linjc16/ctgov huggingface dataset:
Tailored Nutrition and Food Security Interventions in Comprehensive HIV Care

Study Overview
=================
Brief Summary
-----------------
The study hypothesizes that one form of food supplement to HIV-infected individuals in Haiti (ready-to-use-supplementary food) will result in improved HIV, nutrition and quality of life outcomes when compared to a second type of food supplement (corn-soy-blend) over the course of 12 months of food supplementation.

Official Title
-----------------
A Randomized Trial of Ready-to-use-supplementary Food Compared to Corn-soy-blend+ as Food Rations for HIV-infected Adults on Antiretroviral Therapy in Rural Haiti

Conditions
-----------------
HIV, Food Insecurity, Malnutrition

Intervention / Treatment
-----------------
* Other: traditional food
* Other: food that is nutrient dense


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: documented to have HIV infection by standard laboratory procedures live in the geographic catchment area of PIH services where study is taking place 18 years of age or older started antiretroviral therapy for HIV in the 24 months prior to study enrollment Exclusion Criteria: if another household member is also eligible for food assistance if subject is pregnant at the time of enrollment if unable to give 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?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Corn-soy-blend plus<br>food A type of ground meal called corn-soy-blend plus | Other: traditional food<br> <br> |
| Active Comparator: Ready-to-use-supplementary food<br>food A nutrient dense food comprised of peanuts, oil, multivitamins. | Other: food that is nutrient dense<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Mass Index over time |  | 6-month, 12-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life over time |  | 6-month, 12-month |
Assessment of Insulin Glargine in Type 2 Patients for Good Glycemic Control

Study Overview
=================
Brief Summary
-----------------
Primary objective: To observe the efficacy of the forced titration to reach good glycemic control in Lantus treated patients Secondary objectives: To assess the forced titration on physician and patient satisfaction To evaluate the impact of training tools by means of patient profile

Official Title
-----------------
Assessment of Forced Titration to Reach the Effective Dose for Good Glycemic Control in Lantus Treated Type 2 Patients

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

Intervention / Treatment
-----------------
* Drug: Insulin glargine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: T2 insulin naïve patients Patients whom their physician is considering initiation of Lantus treatment Poor glycemic control 7,5 %10 % T2 treatment with OADs more than 3 months BMI<40 kg/m2 Exclusion Criteria: Impaired renal function (Cr>2mg/dl or current renal dialysis) Acute or chronic metabolic acidosis Active liver disease or serum ALT or AST >2,5 than normal History of hypoglycemia unawareness Diabetic retinopathy with surgery in the previous 3 months or planned within 3 months after study entry Pregnancy, breast feeding The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Insulin glargine | Drug: Insulin glargine<br>* The dose is titrated according to patient needs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c, FBG |  | after treatment end (6 months) | 
| Final dose |  | after treatment end (6 months) | 
| Number of dose adjustment |  | after treatment end (6 months) | 
| Time to dose titration |  | after treatment end (6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoglycemia |  | after treatment end (6 months) | 
| Noctural hypoglycemia |  | after treatment end (6 months) | 
| DTSQ |  | after treatment end (6 months) | 
| Physician Satisfaction Questionnaire |  | after treatment end (6 months) |
A Study to Examine the Use of Zemplar to Increase Serum Calcium Levels in ICU Subjects

Study Overview
=================
Brief Summary
-----------------
A study to determine the effect of Zemplar on the regulation of serum calcium levels and the need for administration of elemental calcium in hypocalcemic intensive care patients

Official Title
-----------------
A Placebo-Controlled, Double-Blind Study to Examine the Use of Zemplar to Increase Serum Calcium Levels in ICU Subjects

Conditions
-----------------
Hypocalcemia

Intervention / Treatment
-----------------
* Drug: paricalcitol injection (Zemplar)
* Behavioral: Effects on calcium regulation
* Behavioral: Administration of elemental Ca during hypocalcemic ICU pts.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICU patients APACHE III score between 70 - 150 at screening and within 24 hours of enrollment and a whole blood ionized calcium level less than 0.90 mmol/L or corrected whole blood calcium level less than or equal to 7.5 mg/dL. Exclusion Criteria: Serum creatinine greater than 2.5 mg/dL

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: Factorial Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: paricalcitol injection (Zemplar)|nan|
|Behavioral: Effects on calcium regulation|nan|
|Behavioral: Administration of elemental Ca during hypocalcemic ICU pts.|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy variable will be the change from Day 1 to last day of dosing in pH adjusted, serum ionized calcium levels. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypocalcemia, ionized calcium, intensive care
ExoDx Prostate Evaluation in Active Surveillance Patient Population

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to test whether the ExoDx Prostate test add value in biopsy decision making to patients with prostate cancer on an active surveillance regimen.

Detailed Description
-----------------
The current trial seeks to evaluate the role of the ExoDx Prostate test in men with low and favorable intermediate prostate cancer undergoing an active surveillance regimen.

Official Title
-----------------
ExoDx Prostate Evaluation in Active Surveillance Patient Population

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: ExoDx Prostate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male, 45+ years of age diagnosed with low-grade or favorable-intermediate prostate cancer and on an active surveillance regimen Exclusion Criteria: Clinical symptoms of urinary tract infection at time of enrollment. History of invasive treatment for benign prostatic hypertrophy with in 6 months of enrollment. Known hepatitis or HIV History of concurrent renal/bladder tumors

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: ExoDx Prostate|Observational only.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Develop and evaluate risk-based scoring using the ExoDx Prostate test. |  | 1yr after last enrolled patient |
Safety/Efficacy of Balicatib (AAE581) in Adults With Osteoarthritis of the Knee

Study Overview
=================
Brief Summary
-----------------
This study will test efficacy and safety of AAE581 compared to placebo in limiting cartilage loss in patients with painful knee osteoarthritis which is confirmed by X-ray

Official Title
-----------------
A Phase II, 12-month, Double-blind, Placebo-controlled, Dose-finding, Multicenter Study to Evaluate the Safety, Tolerability, and Disease Modifying Efficacy of Daily Oral AAE581 (10, 25 and 50 mg Tablets) in Patients With Painful Knee Osteoarthritis, Kellgren-Lawrence Grade 3 by X-ray

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

Intervention / Treatment
-----------------
* Drug: balicatib (AAE581)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least one knee with osteoarthritis with Kellgren-Lawrence grade 3 Significant osteoarthritis pain in the knee Presence of at least one of the risk factors: obesity (BMI > 28), osteoarthritis at other sites, knee effusion, family history of total joint replacement Exclusion Criteria: Women with childbearing potential Secondary osteoarthritis Treatment with intra-articular or systemic steroids Inability to undergo MRI acquisition Other protocol defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: balicatib (AAE581)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in knee cartilage volume in the target compartment after 6 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in: |  |  | 
| - Cartilage volume in the different regions of the knee after 6 and 12 months, |  |  | 
| - Cartilage score (Whole Organ MRI Scoring system (WORMS)) in the different regions of the knee after 6 and 12 months, |  |  | 
| - Bone marrow edema score (WORMS) in the different regions of the knee after 6 and 12 months, |  |  | 
| - Joint space width after 6 and 12 months, |  |  | 
| - Markers of bone and cartilage degradation (CTX-I and CTX-II at 3, 6, 9, and 12 months |  |  | 
| - Pain (analgesic consumption, Western Ontario and McMaster Universities Osteoarthritis Index, Visual Analogue Scale, criteria of the Outcome Measures in Rheumatology Osteoarthritis-Research Society International at 1, 3, 6, 9, and 12 months |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Knee, osteoarthritis, pain, disease modifying
A Study of the Effect of a Nurse Navigator Program on High Risk Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine if educational intervention in high risk patients can lead to decreased hospital readmissions when compared to patients who are not in the intervention program. Additionally, to determine patient satisfaction with the educational program.

Official Title
-----------------
The Effect of a Nurse Navigator Program on Readmission Rates for Patients With Elevated BMI, COPD, CHF, Dialysis Use, and H/o Alcohol Abuse

Conditions
-----------------
Body Mass Index, Alcoholism, Patient Readmission, Arthroplasty, Replacement, Knee, Arthroplasty, Replacement, Hip, Heart Failure, Pulmonary Disease, Chronic Obstructive, Renal Insufficiency

Intervention / Treatment
-----------------
* Other: Nurse Navigator Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Require total or partial hip or knee replacement and have one or more of the following diagnosis: Heart Failure (HF); Chronic obstructive pulmonary disease (COPD); Dialysis; Alcohol Abuse; Low BMI. Exclusion Criteria: - Decrease cognitive capacity to consent to the study.

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Practice<br>Patients with chronic conditions slated for surgery contacted once by pre-operative nurse to discuss surgery | |
| Experimental: Nurse Navigator<br>Patients with chronic conditions slated for surgery contacted once by pre-operative nurse to discuss surgery, then contacted at intervals by nurse navigator study team members | Other: Nurse Navigator Program<br>* Identification of specific chronic conditions and suggestion of management care of primary care physicians and referrals to specialists via nurse navigator team members.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmission rates |  | One year |
Development of a Space Exploration Assessment for Children With Spinal Muscular Atrophy

Study Overview
=================
Brief Summary
-----------------
The aim of this randomized study is to develop a new motor assessment of space exploration in a 2D environment with upper limbs for children with spinal muscular atrophy 1 and 2 from 3 until 16 years old.

Detailed Description
-----------------
Thirty children are included in the prospective randomized study. They are evaluated with the new test, Space Exploration Test (TES), and with the Motor Function Measure (MFM), a gold standard scale. The objective is to compare the results and to demonstrate the complementarity of the two tools.

Official Title
-----------------
Development of a Space Exploration Assessment for Children With Spinal Muscular Atrophy

Conditions
-----------------
Spinal Muscular Atrophy, Assessment, Self

Intervention / Treatment
-----------------
* Other: Motor assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children, girls and boys, from 3 to 16 years old, with Spinal Motor Atrophy 1 and 2 with social protection Exclusion Criteria: cognitive disorders preventing understanding

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 16 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Evaluation<br>Included patients will be invited to participate in 1 session, to be evaluated with the Motor Function Measure and the new test of space exploration, during 2 hours maximum, to compare scores with these 2 tests. An occupational therapist will be required to install the patient in front of the table and to give the instructions. | Other: Motor assessment<br>* An occupational therapist install the patient sitting in front of the test board and tell him the instructions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor Function Measure (MFM) | Clinical Evaluation | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Space Exploration Test (SET) | The SET is made through a test board 170 cm long and 60 cm deep, developed by in our lab | 20 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal Muscular Atrophy, Children, Motor assessment, Space exploration, Upper limbs
Use of Magnetic Imaging to Asses the Efficacy of Cap Assisted Colonoscopy in Reducing Looping and Improving Patient Acceptance for the Colonoscopy Procedure

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare the mechanism of loop formation and acceptance of CAC and regular colonoscopy by MEI.

Detailed Description
-----------------
Colonoscopy is widely used for the investigation of lower gastrointestinal tract disease.However,colonoscopy remains a technically difficult procedure. As the colon is a mobile organ, looping may occur when the colonoscope passes through.Hence,reducing looping during procedure is very improtant to achieve succes as well as patient acceptance.Recently,some studies shown that cap-assisted colonoscopy(CAC)allow better visualisation of the colonic folds, thus increase success rate.However, previous studies shown that magnetic endoscope imaging (MEI)is useful as an adjunct to assist endoscopist in performing the procedure and as a modality to look for the mechanism of looping. Because of such concern,our study is to compare the mechanism of looping formation and acceptance of CAC and regular colonoscopy by MEI.

Official Title
-----------------
A Double-Blinded Randomized Study Comparison the Mechanism of Looping Formation and Subject's Acceptance During CAC and Regular Colonoscopy by MEI (MIC Study)

Conditions
-----------------
Colonoscopy

Intervention / Treatment
-----------------
* Procedure: MEI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient undergo first colonoscopy examination Signed informed consent Exclusion Criteria: Patient had received colonoscopy examination before. Patient had prior colorectal surgery done(apart from appendectomy) Known to have colonic stricture or obstructing tumour from the result of other investigations such as CT scan or barium enema. Presence of acute surgical conditions such as severe colitis, megacolon, ischaemic colitis and active gastrointestinal bleeding. Patient could not provide consent.
Sexes Eligible for Study
-----------------
All

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: MEI|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The MEI score difference between regular colonoscopy and CAC. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
First colonoscopy examination
Absorption, Metabolism, Excretion, and Mass Balance Study of [14C]-VVZ-149 in Healthy Adult Male Subjects

Study Overview
=================
Brief Summary
-----------------
This is an open-label, single-dose, absorption, metabolism, excretion, and mass balance study following a single IV infusion of [14C]-VVZ-149 in healthy adult male subjects. Whole blood, plasma, urine, and fecal samples will be analyzed for at least 72 hours following the start of infusion to measure total radioactivity and plasma drug concentrations.

Official Title
-----------------
Phase 1, Open-Label Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of a Single Intravenous Dose of [14C]-VVZ-149 in Healthy Adult Male Subjects

Conditions
-----------------
Healthy Adult Male

Intervention / Treatment
-----------------
* Drug: [14C]-VVZ-149


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Healthy, adult, male, 19-55 years of age, inclusive Continuous non-smoker BMI ≥ 18.0 and ≤ 32.0 kg/m2 Medically healthy with no clinically significant medical history or findings Must agree to adhere to the contraception requirements Key Exclusion Criteria: History or presence of clinically significant medical or psychiatric condition or disease History or presence of alcohol or drug abuse within the past 2 years History, presence or evidence of cardiovascular, renal or hepatic impairment Less or abnormal bowel movements Unable to refrain from or anticipates the use of any prohibited drugs Recent donation of blood/plasma or significant blood loss Radiation exposure within 12 months Participation in another clinical study within 30 days

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VVZ-149 Injections<br> | Drug: [14C]-VVZ-149<br>* A single IV infusion of radio-labeled VVZ-149<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mass balance | Sum of the percent of the total radioactivity recovered in urine and feces relative to the administered radioactivity dose | Day 15 | 
| Total radioactivity (TRA) concentration equivalents in plasma |  | Day 15 | 
| TRA concentration equivalents in urine |  | Day 15 | 
| TRA concentration equivalents in feces |  | Day 15 | 
| Drug concentrations in plasma |  | Hour 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-emergent adverse events |  | Day 15 |