linjc16/ctgov huggingface dataset:
Internet Cognitive Behavioural Therapy to Patients With Heart Failure and Depression

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the short (9 weeks) and long (6 and 12 months) term effects of an 9 weeks intervention of internet-based cognitive behavioural therapy on depressive symptoms, worrying/anxiety, sleep, self-care knowledge and quality of life in patients with chronic heart failure and depression.

Official Title
-----------------
Internet Cognitive Behavioural Therapy to Patients With Heart Failure and Depression A Randomised Controlled Study of Short and Long Term Effects on Depressive Symptoms

Conditions
-----------------
Heart Failure, Depressive Symptoms

Intervention / Treatment
-----------------
* Behavioral: Cognitive behaviour therapy
* Behavioral: Discussion group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years have time to participate in the study, treatment for HF according to the European Society of Cardiology guidelines2 stable HF (NYHA class I-III) and not being hospitalized for HF the latest month signs of suffering of depressive symptoms (Patient Health Questionnaire-9 >9 points Exclusion Criteria: severe HF (NYHA IV) or another severe chronic life threatening disease. severe depression assessed to need hospital care

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cogntive behaviour therapy<br>Internet based Cognitive behaviour therapy during 9 weeks | Behavioral: Cognitive behaviour therapy<br>* Internet based, weekly home task and weekly feedback provided by health care professional.<br>|
| Active Comparator: Discussion group<br>Internet moderated discussion group during 9 weeks | Behavioral: Cognitive behaviour therapy<br>* Internet based, weekly home task and weekly feedback provided by health care professional.<br>Behavioral: Discussion group<br>* Internet moderated discussion group. Patients will be provided weekly question which will be used by the participant to start discuss with each others.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive Symptoms | Depressive Symptoms measured with Patient Health Questionnaire-9 (PHQ-9). The number of patients per study arm is planned to be n=60. According to an earlier metaanalysis, the effect size of internet CBT intervention can be expected to be at least at the level of 0.5. The score on the PHQ-9 ranges from 0-27. A score between 5-10 indicate a mild depression whereas a score >10 indicate at least moderate depression. | 9 weeks |
Safety of ADSTEM Injection in Patients With Moderate to Severe Subacute and Chronic Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate safety in subjects with over moderately subacute and chronic atopic dermatitis after an intravenous injection of ADSTEM Inj. Since this is an observational study of patients participated in Phase 1 clinical trials, no drug is administered in this study.

Detailed Description
-----------------
Participants will be followed-up for adverse events on each visit. Visits will be on 6, 12, 18, 24, 30, 36, 48, 60months after treatment of ADSTEM Inj. Time perspective is both retrospective and prospective.

Official Title
-----------------
Observational Study to Evaluate the Safety of ADSTEM Injection in Patients With Moderate to Severe Subacute and Chronic Atopic Dermatitis

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Drug: ADSTEM Inj.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who participated in Phase I clinical trials Patients who voluntarily agreed to participate in the study Exclusion Criteria: Patients who can not follow-up from the end of the phase 1 clinical trial to the end of the study

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 70 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 |
| --- | --- |
| Drug: ADSTEM Inj.<br>Participants in Phase I clinical trials treated with ADSTEM Inj. | Drug: ADSTEM Inj.<br>* ADSTEM Inj. 1.0x10^8 mesenchymal stem cells as an intravenous infusion once in Phase I clinical trial. ADSTEM Inj. 3.0x10^8 mesenchymal stem cells as an intravenous infusion once in Phase I clinical trial.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor formation | The number of subjects with treatment-related tumor formation | 60months after treatment of ADSTEM Inj. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | The number of subjects with treatment-related adverse events | 60months after treatment of ADSTEM Inj. |
Multi-slice CT Coronary Angiography in Patients With Stable Angina

Study Overview
=================
Brief Summary
-----------------
early identification of vulnerable plaques by remodeling index prior to rupture and development of acute event is of considerable importance especially by a reliable non-invasive method as CT coronary angiography.

Detailed Description
-----------------
single-center, cross section, observational study included 150 patients with stable angina with normal resting ECG, negative markers, normal systolic function by 2D echocardiography (EF>50%) and without regional wall motion abnormality at rest who were referred to MSCT evaluation of the coronary artery tree.

Official Title
-----------------
Multi-slice CT Coronary Angiography Assessment of Remodeling Index in Patients With Low to Intermediate Risk Stable Angina

Conditions
-----------------
Chronic Stable Angina

Intervention / Treatment
-----------------
* Radiation: multisclice CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: first attack, low to intermediate risk stable angina normal resting ECG, negative markers normal systolic function by 2D echocardiography (EF>50%) without regional wall motion abnormality at rest who were referred to MSCT evaluation of the coronary artery tree. Exclusion Criteria: previous acute coronary syndrome or revascularization, those with renal impairment or dye hypersensitivity, patients with morbid obesity (BMI>40kg/m²), rhythm other than sinus rhythm inability to hold breath for 10sec to acquire the image lesions with heavy calcium score.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: multisclice CT|assessment of the remodeling index by multisclice CT in patients with chronic stable angina|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| remodeling of the coronary artery | to study the changes in wall of the arteries in patients with chronic stable angina early changes don't appear in coronary angiography as it occurs in the form of positive remodeling which can be detected by multisclice coronary angiography Remodeling index is defined as the ratio of the maximum vessel area (or diameter) to a normal reference vessel area (or diameter), and plaques are classified as having significant positive remodeling when the remodeling index is >1.1 | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic stable angina, multislice CT, remodeling index
Non-Invasive Hemoglobin Study

Study Overview
=================
Brief Summary
-----------------
The investigators clinical trials will be for a medical device that is non-invasive in nature. The investigators will be studying whether their non-invasive medical device gets data that is as good as, or better than, an FDA previously approved, blood analysis device. There is no study hypothesis for this study.

Official Title
-----------------
Non-Invasive Hemoglobin Multi-Center Observational Study

Conditions
-----------------
Anemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria for this study are: Subject is capable of giving informed consent. Subject has an anatomically intact digit capable of having a capillary sample taken and of being placed in the POCT device. Exclusion criteria for this study are: Age less than 18 years at time of research Subject lacks the digits to place in the POCT device Subject displays symptoms or has a history of Raynaud's disease Subject has a neurological disorder resulting in an inability to hold the index finger steady for 20 sec. Subject has a history of long term continuous decreased perfusion to either hand (>30 days). Subject has had surgery within the last 2 weeks on finger or hand that he wishes to use in the study Subject's same day participation in this study Capillary sample volume is not adequate to complete testing on the comparative device. Cold agglutinin disease

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Hemoglobin in Blood At Time of Test |  | Up to 30 seconds |
Art for Hearts/Black Women's Hearts Paint Night

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to learn about different techniques that can be used to increase self-reflection, reduce stress, manage high blood pressure in Black women.

Detailed Description
-----------------
The researchers want to know how Black women process stress and cope with it during the pandemic, and if managing stress related through a tailored stress reduction activity/art program affect psychological and blood pressure outcomes over the course of 2 months. It is possible that this information may help people reduce their stress and get treatment for high blood pressure sooner, which can help prevent other heart problems over time.

Official Title
-----------------
Art for Hearts/Black Women's Hearts Paint Night

Conditions
-----------------
Stress, Blood Pressure

Intervention / Treatment
-----------------
* Behavioral: Paint Night


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: self-identify as African American or black have a measured blood pressure (BP) of <140/90 mmHg Exclusion Criteria: Are experiencing cognitive impairment Report an untreated psychotic disorder, bipolar disorder, any organic brain syndromes, or substance abuse disorder that the study team believes may result in being a threat to themselves or others Report hospitalization for any psychiatric disorder within the past 12 months

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

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

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paint Night<br> | Behavioral: Paint Night<br>* There will be 8 Sessions (4 paint nights and 4 educational sessions alternating weeks). For the painting sessions, participants will paint for 45 minutes and then participate in a combined presentation/discussion session (45 minutes). For the educational sessions, they will attend a 30-minute presentation presented by a researcher on heart health and then have the opportunity to discuss with the researcher and other members of the group (60 minutes).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood pressure | Participants will take their BP at least once a week (with at least 7 days separating the first and last reading each month) for eight consecutive weeks. | Baseline to 8 weeks | 
| Change in psychological state | Participants will complete a survey regarding their psychological state at baseline at the conclusion of their 8-week series. | Baseline to 8 weeks |
Evaluation of CPD MNV as an Aid in the Diagnosis and Risk Assessment of Sepsis (Protocol # Sepsis 1-14)

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that CPD parameters will provide improved prediction of sepsis compared to currently employed laboratory parameters. These studies hold the potential to shape practitioner guidelines and improve the timeliness and accuracy with which patients with sepsis are treated today.

Official Title
-----------------
Evaluation of CPD (Cell Population Data) MNV (Mean Neutrophil Volume) as an Aid in the Diagnosis and Risk Assessment of Sepsis (Protocol # Sepsis 1-14)

Conditions
-----------------
Sepsis, Severe Sepsis and Septic Shock

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (≥18 to 90 years) Patients presenting to the Emergency Department CBC (Complete Blood Count) with differential testing performed and CPD data retrieved Exclusion Criteria: Previously enrolled in this study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| We are measuring CBC (complete blood count) and MNV (Mean Neutrophil Volume) | Evaluate the clinical utility of CPD MNV as an aid in the diagnosis and risk assessment of Emergency Department patients for progression to sepsis, severe sepsis and septic shock. | approximately 10 months |
Evaluation of a Fracture Liaison Service in the Osteoporosis Care

Study Overview
=================
Brief Summary
-----------------
The St JOSEPH'S HOSPITAL set up a fracture liaison service for osteopotic fracture. A specific nurse screens eligible patient admitted in emergency yard and call them to propose a bone densitometry and a medical coverage.. The aim of the study is to evaluate this new organisation

Official Title
-----------------
Evaluation of a Fracture Liaison Service in the Osteoporosis Care

Conditions
-----------------
Osteoporotic Fractures

Intervention / Treatment
-----------------
* Other: osteoporotic fracture liaison service


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 45 and 95 years old. Admitted in emergency yard for law energy trauma Exclusion Criteria: feet fracture fracture on prothesis patient transferred elsewhere homeless people patient with lot of comorbidities

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 95 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: osteoporotic fracture liaison service|a specific nurse calls patient and propose them to follow the osteoporotic fracture liaison service|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| valuable osteoporosis care | valuable osteoporosis care means a bone densitometry for minor fracture and a medical treatment for major fracture | Month 1 |
Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck (VIMS) - Shoulder Function

Study Overview
=================
Brief Summary
-----------------
Basic strength training for the neck/shoulder muscles can decrease intensity of neck/shoulder pain, but it is uncertain whether training should focus directly on the upper trapezius - which is most often tender - or on the lower compartments and serratus anterior. We hypothesize that strengthening exercise for the lower and middle trapezius as well as the serratus anterior will decrease intensity of neck/shoulder pain among office workers

Official Title
-----------------
Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck (VIMS) - Shoulder Function

Conditions
-----------------
Rehabilitation, Neck Pain, Shoulder Pain, Scapular Dyskinesis, Muscle Activation

Intervention / Treatment
-----------------
* Behavioral: Training
* Behavioral: Reference


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: employees more than 30 days with pain previous year pain intensity of at least 3 on a scale of 0-10 Exclusion Criteria: trauma life threatening disease pregnanacy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training<br>Training of scapular function with strengthening exercises using bodyweight and elastic resistance | Behavioral: Training<br>* Training of scapular function with strengthening exercises using bodyweight and elastic resistance<br>|
| Active Comparator: Reference<br>Health check and advice to continue ordinary physical activity | Behavioral: Reference<br>* Health check and advice to continue ordinary physical activity<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neck/shoulder pain | Neck/shoulder pain will be assessed by: self-report (pain intensity) clinical examination of muscle tenderness | December 2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle function | Muscle strength and electromyography assessment | December 2010 |
Gestational Diabetes Mellitus and Neurodevelopment in Newborns

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the feasibility of using a quantitative EEG method to evaluate neurodevelopment in newborns and to evaluate whether subtle neurodevelopmental deficits can be detected in newborns from mothers with gestational diabetes mellitus (GDM) compared to control newborns. The second purpose of this study is to determine whether cord blood concentration in docosahexaenoic acid (DHA), an omega-3 fatty acid, is similar in neonates of well-controlled mothers with gestational diabetes mellitus (GDM) compared to control mothers, and to evaluate whether this contributes to neonates neurodevelopment status.

Detailed Description
-----------------
Maternal weight is measured close to delivery and BMI is calculated. Birth weight, length, head circumference, Apgar score and glycaemia are recorded at birth. An EEG are performed on the newborn within 48 hrs after birth.A maternal blood sample is collected at admission to measure maternal glycated hemoglobin (A1C). Cord blood samples are collected in the umbilical vein after delivery.

Official Title
-----------------
Does Brain Functions Depend on Omega 3 Transferred to the Fetus During the Intra Uterine Life ?

Conditions
-----------------
Diabetes, Gestational, Glucose Metabolism Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: singleton pregnancy aged between 18 and 40 years Exclusion Criteria: smoking, illicit drug consumption, omega-3/6 consumption, liver or renal disease, cancer any medical conditions affecting glucose/lipid metabolism.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GDM newborns<br>Newborns from gestational diabetes mellitus pregnancy | |
| No GDM newborns<br>Newborn from a normal pregnancy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in neurodevelopment | Evaluate change in neurodevelopment with GDM | At birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in DHA level in cord blood | Evaluate change in DHA level with GDM | At birth | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neurodevelopment, electroencephalography, gestational diabetes mellitus, omega 3 polyunsaturated fatty acids