linjc16/ctgov huggingface dataset:
Efficacy of SASI Bypass in Super Obese Patients

Study Overview
=================
Brief Summary
-----------------
Although previous studies investigated weight loss and improvement in comorbidities after SASI bypass, patients included in these studies had a BMI less than 50 Kg/m2. Therefore, the aim of the present study was to investigate the outcome of SASI bypass in patients with super obesity to assess the success of this novel bariatric procedure in this challenging group of patients in regards weight loss and improvement in associated comorbid conditions at 12 months postoperatively.

Official Title
-----------------
Assessment of the Efficacy of SASI Bypass in Super Obese Patients With BMI> 50 Kg/m2

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

Intervention / Treatment
-----------------
* Procedure: SASI bypass


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients included to the present study were adult patients of both genders aging between 18 and 65 years with primary morbid obesity with BMI ≥50 kg/m2 with or without obesity-associated comorbidities such as hypertension, diabetes mellitus (DM), dyslipidemias, and gastroesophageal reflux disease (GERD). Exclusion Criteria: Pregnant women. Patients unfit for general anasthesia (ASA 4, 5) Endocrine or psychiatric disorders. History of previous upper abdmominal laparotomy. Alcoholic addiction Liver cirrhosis Coagulopathy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SASI bypass<br>Patients with super obesity underwent SASI bypass | Procedure: SASI bypass<br>* Sleeve gastrectomy with single loop anastomosis between gastric antrum and ileum, 3 meters away from ileocecal junction<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of excess weight loss | [preoperative weight - weight at 12 months]/preoperative excess weight X 100 | at 12 months of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of diabetes mellitus | number of patients with fasting plasma glucose level <110 mg/dL or HbA1C level <6% without hypoglycemic medication | at 12 months of follow-up |
Second Trimester Pregnancy Termination With Foley Catheter

Study Overview
=================
Brief Summary
-----------------
One of the methods used to induce second trimester pregnancy termination is the placement of a transcervical Foley catheter. The aim of this randomized controlled study was to assess in pregnant women with an unfavourable cervix, whether there is a difference in efficacy between the two most commonly used insufflation volumes of Foley catheter (30mL and 50mL).

Official Title
-----------------
Second Trimester Pregnancy Termination With Foley Catheter With 30 ml vs 50 ml: Prospective Randomised Study

Conditions
-----------------
Pregnancy Termination

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: singleton pregnancies second trimester pregnancy ermination Exclusion Criteria: multiple pregnancies

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Foley catheter filled with 30 ml<br>The transcervical placement of the foley catheter will be performed and it will be filled with 30 ml saline. A gentle traction will be applied. | Device: Foley catheter<br>* Transcervical foley catheter will be applied<br>|
| Active Comparator: Foley catheter filled with 50 ml<br>The transcervical placement of the foley catheter will be performed and it will be filled with 50 ml saline. A gentle traction will be applied. | Device: Foley catheter<br>* Transcervical foley catheter will be applied<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| induction abortus interval | time to abortus will be recorded | up to five days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pregnancy termination, second trimester, foley catheter
NMR Scanning on Patients

Study Overview
=================
Brief Summary
-----------------
This protocol is designed to investigate the use of novel techniques in MRI that may not yet be commercially available. Specifically, the protocol enables patients to take advantage of new pulse sequence software, coil design or post processing capabilities not otherwise available. The informed consent explains MRI in lay terms, describes the use of contrast agents and lists contraindications to MRI.

Detailed Description
-----------------
NMR imaging promises to provide useful and unique diagnostic information in a variety of diseases. In an attempt to evaluate its role, we plan to study a wide range of diseases during the initial year of imaging. Exposure to magnetic fields and radiofrequency energies of this magnitude have demonstrated no deleterious effects clinically or in the laboratory. The only restrictions will be those imposed by ferromagnetic objects within the patient which would increase the risk of placing them in a strong magnetic field.

Official Title
-----------------
NMR Scanning on Patients

Conditions
-----------------
Diagnostic Imaging

Participation Criteria
=================
Eligibility Criteria
-----------------
Any patient undergoing MRI for research or clinical purposes who is participating in a currently active NIH protocol. No patients with pacemakers, cochlear implants, implanted pumps, shrapnel, metal in the globe of the eye, cerebral aneurysm clips or other contraindication to MRI.
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
-----------------
Helium Cryogen, Magnetic Field, Multi-Institute, Nitrogen Cryogen, Radiofrequency
Predictability of the Ability to Perform an Emergency Stop After Surgery for Inguinal Hernia

Study Overview
=================
Brief Summary
-----------------
Several studies exist on patient performance in drive simulators especially around and after surgery. Recommendations concerning the ability to drive after inguinal hernia are scarce and so far do not offer conclusive results. Aim of the study is to analyse reaction time and foot transfer time (together brake response time) and brake force in a brake simulator before and after scheduled inguinal hernia surgery (Liechtenstein procedure).

Official Title
-----------------
Predictability of the Ability to Perform an Emergency Stop After Surgery for Inguinal Hernia

Conditions
-----------------
Inguinal Hernia

Intervention / Treatment
-----------------
* Other: Braking performance in a brake simulator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: scheduled surgery for inguinal hernia of the right groin with Lichtenstein procedure valid driving license male and female Exclusion Criteria: lacking driving license pregnancy neuromuscular disorder (e.g. myopathy, muscular dystrophy) central neurological disorders/diseases (e.g. apoplexia, psychiatric diseases)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Braking after inguinal hernia surgery<br>Cohort testing of driving performance in a brake simulator in patients before and after scheduled inguinal hernia surgery | Other: Braking performance in a brake simulator<br>* Braking performance is tested in a real middle size car cabin to simulate ergonomic conditions of driving a car. This testing cabin has been equipped with customised equipment to allow measurement of reaction time, foot transfer time, brake response time and brake force.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Braking performance 1 | Improvement of Braking performance from preoperatively to 2 days postoperatively in the brake simulator with the focus on brake response time (ms) | measurements will be: preoperatively, 2 days postoperatively | 
| Braking performance 2 | Improvement of Braking performance from preoperatively to 8 days postoperatively in the brake simulator with the focus on brake response time (ms) | measurements will be: preoperatively, 8 days postoperatively |
Corneal Collagen Cross-Linking for Ectasia (CXL)

Study Overview
=================
Brief Summary
-----------------
Prospective, randomized multicenter study to determine the safety and effectiveness of performing corneal collagen cross-linking (CXL) using riboflavin and UVA light in eyes with ectasia after refractive surgery.

Detailed Description
-----------------
Subjects are randomized to a control group or a treatment group, with the control group crossed over to the treatment group at the 3 month visit. Corneal collagen cross-linking is performed as a single treatment. Subjects are followed for 12 months after the procedure to evaluate the long term effects of corneal collagen cross-linking.

Official Title
-----------------
Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking in Eyes With Corneal Ectasia After Refractive Surgery

Conditions
-----------------
Ectasia

Intervention / Treatment
-----------------
* Drug: riboflavin ophthalmic solution
* Device: UVA Irradiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of ectasia after refractive surgery Documented ectasia on Pentacam or topography map BSCVA worse than 20/20 Must complete all study visits Exclusion Criteria: History of delayed wound healing History of corneal melt or corneal dystrophy

Ages Eligible for Study
-----------------
Minimum Age: 14 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 |
| --- | --- |
| Active Comparator: Corneal Collagen Cross-linking (CXL) Treatment Group<br>riboflavin ophthalmic solution and UVA irradiation | Drug: riboflavin ophthalmic solution<br>* riboflavin 0.1% ophthalmic solution (approximately 32 drops, or 1.6 mL)<br>Device: UVA Irradiation<br>* UVA light (365 nm at an irradiance of 3 mW/cm2) for 30 minutes<br>* Other names: UV-X™ Illumination System;|
| Sham Comparator: Control Group<br>riboflavin opthalmic solution without UVA irradiation | Drug: riboflavin ophthalmic solution<br>* riboflavin 0.1% ophthalmic solution (approximately 32 drops, or 1.6 mL)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Maximum Keratometry (Kmax) | The primary efficacy parameter was corneal curvature, as measured by maximum keratometry (Kmax) in the study eyes. Study success was defined as a difference of ≥1 D in the mean change in Kmax from baseline to 12 months between the CXL group and control group. Keratometry was measured manually and by pentacam. | baseline,12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ectasia, cross-linking, crosslinking, cornea, riboflavin, UVA
Clinical MR Spectroscopy of Brain Metastases at 1,5T and 3T.

Study Overview
=================
Brief Summary
-----------------
Increasing magnetic field is known to give improvements in signal-to-noise-ratio (SNR) and spectral resolution. To investigate this, spectra from different subjects were examined using two clinical MR instruments operating at 1.5T and 3T respectively.

Official Title
-----------------
In Vivo Proton MR Spectroscopy of Brain Metastases Obtained at 1,5T and 3T.

Conditions
-----------------
Neoplasm Metastases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: brain metastases Exclusion Criteria: children pregnancy

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 |
| --- | --- |
| brain metastases<br>6 patients | |
| healthy<br>13 volunteers | |

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
-----------------
brain metastasis, signal to noise ratio, spectral resolution
VEGF Gene Transfer for Diabetic Neuropathy

Study Overview
=================
Brief Summary
-----------------
This gene therapy study is being conducted to evaluate intramuscular gene transfer using VEGF (Vascular Endothelial Growth Factor) in patients with diabetic neuropathy in the legs. This condition causes a decrease in feeling and sensation due to diabetes. VEGF is DNA, or genetic material that is injected into the muscles of the leg. Once in the leg, it has been shown to cause new blood vessels to grow under a variety of conditions.

Official Title
-----------------
p.VGI.1 (VEGF2) Gene Transfer for Diabetic Neuropathy

Conditions
-----------------
Diabetic Neuropathy

Intervention / Treatment
-----------------
* Biological: VEGF
* Biological: VEGF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: To be eligible to enroll and remain in the study, patients must meet the following criteria: Be at least 21 years old. Have type I or type II diabetes mellitus and require oral anti-hyperglycemic agents or insulin. Have peripheral neuropathy related to diabetes. Exclusion criteria Patients are to be excluded from the trial if any of the following conditions are met: Have a history of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years. Be unable to meet study requirements, including approximately 7-9 out-patient visits over a 12 month period.

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>VEGF | Biological: VEGF<br>* 3 sets of injections, at 2 week intervals<br>|
| Placebo Comparator: 2<br>Placebo | Biological: VEGF<br>* 3 sets of injections, at 2 week intervals<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus, Neuropathy, Peripheral Artery Disease
Efficacy and Safety Study of Eprotirome in HeFH Patients Who Are on Optimal Standard of Care

Study Overview
=================
Brief Summary
-----------------
Eprotirome is a liver selective thyroid hormone that can reduce several independent risk factors for cardiovascular disease, while an euthyroid state is preserved in the extrahepatic tissue. The purpose of this Phase III study is to assess the long-term efficacy and safety of Eprotirome in Patients with heterozygous Familial Hypercholesterolaemia who are on optimal standard of care.

Official Title
-----------------
A Placebo-controlled, Double-blind, Randomised, Parallel-group, Long Term Phase III Trial Assessing the Safety and Efficacy of Eprotirome in Patients With Heterozygous Familial Hypercholesterolaemia Who Are on Optimal Standard of Care

Conditions
-----------------
Heterozygous Familial Hypercholesterolaemia

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Eprotirome
* Drug: Eprotirome


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with confirmed HeFH and 18 years of age at screening Presence of clinical atherosclerotic disease that confers high risk for CAD events together with an LDL-C more than 2 mmol/L (more than 80 mg/dL) Presence of risk factors for CVD (other than the HeFH diagnosis) together with an LDL-C more than 2.5 mmol/L (more than 100 mg/dL) On an optimal standard of care, defined as being on a stable dose of statin (rosuvastatin, atorvastatin, or simvastatin) with or without ezetimibe for 8 weeks prior to randomisation Exclusion Criteria: Significant health problems in recent past including heart failure,cardiac electrophysiologic instability, rheumatoid arthritis, thyroid dysfunction, liver disease, cancer, secondary dyslipidaemia

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Tablets taken daily<br>|
| Experimental: Eprotirome I<br> | Drug: Eprotirome<br>* Tablets taken daily<br>* Other names: KB2115;|
| Experimental: Eprotirome II<br> | Drug: Eprotirome<br>* Tablets taken daily<br>* Other names: KB2115;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent reduction in low-density lipoprotein cholesterol (LDL-C) from baseline |  | 12 weeks treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypercholesterolemia,, dyslipidemia,, thyroid,, safety,, Heterozygous Familial Hypercholesterolaemia, coronary artery disease
Evaluation of Adult Onset Still Disease Classification Criteria and Differential Diagnosis at Eighteen Months of Follow-up

Study Overview
=================
Brief Summary
-----------------
Adult Onset Still Disease (AOSD) is an acquired inflammatory disease of unknown etiology, presenting with non specific symptoms. Its diagnosis rely on sets of criteria, i.e. Fautrel Criteria and Yamaguchi Criteria. However, differential diagnosis might appear during follow-up of patients. The aim of this study is to assess diagnostic performance of Fautral and Yamaguchi Criteria after 18 months of follow-up, and to describe differential diagnosis appearing during follow-up.

Detailed Description
-----------------
Adult Onset Still Disease (AOSD) is an acquired inflammatory disease of unknown etiology, presenting with non specific symptoms. Other conditions such as cancer, infection or other inflammatory disease might mimick its symptoms. Its diagnosis rely on sets of criteria, i.e. Fautrel Criteria and Yamaguchi Criteria. However, differential diagnosis might appear during follow-up after an initial diagnosis of AOSD. The aim of this study is to assess diagnostic performance of Fautral and Yamaguchi Criteria after 18 months of follow-up, and to describe differential diagnosis appearing during follow-up.

Official Title
-----------------
Evaluation of Adult Onset Still Disease Classification Criteria and Differential Diagnosis at Eighteen Months of Follow-up

Conditions
-----------------
Adult Onset Still Disease

Intervention / Treatment
-----------------
* Other: diagnosis criteria performance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults with glycosylated ferritin dosage for suspected adult onset still disease with at least 18 month of follow-up Exclusion Criteria: known infectious disease known cancer known active connective tissue disease or vasculitis

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


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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: diagnosis criteria performance|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnosis performance of Yamaguchi and Fautrel criteria at 18 months of follow-up | Sensitivity, Specificity, positive predictive value, negative predictive value | after 18 months of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| description of differential diagnosis mimicking adult onset still disease |  | after 18 months of follow-up | 
| identifying factors associated with the occurence of a differential diagnosis during follow-up |  | after 18 months of follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adult onset still disease, differential diagnosis, diagnosis performance