linjc16/ctgov huggingface dataset:
Study of Impact of Art Therapy Sessions Given to Family Caregivers of Children With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
Diagnostic of diabetes in childhood brought modification of family way of life, particularly in child and caregivers lifes. The education patient programs are in France centered on curative competencies of care. It is possible that art-therapy improve psycho-social competencies The aim of the study is to evaluate art-therapy sessions on quality of life of caregivers

Conditions
-----------------
Quality of Life

Intervention / Treatment
-----------------
* Behavioral: art-therapy sessions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: one of the family caregivers of child with diabetes enrolled in patient education programs of 3 hospitals (Hospital of Poitiers, Hospital of Niort and Hospital of La Rochelle) who accept the study ≥ 18 years free, with protection of vulnerable adult caregivers of child with who have insurance with free, enlightened, signed consent Exclusion Criteria: other research participation < 18 years host family with protection of vulnerable adult caregivers of child with who have not insurance

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: art-therapy sessions<br>Caregivers will receive 6 art-therapy sessions | Behavioral: art-therapy sessions<br> <br> |
| No Intervention: no art-therapy sessions<br>Caregivers will not receive 6 art-therapy sessions during the evaluation period | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PedsQL Family Impact score to assess Family Quality of Life |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety score of caregivers |  | 6 weeks | 
| self esteem score of caregivers |  | 6 weeks | 
| quality of life score |  | 6 weeks | 
| satisfaction score |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Art Therapy, Caregiver's
To Find Out Whether Valsartan With or Without Other Blood Pressure Medications Would Improve the Ability of the Heart to Fill and Empty, and the Ability of the Heart Muscle to Relax Adequately in People With High Blood Pressure.

Study Overview
=================
Brief Summary
-----------------
Patients who have had high blood pressure for a long time may have diastolic dysfunction. Diastolic Dysfunction is when your heart has difficulty filling and emptying, and relaxing adequately. This study is to find out if Valsartan) will improve the ability of the heart to fill, empty, and relax appropriately when given alone or with other medicines to treat high blood pressure.

Official Title
-----------------
A Multi-center, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Effect of the Angiotensin II Antagonist Valsartan on Diastolic Function in Patients With Hypertension and Diastolic Dysfunction

Conditions
-----------------
Hypertension, Diastolic Dysfunction

Intervention / Treatment
-----------------
* Drug: Valsartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis/History of high blood pressure Male or Female age 45 years or older Exclusion Criteria: History of stroke, transient ischemic attack or heart attack within the last 6 months A hospital admission for congestive heart failure within the last year Use of certain high blood pressure medications such as ACE inhibitors, Angiotensin Receptor Blockers or aldosterone antagonists or other agents that may work in the same pathway (RAAS) as valsartan within the past 3 months. Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Valsartan|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in diastolic heart function at 38 weeks, measured by echocardiogram |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the wall thickness of left heart ventricle after 38 weeks |  |  | 
| Change from baseline in the size (mass) left heart ventricle after 38 weeks |  |  | 
| Change from baseline in heart function after 38 weeks |  |  | 
| Change from baseline in circulating marker of ventricular function after 38 weeks |  |  | 
| Change from baseline in circulating marker of inflammation |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, High Blood Pressure, Diastolic Dysfunction,, Heart Disease
Imaging Study of Chronic Low Back Pain in Patients Taking Pain Medication

Study Overview
=================
Brief Summary
-----------------
Duloxetine has recently been shown to be effective in reducing the pain in chronic pain patients. Duloxetine is known to exert a central mechanism, however the precise human brain structures responsible for mediating its pain-relieving properties are not known. We will use functional magnetic resonance imaging (FMRI) to investigate the neural and functional correlates of pain.

Official Title
-----------------
Functional MRI Neural Correlates of Medication Efficacy in Patients With Chronic Low Back Pain

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Drug: duloxetine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:- Males aged 18-60 Back Pain Must be able to comply with study visit schedule and other study requirements Capable of performing the experimental tasks Exclusion Criteria:- Contraindications for MRI examination (e.g., metallic implants such as pacemakers, surgical aneurysm clips, or known metal fragments embedded in the body) Known hypersensitivity to duloxetine or any of the inactive ingredients Uncontrolled narrow-angle glaucoma

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo - sugar pill<br> | Drug: Placebo<br>* Placebo pill once daily<br>|
| Experimental: Duloxetine<br> | Drug: duloxetine<br>* 30-60mg of duloxetine daily<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Brief Pain Inventory (BPI) scores were obtained at baseline, weeks 1, 2, 6, 7, 8, and 12, and a follow-up visit one week after completing the study. Responses are rated on a scale from 0-10, with 0 = no pain and 10 = pain as bad as you can imagine. Placebo and duloxetine pain scores calculated by averaging pain scores from each visit after baseline. Values were converted to percent change in pain: [(baseline pain - end point pain)/baseline pain] x 100. | 3 months | 
| Neural Correlates of Pain Relief | Scores reflect the average connectivity strength of that region of interest to the rest of the cortex. There were no minimum or maximum values on this scale. Higher scores reflect stronger connectivity, and lower scores reflect less connectivity (all scores fell within -3 and 3). Subscales are averaged. | 3 months |
HPA Axis Activity Due To Early Traumatic Stress and Metabolic Symptoms

Study Overview
=================
Brief Summary
-----------------
This study evaluates the association between early trauma, depression and metabolic symptoms.

Detailed Description
-----------------
Early traumatic stress is associated with alterations of the hypothalamic-pituitary-adrenal axis (HPA-axis) indicated by an increased response to stress, a diminished negative feedback and alterations in expression of glucocorticoid receptors. Patients with a history of childhood trauma are more likely to develop metabolic disorders such as diabetes mellitus type 2 or metabolic syndrome. The investigators will examine participants with and without early life stress and with and without major depression. The investigators assume that traumatized study participants (1) show an increased endocrine stress reaction to psychosocial stress, (2) display an altered sensitivity of GR, and (3) therefore suffer from an adverse cardiovascular risk profile in comparison to not-traumatized participants. The investigators study will increase current knowledge on possible sequel of early traumatic stress. The results will lead to a more comprehensive understanding of stress-related eating behaviour and its implications.

Official Title
-----------------
Altered Hypothalamic-Pituitary-Adrenal Axis (HPA-Axis) Activity Due To Early Traumatic Stress and Its Relevance for Metabolic Symptoms

Conditions
-----------------
Childhood Trauma, Major Depressive Disorder

Intervention / Treatment
-----------------
* Other: stress


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of MDD and/or experience of early trauma Exclusion Criteria: severe illness, control group: no diagnosis of MDD and experience of early trauma

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Depression with early trauma<br>stress | Other: stress<br> <br> |
| Experimental: Depression without early trauma<br>stress | Other: stress<br> <br> |
| Experimental: Healthy with early trauma<br>stress | Other: stress<br> <br> |
| Experimental: Healthy without early trauma<br>stress | Other: stress<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endocrine response to stress (salivary cortisol) | salivary cortisol | 2 hours | 
| glucose to oral glucose tolerance test (plasma insulin) | plasma glucose | 2 hours | 
| insulin to oral glucose tolerance test (plasma insulin) | plasma insulin | 2 hours | 
| cortisol to corticotropin releasing factor (salivary cortisol) | salivary cortisol | 3 hours |
Immune Checkpoint Inhibitors and Pre-existing Autoimmune Diseases

Study Overview
=================
Brief Summary
-----------------
The tolerance of immune checkpoint inhibitors is unknown in patients with pre-existing autoimmune conditions. This retrospective nation-wide study will assess their tolerance in patients with pre-existing autoimmune conditions who received immune checkpoint inhibitors for an advanced cancer in clinical practice.

Official Title
-----------------
Retrospective Observational Study on the Safety of Immune Checkpoint Inhibitors in the Treatment of Advanced Melanoma and Lung Cancers in Patients With Pre-Existing Autoimmune Diseases

Conditions
-----------------
Autoimmune Diseases, Advanced Cancer

Intervention / Treatment
-----------------
* Drug: Checkpoint inhibitor therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pre-existing autoimmune disease as diagnosed by the physician Immune checkpoint inhibitor therapy for an advanced cancer Exclusion Criteria: Auto-immune disease developed only after the start of the immune checkpoint inhibitor therapy Absence of follow-up

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Checkpoint inhibitor therapy|Treatment by ipilimumab, nivolumab or pembrolizumab for advanced cancer in clinical practice|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Autoimmune disease flare | Increase in the activity of the pre-existing autoimmune disease as assessed by the treating physician | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other immune/inflammatory complications | Development of a new immune/inflammatory condition after the start of the therapy | through study completion, an average of 1 year |
A Trial Investigating Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Male and Female Subjects Being Overweight or With Obesity

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in the United States of America. The aim of the trial is to investigate Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Male and Female Subjects being overweight or with obesity

Official Title
-----------------
A Double-blinded Placebo-controlled Multiple Dose Trial Investigating Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Male and Female Subjects Being Overweight or With Obesity

Conditions
-----------------
Metabolism and Nutrition Disorder, Obesity

Intervention / Treatment
-----------------
* Drug: NNC9204-0530
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, age between 18 and 55 years (both inclusive) at the time of signing informed consent Body mass index between 25.0 and 39.9 kg/m^2 (both inclusive) at screening. Exclusion Criteria: Haemoglobin A1c (HbA1c) equal or above 6.5% Any clinically significant weight change (above or equal to 5% self-reported change) or dieting attempts (e.g. participation in an organized weight reduction program) within the last 90 days prior to screening Any prior obesity surgery or currently present gastrointestinal implant. Abnormal ECG (electrocardiogram) results including 2nd or 3rd degree AV-block, prolongation of the QRS complex above 120 ms, or the QTcF interval above 430 ms (males) or above 450 ms (females), or other clinically relevant abnormal results, as judged by the investigator A history of additional risk factors for Torsades de pointes (e.g., heart failure, hypokalaemia, family history of Long QT Syndrome) History of pancreatitis (acute or chronic)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NNC9204-0530<br>Dose-escalation within the cohort before reaching final dose | Drug: NNC9204-0530<br>* Administered daily subcutaneously (s.c., under the skin)<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* Administered daily subcutaneously (s.c., under the skin)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of treatment emergent adverse events |  | Day 1-112 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the NNC9204-0530 serum concentration-time curve |  | Day 84-112 | 
| Time to maximum serum concentration of NNC9204-0530 |  | Day 84-112 | 
| Change in HbA1c |  | Day -1, Day 85 |
Epidemiology and Long-term Outcome of Patients With VHD

Study Overview
=================
Brief Summary
-----------------
Valvular heart diseases are significant problem in Polish population. Coexistence of coronary artery disease in patients with VHD increases the risk of death and affects further therapeutic strategy. The aim of the study is analysis the epidemiology and the long-term prognosis among patients with VHD.

Detailed Description
-----------------
Valvular heart diseases are significant problem in Polish population. Coexistence of coronary artery disease in patients with VHD increases the risk of death and affects further therapeutic strategy. Patients with moderate and severe valvular heart diseases are included into the study. The set of variables subject to interpretation consisted of demographic data, medical history, result of coronary angiography, and type of applied percutaneous and surgical treatment

Official Title
-----------------
Epidemiology and Long-term Prognosis of Patients With Valvular Heart Diseases (BIA-WAD Study)

Conditions
-----------------
Mitral Stenosis, Valvular Disease, Valvular Heart Disease, Aortic Valve Stenosis, Mitral Insufficiency and Aortic Stenosis, Coronary Artery Disease, Chronic Kidney Diseases

Intervention / Treatment
-----------------
* Procedure: Innovative medical technologies in invasive cardiology and cardiac surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Valvular heart disease in moderate and severe stages Exclusion Criteria: Age < 18 years old

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| VHD patients<br>Patients with moderate and severe valvular heart diseases | Procedure: Innovative medical technologies in invasive cardiology and cardiac surgery<br>* A follow-up study included the analysis of medical documentation of the Cardiosurgery and the Invasive Cardiology Departments to provided information on the duration and type of procedure performed.<br>* Other names: Cardiosurgery;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death | All-cause of mortality | 3665 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACCE | Mocardial infarction, stent thrombosis, stroke or transient ischemic attack, urgent revascularization | 3665 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Valvular Heart Disease, Aortic Valve Stenosis, Mitral Insufficiency, Coronary Artery Disease, Chronic Kidney Diseases
Observational Study of Males With Creatine Transporter Deficiency

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to illustrate the clinical, neuro/electrophysiologic, biochemical, and developmental status and progression of patients with Creatine Transporter Deficiency (CTD) and to evaluate the utility of performance-based and other measures in the CTD population.

Detailed Description
-----------------
This is an observational study designed to determine an appropriate clinical assessment battery for males with CTD, and to evaluate Magnetic resonance spectroscopy (MRS) along with other potential biomarkers. It is designed to explore developmental domains of interest and to examine the feasibility and utility of various neuropsychological assessments to measure domains of interest, and to identify possible endpoints for interventional studies. Study will also explore genotype-phenotype correlations. Clinical adverse events will be monitored throughout the study. This study was previously posted by Lumos Pharma, which has been transferred to Ultragenyx in June 2019.

Official Title
-----------------
Observational Study of Males With Creatine Transporter Deficiency

Conditions
-----------------
Creatine Deficiency, X-linked

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has genomic confirmation of a pathologic mutation in the SLC6A8 gene. Subject is able to complete study-related procedures. Subjects' parents/guardians/caregivers must provide written consent (informed consent) to study-related procedures, and if appropriate, the subject will provide an assent. Exclusion Criteria: Subject has had status epilepticus within 3 months of screening. Subject is unable to comply with the study procedures or with a clinical disease or laboratory abnormality that in the opinion of the investigator would potentially increase the risk of participation.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change Over Time Through Month 48 in the Bayley Scales of Infant and Toddler Development, 4th Edition (Bayley-4) |  | Month 48 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Creatine transporter, developmental delay, intellectual disability, X-linked, language, seizure, observational, brain spectroscopy