linjc16/ctgov huggingface dataset:
Vitamin D and Screening Colonoscopy or Polyp Surveillance

Study Overview
=================
Brief Summary
-----------------
The investigators will recruit DoD beneficiaries 18 years or older, that have been referred for a screening colonoscopy or polyp surveillance (or had one in the last 2 weeks), and have no previous diagnosis of colorectal cancer. They will have a 25 OH Vitamin D level drawn to determine if there is an association between the level obtained and findings on colonoscopy, or previous findings (if repeating).

Detailed Description
-----------------
DoD beneficiaries age 18 or older will be recruited from the clinics at the Mike O'Callaghan Federal Medical Center (MOFMC). Subjects meeting the inclusion/exclusion criteria will be offered an opportunity to participate: Screening Visit: Obtain signed Informed Consent Document and HIPAA Authorization (research-driven). Record: Date of birth, age, gender, race, ethnicity, current email address, height (in inches), weight (in pounds), waist circumference (in inches) measurement, blood pressure, and whether subject is taking or has taken any vitamin D supplement or derivative, and if so, note the dosage, frequency, and duration of therapy. Subjects will be told to fast for at least 10 hours prior to Visit 1 Visit 1 (within two weeks of their screening colonoscopy): -Subjects will have the following research-driven blood test drawn which include: Serum 25-OH vitamin D via 1 venipuncture (5-10 mls, approximately 1-2 teaspoons of blood will be drawn)

Official Title
-----------------
Association of 25-OH Vitamin D Status With Findings on Screening Colonoscopy.

Conditions
-----------------
Colon Cancer

Intervention / Treatment
-----------------
* Other: Screening Colonoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY. Inclusion: DoD beneficiaries 18 years or older Referred for a screening colonoscopy or polyp surveillance or had one in the last 2 weeks Exclusion: Previous diagnosis of colorectal cancer, adenomatous polyps, and/or cancer Military trainees Pregnant women

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 |
| --- | --- |
| Screening Colonoscopy<br>Referred for a screening colonoscopy or polyp surveillance or had one in the last 2 weeks | Other: Screening Colonoscopy<br>* we will obtain serum vitamin D blood levels from those scheduled for a screening colonoscopy or polyp surveillance<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Vitamin D | Vitamin D blood levels will be obtained at the time of procedure. | 2 weeks |
A Trial Of Gemcitabine Plus Paclitaxel And Gemcitabine Plus Docetaxel In Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The combination of docetaxel and gemcitabine has shown significant activity in patients with metastatic breast cancer. Several studies have activity in patients of multiple lines of therapy, including patients that have been treated with prior taxane therapy. Overall responses have ranged from 30% to 79%. The major side effects of the combination chemotherapy have been neutropenia, anemia, asthenia, neuropathy, nausea, mucositis, and neutropenic fever

Official Title
-----------------
A Phase II Randomized Trial Of Gemcitabine Plus Paclitaxel And Gemcitabine Plus Docetaxel In Patients With Metastatic Breast Cancer

Conditions
-----------------
Breast Neoplasms

Intervention / Treatment
-----------------
* Drug: Gemcitabine
* Drug: Paclitaxel
* Drug: Docetaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced or metastatic breast cancer Disease that can be measured by the physician or radiologic test. May have had one chemotherapy treatment for advanced or metastatic disease. Patients may have received any prior adjuvant chemotherapy, including taxane containing regimens, provided this treatment was completed at least 6 months prior to enrollment. Patients may have received prior hormone therapy or immunotherapy. Exclusion Criteria: Patients with only non-measurable disease Cancer that has spread to the brain A patient who received a taxane with metastatic disease. Pregnancy Patients who received prior gemcitabine

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gemcitabine|nan|
|Drug: Paclitaxel|nan|
|Drug: Docetaxel|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate the response rate of two regimens separately. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate the following activities of two regimens separately:Progression-free survival;Time to progressive disease;duration of response;Overall survival, changes in performance status |  |  | 
| Nature of toxicities experienced on each arm of the study |  |  |
Pulmonary Arterial Hypertension in Systemic Sclerosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the role of stress echocardiography, compared to standard echocardiography in the early identification of pulmonary arterial hypertension in systemic sclerosis. To evaluate the role of BNP in this setting.To analyze data recorded with respect to the parameters commonly used for SSc evaluation (eg thorax HRCT, pulmonary function tests + DLCO, nailfold capillaroscopy, etc); these parameters are available starting for 1999.

Official Title
-----------------
Stress Echocardiography in the Early Identification of Pulmonary Arterial Hypertension in Systemic Sclerosis

Conditions
-----------------
Systemic Sclerosis, Pulmonary Arterial Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with systemic sclerosis according to LeRoy criteria Exclusion Criteria: Pregnancy Significant valvular disease Low left ventricular function upon echocardiography (ejection fraction<55%) History of atrial fibrillation, myocardial infarction, pulmonary thromboembolisms, neoplasia or severe hepatic disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
Stem Cells Therapy in Advanced Heart Failure

Study Overview
=================
Brief Summary
-----------------
stem cells therapy may be a choice therapy for advanced heart failure patients refractory to medical therapy, internal cardiovertor with a defibrillator (ICD) recipients, and a previous history of myocardial infarction and coronary artery revascularization. These patients, without indication to receive a cardiac resynchronization therapy (CRT), may have a worsening of heart failure, and symptoms of coronary artery disease. In this study we have evaluated in consecutive 30 selected patients the amelioration in failing heart NYHA class, hospitalization rate, echocardiographic left ventricle functionality, and associated to reduction of angina after a treatment with stem cells intra thoracic infusion.

Official Title
-----------------
Intra Cardiac Autologous Stem Cells Infusion May Improve Clinical Outcomes in Failing Heart Subjects Refractory to Maximal Drug Therapy and Internal Cardioverter With a Defibrillator (ICD) Recipients

Conditions
-----------------
Congestive Heart Failure

Intervention / Treatment
-----------------
* Drug: stem cells infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: heart failure post coronary artery disease, refractory to maximal medical therapy, previous coronary artery surgical revascularization. Exclusion Criteria: inflammatory chronic diseases, neoplastic diseases.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stem cells infusion<br> | Drug: stem cells infusion<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NYHA class improvement |  | 12 months | 
| reduction in hospitalization rate |  | 12 months | 
| reduction in angor symptoms |  | 12 months |
Role of Maternal Physical Exercise on Spontaneous Labor Onset

Study Overview
=================
Brief Summary
-----------------
Evaluate the effects of the practice of maternal physical exercise on the term of pregnancy as a method to enhance spontaneous labor.

Detailed Description
-----------------
At 38 weeks low-risk pregnant women, with singleton cephalic fetus and without previous cesarean delivery, were randomized into 2 groups: a control group without maternal physical exercise practice and a study group with 30 minutes of walking, 3 times a week at 4 Km/h. Induction of labor was performed at 41 weeks

Official Title
-----------------
The Role of Maternal Physical Exercise on Spontaneous Labor Onset - A Randomized Clinical Trial

Conditions
-----------------
Pregnancy, Labour Onset and Length Abnormalities

Intervention / Treatment
-----------------
* Behavioral: Study group: Maternal Physical Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 38 weeks low-risk pregnant women singleton cephalic fetus without previous cesarean delivery Exclusion Criteria: pathological pregnancy twin pregnancy previous cesarean section

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Without maternal physical exercise practice | |
| Active Comparator: Study Group<br>Behavioral: 30 minutes of walking, 3 times a week at 4 Km/h. Induction of labor was performed at 41 weeks. | Behavioral: Study group: Maternal Physical Exercise<br>* Exercise: 30 minutes of walking, 3 times a week at 4 Km/h.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of labor induction | Rate of labor induction will be analysed | 41 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational age on spontaneous labor onset | Gestational age will be analysed on spontaneous labor onset | 5 week | 
| Active stage duration |  | 1 day | 
| Cesarean section rate |  | 1 day |
Shared Decision Making With Pharmaceutical Care

Study Overview
=================
Brief Summary
-----------------
A research study to enhance clinical discussion between patients and pharmacists using a shared decision making tool for type 2 diabetes or usual care.

Official Title
-----------------
Examining the Use of a Shared Decision Making Tool With Pharmaceutical Care in Type 2 Diabetes

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Other: Diabetes Issue Cards Decision Aids
* Other: Usual Pharmaceutical Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults ≥ 18 years of age Diagnosed with type II diabetes by ICD-9 code for more than one year HbA1c of 7%-9.5% within past 6 months Prescribed three or less anti-hyperglycemic medications as indicated by the medication list within the medical record Exclusion Criteria: Prescribed insulin Pregnancy Appointment with provider within a month Appointment with provider within the last month Followed by endocrinology

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmaceutical care with shared decision making<br>Use of Diabetes Issue Cards Decision Aids | Other: Diabetes Issue Cards Decision Aids<br> <br> |
| Active Comparator: Usual Pharmaceutical care<br>Usual Care | Other: Usual Pharmaceutical Care<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Involvement Questionnaire |  | Post-Visit up to 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Knowledge regarding Diabetes treatments Questionnaire |  | post visit up to 2 weeks | 
| Patient Medication Adherence Questionnaire |  | 1 month post visit |
MiRNAs Evaluating Lymphocyte Proliferation and Apoptosis as Well as Prognosis of Sepsis

Study Overview
=================
Brief Summary
-----------------
Sepsis is a systemic inflammatory reaction caused by infection, trauma, etc. In the process of sepsis, the apoptosis of lymphocyte serves as a vital factor of immune dysfunction. Micro-RNAs (miRNAs) are endogenous small non-coding RNA molecules. Our previous studies have showed the diagnostic and prognostic value of a series circulant miRNAs in human serum in sepsis. The present research further study the regulatory mechanism of those miRNAs in lymphocyte in sepsis. Our research is based on the clinical value of miR-223, miR-15a, miR-16. The investigators discuss the potential role of miR-223, miR-15a, miR-16 in regulating the proliferation and apoptosis of lymphocyte in sepsis and aim to find new targets for sepsis treatment.

Detailed Description
-----------------
Blood samples were collected from the Chinese People's Liberation Army General Hospital. The investigators collected samples in emergency intensive care unit (EICU), surgical intensive care unit (SICU) and respiratory intensive care unit (RICU) between July 2014 to March 2015. Septic patients were divided into sepsis, severe sepsis and septic shock according to the diagnostic criteria. Peripheral white blood cells were sorted into monocytes, lymphocytes and neutrophils by using flow cytometry (Flow Cytometry, FCM). Jurkat T cell lines were purchased from Chinese Academy of Medical Sciences Institute of basic medical sciences. miRNAs agomirs and antagonists were used to establish miR-223, miR-15a, miR-16 overexpression and knock-out transient transfection cell lines. Western blot was used to detect difference expression of protein expression.

Conditions
-----------------
T Lymphocyte Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Sepsis Agree with this study Exclusion Criteria: Age <18 years Died within 24 hours Combined with HIV infection Agranulocytosis

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 |
| --- | --- |
| sepsis, severe sepsis and septic shock<br>Septic patients were divided into sepsis, severe sepsis and septic shock | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality |  | 28 days after admitted to ICU | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sepsis, microRNAs
Prevalence Survey of Plasmodium Falciparum Antimalarial Drug Resistance Markers

Study Overview
=================
Brief Summary
-----------------
This study is to measure prevalence of established and candidate molecular markers of drug resistant malaria at Komé, Doba, Republic of Chad.

Detailed Description
-----------------
This is a cross-sectional, observational study using dried blood samples collected from P. falciparum-infected individuals at the time of malaria diagnosis to measure the prevalence of known and candidate molecular markers of resistance to artemisinin and non-artemisinin ACT partner drugs. A maximum of 200 participants will be enrolled at each participating site per year. Study duration is 2 years. Therefore total participant is up to 400. Prospective participants will have blood collected for dried blood spot (DBS) study sample after providing informed consent. Individuals with confirmed P. falciparum infection will have DBS samples included for molecular analyses for known and candidate molecular markers of antimalarial drug resistance.

Official Title
-----------------
Prevalence Survey of Plasmodium Falciparum Antimalarial Drug Resistance Markers in Komé, Doba, Republic of Chad

Conditions
-----------------
Plasmodium Falciparum

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants must meet all of the inclusion criteria to participate in the study. Patients (6 months - 75 years) with confirmed uncomplicated P. falciparum infection Written informed consent obtained Exclusion Criteria: Patients presenting signs of severe malaria will be excluded from the survey to prevent any delay in the management of the patient.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent prevalence of kelch13 mutants (marker of resistance to artemisinins) |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent prevalence of specimens with pfmdr1 copy number >1 (marker of resistance to mefloquine) |  | 2 years | 
| Visualization and dissemination of molecular marker prevalence data to inform public health officials, researchers, policymakers and key stakeholders |  | 2 yeas | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antimalarial drug, Resistance, Republic of Chard
Yoga@Work for Reducing Musculoskeletal Pain in Neck and Shoulder

Study Overview
=================
Brief Summary
-----------------
Work-related musculoskeletal disorders (MSDs) are disorders of muscles, tendons, joints and nerves which can affect all body parts, although the neck, upper limb and back are the most common areas. The peer-reviewed literature about workplace prevention describes a variety of interventions that have been implemented and evaluated.but only few studies show sustainable positive effects on symptom outcomes. Yoga@Work program was developed to self manage pain around neck and shoulder areas among office workers.

Official Title
-----------------
Effectiveness of Yoga@Work Program for Reducing Musculoskeletal Pain in Neck and Shoulder: Evaluation Study

Conditions
-----------------
Neck Pain, Shoulder Pain, Musculoskeletal Pain

Intervention / Treatment
-----------------
* Other: Yoga


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Office workers Willing to participate and give consent non specific neck and shoulder pain Exclusion Criteria: neck injury Trauma Cancer related pain psychiatric disorder/ medication Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum 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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga@Work<br>Yoga sessions specifically designed for office workers were provided in work settings. participants were given handouts and encouraged to practice in their own time and space during work days. | Other: Yoga<br>* Yoga sessions includes sukshma vyayama (strengthening yoga expertise), stretching and relaxing postures (asana) on chair or standing, breathing and meditation practices.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neck and Shoulder pain | self reported neck and shoulder pain using visual analogue scale on 0 to 10 scale, where 0 is no pain and 10 is worst pain. | From baseline to 4-week post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Outcome | Patient Global Received Rating of Improvement or Satisfaction | from baseline to 5 week post intervention |