louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01203865: Prevalence of Fibromyalgia in Israel
Official title: Prevalence of Fibromyalgia in Israel
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Fatigue
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Pfizer
First posted: 2010-09-16
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: PROBABILITY_SAMPLE
Study population: Telephone survey - general population over age 18 Rheumatology patients - patients attending the rheumatology clinic for any reason

Brief summary: The prevalence of fibromyalgia syndrome in the Israeli population is of importance fro planning resource allocation of medical expenditure as well as for identifying demographic and ethnic differences of this unique population compared with other western samples. In the current study the investigators aim at estimating the prevalence of fibromyalgia in this population. For this purpose a two - stage process will be used. First, a population survey will be conducted by telephone, screening for widespread pain and fatigue in the general population. This survey will use the London Fibromyalgia Epidemiology Study Screening Questionnaire. Second, a sample of patients attending the rheumatology clinic will be surveyed with this tool and will be examined in order to determine the actual proportion of patients fulfilling ACR criteria for fibromyalgia. This will enable us to calculate the positive predictive value of the London Fibromyalgia Epidemiology Study Screening Questionnaire in our population and hence to calculate the prevalence of fibromyalgia in the population.


Eligibility criteria: Inclusion Criteria:

* Individuals over 18 who consent to answer the survey questions

Primary outcomes:
measure: Prevalence of fibromyalgia in the Israeli population
timeFrame: 9 months
Secondary outcomes:
measure: Demographic data on fibromyalgia patients
timeFrame: 9 months
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv SOurasky Medical center
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Jacob N Ablin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Branco JC, Bannwarth B, Failde I, Abello Carbonell J, Blotman F, Spaeth M, Saraiva F, Nacci F, Thomas E, Caubere JP, Le Lay K, Taieb C, Matucci-Cerinic M. Prevalence of fibromyalgia: a survey in five European countries. Semin Arthritis Rheum. 2010 Jun;39(6):448-53. doi: 10.1016/j.semarthrit.2008.12.003. Epub 2009 Feb 27.
Clinical trial NCT01822665: Gastrointestinal Safety Evaluation of Two Over the Counter Analgesics
Official title: A Study to Investigate the Gastrointestinal Safety of OTC Analgesics in Healthy Volunteers by Endoscopic Examination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastrointestinal Mucosal Damage
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2013-04-02
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study evaluated the effect of oral fast-dissolving formulations of paracetamol and ibuprofen on the lining of the stomach and duodenum (gastrointestinal mucosa). Endoscopic examinations were conducted to determine the gastrointestinal damage produced post a 7 day treatment regimen.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index: 18-30 kg/m\^2
* Body Weight 60-80 kg
* Participant with both a normal stomach and proximal duodenum mucosa as evidenced by endoscopic results

Exclusion Criteria:

* Participant with evidence of current/active, or a history of gastrointestinal disease
* Participant with a history of renal disease, pulmonary edema, cardiomyopathy, liver disease, intrinsic coagulation defects, bleeding diseases or anticoagulant therapy
* Participant with a history of using antacids, H2 receptor antagonists, proton pump inhibitors, or misoprostol more than twice a month or has used any of these medications within 1 week of Visit 1.
* Participant with a current or recurrent disease, within 12 months of Visit 1, that could affect the action, absorption, disposition, or excretion of the study treatments or evaluation of the clinical or laboratory tests

Primary outcomes:
measure: Gastromucosal Damage (GMD) Score of Paracetamol Tablet vs Ibuprofen Capsule
timeFrame: Day 7
Secondary outcomes:
measure: GMD Scores of Paracetamol Tablet; Ibuprofen Capsule; Ibuprofen Tablet; and Placebo Tablet
timeFrame: Day 7
measure: Duodenal Mucosal Damage (DMD) Scores
timeFrame: Day 7
measure: Incidence of Gastric and/or Duodenal Mucosal Injury
timeFrame: Day 7
measure: Incidence of Fecal Occult Blood
timeFrame: Day 7
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Institute for Clinical Research
state: Texas
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00704665: Recombinant Human Relaxin in the Treatment of Diffuse Scleroderma
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial of Recombinant Human Relaxin in the Treatment of Systemic Sclerosis With Diffuse Scleroderma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Systemic Sclerosis
Keywords: Diffuse Scleroderma
Skin score
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: Boston University
name: University of Chicago
name: UConn Health
name: Johns Hopkins University
name: University of Pittsburgh
name: Medical University of South Carolina
name: Stanford University
name: Georgetown University
name: University of California, San Diego
name: Wayne State University
name: University of Colorado, Denver
name: Medical College of Wisconsin
First posted: 2008-06-25
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Relaxin is a naturally occurring protein prduced by the ovary or placenta in pregnancy. It has ani-fibrotic properties. Previous studies have shown that relaxin is safe at concentrations upto 60 times higher than achieved in pregnancy. Study is designed to see if skin improvement and improvement in functional ability can be achieved.


Eligibility criteria: Inclusion Criteria:

* Men and women 18 to 70 years of age with diffuse SSc
* Disease duration 5 years since the onset of the first non-Raynaud sign or symptom
* A baseline modified Rodnan skin score (MRSS) of 20 or greater, or at least 16 if truncal involvement was present.
* Recombinant human relaxin (10 or 25 ug/kg/day), or placebo was administered for 24 weeks as a continuous subcutaneous infusion and there was a follow-up safety visit at week 28.

Primary outcomes:
measure: MRSS
timeFrame: baseline, weeks 4,12, and 24
Secondary outcomes:
measure: HAQ-DI
timeFrame: baseline, weeks 4, 12, and 24
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00117065: Study of Transplant Related Anemia Treated With Aranesp® (STRATA)
Official title: Study of Transplant Related Anemia Treated With Aranesp® (STRATA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anemia
Keywords: Kidney transplant, Renal transplant
Aranesp®, Darbepoetin alfa
Amgen, Q2W dosing, Q4W dosing
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-07-04
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 was to evaluate Aranesp® administered subcutaneously (SC) to maintain hemoglobin (Hb) levels in renal transplant recipients.


Eligibility criteria: Inclusion Criteria: - Subjects who are greater than 6 months post-renal transplant (living or cadaveric) - Using adequate contraceptive precaution, if of childbearing potential - Available for follow-up assessments and dosing visits - Hb concentration less than 11.0 g/dL within 3 months of screening and a hemoglobin concentration less than 11.0 during the screening period Exclusion Criteria: - Expected to initiate dialysis or transplantation or be scheduled for a kidney transplant within 6 months of study start, or have less than 1 year life expectancy - Systemic hematologic disease, myeloma, hemolytic anemia, or malignancy (excluding basal cell carcinoma) - Active systemic or chronic infection - Uncontrolled hypertension defined as diastolic blood pressure greater than 110 mm Hg on 2 separate occasions during the 2 weeks prior to screening - Known hypersensitivity to Aranesp® or any of the product's excipients - Disorders that compromise the ability of the subject to give written informed consent and/or to comply with study procedures - Use of any erythropoietic protein or androgen therapy within the 12 weeks prior to screening - Females who are pregnant or breast-feeding - Currently enrolled in or received treatment in an investigational drug/device trial within the past 30 days - Have previously been enrolled in this study - Recent history (within 12 weeks prior to screening) of severe cardiovascular events, grand mal seizure, dialysis or major surgery - Have received a red blood cell transfusion(s) within 8 weeks prior to screening, or currently have active bleeding

Primary outcomes:
measure: Hemoglobin values
Secondary outcomes:
measure: SF-36 summary and individual domain scores at week 24
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Bloom RD, Bolin P, Gandra SR, Scarlata D, Petersen J. Impact on health-related quality of life in kidney transplant recipients with late posttransplant anemia administered darbepoetin alfa: results from the STRATA study. Transplant Proc. 2011 Jun;43(5):1593-600. doi: 10.1016/j.transproceed.2011.02.009.
Clinical trial NCT06752265: Application for Sexual Abuse Prevention Based On Empowerment of Parents And School Teachers
Official title: Sexual Abuse Prevention Application On Children And Adolescents (Application Of Peran Sadar) Based On Empowering Parents And School Teachers In West Java
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Child Abuse
Parents
Teachers
Keywords: Children
Application
Sexual abuse
Prevention
Adolescents
Lead sponsor: Universitas Padjadjaran
Sponsor class: OTHER
First posted: 2024-12-30
Enrollment: 88
Sex: ALL
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the research is to Analyze the influence of providing the PERAN SADAR Application on the knowledge, attitudes, self-awareness, and communication practices of parents, teachers, children, and adolescents

Participants will get education that is given using the PERAN SADAR_ APPLICATION for 9 consecutive days. Teachers at school and parents at home were encouraged to provide information on preventing sexual abuse to their children after they had read and listened to the information in the PERAN SADAR_ Application. Information was given every day for 1 month. Children were given a knowledge questionnaire (which had been tested for validity and construct in previous studies) before being given an intervention to provide information on preventing sexual violence. After 1 month, knowledge, attitudes, self-awareness, and communication practices were measured for teachers and parents, while knowledge measurements were carried out for children.


Eligibility criteria: Inclusion Criteria:

* student at elementary school

Exclusion Criteria:

* sick, refuse to join

Primary outcomes:
measure: Knowledge
timeFrame: one month
measure: Attitudes
timeFrame: one month
measure: Self-Awareness
timeFrame: one month
measure: Communication practices
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Sumedang
country: Indonesia
facility: Classroom
state: Jawa Barat
Study officials:
References:
Clinical trial NCT03708666: Nephrocare mHealth Project: Telemonitoring of Blood Pressure
Official title: Nephrocare mHealth: Improvement of Patient Empowerment and Self-management by the Use of Telemonitoring.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Diseases
Blood Pressure
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: General Hospital Groeninge
First posted: 2018-10-17
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The Nephrocare mHealth project supports patients with Chronic Kidney Disease with a mobile application and telemonitoring. The application includes the follow-up of blood pressure.

Detailed description: Patients that are included in the Nephrocare mHealth project send their blood pressure results through an app or online website.

The clinical decision support system will alert the patient, as well as the general practitioner and the hospital when the blood pressure is too high or low. In addition the clinical decision support will calculate monthly averages and all the data are connected with the electronic patient files.

Eligibility criteria: Inclusion Criteria:

* Dutch-speaking
* Signed and approved informed consent
* Follow-up by nephrology at the University Hospitals Leuven or General Hospital Groeninge

Exclusion Criteria:

* No Dutch-speaking
* Impaired cognitive condition or medically unstable

Primary outcomes:
measure: Systolic and diastolic blood pressure under control
timeFrame: 6 months
Secondary outcomes:
measure: Adaptations of treatment
timeFrame: 6 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Kathleen Claes, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004366: Pilot Study of Vestibular Rehabilitation Training for Panic Disorder With Vestibular Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vestibular Diseases
Agoraphobia
Panic Disorder
Keywords: agoraphobia
anxiety disorder
disease-related problem/condition
neurologic and psychiatric disorders
panic disorder
rare disease
vestibular diseases
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: University of Pittsburgh
First posted: 1999-10-19
Enrollment: 20
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: ECT

Brief summary: OBJECTIVES:

I. Evaluate whether vestibular rehabilitation training is of value in reducing anxiety symptoms in patients with panic disorder with or without agoraphobia who have vestibular dysfunction as identified by clinical vestibular tests.

Detailed description: PROTOCOL OUTLINE: During the first 4 weeks of study, patients meet with a clinical nurse specialist once a week for approximately 1 hour. During this time, the nature of the anxiety disorder is explained and exposure to previously feared situations is encouraged.

Only patients who remain symptomatic at a stable level following self-exposure will proceed with rehabilitation training.

Patients meet with a physical therapist once a week for 4 weeks to further evaluate the extent of problems associated with balance. Then, patients undergo weekly 1 hour exercises for 8 weeks with the physical therapist, focusing on sensation, head and eye coordination, movement with eyes opened and closed, and gait.

Concurrently, patients meet with the clinical nurse specialist every 4 weeks during and after physical therapy to evaluate the effects of vestibular treatment on anxiety symptoms.

Training is continued if patient is symptomatic; otherwise, patient is discharged from study.

Eligibility criteria: * Diagnosed panic disorder with or without agoraphobia
* Vestibular dysfunction, as defined by abnormalities in the caloric and/or rotational tests
* Continued symptomatology after general instructions of the importance of exposure to feared situations
* Absence of acute symptoms of anxiety or depression assessed to need immediate clinical care

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Pittsburgh
name: Rolf G. Jacob
role: STUDY_CHAIR
References:
Clinical trial NCT06746766: Registry Study on Rare Cancers in Korea
Official title: Registry Study on Rare Cancers in Korea
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rare Cancer
Keywords: Rare Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2024-12-24
Enrollment: 500
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data collection includes:

* Clinical characteristics (diagnosis, treatment information, primary/metastatic sites, staging, gender/age)
* Survival information (diagnosis date, recurrence date, death date, disease progression)
* Pathological information (diagnosis, genomic information)

Brief summary: This study aims to determine the participation rate of patients with registered rare cancers in clinical research.

Detailed description: Data collection includes:

* Clinical characteristics (diagnosis, treatment information, primary/metastatic sites, staging, gender/age)
* Survival information (diagnosis date, recurrence date, death date, disease progression)
* Pathological information (diagnosis, genomic information)

Eligibility criteria: Inclusion Criteria:

* Adults aged ≥19 years
* Confirmed rare cancer
* Life expectancy ≥3 months

Exclusion Criteria:

-Serious or unstable medical/psychiatric conditions

Primary outcomes:
measure: Establish a registry
timeFrame: 1 year
Secondary outcomes:
measure: Clinical trial registration rate (%)
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Yonsei Cencer center
name: Hyo Song Kim, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gatta G, Capocaccia R, Trama A, Martinez-Garcia C; RARECARE Working Group. The burden of rare cancers in Europe. Adv Exp Med Biol. 2010;686:285-303. doi: 10.1007/978-90-481-9485-8_17.
citation: Very rare cancers--a problem neglected. Lancet Oncol. 2001 Apr;2(4):189. doi: 10.1016/s1470-2045(00)00273-4. No abstract available.
citation: Pritchard-Jones K, Kaatsch P, Steliarova-Foucher E, Stiller CA, Coebergh JW. Cancer in children and adolescents in Europe: developments over 20 years and future challenges. Eur J Cancer. 2006 Sep;42(13):2183-90. doi: 10.1016/j.ejca.2006.06.006.
Clinical trial NCT03248466: PRG Combined With Autologous BMMSCs for Treatment of Diabetic Foot Ulcer
Official title: Transplantation of Autologous Platelet Rich Gel Combined With Autologous Bone Marrow Mesenchymal Stem Cells for Treatment of Diabetic Foot Ulcer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Diabetic Foot Ulcer
Keywords: platelet rich gel
BMMSCs
diabetic foot ulcer
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2017-08-14
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: diabetic foot ulcer which Wagner classification at 2-3 grade.
Primary purpose: TREATMENT

Brief summary: To investigate the treatment effect between Traditional treatment and transplantation of autologous PRG combined with autologous BMMSCs for treatment of diabetic foot ulcer.

Detailed description: 60 diabetic foot ulcer in our hospital will divide into 3 groups: group A (20 diabetic foot ulcer who give Traditional treatment), group B (20 diabetic foot ulcer who give Traditional treatment and transplantation of autologous platelet rich gel)，group C (20 diabetic foot ulcer who give Traditional treatment and transplantation of autologous platelet rich gel combined with autologous bone marrow mesenchymal stem cells). The age, height, weight, blood glucose, glycosylated hemoglobin A1c（HbA1c）, lipid, blood pressure, course of disease, Wound healing rate,transcutaneous oxygen pressure,Amputation rate,Hospital stay will record respectively. And High-sensitive C-reactive protein (HsCRP) and Tumor necrosis factor-α（TNF-α） will detect as Baseline. After each group's treatment, Change from baseline of all indexes will record, one way Analysis of Variance will be analyzed the significantion among 3 groups.

Eligibility criteria: Inclusion Criteria:

* Diabetic foot according to The Wagner is 2-3 graded;

Exclusion Criteria:

* Type 1 diabetes mellitus,presence of autoimmune diabetes;
* Gestational diabetes;
* Patients with heart, liver, or renal function impairment;presence of severe infections or cerebrovascular disease.

Primary outcomes:
measure: Amputation rate
timeFrame: up to 6 months
measure: hospital stay
timeFrame: up to 6 months
Secondary outcomes:
measure: Wound healing time
timeFrame: up to 6 months
measure: Transcutaneous oxygen partial pressure
timeFrame: Transcutaneous oxygen partial pressure up to 6 months
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Southwest Hospital of the Third Military Medical University
state: Chongqing
city: Chongqing
country: China
facility: Endocrine Department, the First Affiliated Hospital of the Third Military Medical University
state: Chongqing
Study officials:
References: