louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04509830: Efficacy of Hip Strengthening on Dynamic Knee Stability, Disability and Gait in Knee Osteoarthritis
Official title: Efficacy of Hip Strengthening on Dynamic Knee Stability, Disability and Gait in Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-08-12
Enrollment: 88
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized control trial
Primary purpose: TREATMENT

Brief summary: this study will be conducted to investigate the role of hip strengthening in improving dynamic knee stability, gait parameter, lower extremity strength and disability in knee osteoarthritis

Detailed description: knee osteoarthritis accounts for more than 80% of the total burden of the diseases. patients with knee osteoarthritis had worse spatiotemporal gait parameter and dynamic instabitity. there are significant hip muscle weakness in knee osteoarthritis. hip muscle weakness leads to improper alignment and stress in knee joint. hip muscle strength can affect knee joint loading and disease progression in knee osteoarthritis. muscles of the lower extremity play a critical role in the preservation of normal knee joint function by providing dynamic knee joint stability and shock absorption, while maintaining safe transfer of forces across the joint.

Eligibility criteria: Inclusion Criteria:

age 40 to 65 years grade 2-3 on KL grade BMI 25 to 32 kg/m2 medial KOA

Exclusion Criteria:

* lateral KOA intraarticular corticosteriod injection into knee within pervious 3 months significant comorbidity individuals with known hip osteoarthritis previous trauma affection one or both hips history of other medical conditions affecting the knee joint previous replacement of any joint in the lower extremity low back pain cognitive impairment

Primary outcomes:
measure: dynamic knee stability
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01131130: Feasibility of a New Silicone Hydrogel Lens
Official title: A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: Contact lens
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2010-05-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The objective of this study is to determine the product feasibility of the investigational contact lens (Test) when compared to the currently marketed Acuvue Oasys contact lens (Control) and the Air Optix Aqua contact lens (Control) when worn by adapted wearers of soft contact lenses.


Eligibility criteria: Inclusion Criteria:

* Participants must have clear central corneas and be free of any anterior segment disorders.
* Participants must be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
* Participants must be myopic and require lens correction from -0.75 D to - 4.75D in each eye.

Exclusion Criteria:

* Participants who have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
* Participants with any systemic disease affecting ocular health.
* Participants using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
* Participants with an active ocular disease or are using any ocular medication.
* Participants who have had any corneal surgery (eg, refractive surgery).
* Participants who are allergic to any component in the study care products.

Primary outcomes:
measure: Comfort Throughout the Day - Test Lens vs. Air Optix Aqua Lens
timeFrame: 7 days
measure: Comfort Throughout the Day - Test Lens vs. Acuvue Oasys
timeFrame: 7 days
Secondary outcomes:
measure: Lens Wettability, Test Lens vs. Acuvue Oasys
timeFrame: 7 days
measure: Lens Wettability, Test Lens vs. Air Optix Aqua
timeFrame: 7 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Gerard Carains, MCOptom, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01075230: Standard Total Knee Arthroplasty Using Platelet Rich Plasma (PRP)
Official title: A Prospective, Randomized, Single-blind, Multi-center Clinical Study to Evaluate the Effect of Platelet Rich Plasma (PRP) on Short-term Patient Outcomes Following Total Knee Replacement.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteoarthritis
Keywords: PRP, TKA, pain scale, hemoglobin, hematocrit, narcotics
Lead sponsor: Exactech
Sponsor class: INDUSTRY
First posted: 2010-02-25
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical study to determine if there is a difference in hemoglobin level between patients undergoing total knee arthroplasty with and without platelet-rich plasma.

Detailed description: The purpose of this study is to determine if there is a difference in hemoglobin level between patients undergoing total knee arthroplasty with and without platelet-rich plasma.

Eligibility criteria: Inclusion Criteria:

* Patient is a male or female who is undergoing primary unilateral surgery or the first surgery of a staged bilateral total knee replacement where the second stage will be at least 6 weeks later
* Patient agrees to be blinded to their treatment group assignment
* Patient is willing and able to return for follow-up over at least a six (6) month post-operative period although longer follow-up may be desired
* Patient agrees to participate by signing an IRB approved Informed Consent Form

Exclusion Criteria:

* Patient will have a staged bilateral total knee replacement with the second stage to be performed less than 6 weeks after the first stage surgery PRP in
* Patient has had previous surgery on the operative knee that will necessitate the removal of existing hardware (e.g. previous osteotomy)
* Patient has a known adverse reaction or sensitivity to bovine (cow) thrombin (used as part of the platelet rich plasma system) or other bovine-derived products
* Patient has hemoglobin \< 12.0 (males), \< 11.0 (females)
* Patient has a clinically significant anxiety disorder
* Patient is on therapeutic anticoagulation medication and has an INR \> 1.3
* Patient has a severe bleeding disorder
* Patient has a known addiction to drugs or alcohol, including, but not limited to: chronic daily use of narcotic medications for more than 90 days prior to surgery
* Patient is pregnant
* Patient is a prisoner
* Patient is involved in a personal litigation (e.g. Worker's Compensation) that relates to their knee surgery
* Patient is actively participating in another medical device, drug, or biologic clinical trial (active defined as having treatment within the last 30 days)

Primary outcomes:
measure: Change in hemoglobin (Hgb) level
timeFrame: Preop, post-op day 2
Secondary outcomes:
measure: Visual analog scale (VAS) for pain
timeFrame: Preop, post-op day 1, post-op day 2, discharge, 6 weeks
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Henrico Doctors' Hospital
state: Virginia
Study officials:
References:
Clinical trial NCT06917430: Muscle MRI Outlining of Neuromuscular Diseases Using Artificial Intelligence
Official title: Muscle MRI Outlining of Neuromuscular Diseases Using Artificial Intelligence
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Becker Muscular Dystrophy
FSHD - Facioscapulohumeral Muscular Dystrophy
Hypokalemic Periodic Paralysis
Keywords: AI
muscle delineation
automated segmentation
Becker muscular dystrophy
FSHD
HypoPP
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from Copenhagen Neuromuscular Centre.

Brief summary: Background and aim:

Neuromuscular diseases encompass a range of conditions affecting muscle cells, nerves, or the interaction between the two. A common pathological feature of these conditions is the pro-gressive replacement of muscle tissue with fat, which can be visualised using magnetic reso-nance imaging (MRI). MRI-based fat quantification serves as a key biomarker for disease characterisation, progression tracking, and treatment assessment. Currently, manual segmenta-tion of MRI scans for fat quantification is very time-consuming, requiring individual muscle delineation. Therefore, an artificial intelligence (AI) model is being developed to automate the segmentation. The aim of this study is to validate this AI model and assess its possibilities and limitations.

Method:

The study is ongoing. Retrospective MRI scans of patients with four different muscle diseases (anoctaminopathy, Becker muscular dystrophy, facioscapulohumeral muscular dystrophy, and hypokalemic periodic paralysis) are collected and manual delineation used for training the AI-model is being performed. The intramuscular fat fraction of individual muscles of the pelvis, thigh, and calf will be analysed using the AI model. The performance of the AI model will be compared to manual segmentation. The AI will be evaluated on metrics such as segmentation accuracy and time efficiency.


Eligibility criteria: Inclusion Criteria:

* Genetically verified diagnosis of neuromuscular diseases.
* Age above 18 years

Exclusion Criteria:

* Contraindications to perform an MRI
* Competing disorders and other muscle disorders, which may alter measurements. The investigator will decide whether the competing disorder can significantly influence the results

Primary outcomes:
measure: Difference in fat fraction between manual and AI outlining.
timeFrame: Analysis of the muscle fat fraction takes 1 hour per patient.
Secondary outcomes:
measure: Correlation between Manual/AI outlining discrepancies and disease severity
timeFrame: The analysis of the MRI takes around an hour
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00568230: Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device to Reduce Mitral Regurgitation
Official title: An Open-Label, Single-Arm Feasibility Study of the Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty (PTMA) Device Used to Reduce Mitral Regurgitation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Heart Failure
Mitral Regurgitation
Keywords: heart failure
mitral regurgitation
Lead sponsor: Viacor
Sponsor class: INDUSTRY
First posted: 2007-12-05
Enrollment: 12
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Improvement of heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implanted device.


Eligibility criteria: Inclusion Criteria:

* symptomatic heart failure
* moderate to severe mitral regurgitation
* 20 - 50% LVEF

Exclusion Criteria:

* mitral regurgitation of organic origins
* recent interventions
* severe comorbidities

Primary outcomes:
measure: percent of patients who remain free from device-related major adverse events (death, myocardial infarction, tamponade, emergent cardiac surgery)
timeFrame: 30 days
Secondary outcomes:
measure: percent of implanted patients who maintain a sustained 1 grade reduction in mitral regurgitation and reduction of mitral annulus anterior posterior dimension
timeFrame: 30 days
measure: improvement of clinical symptoms of heart failure as defined by percent of patients who exhibit one of the following: decrease in NYHA class, improvement in Minnesota QOL survey, increase in exercise capacity: 6 minute walk or VO2max
timeFrame: 30 days
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Universitat Duisburg-Essen
Study officials:
affiliation: Universitat Duisburg-Essen
name: Stefan Sack, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00953030: Cost Effective Health Promotion for Older Adults
Official title: Cost Effective Health Promotion for Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Working Adults
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2009-08-06
Enrollment: 423
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED

Brief summary: This project tests the cost-effectiveness of two promising evidence-based health promotion/ behavior change interventions. The first intervention is the COACH Program, a revised version of the Health Enhancement Program (HEP) that has been implemented to date with older adults at multiple Senior Centers across the country (Leveille et al, 1998). The second is the web-based RealAge program which is also being implemented for older adults at multiple sites nationally and internationally. The Coach program combines a web-based risk assessment with individualized counselling. In contrast, RealAge is a totally web-based program.

The specific hypotheses that we will test in the proposed cost-effectiveness study are shown below.

Primary Study Hypotheses:

COACH participants will experience significantly greater reductions in absenteeism, disability days, and healthcare use and cost at 6 and 12 months than RealAge participants. Participants in both the COACH and RealAge treatment groups will experience significantly greater reductions in absenteeism, disability days, and healthcare use and cost than control group participants at 6 and 12 months.

Secondary Study Hypotheses:

COACH participants will experience significantly greater levels of adherence to health promotion Action Plans and greater reduction in weight, body mass index, blood pressure and depression and greater increase in vitality and quality of life than RealAge participants at 6 and 12 months. Participants in both the COACH and RealAge treatment arms will experience significantly better outcomes on these measures at 6 and 12 months than control group participants.


Eligibility criteria: Inclusion Criteria:

* Current employee of the University of Illinois at Chicago
* 40+ years of age

Exclusion Criteria:

* Those not currently employed by the University of Illinois at Chicago
* Those under the age of 40

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois Chicago
state: Illinois
Study officials:
References:
Clinical trial NCT07007130: Effect of Intraperitoneal Insulin Administration After Laparoscopy in Insulin-Resistant Patients on Prevention of Postoperative Adhesion Recurrence: A Randomized Controlled Trial
Official title: Effect of Intraperitoneal Insulin Administration After Laparoscopy in Insulin-Resistant Patients on Prevention of Postoperative Adhesion Recurrence: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prevention of Postoperative Adhesions
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Adhesion formation following laparoscopic pelvic surgery remains a significant cause of chronic pelvic pain, infertility, and surgical complications. Patients with insulin resistance (IR) may have heightened inflammatory responses and impaired tissue healing, contributing to a higher risk of adhesion formation. Intraperitoneal administration of insulin has shown promising results in animal models by modulating inflammatory mediators and enhancing fibrinolysis. This trial aims to evaluate the efficacy and safety of intraperitoneal insulin instillation at the end of laparoscopy in women with insulin resistance.

Detailed description: This is a prospective, randomized, controlled, double-blind clinical trial designed to evaluate the efficacy of intraperitoneal insulin administration at the end of laparoscopic surgery in women with insulin resistance, aiming to reduce postoperative adhesion formation. The study will be conducted at a dr saed hospital and will enroll 100 female patients diagnosed with insulin resistance undergoing laparoscopy for infertility or chronic pelvic pain.

Eligibility criteria: Inclusion Criteria:

* Women aged 18-40 years
* Diagnosed insulin resistance (e.g., HOMA-IR \>2.5 or fasting insulin \>15 uIU/mL)
* Indicated for laparoscopy for infertility or pelvic pain
* BMI 20-35 kg/m²
* Able and willing to give informed consent

Exclusion Criteria:

* Diabetes mellitus requiring pharmacologic treatment
* History of peritonitis or major abdominal surgery in the past 6 months
* Known allergy or sensitivity to insulin
* Chronic steroid or immunosuppressive use
* Pregnancy or lactation
* Participation in another clinical trial within the last 3 months

Primary outcomes:
measure: Adhesion scoring at second-look laparoscopy
timeFrame: 4-6 weeks postoperatively
Secondary outcomes:
measure: Postoperative pain scores
timeFrame: Immediately after operation
measure: Hypoglycemic events
timeFrame: 2 hours after the operation
measure: Hypoglycemic events
timeFrame: 4 hours after the operation
measure: Fertility rates
timeFrame: At 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02392130: A Clinical Trial to Assess the Potential of LEO 130852A Gel to Reduce Steroid Induced Skin Atrophy on Healthy Skin
Official title: A Prospective, Randomised, Investigator-Blinded, Vehicle-Controlled, Phase I Clinical Trial With Intra-Individual Comparison of Treatments to Assess the Potential of LEO 130852A Gel to Reduce Steroid Induced Skin Atrophy on Healthy Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Skin Tissue Diseases
Connective Tissue Diseases
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2015-03-18
Enrollment: 40
Sex: MALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to assess the effect of LEO 130852A gel 1% in maintaining skin thickness in healthy skin treated with steroid.


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers, 25 to 50 years old inclusive
* Healthy skin on volar arms with a hairless area sufficient for measurements

Exclusion Criteria:

* Clinical skin atrophy, telangiectasia or striae on volar arms
* Presence of any skin condition or colouration that would interfere with test sites or the response or assessment
* Fitzpatrick skin type IV - VI
* History or current evidence of infection, eczema or other relevant skin disease

Primary outcomes:
measure: Skin thickness measured by sonography and histology
timeFrame: 4 weeks
Secondary outcomes:
measure: Clinical assessments measured by atrophy score
timeFrame: 4 weeks
measure: Clinical assessments measured by telangiectasia score
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: bioskin GmbH
Study officials:
References:
Clinical trial NCT05266430: Prospective Group-Matched Study With Belzupacap Sarotalocan (Bel-sar; AU-011) or Plaque Radiotherapy for Primary Indeterminate Lesions or Choroidal Melanoma (IL/ CM)
Official title: A Prospective Group-Matched Study of Visual Outcomes in Subjects Treated With Belzupacap Sarotalocan (AU-011) or Plaque Radiotherapy for Primary Indeterminate Lesions or Choroidal Melanoma (IL/ CM)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Choroidal Melanoma
Indeterminate Lesions
Keywords: AU-011
Belzupacap sarotalocan
Choroidal melanoma
Plaque radiotherapy
Matched case control
Visual acuity
bel-sar
Lead sponsor: Aura Biosciences
Sponsor class: INDUSTRY
First posted: 2022-03-04
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with primary Choroidal Melanoma and Indeterminate Lesions who are planned to receive plaque radiotherapy (Control Group) and subjects with primary Choroidal Melanoma and Indeterminate Lesions who participated in previous Aura Biosciences sponsored clinical trial. (Case Group)

Brief summary: This is a prospective multicenter, group-matched study of patients with primary indeterminate lesions or choroidal melanoma who receive treatment with belzupacap sarotalocan (bel-sar; AU-011) and patients who are planned to receive standard of care (SOC) treatment with plaque radiotherapy (plaque) to compare the visual outcomes of AU-011 and plaque radiotherapy.

Detailed description: Up to approximately 45 patients who are planned to receive plaque radiotherapy for the treatment of IL/CM based on the expert judgment of the Investigator are planned to be enrolled.

Eligibility criteria: Have per the investigator's expert clinical judgment, a clinical diagnosis of primary indeterminate lesion or choroidal melanoma based on the clinical history, ophthalmic examination, fundus photography and conventional ocular ultrasound.

Primary outcomes:
measure: Visual Acuity
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: Associated Retinal Consultants, P.C.
state: Michigan
city: Portland
country: United States
facility: Oregon Health & Science University Casey Eye Institute
state: Oregon
city: Greenville
country: United States
facility: Retina Consultants of Carolina, PA
state: South Carolina
city: Nashville
country: United States
facility: St. Thomas Health/Tennessee Retina, P.C.
state: Tennessee
city: Bellaire
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Dallas
country: United States
facility: Texas Retina Associates
state: Texas
city: Madison
country: United States
facility: University of Wisconsin Dept of Ophthalmology & Visual Sciences
state: Wisconsin
Study officials:
affiliation: Aura Biosciences, Inc.
name: Medical Monitor
role: STUDY_DIRECTOR
References: