louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00926302: A Bioequivalence Study of Levetiracetam Versus Keppra
Official title: A Randomized, Single, Two-Way Crossover Pivotal Study to Assess the Bioequivalence Study of Levetiracetam vs. Keppra Administered Under Fasting Conditions to Healthy Adult Subject
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: The bioequivalence of Levetiracetam vs. Keppra
volunteer
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2009-06-23
Enrollment: 26
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to assess the bioequivalence of Levetiracetam versus Keppra administered under fasting conditions to healthy adult subjects.

Detailed description: This study is a randomized, single, two-way crossover pivotal study. The pharmacokinetic blood samples and vital signs were obtained before and after administration at scheduled intervals as indicated in the study protocol.

Eligibility criteria: Inclusion Criteria:

1. Provision of signed written informed consent before enrollment into the study, ability to communicate with the investigators, and to understand and comply with the requirements of the study.
2. Healthy adult male, aged between 20 and 40 years old.
3. Body Mass Index between 18.5 and 25 (inclusive).
4. Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, chest x-ray and electrocardiogram.
5. No significant deviation from normal biochemistry examination.
6. No significant deviation from normal hematology examination.
7. No significant deviation from normal urinalysis examination.

Exclusion Criteria:

1. History of drug or alcohol abuse within the past year.
2. Medical history of severe drug allergy or sensitivity to analogous drug.
3. Evidence of acute or chronic disease or having undergone surgery from 4 weeks prior to Period I dosing.
4. Evidence of any clinical significant renal, cardiovascular, hepatic, hematopoietic, neurological, pulmonary or gastrointestinal pathology.
5. Ongoing peptic ulcer and constipation.
6. Planned vaccination during the time course of the study.
7. Taking any clinical investigation drug from 2 months prior to Period I dosing.
8. Use of any medication, including herb medicine or vitamins from 4 weeks before the study.
9. Blood donation of more than 500 mL within the past 3 months.
10. A positive Hepatitis B surface antigen or positive Hepatitis C antibody result.
11. A positive test for HIV antibody.

Primary outcomes:
measure: To assess the bioequivalence
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tri-Service General Hospital
name: I-Shin Shiah, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06296602: Screening Anal HPV Colonization in Men Sex Men Using Pre-exposure Prophylaxis for HIV (ANAPreP'HPV)
Official title: Screening Anal HPV Colonization in Men Sex Men Using Pre-exposure Prophylaxis for HIV
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pre-Exposure Prophylaxis
Keywords: PreP
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2024-03-06
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A prelevement for HPV genotyping and anal cytology will be carried out in addition to the anal swabs taken quarterly to screen for other sexually transmitted infections.

A questionnaire will be completed by the doctor to record the data of interest.
Primary purpose: PREVENTION

Brief summary: This is an interventional study investigating HPV carriage and liquid-based cytology at anal level. It will be offered to all patients undergoing PreP consultations at Besançon University Hospital. The anal swab will be taken by the doctor using a cyto-brush during the consultation.

Detailed description: The duration of participation in the study is 3 months for the submission of the results of the samples. A medical proctology consultation may also be offered, depending on the results of the screening.

This will be carried out in addition to the anal swabs taken quarterly to screen for other sexually transmitted infections.

A questionnaire will be completed by the doctor to record the data of interest. From additional data already entered in the e-NADIS software will be included for study.

Eligibility criteria: Inclusion Criteria:

Men sex Men Using Pre-exposure Prophylaxis for HIV Follow up au CHU de Besançon.

Exclusion Criteria:

* Women
* No MSM
* Under 18
* History of HPV related cancer

Primary outcomes:
measure: prevalence HPV
timeFrame: day 1
measure: typing HPV
timeFrame: day 1
Secondary outcomes:
measure: High risk HPV risk factors
timeFrame: day 1
measure: Cytologist abnormalies
timeFrame: day 1
Other outcomes:
Locations:
city: Besancon
country: France
facility: CHU Besançon
Study officials:
References:
Clinical trial NCT01819402: Pioglitazone Decreases Visceral Fat Metabolism
Official title: Effects of Pioglitazone on Visceral Fat Metabolic Activity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: To Evaluate the Effect of Pioglitazone on Glucose Metabolism of Fat Tissue by Using FDG-PET/CT Imaging
Keywords: visceral fat metabolism; FDG-PET/CT; pioglitazone; glimepiride; adiponectin
Lead sponsor: Kurume University
Sponsor class: OTHER
First posted: 2013-03-27
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 58
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Excess visceral fat is associated with chronic systemic inflammation and cardiovascular complications. Pioglitazone has been reported to variably influence visceral fat volume, but it its effect on metabolic activity of the visceral fat remains uncharacterized. To evaluate the effect of pioglitazone on glucose metabolism of fat tissue by using 18F-fluorodeoxyglucose (FDG)-positron emission tomography (PET) and computed tomography (CT) imaging.


Eligibility criteria: Inclusion Criteria:

* Subjects between the ages of 35 and 85 years
* Subjects with impaired glucose tolerance and type 2 diabetes

Exclusion Criteria:

* Subjects with insulin treatment
* Subjects with uncontrolled diabetes, hypertension, symptomatic coronary artery disease, symptomatic cerebrovascular disease
* Subjects taking more than three antidiabetic medications
* Subjects taking anti-platelet, statins, antidiabetic agents, thiazolidinediones within 8 weeks prior to randomization
* Subjects with cardiac failure (New York Heart Association Class \> III) or left ventricular dysfunction (LVEF \< 40%)
* Subjects with systemic disorders such as active inflammatory, liver, renal, hematopoietic, and malignant disease

Primary outcomes:
measure: Effect of treatment on the nominal change in FDG uptake of fat tissue from baseline after 16 weeks of treatment as measured by FDG-PET/CT imaging.
timeFrame: Baseline and 16 weeks after treatment
Secondary outcomes:
measure: Change from baseline in plasma glucose/insulin homeostatic parameters and circulating inflammatory markers
timeFrame: Baseline and 16 weeks after treatment
Other outcomes:
measure: All cardiovascular events and all cause death for 5 years
timeFrame: Baseline and 5 years after treatment
Locations:
city: Kurume
country: Japan
facility: Kurume University
Study officials:
References:
Clinical trial NCT01569802: A Comparison of Recall Rates Between Conventional 2d Mammography and 2d Plus 3d (Tomosynthesis) Mammography in a Screening Population
Official title: A Comparison of Recall Rates Between Conventional 2d Mammography and 2d Plus 3d (Tomosynthesis) Mammography in a Screening Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: breast cancer screening
tomosynthesis
FFDM
Lead sponsor: Rose Imaging Specialists, P.A.
Sponsor class: OTHER
Collaborators: name: Hologic, Inc.
First posted: 2012-04-03
Enrollment: 10000
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: radiology clinic screening population

Brief summary: The primary aim of this study is to measure, document and compare recall rates of two-dimensional plus three dimensional (2D plus 3D) (Tomosynthesis) mammography to that of 2D mammography in a screening population. This study will compare recall rates for both non-cancer and cancer cases.


Eligibility criteria: Inclusion Criteria:

* Subject is female of any race and ethnicity
* The subject is asymptomatic and presents for routine screening mammography and chooses to have a combination 2D + 3D mammogram as her standard of care.

Exclusion Criteria:

* Patient chooses standard 2D mammography over a combination 2D + 3D mammogram

Primary outcomes:
measure: Recall Rate
timeFrame: up to 1 year
Secondary outcomes:
measure: Cancer detection Rate
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Houston
country: United States
facility: TOPS
state: Texas
Study officials:
References:
Clinical trial NCT03822702: Biomechanical Assessment and Biofeedback-training System for Handwriting
Official title: An Alternative Perspective to Comprehend Handwriting Performance: Development and Applications of a Biomechanical Assessment and Biofeedback-training System for Handwriting (BABSH)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Writing Learning Disability
Keywords: handwriting
kinetics
kinematics
handwriting difficulty
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2019-01-30
Enrollment: 125
Sex: ALL
Minimum age (years): 5
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to investigate the real-time kinetics of handwriting regarding the design of the utensil and fine motor performances from biomechanical perspectives. It includes three parts.

The first part is an observational study design and the specific aim of the first part of the study is to establish a novel kinetic assessment system incorporated with Force Acquisition Pens (FAPs) designed with different barrel sizes and shapes for handwriting. The thorough calibration, examination of reliability and validity will be presented in this study.

The second part is also an observational study design and the specific aim of the second part of the study is to investigate the handwriting mechanisms using the kinetic assessment system incorporated with the motion capture system with children who have writing difficulties.

The third part is an interventional study design and the aim of this final part is to integrate the kinetic assessment system and the intervention concept to establish a Biomechanical Assessment and Biofeedback-training System for Handwriting (BABSH). Comparison of the intervention effect of the BABSH and traditional training for the children with handwriting difficulties will also be carried out in this part.


Eligibility criteria: Inclusion Criteria:

1. Able to use pen to write
2. Children volunteers must study in elementary schools

Exclusion Criteria:

- Handwriting problems are related to muscular, skeletal, nerve and brain damage or disease.

Primary outcomes:
measure: Change in the result of Chinese Handwriting Evaluation Form
timeFrame: baseline, 1.5 months
measure: Change in the total point score of three subtests of Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)
timeFrame: baseline, 1.5 months
measure: Change in the handwriting kinetic parameters
timeFrame: baseline, 1.5 months
measure: Change in the handwriting kinematic parameters
timeFrame: baseline, 1.5 months
Secondary outcomes:
measure: Change in the pinch force
timeFrame: baseline, 1.5 months
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng-Kung University
Study officials:
References:
Clinical trial NCT00659802: Phase II Study of HMPL-004 in Patients With Ulcerative Colitis
Official title: A Phase II, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative Colitis With or Without Mesalamine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ulcerative Colitis
Lead sponsor: Hutchmed
Sponsor class: INDUSTRY
First posted: 2008-04-16
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of HMPL-004 in patients with active mild to moderate ulcerative colitis (UC), compared with placebo.

Detailed description: This is a double-blind, randomized, placebo-controlled Phase II study conducted in North America (U.S. and Canada) and Europe (Romania and Ukraine) in patients with mild to moderate ulcerative colitis. Treatment consisted of one of 2 doses of HMPL-004 (1200 mg daily or 1800 mg daily, administered in 3 divided doses) or matching placebo. Assessment of treatment effect is based on the Mayo score. Subjects eligible for the study will include those ≥18 years of age with mild to moderate ulcerative colitis, having a Mayo score of 4 to 10, with activity confirmed by endoscopy within 2 weeks prior to study entry, and having a Mayo endoscopy score ≥1. Subjects who are using concomitant mesalamine could enter the study. The randomization will be stratified by mesalamine use or non-use.

Eligibility criteria: Inclusion Criteria:

* Have active confirmed mild to moderate ulcerative colitis

Exclusion Criteria:

* Diagnosed with Crohn's Disease or

Primary outcomes:
measure: Number of Participants With a Clinical Response at Week 8
timeFrame: 8 weeks
Secondary outcomes:
measure: Number of Participants With a Clinical Remission at Week 8
timeFrame: 8 weeks
measure: Number of Participants With Mucosal Healing at Week 8
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02191202: Impact of Switching to NNRTI-based Therapy on the Quality of Life of HIV-infected Patients With Virological Suppression
Official title: Observational Study of the Impact on Quality-of-life of a Switch From a Virologically Effective Regimen to a Regimen Containing a Non-Nucleoside Reverse Transcriptase Inhibitor (QUALVI) Nevirapine (Viramune®) Clinical Phase IV
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-16
Enrollment: 283
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital physicians, specialized in treatment of patients infected by the HIV

Brief summary: Observational study to evaluate therapeutic switch to a NNRTI-based regimen on quality of life of HIV-positive patients


Eligibility criteria: Inclusion Criteria:

* NNRTI-naive patients with positive HIV serology, treated with at least triple combination therapy, with a viral load \< 500 copies/ml, in whom a new treatment comprising an NNRTI is initiated for a reason other than inefficacy of treatment will be included
* Patients must read and write French

Exclusion Criteria:

* Patients in whom a new treatment is initiated because of treatment failure
* new treatment does not comprise an NNRTI

Primary outcomes:
measure: Changes in World Health Organization Quality of Life - HIV (WHOQOL-HIV) score
timeFrame: Baseline, month 1, 6 and 12
Secondary outcomes:
measure: Comparison of Short version of the Medical Outcomes Study Short-Form General Health Survey-36 (SF12) scores of the study population compared to the general population
timeFrame: Baseline, 12 months
measure: Changes in symptom scale score
timeFrame: Baseline, month 1, 6 and 12
measure: Changes in Hospital Anxiety and Depression scale (HADS)
timeFrame: Baseline, month 1, 6 and 12
measure: Changes in cluster of differentiation 4 (CD4) cell count
timeFrame: Baseline and month 3, 6, 9, 12
measure: Changes in viral load
timeFrame: Baseline and month 3, 6, 9, 12
measure: Changes in liver function tests
timeFrame: Baseline and month 3, 6, 9, 12
measure: Changes in total cholesterol
timeFrame: Baseline, month 6 and 12
measure: Changes in triglycerides
timeFrame: Baseline, month 6 and 12
measure: Changes in fasting blood glucose
timeFrame: Baseline, month 6 and 12
measure: Changes in haemoglobin
timeFrame: Baseline, month 6 and 12
measure: Changes from baseline in plasma urea
timeFrame: Baseline, month 12
measure: Changes from baseline in creatinine
timeFrame: Baseline, month 12
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00113802: Study of Epratuzumab (hLL2) in Patients With Waldenstrom's Macroglobulinemia
Official title: A Phase II, Single-Arm Trial of Epratuzumab, an Anti-CD22 Humanized Antibody, in Patients With Waldenstrom's Macroglobulinemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Waldenstrom Macroglobulinemia
Keywords: Epratuzumab (hLL2- anti-CD22 humanized antibody)
Waldenstrom's Macroglobulinemia
Waldenstrom Macroglobulinemia
Hematologic Disease
Hematologic Diseases
Paraproteinemias
Vascular Hemostatic Disorders
Lymphoproliferative Disorders
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2005-06-13
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether epratuzumab provides effective therapy in Waldenström's Macroglobulinemia (WM).

Detailed description: This multi-center, single-arm study of epratuzumab is in patients with Waldenström's Macroglobulinemia (WM) who failed chemotherapy. After baseline evaluations, patients receive epratuzumab infused over approximately 30-60 minutes at 360 mg/m2, administered once weekly for 4 consecutive weeks (days 1, 8, 15, 22). Post-treatment evaluations occur on the day of the last infusion, then at 6 and 12 weeks. Patients without progression of disease continue long-term follow up until disease progression or for at least 5 years, with evaluations every 3 months for 2 years, then semi-annually. Otherwise, follow-up is only required until resolution of any treatment related abnormalities.

Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of Waldenström's Macroglobulinemia using criteria proposed at 2nd International Workshop on WM, Athens, Greece, 2002.
* Measurable disease, defined as serum monoclonal IgM protein ≥1000 mg/dL by electrophoresis.
* Lymphoplasmacytic infiltration of the bone marrow \>10% involvement.
* Failed at least one, but no more than 3, regimen(s) of prior therapy.

(Please consult with study site for full eligibility criteria)

Primary outcomes:
measure: Serum measurements of IgM will be the primary determination of efficacy.
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Medical College of Cornell/ New York Presbyterian Hospital
state: New York
city: New York
country: United States
facility: Columbia University College of Physicans & Surgeons
state: New York
Study officials:
References:
Clinical trial NCT00286702: Does Splinting Prevent Contractures Following Stroke?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Accident
Keywords: splints
Occupational Therapy
Lead sponsor: University of Western Sydney
Sponsor class: OTHER
First posted: 2006-02-03
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: After a stroke, many people develop contracture of the muscles in their affected wrist and hand which leads to a permanently clenched, painful hand. A contracture is often treated by therapists who use hand splinting to prevent it occurring or slow down its progression. Despite their wide use, there has not been research completed to investigate whether or not splinting prevents contracture in people following stroke. In fact, this project will be the first of its kind in the world and is therefore vital to stroke rehabilitation.

The study is a multi-centre, randomised controlled trial that will measure the effect of hand-splinting in two positions on the prevention of contracture, functional use of the hand, and quality of life.


Eligibility criteria: Inclusion Criteria:

* first ever stroke
* score of \<1 on Motor Assessment Scale item 6

Exclusion Criteria:

* comorbidity resulting in previous contracture of the wrist/hand

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Western Sydney
name: Natasha Lannin, BSc(OT)
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Western Sydney
name: Anne Cusick, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00670202: Rho Kinase (ROCK) Inhibition in Carotid Atherosclerosis
Official title: The Effect of Fasudil on Rho Kinase Activity in Patients Scheduled for Elective Carotid Endarterectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Carotid Stenosis
Keywords: Patients scheduled for elective carotid endarterectomy
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Doris Duke Charitable Foundation
First posted: 2008-05-01
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, placebo controlled, parallel arm design
Primary purpose: OTHER

Brief summary: To evaluate the causal relationship between Rho/Rho kinase overactivity and mechanisms of vascular dysfunction in patients with atherosclerosis.


Eligibility criteria: Inclusion Criteria:

* Subjects with \>= 70% carotid stenosis (unilateral or bilateral) who are scheduled to undergo elective carotid endarterectomy
* Age \>= 18 years
* Agreement of the operating surgeon for patient to participate

Exclusion Criteria:

* Surgery scheduled \< 14 days after randomization
* Pregnancy
* ALT, GGT \> 3x upper limit of normal (ULN)
* Creatinine \> 3.5 mg/dL
* Prior intolerance to statins
* Reluctance to add or change dosage of statin therapy during study

Primary outcomes:
measure: Decrease in Rho/ROCK Expression With Concordant Increase in eNOS Expression/Activity in Carotid Specimens.
timeFrame: >= 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Anju Nohria, MD
role: PRINCIPAL_INVESTIGATOR
References: