linjc16/ctgov huggingface dataset:
Pharmacokinetics and Safety of Intravenous Topiramate in Adult Patients

Study Overview
=================
Brief Summary
-----------------
The aims of this study are to determine, in adult patients on maintenance topiramate therapy, the steady-state pharmacokinetics and safety of orally and intravenously administered topiramate.

Detailed Description
-----------------
The long-term goal of this research project is to develop a more effective, safer therapy for neonatal seizures. Prior to using an investigational intravenous topiramate formulation in children and neonates, the pharmacokinetics and safety of the formulation must be demonstrated in adults. The immediate aims of this study are to determine the pharmacokinetics and safety of a novel intravenous topiramate formulation. An additional aim is to determine if sex, advancing age, or genotype affects topiramate absorption, distribution, or elimination.

Official Title
-----------------
Phase I Pharmacokinetic and Safety Study of Intravenous Topiramate in Adult Patients

Conditions
-----------------
Epilepsy, Migraines

Intervention / Treatment
-----------------
* Drug: intravenous topiramate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persons taking topiramate Persons 18 years of age and older Exclusion Criteria: Patients who are pregnant Patients who are breast feeding Patients with significant medical problems who may not tolerate intravenous administration Patients taking medications known to affect topiramate disposition

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>This is a one arm pharmacokinetic and safety study. | Drug: intravenous topiramate<br>* Single 25 mg IV dose given in addition to subject's normal morning dose of topiramate<br>* Other names: Topamax;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as measured by the occurrence of adverse events | Occurrence of adverse events in the 4 days following Topiramate dose | 96 hours after dosing |
Proton Therapy for Low and Intermediate Risk Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to give a shorter course (5 ½ weeks) of radiation that has as little side effects on normal bladder and rectal tissues as the usual longer course (8 weeks) of radiation, without decreasing the chance of killing prostate cancer cells.

Detailed Description
-----------------
Low Risk - Total of 70 Gy/CGE over 28 treatments Intermediate Risk - Total of 72.5 Gy/CGE over 29 treatments

Official Title
-----------------
A Phase II Study of Hypofractionated Image Guided Proton Radiation Therapy for Low and Intermediate Risk Adenocarcinoma of the Prostate

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Radiation: Low Risk Proton Radiation
* Radiation: Intermediate Risk Proton Radiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Prostate cancer. Gleason score 2-7. PSA ≤ 20 ng/ml. Exclusion Criteria: Previous prostate cancer surgery or pelvic radiation. Prior or current chemotherapy for prostate cancer. Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum. History of proximal urethral stricture requiring dilatation. History of hip replacement. Diabetes requiring medication. Prior intrapelvic surgery. Current and continuing anticoagulation with Warfarin sodium (Coumadin), Clopidogrel bisulfate (Plavix), enoxaparin sodium (Lovenox), or aspirin/er dipyridamole (Aggrenox). On Flomax (Tamsulosin), Hytrin (Terazosin) or Cardura (Doxazosin), Uroxatral (alfuzosin HCl). Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Risk Proton Radiation<br>70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx | Radiation: Low Risk Proton Radiation<br> <br> |
| Experimental: Intermediate Risk Proton Radiation<br>72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx | Radiation: Intermediate Risk Proton Radiation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Grade 3 (NCI CTC v4.0) or Higher Treatment-related Toxicity Rate. |  | 6 months after the end of radiation therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Control |  | 20 years after end of radiation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate Cancer, Proton Radiation
SAPPHIRE Worldwide: Stenting and Angioplasty With Protection in Patients At High-Risk for Endarterectomy

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess the outcomes of stenting with distal protection in the treatment of obstructive carotid artery disease. The devices to be utilized are the Cordis PRECISE® Nitinol Stent Systems (5.5F and 6F) and the Cordis ANGIOGUARD™ XP Emboli Capture Guidewire (ECGW).

Detailed Description
-----------------
Carotid Artery Stenting

Official Title
-----------------
Stenting and Angioplasty With Protection in Patients At High-Risk for Endarterectomy (SAPPHIRE Worldwide)

Conditions
-----------------
Carotid Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: High-surgical risk patients to be treated consistent with IFU labeling The patient or legally authorized representative has signed a written informed consent and HIPAA authorization, prior to the procedure, using a form that is approved by the Institutional Review Board or Medical Ethics Committee. Exclusion Criteria: Patients not treated per the IFU Patients who are contraindicated per the IFU Patients previously enrolled in the study Patients requiring stenting of in-stent restenosis after CAS Inability or refusal to provide informed consent.

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 |
| --- | --- | --- |
| Any death, stroke or any MI |  | up to 30-days post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the consistency of MAE rates of stenting with distal protection in the treatment of obstructive carotid artery disease among high, medium and low volume centers with physicians who have validated CASES training levels of 1, 2, 2P or 3 |  | 30 days | 
| Assess the real-world cost-effectiveness of carotid artery stenting in subjects enrolled |  | Every follow-up where a PRO instrument QoL was assessed | 
| Estimate MAE (death and ipsilateral stroke) rate in a subset of the planned total enrollment |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Carotid Artery Stenting (Endovascular)
Consultation Reasons in Family Medicine

Study Overview
=================
Brief Summary
-----------------
The Tunisian society of family medicine STMF proposes to coordinate a national, observational, transversal and multicenter survey, at the consultations of general medicine / family medicine.

Detailed Description
-----------------
The Tunisian society of family medicine STMF proposes to coordinate a national, observational, transversal and multicenter survey carried out during two weeks, at the consultations of general medicine / family medicine. The main objective of the survey is to describe the reasons for consultation in general medicine / family medicine. The results obtained from this survey will make it possible to specify the specificities inherent to the reasons for consultations of Tunisians but especially to the peculiarities of the local health system (public and private). This survey will help us to assimilate our practices and harmonize them in order to optimize patient care and reposition family medicine in the patient's care path as well as the degree of adherence of practitioners to international recommendations in the care of the patient.

Official Title
-----------------
EMOCONSULT : Consultation Reasons in Family Medicine, a Tunisian National Survey

Conditions
-----------------
Evaluate the Reasons for Consultation in Family Medicine

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Informed consent, read and signed Exclusion Criteria: • Consent not obtained

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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 |
| --- | --- | --- |
| Describe the reasons for consultation in family medicine / general medicine | All patients presenting in consultation in general medicine / family medicine will be recruited in the survey in order to describe the different reasons for consultation | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Reasons for consultation, Family Medicine
Effects of Different Modes of Ventilation and Head Position on Size of Vena Jugular Interna

Study Overview
=================
Brief Summary
-----------------
It is widely known that positive mechanical ventilation increases the positive intrathoracic pressure which affects the pressure in the RIJV, resulting in an increase of the CSA. Currently, there appears to be a lack of studies in the literature that assess the effects of different modes of ventilation of this increase. The aim of our study is to evaluate the changes in cross-sectional area and diameters of RIJV under two different mechanical ventilation modes (PCV and VCV) and spontaneous ventilation in head neutral and 30 degree rotated lateral position by using ultrasonography and to determine the ventilation mode that is most suitable for catheterization.

Official Title
-----------------
Comparing the Size of the Vena Jugular Interna Under Spontaneous Ventilation and Different Mechanical Ventilation Modes When Head is in Neutral and 30 Degree Lateral Position:Clinical Trial

Conditions
-----------------
Central Line Complication

Intervention / Treatment
-----------------
* Other: Ultrasonography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 30 ASA status I-II patients between 18-80 years old undergoing elective abdominal surgery Exclusion Criteria: Patients with a history of congestive heart failure, pulmonary hypertension, chronic renal failure, diabetes mellitus, rheumatological diseases, neck surgery, valvular disease, obesity or RIJV catheterization will be excluded from the study

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Spontenous Ventilation (Group S)<br>ultrasonography of Right internal jugular vein | Other: Ultrasonography<br> <br> * Other names: The crosssectional area and diameter of right internal jugular vein will be measured by ultrasonography;|
| Pressure control Ventilation (Group P)<br>ultrasonography of Right internal jugular vein | Other: Ultrasonography<br> <br> * Other names: The crosssectional area and diameter of right internal jugular vein will be measured by ultrasonography;|
| Volume control ventilation (Group V)<br>ultrasonography of Right internal jugular vein | Other: Ultrasonography<br> <br> * Other names: The crosssectional area and diameter of right internal jugular vein will be measured by ultrasonography;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparing the size of right internal jugular vein in different mechanical ventilation modes |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect of different head positions on the right internal jugular vein size |  | 1 month |
Effectiveness Study of Hylan G-F 20 to Preserve Cartilage in Osteoarthritis of the Knee

Study Overview
=================
Brief Summary
-----------------
That Hylan G-F 20 may act to protect cartilage from the expected degree of degradation over a 12 month period in subjects with moderate to marked osteoarthritis of the knee

Detailed Description
-----------------
Two courses of Hylan G-F 20 ( Synvisc) administered by intra-articular injection at 6 monthly intervals. MRI examinations of the knee for estimation of cartilage volume prior to treatment, before second course and at 12 months in 40 subjects with Grade 2/3 osteoarthritis of knee . A further 40 subjects with similar degree of osteoarthritis of knee who do not receive Hylan G-F therapy will be assessed by MRI in identical manner.

Official Title
-----------------
A Single-Blind Prospective Parallel Control Group Pilot Study to Assess the Effect of Hylan G-F 20 (Synvisc) Supplementation on Cartilage Preservation in Osteoarthritis of the Knee

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Drug: intra-articular injection of Hylan G-F 20


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: grade 2 or 3 osteoarthritis knee age 18 - 80 pain score VAS >39 mm on 100mm scale Exclusion Criteria: surgery in prior 12 months significant valgus deformity recent trauma use of opioid analgesia unstable medical condition recent corticosteroid injection morbid obesity

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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: intra-articular injection of Hylan G-F 20|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cartilage volume as assessed by magnetic resonance imaging |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteoarthritis, knee, hylan
A Study to Evaluate Response of Overactive Bladder Symptom Score (OABSS) to Treatment

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate change of overactive bladder symptom scores (OABSS) between, before and after solifenacin treatment to OAB subjects.

Official Title
-----------------
Reproducibility Study of OABSS and Its Response to Treatment in Indonesia - Part 2: Responsiveness

Conditions
-----------------
Overactive Bladder

Intervention / Treatment
-----------------
* Drug: Solifenacin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptoms OAB for 3 months or longer At least 3 urgency episode in last 3 days Symptoms of OAB as verified by the screening 3-day bladder diary, defined by: Number of micturition ≥8 times/day Number of urgency episodes in 3 days ≥3 Exclusion Criteria: Significant stress incontinence or mixed stress/urge incontinence Subject with indwelling catheters or practicing intermittent self-catheterization Symptomatic urinary tract infection, chronic inflammation Diabetic neuropathy Subjects who are prohibited from taking solifenacin as contraindications Drug or non-drug treatment for OAB was started, quitted or changed in 4 weeks Participation in any clinical trial in 30 days except for Part-1 of RESORT

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Solifenacin|oral|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OABSS |  | Weeks 0, 4 and 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Prostate Symptom Score (IPSS) |  | Weeks 0, 4 and 12 | 
| Quality of Life (QOL) Score |  | Weeks 0, 4 and 12 | 
| Patient Perception of Bladder Condition (PPBC) |  | Weeks 0, 4 and 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OABSS, IPSS, PPBC, 3-day micturition diary, Solifenacin
Study of Inflammatory Role of Epstein-Barr Virus (EBV) in Atrophic and Erosive Forms of Oral Lichen Planus

Study Overview
=================
Brief Summary
-----------------
Oral lichen planus (OLP) is a chronic inflammatory and relapsing. The average prevalence is 1 to 4%. The clinics forms are many and symptoms are varied. The erosive form, painful and debilitating is characterized by erosive areas, ulcerated on an erythematous base with or without a keratinocyte lichenien network. The literature data moving towards an autoimmune origin, but the pathophysiological mechanisms of OLP remain unknown. This project represents the first part of a comprehensive project to examine the oral pathogenesis of different viruses (Herpes and papillomavirus HPV) and centered on Epstein-Barr Virus (EBV).

Official Title
-----------------
Study of Inflammatory Role of Epstein-Barr Virus (EBV) in Atrophic and Erosive Forms of Oral Lichen Planus

Conditions
-----------------
Lichen Planus, Oral

Intervention / Treatment
-----------------
* Biological: buccal cavity sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient ≥ 18 years Clinical and/or histological diagnosis of erosive or atrophic OLP No signs of severe dysplasia at the sampling Exclusion Criteria: o immunosuppressive or anti-inflammatory therapies at the inclusion

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral lichen planus disease<br>buccal cavity sample | Biological: buccal cavity sample<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of level of EBV nucleic acids |  | day 1 |
Risk of Coccidioidomycosis in Patients Receiving Anti-TNF and Other Biologic Agents for an Inflammatory Arthritis

Study Overview
=================
Brief Summary
-----------------
The goal of the project is to study the risk of coccidioidomycosis (valley fever) in patients receiving anti-TNF and other biologic agents for inflammatory arthritis in Tucson, Arizona.

Detailed Description
-----------------
Retrospective chart review of all patients with an inflammatory arthritis seen at the University Rheumatology clinic since January 2000.

Official Title
-----------------
Risk of Coccidioidomycosis in Patients Receiving Anti-TNF and Other Biologic Agents for an Inflammatory Arthritis

Conditions
-----------------
Coccidioidomycosis, Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All active patients with an inflammatory arthritis seen at the University of Arizona from January 2000 Exclusion Criteria: None
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 |
| --- | --- |
| Biologics<br>Patients receiving TNF inhibitors or biologic agents | |
| DMARD<br>Patients receiving methotrexate without any biologic | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the incidence rate and calculate the risk of coccidioidomycosis in patients receiving various anti-TNF agents or other biologics, and patients not receiving these agents for their inflammatory arthritis |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To calculate the incidence density of coccidioidomycosis cases in patients receiving each drug. |  | One year | 
| To compare number of disseminated cases of coccidioidomycosis in each group |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TNF inhibitors, Biologic agents, coccidioidomycosis, Rheumatoid arthritis
Prognostic Factors for All Types of Cancer Combined

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate every possible applicability of flow cytometrical analysis in the intracellular detection of tumor-related material in activated macrophages in the broadest range of cancer types.

Official Title
-----------------
Flow Cytometrical Analysis of the Human Immune System to Assess Tumor-related Material Piling up in Activated Macrophages in All Relevant Cancer Types.

Conditions
-----------------
Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (Suspicion of) presence of cancer in the broadest sense of the word Must be able to understand and sign written informed consent Exclusion Criteria: None

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| screening and followup |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer occurence, cancer recurrence, neo-adjuvant treatment response measurement