linjc16/ctgov huggingface dataset:
Open-angle Glaucoma Subjects on One Topical Hypotensive Medication Randomized to Treatment With One or Two Trabecular Micro-bypass Stents in Conjunction With Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
Evaluation of intraocular pressure (IOP) lowering effect of one iStent versus two iStents in conjunction with cataract surgery in subjects with primary open-angle glaucoma, washed out of one anti-glaucoma medication prior to stent implantation.

Official Title
-----------------
A Prospective Evaluation of Open-angle Glaucoma Subjects on One Topical Hypotensive Medication Randomized to Treatment With One or Two Trabecular Micro-bypass Stents in Conjunction With Cataract Surgery

Conditions
-----------------
Open-angle Glaucoma

Intervention / Treatment
-----------------
* Device: One iStent
* Device: Two iStent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Phakic study eye requiring cataract removal and posterior chamber intraocular lens (PC-IOL) implantation Primary open-angle glaucoma (including pigmentary or pseudoexfoliative) Exclusion Criteria: Aphakic or pseudophakic with posterior or anterior chamber IOLs (PC-IOLs or AC-IOLs) (study eye) Prior stent implantations (study eye)

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 |
| --- | --- |
| Active Comparator: One iStent<br>Implantation of one iStent in conjunction with cataract surgery | Device: One iStent<br>* Implantation of one iStent in conjunction with cataract surgery<br>|
| Active Comparator: Two iStent<br>Implantation of two iStent devices in conjunction with cataract surgery | Device: Two iStent<br>* Implantation of two iStent in conjunction with cataract surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean diurnal IOP reduction of ≥ 20% vs. baseline mean diurnal IOP |  | 12 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Open angle glaucoma, Pigmentary glaucoma, Pseudoexfoliative glaucoma
Mi-RNAs and Specificity of Hs-TnT in Symptomatic ED Patients

Study Overview
=================
Brief Summary
-----------------
Biomarkers play a key role in the diagnostic workup of patients presenting to an emergency department (ED). European and American guidelines recommend cardiac Troponin (T or I) as the biomarker gold standard for the diagnosis of non-ST-elevation myocardial infarction (non-STEMI). Today, high-sensitivitiy assays are available and allow an early diagnosis of non-STEMI and the detection of troponin in individuals that would have been classified as unstable angina with former assays. As many patients are detected with elevated troponin values with the high sensitivity assays, specificity for non-STEMI has inevitably decreased. Micro-RNAs (mi-RNA) are new biomarkers with a wide spectrum of detectable conditions that allow specific identification of myocardial infarction. The aim of this study is to develop a biomarker protocol that combines the high sensitivity of cardiac Troponin T and the high specificity of mi-RNA profiles for early and safe identification of non-STEMI in ED patients.

Official Title
-----------------
Clinical Use of Mi-RNAs to Improve Specificity of High-sensitivity Troponin T in Symptomatic Patients Presenting to the ED

Conditions
-----------------
Coronary Artery Disease, Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted to the emergency department (chest pain unit), Dept. of Cardiology, University Hospital Heidelberg Symptoms suggestive of ACS incl. chest pain, dyspnea, atypical pain Age >= 18 years Written informed consent Exclusion Criteria: Mental disorders, dementia Pregnancy, breast feeding Age < 18 years

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 |
| --- | --- | --- |
| Death |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial Infraction |  | 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac Troponin T, Micro-RNA, Sensitivity, Specificity
Development of a Non-invasive Assessment of Skeletal Muscle Loss in Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The long-term objective of this research is to develop a non-invasive approach for early assessment of which patients are at high risk for future development of skeletal muscle atrophy. The investigators hypothesize that the rate constant for the terminal portion of the isotope decay curve following ingestion of a single oral dose of deuterated-3-methylhistidine (D-3MH) provides an accurate measure of this increased risk and that this rate constant can be measured non-invasively from timed spot urine samples. In addition, the investigators hypothesize that ingestion of a meat-containing meal will stimulate synthesis of skeletal muscle proteins to a greater extent than a non-meat-containing meal.

Official Title
-----------------
Development of a Non-invasive Assessment of Skeletal Muscle Loss in Cancer Patients

Conditions
-----------------
Cachexia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male 30-85 years Body Mass Index (BMI) <30 kg/m2 Exclusion Criteria: Uncontrolled hypertension Glomerular filtration rate less than 60 mL/min/1.73 m2 History of recurrent gastrointestinal bleeding Unable or unwilling to provide informed consent Ongoing anti-coagulant therapy

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| healthy control male<br> | |
| lung cancer male<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the slope of terminal D-3MH/3MH decay curve post-dosing. | Assess the slope of the terminal D-3MH/3MH decay curve for the post-dosing time period as calculated using plasma or urine samples and after a meat-containing or meat-free test meal. | Post-dosing 12 to 22 hours |
Total Lymphoid Irradiation (TLI) to Prevent Focal Segmental Glomerulosclerosis (FSGS)Recurrence in the Renal Graft

Study Overview
=================
Brief Summary
-----------------
The purpose was study the immunosuppression using total lymphoid irradiation plus Csa, MMF and prednisone pretransplant to prevent focal segmental glomerulosclerosis recurrence in the renal graft

Detailed Description
-----------------
Focal and segmental glomerulosclerosis (FSGS) is resistant to treatment with immunosuppressants and after transplant, 40% of such patients have recurrences in renal allograft. The purpose of this trial was to use Total Lymphoid Irradiation (TLI) plus mycophenolate mofetil (MMF), cyclosporine A (CsA) and prednisone (PRED) to prevent recurrence.

Official Title
-----------------
Phase 1 Study of TLI Pretransplant to Prevent Recurrence of FSGS in the Graft

Conditions
-----------------
Glomerulosclerosis, Focal

Intervention / Treatment
-----------------
* Procedure: Total Lymphoid irradiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients (age > 18 years) Biopsy-proven primary FSGS End-stage renal failure at presentation or prior allograft loss due to recurrent FSGS. Signed the informed consent before entering in the study. Exclusion Criteria: Age < or equal 18 years No biopsy-proven FSGS Without living donor to perform the transplant No signed the informed consent

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Total Lymphoid irradiation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of immunosuppression using TLI plus CsA, MMF and Pred in prevent recurrence of FSGS after the renal transplant |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity and mortality ot the treatment |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glomerulosclerosis, focal, pretransplant immunosuppression, total lymphoid irradiation, renal transplant, recurrence
Comparison of the Efficacy of Rhomboid Intercostal Block and Erector Spinal Plane Block on Myofascial Pain Syndrome

Study Overview
=================
Brief Summary
-----------------
The investigators evaluate the effect of Ultrasound guided Rhomboid Intercostal Block and Erector Spinal Plane Block on lower cervical and inter scapular Myofascial Pain

Detailed Description
-----------------
Myofascial pain syndrome (MPS) is the most common cause of musculoskeletal pain and its prevalence in the population is reported to be 21-30%. In this study, the investigators compare the effect of two regional anesthesia block techniques with the ultrasound guidance.

Official Title
-----------------
Comparison of the Efficacy of Ultrasound Guided Rhomboid Intercostal Block and Erector Spinal Plane Block on Lower Cervical and Interscapular Myofascial Pain Syndrome

Conditions
-----------------
Myofascial Pain Syndrome

Intervention / Treatment
-----------------
* Procedure: Rhomboid intercostal block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Complaint of myofascial pain Pain that is rated at least 3 on a numerical rating scale (NRS, 0 = no pain, 10 = the worst pain) Exclusion Criteria: pregnancy presence of coagulopathy, or the use of anticoagulants a history of surgery on the block area allergic to bupivacaine decline to participate

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rhomboid intercostal block<br>Ultrasound guided rhomboid intercostal block | Procedure: Rhomboid intercostal block<br>* two regional anesthesia block techniques are applied<br>* Other names: Erector spinae plane block;|
| Active Comparator: Erector spinae plane block<br>Ultrasound guided erector spinae plane block | Procedure: Rhomboid intercostal block<br>* two regional anesthesia block techniques are applied<br>* Other names: Erector spinae plane block;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Rating Scale (NRS) | Pain Score Change The 11-point NRS consists of numbers between 0 and 10 where 0 indicates no pain and 10 indicates maximum pain. The patient is instructed to identify one number between 0 and 10, which is best representative of their pain intensity. | Change from baseline to minutes 30, day 1, week 1, 2, 4, 6 after the block |
Can a Very High Result From a Screening Test for Celiac Disease be Used to Diagnose Celiac Disease?

Study Overview
=================
Brief Summary
-----------------
This study is to see if a high response to the TTG screening test for celiac disease is as accurate as the current method of diagnosing celiac disease which entails a general anesthetic and upper endoscopy to obtain biopsies of the small intestine. If the screening blood test is highly accurate, then some patients that are being evaluated for celiac disease may not require an upper GI endoscopy and can be treated more quickly. If they respond to the therapy then they will be deemed to have celiac disease.

Detailed Description
-----------------
All patients scheduled for upper GI endoscopy will be approached for recruitment into the study. A minimum of 4 small intestinal biopsies will be taken from all subjects and controls. All TTG specimens will be run through the hospital laboratory. Intermediate level TTG values 20-100 will be assessed separately and as part of the larger group. An optional part B of the study will assess the frequency of lactose intolerance in subjects prior to the start of a gluten free diet.

Official Title
-----------------
Prospective Assessment of High Titre TTG to Diagnose Celiac Disease in Select Paediatric Patients.

Conditions
-----------------
Celiac Disease

Intervention / Treatment
-----------------
* Procedure: Diagnosis of Celiac Disease


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion-All patients planned to undergo upper GI endoscopy with biopsies. Exclusion Criteria: Exclusion-refusal to participate, not planning to have biopsies performed with the endoscopy.

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Diagnosis of Celiac Disease|During GI endoscopy a minimum of 4 small intestinal biopsies will be taken from all subjects and 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
-----------------
TTG, pediatric, comparison study
Neuromuscular Block in Laryngeal Mask Airway(LMA) Insertion

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the success rate, insertion time and complication depending on the use of neuromuscular blocking agent when inserting the laryngeal mask airway (LMA).

Official Title
-----------------
Effect of Neuromuscular Blockade on the Insertion of ProSeal™ Laryngeal Mask Airway and Postoperative Pharyngolaryngeal Discomfort

Conditions
-----------------
General Anesthesia, Breast Disease

Intervention / Treatment
-----------------
* Drug: use of rocuronium when the LMA is inserted


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-70 year american society of anesthesiologist status 1-2 elective general anesthesia Exclusion Criteria: known or predicted difficult airway recent sore throat mouth opening less than 2.5 cm at risk of aspiration

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group N<br>Anesthesia is induced with propofol and remifentanil and LMA is inserted by the standard technique according to eht manufacturer's instruction. Rocuronium is administered for the operation. | Drug: use of rocuronium when the LMA is inserted<br>* Anesthesia is induced with a propofol and remifentanil in both groups, however rocuronium 0.06 mg/kg is injected only in group R. Insertion of LMA is performed by the standard technique according to the manufacturer's instruction. In group N, rocuronium is administered for the operation.<br>* Other names: esmeron;|
| Active Comparator: group R<br>Anesthesia is induced with a propofol and remifentanil and rocuronium 0.06 mg/kg is injected. Insertion of LMA is performed by the standard technique according to the manufacturer's instruction. | Drug: use of rocuronium when the LMA is inserted<br>* Anesthesia is induced with a propofol and remifentanil in both groups, however rocuronium 0.06 mg/kg is injected only in group R. Insertion of LMA is performed by the standard technique according to the manufacturer's instruction. In group N, rocuronium is administered for the operation.<br>* Other names: esmeron;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success rate and insertion time |  | when laryngeal mask airway is inserted | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complication after the remove of LMA - bleeding, sore throat |  | 1 hour after the LMA is removed |
Evaluation of a Rehabilitation Program After Lung Surgery

Study Overview
=================
Brief Summary
-----------------
Fast track programs, multimodal therapy strategies, have been introduced in many surgical fields to minimize postoperative morbidity and mortality. This study is intended to evaluate a rehabilitation program in comparison with a historical series.

Official Title
-----------------
Evaluation of a Rehabilitation Program After Lung Surgery (Prospective Observational Study)

Conditions
-----------------
Thoracic Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patient ASA 1, 2 or 3 lung surgery (postero-lateral or axillary approach) epidural analgesia Exclusion Criteria: preoperative oxygen therapy lack of autonomy unstable coronary artery disease FEV1 < 50% 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of postoperative hospital stay |  | end of hospitalisation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Program Monitoring |  | end of hospitalisation | 
| postoperative complications |  | end of hospitalisation |
Prospective Randomized Trial Comparing Two Techniques of Sleeve Gastrectomy

Study Overview
=================
Brief Summary
-----------------
This study compares if there is any difference doing antrectomy while performing a sleeve gastrectomy for treating morbid obesity. The investigators compare the differences between leaving or not leaving the antrum in terms of food tolerance, weight lost and quality of life.

Official Title
-----------------
Prospective Randomized Trial Comparing Two Techniques of Sleeve Gastrectomy

Conditions
-----------------
Morbid Obesity

Intervention / Treatment
-----------------
* Procedure: Sleeve gastrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI>40 kg/m2 Age >18 years old Eligible for laparoscopic surgery Exclusion Criteria: Prior bariatric surgery Sleeve gastrectomy as a part of a duodenal switch Second time surgery before 18 months Other procedures done during the surgery Conversion to laparotomy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Antrectomy<br> | Procedure: Sleeve gastrectomy<br>* Perform a gastrectomy guided by a 38F catheter and parallel to the small curvature of the stomach<br>|
| Active Comparator: Without antrectomy<br> | Procedure: Sleeve gastrectomy<br>* Perform a gastrectomy guided by a 38F catheter and parallel to the small curvature of the stomach<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight lose |  | One year | 
| Food tolerance |  | One year | 
| Quality of life |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic syndrome outcome |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Morbid obesity, High risk