linjc16/ctgov huggingface dataset:
Comparing Between Two Different Restoration

Study Overview
=================
Brief Summary
-----------------
Clinical performance of two different ceramic restoration in patient mouth after 3 years follow up

Detailed Description
-----------------
Comparing two different dental restoration in patient mouth after 3 years follow up by using USPHS criteria

Official Title
-----------------
Clinical Performance of Lithium Disilicate Versus Hybrid Resin Ceramic for Inlay and Onlay Restoration After 3 Years Follow up

Conditions
-----------------
Dental Restoration Failure

Intervention / Treatment
-----------------
* Other: Full Ceramic restoration
* Other: Hybrid resin Ceramic restoration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: good oral hygiene Exclusion Criteria: bad oral hygiene

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 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
Interventional Model Description: Two different restorations in patient mouth
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Hybrid resin ceramic restoration<br>Dental restoration | Other: Hybrid resin Ceramic restoration<br>* Hybrid resin Ceramic restoration<br>|
| Other: Full ceramic restoration<br>Dental restoration | Other: Full Ceramic restoration<br>* Two different dental restoration inserted in patient mouth ( split mouth)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of two different restoration | Using (USPHS) criteria | 3 years |
Laparoscopy-Assisted Transgastric ERCP

Study Overview
=================
Brief Summary
-----------------
We describe a case of a 57-year-old patient with altered RYGB anatomy, who underwent a laparoscopic cholecystectomy with a intra-operative cholangiogram showing a stone on the common bile duct. A laparoscopic assisted trans-gastric ERCP was successfully performed. The presentation of the case is presented as well a review of the literature.

Detailed Description
-----------------
The exclusion of the stomach after Roux-en-Y-Gastric bypass (RYGB) makes access to the biliary tree very challenging for the surgeon or the endoscopist. There are different techniques described to overcome this downside, being laparoscopic assisted trans-gastric endoscopic retrograde cholangiopancreatography (ERCP) approach an outstanding method to access the remnant stomach for reaching the duodenal papilla, with a high rate of success reported. We describe a case of a 57-year-old patient with altered RYGB anatomy, who underwent a laparoscopic cholecystectomy with a intra-operative cholangiogram showing a stone on the common bile duct. A laparoscopic assisted trans-gastric ERCP was successfully performed, introducing the duodenoscope through a gastrostomy without the need of an intra-gastric trocar. The patient evolved favorably and was discharged on his second postoperative day without complications.

Official Title
-----------------
Laparoscopy-Assisted Transgastric Endoscopic Retrograde Cholangiopancreatography for Choledocholithiasis After Roux-en-Y Gastric Bypass

Conditions
-----------------
Biliary Obstruction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with altered Roux en Y Gastric Bypass anatomy Exclusion Criteria: Patients without Roux en Y Gastric Bypass anatomy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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 |
| --- | --- | --- |
| Proof the efficacy of laparoscopic assisted transgastric endoscopic retrograde cholangiopancreatography | This technique is a feasible and achievable procedure with low rate of complications for treating patients with altered RYGB anatomy that present biliary tract disorders, allowing an endoscopic treatment and cholecystectomy to be performed in a single setting. | April 2019 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
biliary disease, gallstones, obesity
Efficacy and Safety of Enteric-coated Mycophenolate Sodium in Heart Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
This purpose of this extension study of patients being treated with EC-MPS is to assess the long term safety of this medication.

Official Title
-----------------
A Prospective, Open-label, Multicenter Extension Study on the Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Heart Transplant Recipients

Conditions
-----------------
Patients Successfully Completing the 12-month Treatment Period of the Core Study (de Novo Heart Recipients) Who Were Interested of Being Treated With EC-MPS

Intervention / Treatment
-----------------
* Drug: EC-MPS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who were participating in the core study CERL080A2401 and have successfully completed the first 12 months of the core study Exclusion Criteria: Patients who did not complete the 12-month core study CERL080A2401 Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: EC-MPS|nan|

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
-----------------
Enteric-coated mycophenolate sodium, heart transplant recipients, long term safety
Use of Intravitreal Bevacizumab in Eyes With Choroidal Neovascularization Secondary to Angioid Streaks

Study Overview
=================
Brief Summary
-----------------
Intravitreal Bevacizumab is an effective treatment for choroidal neovascularization secondary to Angioid Streaks

Detailed Description
-----------------
A consecutive case series of patients with angioid streaks that developed subfoveal choroidal neovascularization were treated with a primary 2.5 mg injection of Bevacizumab (Avastin) intravitreally. All patients were evaluated with BCVA at 1, 2 , 4 and 12 weeks and OCT and fluoresceine angiography at month 1 and 3. (Patients will be follow 6 months)

Official Title
-----------------
OCT, Visual Outcome and Angiographic Analysis of Choroidal Neovascularization in Six Eyes With Angioid Streaks Treated With a Single Intravitreal Injection of Bevacizumab

Conditions
-----------------
Angioid Streaks, Choroidal Neovascularization

Intervention / Treatment
-----------------
* Drug: Intravitreal Bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Angioid Streaks Choroidal neovascularization associated Untreated patients or patients treated once with PDT Exclusion Criteria: Ocular surgery excepting uncomplicated phacoemulsification Glaucoma or any other ocular pathology
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 |
| --- |
|Drug: Intravitreal Bevacizumab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BCVA |  |  | 
| Fluoresceine Angiography |  |  | 
| Optical Coherence Tomography |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Angioid Streaks, Choroidal Neovascularization, Bevacizumab
Surgical Bypass Versus Hybrid Approaches for Critical Limb Ischemia

Study Overview
=================
Brief Summary
-----------------
The present randomized study proposed to compare the immediate postoperative and 2-year clinical outcomes of long surgical bypass and hybrid approaches in patients with multilevel critical lower limb ischemia.

Official Title
-----------------
Long Surgical Bypass Versus Hybrid Approaches for Management of Critical Limb Ischemia

Conditions
-----------------
Critical Lower Limb Ischemia

Intervention / Treatment
-----------------
* Procedure: long surgical bypass
* Procedure: Hybrid approach


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: TASC II type D femoropopliteal lesions with intact ipsilateral femoral pulse. Fontaine classification stage IV (gangrene or necrosis). Rutherford grade III and IV category 5 and 6 with salvageable foot Exclusion Criteria: heart failure liver failure renal impairment

Ages Eligible for Study
-----------------
Minimum Age: 50 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: long surgical bypass<br>long surgical bypass for multilevel lower limb ischemia | Procedure: long surgical bypass<br>* long surgical bypass and hybrid approaches in patients with multilevel critical lower limb ischemia.<br>|
| Experimental: Hybrid approach<br>surgical bypass and endovascular treatment for multilevel lower limb ischemia | Procedure: Hybrid approach<br>* Hybrid approach including bypass and endovascular revascularization<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late occlusion | Late occlusion of the affected vessels | 2 years |
Osteopathic Treatment in Adult Patients With Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
To study the contribution of osteopathy on the reduction of pain in adult patients with cystic fibrosis

Detailed Description
-----------------
To compare the impact of osteopathic treatment to a placebo of osteopathic treatment and to usual care on pain at 6 months in adult patient with cystic fibrosis localized to chest, cervical, dorsal neck or back.

Official Title
-----------------
Impact of an Osteopathic Manipulative Treatment on Pain of Adult Patients With Cystic Fibrosis - a Pilot Study

Conditions
-----------------
Cystic Fibrosis, Back Pain, Neck Pain, Chest Pain

Intervention / Treatment
-----------------
* Procedure: Osteopathic treatment
* Procedure: Sham Placebo
* Procedure: Usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria : Diagnosis of cystic fibrosis ( positive sweat test and / or presence of 2 disease causing mutations in the CFTR gene Age > 18 years Patient with chronic chest , neck or back pain Written Informed Consent with health insurance Exclusion criteria : regular follow-up by an osteopathic physician in the previous 3 months patients awaiting lung transplantation history of lung transplantation pregnancy understanding disorders preventing the patient to apply the study participation in another clinical interventional study protocol

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Osteopathic treatment | Procedure: Osteopathic treatment<br>* Real treatment of osteopathy<br>* Other names: Real treatment of osteopathy;|
| Placebo Comparator: Placebo<br>Sham osteopathic treatment | Procedure: Sham Placebo<br>* Sham treatment of osteopathy<br>* Other names: Sham treatment of osteopathy;|
| Active Comparator: Usual care<br>Classic treatment of cystic fibrosis patients | Procedure: Usual care<br>* Classical treatment of pain in cystic fibrosis patients<br>* Other names: Classical treatment of pain in cystic fibrosis patients;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score |  | at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life scores |  | at 6 months | 
| Co-interventions |  | at 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Complementary and alternative medicine, Osteopathic treatment
Life Quality and Health in Patients With Klinefelter Syndrome

Study Overview
=================
Brief Summary
-----------------
Klinefelter syndrome is the most common sex-chromosome disorder in men with a prevalence of 1 in 660 men. The syndrome is associated with hypogonadism. Many patients with Klinefelter syndrome have psychological complaints and physical discomfort. Some patients report a positive effect of testosterone treatment, whereas others do not. The aim of this study is: (i) To investigate quality of life in patients with Klinefelter syndrome. (ii) To investigate functional, physical and mental health in patients with Klinefelter syndrome. Questionnaire concerning mental and physical health and life quality are sent out to patients with KS and to age-, educational- and zipcode-matched men from the general population. The questionnaire include questions about housing, income, marital status, fatherhood, medication, chronic disease,school and education, attachment to the labor, sexual and erectile function, life quality, mental and physical health, satisfaction with life and symptoms of attention deficits hyperactivity disorders.

Official Title
-----------------
Life Quality and Health in Patients With Klinefelter Syndrome - a Questionnaire Survey

Conditions
-----------------
Klinefelter Syndrome, Quality of Life, Physical Disorders, Mental Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
For the Klinefelter group: Inclusion Criteria: Verified Klinefelter syndrome Exclusion Criteria: none For the control group: Inclusion Criteria: age-,educational,and residence-matched Exclusion Criteria: none

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Klinefelter<br>Men with Klinefelter syndrome | |
| Control<br>Men from the general population, matched by age, education and zipcode. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Quality of life score is measured with the WHOQOL-Brief questionnaire | 3 month | 
| Satisfaction with life | Satisfaction with life is measured with the SWLS - Satisfaction with Life Scale | 3 month | 
| ADHD symptoms | ADHD symptoms are measured by Adult ADHD Self-Report Scale (ASRS-v1.1) Symptom Checklist | 3 month | 
| General health | General health is measured by SF-36 questionnaire | 3 month | 
| Erectile function | Erectile function is measured by the International index of erectile function (IIEF-5) as a diagnostic tool for erectile function. | 3 month |
Quality Improvement in Handover of General Internal Medicine In-patients

Study Overview
=================
Brief Summary
-----------------
Miscommunication during patient handover can jeopardize patient safety and is the focus of Quality Improvement initiatives by many organizations. It is widely recognized that such miscommunication is preventable using a number of strategies identified in the literature. Currently, there is no formal handover process of General Internal Medicine in-patients, otherwise known as the Clinical Teaching Unit (CTU) at Vancouver General Hospital, which is a major patient safety concern. This project will implement a formal handover program and evaluate whether there are changes in resident satisfaction with handover, but more importantly, whether the investigators can improve patient outcomes.

Official Title
-----------------
Quality Improvement in Handover of General Internal Medicine In-patients

Conditions
-----------------
Quality Improvement in Patient Handoff

Intervention / Treatment
-----------------
* Other: Handover program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Residents, medical students, and patients Residents and medical students will be any rotating through General Internal Medicine at Vancouver General Hospital Patients will be any admitted to General Internal Medicine and cared for during on-call hours (defined as 18:00 - 07:00) Exclusion Criteria: None for residents and medical students Patients who are not being cared for during on-call hours (defined as 18:00 - 07:00)
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Handover program<br>Standardized handover program Dedicated place and time Template Face-to-face communication Evidence-based education session Feedback and audit | Other: Handover program<br> <br> |
| No Intervention: Usual handover practice<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients handed over to the on-call resident/Clinical Associate (CA) |  | 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Handover, Handoff, Signout, Quality Improvement, General Internal Medicine
Skin Denervation in Systemic Lupus Erythematosus

Study Overview
=================
Brief Summary
-----------------
To address the issues of skin denervation and its clinical and pathological correlations in systemic lupus erythematosus

Detailed Description
-----------------
To address the issues of skin denervation and its clinical and pathological correlations in lupus, we will study a systemic lupus erythematosus (SLE) cohort by evaluating the extent of cutaneous innervation. Patients are recruited from the rheumatologic clinic, and various neuropsychiatric syndromes are diagnosed based on clinical judgement following detailed history taking and neurological examinations. Skin biopsy with PGP 9.5 immunohistochemistry will be performed following established procedures after informed consent is obtained, and punches of 3 mm in diameter will be taken from the lateral side of the distal leg, 10 cm above the lateral malleolus. Intraepidermal nerve fibre densities will be compared with results of immunological, pathological, psychophysical, and electrophysical studies to understand the pathogenesis of peripheral neuropathy in SLE.

Conditions
-----------------
Systemic Lupus Erythematosus

Intervention / Treatment
-----------------
* Procedure: 3 mm-punch biopsies of the skin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of systemic lupus erythematosus based on the consensus criteria Exclusion Criteria: Conditions known to be associated with peripheral neuropathy, such as diabetes, uremia, alcoholism, and the administration of potentially neurotoxic agents, such as alkylating agents, methotrexate, cyclosporine, and antibiotics.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: 3 mm-punch biopsies of the skin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitation of epidermal innervation |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peripheral neuropathy;systemic lupus erythematosus