linjc16/ctgov huggingface dataset:
Evaluation Rehabilitation on Glycometabolic State in Non-Diabetic Coronary Artery Disease (CAD) Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of an intensive Cardiac rehabilitation program on glucose metabolism of non-diabetic coronary artery disease patients.

Official Title
-----------------
Effect of Cardiac Rehabilitation on Glucometabolic State in Non-Diabetic Patients With Chronic Ischemic Heart Disease

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Behavioral: physical training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients admitted to undergo a cycle of in-hospital cardiac rehabilitation patients without a previous diagnosis of diabetes mellitus patients able to start physical training within three days from admission fasting blood glucose at admission < 126 mg/dl Exclusion Criteria: previous diagnosis of diabetes mellitus acute coronary events or acute heart failure in the past three months physical disabilities that contraindicate training
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| physical training<br> | Behavioral: physical training<br>* intensive cardiac rehabilitation program<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate the effective prevalence of glucose metabolism alterations in patients with chronic ischemic heart disease and stable chronic heart failure, without previous diagnosis of diabetes mellitus |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate the potential beneficial effect of physical training on the glycometabolic state |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exercise training, functional recovery, heart diseases, altered glucose metabolism early after an acute cardiac event, non diabetes CAD patients, glycometabolic state
Interleukin-1 Blockade for the Treatment of Heart Failure in Patients With Advanced Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
Interleukin-1 blockade for the treatment of heart failure in patients with advanced chronic kidney disease (End-stage renal disease and Heart fAilure - Anakinra Remodeling Trial) is a Phase 2, single-arm trial designed to estimate the effect of anakinra, a recombinant human Interleukin-1 (IL-1) receptor antagonist, on cardiorespiratory fitness in patients with advanced chronic kidney disease and heart failure.

Official Title
-----------------
Interleukin-1 Blockade for the Treatment of Heart Failure in Patients With Advanced Chronic Kidney Disease (E-HART)

Conditions
-----------------
Heart Failure, Systolic, Renal Disease, End Stage, Chronic Kidney Diseases

Intervention / Treatment
-----------------
* Drug: Anakinra


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent 18 years or older Chronic heart failure Left ventricular ejection fraction less than 50% C-reactive protein greater than or equal to 2 mg/L Maintenance hemodialysis with a biocompatible membrane, acceptable dialysis adequacy (Kt/V > 1.2), and receipt of a stable hemodialysis prescription for at least 4 weeks OR chronic kidney disease stage IV/V (estimated glomerular filtration rate <30 mL/min/1.73m2) Exclusion Criteria: Inability to complete maximal cardiopulmonary exercise testing Need for urgent or emergent care Recent use of immunosuppressant, anti-inflammatory therapies or active rheumatologic disease Allergy to rubber, latex, Escherichia coli or anakinra

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: Active Treatment<br>Anakinra (Kineret) | Drug: Anakinra<br>* Anakinra (Kineret)<br>* Other names: Kineret;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak oxygen consumption (PVO2) | Peak oxygen consumption during cardiopulmonary exercise | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Failure Hospitalization | Number of participants with a hospitalization for heart failure during the 6 months of treatment | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart failure, End-stage renal disease, Interleukin-1, Interleukin-1 receptor antagonist, Metabolomics, Lipidomics, Chronic kidney disease
A Study to Assess the Persistence of a GBS Antibody in Women Previously Immunized With a GBS Vaccine

Study Overview
=================
Brief Summary
-----------------
This study looks at the body's immune responses to a GBS vaccine 2 years after the orginal vaccine(s) were given in the V98P1 study. Blood will be drawn and evaluated for GBS antibody levels.

Official Title
-----------------
A Phase I Extension Study to Assess the Long-Term Persistence of GBS Serotype Ia Antibodies in Women Previously Immunized With a GBS Ia Crm-Glycoconjugate Vaccine

Conditions
-----------------
Group B Streptococcus (GBS) Disease

Intervention / Treatment
-----------------
* Biological: Group B streptococcus (GBS) vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals who have given written consent. Individuals who participated in V98P1 and received the complete schedule of vaccinations. Exclusion Criteria: Individuals who have not given written consent. Subjects who did not receive the complete schedule of vaccination in V98P1.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 42 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Arm 1<br>This is a phlebotomy study. | Biological: Group B streptococcus (GBS) vaccine<br>* No vaccine will be administered in this study. Only one study visit is required. Subjects will return to the clinic for a single visit at 24 months (± 3 months) after the last injection administered in the V98P1 study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody (Ab) response data at 24-months after the last injection given in study V98P1 GMCs, GMRs and associated 95% confidence intervals will also be determined |  | 24- months post last injection from V98P1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Group B streptococcus, GBS, Vaccine
Diabetes Prevention in Clinical Practice.

Study Overview
=================
Brief Summary
-----------------
We randomize individuals with impaired glucose tolerance to one of three arms for degree of physical activity: 1. Continue with your current life style; 2. Ordinary life activities for increased physical activity; 3. Scheduled group activities for changed behavior. The overall aim is to focus on change of physical activity and to keep other life style activities more or less unchanged (diet, smoking, etc) and the effect on metabolic variables.

Official Title
-----------------
Diabetes Prevention in Primary Health Care With Special Emphasis on Physical Activity.

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

Intervention / Treatment
-----------------
* Behavioral: Low intensity intervention
* Behavioral: High intensity intervention.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Impaired glucose tolerance Age: 20-85yrs Exclusion Criteria: Type2 diabetes Significant disease making life style changes unlikely to happen Unable to communicate in Swedish

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No intervention<br> | |
| Experimental: Low intensity intervention<br> | Behavioral: Low intensity intervention<br>* We administer, a pedometer and the participants receive a prescription on physical exercise.<br>|
| Experimental: High intensity intervention<br> | Behavioral: High intensity intervention.<br>* We schedule group sessions for changes in behavior e.g. type of physical activity to prefer, barriers for change of life style etc.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HOMA IR | Insulin resistance according to HOMA | 12 months after inclusion (baseline) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes, insulin resistance, exercise
Effect of Dental Waterjet on Oral Hygiene for Patients With Braces

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the efficacy of dental water jet in plaque removal and gingival health during orthodontic treatment with fixed appliances.

Detailed Description
-----------------
Subjects will be randomized into two groups. The first group will receive a dental water jet and the second group will receive dental floss. Plaque accumulation using plaque index and gingival health using gingival index will be measured at baseline and after four weeks for each group and then, results will be compared.

Official Title
-----------------
The Efficacy of Dental Water Jet in Plaque Removal During Orthodontic Treatment With Fixed Appliances: A Randomized Controlled Trial

Conditions
-----------------
Oral Hygiene

Intervention / Treatment
-----------------
* Device: Dental Water Jet
* Device: Dental Floss


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects having orthodontic fixed appliance. Subjects aged 12 years old and above who own mobile phones and no mental or physical disabilities. Subjects willing to comply with given oral hygiene instructions.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dental water jet<br>Dental water jet (Jetpik JP210) | Device: Dental Water Jet<br>* Dental Water Jet will be used by subjects to clean their teeth in the interproximal areas.<br>|
| Active Comparator: Dental floss<br>Dental floss | Device: Dental Floss<br>* Dental Floss will be used by subjects to clean their teeth in the interproximal areas.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in plaque index | Plaque index: 0, no plaque, 1, plaque seen on the tip of the explorer or with disclosing agent, 2. plaque seen with the naked eye, 3, abundance of plaque. | At baseline and after 4 weeks. | 
| Change in gingival index | Gingival index: 0, normal gingiva, 1, mild inflammation - slight change in color, slight edema and no bleeding on probing, 2, moderate inflammation - redness, edema and glazing and bleeding on probing, 3, severe inflammation - marked redness and edema, ulceration and tendency to spontaneous bleeding. | At baseline and after 4 weeks. |
Tissue Eosinophils in Non-Small Cell Lung Cancer (the TEN Study)

Study Overview
=================
Brief Summary
-----------------
The primary objective is to describe eosinophil infiltration in resected (early stage) NSCLC. Secondary objectives are: to investigate the correlation of T-Eos and B-Eos in the aforementioned patient population; to investigate the correlation between T-Eos and overall & disease-free survival; to investigate the localization of T-Eos (periphery vs. center of the tumor lesions).

Official Title
-----------------
Tissue Eosinophils in Non-Small Cell Lung Cancer (the TEN Study)

Conditions
-----------------
Non-small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Resected, early stage NSCLC between 01-01-2015 and 30-04-2022 with available tumour tissue Exclusion Criteria: Inclusion in a clinical study contraindicating enrollment in the present 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of tumor associated tissue eosinophilia by immunohistochemistry and computerised quantification |  | October 2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to investigate the correlation of tissue (T)-Eos and blood (B)-Eos in the aforementioned patient population | Tissue and blood eosinophil correlation | December 2022 | 
| to investigate the correlation between T-Eos and overall & disease-free survival | overall and disease-free survival | December 2022 | 
| to investigate the localization of T-Eos (periphery vs. center of the tumor lesions) | tissue eosinophil localisation | December 2022 |
Effect of Saccharomyces Boulardii on Necrotizing Enterocolitis in Very Low Birth Weight Infants

Study Overview
=================
Brief Summary
-----------------
Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. Necrotizing enterocolitis incidence is 10-25% in newborn infants whose birth weights are < 1500 gr. Although bifidobacterium and lactobacilli sp. have been used to reduce the incidence of NEC in clinical trials, Saccharomyces boulardii has not been used in the prevention of NEC in very low birth weight infants yet. The objective of this study is to evaluate the efficacy of orally administered S boulardii in reducing the incidence and severity of NEC in very low birth weight infants.

Detailed Description
-----------------
The primary outcome of this study is to evaluate the efficacy of orally administered S boulardii in reducing the incidence and severity of NEC in very low birth weight infants.

Official Title
-----------------
Role Of Saccharomyces Boulardii in Preventin Necrotizing Enterocolitis in Very Low Birth Weight Infants

Conditions
-----------------
Necrotizing Enterocolitis, Very Low Birth Weight Infants

Intervention / Treatment
-----------------
* Drug: Saccharomyces boulardii
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Very low birth weight infants < 1500 gr Exclusion Criteria: Genetic anomalies Not willing to participate Allergy to S. boulardii components

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 2 Months

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Saccharomyces boulardii<br>Saccharomyces boulardii 5 million unit/day for 3 months | Drug: Saccharomyces boulardii<br>* 5 million units/day for 3 months<br>* Other names: Reflor;|
| Placebo Comparator: control<br>Placebo- for 3 months | Drug: Placebo<br>* Placebo for 3 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Saccharomyces boulardii on necrotizing enterocolitis in VLBW infants |  | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Saccharomyces boulardii on culture proved sepsis |  | 6 months | 
| Effect of Saccharomyces boulardii on weight gain |  | up to 6 months | 
| Effect of Saccharomyces boulardii on length of hospital stay |  | up to 6 months | 
| Effect of Saccharomyces boulardii on mortality |  | up to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Saccharomyces boulardii, necrotizing enterocolitis
Compromised Microcirculation in Women With Polycystic Ovary Syndrome

Study Overview
=================
Brief Summary
-----------------
The scientific aims of the study are to determine how peripheral microcirculatory responsiveness is altered in obese women with Polycystic Ovary Syndrome (PCOS) during local heating and to determine the mechanism for testosterone effects on peripheral microcirculatory responsiveness in women with PCOS.

Detailed Description
-----------------
In these studies, we propose to use the skin as a relatively non-invasive model to examine cardiovascular and endothelial function in obese women with and without PCOS. Data have indicated an important role for testosterone in influencing the peripheral microcirculation. While testosterone can lead to vasodilation in the peripheral microcirculation in both men and in women without PCOS, testosterone appears to induce vasoconstriction in women with PCOS. The differential response between women with and without PCOS, and between men and women may be the result of differential ET-1 actions in the vessel, and regulated by the receptor subtype is involved in these actions.

Official Title
-----------------
Compromised Microcirculation in Women With Polycystic Ovary Syndrome

Conditions
-----------------
Polycystic Ovary Syndrome

Intervention / Treatment
-----------------
* Drug: ganirelix acetate
* Drug: methyl testosterone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obese women (18-35) years with and without PCOS Exclusion Criteria: Conditions that would preclude safe use of hormones

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>GNRH antagonist alone | Drug: ganirelix acetate<br>* GnRH antagonist, subcutaneous injection, 0.25 mg/day for 21 days<br>* Other names: Antagon;|
| Experimental: 2<br>GnRH with Testosterone | Drug: methyl testosterone<br>* testosterone, oral administration, day 5 of GnRH administration, 2.5 mg/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin blood flow and cutaneous vascular conductance |  | 6 non consecutive days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
skin blood flow, microcirculation
Multi Cervical Unit Measures of Cervical Isometric Strength and Range of Motion: A Pilot Study

Study Overview
=================
Brief Summary
-----------------
This study is designed to collect normative data on cervical isometric strength and range of motion to supplement an existing normative data base.

Conditions
-----------------
Cervicogenic Headache, Neck Pain, Whiplash, Kyphotic and Reversed Cervical Curves

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Logan students, faculty and staff Exclusion Criteria: recent surgery,or unstable or fused joints of the cervical spine using medications, prescription or herbal muscle stimulants, relaxants, etc previous cervical spine injury, surgery or condition that would affect your range of motion in the cervical spine currently have any local infection, injury or other malignancy affecting the cervical spine congenital conditions affecting the cervical spine, i.e. block vertebrae systemic illness with an adverse effect on the cervical spine a history of dizziness, light headedness or passing out, or any seizure disorder had a neck, shoulder or back injury ever been in an automobile accident exercise regularly pregnant spinal manipulation mobilization or other therapy in the last 48 hours

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Males<br> | |
| Females<br> | |

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

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