linjc16/ctgov huggingface dataset:
FOOD PRESCRIPTION APP

Study Overview
=================
Brief Summary
-----------------
This study will develop and test and app that will create meal plans to improve diet quality and support weight loss. This app will allow participants to customize their meal plans and substitute recipes for nutritionally equivalent options that they find more appealing, thus potentially increasing adherence.

Detailed Description
-----------------
We are specifically planning app to create meal plans that are affordable, meet the recommended dietary allowances (RDAs) and adhere to sustainability guidelines to reduce the food-related carbon footprint. The app will enable participants to customize their weekly meal plans. We hypothesize that having the ability to customize the weekly menus through a FoodRx app will improve outcomes, as the lack of customization appeared to be a barrier for some families to improve their diet quality and achieve weight loss goals. (eg, some families did not like tofu or oatmeal, and would have preferred a substitute). We will be able to test the impact of the Food Rx app by comparing participants who use it to our control group that does not currently have access to the standard menus/grocery delivery or FoodRx app.

Official Title
-----------------
FOOD PRESCRIPTION APP TO EXTEND AND CUSTOMIZE HEALTHY MEALS FOR A BETTER DIET

Conditions
-----------------
Diet, Healthy

Intervention / Treatment
-----------------
* Behavioral: Customized meal plan and grocery delivery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Already enrolled in FoodRx study >18 years BMI>27 and wants to lose weight - Exclusion Criteria: Not enrolled in Food Rx -

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>These participants will use the app to customize their weekly meal plan and grocery delivery | Behavioral: Customized meal plan and grocery delivery<br>* Participants will use an app to customize their meal plans<br>|
| No Intervention: comparison<br>These participants will not receive a weekly meal plan and will not get grocery delivery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dietary Quality | HEI (Healthy Eating Index) | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss | BMI will be measured | 1 month |
BDP/FF Versus Formoterol Fumarate (FF) in Patients With Severe COPD (Lung Function and Exacerbation Rate)

Study Overview
=================
Brief Summary
-----------------
a 48-week, 2-arm parallel group, fixed combination beclomethasone dipropionate plus formoterol fumarate versus formoterol in patients with severe chronic obstructive pulmonary disease

Detailed Description
-----------------
a 48-week, double blind, randomized, multinational, multicentre, 2-arm parallel group, reference treatment controlled clinical trial of fixed combination beclomethasone dipropionate plus formoterol fumarate versus formoterol in patients with severe chronic obstructive pulmonary disease

Official Title
-----------------
a 48-week, Double Blind, Randomized, Multinational, Multicentre, Fixed Combination Beclomethasone Dipropionate Plus Formoterol Fumarate Versus Formoterol in Patients With Severe Chronic Obstructive Pulmonary Disease

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

Intervention / Treatment
-----------------
* Drug: CHF1535
* Drug: Formoterol fumarate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe COPD At least one COPd exacerbation in previous year Exclusion Criteria: Asthma, allergic rhinitis or other atopic disease Unstable concurrent disease: Evidence of heart failure

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BDP/FF<br>Beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg/per metered dose inhaler | Drug: CHF1535<br>* Beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg/per metered dose<br>* Other names: Foster, Fostair;|
| Active Comparator: Formoterol fumarate<br>Formoterol fumarate 12 µg per metered dose | Drug: Formoterol fumarate<br>* Formoterol fumarate 12 µg per metered dose<br>* Other names: Atimos;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exacerbation rate Change in pre-dose FEV1 |  | 0-4-12-24-36-48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary function parameters(FEV1 - FVC) St George's Questionnaire Use of rescue medication |  | 0-4-12-24-36-48 weeks |
Autonomic Dysfunction and Inflammation in Chronic Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
This study investigates the relationship between autonomic dysfunction and chronic inflammation in hemodialysis patients.

Official Title
-----------------
Autonomic Dysfunction and Inflammation in Chronic Hemodialysis Patients

Conditions
-----------------
Autonomic Dysfunction, Chronic Renal Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic Kidney Disease Stadium KDIGO 5D for at leat 3 months on Dialysis Age >18 years Sinus action in EKG Patient capable for informed consent Written and signed informed consent Exclusion Criteria: Clinical overt signs of infections of any kind Active malign disease CRP levels above 50 mg/L Cardiac Pace Maker Atrial Fibrillation Refusal of informed consent Cardiac Transplantation Immunosuppressive medication

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Diabetic Dialysis Patients | |
| 2<br>Non-Diabetic Dialysis Patients | |
| 3<br>Healthy Controls | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Patupilone Activity in Advanced/Metastatic Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety, efficacy, and activity of patupilone in patients with advanced unresectable and/or metastatic hepatocellular carcinoma based on tumor response using modified RECIST criteria.

Official Title
-----------------
An Open-label, Phase II Trial of Patupilone (EPO906) as Monotherapy to Evaluate Activity of Patupilone in Patients With Advanced Unresectable and/or Metastatic Hepatocellular Carcinoma (HCC)

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

Intervention / Treatment
-----------------
* Drug: Patupilone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - Hepatocellular carcinoma patients with at least 1 previously un-irradiated, measurable lesion without any systemic single agent or combination chemotherapy. Previous local therapy is allowed. Exclusion criteria: Additional protocol-defined inclusion/exclusion criteria 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patupilone<br>was administered at 10 mg/m2, as a single intravenous infusion over 20 minutes, once every 3 weeks | Drug: Patupilone<br>* Patupilone was in dosage strength of 10 mg/4 mL as a clear, colorless concentrate for solution for injection in individual 10 mL glass vials<br>* Other names: EPO906;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST) |  | at screening and at completion of every 6 weeks prior to the next dose administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression |  | at screening and at completion of every 6 weeks prior to the next dose administration | 
| Overall survival |  | at screening and at completion of every 6 weeks prior to the next dose administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced unresectable metastatic hepatocellular carcinoma, Liver cancer
Observational Studies of the Application of Bevacizumab in HER2-negative Breast Cancer Neoadjuvant Chemotherapy

Study Overview
=================
Brief Summary
-----------------
- The purpose of this study is to evaluate the efficacy and safety of the application of bevacizumab combined neoadjuvant chemotherapy in HER2-negative breast cancer.

Official Title
-----------------
Observational Studies of the Application of Bevacizumab in HER2-negative Breast Cancer Neoadjuvant Chemotherapy

Conditions
-----------------
Breast Cancer, Bevacizumab, Neoadjuvant Chemotherapy, Molecular Targeted Therapy

Intervention / Treatment
-----------------
* Drug: bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HER2-negative breast cancer patients Without surgery Plans to neoadjuvant chemotherapy Exclusion Criteria: HER2-positive breast cancer patients Post-operative patients

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| bevacizumab combined neoadjuvant chemotherapy<br> | Drug: bevacizumab<br>* The patients will be treated with Avastin combined neoadjuvant chemotherapy<br>* Other names: Avastin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years. | From enrollment to disease progression | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall response | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years. | From enrollment to disease progression | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bevacizumab, neoadjuvant chemotherapy, HER2-negative breast cancer
Efficacy of Adding Lower Extremity Weights on Balance in Children With Ataxic Cerebral Palsy

Study Overview
=================
Brief Summary
-----------------
Ataxic CP is one type of cerebral palsy. children with ataxic cerebral palsy have trouble with balance and coordination. They may walk with their legs farther apart than other kids and have a hard time with activities that use small hand movements, like writing. Some also have trouble with depth perception This means being able to accurately judge how close or far away something is

Official Title
-----------------
Efficacy of Adding Lower Extremity Weights on Balance in Children With Ataxic Cerebral Palsy

Conditions
-----------------
Ataxic Cerebral Palsy

Intervention / Treatment
-----------------
* Other: adding lower extremity weights
* Other: traditional physical therapy group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ataxic cerebral palsy aged 7-13 years Exclusion Criteria: any musculoskeletal conditions that affect balance previous surgeries that affecting balance

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 13 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: traditional physical therapy group<br>received traditional physical therapy protocol | Other: traditional physical therapy group<br>* traditional physical therapy group<br>|
| Experimental: lower extremity weights group<br>received the same traditional physical therapy in addition to lower extremity weights | Other: adding lower extremity weights<br>* All children in the two groups received physical therapy protocol for 30 minutes in addition to half kg of sandbags weights attached for each leg<br>Other: traditional physical therapy group<br>* traditional physical therapy group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in overall stability index | change in overall stability index will measured by using biodex balance system | baseline and after 3 months of intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| antero-posterior stability index | change in antero-posterior stability index will measured by using biodex balance system | baseline and after 3 months of intervention. | 
| mediolateral stability index | change in mediolateral stability index will measured by using biodex balance system | baseline and after 3 months of intervention. |
Conversion of Prograf to Advagraf in Pediatric Renal Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
This study was designed to compare the pharmacokinetics of Prograf and Advagraf in stable pediatric kidney transplant recipients. Enrolled patients on prograf will have pharmacokinetic study of tacrolimus for 24 hours and after that, the same dose of advagraf will be prescribed. The patients will have another pharmacokinetic study of tacrolimus after conversion to advagraf.

Official Title
-----------------
Conversion of Twice-a-day Tacrolimus to Once-Daily Tacrolimus Extended-Release Formulation in Stable Pediatric Kidney Transplant Recipients

Conditions
-----------------
Kidney Transplantation, Pediatric Patients, Maintenance With Tacrolimus

Intervention / Treatment
-----------------
* Drug: tacrolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ABO-compatible kidney-only transplantation more than 1 year after kidney transplantation 5 to 15 years old patients maintained on Prograf tacrolimus level of determined previously: 4 to 20 ng/ml eGFR by Schwartz equation > 50mL/min Exclusion Criteria: patients with acute rejection within 90 days patients with acute rejection requiring antibody therapy within 6 months patients with more than 2 times of acute rejection within 1 year AST/ALT 2 times more than upper normal limit ABO-incompatible or crossmatch-positive transplantation multiorgan transplantation

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 15 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Advagraf<br>single group, conversion of prograf to advagraf | Drug: tacrolimus<br> <br> * Other names: Advagraf;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve of tacrolimus pharmacokinetics (AUC0-24) | The investigator will compare the changes in AUC0-24 of tacrolimus, Cmax, Tmax and correlation between C0 and Cmax |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Event |  |  |
Neoadjuvant Chemotherapy for Resectable Cancer of the Pancreatic Head

Study Overview
=================
Brief Summary
-----------------
Neodajuvant chemotherapy with gemcitabine / cisplatin is applied to patients with resectable cancer of pancreatic head.

Detailed Description
-----------------
Neodajuvant chemotherapy with gemcitabine / cisplatin is applied to patients with resectable cancer of pancreatic head. Two cycles of chemotherapy are given on day 1 and 15 each. After restaging excludes disease progression, a standard Whipple procedure is performed. Staging and restaging procedures include abdominal CT, diagnostic laparoscopy, PET/CT, tumor markers (CEA, CA 19-9) and assessment of the quality of life by the QLQ-30. Trial with medicinal product

Official Title
-----------------
Neoadjuvant Chemotherapy for Resectable Cancer of the Pancreatic Head

Conditions
-----------------
Cancer of the Pancreatic Head

Intervention / Treatment
-----------------
* Drug: Gemcitabine / Cisplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - Age > 18 years Histologically or cytologically confirmed resectable ductal adenocarcinoma of the pancreatic head WHO-performance status 0-2 Written informed consent Discussion in an intrdisciplinary conference Exclusion criteria: - Insufficient renal function (calculated creatinin clearance < 60ml(min) Insufficient hematologic function (neutrophil count <1'000/ul, platelets < 100'000/ul) Uncorrectable coagulopathy Severe cholestasis (bilirubin >100mmol/l) Distant metastases in liver, lungs or other organs Peritoneal carcinomatosis Unresectable tumor (s. 4.2.) Contraindication for Whipple procedure Uncontrolled infection Neurotphil count > Â°2 Estimated life experience < 6 months HIV Infection Severe medical or psychatric comorbidities which interefere with the participation in this trial or the informed consent Female patients in child-bearing age without adequate contraception

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

| Intervention/Treatment |
| --- |
|Drug: Gemcitabine / Cisplatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resectability rate > 70% after restaging |  | 2007 |
Prevalence of Clopidogrel (Plavix) Resistance in Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
The investigators are trying to find out if Clopidogrel (Plavix) is as effective in hemodialysis patients as in patients not hemodialysed.

Detailed Description
-----------------
Cardiovascular disease is very frequent in hemodialysis patients. Lot of hemodialysis patients are on Clopidogrel (plavix). Their is some evidence that clopidogrel is not effective in hemodialysis as it is effective in patient without kidney problem. VerifyNow plavix is a machine that measure the ability of the blood to clot after giving plavix. We will collect blood from hemodialysis patients on plavix and check the ability of their blood to clot and thus indirectly measuring the efficacy of Plavix.

Official Title
-----------------
Prevalence of Clopidogrel (Plavix) Resistance in Hemodialysis Patients

Conditions
-----------------
Cardiovascular Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients on hemodialysis taking Plavix Exclusion Criteria: known to have bleeding disorder Severely anemic with hemoglobin level (Hb) < 10g/dl Low Platelets < 10000

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 |
| --- | --- |
| patient on hemodialysis taking plavix<br>patient on hemodialysis taking plavix | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence Of Plavix resistance | Plavix resistance is reported using the PRU values given by the VerifyNow machine. PRU is P2Y12 Reaction Units which is correlated with platelet aggregation. | 1 day ( one study visit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assess the risk factors for plavix resistance in the hemodialysis population | Coronary Artery Disease (CAD) is very common in dialysis patients. Treatment of CAD include medical therapy, stent placement and surgery. Since Plavix is a medication that is commonly used after stent placement, we would like to assess the efficacy of this medication in this patient population. | 1 day (one study visit) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Plavix or clopidogrel resistance