louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05763017: Comparing Relative Motion Splint and Metacarpophalangeal Joint Blocking Splint for Trigger Finger
Official title: A Randomized Comparative Trial of Relative Motion Splint Versus Metacarpophalangeal Joint Blocking Splint in the Management of Trigger Finger
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trigger Finger
Stenosing Tenosynovitis
Keywords: relative motion splint
metacarpophalangeal joint blocking splint
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 36
Sex: ALL
Minimum age (years): 21
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 effectiveness of relative motion splint and metacarpophalangeal joint blocking splints in terms of sign and symptoms, hand function, occupational performance, and perception of splint wearability (comfort and satisfaction) after six weeks of TF management.


Eligibility criteria: Inclusion Criteria:

* single or multiple trigger finger
* unilateral or bilateral trigger finger
* neutral metacarpophalangeal joint position can be attained during passive isolated metacarpophalangeal joint extension of the affected finger

Exclusion Criteria:

* trigger thumb
* steroid injection of the affected finger within last six months
* A1 pulley release of the affected finger.
* history of fracture, tendon injury, nerve injury, Dupuytren's contracture, and other soft tissue injuries of the affected finger or adjacent fingers.

Primary outcomes:
measure: Stages of Stenosing Tenosynovitis (SST)
timeFrame: Baseline, 6 weeks after splint wear
Secondary outcomes:
measure: Visual Analog Scale (VAS) for pain
timeFrame: Baseline, 6 weeks after splint wear
measure: Number of triggering events in ten active fists
timeFrame: Baseline, 6 weeks after splint wear
measure: Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure
timeFrame: Baseline, 6 weeks after splint wear
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: Baseline, 6 weeks after splint wear
measure: Visual Analog Scale (VAS) for splint comfort
timeFrame: Baseline, 3 and 6 weeks after splint wear
measure: Visual Analog Scale (VAS) for splint satisfaction
timeFrame: Baseline, 3 and 6 weeks after splint wear
Other outcomes:
Locations:
city: Temerluh
country: Malaysia
facility: Hospital Sultan Haji Ahmad Shah
state: Pahang
Study officials:
affiliation: Occupational Therapy Programme, Center for Rehabilitation & Special Needs Studies (iCaRehab)
name: Siaw Chui Chai, PhD (OT)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05861817: Effect of Low Level Laser Therapy in Patients With Chronic Rhinosinusitis.
Official title: Effect of Low Level Laser Therapy on Headache, and Fatigue in Patients With Chronic Rhinosinusitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rhinosinusitis
Headache
Fatigue
CT
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-05-17
Enrollment: 31
Sex: ALL
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to evaluate the efficacy of low-level laser therapy (LLLT) for Chronic sinusitis in a randomized, double-blind, placebo-controlled trial.

Detailed description: Chronic sinusitis, or chronic rhinosinusitis, is an inflammatory condition defined by symptomatic inflammation of the paranasal sinuses lasting longer than 3 months. Common presenting symptoms include nasal obstruction, facial pressure or fullness, nasal discharge (anterior or posterior), and olfactory loss. Furthermore, chronic sinusitis is associated with reductions in patient quality of life (QOL), sleep quality, and daily productivity.

It has been suggested that low-level laser can be used in treating chronic sinusitis but there are limited studies about its usage.

HYPOTHESES:

There is no statistically significant effect of laser therapy on headache, fatigue, or CT finding in patients with chronic sinusitis.

Eligibility criteria: Inclusion Criteria:

* patients suffering from mild to moderate symptoms.

Exclusion Criteria:

* Pregnant or breastfeeding women
* Patients with a definite deviated nasal septum, sinusitis, or history of operation within the last 6 months.
* Patients with hypertension, diabetes mellitus, malignancy, active pulmonary tuberculosis, infection, active respiratory disease like asthma, or other systemic diseases; • patients with long-term use of corticosteroids or immunosuppressive agents.
* Patients with hypersensitivity to the laser.
* Patients who were involved in another clinical study within 30 days.
* Patients who were unable to comply with the follow-up schedules.
* patients who had used antihistamines within 1 week, topical corticosteroids within2 weeks, systemic corticosteroids within 4 weeks, anti-cholinergic drugs within 3 days, antileukotriene drugs within 1 week, decongestants within 3 days, tricyclic antidepressants or phenothiazines within 2 weeks, non-steroidal analgesics within 2 weeks, and other drugs whi

Primary outcomes:
measure: Headache
timeFrame: Baseline
measure: Headache
timeFrame: One month
Secondary outcomes:
measure: Fatigue
timeFrame: Baseline
measure: Fatigue
timeFrame: One month
measure: Ct finding
timeFrame: Baseline
measure: Ct finding
timeFrame: One month
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of physical therapy, Cairo university
state: Dokki
city: Giza
country: Egypt
facility: Olfat Ibrahim Ali
state: Dokki
Study officials:
affiliation: Cairo University
name: Olfat I Ali, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03861117: Pressure Support and Positive End Expiratory Pressure During Spontaneous Breathing Trial
Official title: Impact of the Combination of Pressure Support and Positive End Expiratory Pressure During Spontaneous Breathing Trial Versus T-piece on the Time to Successful Extubation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critically Ill Adult Patients With Difficult Weaning
Keywords: Critical care
spontaneous breathing trial
T-piece
positive end-expiratory pressure
difficult weaning
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-03-04
Enrollment: 98
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 aim of this study is to assess if a bundle associating pressure support and positive end-expiratory pressure during spontaneous breathing trial and detection by T-piece of patients with high-risk of extubation failure can reduce the time to successful extubation in critically ill patients.


Eligibility criteria: Inclusion Criteria:

* Patient 18 years old or more
* Intubated and ventilated in intensive care unit for more than 24 hours
* Patient ready for weaning evaluation
* Failure of a first T-piece SBT

Exclusion Criteria:

* Chronic neuromuscular disease
* Guillain-Barré Syndrome
* Central nervous system disease with consciousness disorder
* Tracheostomy
* Chronic disease with life expectancy less than 1 year
* Pregnancy, breast feeding
* Withholding life support regarding a reintubation
* Prisoner or patient interned in psychiatric hospital
* Guardianship
* Language barrier
* Lack of medical insurance
* Lack of the patient's consent (or of the next of kin where appropriate)
* Patient under an exclusion period after enrollment in another research study

Primary outcomes:
measure: Time (hours) to successful extubation
timeFrame: 90 days
Secondary outcomes:
measure: Rate of first extubation
timeFrame: 90 days
measure: Invasive mechanical ventilation duration
timeFrame: 90 days
measure: duration of non-invasive and invasive mechanical ventilation
timeFrame: 90 days
measure: ventilator-free days at Day 90
timeFrame: 90 days
measure: Intensive care unit length of stay
timeFrame: 90 days
measure: hospital length of stay
timeFrame: 90 days
measure: Day 90 mortality
timeFrame: 90 days
measure: reintubation rate
timeFrame: 90 days
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital de la Croix-Rousse
Study officials:
References:
Clinical trial NCT03629717: RANKL Inhibition and Breast Tissue Biomarkers
Official title: RANKL Inhibition and Breast Tissue Biomarkers in Premenopausal Women With Dense Breasts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Breast Cancer Prevention
Mammographic Density
Keywords: Mammographic density
Premenopausal
Breast cancer
Chemoprevention
Denosumab
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 10
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: A robust knowledge of how to reduce breast density could play a key role in breast cancer prevention in premenopausal women, but viable preventative targets to reduce breast density-associated breast cancer risk are yet to be developed. The investigators propose to investigate the effect of RANKL inhibition with denosumab on breast tissue markers in high-risk premenopausal women with dense breasts. Study findings could provide robust evidence to move forward with a clinical trial targeting RANKL inhibition in premenopausal breast cancer prevention.


Eligibility criteria: Inclusion Criteria:

* Female.
* Premenopausal.
* At least 35 years of age.
* Dense breasts on routine mammogram.
* Willing to take calcium (1,200mg) and vitamin D (800 IU) daily.
* At increased risk for breast cancer using any of the following:

  * Positive family history of breast cancer
  * Breast cancer risk prediction models
* Able and willing to return for repeat biopsy.
* Able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion Criteria:

* Current use of tamoxifen, aromatase inhibitors, or bisphosphonates.
* Concurrently participating in another cancer chemoprevention trial (unless no longer receiving the intervention).
* Pregnant or lactating.
* Recent tooth extraction or dental procedure.
* Unhealed and/or planned dental/oral surgery.
* History of osteonecrosis/osteomyelitis of the jaw.
* History of osteoporosis or severe osteopenia.
* Unable/unwilling to return for repeat biopsy.

Primary outcomes:
measure: Effect of denosumab on breast tissue gene pathway gene expression
timeFrame: Between baseline and day 60
measure: Effect of denosumab on pathways that may influence breast cancer development as measured by spatial transcriptomic analysis
timeFrame: Between baseline and day 60
measure: Effect of denosumab on pathways that may influence breast cancer development as measured by metabolomic analysis
timeFrame: Between baseline and day 60
Secondary outcomes:
measure: Correlation of breast tissue gene expression with circulating biomarker levels
timeFrame: 60 days
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Adetunji T Toriola, M.D., Ph.D., MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00175617: Efficacy of Therapy With the Spironolactone Pills Compared to Minoxidil Lotion in Female Pattern Hair Loss
Official title: Efficacy of Therapy With the Anti-androgen Spironolactone Compared to Topical Minoxidil in Female Pattern Hair Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Female Pattern Hair Loss
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficacy of therapy with the anti-androgen spironolactone compared to topical minoxidil in female pattern hair loss.


Eligibility criteria: Inclusion Criteria:

* Subjects must be premenopausal women older than 18 with female pattern hair loss.

Exclusion Criteria:

* Androgen excess
* Other scalp or hair disorders
* Contraindications to spironolactone treatment, especially pregnancy, electrolyte imbalances, history of breast cancer, or intake of interfering drugs
* Contraindications to minoxidil treatment, especially patients who are allergic to this treatment or have a history of low blood pressure or irregular heart beats

Primary outcomes:
measure: hair density
timeFrame: after 3, 6 and 9 months
Secondary outcomes:
measure: percentage of subjects who experience side effects
measure: subject assessment of treatment effect
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: UBC Division of Dermatology, Hair Research and Treatment Centre
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Jerry Shapiro, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01365117: Pharmacokinetic Study in Healthy Volunteers
Official title: Phase 1, Single-center, Open-label, Randomized, Crossover Design Clinical Trial in Healthy Normal Volunteers to Evaluate Insulin Exposure and Dose-proportionality Following Inhalation of Technosphere® Insulin Inhalation Powder (3 U and 4 U Insulin/mg) Using the Gen2 Inhaler
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Mannkind Corporation
Sponsor class: INDUSTRY
First posted: 2011-06-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Phase 1 clinical trial to evaluate insulin exposure using different formulations of Technosphere Insulin Inhalation Powder using the Gen2 inhaler in healthy normal volunteers.

Detailed description: Phase 1, single-center, open-label, randomized, crossover clinical trial to evaluate insulin exposure using the 3 U/mg and 4 U/mg Technosphere Insulin Inhalation Powder formulations administered using the Gen2 inhaler in 31 healthy volunteers. Drop outs will be replaced. Each subject will undergo a screening visit and either 4 or 5 days of in clinic stay and dosing, depending on randomization schedule.

Eligibility criteria: Inclusion Criteria:

* Non-smoking (within the last 6 months) men and women aged 18 to 45 years who are considered healthy
* Body mass index (BMI) \< 32 kg/m2
* FEV1 ≥ 80% of the Third National Health and Nutrition Examination Survey (NHANES III) predicted

Exclusion Criteria:

* Pre-existing asthma or chronic obstructive pulmonary disease (COPD)
* History of coronary artery disease, peripheral vascular disease, or congestive heart failure
* Blood donation within the previous 3 months

Primary outcomes:
measure: The relative exposure (Cmax and AUC0-120) of insulin from TI Inhalation Powder as delivered
timeFrame: 0-120 minutes
Secondary outcomes:
measure: Safety will be assessed by adverse events
timeFrame: 32 days
measure: Safety will be assessed by Spirometry (FEV1)
timeFrame: 32 Days
measure: Safety will be assessed by vital sign measurements
timeFrame: 32 Days
measure: Safety will be assessed by physical examination findings.
timeFrame: 32 Days
measure: Safety will be assessed by clinical laboratory test results.
timeFrame: 32 Days
Other outcomes:
Locations:
city: Neptune
country: United States
facility: Celerion
state: New Jersey
Study officials:
affiliation: Celerion
name: Sandra Connolly, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00321217: Pharmacogenomics of Anti-TNF (Anti-tumor Necrosis Factor) Treatment in Patients With Rheumatoid Arthritis
Official title: Pharmacogenomics of Anti-TNF Treatment in Patients With Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Keywords: rheumatoid arthritis
pharmacogenetics
anti-TNF
high throughput genotyping
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2006-05-03
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with RA according to the ACR criteria who are treated with monoclonal anti-TNF antibodies.

Brief summary: The main aim of this study is to identify genetic markers (at DNA and RNA level) which are involved in the response to treatment with monoclonal antibodies against TNF in patients with rheumatoid arthritis.

Detailed description: Rheumatoid Arthritis (RA) is a severe inflammatory disease and genetic factors are known to play an important role in its pathogenesis. Genetic factors are also involved in determining the prognosis of RA. Identifying the genetic factors that predispose to mild or aggressive RA is not easy and up to now only a few of these factors -like certain HLA-DR species- are known.

The Rheumatology department of the Radboud University Nijmegen Medical Centre (RUNMC) has collected a unique inception cohort of over 500 patients with RA, that have been followed from an early stage of disease for up to 10 years with detailed measurements of disease activity, joint damage and other characteristics of disease progression.

In this project we use this patient group to study polymorphisms in a large battery of genes for their effect on RA disease activity/progression.

Eligibility criteria: Inclusion Criteria:

* Patients with RA according to the ACR criteria who are treated with monoclonal anti-TNF antibodies.

Exclusion Criteria:

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
city: Nijmegen
country: Netherlands
facility: St Maartenskliniek
Study officials:
affiliation: Radboud University Medical Center
name: M. J. Coenen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03482817: Drug Cocktail Interaction Study of St. John's Wort Dry Extract Ze 117
Official title: Drug Cocktail Interaction Study to Investigate the Effect of St. John's Wort Dry Extract Ze 117 on Several Cytochrome P450 Enzymes and on Transporter P-Glycoprotein in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Drug Interaction Study
Lead sponsor: Max Zeller Soehne AG
Sponsor class: INDUSTRY
First posted: 2018-03-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: open-label, non-randomized, single-sequence study
Primary purpose: TREATMENT

Brief summary: This Study evaluates the Effect of St. John's Wort dry Extract Ze 117 on Several Cytochrome P450 Enzymes and on Transporter P-Glycoprotein in Healthy Volunteers.

Detailed description: Current data indicate that St. John's wort preparations may induce hepatic cytochrome P450 enzymes and transport proteins. This can result in drug interactions.

The study design is standard for DDI studies and is based on the regulatory guidance of the Food and Drug Administration (FDA) and of the European Medicines Agency (EMA).

A cocktail approach involving the administration of multiple cytochrome P450 (CYP)- or P-glycoprotein (P-gp)-specific probe drugs is used to simultaneously assess the activities of these enzymes and the transporter P-gp.

Eligibility criteria: Inclusion Criteria:

* written informed consent
* Caucasian male or female subjects aged between ≥18 and ≤55years
* Physically and mentally healthy
* BMI between ≥19 and ≤29 kg/m2, and body weight ≤90 kg
* Non-smoker
* If female, the pregnancy test at screening and at admission must be negative

Exclusion Criteria:

* Known or suspected hypersensitivity to study drugs
* history of, any clinically significant diseases
* Positive test of hepatitis B, hepatitis C or HIV Screening
* Known photohypersensitivity

Primary outcomes:
measure: Area under the Plasma concentration versus time curve (AUC0-t)
timeFrame: 72 hours
Secondary outcomes:
measure: Area under the Plasma concentration versus time curve (AUC0-inf)
timeFrame: 72 hours
measure: Peak Plasma Concentration (Cmax)
timeFrame: 72 hours
measure: Elimination rate constant (Ke)
timeFrame: 72 hours
measure: Elimination half life (t1/2)
timeFrame: 72 hours
Other outcomes:
Locations:
city: Neu-Ulm
country: Germany
facility: Nuvisan GmbH
Study officials:
affiliation: Neu-Ulm
name: Michael Lissy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00676117: Drug-Drug Interaction Study of Esomeprazole (D961H) Capsule and Loxoprofen Tablet After Repeated Oral Administration in Japanese Males
Official title: A Single-Centre, Open, Randomised, Three-Way Cross-Over Drug-Drug Interaction Study of Esomeprazole (D961H) Capsule and Loxoprofen Tablet After Repeated Oral Administration in Japanese Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: male
Japan
Japanese
Healthy volunteers
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-05-12
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the pharmacokinetic profile of Esomeprazole (D961H) during repeated oral administration with and without co-administration of loxoprofen and the pharmacokinetic profile of loxoprofen during repeated oral administration with and without co-administration of Esomeprazole (D961H).


Eligibility criteria: Inclusion Criteria:

* Healthy Japanese male
* Body Mass Index (BMI=weight/height2) 19-27 (kg/m2)
* Body weight 50-80 kg

Exclusion Criteria:

* Past or present NSAIDs induced asthma, hepatic dysfunction, peptic ulcer or blood disorders
* Significant clinical illness from the 2 weeks preceding the pre-entry visit to the randomisation, as judged by the investigator(s) , eg, acute inflammatory disease which requires medical intervention
* Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease, as judged by the investigator(s), eg, sequelae of myocardial infarction, nephritis, hepatitis and cerebral infarction

Primary outcomes:
measure: pharmacokinetic profile of D961H during repeated administration with and without co-administration of loxoprofen and pharmacokinetic profile of loxoprofen during repeated administration with and without co-administration of D961H, assessing plasma conc.
timeFrame: 5-7 days after the last dose of study medication is given
Secondary outcomes:
measure: The safety of D961H with and without coadministration of loxoprofen by assessment of adverse events, clinical laboratory tests (clinical chemistry, haematology, urinalysis and haemoccult test), ECG, blood pressure, pulse rate and body temperature
timeFrame: 5-7 days after the last dose of study medication is given
Other outcomes:
Locations:
city: Osaka-city
country: Japan
facility: Research Site
state: Osaka
Study officials:
affiliation: AstraZeneca
name: Naotsugu Oyama, MD, PhD
role: STUDY_DIRECTOR
affiliation: Osaka Pharmacology Clinical Research Hospital
name: Michio Yagi
role: PRINCIPAL_INVESTIGATOR
References: