louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03623633: Comparative Antiresorptive Efficacy Discontinuation of Denosumab
Official title: Comparative Antiresorptive Efficacy of Alendronate or Raloxifene Following Discontinuation of Denosumab
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Osteoporosis, Postmenopausal
Osteoporosis
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 51
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Osteoporosis remains a significant healthcare burden for the United States. Current FDA-approved osteoporosis treatments include teriparatide, abaloparatide, bisphosphonates, denosumab, and raloxifene.

Denosumab is a fully human monoclonal antibody that specifically binds to receptor activator of nuclear factor kappa-B ligand (RANKL). Denosumab potently suppresses osteoclastic activity but bone turnover rapidly normalizes and bone turnover marker levels can rebound above baseline levels after the drug is discontinued.

This study will help us determine the optimal duration and relative efficacy of two oral antiresorptive medications that are FDA-approved for treatment of postmenopausal osteoporosis (alendronate and raloxifene) in preventing the rebound increase in bone turnover that occurs after denosumab discontinuation.


Eligibility criteria: Inclusion Criteria:

* women aged 45+
* postmenopausal
* osteoporotic with high risk of fracture as per National Osteoporosis Foundation guidelines

Exclusion Criteria:

* no significant previous use of bone health modifying treatments
* hip fracture within one year of enrollment
* known congenital or acquired bone disease other than osteoporosis
* significant renal disease, liver disease, cardiopulmonary disease, or psychiatric disease
* abnormal calcium or parathyroid hormone level
* serum vitamin D \<20 ng/dL
* anemia (hematocrit \<32%)
* history of malignancy (except non-melanoma skin carcinoma)
* excessive alcohol use or substance abuse
* extensive dental work involving extraction or dental implant within the past 6 months or in the upcoming 12 months
* known contraindications to denosumab, alendronate, or raloxifene

Primary outcomes:
measure: Serum c-telopeptide (CTX)
timeFrame: Month 12 to 18 months
measure: Bone mineral density (BMD)
timeFrame: Month 24 to 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: MGH
name: Joy Tsai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04124133: Evaluation of Efficacy and Safety of Ialuset Cream and Gauze in Second-degree Burns on Child
Official title: Observational Retrospective Study Evaluating Efficacy and Safety of Ialuset Cream or Gauzepad in Second Degree Burns Use for Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Second-degree Burn of Children
Lead sponsor: Laboratoires Genévrier
Sponsor class: INDUSTRY
First posted: 2019-10-11
Enrollment: 92
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children from 1month to 15 years with a second degree burn

Brief summary: Observational retrospective monocentric study occured in the univeristy hospital center of Bensançon the department of pediatric surgery.

Data of patients treated in the hospital between January 2016 and January 2019 have been collected.

Detailed description: Coordinator investigator have put in place a protocol care for children with second degree burns since 2016.

It consists in detersion and cleaning of wound, application of ialuset cream and gauzepad (hyaluronic acid) during 21 days. After 21 days if patients are not healed, physician consider to perform grafting

Eligibility criteria: Inclusion Criteria:

* second-degree burns
* less than 20% of the body surface
* less than 15 years old
* treated within 24 hours
* 1st line of treatment with ialuset
* treated at the center between 2016 and 2019

Exclusion Criteria:

* patient who refused data collection

Primary outcomes:
measure: Patient rate with complete healing
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU Besançon
Study officials:
affiliation: CHU Besançon
name: Arnaud Fotso Kamdem
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06845033: Effects of Antagonizing the Ghrelin Receptor on Brain Food Cue Reactivity in Obesity
Official title: Effects of Antagonizing the Ghrelin Receptor on Brain Food Cue Reactivity in Obesity
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity and Overweight
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 28
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The naturally occurring peptide hormone liver-expressed antimicrobial peptide 2 (LEAP2) in an antagonist/inverse agonist towards the ghrelin receptor. Ghrelin administration has previously been shown to increase food cue reactivity in brain regions related to appetite and reward using functional MRI scans.

The aim of this clinical study is to investigate the effects of LEAP2 infusion on food cue reactivity in brain regions related to appetite and reward. Since LEAP2 is an antagonist/inverse agonist towards the ghrelin receptor we hypothesize, that LEAP2 infusion will decrease food cue reactivity in the above-mentioned regions compared to placebo infusion.

Participants with obesity (BMI 30-50 kg/m2) will be included and complete two experimental days with either LEAP2 or placebo infusion in a randomized crossover manner. On experimental days, participants will undergo a MRI scan with functional and anatomical modalities.

The study will attribute to gain a deeper understanding of the ghrelin system and its interaction with appetite regulation.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 60 years at the time of inclusion
* Body mass index 30-50 kg/m2
* Men
* Informed consent

Exclusion Criteria:

* Anaemia (haemoglobin below normal range)
* Alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT) \>2 times normal values) or present hepatobiliary and/or gastrointestinal disorder(s)
* Nephropathy (serum creatinine above normal range and/or albuminuria)
* Glycated haemoglobin (HbA1c) ≥48 mmol/mol and/or type 2 diabetes requiring medical treatment
* Regular tobacco smoking or use of other nicotine-containing products
* Claustrophobia
* Any ongoing medication that the investigator evaluates would interfere with trial participation.
* Any physical or psychological condition that the investigator evaluates would interfere with trial participation including any acute or chronic illnesses

Primary outcomes:
measure: Difference in food cue reactivity between experimental days
timeFrame: time 75 - 135 minutes
Secondary outcomes:
measure: Difference in appetite ratings
timeFrame: From baseline to end of infusion
measure: Changes in peptide hormone concentrations
timeFrame: From baseline to end of infusion
Other outcomes:
measure: Reactivity from Negative Emoition Reactivity Test (NERT)
timeFrame: time 75 - 135 minutes
measure: Plasma glucose
timeFrame: Through experimental day. From timepoints -15 to 135 min
Locations:
Study officials:
References:
Clinical trial NCT06829433: Movement Dynamics of Knee Osteoarthritis and Total Knee Replacement
Official title: Quantifying the Movement Dynamics of Adults Living With Total Knee Arthroplasty and Knee Osteoarthritis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Knee Osteoarthritis
Total Knee Replacement
Lead sponsor: University of Portsmouth
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 36
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Local private physiotherapy clinics and local sports clubs

Brief summary: This research aims to explore differences in walking and functional movement mechanics, exercise response, and physical activity between people with osteoarthritis (OA), those who have undergone total joint replacement, and healthy individuals.

Detailed description: People living with OA tend to be less physically active than those without the disease, which is often due to pain, stiffness and joint instability. This reduction in physical activity can lead to additional health problems down the line. When the disease becomes severe, joint replacement surgeries are sometimes performed to relieve pain and improve individuals' quality of life. However, despite reducing pain, there is little evidence to show that joint replacement surgeries encourage individuals to return to healthy physical activity levels.

Reasons for the lack of change may include a failure to address unhealthy walking and movement patterns which could still be causing pain and instability and reduced physical fitness levels.

By investigating these reasons, we hope that findings from this study will help to inform future interventions that improve clinical outcomes and quality of life for individuals with OA and post-joint replacement.

Eligibility criteria: Inclusion Criteria:

* Diagnosed symptomatic bilateral or unilateral knee osteoarthritis, self-reported ability to walk without an aid for 10 minutes and to ascend and descend stairs, no neurological conditions or other musculoskeletal pathology/injury which would impact walking gait.

Exclusion Criteria:

* Unable to walk at 0.8 m/s, exclusion based on IMO screening, non-English speaking, lacking ability to consent.

Primary outcomes:
measure: Peak knee adduction moment
timeFrame: From the start of a biomechanical movement testing visit to the end (approximately 2 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Portsmouth
country: United Kingdom
facility: School of Psychology, Health and Sport Sciences, University of Portsmouth
state: Hampshire
Study officials:
References:
Clinical trial NCT01144533: Comparative Analysis of Intra-articular Injection of Steroid and/or Sodium Hyaluronate in Adhesive Capsulitis
Official title: Comparative Analysis of Intra-articular Injection of Steroid and/or Sodium Hyaluronate in Adhesive Capsulitis: A Randomized, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adhesive Capsulitis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2010-06-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy of intra-articular steroid injection, sodium hyaluronate injection, a combination of the two, and placebo in the treatment of adhesive capsulitis of the shoulder.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis : Adhesive Capsulitis of the Shoulder
* defining of adhesive capsulitis

  * the presence of shoulder pain
  * limitation of both active and passive movements of the glenohumeral joint of ≥25% in at list 2 directions(abduction,flexion,external rotation,internal rotation), as compared with the contralateral shoulder
* duration : symptomatic for \< 1 year

Exclusion Criteria:

* bilateral symptoms
* uncontrolled diabetes mellitus
* overt hypothyroidism or hyperthyroidism
* previous shoulder surgery
* previous glenohumeral joint injection within recent 6months
* trauma to the shoulder the last six months that required hospital care
* neurological symptoms
* allergy to injection material
* secondary adhesive capsulitis
* systemic inflammatory ds including rheumatoid arthritis
* degenerative arthritis of shoulder joint
* infectious arthritis of shoulder joint
* dislocation of shoulder joint
* blood coagulation disease
* rotator cuff tear
* serious mental illness
* pregnancy
* fracture in shoulder lesion
* CVA

Primary outcomes:
measure: SPADI Score (Shoulder Pain and Disability Index)
timeFrame: Postinjection 1month
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
Study officials:
affiliation: Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
name: Chris H. Jo, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06751433: Evaluation of Clinical, Perceived and Instrumental Efficacy of a Scar Gel in Preventing Hypertrophic Scars
Official title: Evaluation of Clinical, Perceived and Instrumental Efficacy of a Scar Gel Versus Benchmark in Preventing Hypertrophic Scars and Improving Scar Appearance
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Acceptability Study
Real-use Conditions
Safety and Efficacy
Topical Administration
Hypertrophic Scars
Keloid Scars
Lead sponsor: Herbarium Laboratorio Botanico Ltda
Sponsor class: INDUSTRY
First posted: 2024-12-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinical trial, double arm, double blind, randomized
Primary purpose: PREVENTION

Brief summary: Evaluation of the safety and topical efficacy of a scar gel after 90 days of continuous use, comparing it to a benchmark for preventing hypertrophic scars and improving appearance, hydration and pigmentation.

Detailed description: Evaluation of the safety and topical efficacy of a scar gel after 90 days of continuous use. Comparison of the efficacy of the investigational product with the benchmark product in preventing hypertrophic scars and improving scar appearance, as well as analyzing parameters such as skin hydration, pruritus, discomfort, and normalization of scar pigmentation.

Eligibility criteria: Inclusion Criteria:

1. Participants of both sexes aged between 18 and 70 years;
2. Participants with recent scars (\<30 days);
3. Participants with phototypes III to VI according to the Fitzpatrick scale;
4. Agree to follow the trial procedures and attend the center on the days and times determined for evaluations;
5. Understand, agree to and sign the free and informed consent form.
6. Types of scars: cesarean section, breast implant or blunt cut injury.

Exclusion Criteria:

1. Pregnancy or risk of pregnancy;
2. History of atopic or allergic reactions to cosmetic products;
3. Participants who are using topical antibiotics or other skin products on the same area being evaluated;
4. Immunosuppression due to drugs or active diseases;
5. Decompensated endocrine diseases;
6. Relevant clinical history or current evidence of alcohol or other drug abuse;
7. Known history or suspected intolerance to products in the same category;
8. Intense sun exposure up to 15 days before the evaluation;
9. Patients who are using topical antibiotics or other skin products on the same area being evaluated.

Primary outcomes:
measure: Assessment of clinical and perceived efficacy
timeFrame: 90 days
Secondary outcomes:
measure: Perceived efficacy
timeFrame: 90 days
Other outcomes:
Locations:
city: Osasco
country: Brazil
facility: Medcin Instituto da Pele Ltda
state: São Paulo
city: Osasco
country: Brazil
facility: MEDCIN
Study officials:
References:
Clinical trial NCT00215033: Relationship Between EBV and PTLD
Official title: Relationship Between Quantitative Epstein-Bar Viral(EBV) Titres and Post-Transplant Lymphoproliferative Disease
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pediatric Heart Transplant
Keywords: Epstein-Barr virus
pediatric health
cardiac
heart transplant
lymphoproliferative disease
post-transplant
pediatric transplant
Lead sponsor: Children's Healthcare of Atlanta
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 160
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergone pediatric heart transplant

Brief summary: The purpose of this study is to determine the significance of an elevated quantitative EBV PCR and to determine the relationship between a EBV PCR value and the risk of developing PTLD.

Detailed description: The relationship between Epstein-Barr virus and lymphoproliferative disease has been established, particularly in the immuno-suppressed patient. Over the past several years a quantitative EBV PCR lab test has been established. Unfortunately, the significance of an elevated test remains unclear. The relationship of a particular EBV PCR value and the risk of developing PTLD is unknown. The primary aims will be to determine the significance of an elevated quantitative EBV PCR and to determine the relationship between a EBV PCR value and the risk of developing PTLD. The study will be conducted through a retrospective chart review of approximately 160 patients and we will look at postoperative data including Quantitative EBV PCR results, the presence / absence of PTLD and the treatment of PTLD and results of EBV PCR with treatment.

Eligibility criteria: Inclusion Criteria:

* patients undergone pediatric heart transplant
* followed by pediatric heart transplant program

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Emory University
name: Brian Kogon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01316133: A Study to Evaluate the Efficacy and Safety of Tacrolimus With Steroid in Korean Lupus Nephritis Patients
Official title: A Multicenter, Non-comparative, Open-labeled, Prospective Study to Evaluate the Efficacy and Safety of Tacrolimus (Prograf®) With Steroid in Korean Lupus Nephritis Patients Who Are Non-responders to Steroid Monotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Lupus Nephritis
Keywords: Tacrolimus
Prograf
FK506
Proteinuria
Calcineurin inhibitor
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2011-03-16
Enrollment: 37
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to evaluate efficacy and safety of tacrolimus with steroid by observing remission rate at 24 weeks in lupus nephritis patients who are non-responders to steroid monotherapy.


Eligibility criteria: Inclusion Criteria:

* Patients who satisfy more than 4 criteria for diagnosis of systemic lupus erythematosus (ARA criteria, 1982)
* Patients who fall under WHO class III-IV lupus nephritis on renal biopsy
* Patients with refractory lupus nephritis
* Proteinuria ≥ 0.5 g/day
* Patients who took steroid ≥ 20 mg/day over one month prior to the study
* Patients who failed a first-line therapy (non-responders to steroid monotherapy)

Exclusion Criteria:

* Patients who are allergic or resistant to macrolide antibiotics or tacrolimus
* Patients who received tacrolimus in the past (excluding drugs for external use)
* Patients who used other immunosuppressants within 4 weeks before initiation of the study
* Patients who have been receiving systematic chemotherapy since before enrollment (local chemotherapy is allowed.)
* Patients with malignant tumor which developed within the recent 5 years or history of malignant tumor
* Patients who have severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorders which may influence absorption of tacrolimus
* Patients with S-Cr ≥ 200 µ㏖/L or ≥ 2.3 mg/dL
* Patients with liver function levels of more than twice the upper limit of normal or acute active hepatitis

Primary outcomes:
measure: Remission rate
timeFrame: 24 weeks
Secondary outcomes:
measure: Complete remission rate
timeFrame: 24 weeks
measure: Change from baseline in urine protein to creatinine ratio
timeFrame: Baseline, 4 weeks, 12 weeks and 24 weeks
measure: Change from baseline in serum creatinine
timeFrame: Baseline, 4 weeks, 12 weeks and 24 weeks
measure: Safety assessed by the incidence of adverse events, abnormal findings of laboratory tests and vital signs
timeFrame: for 24 weeks
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Daejeon
country: Korea, Republic of
city: Gwangju
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Jeonju
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT00883233: Comparison of Four Different Regimens of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in Acne Vulgaris
Official title: Efficacy and Safety Comparison of Four Different Regimens of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in the Treatment of Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne
Keywords: Acne
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2009-04-17
Enrollment: 123
Sex: ALL
Minimum age (years): 12
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the tolerability of 3 treatment regimens containing Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel with that of Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 weeks in the treatment of acne vulgaris. The efficacy of the four treatment regimens will also be evaluated.


Eligibility criteria: Inclusion Criteria:

* Male or female Subjects of any race, aged 12 to 35 years inclusive
* Subjects with mild or moderate facial acne vulgaris
* Subjects with skin phototype I to IV

Exclusion Criteria:

* Subjects with more than 1 nodules or cysts on the face,
* Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.)

Primary outcomes:
measure: Local Tolerability Was Analyzed in Terms of Worst Score Post-Baseline.
timeFrame: Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Windsor
country: Canada
facility: Galderma Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Galderma Investigational Site
state: Quebec
Study officials:
affiliation: Windsor, ON, Canada
name: Jerry Tan, MD
role: PRINCIPAL_INVESTIGATOR
References: