linjc16/ctgov huggingface dataset:
The T1D Exchange Registry

Study Overview
=================
Brief Summary
-----------------
The T1D Exchange Registry is a research study, conducted over time, for individuals with type 1 diabetes and their supporters. Participants volunteer to provide their data for research (for example, by answering questions in annual surveys). Once enrolled, Registry participants have the opportunity to sign up for other studies on various topics related to type 1 diabetes. To participate, you will be asked to: Read and sign an online informed consent form Take a survey describing specific demographic and type 1 diabetes management information Update your information annually Periodically opt in for additional research opportunities (if you choose), i.e. taking new surveys or uploading health device data

Official Title
-----------------
The T1D Exchange Registry

Conditions
-----------------
Diabetes Mellitus, Type 1, Diabetes, Type 1 Diabetes, Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of type 1 diabetes. Individuals younger than 18 years of age must have parent/guardian consent. Must be able to read and understand English. Currently living in the United States Exclusion criteria: Does not use insulin and has not had a pancreatic or islet cell transplant. Cannot fully read and understand English. Does not currently live in the United States.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Individuals diagnosed with type 1 diabetes<br>T1D Exchange Registry is currently looking for participants: Of all ages, genders, races, and ethnic groups Living in the United States Diagnosed with type 1 diabetes Currently taking insulin or have had a pancreatic or islet cell transplant | Other: No intervention<br>* Observational research study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gather longitudinal data from individuals living with type 1 diabetes. | Gather longitudinal data on disease, health status, and patient-reported outcomes of individuals living with type 1 diabetes. This will be achieved by presenting participants with annual questionnaires, tracking any changes in their responses over time. | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
insulin, t1d, dm, diabetes, type 1, glucagon
Racial Differences in the Coronary Microcirculation

Study Overview
=================
Brief Summary
-----------------
To study mechanisms of excess coronary ischemia secondary to alterations in autoregulation and arteriolar vasoreactivity in Black Americans with hypertension, varying degree of left ventricular hypertrophy, and angiographically normal or mildly diseased coronary arteries.

Detailed Description
-----------------
BACKGROUND: Although studies in 1992 with a sufficient number of minority patients were sparse, those available suggested that Black Americans had a higher case fatality from coronary heart disease, but lesser amounts of atherosclerotic coronary artery disease. A possible explanation for this apparent paradox was that myocardial ischemia might be more prevalent with less coronary artery atherosclerosis in Black Americans because of comorbid diseases or differences in coronary physiology. This could be secondary to excess hypertension and left ventricular hypertrophy in Black Americans but might also have been related to intrinsic or acquired differences in coronary artery autoregulation and vasoreactivity leading to depression in coronary blood flow and reserve. DESIGN NARRATIVE: The intracoronary Doppler flow velocity guidewire together with quantitative coronary angiography was used to study changes in coronary blood flow in blacks secondary to pharmacologic provocateurs known to induce arteriolar vasodilation. White Americans with similar demographic characteristics and equivalent amount of ventricular hypertrophy and coronary disease were similarly studied in a parallel fashion for comparison. A control group of normal white and Black Americans were studied to detect unexpected intrinsic differences. Both endothelium dependent and independent induction of coronary arteriolar vasodilation were studied. In 25 percent of patients with endothelium dependent defects in arteriolar vasodilation, retesting was performed after intracoronary infusion of L-arginine, the precursor of endothelium dependent relaxing factor. Finally, the possibility of a rightward shift in coronary artery autoregulation in chronic hypertension was investigated. This finding would necessitate that the lower limit of autoregulation occurred at higher diastolic pressures, resulting in a drop-off of coronary perfusion at normal physiologic pressures and ischemia. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Coronary Disease, Hypertension, Myocardial Ischemia, Hypertrophy, Left Ventricular

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Posterior IVS Versus Sacrospinous Suspension in Vaginal Vault Prolapse Repair

Study Overview
=================
Brief Summary
-----------------
Hypothesis / aims of study The aim of this multicentre study is to evaluate anatomical and functional results of an innovative posterior tape in vaginal prolapse repair by vaginal route, in comparison to the sacrospinous suspension. Study design, materials and methods This study involves 5 centres in French Public Hospital. Patients will be randomly allocated to be operated by a sacrospinous suspension or by an posterior IVSTM (Tyco Healthcare, France). Prolapse severity will be evaluated using the POP-Q system. In order to evaluate the patient's quality of life, the validated PFDI and the PFIQ questionnaires will be used preoperatively and during follow-up, as well as a validated questionnaire on sexual problems. The difference on early post-operative pain should be 30% (40% for the sacrospinous suspension and 10% for the posterior IVS). Then the estimated number of patient is 40 in each arm.

Official Title
-----------------
Clinical Evaluation of Morbidity and Efficacy of Posterior IVS (Infracoccygeal Sacropexy), in Comparison to the Standard Sacrospinous Suspension in the Surgical Treatment of Vaginal Vault Prolapse by the Vaginal Route.

Conditions
-----------------
Vaginal Prolapse

Intervention / Treatment
-----------------
* Device: IVS
* Procedure: Sacrospinofixation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age more than 18 Vaginal vault prolapse of grade 2 or more (POP-Q system) Symptomatic prolapse Exclusion Criteria: Patient unable to read French language Cystocele without vaginal vault prolapse Vaginal vault prolapse of grade 1 Associated rectal prolapse Rectal inflammatory disease (Crohn, RCH).

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

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

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

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 |
| --- | --- |
| Experimental: Infracoccygeal sacropexy<br>Intervention: IVS | Device: IVS<br>* Infracoccygeal sacropexy<br>|
| Active Comparator: Sacrospinofixation<br>Intervention: Sacrospinofixation | Procedure: Sacrospinofixation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early post-operative pain evaluated by a visual analogic pain the next day after the operation. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Peri-operative morbidity |  |  | 
| - Patient satisfaction |  |  | 
| - Quality of life |  |  | 
| - Post-operative sexuality |  |  | 
| - Anatomical cure rate on vaginal vault support |  |  |
Preterm Delivery Risk Prediction by Measurement of Prenatal Serum Screening Markers

Study Overview
=================
Brief Summary
-----------------
This protocol seeks to longitudinally collect blood samples from a cohort of pregnant women. The biological specimens will be used to determine the predictive power of biochemical markers routinely used in Down syndrome screening in the assessment of patient's risk of preterm delivery.

Detailed Description
-----------------
The study will investigate whether the levels of individual maternal serum screening biomarkers, their combinations or temporal changes in the level can be associated with an increased risk of preterm delivery. Blood samples at three time points in pregnancy will be collected from the study participants. The first two blood draws will be timed to coincide with the first and second trimester maternal serum testing. The third blood draw will coincide with the screening for gestational diabetes. Pregnancy outcome information will be collected from the physicians and linked to the subject samples. Subject samples from a case-control patient group will be analyzed by the serum screening biochemical assay. Statistical analyses will be performed to achieve the study objectives. NOTE: This study is recruiting in Florida, USA. The laboratory data coordination is being performed in Massachusetts, USA and New Mexico, USA. New study locations will be identified on an ongoing basis.

Official Title
-----------------
Early Prediction Of Preterm Delivery By Measurement Of Maternal Serum Markers

Conditions
-----------------
Preterm Delivery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The participant understands the nature of the study and its requirements. To this end, we will require that the participants have command of the English language. The participant consents to and signs the approved consent form. The participant is 18 years of age or older. The participant has a singleton pregnancy. The participant is planning on continuing the pregnancy. The participant has intent to clinically test for Down syndrome risk. The participant consents to the study at the first trimester of her pregnancy. The participant understands the nature of the study and its requirements. To this end, we will require that the participants have command of either the English or Spanish language. Exclusion Criteria: N/A

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Preterm delivery, preterm labor, maternal-fetal care, maternal serum screening biomarkers, alphafetoprotein, AFP, human chorionic gonadotropin, hCG, unconjugated estriol, Inhibin A, pregnancy associated plasma protein, PAPP-A, maternal screening
Impact of Pulmonary Rehabilitation on Direct Healthcare Costs in Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the direct cost of illness study of COPD patients who participated in a Pulmonary rehabilitation program for 8 weeks.

Official Title
-----------------
A Retrospective Case-control Study Comparing the Direrct Healthcare Costs of Conventionally Managed COPD Patients With Those Who Have Completed a Pulmonary Rehabilitation Programme

Conditions
-----------------
COPD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, Pulmonary rehabilitation
Masimo CO-Oximeter Study

Study Overview
=================
Brief Summary
-----------------
This is a study to evaluate the accuracy of the Masimo Rainbow SET Pulse CO-Oximeter in monitoring the hemoglobin levels of patients undergoing isovolemic hemodilution.

Official Title
-----------------
Use of the Masimo Rainbow SET Pulse CO-Oximeter in Patients Undergoing Isovolemic Hemodilution

Conditions
-----------------
Cardiac Surgical Procedures

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any subject that is scheduled to have isovolemic hemodilution Exclusion Criteria: Anything that prevents a subject from having isovolemic hemodilution
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pulse CO-oximeter<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemoglobin value | The accuracy of the hemoglobin value from the Masimo pulse oximeter during isovolemic hemodilution. | 1 Day (day of surgery) |
A Study of Trimetrexate Plus Leucovorin in Children With Pneumocystis Carinii Pneumonia

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and efficacy of trimetrexate glucuronate with leucovorin protection in pediatric patients with Pneumocystis carinii pneumonia (PCP) who are refractory to or have demonstrated severe or life-threatening toxicities to standard therapies (e.g., TMP/SMX or parenteral pentamidine).

Detailed Description
-----------------
Patients receive intravenous infusions of trimetrexate glucuronate and leucovorin for 21 days. Leucovorin is continued for 3 additional days after discontinuation of trimetrexate glucuronate. Patients are followed for 1 month.

Official Title
-----------------
A Study of Neutrexin (Trimetrexate Glucuronate) With Leucovorin Protection for Pediatric Patients (Ages 2-12) With Pneumocystis Carinii Pneumonia

Conditions
-----------------
Pneumonia, Pneumocystis Carinii, HIV Infections

Intervention / Treatment
-----------------
* Drug: Trimetrexate glucuronate
* Drug: Leucovorin calcium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: Pneumocystis carinii pneumonia (PCP) confirmed within 15 days prior to study entry. Serious intolerance and/or resistance to standard therapies (such as trimethoprim/sulfamethoxazole and parenteral pentamidine) during the course of therapy for the current episode of PCP, OR a documented history of such intolerance during a prior episode. Exclusion Criteria Patients with the following prior conditions are excluded: History of Type I hypersensitivity (i.e., urticaria, angioedema, or anaphylaxis), exfoliative dermatitis, or other life-threatening reactions due to trimetrexate glucuronate.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Trimetrexate glucuronate|nan|
|Drug: Leucovorin calcium|nan|

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
-----------------
Trimetrexate, Pneumonia, Pneumocystis carinii, Leucovorin, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome
European Serrated Adenoma Classification Score

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to develop a score system in order to differentiate adenomatous polyps, hyperplastic polyps and serrated adenomas on the basis of optical features. Endoscopic images of colorectal polyps will be collected from a prospectively managed database. Histopathological diagnoses are available for all polyps. Histopathological diagnoses serve as gold standard in this study. In the first phase of the study optical features of serrated adenomas are extracted from the database. Discriminators are then defined on the basis of the extracted features. In the second phase a test set of high quality pictures are provided to both novices and experts of colorectal endoscopy. Participants are asked to use the above named discriminators in order to rate pictures and to classify polyps into three classes (adenomatous polyps, hyperplastic polyps and serrated adenomas). In the third phase of the study accuracy of optical bases diagnoses is calculated by comparing optically derived diagnoses with histopathological diagnoses (gold standard).

Official Title
-----------------
Development of an Endoscopic Classification Score System for Serrated Adenomas in the Colorectum

Conditions
-----------------
Colorectal Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: indication for colonoscopy patients >= 18 years Exclusion Criteria: pregnant women indication for colonoscopy: inflammatory bowel disease indication for colonoscopy: polyposis syndrome indication for colonoscopy: emergency colonoscopy e.g. acute bleeding contraindication for polyp resection e.g. patients on warfarin

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- | --- |
| Optical diagnosis of each colorectal polyp | The predicted polyp histology (determined according to optical polyp features) will be assessed; the predicted diagnosis will be compared with the histopathological diagnosis (gold standard) after; | Participants will be followed for the duration of the study an expected average of 6 month |
A Study to Evaluate Suppression of the Pituitary-Ovarian Axis With Three Different Oral Contraceptive Regimens

Study Overview
=================
Brief Summary
-----------------
This is a randomized, open-label study to evaluate pituitary ovarian suppression in healthy, reproductive-aged women using three different regimens of oral contraceptives (OCs). Two extended regimen OCs, Seasonale (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 84 days followed by 7 days of placebo), and Seasonique (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 84 days followed by 7 days of ethinyl estradiol 0.01 mg), and a 28-day regimen OC, Portia (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 21 days followed by 7 days of placebo).

Official Title
-----------------
A Prospective, Single-Center, Open-Label, Randomized Study to Evaluate Suppression of the Pituitary-Ovarian Axis With Three Different Regimens of Oral Contraceptive Pills

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

Intervention / Treatment
-----------------
* Drug: Seasonale [levonorgestrel (LNG)/ethinyl estradiol (EE)]
* Drug: Seasonique (LNG/EE and EE)
* Drug: Portia (LNG/EE)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Premenopausal Not pregnant or breastfeeding Weight <200 lbs Currently taking oral contraceptives in the standard 28-day regimen for at least two months Exclusion Criteria: Any contraindication to the use of oral contraceptives Pregnancy within the last 3 months Smoking > 10 cigarettes per day

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Seasonique (LNG/EE and EE)<br>* 1 tablet daily<br>|
| Active Comparator: 2<br> | Drug: Seasonale [levonorgestrel (LNG)/ethinyl estradiol (EE)]<br>* 1 tablet daily<br>|
| Active Comparator: 3<br> | Drug: Portia (LNG/EE)<br>* 1 tablet daily x 28 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare differences in hormone patterns (follicle stimulating hormone [FSH], luteinizing hormone [LH], inhibin-B, and estradiol) |  | Before, during and after the 7-day hormone free interval or EE-supplemented interval | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the differences in hormone withdrawal symptoms |  | Before, during and after the 7-day hormone free interval or EE-supplemented interval | 
| Compare differences in ovarian follicular development |  | Before, during and after the 7-day hormone free interval or EE-supplemented intervals |