linjc16/ctgov huggingface dataset:
A Comparative Clinical Trial Evaluating the Effect and Safety of Tacrolimus Versus Hydrocortisone

Study Overview
=================
Brief Summary
-----------------
One of the most frequent skin conditions is atopic dermatitis (AD), characterized by its pruritic inflammation effect. Where the prevalence of AD increased in the last three decades by two or three folds worldwide, especially in developed countries, AD is supposed to affect about 15% to 30% of children, and 2% to 10% of adults. This type of dermatitis is frequently linked to a family history of other atopic illnesses such as allergic rhinitis or asthma.

Official Title
-----------------
A Comparative Clinical Trial Evaluating the Effect and Safety of Tacrolimus Versus Hydrocortisone in Management of Atopic Dermatitis in Children

Conditions
-----------------
Dermatologic Disease

Intervention / Treatment
-----------------
* Drug: Tacrolimus ointment
* Drug: Hydrocortisone 1% cream


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, 2-16 years old AD patients. Exclusion Criteria: patients diagnosed with other skin disorders of serious type and who are taking systemic corticosteroids or anti-inflammatory medications.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 16 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
Interventional Model Description: • A randomized, controlled, and parallel study will comprise 100 patients with AD
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tacrolimus Group<br>50 patients will be treated with a thin layer of 0.03% topical tacrolimus ointment on the affected areas twice daily for 4 months. | Drug: Tacrolimus ointment<br>* tacrolimus is an immunosuppressive drug acting as an immunomodulator to assist manage acute flares and reducing the severity of future flares<br>|
| Active Comparator: Hydrocortisone Group<br>50 patients will be treated with a thin layer of 1% hydrocortisone cream on the affected areas twice daily for 4 months. | Drug: Hydrocortisone 1% cream<br>* Topical corticosteroids (TCS) are the cornerstone for the management of AD to which other treatments are compared.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the impact of topical tacrolimus ointment to topical hydrocortisone cream by measuring inflammatory cytokine levels in the blood. | To compare the impact of topical tacrolimus ointment to topical hydrocortisone cream by measuring inflammatory cytokine levels in the blood such as interleukin-6 (IL-6), and IL-10. | 4 months |
Telesupport: Evaluation of Professionally Led Support Groups for Caregivers

Study Overview
=================
Brief Summary
-----------------
This study is a collaborative effort between a community-based service organization, Supportive Older Women's Network (SOWN), and an academic research division at Thomas Jefferson University (TJU). We plan to use a randomized controlled two-group design to: 1) test the effectiveness of the intervention at 6 months to enhance social support and perceived efficacy in comparison to a control group; 2) test if gains are sustained over 12 months (within experimental group comparison); and 3) evaluate the cost and cost effectiveness of the intervention. Three secondary study aims are to describe the process and content of tele-support groups (dose/intensity, support group topics); evaluate the relative benefits for African American and White females; and determine if control group subjects benefit from receiving a peer's telephone number for mutual support (within group comparison between 6 and 12 months).

Official Title
-----------------
Evaluation of Professionally Led Support Groups for Caregivers

Conditions
-----------------
Caregiver Burden

Intervention / Treatment
-----------------
* Behavioral: Caregiver support via telephone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Caregivers will be recruited for study participation who fit the following criteria: 1) female, 2) 55 or older, 3) has been a caregiver for a minimum of 6 months, 3) provides care to a person with a physician's diagnosis of ADRD, 4) has weekly access to a telephone for one hour without interruption during working hours, or if unable to have uninterrupted time, willing to have home-maker service. Homemaker service during the tele-group meetings will be arranged by the recruitment source. For this study, we plan to recruit only females since they represent the majority of those providing care to persons with ADRD and have been shown to demonstrate significantly more stress and negative health outcomes than male caregivers. Exclusion Criteria: Male under age of 55 not a caregiver of person with ADRD

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Caregiver support via telephone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caregiver depression |  |  | 
| Caregiver burdern |  |  | 
| Caregiver social support |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Support groups, Alzheimer's Disease
Detection of hEad Pulse for Ischemic StrOke Verification Study

Study Overview
=================
Brief Summary
-----------------
Prehospital providers encounter patients with suspected stroke frequently. Prehospital providers need tools to help triage large vessel stroke patients to comprehensive stroke centers. This device will identify large vessel stroke to ultimately improve triage decisions and optimize outcomes.

Detailed Description
-----------------
Patients suspected of stroke by a prehospital provider will have a headset placed to record their headpulse during the encounter. These measurements will be used to assess the accuracy of the device at predicting the presence of large vessel occlusion (LVO) stroke. The MindRhythm, Inc., Harmony® 5000 device is intended to be used in the pre-hospital setting by medical professionals to diagnose large vessel occlusion stroke in adults suspected of having a stroke.

Official Title
-----------------
EPISODE-VS: hEad Pulse for Ischemic StrOke Verification Study

Conditions
-----------------
Stroke, Acute

Intervention / Treatment
-----------------
* Device: Harmony


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • suspected stroke in the prehospital setting Exclusion Criteria: scalp laceration Patient refusal Prisoner, other vulnerable population Prehospital provider feels that the recording may interfere with care

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MINDRHYTHM HARMONY<br>Passive Recording of the head pulse | Device: Harmony<br>* Passive recording of the head pulse<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary effectiveness objective is to estimate the sensitivity and specificity of LVO diagnosis with Harmony®. | The subject's final discharge diagnosis based on the CTA scan and the neurologist's assessment will serve as the ground truth diagnosis. The sensitivity and specificity will be estimated as the point estimate (Harmony® identified correctly divided by the ground truth number); the confidence intervals will be estimated by the Clopper-Pearson method (exact intervals for proportions). | Through study completion, an average of 6 months |
Psychosocial Intervention Pilot for Partners in BRCA Testing

Study Overview
=================
Brief Summary
-----------------
A brief psychosocial intervention for partners of women affected by or at risk for breast cancer and harboring BRCA genetic alterations.

Official Title
-----------------
Psychosocial Intervention Pilot for Partners in BRCA Testing

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Behavioral: psychosocial counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age, married/partnered status Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Behavioral: psychosocial counseling<br>* A problem-solving and psychosocial skill-building intervention.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Communication of genetic test results | A binary (yes/no) epidemiological item to determine if parental communication of genetic test results occurred to the child. | 1 Month |
Clinical Evaluation of the FilmArray® Global Fever (GF) Panel

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the clinical sensitivity and specificity of the FilmArray Global Fever (GF) Panel.

Detailed Description
-----------------
The FilmArray Global Fever (GF) Panel, developed by BioFire Defense in collaboration with the U.S. Department of Defense and NIAID, uses an automated, multiplex PCR system to evaluate whole blood samples for 19 pathogens simultaneously in under an hour. Targets of the GF Panel are Chikungunya virus, CCHF virus, dengue virus (serotypes 1-4), Ebolavirus, Lassa virus, Marburgvirus, West Nile virus, Yellow fever virus, Zika virus, Bacillus anthracis, Francisella tularensis, Leptospira spp., Salmonella enterica serovar Typhi and Paratyphi A, Yersinia pestis, Leishmania donovani complex, Plasmodium spp., P. falciparum, and P. ovale/vivax. BioFire Defense is conducting a prospective clinical study to evaluate the sensitivity and specificity of the GF Panel when used to test blood collected from subjects with fever or who have recently had fever. This multi-center study is being conducted at locations around the world.

Official Title
-----------------
Clinical Evaluation of the FilmArray® Global Fever (GF) Panel

Conditions
-----------------
Fever

Intervention / Treatment
-----------------
* Other: Observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Whole blood in EDTA (prospectively collected via informed consent) Subject has a recorded or self-reported fever within the past two days. Subject has not participated in the study within the last 30 days.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects/Specimens<br>Subjects/Specimens that meet the eligibility criteria | Other: Observational study<br>* Observational study<br>* Other names: FilmArray;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical sensitivity and specificity of the FilmArray Global Fever (GF) Panel | Percent Positive Agreement and Percent Negative Agreement between FilmArray Result and Comparator Assay | 18 months |
Genetic of SportS Induced Endofibrotic Remodeling

Study Overview
=================
Brief Summary
-----------------
search for a genetic cause of vascular endofibrose

Detailed Description
-----------------
Perform a DNA analysis to mark the existence of mutations in one or more genes encoding proteins involved in vascular remodeling high. 5 patients or relatives of patients topics

Official Title
-----------------
Endofibrose Vasculaire et génétique

Conditions
-----------------
Genetic Syndrome

Intervention / Treatment
-----------------
* Genetic: GENETIC ANALYSIS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: High level reached Cyclists vascular endofibrose Cyclist high level and not sick with a brother or sister is senior cyclist reaches the vascular endofibrose. Exclusion Criteria: not obtaining consent

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GENETIC ANALISYS<br>GENETIC ANALYSIS AND RESEARCH OF GENETIC BLOOD SAMPLE | Genetic: GENETIC ANALYSIS<br>* prélevement blood to search for a genetic cause of vascular endofibrose. Search genetic mutations in 5 subjects.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of mutations or nucleotides variations | DNA analysis and search for genetic mutations | 1 hour |
Comparing Skin Conductance and Nol-index

Study Overview
=================
Brief Summary
-----------------
Comparison of twà different nociception monitors during general anesthesia

Detailed Description
-----------------
Analgesia remains a challenge in anesthesia. Several monitors have shown potential in detecting insufficient analgesia during general anesthesia, but they have not been investigated in patients undergoing cardiac and vascular surgery. In this study, we will compare skin conductance (Medstorm, Norway) and nol-index (Medasense, Israel) w during noxious and non-noxious stimuli. This study is carried out on patients included in another study (Nol-Index Guided Remifentanil Analgesia Versus Standard Analgesia During Moderate-to-High Risk Cardiovascular Surgery).

Official Title
-----------------
Nociceptive Monitoring With Skin Conductance and Nol-index in Moderate-to-high Risk Cardiovascular Patients

Conditions
-----------------
Analgesia, Anesthesia, Monitoring, Vascular Diseases, Cardiac Disease

Intervention / Treatment
-----------------
* Device: Nol-Index
* Device: Skin Conductance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: moderate-to-high risk cardiac or vascular surgery ASA 2-4 Exclusion Criteria: chronic arrhythmia (e.g. atrial fibrillation) aortic insufficiency pacemaker implanted defibrillator valve surgery

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing general anesthesia<br>Patients are monitored with Nol-Index, skin conductance, and antinociception-index | Device: Nol-Index<br>* Multiparametric monitor that studies that establishes an index as a surrogate to nociception<br>* Other names: PMD-200;Device: Skin Conductance<br>* Measures skin conductance as a surrogate to nociception<br>* Other names: The PainMonitor Index;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nol-Index response | Nol-Index (diminsenliss value from 0 to 100) will be assessed during noxious and non noxious stimuli | 1 to 2 hours | 
| Skin conductance response | Peaks per second change during noxious and non noxious stimuli | 1 to 2 hours |
Brain Mechanisms of Reducing Polysubstance Use Following a Novel Body-mind Intervention

Study Overview
=================
Brief Summary
-----------------
The proposed study will examine brain mechanisms of a brief mindfulness intervention - IBMT on ATC reduction.

Detailed Description
-----------------
The R61 phase of the proposed study will examine brain mechanisms of a brief mindfulness intervention - IBMT that targets at self-control networks in the brain, and test IBMT effects on ATC reduction.

Official Title
-----------------
Brain Mechanisms of Reducing Polysubstance Use Following a Novel Body-mind Intervention

Conditions
-----------------
Multiple Drug Use

Intervention / Treatment
-----------------
* Behavioral: IBMT
* Behavioral: RT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (1) at least 18 years old; (2) free of any psychiatric diagnoses or medication (besides a SUD to alcohol, tobacco, or cannabis); (3) in the past month, at least 4 episode of heavy episodic drinking; at least 3 occasion of cannabis use; and daily cigarette use for at least the past month; (4) normal or corrected-to-normal vision; (5) written informed consent; (6) no previous meditation or NF experiences. Exclusion Criteria: (1) any psychiatric diagnoses other than an SUD; (2) medical disorder(s) that may affect the central nervous system; medications that affect the central and autonomic nervous system; or a positive pregnancy test result (females); (3) excluding cannabis, evidence of recent (past month) illicit drug use.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 23 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Integrative Body Mind Training (IBMT)<br>mindfulness | Behavioral: IBMT<br>* mindful presence in a non-judgmental way<br>|
| Active Comparator: Relaxation Training (RT)<br>relaxation | Behavioral: RT<br>* progressive muscle relaxation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain changes of IBMT on polysubstance use | 70 participants with polysubstance use are assessed by changes of behavior (NIH PhenX Toolkit, RDoC matrix) and brain (fMRI) before (baseline) and after interventions (2-4 Weeks) and 3 months of follow-ups. | The outcome measures are assessed at baseline, 2-4 weeks and 3 months |
Registry for Perioperative Data in Patients Undergoing Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this registry is to obtain perioperative data in patients undergoing cardiac surgery and find out relations between the data and investigate several causes affecting postoperative complications.

Conditions
-----------------
Cardiac Surgical Procedures, Anesthesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing cardiac surgery Exclusion Criteria: refused to participate

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Cardiac surgery<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| perioperative data | To obtain the perioperative data in patients undergoing cardiac surgery. Data will be collected including demographics, surgery and postoperative complications. In addition, laboratory data such as coagulation and cytokine will be obtained. Intraoperative monitoring including bispectral index, cerebral oximeter, tissue oxygen saturation [InspectraTM StO2 (Hutchinson Technology Inc., MN, USA)], cardiac index [FloTrac/EV1000 (Edwards Lifesciences, Irvine, CA, USA), VolumeView/EV1000 (Edwards Lifesciences, Irvine, CA, USA), Vigilance II (Edwards Lifesciences, Irvine, CA, USA)] and mixed venous oxygen saturation will be evaluated. | 1 year after surgery |
Prevalence of Diastasis m. Rectus Abdominis in Postpartum Women

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the prevalence of diastasis m. rectus abdominis after delivery. Relationship of Diastasis Recti Abdominis with urine leakage, pelvic floor muscle function and morphometry in postpartum women.

Detailed Description
-----------------
Evaluation of the width of the linea alba within the evaluation of diastasis of the rectus abdominis by 2D USG relation to pelvic floor muscle function (strength and endurance of pelvic floor muscles) and pelvic floor muscle morphometry by 3D/4D USG .

Official Title
-----------------
Prevalence of Diastasis m. Rectus Abdominis and Pelvic Floor Muscle Dysfunction in Postpartum Women

Conditions
-----------------
Diastasis of m. Rectus Abdominis

Intervention / Treatment
-----------------
* Diagnostic Test: 2D usg and 3D/4D usg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women from six weeks to up to 6 months after birth, age over 18 years old. Exclusion Criteria: Psychiatric illness, postpartum depression, non-cooperation. Neurological diseases conditions after a stroke, a history of brain injury, significant visual and hearing damage, confirmed by neurological examination. Serious internal, orthopedic and oncological diseases. Disagreement with inclusion in the study.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: 2D usg and 3D/4D usg|IRD distance measured by a linear probe 2D usg. Pelvic floor muscle morphometry measured by 3D/4D usg|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Diastasis Recti Abdominis in Postpartum Women. | IRD distance measured by a linear probe 2D usg, 4.5 cm above the navel, 4.5 cm below the navel. At rest, and when raising the lower limbs. | Six weeks to up to 6 months after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship of Diastasis Recti Abdominis with urine leakage, pelvic floor muscle function and morphometry in postpartum women. | Occurrence of stress urinary incontinence using the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-UI SF). | Six weeks to up to 6 months after birth. | 
| Relationship between Diastasis Recti Abdominis and back pain in postpartum women. | Occurrence of low back pain using the Oswestry Disability Index (ODI). | Six weeks to up to 6 months after birth. |