louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06715267: Children, Adolescents and Young Adults with Myeloproliferative Neoplasia: Study of Clinico-biological Characteristics and Complications (VYP)
Official title: Children, Adolescents and Young Adults with Myeloproliferative Neoplasia: Study of Clinico-biological Characteristics and Complications
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myeloproliferative Neoplasm
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 200
Sex: ALL
Minimum age (years): 0
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with non-LMC myeloproliferative neoplasm before age 30 (Polycythemia vera, essential thrombocythemia, primary myelofibrosis, prefibrotic myelofibrosis).

Brief summary: The creation of a national database will provide access to solid data on the diagnosis of myeloproliferative neoplasia for patients under 30, giving a true picture of their care. It will also make it possible to identify the biological samples (histological and molecular) available in routine laboratories, enabling teams of researchers and anatomopathologists to (re)perform certain analyses to re-evaluate diagnoses and search for hitherto unknown molecular prognostic factors.


Eligibility criteria: Inclusion Criteria:

* Patient diagnosed with non-LMC MPN before the age of 30 (PV or TE or MFP or PreMF) according to the 2016 WHO criteria.
* Signature of the consent form for participation in the FIMBANK project.
* Agreement to participate in the VYP study.
* Patient of legal age at the time of inclusion in VYP.
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Refusal to participate by patients of full age
* Patient under legal protection (guardianship, curatorship, etc.)

Primary outcomes:
measure: Describe the epidemiological characteristics of the study population
timeFrame: at enrollment
measure: Describe the mutational landscape of these MPNs
timeFrame: at enrollment
Secondary outcomes:
measure: Describe the classical MPN (Myeloproliferative neoplasia) outcomes-1
timeFrame: At 10 years
measure: Describe the classical MPN outcomes-2
timeFrame: At 10 years
measure: Describe the classical MPN outcomes-3
timeFrame: At 10 years
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU de Brest
Study officials:
References:
Clinical trial NCT00862667: A Study To Estimate The Time Course Of PF-00241939 Concentration In The Blood Following Dosing By Oral Inhalation From Dry Powder Inhalers.
Official title: An Open Study To Estimate The Plasma Pharmacokinetics Of PF-00241939 Administered Via Oral Inhalation Using Dry Powder Inhalers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Pharmacokinetics
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-03-17
Enrollment: 36
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the time course of PF-00241939 concentration in the blood following dosing by oral inhalation from dry powder inhalers.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 21 and 55 years.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* A positive urine drug screen.
* History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males.
* Pregnant or nursing females.

Primary outcomes:
measure: Plasma pharmacokinetic parameters: AUClast & Cmax.
timeFrame: 48 hours
Secondary outcomes:
measure: Plasma pharmacokinetic parameters: AUC0-12, AUC0-24, AUCinf, Tmax and t½.
timeFrame: 48 hours
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04701567: Diagnostic and Evaluation of Hepato-pancreatico-biliary Disease With MRI
Official title: Diagnostik Und Evaluierung Hepato-pankreatiko-biliärer Erkrankungen Mittels Morphologischer Und Funktioneller Magnetresonanztomographie
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Diseases
Pancreas Disease
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2021-01-08
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with suspicion for or diagnosed focal and/or diffuse liver or pancreatic disease who underwent MRI of the abdomen.

Brief summary: This is a retrospective review of images from patient data. There is no recruitment necessary for this study.

Research Question: Can advanced multiparametric MRI techniques improve the detection and characterization of focal and diffuse liver disease, accurately assess treatment response and predict patient outcomes based on longitudinal monitoring? Hypotheses: Advanced multiparametric MRI techniques improve the detection, characterization and response assessment of focal and diffuse liver disease and can predict serious liver related outcomes.


Eligibility criteria: Inclusion Criteria:

* Patients with suspicion for or diagnosed focal and/or diffuse liver or pancreatic disease who underwent MRI of the abdomen.
* 18 years of age and older.

Exclusion Criteria:

* Age less than 18 years.
* Lack of MRI of the abdomen.
* Inadequate image quality.
* Documented rejection to participate in research studies

Primary outcomes:
measure: Pathology findings in focal and/or diffuse liver disease
timeFrame: 1 year
measure: Pathology findings in focal and/or diffuse pancreatic disease
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University of Zurich
name: Caecilia Reiner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05896267: SpO2 Data Collection in Pediatric Patients Using INVSENSOR00061
Official title: SpO2 Data Collection in Pediatric Patients Using INVSENSOR00061
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spo2
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2023-06-09
Enrollment: 64
Sex: ALL
Minimum age (years): 37
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: This is a prospective, non-randomized data collection study to evaluate the form, fit, and function of INVSENSOR00061.


Eligibility criteria: Inclusion Criteria:

* • Subject is a full-term newborn (37 weeks) to 18 months of age.

Exclusion Criteria:

* • Subject has underdeveloped skin.

  * Subject has a skin condition and/or deformity at the planned application site, which would preclude sensor placement and measurements.
  * Subject has an absence or deformities of limbs or severe edema, which would interfere with sensor application or prevent the proper fit of the sensors.
  * Subject is not suitable for the investigation at the discretion of the Investigator.

Primary outcomes:
measure: SpO2 Accuracy of INVSENSOR00061
timeFrame: Approximately 15 minutes
measure: Pulse Rate Accuracy of INVSENSOR00061
timeFrame: Approximately 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: National City
country: United States
facility: Bailony Pediatrics
state: California
Study officials:
References:
Clinical trial NCT03274167: Efficacy of Gabapentin in Alcohol Dependency Treatment
Official title: Efficacy of Gabapentin in Alcohol Dependency Treatment: a Double-blinded Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alcohol Drinking
Heavy Drinking
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
Collaborators: name: Princess Mother National Institute on Drug Abuse and Treatment
First posted: 2017-09-06
Enrollment: 112
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 study aims to study the effect of gabapentin on the number of alcohol drinking days and heavy drinking days in the Thai clinical alcohol-dependent population by using the double-blinded randomized controlled approach. One-hundred and twelve individuals with alcohol dependence were randomly assigned equally into two groups including treatment with gabapentin and placebo. Thirty-four patients (30.3%) completed the study protocol, i.e. treatment with gabapentin at least 300 mg per day or placebo orally once a day for twelve weeks. Pattern of alcohol drinking were obtained from the timelime followback. Drinking behaviors were compared between the two groups by poisson repeated measures model.


Eligibility criteria: Inclusion Criteria:

* current diagnosis of alcohol dependence

Exclusion Criteria:

* having major psychiatric disorders including schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder, or suicide risk based on a clinical interview by attending psychiatrist
* receiving other medications not in the protocol of the study for any reasons or having history of using other substances including methamphetamine, heroin, cannabis, inhalants, mitragyna speciosa (or kratom in Thai), except tobacco based on self-report
* having a medical disease, e.g. essential hypertension, diabetes, renal (e.g., normal renal test) or liver disease (e.g., liver function test was not higher than two times of normal range and gamma-glutamyl transferase (GGT) is less than 800 U/L), epilepsy, stroke
* having history of alcohol withdrawal seizure or delirium based on clinical interview by attending psychiatrist
* having moderate to severe alcohol withdrawal symptoms based on score \>13 of the Clinical Interview for Withdrawal Alcohol Arlington (CIWA - Ar) at the time of recruitment
* having cognitive impairment based on score \< 24 from the Mini Mental State Exam (MMSE)
* having history of allergy to gabapentin
* pregnancy or breast feeding.

Primary outcomes:
measure: Frequency of heavy drinking
timeFrame: weekly for 12 weeks
Secondary outcomes:
measure: Frequency of drinking
timeFrame: weekly for 12 weeks
Other outcomes:
Locations:
city: Pathum Thani
country: Thailand
facility: Princess Mother National Institute on Drug Abuse and Treatment
Study officials:
affiliation: Princess Mother National Institute on Drug Abuse and Treatment
name: Sumnao Nilaban
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03068767: The Relationship Between Vitamin D and Hepatitis B Virus Replication
Official title: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D and Hepatitis B Virus
Keywords: HBV DNA, qHBsAg
Lead sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Sponsor class: OTHER
First posted: 2017-03-03
Enrollment: 149
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1: vitamin D supplement Group 2: controls
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 149 HBV carriers with inadequate serum vitamin D levels were randomized to two groups: one is supplied with vitamin D and another without as controls. The markers of HBV replication were compared before and after treatment.

Detailed description: This is a randomized case-control trial. A total of 149 HBV carriers with inadequate vitamin D (\< 30 ng/mL) level were enrolled. They were randomly divided to two groups: one group receiving vitamin D supplement (1600 IU/day) for 2 months and another group as controls. The serum vitamin D, HBV DNA and qHBsAg levels were measured at baseline and after vitamin D supplement. Whether HBV DNA and qHBsAg have significant change after vitamin D supplement can be determined.

Eligibility criteria: Inclusion Criteria:

* \>20 y/o, HBV carrier
* serum vitamin D \< 30ng/ml

Exclusion Criteria:

* Other known causes of hepatitis

Primary outcomes:
measure: The Dynamic Change of HBV DNA
timeFrame: baseline, after 2-month vitamin D supplement
measure: The Change of Serum qHBsAg (IU/mL)
timeFrame: baseline, after 2-month vitamin D supplement
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei city
country: Taiwan
facility: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Study officials:
affiliation: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
name: Chia-Chi CC Wang, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01354340: Dose Effect of Limicol on (LDL)-Cholesterol Levels
Official title: Dose Effect of Limicol on (LDL)-Cholesterol Levels in Moderate Hypercholesterolaemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolaemia
Keywords: Cholesterol
LDL-cholesterol
Coronary artery disease
Red yeast rice
Plants extract
Cholesterol excess
Delivery of Health Care
Lead sponsor: Lescuyer Laboratory
Sponsor class: INDUSTRY
Collaborators: name: BioFortis
First posted: 2011-05-16
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The principal objective of this study is to investigate the dose-effect of the Limicol food supplement on LDL-cholesterol level in moderate hypercholesterolaemia subjects.


Eligibility criteria: Inclusion Criteria:

* About 18 to 65 years (inclusive).
* Subject has a stable weight for at least three months before the start of the study.
* Subject able and willing to comply with the protocol and agreeing to give their consent in writing.
* Subject affiliated with a social security scheme.
* Subject willing to be included in the national register of volunteers who lend themselves to biomedical research.

Primary outcomes:
measure: Change from Baseline in blood LDL-cholesterol levels after 4 weeks of supplementation (limicol double dose group versus placebo group)
timeFrame: 4 weeks after baseline
Secondary outcomes:
measure: Change from Baseline in blood LDL-cholesterol levels after 4 weeks of supplementation (limicol double dose group versus limicol simple dose group)
timeFrame: 4 weeks after baseline
measure: Change from Baseline in blood total cholesterol, HDL-cholesterol and TAG levels after 4 weeks of supplementation (limicol double dose group versus limicol simple dose group versus placebo group)
timeFrame: 4 weeks after baseline
measure: Change from Baseline in blood LDL-cholesterol, total cholesterol, HDL-cholesterol and TAG levels 4 weeks after end of supplementation (limicol double dose group versus limicol simple dose group versus placebo group)
timeFrame: 8 weeks after baseline
measure: Change from Baseline in CK, LDH and other safety biomarkers levels after 4 weeks of supplementation (limicol double dose group versus placebo group versus placebo group)
timeFrame: 4 weeks after baseline
Other outcomes:
Locations:
city: Nantes
country: France
facility: Biofortis
Study officials:
affiliation: Lescuyer Laboratory
name: Sebastien Peltier, PhD
role: STUDY_DIRECTOR
References:
citation: Barrat E, Zair Y, Sirvent P, Chauveau P, Maudet C, Housez B, Derbord E, Lescuyer JF, Bard JM, Cazaubiel M, Peltier SL. Effect on LDL-cholesterol of a large dose of a dietary supplement with plant extracts in subjects with untreated moderate hypercholesterolaemia: a randomised, double-blind, placebo-controlled study. Eur J Nutr. 2013 Dec;52(8):1843-52. doi: 10.1007/s00394-012-0486-2. Epub 2012 Dec 25.
Clinical trial NCT02005640: Transcatheter Heart Valve (THV) Sizing and Leakage After Transcatheter Aortic Valve Implantation (TAVI) Before and After Establishing Routine Preprocedure Multi Slice Computerized Tomography (MSCT) Aortic Assessment. A Retrospective Registry Study
Official title: Transcatheter Heart Valve (THV) Sizing and Leakage After Transcatheter Aortic Valve Implantation (TAVI) Before and After Establishing Routine Preprocedure Multi Slice Computerized Tomography (MSCT) Aortic Assessment. A Retrospective Registry Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Stenosis
Lead sponsor: Aarhus University Hospital Skejby
Sponsor class: OTHER
First posted: 2013-12-09
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary analysis will be done in patients with a successful THV implantation and availability of high quality echocardiographic assessment and in the post routing MSCT group on the availability of a high quality MSCT scan.

Brief summary: The objective of this study is to evaluate the effect of annular sizing strategy (MDCT versus TEE) in transcatheter aortic valve implantation on the prevalence and severity of paravalvular regurgitation.


Eligibility criteria: Inclusion Criteria:

* Patients implanted with a THV at Aarhus University Hospital

Exclusion Criteria:

* Learning curve patients (the first 40 patients implanted with a THV device at Aarhus University Hospital, Skejby).

Primary outcomes:
measure: Rate of no/ mild paravalvular leakage before and after introduction of routing preoperative MSCT
timeFrame: 1 week to 3 months post-TAVI
measure: MSCT vs. echocardiographic aortic valve sizing before TAVI
timeFrame: time of TAVI
measure: THV size before and after introduction of routing preoperative MSCT
timeFrame: time of TAVI
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Department of Cardiology and Cardiothoracic Surgery, Aarhus University Hospital
Study officials:
References:
Clinical trial NCT06372340: Intelligent Diagnosis and Treatment System for Pelvic Floor Dysfunction in Elderly Women
Official title: The Development and Application of an Intelligent Diagnosis and Treatment System for Pelvic Floor Dysfunction in Elderly Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pelvic Organ Prolapse
Urinary Incontinence
Diagnosis
Keywords: Urinary incontinence
Pelvic floor muscle
Intelligent diagnosis and treatment system
Elderly female
Pelvic floor dysfunction
Lead sponsor: Beijing Hospital
Sponsor class: OTHER_GOV
First posted: 2024-04-18
Enrollment: 300
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants will be allocated to experimental group(EG) or the control group(CG). Subjects in the experimental group (EG) will receive personalized pelvic floor muscle training guidance provided by the system, whereas subjects in the control group(CG) will exercise according to the handbook or oral guidance.
Primary purpose: TREATMENT

Brief summary: The aim of this study is to propose an intelligent diagnosis and treatment system for for pelvic floor dysfunction in elderly women. The main question it aims to answer: 1) How can the investigators find out early if older women have different pelvic floor muscle functions? 2）How can the investigators give personalized treatment plans based on differences in pelvic floor function? Participants will be assigned different training programs by the system. The investigators will compare the treatment effects and costs of older women with pelvic floor dysfunction using and not using the system. All the participants will be offered examinations for pelvic floor function and different treatments. All examinations and treatments are non-invasive.


Eligibility criteria: Inclusion Criteria:

- Women over 60 years old.

Exclusion Criteria:

* Severe pelvic organ prolapse (POP-Q stage\>III)
* History of pelvic floor surgery
* Malignant tumor in pelvic
* Allergic to nickel
* Acute inflammation of pelvic or genital tract
* Subjects who has cognitive impairment and cannot sign an informed consent

Primary outcomes:
measure: Modified Oxford Scale (MOS)
timeFrame: Baseline, Month 3, Month 6, Month 12
measure: Surface Electromyography Data
timeFrame: Baseline, Month 3, Month 6, Month 12
Secondary outcomes:
measure: The score of Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
timeFrame: Baseline, Month 3, Month 6, Month 12
measure: The score of the Pelvic Floor Distress Inventory (PFDI-20)
timeFrame: Baseline, Month 3, Month 6, Month 12
measure: Subjective staging used Pelvic Organ Prolapse Quantification (POP-Q) System
timeFrame: Baseline, Month 3, Month 6, Month 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
Study officials:
affiliation: Beijing Hospital
name: Mi Li, Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT00000340: Pemoline in the Treatment of Stimulant Dependence - 5
Official title: Pemoline in the Treatment of Stimulant Dependence
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Keywords: cocaine dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy of pemoline in treating cocaine and/or methamphetamine dependent adults with comorbid Adult Attention Deficit Hyperactivity Disorder (ADHD).


Eligibility criteria: Inclusion Criteria:

M/F ages 21-50. Meet DSM-IV criteria for cocaine dependence. Agree to conditions of the study and sign informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.

Primary outcomes:
measure: Retention
measure: Depression
measure: Incidence of stimulant use
measure: Severity of stimulant withdrawal symptoms
measure: ADHD symptom severity
measure: Degree of drug craving
measure: Frequency of IV drug use and sexual risk behaviors
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Friends Research Institute, Inc.
name: Walter Ling, M.D.
role: PRINCIPAL_INVESTIGATOR
References: