linjc16/ctgov huggingface dataset:
Feasibility of Integrating Indirect Calorimetry (IC) Technology in Primary Care

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the feasibility of using indirect calorimetry (IC) within a comprehensive weight reduction program. Will individuals that receive a personalized nutrition program, at baseline, from IC technology respond better to treatment compared to individuals receiving IC technology at three months.

Official Title
-----------------
Feasibility Study of Integrating IC Technology With the WatchWT Comprehensive Weight Reduction Program.

Conditions
-----------------
Obesity, Hypertension

Intervention / Treatment
-----------------
* Behavioral: Individualized IC treatment
* Behavioral: Usual Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI greater than 30 kg/m2 18-70 years of age Exclusion Criteria: No participation in other weight loss efforts outside study. Pregnant or lactating

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E1<br> | Behavioral: Usual Care<br>* Individuals will receive standard dietary plan. Women will receive 1200 Kcal/day and men will receive 1600 Kcal/day. Individuals will receive RMR measurement at three months. RMR information will be used to help improve eating behavior.<br>* Other names: MedGem indirect Calorimeter;|
| Active Comparator: A1<br> | Behavioral: Individualized IC treatment<br>* Individuals will receive IC measurement at baseline and three months. Nutrition and physical activity plan will be developed and adjusted from measured RMR and lifestyle.<br>* Other names: MedGem indirect Calorimeter;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bodyweight |  | Six Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychobehavioral: Self-Efficacy |  | Six Months | 
| Quality Life |  | Six Months | 
| Blood Pressure |  | Six Months | 
| Eating Behavior |  | Six Months |
Study of Muscle Effects of BYM338 in Mechanically Ventilated Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of BYM338 on muscle mass and function in Group III failure to wean patients, as compared to placebo controls.

Official Title
-----------------
An Exploratory, Randomized, Double-blind, Placebo-controlled Study to Investigate the Effect of BYM338 on Muscle in Patients Requiring Prolonged Mechanical Ventilation

Conditions
-----------------
Mechanical Ventilation

Intervention / Treatment
-----------------
* Drug: BYM338
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults on mechanical ventilation for at least 7 days with a tracheostomy in place for >24 hours. Expected to survive at least 14 days. Receiving adequate nutritional support, defined as at least 20 kcal/kg and 0.6 g/kg protein per day (unless lower protein intake required by clinical status). Exclusion Criteria: Patients deemed to be terminal wean patients. Patients who have progressive neuromuscular degenerative disorders. Patients who are comatose. Evidence of unstable medical status.
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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|
| Experimental: BYM338<br> | Drug: BYM338<br>* BYM338<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in thigh muscle thickness |  | After 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events as a measure of safety and tolerability |  | After 12 weeks | 
| Sparse sampling of BYM338 serum levels to assess pharmacokinetic profile in mechanically ventilated patients |  | After 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Muscle, anabolism, cachexia, respiratory failure, diaphragm
Compassionate Use of Ibalizumab for the Treatment of HIV Infection

Study Overview
=================
Brief Summary
-----------------
Ibalizumab is a humanized immunoglobulin G monoclonal antibody directed against a human T-cell receptor (CD4) and thus suppresses HIV replication by blocking entry of HIV into CD4+ lymphocytes. Ibalizumab has completed phase I and II clinical studies in HIV-negative and HIV-infected individuals showing safety and efficacy for suppressing HIV replication.

Detailed Description
-----------------
Ibalizumab is a humanized immunoglobulin G monoclonal antibody directed against a human T-cell receptor (CD4) and thus suppresses HIV replication by blocking entry of HIV into CD4+ lymphocytes. Ibalizumab is in the pipeline for FDA approval to treat HIV infection. Phase I and II clinical studies have been completed in HIV-negative and HIV-infected individuals showing safety and efficacy for suppressing HIV replication. Use of this medication requires that a single patient IND be obtained from the FDA for each patient requiring ibalizumab. An individual use IND has been approved by the FDA for one patient on treatment through this protocol; The IND number is 114515. The manufacturer of ibalizumab (TaiMed Biologics, Inc) will ship the drug directly to the Denver Health pharmacy.

Official Title
-----------------
Compassionate Use of Ibalizumab for the Treatment of HIV Infection

Conditions
-----------------
Human Immunodeficiency Virus (HIV)

Intervention / Treatment
-----------------
* Drug: Dolutegravir Sodium Monohydrate
* Drug: Ibalizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with a diagnosis of HIV-infection with resistance or intolerance to currently available antiretroviral medications available in the United States or in whom additional drugs need to be added to their regimen because of inadequate response to existing therapy Patients with HIV infection that is expected to be sensitive to dolutegravir and ibalizumab Patients who do not qualify for or who are otherwise ineligible for clinical trials of medications not currently approved for treatment of HIV infection in the U.S. Exclusion Criteria: Patients who are allergic to or have had a severe adverse reaction to dolutegravir or ibalizumab in the past. Age <18 years or >89 years Women may not be pregnant Prisoners and decisionally challenged patients will be excluded

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Dolutegravir Sodium Monohydrate|Dolutegravir taken 50mg orally twice daily|
|Drug: Ibalizumab|Ibalizumab will be administered intravenously at a dose of 800mg once every two weeks.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Trial Comparing Tisseel as an Adjunct to Traditional Hemostasis After Redo Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Bleeding after redo cardiac surgery is a common, unresolved and consequences-heavy event as per present day. Tisseel (Baxter inc) sprayed on the already hemostased mediastinum jut before closing seems a promising technique to radically diminish bleeding. This study aims to verify this efficacy volume in chest drains) and possibly the consensual blood transfusion lessening.

Official Title
-----------------
Randomized Prospective Comparison of Tisseel Or Control to Diminish Blood Loss After Redo Redo Cardiac Surgery: the Study

Conditions
-----------------
Hemorrhage

Intervention / Treatment
-----------------
* Procedure: Spray Fibrin Sealant
* Procedure: Traditional Hemostasis and chest Closure Routine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing any kind of redo cardiac surgery with ati least one previous sternotomy Exclusion Criteria: None
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: TISSEEL<br>Spray Fibrin Sealant | Procedure: Spray Fibrin Sealant<br>* Baxter Tisseel (Fibrin Sealant) is sprayed in the mediastinum at the end of the operation afetr routine chest hemostasis protocol has been completed, right before closing the chest.<br>* Other names: TISSEEL;|
| Active Comparator: CONTROL<br>Traditional hemostasis and chest closure routine | Procedure: Traditional Hemostasis and chest Closure Routine<br>* Routine chest hemostasis and closure protocol (gauzes and inspection till satisfactory according to the surgeon)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding (Amount of blood (ml) collected in chest drainage) | Amount of blood (ml) collected in chest drainage in the first 24 hours after operation | first 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Allogeneic blood Sparing (Amount of Allogeneic Blood units (number) transfused in the first 4 days after surgery) | Amount of Allogeneic Blood units (number) transfused in the first 4 days after surgery | 4 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bleeding, Heart Surgery, Reoperation
Skin Prick Test for the Diagnosis of Food Allergy- a Comparison of Different Commercial Extracts and Raw Food

Study Overview
=================
Brief Summary
-----------------
Immediate food allergy is , sometimes , a life threatening situation . Diagnosis is done by skin prick test with commercial extracts. Nevertheless, some of the extracts are not optimal and reproduce false negative results (no allergy) in patients with history highly suggestive of allergic reaction. The aim of this study is to compare the reproducibility of different commercial extracts and raw food in patients with convincing history of acute allergic symptoms related to food .

Official Title
-----------------
Skin Prick Test for the Diagnosis of Food Allergy- a Comparison of Different Commercial Extracts and Raw Food

Conditions
-----------------
Food Allergy

Intervention / Treatment
-----------------
* Procedure: skin test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspected immediate allergic reaction to food Exclusion Criteria:none

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 120 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: raw food skin test<br>skin test with the suspected raw food | Procedure: skin test<br>* skin test with the Suspected raw food<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between the results of skin test with commercial extracts and raw food |  | immediate | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
skin test, raw food, commercial extract
Study of the Absolute Oral Bioavailability of Dapagliflozin in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to estimate the absolute oral bioavailability of dapagliflozin.

Official Title
-----------------
Study of the Absolute Oral Bioavailability of Dapagliflozin in Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: Dapagliflozin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subjects (ages 18 to 45) as determined by medical history, physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations will be eligible to participate in the study Exclusion Criteria: Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations Participation in a radiolabeled investigational study drug trial within 12 months prior to admission to the clinical facility Exposure to significant radiation within 12 months prior to admission to the clinical facility

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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 |
| --- | --- |
| Other: Dapagliflozin<br>PO and IV | Drug: Dapagliflozin<br>* Tablet and IV solution, Oral and IV, 10 mg po and 100 µg IV, Single oral dose followed by a single IV dose (IV dose administered at 1h after oral dose), 1 day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute oral bioavailability |  | Within the 3 days after study drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events (AE) |  | Within the 3 days after study drug administration | 
| Vital signs |  | Within the 3 days after study drug administration | 
| Clinical safety labs |  | Within the 3 days after study drug administration | 
| Electrocardiograms (ECGs) |  | Within the 3 days after study drug administration |
Analysis of miRNA Expression in Endometrial Cancer

Study Overview
=================
Brief Summary
-----------------
The TCGA project identified four distinct prognostic groups of endometrial carcinoma (EC) based on molecular alterations: (i) the ultramutated subtype that encompasses POLE mutated (POLE) cases; (ii) the hypermutated subtype, characterized by MisMatch Repair deficiency (MMRd); (iii) the copy-number high subtype, with p53 abnormal/mutated features (p53abn); (iv) the copy-number low subtype, known as No Specific Molecular Profile (NSMP). Although the prognostic value of TCGA molecular classification, NSMP carcinomas present a wide variability in molecular alterations and biological aggressiveness. Given that the study aims to evaluate the miRNA expression profile to identify novel potential biomarkers to better stratify the EC patients, taking into account the molecular status

Official Title
-----------------
Identification of miRNAs in Endometrial Cancer as Novel Diagnostic and Prognostic Biomarkers

Conditions
-----------------
Endometrial Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age>18yo histological diagnosis of endometrial cancer tumor resection patient's informed consent Exclusion Criteria: patients with other neoplasia within the last 5 years

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

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

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 |
| --- | --- | --- |
| Evaluation of miRNA expression based on the 4 molecular groups | Evaluate miRNA expression based on the 4 molecular groups recently identified | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Integration of molecular results with clinico-pathological data | Integration of molecular results with clinico-pathological data | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endometrial cancer, miRNA, microRNA, TGCA
Evaluation of the Arthritis Basics for Change (ABCs) Self Management Program

Study Overview
=================
Brief Summary
-----------------
While there are a variety of arthritis education materials available, the evidence-base on most of them is slim, so it i impossible to know what benefits they may have for the people who participate. The purpose of this project is to evaluate the effectiveness of the mail-delivered self-management education program, Arthritis Basics for Change (ABCS) with an emphasis on changes in knowledge, beliefs, behavior, self efficacy and health outcomes, and to evaluate the appropriateness, usefulness, and readibility of the program. This project will assist CDC's Arthritis Program in determining the usefulness of the ABCs program for helping people with arthritis improve their quality of life.

Official Title
-----------------
Evaluation of the Arthritis Basics for Change (ABCs) Self Management Program

Conditions
-----------------
Arthritis

Intervention / Treatment
-----------------
* Behavioral: Arthritis Basics for Change Education program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults with arthritis Exclusion Criteria: -

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: Educational/Counseling/Training
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Arthritis Basics for Change Education program|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arthritis management knowledge at 6 months |  |  | 
| self management beliefs at 6 months |  |  | 
| Self management behaviors at 6 months |  |  | 
| Self efficacy for arthritis management at 6 months |  |  | 
| Health status at 6 months |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
arthritis, self management, patient education
A Controlled Study of Community-based Exercise Training in Patients With Moderate COPD

Study Overview
=================
Brief Summary
-----------------
The effectiveness of clinic-based pulmonary rehabilitation in advanced Chronic Obstructive Pulmonary Disease (COPD) is well established, but few data exist for less severe patients treated in alternative settings. The purpose of this study was to investigate whether a novel, community-based exercise program was feasible and effective for patients with moderate COPD.

Official Title
-----------------
A Controlled Study of Community-based Exercise Training in Patients With Moderate COPD

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

Intervention / Treatment
-----------------
* Other: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with moderate COPD and self-reported exercise impairment Exclusion Criteria: current smokers, pulmonary diseases other than COPD, use of supplemental oxygen, musculoskeletal disease that impaired exercise performance and unstable coronary artery disease or congestive heart failure
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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>Enrollment in pulmonary rehabilitation | Other: Exercise<br> <br> |
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endurance | Change in endurance of physical activity was measured in seconds. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle Strength | Change in muscle strength was measures in pounds of weight lifted | 12 weeks |
Function and Modulation of Fibulin-1 Assembly in Nucleus of Corneal Fibroblasts

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the role of nuclear Fibulin-1 (FBLN1) in Human Corneal Fibroblasts under treatment of mitomycin C (MMC).

Conditions
-----------------
Function of Mitomycin C in Cornea

Intervention / Treatment
-----------------
* Drug: Mitomycin C


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The frozen storage cells in liquid nitrogen were amplified from the residual corneal rim of the donors with more than 20 years old following penetrating keratoplasty. Exclusion Criteria: The donors were younger than 20 years old.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Mitomycin C|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modification of nuclear Fibulin-1 accumulation in suppressing gene expression |  | 3 days post mitomycin C treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Human corneal fibroblasts, Fibulin-1, Nuclear accumulation