linjc16/ctgov huggingface dataset:
The Mechanism of Melanocyte Self-Assembly on Biomaterials and the Functional Analysis

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to survey melanocytes in the ability of self-assembly on biomaterials and functional analysis in vitro. Also, this study may provide a better way for treatment of vitiligo after understanding the functional aspects of melanocytes.

Detailed Description
-----------------
Vitiligo is a chronic disease that causes loss of melanocyte and pigment of the skin. Traditional treatments for vitiligo including topical corticosteroids and phototherapy lead to limited clinical effects. Autologous melanocyte transplantation is another way to treat vitiligo. However, the effect is largely affected by whether cultivated melanocytes are successfully uptaken by vitiliginous skin. The aim of this study is to survey the self-assembly on biomaterials and functional analysis. In the long run, this study may provide a better way for treatment of vitiligo.

Official Title
-----------------
The Mechanism of Melanocyte Self-Assembly on Biomaterials and the Functional Analysis

Conditions
-----------------
Melanocyte, Vitiligo

Intervention / Treatment
-----------------
* Behavioral: melanocyte self-assembly and functional analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients receiving cosmetic removal of moles Exclusion Criteria: No special exclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: melanocyte self-assembly and functional analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
An Observational Study of TNKase in Patients Enrolled in the National Registry of Myocardial Infarction 4 and 5 (POST)

Study Overview
=================
Brief Summary
-----------------
The POST study comprised patients whose data were entered into the NRMI 4 and 5 databases. NRMI is a prospective, observational study of patients presenting with AMI in the United States. NRMI was launched in 1990 and to date has enrolled more than 2.5 million AMI patients. More than 1,700 hospitals have participated in NRMI during the last 16 years. The NRMI 4 and 5 substudies were sponsored by Genentech and collected data on approximately 160,000 AMI patients (both ST elevation and non-ST-elevation MI) hospitalized in the United States each year. This corresponds to approximately 18% of the AMI patients in the United States.

Official Title
-----------------
A Phase IV, Prospective, Observational Study of TNKase in Patients Enrolled in the National Registry of Myocardial Infarction 4 and 5 (POST)

Conditions
-----------------
Acute Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of LBBB or ST-segment elevation (new or of unknown duration) ICD-9-CM discharge code of 410.X1 Treatment with one of the following regimens: TNKase; Other thrombolytic regimens; No initial reperfusion Exclusion Criteria: Patients who were transferred out of the facility Patients with pending data clarification forms on fields related to study variables
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TNKase, AMI
A Study of GT160-246 Versus Vancomycin in Patients With Clostridium Difficile-Associated Diarrhea

Study Overview
=================
Brief Summary
-----------------
Approximately 300 patients will be entered into this study taking place throughout the United States, Canada and the United Kingdom. This study aims to determine if an investigational drug is safe and effective for treating the symptoms of C. difficile-associated diarrhea and lowering the risk of repeat episodes of diarrhea. The investigational drug will be evaluated in comparison to current standard antibiotic treatment, so all patients will receive active medication. All study-related care is provided including doctor visits, physical exams, laboratory tests and study medication. Total length of participation is approximately 10 weeks.

Official Title
-----------------
A Randomized, Double-Blind Study of GT160-246 Versus Vancomycin in Patients With C. Difficile-Associated Diarrhea

Conditions
-----------------
Clostridium Difficile-Associated Diarrhea, Clostridium Enterocolitis, Clostridium Difficile Diarrhea, Antibiotic-associated Colitis, Antibiotic-associated Diarrhea

Intervention / Treatment
-----------------
* Drug: GT160-246


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be at least 18 years old. Have active mild to moderate C. difficile- Associated Diarrhea (CDAD). Be able to tolerate oral medication. Not be pregnant or breast-feeding. Sign and date an informed consent form.

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: GT160-246|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CDAD, C. difficile-associated diarrhea, Clostridium difficile-Associated Diarrhea, Clostridium enterocolitis, antibiotic-associated diarrhea, clostridium difficile colitis, infectious diarrhea, chronic diarrhea, antibiotic-associated colitis
A Clinical Trial of YH23537 in Patients With Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate efficacy and safety of YH23537 versus celebrex in patients with knee osteoarthritis.

Official Title
-----------------
A Randomized, Double-blind, Placebo- and Active-Controlled, Multicenter, Phase 2 Trial to Evaluate the Efficacy and Safety of YH23537 in Patients With Osteoarthritis of the Knee

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Drug: YH23537
* Drug: Celecoxib
* Drug: YH23537 placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed Informed Consent Men and women ≥ 40 years of age Patients with knee osteoarthritis at one or both knee by ACR Exclusion Criteria: Patients with known or suspected secondary knee osteoarthritis Other exclusions applied

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| Experimental: YH23537<br>YH23537 750/1500/3000mg | Drug: YH23537<br>* Drug: YH23537 750mg Drug: YH23537 1500mg Drug: YH23537 3000mg<br>* Other names: YH23537 750mg/1500mg/3000mg;|
| Active Comparator: Celebrex<br>Celecoxib 200mg | Drug: Celecoxib<br>* Drug: Celecoxib 200mg<br>* Other names: Celecoxib 200mg;|
| Placebo Comparator: Placebo<br>YH23537 Placebo | Drug: YH23537 placebo<br>* Drug: YH23537 750mg placebo Drug: YH23537 1500mg placebo Drug: YH23537 3000mg placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in VAS score to assess pain at Week 12 |  | baseline and week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in VAS score to assess pain at Week 4, 8 |  | baseline, week 4 and week 8 | 
| Change From Baseline in Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) score at Week 4, 8, 12 |  | baseline, week 4, week 8 and week 12 | 
| Change From Baseline in WOMAC subgroup(pain, stiffness, difficulty performing daily activities) score at Week 4, 8, 12 |  | baseline, week 4, week 8 and week 12 | 
| Percentage From Baseline in WOMAC responder at Week 4, 8, 12 |  | baseline, week 4, week 8 and week 12 | 
| Percentage of positive response(+1) in Patient Global Impression of Change (PGIC) at Week 12 |  | week 12 | 
| Percentage of positive response(excellent, good and fair response) in Physician's Global Assessment of Response to Therapy (PGART) at Week 12 |  | week 12 |
Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor?

Study Overview
=================
Brief Summary
-----------------
The hypothesis is if administration of acetaminophen during labor will reduce the amount of neuraxial pain medication required for comfort. For the study, Acetaminophen or placebo capsules will be administered at the time of neuraxial analgesia placement and then administered every 6 hours until delivery. Overall consumption of neuraxial pain medication will be determined.

Detailed Description
-----------------
Acetaminophen 1000 mg or placebo capsules will be administered at the time of neuraxial analgesia placement and continued every 6 hours until delivery. Vital signs, scores for pain, nausea, itching, and sleepiness will be also obtained. Evaluation of consumption of neuraxial analgesic medication will be included in the final analysis for the differences between the 2 groups

Official Title
-----------------
Does Acetaminophen Reduce Neuraxial Analgesic Requirement During Labor

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Acetaminophen
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >/= 18 years of age not allergic to study medications Exclusion Criteria: pre-eclampsia in labor AND with demonstrated significant abnormal liver enzyme function changes non-English speaking subjects

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: acetaminophen<br>1000 mg every 6 hours during labor up to maximum 3 doses | Drug: Acetaminophen<br>* administered every 6 hours by mouth up to 4 doses<br>* Other names: tylenol;|
| Placebo Comparator: placebo<br>placebo capsule identical to the acetaminophen capsule will be administered every 6 hours to a maximum of 4 doses | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuraxial Analgesic Drug Consumption Per Hour | subject evaluated every 2 hours with the amount of neuraxial analgesia consumed during that time period. Study med administered up to 24 hours. labor analgesia continue until delivery. | up to 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
labor pain, acetaminophen
Treatment of Severe Depressive Illness by Targeted Brain Surgery

Study Overview
=================
Brief Summary
-----------------
This study will report on the outcome of a clinical program, operational since 1998, that has used surgery targeting an emotional pathway in the brain in the treatment of severe depressive illness that has failed to respond to all other available interventions. Benefit from surgery was anticipated on the basis that the lesion (bilateral anterior capsulotomy) is a well established surgical target for treating severe treatment resistant depression.

Detailed Description
-----------------
Since 1998 bilateral anterior capsulotomy (BAC) has been available to patients in British Columbia Canada who have treatment refractory severe depressive illness. This study will report on the outcome of patients who have received this intervention. BAC is achieved by stereotactic radiofrequency lesioning. To date 8 patients have received BAC. For all patients there is follow-up data of at least 24 months. The purpose of this retrospective study is to report on the surgical protocol and to demonstrate the efficacy and safety of BAC in severe depression.

Official Title
-----------------
Bilateral Anterior Capsulotomy For Intractable Depression

Conditions
-----------------
Major Depressive Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe treatment resistant depression of at least 5 years duration older than 18 years Exclusion Criteria: Comorbid organic mental disorder Delusional disorder Substance disorder Neurological disease Cluster B personality disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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>All subjects who received BAC for treatment resistant depression between 2000 and 2009 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Limbic surgery, Stereotactic surgery, Major Depressive Disorder: Treatment Refractory
New Options for Preoperative Anesthesia in Intrauterine Needling

Study Overview
=================
Brief Summary
-----------------
The concept of fetal pain is becoming increasingly relevant due to growing possibilities for invasive intrauterine treatment. There is much debate as to whether the fetus is mature enough to be able to perceive pain at all. Recent studies have suggested that the fetus is at least capable of exhibiting a stress response to intrauterine needling. Intrauterine transfusions are most commonly performed by inserting a needle either in the umbilical cord root at the placental surface, or in the intrahepatic portion of the umbilical vein of the fetus. Recently, intrauterine needling in the intrahepatic vein has been shown to result in alterations in fetal stress hormones, which has been interpreted as a reaction to pain. These changes were not observed in intrauterine needling in the umbilical cord root, or after administration of analgesics to the fetus. The investigators tested the hypothesis that remifentanil provides fetal analgesia, assessed by a reduced fetal stress response. The investigators performed a randomised controlled trial comparing fetal stress response between patients undergoing intrauterine transfusions for alloimmune fetal anemia receiving remifentanil, or placebo.

Official Title
-----------------
NO PAIN: New Options for Preoperative Anesthesia in Intrauterine Needling

Conditions
-----------------
Stress, Pain

Intervention / Treatment
-----------------
* Drug: Remifentanil
* Drug: saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: singleton pregnancy clinically indicated intrauterine transfusion red cell alloimmunisation Exclusion Criteria: severe adipositas suspicion of structural anomalies fetal hydrops contraindication for remifentanil

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: remifentanil<br> | Drug: Remifentanil<br>* 0.15 microgram/kg/min continuous infusion.<br>|
| Placebo Comparator: saline<br> | Drug: saline<br>* continuous infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evidence of fetal stress response by changes in fetal stress hormones beta-endorphin, noradrenalin and cortisol |  | 15-60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| influence of analgesics (remifentanil) on the fetal stress response |  | 15-60 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fetal pain, intrauterine, needling
A Study of an Implantable Miniature Telescope in Patients With With End-Stage AMD

Study Overview
=================
Brief Summary
-----------------
Evaluation of pre and post-implantation management of patients with end-stage age-related macular degeneration (AMD) who have been implanted with the implantable telescope (IMT) under CE Mark indicated use. This study is designed to evaluate in particular the optimal parameters for patient selection for use of this device in routine clinical practice.

Official Title
-----------------
A Prospective Multicenter Clinical Study of the Implantable Miniature Telescope* in Patients With Central Vision Impairment Associated With AMD: IMT-UK Protocol (*IMT by Dr. Isaac Lipshitz)

Conditions
-----------------
End Stage Macular Degeneration

Intervention / Treatment
-----------------
* Device: Telescope prosthesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CE Mark approved indication of use which includes At least 55 years of age Bilateral visual impairment due to geographic atrophy or disciform scars Evidence of cataract Exclusion Criteria: Active CNV (or 'wet' AMD) Prior cataract or refractive surgery in the study eye

Ages Eligible for Study
-----------------
Minimum Age: 55 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: I<br> | Device: Telescope prosthesis<br>* Monocular implantation of the telescope prosthesis after cataract extraction<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best-Corrected Visual Acuity |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Macular Degeneration, Visual Impairment, Quality of Life, Implantable Telescope
Efficacy and Safety of Repaglinide, Glurenorm® and Glucobay® in Chinese Subjects With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Asia. The aim of this trial is to compare the efficacy and safety of repaglinide and Glurenorm® and Glucobay® given as the mono-therapy in Chinese subjects being treatment-naive type 2 diabetics.

Official Title
-----------------
Efficacy and Safety of Repaglinide, Glurenorm® and Glucobay® in Chinese Subjects With Type 2 Diabetes Mellitus

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

Intervention / Treatment
-----------------
* Drug: repaglinide
* Drug: Glurenorm®
* Drug: Glucobay®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes No previous treatment for diabetes HbA1c: 7.0-12.0% Exclusion Criteria: Type 1 diabetes Uncontrolled treated/untreated hypertension Any condition that the Investigator and/or Sponsor feels would interfere with trial participation or evaluation of results Pregnancy, breast-feeding, the intention of becoming pregnant or judged to be using inadequate contraceptive measures (adequate contraceptive measures are: sterilisation, intra-uterine device (IUD), oral contraceptives or barrier methods)

Ages Eligible for Study
-----------------
Minimum Age: 30 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

| Intervention/Treatment |
| --- |
|Drug: repaglinide|nan|
|Drug: Glurenorm®|nan|
|Drug: Glucobay®|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | after 3 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fasting blood glucose |  |  | 
| hypoglycaemia episodes |  |  | 
| adverse events |  |  |
Special Drug Use Investigation for ALLERMIST (Long Term)

Study Overview
=================
Brief Summary
-----------------
This post-marketing surveillance study is to investigate possible problems or questions in safety and efficacy of ALLERMIST Nasal Spray for long-term use in Japanese subjects with allergic rhinitis under the conditions of actual practical use.

Official Title
-----------------
Special Drug Use Investigation for ALLERMIST (Long Term)

Conditions
-----------------
Rhinitis

Intervention / Treatment
-----------------
* Drug: Fluticasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of allergic rhinitis Use ALLERMIST for the first time Expected to use ALLERMIST for long-term (1 year). Exclusion Criteria: Subjects with infection which fluticasone is not effective Subjects with deep mycosis Subjects with hypersensitivity to fluticasone
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects prescribed ALLERMIST<br>Subjects with allergic rhinitis prescribed ALLERMIST during study period | Drug: Fluticasone<br>* Collection of safety data<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of incidence of adverse events in Japanese subjects treated with ALLERMIST Nasal Spray for long-term use |  | One year | 
| Efficacy evaluation based on the subjective/objective symptom progresses in the period from the start of Allermist treatment to the end of the observation period |  | One year |