linjc16/ctgov huggingface dataset:
Estradiol Pretreatment With Misoprostol in Second Trimester Miscarriage

Study Overview
=================
Brief Summary
-----------------
To compare the effectiveness of estradiol pretreatment with misoprostol and vaginal misoprostol alone in induction of second trimestr miscarriage.

Official Title
-----------------
Estradiol Pretreatment With Misoprostol in Second Trimester Miscarriage: A Prospective, Double-blind, Randomized Clinical Trial

Conditions
-----------------
Miscarriage

Intervention / Treatment
-----------------
* Drug: Estradiol
* Drug: Placebo Oral Tablet
* Drug: Misoprostol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Maternal age more than 18 years old (age of legal consent). Gestational age between 12-26 weeks. Hb level > 10 g/dL. BMI between 25 kg/m2 and 35 kg/m2. Missed abortion. Living fetus with multiple congenital malformations incompatible with life. PPROMS with drained liquor and parents are consenting for termination of pregnancy. Exclusion Criteria: Maternal age less than 18 years old. Gestational age less than 12 weeks or more than 26 weeks. Hb level < 10 g/dL. Scared uterus (previous myomectomy - cesarean section - hysterectomy and ruptured uterus). Polyhydramnios. Anencephaly. Fibroid uterus. BMI less than 25 kg/m2 and more than 35 kg/m2. Coagulopathy. Previous attempts for induction of abortion in the current pregnancy. Allergy to misoprostol or estradiol. Placenta previa. Medical disorder that contraindicate induction of abortion (e.g. heart failure).

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Estradiol + Misoprostol<br> | Drug: Estradiol<br>* Estradiol<br>Drug: Misoprostol<br>* Misoprostol<br>|
| Placebo Comparator: Placebo + Misoprostol<br> | Drug: Placebo Oral Tablet<br>* Placebo<br>Drug: Misoprostol<br>* Misoprostol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of induction of abortion |  | 24 hours |
Efficacy of Cyclosporine for the Prevention and Treatment of Dry Eye Symptoms Following LASIK or Photorefractive Keratectomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of topical cyclosporine ophthalmic solution 0.05% (Restasis, Allergan) on the signs and symptoms of dry eye in patients undergoing LASIK or photorefractive keratectomy (PRK).

Official Title
-----------------
Efficacy of Topical Cyclosporine Ophthalmic Emulsion for the Prevention and Treatment of Dry Eye Symptoms Following LASIK or Photorefractive Keratectomy

Conditions
-----------------
Dry Eye Syndromes

Intervention / Treatment
-----------------
* Drug: Cyclosporine, Refresh Plus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females > 18 years old Mild-moderate symptoms of dry eye prior to surgery Scheduled to undergo bilateral LASIK or PRK Likely to complete all study visits and able to provide informed consent Exclusion Criteria: Prior use of topical cyclosporine within the last 1 year Known contraindications to any study medication or ingredients Female of child bearing potential not using reliable methods of birth control, or pregnant or lactating females. Ocular disorders Active ocular diseases or uncontrolled systemic disease Active ocular allergies

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Cyclosporine, Refresh Plus<br>* Cyclosporine 0.4ml (in the eye) on for 3 months instill one drop in randomized eye twice daily. Refresh Plus 0.4ml (in the eye) on for 3 months instill one drop in randomized eye twice daily.<br>|
| Placebo Comparator: 2<br> | Drug: Cyclosporine, Refresh Plus<br>* Cyclosporine 0.4ml (in the eye) on for 3 months instill one drop in randomized eye twice daily. Refresh Plus 0.4ml (in the eye) on for 3 months instill one drop in randomized eye twice daily.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dry Eye Symptoms |  | 1.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dry eye signs |  | 1.5 yrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry eye
Exploration of Wrist Soft Tissue Injuries Associated With Wrist Fractures

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe and stage lesions of the triangular fibrocartilage complex (TFCC) in association with distal radius fractures. 20 patients with dorsally dislocated AO type A fractures of the distal radius with sufficient displacement (based of cadaveric data) will be included. After stability testing and wrist arthroscopy. The TFCC is explored through a volar incision and injuries were documented and repaired from this approach.

Official Title
-----------------
Exploration of Acute TFCC-injuries in Association With Distal Radius Fractures

Conditions
-----------------
Triangular Fibrocartilage Complex Injuries

Intervention / Treatment
-----------------
* Procedure: Arthroscopy, surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-65 Distal radius fracture Displacement > 20 degrees of dorsal angulation Exclusion Criteria: Previous significant wrist injury Declines to participate Ulnar styloid fracture at base or proximal to it

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

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

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

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 |
| --- | --- |
| Other: Surgical exploration<br>Descriptive | Procedure: Arthroscopy, surgery<br>* Ulno-volar wrist approach to the TFCC<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual instability symptoms | Mechanisms of injury are poorly previously described. This study will hopefully confirm cadeveric data. There is some evidence that patients might benefit from acute repair. Residual instability can be both ulnocarpal and radioulnar. | Approx 2-6 months to include the patients that meet the inclusion criteria. They will be followed for 6 momths | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Patients that accept to participate will undergo exploration from a (new) ulnovolar approach. The study is purely descriptive. Patients are monitored for adverse events such as nerve injury and infection for 3 months. | Three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TFCC injuries, Distal radius fractures
Cognitive Decline in AD

Study Overview
=================
Brief Summary
-----------------
There is lack of information on the risk factors of accelerated cognitive decline in older people with Alzheimer disease (AD). The extent of neurodegeneration and white matter disease has been reported to be important factors. In addition there may be biomarkers e.g. inflammatory cytokines that can contribute to cognitive decline. The impact of care arrangement and physical activity may also be important. Insulin signaling is impaired in Alzheimer disease (AD). We therefore propose to perform a cohort study of older people with AD. This will be based on an on-going AD registry which was designed to identify genetic biomarkers for AD. Detailed neurocognitive tests and lifestyle information are available. In addition, volumetric MRI brain scans were performed in all AD subjects. The hypothesis is that MRI brain volumes, serum biomarkers, physical activity, physical functioning are independently associated with cognitive decline in older people with AD. The objective is to identify risk factors of accelerated cognitive decline so that preventive measures can be designed to delay dependency in AD.

Official Title
-----------------
A Cohort Study of Cognitive Decline in Alzheimer Disease

Conditions
-----------------
Alzheimer Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sufficient Cantonese competency for cognitive test Clinical diagnosis of AD FAST test staging 3-5 Exclusion Criteria: Subjects who refuse blood taking procedure No reliable family caregiver informant (person contact at least once a month)

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 92 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 |
| --- | --- | --- |
| Alzheimer's Disease Assessment Scale-cognitive subscale ADAS-COG | Cognitive assessment for dementia | 24-Months |
Single Dose and 34-Day Tolerance Study of INGAP Peptide in Insulin Deficient Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and tolerability of single and multiple doses of intramuscular INGAP Peptide given for the first time in humans as a potential treatment for diabetes.

Official Title
-----------------
Single Dose and 34-Day Tolerance Study of INGAP Peptide in Insulin Deficient Patients

Conditions
-----------------
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: INGAP Peptide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients meeting all of the following inclusion criteria at screening can be considered for admission to the study. Stage 1 and Stage 2: Male and female patients with, type 1 diabetes mellitus that are 18 through 70 years of age, or type 2 diabetes mellitus that are 30 through 70 years of age. Patients who are insulin deficient and are diagnosed with type 1 or type 2 diabetes mellitus, and are currently well managed with insulin, with or without metformin. Patients who have been on stable doses of insulin treatment for 90 days prior to study randomization. Exclusion Criteria: Patients meeting any of the following exclusion criteria at screening will not be enrolled in the study: Patients with a history of any clinically significant retinopathy, symptomatic autonomic neuropathy, unstable angina, or kidney problems. Patients with an uncontrolled or untreated significant pulmonary, neurological condition, or cardiovascular disease, including hypertension, congestive heart failure, angina, or peripheral vascular disease. Patients who have received any investigational product within 30 days of admission into the study. Patients with a history or clinical evidence of multiple organ autoimmune disorders. Patients with a medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up. Patients who are lactating and breastfeeding.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: INGAP Peptide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Comparison of Prilosec OTC® Versus Zegerid® for Gastric Acid Suppression

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare Prilosec OTC® and Zegerid® in their effects on gastric acid suppression.

Official Title
-----------------
Comparison of Prilosec OTC® Versus Zegerid® for Gastric Acid Suppression

Conditions
-----------------
Normal Healthy Subject Population

Intervention / Treatment
-----------------
* Drug: Zegerid®
* Drug: Prilosec OTC®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal subjects who are 18-65 years of age; Non-childbearing potential females or those using birth control Exclusion Criteria: History of significant GI disease Any significant medical illness History of hypersensitivity, allergy or intolerance to omeprazole or other proton pump inhibitors; Currently using GI medications GI disorder or surgery leading to impaired drug absorption

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Zegerid® | Drug: Zegerid®<br>* capsule(20 mg omeprazole/sodium bicarbonate), single dose<br>|
| Experimental: 2<br>Prilosec OTC® | Drug: Prilosec OTC®<br>* Omeprazole-magnesium 20.6 mg, tablet, single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Mean Percent Time Gastric pH > 4.0 on Day 1 | In this study, there was evidence of gastric pH probe failure and a high incidence of biologically improbable pH measurements (sustained pH < 1.0) that bring the validity of the results into question. The results of this study are, therefore, inconclusive. | continuously over a 24 hour period |
Adjuvant Anti-Recurrence Treatment With Rapamycin on Early-stage HCC

Study Overview
=================
Brief Summary
-----------------
To evaluate the clinical effect of rapamycin combined with TACE on early-stage HCC with overexpression of ASPH after radical surgery using randomized controlled study and provide a new anti-recurrence treatment for HCC patients after operation.

Official Title
-----------------
A Randomized Controlled Study on the Effect of Adjuvant Anti-recurrence Treatment With Rapamycin on Early-stage HCC With Overexpression of ASPH After Radical Surgery.

Conditions
-----------------
Hepatocellular Carcinoma, Rapamycin

Intervention / Treatment
-----------------
* Drug: Rapamycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Via clinical diagnosis and confirm it is primary liver cancer Pathological evidence of HCC Estimate tumor can gain treatment of curing operation No evidence for extrahepatic metestasis liver function ：Child-Pugh A/B BCLC stage：0/1；TNM stage：Ⅰ Exclusion Criteria: reject to attend； impossible to come to our hospital for physical examination regularly. cancer epitome、seed focus、lymph node or distant metastasis Blood clotting function hindrance; 5, Patients with other diseases which may affect the treatment mentioned.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| No Intervention: control group<br>Patients will be treated with radical hepatectomy only. | |
| Active Comparator: transcatheter arterial chemoembolization<br>Patients will be treated with TACE | Drug: Rapamycin<br>* 2mg,po,bid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recurrence |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aspartate beta hydroxylase, transcatheter arterial chemoembolization
Expanded Access for Anti-IL8

Study Overview
=================
Brief Summary
-----------------
This is an expanded access designed to provide access to Anti-IL8 for eligible participants.

Intervention / Treatment
-----------------
* Biological: Anti-IL8


Participation Criteria
=================

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Anti-IL8|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Safety of Sports for Patients With Implantable Cardioverter-Defibrillators

Study Overview
=================
Brief Summary
-----------------
The registry will obtain information to determine the safety of sports participation for patients with defibrillators (ICDs).

Detailed Description
-----------------
Patients who are participating in sports who have defibrillators will be invited to participate in a prospective registry to determine the rate of adverse events occurring during sporting activities. Patients will be followed for four years and adverse events quantified. Yale is the coordinating center for this multicenter registry.

Official Title
-----------------
Safety of Sports for Patients With Implantable Cardioverter-Defibrillators: A Multi-Center Registry

Conditions
-----------------
Heart Arrhythmias

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: individuals between the ages of 10 and 60 has a defibrillator plays a competitive/organized sport more vigorous than golf or bowling or participates in a dangerous sport Exclusion Criteria: children under 10 years (as they engage in primarily recreational sports) individuals over the age of 60 years (maintain a homogenous population) inability to give informed consent

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 60 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 |
| --- | --- | --- |
| Resuscitated arrest or death during sports, or injury during sports due to arrhythmic symptoms and/or shock. |  | four years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| System malfunction and incidence of ventricular arrhythmias (VA) requiring multiple shocks for termination |  | four years. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICD, Sports
Study of ONTAK (Denileukin Diftitox) in Cutaneous T-Cell Lymphoma (CTCL) Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effectiveness of two dose levels of ONTAK (denileukin diftitox) in treating patients who have recurrent or persistent cutaneous T-cell lymphoma.

Official Title
-----------------
A Multicenter Phase III Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy of Two Dose Levels of DAB389IL-2 (9 and 18 Mcg/kg/Day) in Cutaneous T-Cell Lymphoma (CTCL) Patients With Stage Ia-III Disease Who, Following Less Than or Equal to 3 Previous Therapies, Have Recurrent or Persistent Disease That Has Been Biopsy-Documented to Express CD25

Conditions
-----------------
Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides, Sezary Syndrome

Intervention / Treatment
-----------------
* Drug: ONTAK


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histopathologically confirmed recurrent or persistent CTCL as determined by reference pathology lab; Patient must have had 1 to 3 prior CTCL therapies. Repeated use of the same agent is considered to be 1 therapy unless it is part of a different combination regimen. Only 1 prior combination cytotoxic regimen is permitted. Topical or systemic steroids are not considered a therapy; Interleukin-2 receptor (IL-2R) expression on at least 20% of tumor cells as determined by immunohistochemistry. Stage IA - III disease and unlikely to progress during the first month on study. Life expectancy of at least 12 months. Measurable or evaluable disease. Lymph node involvement no greater than LN2. No CTCL involvement of bone marrow. No active CNS disease, kidney or liver disease, significant pulmonary disease, or cardiac disease. No systemic infections; Willingness to be randomized to a placebo treatment only arm; ECOG performance status 0 or 1; Exclusion Criteria: • Patients must not have previously received treatment with DAB389IL-2 or DAB486IL 2 (previous candidate compound evaluated in a clinical setting).

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: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Rate of Response (ORR), defined as CR + CCR + PR |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-to-Treatment Failure |  |  | 
| Time-to-Progression |  |  | 
| Duration of Response |  |  |