linjc16/ctgov huggingface dataset:
Comparison of 4L Polyethylene Glycol and 2L Polyethylene Glycol With Ascorbic Acid in Inactive UC Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare preference of the patients, efficacy of preparation, and safety between 4 L polyethylene glycol and 2 L of polyethylene glycol with ascorbic acid in patients with inactive ulcerative colitis.

Official Title
-----------------
Comparison of 4L Polyethylene Glycol and 2L Polyethylene Glycol With Ascorbic Acid in Patients With Inactive Ulcerative Colitis; Randomized, Single Blind, Multicenter Study

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Drug: polyethylene glycol
* Drug: Ascorbic Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >18 years old ulcerative colitis patients without symptoms for at least 1 year ulcerative colitis patients who undergo colonoscopy for surveillance Exclusion Criteria: subjects who had abdominal surgery pregnant or breast feeding

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: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: polyethylene glycol<br>4L polyethylene glycol | Drug: polyethylene glycol<br> <br> |
| Experimental: polyethylene glycol with ascorbic acid<br>2L polyethylene glycol and ascorbic acid | Drug: polyethylene glycol<br> <br> Drug: Ascorbic Acid<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who are willing to use the same preparation method for the next colonoscopy. |  | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who have ulcerative colitis symptom aggravation within 30 days after bowel preparation, measured by simple clinical colitis activity index (SCCAI). |  | within 30 days after bowel preparation for colonoscopy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ulcerative colitis, bowel preparation
Wrist Extension Dynasplint (WED) Distal Radius Fracture

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness of a dynamic splinting system for wrist extension contracture following a distal radius fracture.

Official Title
-----------------
Contracture Reduction Following Distal Radius Fracture

Conditions
-----------------
Distal Radius Fracture, Wrist Contracture

Intervention / Treatment
-----------------
* Device: Wrist Extension Dynasplint


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Distal radius fracture treated with surgical management and wrist flexion contracture upon follow up Exclusion Criteria: Carpal Fractures (Scaphoid, Lunate, Hamate, and Trapezium) Radial nerve entrapment Arthrodesis Traumatic dislocation of the distal ulna

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental<br>Patients will be treated with the Standard of Care physical therapy, NSAIDs as well as a Wrist Extension Dynasplint | Device: Wrist Extension Dynasplint<br>* Dynamic Splinting utilizes the protocols of Low-Load, Prolonged-Duration Stretch (LLPS) with calibrated, adjustable tension to increase the Total End Range Time (TERT) to reduce contracture. The Knee Extension Dynasplint for the Experimental group will have tension chambers delivering therapeutic treatment from the device.<br>|
| No Intervention: Control<br>Patients will receive standard of care physical therapy and NSAIDS | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in maximal active range of motion in wrist extension |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
distal radius fracture, wrist contracture, dynasplint
More Time Better Outcome - a Randomised Trial to Investigate the Effect of More Dietetic Time in Dialysis Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether spending more time with a dietitian will improve dietary compliance in a group of hemodialysis patients, with particular respect to phosphate control.

Detailed Description
-----------------
randomised prospective controlled trial stable haemodialysis patients on thrice weekly haemodialysis (URR > 66%) either had standard dietetic review - 6 monthly or intensive review - monthly all patients had to have a serum phosphate > 1.8 mmol/l over the previous three months to be recruited study period 6 months, and then patients followed for a further 3 months

Official Title
-----------------
More Time Better Outcome - a Randomised Trial to Investigate the Effect of More Dietetic Time on Phosphate Levels in End Stage Renal Failure Patients

Conditions
-----------------
Renal Failure

Intervention / Treatment
-----------------
* Behavioral: additional review by dietician


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stable chronic hemodialysis patients serum phosphate > 1.8 mmol/l sustained over 3 months prior to trial entry adequate dialysis treatment as assessed by urea reduction Exclusion Criteria: pregnancy unable to give consent phosphate < 1.8 mmol/l inadequate dialysis aged < 18 or > 80 poor nutritional state weight loss in proceeding three months

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: additional review by dietician|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| phosphate control |  |  | 
| calcium phosphate product |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| parathyroid hormone |  |  | 
| number and type of phosphate binders prescribed |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hemodialysis, phosphate, calcium phosphate product, dietician, dietetic advice
Non-interventional Treatment Patterns Study in Chronic Phase Chronic Myelogenous Leukemia (CP-CML)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate treatment patterns and associated outcomes for CP-CML patients who fail Imatinib 400 mg daily in a real-world setting.

Detailed Description
-----------------
Time Perspective: Retrospective and Prospective

Official Title
-----------------
Treatment Patterns and Associated Outcomes in Chronic Phase (CP) Chronic Myelogenous Leukemia (CML) Patients Who Fail Imatinib 400 mg Daily

Conditions
-----------------
Chronic Myeloid Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: Adult patients (18 years or older) in Chronic phase CML patients who have been treated with Imatinib 400 mg and have failed.

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 |
| --- | --- |
| CP-CML patients who have failed Imatinib 400 mg daily<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Cytogenic Response (CCyR) for CP-CML patients who failed Imatinib 400 mg daily |  | At 3 months post treatment change | 
| Complete Cytogenic Response (CCyR) for CP-CML patients who failed Imatinib 400 mg daily |  | At 6 months post treatment change | 
| Complete Cytogenic Response (CCyR) for CP-CML patients who failed Imatinib 400 mg daily |  | At 12 months post treatment change | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prognostic factors (clinical and demographic characteristics) that influence treatment selection for CP-CML patients who fail imatinib 400 mg daily |  | Baseline | 
| Prognostic factors (clinical and demographic characteristics) that influence treatment selection for CP-CML patients who fail imatinib 400 mg daily |  | 3 months after start of treatment | 
| Prognostic factors (clinical and demographic characteristics) that influence treatment selection for CP-CML patients who fail imatinib 400 mg daily |  | 6 months after start of treatment | 
| Prognostic factors (clinical and demographic characteristics) that influence treatment selection for CP-CML patients who fail imatinib 400 mg daily |  | 12 months after start of treatment | 
| Best response rates achieved by patients if no CCyR |  | Baseline | 
| Best response rates achieved by patients if no CCyR |  | 3 months after start of treatment | 
| Best response rates achieved by patients if no CCyR |  | 6 months after start of treatment | 
| Best response rates achieved by patients if no CCyR |  | 12 months after start of treatment |
Folfiri as Third Line of Treatment

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the activity of Folfiri as Third line of treatment in mGC progressed after ramuciramb-based second line.

Official Title
-----------------
FOLFIRI as a Second-line Therapy in Patients With Docetaxel-pretreated Gastric Cancer

Conditions
-----------------
Gastric Cancer, Ramucirumab, Third Line

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with histologically confirmed, ramucirumab pretreated metastatic gastric cancer who received Eastern Cooperative Oncology Group performance status ≤2 (ECOG PS) aged > 18 years neutrophil count ≥1500/μl platelet count ≥100 000/μl), renal (serum creatinine ≤1.5 mg/dl) liver (serum bilirubin ≤2 mg/dL) functions normal cardiac function, absence of second primary tumor other than non-melanoma skin cancer no concurrent uncontrolled medical illness. Exclusion Criteria: Eastern Cooperative Oncology Group performance status >2 (ECOG PS) No prior treatment with ramucirumab operable metastatic disease were excluded from the study severe cardiac dysfunction, congestive heart failure or a recent myocardial infarction uncontrolled sites of infection.

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- | --- |
| response rate (confirmed complete and partial response). | rate of patients with complete or partial response | From date of enrollment to best radiological evaluation, up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival | Time from start of treatment to Progression or death | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months | 
| Overall survival | Time from start of treatment to Death for any cause | From date of enrollment until the date of death from any cause, whichever came first, assessed up to 12 months | 
| Toxicity | Incidence of Toxicity according National Cancer Institute Common Terminology Criteria | From date to start therapy up to 12 months |
Impact of Unapproved Drug Initiative on Colchicine Use

Study Overview
=================
Brief Summary
-----------------
Measure if FDA regulation of Colchicne in 2009 has resulted in safer use in clinical settings. Our study will assess the impact of this Initiative on colchicine use and will provide data that supports its continuation and expansion.

Official Title
-----------------
Impact of Unapproved Drug Initiative on Colchicine Use

Conditions
-----------------
Gout

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of gout Current use of colchicine/colcrys to treat gout Ablility to provide Informed consent Exclusion Criteria: -Inability to provide Informed consent

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 |
| --- | --- |
| Diagnosis with Gout and use of colchicine<br>Observational study age 18+ | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of use of colchicine in an unapproved fashion in contemporary medical proactice. | We expect to understand the impact of regulatory approach to colchicine preparation and how marketing can affect clinical use patterns in the real world. | This is an oberservational study and patients will be followed for upto 2 years from enrollment. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gout, colchicine
Peri Kasai Portoenterostomy Anchoring of the Jejunal Loop

Study Overview
=================
Brief Summary
-----------------
the study of the effect o the hanging of the jejunal loop to the peri KPE Glisson capsule on the rate of bile drainage and requirement of liver transplantation

Detailed Description
-----------------
To evaluate the effect of anchoring jejunal loop to Glisson capsule of liver after completion of modified Kasai portoenterostomy (KPE) on the frequency of attacks of cholangitis and the overall incidence of native liver survival. Methods: Retrospective study included 29 infants diagnosed as biliary atresia (BA). They were subjected to modified KPE. Two subgroups were present. Group A included 16 infants and had KPE. Group B included 13 infants and had the assumed modification. Wider dissection of fibrous portal plate was considered in both groups. After completion of KPE, the jejunal loop anchored to Glisson capsule of liver at porta hepatis in group B.

Conditions
-----------------
Biliary Atresia

Intervention / Treatment
-----------------
* Procedure: kasai portoenterostomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infants with biliary atresia diagnosed and treated before 60th day of age Exclusion Criteria: infants older than 60 days

Ages Eligible for Study
-----------------
Minimum Age: 4 Weeks
Maximum Age: 8 Weeks

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: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: classic KPE<br>the classic management of biliary atresia as described | Procedure: kasai portoenterostomy<br>* surgical creation of stoma between porta hepatis and jejunal loop<br>|
| Other: modified KPE<br>we added 2 sutures posterior, one on each side and two anterior. this will hang the jejunal loop to promote tension free anastomosis | Procedure: kasai portoenterostomy<br>* surgical creation of stoma between porta hepatis and jejunal loop<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the total number of cholangitis | the total attacks of chollangitis | two years | 
| number of native liver survivors | the decrease of the need of liver transplantation in children with biliary atresia | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| early improvement of liver functions | normalization of liver function | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
biliary atresia, kasai portoenterostomy, modified, cholangitis
Community Trial of Zinc Supplementation on Preschool Child Mortality and Morbidity in Southern Nepal

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether daily supplementation of young children in Nepal with either zinc, iron-folic acid, or both can reduce mortality and morbidity. Young children in Nepal have numerous nutritional deficiencies and high rates of morbidity and mortality. Zinc and/or iron supplementation may be a cost-effective method for reducing these risks.

Detailed Description
-----------------
Mortality rates among preschool age children in Nepal and many other developing countries remain high despite significant progress made over the past 20 years. There remain significant nutritional deficiencies in these populations, especially important are vitamin and mineral deficiencies. Comparisons: In this study, we are comparing the morbidity and mortality experience for children 1-36 months of age randomized to one of four daily supplementation regimens: placebo, zinc alone, iron-folic acid alone, zinc + iron-folic acid.

Official Title
-----------------
Zinc Supplementation Impact on Child Mortality--Nepal

Conditions
-----------------
Nutrition

Intervention / Treatment
-----------------
* Drug: zinc sulphate dietary supplement
* Drug: iron sulphate-folic acid dietary supplement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All children 1-35 months of age living in 30 Village Development Committees of Sarlahi District in southern Nepal. Exclusion Criteria: Parent refusal

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 36 Months

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: zinc sulphate dietary supplement|nan|
|Drug: iron sulphate-folic acid dietary supplement|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death among children 1-36 months of age |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rates of selected morbidities including diarrhea, dysentery, acute respiratory infections |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
zinc, child mortality, child morbidity, community trial, prevention trial, dietary supplement
Trial of SAVVY and HIV in Ghana

Study Overview
=================
Brief Summary
-----------------
Heterosexual contact is now the primary route of transmission for HIV worldwide. This study is a phase 3 trial designed to determine the effectiveness and safety of the 1.0% C31G (SAVVY) vaginal gel for the prevention of male-to-female transmission of HIV among women at high risk.

Detailed Description
-----------------
Heterosexual contact is now the primary route of transmission for HIV worldwide. This study is a phase 3 multi-center, fully-masked, randomized, placebo controlled trial designed to determine the effectiveness and safety of the 1.0% C31G (SAVVY) vaginal gel for the prevention of male-to-female transmission of HIV among women at high risk.

Official Title
-----------------
Randomized Controlled Trial of SAVVY and HIV in Ghana

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: 1.0% C31G SAVVY vaginal gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 35 year old women HIV negative More than one sexual partner in past 3 months Average of 3 coital acts per week Willing to use vaginal gel and condoms for 12 months Exclusion Criteria: HIV positive Pregnant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 1.0% C31G SAVVY vaginal gel|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| combined incidence of HIV-1 and HIV-2 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV transmission