linjc16/ctgov huggingface dataset:
Randomized Prospective Trial: Single Port Laparoscopic Vertical Sleeve Gastrectomy Versus Conventional Five Port Laparoscopic Vertical Sleeve Gastrectomy Surgery

Study Overview
=================
Brief Summary
-----------------
Vertical Sleeve Gastrectomy has been shown to significantly reduce weight and has been approved as a treatment of morbid obesity. The standard laparoscopic operation requires five small incisions for the introduction of instruments and the band into the patient's abdomen. The investigators have developed a technique for performing this operation through a single incision at the belly button. This study compares this method to the conventional 5-incision approach.

Official Title
-----------------
Randomized Prospective Trial: Single Port Laparoscopic Vertical Sleeve Gastrectomy Versus Conventional Five Port Laparoscopic Vertical Sleeve Gastrectomy Surgery

Conditions
-----------------
Obesity, Nutrition Disorders, Body Weight

Intervention / Treatment
-----------------
* Procedure: Laparoscopic vertical sleeve gastrectomy
* Procedure: Laparoscopic vertical sleeve gastrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI >40 ASA I or II Exclusion Criteria: Comorbid cardiac, pulmonary, renal, hepatic disease Bleeding disorder Previous gastric/esophageal surgery

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Single incision laparoscopic vertical sleeve gastrectomy<br>Active Comparator Patients in this group will undergo laparoscopic vertical sleeve gastrectomy through a single periumbilical incision. | Procedure: Laparoscopic vertical sleeve gastrectomy<br>* Laparoscopic vertical sleeve gastrectomy for the treatment of morbid obesity.<br>|
| Active Comparator: Five port laparoscopic vertical sleeve gastrectomy<br>Patients in this group will undergo conventional laparoscopic vertical sleeve gastrectomy using 5 small incisions. | Procedure: Laparoscopic vertical sleeve gastrectomy<br>* Laparoscopic vertical sleeve gastrectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Loss |  | 1 month and 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | 1 week and 3 months | 
| Peri-Operative Complications |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
overweight, Obesity, Morbid
Brief Child Safety Interventions in Emergency Departments (Safety in Seconds)

Study Overview
=================
Brief Summary
-----------------
Safety in seconds is a randomized controlled trial of a computer tailored Injury Prevention program which was conducted in the waiting area of a level 1 pediatric trauma center. A computer kiosk was used to randomly assign participants to study groups, collect baseline data and generate tailored reports based on responses to assessment items. An intervention group received a personalized and stage-tailored safety report and a control group received a personalized, but otherwise generic report on other child health topics. Telephone follow-up interviews were conducted 2-4 weeks and again 4-6 months after enrollment. Home visits were completed for a subset (n=100) of parents who completed the 4-6 month follow-up interview. The study aimed to increase knowledge, self reported and observed safety behaviors.

Official Title
-----------------
Brief Child Safety Interventions in Emergency Departments (Safety in Seconds)

Conditions
-----------------
Injury Prevention

Intervention / Treatment
-----------------
* Behavioral: tailored health education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible parents or guardians had to be English-speaking; have a child between 4-66 months of age seeking treatment for an injury or medical complaint, or have an age-appropriate sibling of a child being seen for these reasons; live in Baltimore City; and live with the child at least some of the time. Exclusion Criteria: -parents which did not meet inclusion criteria
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Prevention


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: tailored health education|Health Information via a computer kiosk in the pediatric emergency department|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge outcome | Measures of Home safety Knowledge |  | 
| Reported and Observed Home Safety behaviors | Reportedf and Observed Home Safety Behaviors (Car Seats, Smoke Alarms) |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Injury prevention, smoke alarms, car seats
Preoperative vs. Postoperative Rectal Misoprostol in Cesarean Section

Study Overview
=================
Brief Summary
-----------------
This prospective double-blind placebo-controlled randomized clinical trial will be conducted at Ain-Shams University Maternity Hospital from April 2017 till December 2017. Group 1 women, candidates for cesarean section, will receive preoperative rectal 400 microgram of misoprostol, and Group 2 women will receive postoperative rectal 400 microgram of misoprostol. 2017. 120 women candidate foe elective cesarean section will receive preoperative sublingual 400 microgram of misoprostol, and another 120 women will receive postoperative sublingual 400 microgram of misoprostol.

Official Title
-----------------
Preoperative vs. Postoperative Rectal Misoprostol in Cesarean Section: A Randomized, Double Blind Clinical Trial

Conditions
-----------------
Neonatal Outcome

Intervention / Treatment
-----------------
* Drug: Misoprostol
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients candidate for cesarean section. Full term pregnancies (GA 37- 42 Wks). Age (18-40 yrs). body mass index (BMI) (20-30(Kg/m2 . Exclusion Criteia: Contraindication to spinal anesthesia. Blood dyscrasias. Large fibroids. Contraindications to prostaglandin therapy (e.g. history of severe bronchial asthma or allergy to misoprostol. Emergency CS such as fetal distress Extreme of BMI (<20 or >30 Kg/m2 ).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Preoperative<br>Group no.1 will receive preoperative rectal 400 microgram of misoprostol (Sigma) 2 tablets and postoperative rectal placebo2 tablets. | Drug: Misoprostol<br>* Cytotec<br>* Other names: Mesotac;Other: Placebo<br>* Placebo tablet similar in shape, odour and consistency to misoprostol tablet.<br>|
| Active Comparator: Postoperative<br>Group no.2 will receive preoperative rectal placebo 2 tablets and postoperative rectal 400 microgram of misoprostol (Sigma)  2 tablets . | Drug: Misoprostol<br>* Cytotec<br>* Other names: Mesotac;Other: Placebo<br>* Placebo tablet similar in shape, odour and consistency to misoprostol tablet.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal outcome | measured by APGAR score at 5 minutes | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NICU admission | Number of neonates admitted to NICU within 24 hours. | 24 hours | 
| amount of blood loss |  | 24 hours | 
| Postpartum hemorrhage |  | 24 hours | 
| Need for extra uterotonics |  | 24 hours |
CTC in Predicting Neoadjuvant Chemotherapy Among LABC Patients: a Single-center, Prospective, Exploratory Clinical Trial

Study Overview
=================
Brief Summary
-----------------
The GILUPI CellCollector® is the first in vivo CTC isolation product worldwide, which is CE approved. The purpose of this clinical trial is to evaluate the predictive value of CTC in neoadjuvant chemotherapy among locally advanced breast cancer patients.

Official Title
-----------------
Predictive Value of Circulating Tumor Cells in Neoadjuvant Chemotherapy Among Locally Advanced Breast Cancer Patients: a Single-center, Prospective, Exploratory Clinical Trial

Conditions
-----------------
Locally Advanced Breast Cancer, Circulating Tumor Cell

Intervention / Treatment
-----------------
* Device: GILUPI CellCollector®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with histologically confirmed primary invasive breast adenocarcinoma, anatomic stage T2-4N0-3M0 or T1N1-3M0 before neoadjuvant chemotherapy ECOG 0-1 Adequate organ function Consent to undergo CTC analysis in vivo Exclusion Criteria: Pregnant or breastfeeding patients Metastatic or recurrent patients Uncontrollable infection

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

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

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: GILUPI CellCollector®<br> | Device: GILUPI CellCollector®<br>* Use of GILUPI CellCollector® to detect CTC<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive value of CTC in ypT0 ypN0 |  | Change from pre-chemotherapy to 22-28(±7) days after first dose of neoadjuvant chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive value of CTC in ypT0, ypT0/is ypN0, near pCR |  | before and 22-28(±7) days after first dose of neoadjuvant chemotherapy | 
| hypersensitivity | Number of participants with hypersensitivity as assessed by CTCAE v4.0 | up to 1 year | 
| Detection rate of GILUPI CellCollector® |  | before and 22-28(±7) days after first dose of neoadjuvant chemotherapy |
Surgery for Esotropia Under Topical Anesthesia

Study Overview
=================
Brief Summary
-----------------
Adult patients requiring surgery for esotropia will be randomized to surgery under topical anesthesia or sub-Tenon's anesthesia. Amount of surgery required with the two anesthetic procedures will be compared. Motor and sensory outcome of the two treatment groups will also be compared.

Official Title
-----------------
Amount of Surgery for Esotropia Under Topical Anesthesia

Conditions
-----------------
Esotropia

Intervention / Treatment
-----------------
* Procedure: Topical strabismus surgery
* Procedure: Sub-Tenon's strabismus surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Esotropia deviation angle equal to or lower than 45 prism dioptres (requiring one or two-muscle surgery) Visual acuity at least 20/40 in each eye Cooperation for topical anesthesia Exclusion Criteria: Paretic or restrictive strabismus Previous eye muscle surgery Significant eye disease other than strabismus

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 60 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Topical anesthesia<br>Patients undergo strabismus surgery for esotropia using topical anesthesia (instillation of drops plus gel) | Procedure: Topical strabismus surgery<br>* Surgery is carried out after instilling drops for anesthesia and administering lidocaine gel during the procedure<br>|
| Active Comparator: Sub-Tenon's anesthesia<br>Patients undergo surgery for strabismus (esotropia) using sub-Tenon's administration of anesthetic (xylocaine) | Procedure: Sub-Tenon's strabismus surgery<br>* Surgery is carried out after sub-Tenon's injection of xylocaine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of surgery required in mm and mm/degree of deviation angle |  | Immediate | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor (deviation angle) and stereoacuity outcome |  | 6 months |
Comparative Effects of Nebivolol and Carvedilol on Diastolic Function in the Elderly Heart Failure Patients

Study Overview
=================
Brief Summary
-----------------
Heart failure (HF) is a common and disabling condition in the elderly. Randomized clinical trials and meta-analyses have clearly demonstrated that long-term use of β blockers improves the outcomes of patients with HF. However, limited data have been available on the treatment of HF with preserved ejection fraction (EF) in the elderly. No study has specifically compared the relative effectiveness of carvedilol and nebivolol in treating HF in old age patients with preserved EF.

Detailed Description
-----------------
This trial is a prospective, randomized, open-label, active controlled study designed to investigate effects of nebivolol and carvedilol on diastolic function of the left ventricle (LV) in the elderly HF patients with preserved EF. Patients will be included in the study if they had LVEF ≥ 40%, NYHA functional class I, II or III, and clinical stability without hospital admission for HF in the preceding 3 months.

Official Title
-----------------
Comparative Effects of Nebivolol and Carvedilol on Diastolic Function of the Left Ventricle in the Elderly Heart Failure Patients With Preserved Ejection Fraction: Study Protocol for a Randomized Controlled Trial

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

Intervention / Treatment
-----------------
* Drug: Nebivolol
* Drug: Carvedilol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: more than 70 years EF ≥ 40% Exclusion Criteria: contraindication to the study drug

Ages Eligible for Study
-----------------
Minimum Age: 70 Years
Maximum Age: 95 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: Nebivolol<br>Nebivolol 10mg, once a day | Drug: Nebivolol<br>* Nebivolol 10mg, once a day<br>|
| Active Comparator: Carvedilol<br>Carvedilol 25mg, twice a day | Drug: Carvedilol<br>* Carvedilol 25mg, twice a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the ratio of transmitral E velocity to early diastolic mitral annular velocity (E/E') |  | 12 months |
Functional Urodynamic Changes in Chronic Kidney Disease Patients and Does Insertion of Urinary Catheter Delay the Need for Kidney Dialysis

Study Overview
=================
Brief Summary
-----------------
The aim of the investigators work is to describe the urodynamic results in the CKD (chronic kidney disease) grade 4 patients and to verify observations that urinary catheter may improve kidney function in those patients. 100 patients with CKD grade 4 will do urodynamic examination. All patients will be randomized into two groups / the intervention group that will be inserted urinary catheter for 2 weeks and the follow up group. Kidney function will be monitored by creatinin values and the investigators will measure the time to dialysis in the two groups.

Official Title
-----------------
Functional Urodynamic Changes in Chronic Kidney Disease Patients and Does Insertion of Urinary Catheter in Chronic Kidney Disease Patients Grade 4 Delay the Need for Kidney Dialysis

Conditions
-----------------
Renal Insufficiency, Chronic

Intervention / Treatment
-----------------
* Device: urinary catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 chronic kidney disease grade 4-5 (eGFR (estimated glomerular filtration rate) <30) eligible to sign a consent form Exclusion Criteria: non controlled Diabetes Melitus (HbA1C>10%) not controlled HTN (Hypertension) cardiovascular event requiring cardiac stenting renal hydronephrosis or post void rest > 200CC according to US (Ultrasound) acute renal failure not eligible for urodynamics for any reason constant urinary catheter for any reason

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 |
| --- | --- |
| Experimental: catheter insertion for 2 weeks<br>50 randomized patients that will do urodynamic urinary examination and will be inserted urinary catheter for 2 weeks | Device: urinary catheter<br> <br> |
| No Intervention: follow up<br>50 randomized patients that will do urodynamic urinary examination and will be regularly followed by nephrologist | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| kidney function change | measured by creatinine values mg/dL | At the time of urinary catheter insertion. Two weeks from the insertion and than after 8,16, 24, 32, 40 and 48 weeks after the urinary catheter insertion. (at total 52 weeks of follow up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to dialysis |  | at least 1 year from the time of catheter insertion |
Intraluminal Imaging of Duodenal Layer Morphometry in Patients With and Without Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This observational study is conducted to determine how the duodenal layer thicknesses (mucosa, submucosa, and muscularis) vary with several factors in patients with and without type 2 diabetes.

Detailed Description
-----------------
Study Objectives To assess duodenal layer (mucosa, submucosa and muscularis) thickness differences between patients with and without type 2 diabetes using endoscopic ultrasound (EUS) and optical coherence tomography (OCT). To assess duodenal layer thickness differences between patients with type 2 diabetes. To assess duodenal layer thickness differences as a function of measurement location along the length of the duodenum. To compare measurements obtained by endoscopic ultrasound, to those obtained by optical coherence tomography.

Official Title
-----------------
A Single-center, Observational, Intraluminal Imaging Study of Duodenal Layer Morphometry in Patients With and Without Type 2 Diabetes Undergoing Endoscopy of the Upper Gastrointestinal Tract

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

Intervention / Treatment
-----------------
* Procedure: EUS and OCT imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is already scheduled for upper endoscopy with ultrasound or OCT, such as those with Barrett's esophagus. Patient is willing to sign an informed consent form. Exclusion Criteria: Patient is not a candidate for endoscopy, EUS, or OCT, such as those with strictures, inflammatory disease or previous anastomosis of the esophagus or duodenum.

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 |
| --- | --- |
| With T2DM<br>Subjects with type 2 diabetes. | Procedure: EUS and OCT imaging<br>* Intraluminal imaging using endoscopic ultrasound and endoscopic optical coherence tomography<br>|
| Without T2DM<br>Subjects without type 2 diabetes | Procedure: EUS and OCT imaging<br>* Intraluminal imaging using endoscopic ultrasound and endoscopic optical coherence tomography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thickness of the duodenal mucosa using OCT, and EUS if possible |  | During imaging | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thickness of the duodenal submucosa using OCT if possible, and EUS |  | During imaging |