linjc16/ctgov huggingface dataset:
A Dose-escalation Study of the Safety and Tolerability of Orally Administered TG101348 in Patients With Myelofibrosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and tolerability of orally administered TG101348 in patients with myelofibrosis.

Detailed Description
-----------------
TG101348 is a potent small molecule inhibitor of Janus kinase 2 (JAK2). This is a first-in-human study that will include a dose-escalation phase, to establish the maximum tolerated dose, and an expanded cohort, dose-confirmation phase. The safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of TG101348 in patients with myelofibrosis will be evaluated.

Official Title
-----------------
A Phase 1, Open-label, Dose-escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered TG101348 in Patients With Primary, Post-polycythemia Vera, or Post-essential Thrombocythemia Myelofibrosis

Conditions
-----------------
Myelofibrosis

Intervention / Treatment
-----------------
* Drug: TG101348


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of myelofibrosis (primary, post-polycythemia vera, or post-essential thrombocythemia) At least 18 years of age. ECOG PS 0, 1, or 2. Exclusion Criteria: Any chemotherapy, immunomodulatory therapy, immunosuppressive therapy, corticosteroids, or growth factor treatment within 14 days prior to initiation of study drug. Major surgery or radiation therapy within 28 days prior to initiation of study drug.

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: TG101348<br>* Orally administered, once a day, for 28 days, up to 6 cycles.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (i.e., adverse events; effects on laboratory parameters, vital signs, and ECGs; dose-limiting toxicities), tolerability, and MTD |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics and pharmacodynamics |  | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
primary myelofibrosis, post-polycythemia vera myelofibrosis, post-essential thrombocythemia myelofibrosis
Daily Wear Comparison of Enhanced and Non-Enhanced Silicone Hydrogel Lenses

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare an experimental contact lens with a currently marketed contact lens.

Official Title
-----------------
Daily Wear Comparison of Enhanced and Non-Enhanced Silicone Hydrogel Lenses

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Device: Lotrafilcon A Experimental Contact Lens
* Device: Lotrafilcon A Commercial Contact Lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to wear contact lenses for a minimum of 5 days a week, at least 8 hours a day On exam have ocular findings that are considered normal and would not prevent the safe wear of contact lenses Other protocol-defined inclusion/exclusion criteria may apply Exclusion Criteria: Requires concurrent ocular medication Eye injury or surgery within twelve weeks immediately prior to enrollment Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of their accessory solutions Any active corneal infection Any use of medications for which contact lens wear would be contraindicated History of corneal refractive surgery Wears toric contact lenses Other protocol-defined inclusion/exclusion criteria may apply

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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Lotrafilcon A Contact Lens<br>Lotrafilcon A experimental contact lens randomly assigned to one eye | Device: Lotrafilcon A Experimental Contact Lens<br>* Experimental spherical, silicone hydrogel soft contact lens<br>|
| Active Comparator: Commercial Lotrafilcon A Contact Lens<br>Lotrafilcon A commercial contact lens randomly assigned to one eye | Device: Lotrafilcon A Commercial Contact Lens<br>* Commercially marketed spherical, silicone hydrogel soft contact lens<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Vision | Overall vision was interpreted by the subject and recorded on a questionnaire as a single, retrospective evaluation of 1-week wear time. Overall vision was evaluated by eye and rated on a 10-point scale, with 1 being poor and 10 being excellent. | 1 week |
AVANDAMET Versus Metformin And Sulphonylurea In People With Poorly Controlled Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study compares the effects of Avandamet (rosiglitazone maleate/metformin) treatment and metformin plus sulphonylurea treatment in overweight people with type 2 diabetes.

Official Title
-----------------
A Randomised, Multi-Centre, Phase IV, Double-Blind, Parallel Group Study Comparing the Effects of 52 Weeks Administration of AVANDAMET and Metformin Plus Sulphonylurea on Change in HbA1c From Baseline in Overweight Type 2 Diabetics Poorly Controlled on Metformin.

Conditions
-----------------
Non-Insulin-Dependent Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: metformin
* Drug: sulphonylurea
* Drug: Avandamet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Body mass index > or = to 25 kg/m2. HbA1c > or =7% and < or =10% at screening. FPG > or = 7.0mmol/L (126mg/dL) at visit 2. Receiving at least 0.85g of metformin at constant dose(s) for at least 8 weeks prior to visit 1a. Female subjects must be postmenopausal or using effective contraceptive measures. Exclusion criteria: Use of any other oral antidiabetic drug other than metformin within 12 weeks prior to screening. Subjects with clinically significant ongoing oedema requiring pharmacological treatment or with a history of oedema requiring pharmacological treatment. Subjects with a history of severe hypoglycaemia. Renal disease or renal dysfunction. Presence of clinically significant hepatic disease. Presence of unstable or severe angina or known NYHA grade I-IV congestive heart failure. Subjects who have had a previous myocardial infarction, percutaneous transluminal coronary angioplasty, coronary artery bypass graft or cerebrovascular accident within 3 months prior to screening.

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: metformin|nan|
|Drug: sulphonylurea|nan|
|Drug: Avandamet|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c level from baseline following 52 weeks of treatment. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in FPG (fasting plasma glucose) |  |  | 
| insulin sensitivity |  |  | 
| beta cell function |  |  | 
| change in PAI-1 |  |  | 
| CRP |  |  | 
| number of hypoglycaemic events |  |  | 
| Change in 24 hr ABPM |  |  | 
| Diabetes treatment satisfaction. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes, overweight, AVANDAMET, metformin, sulphonylurea
Human Epidermal Growth Factor Receptor 2 (HER2) Advanced Gastric Epidemiology Study in Korea

Study Overview
=================
Brief Summary
-----------------
This study is designed to gather epidemiological data in Korea on HER2 incidence in gastric and gastroesophageal junction cancer as assessed by local laboratories in a real-life setting. No investigational products will be provided or evaluated.

Official Title
-----------------
HER2 Advanced Gastric Epidemiology Study in Korea: An Assessment of HER2 Status in Tumor Tissue Samples of Gastric and Gastro-esophageal (GE) Junction Cancer

Conditions
-----------------
Gastric Cancer, Gastroesophageal Junction Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Formalin-fixed, paraffin-embedded tumor tissue samples with histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction with locally advanced, recurrent, and/or metastatic disease Sufficient invasive tumor tissue for HER2 evaluation, including surgical excision specimens or at least 6 to 8 available biopsies Exclusion Criteria: None specified
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Population<br>Available tumor samples from patients with gastric or gastroesophageal junction cancer will be analyzed. No study visits or interventions are planned. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of HER2 positivity among gastric and gastroesophageal junction tumor samples |  | Up to 12 months of sample collection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between HER2 status and tumor stage |  | Up to 12 months of sample collection | 
| Correlation between HER2 status and tumor type |  | Up to 12 months of sample collection | 
| Correlation between HER2 status and cancer diagnosis |  | Up to 12 months of sample collection | 
| Correlation between HER2 status and age |  | Up to 12 months of sample collection | 
| Correlation between HER2 status and gender |  | Up to 12 months of sample collection |
Fractional Nonablative 1540 nm Laser Resurfacing for Burn Scars- A Randomised Controlled Trial

Study Overview
=================
Brief Summary
-----------------
The objective was to evaluate the efficacy of 1540 nm fractional laser treatment of mature burn scars.

Official Title
-----------------
Fractional Nonablative 1540 nm Laser Resurfacing for Burn Scars- A Randomised Controlled Trial

Conditions
-----------------
Burn Scar Patients

Intervention / Treatment
-----------------
* Device: 1540 nm fractional laser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Burn scars with and without previous skin grafting. Exclusion Criteria: A tendency to produce hypertrophic scars or keloids, Previous treatment with dermabrasio, chemical peel, filler, laser treatment or Intense Pulsed Light (IPL) of study areas, Photosensitivity, Pregnancy or lactation, Current anticoagulative medication, Oral retinoid drugs within the past 6 months, Pigmentation after recent exposure to sun or solarium, Patients not considered to be able to follow the treatment protocol.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Device: 1540 nm fractional laser<br> <br> |
| No Intervention: B<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of skin texture from baseline |  |  |
A Study to Evaluate the Effectiveness, Tolerability and Safety of Laquinimod

Study Overview
=================
Brief Summary
-----------------
Teva is developing laquinimod tablets as a new oral treatment for MS. Laquinimod has immunomodulating properties. In a previous clinical study laquinimod showed evidence of biological activity by reducing the number of acute brain lesions. The duration of the current study is 36 weeks.

Official Title
-----------------
A Multinational, Multicenter Randomized Double-Blind, Parallel-Group, Placebo-Controlled Study, to Evaluate the Efficacy, Tolerability and Safety of Two Doses of, Oral Laquinimod in Relapsing Remitting (R-R) Multiple Sclerosis (MS) Subjects

Conditions
-----------------
Relapsing Remitting Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: laquinimod 0.3
* Drug: laquinimod 0.6
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willing and able to give written informed consent Confirmed MS diagnosis as defined by the McDonald criteria R-R MS disease course. At least one gadolinium-enhanced lesion on screening MRI Women of child-bearing potential must practice a reliable method of birth control. Must understand the requirements of the study and agree to comply with the study protocol. Exclusion Criteria: Subjects who suffer from any form of progressive MS. Any condition which the investigator feels may interfere with participation in the study. Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation, Subjects who received any investigational medication, immunosuppressives or cytotoxic agents within 6 months prior to screening Previous treatment with immunomodulators within two months prior to screening

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laquinimod 0.3 mg<br>Laquinimod 0.3 mg | Drug: laquinimod 0.3<br>* laquinimod 0.3mg<br>|
| Active Comparator: Laquinimod 0.6 mg<br>Laquinimod 0.6 mg | Drug: laquinimod 0.6<br>* laquinimod 0.6mg<br>|
| Placebo Comparator: Placebo<br>Blinded Placebo | Other: Placebo<br>* Blinded Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of brain lesions in the last 4 months of the study |  | 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse rate |  | 36 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Relapsing Remitting Multiple Sclerosis
VALID: Study to Compare the Reduction of Predialysis Systolic Blood Pressure With Valsartan Compared to Irbesartan in Patients With Mild to Moderate Hypertension on Long-term Hemodialysis

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare the efficacy, safety and tolerability of valsartan 80 mg (with a starting dose of 40 mg) to irbesartan 150 mg (with a starting dose of 75 mg) in patients on long-term haemodialysis with mild to moderate increased mean supine systolic blood pressure (MSSBP).

Official Title
-----------------
A 2 x 5-week Multicenter, Cross-over Study to Compare the Reduction of Predialysis Systolic Blood Pressure With Valsartan 80 mg Compared to Irbesartan 150 mg in Patients With Mild to Moderate Hypertension on Long-term Hemodialysis

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: valsartan
* Drug: irbesartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with mild and moderate hypertension defined by a MSSBP ≥ 140 mmHG and < 180 mmHG at Visits 1 and 2 for treated and untreated patients Chronic hemodialysis for at least 6 months prior to Visit 1 as substitution therapy. If treated with epoetin: patients with a stable hematocrit ≤ 40% (± 5%). Exclusion Criteria: Inability to discontinue angiotensin II receptor blockers (ARBs) safely for a period of 1 week, as required by the protocol. Treatment with more than 3 different compounds for the treatment of hypertension at Visit 1. Atrial fibrillation Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: valsartan|nan|
|Drug: irbesartan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in systolic blood pressure after 4 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in diastolic blood pressure after 4 weeks |  |  | 
| Systolic blood pressure less than 100 mmHg with or without symptoms of low blood pressure |  |  | 
| Adverse events and clinical laboratory abnormal results |  |  | 
| Change from baseline in average 24-hour ambulatory blood pressure after 4 weeks |  |  | 
| Change from baseline in daytime and nighttime ambulatory blood pressures after 4 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, Valsartan, Dialysis, Renal Disease
Risk Factors of Individuals With Coronary Artery Disease

Study Overview
=================
Brief Summary
-----------------
It would be useful to study coronary arteriovenous difference of various markers in patients who are undergoing coronary angiography for suspected coronary artery disease. Environmental and genetic factors may play a role in the progression of coronary artery disease. The goal of this project is to establish a series of cross-sectional / case-control studies to evaluate risk factors of coronary artery disease in China.

Detailed Description
-----------------
This study is designed to investigate the epidemiologic, genetic, laboratory and clinical characterization of individuals with coronary artery disease. The study group will consist of consecutive patients who are undergoing coronary angiography for suspected coronary artery disease. The diagnosis of coronary artery disease will be confirmed by coronary angiography performed with the Judkins technique using a quantitative coronary angiographic system. Coronary artery disease will be considered to be present if there is a diameter stenosis of at least 50% in at least one of the three major epicardial coronary arteries. The number of diseased vessels will be determined and a classification of 1-, 2-, and 3-vessel disease will be used. Coronary artery segments will be defined according to the Coronary Artery Surgery Study classification. Blood samples from vein and coronary artery will be collected. We will study coronary arteriovenous difference of various markers. Urinary samples will be obtained the day of coronary angiography. We will explore the environmental (including family history, life style, diet, physical activity, neuropsychological functioning，plasma levels of oxidative stress factors, angiogenic factors, and inflammatory markers, etc.) and genetic (including oxidative stress factors and inflammatory factors, etc.) risk factors. We will study the association between various environmental risk factors with the clinical characterization and correlation between the genetic polymorphisms and the presence of coronary artery disease.

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: This is a study only of Chinese. Subjects will be allowed to participate if they self-identify as Chinese. The age range of the participants will be between 18 and 89 years. The study group will consist of consecutive patients who are undergoing coronary angiography for suspected coronary artery disease. Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 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 |
| --- | --- | --- |