linjc16/ctgov huggingface dataset:
A Comparison of Balloon Catheter Versus Ocytocin for Cervical Ripening on Scarred Uterus With Unfavorable Cervix

Study Overview
=================
Brief Summary
-----------------
Increasing cesarean rate in France is worrying. Different methods are described for ripening labor : the use of prostaglandins is described but maybe dangerous for patients with scarred uterus and is not recommended. Intracervical balloon is an efficient alternative methods which as already been tested for unfavorable cervix ripening on nulliparous women. But it was rarely tested on women with scared uterus and unfavorable cervix (bishop score <4). The investigators propose a prospective randomised trial comparing cervix ripening with intracervical balloon inflated by 50 ml sterile water during 12 hours versus ocytocin (reference method). The investigators expect to demonstrate what it's a safe method to increase vaginal delivery for women with previous cesarean section who need an induction of labour.

Conditions
-----------------
Scarred Uterus

Intervention / Treatment
-----------------
* Drug: oxytocin
* Procedure: balloon catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnancy over 37 weeks Singleton pregnancy Vertex presentation Previous caesarean section with unique Transversal segmentary incision Medical indication of induction of labor Unfavorable cervix with Bishop score < 4 No Premature Rupture Of Membranes Informed consent Exclusion Criteria: Before 18 years old Placenta Praevia Premature Rupture Of Membranes Uterine scar other than transversal segmentary incision Cervical infection (except Streptoccoccus Agalactiae carrier) or choriamnionitis Multiple pregnancy Fetal malpresentation Cesarean indication Latex allergy No informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: oxytocin<br> | Drug: oxytocin<br> <br> |
| Experimental: balloon catheter<br>Dufour 1859H18 | Procedure: balloon catheter<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of childbirth by low way | The childbirth by low way being considered as a success of the treatment |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of incidence of materno-fœtales morbidity | number |  |
Study Of JAK3 Inhibitor For The Prevention Of Acute Rejection In Kidney Transplant Patients

Study Overview
=================
Brief Summary
-----------------
A new immunosuppressive drug based on the inhibition of an important enzyme in the immune system called JAK3, is being developed by Pfizer to prevent transplant rejection. In this research study, a JAK3 inhibitor or cyclosporine will be given to new kidney transplant patients for 12 months in addition to other standard transplant medications such as prednisone.

Official Title
-----------------
A Pilot Randomized, Multicenter, Open-Label, Active Comparator-Controlled Trial Of A CP-690,550-Based Regimen In De Novo Kidney Allograft Recipients

Conditions
-----------------
Kidney Transplantation

Intervention / Treatment
-----------------
* Drug: Cyclosporine
* Drug: CP-690-,550


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recipient of first time kidney transplant Between the ages of 18 and 70 years, inclusive Exclusion Criteria: Recipient of any non-kidney transplant

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment Arm 1<br>Treatment Arm 1 will also receive standard of care medications. | Drug: Cyclosporine<br>* Standard of care<br>|
| Experimental: Treatment Arm 2<br>Treatment Arm 2 will also receive select standard of care medications. | Drug: CP-690-,550<br>* CP-690550 20 mg BID in Months 1-6 then 15 mg BID in Months 7-12<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical biopsy proven acute rejection rate at 6 months |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of CP-690,550 |  | 12 months | 
| Lymphocyte subsets |  | 12 months | 
| Posttransplant humoral alloreactivity |  | 12 months | 
| Safety and tolerability of CP-690,550 |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immunosuppression, JAK3 inhibitor, kidney transplantation
Irreversible Electroporation Ablation for Colorectal Metastases to the Lung

Study Overview
=================
Brief Summary
-----------------
The investigators are investigating the use of a new cancer treatment called Irreversible Electroporation (IRE). This treatment delivers electrical energy between two needles placed in a cancer. The electrical energy causes cells to die. While this has been used in patients for different applications, the investigators are trying to understand how safe and well it works in colon cancer that has spread to the lung. Once the irreversible electroporation procedure is completed during the operation, the surgeon will then remove the cancer according to standard procedure. As part of the study, they will be measuring safety of the electrical energy delivered and will be reviewing the resected specimen under the microscope.

Official Title
-----------------
Irreversible Electroporation Ablation for Colorectal Metastases to the Lung

Conditions
-----------------
Colorectal Metastases to the Lung

Intervention / Treatment
-----------------
* Device: Irreversible Electroporation Ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed Colorectal cancer with oligometastatic colorectal cancer in the lung Lung lesion size is greater than 1 cm Patient will undergo surgical resection as per consultation with their thoracic surgeon and medical oncologist Patient is cleared to undergo paralytic anesthesia. Patients 18 years old and older Exclusion Criteria: Patients with history of cardiac dysrhythmia Known heart failure (EF < 40%) Pacemaker/defibrillator Patient's with any metallic cardiac implant Patient on anti-coagulation therapy and are unable to stop therapy for the perioperative period Women who are pregnant and/or nursing

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IRE procedure<br>The IRE procedure will be performed in the operating room at the time of scheduled clinical resection of colorectal lung metastases by the surgeon with guidance from the Interventional Radiologist. | Device: Irreversible Electroporation Ablation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Frequency of Adverse Events | Safety will be measured by using the NCI Common Terminology Criteria for Adverse Events (CTCAE v4.0). The goal of this study is to establish safety. If there are 3 or more grade 3 or higher device related AEs, then we will stop the study. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Irreversible Electroporation Ablation, 15-001
DPBRN Reasons for Placing the First Restoration on Permanent Tooth Surfaces

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to document the reasons for placing the first restoration (filling) on a previously un-restored surface in a permanent (adult) tooth.

Detailed Description
-----------------
The aims of this study were to (1) quantify DPBRN practitioner-investigators pre-operative and post-operative assessments of the depth of the caries lesion being treated; (2) quantify the prevalence of dental material types used to restore the first restoration in a permanent tooth surface; and (3) test the hypothesis that DPBRN practitioner investigators in the Assessment of caries diagnosis and caries treatment study who stated that they wait until the caries lesions reach dentin before they place the first restoration are in fact more likely in this study to do restoration in teeth that have caries reaching into dentin. The aims were met by enrolling 230 DPBRN practitioner-investigators in the Reasons for placing the first restoration on permanent tooth surfaces study, each of whom recorded information about approximately 50 consecutive restorations that they placed on unrestored surfaces. This study about restorative treatment received by patients provided the opportunity to record the variations in the treatment provided, and also provided a basis for subsequent future studies to investigate how defects on fillings develop over time. These results will also be related to the findings from Assessment of caries diagnosis and caries treatment study where practitioners outlined how they detected dental decay, the stage at which the decay was treated by placing fillings, and how they rely on preventive measures to stop the decay process without placing fillings.

Official Title
-----------------
Reasons for Placing the First Restoration on Permanent Tooth Surfaces

Conditions
-----------------
Dental Caries

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: participants directly involved in this study were patients who sought dental treatment in the practitioner-investigators' practices any tooth surface that was previously unrestored was eligible for this study, provided that it was on a permanent (adult) tooth. This means that permanent first molars were eligible, which typically erupt at about age 6 years. This means that persons age 6 and older were enrolled in the study and there was no upper age limit. Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 6 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
-----------------
Dental caries, Assessments, dental materials
Prevalence of Glucose Intolerance and Risk Factors in Ethiopian Immigrants in Israel; Follow-up Study.

Study Overview
=================
Brief Summary
-----------------
High risk population: Screening for impaired glucose tolerance.

Conditions
-----------------
Diabetes Mellitus, Glucose Intolerance

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participation in the year 2000 study Signature of Informed Consent Form Exclusion Criteria: Pregnancy -

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 90 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 |
| --- | --- |
| Ethiopians participating in previous study, year 2000<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of patients with Diabetes Mellitus or impaired glucose tolerance |  | Day 1 of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of hypertension and hyperlipidemia |  | Day 1 of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ethiopians, Diabetes Mellitus, Glucose tolerance, Israel, Included in the year 2000 study
Telemedicine Medical Abortion Service Using the No-test Protocol in Ukraine and Uzbekistan.

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to pilot and evaluate a telemedicine medical abortion service delivery that allows remote communication between the woman and provider and limits medically unnecessary in-person visits to health or diagnostic centers.

Official Title
-----------------
Safety and Acceptability of a Telemedicine Medical Abortion Service Using the No-test Protocol In Ukraine and Uzbekistan.

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

Intervention / Treatment
-----------------
* Drug: medical abortion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Is pregnant as determined by a pregnancy test or ultrasound (if obtained prior to contacting the study site) Has no contraindications to medical abortion Has access to a phone Is able to take mifepristone on or before 63 days gestation Exclusion Criteria: Medically ineligible for medical abortion Gestational age above 63 days based on LMP
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: medical abortion|medical abortion|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of adverse events resulting from remote provision of medical abortion | Adverse events such as regimen non-compliance or medically unnecessary interventions associated with remote provision of medical abortion. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with remote provision of medical abortion | Satisfaction with remote provision of medical abortion measures by 5-point Likert scale. | 6 weeks |
Resistant Hypertension and Physical Activity Performed in a Heated Pool

Study Overview
=================
Brief Summary
-----------------
patients with resistant hypertension will be submitted to an exercise protocol in a heated pool for three months

Detailed Description
-----------------
pacient´s blood pressure behavior will be compared before and after intervention

Official Title
-----------------
Effects of Training in a Heated Pool in Patients With Refractory Hypertension

Conditions
-----------------
Hypertension, Resistant to Conventional Therapy

Intervention / Treatment
-----------------
* Other: exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with uncontrolled blood pressure despite concurrent use of 3 antihypertensive agents, including a diuretic, or the need for more than 3 medications to control blood pressure Exclusion Criteria: poor adherence to the treatment obesity diabetes smokers secondary causes of hypertension motor disabilities to perform the training

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: exercise<br>the patients will be submitted to an exercise protocol | Other: exercise<br>* practice of physical exercise<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure value | participants will be followed for the duration of the exercise protocol, an expected average of 12 weeks | Change from Baseline in Blood Pressure at 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Resistant Hypertension
Pomegranate Juice and Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
The effect of pomegranate juice (PJ) intake on cardiovascular risks in subject with metabolic syndrome.

Detailed Description
-----------------
The effect of pomegranate juice (PJ) intake on cardiovascular risks in subject with metabolic syndrome in shabestar.

Official Title
-----------------
The Effect of Pomegranate Juice Intake on Cardiometabolic Factors in Subjects With Metabolic Syndrome.

Conditions
-----------------
Metabolic Syndrome

Intervention / Treatment
-----------------
* Other: pomegranate juice
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: presence of ≥3 of the following diagnostic of MetS: serum TGs of at least 150 mg/dL, waist circumference of more than 102 cm (40 in) in men and more than 88 cm (35 in) in women, high-density lipoprotein (HDL) level less than 40 mg/dL in men and less than 50 mg/dL in women, blood pressure 135/85 mm Hg or higher, or fasting glucose 100 mg/dL or Higher Exclusion Criteria: liver cirrhosis, chronic pancreatitis, gastrointestinal or connective diseases, kidney stones, or renal failure, alcohol Consumption, having an allergy to pomegranate juice, a change in diet, the large increase in LDL so that required drug treatment. use of statins of fibrates, corticosteroids, nitrates, acetyl-salicylic acid or other anti-platelet drugs, oral hypoglycemic drugs, nonsteroidal anti-inflammatory drugs, or drugs interfering with coagulation; pregnancy or lactation in the past 6 mo, supplementation with vitamins or antioxidants

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: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pomegranate juice<br>pomegranate juice: 500 ml | Other: pomegranate juice<br>* Randomized clinical trial or RCT<br>Other: placebo<br>* Randomized clinical trial or RCT<br>|
| Placebo Comparator: placebo<br>sugar + aroma+ color: 500ml | Other: pomegranate juice<br>* Randomized clinical trial or RCT<br>Other: placebo<br>* Randomized clinical trial or RCT<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in values of metabolic syndrome components at 1 week |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in values of insulin resistance (HOMA-IR), total cholesterol, LDL-C, VLDL-C and hs-CRP at 1 week | Insulin resistance via HOMA-IR | 1 weeks |
Comparison the Topical Anesthesia and Retrobulbar Anesthesia for 27-gauge Vitrectomy for Vitreous Floaters

Study Overview
=================
Brief Summary
-----------------
Routine anesthesia methods for vitrectomy surgery include retrobulbar and peribulbar anesthesia. However, both methods have potential complications that can vary from minor to severe. Vitrectomy surgery for vitreous floaters is widely considered straighter forward than other vitreoretinal surgeries. Hence, the investigators compared the effect of topical anesthesia (with eye drops) and retrobulbar anesthesia for 27-gauge par plana vitrectomy for symptomatic vitreous floaters.

Conditions
-----------------
Perioperative Pain Experiences

Intervention / Treatment
-----------------
* Drug: vitrectomy under topical anesthesia [Proparacaine HCL (Alcaine®)]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who is going to undergo vitrectomy surgery for vitreous floaters age>18 years patients who are willing to participate in this study Exclusion Criteria: patients who had vitrectomy surgery before patients who had penetrating ocular trauma before

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: vitrectomy under retrobulbar anesthesia<br>27-gauge vitrectomy for vitreous floaters under traditional retrobulbar anesthesia | Drug: vitrectomy under topical anesthesia [Proparacaine HCL (Alcaine®)]<br>* to observe the anesthesia effect of topical anesthesia of 27-gauge vitrectomy for vitreous floaters<br>* Other names: 0.5% proparacaine HCL (Alcaine®, Alcon, TX);|
| Experimental: vitrectomy under topical anesthesia<br>27-gauge vitrectomy for vitreous floaters under topical anesthesia | Drug: vitrectomy under topical anesthesia [Proparacaine HCL (Alcaine®)]<br>* to observe the anesthesia effect of topical anesthesia of 27-gauge vitrectomy for vitreous floaters<br>* Other names: 0.5% proparacaine HCL (Alcaine®, Alcon, TX);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Pain Scale |  | 2 hour post-operation |