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D004194: Disease

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 (66)


Name (Synonyms) Correlation
drug1298 Favipiravir + Standard of Care Wiki 0.20
drug1684 Interleukin assessment in semen Wiki 0.20
drug858 Connor-Davidson Resilience Scale 10 items (CD-RISC 10) Wiki 0.20
Name (Synonyms) Correlation
drug2458 Personal protective equipment from biological hazard Wiki 0.20
drug3331 Tele-delivered psychological intervention Wiki 0.20
drug2590 Plitidepsin 1.5 mg/day Wiki 0.20
drug3651 WJ-MSCs Wiki 0.20
drug1637 Impact of Event Scale-Revised Wiki 0.20
drug555 CCP Wiki 0.20
drug1105 Dysphagia Handicap Index (DHI) Wiki 0.20
drug353 Açaí palm berry extract - natural product Wiki 0.20
drug3608 Videofluoroscopy Wiki 0.20
drug376 BIO101 Wiki 0.20
drug2057 MinnRAP Peer Support Program Wiki 0.20
drug3642 Voice Symptom Scale (VoiSS) Wiki 0.20
drug3713 [68Ga]Ga-DOTA-(RGD)2 PET/CT Wiki 0.20
drug1707 Interview by psychologists Wiki 0.20
drug2902 SARS-CoV 2 RNA PCR Urine Wiki 0.20
drug2901 SARS-CoV 2 RNA PCR Semen Wiki 0.20
drug3671 Withings ScanWatch Wiki 0.20
drug3892 inhaled type I interferon Wiki 0.20
drug3727 albuterol sulfate (nebulizer) Wiki 0.20
drug3723 after-each-case room disinfection Wiki 0.20
drug3647 WFI water nebulization Wiki 0.20
drug438 Bioarginina® Wiki 0.20
drug2960 SECRET questionnaire Wiki 0.20
drug3672 Woebot Substance Use Disorder Wiki 0.20
drug697 Cannabis, Medical Wiki 0.20
drug1950 Male Sexual Health Questionnaire (MSHQ) Wiki 0.20
drug2591 Plitidepsin 2.0 mg/day Wiki 0.20
drug405 Baricitinib or Anakinra Wiki 0.20
drug2843 Reporting of anosmia, ageusia and other clinical symptoms Wiki 0.20
drug3725 airway management during sedation or general anesthesia Wiki 0.20
drug553 CBD Wiki 0.20
drug416 Behaviour Change Technique Intervention to Improve Quality of Life Wiki 0.20
drug3721 aerosol box Wiki 0.20
drug2592 Plitidepsin 2.5 mg/day Wiki 0.20
drug1306 Fibreoptic Endoscopic Evaluation of Swallowing (FEES) Wiki 0.20
drug1253 Exposure to the SARS-CoV-2 and its consequences Wiki 0.20
drug3655 Wearing surgical face mask sprayed with hypertonic saline Wiki 0.20
drug1015 Depression, Anxiety and Stress Scale Wiki 0.20
drug3657 Web Based Survey Wiki 0.20
drug2466 Phone call Wiki 0.20
drug1303 Feeling Good Digital App Wiki 0.20
drug1584 IIEF-5 questionnaire Wiki 0.20
drug1265 Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol Wiki 0.20
drug3458 Training session adressing information and health literacy Wiki 0.20
drug3811 daily room disinfection Wiki 0.20
drug2641 PrimePro™/ PrimeMSK™ Wiki 0.20
drug1698 Intervention App Wiki 0.20
drug3726 albuterol sulfate (MDI) Wiki 0.20
drug3658 Web application users Wiki 0.20
drug3375 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 0.20
drug444 Biological collection with nasopharyngeal samples, saliva, blood, stool and urine Wiki 0.20
drug1595 IPSS questionnaire Wiki 0.20
drug567 CLIA of IgG and IgM against SARS-Cov-2 Wiki 0.20
drug3044 Semen Qualitative Analysis Wiki 0.20
drug4123 transparent sheet Wiki 0.20
drug524 Brief Psychiatric Rating Scale Wiki 0.20
drug2514 Placebo Comparator Wiki 0.14
drug394 Bacille Calmette-Guérin (BCG) Wiki 0.14
drug3688 Yoga Wiki 0.11
drug367 BCG vaccine Wiki 0.10
drug2744 Questionnaires Wiki 0.07
drug3191 Standard of Care Wiki 0.03
drug2490 Placebo Wiki 0.03

Correlated MeSH Terms (79)


Name (Synonyms) Correlation
D001289 Attention Deficit Disorder with Hyperactivity NIH 0.34
D001523 Mental Disorders NIH 0.26
D013313 Stress Disorders, Post-Traumatic NIH 0.25
Name (Synonyms) Correlation
D006685 Hoarseness NIH 0.20
D019964 Mood Disorders NIH 0.20
D013001 Somatoform Disorders NIH 0.20
D000067877 Autism Spectrum Disorder NIH 0.20
D000070627 Chronic Traumatic Encephalopathy NIH 0.20
D009080 Mucocutaneous Lymph Node Syndrome NIH 0.20
D009069 Movement Disorders NIH 0.20
D001997 Bronchopulmonary Dysplasia NIH 0.20
D008595 Menorrhagia NIH 0.20
D006948 Hyperkinesis NIH 0.20
D006929 Hyperaldosteronism NIH 0.20
D014552 Urinary Tract Infections NIH 0.20
D009140 Musculoskeletal Diseases NIH 0.20
D054559 Hyperphosphatemia NIH 0.20
D055154 Dysphonia NIH 0.20
D040921 Stress Disorders, Traumatic NIH 0.20
D004314 Down Syndrome NIH 0.20
D048909 Diabetes Complications NIH 0.20
D011602 Psychophysiologic Disorders NIH 0.20
D019636 Neurodegenerative Diseases NIH 0.20
D003291 Conversion Disorder NIH 0.20
D005879 Tourette Syndrome NIH 0.20
D014832 Voice Disorders NIH 0.20
D003424 Crohn Disease NIH 0.20
D000309 Adrenal Insufficiency NIH 0.20
D007008 Hypokalemia NIH 0.20
D000066553 Problem Behavior NIH 0.20
D010300 Parkinsonian NIH 0.16
D001008 Anxiety Disorders NIH 0.15
D000070642 Brain Injuries, Traumatic NIH 0.14
D015775 Fractures, Stress NIH 0.14
D000690 Amyotrophic Lateral Sclerosis NIH 0.14
D012640 Seizures NIH 0.14
D002659 Child Development Disorders, Pervasive NIH 0.14
D012871 Skin Diseases NIH 0.14
D016472 Motor Neuron Disease NIH 0.14
D000068376 Compassion Fatigue NIH 0.14
D000067073 Psychological Trauma NIH 0.14
D006526 Hepatitis C NIH 0.14
D003680 Deglutition Disorders NIH 0.11
D001321 Autistic Disorder NIH 0.11
D006470 Hemorrhage NIH 0.11
D013651 Taste Disorders NIH 0.11
D000437 Alcoholism NIH 0.11
D001714 Bipolar Disorder NIH 0.11
D005356 Fibromyalgia NIH 0.10
D019966 Substance-Related Disorders NIH 0.10
D000755 Anemia, Sickle Cell NIH 0.10
D001930 Brain Injuries, NIH 0.09
D001927 Brain Diseases NIH 0.09
D000857 Olfaction Disorders NIH 0.09
D009422 Nervous System Diseases NIH 0.09
D007153 Immunologic Deficiency Syndromes NIH 0.08
D009461 Neurologic Manifestations NIH 0.08
D001327 Autoimmune Diseases NIH 0.07
D015212 Inflammatory Bowel Diseases NIH 0.07
D013315 Stress, Psychological NIH 0.07
D012598 Scoliosi NIH 0.07
D007238 Infarction NIH 0.07
D009103 Multiple Sclerosis NIH 0.07
D059350 Chronic Pain NIH 0.07
D009203 Myocardial Ischemia NIH 0.06
D020521 Stroke NIH 0.05
D020141 Hemostatic Disorders NIH 0.05
D001778 Blood Coagulation Disorders NIH 0.05
D006973 Hypertension NIH 0.05
D008171 Lung Diseases, NIH 0.04
D003866 Depressive Disorder NIH 0.04
D013577 Syndrome NIH 0.04
D014947 Wounds and Injuries NIH 0.04
D045169 Severe Acute Respiratory Syndrome NIH 0.03
D002318 Cardiovascular Diseases NIH 0.03
D003141 Communicable Diseases NIH 0.03
D018352 Coronavirus Infections NIH 0.03
D007239 Infection NIH 0.03
D016638 Critical Illness NIH 0.02

Correlated HPO Terms (30)


Name (Synonyms) Correlation
HP:0007018 Attention deficit hyperactivity disorder HPO 0.34
HP:0000729 Autistic behavior HPO 0.23
HP:0002905 Hyperphosphatemia HPO 0.20
Name (Synonyms) Correlation
HP:0002900 Hypokalemia HPO 0.20
HP:0000846 Adrenal insufficiency HPO 0.20
HP:0002487 Hyperkinetic movements HPO 0.20
HP:0001618 Dysphonia HPO 0.20
HP:0001621 Weak voice HPO 0.20
HP:0000132 Menorrhagia HPO 0.20
HP:0000859 Hyperaldosteronism HPO 0.20
HP:0100280 Crohn's disease HPO 0.20
HP:0001609 Hoarse voice HPO 0.20
HP:0100022 Abnormality of movement HPO 0.20
HP:0000708 Behavioral abnormality HPO 0.20
HP:0006802 Abnormal anterior horn cell morphology HPO 0.14
HP:0000717 Autism HPO 0.14
HP:0100754 Mania HPO 0.14
HP:0007354 Amyotrophic lateral sclerosis HPO 0.14
HP:0002015 Dysphagia HPO 0.11
HP:0001250 Seizure HPO 0.11
HP:0000458 Anosmia HPO 0.09
HP:0001298 Encephalopathy HPO 0.09
HP:0002721 Immunodeficiency HPO 0.08
HP:0002037 Inflammation of the large intestine HPO 0.07
HP:0012532 Chronic pain HPO 0.07
HP:0001658 Myocardial infarction HPO 0.06
HP:0001297 Stroke HPO 0.05
HP:0001928 Abnormality of coagulation HPO 0.05
HP:0000822 Hypertension HPO 0.05
HP:0000716 Depressivity HPO 0.04

Clinical Trials

Navigate: Correlations   HPO

There are 26 clinical trials


1 Outcomes Mandate National Integration With Cannabis as Medicine for Prevention and Treatment of COVID-19

This will be a multistate, multicenter clinical study to determine the efficacy and safety of medical cannabis for a wide variety of chronic medical conditions.

NCT03944447
Conditions
  1. Chronic Pain
  2. Chronic Pain Syndrome
  3. Chronic Pain Due to Injury
  4. Chronic Pain Due to Trauma
  5. Fibromyalgia
  6. Seizures
  7. Hepatitis C
  8. Cancer
  9. Crohn Disease
  10. HIV/AIDS
  11. Multiple Sclerosis
  12. Traumatic Brain Injury
  13. Sickle Cell Disease
  14. Post Traumatic Stress Disorder
  15. Tourette Syndrome
  16. Ulcerative Colitis
  17. Glaucoma
  18. Epilepsy
  19. Inflammatory Bowel Diseases
  20. Parkinson Disease
  21. Amyotrophic Lateral Sclerosis
  22. Chronic Traumatic Encephalopathy
  23. Anxiety
  24. Depression
  25. Insomnia
  26. Autism
  27. Opioid-use Disorder
  28. Bipolar Disorder
  29. Covid19
  30. SARS-CoV Infection
  31. COVID-19
  32. Corona Virus Infection
  33. Coronavirus
Interventions
  1. Drug: Cannabis, Medical
MeSH:Infection Communicable Diseases Hepatitis C Coronavirus Infections Severe Acute Respiratory Syndrome Fibromyalgia Crohn Disease Inflammatory Bowel Diseases Parkin Parkinson Disease Multiple Sclerosis Brain Injuries Brain Injuries, Traumatic Seizures Motor Neuron Disease Amyotrophic Lateral Sclerosis Brain Diseases Tourette Syndrome Chronic Traumatic Encephalopathy Anemia, Sickle Cell Disease Syndrome Sclerosis Chronic Pain Wounds and Injuries Stress Disorders, Traumatic Bipolar Disorder Stress Disorders, Post-Traumatic
HPO:Abnormal anterior horn cell morphology Amyotrophic lateral sclerosis Bilateral tonic-clonic seizure Bipolar affective disorder Chronic pain Crohn's disease Encephalopathy Focal-onset seizure Generalized-onset seizure Inflammation of the large intestine Mania Seizure

Primary Outcomes

Description: Covid-19 infection rates in cannabis users will be compared to rates in the general population. Our online questionnaire responses will compare infection rates of cannabis users in this study against the Johns Hopkins University Coronavirus Research Center data (https://coronavirus.jhu.edu).

Measure: Prevention of COVID-19

Time: Five years

Description: Severity of persistent symptoms in cannabis users testing positive for active infection and/or antibodies will also be compared to the general population. Patients will answer the widely used FLU-PRO questionnaire, which asks about flu symptoms and severity, to capture diagnoses, symptoms, and medical interventions related to COVID-19. The data from cannabis user patients will be compared with national and international data surveys, such as the Covid Symptom Study (https://covid.joinzoe.com/us-2).

Measure: Treatment of COVID-19

Time: Five years

Description: The primary objective is to assess the efficacy and safety of medical cannabis as medicine for treatment of chronic pain and other chronic debilitating diseases. Pain will be measured by Brief Pain Inventory (BPI) numeric scale. Change from baseline in BPI will be assessed at 3-month intervals. For prospective associations between cannabis use and outcomes, use of a lagged mixed-effects models will examine temporal associations between cannabis use and pain severity, opioid sparing, and patient satisfaction. Data will be analyzed from baseline and the annual follow-up waves.

Measure: Treatment of Symptoms

Time: Five years

Secondary Outcomes

Description: Secondary objectives include evaluating increases or decreases in quality of life, and increases or decreases in concomitant opioid use. Satisfaction with treatment will be measured by a Visual Analog Score (VAS). Change From baseline in Satisfaction with treatment measured by (VAS) be assessed at 3-month intervals.

Measure: Cannabis Impact on Quality of Life

Time: Five years

Description: Tertiary objectives will examine preferences for routes of administration, and preferences for THC / CBD ratios. Categorical factors will be summarized using frequencies and percentages, while continuous measure distributions will be described using means, standard deviations, and quartiles of interest.

Measure: Cannabis Route and Dosing

Time: Five years

Description: Incidence of Treatment-Related Adverse Events will be measured by Physician Global Assessment (PGA) numeric scale. Number of participants with Treatment-Related Adverse Events will be assessed by CTCAE v4.0.

Measure: Monitoring Adverse Events

Time: Five years
2 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. Insomnia
  14. Pneumonia
  15. Skin Infection
  16. Arrythmia
  17. Asthma in Children
  18. Bronchopulmonary Dysplasia
  19. Adrenal Insufficiency
  20. Fibrinolysis; Hemorrhage
  21. Attention Deficit Hyperactivity Disorder
  22. Multisystem Inflammatory Syndrome in Children (MIS-C)
  23. Kawasaki Disease
  24. Coagulation Disorder
  25. 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.
3 Mental Health Impact of COVID-19 Pandemic on NIMH Research Participants and Volunteers

Background: The COVID-19 outbreak has caused many changes to people s normal social patterns. The respiratory illness has been the major focus of public health efforts. But most experts also agree that government and public health mandates to slow the spread of the illness, such as social distancing, have a significant effect on people s mental health. Environmental stressors, such as constraints on activities, social contact, and access to resources, take a toll. Researchers want to learn how stressors related to COVID-19 affect mental health over time. Objective: To learn the relationship between stressors related to COVID-19 and self-rated measures of mental health symptoms and distress among a range of people. Eligibility: English-speaking adults ages 18 and older Design: This study will be conducted online. Participants will give their first and last name and email address. They will indicate if they have ever been in an NIH research study. They will get a username and password. Every 2 weeks for up to 6 months, participants will complete online study surveys. They will get email reminders. Some surveys will be repeated. At the end of the study, they will complete a set of end-of-study surveys. The surveys will ask about the following: Age, sex, race, and other sociodemographic data Mental and medical illness history and treatment Family medical history Mobility, self-care, and life activities Behaviors related to alcohol and substance use disorder Mental illness symptoms Psychological distress Stressors caused by the COVID-19 pandemic. Participants will get links to mental health resources, such as hotlines. They will also get guidance on steps to take to seek care or support. Study website: nimhcovidstudy.ctss.nih.gov

NCT04339790
Conditions
  1. Healthy Volunteer
  2. Mood Disorder
  3. Anxiety Disorder
  4. Preexisting Medical Condition
MeSH:Disease Anxiety Disorders Mood Disorders

Primary Outcomes

Description: Thoughts and feelings about mental health impact of COVID-19

Measure: NIMH COVID Study survey - adult responses

Time: Biweekly online responses

Secondary Outcomes

Description: Ratings on measures of mental health symptoms and distress

Measure: DSM XC and KS survey

Time: Biweekly online self report
4 The Impact of the Covid-19 Pandemic on the Mental Health of Workers in Health Services: The Covid-19 HEalth caRe wOrkErS (HEROES) Study

Since December 2019 the world has been shaken with an enormous global threat: the Covid-19 pandemic. This new kind of coronavirus is generating an unprecedented impact both on the general population and on the healthcare systems in most countries. Health services are trying to expand their capacity to respond to the pandemic, taking actions such as increasing the number of beds; acquiring necessary equipment to provide intensive therapy (ventilators), and calling retired health professionals and health students so they can assist the overwhelmed health care workforce. Unfortunately, these organizational changes at health facilities, along with the fears and concerns of becoming ill with the virus or infecting their families, put an enormous emotional burden on workers in health services which may lead to negative outcomes on mental health in this population. Recent cross-sectional studies in China indicate that health service workers exposed to people with Covid-19 reported higher rates of depressive and anxious symptoms. This negative impact on mental health among health workers in China has also been informally reported in other countries where the Covid-19 pandemic has been devastating in its effects (such as Spain and Italy), as well as in countries where the pandemic is becoming a growing public health problem. This is particularly relevant in regions with fewer resources (Latin America, North Africa), where there are limited means and the response from the health system is usually insufficient. Moreover, it is necessary to study these negative effects longitudinally considering that some effects will appear over time (post-traumatic stress). Accordingly, this prospective (0, 3, 6 and 12 months), multisite cohort study aims to describe, examine, and evaluate the impact of the Covid-19 pandemic on mental health and social factors among workers at health services from Latin America and the Caribbean, Europe and neighboring countries, the Middle East and North Africa, as well as Sub-Saharan Africa and Asia. Additionally, a team from the United States of America will also participate in this collaborative effort providing expertise on psychiatric epidemiology and supporting coordination across countries.

NCT04352634
Conditions
  1. Covid-19
  2. Mental Health Disorder
  3. Stress Disorder
  4. Anxiety
  5. Depression
  6. SARS-CoV-2
Interventions
  1. Other: Exposure to the SARS-CoV-2 and its consequences
MeSH:Disease Mental Disorders

Primary Outcomes

Description: The 12-item version of the General Health Questionnaire (GHQ-12) is a self-reported instrument that measures symptoms of anxiety and depression. It provides cut-off points to identify people at risk of anxiety and/or depression, which differ slightly between countries

Measure: Anxiety and depressive symptoms

Time: 12 months

Secondary Outcomes

Description: Ad hoc survey on experiences, fears, and concerns about Covid-19

Measure: Experiences, fears and concerns about the Covid-19

Time: Baseline

Description: Ad hoc survey on experiences, fears, and concerns about Covid-19

Measure: Experiences, fears and concerns about the Covid-19

Time: 3 months

Description: Ad hoc survey on experiences, fears, and concerns about Covid-19

Measure: Experiences, fears and concerns about the Covid-19

Time: 6 months

Description: Ad hoc survey on experiences, fears, and concerns about Covid-19

Measure: Experiences, fears and concerns about the Covid-19

Time: 12 months

Description: Ad hoc survey on Covid-19 training and resource prioritization

Measure: Training and resource prioritization

Time: Baseline

Description: Ad hoc survey on Covid-19 training and resource prioritization

Measure: Training and resource prioritization

Time: 3 months

Description: Ad hoc survey on Covid-19 training and resource prioritization

Measure: Training and resource prioritization

Time: 6 months

Description: Ad hoc survey on Covid-19 training and resource prioritization

Measure: Training and resource prioritization

Time: 12 months

Description: Item from the Columbia Suicide Severity Rating Scale (C-SSRS) that measures suicidal ideation with a dichotomous answer (presence/absence)

Measure: Suicide ideation (presence)

Time: Baseline

Description: Item from the Columbia Suicide Severity Rating Scale (C-SSRS) that measures suicidal ideation with a dichotomous answer (presence/absence)

Measure: Suicide ideation (presence)

Time: 3 months

Description: Item from the Columbia Suicide Severity Rating Scale (C-SSRS) that measures suicidal ideation with a dichotomous answer (presence/absence)

Measure: Suicide ideation (presence)

Time: 6 months

Description: Item from the Columbia Suicide Severity Rating Scale (C-SSRS) that measures suicidal ideation with a dichotomous answer (presence/absence)

Measure: Suicide ideation (presence)

Time: 12 months

Description: 5-point Likert item from the Columbia Suicide Severity Rating Scale (C-SSRS). Higher scores indicate higher frequency.

Measure: Suicide ideation (frequency)

Time: Baseline

Description: 5-point Likert item from the Columbia Suicide Severity Rating Scale (C-SSRS). Higher scores indicate higher frequency.

Measure: Suicide ideation (frequency)

Time: 3 months

Description: 5-point Likert item from the Columbia Suicide Severity Rating Scale (C-SSRS). Higher scores indicate higher frequency.

Measure: Suicide ideation (frequency)

Time: 6 months

Description: 5-point Likert item from the Columbia Suicide Severity Rating Scale (C-SSRS). Higher scores indicate higher frequency.

Measure: Suicide ideation (frequency)

Time: 12 months

Description: Ad hoc 3-item survey to evaluate acute stress disorder. Higher values of the 5-points Likert scales suggest higher frequency of symptoms

Measure: Acute stress symptoms

Time: Baseline

Description: Ad hoc 3-item survey to evaluate acute stress disorder. Higher values of the 5-points Likert scales suggest higher frequency of symptoms

Measure: Acute stress symptoms

Time: 3 months

Description: Ad hoc 3-item survey to evaluate acute stress disorder. Higher values of the 5-points Likert scales suggest higher frequency of symptoms

Measure: Acute stress symptoms

Time: 6 months

Description: Ad hoc 3-item survey to evaluate acute stress disorder. Higher values of the 5-points Likert scales suggest higher frequency of symptoms

Measure: Acute stress symptoms

Time: 12 months

Description: Ad hoc survey on support network. The answers to the multiple items will be adjusted so higher values indicate higher levels of psychological and social support

Measure: Psycho/social support and network

Time: Baseline

Description: Ad hoc survey on support network. The answers to the multiple items will be adjusted so higher values indicate higher levels of psychological and social support

Measure: Psycho/social support and network

Time: 3 months

Description: Ad hoc survey on support network. The answers to the multiple items will be adjusted so higher values indicate higher levels of psychological and social support

Measure: Psycho/social support and network

Time: 6 months

Description: Ad hoc survey on support network. The answers to the multiple items will be adjusted so higher values indicate higher levels of psychological and social support

Measure: Psycho/social support and network

Time: 12 months

Description: The Brief Resilience Scale (BRS) is a 6-item self-reported instrument that measures resilience. The range of scores is 6-30. Higher scores indicate higher resilience levels.

Measure: Resilience

Time: Baseline

Description: The Brief Resilience Scale (BRS) is a 6-item self-reported instrument that measures resilience. The range of scores is 6-30. Higher scores indicate higher resilience levels.

Measure: Resilience

Time: 3 months

Description: The Brief Resilience Scale (BRS) is a 6-item self-reported instrument that measures resilience. The range of scores is 6-30. Higher scores indicate higher resilience levels.

Measure: Resilience

Time: 6 months

Description: The Brief Resilience Scale (BRS) is a 6-item self-reported instrument that measures resilience. The range of scores is 6-30. Higher scores indicate higher resilience levels.

Measure: Resilience

Time: 12 months

Description: The 12-item version of the General Health Questionnaire (GHQ-12) is a self-reported instrument that measures symptoms of anxiety and depression. It provides cut-off points to identify people at risk of anxiety and/or depression, which differ slightly between countries

Measure: Anxiety and depressive symptoms

Time: Baseline

Description: The 12-item version of the General Health Questionnaire (GHQ-12) is a self-reported instrument that measures symptoms of anxiety and depression. It provides cut-off points to identify people at risk of anxiety and/or depression, which differ slightly between countries

Measure: Anxiety and depressive symptoms

Time: 3 months

Description: The 12-item version of the General Health Questionnaire (GHQ-12) is a self-reported instrument that measures symptoms of anxiety and depression. It provides cut-off points to identify people at risk of anxiety and/or depression, which differ slightly between countries

Measure: Anxiety and depressive symptoms

Time: 6 months
5 Coronavirus Outcomes Registries in Immunocompromised Individuals Australia (CORIA): a Multisite Registry and Optional Biorepository in People With COVID-19 and Selected Conditions Affecting Immune Function

CORIA is an observational cohort study of immunosuppressed populations who test positive for COVID-19. This includes people living with HIV, cancer, acquired immunodeficiency associated with other immunosuppressive therapy, primary immunodeficiency and recipients of a solid organ transplant. Participants will have routine clinical data collected with optional baseline collection and storage of a blood sample for storage . The study will be conducted in up to 30 sites within Australia.

NCT04354818
Conditions
  1. HIV-1-infection
  2. Cancer
  3. Primary Immune Deficiency Disorder
  4. Immunosuppression Disorders
  5. COVID-19
MeSH:Immunologic Deficiency Syndromes Disease
HPO:Immunodeficiency

Primary Outcomes

Measure: percentage of patients who required hospitalisation, developed severe illness (ICU admission) or died

Time: Day 28

Secondary Outcomes

Measure: percentage of patients who required hospitalisation, developed severe illness (ICU admission) or died

Time: 3 months
6 PSYCHIatric Disorders and Covid-19 (PSYCHIC) : Observatory of the Psychiatric, Somatic and Pharmacological Impacts of the COVID-19 Pandemic on Patients Hospitalized for Psychiatric Disorders and Suspected to be Infected by COVID-19

Given the possible risks and complications of a comorbidity between psychiatric disorder and coronavirus disease 2019 (COVID-19), it seems particularly important to specify the impact of the COVID-19 pandemic in patients with psychiatric disorders and suspected of infection, hospitalized in a specific unit, at the psychiatric, somatic and pharmacological level.

NCT04358042
Conditions
  1. Psychiatric Disorder
  2. Covid19
Interventions
  1. Other: Brief Psychiatric Rating Scale
  2. Other: Depression, Anxiety and Stress Scale
  3. Other: Impact of Event Scale-Revised
  4. Other: Connor-Davidson Resilience Scale 10 items (CD-RISC 10)
MeSH:Disease Mental Disorders Problem Behavior
HPO:Behavioral abnormality

Primary Outcomes

Description: total severity score from the Impact of Event Scale-Revised (IES-R)

Measure: impact of the COVID-19 pandemic on psychiatric symptomatology

Time: through study completion, an average of 2 year
7 Cohort of Patients With Covid-19 Presenting Neurological or Psychiatric Disorders: An Observational Study of the Covid-19 Neurological and Psychiatric Manifestations

Covid-19 pandemic now affects more than two million people worldwide. The neurotropism of the virus is assumed by its frequent association with neurological symptoms (anosmia, ageusia, headaches) but the extent of the central or peripheral nervous system involvement and the associated symptomatology remain poorly known for now. The main objective of this study is to describe the neurological and psychiatric manifestations occurring in the context of Covid-19 infection in patients hospitalized or followed-up in the APHP.SU hospital group. A better understanding of the neuropsychiatric impairment related to Covid-19 would improve the management of these patients in the acute phase, and knowledge of subsequent complications would allow adapting their rehabilitation and follow-up. The precise phenomenological description of these manifestations and the imaging, biology and neuropathology data will be compiled from the data collected by the physicians in charge of these patients as part of their inpatient or outpatient care. This study will also allow collecting unusual clinical manifestations from patients followed for neurological or psychiatric pathology in hospital departments and presenting a Covid-19 infection, in order to optimize the reorganization of their management, follow-up and rehabilitation in the epidemic context.

NCT04362930
Conditions
  1. Neurologic Manifestations
  2. Psychiatric Disorders
  3. COVID-19
MeSH:Neurologic Manifestations Disease Mental Disorders Problem Behavior
HPO:Behavioral abnormality

Primary Outcomes

Description: Frequency of central or peripheral neurological or psychiatric symptoms observed in patients with COVID-19

Measure: Central or peripheral neurological symptoms or psychiatric symptoms observed in patients with Covid-19

Time: 12 months

Secondary Outcomes

Description: Impact on neurological or psychiatric disease trajectories assessed by severity scores or subjective progression (improved, stable, impaired) during and after COVID-19 pathology in patients with pre-existing neurological and psychiatric diseases

Measure: Progression of pre-existing neurological or psychiatric pathologies

Time: 12 months
8 A Double-blinded Randomized Controlled Trial to Examine the Effectiveness of a Mobile-based Intervention to Reduce Mental Health Problems in Healthcare Workers at the Frontline Against COVID-19 in Spain: the PsyCovidApp Trial

This study aims at evaluating the effectiveness of a mobile phone based intervention to prevent and manage mental health problems in healthcare workers at the frontline against COVID-19 in Spain. The intervention will consist in psychoeducation, delivered via a mobile App. Participants will be followed up during two weeks. The primary outcome will be symptomatology of depression, anxiety or stress.

NCT04393818
Conditions
  1. Mental Health Disorder
  2. Depression
  3. Posttraumatic Stress Disorder
  4. Burnout
  5. Anxiety Disorders
Interventions
  1. Behavioral: Intervention App
MeSH:Disease Anxiety Disorders Stress Disorders, Post-Traumatic Mental Disorders

Primary Outcomes

Description: Depression, anxiety and stress scales (DASS21). Score range: 0 (worst outcome) to 21 (best outcome)

Measure: Depression, anxiety and stress

Time: 2 weeks

Secondary Outcomes

Description: Davidson Trauma Scale (DTS). The DTS is a 17-item, Likert-scale, self-report instrument that assesses the 17 DSM-IV symptoms of PTSD. Both a frequency and a severity score can be determined. The DTS yields a frequency score (ranging from 0 to 68), severity score (ranging from 0 to 68), and total score (ranging from 0 to 136). Higher scores are indicative a worse outcome.

Measure: Post-traumatic stress syndrome

Time: 2 weeks

Description: Insomnia Severity Index. Score range: 0 (best outcome) to 28 (worst outcome)

Measure: Insomnia

Time: 2 weeks

Description: General Self-Efficacy Scale. Score range: 10 (worst outcome) to 40 (best outcome)

Measure: Self Efficacy

Time: 2 weeks
9 The Professional Peer Resilience Initiative: Leveraging a Data-Driven Model to Maximize the Resilience of Healthcare Workers During the COVID-19 Pandemic

The Professional Peer Resilience Initiative (PPRI) study is an observational study aimed at understanding how symptoms of traumatic stress and resilience evolve over time in the University of Minnesota (UMN) healthcare workforce during the coronavirus disease 2019 (COVID-19) pandemic. The study is being conducted concurrently with a UMN peer support program called the MinnRAP program and will remotely administer quality of life and mental health surveys to healthcare workers before they start the MinnRAP program and throughout their participation in the program.

NCT04396600
Conditions
  1. Stress
  2. Stress Disorder
  3. Stress, Psychological
  4. Trauma, Psychological
  5. Anxiety
  6. Anxiety State
  7. Post Traumatic Stress Disorder
  8. Secondary Traumatic Stress
  9. Professional Quality of Life
  10. Stress Related Disorder
  11. Stress Reaction
  12. Stress Risk
  13. Mental Resilience
  14. Emotional Resilience
Interventions
  1. Behavioral: MinnRAP Peer Support Program
MeSH:Disease Compassion Fatigue Fractures, Stress Anxiety Disorders Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Stress, Psychological Psychological Trauma

Primary Outcomes

Description: Professional Quality of Life Questionnaire (proQOL): min score of 10; max score of 50; higher scores mean worse outcome

Measure: Change in professional quality of life

Time: Before peer support program, through study completion (an average of 7 months)

Secondary Outcomes

Description: Stress Risk & Resilience Self-Index: min score 0; max score of 12; higher scores mean worse outcome

Measure: Change in mental health symptoms and resilience markers

Time: Before peer support program, through study completion (an average of 7 months)
10 Diagnostic Value of Patient - Reported and Clinically Verified Olfactory Disorders in a Population Tested for COVID-19

Participants are healthcare workers and adult outpatients referred in a COVID-19 screening center. Patients-reported symptoms are collected, then participants underwent a simple olfactory test (CODA for Clinical Olfactory Dysfunction Assessment), prior to swabbing for SARS-CoV-2 diagnosis (RT-PCR). We aimed to evaluate the prevalence of smell and taste disorders, and to calculate the diagnostic value of patient-reported and clinically verified smell disorders in persons with suspected COVID-19.

NCT04407494
Conditions
  1. COVID-19
Interventions
  1. Biological: Reporting of anosmia, ageusia and other clinical symptoms
MeSH:Disease

Primary Outcomes

Description: Diagnostic values of anosmia and ageusia for COVID-19 with questionnaire

Measure: Diagnostic values of anosmia and ageusia for COVID-19

Time: at inclusion

Secondary Outcomes

Description: Diagnostic values of CODA (Clinical Olfactory dysfunction Assessment) score for COVID-19 : Simple, fast, semi-objective olfactory test developed for epidemic context

Measure: Diagnostic values of CODA

Time: at inclusion
11 COVID-19 Caregiver Emotional Support

The experience of a loved one's stay in a COVID-19 intensive care unit (ICU), either intubated or on respiratory support, forces family caregivers (hereafter 'caregivers') to face core existential fears, such as uncertainty and death. It also poses a serious threat to basic human needs for autonomy, competence, and relatedness, as family caregivers have no control over the illness, and limited prior competence in dealing with critical illness. COVID-19 likely aggravates this experience, as social distancing cuts caregivers off from visiting patients in the ICU, from using their usual social supportive network and the threat of infection extends to caregivers themselves, their children and family. Combined, these extreme circumstances put caregivers in emotional turmoil and in need of psychological support and assistance in managing difficult emotions. ICU caregivers are at risk of developing clinically relevant symptoms of anxiety or posttraumatic stress. During the patient's ICU stay, caregivers experience peri-traumatic distress, such as helplessness, grief, frustration and anger, that may predict later posttraumatic stress disorder (PTSD). Symptoms of anxiety and PTSD may last for months to years after the patient's discharge. Further, caregivers of patients who die in an ICU may be at greater risk of prolonged grief disorder. Supportive interventions may reduce psychological late effects in ICU caregivers, but the primary focus of the majority of interventions has been on communication or surrogate decision making. The CO-CarES study aims to develop and test the feasibility of a tele-delivered psychological intervention to enable caregivers of ICU patients with COVID-19 to better endure the overwhelming uncertainty and emotional strain and reduce the risk of posttraumatic stress and prolonged grief. The study hypothesizes that providing psychological intervention during and after the patients' hospitalization, can decrease peri-traumatic distress during ICU hospitalization and decrease risk of post-traumatic stress, anxiety, depression and perceived stress following discharge, as well as prolonged grief in bereavement. A secondary hypothesis is that changes in emotion regulation mediate effects of the intervention on long-term psychological outcomes.

NCT04409821
Conditions
  1. Posttraumatic Stress Disorder
  2. Prolonged Grief Disorder
  3. COVID
Interventions
  1. Behavioral: Tele-delivered psychological intervention
MeSH:Disease Stress Disorders, Post-Traumatic

Primary Outcomes

Description: Rate of consent among informed eligible participants

Measure: Recruitment rate

Time: At inclusion

Description: Rates of completion of intervention sessions among participants

Measure: Completion rate

Time: During and post-intervention (1 month)

Description: Symptoms of peri-traumatic distress, min. score 0, max score 24, higher score corresponds to worse distress

Measure: Peri-traumatic distress inventory (negative emotions)

Time: Pre-post intervention (1 month after discharge/death)

Description: Posttraumatic stress, min. score 6, max score 24, higher score corresponds to worse distress

Measure: Impact of Events Scale (6 item)

Time: 1 month post intervention

Description: Posttraumatic stress, min. score 6, max score 24, higher score corresponds to worse distress

Measure: Impact of Events Scale (6 item)

Time: 6 months post intervention

Description: Posttraumatic stress, min. score 6, max score 24, higher score corresponds to worse distress

Measure: Impact of Events Scale (6 item)

Time: 12/13 months post intervention

Secondary Outcomes

Description: Prolonged Grief, scored according to diagnostic criteria for prolonged grief disorder

Measure: Prolonged Grief-13-scale

Time: 6 and 13 months

Description: Symptoms of depression, min. score 8, max score 40, higher score corresponds to worse symptoms

Measure: PROMIS Depression (8 item scale)

Time: Baseline to 1, 6, and 12/13 months

Description: Symptoms of anxiety, min. score 8, max score 40, higher score corresponds to worse symptoms

Measure: PROMIS Anxiety (8 item scale)

Time: Baseline to 1, 6, and 12/13 months

Description: Perceived stress, min. score 0, max score 16, higher score corresponds to worse stress

Measure: Perceived Stress Scale (4 item)

Time: Baseline to 1, 6, and 12/13 months

Other Outcomes

Description: Worry, min. score 3, max score 15, higher score corresponds to greater worry

Measure: Short Penn State Worry Questionnaire (3 items)

Time: Baseline to 1, 6, and 12/13 months

Description: Brooding, min. score 5, max score 20, higher score corresponds to greater brooding/rumination

Measure: Brooding subscale of Ruminative Responses Scale

Time: Baseline to 1, 6, and 12/13 months

Description: Intolerance of uncertainty, min score 2, max score 8, greater score indicates greater uncertainty intolerance

Measure: Intolerance of uncertainty Scale (2 item)

Time: Baseline to 1, 6, and 12/13 months
12 Clinical Evolution and Parenting in Children and Adolescents With Autism Spectrum Disorder or Attention Deficit Hyperactivity Disorder Quarantined Because of Covid-19 Outbreak

In response to the coronavirus disease 2019 (covid-19) outbreak, the home confinement of the population ordered by governments in many countries raise questions about its impact on individuals' physical and mental health in the short and longer term. In children, reduced physical activity, changes in lifestyle, disturbances in sleep patterns, lack of in-person contact with peers, poor or inadequate understanding of health risks may be risk factors of anxiety, stress, fatigue, sleep disorders (Brooks et al, 2020; Wang et al, 2020; Sprang et al, 2013). These problematic effects could be modulated by social factors (housing in urban or rural areas, availability of personal space at home, parenting stress, etc.) (Cluver et al, 2020; Liu et al, 2020).

NCT04416360
Conditions
  1. Autism Spectrum Disorder
  2. Attention-deficit Hyperactivity Disorder
Interventions
  1. Other: Interview by psychologists
MeSH:Hyperkinesis Disease Autistic Disorder Attention Deficit Disorder with Hyperactivity Autism Spectrum Disorder Child Development Disorders, Pervasive
HPO:Attention deficit hyperactivity disorder Autism Autistic behavior Hyperactivity Hyperkinetic movements

Primary Outcomes

Description: composition, home confinement, change in the environment, personal room at home, screens with internet access, parents' current professional status, teleworking, care, family concerns related to Covid-19, parenting stress, schooling, recurrent complaints.

Measure: Interview of the parents : contextual data

Time: Baseline

Description: related to education; related to daily family life; related to leisure, related to care (children/adolescents, parents)

Measure: Interview of the children/adolescents/ parents : Experience of the confinement in general

Time: Baseline

Description: related to education; related to daily family life; related to leisure, related to care (children/adolescents, parents)

Measure: Interview of the children/adolescents/ parents : Experience of the confinement in general

Time: 1 month

Description: related to education; related to daily family life; related to leisure, related to care (children/adolescents, parents)

Measure: Interview of the children/adolescents/ parents : Experience of the confinement in general

Time: 3 months

Description: Data relating to disease and management of care. Experience of the referring caregiver.

Measure: Interview of the referring caregiver : data relating to disease and management of care

Time: 3 months
13 Assessment of Thermal Condition of Health Workers Who Use Personal Protective Equipment for Biological Factors During Their Work With COVID-19 Patients

This research will provide data on thermal condition of medical workers who use personal protective equipment from biological hazards. Aquired data will be used to define acceptable period of use for these protective costumes. This research will recruit 6 volunteers. During 6 hours each subject will perform their work using protective costume. Heart rate, skin and air temperature under costume and hygrometric data will be registered. Also there will be questionnaires for volunteers for subjective assessment of thermal and moisture sensations.

NCT04427267
Conditions
  1. Thermal Condition of Health Workers Who Use Personal Protective Equipment From Biological Hazards During Their Work With COVID-19 Patients
Interventions
  1. Other: Personal protective equipment from biological hazard
MeSH:Disease

Primary Outcomes

Description: DS1923-F5 Thermochron iButtons

Measure: Skin thermometry

Time: 6 hours

Description: DS1923-F5 Thermochron iButtons

Measure: Hygrometry under costume

Time: 6 hours

Description: A Polar H10 heart rate monitor (Polar Electro, Finland) will carry all items during the entire research

Measure: Heart rate

Time: 6 hours

Description: Meteoscop - M

Measure: Air thermometry

Time: 6 hours

Description: Meteoscop - M

Measure: Air hygrometry

Time: 6 hours
14 Brain Imaging and Infant Development

The aims of the BIBS Study The Brain Imaging in Babies study (BIBS) aims to improve understanding of how a baby's brain develops from before birth, up until 3-4 years of age. Working with children from a variety of backgrounds and communities, the investigators use a combination of state-of-the-art diagnostic tools such as MRI scans alongside traditional behavioural assessments to capture the earliest information on infant brain development. The focus of the BIBS study MRI scanning is a safe way of producing detailed images using strong magnetic fields and radio waves. It does not use X-ray. Along with learning more about brain development in general, the investigators also try to identify features that may in future help predict whether a child will or will not develop traits of conditions such as Autism Spectrum Disorder (ASD) or Attention Deficit Hyperactivity Disorder (ADHD). Long-term, this may help target useful interventions early on, helping children who are most in need. Since COVID-19 arrived in the United Kingdom (U.K.) in 2020, the investigators have been given ethical approval to include testing for this infection in the mothers and children participating in the study. This may provide an opportunity to better understand how mother and baby respond to infections. The investigators particularly welcome mothers who have had a positive COVID-19 test during their pregnancy to join the study.

NCT04443179
Conditions
  1. Autism Spectrum Disorder
  2. Attention Deficit Hyperactivity Disorder
  3. Neurodevelopmental Conditions
  4. COVID-19
MeSH:Disease Attention Deficit Disorder with Hyperactivity Autism Spectrum Disorder
HPO:Attention deficit hyperactivity disorder Autistic behavior

Primary Outcomes

Measure: Neurodevelopmental Outcomes

Time: 3-4 years of age
15 COVID-19 (SARS-CoV-2) in Urine and Semen: Qualitative and Quantitative Analyses and Evaluation of STD, Sexual Function, Fertility and Urinary Function

This study is part of the current global emergency scenario due to infection with Coronavirus, SARS-CoV-2 as indicated by the international taxonomy. Study aim is to investigate the possibility of the presence of the virus within the seminal fluid and in the urine of infected patients, both during the acute phase and remotely. Current evidences show that Coronaviruses can be present inside the testicle and sperm in other species, such as in feline and avian models. In human beings, current researches have mixed results regarding the presence of SARSCoV-2 in urine, as several studies with a large sample found no traces of the same with Real-Time Reverse method Transcriptase - Polymerase Chain Reaction or with method of nucleic acid amplification. By contrast, in just over 6% of 58 patients with Real Time Polymerase Chain Reaction method have found the presence of SARS-CoV-2 in the urine, even at a distance from the last negative nasopharyngeal swab. Given the topicality of the problem, our study has the objective of specifically researching the presence and possible persistence over time of SARS-CoV-2 in seminal fluid and urine. A saliva sample will also be collected as a control. At the moment there are no studies in literature that tested this possibility. If confirmed, it would lead to find out another potential method of transmission, the sexual one, in asymptomatic patients or apparently no longer infectious with negative buffer. The rationale for our study is the evidence that in other species this type of transmission by coronaviruses is possible and that at present it has not been verified in mankind. The relevance of the study would be both in the case of a negative result, as the first study in its generally, both in the case of a positive result, due to the possibility of introducing new prevention measures in the long run.

NCT04446169
Conditions
  1. SARS-CoV 2
  2. Sexual Function and Fertility Disorders
  3. Urinary Function Disorders
  4. Urine
  5. Semen
Interventions
  1. Diagnostic Test: SARS-CoV 2 RNA PCR Urine
  2. Diagnostic Test: SARS-CoV 2 RNA PCR Semen
  3. Diagnostic Test: Semen Qualitative Analysis
  4. Diagnostic Test: IIEF-5 questionnaire
  5. Diagnostic Test: Male Sexual Health Questionnaire (MSHQ)
  6. Diagnostic Test: IPSS questionnaire
  7. Diagnostic Test: SECRET questionnaire
  8. Diagnostic Test: Interleukin assessment in semen
MeSH:Disease

Primary Outcomes

Description: SARS-CoV 2 RNA PCR in semen

Measure: SARS-CoV 2 presence in semen

Time: Enrollment

Description: SARS-CoV 2 RNA PCR in urine

Measure: SARS-CoV 2 presence in urine

Time: Enrollment

Description: Interleukin quantitative analysis in Semen, to assess if past inflammation due to SARS-CoV 2 Infection was present

Measure: Inflammation in Semen

Time: Enrollment

Description: Spermiogram done following WHO guidelines and criteria

Measure: Semen quantitative and qualitative analysis

Time: Enrollment

Secondary Outcomes

Description: International Index of Erectile Function (IIEF-5) questionnaire administration. Score range from 0 to 25. Higher scores mean good erectile function

Measure: Erectile Function

Time: Enrollment

Description: SExual Chronicle REcording Table (SECRET) questionnaire administration Questionnaire helps to assess the sexual habits of individuals

Measure: Sexual Habits

Time: Enrollment

Description: International Prostate Symptom Score (IPSS) questionnaire administration Score range from 0 to 35. Higher scores mean worst urinary function

Measure: Urinary function

Time: Enrollment

Description: Male Sexual Health Questionnaire Short Form (MSHQ-SF) admnistration Higher scores mean better sexual and ejaculatory function

Measure: Sexual and Ejaculatory Function

Time: Enrollment
16 Psychological Impact of Admission With Covid-19 During the SARS-CoV-2 Pandemic: Naturalistic Cohort Study With a Digital Intervention

Studies have shown that admission to hospital during a coronavirus epidemic is associated with increased levels of anxiety, depression and panic disorder. During the SARS-CoV-2 pandemic in North London the Royal Free Hospital admitted over 500 patients with Covid-19. As part of the standard of care, these patients are screened at 8 weeks post discharge for signs of anxiety and depression. The Feeling Good app is a NHS approved digital application which utilises applied relaxation, mindfulness based cognitive therapy and positive visualisation through audio tracks for the treatment of anxiety and depression. This is a naturalistic cohort study aimed to track the post illness psychological symptoms of those who have been admitted with Covid-19 to the Royal Free hospital up to 5-7 months after discharge. The study population is those who are exhibiting anxiety or depressive symptoms as measure by the PHQ-2 or TSQ questionnaires. All those with symptoms will be offered free access to a NHS approved app for anxiety and depression, and followed up for 3 months after recruitment to track changes to their symptoms.

NCT04449627
Conditions
  1. Anxiety Disorders
  2. Post Traumatic Stress Disorder
  3. Depressive Disorder
  4. Covid19
Interventions
  1. Other: Feeling Good Digital App
MeSH:Disease Depressive Disorder Stress Disorders, Traumatic Anxiety Disorders Stress Disorders, Post-Traumatic
HPO:Depressivity

Primary Outcomes

Description: Generalised anxiety disorder score (GAD-7) scale. Score 0-21, with a higher score associated with greater anxiety symptoms. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. GAD-7 score at baseline will be controlled for.

Measure: Anxiety as measured by generalised anxiety disorder score (GAD-7) scale

Time: Day 14

Secondary Outcomes

Description: The Patient Health Questionnaire (PHQ-9) is a screening tool for the identification of depressive disorders, which has been validated for use in primary care. Each of the nine items in the questionnaire is based on the DSM diagnostic criteria for clinical depression. The PHQ-9 is scored out of 27 according to severity, where score of 5-9 indicates mild depression, 10-14 moderate, 15-19 moderately severe, and 20 or above severe depression.

Measure: Depression as measured by the patient health questionnaire 9 (PHQ-9)

Time: 14 days and week 12

Description: The Trauma screening questionnaire (TSQ) is a 10 point scale used to identify symptoms of post traumatic stress disorder (PTSD), with a score between 0 and 10, with a score of 6 or higher scored as positive.

Measure: Trauma as measured by Trauma screening questionnaire (TSQ)

Time: 12 weeks

Description: Generalised anxiety disorder score (GAD-7) scale. Score 0-21, with a higher score associated with greater anxiety symptoms. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. GAD-7 score at baseline will be controlled for.

Measure: Anxiety as measured by generalised anxiety disorder score (GAD-7) scale

Time: Week 12

Other Outcomes

Description: Risk factors for psychological distress from admission with Covid-19 will be collected, these will include, age, gender, ethnicity, length of hospital stay, oxygen requirement, co-morbidites, years of education, smoking status, occupation.

Measure: Risk associated with distress

Time: Baseline analysis

Description: Framework analysis. Qualitative feedback of patient experience. Semi structured interviews of a subset of patients will be performed to gain further insight into the patient experience. These will be analysed using a framework thematic analysis, to identify themes which will then be used to code the text.

Measure: Qualitative analysis

Time: Baseline
17 Therapies to Achieve Treatment Goals While Being Exposed to Hygiene and Distance Rules: Feasibility and Benefits of Digital Services During the COVID19 Pandemic (Anhand-COVID19)

As a result of the pandemic, hygiene and distancing rules must be followed in Health care/ rehabilitation clinics to ensure the safety of patients and staff. This has led to extensive changes in the therapy processes, including a reduction in group sizes and maintaining distances within the groups, resulting in a reduction in the range of therapies available to individuals, since the number of employees remains unchanged and cannot be increased at will and in the short term due to the lack of qualified staff. In order for the treatment/rehabilitation goals to be achieved nonetheless, new forms of implementation of therapy programs must be developed in addition to organizational adjustments. Digitalization can be a significant support in this respect. The majority of patients in psychosomatic rehabilitation/parkinson treatment possess smartphones, meaning that the necessary infrastructure for the utilization of digital offers is available and can be used to the greatest possible extent. The use of digital measures within the therapeutic services supports the independence of the patients, as they can use the digital offers independently and flexibly in their own time. How should Health care/rehabilitation services be designed in light of the SARS-CoV-2 pandemic and which services have the potential to buffer future crises: What general recommendations can be derived for the design of such services for routine care?

NCT04453475
Conditions
  1. Psychosomatic Disorder
  2. Parkinson
  3. Psychological Distress
  4. Psychological Stress
  5. Psychological Disease
  6. Psychological Disorder
  7. Psychological Impairment
  8. Psychological Disability
  9. Psychological Adjustment
  10. Psychological Adaptation
  11. Communication
  12. Health Care Seeking Behavior
  13. Anxiety
  14. Behavior, Health
  15. Health Risk Behaviors
  16. Healthy Lifestyle
Interventions
  1. Behavioral: Training session adressing information and health literacy
MeSH:Disease Psychophysiologic Disorders Stress, Psychological Mental Disorders Somatoform Disorders

Primary Outcomes

Description: Quantitative online questionnaire Survey using UniPark

Measure: Interest in digital interventions (attitudes, behavioral intentions, behavioral experiences)

Time: T1 (prior/beginning of rehab/clinic stay); T2 (end of rehab/clinic stay approx. 5 weeks after T1)

Description: Quantitative online questionnaire Survey using UniPark

Measure: Usability and effectiveness of digital interventions

Time: T1 (prior/beginning of rehab/clinic stay); T2 (end of rehab/clinic stay approx. 5 weeks after T1)

Description: Quantitative online questionnaire Survey using UniPark

Measure: Stressors and barriers due to Covid-19

Time: T1 (prior/beginning of rehab/clinic stay); T2 (end of rehab/clinic stay approx. 5 weeks after T1)
18 EMERALD: Can a Virtual Eye Movement Desensitisation and Reprocessing Intervention Improve Psychological Outcome Following Covid-19 Related Critical Illness: A Feasibility Trial

Primary objective is to evaluate the feasibility of delivering an online early Eye Movement Desensitisation Reprocessing (EMDR) Recent Traumatic Events Protocol (R-TEP) to patients who have survived Covid-19 related critical illness, within the context of a randomised controlled trial (RCT). This will inform the design of a future RCT investigating the effectiveness of EMDR R-TEP in reducing psychological symptoms, for adult survivors of intensive care.

NCT04455360
Conditions
  1. Post Traumatic Stress Disorder
  2. Intensive Care Psychiatric Disorder
  3. Anxiety Disorders
  4. Depression
  5. Critical Care
  6. COVID
Interventions
  1. Other: Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol
MeSH:Disease Critical Illness Stress Disorders, Traumatic Anxiety Disorders Stress Disorders, Post-Traumatic Mental Disorders Problem Behavior
HPO:Behavioral abnormality

Primary Outcomes

Description: Feasibility will be determined by the following measures: Able to recruit >30% of eligible patients approached Complete early EMDR intervention programme in 75% or more of trial participants randomised to intervention. Protocol adherence Assignment of causality of serious events will be assessed by the chief investigator. Events attributable to trial procedures will be reviewed by trial management board, study sponsor and the research ethics committee, in order to determine ongoing feasibility. Outcome measures completed in 75% or more of trial participants

Measure: Feasibility of recruitment, intervention adherence, incidence of treatment related adverse events and trial completion to final assessment timepoints

Time: 12 months

Secondary Outcomes

Description: The PTSD Checklist-Civilian Version (PCL-C) is a validated, standardised self-reporting questionnaire for PTSD comprising of 17 items that correspond to key PTSD symptoms

Measure: Post-Traumatic stress disorder

Time: 6 months post-hospital discharge

Description: Hospital Anxiety and Depression Scale (HADS) is a 14-item, self-reported measure with 7-items relating to symptoms of anxiety and 7-items relating to depression

Measure: Anxiety and depression

Time: 6 months

Description: Montreal Cognitive Assessment (MoCA) is a validated tool, used to detect cogntive impairment

Measure: Cognitive function

Time: 6 months post-hospital discharge

Description: EQ5D -5L comprises five quality-of-life dimensions; mobility, self-care, usual activities, pain/discomfort andanxiety/depression.

Measure: Health Related Quality of Life

Time: 6 months post-hospital discharge

Description: WHODAS 2.0 is a generic assessment tool that produces standarised disability levels and profiles

Measure: Health and disability

Time: 6 months post-hospital discharge

Description: Wrist worn physical activity monitoring

Measure: Physical activity

Time: 6 months post-hospital discharge

Description: Patient generated subjective global assessment

Measure: Nutritional status

Time: 6 months post-hospital discharge
19 Woebot for Substance Use Disorders During COVID-19

The purpose of this study is to test the efficacy of a substance use disorder intervention delivered via a mobile application in an adult population during the COVID-19 pandemic. This study that will test the comparative efficacy of the mobile-app based substance use disorder program to reduce substance use relative to a wait list control condition, and explore between group differences on quality of life indices as well as retention and engagement during COVID-19.

NCT04460027
Conditions
  1. Substance Use Disorders
  2. Alcohol Use Disorder
Interventions
  1. Other: Woebot Substance Use Disorder
MeSH:Disease Alcoholism Substance-Related Disorders

Primary Outcomes

Measure: Change of number of days drinking

Time: Difference between baseline and post-treatment (8 weeks from baseline)

Measure: Change of number of days drug use

Time: Difference between baseline and post-treatment (8 weeks from baseline)

Secondary Outcomes

Measure: Alcohol Use Disorder and Associated Disabilities Interview Schedule-5 (AUDADIS-5 (AUDADIS-V)

Time: Difference between baseline and post-treatment (8 weeks from baseline)

Measure: Short Inventory of Problems - Alcohol and Drugs (SIP-AD)

Time: Difference between baseline and post-treatment (8 weeks from baseline)

Measure: Drug Abuse Screening Test (DAST-10)

Time: Difference between baseline and post-treatment (8 weeks from baseline)

Measure: Brief Situational Confidence Questionnaire (BSCQ)

Time: Difference between baseline and post-treatment (8 weeks from baseline)

Measure: Craving rating

Time: Difference between baseline and post-treatment (8 weeks from baseline)

Description: Range from 0-100 (no pain to worst pain imaginable)

Measure: Pain rating

Time: Difference between baseline and post-treatment (8 weeks from baseline)

Description: Total score between 0-27, higher scores indicate greater levels of depression

Measure: Patient Health Questionnaire-9 (PHQ-9)

Time: Difference between baseline and post-treatment (8 weeks from baseline)

Description: Total score between 0-21, higher scores indicate greater levels of anxiety

Measure: General Anxiety Disorder-7 (GAD-7)

Time: Difference between baseline and post-treatment (8 weeks from baseline)

Measure: CAIR Pandemic Impact Questionnaire (CAIR-PIQ)

Time: Difference between baseline and post-treatment (8 weeks from baseline)

Description: Range from 8 to 32, with higher values indicating higher satisfaction

Measure: Client Satisfaction Questionnaire (CSQ)

Time: Post-treatment (8 weeks from baseline)

Measure: Usage Rating Profile Intervention (URPI)

Time: Post-treatment (8 weeks from baseline)
20 Objective Assessment of Olfactory Dysfunction and Impact on Quality of Life in SARS CoV-2 (COVID-19)Infection Using the UPSIT, eQOD and SNOT-22 Questionnaires: A Prospective Observational Cohort Study

This study is designed to investigate the acuity of olfactory dysfunction in COVID-19 positive patients in the United Kingdom. In particular defining severity with objective testing and determining if this has any predictive value on the outcome of the SARS CoV-2 infection. In addition, this study will strive to determine duration / natural history of olfactory dysfunction in these patients in respect to a positive SARS CoV-2 diagnosis. It should also demonstrate the impact of olfactory dysfunction on patient Quality of Life (QOL).

NCT04466982
Conditions
  1. Olfactory Disorder
  2. COVID19
  3. SARS-CoV-2
  4. Anosmia
  5. Microsomia
  6. Smell Disorder
  7. Quality of Life
MeSH:Olfaction Disorders Disease
HPO:Anosmia

Primary Outcomes

Description: I. Primary endpoint is olfactory function assessed using the UPSIT and classified as Anosmia; Mild, moderate, and severe microsomia. assessed at the time COVID-19 diagnosis (+1 week) or at the time of registration for in hospital patients

Measure: UPSIT scores

Time: At time of diagnosis (+1 week ) post COVID 19 diagnosis or at time of recruitment into study

Secondary Outcomes

Description: I. The changes in olfaction in patients with SARS CoV-2 infection over an initial 12 month period (at day 0, 1 month, 3 month, 6 month, 9 month and 12 month) using the UPSIT.

Measure: UPSIT scores

Time: at day 0, 1 month, 3 month, 6 month, 9 month and 12 month

Description: Quality of Life using the validated Questionnaire of Olfactory Disorders for English speakers (eQOD)

Measure: eQOD scores

Time: at day 0, 1 month, 3 month, 6 month, 9 month and 12 month

Description: Quality of Life using the validated SinoNasal Outcome Tool-22 (SNOT-22)

Measure: SNOT 22 scores

Time: at day 0, 1 month, 3 month, 6 month, 9 month and 12 month
21 Impact of the Psychiatric Intervention OLAF on the Post Traumatic Disorder in the Relatives of Patients Hospitalized in Intensive Care Unit During the SARS-Cov-2 Pandemic Confinement in France.

The investigators thought that the confinement measure took in France could induce an increase in the post traumatic syndrome in the relative of patient hospitalized in ICU during this period indeed the restricted visit and the limited interaction with ICU team are documented risk factors for PTSD in this population. The investigators designed an intervention in order to prevent the effect of the confinement measures on PTSD in relatives named OLAF. In this research the investigators aimed to study the impact on this intervention on PTSD.

NCT04470869
Conditions
  1. Post Traumatic Stress Disorder
Interventions
  1. Other: Phone call
MeSH:Disease Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

Description: To demonstrate the benefits of a comprehensive family approach (OLAF) on the incidence of PTSD observed in 2 close referents of a patient, 6 months after leaving the intensive care unit, in the context of confinement linked to the SARS pandemic- CoV2.

Measure: incidence of PTSD observed 6 months after patient's discharge from the intensive care unit

Time: Month 6

Secondary Outcomes

Description: The incidence of PTSD 6 months after patient's death in the intensive care unit

Measure: incidence of PTSD observed 6 months after patient's death in the intensive care unit

Time: Month 6

Description: The incidence of PTSD 3 months after the death or discharge from the intensive care unit

Measure: PTSD incidence at month 3

Time: Month 3

Description: The incidence of PTSD 12 months after the death or discharge from the intensive care unit

Measure: PTSD incidence at month 12

Time: Month 12

Description: The incidence of symptoms of anxiety and / or depression 3 months after death or discharge from the intensive care unit

Measure: Symptoms incidence at month 3

Time: Month 3

Description: The incidence of symptoms of anxiety and / or depression 6 months after death or discharge from the intensive care unit

Measure: Symptoms incidence at month 6

Time: Month 6

Description: The incidence of symptoms of anxiety and / or depression 12 months after death or discharge from the intensive care unit

Measure: Symptoms incidence at month 12

Time: Month 12

Description: The incidence of persistent complicated grief 3 months after death in intensive care

Measure: incidence of persistent complicated grief at month 3

Time: Month 3

Description: The incidence of persistent complicated grief 6 months after death in intensive care

Measure: incidence of persistent complicated grief at month 6

Time: Month 6

Description: The incidence of persistent complicated grief 12 months after death in intensive care

Measure: incidence of persistent complicated grief at month 12

Time: Month 12
22 Taste and Smell Impairment in Critically Ill COVID-19 Patients

Evaluating the smell and taste perceptions of patients hospitalized in the intensive care unit with suspicion of Coronavirus disease-19 diagnosis with a survey study

NCT04532632
Conditions
  1. Smell Disorder
  2. Taste Disorders
  3. Coronavirus Infection
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Taste Disorders Olfaction Disorders Disease
HPO:Anosmia

Primary Outcomes

Description: incidence of taste and smell impairment in critically ill subjects

Measure: taste and smell impairment

Time: up to 3 months
23 Impact of COVID-19 on Unplanned Admissions for Acute Cardiovascular and Neurovascular Conditions in France

The COVID-19 pandemic has had dramatic effects on health systems and on non-COVID health care. Using French inpatient claims data and retrospectively collected clinical data, the investigators will assess the changes in hospital admissions for acute cardiovascular and neurovascular conditions in France during and after the national lockdown.

NCT04542083
Conditions
  1. COVID-19
  2. Acute Cardiovascular Condition
  3. Acute Neurovascular Condition
  4. Stroke
  5. Acute Myocardial Infarction
MeSH:Stroke Myocardial Infarction Infarction Disease
HPO:Myocardial infarction Stroke

Primary Outcomes

Description: Daily number of admissions for acute cardio- and neurivascular conditions in France.

Measure: Daily number of admissions for acute cardio- and neurivascular conditions in France.

Time: 1 day

Secondary Outcomes

Description: Specific mortality rate.

Measure: Specific mortality rate.

Time: 1 day
24 Clinical Correlates of COVID-19 Pandemic in Patients With Functional Movement Disorder (FMD) and Parkinson's Disease (PD)

The purpose of this study is to investigate the clinical correlates of the effects of the COVID-19 pandemic on patients with Functional movement disorder (FMD) and Parkinson s Disease (PD). Primary objectives: To evaluate the change in neurological symptoms domain of the survey between pre and post-COVID 19 in FMD and PD patients. Secondary objectives: - To evaluate the change in total score of the survey between pre and post COVID 19 in FMD and PD patients - To evaluate the change in other symptom domains of the survey between pre and post COVID 19 in FMD and PD patients. Domains include: Mood/Energy, sleep, symptoms of abnormal movements related or unrelated to primary disease, physical health and exercise related change Exploratory objectives: - To evaluate whether there is a modifying effect of disease group in the changes in total score or symptom domains - To evaluate whether there is a relationship between disease severity and changes in total score or symptom domains - To evaluate whether there is a correlation between changes across symptom domains - To evaluate whether there is a correlation in raw score across symptom domains within each period Research Methods: Data will be solely collected through the use of online instruments via CiSTAR as a designed questionnaire. Questionnaire items A questionnaire aimed at determining the effects of the COVID 19 pandemic and subsequent isolation on functional state of patients with FMD and PD. The questionnaire items include: Items investigating Mood/Energy before and after COVID 19 out break Items investigating Sleep habits before and after COVID 19 out break Items investigating Neurological symptoms before and after COVID 19 out break Items investigating daily functioning before and after COVID 19 out break Items investigating Exercise habits before and after COVID 19 out break No questionnaire items will be actionable , which are items that would identify an imminent risk for participant safety requiring urgent and immediate medical or psychiatric

NCT04565080
Conditions
  1. Parkinson's Disease
  2. Functional Movement Disorders
  3. COVID-19
MeSH:Parkinson Disease Movement Disorders Disease Conversion Disorder
HPO:Abnormality of movement

Primary Outcomes

Description: Change in neurological symptoms domain of the survey between pre and post COVID 19 in FMD and PD patients.

Measure: Change in neurological symptoms domain of the survey between pre and post COVID 19 in FMD and PD patients.

Time: December 2021
25 Dysphagia and Dysphonia Outcomes in SARS CoV-2 (COVID-19): A Prospective Observational Cohort Study.

This study examines the presence, severity and natural history of dysphagia and dysphonia in the post-extubation and severely unwell COVID-19 patient.

NCT04584658
Conditions
  1. Dysphagia
  2. Dysphonia
  3. Subglottic Stenosis
  4. Voice Disorders
  5. Swallowing Disorder
  6. Covid19
  7. SARS (Severe Acute Respiratory Syndrome)
  8. SARS Pneumonia
  9. Quality of Life
  10. SARS-CoV-2 Infection
Interventions
  1. Diagnostic Test: Fibreoptic Endoscopic Evaluation of Swallowing (FEES)
  2. Diagnostic Test: Videofluoroscopy
  3. Other: Dysphagia Handicap Index (DHI)
  4. Other: Voice Symptom Scale (VoiSS)
MeSH:Infection Severe Acute Respiratory Syndrome Coronavirus Infections Deglutition Disorders Dysphonia Hoarseness Voice Disorders Disease
HPO:Dysphagia Dysphonia Hoarse voice Oral-pharyngeal dysphagia Weak voice

Primary Outcomes

Description: Based on therapy outcome measures from FEES, VoiS

Measure: Primary endpoint is severity of dysphonia and dysphagia at the time of initial assessment t = day 0 (for ITU patients: Day 0 = 24 hours after extubation or decannulation).

Time: t = day 0 (for ITU patients: Day 0 = 24 hours after extubation or decannulation).

Secondary Outcomes

Description: Clinical assessment including outcome measures, FEES and/or Videofluoroscopy

Measure: The severity of dysphonia and/or dysphagia over an initial 12 month period (at t = 14 days, 1 month, 3 months, 6 months, 9 months, 12 months)

Time: t = 14 days, 1 month, 3 months, 6 months, 9 months, 12 months

Description: Clinical assessment including outcome measures, FEES and/or Videofluoroscopy

Measure: The severity of dysphonia and/or dysphagia at t = day 5, day 10, day 14, day 21 - For in-patients only.

Time: t = day 5, day 10, day 14, day 21 - For in-patients only.

Description: Clinical assessment including outcome measures, FEES and/or Videofluoroscopy

Measure: Relationship between severity of dysphonia and/or dysphagia with grade of ARDS

Time: t = day 0 and 9 months

Description: Clinical assessment including outcome measures, FEES and/or Videofluoroscopy

Measure: Relationship between severity of dysphonia and/or dysphagia with length of intubation

Time: t = day 0 and 9 months

Description: Clinical assessment including outcome measures, FEES and/or Videofluoroscopy

Measure: Relationship between severity of dysphonia and/or dysphagia with duration of mechanical ventilation

Time: t = day 0 and 9 months

Description: Questionnaire assessment: This is a 30-item validated quality of life tool that is also a self-reporting tool. It appraises the impact of the patient's abnormal voice from an emotional perspective, related physical symptoms and stratifies the impairment itself in context of day to day activities. VoiSS is currently the most psychometrically robust voice outcome measure. Each item is scored 0 - 4 on the frequency responses: never, occasionally, some of the time, most of the time, always. The total score of 120 measures general voice pathology which is made up of Impairment = maximum score of 60; Emotional = maximum score of 32; Physical = maximum score of 28

Measure: Relationship between severity of dysphonia on quality of life using Voice Symptom Scale (VoiSS) questionnaire over time at day 0, 1 month and 9 months.

Time: t = day 0, 1 month and 9 months.

Description: Questionnaire assessment: This is a 25-item questionnaire assessing three domains: physical (9 items), functional (9 items), and emotional aspects (7 items) of the Quality of Life (QOL) in patients suffering with dysphagia. For each statement the patient checks if it applies to him/her all the time, some of the time or never. The suggested scores are 0, 2 and 4, respectively. Using this scoring system amounts to a DHI score range of 0 - 100. The higher the score, the worse the dysphagia related QOL. The patient is also asked to provide a rating of their own impression of the severity of the dysphagia experienced on a scale from 1 (normal) to 7 (severe problem).

Measure: Relationship between severity of dysphagia on quality of life using Dysphagia Handicap Index (DHI) questionnaire over time at day 0, 1 month and 9 months

Time: t = day 0, 1 month and 9 months
26 Evaluation of the Safety, Tolerability and Efficacy of Regenerative Therapy for the Treatment of Various Chronic and Acute Conditions

This multi-arm, multi-site study investigates the safety, tolerability, and efficacy of stem cell therapy for the treatment of various acute and chronic conditions. Clinically observed initial findings and an extensive body of research indicate regenerative treatments are both safe and effective for the treatment of multiple conditions.

NCT04684602
Conditions
  1. Autoimmune Diseases
  2. Cardiovascular Disorders
  3. Diabetes Complications
  4. Integumentary Disease
  5. Musculoskeletal Disorders
  6. Neurodegenerative Disorders
  7. Neurologic Disorders
  8. Pulmonary Disorders
  9. Sexual Dysfunction
  10. Urologic Disorders
  11. Viral Illness
Interventions
  1. Biological: PrimePro™/ PrimeMSK™
MeSH:Musculoskeletal Diseases Lung Diseases Nervous System Diseases Neurodegenerative Diseases Cardiovascular Diseases Skin Diseases Diabetes Complications Autoimmune Diseases Disease
HPO:Abnormal lung morphology Abnormality of the cardiovascular system Abnormality of the skin Autoimmunity Neurodegeneration

Primary Outcomes

Description: General Health Outcome Instrument used to derive a simple psychometric score for health related quality of life which provides scores on various dimensions or items describing the systems. The score is derived by adding the unweighted response order of each question, with a lower score denoting a better quality of life.

Measure: Assessment of quality of life (QOL) via 36-Item Short Form Survey (SF-36) change from baseline at 6 and 12 months.

Time: Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.

Description: Upper Extremity Outcome Instrument

Measure: Assessment of disabilities of arm, shoulder, hand via DASH Questionnaire change from baseline at 6 and 12 months.

Time: Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.

Description: Erectile Function Questionnaire. Scoring exists from 0 to 25. The lower the score, the more severe the Erectile Dysfunction.

Measure: Assessment of erectile function via International Index of Erectile Function (IIEF-5) change from baseline at 6 and 12 months.

Time: Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.

Description: COPD Outcome Instrument. Items are scored on a Likert scale (range 0-60). Higher scores indicate a worse health status.

Measure: Assessment of COPD via Clinical Chronic Obstructive Pulmonary Disease Questionnaire change from baseline at 6 and 12 months.

Time: Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.

Description: Memory Outcome Instrument. The maximum MMSE score is 30 points. The lower the score, the more severe the dementia.

Measure: Assessment of mental state via Mini Mental State Examination (MMSE) change from baseline at 6 and 12 months.

Time: Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.

Description: Voiding and Pain Indices. Possible score of 0-20 with higher scores denoting better function.

Measure: Assessment of interstitial cystitis via O'Leary/Sant Questionnaire change from baseline at 6 and 12 months.

Time: Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.

Description: Low Back Pain Outcome Instrument. Possible score of 0-100 with lower scores denoting better function.

Measure: Assessment of back pain via Oswestry Low Back Pain Disability Questionnaire change from baseline at 6 and 12 months.

Time: Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.

Description: Arthritis Outcome Instrument. Individual question scores are then summed to form a raw score ranging from 0 (worst) to 96 (best)

Measure: Assessment of osteoarthritis via Western Ontario and McMaster Osteoarthritis Index (WOMAC) change from baseline at 6 and 12 months.

Time: Follow up time-frames will measure changes occurring from baseline post procedure at 6 months and 12 months.

HPO Nodes


HPO

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


HPO Nodes


Reports

Data processed on January 01, 2021.

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

4,818 reports on interventions/drugs

MeSH

706 reports on MeSH terms

HPO

306 reports on HPO terms

All Terms

Alphabetical index of all Terms

Google Colab

Python example via Google Colab Notebook