linjc16/ctgov huggingface dataset:
Defibrotide in Children With High Risk Kawasaki Disease

Study Overview
=================
Brief Summary
-----------------
This study evaluates the safety of defibrotide with IVIG in children with high risk Kawasaki disease.

Official Title
-----------------
A Pilot Study to Determine the Safety of Defibrotide in Children With High Risk Kawasaki Disease

Conditions
-----------------
Kawasaki Disease

Intervention / Treatment
-----------------
* Drug: Defibrotide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Kawasaki disease presumptive diagnosis defined according AHA criteria; Signed informed consent and patient assent (if applicable) Diagnosis of KD and initiation of defibrotide within 96 hours from the conclusion of IVIG treatment Age: 0 - 11 years old High risk category defined as patient meeting ≥2 of the following criteria: male, age <6 months or >8yrs, IVIG-resistance, Fever lasting greater than 10 days, prior to diagnosis, Coronary artery aneurysms, and/or Laboratory tests indicating worse systemic inflammation PT and PTT within institutional normal limits Platelet count ≥100,000/mm3 Exclusion Criteria: History of Grade III or IV hemorrhage or active bleeding; Previous Grade II-IV hypersensitivity to defibrotide Current systemic anti-coagulant therapy and/or fibrinolytic therapy, excluding aspirin (5 mg/kg/dose maximum). Patients on an active experimental trial for Kawasaki disease

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 11 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional<br>Defibrotide 6.25 mg/kg IV q6h | Drug: Defibrotide<br>* Defibrotide 6.25 mg/kg IV q6h up to 7 days<br>* Other names: Defitelio®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with grade III/IV allergic reaction to defibrotide | All patients will be monitored for allergic reaction probably or definitely related to defibrotide administration. | 30 days | 
| Number of patients with grade III/IV hemorrhage attributable to defibrotide | All patients will be monitored for hemorrhage probably or definitely related to defibrotide. | 42 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with improvement in clinical progression/signs of Kawasaki disease | Patients will have pre and post treatment assessments with imaging and blood tests to monitor clinical signs of Kawasaki disease | 42 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kawasaki, Children, Defibrotide
Drug-Drug Interaction Study of VCH-222 and Telaprevir in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the pharmacokinetics, safety, and tolerability of the co-administration of VCH-222 and telaprevir in healthy subjects.

Official Title
-----------------
A Phase 1, Randomized, Double-blind, Placebo-controlled, Sequential-group, Multiple-dose, Drug-drug Interaction Study of VCH-222 and Telaprevir in Healthy Subjects

Conditions
-----------------
Hepatitis C

Intervention / Treatment
-----------------
* Drug: VCH-222
* Drug: VCH-222
* Drug: VCH-222
* Drug: telaprevir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males, and/or healthy females of non-childbearing potential, aged 18 to 55 years (inclusive) Body mass index (BMI) between 18 and 31 kg/m2 (inclusive) and weight > 50 kg Exclusion Criteria: Women of child bearing potential Subjects positive for Hepatitis B, Hepatitis C, or HIV Subjects who have participated in a clinical study involving administration of an investigational drug within 2 months

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br> | Drug: VCH-222<br>* Capsules, Oral, 400 mg, q12h, Days 1-10 and Days 28-37<br>Drug: telaprevir<br>* Tablet, Oral, 1125 mg, q12h, Days 18-37<br>|
| Experimental: Cohort 2<br> | Drug: VCH-222<br>* Capsules, Oral, 750 mg, q12h, Days 1-10 and Days 28-37<br>Drug: telaprevir<br>* Tablet, Oral, 1125 mg, q12h, Days 18-37<br>|
| Experimental: Cohort 3<br> | Drug: VCH-222<br>* Capsules, Oral, 1000 mg, q12h, Days 1-10 and Days 28-37<br>Drug: telaprevir<br>* Tablet, Oral, 1125 mg, q12h, Days 18-37<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability based on vital signs, 12-lead electrocardiograms (ECGs), physical examination, laboratory assessments, and adverse events |  | Day 47 safety assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters (Cmax, tmax, C12 h, Cmin, and AUC0-12 h) of VCH-222 at steady-state in plasma in the presence and absence of telaprevir at steady-state |  | Day 37 pharmacokinetic assessment | 
| Pharmacokinetics parameters (Cmax, tmax, C12 h, Cmin, and AUC0-12 h) of telaprevir at steady-state in plasma in the presence and absence of VCH-222 at steady-state |  | Day 37 pharmacokinetic assessment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
VX-950, VX-222, STAT-C
A Safety Study of Dapivirine (TMC120) Vaginal Microbicide Gel in South Africa

Study Overview
=================
Brief Summary
-----------------
Approximately 42 HIV-negative women, aged >18 and < 50, will be enrolled in this study. Each volunteer will have a 2:1 chance of receiving Dapivirine Gel-002 versus placebo. The volunteers will receive investigational product for a total of 42 days.

Official Title
-----------------
A Phase I/II Single-Centre Double-Blinded Randomized Study of the Safety and Tolerability of TMC120 Vaginal Microbicide Gel (TMC120 Gel-002) vs. HEC-Based Universal Placebo Gel in Healthy HIV-Negative Women.

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: dapivirine (TMC120) vaginal gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-negative Willing to participate and sign an informed consent form Willing to be tested for HIV, use an experimental vaginal gel, and to be randomized to a study group that includes the possibility of being assigned to a placebo group. Willing to use two forms of contraception during the study Willing to undergo pelvic examinations with colposcopy and photographic documentation according to the protocol throughout the study. Have a regular menstrual cycle defined as having a minimum of 21 days and a maximum of 36 days between menses Exclusion Criteria: Currently pregnant or breast-feeding Clinically detectable genital abnormality on the vulva, vaginal walls or cervix Laboratory confirmed gonorrhea, chlamydia, trichomonas, syphilis, or vaginal candidiasis or clinically diagnosed GUD or active HSV-2 lesion Breakthrough bleeding or gynecologic surgery within 60 days prior to randomization Symptomatic bacterial vaginosis at Screening and unwilling to undergo treatment. Women who require treatment for tuberculosis (TB) within 21 days prior to randomization.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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 |
| --- |
|Drug: dapivirine (TMC120) vaginal gel|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local and systemic safety and tolerability. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV-1, HIV Seronegativity
Haemate HS in Patients With Severe Bleeding Undergoing Valve Replacement Due to Aortic Stenosis

Study Overview
=================
Brief Summary
-----------------
Evaluation of efficacy by determination of transfusion requirements and safety by determination of adverse events in administration of Von Willebrand factor concentrate F VIII (Haemate).

Official Title
-----------------
Phase 2 Study in Evaluation of the Efficacy and Safety of Haemate HS in This Clinical Setting (Patients With Severe Bleeding Undergoing Valve Replacement Due to Aortic Stenosis)

Conditions
-----------------
Blood Loss, Surgical

Intervention / Treatment
-----------------
* Drug: Haemate HS
* Other: NaCl-solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with isolated valvular aortic stenosis or combined aortic-valve defect with prevailing stenosis with severe bleeding during aortic-valve replacement Caucasian written informed consent (Classification of bleeding as normal, moderate or excessive by the surgeon.Classification as excessive leads to recruitment) Exclusion Criteria: active endocarditis history suggestive for inherited oe acquired bleeding disorder concomitant coronary heart disease agents impairing platelet function up to 14 days before surgery Pregnancy inherited platelet function known intolerance against HAEMATE HS previous thromboembolic complications Hepatitis B, C or HIV infection previous chemotherapy emergency surgery within the last 7 days weight < 50 kg and > 100 kg

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>intravenous infusion of Haemate (dosage dependent on body weight) | Drug: Haemate HS<br>* intravenous infusion of Haemate (dosage dependent on body weight)<br>|
| Placebo Comparator: 2<br>intravenous infusion of 0.9% NaCl solution | Other: NaCl-solution<br>* intravenous infusion of 0.9%NaCl-Solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intra- and postoperative transfusion requirements of packed red cells, platelet concentrates and fresh frozen plasma according to defined transfusion thresholds |  | begin of surgery and 48h after administration of medication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of adverse events and viral safety |  | 1.perioperative 2. during hospital admission 3. within 90 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intraoperative bleeding, aortic-valve replacement, aortic stenosis, Von Willebrand, HEAMATE
A Study of the Pre- and Post-operative Semen Analyses and Reproductive Hormone Levels of Men Undergoing Weight-reduction Surgery

Study Overview
=================
Brief Summary
-----------------
A correlation between obesity and male fertility has been observed in a few clinical studies. Normal weight men appear to have higher sperm concentrations and sperm motility when compared to obese men, suggesting that weight loss might improve sperm function. However, there also are reported cases of severe male factor infertility following weight loss surgery in previously fertile men. The aim of this study is to determine if there are differences in the semen analyses and hormone levels of men obtained before and after undergoing weight loss (bariatric) surgery. This will direct future research and treatment.

Detailed Description
-----------------
We will recruit 60 subjects for this study. Volunteers will provide pre-operative semen and blood samples prior to undergoing weight-reduction surgery. Those with normal pre-operative sperm samples will be invited to continue participating in the study by providing subsequent post-operative semen samples and hormonal testing over a two year time period. It is estimated to take approximately one year to enroll the desired 60 subjects. The study will conclude two years from the last enrollment. The main analysis will be a comparison of sperm concentrations over time.

Official Title
-----------------
Weight Loss Surgery and Male Fertility

Conditions
-----------------
Male Infertility

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult male subjects between the ages of 18-65 undergoing bariatric surgery Exclusion Criteria: Subjects with abnormal sperm analysis

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in semen analyses and reproductive hormone measurements |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trends in semen analysis & reproductive hormone parameters over the two-year data collection period, Changes in semen analysis & reproductive hormone parameters as a function of BMI |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bariatric surgery, weight loss surgery, male infertility, Roux-En-Y, gastric banding
Bridging Intestinal Failure With Teduglutide - a Case Report

Study Overview
=================
Brief Summary
-----------------
In this case report the investigators present a novel strategy for using teduglutide as a bridging therapy to intestinal reconstruction.

Official Title
-----------------
Bridging Intestinal Failure With Teduglutide - a Case Report

Conditions
-----------------
Short Bowel Syndrome

Intervention / Treatment
-----------------
* Drug: Teduglutide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: short bowel syndrome Exclusion Criteria: <18 years
Sexes Eligible for Study
-----------------
Male

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Teduglutide|bridging intestinal failure with teduglutide until reconstruction|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| enteral autonomy (complete discontinuation of parenteral support) | observe if enteral autonomy may be achieved before reconstruction | 6 months |
Postoperative Pain in Adolescent Idiopathic Scoliosis Surgery

Study Overview
=================
Brief Summary
-----------------
Scoliosis is a 3-dimensional, structural deformity of the spine. Idiopathic scoliosis is the most common type and it constitutes 75-80% of all scoliosis. Surgical methods are the most effective way to correct the deformity in patients who cannot achieve adequate improvement with supportive therapy. Adolescent idiopathic scoliosis surgeries are among the most invasive surgeries performed on children and adolescents. Large surgical incision and massive tissue damage cause severe postoperative pain. In this study, we aim to compare posterior instrumentation (PE) and vertebral body tethering (VBT) surgeries performed in adolescent idiopathic scoliosis patients in terms of anesthetic management and postoperative pain.

Official Title
-----------------
Evaluation of Surgical Methods in Terms of Postoperative Pain in Adolescent Idiopathic Scoliosis

Conditions
-----------------
Scoliosis; Adolescence

Intervention / Treatment
-----------------
* Procedure: Vertebral Body Tethering


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA score 1-3 patients Adolescent idiopathic scoliosis patients Patients who accepted to be included in the study and received written parental consent Exclusion Criteria: Patients with vertebral anomaly due to a secondary reason Patients with a diagnosed syndrome Patients with a Cobb angle below 40. Patients who undergoing reoperation

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Posterior Spinal Instrumentation<br> | |
| Experimental: Vertebral Body Tethering<br> | Procedure: Vertebral Body Tethering<br>* VBT surgery is a surgery performed by thoracotomy in adolescent idiopathic scoliosis patients.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison in terms of postoperative pain | Opioid consumption and VAS (visual analog scale) (0: no pain, 10: the worst pain imaginable) for measurement of postoperative pain | 48 hours |
Ezetimibe Plus (+) Simvastatin Versus Atorvastatin Comparative Study (0653A-092)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
This is an efficacy and safety study of Vytorin (ezetimibe (+) simvastatin) compared to atorvastatin (ezetimibe/simvastatin) at week 6 in primary hypercholesterolemia patients in Korea. The primary hypothesis being tested is that daily administration of Vytorin will result in a greater reduction of low density lipoprotein cholesterol (LDL-C) concentration from baseline after 6 weeks treatment compared to atorvastatin.

Official Title
-----------------
A Multicenter, Randomized, Open-label Study to Evaluate the Lipid-Altering Efficacy and Safety of Ezetimibe (+) Simvastatin Versus Atorvastatin in Patients With Primary Hypercholesterolemia

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: ezetimibe (+) simvastatin
* Drug: atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of hypercholesterolemia LDL-C >/= 130 mg/dL but </=250 mg/dL and triglyceride (TG) </= 350 mg/dL National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III guideline Exclusion Criteria: Hypersensitivity to 3-hydroxy-3-methyl-glutaryl-CoA reductase (HMG-CoA reductase) inhibitors or Ezetimibe

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: Vytorin<br>Ezetimibe 10 mg/Simvastatin 20 mg | Drug: ezetimibe (+) simvastatin<br>* simvastatin/ezetimibe 10/20 mg<br>* Other names: Vytorin®;|
| Active Comparator: Atorvastatin<br>Atorvastatin 10 mg | Drug: atorvastatin<br>* atorvastatin 10 mg<br>* Other names: Lipitor®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-C Lowering Efficacy | LDL-C = low density lipoprotein cholesterol, measured in mg/dl. | 6 weeks |
Audit of Hip Fractures Surgically Managed

Study Overview
=================
Brief Summary
-----------------
Investigators are reviewing the the charts and medical records of participants who were operated at our institute from 2010 onward for hip fractures. Checking their outcomes (Postoperative complications, length of hospital stay and mortality) and studying their background characteristics and potential associated factors.

Detailed Description
-----------------
This retrospective study is a cohort with multiple exposures and groups. From this nested case control will be analysed as well.

Official Title
-----------------
Hip Fractures Surgical Management and Complications: Retrospective Study

Conditions
-----------------
Hip Fractures

Intervention / Treatment
-----------------
* Procedure: hip fracture surgeries


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients, regardless of gender, commodities and age Hip fractures which were managed surgically. operated at our institute. Exclusion Criteria: Participants with incomplete data or missing information in either the primary exposure or the outcome of interest. Participants with pathological fracture, open fractures, poly-trauma or revision surgeries.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: hip fracture surgeries|fixation or replacement|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative complications | minor or major, in-hospital or within 30 days postoperativel | 30 days postoperative |