linjc16/ctgov huggingface dataset:
Diazepam and Blood Pressure Regulation

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the acute effects of diazepam on beat-to-beat blood pressure variability and baroreflex control.

Detailed Description
-----------------
Benzodiazepines are widely prescribed for a variety of clinical conditions. However, its cardiovascular consequences remain controversial. In this study, the investigators sought to determine the acute effects of a single dose of oral diazepam (10mg) on resting beat-to-beat blood pressure variability and cardiac and sympathetic baroreflex sensitivity in a cohort of young, healthy individuals.

Official Title
-----------------
The Acute Effects of Diazepam on Blood Pressure Regulation

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Diazepam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 40 years of age Healthy, free of known cardiovascular, metabolic, or musculoskeletal disease Exclusion Criteria: History of smoking (tobacco or cannabis), defined as any smoking within the past 3 months Diagnosed cardiovascular or metabolic disease(s) Prescription of chronic medications other than oral contraceptives History of hypertension or presence of arrhythmia

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diazepam<br>Oral | Drug: Diazepam<br>* Oral administration of 10 mg of diazepam<br>|
| Placebo Comparator: Placebo<br>Oral | Drug: Diazepam<br>* Oral administration of 10 mg of diazepam<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resting beat-to-beat blood pressure variability | Finger photoplethysmography | Change from baseline at 60 min | 
| Systolic and diastolic blood pressure | Oscillometric device | Change from baseline at 60 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle sympathetic nerve activity | Microneurography | Change from baseline at 60 min | 
| Baroreflex sensitivity | The relationship between changes in beat-to-beat blood pressure and heart rate (cardiac baroreflex) or MSNA (sympathetic baroreflex). | Change from baseline at 60 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blood pressure, Benzodiazepine, Autonomic nervous system
Accuracy of Spircare Device as Compared to the Conventional Plethysmograph

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the accuracy of FRC and airway resistance calculate values of Spircare device as compared to the conventional body plethysmograph in healthy adults and patients with obstructive and restrictive pulmonary diseases/disorders.

Official Title
-----------------
Accuracy of Spircare Device as Compared to the Conventional Plethysmograph

Conditions
-----------------
COPD Asthma, Pulmonary Fibrosis

Intervention / Treatment
-----------------
* Device: Plethysmograph


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed Informed consent. Age≥18 year. Subject is cooperative and capable of following instructions. Phase I: Healthy asymptomatic subjects, never smokers without known history of respiratory, cardiovascular, hepatic, renal or metabolic disease. Phase II: Chronic pulmonary patients with lung volume disorders: COPD Asthma Restrictive diseases such as pulmonary fibrosis, other interstitial lung diseases, kyphoscoliosis, neuro-muscular disorders. Exclusion Criteria: Subjects unable or unwilling to give informed consent. Subjects who are unable to satisfactorily perform routine, full lung function testing (due to non-compliance or claustrophobia). History suggesting upper respiratory infection during the four weeks prior to testing Physical activity during 1 hour prior to the Study. Patients with a tracheostomy. Pregnant women.

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

| Intervention/Treatment |
| --- |
|Device: Plethysmograph|A full Body Plethysmography examination|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The FRC and air way resistance values of the body plethysmograph will be compared to the values of the Spircare device | The primary outcome of the FRC and air way resistance of the Spircare device against the plethysmograph will be displayed as scatter plot. A linear regression and the R2 value will be display as well. The associated Bland-Altman plots comparing the FRC and airway resistance of the Spircare device to the plethysmograph with lines that represent width of 0.1 (±1.96*SD). | September 2017 |
A Comparison of Bile Duct Injuries Following Open Cholecystectomy Versus Laparoscopic Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
In this prospective study the investigators compared common bile duct injuries (CBDI) following laparoscopic cholecystectomy (LC) and open cholecystectomy (OC) procedures, 35 patients in each group. To date, no detailed study concerning this matter has been published. LC - CBDI in comparison with OC - CBDI more often concerned young females with a narrow CBD, they were located closer to the liver hilus, and they were more extended.

Official Title
-----------------
Comparison of Iatrogenic Common Bile Duct Injuries Following Open Cholecystectomy vs Laparoscopic Cholecystectomy

Conditions
-----------------
Cholecystectomy, Common Bile Duct Diseases, Major Bile Duct Injury

Intervention / Treatment
-----------------
* Procedure: Surgical reconstruction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major common bile duct injury Exclusion Criteria: Minor common bile duct injury

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients with common bile duct injury after open cholecystectomy | Procedure: Surgical reconstruction<br>* Hepaticojejunostomy End-to-end anastomosis Duct suture over T-tube<br>|
| 2<br>Patients with common bile duct injury after laparoscopic cholecystectomy | Procedure: Surgical reconstruction<br>* Hepaticojejunostomy End-to-end anastomosis Duct suture over T-tube<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Measurement of Glycaemic Responses of Bakery and Confectionery Products

Study Overview
=================
Brief Summary
-----------------
This study aims to determine the glycemic index, glycemic load and insulin index of eleven Fazer bakery and confectionary products.

Official Title
-----------------
Measurement of Glycaemic Responses of Bakery and Confectionery Products

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Other: Bakery and confectionary products


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: voluntarily given written consent for participation in research healthy man or women, age between 18 ang 65 years regular eating Body Mass Index 18,5 - 24,9 kg/m2 Exclusion Criteria: diabetes gastrointestinal diseases hepatic, kidney, pancreas or thyroid disease or disorder arthritis pregnancy or breast feeding smoking allergy severe diseases blood donation

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Bakery and confectionary products|Control product: Glucose solution, Test products: 11 bakery and confectionary products|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic index (GI) | The 2 hours glycemic responses to bakery and confectionery products (the incremental area under the glucose response curve, IAUC). |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin index (II) | The 2 hours insulinemic responses to bakery and confectionery products (the incremental area under the insulin response curve, IAUC). |  | 
| Glycemic load (GL) |  |  |
Study Of SU011248 In Combination With Docetaxel In Patients With Advanced Cancer

Study Overview
=================
Brief Summary
-----------------
This study is determining the maximum tolerated dose and safety of SU011248 (sunitinib malate, SUTENT) in combination with docetaxel (Taxotere). Several dosing regimens will be tested in patients with advanced solid tumors, including non small cell lung cancer.

Official Title
-----------------
A Phase 1 Safety And Pharmacokinetic Study Of SU011248 In Combination With Docetaxel In Patients With Advanced Solid Tumors

Conditions
-----------------
Advanced Solid Tumors, Non Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: sunitinib
* Drug: docetaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced solid tumor malignancy ECOG 0 or 1 Exclusion Criteria: Prior treatment with with high-dose chemotherapy requiring stem cell rescue Prior irradiation to ≥25% of the bone marrow (e.g. whole pelvis=25%) Patients with centrally located lung lesions unless recently treated with radiotherapy

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>SU011248 in combination with docetaxel | Drug: sunitinib<br>* 25, 37.5 and 50 mg/day, oral, administered on an outpatient basis in two different dosing regimens: schedule 2/1 (2 weeks on, 1 week off) and schedule 4/2 (4 weeks on, 2 weeks off)<br>Drug: docetaxel<br>* 60, 75, and 100 mg/m2 docetaxel administered every 21 days as a 1-hr IV infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities |  | November 2007 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters of SU011248 (and its active metabolite, SU012662), and docetaxel. |  | November 2007 | 
| Objective disease response |  | November 2007 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
advanced solid tumors, non small cell lung cancer, pulmonary neoplasms, sunitinib (SUTENT), docetaxel (Taxotere), Angiogenesis Inhibitors
Protection of Ovarian Function in Female Patients With Hodgkin Lymphoma

Study Overview
=================
Brief Summary
-----------------
This study is designed to test the the protective capacity of Goserelin compared with oral contraceptive

Official Title
-----------------
Randomisierte Phase II Studie Zum Einsatz Von Goserelin Und Oralen Kontrazeptiva Zur Reduktion Ovarieller Toxizitäten während Zytostatischer Primärtherapie Bei Fertilen Patientinnen Mit Hodgkin Lymphom in Fortgeschrittenen Stadien

Conditions
-----------------
Hodgkins Lymphoma

Intervention / Treatment
-----------------
* Drug: 8 cycles BEACOPPesc plus oral contraceptive
* Drug: 8 cycles BEACOPPesc plus Goserelin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced stage Hodgkins Lymphoma (histologically proven) Normal FSH-levels Written informed consent Exclusion Criteria: Hodgkins Lymphoma as composite lymphoma Primary ovarial dysfunction Age > 40

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Drug: 8 cycles BEACOPPesc plus oral contraceptive<br> <br> |
| Experimental: B<br> | Drug: 8 cycles BEACOPPesc plus Goserelin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FSH level 6 month after end of treatment |  | 6 month |
A Study to Demonstrate Bioequivalence Between 6 x 2 mg Tablets of Perampanel and a Single 12 mg Tablet of Perampanel in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the bioequivalence between 6 x 2 mg tablets and one 12 mg tablet of perampanel in healthy subjects.

Detailed Description
-----------------
A Single Centre, open label, 2-period, 2-sequence crossover bioequivalence study in one group of 28 subjects.

Official Title
-----------------
A Randomized, Open-label, Crossover Study to Demonstrate Bioequivalence Between 6 x2 mg Tablets of Perampanel and a Single 12 mg Tablet of Perampanel in Healthy Subjects

Conditions
-----------------
Partial Onset Epilepsy

Intervention / Treatment
-----------------
* Drug: perampanel
* Drug: perampanel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or female subjects aged between 18-55 years. BMI of 18-32 kg/m ^2. Willing and able to provide written informed consent. Exclusion criteria: Subjects taking prescribed or over the counter (OTC) medications in 2 weeks prior to screening. Subjects on special diets or dietary aids known to modulate drug metabolizing enzymes. Subjects who have taken inhibitor of CYP450 within 2 weeks of first dose. Subjects who have received any experimental drug in the 12 weeks prior to study drug treatment. Subjects with a history of alcohol abuse or who drink more than the recommended number of alcohol units per week. Subjects who consume more than five caffeinated beverages per day. Subjects who smoke more than 5 cigarettes per day. Subjects with a history of drug abuse or who have a positive urine drug screening test. Women who do not agree to use two methods of contraception.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental 1<br> | Drug: perampanel<br>* Single dose of 6 tablets 2 mg orally<br>|
| Experimental: Experimental 2<br> | Drug: perampanel<br>* Single dose of 1 tablet 12 mg orally<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate and compare the pharmacokinetic (PK) profile, safety, and tolerability of 6 x 2-mg tablets of perampanel with a single 12-mg tablet. |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
epilepsy
A Natural History Study of Patients With Dry Eye

Study Overview
=================
Brief Summary
-----------------
This is a multi-center, prospective, controlled, observational study of the natural history of patients with dry eye disease.

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Other: Artificial Tears


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males at least 55 years old or females, at least 40 years old with perimenopausal symptoms Baseline OSDI score of ≥ 13 Patients with mild to moderate dry eye (dry eye disease patients only; not applicable for control group) Exclusion Criteria: Use of any topical cyclosporine ophthalmic emulsion within 3 months of baseline History of herpes keratitis or varicella zoster keratitis Any history of allergic conjunctivitis Temporary or permanent occlusion or cauterization of the lacrimal puncta for either eye Any anterior segment surgery involving a limbal or corneal incision (cataract surgery), keratorefractive procedure (LASIK, LASEK, PRK) within 12 months of baseline, or expectation of such surgery within 2 years Patients with known systemic disease Any history of corneal transplant

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| Patients with dry eye<br>No treatment is prescribed for the study. Patient dry eye progression will be followed for up to 60 months. Patients may use artificial tears to treat their dry eye symptoms. | Other: Artificial Tears<br>* Artificial tears (any brand) may be used to treat dry eye symptoms.<br>|
| Patients with no history of dry eye<br>No treatment is prescribed for this control group. Patients will be followed for up to 60 months. If needed, patients may use artificial tears. | Other: Artificial Tears<br>* Artificial tears (any brand) may be used to treat dry eye symptoms.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients with Progression of Dry Eye Disease |  | Baseline, 60 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Ocular Surface Disease Index© (OSDI©) Score |  | Baseline, 60 Months | 
| Percentage of Patients with an Increase in Blurred Vision |  | Baseline, 60 Months | 
| Change from Baseline in Schirmer's Test |  | Baseline, 60 Months | 
| Change from Baseline in Conjunctival Staining Score on a 6-Point Scale |  | Baseline, 60 Months | 
| Change from Baseline in Corneal Staining Score on a 6-Point Scale |  | Baseline, 60 Months |
Evaluation of New Diagnostic Methods of Cardio-embolic Related (Atrial Fibrillation) Cerebral Infarction

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to estimate the contribution of abdominal imaging by magnetic resonance Imaging (MRI) and abdominal scanner in the detection of subdiaphragmatic infarction associated to the atrial fibrillation in the cerebral infarction.

Official Title
-----------------
Evaluation of New Diagnostic Methods of Cardio-embolic Related (Atrial Fibrillation) Cerebral Infarction

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Procedure: MRI
* Procedure: Abdominal scanner


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient over 18 Patient having a CHADS-VAsc Score ≥ 2; Patient hospitalized for a secondary established ischemic accident in an atrial fibrillation not anticoagulated (INR<2 and/or receiving antiplatelet (aspirin, clopidogrel)) for less than 14 days; Patient affiliated to a national insurance scheme or beneficiary Patient having given a written consent Exclusion Criteria: Patient presenting cognitive disorders incompatible with the planned examinations (MRI / SCANNER). Pacemaker or implantable defibrillator, or other contraindication in the MRI (metallic eye brightness, intra cerebral clip). Contraindication in injected scanner. Current 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stroke<br> | Procedure: MRI<br> <br> Procedure: Abdominal scanner<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with subdiaphragmatic infarctions detected by abdominal MRI |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with subdiaphragmatic infarctions detected by abdominal scanner |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Subdiaphragmatic infarction