linjc16/ctgov huggingface dataset:
Screening Herbs for Drug Interactions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to detect potential herb-drug interactions in volunteers.

Detailed Description
-----------------
The use of herbal medicines in the treatment of various medical and psychiatric conditions has accelerated in the last decade. It has also become evident that herbal medications are being used concomitantly with conventional prescription and over-the-counter medications. However, the systematic evaluation of the potential of these agents to interact with conventional medications has been generally neglected. Compounding this problem is the fact that even single entity herbal products can contain a multitude of naturally occurring chemicals which serve as candidates for potential herb-drug interactions by inhibiting or inducing specific hepatic isozymes. Numerous reports document the importance of pharmacokinetic interactions involving inhibition or induction of the cytochrome P450 (CYP) enzyme system. In this study, the ten most commonly used herbal products in the US will be systematically evaluated for inhibition of CYP 3A4 and 2136, and induction of CYP 3A4. Collectively, these enzyme systems are involved in the metabolism of approximately 80% of all marketed medications. Participants in this study will receive a single dose of the prescription drug alprazolam and the over-the-counter cough suppressant, dextromethorphan on two occasions. A combination of probe drugs will be given to normal volunteers both in the absence and presence of herbal medications. The plasma and urine concentration of these agents and their respective metabolites will be determined in order to evaluate individual herbal products degree and specificity of enzyme inhibitory or inductive effects.

Official Title
-----------------
R-21 Project: Screening Herbs for Drug Interference

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

Intervention / Treatment
-----------------
* Drug: herbals


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal healthy volunteers who are taking no medications. Must be non-smokers.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: herbals|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Roles of Tissue Factor in Malignant Gliomas

Study Overview
=================
Brief Summary
-----------------
To explore the relationship between tissue factor levels, tumour progression, activation of blood coagulation and venous thromboembolism with malignant glioma

Detailed Description
-----------------
To explore the relationship between tissue factor levels, tumour progression, activation of blood coagulation and venous thromboembolism with malignant glioma

Official Title
-----------------
The Roles of Tissue Factor in Malignant Gliomas

Conditions
-----------------
Venous Thromboembolism, Brain Tumors

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: participation in PRODIGE adult patients newly diagnosed, biopsy-confirmed grade III/IV malignant gliomas undergone craniotomy or stereotactic biopsy > 2 days and < 4 weeks before Exclusion Criteria: have known hereditary thrombophilia are receiving experimental antiangiogenic therapy

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
venous thromboembolism, brain tumours, glioma, tissue factor, blood coagulation, tumour progression, low molecular weight heparin
Efficacy of NovoSeven® in Bleeding Prophylaxis in Hemophilia

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Africa, Asia, Europe, South America, and the United States of America (USA). The purpose of this study is to evaluate the effectiveness of secondary prophylactic treatment with NovoSeven® in haemophilia A and B patients with inhibitors.

Official Title
-----------------
Exploratory, Multi-centre, Randomised, Double-blind, Uncontrolled Trial Evaluating the Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Secondary Bleeding Prophylaxis in Congenital Haemophilia A or B Patients With Inhibitors

Conditions
-----------------
Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors

Intervention / Treatment
-----------------
* Drug: activated recombinant human factor VII


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of congenital haemophilia A or B with inhibitors development against FVIII or FIX, respectively Exclusion Criteria: Prophylactic administration of any haemostatic drug within 3 last months prior to entering the trial.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years

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

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: activated recombinant human factor VII|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of bleeds |  | During 3 months treatment period as compared to 3 months observation period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy variables |  |  |
To Evaluate the Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures

Study Overview
=================
Brief Summary
-----------------
To evaluate the long-term safety and efficacy of pregabalin in patients with partial seizures.

Official Title
-----------------
Pregabalin Open-Label Add-On Trial: An Open-Label, Multicenter Follow-On Study to Determine Long-Term Safety and Efficacy in Patients With Partial Seizures.

Conditions
-----------------
Seizure Disorder, Partial

Intervention / Treatment
-----------------
* Drug: Pregabalin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have met the inclusion criteria for the preceding double-blind study Have received double-blind study medication and wish to receive open-label pregabalin. Exclusion Criteria: Cannot have absence seizures.

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 |
| --- |
|Drug: Pregabalin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Efficacy |  |  |
Increasing Atrial Base Rate Pacing to Reduce Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
This study aims to determine whether increasing atrial base rate pacing to achieve at least 75-80% atrial pacing in patients with sick sinus syndrome undergoing the implementation of dual-chamber pacemaker can be useful to prevent or decrease the atrial fibrillation during 6 months follow-up duration.

Conditions
-----------------
Sick Sinus Syndrome, Paroxysmal Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: HBR
* Device: DD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sick sinus syndrome patients having dual-chamber pacemaker Having paroxysmal AF defined as at least 2 episodes of AHR/AMS >190 b/min lasting >6 minutes Having normal atrioventricular conduction Exclusion Criteria: Other clinical indications for pacing except sick sinus syndrome (bradycardia-tachycardia syndrome) History of acute coronary syndrome Significant heart valve disease Chronic AF before randomization Overt heart failure Malignancy Any reasons for antiarrhythmic medication use Inability to follow patients every 3 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Atrial Base Rate Pacing<br>The base rate of pacemaker will be determined 75-100 beats/minute in condition that during first step of follow-up, his/her atrial pacing will be more than 80% of atrial high rate/automatic mode switch | Device: HBR<br> <br> * Other names: High Atrial Base Rate Pacing;|
| Active Comparator: Device Default<br>The base rate of pacemaker will be determined 60 beats/minute | Device: DD<br> <br> * Other names: Device Default;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial high rate/Automatic mode switch episodes | The number of AHR/AMS episodes recorded by pacemaker | During 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke | The development of stroke during follow-up | During 6 months | 
| Myocardial infarction | The development of MI during follow-up confirmed by ischemic chest pain, 12-ECG, or cardiac enzyme elevation | During 6 months | 
| Heart failure | The development or progression of heart failure during follow-up | During 6 months | 
| Worsening Functional Class | The worsening of functional class | During 6 months | 
| Death | Death | During 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sick sinus syndrome, paroxysmal atrial fibrillation, atrial pacing, high atrial base rate pacing
Use of Local Analgesia With Epinephrine During Total Hip Arthroplasty (THA)

Study Overview
=================
Brief Summary
-----------------
The aim is to determine if the use of infiltration with an adrenalin solution in the operative field of Total Hip Arthroplasty (THA), allays a significant reduction of the cumulated volume of bleeding (pre and post operative) without increasing the per and post operative risks. At the same time, the effect on the post operational pains is evaluated.

Detailed Description
-----------------
This prospective randomized study compares a population receiving a local anaesthetic (ropivacaine, adrenalin and physiological serum) in the operative field to a population undergoing a standard protocol. The cumulated volume of bleeding per and post operative are recorded and complete blood count (CBC).

Official Title
-----------------
Effect of the Injection of Local Analgesia With Epinephrine During Total Hip Arthroplasty on the Blood Losses Per and Operatively.

Conditions
-----------------
Arthroplasty, Replacement, Hip

Intervention / Treatment
-----------------
* Drug: ropivacaine, physical serum and adrenalin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary total hip arthroplasty Age between 50 and 85 Exclusion Criteria: fracture of the femoral neck patients with contraindications for local anaesthesia

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 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 |
| --- | --- |
| Experimental: Ropivacaine, serum, adrenalin<br>235 mg of ropivacaine, 5 ml physical serum and 0.5 mg of adrenalin. | Drug: ropivacaine, physical serum and adrenalin<br>* A: experimental group: 235 mg of ropivacaine, 5 ml physical serum and 0.5 mg of adrenalin<br>|
| No Intervention: No infiltration<br>B: no infiltration | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measuring volume of cumulated bleeding per and post operative and analyse of complete blood count (CBC) |  | pre and post operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Womac score pre operative, at 3 months and at 12 months |  | at 3 months and 12 months | 
| Visual analogue pain score (VAS) during hospitalisation |  | at 3 months and 12 months | 
| Consumption of analgesics |  | at 3 months and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arthroplasty, hip, blood losses, pain, local analgesia, epinephrine, Primary total hip arthroplasty
Live Validation of the Lower Eyelid Steatoblepharon Severity (LESS) Scale

Study Overview
=================
Brief Summary
-----------------
This observational study will test the inter-rater and test-retest reliability of the LESS scale in a live context.

Official Title
-----------------
Live Validation of the Lower Eyelid Steatoblepharon Severity (LESS) Scale

Conditions
-----------------
Steatoblepharon

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must provide informed consent Exclusion Criteria: Unable or unwilling to complete study procedures

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 80 Years

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 |
| --- | --- | --- |
| LESS score (Clinician-Reported) |  | Eyelids will be assessed on one day only (cross-sectional study) |
Pharmacokinetics Of Alprazolam Sublingual Tablet Versus Conventional Tablet

Study Overview
=================
Brief Summary
-----------------
To assess if the sublingual tablet will have similar pharmacokinetics as the conventional tablet of alprazolam.

Official Title
-----------------
Open-label, Randomized, Single-Dose, 2 Way Crossover Bioequivalence Study Comparing A New Alprazolam Sublingual Tablet Formulation To A Reference Alprazolam Immediate Release Tablet

Conditions
-----------------
Anxiety Disorder

Intervention / Treatment
-----------------
* Drug: Alprazolam tablet
* Drug: Alprazolam sublingual


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2. Signed informed consent. Exclusion Criteria: Evidence or history of clinically significant abnormalities Positive drug screen, excessive alcohol and tobacco use

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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Alprazolam conventional tablet<br>Alprazolam conventional tablet | Drug: Alprazolam tablet<br>* 1 mg single dose of alprazolam conventional tablet<br>|
| Experimental: Alprazolam sublingual tablet<br>Alprazolam sublingual tablet | Drug: Alprazolam sublingual<br>* 1 mg single dose of alprazolam sublingual tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve (AUC) from time zero to last measurable time of alprazolam |  | 72 hours | 
| Peak concentration of alprazolam |  | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve from time zero to infinity |  | 72 hours | 
| AUC% extrapolated |  | 72 hours | 
| Time of Cmax |  | 72 hours | 
| half-life of alprazolam |  | 72 hours | 
| Clinically significant safety laboratory tests |  | Screening, Day 0, Day 4 | 
| Clincally significant vital signs |  | Screening, Day 4 | 
| Clinically significant adverse events |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bioequivalence, sublingual, alprazolam, pharmacokinetics
Training in Hypoxia to Prevent Acute Mountain Sickness

Study Overview
=================
Brief Summary
-----------------
Some studies suggest that high-altitude related illnesses - like acute mountain sickness - could be prevented by acclimatisation, reached at low altitude using training in simulated altitude. The purpose of this study is to determine whether training in hypoxia is suitable to prevent acute mountain sickness.

Detailed Description
-----------------
In a three week-period, healthy probands undergo 3 times a week a bicycle ergometer training in simulated altitude followed by 1 week passive exposure at simulated low altitude. 5 days after last exposure, a field study starts performing a rapid ascent to the Capanna Regina Margherita (4559m). Acute mountain sickness is assessed by established scoring systems.

Official Title
-----------------
Prevention of Acute Mountain Sickness (AMS) by Intermittent Hypoxic Training

Conditions
-----------------
Acute Mountain Sickness, Healthy

Intervention / Treatment
-----------------
* Other: hypoxia
* Other: normoxia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy non-smoker endurance training min. 2x/week Exclusion Criteria: any diseases previous exposure to altitudes higher than 2000m (last 6 weeks)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hypoxia<br>training in simulated altitude | Other: hypoxia<br>* training in simulated altitude in a hypoxic chamber (normobaric hypoxia)<br>|
| Placebo Comparator: Normoxia<br>training under normoxic conditions | Other: normoxia<br>* training under normoxic conditions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of acute mountain sickness |  | after 20 hours at 4559m | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of acute mountain sickness |  | after 20 hours at 4559m | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mountain sickness
Investigation of Corneal Aberrations and Visual Outcomes in Patients Implanted With an AcrySof Toric Intraocular Lens (IOL)

Study Overview
=================
Brief Summary
-----------------
A prospective evaluation of postoperative corneal aberrations and visual parameters (e.g. visual acuity) in patients implanted with an AcrySof Toric IOL.

Conditions
-----------------
Cataracts, Astigmatism

Intervention / Treatment
-----------------
* Device: Toric


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Operable cataracts; Good ocular health; Qualifies for AcrySof Toric IOL via AcrySof Toric Calculator (1.03-2.06 D cylinder at corneal plane) Exclusion Criteria: >2.06 D astigmatism at corneal plane; irregular astigmatism; prior or ongoing corneal disease or scarring; history of ocular disease

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Toric<br>AcrySof Toric IOL to assess corneal aberration | Device: Toric<br>* AcrySof Toric IOL<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal Aberration |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity, residual refractive cylinder, lens alignment |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cataract, Toric IOL, Corneal Aberration, Astigmatism, AcrySof