linjc16/ctgov huggingface dataset:
A Prospective Randomized Controlled Study of Natural Orifice Medium-low Rectal Endometriosis Resection

Study Overview
=================
Brief Summary
-----------------
To evaluate the postoperative outcome of low medium-low rectal endometriosis: Natural orifice surgery VS transabdominal surgery.

Detailed Description
-----------------
To evaluate the postoperative outcome of low medium-low rectal endometriosis: Natural orifice surgery VS transabdominal surgery.Both of the two kinds of surgery is conventional,but the comparison is still unclear.The investigators divide the patients into two groups, and compare the differences of postoperative outcomes by statistics.

Official Title
-----------------
A Prospective Randomized Controlled Study of Natural Orifice Medium-low Rectal Endometriosis Resection

Conditions
-----------------
Colon Rectal Resection

Intervention / Treatment
-----------------
* Procedure: transvaginal laparoscopic surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Childbearing age women, older than 18 years, diagnosed with intestinal endometriosis, rectum clinical symptoms for invalid medical treatment, dysmenorrhea, dyspareunia dyschezia, infertility, defecate carries blood, endometriosis in the lower rectum by intraoperative judgment Exclusion Criteria: without endometriosis rectum, history of colorectal surgery, intolerance to laparoscopic surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| transabdominal laparoscope surgery<br>transabdominal laparoscope surgery | |
| transvaginal laparoscopic surgery<br>transvaginal laparoscopic surgery | Procedure: transvaginal laparoscopic surgery<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rectovaginal fistula | number of participants | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative constipation | number of patients | one year | 
| postoperative uroschesis | number of patients | one year | 
| intestinal obstruction | number of patients | one year | 
| surgical wound infection | number of patients | one year |
Pharmacological Postconditioning During the Aortic Valvular Surgery

Study Overview
=================
Brief Summary
-----------------
Primary objective: To evaluate the efficacy of the cyclosporin A administration to induce a cardioprotection during the valvular surgery.

Official Title
-----------------
Pharmacological Postconditioning During the Aortic Valvular Surgery

Conditions
-----------------
Aortic Valvular Surgery

Intervention / Treatment
-----------------
* Drug: cyclosporine A
* Other: No injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or females, scheduled for an aortic valvular surgery; 18 years of age or older. Exclusion Criteria: Combined valvular and coronary surgery; Significant coronary artery stenosis (upper than 70%); Left ventricular dysfunction (ejection fraction < 40%); Emergency surgery and/or infectious endocarditis; Known cyclosporin hypersensitivity; History of known recent immunosuppression (< 6 months): cancer, lymphoma, positive serology for HIV, hepatitis; Renal insufficiency (creatininaemia > 150 µmol/l); Hepatic insufficiency (prothrombin time < 50%); Uncontrolled arterial hypertension defined by a systolic arterial pressure > 180 mm Hg; Women of child bearing potential, who are pregnant or not under efficient contraception; Patients treated with nicorandil, sulfonylurea or rosuvastatine; Patients under judicial control.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cyclosporine<br>A single bolus of 2.5 mg/kg cyclosporine is administered before aortic cross-declamping | Drug: cyclosporine A<br>* a single bolus of 2.5 mg/kg, administered before aortic cross-declamping<br>|
| Other: Control<br>No cyclosporine A is administered before aortic cross-declamping | Other: No injection<br>* No cyclosporine A is administered before aortic cross-declamping.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The peak of the cardiac troponin I blood level measured during the first 72 hours of surgery follow-up. |  | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under curve of the cardiac troponin I release, BNP, length of mechanical ventilation, length of stay in ICU, SAPS, necessity of a catecholaminergic support to assure hemodynamic stability, SAE |  | 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postconditioning, cyclosporine A, myocardial ischemia, cardiac surgery, aortic valvulopathy
The Difference Between Elasticity of the Uterine Cervix in Singleton and Twin Pregnancies

Study Overview
=================
Brief Summary
-----------------
The investigators aim to compare elasticity of the uterine cervix in singleton and twin pregnancies of similar gestational age.

Detailed Description
-----------------
Softening of the uterine cervix occurs during pregnancy.There is a possibility that this process occurs earlier in twin versus singleton pregnancies.The softening of the cervix is reflected by the level of its elasticity which can be measured sonoelastographically. A two dimension image of the cervix is obtained in the midsagittal section and the length is noted. A 2nd sonoelastography image is obtained before pressure is applied with the transducer in the area of the internal os and a third sonoelastography image is obtained until no more shortening of the anterior-posterior diameter is observed.Elastography measurements of the internal os are performed using a color map: red (soft), yellow (medium soft), blue (medium hard) and purple (hard) before and after the application of strain.The change between the color maps before and after strain application in singleton pregnancies will be compared to the change in twin pregnancies of similar gestational age.

Official Title
-----------------
The Difference Between Elasticity of the Uterine Cervix in Singleton and Twin Pregnancies

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Low risk singleton and twin pregnancies Exclusion Criteria: Patients with pregnancy complications

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 44 Years

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

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 |
| --- | --- | --- |
| Comparison of elasticity levels in singleton and twin pregnancies (Elastographic measurements of the internal os) |  | 6 months |
Developement of Questionnaire to Evaluate a Regularity of Lifestyle in Type 2 Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
In order to manage of type 2 diabetic patients with irregular lifestyle, developement of an appropriate questionnaire to evaluate a regularity of lifestyle is necessary.

Detailed Description
-----------------
We have a plan to perform the seven day's records and the questionnaires which is necessary to type 2 diabetic patients for the initial step. Next, we will revise a questionnaire with professional advices for several times. Finally we will test a reliability with a final version as form of multisite based study and will confirm a questionnaire for a regularity of lifestyle in type 2 diabetes.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetic patients Exclusion Criteria: Type 1 diabetic patients, gestational DM patients

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 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
-----------------
questionnaire developement, regularity, lifestyle, type 2 diabetes
Effects of Endurance Training on Patients With Reduced Left Ventricular Ejection Fraction (LVEF) and Cardiac Resynchronisation Therapy Especially for Cardiac Arrhythmias

Study Overview
=================
Brief Summary
-----------------
A severely reduced left ventricular ejection fraction is associated with increased mortality due to pump failure as well as to malignant ventricular arrhythmia. We hypothesize that targeted training may lead to improved survival and to increased parameters of risk stratification for malignant arrhythmia. Additionally, the training may lead to an improved psychological and mental condition of the patients

Official Title
-----------------
Effects of Endurance Training on Patients With Reduced LVEF and Cardiac Resynchronisation Therapy Especially for Cardiac Arrhythmias

Conditions
-----------------
Heart Failure, Cardiac Resynchronisation Therapy, Sudden Cardiac Death

Intervention / Treatment
-----------------
* Behavioral: endurance training
* Behavioral: exercise training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CRT Device Exclusion Criteria: refused informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1, Training<br>Group for training therapy | Behavioral: exercise training<br>* Treadmill exercise training to optimize physical endurance<br>|
| Active Comparator: 2, Control<br> | Behavioral: endurance training<br>* control group.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| left ventricular function |  | 3 months | 
| aerobic threshold |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life |  | 3 months |
Presence of Minor Anti Phospholipid Antibodies in Blood Samples of Ischemic Stroke Patients and Healthy Controls

Study Overview
=================
Brief Summary
-----------------
The investigators expect to find higher levels of both classical and minor antiphospholipid (APL) antibodies among the stroke cases. Furthermore, the investigators expect to find not only classical APLA but also minor antibodies. The investigators believe that minor antibodies have a major role in the hypercoagulability state.

Official Title
-----------------
Presence of Minor Anti Phospholipid Antibodies in Blood Samples of Ischemic Stroke Patients and Healthy Controls.

Conditions
-----------------
Ischemic Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stroke diagnosis blood sampling within 36hrs from the event written agreement Exclusion Criteria: a stroke, MI or major operation prior to the current stroke hypercoagulable state known in this patient a severe chronic disease known at the time of the stroke an infection on arrival (based on anamnesis, physical exam and lab tests) thrombolytic treatment

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| treatment<br>Stroke patients | |
| Controls<br>healthy controls | |

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
-----------------
APS, APLA, Stroke, minor anti body, major anti body, APLA antibodies in Serum
Triage Score VS Quick-Sofa Score in Septic Patients in the Emergency Department

Study Overview
=================
Brief Summary
-----------------
Sepsis represents by its frequency, its morbidity and mortality and its cost to society a major public health issue with a constantly increasing incidence. It affects millions of people around the world each year and is the 2nd leading cause of death in intensive care units. The incidence of sepsis has been estimated by the World Health Organization (WHO), based on US data, at 15 to 19 million cases of sepsis per year worldwide.

Detailed Description
-----------------
This is a descriptive, mono-center study aimed at comparing a local triage score with that of qsofa in patients presenting to the Sahloul Emergency Department with sepsis. A local triage score was calculated for each patient consulting the emergency room; this score makes it possible to classify patients according to severity and to predict the time to treatment. A form is completed prospectively for each patient admitted to the observation unit whose diagnosis of sepsis is confirmed and validated by a senior during the morning staff. The validated data were included in the ReSSUS register (Sepsis Register of the Sahloul Emergency Department). This is an observational database on the management of sepsis admitted to the emergency department in Sahloul. It ensures a high level of confidentiality and protection of medical data. Subsequent follow-up of patients was done by telephone contact to verify mortality at one month and one year.

Official Title
-----------------
Comparison of the Triage Score With the Quick-Sofa Score (qSofa) in Septic Patients in the Emergency Department: Diagnostic and Prognostic Value.

Conditions
-----------------
Sepsis, Emergencies

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years old each patient diagnosed as an acute Sepsi consulting the emergencies of CHU Sahloul, Sousse Exclusion Criteria: no exclusion

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Mortality |  | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality and /or readmission | Mortality and /or readmission | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sepsis, severity, prognosis, triage, Mortalty
Comparison of a Laser Keratome to a Mechanical Microkeratome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to evaluate the performance of the INTRALASE®, a laser keratome which creates a corneal flap, and compare it to a mechanical microkeratome (Amadeus™). Our hypothesis is that there is no difference between the 2 devices.

Official Title
-----------------
Comparison of INTRALASE® to AMADEUS™ Microkeratome

Conditions
-----------------
Myopia, Astigmatism, Myopic Astigmatism

Intervention / Treatment
-----------------
* Device: Amadeus Microkeratome
* Device: IntraLase


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Candidate for bilateral wavefront-guided LASIK Myopia up to -7.00 D Astigmatism of 0.00 to -1.50 D Exclusion Criteria: History of ocular pathology Previous ocular surgery Very large pupils (greater than 8mm diameter, infrared measurement) Thin corneas (preoperatively calculated minimal residual bed < 250 um) Irregular astigmatism Asymmetric astigmatism Unstable refraction Any other criteria that precludes subject to undergo LASIK

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 |
| --- |
|Device: Amadeus Microkeratome|nan|
|Device: IntraLase|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity |  |  | 
| Contrast sensitivity |  |  | 
| Induction of high order aberration |  |  | 
| Corneal sensation |  |  |
Effects of Prebiotics on GLP-1 in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to compare the effects of prebiotics versus placebo on blood concentrations of glucagon-like peptide-1 in subjects with diabetes type 2.

Detailed Description
-----------------
We looked at 6 weeks supplementation with a prebiotic fibre mix of inulin and FOS. Cross over design compared to maltodextrin as placebo. Additional outcome measures: blood glucose, insulin, GLP-2, ghrelin, PYY and leptin after a standardized mixed meal test. Also measured changes in microbiota composition and SCFA in feces before and after intervention/placebo periods, and subjective measures of appetite.

Official Title
-----------------
Effects of Prebiotics on GLP-1 in Type 2 Diabetes

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

Intervention / Treatment
-----------------
* Dietary Supplement: Prebiotic fibers: oligofructose and inulin
* Dietary Supplement: Maltodextrin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diabetes type 2 BMI 18,5 - 40 Not medicated with insulin, GLP-1 analogues or DPP4 inhibitors Moderate intake of alcohol Not excessive exercise Less than 3 kg weight change the last two months Intake of less than 30 g dietary fiber per day Exclusion Criteria: IBD IBS Coeliac disease Have used antibiotics within the last two months Have used supplements with prebiotics or probiotics the last two months Pregnancy

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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm A<br>Prebiotic fibers: Oligofructose and inulin | Dietary Supplement: Prebiotic fibers: oligofructose and inulin<br> <br> |
| Placebo Comparator: Arm B<br>Maltodextrin | Dietary Supplement: Maltodextrin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in plasma GLP-1 in response to standardized test meal before and after six weeks of ingestion of prebiotic fibers or placebo | The changes in GLP-1 response to either prebiotic fibers or placebo will be compared in a cross-over manner where the participants are their own controls. In between the intervention periods there will be a wash-out period of 4 weeks. | six weeks |
Sorafenib in Liver Function Impaired Advanced Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
Due to the HBV and HCV infection, about 55% hepatocellular carcinoma patients happened in China. Among them, only 10% patients can be diagnosed in early stage. Sorafenib increased PFS and OS in advanced hepatocellular carcinoma patients with liver function of Child-Pugh class A patients, but the result for Child-Pugh class B patients is unclear.

Official Title
-----------------
Phase 2 Study of Sorafenib in the Management of Liver Function Impaired Advanced Hepatocellular Carcinoma

Conditions
-----------------
Liver Cancer

Intervention / Treatment
-----------------
* Drug: Sorafenib
* Other: Best Supportive Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pathological or cytological confirmed advanced hepatocellular carcinoma 18 years to 80 years liver function Child-Pugh class B BCLC stage B or C estimated life time 2 months or longer Exclusion Criteria: previous target therapy allergy to Sorafenib Uncontrolled Bleeding or diarrhea eligible for locoregional treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sorafenib<br>sorafenib 400mg, oral, twice a day until disease progression defined by RECIST. | Drug: Sorafenib<br> <br> * Other names: Nexavar;Other: Best Supportive Care<br> <br> |
| Active Comparator: Best Supportive Care<br>treatment mainly on nutrition and symptoms control | Other: Best Supportive Care<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival and overall survival |  | From date of randomization until the date of first documented progression or date of death from any cause up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate |  | every 4 weeks till progression, total up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sorafenib, Hepatocellular carcinoma, Best supportive care, Survival