linjc16/ctgov huggingface dataset:
Long-term Safety of Tafamidis in Subjects With Transthyretin Cardiomyopathy

Study Overview
=================
Brief Summary
-----------------
Open label study to evaluate tafamidis for the treatment of transthyretin cardiomyopathy

Detailed Description
-----------------
Global Phase 3, open label long term extension safety study designed to obtain additional safety data for tafamidis meglumine 20 mg and 80 mg (or tafamidis 61 mg where available), and to continue to provide enrolled subjects with tafamidis for up to 60 months, or until subject has access to tafamidis for ATTR CM via prescription, whichever occurs first.

Official Title
-----------------
A PHASE 3 MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY OF DAILY ORAL DOSING OF TAFAMIDIS MEGLUMINE (PF-06291826-83) 20 MG OR 80 MG [OR TAFAMIDIS (PF-06291826-00) 61 MG] IN SUBJECTS DIAGNOSED WITH TRANSTHYRETIN CARDIOMYOPATHY (ATTR-CM)

Conditions
-----------------
Transthyretin (TTR) Amyloid Cardiomyopathy

Intervention / Treatment
-----------------
* Drug: Tafamidis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cohort A: Completion of 30 months of study treatment on Pfizer Protocol B3461028 Cohort B: Patients in specific countries diagnosed with ATTR-CM who did not previously participate in Pfizer Study B3461028 Exclusion Criteria: -Liver and/or heart transplant, or implanted cardiac mechanical assist device

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
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tafamidis<br>Active treatment - 61 mg or if not available, tafamidis megulmine 80 mg | Drug: Tafamidis<br>* Soft gel capsules administered once a day for 60 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality and incidence of treatment emergent adverse events | Safety endpoints for analysis of the treatment groups | Baseline to Month 60 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
amyloidosis, amyloid, transthyretin, TTR, ATTR-CM
SB3 Battery Life Observational Study

Study Overview
=================
Brief Summary
-----------------
Capsule endoscopy (CE) is a non-invasive means of visualizing the small bowel. Common indications for CE include obscure gastrointestinal (GI) bleeding, inflammatory bowel disease like crohn's disease or ulcerative colitis, celiac disease, and polyposis syndrome. While CE has high diagnostic value for small bowel lesions, a significant limitation of this technology is the finite battery life which results in incomplete examination of the small bowel approximately 16.5% of the time. Numerous attempts of using pharmacological (e.g. prokinetics, purgatives) as well as non-pharmacological measures (e.g. real-time viewer, chewing gum) to improve completion rates, defined by entry of CE into the cecum, led to mixed results. Currently routine use of prokinetics (agents that speeds up gut motility) is not recommended. This study aims to determine whether longer battery of the newer generation capsule endoscopy system improves study completion rate and diagnostic yield.

Official Title
-----------------
Clinical Impact of Longer Battery Life on Small Bowel Capsule Endoscopy: a Prospective Observational Study

Conditions
-----------------
Capsule Endoscopy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female age 19 or greater who are referred for small bowel capsule endoscopy Willing and able to provide written informed consent Exclusion Criteria: Unwillingness or inability to swallow pill Known or suspected obstruction or bowel stricture Endoscopic placement of capsule camera Concomitant enrollment in a prospective study in the treatment arm receiving prokinetics for the purpose of enhancing bowel motility. (i.e. control arm not receiving any motility-enhancing agent can be included)

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- | --- |
| Completion Rate (Rate at Which Small Bowel is Completely Examined) | rate at which small bowel is completely examined (capsule endoscopy enters cecum) | 0.1 - 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Yield | rate at which a pathological finding is identified on capsule endoscopy | 0.1 - 12 hours | 
| Gastric Transit Time | time it takes for capsule camera to traverse the stomach | 0.1 - 12 hours | 
| Small Bowel Transit Time | times it takes for capsule camera to traverse the entire small bowel. | 0.1 - 12 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
capsule endoscopy, battery life, completion rate, diagnostic yield
Yoga in the Treatment of Eating Disorders: a Randomized Trial

Study Overview
=================
Brief Summary
-----------------
Yoga facilitates the treatment of eating disorders by decreasing symptom severity over time.

Official Title
-----------------
Yoga in the Treatment of Eating Disorders: a Randomized Trial

Conditions
-----------------
Anorexia Nervosa, Bulimia Nervosa

Intervention / Treatment
-----------------
* Behavioral: yoga


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: admitted to the Anna Westin House treatment facility of the Emily Program in MN during timeframe study is being run Exclusion Criteria: declines participation in study

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: body awareness yoga<br>body awareness yoga session prior to breakfast meal | Behavioral: yoga<br> <br> |
| No Intervention: Control Arm<br>No intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants' level of mood and anxiety | The Positive And Negative Affect Scale will be administered daily prior to and after supper in order to assess anxiety and mood. | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of eating disorder symptoms | The Eating Disorder Examination-Questionnaire will be administered to evaluate clients' eating disorder symptoms and prevalence. | Week 4 | 
| Participants' ability to tolerance distress | The Distress Tolerance Scale will be administered to follow clients' ability to cope with highly charged emotions. | Week 4 |
Safety and Efficacy Study of the Cardiapex Percutaneous Trans-apical Access and Closure System

Study Overview
=================
Brief Summary
-----------------
A prospective, multicenter, uncontrolled study to evaluate the safety and efficacy of the Cardiapex percutaneous trans-apical access and closure system. The Cardiapex device intended for percutaneous access and closure of the left ventricular apex in conjunction with transapical Transcatheter Aortic Valve Implantation (TAVI).

Official Title
-----------------
A Prospective, Multicenter, Uncontrolled Study to Evaluate the Safety and Efficacy of the Cardiapex Percutaneous Trans-apical Access and Closure System

Conditions
-----------------
Transapical Transcatheter Aortic Valve Implantation

Intervention / Treatment
-----------------
* Device: Cardiapex device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient scheduled for transapical TAVI Patient ≥ 70 years of age Patient able to give informed written consent Patient able to attend follow up examinations Exclusion Criteria: Scheduled concomitant non-TAVI cardiac procedure Patient with Left Ventricular Ejection Fraction (LVEF) < 30% at time of enrollment Patient with known apical infarcted area Patient with a distinct large vessel right at the anatomical apex9 (based on pre-operative coronary angiography Patients with known lung tissue surrounding the apex and possibly interfering with the in-out puncture (based on preoperative gated CT assessment Patient with contra-indications to transapical TAVI Patient's inability to tolerate or comply with normal post-surgical drug regimen Patient's inability to comply with required follow-ups, including echocardiography Patient participation in other clinical trials within previous month

Ages Eligible for Study
-----------------
Minimum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardiapex device<br>Use of the Cardiapex device in the context of transapical TAVI procedures | Device: Cardiapex device<br>* Cardiapex percutaneous transapical access and closure system<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful performance of percutaneous transapical TAVI defined as: Successful percutaneous transapical access and deployment of a single prosthetic heart valve |  | Outcome measure assessed during the TAVI surgical procedure - an average of 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ≤30 day apical bleeding requiring surgical intervention |  | 30 days |
Safety and Effectiveness Study of a Non-Crosslinked HA Alkylamide HYADD(TM) 4 Hydrogel for Osteoarthritis of the Knee

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether intra-articular hyaluronic acid provides symptomatic relief of osteoarthritis of the knee.

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

Intervention / Treatment
-----------------
* Device: HYMOVIS
* Device: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic osteoarthritis of the knee. Exclusion Criteria: No disorders which could interfere with study required assessments.

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: HYMOVIS<br>HYADD(TM) 4 Hydrogel Intra-Articular Injection | Device: HYMOVIS<br>* Intra-articular injection<br>* Other names: HYADD(TM) 4 Hydrogel Intra-Articular Injection;|
| Placebo Comparator: Placebo<br>Saline Intra-Articular Injection | Device: Placebo<br>* Intra-Articular Injection<br>* Other names: Placebo Intra-Articular Injection;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Sub-score |  | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Global Assessment |  | 26 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hyaluronic Acid, Osteoarthritis, Knee, Hyaluronan, Viscoelastic, Hydrogel
Usability Evaluation of a Portable Oxygen Concentrator

Study Overview
=================
Brief Summary
-----------------
This study evaluates how well an individual can put together and use a Portable Oxygen Concentrator (POC) by following the instructions in the User Manual.

Detailed Description
-----------------
The Belluscura X-PLO2R Portable Oxygen Concentrator (POC) is intended for the provision of supplemental oxygen to patients with chronic pulmonary diseases, such as Chronic Obstructive Pulmonary Disease (COPD), and for a patient requiring supplemental oxygen, as prescribed by a physician. The purpose of this study is to evaluate if the X-PLO2R POC can be used by the intended users without serious errors or problems for the intended use and under the expected use conditions. Specifically, the study is to evaluate if potential users of the device can correctly, safely and effectively set-up, activate and operate the X-PLO2R POC to receive the required supplemental oxygen; if the intended user can understand and apply the information contained in the Belluscura X-PLO2R Quick Start Guide and User Manual; and to identify any and all use difficulties, problems and errors made during device assembly and operation, and to subsequently mitigate each identified instance of use error through device and/or materials modification, and to subsequently evaluate the effectiveness of each modification.

Official Title
-----------------
Human Factors Validation Testing for Use of the Belluscura X-PLO2R™ Portable Oxygen Concentrator (POC) System

Conditions
-----------------
Supplemental Oxygen

Intervention / Treatment
-----------------
* Device: X-PLO2R POC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older. Male or female. Suitable for supplemental oxygen use from a suitably qualified and licensed medical professional. Voluntarily signed subject consent form. Exclusion Criteria: Company employee. Former human factors study participants.

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

| Intervention/Treatment |
| --- |
|Device: X-PLO2R POC|Portable Oxygen Concentrator (POC)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability to correctly assemble and use the X-PLO2R POC | A subject who is able to follow the instructions to correctly assemble and receive oxygen through the X-PLO2R POC will be considered a study pass.A subject who is not able to follow the instructions and does not correctly assemble and receive oxygen through the X-PLO2R POC will be considered a study fail. | 2 hours |
Pilot Study Differential Dissector™ for Blunt Dissection

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to evaluate the quality of blunt dissection during abdominal and pelvic surgery involving dissection of adhesions, separation of blood vessels and neurovascular structures while preserving the integrity of these structures.

Official Title
-----------------
Pilot Study Differential Dissector™ for Blunt Dissection

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

Intervention / Treatment
-----------------
* Device: Differential Dissector
* Other: Standard Dissection Method


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than 18 Patient will be undergoing open abdominal surgery Patient willing and able to provide his/her own consent Exclusion Criteria: Current alcohol or other substance abuse Current incarceration

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Differential Dissector<br>For patients in the study device group, blunt dissection will be performed with the Differential Dissector whenever the surgeon believes its use is appropriate. | Device: Differential Dissector<br> <br> |
| Active Comparator: Standard Dissection Method<br>For patients in the control group, blunt dissection will be performed by standard method. | Other: Standard Dissection Method<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative Blood Loss |  | From start of surgery to wound closure | 
| Post-operative Blood Loss |  | After surgical closure and drain insertion through drain removal | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Abdominal surgery, Pelvic surgery, Stoma takedown, Bowel resection, Lysis of abdominal adhesions
Combined Package of Interventions for Environmental Enteropathy

Study Overview
=================
Brief Summary
-----------------
Randomized, double-blind, placebo controlled trial of a combined intervention of zinc, albendazole, and multiple micronutrients in improving environmental enteropathy in Malawian children.

Official Title
-----------------
Randomized, Double Blind, Placebo Controlled Trial Comparing the Impact of a Combined Package of Interventions vs Placebo in the Treatment of Sub-clinical Environmental Enteropathy in Rural Malawian Children

Conditions
-----------------
Environmental Enteropathy

Intervention / Treatment
-----------------
* Drug: Albendazole
* Dietary Supplement: Zinc
* Dietary Supplement: Multiple Micronutrient Supplement
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children residing in catchment area of Limela, Machinga District, Malawi aged 12-35 months youngest eligible child in each household Exclusion Criteria: severe acute malnutrition severe chronic illness children unable to drink 20 mL of dual sugar solution children in need of acute medical treatment for illness or injury at time of enrollment

Ages Eligible for Study
-----------------
Minimum Age: 12 Months
Maximum Age: 35 Months

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multiple Intervention Arm<br>single dose albendazole, two weeks of zinc, 24 weeks of multiple micronutrients | Drug: Albendazole<br> <br> Dietary Supplement: Zinc<br> <br> Dietary Supplement: Multiple Micronutrient Supplement<br> <br> |
| Placebo Comparator: Placebo<br>three placebos | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dual Sugar Absorption Test | lactulose-mannitol ratio in urine | 12 weeks | 
| Dual Sugar Absorption Test | lactulose-mannitol ratio in urine | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lactulose Excretion | percentage of ingested lactulose excreted in urine | 12 weeks | 
| Lactulose Excretion | percentage of ingested lactulose excreted in urine | 24 weeks | 
| Mannitol Excretion | percentage of ingested mannitol excreted in urine | 12 weeks | 
| Mannitol Excretion | percentage of ingested mannitol excreted in urine | 24 weeks |
A Trial Comparing S1 Generic With Capecitabine in Metastatic Breast Cancer (MBC)

Study Overview
=================
Brief Summary
-----------------
Comparing S1 generic With Capecitabine in Patients With Metastatic Breast Cancer.

Detailed Description
-----------------
Comparing S1 generic(Tegafur，Gimeracil and Oteracil Potassium Capsules) With Capecitabine in Patients With Metastatic Breast Cancer.

Official Title
-----------------
A Randomized Open Label Multicenter Phase 3 Trial Comparing S1 Generic With Capecitabine in Patients With Metastatic Breast Cancer.

Conditions
-----------------
Metastatic Breast Cancer

Intervention / Treatment
-----------------
* Drug: capecitabine
* Drug: S1 generic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed breast cancer Pretreated metastatic breast cancer not more than 2 lines chemotherapy Have not been previously treated with capecitabine,oral fluracil ECOG performance status of ≤ 1 Be female and ≥ 18 and ≤ 75 years of age Have at least one target lesion according to the RECIST criteria 1.1 Exclusion Criteria: Pregnant or lactating women ECOG ≥ 2 Have been treated with capecitabine Evidence of CNS metastasis History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix or a contralateral breast cancer Abnormal laboratory values: hemoglobin < 10.0 g/dl, absolute neutrophil count < 1.5×10^9/L, platelet count < 100×10^9/L, serum creatinine > upper limit of normal (ULN), serum bilirubin > ULN, ALT and AST > 5×ULN, AKP > 5×ULN Serious uncontrolled intercurrent infection Life expectancy of less than 3 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S1 generic<br>40mg／m2 bid four weeks on two weeks off | Drug: S1 generic<br>* 40mg／m2 bid four weeks on two weeks off<br>* Other names: Tegafur，Gimeracil and Oteracil Potassium Capsules;|
| Active Comparator: capecitabine<br>2500mg／m2／day divided into twice two weeks on one week off | Drug: capecitabine<br>* 2500mg／m2／day divided into twice two weeks on one week off<br>* Other names: Xeloda;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate |  | 1.5 months | 
| overall survival |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
capecitabine, Tegafur，Gimeracil and Oteracil Potassium Capsules