linjc16/ctgov huggingface dataset:
Non--operative Treatment of the Medial Malleolus in bi- and Trimalleolar Ankle Fractures

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to determine if internal fixation of the medial malleolus is necessary following open reduction and internal fixation of the lateral and, if required, the posterior malleolus treating displaced bi-or trimalleolar ankle fractures.

Official Title
-----------------
Non--operative Treatment of the Medial Malleolus in bi- and Trimalleolar Ankle Fractures. A Randomized Controlled Trial

Conditions
-----------------
Ankle Malleolus Fracture Bimalleolar, Fracture of Medial Malleolus, Fracture of Ankle

Intervention / Treatment
-----------------
* Procedure: Internal fixation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Orthopaedic Trauma Association (OTA) type 44 fractures (B2-3 and C2-3). Exclusion Criteria: Patients with OTA type 43 distal tibia fractures. Patients with soft tissue injuries involving the medial malleolus.

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 |
| --- | --- |
| Other: Surgery<br> | Procedure: Internal fixation<br>* Internal fixation of the medial malleolus following open reduction and internal fixation of the lateral and, if required, posterior malleolus.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Orthopaedic Foot and Ankle Society ankle hind foot score (AOFAS) |  | Average of 42 months | 
| The Olerud Molander Ankle score (OMAS) |  | Average of 42 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Posttraumatic osteoarthritis (OA) according to the criteria of Magnusson (stage I-IV) |  | Average of 42 months | 
| VAS score | Pain evaluated at rest, in the morning, in the evening and during the night. | Average of 42 months |
A Parallel Group Phase II Study of KCT-0809 in Patients With Dry Eye Syndromes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of KCT-0809 compared to placebo in patients with dry eye syndromes.

Official Title
-----------------
A Randomized, Double Blind, Placebo Controlled, Parallel Group Phase II Study of KCT-0809 in Patients With Dry Eye Syndromes

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

Intervention / Treatment
-----------------
* Drug: KCT-0809
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Corneal and conjunctival damage Insufficiency of lacrimal secretion Ocular symptom Exclusion Criteria: Severe ophthalmic disorder Punctual plugs or surgery for occlusion of the lacrimal puncta

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KCT-0809 ophtalmic solution<br> | Drug: KCT-0809<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score of the Corneal conjunctival staining |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry eye syndromes, Corneal diseases, Conjunctival diseases
An Investigational Drug Study to Assess Weight Loss in Patients With Type 2 Diabetes Mellitus (0364-011)(TERMINATED)

Study Overview
=================
Brief Summary
-----------------
A worldwide study with extension in patients with type 2 diabetes mellitus to assess the safety and tolerability as well as the effects of treatment with an investigational drug for weight loss on body weight.

Official Title
-----------------
A Phase III Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of Taranabant (MK0364) in Overweight and Obese Patients With Type 2 Diabetes Mellitus (T2DM) Followed by a 1-Year Extension

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

Intervention / Treatment
-----------------
* Drug: Taranabant
* Drug: Comparator: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body Mass Index (BMI) between 27 kg/m2 and 43 kg/m2 and HbA1c between 7.0% and 10% Exclusion Criteria: History of major psychiatric disorder Blood pressure greater than 160/100 Use of any antihyperglycemic agent other than metformin Triglycerides greater then 600 mg/dL

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Arm 1: MK0364 0.5 mg capsule once daily | Drug: Taranabant<br>* Taranabant 0.5 mg, 1 mg capsule, 2 mg capsule once daily Treatment for 52 weeks.<br>|
| Experimental: 2<br>Arm 2: MK0364 1 mg capsule once daily | Drug: Taranabant<br>* Taranabant 0.5 mg, 1 mg capsule, 2 mg capsule once daily Treatment for 52 weeks.<br>|
| Experimental: 3<br>Arm 3: MK0364 2 mg capsule once daily | Drug: Taranabant<br>* Taranabant 0.5 mg, 1 mg capsule, 2 mg capsule once daily Treatment for 52 weeks.<br>|
| Placebo Comparator: 4<br>Arm 4: Pbo capsule once daily | Drug: Comparator: Placebo<br>* Placebo capsule once daily. Treatment for 52 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight at 36 weeks, HbA1c at 36 weeks |  | 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight at 24 and 52 weeks, HbA1c at 24 and 52 weeks |  | 24 and 52 weeks |
Use of Intra-Operative Shear Wave Ultrasound Vibrometry for Characterization of Esophageal Malignant Tumors

Study Overview
=================
Brief Summary
-----------------
Using the analysis of group velocity for a screening application and then higher order analysis based on the elastic and viscious components of the shear modulus may allow discrimination between extent of tumor invasion through the esophageal wall if appropriately correlated with pathological findings.

Detailed Description
-----------------
Use of ultrasound-based vibrometry in this setting would allow for a relatively simple study and translation of clinical practice, as the same devices are already used in this setting, and operators have familiarity with the equipment. Incorporating another additional method to generate contrast for determining malignant tissue from normal based on biomechanical properties with the same probe would have benefit as an additional diagnostic modality.

Official Title
-----------------
Use of Intra-Operative Shear Wave Ultrasound Vibrometry for Characterization of Esophageal Malignant Tumors

Conditions
-----------------
Esophageal Cancer

Intervention / Treatment
-----------------
* Device: General Electric LOGIQ E9 ultrasound system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 years old Scheduled to undergo esophageal reconstruction for presumed or known esophageal cancer Subject is able to understand the study procedures and provide informed consent. Exclusion Criteria: Subject is pregnant or breast feeding.

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: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: Shear wave vibrometry and B-mode imaging will be performed after esophageal distension with a fluid filled balloon intra-operatively.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound<br> | Device: General Electric LOGIQ E9 ultrasound system<br>* Patients will be brought to the operating room in line with standard clinical practice and after esophageal exposure, but before surgical mobilization of the esophagus, shear wave vibrometry and B-mode imaging will be performed after esophageal distension with a fluid filled balloon intra-operatively.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determining malignant esophageal tissue from normal tissue | Determining malignant esophageal tissue from normal tissue by measurements using the General Electric LOGIQ E9 ultrasound system. | 1 week |
Registry Study on Cystic Fibrosis in Chinese Children

Study Overview
=================
Brief Summary
-----------------
This study is a multicenter, prospective cohort study of patients diagnosed with cystic fibrosis, the clinical information of recruited patients, including clinical manifestations, lung function, chest imaging, quality of life and other indicators, will be followed for 10 years.

Detailed Description
-----------------
All new cases of cystic fibrosis which was confirmed or probably diagnosed at each center from the beginning of the study are made the investigation of the clinical manifestations, sweat test and CFTR mutations by the standard diagnostic process.Then all the patients' following clinical data will be followed for 10 years (once per six month): clinical manifestations, lung function, chest imaging (once per year), quality of life and other indicators.

Official Title
-----------------
Registry Study on Cystic Fibrosis in Chinese Children-a Multicenter, Prospective Cohort Study

Conditions
-----------------
Cystic Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 0 18 years old Any organ system symptoms consistent with CF, such as chronic sinopulmonary disease, gastrointestinal and nutritional abnormalities, obstructive azoospermia or having siblings with CF CFTR dysfunction indicated by elevated sweat chloride levels ≥60 mmol/L twice, or one sweat chloride levels ≥40 mmol/L plus presence of two pathogenic CFTR mutations on different alleles Probable CF patients with sweat chloride levels among 40 59 mmol/L plus with presence of 0-1 pathogenic CFTR mutation Consent to provide the related clinical specimen to the certain hospital The guardians of the patients fully understand the purpose of the study, volunteer their children to participate in this study and sign informed consent. Exclusion Criteria: Subject will be excluded if she or he has one of the following: It is unable to provide complete medical records or the current condition can not accept the diagnosis process. She or he does not agree to participate in the test.

Ages Eligible for Study
-----------------
Maximum Age: 18 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 |
| --- | --- | --- |
| Change from baseline in lung function on the spirometry | forced expiratory volume at one second (FEV1) in Liter | ten years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cystic fibrosis, Chinese, children
Multi-pronged Ethanol Ablation and Radiofrequency Ablation of Early-stage Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effectiveness of percutaneous ethanol ablation using a multi-pronged needle (QFEA) with that of percutaneous radiofrequency ablation (RFA) in the treatment of early-stage hepatocellular carcinoma (HCC).

Detailed Description
-----------------
Patients with early-stage (single tumor no more than 5 cm or up to 3 tumors each no more than 3 cm in size) primary hepatocellular carcinoma will be randomized into two percutaneous ablation treatment arms, including radiofrequency ablation and multi-pronged ethanol ablation. The local treatment responses, complications,and long-term disease-free survivals and overall survivals are analyzed.

Official Title
-----------------
Ethanol Ablation Using a Multi-pronged Needle and Radiofrequency Ablation of Early-stage Hepatocellular Carcinoma: a Randomized Clinical Trial

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Procedure: multi-pronged ethanol ablation
* Procedure: radiofrequency ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary hepatocellular carcinoma, single tumor ≤5 cm or up to 3 tumors each ≤3 cm Ultrasound detectable tumor Liver function classified as Child-Pugh A or B Platelet count > 50,000/mm3, or prothrombin activity > 50% Not suitable for resection or patient refused surgery Exclusion Criteria: Vascular invasion and extrahepatic spread Patients allergic to ethanol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: QFEA<br>multi-pronged ethanol ablation | Procedure: multi-pronged ethanol ablation<br>* Under ultrasound guidance, insert an applicator into the tumor percutaneously and then inject ethanol to destroy the whole tumor tissue.<br>|
| Active Comparator: RFA<br>radiofrequency ablation | Procedure: radiofrequency ablation<br>* Under ultrasound guidance, insert an applicator into the tumor percutaneously and then deliver radiofrequency energy to destroy the whole tumor tissue.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local treatment responses |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survivals and overall survivals |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PEI, hepatocellular carcinoma, RF ablation, tumor ablation
Registry Experience at the Washington Hospital Center, DES - Xience V

Study Overview
=================
Brief Summary
-----------------
Single center registry of patients who have received a Xience V everolimus-eluting stent at the Washington Hospital Center, with the primary objective to assess clinical success and safety at 30 days, 6 months and 1 year post-implantation.

Detailed Description
-----------------
Interventional cardiology was revolutionized by the invention of stents, initially with the bare-metal stents (BMS) and recently with the drug-eluting stents (DES). The everolimus eluting, Xience V stents have shown very promising results in randomized clinical trials, demonstrating a reduction of clinical and angiographic restenosis in comparison to BMS, and comparable clinically-driven target lesion revascularization rates in comparison with sirolimus-eluting stents. While registry data is available from outside of the United States, it will be important to collect real-world data regarding the stent usage and outcomes in the United States. In this study we propose to follow patients who received at least one Xience V® Stent for at least 1 year post initial stent implantation.

Official Title
-----------------
REWARDS (Registry Experience at the Washington Hospital Center, DES - Xience V)

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients, male or female, >18 years of age Patients who received at least one Xience V drug-eluting stent at the Washington Hospital Center Exclusion Criteria: Patients who received another type of DES (other than Xience V) or a bare metal stent at the time of initial Xience V stent implantation

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Xience V<br>Patients treated with a Xience V everolimus-eluting stent | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Major Adverse Cardiac Events (MACE) post Xience V implantation |  | Follow Up |
Clinical Evaluation Of GW815SF For Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema)

Study Overview
=================
Brief Summary
-----------------
This study compares the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease). This study will last up to 18 weeks, and subjects will visit the clinic 5 times. Subjects will be given breathing tests, and will record their breathing symptoms daily on diary cards.

Detailed Description
-----------------
Clinical Evaluation of GW815SF for Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema) Assessment of the Effect of Addition of Fluticasone Dipropionate to Salmeterol Xinafoate 50µg after Switching under Double-blinded conditions to GW815SF 50/250µg in Chronic Obstructive Pulmonary Disease

Official Title
-----------------
See Detailed Description

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: fluticasone propionate/salmeterol combination DISKUS
* Drug: salmeterol xinafoate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Diagnosis of COPD. Exclusion criteria: Diagnosis of asthma or an uncontrolled medical condition or respiratory disorder other than COPD. Other inclusion and exclusion criteria will be evaluated at the first study visit.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: fluticasone propionate/salmeterol combination DISKUS|nan|
|Drug: salmeterol xinafoate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in pre-dose FEV1 at 4 weeks after starting medication of GW815SF 50/250µg |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in morning PEF |  |  | 
| Changes in pre-dose FVC, V50, V25 |  |  | 
| Use of rescue medication |  |  | 
| Changes in symptom scores |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, Chronic Bronchitis, Emphysema
Activity of AVE1625 in Mild to Moderate Alzheimer's Patients.

Study Overview
=================
Brief Summary
-----------------
Primary: This study is being conducted to evaluate if AVE1625 is safe and tolerated in patients with Alzheimer's disease that is not too severe. There is also evaluation of whether patients who take the study medication improve compared to patients who take a placebo (sugar pill). Secondary:The study will also evaluate the blood levels of the study medication, AVE1625 in patients who join the study.

Official Title
-----------------
A Double-Blind Placebo-Controlled Study of the Activity of AVE1625 at Doses of 10 mg and 40mg for 12 Weeks in Patients With Mild to Moderate Alzheimer's Disease

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

Intervention / Treatment
-----------------
* Drug: AVE1625


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The diagnosis of Alzheimer's disease Recent brain image(Computerized Axial Tomographic Scan -CAT scan or Magnetic Resonance Imaging - MRI) Mild to moderate range of disease; not too severe Exclusion Criteria: Severe or unstable medical diseases Neurological disorder other than Alzheimer's disease Depression that is not well controlled Treatment with memantine Inpatient in a total care facility (e.g.: Nursing home) Lack of reliable caregiver

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AVE1625|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability throughout the study:adverse events collected by spontaneous report |  |  | 
| physical examination and neurological assessment |  |  | 
| vital sign monitoring, clinical laboratories, and ECGs. |  |  | 
| Efficacy variables:measures of change in cognition, global functioning and behavior at week 12. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters will be assessed throughout the 12-week treatment period. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer's disease, symptomatic, cognition