louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02804087: Controlling And Lowering Blood Pressure With the MobiusHDTM Device
Official title: CALM-START - Controlling And Lowering Blood Pressure With the MobiusHDTM Device: STudying Effects in A Randomized Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hypertension
Lead sponsor: Vascular Dynamics, Inc.
Sponsor class: INDUSTRY
First posted: 2016-06-17
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and performance of the MobiusHD system in subjects with resistant hypertension.

Detailed description: This is a prospective, randomized, double-blind, sham-controlled, multi-center post market study investigating the efficacy and safety of MobiusHD System, and the efficacy of the MobiusHD device in lowering mean systolic 24-hour ABP in subjects with resistant hypertension.

Eligibility criteria: Inclusion Criteria:

* Aged 18-70 years;
* Diagnosed with resistant hypertension;
* A mean systolic 24-hour ABP of 135-170 mmHg following at least 30 days on a stable antihypertensive medication regimen (no changes in medications or dose).
* A mean systolic 24-hour ABP of 135-170 mmHg after washout of all antihypertensive medications.

Exclusion Criteria:

* Known or clinically suspected baroreflex failure or autonomic neuropathy
* Treatable cause of resistant hypertension
* Hypertension secondary to an identifiable and treatable cause other than sleep apnea

Primary outcomes:
measure: The change in mean systolic 24-hour ABP from baseline to 90 days post-randomization, between the treatment arm and the sham arm.
timeFrame: From Baseline to 90 days post-randomization
Secondary outcomes:
measure: Major adverse clinical events, including death, stroke, carotid interventions, and myocardial infarction, from baseline to 30 days post-randomization, between the treatment arm and the sham arm.
timeFrame: From Baseline to 30 days post-randomization
Other outcomes:
Locations:
city: The Hague
country: Netherlands
facility: HagaZiekenhuis
state: AA
city: Maastricht
country: Netherlands
facility: Maastricht UMC+
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Utrecht
country: Netherlands
facility: UMCU
Study officials:
affiliation: UMC Utrecht
name: Wilko Spiering, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Antonius Hospital
name: Jan Van der Heyden, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01481987: Microperimetry and Optical Coherence Tomography (OCT) in Idiopathic Epiretinal Membrane
Official title: Retinal Sensitivity and Optical Coherence Tomography Findings in Eyes With Idiopathic Epiretinal Membrane
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epiretinal Membrane
Keywords: Microperimetry
OCT
idiopathic epiretinal membrane
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2011-11-30
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Purpose: To evaluate macular sensitivity and its correlation with visual acuity and Spectral Domain Optical Coherence Tomography (SD-OCT) in eyes with idiopathic epiretinal membrane (ERM).

Design: Cross sectional case-control series.

Methods:

Setting: Dijon University Hospital. Patients: Forty nine patients (49 eyes) with idiopathic ERM and twenty-seven healthy patients (27 eyes) as a control group.

Main outcome measurement: Microperimetry, Spectral Domain Optical Coherence Tomography (SD-OCT).


Eligibility criteria: Inclusion Criteria:

* Epiretinal Membrane

Exclusion Criteria:

* Age related macular degeneration
* Diabetic macular edema

Primary outcomes:
measure: Macular sensitivity
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Ophthalmology Department CHU Dijon
state: Burgundy
Study officials:
affiliation: CHU Dijon
name: Catherine Creuzot-Garcher, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04984187: Effect of High Intensity Laser Versus Plus Exercises
Official title: Effectiveness of High Intensity Laser Therapy Plus Therapeutic Interventions in Treatment of Girls Gymnasts With Non-specific Wrist Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effect of High Intensity Laser Plus Exercises on Wrist Pain
Lead sponsor: Badr University
Sponsor class: OTHER
First posted: 2021-07-30
Enrollment: 36
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: High-intensity laser therapy (HILT) has been used more recently in the therapeutic protocols of musculoskeletal pain management. This study is conducted to find out the effect of high intensity laser therapy only versus high intensity laser pulse exercises on level of wrist pain, function and Joint position sense in girls Gymnasts

Detailed description: Effect of high intensity laser plus exercises on wrist pain ..three groups of gymnastics girls suffer from non specific wrist is allocating ..the first group will receive exercises only , the second will receive laser only while the third will receive exercises plus laser

Eligibility criteria: Inclusion Criteria:

* All girls diagnosed with generalized chronic wrist pain and referred by orthopaedic physician.
* Their age between 10-16 years old
* They will be able to follow instructions.
* All are medically stable

Exclusion Criteria:

* • Bone fractures and tumors.

  * Cases after plastic surgery.
  * Hypertension (due to secondary vasoconstriction)
  * Diabetes mellitus
  * Pacemakers

Primary outcomes:
measure: PRWE
timeFrame: pre and post 4 weeks of intervention, decrease score indicate improvement
Secondary outcomes:
measure: JBS
timeFrame: pre and post 4 weeks of intervention, decrease score indicate improvement
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Hanaa Mohsen
Study officials:
References:
Clinical trial NCT01770587: A Sleep-Oriented Intervention for Suicidal Behaviors
Official title: A Sleep-Oriented Intervention for Suicidal Behaviors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Suicidal Ideation
Keywords: Insomnia
Sleep
Behavioral Medicine
Suicide
Suicidal Ideation
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2013-01-18
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An open-label trial to investigate the use of a behavioral insomnia treatment for suicidal ideation.


Eligibility criteria: * Age 18 or older
* Clinically significant sleep disturbances
* Diagnosis of depression

Primary outcomes:
measure: Suicidal Ideation
timeFrame: Change from Baseline in Suicidal Ideation at 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University, Dept. of Psychiatry and Behavioral Sciences
state: California
Study officials:
affiliation: Stanford University
name: Rebecca A Bernert, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02742987: Clopidogrel Versus Ticagrelor in Type-2 Diabetes
Official title: CLOpidogrel Versus TIcagreLor for Antiplatelet Maintenance in DIAbetic Patients Treated With Percutaneous Coronary Intervention: Results of the CLOTILDIA Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Diabetes Mellitus
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2016-04-19
Enrollment: 42
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: CLOTILDIA is a single-center, prospective, randomized, open label, cross-over study evaluating the effects of ticagrelor versus high-dose clopidogrel on endothelial function and platelet reactivity in patients with type-2 diabetes mellitus (T2DM) treated with percutaneous coronary intervention (PCI).


Eligibility criteria: Inclusion Criteria:

* type 2 diabetes mellitus
* stable coronary disease
* coronary revascularization with PCI at least 1 month prior to recruitment

Exclusion Criteria:

* acute coronary syndrome
* platelet count \<70x109/l
* active bleeding or bleeding diathesis
* history of intracranial bleeding
* gastrointestinal bleeding \<6 months
* cerebrovascular accident \<3 months
* history of malignancy
* concomitant need for oral anticoagulant therapy
* severe liver disease or chronic renal failure (glomerular filtration rate \<30 ml/min /1.73m2)

Primary outcomes:
measure: Flow-mediated Dilation of the Brachial Artery
timeFrame: 4 weeks
Secondary outcomes:
measure: Number of Patients With Flow-mediated Dilation of the Brachial Artery <7%
timeFrame: 4 weeks
measure: Endothelium-independent Dilation of the Brachial Artery
timeFrame: 4 weeks
measure: Platelet Reactivity
timeFrame: 4 weeks
measure: Number of Patients With Platelet Reactivity >256 P2Y12 Reaction Units
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03962387: Evalution the Safety and Efficacy in Atopic Dermatitis Patients
Official title: A Multi-center, Open, Long-term Follow-up Study to Evaluate the Efficacy and Safety of FURESTEM-AD Inj. in Patients With Moderate to Severe Chronic Atopic Dermatitis: 5-year Results From the K0102 Extension Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atopic Dermatitis
Lead sponsor: Kang Stem Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-05-24
Enrollment: 98
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: moderate to severe chronic atopic dermatitis

Brief summary: A multi-center, open, long-term follow-up study to evaluate the efficacy and safety of FURESTEM-AD inj. in patients with moderate to severe chronic atopic dermatitis: 5-year results from the K0102 extension study


Eligibility criteria: Inclusion Criteria:

1. Subject who enrolled K0102 Clinical Trial(parent study).
2. Subjects who understand and voluntarily sign an informed consent form

Exclusion Criteria:

1. In case follow-up is not possible from end of K0102 clinical trial to end of this study period
2. Any other condition which the investigator judges would make patient unsuitable for study participation

Primary outcomes:
measure: Safety Assessment (Rate of Adverse Event, Number of Participants with Adverse Event)
timeFrame: 5 years
Secondary outcomes:
measure: Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 50% at Week 12 (EASI-50)
timeFrame: 3 years
measure: Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 75% at Week 12 (EASI-75)
timeFrame: 3 years
measure: Rate of change in EASI from baseline
timeFrame: 3 years
measure: Change in EASI from baseline
timeFrame: 3 years
measure: Percentage of subjects whose Investigator's Global Assessment (IGA) score at each visit is 0 or 1
timeFrame: 3 years
measure: Percentage of subjects whose IGA at each visit is 0 or 1, or improved to 2 or higher
timeFrame: 3 years
measure: Percentage of subjects whose SCORing Atopic Dermatitis (SCORAD) INDEX was decreased from baseline by more than 50% at each visit (SCORAD-50)
timeFrame: 3 years
measure: Rate of change in SCORAD index from baseline at each visit
timeFrame: 3 years
measure: Change in SCORAD index from baseline at each visit
timeFrame: 3 years
measure: Rate of change in Body Surface Area(BSA) of the lesion from baseline
timeFrame: 3 years
measure: Change in Body Surface Area(BSA) of the lesion from baseline
timeFrame: 3 years
measure: Change in total serum Immunoglobulin E(IgE) from baseline
timeFrame: 3 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul ST. Mary's Hospital
Study officials:
References:
Clinical trial NCT06524687: A Study of Imvotamab in Active, Refractory Idiopathic Inflammatory Myopathies
Official title: A Phase 1b, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Imvotamab in Adult Participants With Active, Refractory Moderate-Severe Idiopathic Inflammatory Myopathies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Idiopathic Inflammatory Myopathies
Inflammatory Myopathies
Keywords: Myopathies
Moderate-Severe Myopathy
Myositis
Lead sponsor: IGM Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2024-07-29
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and tolerability of imvotamab in patients with Moderate-Severe Idiopathic Inflammatory Myopathies who have failed prior therapies.

Participants will be given imvotamab through a vein (i.e., intravenously).

Detailed description: This is a Phase 1b, open-label study to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of imvotamab in adult participants with active, refractory, moderate-severe Idiopathic Inflammatory Myopathies. Approximately 5-10 participants will be assigned.

Eligibility criteria: Key Inclusion Criteria:

* Age ≥ 18 years at the time of signing ICF
* Diagnosis of probable or definite IIM according to the 2017 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for IIM with subgroup classification of either DM, polymyositis (PM), anti-synthetase syndrome, or immune-mediated necrotizing myositis (IMNM).
* Active IIM despite treatment with corticosteroids and at least 1 immunosuppressive or immunomodulatory standard-of-care agent determined at the discretion of the investigator after at least 3 months of treatment.
* If using oral corticosteroids (OCS), must be on a stable dose equivalent to ≤ 30 mg/day of prednisone for at least 4 weeks prior to first study treatment

Key Exclusion Criteria:

* Pregnant or breastfeeding or intending to become pregnant during the study or within 3 months after the final dose of imvotamab.
* Receipt of an investigational therapy less than 12 weeks or 5 drug-elimination half-lives (whichever is longer) prior to first administration of study treatment and during the study.
* Has inclusion body myositis or myositis-associated with other connective tissue disease.

Primary outcomes:
measure: Safety and tolerability of imvotamab
timeFrame: Time Frame: Up to Week 50
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Standford University
state: California
Study officials:
affiliation: IGM Biosciences
name: Rebecca Kunder
role: STUDY_DIRECTOR
References:
Clinical trial NCT00297687: Study Evaluating the Safety, Immunogenicity and Tolerability of Meningococcal Group B Vaccine in Healthy Adults
Official title: A Randomized, Placebo-Controlled, Double Blind, Phase 1 Trial of the Safety, Immunogenicity, and Tolerability of Ascending Doses of Meningococcal Group B rLP2086 Vaccine in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Meningitis, Meningococcal
Keywords: Vaccines
Healthy Adults
Health
Adult
Meningococcal Vaccines
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-02-28
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To determine the safety \& immunogenicity of a potential vaccine against meningococcal B disease


Eligibility criteria: Inclusion Criteria:

* Healthy 18-25 year olds

Exclusion Criteria:

* Prior history of vaccination with any meningococcal vaccine
* Prior history of any invasive meningococcal disease

Primary outcomes:
measure: Local & systemic safety throughout the trial
Secondary outcomes:
measure: Evidence of an immune response 1 month after dose 2 & 1 month after dose 3
Other outcomes:
Locations:
city: Herson
country: Australia
state: Queensland
city: North Adealaide
country: Australia
state: South Australia
city: Perth
country: Australia
state: Western Australia
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Australia, medinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00148187: Prediction of Medication Compliance Following Renal Transplantation
Official title: Prediction of Medication Compliance Following Renal Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplantation
Keywords: Medication adherence
Patient compliance
Kidney transplant
Organ rejection
Allograft loss
Drug monitoring
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2005-09-07
Enrollment: 30
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pre-operative renal transplant recipients

Brief summary: The purpose of this study is to quantitate pre-transplant medication compliance, dialysis compliance, and related psychological variables, and then examine their validity as predictors of post-transplant noncompliant behaviors and clinically relevant outcomes (acute rejection, graft loss, or death).

Hypothesis: Noncompliance with pre-transplant medication or with the dialysis prescription, and specific psychological variables predict similarly noncompliant behaviors after transplantation.

Detailed description: This pilot study is intended to provide preliminary data about the feasibility of recruiting a cohort of subjects on hemodialysis and following them prospectively through the transplant procedure. The study will document patient adherence to medications and treatment, both before and after surgery. These preliminary data will permit appropriate design and power calculations for a future study assessing our ability to predict post-transplant compliance, based on pre-transplant behaviors.

Eligibility criteria: Inclusion Criteria:

* Adult hemodialysis patients in renal transplant evaluation
* Able to read test forms
* Responsible for their own medications

Exclusion Criteria:

* Patients with a major risk of recurrent primary renal disease, e.g. hemolytic uremic syndrome, oxalosis, membranoproliferative glomerulonephritis type II, focal segmental glomerulosclerosis with nephrotic syndrome.
* Patients with active psychosis
* Patients who do not speak English.
* Patients who live and will be followed outside the United States, except Canada.
* Patients who are physically unable to open the Medication Event Monitoring System (MEMS) cap.
* Patients who are not responsible for taking their own medications, e.g. living in a medical care facility.
* Patients who are younger than 14 years old
* Patients who will receive an extra renal organ (except pancreas), either simultaneously or previously.

Primary outcomes:
measure: Prediction of early medication adherence
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Thomas E Nevins, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05713487: Preventive Treatment of Groin Pain in Football
Official title: Preventive Treatment of Groin Pain Syndrome in élite Young Football Player: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Groin injuries, soccer, athletes, pain, muscle strength
Lead sponsor: Universita degli Studi di Genova
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 42
Sex: MALE
Minimum age (years): 16
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Groin pain represents a common issue in football. Currently, there are no prevention protocols demonstrating real effectiveness. We aimed to investigate the possible positive effect of a prevention program for groin pain.Forty-two élite male athletes belonging to a youth academy of a professional football club were recruited in this prospective, randomized, controlled, single-blind, study.


Eligibility criteria: Inclusion Criteria:

* subjects between the ages of sixteen and eighteen, belonging to the youth sector of a professional club.

Exclusion Criteria:

* Presence of pain or injuries at the level of the hip-hip region at the initial assessment.

Primary outcomes:
measure: Strength in the adductors
timeFrame: One day before the start of the physical protocol and one day after the end of the physical protocol
Secondary outcomes:
measure: Pain in the hip joint
timeFrame: One day before the start of the physical protocol and one day after the end of the physical protocol
measure: Groin pain
timeFrame: One day before the start of the physical protocol and one day after the end of the physical protocol
measure: Range of motion (ROM) of the hip joint
timeFrame: One day before the start of the physical protocol and one day after the end of the physical protocol
Other outcomes:
Locations:
city: Genova
country: Italy
facility: Università degli Studi di Genova
Study officials:
References: