linjc16/ctgov huggingface dataset:
Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study

Study Overview
=================
Brief Summary
-----------------
This study purpose is to evaluate the association between Retinal Vein Occlusion and Obstructive Sleep Apnea.

Detailed Description
-----------------
There will be two groups of 50 patients. One with Retinal Vein Occlusion, and the other one, with no Retinal Vein Occlusion will be chosen from the consultation. The compared group will be paired on different criteria including hypertension, ocular hypertension, diabetes, sex, age. They will all spend a night at home with a Sleeping Monitor (Nox T3) in order to evaluate if they have an Obstructive Sleep Apnea.

Official Title
-----------------
Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study

Conditions
-----------------
Retinal Vein Occlusion, Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Other: Sleeping Monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with an Retinal Vein Occlusion for one group (patients) All patients with no Retinal Vein Occlusion for the other group (control) Non-inclusion Criteria: minor Severe Insomnia Neuromuscular Disease with respiratory muscle impairment Chronic opioid medication Pregnancy women. Patient under guardianship

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: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: case-control comparison study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patient<br>Patient with Retinal Vein Occlusion | Other: Sleeping Monitor<br>* to evaluate obstructive sleep apnea<br>|
| Other: Patient control<br>Patient with no Retinal Vein Occlusion | Other: Sleeping Monitor<br>* to evaluate obstructive sleep apnea<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea Hypopnea index >5/hour | Obstructive Sleepin Apnea diagnostic depends only on the AHI which is measured by the Sleeping Monitor at home. | Hour 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Berlin Questionnaire sleep test | High Risk of Sleep Apnea Syndrome: If there are 2 or more Categories where the score is 2 or above Low Risk of Sleep Apnea Syndrome: If there is only 1 or no Categories where the score is 2 or above | Hour 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Retinal Vein Occlusion, central retinal vein occlusion, branch retinal vein occlusion, obstructive sleep apnea, sleep apnea
The Observer Variation of Shear Wave Elastography

Study Overview
=================
Brief Summary
-----------------
Background: The main goal of diagnosing thyroid nodules is to differentiate the few malignant from the large background of benign lesion. Currently available pre-operative tests are unable to rule out malignancy in a subset of patients and diagnostic surgery is necessary. Therefore there is a need to develope the available diagnostic tools for the pre-operative diagnostic work-up of thyroid nodules. The study will investigate a novel ultrasonographic technique called Shear Wave Elastography (SWE) in the pre-operative evaluation of thyroid nodules. Hypothesis: 1) SWE is a precise tool for evaluation of thyroid nodules in terms of inter- and intra-observer reliability and day-to-day variation. The study will be conducted as part of a larger PhD study, and an evaluation of the diagnostic value of thyroid SWE will be evaluated in a larger study. Perspectives: An optimization of the pre-operative risk-stratification and diagnosis of thyroid nodules can reduce unnecessary thyroid surgery, with a reduction in morbidity and better use of the economic and surgical resources.

Official Title
-----------------
Intra- and Inter-observer Variation of Thyroid Shear Wave Elastography - a Variability Study

Conditions
-----------------
Thyroid Nodular Disease

Intervention / Treatment
-----------------
* Device: Ultrasonographic Shear Wave Elastography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with a thyroid nodule ≥1 cm in largest dimension (solitary or dominating nodule in multinodular goiter), Patients undergoing thyroid surgery. Exclusion Criteria: Nodules located in the isthmus of the thyroid

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Shear Wave Elastography<br>All included patients undergo a supplementary Shear Wave Elastographic scan | Device: Ultrasonographic Shear Wave Elastography<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elasticity index | Elasticity Index is obtained by ultrasonographic Shear Wave Elastography performed by two investigators on the same day. The inter- and intra-observer variation and day-to-day variation is calculated | Repeat measures obtained on the same day (ten minutes to one hour between measurements), and measures obtained on a different day (one day to several weeks). |
Efficacy of Ketoprofen Before Intrauterine Device Insertion

Study Overview
=================
Brief Summary
-----------------
IUD can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the IUD insertion tube, and removing the tube; and placement of the device in the uterus.

Detailed Description
-----------------
To minimize the discomfort and the hazards of an IUD insertion, several measures have been proposed including NSAIDs, anxiolytics, and local anesthetics in the form of intracervical gel, cervical and para-cervical block, but there have not done enough studies about their effectiveness. According to the review published in the Cochrane, non-steroidal anti-inflammatory drugs and misoprostol are not effective on reducing an IUD insertion pain.

Official Title
-----------------
Effect of Oral Ketoprofen on Intra Uterine Device Insertion Pain: A Randomized Controlled Trial

Conditions
-----------------
Pain Relief

Intervention / Treatment
-----------------
* Drug: Ketoprofen
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women not taken analgesics or anxiolytics in the 24 hours prior insertion Women not taken misoprostol prior to insertion No contraindication to Non-steroidal drugs Women who will accept to participate in the study Exclusion Criteria: Any contraindication to device placement

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketoprofen<br>women will take one tablet 150 mg one hour before the procedure | Drug: Ketoprofen<br>* oral non-steroidal antiinflammatory drug<br>* Other names: bi profenid;|
| Placebo Comparator: Placebo<br>women will take one placebo tablet one hour before the procedure | Drug: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean pain score during IUD insertion |  | 5 minutes |
Combination of Benazepril Plus Hydrochlorothiazide in Chinese Patients With Mild to Moderate Essential Hypertension

Study Overview
=================
Brief Summary
-----------------
This study will evaluate efficacy and safety data for benazepril/hydrochlorothiazide in adult Chinese patients with mild to moderate essential hypertension. Patients whose blood pressure is not adequately controlled with benazepril monotherapy during a 4 week run-in period will be randomly allocated to double blind treatment over 8 weeks with either a combination of benazepril/hydrochlorothiazide per day or continuation of benazepril per day.

Official Title
-----------------
Efficacy and Safety of the Combination of Benazepril Plus Hydrochlorothiazide in Chinese Patients With Mild to Moderate Essential Hypertension Not Adequately Controlled With Benazepril

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Benazepril plus hydrochlorothiazide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients, age 18 or older Given informed consent Diagnosed as having mild to moderate essential hypertension Exclusion Criteria: Severe hypertension Significant preexisting cardiovascular and cerebrovascular disease Diabetes mellitus type 1 or poorly controlled diabetes mellitus type II Advanced renal impairment Other protocol-defined inclusion/exclusion criteria may apply.

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 |
| --- |
|Drug: Benazepril plus hydrochlorothiazide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in diastolic blood pressure from baseline to week 8 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in systolic blood pressure from baseline to week 8 |  |  | 
| Proportion of patients with blood pressure less than 140/90 mmHg at week 8 |  |  | 
| Ambulant blood pressure monitoring profiles at baseline and week 8 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, benazepril, hydrochlorothiazide, fixed combination
5FU/VL Vs LV5FU2 + CPT11 in Stage II-III Resected Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
The main objective of this randomized trial is to compare 5FU/LV (Mayo-Clinic regimen or LV5FU2) to LV5FU2 + irinotécan in patients with resected B2 and C rectal cancer. Preoperative radiotherapy is recommended but not mandatory. Main endpoint is disease free survival. Secondary endpoint are overall survival, time to local recurrence, time to distant metastases, and tolerance. A total of 600 patients will be included in the trial.

Conditions
-----------------
Cancer of the Rectum

Intervention / Treatment
-----------------
* Procedure: 5FU/LV Mayo Clinic or LV5FU2
* Procedure: LV5FU2 + irinotecan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: rectal adenocarcinoma R0 surgery T3, N0, M0 or T4, N0, M0 or N1,2, M0 chemotherapy can be started within 8 weeks after surgery Age > 18 Performance status ECOG < 3 preoperative radiotherapy allowed preoperative chemotherapy with 5FU +/- LV allowed Neutrophiles > 1 500/mm3; Pl. > 100 000/mm3 Transaminases < 2 x UNL; Alcalines Phosphatases < 2 x UNL; Bili < 1.1 UNL creatininemia < 120 µmol/l and/or clearance of creatininemia > 60 ml/mn Written informed consent before inclusion Exclusion Criteria: postoperative radiotherapy Distant metastases Contraindication to any drug contained in the chemotherapy regimens Any serious active disease or co-morbid medical condition including digestive inflammatory disease Gilbert disease severe toxicity of radiotherapy Pregnancy or breast feeding Absence of contraception in non menopausal women Adult patient unable to give informed consent because of intellectual impairment Concomitant participation to another trial

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

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

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

| Intervention/Treatment |
| --- |
|Procedure: 5FU/LV Mayo Clinic or LV5FU2|nan|
|Procedure: LV5FU2 + irinotecan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Efficacy Study of Imatinib Mesylate to Treat Philadelphia-Positive Acute Lymphocytic Leukemia

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to determine the efficacy and safety of imatinib mesylate in patients diagnosed as having Philadelphia chromosome positive acute lymphocytic leukemia (ALL).

Official Title
-----------------
Phase II Study of Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia

Conditions
-----------------
Philadelphia Chromosome Positive Acute Lymphocytic Leukemia

Intervention / Treatment
-----------------
* Drug: Imatinib Mesylate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with histologically confirmed diagnosis of ALL. Patients confirmed to be Ph chromosome positive or bcr-abl gene positive. Patients in relapse Patients refractory to initial remission induction therapy Patients ineligible for initial remission induction therapy Patients with an ECOG Performance Status Score from 0 to 2 Serum creatinine concentration of not more than 2 × the upper limit of the normal range (ULN) AST (SGOT) and ALT (SGPT) of not more than 3 × ULN. In patients with hepatic dysfunction from leukemic involvement, AST (SGOT) and ALT (SGPT) should be not more than 5 × ULN Serum bilirubin level not more than 3 × ULN Exclusion Criteria: Patients with findings indicative of leukemic involvement of the central nervous system Patients with any serious concomitant medical condition (e.g., poorly controllable infection, interstitial pneumonia, pulmonary fibrosis, congestive cardiac failure, poorly controlled diabetes mellitus, mental disorder) Patients expected to receive any hematopoietic stem cell transplantation within 6 weeks of the planned initiation of the study drug Patients having received any hematopoietic stem cell transplantation who have a Grade 3 or 4 GVHD. Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 15 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: imatinib mesylate<br> | Drug: Imatinib Mesylate<br> <br> * Other names: Gleevec;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3 month hematological response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of hematological response |  |  | 
| Survival |  |  | 
| Cytogenetic response in every 3 months |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ph+ALL, imatinib mesylate
GSK BHR Study (Sont - Second Study)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to determine whether asthma control and reduced bronchial responsiveness could be achieved and maintained at a lower dose of inhaled corticosteroids with ADVAIR DISKUS BID or FP BID in adult and adolescent patients with persistent asthma

Official Title
-----------------
A Multicenter, Randomized, Double-blind, Parallel Group, 40-week Comparison of Asthma Control Using Bronchial Hyperresponsiveness as an Additional Guide to Long-term Treatment in Adolescents and Adults Receiving Either Fluticasone Propionate/Sameterol DISKUS Twice Daily or Fluticasone Propionate DISKUS Twice Daily (or Placebo Twice Daily if Asymptomatic)

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Placebo
* Drug: FP 100mcg
* Drug: FP 250mcg
* Drug: FP 500mcg
* Drug: FSC 100/50mcg
* Drug: FSC 250/50mcg
* Drug: FSC500/50mcg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of asthma Controller asthma medication or medium dose ICS Current or historical reversibility Exclusion Criteria: Life-threatening asthma Asthma instability Concurrent respiratory disease Drug allergies Respiratory tract infection Systemic corticosteroid use Immunosuppressive medication use Postive pregnancy test Tobacco use Investigation medication use Site affiliation

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- |
| Active Comparator: Fluticasone propionate<br> | Drug: Placebo<br>* Twice daily dosing<br>* Other names: FP 500mcg;Drug: FP 100mcg<br>* Twice daily dosing<br>Drug: FP 250mcg<br>* Twice daily dosing<br>Drug: FP 500mcg<br>* Twice daily dosing<br>|
| Active Comparator: Fluticasone propionate/salmeterol combination<br> | Drug: Placebo<br>* Twice daily dosing<br>Drug: FSC 100/50mcg<br>* Twice daily dosing<br>Drug: FSC 250/50mcg<br>* Twice daily dosing<br>Drug: FSC500/50mcg<br>* Twice daily dosing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average ICS treatment dose over the treatment period |  | Every 8 weeks through 40 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary function measures |  | Every 8 weeks through 40 weeks of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FP, Asthma, Sont, FSC, BHR
A New Anticoagulation Method Using Dalteparin in Quotidian and Nocturnal Home Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
This study evaluates the optimal dosage and safety of Dalteparin when used as an anticoagulant for hemodialysis therapies.

Detailed Description
-----------------
Routine anticoagulation is required during hemodialysis treatments. In North America, the anticoagulant of choice for hemodialysis therapies is unfractionated heparin (UFH), whereas in Western Europe, it is low molecular weight heparin (LMWH). Dalteparin is more commonly used in Canada and has been approved for use in the in-centre thrice-weekly hemodialysis population at a fixed dose of 5000 units. However, there have been no published studies to assess the use of dalteparin in home quotidian and/or nocturnal hemodialysis therapies. Patients on frequent hemodialysis or nocturnal hemodialysis in the home will be converted to Dalteparin from Heparin for 4 weeks to evaluate the optimal dosage and to assess its safety in this population

Official Title
-----------------
A New Anticoagulation Method Using Dalteparin in Quotidian and Nocturnal Home Hemodialysis Patients: A Prospective Study

Conditions
-----------------
Kidney Failure

Intervention / Treatment
-----------------
* Drug: Dalteparin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Currently undergoing short-hour daily and nocturnal hemodialysis through the home dialysis program at London Health Sciences Centre. Exclusion Criteria: Patients with increased bleeding risks Currently on full dose anticoagulants Active bleeding Diabetic retinopathy Active cancer receiving treatment within the past 6 months

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: open label<br>Dalteparin injected as a bolus into the arterial port of the hemodialysis machine every dialysis session for four weeks | Drug: Dalteparin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean dalteparin dose for the daily home hemodialysis patients |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dalteparin, Dosage, Home Hemodialysis