

Time: 10 seconds

Description: Rapid sequential evaluation of organic failures. Evaluate daily the qSOFA items and get your score. Measure in points.

Measure: qSOFA score

Time: 1 minute

Description: Clinically and study-based acquired need to open the airway in order to supply him with oxygen. Check daily if a cannula or tube was placed in the windpipe. Categories: 1.Progress to ventilation. 2. Does not progress to ventilation.

Measure: Progression to ventilation

Time: 10 seconds

Description: Need for a multidisciplinary team, for presenting an acute critical state, with the support of technological resources for monitoring, diagnosis and treatment. It is reviewed daily if the patient is directed to ICU. Categories: 1.Enter ICU. 2. You do not enter ICU.

Measure: Progression to Intensive Care Unit

Time: 10 seconds

Description: Any localized painful discomfort in the head. Evaluate and ask for pain by numbering it from 1-10, where 0 is the absence and 10 is the greatest intensity (Daily, 2 shifts, 21 days).

Measure: Cephalea

Time: 10 seconds

Description: Physical actions that you can take without pain or discomfort. Evaluate what movements and activities he tolerates (Daily, 2 shifts, 21 days). Categories: 1.Walk. 2.He can stand 3.Sit. 4.Postrate.

Measure: Activity level

Time: 10 seconds

Description: Body postures that are used to facilitate the examination of the patient, his treatment, the prevention of injuries due to immobility, and his comfort when he is bedridden. Observe the anatomical position in which he is found (Daily, 2 shifts, 21 days). Categories: 1. In the prone position. 2.In the supine position. 3.Fowler. 4.Semifowler. 5.Other

Measure: Anatomic position

Time: 10 seconds

Description: Evaluate the level of hydration of the hair (Daily, morning, 21 days). Categories: 1.Hydrated, shiny. 2.Opaque. 3.Very dull and dry.

Measure: Hair hydration

Time: 19 seconds

Description: Evaluate hair loss with the "pull sign" by pulling the hair without the intention of plucking, daily in the morning (Daily, morning, 21 days).Categories 1. <5 hairs on hand. 2. 5-10 hairs. 3.> 10 hairs.

Measure: Hair loss

Time: 20 seconds

Description: Targeted search for one or more asymptomatic sudden onset decalvary patches throughout the hair territory (Daily, morning, 21 days). Categories: 1. Without decalvary plates. 2. With regional decalvary plates. 3. Generalized alopecia areata.

Measure: Decalvary patches

Time: 10 seconds

Description: Inspect the scalp for lesions (Daily, morning, 21 days). Categories: 1.No injuries. 2. Flaking. 3.Erythema. 4.Infection. 5. Bleeding.

Measure: Scalp lesions

Time: 15 seconds

Description: Ask about itching of the scalp (Daily, morning, 21 days). Categories: 1.Without itching. 2.Itching.

Measure: Itching scalp

Time: 10 seconds

Description: Evaluate the absence or loss of eyelashes, daily in the morning. Categories: 1.Without alterations. 2.White spaces. 3. Fall when exploring.

Measure: Loss of eyelashes

Time: 15 seconds

Description: Evaluate the absence or drooping of eyebrows (Daily, morning, 21 days). Categories: 1. Without alterations. 2.White spaces. 3. Fall when exploring.

Measure: Drooping of eyebrows

Time: 10 seconds

Description: Evaluate eyelid edema (Daily, morning, 21 days). Categories: 1. Without edema. 2. With edema

Measure: Eyelid edema

Time: 5 seconds

Description: Check the vascularity of the sclera (Daily, morning, 21 days). Categories: 1.White sclera. 2.Small blood vessels. 3. Large blood vessels. 4.Hemorrhage.

Measure: Vascularity of the sclera

Time: 10 seconds

Description: Assess ocular hydration (Daily, morning, 21 days). Categories: 1.Hydrated. 2.Dry mucus. 3.Absence of tears. 4 sunken eyes

Measure: Ocular hydration

Time: 15 seconds

Description: Evaluate sclera color, daily in the morning. Categories: 1.White. 2. Localized yellow. 3.General yellow. 4.Other colors.

Measure: Sclera color

Time: 10 seconds

Description: Evaluation of smell, presenting non-irritating odors and ask if it distinguishes them (Daily, morning, 21 days). Categories: 1.Normal. 2. Hyposmia. 3.Anosmia.

Measure: Sense of smell

Time: 30 seconds

Description: Evaluate the presence of irritation in the nostrils (Daily, morning, 21 days). Categories: 1.No irritation. 2.With irritation.

Measure: Irritation in the nostrils

Time: 10 seconds

Description: Assess nasal secretions (Daily, morning, 21 days). Categories: 1. Absence. 2.Transparent. 3.Of other colors. 4.With blood.

Measure: Nasal secretions

Time: 10 seconds

Description: Evaluate the presence of cheilitis (Daily, morning, 21 days). Categories: 1.Without cheilitis. 2.Unilateral. 3.Bilateral. 4.With ulcers.

Measure: Cheilitis

Time: 5 seconds

Description: Assess taste buds (Daily, morning, 21 days). Categories: 1. Normal. 2. Inflamed. 3. Painful. 4. Bleeding.

Measure: Taste buds

Time: 10 seconds

Description: Evaluate the presence of the saw edge of the tongue (Daily, morning, 21 days). Categories 1.Normal. 2.Flat 3.With serrated edge.

Measure: Saw edge of the tongue

Time: 10 seconds

Description: Look for changes in the body of the tongue (Daily, morning, 21 days). Categories: 1.No alterations. 2.Geographic. 3.Fissured.

Measure: Changes in the body of the tongue

Time: 10 seconds

Description: Look for changes in the thickness of the tongue (Daily, morning, 21 days). Categories: 1. Normal thickness. 2. Abnormal thickness, swollen.

Measure: Thickness of the tongue

Time: 5 seconds

Description: Assess the presence of salivation (Daily, morning, 21 days). Categories: 1.Normal. 2.Excessive salivation. 3 absent.

Measure: Salivation

Time: 10 seconds

Description: Evaluate the taste presenting food from their tray and ask if you distinguish the flavors (Daily, morning, 21 days). Categories: 1.Conserved. 2. Hypogeusia. 3.Ageusia.

Measure: Taste

Time: 30 seconds

Description: Evaluation of the gums (Daily, morning, 21 days). Categories: 1.Normal. 2.Hypersensitive 3.Inflamed. 4. Bleeding.

Measure: Gums

Time: 10 seconds

Description: Evaluation of skin sensitivity (Daily, morning, 21 days). Categories: 1.Normal. 3.Altered sensitivity. 3.Painful.

Measure: Skin sensitivity

Time: 30 seconds

Description: Assess the presence of lesions (Daily, morning, 21 days). Categories: 1. No lesions. 2.Dermatitis. 3. Open lesions.

Measure: Skin lesions

Time: 10 seconds

Description: Assess skin hydration (Daily, morning, 21 days). Categories: 1.Normal. 2.Fat. 3.Dry.

Measure: Skin hydration

Time: 10 seconds

Description: Evaluate skin texture (Daily, morning, 21 days). Categories: 1.Lisa. 2.Rugose. 3.Descamative

Measure: Skin texture

Time: 10 seconds

Description: Check for loss or absence of body hair (Daily, morning, 21 days). Categories: 1.Present. 2.Fall. 3.Absence.

Measure: Absence of body hair

Time: 10 seconds

Description: Evaluate by finger pressure the 7th cervical hypersensitivity (Every 2 days, morning, 21 days). Categories: 1. It does not cause pain. 2. It causes pain.

Measure: Cervical pain points

Time: 5 seconds

Description: Search for hypersensitivity on the inside of the forearm (Every 2 days, morning, 21 days)

Measure: Forearm pain points

Time: 5 seconds

Description: Ask if he presents odynophagia (Daily, 2 shifts, 21 days). Categories: 1.Absent. 2. Present.

Measure: Odynophagia

Time: 5 seconds

Description: Evaluation of the presence of cough (Daily, 2 shifts, 21 days). Categories: 1.Absent. 2.Productive. 3.Dry

Measure: Cough

Time: 5 seconds.

Description: Evaluation of the presence of sneezing (Daily, 2 shifts, 21 days). Categories: 1. Absent. 2. Present.

Measure: Sneezing

Time: 5 seconds

Description: Respiration rhythm evaluation (Daily, 2 shifts, 21 days). Categories: 1. Normal. 2.Altered.

Measure: Respiration rhythm

Time: 1 minute

Description: Assessment of abdominal breathing (Daily, 2 shifts, 21 days). Categories: 1.Absent. 2. Present.

Measure: Abdominal breathing

Time: 20 seconds

Description: Evaluation of the use of accessory muscles when breathing (Daily, 2 shifts, 21 days). Categories: 1.Absent. 2. Present.

Measure: Use of accessory muscles when breathing

Time: 10 seconds

Description: Evaluate the presence of xiphoid retraction when breathing (Daily, 2 shifts, 21 days). Categories: 1. Absent. 2. Present.

Measure: Xiphoid retraction when breathing

Time: 10 seconds

Description: Assess the presence and degree of dyspnea (Daily, 2 shifts, 21 days). Categories: 1.Without difficulty. 2.When standing. 3.When sitting. 2.When speaking, 3.Lying down.

Measure: Dyspnea

Time: 10 seconds

Description: Evaluate the abdomino-cutaneous reflexes (Diary, verpertino, 21 days). Categories: 1. Present. 2. Absent

Measure: Abdomino-cutaneous reflexes

Time: 20 seconds

Description: Assess rebound sensitivity (Daily, verpertino, 21 days). Categories: 1. Without sensitivity. 2. With sensitivity.

Measure: Rebound sensitivity

Time: 15 seconds

Description: Evaluate the presence of pain in the right hypochondrium. (Daily, evening, 21 days) Categories: 1. No pain. 2. With pain.

Measure: Right hypochondrium

Time: 5 seconds

Description: Evaluate the presence of pain in the epigastrium. (Daily, evening, 21 days) Categories: 1. No pain. 2. With pain.

Measure: Epigastrium

Time: 5 seconds

Description: Evaluate the presence of pain in the left hypochondrium. (Daily, evening, 21 days) Categories: 1. No pain. 2. With pain.

Measure: Left hypochondrium

Time: 5 seconds

Description: Assess the presence of pain in the right flank. (Daily, evening, 21 days) Categories: 1. No pain. 2. With pain.

Measure: Right flank

Time: 5 seconds

Description: Assess the presence of pain in the mesogastrium (Daily, evening, 21 days) Categories: 1. No pain. 2. With pain.

Measure: Mesogastrium

Time: 5 seconds

Description: Evaluate the presence of pain in the left flank. (Daily, evening, 21 days) Categories: 1. No pain. 2. With pain.

Measure: Left flank

Time: 5 seconds

Description: Evaluate the presence of pain in the right iliac fossa. (Daily, evening, 21 days) Categories: 1. No pain. 2. With pain.

Measure: Right iliac fossa.

Time: 5 seconds

Description: Evaluate the presence of pain in the hypogastrium. (Daily, evening, 21 days) Categories: 1. No pain. 2. With pain.

Measure: Hypogastrium

Time: 5 seconds

Description: Assess the presence of pain in the left iliac fossa. (Daily, evening, 21 days) Categories: 1. No pain. 2. With pain.

Measure: Left iliac fossa.

Time: 5 seconds

Description: Ask for the presence of vomiting in 24 hours (Daily, evening, 21 days). Categories: 1. Absent. 2. Present.

Measure: Vomiting

Time: 5 seconds

Description: Ask about the presence of appetite (Daily, evening, 21 days). Categories: 1. Increased appetite. 2.Normal 3.Hypoexia. 4.Anorexia.

Measure: Appetite

Time: 5 seconds

Description: Ask about the presence of reflux (Daily, evening 21 days). Categories: 1. Absent. 2. After eating (specify food). 3. At bedtime. 4. Sudden

Measure: Reflux

Time: 5 seconds

Description: Ask about the presence of more common burps than normal (Daily, evening, 21 days). Categories: 1.Normales 2. Augmented.

Measure: Burps

Time: 5 seconds

Description: Evaluation of defecation by means of bowel movements with the Bristol scale (Daily, evening, 21 days). Categories: 1.Normal (T3, T4) 2.Constipation (T1, T2). 3. Diarrhea (T5, T6, T7).

Measure: Bristol scale

Time: 10 seconds

Description: Evaluation of hair loss on legs (Every 2 days, evening, 21 days) Categories: 1. Without alterations. 2.White spaces. 3. Fall when exploring.

Measure: Hair loss on legs

Time: 10 seconds

Description: Evaluation of the sensitivity of the tibial tract (Every 2 days, evening, 21 days) Categories: 1. No pain. 2.Painful.

Measure: Sensitivity of the tibial tract

Time: 10 seconds

Description: Assessment of nail strength (Every 2 days, evening, 21 days). Categories: 1. Strong. 2. Brittle. 3.Not assessable.

Measure: Nail strength

Time: 10 seconds

Description: Check the presence of fungus in the nails of the hands (Every 2 days, evening, 21 days). Categories: 1. Absent. 2. Present. 3.Not assessable.

Measure: Fungus in the nails of the hands

Time: 10 seconds

Description: Look for the presence of white stripes on the nails (Every 2 days, evening, 21 days). Categories: 1. Absent. 2. Present. 3.Not assessable.

Measure: White stripes on the nails

Time: 5 seconds

Description: Look for the presence of white spots on the nails (Every 2 days, evening, 21 days). Categories: 1. Absent. 2. Present. 3.Not assessable.

Measure: White spots on the nails

Time: 5 seconds

Description: Look for the presence of ridges on the nails (Every 2 days, evening, 21 days). Categories: 1.Lisas. 2.With ridges. 3.Not assessable.

Measure: Ridges on the nails

Time: 5 seconds

Description: Taking the height (at the beginning of the protocol). Measure in cm.

Measure: Height

Time: 1 minute

Description: Weight taking (Every 2 days, 2 hours after breakfast, for 21 days). Measured in kg.

Measure: Weight

Time: 1 minute

Description: Calculation of BMI (Every 2 days, morning, for 21 days). Measured in kg / m2.

Measure: BMI

Time: 30 seconds

Description: Measurement by blood sample of erythrocytes (Every 3 days, for 21 days). Measured at 10 ^ 6 / uL.

Measure: Erythrocytes

Time: 20 seconds

Description: Measurement by blood sample of hemoglobin (Every 3 days, for 21 days). Measured in g / dL.

Measure: Hemoglobin

Time: 20 seconds

Description: Measurement by blood sample of hematocrit (Every 3 days, for 21 days). Measurement in %.

Measure: Hematocrit

Time: 20 seconds

Description: Measurement by blood sample of mean corpuscular volume (MCV) (Every 3 days, for 21 days). Measured in fL.

Measure: Mean corpuscular volume

Time: 20 seconds

Description: Measurement by blood sample of mean hemoglobin concentration (Every 3 days, for 21 days). Measurement in pg.

Measure: Mean hemoglobin concentration

Time: 20 seconds

Description: Measurement every 3 days by blood sample of mean corpuscular hemoglobin concentration (Every 3 days, for 21 days). Measured in g / dL

Measure: Mean corpuscular hemoglobin concentration

Time: 20 seconds

Description: Erythrocyte distribution width measurement by blood sample (Every 3 days, for 21 days). Measured in%.

Measure: Erythrocyte distribution width

Time: 20 seconds

Description: Measurement by blood sample of the hemoglobin distribution index (Every 3 days, for 21 days). Measured in g / dL.

Measure: Hemoglobin distribution index

Time: 20 seconds

Description: Measurement by blood sample of leukocytes (Every 3 days, for 21 days). Measured in 10 ^ 3 / μL

Measure: Leukocytes

Time: 20 seconds

Description: Measurement by blood sample of neutrophils (%) (Every 3 days, for 21 days). Measurement in%

Measure: Neutrophils (%)

Time: 20 seconds

Description: Measurement by blood sample of neutrophils (#) (Every 3 days, for 21 days). Measured in 10 ^ 3 / μL

Measure: Neutrophils (#)

Time: 20 seconds

Description: Measurement by blood sample of lymphocytes (%) (Every 3 days, for 21 days). Measurement in%

Measure: Lymphocytes (%)

Time: 20 seconds

Description: Measurement by blood sample of lymphocytes (#) (Every 3 days, for 21 days). Measured in 10 ^ 3 / μL

Measure: Lymphocytes (#)

Time: 20 seconds

Description: Measurement by blood sample of monocytes (%) (Every 3 days, for 21 days). Measurement in%

Measure: Monocytes (%)

Time: 20 seconds

Description: Measurement by blood sample of monocytes (#) (Every 3 days, for 21 days). Measured in 10 ^ 3 / μL

Measure: Monocytes (#)

Time: 20 seconds

Description: Measurement by blood sample of eosinophils (%) (Every 3 days, for 21 days). Measurement in%

Measure: Eosinophils (%)

Time: 20 seconds

Description: Measurement by blood sample of eosinophils (#) (Every 3 days, for 21 days). Measured in 10 ^ 3 / μL

Measure: Eosinophils (#)

Time: 20 seconds

Description: Measurement by blood sample of basophils (%) (Every 3 days, for 21 days). Measurement in%

Measure: Basophils (%)

Time: 20 seconds

Description: Measurement by blood sample of basophils (#) (Every 3 days, for 21 days). Measured in 10 ^ 3 / μL

Measure: Basophils (#)

Time: 20 seconds

Description: Measurement of prothrombin time (PT) by blood sample (Every 3 days, for 21 days). Measure in seconds

Measure: Prothrombin time

Time: 20 seconds

Description: Measurement by blood sample of INR (Every 3 days, for 21 days). Measure in units

Measure: INR

Time: 20 seconds

Description: Measurement by control blood sample (100-50) (Every 3 days, for 21 days). Measure in seconds

Measure: Control blood sample (100-50) 1

Time: 20 seconds

Description: Measurement by blood sample of partial thromboplastin time (Every 3 days, for 21 days). Measure in seconds

Measure: Partial thromboplastin time

Time: 20 seconds

Description: Measurement by control blood sample (100-50) (Every 3 days, for 21 days). Measure in seconds

Measure: Control blood sample (100-50) 2

Time: 20 seconds

Description: Measurement by blood sample of platelets. Measured in 10 ^ 3 / μL

Measure: Platelets

Time: 20 seconds

Description: Measurement by blood sample of mean platelet volume (MPV) (Every 3 days, for 21 days). Measured in fL.

Measure: Mean platelet volume

Time: 20 seconds

Description: Initial screening test to diagnose patients with signs or symptoms suggestive of venous thromboembolism, it is a marker of endogenous fibrinolysis. Measurement by blood sample of dimer D (Every 3 days, for 21 days). Measured in ng / mL

Measure: D-dimer

Time: 20 seconds

Description: Sulfur amino acid that originates in the metabolism of methionine, and is very aggressive for the arterial endothelium. Measurement by blood sample of homocysteine levels (Every 3 days, for 21 days). Measured in µmol / l.

Measure: Homocysteine

Time: 20 seconds

Description: Fat-soluble vitamin involved in calcium homeostasis and bone metabolism, regulation of genes involved in the regulation of cell proliferation, cell differentiation and apoptosis. It has been suggested that it exerts immunomodulatory and antiproliferative effects. Measurement by blood sample of levels of 25-hydroxycholecalciferol (Every 3 days, for 21 days). Measured in nmol / L

Measure: Vitamin D

Time: 20 seconds

Description: Measurement by blood sample of calcium (Every 3 days, for 21 days). Measured in mg / dL.

Measure: Calcium

Time: 20 seconds

Description: Measurement by blood sample of phosphorus (Every 3 days, for 21 days). Measured in mg / dL.

Measure: Phosphorus

Time: 20 seconds

Description: Measurement by blood sample of magnesium (Every 3 days, for 21 days). Measured in mg / dL.

Measure: Magnesium

Time: 20 seconds

Description: Measurement by blood sample of sodium (Every 3 days, for 21 days). Measured in mmol / L.

Measure: Sodium

Time: 20 seconds

Description: Measurement by blood sample of potassium (Every 3 days, for 21 days). Measured in mmol / L.

Measure: Potassium

Time: 20 seconds

Description: Measurement by blood sample of chlorine (Every 3 days, for 21 days). Measured in mmol / L.

Measure: Chlorine

Time: 20 seconds

Description: A measure of the concentration of free glucose in the blood, serum or blood plasma. Measured in mg / dL.

Measure: Blood glucose

Time: 20 seconds

Description: Taking a blood sample of total cholesterol (Every 3 days, for 21 days). Measured in mg / dL.

Measure: Total cholesterol

Time: 20 seconds

Description: Taking a blood sample of triglycerides (Every 3 days, for 21 days). Measured in mg / dL.

Measure: Triglycerides

Time: 20 seconds

Description: Taking a blood sample of LDL cholesterol (Every 3 days, for 21 days). Measured in mg / dL.

Measure: LDL cholesterol

Time: 20 seconds

Description: Taking a blood sample for HDL cholesterol (Every 3 days, for 21 days). Measured in mg / dL.

Measure: HDL cholesterol

Time: 20 seconds

Description: Taking a blood sample to evaluate the level of aspartate aminotransferase (Every 3 days, for 21 days). Measured in U / L.

Measure: Aspartate aminotransferase

Time: 20 seconds

Description: Taking a blood sample to evaluate the level of alanine aminotransferase (Every 3 days, for 21 days). Measured in U / L.

Measure: Alanine aminotransferase

Time: 20 seconds

Description: Taking a blood sample to evaluate the total bilirubin level (Every 3 days, for 21 days). Measured in mg / dL.

Measure: Total bilirubin

Time: 20 seconds

Description: Taking a blood sample to evaluate the level of direct bilirubin (Every 3 days, for 21 days). Measured in mg / dL.

Measure: Direct bilirubin

Time: 20 seconds

Description: Taking a blood sample to evaluate the level of indirect bilirubin (Every 3 days, for 21 days). Measured in mg / dL.

Measure: Indirect bilirubin

Time: 20 seconds

Description: Taking a blood sample to evaluate the level of alkaline phosphatase (Every 3 days, for 21 days). Measured in U / L.

Measure: Alkaline phosphatase

Time: 20 seconds

Description: Taking a blood sample to evaluate the level of total proteins (Every 3 days, for 21 days). Measured in g / dL.

Measure: Total proteins

Time: 20 seconds

Description: Taking a blood sample to evaluate the albumin level (Every 3 days, for 21 days). Measured in g / dL.

Measure: Albumin level

Time: 20 seconds

Description: Taking a blood sample to evaluate the globulin level (Every 3 days, for 21 days). Measured in g / dL.

Measure: Globulin level

Time: 20 seconds

Description: Taking a blood sample to evaluate the A / G ratio (Every 3 days, for 21 days). Measured in g / dL.

Measure: A / G ratio

Time: 20 seconds

Description: ake a blood sample to evaluate the levels of urea nitrogen (Every 3 days, for 21 days). Measured in mg / dL.

Measure: Urea nitrogen

Time: 20 seconds

Description: Take a blood sample to evaluate urea levels (Every 3 days, for 21 days). Measured in mg / dL.

Measure: Urea

Time: 20 seconds

Description: Take a blood sample to evaluate creatitine levels (Every 3 days, for 21 days). Measured in mg / dL.

Measure: Creatitine

Time: 20 seconds

Description: Take a blood sample to evaluate uric acid levels (Every 3 days, for 21 days). Measured in mg / dL.

Measure: Uric acid

Time: 20 seconds

Description: Take a blood sample to evaluate ferritin levels (Every 3 days, for 21 days). Measured in ng/mL.

Measure: Ferritin

Time: 20 seconds

Description: Take a blood sample to evaluate fibrinogen levels (Every 3 days, for 21 days). Measured in mg / dL.

Measure: Fibrinogen

Time: 20 seconds

Description: Take a blood sample to evaluate the levels of C-reactive protein (Every 3 days, for 21 days). Measured in mg/L.

Measure: C-reactive protein

Time: 20 seconds

Description: Use of the appropriate procedures established in the NSS indications (Specific supplementation scheme, based on 1 sachet, intramuscular B vitamins and probiotics). Quantification of empty supplement envelopes (Daily, 2 shifts, 21 days). Categories: 1.On empty. 2. About half. 3.Full.

Measure: Adherence to the Nutritional Support System (NSS)

Time: 5 seconds

Description: Quantification of the time from when the envelope is added in water, until everything is consumed (Daily, 2 shifts, 21 days). Categories: 1. Less than 15 minutes. 2. More than 15 minutes.

Measure: Intake time

Time: 15 minutes

Description: Quantification of the amount of prepared "NSS" he drink (Daily, 2 shifts, 21 days). Categories: 1.All the preparation. 2.Half. 3.Nothing.

Measure: Amount of prepared "NSS" he drink

Time: 15 minutes

Description: In-person verification of the taking of the floratil pill and observe that they do not vomit it (Daily, 2 shifts, first 6 days). Categories: 1. The pill is taken. 2.The pill is not taken.

Measure: Taking of the "floratil" pill

Time: 20 seconds

Description: Corroborate in person the correct application of the neurobion injection (Daily, evening, first 5 days). Categories: 1. It applies. 2.Not applicable.

Measure: Neurobion injection

Time: 1 minute

Description: Unit of thermal energy, which is equal to the amount of heat needed to raise the temperature of 1 gram of water by 1 degree Celsius. Unit of measurement of the energy content of food that consists of the number of calories that a given weight of food can develop in the tissues, or in the physical work equivalent to them. Calculate the grams that the food has of each macronutrient and multiply it by the energy intake. Based on the Mexican Equivalent Food System. Number in Kcal.

Measure: Diet calories

Time: 15 minutes

Description: Evaluate the amount of trans fat in the diet. (Daily, 2 shifts, 21 days). Based on the Mexican Equivalent Food System. Number in g.

Measure: Trans fat in the diet

Time: 2 minutes

Description: Evaluate the amount of saturated fat in the diet. (Daily, 2 shifts, 21 days). Based on the Mexican Equivalent Food System. Number in g.

Measure: Saturated fat in the diet.

Time: 2 minutes

Description: Evaluate the amount of monounsaturated fats in the diet. (Daily, 2 shifts, 21 days). Based on the Mexican Equivalent Food System. Number in g.

Measure: Monounsaturated fats in the diet

Time: 2 minutes

Description: Evaluate the amount of polyunsaturated fat in the diet. (Daily, 2 shifts, 21 days). Based on the Mexican Equivalent Food System. Number in g.

Measure: Polyunsaturated fat in the diet

Time: 2 minutes

Description: Evaluate the amount of protein of animal origin in the diet. (Daily, 2 shifts, 21 days). Based on the Mexican Equivalent Food System. Number in g.

Measure: Protein of animal origin in the diet

Time: 2 minutes

Description: Evaluate the amount of plant-based protein in the diet. (Daily, 2 shifts, 21 days). Based on the Mexican Equivalent Food System. Number in g.

Measure: Plant-based protein in the diet

Time: 2 minutes

Description: Accurate record of the amount of fluids administered. Evaluate the income of 24 hrs. (Daily, 2 shifts, 21 days). Number in ml.

Measure: Fluid balance (income)

Time: 5 minutes

Description: Accurate record of the amount of liquids eliminated by any means. Evaluate the expenses of 24 hrs. (Daily, 2 shifts, 21 days). Number in ml.

Measure: Fluid balance (outcome)

Time: 5 minutes

Description: Need or desire to eat. Observe the percentage of the tray with food that was ingested (Daily, 2 shifts, 21 days). Categories: 1. 100% ingested. 2.75%. 3.50%. 4.25%.

Measure: Hungry

Time: 15 seconds

Description: Cardiovascular disease risk indicator. Measure with a tape measure with the patient standing, feet together, arms at the sides and the abdomen relaxed, encircling the abdomen at the level of the navel at the midpoint between the last rib and the iliac crest and without pressing, taking an inspiration deep, taking the measurement at the moment of expelling the air.

Measure: Abdominal circumference

Time: 1 minute

Description: It is used to know the nutritional status of the patient. It is obtained by measuring the middle part of the arm with a tape measure, taking as a reference the length between the point of the shoulder (acromion) and the head of the radius (olecranon). Take the circumference of the arm using a tape measure (every 2 days, 2 hours after breakfast, in the morning, for 21 days). Measure in mm.

Measure: Arm circumference.

Time: 3 minutes

Description: It is measured on the midline of the back of the arm (triceps) at 1 cm from the height of the midpoint of the arm. Taking triceps fold measuring tape and caliper (every 2 days, 2 hours after breakfast, morning, for 21 days)). Measure in mm.

Measure: Tricipital fold

Time: 3 minutes

Description: Calculation from arm circumference and triceps fold. Calculate it according to the formula proposed by Frisancho. (every 2 days, 2 hours after breakfast, morning, for 21 days). Measure in mm2.

Measure: Arm area

Time: 1 minute

Description: Set of peculiarities that characterize the individuals of a species, dividing them into male and female, and make possible a reproduction characterized by genetic diversification. Based on an official ID. Categories: 1. Male 2. Female

Measure: Biological sex

Time: 30 seconds

Description: Time elapsed from the birth of a living being to the moment the calculation is made. Based on an official ID. Number between 30 and 75.

Measure: Age

Time: 30 seconds

Description: Sugars attached to the surface of red blood cells, and according to their composition. Evaluate by blood sample. Categories: 1.A, 2. B, 3.AB 4.O.

Measure: AB0 system

Time: 2 minutes

Description: Protein in red blood cells or erythrocytes. Obtaining by blood sample. Categories: 1.Rh (+) 2.Rh (-).

Measure: Rh factor

Time: 2 minutes

Secondary Outcomes

Description: Record the use of proton pump inhibitors (omeprazole, pantoprazole) (daily, evening, for 21 days). Categories: 1.Not prescribed. 2.Prescribed.

Measure: Use of proton pump inhibitors

Time: 5 seconds

Description: Record the use of obesity medications (orlistat, acarbose, bile acid sequestrants, etc.) (daily, evening, for 21 days). Categories: 1.Not prescribed. 2.Prescribed.

Measure: Obesity medications

Time: 5 seconds

Description: Record the use of antiepileptic drugs (daily, evening, for 21 days). Categories: 1.Not prescribed. 2.Prescribed.

Measure: Use of antiepileptic drugs

Time: 5 seconds

Description: Record the use of oral contraceptives (daily, evening, for 21 days). Categories: 1.Not prescribed. 2.Prescribed.

Measure: Use of oral contraceptives

Time: 5 seconds

Description: Record the use of antimitotics (colchicine) (daily, evening, for 21 days). Categories: 1.Not prescribed. 2.Prescribed.

Measure: Use of antimitotics

Time: 5 seconds

Description: Chemical substance that kills or prevents the growth of certain classes of sensitive microorganisms. Record the antibiotics that are being administered. (daily, evening, for 21 days) Categories: 1.Not used. 2.Use of antibiotics (specify which)

Measure: Antibiotics

Time: 5 seconds

Description: Medicines whose main pharmacological effect is to relieve pain. Record the analgesics that are being administered (daily, evening, for 21 days). Categories: 1.Not used. 2.Use of analgesics (specify which)

Measure: Analgesics

Time: 5 seconds

Description: Drugs with anti-inflammatory and immunosuppressive effect. Record the corticosteroids that are being administered (daily, evening, for 21 days). Categories: 1.Not used. 2.Use of corticosteroids (specify which).

Measure: Corticosteroids

Time: 5 seconds

Description: Substance that causes the elimination of water and electrolytes from the body through urine. Record the diuretics that are being administered (daily, evening, for 21 days). Categories: 1.Not used. 2.Use of diuretics (specify which)

Measure: Diuretics

Time: 5 seconds

Description: Drugs used to lower blood pressure. Record the antihypertensive drugs that are being administered (daily, evening, for 21 days). Categories: 1.Not used. 2.Use of antihypertensives (specify which)

Measure: Antihypertensive

Time: 5 seconds

Description: Endogenous or exogenous substance that interferes with or inhibits blood clotting, creating an antithrombotic or prohemorrhagic state. Record the anticoagulants that are being administered (daily, evening, for 21 days). Categories: 1.Not used. 2.Use of anticoagulants (specify which)

Measure: Anticoagulants

Time: 5 seconds

Description: Medications that attend to a basic pathology and have not been considered in the previous variables. Record the medications that are being administered and have not been named before (daily, evening, for 21 days). Write the medications.

Measure: Other medications

Time: 5 seconds

Description: Disturbance of the normal state of the level of absorption acutely due to a pathological alteration. Record the acute alterations that affect the absorption of nutrients (daily, evening, for 21 days). Categories: 1.None. 2.Intolerance. 3. Allergies 4. Diarrhea 5. Infection or inflammation in any organ of the digestive system.

Measure: Acute alterations in the absorption of nutrients.

Time: 5 seconds

Description: Any alteration in the response to the action of the drug due to the concomitant reaction of another chemical substance. Side effects reported through the clinic and laboratory (daily, evening, for 21 days). Categories: 1.None. 2.Rash. 3.Head or dizziness. 4.Gastrointestinal pain. 5.Other (specify).

Measure: Drug interactions and adverse effects

Time: 5 seconds

Description: Artificial supply of oxygen (O2) in the inspired air; its main objective is tissue oxygenation. Check the quantity of liters that you have pre-written for 24 hours (daily, evening, for 21 days). Number of liters.

Measure: Oxygen therapy

Time: 5 seconds

Description: Attitude or disposition in emotional life. It is not a transitory emotional situation. It is a state, a way of staying, of being, whose duration is prolonged and fades over the rest of the psychic world. Assess the patient's state of mind (daily, evening, for 21 days). Categories: 1.Happy. 2.Relaxed. 3. Alert. 4. Annoying 5. Sad. 6.Tense. 7.Tired. 8.Depressed

Measure: Mood

Time: 5 seconds
17 Combined Cognitive and Exercise Training for Older Adults: Feasibility & Effectiveness

The overarching aim of this project is to implement and evaluate a proven cognitive training regimen in combination with a community exercise program among older adults who attend wellness exercise programs at the YMCA. To support this aim, the investigators have developed a collaboration with the YMCA of Kitchener-Waterloo, which offer exercise programs targeted to older adults. The specific objectives are: (1) to evaluate the feasibility of a combined exercise and cognitive training in a community-setting among older adults; and (2) to conduct a preliminary evaluation and comparison of changes in cognitive function, physical function, well-being and self-efficacy with 12-weeks of combined exercise and cognitive training versus exercise alone. The hypothesis for each objective are as follows: (1) It is anticipated that this program will be feasible to implement and will be well accepted by the participants and exercise providers. (2) The investigators may not have the power to find statistically significant differences between the control and experimental groups for physical and cognitive function. However, the investigators expect to observe positive changes between the pre- and post-assessments, suggesting improved cognitive function and mobility as a result of the 12-week program.

NCT04515758
Conditions
  1. Osteo Arthritis
  2. Osteoporosis
  3. Joint Replacement
  4. Fibromyalgia
  5. High Blood Pressure
  6. Stable Heart Conditions
  7. Chronic Obstructive Pulmonary Disease
  8. Diabetes
  9. Obesity
Interventions
  1. Other: Exercise and Cognitive Training
  2. Other: Exercise Training Only
MeSH:Osteoporosis Fibromyalgia Osteoarthritis Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Hypertension
HPO:Chronic pulmonary obstruction Hypertension Osteoarthritis Pulmonary obstruction

Primary Outcomes

Description: Total number of people enrolled divided by the total number of people invited to participate (multiplied by 100 to calculate a percentage)

Measure: Recruitment Rate

Time: Pre-program (baseline)

Description: Percentage of people who completed the full program and all assessments

Measure: Completion Rate

Time: Through study completion, 12 weeks

Description: Percentage of people who attended program sessions (exercise and cognitive training components)

Measure: Attendance

Time: Throughout entire intervention (12 weeks, 2 sessions/week per group)

Description: Participant and instructors rating of program components and overall program (via hand-written questionnaire). Participants and instructors must rate their level of agreement (1 = strongly disagree, 2 = disagree, 3 = no opinion, 4 = agree, 5 = strongly agree) with various statements. The higher the rating, the greater the satisfaction. They also must rate if the difficulty of the program was optimal, somewhat easy or hard, or too easy or hard. They must also specify how much money they would be willing to spend on the program. They are also given an opportunity to record optional additional comments/recommendation.

Measure: Change in Participant and Instructor Rating of experience, satisfaction, and feasibility of program

Time: Mid-point (6 weeks) and post-program (12 weeks)

Description: Financial cost of running program (equipment purchased for study - cognitive training tablet and stands - and YMCA staff pay) as reported by researcher and YMCA staff

Measure: Cost of program

Time: Post-program (12 weeks)

Description: Self-reported biological sex (at birth) using basic demographics questionnaire

Measure: Sex

Time: Pre-program (baseline)

Description: One-on-one interview with researcher, answering broad questions about their experience in the program and study

Measure: Participant and Instructor perceived program experience and satisfaction

Time: Post-program (at 12 weeks)

Description: Experience of participants and instructors will also be observed by the researcher (observational notes will be taken by the researcher during each class). No names of participants and instructors will be recorded.

Measure: Participant and Instructor observer-perceived program experience and satisfaction

Time: Throughout entire intervention (12 weeks, 2 sessions/week per group)

Description: Self-reported years of formal education and training (training years for instructors only) using basic demographics questionnaire

Measure: Education

Time: Pre-program (baseline)

Description: Self-reported previous and current occupations using basic demographics questionnaire

Measure: Occupation

Time: Pre-program (baseline)

Description: Self-reported previous and current medical conditions using basic demographics questionnaire

Measure: Medical Condition

Time: Pre-program (baseline)

Description: Self-reported previous and current medications using basic demographics questionnaire

Measure: Medications

Time: Pre-program (baseline)

Description: Using the Montreal Cognitive Assessments (brief clinical tool) to assess visual/spatial abilities, working memory, executive functioning, language, abstraction, and orientation). Will be used to describe participants' baseline cognitive status (a score out of 30 is measured).

Measure: Montreal Cognitive Assessment (global cognitive function)

Time: Pre-program (baseline)

Description: Using the International Physical Activities Questionnaire (IPAQ) to assess physical activity level based on self-reported frequency and duration of job-related, house work-related, transportation-related, and leisure-related physical activities done in the past week. METS-minutes/week will be calculated and reported (i.e. take the number of minutes doing an activity in the past week and multiply by the appropriate metabolic equivalent, which will vary based on the intensity of the physical activity).

Measure: Physical Activity Level

Time: Pre-program (baseline)

Description: Using a cognitive activity scale (score of 0-4 per activity) that requires participants to self-report how often they typically engage in a variety of mentally stimulating activities (i.e. playing card games, reading, cooking, etc.) The more frequently they engage in the activity, the higher the score.

Measure: Participant cognitive activity

Time: Pre-program (baseline)

Description: Using a scale (score of 0-3 per group) that requires participants to self-report how often they typically interact (face-to-face or virtually) with different groups of people (i.e. their spouse, family, friends, co-workers, etc.). The more frequently they interact with the group, the higher the score.

Measure: Participant social activity

Time: Pre-program (baseline)

Description: Self-reported years of age using basic demographics questionnaire

Measure: Participant and Instructor Age

Time: Pre-program (baseline)

Secondary Outcomes

Description: STROOP task which assesses the length of time (seconds) it takes for a participant to correctly name a coloured square (test 1), read the name of a colour (test 2), and say the name of the colour that a word is printed in (test 3). Number of corrected and uncorrected errors are also recorded.

Measure: Change in Stroop Task Performance

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Trails Making Test Part A and B. Part A assesses visual search (participants must connect numbered circles in ascending numerical order (1-2-3-etc). Part B assesses working memory and task-switching (participants must connect circles in ascending numerical and alphabetical order (1-A-2-B- etc.). Time to complete the tests (second) and errors (number) made during the tests are recorded.

Measure: Change in Trail Making Task Performance

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Resting (seated) heart rate (beats per minute) using an automatic blood pressure cuff

Measure: Change in Resting Heart Rate

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Resting (seated) blood pressure (millimeters of mercury) using an automatic blood pressure cuff

Measure: Change in Resting Systolic and Diastolic Blood Pressure

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Using hand dynamometer (assessing grip strength in lbs) for right and left hand (two trials per hand)

Measure: Change in Grip Strength

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Weight (using automatic scale to measure in lbs, converted to kg) and height (measured in feet and inches, converted to meters) measured and combined to provide BMI (kg/m^2)

Measure: Change in Body Mass Index (BMI)

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Divide waist circumference (cm) by hip circumference (cm) to get ratio calculation

Measure: Change in Hip-to-Waist Circumference Ratio

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Agility and functional balance will be assessed using the Timed Up-and-Go (participants stand up from a chair, walk 6 meters, turn around an object, walk back to chair, and sit down). Time to complete test is measured (seconds) and assessor's observational notes of performance are taken.

Measure: Change in Timed Up-and-Go Performance

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Agility and functional balance will be assessed using the Four Square Step Test (participants must step over lines that are set up in a cross formation, creating 4 quadrants. They must step forward, backward, and side to side in a specific pattern (i.e. from quadrant 1 to quadrant 2, to quadrant 3, to quadrant 4). Time to complete test is recorded in seconds.

Measure: Change in Four Square Step Test Performance

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Lower body strength will be assessed using the 5 Time Sit-to-Stand (participants must complete 5 sit-to-stands from a chair as fast as they can). Time to complete all 5 is recorded in seconds.

Measure: Change in Sit-to-Stand Performance

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Functional fitness will be assessed using the 6 minute walk (participants walk along indoor track for 6 minutes). The number of laps achieved in 6 minutes is recorded. Assessor's observational notes of walking performance is also recorded.

Measure: Change in 6-minute walk test Performance

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Well-being will be self-reported using the "Vitality-Plus Scale" (self-reported general health questionnaire - rating of sleep quality, appetite, general energy level, etc.). Participants rate their degree of health on a scale from 1 - 5 (the higher the rating, the better their perceived overall well-being).

Measure: Change in Overall Well-being

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Bandura Scale (named after the researcher who developed it) - self-reported rating of confidence (0 - 100%) to continue exercising routinely in various hypothetical situations (i.e. if one is sick, if the weather is poor, etc). The greater the confidence, the higher the score

Measure: Change in Exercise-related Self-Efficacy

Time: Pre-program (baseline) and post-program (12 weeks)
18 Efficacy and Safety of GMRx2 (a Single Pill Combination Containing Telmisartan/Amlodipine/Indapamide) Compared to Dual Combinations for the Treatment of Hypertension

Recent hypertension guidelines recommend combination therapy as initial treatment for many or most patients. Several trials suggest triple low-dose combination therapy may be highly effective in terms of achieving blood pressure control without increasing adverse effects. This trial is designed to investigate the efficacy and safety of GMRx2 in participants with high blood pressure compared to dual combinations.

NCT04518293
Conditions
  1. Hypertension
Interventions
  1. Drug: Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg
  2. Drug: telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
  3. Drug: Telmisartan 20 mg/amlodipine 2.5 mg .
  4. Drug: telmisartan 40 mg/amlodipine 5 mg
  5. Drug: Telmisartan 20 mg/indapamide 1.25 mg
  6. Drug: telmisartan 40 mg/indapamide 2.5 mg
  7. Drug: Amlodipine 2.5 mg/indapamide 1.25 mg
  8. Drug: amlodipine 5 mg/indapamide 2.5 mg
MeSH:Hypertension
HPO:Hypertension

Primary Outcomes

Measure: Difference in change in home SBP from baseline to week 12

Time: 12 weeks

Secondary Outcomes

Measure: Difference in change in clinic seated mean SBP from baseline to Week 12

Time: 12 weeks

Measure: Difference in change in clinic seated mean SBP from baseline to Week 6

Time: 6 weeks

Measure: Difference in change in clinic seated mean DBP from baseline to Week 12

Time: 12 weeks

Measure: Difference in change in clinic seated mean DBP from baseline to Week 6

Time: 6 weeks

Measure: Percentage of participants with clinic seated mean SBP <140 and DBP <90 mmHg at Week 12

Time: 12 weeks

Measure: Percentage of participants with clinic seated mean SBP <140 and DBP <90 mmHg at Week 6

Time: 6 weeks

Measure: Percentage of participants with clinic seated mean SBP <130 and DBP <80 mmHg at Week 12

Time: 12 weeks

Measure: Percentage of participants with clinic seated mean SBP <130 and DBP <80 mmHg at Week 6

Time: 6 weeks

Measure: Difference in change in home seated mean SBP from baseline to Week 6

Time: 6 weeks

Measure: Difference in change in home seated mean DBP from baseline to Week 12

Time: 12 weeks

Measure: Difference in change in home seated mean DBP from baseline to Week 6

Time: 6 weeks

Measure: Difference in change in trough home seated mean SBP from baseline to week 12

Time: 12 weeks

Measure: Difference in change in trough home seated mean SBP from baseline to Week 6

Time: 6 weeks

Measure: Percentage of participants with home seated mean SBP <135 and DBP <85 mmHg at Week 12

Time: 12 weeks

Measure: Percentage of participants with home seated mean SBP <135 and DBP <85 mmHg at Week 6

Time: 6 weeks

Measure: Percentage of participants with home seated mean SBP <130 and DBP <80 mmHg at Week 12

Time: 12 weeks

Measure: Percentage of participants with home seated mean SBP <130 and DBP <80 mmHg at Week 6

Time: 6 weeks

Other Outcomes

Description: Percentage of participants discontinued trial medication due to AE/SAE from baseline to week 12

Measure: Safety Outcomes

Time: 12 weeks

Description: Percentage of participants discontinued trial medication due to AE/SAE from baseline to Week 6

Measure: Safety Outcomes

Time: 6 weeks

Description: Percentage of participants with an SAE from baseline to Week 12

Measure: Safety Outcomes

Time: 12 weeks

Description: Percentage of participants with SAE from baseline to Week 6

Measure: Safety Outcomes

Time: 6 weeks

Description: Percentage of participants with symptomatic hypotension from baseline to Week 12

Measure: Safety Outcomes

Time: 12 weeks

Description: Percentage of participants with symptomatic hypotension from baseline to Week 6

Measure: Safety Outcomes

Time: 6 weeks

Description: Percentage of participants with serum sodium concentration below 135 mmol/l at Week 12

Measure: Safety Outcomes

Time: 12 weeks

Description: Percentage of participants with serum sodium concentration below 135 mmol/l at Week 6

Measure: Safety Outcomes

Time: 6 weeks

Description: Percentage of participants with serum sodium concentration above 145 mmol/l at Week 12

Measure: Safety Outcomes

Time: 12 weeks

Description: Percentage of participants with serum sodium concentration above 145 mmol/l at Week 6

Measure: Safety Outcomes

Time: 6 weeks

Description: Percentage of participants with serum potassium concentration below 3.5 mmol/l at Week 12

Measure: Safety Outcomes

Time: 12 weeks

Description: Percentage of participants with serum potassium concentration below 3.5 mmol/l at Week 6

Measure: Safety Outcomes

Time: 6 weeks

Description: Percentage of participants with serum potassium concentration above 5.5 mmol/l at Week 12

Measure: Safety Outcomes

Time: 12 weeks

Description: Percentage of participants with serum potassium concentration above 5.5 mmol/l at Week 6

Measure: Safety Outcomes

Time: 6 weeks

Description: Percentage of participants with eGFR drop of over 30% from baseline to Week 12

Measure: Safety Outcomes

Time: 12 weeks

Description: Percentage of participants with eGFR drop of over 30% from baseline to Week 6

Measure: Safety Outcomes

Time: 6 weeks
19 Efficacy and Safety of GMRx2 (a Single Pill Combination Containing Telmisartan/Amlodipine/Indapamide) Compared to Placebo for the Treatment of Hypertension

Recent hypertension guidelines recommend combination therapy as initial treatment for many or most patients. Several trials suggest triple low-dose combination therapy may be highly effective in terms of achieving blood pressure control without increasing adverse effects. This trial is designed to investigate the efficacy and safety of GMRx2 in participants with high blood pressure compared to placebo.

NCT04518306
Conditions
  1. Hypertension
Interventions
  1. Drug: Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg
  2. Drug: Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg
  3. Drug: Placebo
MeSH:Hypertension
HPO:Hypertension

Primary Outcomes

Measure: Difference in change in home SBP from baseline to Week 4

Time: 4 weeks

Secondary Outcomes

Measure: Difference in change in clinic seated mean SBP from baseline to Week 4

Time: 4 weeks

Measure: Difference in change in clinic seated mean DBP from baseline to Week 4

Time: 4 weeks

Measure: Percentage of participants with clinic seated mean SBP <140 and DBP <90 mmHg at Week 4

Time: 4 weeks

Measure: Percentage of participants with clinic seated mean SBP <130 and DBP <80 mmHg at Week 4

Time: 4 weeks

Measure: Difference in change in home seated mean DBP from baseline to Week 4

Time: 4 weeks

Measure: Difference in change in trough home seated mean SBP from baseline to week 4

Time: 4 weeks

Measure: Difference in change in trough home seated mean DBP from baseline to week 4

Time: 4 weeks

Measure: Percentage of participants with home seated mean SBP <135 and DBP <85 mmHg at Week 4

Time: 4 weeks

Measure: Percentage of participants with home seated mean SBP <130 and DBP <80 mmHg at Week 4

Time: 4 weeks

Other Outcomes

Description: Percentage of participants discontinued trial medication due to AE/SAE from baseline to Week 4

Measure: Safety Outcomes

Time: 4 weeks

Description: Percentage of participants with an SAE from baseline to Week 4

Measure: Safety Outcomes

Time: 4 weeks

Description: Percentage of participants with symptomatic hypotension from baseline to Week 4

Measure: Safety Outcomes

Time: 4 weeks

Description: Percentage of participants with serum sodium concentration below 135 mmol/l at Week 4

Measure: Safety Outcomes

Time: 4 weeks

Description: Percentage of participants with serum sodium concentration above 145 mmol/l at Week 4

Measure: Safety Outcomes

Time: 4 weeks

Description: Percentage of participants with serum potassium concentration below 3.5 mmol/l at Week 4

Measure: Safety Outcomes

Time: 4 weeks

Description: Percentage of participants with serum potassium concentration above 5.5 mmol/l at Week 4

Measure: Safety Outcomes

Time: 4 weeks

Description: • Percentage of participants with eGFR drop of over 30% from baseline to Week 4

Measure: Safety Outcomes

Time: 4 weeks
20 Operating Under Resilience (OUR) Project: Stress and Emotion Management for Black/African American Women With Hypertension In a Covid--19 Social Distancing Society

Covid-19 is an additional stressor Black women have to deal with that may interfere with hypertension self-care management. Social connectedness is a source of resilience for Black women to promote mental and physical health. Unfortunately, in the face of the Covid-19 pandemic, social distancing is a challenge further isolating Black women from their networks. How is social connectedness to manage stress and emotional well-being in a social-distancing society for Black women with hypertension? The research team proposed a synchronous web-based version of Enhanced Co-Created Health Education InterventioN (eCo-CHIN) that build the success and best practices derived from the original intervention. A Covid-19 session will be included as a way of helping Black women to maintain resilience and self-care during stressful times. The eCo-CHIN intervention is innovative and timely because the research team are using a synchronous platform preparing Black women on how to deal with Covid-19 while taking care of self. The primary investigator for this pilot study (Dr. Wright) is a Black Early Stage Investigator and former KL2 (career development) awardee. The interdisciplinary research team has the expertise and resources to deliver this Enhanced Co-CHIN intervention.

NCT04526145
Conditions
  1. Stress, Psychological
Interventions
  1. Behavioral: Stress and emotion management
MeSH:Hypertension Stress, Psychological
HPO:Hypertension

Primary Outcomes

Description: Weekly participant attendance will be recorded as date, month and year.

Measure: Determine the feasibility of a synchronous web-based health education program, of OUR project.

Time: 4 weeks

Description: Investigator generated open-ended questions.

Measure: Determine the acceptability of a synchronous web-based health education program, of OUR project.

Time: 1 month

Description: Weight measured in pounds.

Measure: Change from baseline at 3 months weight.

Time: Baseline to 3 months

Description: Waist circumference measured in inches.

Measure: Change from baseline at 3 months waist circumference.

Time: Baseline to 3 months

Description: Self-blood pressure collection using an automatic home blood pressure monitor systolic and diastolic in mmHg

Measure: Change from baseline at 3 months blood pressure.

Time: Baseline to 3 months

Secondary Outcomes

Description: Perceived Stress Scale is a 10-item Likert scale questionnaire regarding stress over the past month with higher scores indicating higher levels of stress. Ranges 0-30.

Measure: Change from baseline stress at 3 months.

Time: baseline to 3 months

Description: Difficulties in Emotion Regulation Scale. This measure has 18 items, each measured on a 5-point rating scale. One total score will calculated by summing the individual item responses. Higher scores represent greater perceived difficulties in emotion regulation capabilities.

Measure: Change from baseline emotional regulation at 3 months.

Time: baseline to 3 months

Description: Dietary Approaches to Stop Hypertension Questionnaire (DASH-Q). The DASH Q had 15 items eliciting responses regarding the consumption of DASH diet foods (e.g., fruits, nuts, and vegetables) in the past seven days. Higher score indicates greater DASH knowledge. Range 0-105.

Measure: Change from baseline dietary approaches to stop hypertension knowledge at 3 months.

Time: baseline to 3 months

Description: The Brief Resilience Scale contains 5 questions on a Likert type scale assessing the ability to "bounce back" from stressors. Scores will be summed and higher scores indicate higher resilience.

Measure: Change from baseline resilience at 3 months.

Time: baseline to 3 months

Description: All of Us Program COVID-19 COPE Survey contains items that are not scored on a summary scale, that include social distancing experiences, COVID-19 related symptoms, and COVID-19 related treatment. Descriptive statistics will be used to summarize participant's experiences.

Measure: Describe participant experience and health during the COVID-19 pandemic.

Time: Baseline

Other Outcomes

Description: The Repeatable Neuropsychiatric Battery (RBANS) will be collected. The RBANS consists of 12 subtests that assess cognitive domains such as Immediate and Delayed Memory, Language, Attention, and Visuospatial/Construction and takes about 30 minutes to administer. A total RBANS sum of index scores will be computed by age.

Measure: Explore the feasibility of collecting cognitive performance data (processing speed, attention, and executive function) via teleconference.

Time: baseline and 3 months
21 Randomized, Double-blind, Placebo-controlled, Multicenter, Multi-arm, Phase II Trial of Novel Agents for the Treatment of Mild to Moderate COVID-19 Positive Outpatients

This is a randomized, double-blind, placebo-controlled, multi-arm, multicenter, phase II trial design to allow a rapid efficacy and toxicity assessment of potential therapies (camostat mesilate and artemisia annua) immediately after COVID-19 positive testing in mild to moderate disease and high-risk factors such as diabetes, hypertension, and obesity among others.

NCT04530617
Conditions
  1. Covid19
  2. Diabetes
  3. Hypertension
  4. Obesity
Interventions
  1. Drug: Camostat Mesilate
  2. Drug: Artemisia Annua Leaf
MeSH:Hypertension
HPO:Hypertension

Primary Outcomes

Description: Decrease in a composite outcome of hospitalization and supplemental oxygen use at day 14 between treatment pairs.

Measure: Rate of hospitalizations and oxygen use

Time: 14 days
22 Personalised Electronic Record Supported Optimisation When Alone for Patients With Hypertension- Pilot Study for Remote Medical Management of Hypertension During the COVID-19 Pandemic

This trial is focusing on blood pressure control for patients with high blood pressure (hypertension) during the COVID-19 pandemic when seeing a doctor for advice may be difficult. The study utilises remote consultations by telephone or video conferencing. Patients record blood pressure and data into an electronic diary on their phone which is reviewed in consultations every 2 weeks by a clinician. Medication for this trial is amlodipine as an oral solution which is uptitrated accordingly for patients receiving medication (anticipated 200). 800 patients will be in an observational group recording the same readings and will not receive any medication.

NCT04559074
Conditions
  1. Hypertension
Interventions
  1. Drug: Amlodipine
MeSH:Hypertension
HPO:Hypertension

Primary Outcomes

Description: The primary objective of the study is to assess precision dosing of amlodipine to deliver reductions in blood pressure in participants with primary hypertension and inadequate BP control by up-titration of amlodipine in 1-2 mg increments.

Measure: Reductions in blood pressure in participants with primary hypertension and inadequate BP control by up-titration of amlodipine in 1-2 mg increments.

Time: 3 months

Secondary Outcomes

Description: Other clinically significant blood pressure measures which related to difference in measured blood pressure between baseline and EOS

Measure: Mean change in daily DBP

Time: 3 months

Description: Difference between mean changes of blood pressure between interventional and observational cohorts.

Measure: Difference between mean changes of blood pressure

Time: 3 months

Description: Reports of side effects using digital diary

Measure: Collect data on tolerability / side effects

Time: 3 months

HPO Nodes


HP:0000822: Hypertension
Genes 411
PLIN1 SMARCAL1 LIMK1 SDCCAG8 ELP1 TSC2 FMR1 CPOX GNAS COX1 SH2B3 LYZ CLCN2 NF1 NOTCH3 ARL6 EDA2R ELN APOA1 CTLA4 CC2D2A MLX FGFR2 ADA2 TRNC MMP14 MTRR BANF1 GLA TRNK TRNL1 CCR6 GPC3 CYP11B2 ERCC8 TRIM32 CFH ACVRL1 COL3A1 LRP6 TRNK XYLT2 CFI CALR ITGA8 SLC37A4 SUGCT GBA NF1 CD46 WT1 WRN KLHL3 BBS4 THPO SDHA POU6F2 ABCG8 CORIN NFIX PDE8B NOD2 ARVCF INVS PRKAR1A RET GLA SLC25A11 SCNN1A TRIM28 TRNQ OFD1 B2M WT1 TNFRSF11B ARMC5 FGFR2 HLA-DPB1 PPARG EDA TP53 BNC2 ALX4 LMX1B NPHP1 ACAT1 ACTA2 GNAS GTF2IRD1 SDHC UFD1 ENPP1 GATA5 LEMD3 MYH11 HGD SDHD RET RFC2 IRF5 KCNJ5 LDLR ERCC6 DLST REST CAV1 GANAB BBS10 SMAD3 TET2 TRNW MUC1 POU3F4 OFD1 ADA2 SDHB ERCC4 BBS9 CD2AP LMNA CYP11B1 MEF2A MMP2 CLIP2 COL4A3 ELN COMT HPSE2 BBS2 XYLT1 PRKACA JMJD1C SMAD4 VANGL1 G6PC WNK4 DIS3L2 TMEM70 HBB ENPP1 MAFB LZTFL1 TRNS2 PKD2 USP8 HIRA TRIP13 DNAJB11 FBN1 TGFBR1 CFHR1 SH2B3 PKD1 LMNA PRKAR1A SDHB SCN2B PRTN3 NR3C2 WDR35 MDH2 DNMT3A ELP1 ALMS1 ELN TRNL1 IQCB1 RET MKKS YY1AP1 LARS2 AIP TBX1 TGFBR2 SPRY2 FBN1 NOTCH1 ABCB6 PRKACA MTTP MYLK ARL6 ABCC6 TRAF3IP1 COL5A2 RET STOX1 H19 LEMD3 FGA TMEM67 SEC24C MAX CYP11B1 SLC25A11 ND6 KIF1B ACTN4 ADA2 HSD11B2 DYRK1B NPHP1 BMPR2 PDE3A ND1 TTC8 JAK2 MGP NOTCH2 VHL SDHB SDHAF2 VHL MYMK NPHP3 ABCC6 TGFBR3 PPARG ALMS1 SMAD6 TRPC6 CCDC28B TMEM127 VHL TNFRSF11A SCNN1B BBS5 SCNN1B ARHGAP31 APOB SDHD SDHD PDE3A GDNF RREB1 CYP11B1 ECE1 TMEM237 TRNE SDHC FH YY1AP1 LMNA TGFB2 COX3 GPR101 CYP17A1 BRCA2 THBD LMX1B WNK1 LRIG2 FIG4 CEP290 HLA-DRB1 XPNPEP3 CCND1 MKS1 ACTA2 FUZ COL4A3 CYTB SMAD4 LMNA TRNV SLC2A10 FBN1 PRKG1 COQ7 MLXIPL KIF1B AIP FLT1 SERPINA6 CFB PLIN1 HLA-B NKX2-5 WT1 PKD1 EGFR MC4R EPAS1 SLC2A10 GCH1 BAZ1B NSMCE2 VHL PCSK9 KRT8 WT1 WDPCP TRNK PKD2 APRT HLA-DPA1 MPL COL4A5 KCTD1 SDHD TRIM28 GP1BB THSD1 BBS12 CEP290 FMO3 CYP21A2 CUL3 NPHP4 PKHD1 BICC1 COL4A4 BSCL2 NR3C1 WT1 GANAB C3 COX2 TRNF IFT27 GTF2I STAT1 SDCCAG8 PAM16 MFAP5 LOX IL12B SLC37A4 LDLRAP1 MYH7 BBS7 TGFB3 CBS ARMC5 CEP164 ADAMTSL4 INVS CDH23 COL5A1 CACNA1D LMNA PTPN22 SCNN1A SDHB ABCG5 TBX1 FN1 TMEM127 BBS1 CYP17A1 FN1 RPGRIP1L AIP PHF21A CACNA1H POR ND5 ENG BBS1 PDE11A EXT2 COL1A1 GUCY1A1 TSC1 FBN1 TBL2 HMBS HMBS C8ORF37 NR3C1 FOXF1 PRKAR1A NPHP1 CEP19 KRT18 MAX ABCC6 VAC14 KIF1B KCTD1 TRNS1 HSD11B2 GJA1 SCNN1G KCNJ5 BBIP1 PDE11A ANGPTL6 CDH23 KCNJ5 MAT2A SMAD4 IDUA IFT172 CACNA1D WDR19 ZMPSTE24 CYP11B1 FOXE3 CCN2 GNAS SCNN1G GUCY1A1 NFU1 VHL USP8 CFHR3 NOS3 COL3A1 JAK2 OSGEP

HPO

Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


HPO Nodes


HP:0000822: Hypertension
Genes 411
PLIN1 SMARCAL1 LIMK1 SDCCAG8 ELP1 TSC2 FMR1 CPOX GNAS COX1 SH2B3 LYZ CLCN2 NF1 NOTCH3 ARL6 EDA2R ELN APOA1 CTLA4 CC2D2A MLX FGFR2 ADA2 TRNC MMP14 MTRR BANF1 GLA TRNK TRNL1 CCR6 GPC3 CYP11B2 ERCC8 TRIM32 CFH ACVRL1 COL3A1 LRP6 TRNK XYLT2 CFI CALR ITGA8 SLC37A4 SUGCT GBA NF1 CD46 WT1 WRN KLHL3 BBS4 THPO SDHA POU6F2 ABCG8 CORIN NFIX PDE8B NOD2 ARVCF INVS PRKAR1A RET GLA SLC25A11 SCNN1A TRIM28 TRNQ OFD1 B2M WT1 TNFRSF11B ARMC5 FGFR2 HLA-DPB1 PPARG EDA TP53 BNC2 ALX4 LMX1B NPHP1 ACAT1 ACTA2 GNAS GTF2IRD1 SDHC UFD1 ENPP1 GATA5 LEMD3 MYH11 HGD SDHD RET RFC2 IRF5 KCNJ5 LDLR ERCC6 DLST REST CAV1 GANAB BBS10 SMAD3 TET2 TRNW MUC1 POU3F4 OFD1 ADA2 SDHB ERCC4 BBS9 CD2AP LMNA CYP11B1 MEF2A MMP2 CLIP2 COL4A3 ELN COMT HPSE2 BBS2 XYLT1 PRKACA JMJD1C SMAD4 VANGL1 G6PC WNK4 DIS3L2 TMEM70 HBB ENPP1 MAFB LZTFL1 TRNS2 PKD2 USP8 HIRA TRIP13 DNAJB11 FBN1 TGFBR1 CFHR1 SH2B3 PKD1 LMNA PRKAR1A SDHB SCN2B PRTN3 NR3C2 WDR35 MDH2 DNMT3A ELP1 ALMS1 ELN TRNL1 IQCB1 RET MKKS YY1AP1 LARS2 AIP TBX1 TGFBR2 SPRY2 FBN1 NOTCH1 ABCB6 PRKACA MTTP MYLK ARL6 ABCC6 TRAF3IP1 COL5A2 RET STOX1 H19 LEMD3 FGA TMEM67 SEC24C MAX CYP11B1 SLC25A11 ND6 KIF1B ACTN4 ADA2 HSD11B2 DYRK1B NPHP1 BMPR2 PDE3A ND1 TTC8 JAK2 MGP NOTCH2 VHL SDHB SDHAF2 VHL MYMK NPHP3 ABCC6 TGFBR3 PPARG ALMS1 SMAD6 TRPC6 CCDC28B TMEM127 VHL TNFRSF11A SCNN1B BBS5 SCNN1B ARHGAP31 APOB SDHD SDHD PDE3A GDNF RREB1 CYP11B1 ECE1 TMEM237 TRNE SDHC FH YY1AP1 LMNA TGFB2 COX3 GPR101 CYP17A1 BRCA2 THBD LMX1B WNK1 LRIG2 FIG4 CEP290 HLA-DRB1 XPNPEP3 CCND1 MKS1 ACTA2 FUZ COL4A3 CYTB SMAD4 LMNA TRNV SLC2A10 FBN1 PRKG1 COQ7 MLXIPL KIF1B AIP FLT1 SERPINA6 CFB PLIN1 HLA-B NKX2-5 WT1 PKD1 EGFR MC4R EPAS1 SLC2A10 GCH1 BAZ1B NSMCE2 VHL PCSK9 KRT8 WT1 WDPCP TRNK PKD2 APRT HLA-DPA1 MPL COL4A5 KCTD1 SDHD TRIM28 GP1BB THSD1 BBS12 CEP290 FMO3 CYP21A2 CUL3 NPHP4 PKHD1 BICC1 COL4A4 BSCL2 NR3C1 WT1 GANAB C3 COX2 TRNF IFT27 GTF2I STAT1 SDCCAG8 PAM16 MFAP5 LOX IL12B SLC37A4 LDLRAP1 MYH7 BBS7 TGFB3 CBS ARMC5 CEP164 ADAMTSL4 INVS CDH23 COL5A1 CACNA1D LMNA PTPN22 SCNN1A SDHB ABCG5 TBX1 FN1 TMEM127 BBS1 CYP17A1 FN1 RPGRIP1L AIP PHF21A CACNA1H POR ND5 ENG BBS1 PDE11A EXT2 COL1A1 GUCY1A1 TSC1 FBN1 TBL2 HMBS HMBS C8ORF37 NR3C1 FOXF1 PRKAR1A NPHP1 CEP19 KRT18 MAX ABCC6 VAC14 KIF1B KCTD1 TRNS1 HSD11B2 GJA1 SCNN1G KCNJ5 BBIP1 PDE11A ANGPTL6 CDH23 KCNJ5 MAT2A SMAD4 IDUA IFT172 CACNA1D WDR19 ZMPSTE24 CYP11B1 FOXE3 CCN2 GNAS SCNN1G GUCY1A1 NFU1 VHL USP8 CFHR3 NOS3 COL3A1 JAK2 OSGEP

Reports

Data processed on September 26, 2020.

An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

Drug Reports   MeSH Reports   HPO Reports  

Interventions

4,180 reports on interventions/drugs

MeSH

691 reports on MeSH terms

HPO

263 reports on HPO terms

All Terms

Alphabetical index of all Terms

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