linjc16/ctgov huggingface dataset:
Collection of Blood in Studying Metabolites in Patients With Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
This pilot research trial utilizes the collection of blood in studying metabolites in patients with prostate cancer. Metabolites are the small molecule products of cellular metabolism that are produced naturally in all living cells. Collecting blood in order to study metabolites may help doctors monitor and treat prostate cancer more effectively.

Detailed Description
-----------------
PRIMARY OBJECTIVES: I. Develop blood sample collection and preparation procedures for reliable, meaningful metabolomic profiling of peripheral blood mononuclear cells (PBMCs) by liquid chromatography/quadruple-time of flight/mass spectrometry (LC/Q-TOF/MS) that can be implemented in a clinical setting. II. Optimize data analysis methods and software usage to create a metabolic profile for patients at the time of blood collection. III. Compare metabolite profiles of isolated PBMCs versus (vs.) other blood fractions (plasma, red blood cells [RBCs], and whole blood). IV. Identify elements of the PBMC metabolite profile that may correlate to patient disease state. OUTLINE: Patients undergo collection of blood for metabolic profiling via LC/Q-TOF/MS.

Official Title
-----------------
Metabolic Profiling of Peripheral Blood Mononuclear Cells (PBMCs) by LC-MS in Prostate Cancer Patients

Conditions
-----------------
Prostate Carcinoma

Intervention / Treatment
-----------------
* Procedure: Biospecimen Collection
* Other: Laboratory Biomarker Analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All subjects will have histologically confirmed prostate cancer Provide written consent/authorization to participate in this study Have no signs or symptoms of active infection Exhibit a willingness to comply with the experimental procedures as outlined in this protocol

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diagnostic (biospecimen collection)<br>Patients undergo collection of blood for metabolic profiling via LC/Q-TOF/MS. | Procedure: Biospecimen Collection<br>* Undergo collection of blood<br>Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood sample collection | The blood will be used to analyze the metabolites produced by white blood cells. | Baseline |
FluAlert: Influenza Vaccine Alerts for Providers in the Electronic Health Record

Study Overview
=================
Brief Summary
-----------------
Childhood influenza coverage rates are far below rates for the other childhood vaccinations. Increasing influenza vaccine coverage rates is important not only for the health of the child, but for that of the child's household and community. Yet,influenza vaccine delivery rates at pediatric clinics are low, even when the vaccine is available. The proposed project will take advantage of existing health information technology to tailor, implement and evaluate influenza vaccine alerts in the electronic health record (EHR) for pediatric providers to help improve health care decision making.

Official Title
-----------------
FluAlert: Influenza Vaccine Alerts for Providers in the Electronic Health Record

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Other: Provider Alert


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medical (medical doctor/nurse practitioner (MD/NP)) or nursing providers (registered nurse, licensed practical nurse (RN/LPN)) at participating practices Parents of a child 6 months - 18 years who is a patient at one of the participating ACN practice Parents fluent in English or Spanish Children 6 months- 18 years with visit to participating practice during influenza season

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 75 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Provider Alert<br>Provider receives alert for patient visit | Other: Provider Alert<br>* Provider influenza vaccine alert<br>* Other names: alert for provider in electronic health record;|
| No Intervention: No Alert<br>No alert provided | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| influenza vaccination |  | September through March 2011-2012 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Documentation of reason for vaccine refusal |  | Sept 2011-March 2012 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
influenza, vaccine, clinical decision support
Clinical Study About Fat Measurement on Multifunction Keito by Comparison Versus Its Predicate K014009

Study Overview
=================
Brief Summary
-----------------
The researchers believe that the multifunction Keito devices shares with TANITA TBF-300 (K014009) the same efficacy on the body fat measurement. Even if the body contact points are not the same, the researchers deeply believe that the tetrapolar BIA used by the predicate gives results as similar as the multifunction keito does.

Detailed Description
-----------------
177 volunteers were enrolled in this clinical Study. Before taking the fat measurement by the devices under test, the observers measured the weight and height of each volunteer prior to measure the body fat. This was done to configure a preliminary idea about the body composition of the subject. Both devices are designed by the same technology to emit a low current through the body, and finally make a measurement of the impedance found between the body contact points. We expected the results to be very similar.

Conditions
-----------------
Body Fat

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All population who meet with the requirements described on the user's manual. Exclusion Criteria: Pregnant women. Individuals who have a pacemaker or any other internal medical device. Population whose weight is under 15 Kg and less than 135 cm tall.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 82 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
To demonstrate that multifunction Keito is as effective, as safe and accurate as the predicate K014009 on its body fat measurement.
The Effect of Social Media Use on Eating Behaviours

Study Overview
=================
Brief Summary
-----------------
This project aims to explore how social media use, in particular food photography, influences eating behaviours. It will be approached through three methods - a correlational experience sampling method, an experimental experience sampling method, and an experimental laboratory method. This registration describes the correlational experience sampling method.

Detailed Description
-----------------
This project aims to explore how social media use, in particular food photography, influences eating behaviours. The research question will be approached using a combination of methods. The first is the experience sampling method, where data is gathered from participants as they are going about their day-to-day lives. This method comprises two sub-sections - a correlational study, and an experimental study. This registration describes the correlational experience sampling method. The study will measure participants' regular phone use and eating behaviours. Participants will be recruited via online platforms and participate in the study for one week. At the beginning of the week, they will be required to fill in some online questionnaires (e.g. demographic information). For the rest of the week, they will be prompted at specific time points in the day via smartphone to answer some questions about their phone use and eating behaviours. The expected outcome of the project is to collectively evaluate the data from the various methods to conclude how social media use, and in particular the act of food photography, influences the various aspects of eating behaviours.

Official Title
-----------------
The Effect of Social Media Use on Eating Behaviours

Conditions
-----------------
Eating Behavior

Participation Criteria
=================
Eligibility Criteria
-----------------
Exclusion Criteria: Symptoms / history of any medical or psychiatric conditions Allergies to food products History of eating disorders Excessive exercise (≥ 5 times a week of self-reported exercise) Currently on a special diet or deliberating restricting caloric intake Currently on a weight loss program

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enjoyment of food consumed | Self-reported rating between 1-7, where 1 is not at all and 7 is very much | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of food consumed | Self-reported rating between 1-7, where 1 is less than normal and 7 is more than normal | 15 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Technology, External eating, Photography, Social media
BP Limb Length of 60cm vs 100cm in Roux-en-Y Gastric Bypass

Study Overview
=================
Brief Summary
-----------------
Patients will be randomized into 2 groups: Group 60: Patients will undergo a Roux-en-Y gastric bypass with a Biliopancreatic limb length of 60cm Group 100: Patients will undergo a Roux-en-Y gastric bypass with a Biliopancreatic limb length of 100cm Bone mineral density will be evaluated before surgery and 2 years after it.

Detailed Description
-----------------
Patients will be randomized into 2 groups: Group 60: Patients will undergo a Roux-en-Y gastric bypass with a Biliopancreatic limb length of 60cm Group 100: Patients will undergo a Roux-en-Y gastric bypass with a Biliopancreatic limb length of 100cm Alimentary limb will be constant in both groups (150cm length) Bone mineral density will be evaluated before surgery and 2 years after it, by means of X ray absorptiometry (DEXA). Changes in bone mineral density in lumbar column will be assessed.

Official Title
-----------------
Impact of Biliopancreatic Limb Length of 60cm vs 100cm in Roux-en-Y Gastric Bypass on Bone Mineral Density 2 Years After Surgery

Conditions
-----------------
Osteopenia

Intervention / Treatment
-----------------
* Procedure: biliopancreatic limb length of 60cm.
* Procedure: biliopancreatic limb length of 100cm.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index >40 Kg/m2 Body mass index >35 Kg/m2 associated to obesity related comorbidities Exclusion Criteria: Bone pathologies Active neoplasms Disorders in calcium or vitamin D metabolism

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biliopancreatic limb 60cm<br>Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 60cm. | Procedure: biliopancreatic limb length of 60cm.<br>* Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 60cm.<br>|
| Active Comparator: Biliopancreatic limb 100cm<br>Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 100cm. | Procedure: biliopancreatic limb length of 100cm.<br>* Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 100cm.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone mineral density | Bone mineral density will be evealuated by absorptiometry at the level of lumbar column | 2 years after surgery |
Confocal Laser Endomicroscopy With Topical Cresyl Violet for Colorectal Polyps

Study Overview
=================
Brief Summary
-----------------
Probe-based confocal laser endomicroscopy (pCLE) has been shown to a reliable diagnostic method enabling in vivo microscopic imaging during ongoing endoscopy. Usually fluorescein then serves as a contrast agent for pCLE, but it does not allow direct nuclear visualization, must be injected, leads to a transient skin discoloration, and may have allergic side effects. This study aimed to establish a single topical dye, cresyl violet (CV) for pCLE imaging, to describe pCLE interpretation criteria for the characterization of colorectal polyps with histopathological correlation, and to perform the validation of these criteria.

Official Title
-----------------
Probe-based Confocal Laser Endomicroscopy With Topical Cresyl Violet for Diagnosis of Colorectal Polyps

Conditions
-----------------
Colorectal Polyps

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged from 18 to 75 years, with polyps found during surveillance or screening colonoscopies. Exclusion Criteria: Contraindications to CV (such as allergy); Pregnancy or breastfeeding; Serous cardiopulmonary diseases, severe coagulopathy dysfunction, impaired kidney function; Inability to provide informed consent.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pCLE with topical CV interpretation criteria for the characterization of colorectal polyps with histopathological correlation |  | 5 months | 
| Number of diagnostic agreement between pCLE with topical CV and histopathological results |  | 5 months | 
| Number of participants with procedure-related adverse events |  | 5 months | 
| Number of pCLE imaging failure with topical CV |  | 5 months |
Vitamin D Deficiency in Subjects With Chronic Hepatitis C Compared to Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to assess the prevalence of vitamin D deficiency in patients with chronic Hepatitis C compared to a matched control group of healthy individuals in the Sioux Falls area. It is the hypothesis of this study that vitamin D deficiency is more common in patients with chronic Hepatitis C compared to the healthy control group.

Detailed Description
-----------------
In this study, we will measure vitamin D levels in patients with chronic Hepatitis C and healthy individuals. This study will be important to assess vitamin D inadequacy in patients with chronic Hepatitis C and healthy individuals in this area.

Official Title
-----------------
A Pilot Study on Vitamin D Deficiency in Subjects With Chronic Hepatitis C Compared to Healthy Volunteers

Conditions
-----------------
Chronic Hepatitis C

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for Study Group: Men and women between the ages of 25 and 55 Diagnosis of chronic hepatitis C Exclusion Criteria for Study Group: Taking a vitamin D supplement (by itself or as part of a multivitamin), a calcium supplement and/or biphosphonates Has acute hepatitis C infection Has chronic hepatitis B infection Had gastric bypass surgery Has chronic kidney disease Inclusion Criteria for Control Group: Men and women between the ages of 20 and 60 Has a body mass index (BMI) between 20 and 35 Exclusion Criteria for Study Group: Taking a vitamin D supplement (by itself or as part of a multivitamin), a calcium supplement and/or biphosphonates Has any significant illness or medical problem that is not under control or being controlled by medication History of hepatitis or abnormal liver chemistry tests History of intravenous drug use

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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 |
| --- | --- |
| Study Group<br>Individuals with chronic Hepatitis C | |
| Control Group<br>Healthy individuals | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Vitamin D levels of the 100 subjects will be statistically analyzed as the primary variable and correlated with the rest of the variables via ANOVA and meta-analysis | This research study consists of a single clinic visit. After study subjects have completed the informed consent process and are determined to meet study eligibility, a blood sample will be collected. Values from these lab samples will be compared between study arms. | Initial clinic visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis C, Chronic Hepatitis C, Vitamin D, Vitamin D deficiency
Phase II Trial of Pentostatin in Steroid Refractory Acute Graft Versus Host Disease

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the response rate to treatment with pentostatin in steroid-refractory acute graft versus host disease.

Official Title
-----------------
Phase II Trial of Pentostatin in Steroid Refractory Acute Graft Versus Host Disease

Conditions
-----------------
Graft-Versus-Host Disease

Intervention / Treatment
-----------------
* Drug: Pentostatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have biopsy proven grade II-IV acute GVHD refractory to systemic corticosteroids No chronic GVHD Age ≥ 18 years Evidence of myeloid engraftment (ANC ≥ 0.5 x 109/l) Performance status 0-3 Exclusion Criteria: Patients on mechanical ventilation or who have resting O2 saturation <90% by pulse-oximetry. Patients on renal dialysis or who have an estimated creatinine clearance of < 30 ml/min/1.73 m2. Patients with documented clinical infection (progressive symptoms despite antibiotics or continued fever) cannot be enrolled on study until infection is controlled.

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: Pentostatin<br>Pentostatin is given at a dose of 1.5 mg/m2/day IV x 3 consecutive days. Each IV infusion of pentostatin will be administered over 20-30 minutes in 100-250 ml of D5W or NS. | Drug: Pentostatin<br>* Pentostatin is given at a dose of 1.5 mg/m2/day IV x 3 consecutive days. Each IV infusion of pentostatin will be administered over 20-30 minutes in 100-250 ml of D5W or NS. To prevent nephrotoxicity, patients will also receive 500 ml normal saline as pre- and post drug hydration (total 1000 ml).<br>* Other names: (Nipent®, Supergen);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the response rate (complete and partial) to treatment with pentostatin in steroid-refractory acute GVHD (graft-versus-host disease). |  | up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigate the pharmacokinetics of pentostatin in patients with acute GVHD to correlate the response with area under the curve (AUC). |  | up to 2 years | 

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