linjc16/ctgov huggingface dataset:
Efficacy of Combined Contraceptive Vaginal Ring(NuvaRing)in Women With Idiopathic Menorrhagia

Study Overview
=================
Brief Summary
-----------------
To compare the efficacy of a combined contraceptive vaginal ring (NuvaRing) and oral Norethisterone Acetate in treatment of Idiopathic heavy menstrual bleeding during fertile age

Official Title
-----------------
Combined Contraceptive Vaginal Ring or Norethisterone for Treatment of Idiopathic Menorrhagia

Conditions
-----------------
Menorrhagia

Intervention / Treatment
-----------------
* Drug: NuvaRing
* Drug: Norethisterone Acetate tablets - 5mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with heavy menstrual bleeding based on PBAC score over 185 (mean of two control cycles)and desire contraception Exclusion Criteria: Menorrhagia of endocrine or systemic origin other pathology e.g. patients with fibroids of any size, adenomyosis, endometriosis, pelvic inflammatory disease.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NuvaRing<br>For the first cycle, women inserted the ring between days 1 and 5 of the menstrual cycle. Treatment continued for three cycles. Each cycle consisted of 3 weeks of ring use followed by a 1 week ring-free period. | Drug: NuvaRing<br>* For the first cycle, women inserted the ring between days 1 and 5 of the menstrual cycle. Treatment continued for three cycles. Each cycle consisted of 3 weeks of ring use followed by a 1 week ring-free period.<br>|
| Active Comparator: Norethisterone Acetate<br>Norethisterone Acetate tablets at a dose of 5 mg three times daily from day 5 to 26 of the cycle over three cycles. Male condom used for contraception during treatment | Drug: Norethisterone Acetate tablets - 5mg<br>* Norethisterone Acetate tablets 5 mg three times daily from day 5 to 26 of the cycle over three cycles. Male condom used for contraception during treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in menstrual blood loss at the end of study (cycle 3) measured by pictorial blood loss assessment chart. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haemoglobin and serum ferritin at the end of study (cycle 3) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Menorrhagia, Vaginal ring, Norethisterone Acetate
Build a Decision Aid Tool to Help Emergency Intensive Care Specialists in the Context of Hypoxic Ischemic Encephalopathy

Study Overview
=================
Brief Summary
-----------------
The project aims at designing a machine learning solution able to recognize characteristics signals patterns of brain damages in full term babies born within a context of Hypoxic Ischemic Encephalopathy (HIE)

Detailed Description
-----------------
Retrospective study based on a digital EEG signal library intending to design, train and test an efficient AI solution for hypothermia protocol start indications. The output of the Project is to make available to pediatric resuscitation units an adequate tool to guide them in the decision of hypothermia protocol start in a general context of neurophysiologist competence scarcity. EEG signal that would allow the algorithm design will be based on several parameters of the conventional EEG and not only on signal amplitude

Official Title
-----------------
Build a Decision Aid Tool to Help Emergency Intensive Care Specialists in the Context of Hypoxic Ischemic Encephalopathy. NEWBORN NEURO-DIGITAL STUDY

Conditions
-----------------
Encephalopathy

Intervention / Treatment
-----------------
* Other: Decision of hypothermia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Full term (> 36 weeks) HIE context EEG recording before 6 hours of life Exclusion Criteria: -Opposition of parental authority holders of a patient born after 2015

Ages Eligible for Study
-----------------
Maximum Age: 2 Days

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Decision of hypothermia|Decision of hypothermia thanks to EEG signal|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decision of hypothermia protocol start | algorithm derived from EEGs | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EEG, HIE, Full Term Newborn
Effects of Allopurinol on Diastolic Function in Chronic Heart Failure Patients

Study Overview
=================
Brief Summary
-----------------
In patients with chronic heart failure (CHF)due to dilated cardiomyopathy diastolic dysfunction occurs frequently and is related to a poor outcome. We have previously shown that parameters of diastolic function significantly correlate with uric acid levels, a marker of impaired oxidative metabolism. We aimed to determine whether inhibition of xanthine oxidase with allopurinol might affect diastolic function in patients with CHF.

Official Title
-----------------
Effects of Allopurinol on Diastolic Function in Chronic Heart Failure Patients

Conditions
-----------------
Chronic Heart Failure

Intervention / Treatment
-----------------
* Drug: allopurinol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic heart failure; left ventricular systolic dysfunction (ejection fraction <45%) stable clinical conditions in the previous three months optimal medical therapy for CHF normal sinus rhythm written informed consent age >18 years Exclusion Criteria: renal failure (s-creatinine >2.5 mg/dl) already on allopurinol malignancies chronic inflammatory diseases

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: allopurinol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diastolic function uric acid levels BNP |  | three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic heart failure, diastolic dysfunction, uric acid
Job Adaptation in Patients With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The specific aim of this study is to compare the rate of negative work role events in individuals with rheumatoid arthritis compared to healthy controls.

Detailed Description
-----------------
Rheumatoid arthritis can cause multiple socio-medical disabilities, with work disability among the most marked. While a major focus has been documenting the rates of job loss and returning patients to the workforce, there is little information about how to foster job retention in those still employed. The goals of this study are to document negative workplace events over 1 year in 122 employed patients with rheumatoid arthritis, and to compare these to 122 healthy controls, who are included to account for the effects of socioeconomic status on employment. Events will be recorded with the work domain of the Psychiatric Epidemiology Research Life Events Scale. Additional goals are to compared fatigue, physical activity, functional status and sleep disturbances as covariates.

Official Title
-----------------
Job Adaptation in Patients With Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients are eligible if they are: over age 18; meet American Rheumatism Association criteria for rheumatoid arthritis; and are employed for salary or monetary reimbursement. Controls are eligible if they are: over age 18; have no major comorbidity; and are employed for salary or monetary reimbursement. Exclusion Criteria: Patients and controls are excluded if they: have cognitive deficits and cannot provide informed consent; do not speak English or Spanish; or their physicians do not grant permission to enroll them.

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

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

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
Negative workplace events, Healthy controls, Employment, Fatigue, Physical activity
ClearSight System CHN Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical trial is to demonstrate that cardiac output (CO) as determined with the Clinical Platform (Model:EV1000A, Software Version:1.9) in a noninvasive manner is comparable to CO as determined by Pulmonary Artery Catheter (PAC) thermodilution (TD). The results of this study may be used for registration and regulatory submissions.

Official Title
-----------------
A Prospective, Nonrandomized, Non-interventional Trial to Evaluate ClearSight System Cardiac Output in China

Conditions
-----------------
Patient With Clinically Indicated Invasive Monitoring

Intervention / Treatment
-----------------
* Device: EV1000NI Clinical Platform: Noninvasive Hemodynamic Monitoring utilizing ClearSight System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must be at least 18 years of age Subjects provide written informed consent prior to trial procedures Subjects' height and weight must be accurately obtained prior to study start. Exclusion Criteria: Aortic or tricuspid valve regurgitation Aortic stenosis or aneurysms Cardiac rhythm disorder Patients with extreme contraction of the smooth muscle in the arteries and arterioles in the lower arm and hand, such as may be present in patients with Raynaud's or Buerger's disease or with extremely cold hands Inability to place the finger cuff appropriately due to subject anatomy or condition Known pregnancy Patients being treated with an intra-aortic balloon pump Patient is currently participating in an investigational drug or another device study that clinically interferes with the study endpoints Intracardiac shunt

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

| Intervention/Treatment |
| --- |
|Device: EV1000NI Clinical Platform: Noninvasive Hemodynamic Monitoring utilizing ClearSight System|EV1000NI Clinical Platform: Noninvasive Hemodynamic Monitoring utilizing ClearSight System|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Output using the Non-invasive ClearSight System | Cardiac Output using the Non-invasive ClearSight System | Expected to last no more than 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage error (PE) between the ClearSight System CO and TD | The percentage error (PE) between the ClearSight System CO and TD | Expected to last no more than 6 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Elective Major Cardiothoracic, Mitral Valve Surgery, Coronary Artery Bypass Grafting
A Predictive Model Based on Narrow Band Imaging for Early Gastric Cancerous Lesions

Study Overview
=================
Brief Summary
-----------------
Without high diagnostic efficacy of endoscopic forceps biopsy (EFB) and with low diagnostic efficacy of narrow band imaging (NBI) in novice endoscopists and endoscopists of community hospitals in China, it is urgent to improve diagnostic efficacy for gastric cancerous lesions.The investigators will conduct a study to develop and validate a diagnostic model based on NBI for early gastric cancerous lesions under endoscopic observation.

Detailed Description
-----------------
Endoscopic forceps biopsy (EFB) is considered the gold standard and most commonly used for histological diagnosis of gastric epithelial neoplasia before proper management.Many studies have shown that there exist considerable discrepancies between EFB and subsequently resected specimens with discrepancy rate of 27.1-44.5%. On the other hand, with low diagnostic efficacy of narrow band imaging (NBI) in novice endoscopists and endoscopists of community hospitals in China, not higher diagnostic accuracy of gastric cancerous lesions could be observed. Here, the investigators will conduct a study to develop and validate a diagnostic model based on narrow band imaging for early gastric cancerous lesions under endoscopic observation, trying to improve overall diagnostic efficacy for gastric cancerous lesions.

Official Title
-----------------
Development and Validation of a Predictive Model for Early Gastric Cancerous Lesions Under Endoscopic Observation

Conditions
-----------------
Early Gastric Cancer

Intervention / Treatment
-----------------
* Device: NBI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspected of having a cancerous lesions The age of patients is from 40-80 years Patients must undergo esophagogastroduodenoscopy Exclusion Criteria: Clinical diagnosis of advanced gastric cancer Acute upper gastrointestinal bleeding Severe systemic diseases Refuse to attend the study

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Suspected gastric cancerous lesions<br>Magnifying endoscopy with NBI would be conducted for every patient included in our study | Device: NBI<br>* Endoscopic factors under white light view and simplified narrow band imaging classification assisting in diagnosing cancerous lesions will be recorded.<br>* Other names: magnifying colonoscopes (CF-H260AZL, Olympus Inc, Japan);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of the diagnostic model in histological prediction of gastric cancerous lesions |  | 36 months |
Multiple Firings in Double-stapled Colorectal Anastomosis

Study Overview
=================
Brief Summary
-----------------
Multiple linear stapler firings during double stapling technique (DST) is associated with anastomotic leakage (AL) after laparoscopic low anterior resection (LAR). We aim to investigate the risk factors and then to develop a deep learning model to predict the usage of ≥3 linear stapler cartridges during DST anastomosis.

Official Title
-----------------
Risk Factors for the Usage of ≥3 Linear Stapler Cartridges During Double Stapling Anastomosis in Laparoscopic Low Anterior Resection of Rectal Cancer

Conditions
-----------------
Rectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1) carcinoma of rectum confirmed by histopathological evaluation; 2) tumor located in the mid-low rectum (less than 10cm from the anal verge); 3) performance of DST anastomosis; 4) pelvic MRI obtained within 14 days before surgery. Exclusion Criteria: 1) other anastomotic techniques (e.g., trans-anal rectal excision); 2) Hartmann's operation or other procedures without anastomosis; 3) the number of linear stapler cartridges was not traceable in the operative report.
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 |
| --- | --- | --- |
| the number of linear stapler cartridges | the number of linear stapler cartridges used during DST anastomosis | during surgery |
Buprenorphine Maintenance for Opioid Addicts - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of buprenorphine and desipramine in treatment of opiate and cocaine dependence.

Official Title
-----------------
Buprenorphine Maintenance for Opioid Addicts

Conditions
-----------------
Opioid-Related Disorders

Intervention / Treatment
-----------------
* Drug: Buprenorphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Buprenorphine|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
-----------------
Opioid-Related Disorders
Efficacy and Safety of Androgel in the Treatment of Hypogonadal and Low Testosterone Men With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study is to investigate how well Androgel, when tested against placebo gel, helps to control blood sugar levels in males with type 2 diabetes who have low testosterone (the main male hormone) blood levels and are taking oral diabetic medicines alone or in combination with insulin.

Official Title
-----------------
A Double Blind, Randomized, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of Androgel, as an Adjunct to Hypoglycemic Therapy, in the Treatment of Hypogonadal and Low Testosterone Men With Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes, Hypogonadism

Intervention / Treatment
-----------------
* Drug: Androgel (testosterone gel)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to read and write Males Between 30-80 years old Have type 2 diabetes Diagnoses of hypogonadism or low testosterone Exclusion Criteria: On insulin monotherapy Use of testosterone therapy within the last 6 months Male breast cancer History of prostate cancer History of clinically significant sleep apnea

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 Years

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

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

| Intervention/Treatment |
| --- |
|Drug: Androgel (testosterone gel)|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
-----------------
Type 2 diabetes, hypogonadism, testosterone, glycosylated hemoglobin A1C
Role of Nitric Oxide in Cirrhosis: Relationship With Systemic Hemodynamics, Renal Function, Vasoactive Systems and Endotoxemia

Study Overview
=================
Brief Summary
-----------------
This study is to determine whether a compound, nitric oxide, made within the body, is the factor responsible for the changes in blood pressure and renal (kidney) functions that may occur during the course of cirrhosis. Patients with cirrhosis (liver scarring which causes poor liver function) will be eligible to participate. A group of healthy subjects will also be studied to compare the effects of the treatment to patients with cirrhosis and to confirm safety. A total number of 30 patients with cirrhosis and 10 healthy subjects will be enrolled in the study.

Detailed Description
-----------------
Upon admission, the patients will be physically examined and started on a special diet that will continue throughout the study. During the first four days of the study, the weight, heart rate and blood pressure of the patients will be measured every morning and 24-hour urine will be collected. On day 5, intravenous lines will be inserted in the patient's arms. One line will be used to draw blood samples and the other line will be used to infuse medications. Blood samples will be taken to measure liver and kidney function, nitric oxide, and other hormones that participate in the regulation of body fluids and blood pressure. Inulin and paraaminohippurate infusions (substances used routinely in the study of kidney function) will be started and blood and urine samples will then be taken at periodic intervals. Ninety minutes after the initiation of inulin and PAH infusions, L-NMMA (an investigational drug expected to increase the blood pressure and improve the kidney functions) will be infused. Blood and urine samples will be collected every 30 minutes. These procedures will take 4 hours. A total amount of about 10 tablespoons of blood will be drawn during the study. The patients will be discharged from the GCRC the next morning and restarted on their regular medications.

Conditions
-----------------
Cirrhosis, Liver Cirrhosis

Intervention / Treatment
-----------------
* Drug: N-monomethyl-L-arginine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with compensated cirrhosis without previous history of ascites or edema Cirrhotic patient with ascites without renal failure Cirrhotic patients with ascites with functional renal failure Age and sex-matched healthy subjects

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: N-monomethyl-L-arginine|nan|

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

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