linjc16/ctgov huggingface dataset:
Evaluation of the Positive Prevention PLUS Program

Study Overview
=================
Brief Summary
-----------------
This study aims to determine if the Positive Prevention PLUS teen pregnancy prevention program has an impact on abstinence, birth control use, and likelihood of becoming pregnant.

Detailed Description
-----------------
A clustered randomized controlled trial (CRCT) was employed where participating high school sites were randomly assigned either to a treatment group that implemented the Positive Prevention PLUS program or a control group. Students completed a self-administered survey at baseline (prior to program implementation) and a 6 month follow-up survey (post program implementation). Eligible students in the sample included all male and female 9th-grade students from 21 high schools enrolled in mandatory 9th-grade health, science, or physical education classes, to which the district assigns students randomly. Of the 7,042 eligible students, 4,267 received parental consent and were enrolled in the study. Outcome variables include initiation of sexual activity, ever been pregnant, and birth control use.

Official Title
-----------------
Evaluation of the Positive Prevention PLUS Program Teen Pregnancy Prevention Program

Conditions
-----------------
Pregnancy in Adolescence

Intervention / Treatment
-----------------
* Behavioral: Positive Prevention PLUS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have parental consent and be in the eligible school sites. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 19 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Received the 11 lesson Positive Prevention Curriculum | Behavioral: Positive Prevention PLUS<br>* PP+ has elven 45 minute lessons: (1) Getting Started, (2) Life Planning, (3) Healthy Relationships, (4) Relationship Violence, (5) Family Planning and Contraceptives, (6) Myths and Stereotypes, (7) HIV Disease and AIDS, (8) Recognizing and Reducing Risk, (9) Peer and Media Pressures, (10) Human Immunodeficiency Virus (HIV)/Sexually Transmitted Disease (STD) Testing and Community Resources, and (11) Steps to Success.<br>|
| No Intervention: Control<br>Did not receive any sex-related instruction | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ever had sex (Yes/No) | Ever had sex (Yes/No) | 6 months | 
| Ever been pregnant (Yes/No) | Ever Been Pregnant (or gotten someone pregnant) (Yes/No) | 6 months | 
| Sex without using birth control in prior 3 months (Yes/No) | Ever had sex without using birth control in prior 3 months (Yes/No) | 6 months |
Cholesterol Metabolism in Plasma and Interstitial Fluid Among Subjects Undergoing Hemodialysis.

Study Overview
=================
Brief Summary
-----------------
Because the atherosclerosis process partly occur in the intercellular space of the vessel wall, the determination of the constitution of lipoproteins in the interstitial fluid may expand the knowledge about the atherosclerosis process and lead to a better understanding of what constitutes the increased risk of developing cardiovascular disease in patients with chronic diseases. The investigators hypothesize that the apoB-containing particles in T2D patients are more susceptible to be retained or consumed in the intercellular compartment, which in turn could be one explanation for the elevated risk of atherosclerosis. The investigators hypothesise that with the progression of chronic kidney disease this process is further increased. Patients undergoing dialysis are known to have a very high risk of cardiovascular disease. The investigators now want to study the cholesterol metabolism in interstitial fluid in subjects undergoing hemodialysis because of diabetic nephropathy and in subjects undergoing hemodialysis because of chronic kidney disease of other causes.

Official Title
-----------------
Cholesterol Metabolism in Plasma and Interstitial Fluid Among Subjects Undergoing Hemodialysis.

Conditions
-----------------
Diabetes Mellitus, Type 2, Diabetic Nephropathies, Chronic Kidney Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetic nephropathy, because of type 2 diabetes, undergoing hemodialysis and subjects with chronic kidney disease of other causes undergoing hemodialysis. Exclusion Criteria: Active infection that increases the risk of secondary infection in the skin where the vesicles containing interstitial fluid have been emptied of interstitial fluid with a fine needle and the bladder roof is intact. Treatment with Warfarin due to increased risk of Calciphylaxis (calcific uremic arteriolopathy, CUA)

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diabetic nephropathy, on hemodialysis<br> | |
| Chronic kidney disease, on hemodialysis<br>Chronic kidney disease of other causes than Diabetes. | |
| Chronic kidney disease, predialysis<br>Renal outpatients at Nephrology Unit, Karolinska University Hospital Huddinge | |
| Diabetic nephropathy, predialysis<br>Renal outpatients at Nephrology Unit, Karolinska University Hospital Huddinge | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interstitial fluid-to-serum ratio for LDL cholesterol |  | 2 hours |
Reciprocal Influence of Sex Steroid Environment and Adipocyte Function in Men

Study Overview
=================
Brief Summary
-----------------
Aromatase inhibition versus estradiol during 1 week

Official Title
-----------------
Reciprocal Influence of Sex Steroid Environment and Adipocyte Function in Men.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Aromatase inhibition
* Drug: Estradiol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent obtained. Male subjects Age 18 - 40 weight < 120 kg Exclusion Criteria: Primary hypogonadism or secondary hypogonadism due to genetic causes (Kallman syndrome etc.), tumors, infiltrative diseases, infections, pituitary apoplexy, trauma, critical illness, chronic systemic illness or intentional. Treatment with insulin, corticoids, opiates (on a daily basis), androgen- or estrogen analogs or CYP2A6 substrates (Dexmedetomidine, Ifosfamide, Methoxsalen, Miconazole, Tranylcypromine). Impaired renal function defined as serum-creatine > 1.5 mg/dL Impaired liver function, defined as ALAT > 2.5 times upper limit of normal Clinically significant active cardiovascular disease including history of myocardial infarction within the past 6 months and/or heart failure (NYHA class III or IV) at the discretion of the investigator Cancer or any clinically significant disease or disorder, which in the investigator's opinion could interfere with the results of the trial Palpable prostate nodule or induration, PSA > 3 ng/mL, prostatism, untreated sleep apnee syndrome, erythrocytosis (hematocrit > 50%) or hyperviscosity. Known or suspected abuse of alcohol or narcotics Mental incapacity, unwillingness, or language barrier precluding adequate understanding or cooperation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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: 1<br>Aromatase inhibition | Drug: Aromatase inhibition<br>* Letrozole<br>|
| Active Comparator: 2<br>Estradiol | Drug: Estradiol<br>* Dermestril<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of sex steroids on adipocytes |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of sex steroids on lipid metabolism |  | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physiology, males
Collections of Blood and Stool Samples in Patients With Acute Hepatitis

Study Overview
=================
Brief Summary
-----------------
Hepatitis is an inflammation of the liver. Hepatitis can be caused by an infection with a virus, but poisonous (toxic) substances can also cause it. Researchers have identified several of the viruses responsible for hepatitis, however some patients with hepatitis show no evidence of being infected with known hepatitis viruses. Researchers call conditions like this, seronegative hepatitis. It means that a patient has hepatitis but he/she does not have evidence in their blood of a viral infection. Seronegative hepatitis is often complicated by autoimmune disorders and associated severe disorders especially, fulminant hepatitis of childhood and post-hepatitis aplastic anemia. Researchers have attempted to identify the cause of these conditions but have been unsuccessful. Therefore, this study was developed to collect blood and stool samples from patients with seronegative hepatitis in order to help identify the virus responsible.

Detailed Description
-----------------
While several viruses have been identified as agents of liver inflammation, some proportion of cases of acute hepatitis are seronegative and show no evidence of prior infection with known hepatitis viruses A, B, C, or E. Seronegative acute hepatitis is often complicated by autoimmune phenomena or late severe consequences, especially fulminant hepatitis of childhood and post-hepatitis aplastic anemia. Efforts in the Hematology Branch to identify an infectious agent in these latter two syndromes have been unsuccessful, probably because they are immune-mediated and also accompanied by massive tissue destruction. We now propose systematic collection of blood and fecal samples from patients with seronegative acute hepatitis for purposes of virus identification research. Samples will be collected from patients in United States Army clinics; patient identifiers will be employed.

Official Title
-----------------
Collection of Blood and Stool Samples in Patients With Acute Hepatitis

Conditions
-----------------
Hepatitis

Participation Criteria
=================
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Serum, Liver Disease, Novel Agents, Viruses, non-A,G Hepatitis, Seronegative Acute Hepatitis
Is a Low Thyreotropin Level Predictive of Recurrent Arrhythmia After Catheter Ablative Surgery?

Study Overview
=================
Brief Summary
-----------------
Overt hyperthyroidism (so-called goiter in lay language) is a hormonal disturbance that is known to increase the risk of atrial fibrillation (a common heart arrhythmia with potentially severe consequences) in some patients. Previous research has indicated that even slight elevations in thyroid hormone levels - so called subclinical hyperthyroidism - may increase this risk. When atrial fibrillation and overt hyperthyroidism are found simultaneously in a patient, the hormonal imbalance must be treated first in order to later resolve the arrhythmia. It is unclear whether this strategy holds true for subclinical hyperthyroidism. Our two hypotheses are: 1) Subclinical hyperthyroidism is more prevalent in patients admitted for atrial fibrillation ablation than in the population as a whole, and 2) Patients with subclinical hyperthyroidism and atrial fibrillation benefit less from ablation than others. As a control group, we have chosen patients admitted for ablation of AV-nodal Reentry Tachycardia at the same clinics as the cases. No correlation has ever been shown between AV-nodal Reentry Tachycardia and hyperthyroidism.

Official Title
-----------------
Observational Prospective Case-control Study on Prevalence and Impact of Subclinical Hyperthyroidism in Patients Undergoing Atrial Fibrillation Ablation

Conditions
-----------------
Atrial Fibrillation, Subclinical Hyperthyroidism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Atrial fibrillation or AV-nodal reentry tachycardia Fulfills criteria for ablation (severe arrhythmia symptoms; for atrial fibrillation patients, having tried at least one antiarrhythmic agent with poor effect) Admitted for ablation for the first time Has left blood samples for thyroid status (TSH, free T4, free T3) Exclusion Criteria: Atrial flutter Overt hyperthyroidism

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 |
| --- | --- |
| Atrial fibrillation<br>Patients with atrial fibrillation undergoing ablation | |
| AV-nodal reentry tachycardia<br>Patients with AV-Nodal Reentry Tachycardia undergoing ablation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of subclinical hyperthyroidism in patients undergoing atrial fibrillation ablation |  | 1 day (Measured upon inclusion) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent atrial fibrillation after ablation |  | 6 months |
A Study to Assess the Safety, Tolerability and Clinical Activity of TD-1211 in Patients With Opioid-Induced Constipation

Study Overview
=================
Brief Summary
-----------------
A dose-escalation study to assess the safety, tolerability and clinical activity of TD-1211 in patients with opioid-induced constipation.

Official Title
-----------------
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, and Clinical Activity of TD-1211 in Subjects With Opioid-Induced Constipation

Conditions
-----------------
Opioid-induced Constipation (OIC)

Intervention / Treatment
-----------------
* Drug: TD-1211
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females between 18 and 65 years of age, inclusive Subjects with documented OIC on stable opioid regimen Willingness to stop all laxatives throughout run-in and treatment period Exclusion Criteria: Any clinically significant findings in subjects with OIC Have participated in another clinical trial of an investigational drug 30 days prior to screening History of chronic constipation prior to opioid therapy in OIC subjects Active medical disorders associated with diarrhea or intermittent loose stools in OIC subjects

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>Escalating Doses of TD-1211 | Drug: TD-1211<br>* Escalating doses<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and Severity of Treatment Emergent Adverse Events in Subjects with Opioid-Induced Constipation Treated with TD-1211 |  | Daily doses, safety assessments and activity of TD-1211 as compared to placebo for up to six weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of clinical activity measured as frequency of bowel-movements at different dose levels |  | Continuous assessments for up to six weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
constipation, opioid induced
Autoimmune Diabetes: Markers of the Disease and Treatment of Latent Autoimmune Diabetes in Adults (LADA)

Study Overview
=================
Brief Summary
-----------------
Autoimmunity is the main cause of diabetes type 1 and an important factor as cause of Latent Autoimmune Diabetes in Adults (LADA). Recently, research has found that being deficient of T-reg cells is an important cause of autoimmunity. The study hypothesis are: Patients with newly found diabetes type 1 have less T-reg than healthy. Patients with newly found diabetes type 1 have less T-reg than patients with long duration of the illness. The number of T-reg is negative associated with HLA-risk-haplotype. The number of T-reg is negative associated with LADA. Differences relating to inflammatory cytokines will be seen among patients with newly found diabetes type 1, but not among others.

Detailed Description
-----------------
Research has worked out that b-cells are being destroyed by cytokines released from inflammatory cells. One hypothesis in that T-reg is a cause of autoimmunity, and that T-reg concentrations are low in patients with newly diagnosed diabetes type 1. Blood samples will be taken from 10 patients with newly diagnosed type 1 diabetes, Latent Autoimmune Diabetes in Adults (LADA) and type 1 diabetes older than 10 years and the same amount of samples from healthy, age- and sex-matched blood donors. Markers of autoimmune diabetes will be analyzed.

Official Title
-----------------
Autoimmune Diabetes: Disease Markers and Treatment of Latent Autoimmune Diabetes in Adults (LADA)

Conditions
-----------------
Autoimmune Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: newly diagnosed diabetes type 1 LADA diabetes type 1 older than 10 years Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 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 |
| --- | --- |
| Diabetes type 1 older than 10 years<br>Blood samples will be taken from 10 patients with diabetes type 1 older than 10 years and 10 healthy age-and sexmatched controls. | |
| Newly diagnosed type 1 diabetes<br>Blood samples will be taken from 10 patients with newly diagnosed type 1 diabetes and 10 healthy age-and sexmatched controls. | |
| LADA<br>Blood samples will be taken from 10 patients with LADA and 10 healthy age-and sexmatched controls. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T-reg | ?????? |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HLA, anti-GAD, anti-IA2, white blood count, CRP, fasting C-peptide, HbA1c | ????? |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autoimmune diabetes, LADA, T-reg, cytokine
An Observational Study to Assess the Prevalence of Heart Failure in Type 2 Diabetes Patients

Study Overview
=================
Brief Summary
-----------------
An Observational Study to assess the Prevalence of Heart Failure in Type 2 Diabetes Patients in India.

Detailed Description
-----------------
This is a cross sectional, observational, multi-centre study to be conducted at 40 centres in India. The study targets to enrol 1000 patients with approx. 25 patients per site. The study would enrol Type 2 Diabetes Mellitus patients who provide written informed consent. No study medication will be prescribed or administered as a part of study procedure. Patients, who have been treated as per Investigators' routine clinical practice will be screened for enrolment in study. The study will be initiated after obtaining written approval of Independent Ethics Committee (IEC) /Institutional Review Board (IRB).

Official Title
-----------------
An Observational, Cross Sectional Study to Assess the Prevalence of Heart Failure in Type 2 Diabetes Patients in India

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both men and women aged ≥ 18 years Diagnosed with type 2 diabetes (as per ADA Criteria) Duration of diabetes for 1 year or more Willing to provide the informed consent Exclusion Criteria: Patients with evidence of coronary artery disease - CAD (based on the clinical expertise of the physician). Patients who were previously diagnosed with heart failure. Patients with evidence of valvular disease based on clinical judgement of the Principle Investigator (PI). Current treatment with digoxin. History of symptoms of peripheral artery disease, chronic obstructive pulmonary disease and arrhythmias. Patients diagnosed with stage III/IV CKD Diabetes other than type 2 diabetes mellitus.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational Study Investigational Product NA<br>Patients : Type 2 Diabetic Patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Left Ventricular dysfunction | based on the BNP levels and echocardiography results. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of Left ventricular dysfunction and heart failure | With demographics and comorbidities of the patients to assess relation between them. | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 Diabetes, Heart Failure