louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02635932: Effectiveness of Trapeziometacarpal Splint
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis of Trapeziometacarpal Joint
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2015-12-21
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 trapeziometacarpal osteoarthritis is a degenerative or inflammatory joint that affects the trapeziometacarpal joint (TMC) of the thumb. Its main symptom is pain that leads to difficulty in manual function and decrease the patient's quality of life. Immobilization of TMC thumb joint by bracing has been effective in reducing pain and improving function. Objective: To compare the effectiveness between day and night functional splint for patients with trapeziometacarpal osteoarthritis in improving pain and function

Detailed description: Randomized clinical trial, and blind where selected 60 patients diagnosed with trapeziometacarpal osteoarthritis.Os patients were assessed by a blinded evaluator at the beginning of treatment and after 45, 90 and 180 days in relation to pain, thumb range of motion, strength hold, tweezers, dexterity, function and satisfaction.

Eligibility criteria: Inclusion Criteria:

* Patients with osteoarthritis in accordance with the American College of Rheumatology classification criteria (ACR); of both genders and age above 18 years; Pain in TMC articulation between 3 and 8 cm in numerical pain scale (END) 10cm

Exclusion Criteria:

* Patients with severe deformities in hand with trapeziometacarpal osteoarthritis not possible to achieve pincer movement between the first, second and third fingers
* Deformity of the distal interphalangeal joint (IFD) of the thumb
* Use of splint the thumb in the last six months; Have surgery scheduled on hand for the next six months
* Allergy to the material of the splint
* Inability to respond to the questionnaire and perform the tests
* Geographic inaccessibility
* Infiltration in hand in the previous 3 months
* Changes in the use of anti-inflammatory and analgesic past 3 months
* Physiotherapy in hand over the last 3 months
* Have the following related diseases: carpal tunnel syndrome, carpal fractures of DeQuervain syndrome, tendonitis, fibromyalgia and chronic inflammatory arthropathy.

Primary outcomes:
measure: Change in pain scale
timeFrame: baseline, after 45, 90 and 180 days
Secondary outcomes:
measure: Change in Functional capacity using the Cochin Hand Functional Scale questionnaire
timeFrame: baseline, after 45, 90 and 180 days
measure: Change in pinch and grip strength
timeFrame: baseline, after 45, 90 and 180 days
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Federal University of Sao Paulo - Rheumatology Division
state: SP
Study officials:
References:
Clinical trial NCT01160432: Naloxone Methadone Combination (NAMEKO)
Official title: The Safety and Tolerability of Methadone/Naloxone Combination in Opioid Substitution Treatment
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Opiate Dependence
Keywords: opiate dependence
methadone
naloxone
withdrawal symptom
substitution treatment
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
First posted: 2010-07-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the study is to examine the tolerability and abuse potential of the diluted methadone solution (5 mg/ml → 2 mg/ml) in combination with naloxone in opioid substitution treatment.

Study hypothesis: Treatment with this diluted combination product is safer than with methadone alone (5 mg/ml) and combination product does not precipitate withdrawal symptoms in opioid dependent patients.


Eligibility criteria: Inclusion Criteria:

* opioid dependence
* methadone treatment
* no changes in methadone dose during the last 10 days
* good treatment compliance according to doctor
* normal ALAT and AFOS values (increased if double the normal level)

Exclusion Criteria:

* severe renal or hepatic failure
* acute psychosis
* age under 18
* pregnancy
* legal incompetence
* severe somatic disease
* chaotic situation in life
* medication or disease which is contraindication to study treatment

Primary outcomes:
measure: Withdrawal symptoms (Clinical Opioid Withdrawal Scale COWS, Subjective Opiate Withdrawal Scale SOWS)
timeFrame: 1/2 hours after the first intake of medicine every week
Secondary outcomes:
measure: The effectiveness of treatment (Treatment Outcomes Profile TOP)
timeFrame: Before study begins, after 4 week study period and 4 weeks after the end of the clinical phase.
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
Study officials:
affiliation: Kuopio University Hospital, University of Eastern Finland
name: Ulrich Tacke, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02892032: Attention Training Trial
Official title: Mobile Based Attention Bias Modification Training for Chronic Pain
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Pain
Lead sponsor: York University
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to examine the effects of smartphone-based Attention-Bias Modification Training (ABMT) in chronic pain participants.


Eligibility criteria: Inclusion Criteria:

* existing chronic pain condition

Exclusion Criteria:

* None

Primary outcomes:
measure: pain intensity
timeFrame: 1 hour
Secondary outcomes:
measure: pain interference
timeFrame: 1 hour
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: York University
state: Ontario
Study officials:
References:
Clinical trial NCT04281732: Visual Performance Measures in a Virtual Reality Environment for Assessing Clinical Trial Outcomes in Those With Severely Reduced Vision
Official title: Visual Performance Measures in a Virtual Reality Environment for Assessing Clinical Trial Outcomes in Those With Severely Reduced Vision
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Low Vision
Retinitis Pigmentosa
Stargardt Disease 1
Stargardt Disease 3
Stargardt Disease 4
Albinism
Keywords: Virtual Reality
Quality of life
Lead sponsor: Queen's University, Belfast
Sponsor class: OTHER
Collaborators: name: University of Sussex
First posted: 2020-02-24
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Stargardt's disease, advanced retinitis pigmentosa and Albinism.

Brief summary: Purpose:

To validate a newly developed battery of performance-based tests of visual function to be presented using virtual reality. The tests are intended as potential outcome measures for clinical trials of treatments of eye disease: they measure visual performance in patients with low vision on visual tasks that a relevant for daily life.

Detailed description: Aims of the Research Project:

1. To validate a new virtual reality (VR)-based battery of performance-based tests of visual function that are relevant for patients' daily lives.
2. To quantify the reproducibility of the performance-based tests.
3. To gather acceptability and ease-of-use data from patients.

Eligibility criteria: Inclusion Criteria:

1. Male and female participants
2. Age 20-50
3. Bilateral sight impairment due to Stargardt's disease, retinitis pigmentosa or albinism.
4. Sight impairment criteria are as follows:

   * Visual acuity of 3 / 60 to 6 / 60 with a full field of vision.
   * Visual acuity of up to 6 / 24 with a moderate reduction of field of vision

Exclusion Criteria:

1. Any physical impairment that would make use of the virtual reality headset difficult or unsafe.
2. A history of vertigo or dizziness.

Primary outcomes:
measure: Test repeatability
timeFrame: All statistical analysis will take place once all data collection has ended, average 1 year.
Secondary outcomes:
measure: Ease of use and acceptability questionnaire
timeFrame: Responses from all participants will be collated and summarised at the end of the study, average 1 year.
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: NI Clinical Research Facility
state: Northern Ireland
Study officials:
affiliation: Queen's University, Belfast
name: Ruth E Hogg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01127932: Developing an Intervention to Address Suicide Risk During Substance Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Substance-Related Disorders
Keywords: Cognitive Behavioral Therapy
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2010-05-21
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a 2-year study designed to: (1) adapt and refine an existing cognitive-behavioral treatment (CBT) intervention to decrease suicidal thoughts and behaviors for use in Substance Use Disorder (SUD) treatment settings, and (2) conduct a pilot randomized controlled trial with 50 patients in treatment for SUDs comparing the CBT intervention to an enhanced control condition. Through this pilot randomized controlled trial, the investigators hope to not only obtain information about the feasibility of implementing these procedures in residential SUD treatment, but to also determine whether this intervention decreases the level of suicidal ideation, suicide attempts, hopelessness, and frequency of substance use relative to the control condition.

Detailed description: Existing research indicates that problematic alcohol and drug use are closely linked to both fatal and non-fatal suicide attempts. Given the strong association between substance use and suicide, an episode of substance use disorder (SUD) treatment provides a unique opportunity to decrease the likelihood of suicidal behaviors. However, there are no data on the effectiveness of specific interventions designed to decrease suicidal thoughts and behaviors during an episode of SUD treatment in individuals at high risk for suicide. Patients for this trial will be screened at the SUD treatment site for a combination of a past suicide attempt and current suicidal ideation and will be randomized to CBT or control conditions. All participants in the pilot randomized controlled trial will be assessed at baseline, at the end of treatment, and at a 3-month follow-up. From a public health perspective, SUD treatment programs contain large numbers of patients at high risk for future suicidal behaviors and therefore have the potential to play a central role in our nation's efforts to decrease suicide.

Eligibility criteria: Inclusion Criteria:

* Must be over 18 years of age
* Report a past lifetime suicide attempt
* Report current suicidal ideation
* Resided in treatment for less than 4 weeks
* In treatment for less than 6 months

Exclusion Criteria:

* Mental incompetence (e.g. unable to provide informed consent)
* Diagnosis of schizophrenia or currently psychotic

Primary outcomes:
measure: Level of Suicidal Ideation
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: Waterford
country: United States
facility: Community Programs, INC.
state: Michigan
Study officials:
References:
Clinical trial NCT01150032: Bone Quality Lyon Orleans
Official title: Bone Quality and Improvement of Fracture Risk Prediction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteopenic Women
Keywords: Osteoporosis
Fracture
Bone microarchitecture
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2010-06-24
Enrollment: 1605
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 years old or older women with lowered Bone Mineral Density

Brief summary: QUALYOR is a prospective study on the predictive value for fragility fracture of various new techniques assessing bone quality, among postmenopausal women with low bone mass.


Eligibility criteria: Inclusion Criteria:

* 50 or older women
* post-menopausal since at least one year
* with osteopenia (T-score between -1.0 and -2.5 (with clinical factor risk) or -3.0 (without clinical factor risk)

Exclusion Criteria:

* corticosteroid therapy \> 3 months, at least 7.5mg/day equivalent prednisolon (stopped since at least 1 year)
* osteoporosis treatment antecedent
* fragility fracture antecedent
* on going post-menopausal hormonal treatment
* clinical signs of hepatic, cardiac or respiratory insufficiency, diseases possibly affecting bone metabolism
* life expectancy \< 4 years, mental or serious illness

Primary outcomes:
measure: Fragility fracture
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Orléans
country: France
facility: Centre Hospitalier d'Orléans
Study officials:
affiliation: Hospices Civils de Lyon
name: Roland CHAPURLAT, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chapurlat R, Pialat JB, Merle B, Confavreux E, Duvert F, Fontanges E, Khacef F, Peres SL, Schott AM, Lespessailles E. The QUALYOR (QUalite Osseuse LYon Orleans) study: a new cohort for non invasive evaluation of bone quality in postmenopausal osteoporosis. Rationale and study design. Arch Osteoporos. 2017 Dec 27;13(1):2. doi: 10.1007/s11657-017-0412-6.
Clinical trial NCT01566032: Digital Versus Analog Pleural Drainage in Patients With Pulmonary Air Leak
Official title: Digital Versus Analog Pleural Drainage in Patients With Pulmonary Air Leak
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Air Leak
Keywords: pulmonary air leak
Thopaz
analog
digital
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2012-03-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A target of 30 patients at the Ottawa Hospital who experienced pulmonary air leak following pulmonary resection will be recruited.

Brief summary: The amount of air leaking from a chest tube can be measured in two main ways:

1. electronic monitor connected to the chest tube
2. numerical (non-electronic) monitor connected to the chest tube

For people who have had lung surgery, it is important to understand the impact of measuring air leaks accurately in both the short term and the long term. An electronic medical device called Thopaz measures air leak electronically. Another medical device called Pleur-evac measures air leak numerically. The purpose of this study is to understand the accuracy of the method used by doctors and nurses to determine if a chest tube has an air leak. It is also important to determine the size or severity of an air leak.

Detailed description: Patients with air leaks following lung surgery will be assessed by a target number of 6 observers each (three nurses and three MDs) who will be randomly asked to participate. Patients will first be connected to the numerical air leak detector, followed by the electronic air leak detector. Observers will record their responses for each device. They will be blinded to responses from other observers.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or over
* Male and Female.
* Air leak occuring after any pulmonary resection
* Air leak persisting on or after the first post-op day of pleural drainage
* Air leak not entirely secondary to poor air seal at the pleural drainage incision site
* Pulmonary resection for benign or neoplastic diagnosis

Exclusion Criteria:

* Tension pneumothorax
* Traumatic or iatrogenic pneumothorax
* Primary or recurrent spontaneous pneumothorax awaiting surgery
* Pneumonectomy patient (history of or current)

Primary outcomes:
measure: Inter-rater variability of air leak measurements.
timeFrame: Post-op
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa General Hospital
state: Ontario
Study officials:
affiliation: Ottawa Hospital/Ottawa Hospital Research Institute
name: Sebastien Gilbert, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03934632: The Impact of Leg Immobilization on Postabsorptive and Postprandial Muscle Protein Breakdown in Healthy Young Males
Official title: The Impact of Leg Immobilization on Postabsorptive and Postprandial Muscle Protein Breakdown in Healthy Young Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Exeter
Sponsor class: OTHER
First posted: 2019-05-02
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The present study will seek the quantify the simultaneous muscle protein synthesis and breakdown response with and without amino acid provision in humans following 2 days of immobilisation.


Eligibility criteria: Inclusion Criteria:

* Male
* 18-40 years of age
* Body mass index between 18.5 and 30

Exclusion Criteria:

* Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes)
* Any diagnosed cardiovascular disease (e.g. deep vein thrombosis) or hypertension
* Chronic use of any prescribed or over the counter pharmaceuticals (that may modulate muscle protein metabolism)
* A personal or family history of epilepsy, seizures or schizophrenia
* Any known disorders in muscle metabolism
* Regular use of nutritional supplements
* Allergy to lidocaine
* Allergy to one or multiple amino acids
* Recent (within the last 6 months) or current musculoskeletal injury (e.g. leg fracture) as these could be exacerbated by the intervention e.g. unilateral leg immobilisation, or mean the participant is unable to use crutches.
* Having received or ingested a stable isotope tracer in the past

Primary outcomes:
measure: Muscle protein breakdown rate
timeFrame: 1 hour
Secondary outcomes:
measure: Muscle protein breakdown rate
timeFrame: 3 hours
measure: Muscle protein synthesis rate
timeFrame: 3 hours
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: University of Exeter
state: Devon
Study officials:
affiliation: University of Exeter
name: Marlou Dirks, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03106532: Evaluation of PHP-201 Ophthalmic Solution in Patients With Normal Tension Glaucoma
Official title: A Multicenter, Randomized, Placebo-controlled, Double-blind, Dose-finding Phase 2 Clinical Trial to Evaluate the Efficacy in Reduction of Intraocular Pressure and Safety of PHP-201 in Patients With Normal Tension Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Normal Tension Glaucoma
Lead sponsor: pH Pharma
Sponsor class: INDUSTRY
First posted: 2017-04-10
Enrollment: 119
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of the optimal dose for the efficacy in reduction of intraocular pressure and safety of PHP-201 ophthalmic solution in patients with normal tension glaucoma

Detailed description: Data collection (electronic case report forms), Data dictionary (MedDRA)

Eligibility criteria: Inclusion Criteria:

* 19 years and older, female and male
* IOP ≤21 mmHg
* Subject showing open angle finding, glaucomatous optic nerve damage and visual field defects
* BCVA ≥+0.2

Exclusion Criteria:

* Subject with the disease and surgery history that are not eligible to participate (acute closed angle glaucoma, narrow angle glaucoma, advanced glaucomatous loss, ocular trauma, eye surgery or laser surgery, unstable angina, myocardial infarction, uncontrolled hypertension and diabetes, etc)
* Subject who can't discontinue contact lenses
* Subject who can't discontinue topical/systemic IOP lowering medication

Primary outcomes:
measure: Mean diurnal IOP change
timeFrame: 4 weeks
Secondary outcomes:
measure: The number of patient with adverse events
timeFrame: 28 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT05107232: OSV-IRM - Volunteer MRI Sequence Optimization
Official title: OSV-IRM - Volunteer MRI Sequence Optimization
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: MRI
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2021-11-04
Enrollment: 600
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Optimization of magnetic resonance imaging (MRI) protocols on healthy volunteers and voluntary patients.

In MRI, a large number of technical parameters (sequence, parameters in sequence, antenna, reconstruction method, etc.) can be changed to optimize the diagnostic quality of the exam. Some optimizations can be performed on participants healthy volunteers, others need to be carried out on images pathological and acquired in voluntary patients.

Detailed description: An inclusion visit is planned to verify the criteria for selection, then an imaging visit to perform the MRI examination.

The imaging visit can take place at the end of the inclusion visit and until the following 15 days. For healthy volunteers, the visits are organized according to their availability. For patients, on the other hand, participation in the research will depend on the programming of the MRI within the framework care.

This is a single-center prospective study carried out at two sites in the Rennes University Hospital.

Eligibility criteria: Inclusion Criteria:

* Criteria common to all participants:

  * Minor or major subject
  * Affiliated, himself or through his parents if he is a minor, to a a social security scheme
  * Having given their free, informed and written consent, and/or which the free, informed and written consent of the holder(s) parental authority has been obtained for minors

Specific criteria for healthy volunteers:

o No medical or surgical history related to the anatomical area(s) scanned

Specific criteria for voluntary patients:

o Indication for an MRI exam as part of its management

Exclusion Criteria:

* - Contraindication to an MRI (pacemaker or pacemaker, neurostimulator, intra-orbital metal body, vascular clip ferromagnetic)
* Pregnancy
* Legal protection measure for adults in progress (safeguard of justice, guardianship, curatorship) or subject deprived of liberty

Primary outcomes:
measure: Quality of MRI signal
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU Rennes
Study officials:
affiliation: CHU Rennes
name: Jean-Christophe FERRE, Pr
role: PRINCIPAL_INVESTIGATOR
References: