linjc16/ctgov huggingface dataset:
Optimizing Diagnosis Of Primary Aldosteronism

Study Overview
=================
Brief Summary
-----------------
To optimize the confirmatory tests for primary aldosteronism.

Detailed Description
-----------------
In this study, the investigators aim to optimize the three confirmatory tests: salt loading, captopril challenge and fludrocortisone suppression, and to confirm a better choice of confirming testing for single or combined diagnosis of primary aldosteronism. Additionally, the investigators plan to collect blood and tissue samples of PA patients for genetic testing, and to proceed a long-term follow-up for further investigating the mechanism underlying PA and evaluating the cardio-cerebrovascular complications risk.

Official Title
-----------------
Case Detection and Confirmation, Subtype Classification of Patients With Primary Aldosteronism

Conditions
-----------------
Primary Aldosteronism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: With hypertension; With adrenal diseases Exclusion Criteria: Pregnant or during lactation period; Under 18 yr; BMI ≤ 19 or ≥ 35 With Cancer medical history Been through cardiovascular diseases in the past 3 months; Been through malignant arrhythmia, respiratory muscle paralysis or skeletal muscle paralysis caused by hypokalemia.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary Aldosteronism<br>Those with hypertension, and with or without hypoglycemia; Those with PAC/PRC≥42.95 pg·mL-1/µIU·mL-1 | |
| Non-Primary Aldosteronism<br>Those with Primary Hypertension; Those with adrenal diseases except for Primary Aldosteronism | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the receiver operating characteristic curve (AUC) for Salt loading test | Salt loading test will be performed and compared to golden standard such as adrenal venous sampling (AVS) and biopsy results. The area under the curve (AUC) will be calculated. | 1 week | 
| AUC for captopril challenge test | Captopril challenge test will be performed and compared to golden standard such as AVS and biopsy results. AUC will be calculated. | 1 week | 
| AUC for fludrocortisone suppression test | Fludrocortisone suppression test will be performed and compared to golden standard such as AVS and biopsy results. AUC will be calculated. | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of cardiovascular diseases in Primary Aldosteronism | Follow-up for the risk of cardiovascular diseases, chronic kidney disease and stroke | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
primary aldosteronism, confirmatory test, hypertension
Phase I Study of AZD2171 co-Administered With Fixed Multiple Oral Doses of ZD1839 in Patients With Advanced Cancer

Study Overview
=================
Brief Summary
-----------------
Phase I AZD2171 in combination with ZD1839 study recruiting patients with advanced cancer

Official Title
-----------------
A Phase I Open-Label Study to Assess the Safety, Tolerability and PK of Ascending Multiple Oral Doses of AZD2171 When co-Administered With Fixed Multiple Oral Doses of ZD1839 (250mg or 500mg Once Daily) in Patients With Advanced Cancer

Conditions
-----------------
Advanced Tumor

Intervention / Treatment
-----------------
* Drug: AZD2171
* Drug: ZD1839


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: tumor progressed on standard therapy or ineligible for standard therapy life expectancy of 12 weeks or more WHO performance status 0-2 Exclusion Criteria: History of active interstitial lung disease

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AZD2171|nan|
|Drug: ZD1839|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| primary objective is to determine the safety and tolerability of multiple oral doses fo AZD2171 when co-administered with fixed daily oral doses of ZD1839 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to explore the PK of AZD2171 when given alone for 7 days and in combination with ZD1839 for 14 days |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phase I, AZD2171, ZD1839, solid tumor
The Effect of Pre-treatment Biopsy for Non-neoplastic Renal Disease vs no Biopsy on Estimated Glomerular Filtration Rate in Patients With Small Renal Mass: a Single-center, Single-blinded, Randomized, Parallel Group Clinical Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if biopsy for non-neoplastic renal disease for patients with a small renal mass results in greater postoperative renal function than the current standard of care (no additional biopsy).

Official Title
-----------------
The Effect of Pre-treatment Biopsy for Non-neoplastic Renal Disease vs no Biopsy on Estimated Glomerular Filtration Rate in Patients With Small Renal Mass: a Single-center, Single-blinded, Randomized, Parallel Group Clinical Trial

Conditions
-----------------
Kidney Neoplasms

Intervention / Treatment
-----------------
* Procedure: Additional biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 or greater Scheduled for renal biopsy as part of clinical care Diagnosis of small renal mass (< 4cm) based on imaging (CT, MRI, Ultrasound, or other) Patient must provide written, informed consent for study procedures before randomization Renal mass must be primarily solid (as opposed to cystic) in nature Exclusion Criteria: Patients less than 18 years of age Patients who are prisoners Women who are pregnant-self reported Patients with Bosniak 3 or 4 cystic renal masses Patients with history of renal transplantation Patients with eGFR less than 30-based on review of clinical labs Patients on dialysis Patients with bleeding disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control SOC<br>Standard of care is followed | |
| Experimental: Experimental additional biopsy<br>Additional biopsy | Procedure: Additional biopsy<br>* • Patients in the experimental group receive the additional biopsy for non-neoplastic disease during the same procedure before the biopsy of the renal mass (with potential for direct benefit to the patient by revealing non-neoplastic renal disease).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference in change in glomerular filtration rate (GFR) |  | 6 months |
National Register of Oesophageal Atresia

Study Overview
=================
Brief Summary
-----------------
The esophageal atresia is a group of birth defects including a break in continuity of the esophagus with or without persistent communication with the trachea (tracheoesophageal fistula), sometimes associated (from 50%) of other malformations (heart, kidney, digestive ...). The current prognosis for this ailment is good. However he persists a mortality (<10%) and significant morbidity, firstly related malformations (heart, kidney, for example), and secondly with particularly difficult anatomical forms (Forms long defect) . The prevalence of this condition is estimated to be 1/2500 in 3000 live births, making an estimated ± 2,500 new cases over to 10 years in France. The current project aims to set up a national registry (Metropolitan France and Dom Tom) to measure the prevalence of esophageal atresia among live births, phenotypic characteristics, the circumstances of their diagnosis, and their initial future at short-term during the first year of life, at which time occurs the vast majority of deaths and complications in this disease.

Official Title
-----------------
National Register of Oesophageal Atresia

Conditions
-----------------
Esophageal Atresia

Intervention / Treatment
-----------------
* Other: data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To be born in France To have a esophageal atresia Exclusion Criteria: To be born abroad

Ages Eligible for Study
-----------------
Maximum Age: 1 Year

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Esophageal atresia<br> | Other: data collection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of esophageal atresia |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data collection patient with esophageal atresia | Circumstances of diagnosis, modalities of follow-up and clinical management | 10 years | 
| Total number of patients with complications |  | 10 years | 
| Death |  | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Esophageal atresia
Readmission Risk Factors and Heart Failure With Preserved Ejection Fraction

Study Overview
=================
Brief Summary
-----------------
Retrospective review of 492 patient from a small community hospital who did not qualify for participation in the Connect HF study sponsored by DCRI.

Detailed Description
-----------------
Retrospective review of adults above the age of 18 with a primary diagnosis of HFpEF between August 2017 and March 2018. Subjects had to fall into one of two classifications (NYHA Class II-IV or ACC/AHA Stage B-D) and had a life expectancy greater than 6 months are included. Individuals with a terminal illness other than HF, prior heart transplant or on a transplant list, or current/ planned left ventricular assist device excluded. The primary objective of this study is to identify risk factors for readmission in patients discharged with a diagnosis of HFpEF.

Official Title
-----------------
Readmission Risk Factors and Heart Failure With Preserved Ejection Fraction

Conditions
-----------------
Heart Failure, Preserved Ejection Fraction

Intervention / Treatment
-----------------
* Other: retrospective observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of Heart failure diagnosis admitted for treatment Ejection fraction < 40% by echocardiogram Exclusion Criteria: Ejection fraction >40% by echocardiogram Chronic Kidney disease requiring dialysis Terminal illness New onset diagnosis of Heart Failure
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| readmission at 30 days<br> | Other: retrospective observation<br>* Retrospective review of study patients excluded from the CONNECT- HF trial who were discharged with a diagnosis of HFpEF between August 1, 2017 and March 1, 2018. Readmission rate at 30 and 90 days along with patient demographics and associated comorbidities were analyzed.<br>|
| readmission at 90 days<br> | Other: retrospective observation<br>* Retrospective review of study patients excluded from the CONNECT- HF trial who were discharged with a diagnosis of HFpEF between August 1, 2017 and March 1, 2018. Readmission rate at 30 and 90 days along with patient demographics and associated comorbidities were analyzed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmission Risk Factors and Heart Failure with Preserved Ejection Fraction | Retrospective review to identify risk factors for readmission in patients discharged with a diagnosis of HFpEF. | August 1, 2017 though March 1, 2018 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart Failure, Readmission Risks
Effect of the Dietary Supplement SAMe on Blood Homocysteine Levels

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if the oral intake of the dietary supplement SAMe increases blood homocysteine levels in healthy human subjects.

Detailed Description
-----------------
S-adenosyl-L-methionine (SAMe or AdoMet) is a commonly used nutritional supplement available in the United States since 1999. SAMe is metabolized to homocysteine, a known cardiovascular risk factor. No study has determined the effect exogenous SAMe administration has on the long-term levels of homocysteine in humans. As a nutritional supplement, SAMe is not regulated by the Food and Drug Administration, despite being used to treat clinical diseases such as depression and osteoarthritis.

Official Title
-----------------
Effect of the Dietary Supplement S-Adenosyl-L-Methionine on Plasma Homocysteine Levels in Healthy Human Subjects

Conditions
-----------------
Heart Disease

Intervention / Treatment
-----------------
* Dietary Supplement: SAMe
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Women and men age 18 - 65 Able to understand and sign a consent form Exclusion criteria: Smoking Pregnant or lactating Women actively trying to conceive Diagnosis of panic disorder or bipolar disorder

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SAMe<br>Two 400 mg pills. | Dietary Supplement: SAMe<br>* 800 mg dose daily for 4 weeks.<br>* Other names: S-Adenosyl-L-Methionine;|
| Placebo Comparator: Placebo<br>Two placebo pills (identical in appearance to SAMe). | Other: Placebo<br>* 2 placebo pills daily for 4 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Homocysteine levels pre- and post- one month of SAMe administration. |  | 1 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| An interim (2 week) homocysteine level, high sensitivity C-reactive protein (hsCRP) level, lipid studies, and liver blood tests. |  | 2 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SAMe, AdoMet, Methylation, Homocysteine, Dietary Supplement, S-Adenosyl-L-Methionine
Changes in mRNA Expression Following Exposure to Naproxen

Study Overview
=================
Brief Summary
-----------------
Using tissue samples obtained from a previous study, the effect of naproxen on the gene expression profiles of antral mucosal tissue will be assessed. We hypothesize that there will be distinct changes in the gene expression profiles of samples taken from individuals treated with naproxen versus samples taken from individuals treated with placebo.

Detailed Description
-----------------
We will use microarray technology to quantify the transcriptome-wide changes in gene expression in said-samples.

Official Title
-----------------
Changes in mRNA Expression Following Exposure to Naproxen

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

Intervention / Treatment
-----------------
* Drug: Naproxen
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult between the ages of 18 and 75 inclusive Written informed consent prior to undergoing any study procedures A physical examination which reveals no clinically significant abnormalities Female subjects of childbearing potential must be taking an acceptable form of contraceptive Exclusion Criteria: Any mucosal breaks within 2 cm of pyloric channel seen on baseline endoscopy Any GDU or >5 gastroduodenal erosions at baseline endoscopy CXB, CPG, ASA, or NS-NSAID use within the prior 2 weeks Previous gastrointestinal ulcer Hypersensitivity or allergy to NSAIDs, ASA, CPG, CXB or other contraindication to taking treatments Baseline complaints of abdominal pain, nausea, and/or cramping Any acid blocking medication including antacids, H-2 receptor blocker within the prior 2 weeks, or PPI use within the prior 30 days Corticosteroids use within the prior 60 days Any documented bleeding tendency Has taken warfarin within the prior 60 days Three or greater alcoholic beverages daily History of cerebro-vascular event

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Naproxen-Treated<br> | Drug: Naproxen<br>* 500mg naproxen, twice daily for 7 days<br>|
| Placebo Comparator: placebo<br> | Drug: Placebo<br>* 1 tab,twice a day for a seven days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fold Change in Gene Expression |  | 7 days |
Development of a Non-invasive Prenatal Test

Study Overview
=================
Brief Summary
-----------------
This is an observational study to aid in the development of a non-invasive prenatal test that may be used to aid in detection of fetal aneuploidy. Pregnant women will be recruited and asked to provide a blood sample to be used for general test development purposes.

Detailed Description
-----------------
Blood samples and information collected for the study will be used for test development and quality control purposes. No test results will be communicated back to study subjects or their health care providers.

Official Title
-----------------
Development of a Non-invasive Prenatal Test

Conditions
-----------------
Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has singleton or twin pregnancy confirmed via evaluation by a healthcare provider Subject is able to provide informed consent Subject is ≥ 18 years of age Subject is at least 10 weeks gestation for general enrollment Subject has no known risk factors for chromosomal abnormalities of the fetus Subject has no suspected or confirmed fetal abnormalities Exclusion Criteria: Subject is pregnant with more than two fetuses Subject is unwilling to undergo a blood draw

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 |
| --- | --- | --- |
| Absence of chromosomal abnormality |  | At time of enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pregnancy, fetus, euploid
OVERWEIGHT AND OBESITY ADVERSELY AFFECT IVF OUTCOMES IN WOMEN WITH PCOS

Study Overview
=================
Brief Summary
-----------------
The effect of overweight and obesity on IVF outcomes is still questionable. The purpose of this study was to determine if overweight/obesity in women with PCOS were associated with an adverse IVF outcome compared to those with normal weight. Design: Retrospective cohort study.

Official Title
-----------------
OVERWEIGHT AND OBESITY ADVERSELY AFFECT IN VITRO FERTILIZATION (IVF) OUTCOMES IN WOMEN WITH POLYCYSTIC OVARY SYNDROME (PCOS)

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All women within the age limit

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Overweight and obesity<br>Women with BMI >25 | |
| Normal weight group<br>Women with BMI =18-24 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth rate | Number of live births divided by the number of aspiration cycle | On the date of delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OBESITY, In Vitro Fertilization (IVF), Polycystic ovary syndrome (PCOS)