louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT07003113: Ischemic Preconditioning in Osteoarthritis and Back Pain
Official title: Ischemic Preconditioning in Osteoarthritis and Back Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Low Back Pain
Knee Osteoarthritis
Keywords: ischemic preconditioning
restricted blood flow
knee pain
back pain
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
First posted: 2025-06-04
Enrollment: 24
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We are examining the use of restricted blood flow, through full occlusion, on a single thigh for 50 minutes (5 minutes on, 5 minutes off), completed every other day for 2 weeks to improve function in individuals with knee osteoarthritis and low back pain.


Eligibility criteria: Inclusion Criteria:

* Reported Knee Pain using ACR Criteria
* Reported Back Pain using ODI Criteria \> 12
* Ability to walk for at least 3 minutes without the use of aids
* Ability to provide written informed consent

Exclusion Criteria:

* Younger than 50 years old
* History of Knee or Hip Replacements
* History of steroid injection within the previous 6 months
* Presence of neuromuscular joint condition that affects lower extremity function
* History of blood clots in the leg or any condition in which compression of the thigh is contraindicated
* History of heart failure or thrombosis
* Allergic to ultrasound gel
* History of spine surgery
* Non-English speaker
* Currently pregnant or intends to become pregnant during the study

Primary outcomes:
measure: Preferred walking speed
timeFrame: At baseline (from enrollment) until end of intervention (3 weeks).
measure: Muscle strength
timeFrame: From baseline (enrollment) until end of intervention (3 weeks)
measure: Patient Reported Outcomes
timeFrame: At baseline (enrollment) through the intervention (3 weeks)
measure: Gait Kinematics
timeFrame: At baseline (from enrollment) until end of intervention (3 weeks).
measure: Gait Kinetics/Moments
timeFrame: At baseline (from enrollment) until end of intervention (3 weeks).
Secondary outcomes:
measure: Cartilage Health
timeFrame: From baseline (enrollment) until completion of intervention (3 weeks)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Human and Sport Performance Lab
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Lindsay Hannigan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05803213: Learning Efficacy and Motivation of Medical Students in Clinical Training With Virtual Reality
Official title: Learning Efficacy and Motivation of Medical Students Between Different Teaching Materials and Methods in Clinical Training for Anesthesia and Perioperative Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Motivation
Efficacy, Self
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: We created a curriculum based on clinical events with 360° camera on an interactive learning platform. We hypothesize that medical students will learn better and be motivated with the immersive 360 video and virtual reality headset during the clinical training.

Detailed description: We created a curriculum based on rapid sequence induction before anesthesia induction with 360° camera and put it on an interactive learning platform. We hypothesize that medical students will have better learning efficacy and motivation with the immersive 360 video and virtual reality headset. Moreover, the learning engagement will be translated into clinical skills acquisition and medical knowledge retention.

Eligibility criteria: Inclusion Criteria:

* Medical students undergoing clinical rotation

Exclusion Criteria:

* Unable to wear virtual reality headset

Primary outcomes:
measure: Learning Efficacy
timeFrame: 6 months
measure: Learning Motivation
timeFrame: 6 months
Secondary outcomes:
measure: Clinical skills
timeFrame: 6 months
Other outcomes:
measure: Medical knowledge
timeFrame: 6 months
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Man-Ling Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00204113: Control of Unsupported Paraplegic Standing
Official title: Integrated Voluntary Control of Unsupported Paraplegic Standing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injury
Stroke
Keywords: spinal cord injury
standing
balance
functional electrical stimulation
Lead sponsor: University of Glasgow
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 10
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will investigate the feasibility of using functional electrical stimulation (FES) of the calf muscles of paraplegic subjects to assist in posture stabilisation during standing. We aim to achieve postural stability by combining controlled FES of the lower-limb muscles with the voluntary motor control skills of the intact upper body.

Detailed description: Aim:

The study will investigate the feasibility of using functional electrical stimulation (FES) of the calf muscles of paraplegic subjects to assist in posture stabilisation during standing. We aim to achieve postural stability by combining controlled FES of the lower-limb muscles with the voluntary motor control skills of the intact upper body.

Background:

In spinal cord injury (SCI), the paralysed muscles generally retain their ability to contract and electrical stimulation can be used in rehabilitation as a therapy. With functional electrical stimulation (FES) the aim is to restore some normal motor functions such as standing, stepping or cycling. A number of studies have investigated the physiological effects and potential therapeutic benefits of lower-limb FES exercise. These studies have shown that the benefits include restoration of muscle bulk and strength, a reduction in the rate of bone demineralisation, improvements in the range of joint motion, and relaxation of spasm. Standing is an important part of rehabilitation therapy for paraplegic patients, and helps to alleviate some of the secondary effects of paralysis.

Eligibility criteria: Inclusion Criteria:

* Neurologically intact, healthy individuals individuals with complete spinal cord lesion between T6 and T12

Exclusion Criteria:

* Incomplete SCI

Primary outcomes:
measure: estimates of physical parameters (ie. stiffness, viscosity, inertia)
Secondary outcomes:
measure: quality of standing
measure: amount of sway
measure: timing of standing
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: University of Glasgow
state: Lanarkshire
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth National Spinal Injuries Unit
state: Lanarkshire
Study officials:
affiliation: University of Glasgow
name: Kenneth J Hunt, BSc, PhD, DSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03027713: Diaphragmatic Activity During Weaning With NAVA, a Pilot Study (NAVA: Neurally Adjusted Ventilatory Assist)
Official title: Diaphragmatic Activity During a Postoperative Rapid Weaning Protocol With Neurally Adjusted Ventilatory Assist in Healthy Lung Patients, a Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Patients
Keywords: NAVA: neurally adjusted ventilatory assist
Diaphragm electromyographic activity
Weaning
Lead sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
Sponsor class: OTHER
First posted: 2017-01-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to describe the diaphragm electromyographic activity (Edi) in healthy lung patients due to obtain a reference to guide the weaning in those patients

Detailed description: We obtained the Edi recording data at each NAVA level during the weaning in NAVA group, and we compared the respiratory parameters between the PSV and NAVA groups

Eligibility criteria: Inclusion Criteria:

* Patients who were scheduled for elective major surgery in which admission to the CCU (critical care unit) for postoperative care and short-term mechanical ventilation with rapid weaning were anticipated.

Exclusion Criteria:

* Preoperative altered central nervous system, neuromuscular or lung disease and ASA (american society of anesthesiologists) classification group IV or NYHA (New York heart association) class IV in the case of cardiac patients. At the CCU, before randomisation, we also excluded patients requiring reoperation, and those who exhibited significant postsurgical bleeding, the development of myocardial infarction, and hemodynamic instability.

Primary outcomes:
measure: Diaphragmatic electromyographic activity description
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Fundación para la investigación del Hospital Clínico Universitario de Valencia
name: Mar Garzando Civera, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05423613: Microneedling for Burn Hypertrophic Scars
Official title: Randomized Controlled Evaluator-blinded Trial of Microneedling for the Treatment of Hypertrophic Scars of Adult Burn Survivors and Patients With Severe Skin Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Burn Scar
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 36
Sex: ALL
Minimum age (years): 16
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Approximately 33 to 91% of severe burn victims will develop hypertrophic scars. Hypertrophic scars are defined as erythematous (red), raised and rigid scars that can cause pain and itching, among other things. They cause psychological distress and affect the quality of life of burn victims. Microneedling is a technique that uses an electrical device to create hundreds of microchannels that penetrate the skin layers. This study is interested in determining the effectiveness of microneedling in improving the pliability, thickness and erythema of hypertrophic scars. Each scar will receive up to 5 ACS-pen treatments followed by the application of cortisone (triamcinolone acetonide). Knowing that microneedling increases the absorption of products applied to the skin by about 80%, it is logical to think that creating these channels to the dermis and applying cortisone afterwards would have a beneficial effect on the hypertrophic scars of these patients.

Detailed description: Patients will receive microneedling once every six weeks for a maximum of five treatments

Eligibility criteria: Inclusion Criteria:

* Any gender or race
* 16 years of age or older
* Have at least 2 HSc that meet the clinical criteria for HSc
* Provide written informed consent.

Exclusion Criteria:

* Patients with keloid scars
* Mature scar site
* A psychiatric condition or cognitive impairment that interferes with their ability to follow the treatment protocol
* Dermatological conditions (i.e. psoriasis, eczema, etc.) in the area of the evaluation site
* An allergy to ultrasound gel
* On anticoagulant medications
* Inability to understand English or French.

Primary outcomes:
measure: Skin Erythema Changes
timeFrame: Baseline, before treatments #3, #4 and #5, post 6 weeks and 12 weeks
measure: Cutometer Skin Elasticity Changes
timeFrame: Baseline, before treatments #3, #4 and #5, post 6 weeks and 12 weeks
measure: Skin Thickness Changes
timeFrame: Baseline, before treatments #3, #4 and #5, post 6 weeks and 12 weeks
Secondary outcomes:
measure: Patient reported effectiveness of intervention
timeFrame: Baseline, 12 weeks post intervention
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Villa Medica Rehabilitation Hospital
Study officials:
References:
Clinical trial NCT03113513: Comparison of Two Apical Repair Methods in Women Undergoing Repairs for Prolapse
Official title: Randomized Trial of Sacrospinous Ligament Fixation Versus McCall Culdoplasty in Women Undergoing Vaginal Hysterectomy and Repairs for Prolapse
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pelvic Organ Prolapse
Surgery
Quality of Life
Complication
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 312
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is designed as a RCT.
Primary purpose: TREATMENT

Brief summary: To date no study has determined prospectively which technique is superior to prevent recurrent Pelvic Organ Prolapse (POP) after vaginal hysterectomy- a major unmet clinical need. The aim of the study is to determine objective anatomical recurrent prolapse after Sacrospinous Ligament Fixation (SLF) vs McCall.

Detailed description: The aim of the study is to determine objective anatomical recurrent prolapse after SLF vs McCall. The study is designed as a Randomized Controlled Trial (RCT). Primary study endpoint will be at 12 months, secondary study endpoint at 24 months. The following parameters will be evaluated after one year: anatomical outcome, Quality of Life (QoL), sexual health, reoperations, and complications.

Eligibility criteria: Inclusion Criteria:

* declined/ failed conservative treatment for POP
* planned vaginal hysterectomy with anterior/posterior colporrhaphy as indicated
* any symptomatic POP or stage II prolapse in any compartment
* at least stage I prolapse in the apical department
* women between 35 and 80 years of age
* good German language skills
* any concomitant prolapse surgery (anterior, posterior vaginal repair, suburethral tapes) as indicated
* concomitant salpingo-oophorectomy if indicated

Exclusion Criteria:

* Unwillingness to participate
* Neurological disorders
* Previous hysterectomy
* Desire to have children
* Connective tissue disorders (i.e. Ehlers-Danlos syndrome, Marfan syndrome)

Primary outcomes:
measure: Number of patients with stage 2 or higher on the Pelvic Organ Prolapse Quantification System (POP-Q).
timeFrame: 12 months after surgery
Secondary outcomes:
measure: Subjective cure
timeFrame: 12 months after surgery
measure: Quality of life as determined by a questionnaire
timeFrame: 12 months after surgery
measure: Sexual health
timeFrame: 12 months after surgery
measure: Reoperation rate
timeFrame: 12 months after surgery
Other outcomes:
Locations:
city: Graz
country: Austria
facility: MUGRAZ
state: Styria
Study officials:
References:
citation: Colombo M, Milani R. Sacrospinous ligament fixation and modified McCall culdoplasty during vaginal hysterectomy for advanced uterovaginal prolapse. Am J Obstet Gynecol. 1998 Jul;179(1):13-20. doi: 10.1016/s0002-9378(98)70245-5.
Clinical trial NCT01394913: Comparison of Two Etanercept Regimens (REUMATOCEPT® Versus ENBREL®) for Treatment of Rheumatoid Arthritis
Official title: A Prospective, Double-blind, Randomized Study to Compare Efficacy of Two Etanercept Regimens (REUMATOCEPT® Versus ENBREL®) for Treatment of Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2011-07-15
Enrollment: 0
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: This study is a comparison of safety and efficacy of two etanercept regimens (REUMATOCEPT® versus ENBREL®) for treatment of Rheumatoid Arthritis.

Detailed description: Study design:

• Double blinded, non-inferiority, prospective parallel-group, intend to treat trial.

Study design:

* Experiment duration: 30 weeks
* 9 visits (days 0, 14, 42, 70, 98, 126, 154, 182, 210)
* Health Assessment Questionnaire (HAQ) evaluation
* Disease Activity Score (DAS28) evaluation
* Clinical Disease Activity Index (CDAI) evaluation
* American College of Rheumatology criteria (ACR) evaluation
* Visual Activity Schedule(VAS) evaluation
* Adverse events evaluation

Eligibility criteria: Inclusion Criteria:

1. Patients must be able to understand the study procedures agree to participate and give written consent.
2. Patients with clinical diagnosis of moderate to severe rheumatoid arthritis according to American College of Rheumatology (ACR) criteria;
3. Patients with at least 6 swollen joints
4. Patients with partial response in treatment with methotrexate for 2 months

Exclusion Criteria:

1. Pregnancy and Lactation
2. Patients with uncontrolled hypertension
3. Patients with other rheumatic disease such as Sjogren syndrome, systemic lupus erythematosus or spondyloarthritis
4. Non-steroidal anti-inflammatory drug in the last 4 weeks
5. Any pathology or past medical condition that can interfere with this protocol
6. Patients with immunodeficiency and/or immunosuppressive disease;
7. Other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation.

Primary outcomes:
measure: Efficacy
timeFrame: day 1 to day 210
Secondary outcomes:
measure: Safety
timeFrame: day 1 to day 210
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Associação de Assitência à Criança Deficiente
Study officials:
affiliation: EMS
name: Felipe Pinho, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01268813: Personalized Medicine for Diabetes Prediction and Prevention of Complications
Official title: Personalized Medicine in Diabetes Using a Nanotechnology Platform
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Metabolic Syndrome
Diabetes
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
Collaborators: name: Technion, Israel Institute of Technology
First posted: 2010-12-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The metabolic syndrome is a collection of related risk factors that predispose to the development of type 2 diabetes Mellitus and cardiovascular disease. The investigators will examine the hypothesis that the metabolic and genomic characteristics of patients with metabolic syndrome and/or diabetes that are at risk for developing complications differ from each other and can be detected using specific biomarkers in blood or in the exhaled breath. Early detection of these individuals will enable personalized treatment to prevent and treat diabetes and its complications

Detailed description: Breath samples will be collected in inert respiratory bag from diabetic and healthy volunteers, and analyzed using a chamber containing nano-chemical sensors. These samples together with blood samples will additionally be characterized using Gas Chromatography-Mass Spectroscopy "GC-MS".

Eligibility criteria: Inclusion Criteria:

* Metabolic Syndrome
* Type 2 diabetes
* Healthy volunteers with 20\<Body Mass Index\<25

Exclusion Criteria:

* Smoking
* Chronic or acute lung disease

Primary outcomes:
measure: Development of Diabetes or complication
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center - Inst. Endocrinology, Diabetes & Metabolism
Study officials:
affiliation: Rambam Medicl Center, Technion
name: Eddy Karnieli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01086813: Phase I, Single Centre, Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD3043
Official title: Phase I, Single Centre, Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous AZD3043 After a Single Ascending Bolus Dose Followed by a Single Infusion Dose in Elderly (=65 Years) Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Safety
Tolerability
Pharmacokinetics
Sedation
Keywords: Safety
Tolerability
Pharmacokinetics
Sedation
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-03-15
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Phase I, Single Centre, Open Label Study to Assess the Safety, Tolerability,Pharmacokinetics and Pharmacodynamics of Intravenous AZD3043 after aSingle Ascending Bolus Dose Followed by a Single Infusion Dose in Elderly(=65 years) Healthy Volunteers

Detailed description: Phase I, Single Centre, Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous AZD3043 after a Single Ascending Bolus Dose Followed by a Single Infusion Dose in Elderly (=65 years) Healthy Volunteers

Eligibility criteria: Inclusion Criteria:

* Pre-anaesthesia assessment judged without remarks by the investigator.
* ASA physical status category 1 to 2 (up to and including 3 depending on applicable patient category)

Exclusion Criteria:

* Lack of a normal range of enzyme activity for BuChE
* Known or suspected history of hypersensitivity to drugs with a similar chemical structure or class to AZD3043 (e.g., emulsion-based products like Diprivan,Intralipid), allergies to soybean or peanut products or any other drugs intended for use during th
* Prolonged QTcF \>450 ms or shortened QTcF \<350 ms or family history of long QT syndrome.

Primary outcomes:
measure: To evaluate safety and tolerability after administration of a bolus and infusion of AZD3043
timeFrame: Heartrate, Bloodpressure, Telemetry, ECG, EtCO2, SPO2, BIS, Respiratory frequency every minute during a 1h session
Secondary outcomes:
measure: To evaluate the PK of AZD3043 and its main metabolite (THRX-108893) in venous blood samples
timeFrame: During 24h
measure: To evaluate the onset, level and recovery from sedation/anaesthesia
timeFrame: During 24h
Other outcomes:
Locations:
Study officials:
affiliation: Quintiles Drug Research Unit at Guy's HospitalQuintiles Ltd6 Newcomen StreetLondonSE1 1YRUnited Kingdom
name: Darren Wilbraham
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Stephen Kanes
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Brendan Smyth
role: STUDY_CHAIR
References: