louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05549375: Neurorehabilitation of the Hand
Official title: Neurorehabilitation of the Hand
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Hand Function
Rehabilitation
Engagement
Motor control
Lead sponsor: IRegained Inc.
Sponsor class: INDUSTRY
Collaborators: name: Laurentian University
name: Health Sciences North
First posted: 2022-09-22
Enrollment: 12
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Stroke is the number one cause of adult disability in the world. Due to the neurological damage from stroke, a vast majority of individuals suffer from hand function disability (\~70%). To improve hand function and overcome challenges from this disability, IRegained has developed the MyHandTM system, a connected mechatronic device with programmed proprietary hand function training protocols developed through deep research in neuroplasticity that provide targeted hand function therapy. When these therapeutic protocols are provided in a gamified format, it enhances the patient engagement and motivation, thereby enabling effective therapy administration with the required intensity and repetition to improve hand function. Participants who have sustained a stroke 6 months or earlier will be eligible to participate in this study, and will undergo hand function therapy for one 1-hour/session, 5 times/week, over a 3-week duration, for a total of 15 sessions. Therapy will be administered through with specific hand functions in a gamified format to enhance greater function in the hand and thereby help patients gain greater independence in performing activities of daily living. This research project will aim to understand the extent to which this approach to therapy impacts patient motivation and engagement in order to develop the most efficient and effective mode of therapy.


Eligibility criteria: Inclusion Criteria:

* sustained a single stroke
* aged between 30-85 years of age.

Exclusion Criteria:

* Participants with severe spasticity or contractures,
* have other musculoskeletal or neuromuscular disorders that compromises sensation or other neuromuscular parameters
* participants who are unable to provide consent to participate

Primary outcomes:
measure: the Nasa-Task Load Index (NASA-TLX)
timeFrame: immediately after each treatment session
measure: ABILHAND- change is being assessed
timeFrame: Baseline- prior to intervention and post- intervention- one day after completing the intervention
measure: Jebson Taylor Hand Function Assessment-change is being assessed
timeFrame: Baseline- prior to intervention and post- intervention- one day after completing the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Sudbury
country: Canada
facility: Norcat
state: Ontario
Study officials:
affiliation: Laurentian University
name: Ratvinder Grewal
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06992375: Shoulder Manipulation in Volleyball Players
Official title: Assessment of the Impact of Shoulder Manipulation on Muscle Strength and Stiffness and Motor Functionality of Volleyball Players During Training
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Manual Therapy
Manipulation
Muscle Strength
Muscles
Musculoskeletal System
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
First posted: 2025-05-28
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Currently, it is difficult to find studies in the literature assessing the influence of manual therapy on kinetic and kinematic factors for the upper limbs of volleyball players, which in the long run may translate into a reduction in injuries by improving strength and balance in athletes, when planning training or therapy.


Eligibility criteria: Inclusion Criteria:

* healthy individuals who are over 18 years old,
* a player from the AZS volleyball league,
* a player who regularly competes in the league,
* expressing informed consent to participate in the study and undertaking to comply with the track regulations and wear a helmet.

Exclusion Criteria:

* lack of volunteer consent,
* previous surgeries of the upper, lower limb and spine,
* other upper limb injuries in the last 6 months,
* pain limiting participation in the study,

Primary outcomes:
measure: Assessment of MVC.
timeFrame: The study will be conducted 3 times: pre-intervention, immediately after the intervention and immediately after training session. Each isometric muscle test lasts 3 seconds.
measure: Assessment of MVC.
timeFrame: The study will be conducted 3 times: pre-intervention, immediately after the intervention and immediately after training session.Each isometric muscle test lasts 3 seconds.
measure: Muscle stiffness
timeFrame: The study will be conducted 3 times: pre-intervention, immediately after the intervention and immediately after training session. Each Myoton application lasts 1 sec for one point.
Secondary outcomes:
measure: Assessment of proprioception.
timeFrame: The test will be performed 3 times: pre-intervention, immediately after the intervention and immediately after training session. Each joint measurement will be performed at three settings: 30, 45 and 90 degrees.
measure: Y balance test
timeFrame: The test will be conducted 3 times: pre-intervention, immediately after the intervention and immediately after training session.
measure: Med Ball Throw
timeFrame: The test will be conducted 3 times: pre-intervention, immediately after the intervention and immediately after training session.
measure: Close Kinetic Chain Upper Extremity Stability Test
timeFrame: The test will be administered 3 times: pre-intervention, immediately after the intervention and immediately after training session.
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: AZS Central Academic Sports Center in Gdańsk
Study officials:
References:
Clinical trial NCT06029075: tACS for Neuropathic Pain Management After SCI
Official title: tACS Brain Neuromodulation for Sensory and Motor Recovery After Neurological Impairments
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Neuropathic Pain Management
Keywords: tACS
Neuropathic Pain
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The overall goal is to investigate the effectiveness of a novel intervention - transcranial alternating current stimulation (tACS) for neuropathic pain management in people after spinal cord injury.


Eligibility criteria: Inclusion/exclusion criteria for SCI subjects

Inclusion criteria: A patient who

1. has neuropathic pain after traumatic spinal cord injury or amputation or brain injury;
2. has chronic pain, \>3 months;
3. is between 18 to 75 years of age;
4. is stable on oral pain medications at least two weeks. Patients are allowed to continue their pain medications, i.e., no change in pain medications.

NOTE: we plan to begin the study with the spinal cord injury (SCI) subject population as a cohort first, then expand to other subject populations

Exclusion criteria: Patients will be excluded if they

1. are currently adjusting oral pain medications for their neuropathic pain;
2. have pain, but not neuropathic, e.g., from inflammation at the incision wound of the residual limb or neuroma;
3. have a pacemaker metal implants or supplemental oxygen;
4. have amputation in their arm(s);
5. fail to have a motor contraction in the arm muscles with TMS;
6. are not able to follow commands, or to give consent;
7. have asthma or other pulmonary disease;
8. are not medically stable;
9. have preexisting psychiatric disorders;
10. alcohol or drug abuse.

Primary outcomes:
measure: Pain scale (visual analogue scale, VAS) measurement
timeFrame: Change of VAS 5 minutes before and after the tACS intervention will be measured.
measure: Heart rate variability (HRV) measurement
timeFrame: Change of HRV 10-15 minutes before and after the tACS intervention will be measured.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Sheng Li, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01246375: Prevalence of Osteoporosis in Patients Who Uses Inhaled Steroids
Official title: Prevalence of Osteoporosis in Patients Who Uses Inhaled Steroids
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoporosis
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-11-23
Enrollment: 20
Sex: MALE
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this research is to determine whether the prevalence of osteoporosis is greater in patients who suffer from Chronic obstructive pulmonary disease (COPD) or Asthma disease and uses inhaled steroids.


Eligibility criteria: Inclusion Criteria:

1. Man at the minimum age of 60 years.
2. Diagnosed with Chronic Obstructive Pulmonary disease (COPD) or Asthma disease.
3. Usage of the following corticosteroids at the minimal doses indicated, for at least 3 years:

Seretide 250/50 mcg Symbicort 320/9 mcg 5.No Diagnosis of thyroid irregularity 6.No diagnosis/treatment for Osteoporosis.

Exclusion Criteria:

1. Usage of systemic steroids more than once during the 12 months prior to the study.
2. Usage of systemic steroids during the month prior to the study.
3. Usage of inhaled steroids in order to treat any other disease except Chronic Obstructive Pulmonary Disease (COPD) or Asthma.

Primary outcomes:
measure: Diagnosis of Osteoporosis
timeFrame: 3 month
measure: Diagnosis of Osteoporosis
timeFrame: 3
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv medical center
Study officials:
affiliation: Tel Aviv Medical Center
name: Yehuda Schwartz, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00630175: Evaluation of the Hypnotic Properties of Zolpidem-MR 12.5 mg and Zolpidem 10 mg Marketed Product Compared to Placebo in Patients With Primary Insomnia
Official title: Evaluation of the Hypnotic Properties of Zolpidem-MR 12.5 mg and Zolpidem 10 mg Marketed Product Compared to Placebo in Patients With Primary Insomnia. A Double-Blind, Randomized, Placebo-Controlled,Three Way Cross-Over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sleep Initiation and Maintenance Disorders
Keywords: Insomnia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-03-06
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective is to evaluate the hypnotic efficacy of zolpidem-MR (modified release) 12.5 mg and zolpidem 10 mg marketed product in comparison with placebo in patients with primary insomnia and sleep maintenance difficulties, using polysomnography (PSG) recordings and patient sleep questionnaires.

The secondary objective is to evaluate the clinical safety and tolerability of zolpidem-MR 12.5 mg and zolpidem 10 mg marketed product in comparison with placebo.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of primary insomnia based on Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria

Primary outcomes:
measure: Polysommography (PSG) wake time after sleep onset (WASO)
Secondary outcomes:
measure: PSG parameters, Patient's sleep questionnaire, Patient's global impression, Relative degree of satisfaction with the different study drugs
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis Administrative Office
state: New Jersey
city: Macquarie Park
country: Australia
facility: Sanofi-Aventis Administrative Office
city: Laval
country: Canada
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02854475: Confocal Raman Spectroscopy: in Vivo Measurement of Physiological Skin Parameters
Official title: Confocal Raman Spectroscopy: in Vivo Measurement of Physiological Skin Parameters - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dermatologic Disorders
Disorder of Cholesterol Metabolism
Keywords: skin parameters
cholesterol
Raman spectroscopy
Lead sponsor: University of Vienna
Sponsor class: OTHER
Collaborators: name: Medical University of Vienna
First posted: 2016-08-03
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to

I. determine several skin parameters, for example natural moisturizing factor (NMF) and cholesterol, with Raman spectroscopy in vivo and

II. compare the results with the corresponding cholesterol levels measured in venous blood.

Detailed description: In vivo Raman experiments will be carried out weekly on voluntary participants using a RiverDiagnostics gen2-SCA Skin Composition Analyzer (RiverDiagnostics, Rotterdam, Netherlands). All experiments will be carried out on the volar forearm. Semi-quantitative concentration profiles for several skin parameters will be determined, for example natural moisturizing factor (NMF) and cholesterol.

Additionally the total cholesterol level will be detected by venous blood sample analysis. The blood samples will be taken weekly within two weeks, similar to the Raman measurements.

Eligibility criteria: Inclusion Criteria:

* Provision of subject informed consent
* Female or male aged between 18 and 65 years

Exclusion Criteria:

* Pregnancy
* Chronic skin conditions

Primary outcomes:
measure: Correlation of the fasting total cholesterol levels measured in skin with confocal Raman spectroscopy and in venous blood collected by venipuncture
timeFrame: 2 weeks
Secondary outcomes:
measure: Concentration curves of various skin substances, such as NMF, urea and water as evidence for the eligibility of confocal Raman spectroscopy for the in vivo measurement of skin
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02905175: Rheumatoid Arthritis Patients and Porphyromonas Gingivalis
Official title: Porphyromonas Gingivalis Contribution in Rheumatoid Arthritis (RA).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: rheumatoid arthritis
Porphyromonas gingivalis
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2016-09-19
Enrollment: 11
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: Rheumatoid arthritis and osteoarthritis

Brief summary: Rheumatoid arthritis (RA) is the most frequent joint inflammatory disease inducing joint destruction strongly correlated with anti-citrullinated protein antibodies citrullinated anti-peptide (ACPA). Precise RA etiology remained unclear with a described association between RA and periodontal disease. The missing link could be a gram-negative anaerobic bacterium called Porphyromonas gingivalis (P. gingivalis), which is heavily involved in periodontal disease and able to induce gingival citrullinated protein via an enzyme called peptidyl arginine deiminase (PAD). DNA of P. gingivalis was detected in synovial tissue and in peripheral blood mononuclear cell. To improve knowledge of P. gingivalis involvement in RA, the investigators will compare its effect on various cell type with comparison with another oral bacteria Provatella intermedia.


Eligibility criteria: Inclusion Criteria:

* Age \>18 ans
* RA or osteoarthritis with joint surgery planned
* Informed consent approved and signed

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Comparison of genetic signature after induction by P. gingivalis and P. intermedia on synoviocytes
timeFrame: day 1
Secondary outcomes:
measure: Comparison of specific transcriptome profile induced by P. gingivalis compared to P. intermedia on peripheral blood mononuclear cells (PBMC) and gingival fibroblasts
timeFrame: day 1
measure: Comparison of transcriptome profile between P. gingivalis and P. intermedia on RA synovial cells.
timeFrame: day 1
measure: Comparison of the transcriptomic profile between RA and osteoarthritis synoviocytes
timeFrame: day 1
Other outcomes:
Locations:
city: Saint-Etienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Hubert Marotte, phD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06694675: The Effect of Sevoflurane on Airway Hyperreactivity During the Perioperative Period.
Official title: An Observational Study on the Effect of Sevoflurane on Airway Hyperreactivity in Children with RSV Infection During the Perioperative Period.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: RSV Infection in Children Less Than 5 Years of Age
General Anesthesia
Keywords: Sevoflurane
general anesthesia
RSV infection
pediatric patients
Lead sponsor: First Hospital of China Medical University
Sponsor class: OTHER
First posted: 2024-11-19
Enrollment: 97
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 80

Brief summary: To investigate the effects of sevoflurane on respiratory parameters and respiratory inflammation in healthy and RSV-infected under general anesthesia and to propose suitable perioperative airway protection measures for children with respiratory virus infection undergoing general anesthesia.


Eligibility criteria: Inclusion Criteria:

1. Patients voluntarily joined this study and signed an informed consent form；
2. Age: 2-5 years old；
3. The patient should have a good general condition and no serious internal medicine comorbidities (ASA classification of the American Anesthesiology Association is Grade I); BMI ≤ 20;
4. Plan to undergo elective adenoidectomy or adenotonsillectomy with tracheal intubation.

Exclusion Criteria:

1. Children with a history of allergic asthma;
2. Children with space-occupying lesions of the chest and lungs, or acute bronchiolitis or pneumonia;
3. Children with cardiovascular diseases that may cause cough, wheezing, and other symptoms;
4. Children who used leukotriene modulators, β2 receptor agonists, anticholinergics, theophyllines, or hormonal treatment drugs within two weeks;
5. Children allergic to propofol, sevoflurane, or other anesthetic agents;
6. Children with a family history of malignant hyperthermia;
7. Children with liver and kidney dysfunction;
8. The result of rapid antigen detection and nucleic acid test for RSV was inconsistent, or children combined with pathogen infections other than RSV;
9. Children with fever.

Primary outcomes:
measure: Intraoperative ventilator parameters
timeFrame: After induction of general anesthesia and intubation; at the end of anesthesia
Secondary outcomes:
measure: Inflammation response indications
timeFrame: After induction of general anesthesia and intubation; at the end of anesthesia
Other outcomes:
Locations:
city: Shenyang
country: China
facility: First hospital of China Mdical University
state: Liaoning
city: Shenyang
country: China
facility: First Hospital of China Medical University
state: Liaoning
Study officials:
References:
Clinical trial NCT04890275: Blood Flow Restricted Resistance Training in Peripheral Arterial Disease
Official title: Blood Flow Restricted Resistance Training in Peripheral Arterial Disease: a Randomised Controlled Trial Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Blood flow restricted resistance exercise
Feasability
Lead sponsor: Sheffield Hallam University
Sponsor class: OTHER
Collaborators: name: Sheffield Teaching Hospitals NHS Foundation Trust
First posted: 2021-05-18
Enrollment: 30
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: A randomised controlled trial evaluating the feasibility and acceptability of a 12 week lower body blood flow restricted resistance exercise programme for people with peripheral arterial disease.

Detailed description: The primary aim of this study is to determine the feasibility of 12 weeks of lower body resistance exercise performed with blood flow restriction (BFR) in people with peripheral arterial disease.

Resistance exercise with BFR involves placing inflatable cuffs proximal to the exercise limbs in order to manipulate blood flow and enhance the training response.

Secondary aim of this study is to evaluate changes in ABPI, muscle size, strength and physical function at mid-and post- intervention.

Eligibility criteria: Inclusion Criteria:

* Men and women with PAD 6 months post diagnosis.
* Ankle-brachial pressure index \<0.9.
* People physically able to perform leg press and leg extension resistance exercise.

Exclusion Criteria:

* Ankle-brachial pressure index \>0.89.
* People unable to visit the laboratory twice weekly for exercise sessions.
* People unable to do leg press and leg extension exercise.
* People whose walking is limited by a non-PAD condition.
* People with PAD with critical limb ischemia (including symptoms of pain at rest and skin ulcers).
* People with Dementia.
* People who have had major surgery or myocardial infarction within the past 6 months.
* Previous stroke.
* Previous thrombosis.
* People who have major surgery scheduled during the intervention period.

Primary outcomes:
measure: Recruitment Rates
timeFrame: 3 months
measure: Retention Rates
timeFrame: 3 months
measure: Acceptability of allocation
timeFrame: 3 months
measure: Acceptability of the exercise study
timeFrame: 3 months
measure: Completion Rates
timeFrame: 3 months
Secondary outcomes:
measure: Change in PAD severity
timeFrame: 3 months
measure: Change in muscle size
timeFrame: 3 months
measure: Change in strength
timeFrame: 3 months
measure: Change in walk ability
timeFrame: 3 months
measure: Change in physical function
timeFrame: 3 months
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Hallam University
state: South Yorkshire
Study officials:
References: