linjc16/ctgov huggingface dataset:
A Study of Octreotide Depot vs Saline Control in Pediatric Hypothalamic Obesity Patients

Study Overview
=================
Brief Summary
-----------------
The extension protocol is designed to allow those patients randomized to placebo in the core portion of the protocol to receive a 6 month treatment of open label octreotide and allow those patients randomized to octreotide who appeared to benefit from treatment, to continue to receive octreotide.

Official Title
-----------------
A Study of Octreotide Depot vs Saline Control in Pediatric Hypothalamic Obesity Patients

Conditions
-----------------
Hypothalamic Obesity

Intervention / Treatment
-----------------
* Drug: Octreotide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria - Patient must provide written informed consent Exclusion Criteria Any patient that experienced unresolved safety complications at any time during the original protocol CSMS995B2403 Patients with a history of gallstones or any patient developing gallstones during the course of the core protocol Patients for whom there are safety or tolerability concerns for continuing Octreotide Depot Any patient requiring additional treatment for their original cranial insult related to cranial trauma, or to tumor recurrence or its treatment Refer to the original protocol for details of inclusion & exclusion criteria. Any patient granted a waiver to participate in the core protocol will be allowed to continue to participate in the extension protocol. Other protocol-defined inclusion / exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 17 Years

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

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in BMI |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in weight, leptin, insulin AUC, C-peptide AUC, amylin AUC, glucose AUC, dietary intake, physical activity, waist-to-hip ratio, visceral and subcutaneous abdominal fat |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity
The Molecular Pathogenesis of Late-onset Fuchs' Endothelial Corneal Dystrophy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to gain further insights into the molecular pathogenesis of Fuchs' endothelial corneal dystrophy (FECD), to identify targets for potential specific drug therapy.

Official Title
-----------------
The Molecular Pathogenesis of Late-onset Fuchs' Endothelial Corneal Dystrophy

Conditions
-----------------
Fuchs' Endothelial Dystrophy

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: FECD normal corneas (including enucleations for uveal melanoma) non-FECD oedematous corneas Exclusion Criteria: prior irradiation therapy for uveal melanoma corneal extension of uveal melanoma
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| late-onset FECD<br>tissue samples from patients with late-onset Fuchs' endothelial corneal dystrophy (FECD) | Other: No intervention<br> <br> |
| normal control<br>tissue samples from patients with normal corneas | Other: No intervention<br> <br> |
| non-FECD edematous control<br>tissue samples from patients with corneal edema but without FECD | Other: No intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cytokine levels | dosage of cytokine levels in aqueous humour (exploratory, non-interventional study) | at time of prelevation (once, no intervention) | 
| gene expression levels | microarray expression analysis, reverse transcriptase - quantitative polymerase chain reaction (RT-qPCR), RNA-sequencing (exploratory, non-interventional study) | at time of prelevation (once, no intervention) | 
| protein content | immunohistochemistry and immunofluorescence | at time of prelevation (once, no intervention) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pathophysiology
Does the Addition of Hydrogen Peroxide to Chlorhexidine Skin Prep to Treat P. Acnes in the Shoulder

Study Overview
=================
Brief Summary
-----------------
This is a prospective, randomized controlled trial to evaluate the ability of hydrogen peroxide preparation in addition to chlorhexidine to decrease the colonization of Propionibacterium acnes(a bacteria commonly found in the dermis of the skin surrounding the shoulder in order to decrease postoperative joint infection.

Official Title
-----------------
Does the Addition of Hydrogen Peroxide to Chlorhexidine Preoperative Skin Preparation Reduce the Rate of Propionibacterium Acnes Positive Culture in the Shoulder

Conditions
-----------------
Propionibacterium Infection

Intervention / Treatment
-----------------
* Drug: a. Standard iodine scrub, 3% hydrogen peroxide prep, follow by ChloraPrep (2% chlorhexidine gluconate and 70% isopropyl alcohol
* Drug: Iodine scrub and ChloraPrep alone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. All male patients (>18) undergoing shoulder arthroscopy Exclusion Criteria: Female patients Patients with active acne Patients who have taken antibiotics within a month of their surgery Subjects allergic to any of the following agents: o Benzoyl peroxide Subjects with psoriatic/eczematous lesions on the shoulder girdle.

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

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

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

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 |
| --- | --- |
| Active Comparator: a. Standard iodine scrub, 3% hydrogen peroxide prep, follow by<br> | Drug: a. Standard iodine scrub, 3% hydrogen peroxide prep, follow by ChloraPrep (2% chlorhexidine gluconate and 70% isopropyl alcohol<br>* a. Standard iodine scrub, 3% hydrogen peroxide prep, follow by ChloraPrep (2% chlorhexidine gluconate and 70% isopropyl alcohol<br>|
| Active Comparator: b. Iodine scrub and ChloraPrep alone<br> | Drug: Iodine scrub and ChloraPrep alone<br>* Iodine scrub and ChloraPrep alone<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| colonization of p.acnes in the dermis of the shoulder | number of colony forming units grown in bacterial culture | 14 days in culture |
Efficacy and Tolerability of Testogel/Nebido in Combination With Exercise and Diet in Hypogonadal Male Patients

Study Overview
=================
Brief Summary
-----------------
With advancing age testosterone levels decline in men. Low testosterone levels plus certain symptoms are called Late Onset Hypogonadism (LOH). Adipose tissue may contribute to testosterone deficiency. On the other hand testosterone deficiency again leads to a decrease in lean body mass and an increase in fat mass - one of the clinical signs / symptoms of LOH. Lifestyle changes (diet, exercise) alone or in combination with testosterone replacement (TRT), have an influence on the symptoms of LOH. The aim of this study is to assess the additional impact of TRT on Aging Male Symptom Score (AMS) and adiposity (waist circumference) in patients, who are on a diet and exercise program.

Official Title
-----------------
Efficacy and Tolerability of Testogel® / Nebido in Combination With a Standardised Exercise and Diet Programme in Hypogonadal Male Patients With Abdominal Obesity Compared With Exercise and Diet Programme

Conditions
-----------------
Hypogonadism

Intervention / Treatment
-----------------
* Drug: Testosterone Undeconate (Nebido-R, BAY86-5037)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male patients > 35yrs Waist Circumference > 102cm Clinically and biochemically confirmed hypogonadism (testosterone group) Willingness to attempt weight optimization Exclusion Criteria: Androgen dependent carcinoma of the prostate or male mammary gland, past or present history of liver tumours hypersensitivity towards the active pharmaceutical ingredient or other ingredients.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 64 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: Testosterone Undeconate (Nebido-R, BAY86-5037)<br>* Male patients > 35yrs in medical practices fulfilling all criteria for documentation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waist Circumference |  | At each visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypogonadism, Abdominal obesity, Physical exercise, Testosterone
Localized Therapeutics for the Treatment of Gastrointestinal Disorders

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the patient preference for a biocompatible thermosensitive solution-gel versus water or saline (liquid) enema. The thermosensitive solution-gel is comprised of poloxamer, an inactive compound that is designated as GRAS (generally recognized as safe) by FDA. It could subsequently be used as a medium for drug delivery. The poloxamer (gel) is administered to study participants in order to assess preference and proximal distribution.

Official Title
-----------------
Localized Therapeutics for the Treatment of Gastrointestinal Disorders

Conditions
-----------------
Healthy Adults

Intervention / Treatment
-----------------
* Other: Thermosensitive gel rectal formulation
* Other: Saline enema


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Generally healthy Age 18 to 70 years old Non-pregnant Exclusion Criteria: GI complaints Pregnancy Patients with previous colonic surgery or current bowel injury or obstruction Allergies to contrast

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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thermosensitive gel formulation<br>Thermosensitive gel rectal formulation or saline (control) enema with crossover to the other. | Other: Thermosensitive gel rectal formulation<br> <br> Other: Saline enema<br> <br> |
| Experimental: Saline enema<br>Thermosensitive gel rectal formulation or saline (control) enema with crossover to the other. | Other: Thermosensitive gel rectal formulation<br> <br> Other: Saline enema<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient preference, as assessed by questionnaire |  | Up to 3 hours post-administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
enema
Safety, Tolerability, and Immunogenicity of an Investigational Vaccine With Recombinant Human Albumin (rHA) in Children 12 to 18 Months of Age (V205C-009)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to study the safety and immune response to measles, mumps, and rubella in children who were vaccinated with an investigational measles-mumps-rubella live vaccine made with artificially made human protein.

Detailed Description
-----------------
The duration of treatment is 6 weeks.

Official Title
-----------------
A Comparison of the Safety, Tolerability, and Immunogenicity of V205C Manufactured With Recombinant Human Albumin (rHA) Versus V205C Manufactured With Pooled-Donor Human Serum Albumin (HSA) in Healthy Children 12 to 18 Months of Age

Conditions
-----------------
Measles, Mumps, Rubella, Varicella

Intervention / Treatment
-----------------
* Biological: measles, mumps, and rubella virus vaccine live
* Biological: Comparator: Measles, Mumps, and Rubella Virus Vaccine Live


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy children 12 to 18 months of age Exclusion Criteria: History or prior exposure to measles, mumps, or rubella History of allergic reactions to any component of the vaccines as evaluated by the study doctor

Ages Eligible for Study
-----------------
Minimum Age: 12 Months
Maximum Age: 18 Months

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: measles, mumps, and rubella virus vaccine live|nan|
|Biological: Comparator: Measles, Mumps, and Rubella Virus Vaccine Live|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody response rates to measles, mumps, and rubella at 6 weeks postvaccination |  | 6 weeks postvaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric mean titers to measles, mumps, and rubella by ELISA at 6 weeks postvaccination |  | 6 weeks postvaccination |
Treatment of ATFL Tears With PRP

Study Overview
=================
Brief Summary
-----------------
PRP will enhance ATFL tears healing by time and quality.

Official Title
-----------------
Treatment of ATFL Tears After Ankle Sprains With PRP

Conditions
-----------------
Soft Tissue Healing

Intervention / Treatment
-----------------
* Biological: PGRF
* Biological: placebo saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: athletes 18-30 years old 1st sprain within 3 days from injury Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>PGRF | Biological: PGRF<br>* injection of 6cc into injured area<br>|
| Placebo Comparator: 2<br>saline | Biological: placebo saline<br>* injection of 6cc into injured area<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to return to active sport |  | 2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PRP, ATFL
Tübingen High Altitude Ophthalmology Study

Study Overview
=================
Brief Summary
-----------------
Tuebingen High Altitude Ophthalmology Study to investigate the effects of high altitude on retinal structure and function as well as anterior chamber in regard to acute mountain sickness.

Official Title
-----------------
Tübingen High Altitude Ophthalmology Study (THAO)

Conditions
-----------------
Altitude, Hypoxia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy subjects, non-smokers, physical fitness, Exclusion Criteria: ocular pathologies, ascent above 2000m 2 weeks prior to study and 2 weeks before post-examination

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
Expression of miRNa-138 and Cyclin D1 in Oral Mucosa of Patients With Oral Lichen Planus

Study Overview
=================
Brief Summary
-----------------
60 individuals were subdivided into 2 groups, 30 patients with oral lichen planus, 30 control individuals. Expression of miRNA-138 and cyclin D1 were evaluated in oral mucosa utilizing Quantitative real-time polymerase chain reaction and immunohistochemistry.

Detailed Description
-----------------
60 individuals were subdivided into 3 groups, into 2 groups, 30 patients with oral lichen planus, 30 control individuals having age, gender and periodontal status matched with both patients groups acting as a control group. Relative gene expression of miRNA-138 was estimated using Quantitative real-time polymerase chain reaction technique in oral mucosa of both oral lichen planus patients and control subjects. Sub grouping of oral lichen planus patients were performed into reticular, atrophic and erosive groups (n=10 each). Cyclin D1 gene expression was estimated using Quantitative real-time polymerase chain reaction technique and Cyclin D1 protein level was estimated using immunohistochemistry.

Official Title
-----------------
Expression of miRNA-138 and Cyclin D1 in Oral Lichen Planus (A Study Utilizing Immunohistochemistry and Real-time Polymerase Chain Reaction)

Conditions
-----------------
Oral Lichen Planus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with oral lichen planus. Exclusion Criteria: any systemic disease other than oral lichen planus. smokers. pregnant females. periodontal diseases.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| oral lichen planus<br>30 patients suffering from reticular, erosive and atrophic oral lichen planus | |
| control subjects<br>30 individuals age, gender and periodontal status matched with oral lichen planus patients and not suffering from any oral mucosal lesions or periodontal disease. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| expression of miRNA-138 | expression of miRNA-138 in oral mucosa of patients with oral lichen planus | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gene expression of cyclin D1 | gene expression of cyclin D1 in oral mucosa of patients with oral lichen planus | 1 day | 
| protein expression of cyclin D1 | protein expression of cyclin D1 in oral mucosa of patients with oral lichen planus | 1 day |
Effects of Developing a Mobile-based Interactive Simulation Scheme for Assisting the Personalized Hands-on Learning of Nasogastric Tube Insertion

Study Overview
=================
Brief Summary
-----------------
A mobile-based interactive simulation scheme (MISS) was proposed and developed to investigate its effects on facilitating hands-on learning of nasogastric tube insertion in undergraduate medical students.

Official Title
-----------------
Effects of Developing a Mobile-based Interactive Simulation Scheme for Assisting the Personalized Hands-on Learning of Nasogastric Tube Insertion: a Randomized Controlled Trial

Conditions
-----------------
Nasogastric Tube Insertion

Intervention / Treatment
-----------------
* Other: A mobile-based interactive simulation scheme (MISS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: fifth-year undergraduate medical students at least 20 years old without any practical clinical experience Exclusion Criteria:

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br> | Other: A mobile-based interactive simulation scheme (MISS)<br>* A mobile-based interactive simulation scheme (MISS) was proposed and developed to investigate its effects on facilitating hands-on learning of NG insertion in undergraduate medical students.<br>|
| No Intervention: control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 10-item evaluation questionnaire on Nasogastric tube insertion knowledge | 0-100. Zero is the worst, and 100 is the best. | one week | 
| The self-confidence scale (C-scale) | 1-5. One is high uncertainty, and five is complete certainty. | one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| System Usability Scale (SUS) | 1-5. One is strongly disagree, and five is strongly agree. | one week | 
| The NASA-TLX (Task load index) | 1-5. One is strongly disagree, and five is strongly agree. | one week | 
| The overall learning satisfaction | 1-5 each. One is strongly disagree, and five is strongly agree. The questionnaire included 20 questions, divided into 11 categories: perceived enjoyment, comparison, diagnosis report, satisfaction, intension to use, perceived usefulness, perceived ease of use, image, output quality, result demonstrability, and cognitive load. | one week | 
| The OSCE (Objective Structured Clinical Examination) test | 0-100. Zero is the worst, and 100 is the best. | one week |