louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01052675: Pharmacological, Clinical and Statistical Assessment of a New Tool Available for Pharmacodependence Report Evaluation
Official title: Pharmacological, Clinical and Statistical Assessment of a New Tool Available for Pharmacodependence Report Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Drug Abuse
Drug Dependence
Keywords: Drug and substance problematic use, abuse or dependence
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2010-01-20
Enrollment: 3180
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pharmacodependent patients

Brief summary: In France, the Afssaps is the body in charge of the evaluation of pharmacodependance. In order to fulfil its mission, the Afssaps has created a network of 11 Centres for Evaluation and Information on Pharmacodependance (CEIP), coordinated by the Drugs and Psychotropics Unit. Pharmacodependence notifications issued by professionals are collected by each Centre which evaluates them. Nantes' CEIP created an original tool to harmonize case reporting and make it possible to homogeneously evaluate the seriousness of pharmacodependence cases as each CEIP had his own way of analysing his cases. The aim of this study is to assess this tool.


Eligibility criteria: Inclusion Criteria:

* case report from one of the French CEIP for drug and substance problematic use, abuse or dependence except alcohol and tobacco.

Primary outcomes:
measure: Psychometrics properties Evaluation of the new questionnaire centered on addiction to medicine .
timeFrame: At the beginning of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hôpital Pellegrin
city: Caen
country: France
facility: CHRU de Caen
city: Grenoble
country: France
facility: CHU de Grenoble
city: Lyon
country: France
facility: Centre Antipoison - Centre de Pharmacovigilance
city: Marseille
country: France
facility: Hôpital Salvator
city: Montpellier
country: France
facility: Hôpital Lapeyronie
city: Nancy
country: France
facility: CHU de Nancy
city: Nantes
country: France
facility: CHU de Nantes
city: Paris
country: France
facility: Hôpital Fernand Widal
city: Toulouse
country: France
facility: Faculté de médecine
Study officials:
affiliation: Nantes's University Hospital
name: Jolliet Pascale, MD
role: STUDY_DIRECTOR
References:
citation: Victorri-Vigneau C, Hardouin JB, Rousselet M, Gerardin M, Guerlais M, Guillou M, Bronnec M, Sebille V, Jolliet P; French Addictovigilance Network. Multicentre study for validation of the French addictovigilance network reports assessment tool. Br J Clin Pharmacol. 2016 Oct;82(4):1030-9. doi: 10.1111/bcp.13044. Epub 2016 Jul 28.
Clinical trial NCT05420675: Different Arm Positions During Single Leg Squat
Official title: Vastus Medialis Muscle Activation During Single Leg Squat Performed With Arm Position Variations in Healthy Participants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Injuries and Disorders
Keywords: healthy subject
movement analysis
muscle activity
kneeling
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2022-06-15
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy Volunteers

Brief summary: The aim of this study is to compare the effects of different arm positions on muscle activity during single leg squat.

Detailed description: The aim of our study is to examine the effect of different positions of the arms on lower extremity muscle activations during Single Leg Squat (SLS). This prospective cross sectional study included single leg squat test assessments in different arm positions: 1) Arms free, 2) Arms flexed 90 degrees, 3) Hands on hip, 4) Arms across the chest. Inclusion criteria were being a young adult (20-30 years old), physical activity level of at least 4 on the Tegner Activity Scale, and volunteering to participate in the study. Those with a history of lower extremity injury in the last 1 year will be excluded from the study. Our study will contribute to distinguishing SLS variations for clinicians and researchers and choosing the appropriate SLS for evaluation and treatment.

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 20-30
* Physical activity level of at least 4 on the Tegner Activity Scale,

Exclusion Criteria:

* History of lower extremity injury in the last 1 year
* Central or peripheral vestibular disorders

Primary outcomes:
measure: Surface Electromyography
timeFrame: Procedure (During the intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Department of Physiotherapy and Rehabilitation
Study officials:
affiliation: Hacettepe University Faculty of Physical Therapy and Rehabilitation
name: Gözde Yağcı, Assoc.Prof.
role: STUDY_DIRECTOR
affiliation: Hacettepe University Faculty of Physical Therapy and Rehabilitation
name: Semra Topuz, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University Faculty of Physical Therapy and Rehabilitation
name: Gökhan Karakaş, M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University Faculty of Physical Therapy and Rehabilitation
name: Alev Doğan, M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University Faculty of Physical Therapy and Rehabilitation
name: Ali Yalçın, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00301275: Assessing Free Immunoglobulin Light Chains in Patients With Myeloma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2006-03-10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Time perspective: PROSPECTIVE

Brief summary: Multiple myeloma is a disorder in which malignant plasma cells accumulate in the bone marrow. These plasma cells produce an abnormal protein called paraprotein / M spike in the serum which can be serially monitored to assess the response of tumour on therapy. The paraprotein has a heavy chain which can be either IgG, IgA, IgM or IgD and a light chain which can be either kappa or lambda.

At present, these can be assessed by serum and urine electrophoresis (SPE and UPE). These techniques are relatively insensitive and poorly quantitative compared with other immunoassays for tumour markers.

The potential of serum free light chain (flc) measurement as a marker for myeloma has been recognised for some time. However, development of such assays has proved elusive, primarily due to the difficulty in developing assays that are both convenient to use and have the required specificity to measure flc in serum. Recently , the assay has been standardised and is in use. Its likely that the assessment of flc might be a sensitive marker of documenting complete remission in patients with myeloma. The aim of this study is to study the flc in patients with myeloma in complete remission (CR) to see if patients have CR documented by standard criteria- are the free light chains still positive and if so are they better markers of remission. The samples will be collected and tested in batches of 60 each.


Eligibility criteria: Inclusion Criteria:

* Multiple Myeloma patients in CR

Exclusion Criteria:

* not being able to give consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: Royal Marsden NHS trust
state: Surrey
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Ray Powles, FRCP, FRCpath
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06477575: Effectiveness of Technology-based Interventions for the Improvement of Cognitive Processes in ADHD.
Official title: Effectiveness of Technology-based Interventions for the Improvement of Cognitive Processes in Children and Adolescents With ADHD.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD, Deficits in Motor Control and Perception
Keywords: ADHD
cognitive rehabilitation
new technologies
Lead sponsor: University of Extremadura
Sponsor class: OTHER
First posted: 2024-06-27
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To scientifically demonstrate the improvements in cognitive functions and core symptoms of children and adolescents diagnosed with ADHD through the implementation of a cognitive rehabilitation program based on the use of the most relevant technologies found in the systematic review carried out during the first phase.

Two intervention groups will be randomly assigned for the study:

G1: composed of 20 patients who will receive neurocognitive therapy based on new technologies. This will be the experimental group.

G2: composed of 20 patients who will receive conventional neurocognitive therapy for ADHD treatment. This group will be the control group


Eligibility criteria: Inclusion Criteria:

* Children and adolescents diagnosed with ADHD
* Age: 6-17 years old

Exclusion Criteria:

* Children and adolescents diagnosed with ADHD + ADD.
* Age: under 6 years old or over 17 years old.
* Other psychopharmacological treatments not specific for ADHD.

Primary outcomes:
measure: WisC-V (Wechsler intelligence scale for children)
timeFrame: 8 weeks
measure: STROOP (Colors and Words Test)
timeFrame: 8 weeks
measure: CARAS-R(Difference perception test)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Badajoz
country: Spain
facility: Berta Caro Puértolas
Study officials:
References:
Clinical trial NCT06385275: The Role of Vitamin K on Knee Osteoarthritis Outcomes
Official title: The Role of Vitamin K on Knee Osteoarthritis Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Osteo Arthritis Knee
Keywords: Vitamin K-1
Vitamin K-2
Menaquinone-7 (MK-7)
Uncarboxylated matrix Gla protein (ucMGP)
Phylloquinone
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2024-04-26
Enrollment: 55
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A stratified permuted block randomization will be used to assign 55 participants in a 1:1:1:1 ratio to each intervention arm. A random allocation sequence will be generated by computer in blocks of 4 or 8, stratified by sex and race.
Primary purpose: TREATMENT

Brief summary: The appropriate form and dosing of vitamin K to benefit relevant outcomes in knee osteoarthritis (OA) are not known. In intervention studies for conditions other than knee OA (e.g., prevention of cardiovascular disease), the most commonly used forms and doses include phylloquinone (vitamin K1; 1000µg or 500µg daily) or menaquinone-7 (MK-7 or vitamin K2; 300µg daily). However, whether these doses are adequate to increase vitamin K to levels that ameliorate risk of adverse OA outcomes is not known. Furthermore, although some studies suggest enhanced bioavailability of MK-7 over vitamin K1, as well as extra-hepatic effects, whether this is relevant for an older population with knee OA is not known,

The overall goal of this pilot randomized clinical trial (RCT) is to test different subtypes and doses of vitamin K supplementation in older adults with knee OA and to measure changes in relevant biochemical measures.


Eligibility criteria: Inclusion Criteria:

* ≥60 years old
* Clinical diagnosis of knee OA by the treating rheumatologist
* English fluency

Exclusion Criteria:

* Anticoagulation use (including warfarin, dabigatran, rivaroxaban, apixaban)

Primary outcomes:
measure: Change in uncarboxylated matrix Gla protein (ucMGP) levels
timeFrame: Baseline, 4 weeks
measure: Change in phylloquinone levels
timeFrame: Baseline, 4 weeks
measure: Sufficient phylloquinone levels
timeFrame: Baseline, 4 weeks
measure: Change in menaquinone-7 (MK-7) levels
timeFrame: Baseline, 4 weeks
Secondary outcomes:
measure: Study adherence
timeFrame: 4 weeks
measure: Participant acceptability of intervention
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center, Rheumatology Clinic
state: Massachusetts
Study officials:
affiliation: Boston University Chobanian & Avedisian School of Medicine, Department of Rheumatology
name: Jean Liew, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02230475: Systemic Mechanisms in Allergic Rhinitis: Assessment of Metabolomic Outcomes.
Official title: Systemic Mechanisms in Allergic Rhinitis: Assessment of Metabolomic Outcomes Using the Environmental Exposure Unit (EEU). Part 2.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergic Rhinitis
Keywords: Allergic Rhinitis
NMR
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2014-09-03
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy males and females 18-55 years old with ragweed induced allergic rhinitis.

Brief summary: This clinical study will use the Environmental Exposure Unit (EEU) to generate allergic rhinitis symptoms in participants under controlled conditions, to collect well-characterized biological samples (urine and blood) before and after they develop these symptoms. The EEU provides the ability to control the timing, duration and levels of allergen exposure, and also other outside environmental factors, yielding ideal biologic samples for analysis with novel, cutting-edge molecular techniques. Results from the analysis of these unique allergic rhinitis samples should help determine if the technique of urine Nuclear Magnetic Resonance analysis could be a useful diagnostic tool in allergic rhinitis. IgE testing will be done on blood samples and compared to spin prick testing and symptoms of allergic rhinitis.


Eligibility criteria: Inclusion Criteria:

* Participant is a healthy, ambulatory male or female volunteer 18 to 55 years of age.
* Participant has a history of Seasonal Allergic Rhinitis due to ragweed for the last two consecutive ragweed seasons.
* Participant has a positive response (wheal diameter greater than or equal to 3 mm larger than diluent control) to a skin prick test to short ragweed allergen at screening or within 12 months of screening visit.

Exclusion Criteria:

* Participant is a female that is pregnant, lactating or actively trying to become pregnant.
* smokers
* Participant is unable to comply with the washout periods for prohibited medications.
* Participant is currently receiving allergen specific immunotherapy injections.

Primary outcomes:
measure: Metabolomics
timeFrame: Participant visits from July 2014 - September 2014; samples and data will be analyzed and presented for up to 2 years following participant visits.
Secondary outcomes:
measure: IgE testing
timeFrame: Participant visits from July 2014 - September 2014; samples and data will be analyzed and presented for up to 2 years following participant visits.
measure: Epigenetics
timeFrame: Participant visits from July 2014 - September 2014; samples and data will be analyzed and presented for up to 2 years following participant visits.
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
Study officials:
affiliation: Queen's University
name: Anne K Ellis, MD MSc FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01090375: Regulation of Intraarticular and Synovium-related Biomarkers of Osteoarthritis. Effect of Acute Mechanical Joint Loading
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Osteoarthritis
Exercise
Keywords: osteoarthritis
biochemical markers
cartilage
inflammation
microdialysis
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: The Danish Rheumatism Association
name: Danish Ministry of Health, Internal Affairs
name: Danish National Research Council
name: The Danish Medical Research Council
First posted: 2010-03-19
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In the present study the microdialysis method is used to investigate biochemical changes within and around the joint simultaneously in both the resting state and in a joint that had been subjected to exercise. The aim of the present study was, by applying the microdialysis technique, to monitor markers of cartilage breakdown and inflammation in 2 different positions of the knee (inside and in the inner part of the knee capsule) in a group of human females with knee osteoarthritis over a period of 3 hours.


Eligibility criteria: Inclusion Criteria:

* verified osteoarthritis (x-ray)of the knee, female,

Exclusion Criteria:

* dementia, inflammatory diseases, regular pain medication

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Helmark IC, Mikkelsen UR, Borglum J, Rothe A, Petersen MC, Andersen O, Langberg H, Kjaer M. Exercise increases interleukin-10 levels both intraarticularly and peri-synovially in patients with knee osteoarthritis: a randomized controlled trial. Arthritis Res Ther. 2010;12(4):R126. doi: 10.1186/ar3064. Epub 2010 Jul 1.
Clinical trial NCT03885375: Diagnostic and Imaging Indicators of Immunocardiomyopathic Patients
Official title: Multimodal Imaging Evaluation of Myocardial Involvement in Immunocardiomyopathic Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Autoimmune Diseases
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-03-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient is diagnosed with autoimmune diseases, including systemic lupus erythematosus (SLE), vasculitis, dermatomyositis, sjogren's syndrome, scleroderma, rheumatoid arthritis and IgG4 associated disease.

Patient is capable of complying with study procedures.

Brief summary: Cardiac involvements in autoimmune diseases (AD) is common but underestimated and an early detection remains a clinical challenge for lacking of efficient imaging methods. The objective of the study was to investigate LV myocardial abnormalities in AD patients by multimodal cardiac imaging, including speckle-tracking echocardiology (STE), cardiac magnetic resonance imaging (CMRI) and positron emission tomography (PET).


Eligibility criteria: Inclusion Criteria:

* Patient is diagnosed with autoimmune diseases, including systemic lupus erythematosus (SLE), vasculitis, dermatomyositis, sjogren's syndrome, scleroderma, rheumatoid arthritis and IgG4 associated disease.
* Patient is capable of complying with study procedures

Exclusion Criteria:

* Patient is pregnant or nursing
* Patient is complicated with congenital heart disease
* Patient had cardiac surgery before
* Patient is complicated with serious infections
* Patient is complicated with organ failure
* Patient is complicated with tumors
* Patient is diagnosed indefinitely
* Patient has been involved in other clinical trial

Primary outcomes:
measure: Change in deformational parameters in echocardiography during follow-up period
timeFrame: 6 months - 1 year - 2 years
measure: Progression of myocardial fibrosis and edema during follow-up period
timeFrame: 1 year - 2 years
measure: Change in myocardial perfusion during follow-up period
timeFrame: 1 year - 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hostipal
state: Beijing
Study officials:
References:
Clinical trial NCT00736775: A Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Anti-Abeta (MABT5102A) in Patients With Alzheimer's Disease
Official title: A Phase I, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Intravenous MABT5102A Administered in a Single-Dose, Dose-Escalation Stage Followed by a Multidose, Parallel-Treatment Stage in Patients With Mild to Moderate Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Keywords: AD
Alzheimer's
Alzheimers
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2008-08-18
Enrollment: 56
Sex: ALL
Minimum age (years): 50
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase I, multicenter, randomized, double-blind, placebo-controlled study that will be conducted in the United States and consists of a single ascending-dose stage followed by a multidose, parallel-treatment stage. This study will be conducted in approximately 50 adult patients between 50-85 years old who have mild to moderate Alzheimer's disease.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of probable AD according to the NINCDS-ADRDA Criteria
* Approved AD treatments (AchE inhibitors+/-memantine) must be stable for ≥ 3 months prior to screening
* Other prescription medications must be stable for ≥ 1 month prior to screening

Exclusion Criteria:

* Female patients with reproductive potential
* History or presence of any clinically significant CNS disease
* History of treatment with any protein therapeutic targeting Abeta

Primary outcomes:
measure: Safety and tolerability of single and multiple doses of MABT5102A
timeFrame: Through study completion or early study discontinuation
Secondary outcomes:
measure: Pharmacokinetics of MABT5102A after single and multiple doses
timeFrame: Through study completion or early study discontinuation
measure: Immunogenicity of MABT5102A after single and multiple doses
timeFrame: Through study completion or early study discontinuation
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: Carole Ho, M.D.
role: STUDY_DIRECTOR
References: