louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00618150: Patient Education in Gastroesophageal Reflux Disease
Official title: Patient Education in Gastroesophageal Reflux Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux Disease
Keywords: GERD
Dyspepsia
Education
Information
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Norwegian Foundation for Health and Rehabilitation
First posted: 2008-02-18
Enrollment: 211
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Patients with gastroesophageal reflux disease (heart-burn, acid regurgitation)may benefit from an educational program explaining the medical aspects of the disease, self-management strategies and how to deal with health services. We hypothesized that patients having participated in an educational program would experience an improved quality of life when compared to patients who did not take part (controls).


Eligibility criteria: Inclusion Criteria:

* heartburn and acid regurgitation the dominant symptom
* needing relief at least 5 days/ week when symptoms were at their worst
* disease history at least 3 months
* ability to give informed consent

Exclusion Criteria:

* current or previous esophagitis stage 2(Savary-Miller) or greater or peptic ulc
* continuous need of proton pump inhibitors or NSAIDs
* wish for surgical treatment
* earlier surgical treatment in the GI-tract
* pregnancy
* alcohol or drug abuse

Primary outcomes:
measure: Quality of life
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Norwegian University of Science and Technology, Med. fac.
Study officials:
affiliation: Norwegian University of Science and Technology
name: Jorgen A Urnes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Urnes J, Farup PG, Lydersen S, Petersen H. Patient education in gastro-oesophageal reflux disease: a randomized controlled trial. Eur J Gastroenterol Hepatol. 2007 Dec;19(12):1104-10. doi: 10.1097/MEG.0b013e3282f163dc.
citation: Urnes J, Petersen H, Farup PG. Disease knowledge after an educational program in patients with GERD--a randomized controlled trial. BMC Health Serv Res. 2008 Nov 13;8:236. doi: 10.1186/1472-6963-8-236.
Clinical trial NCT06690450: Safety and Tolerability of 200mg and 100mg of Venofer Administered to Hemodialysis(HD) Patients
Official title: A Randomized Study to Assess the Safety and Tolerability of 200mg and 100mg of Venofer Administered to Hemodialysis (HD) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hemodialysis
Lead sponsor: American Regent, Inc.
Sponsor class: INDUSTRY
First posted: 2024-11-15
Enrollment: 400
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 Objective of this study is to assess the Safety and Tolerability of 200 mg and 100 mg of Venofer Administered to Hemodialysis(HD) Patients.

Detailed description: This is a randomized open label multi-center study of two parallel patient groups undergoing hemodialysis. Group A will receive 200 mg of iron sucrose, while Group B will receive 100 mg of iron sucrose during the study. The duration of the study for each patient will be approximately 3 weeks including a screening phase, a treatment visit and a follow-up visit.

Eligibility criteria: Inclusion Criteria:

* Males or females over 18 years of age and able to give informed consent.
* Undergoing hemodialysis.
* If receiving epoetin α, then the dose was stable.
* Percentage serum transferrin saturation (TSAT) \<50% and serum ferritin \<800 ng/mL.
* Absence of infection, malignancy, or surgery in the month prior to study start.
* Intolerance of other iron products did not preclude participation in this study.

Exclusion Criteria:

* Known sensitivity to any component of Venofer®.
* Suffering from concomitant severe diseases of the liver, cardiovascular system, severe psychiatric disorders or other conditions which, in the opinion of the investigator, made participation unacceptable.
* Serious bacterial, viral infection, or other acute infectious illness (e.g., hepatitis) unless completely resolved at least 4 weeks prior to inclusion in the study.
* Pregnancy or lactation.
* HIV positive by medical history or laboratory test (optional), or active hepatitis.
* Anemia caused by diseases (including systemic lupus erythematosus (SLE), rheumatoid arthritis, myeloma, or hereditary hemoglobinopathies) other than chronic renal failure or iron deficiency.
* Asthma.
* Clinical evidence of gastrointestinal bleeding.
* Would probably require blood transfusion or might undergo a renal transplant during the study.
* Anticipated surgery of any kind during the study other than vascular access surgery.
* Received an investigational drug within 30 days prior to screening.
* Previously participated in another Venofer® study.

Primary outcomes:
measure: The number of participants with treatment-emergent adverse events (TEAEs) as assessed by CTCAE v4.0
timeFrame: 3 to 6 days
Secondary outcomes:
measure: The number of participants prematurely discontinued the study due to an adverse event
timeFrame: 3 to 6 days
Other outcomes:
Locations:
Study officials:
affiliation: Medical Director
name: Carol Duffy, D.O.,FACC
role: STUDY_DIRECTOR
References:
Clinical trial NCT03969550: Do CCR5 Antagonists Improve the Overall Survival of Patients With AIDS-related Progressive Multifocal Leucoencephalopathy?
Official title: Do CCR5 Antagonists Improve the Overall Survival of Patients With AIDS-related Progressive Multifocal Leucoencephalopathy?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: AIDS
Progressive Multifocal Leucoencephalopathy (PML)
Keywords: Maraviroc
John Cunningham virus (JCV)
Immune reconstitution inflammatory syndrome (IRIS)
Combined antiretroviral treatment (cART)
Overall survival (OS)
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2019-05-31
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with AR-PML, exposed or not to maraviroc, as part of combined antiretroviral treatment (cART).

Brief summary: Progressive multifocal leucoencephalopathy (PML) is a demyelinating disease caused by John Cunningham virus (JCV) reactivation. Numerous molecules have been overstated because there were inaccurately tested in non-rigorous clinical trial.

The objective is to draw lessons from repeatedly false hopes of unconfirmed PML treatments that might contribute to prescribing ineffective drugs on claimed efficacy in case reports or small series and by failing to respect the need for clinical trial evaluation before authorizing their widespread use.


Eligibility criteria: Inclusion Criteria:

* Patients with AR-PML
* Diagnosed between January 2008 and December 2015
* Followed in one of the four University Hospitals' Infectious Diseases Departments

Exclusion Criteria:

Primary outcomes:
measure: Overall survival (OS)
timeFrame: 8 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00575250: Education for Osteoporosis in Persons With Existing Fractures
Official title: Osteoporosis Education Clinic Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Keywords: Osteoporosis/prevention & control
Osteoporosis Prevention and Self-Management Course
Patient Education/*trends//Questionnaires
Adult//Aged//Middle Aged
Life Style//
Lead sponsor: University of Adelaide
Sponsor class: OTHER
Collaborators: name: Osteoporosis SA
First posted: 2007-12-18
Enrollment: 152
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: We wish to investigate whether a weekly, 2½ hour group-based osteoporosis education intervention (the Osteoporosis Prevention and Self-Management Course), is different to one session course (1x 2½ hours) on osteoporosis knowledge, confidence to eat calcium-containing foods, confidence to exercise, and amount of exercise undertaken after three and nine months of follow-up in people aged over 50 years who have already had a bone fracture.

Detailed description: Instruments used to determine change after 3 and 9 months:

Osteoporosis knowledge: Osteoporosis Knowledge Assessment Test (Winzenberg et al. BMC Musculoskelet Disord 2003) Calcium intake: Food frequency questionnaire (Angus et al. J Am Diet Assoc 1989) Calcium and exercise self-efficacy: Osteoporosis Self-Efficacy Scale (Horan et al Res Nurs Health 1998) Physical activity: CHAMPS II (Stewart et al. J Gerontol A Biol Sci Med Sci 2001)

Eligibility criteria: Inclusion Criteria:

* Presented to Modbury Hospital's Accident and Emergency Department with a new bone fracture

Exclusion Criteria:

* Residence in nursing home
* Fracture sustained in motor bike, push bike or motor vehicle accident
* Fracture sustained due to high trauma, such as fall from roof or ladder
* Dementia
* Inability to participate in group settings
* Inability to understand spoken English
* Inability to provide informed consent
* Pathological fracture
* Usual place of residence outside South Australia

Primary outcomes:
measure: Difference between groups at three months on osteoporosis knowledge, confidence in ability to consume calcium and to exercise, actual calcium consumption and exercise levels
timeFrame: Three and nine months
Secondary outcomes:
measure: Changes between baseline and three months within each group on osteoporosis knowledge, confidence in the ability to each calcium-containing foods and exercise, and the amount of calcium consumed in foods and exercise undertaken
timeFrame: Three and nine months
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Modbury Hospital, Modbury
state: South Australia
Study officials:
affiliation: University of Adelaide
name: Laura L Laslett, MMedSci
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Adelaide
name: Julian D McNeil, PhD FRACP
role: STUDY_CHAIR
References:
Clinical trial NCT01615250: Implantation of Peripheral Stem Cells in Patient With Ischemic Cardiomyopathy
Official title: Phase I Study to Evaluate the Efficacy and Safety of Intramyocardial Implantation of Peripheral Mononuclear Cells With CD34+ Stem Cells in Patient With Ischemic Cardiomyopathy After Preparatory Course of Shock - Wave Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Heart Failure
Lead sponsor: Odessa National Medical University
Sponsor class: OTHER
First posted: 2012-06-08
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a randomized study of efficiency and safety of intramyocardial implantation of peripheral mononuclear cells with high concentration of CD34+ stem cells in patients with myocardial ischemia after preparatory course of shock - wave therapy.


Eligibility criteria: Inclusion Criteria:

* Patients with ischemic cardiomyopaty and HF II-IV NYHA class
* MI more than 6 months before the study
* LVEF less than 35%
* Absence effect of coronary revascularization during 6 months
* Optimal pharmacological therapy no less than 8 weeks
* Heart transplantation is contraindicated
* Patients with implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D)
* Patients giving informed consent

Exclusion Criteria:

* Acute coronary syndrome
* Coronary revascularization less than 6 months
* Patients requiring surgical correction of post-MI aneurism
* LV wall thickness less than 5 mm in site of possible injection
* Patients with CRT implanted within 3 month before cells injection
* Clinically significant associated diseases
* Active oncology desiase
* Pregnancy

Primary outcomes:
measure: Change in global left ventricular ejection fraction and regional wall motion score index
timeFrame: 6 and12 months
Secondary outcomes:
measure: Incidence of the major adverse cardiac events
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Odessa
country: Ukraine
facility: Odessa Regional Clinical Hospital
Study officials:
affiliation: Odessa National Medical University
name: Iurii I Karpenko, Dr, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00284050: Safety and Efficacy of Ranibizumab in Diabetic Macular Edema With Center Involvement
Official title: A Randomized, Double-masked, Multi-center, Phase II Study Assessing the Safety and Efficacy of Two Concentrations of Ranibizumab (Intravitreal Injections) Compared With Non-treatment Control for the Treatment of Diabetic Macular Edema With Center Involvement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Macular Edema
Keywords: DME
Diabetic macular edema
ranibizumab
Diabetic macular edema with center involvement
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-01-31
Enrollment: 151
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: This study evaluated the safety and efficacy of ranibizumab on retinal edema and visual acuity in patients with diabetic macular edema with center involvement.


Eligibility criteria: Inclusion Criteria:

* Diabetic macular edema with center involvement in at least one eye
* Type 1 or type 2 diabetes mellitus diagnosed 2 years prior to screening
* Laser photocoagulation in the study eye can be withheld for at least 3 months after randomization

Exclusion Criteria:

* Patients with uncontrolled systemic or ocular diseases
* Have any history of any intraocular surgery in the study eye within the past 6 months preceding screening
* Conditions that require chronic concomitant therapy with systemic or topical ocular corticosteroids

Other protocol-defined inclusion/exclusion criteria applied to the study.

Primary outcomes:
measure: Difference Between the Baseline Level of Visual Acuity (Letters) of the Study Eye and the Mean Visual Acuity Averaged Over All Monthly Post-baseline Assessments From Month 1 to Month 12
timeFrame: Baseline through the end of study (Month 12)
measure: Mean Change From Baseline in Visual Acuity (Letters) of the Study Eye at Month 12
timeFrame: Baseline through the end of study (Month 12)
Secondary outcomes:
measure: Mean Change From Baseline in Central Retinal Thickness (µm) of the Study Eye at Month 12
timeFrame: Baseline through the end of study (Month 12)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Novartis
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis
role: STUDY_CHAIR
References:
citation: Massin P, Bandello F, Garweg JG, Hansen LL, Harding SP, Larsen M, Mitchell P, Sharp D, Wolf-Schnurrbusch UE, Gekkieva M, Weichselberger A, Wolf S. Safety and efficacy of ranibizumab in diabetic macular edema (RESOLVE Study): a 12-month, randomized, controlled, double-masked, multicenter phase II study. Diabetes Care. 2010 Nov;33(11):2399-405. doi: 10.2337/dc10-0493.
Clinical trial NCT00131950: Effect of Lifestyle Factors and Hormone Function on Breast Density in Healthy Hispanic Women Who Are Undergoing Mammography for Breast Cancer Screening
Official title: Chicago Breast Health Project, Phase II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2005-08-19
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Primary purpose: SCREENING

Brief summary: RATIONALE: Lifestyle factors, such as physical activity, diet, and obesity, and hormone function may affect breast density. Screening tests, such as mammography, may help doctors find tumor cells early and plan better treatment for breast cancer.

PURPOSE: This clinical trial is studying the effect of lifestyle factors and hormone function on breast density in healthy Hispanic women who are undergoing mammography for breast cancer screening.

Detailed description: OBJECTIVES:

* Correlate physical activity, diet, and obesity, as measured by body mass index and waist circumference, with percent breast density and the absolute estimate of total dense breast area in healthy Hispanic women undergoing screening mammography.
* Correlate fasting serum insulin growth factor (IGF)-1 and the molar ratio of IGF-1 to IGF binding protein-3 with breast density in participants undergoing screening mammography.
* Correlate insulin concentration and insulin resistance with breast density in participants undergoing screening mammography.

OUTLINE: This is a multicenter study.

Participants undergo blood collection and physical examination. Participants also complete breast cancer risk factor, food frequency, and physical activity questionnaires and receive breast health and physical activity education. Participants then undergo a digital screening mammogram. Participants are notified of mammogram results.

PROJECTED ACCRUAL: A total of 114 participants will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Healthy Hispanic women
* Registered patient at the Erie Family Health Centers' West Town or Humboldt Park clinics
* No screening mammography within the past 12 months
* No abnormality on clinical breast exam
* No history of breast cancer
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age

* 40 and over

Sex

* Female

Menopausal status

* Not specified

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center at Northwestern University
state: Illinois
Study officials:
affiliation: Robert H. Lurie Cancer Center
name: Susan M. Gapstur
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00443950: Study Evaluating the Efficacy and Safety of Etanercept in Chinese Subjects With Rheumatoid Arthritis
Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Etanercept in Chinese Subjects With Active Rheumatoid Arthritis Receiving Methotrexate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthritis, Rheumatoid
Keywords: Arthritis
Chinese
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-03-07
Enrollment: 150
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 objective of this study is to compare in Chinese subjects with rheumatoid arthritis (RA) the efficacy and safety in this subject population of 50 mg once-weekly injections of etanercept versus placebo in subjects receiving methotrexate. This is a multi-center, double-blind, randomized, parallel and placebo-controlled outpatient study. Approximately 150 subjects will participate in this study for about 18 weeks including a screening period up to 4 weeks, 12-week treatment period, and a 2-week follow-up period at approximately 25 sites.


Eligibility criteria: Inclusion Criteria:

* Must be of Chinese ancestry and living in China.
* Meets the American Rheumatism Association 1987 Revised Criteria for the Classification of RA.
* Have active RA at the time of study enrollment (before the start of the screening period,) as demonstrated by 5 swollen and 5 tender/painful joints.

Exclusion Criteria:

* Previous receipt of etanercept; antibody to tumor necrosis factor (TNF) antibody (infliximab, adalimumab), anti-CD4 antibody or diphtheria IL-2 fusion protein (DAB IL-2).

Primary outcomes:
measure: The primary endpoint is ACR20 response at 12 weeks.
Secondary outcomes:
measure: Physician global assessments
measure: Morning stiffness in minutes
measure: Pain visual analog scale(VAS)
measure: Health assessment questionnaire(HAQ)
measure: C-reactive protein (CRP) values, Subject global assessments
measure: Number of tender and swollen joints
measure: ACR20 (at visit other than week 12)
measure: ACR50
measure: ACR70 responses
Other outcomes:
Locations:
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Guangzhou
country: China
city: Shanghai
country: China
city: Xian
country: China
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References: