linjc16/ctgov huggingface dataset:
Effects of Ligands on Human Hair Follicles Grafted Onto SCID Mice

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if immunophilin ligands may have the potential to reverse hair loss.

Detailed Description
-----------------
Preliminary experiments in C57BL/6J mice showed that immunophilin ligand FK506 and its non-immunosuppressive analogs, GP11046 and GP11511 were capable of promoting telogen to anagen transition. Since GP11046 and GP11511 possess the neurotrophic properties of FK506 without its immunosuppressant capability, the neural action of these immunophilin ligands may play an important role in the hair cycle. This finding has significant clinical implications in that immunophilin ligands may have the potential to reverse alopecia. To further investigate this possibility we propose to explore the response of transplanted miniaturized scalp hair follicles to topically applied immunophilin ligands.

Official Title
-----------------
Neurotrophic Effects of Immunophilin Ligands on Human Hair Follicles Grafted Onto Service Combined Immunodeficient (SCID) Mice

Conditions
-----------------
Alopecia

Intervention / Treatment
-----------------
* Drug: FK506, GP11046, GP11511


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy men ages 18-65 with Hamilton type IV or V alopecia Exclusion Criteria: Individuals who do not meet the inclusion criteria.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: FK506, GP11046, GP11511|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The average number of terminal hairs per graft will be compared between the control and the treated group. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of follicles in anagen, catagen and telogen per graft will be averaged for each group. The results will be compared between the control and the treated groups. |  |  |
Effectivity and Efficiency of Turning Frequencies: a Randomised Controlled Trial

Study Overview
=================
Brief Summary
-----------------
Evaluation of the difference in pressure ulcer incidence or the time to develop pressure ulcers depending on the turning frequencies.

Detailed Description
-----------------
Evaluation of the difference in pressure ulcer incidence or the time to develop pressure ulcers depending on the turning frequencies.

Official Title
-----------------
Effectivity and Efficiency of Turning Frequencies: a Randomised Controlled Trial

Conditions
-----------------
Pressure Ulcer Lesions (Grade 2 or More)

Intervention / Treatment
-----------------
* Procedure: Different turning frequencies


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non-blanchable erythema above a bony prominence Informed consent Exclusion Criteria: Pressure ulcers grade 3 or 4 Turning contra-indicated based on medical grounds

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: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Different turning frequencies|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of pressure ulcers |  | during 5 weeks | 
| Time to develop pressure ulcers |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Different risk factors: age, length, weight, incontinence, urinary catheter, blood pressure, mobility, activity, diabetes, CVA, KATZ score, medication, duration in a sitting posture |  |  |
Comparison of Non-invasive vs. Invasive Hemodynamic Measurements

Study Overview
=================
Brief Summary
-----------------
Comparison of a non-invasive method of measuring central venous pressure to the conventional modality of invasive central venous pressure.

Detailed Description
-----------------
The conventional method used to measure central venous pressure has limitations since it is an invasive procedure that requires a central venous catheter. To overcome this challenge, a new technology to assess CVP non-invasively using an oscillometric method is being developed. It is called enclosed zone central venous pressure (ezCVP). A comparison study of ezCVP and CVP is needed to determine accuracy and reproducibility.

Official Title
-----------------
Comparison Study of ezCVP and CVP

Conditions
-----------------
Heart Failure，Congestive

Intervention / Treatment
-----------------
* Device: Non-invasive central venous pressure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult age over 18 years. Arm circumference is 23 cm to 55 cm Subject will have an existing central venous catheter during their ICU stay Subject or legally authorized representative (LAR) is able to understand the risks and potential benefits of participating in the study and is willing to provide written informed consent Subject or LAR is willing and able to comply with protocol procedures Exclusion Criteria: Finger and/or upper arm anatomical anomaly or disease that may interfere with attaching a pulse oximeter sensor and/or blood pressure cuff. Pregnant (self-reported) Upper extremity deep venous thrombosis currently being treated Severe skin disease involving the upper arm(s) Study investigator may exclude patients based on clinical judgement

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 |
| --- |
|Device: Non-invasive central venous pressure|Non-invasive method to measure central venous pressure indicator|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-invasive pressure indicator | Evaluate sensitivity and specificity of ezCVP indication based on the case where CVP is in a 'low range' (0 < CVP < 10 mmHg) or 'high range' (>= 10 mmHg) | 12-72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Direction of change | Correlate the directionality of ezCVP change to invasive CVP change over time (i.e., increasing, decreasing or remaining stable). | 12-72 hours | 
| Correlation with invasive CVP | Quantify the agreement between ezCVP (non-invasive) and CVP (invasive) | 12-72 hours |
Myocardial Physiology And Microanatomy In Individuals Undergoing Heart Surgery

Study Overview
=================
Brief Summary
-----------------
The main focus of the project is to determine to what degree myocardial energy metabolism is linked to impaired function in human cardiomyocytes, whether exercise training and remote ischemic preconditioning can restore cardiomyocyte function and whether this is linked to improved mitochondrial and cell function.

Official Title
-----------------
Study of Gaining Further Understanding of the Underlying Mechanisms of Myocardial Function

Conditions
-----------------
Myocardial Injury

Intervention / Treatment
-----------------
* Behavioral: Exercise training
* Procedure: remote ischemic preconditioning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing coronary heart surgery and heart transplantation Exclusion Criteria: myocardial infarction closer than 4 weeks to project start, serious valve defects, diabetes, unstable angina, uncontrolled hypertension, kidney failure (creatinin > 140)
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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ExerciseTr<br> | Behavioral: Exercise training<br>* exercise training<br>|
| Experimental: Remote ischemic preconditioning group<br> | Procedure: remote ischemic preconditioning<br>* remote ischemic preconditioning<br>|
| No Intervention: Control patient group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mitochondrial respiration | Oxygraph (Strathkelvin) | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physical Activity, pathology, Physical Deconditioning
Development of a Questionnaire to Assess Patient Knowledge About Non-vitamin K Anticoagulants (NOAC)

Study Overview
=================
Brief Summary
-----------------
Pharmacists are in the best position to counsel and educate patients on anticoagulant agents such as NOACs. This should enable patients to play a more active role in their treatment and ultimately enhance adherence behaviour. However, educational elements should be targeted to knowledge. Thus, the investigators will develop and validate a questionnaire that can assess knowledge about NOACs

Official Title
-----------------
Development and Validation of a Novel Educational Program for Patients Prescribed Non-vitamin K Anticoagulants (NOAC)

Conditions
-----------------
Atrial Fibrillation, Pulmonary Embolism, Deep Vein Thrombosis

Intervention / Treatment
-----------------
* Behavioral: Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intake of a NOACs (Rivaroxaban, Edoxaban, Dabigatran, Apixaban) ≥18 years Able to give written Informed consent in German Exclusion Criteria: NOACs for orthopaedic indication Dementia in medical history

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 |
| --- | --- |
| Education<br> | Behavioral: Education<br>* Patients will receive several questionnaires to fill in. Knowledge about NOACs will be assessed with a newly developped questionnaire and an educational program will be dispensed while analysing the answers (reactive educational program).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of the new questionnaire assessed by questionnaire | Patients will rate on a 4-point likert scale feasibility, acceptability and comprehension of the new questionnaire immediately after the questionnaire had been filled in the first time. | measured once at visit 1 (baseline) | 
| Sensitivity of the new questionnaire | Number of correct/incorrect answers measured at visit 2 before and after the educational program has been dispensed (7 days after visit 1) | 7 days after visit 1, before and after the educational program | 
| Test retest validity of the new questionnaire | Number of correct/incorrect answers measured at visit 1 and 2 (0 respectively 7 days after visit 1) | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's adherence assessed by questionnaire | change in adherence between visits 1 (baseline) and visit 3 | 14 days | 
| Patient's satisfaction assessed by questionnaire | change in satisfaction between visits 1 (baseline) and visit 3 | 14 days | 
| Patient's health literacy assessed by questionnaire |  | assessed once at visit 1 (baseline assessment) |
Congenital Heart Disease GEnetic NEtwork Study (CHD GENES)

Study Overview
=================
Brief Summary
-----------------
Congenital heart defects (CHD) are the most common major human birth malformation, affecting  8 per 1,000 live births. CHD are associated with significant morbidity and mortality, and are second only to infectious diseases in contributing to the infant mortality rate. Current understanding of the etiology of pediatric cardiovascular disorders is limited. The Congenital Heart Disease GEnetic NEtwork Study (CHD GENES) is a multi-center, prospective observational cohort study. Participants will be recruited from the Pediatric Cardiac Genomics Consortium's (PCGC) centers of the NHLBI-sponsored Bench to Bassinet (B2B) Program. Biological specimens will be obtained for genetic analyses, and phenotype data will be collected by interview and from medical records. State-of-the-art genomic technologies will be used to identify common genetic causes of CHD and genetic modifiers of clinical outcome. To accomplish this, the PCGC will develop and maintain a biorepository of specimens (DNA) and genetic data, along with detailed, phenotypic and clinical outcomes data in order to investigate relationships between genetic factors and phenotypic and clinical outcomes in congenital heart disease.

Official Title
-----------------
Congenital Heart Disease GEnetic NEtwork Study (CHD GENES)

Conditions
-----------------
Congenital Heart Defects

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Signed consent form Exclusion Criteria: Isolated patent foramen ovale Isolated prematurity-associated patent ductus arteriosus

Ages Eligible for Study
-----------------
Maximum Age: 99 Years

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

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 |
| --- | --- | --- |
Efficacy Study of Cyclosporine Ophthalmic Emulsion in Patients With Dry Eye Disease

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the efficacy of cyclosporine ophthalmic solution vs. other non-prescription treatments in patients with dry eye disease. Patient and physician assessments completed at baseline, at each follow-up visit (follow-up visits are variable as per physician discretion) and at final follow-up visit.

Conditions
-----------------
Keratoconjunctivitis Sicca

Intervention / Treatment
-----------------
* Drug: cyclosporine ophthalmic emulsion 0.05%, artificial tears


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of dry eye disease Currently using artificial tears daily Male or female of legal age of consent Normal lid position and closure Exclusion Criteria Patients currently using cyclosporine ophthalmic emulsion 0.05% Participation in other investigational drug or device study Any current or previous topical ophthalmic or oral cyclosporine use within the last three 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 |
| --- | --- |
| 1<br>cyclosporine ophthalmic emulsion 0.05% artificial tears | Drug: cyclosporine ophthalmic emulsion 0.05%, artificial tears<br>* one drop, twice a day in each eye<br>* Other names: Restasis®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Surface Disease Index (OSDI) Total Score at Baseline | The OSDI consists of 12 questions to assess visual function, ocular symptoms and environmental triggers related to dry eye. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4 = all of the time) which is converted to a total score between 0-100. OSDI total scores of 0-12=normal (best), 13-22= mild ocular surface disease, 23-32 =moderate ocular surface disease, and 33-100=severe ocular surface disease (worst). | Baseline |
Turkish Health Enhancement Lifestyle Profile-Screener Questionnaire

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to evaluate the validity, reliability, and cultural adaptation of the Turkish version of the Health Enhancement Lifestyle Profile Screener (T-HELP-Screener).

Detailed Description
-----------------
Internal consistency of the T-HELP-Screener was measured using Kuder-Richardson. Test-retest reliability was performed with 66 of the 150 participants using intraclass correlation coefficient (ICC). Construct validity of the T-HELP-Screener was analyzed with the Healthy Lifestyle Behavior Scale-II (HLBS-II).

Official Title
-----------------
Psychometric Properties of The Turkish Health Enhancement Lifestyle Profile-Screener Questionnaire (T-Help-Screener)

Conditions
-----------------
Elderly Population

Intervention / Treatment
-----------------
* Other: translation and adaptation study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age over 65 years, no communication problems, and a Mini-Mental State Examination score of 24 or above Exclusion Criteria: communication problem

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: translation and adaptation study|translation and adaptation study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healthy Lifestyle Behavior Scale-II |  | 1 year |
Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601-004)

Study Overview
=================
Brief Summary
-----------------
The purpose of this phase III study is to determine the safety and efficacy of difluprednate in the treatment of inflammation following ocular surgery.

Conditions
-----------------
Inflammation

Intervention / Treatment
-----------------
* Drug: Difluprednate
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled for unilateral ocular surgery. Exclusion Criteria: Systemic administration of any corticosteroid or immunosuppressive drug in the 2 weeks prior to study enrollment.

Ages Eligible for Study
-----------------
Minimum Age: 2 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 2<br>Vehicle | Other: Placebo<br>* Vehicle<br>|
| Experimental: 1<br>Difluprednate | Drug: Difluprednate<br>* Difluprednate<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects with an anterior chamber cell grade of 0 and a flare grade of 0 on Day 14, compared between difluprednate and placebo groups. |  | Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects with an anterior chamber cell grade of 0 and a flare grade of 0 on Day 7, compared between difluprednate and placebo groups. |  | Day 7 |
Randomized Multicentre Study Comparing TEP With Lichtenstein Repair for Primary Inguinal Hernia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to compare the recurrence rate after TEP (laparoscopic method) and Lichtenstein (open method) repair on primary inguinal hernia.

Official Title
-----------------
Randomized Multicentre Study Comparing TEP With Lichtenstein Repair for Primary Inguinal Hernia

Conditions
-----------------
Inguinal Hernia

Intervention / Treatment
-----------------
* Procedure: Open repair
* Procedure: Laparoscopic repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male Age 30-70 years referred to hospital with a primary inguinal hernia. Exclusion Criteria: Recurrent hernia Scrotal or bilateral hernia Previous lower abdominal surgery Unable to participate in follow up ASA more than 3 Bleeding diathesis.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lichtenstein<br> | Procedure: Open repair<br>* Open repair is according to the Lichtenstein technique<br>|
| Experimental: TEP<br> | Procedure: Laparoscopic repair<br>* The TEP (Totally ExtraPeritoneal patch) repair is used as the laparoscopic repair<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative complications, postoperative recovery and chronic pain at 5 years. |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Recurrence rate after inguinal hernia repair on primary inguinal herina.