louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05455970: Effect of Rhythmic Auditory Stimulation on Balance in Children With Cerebral Palsy.
Official title: Effect of Rhythmic Auditory Stimulation on Functional Balance in Children With Cerebral Palsy, A Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Cerebral palsy, Rhythmic Auditory Stimulation, Balance
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 22
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To evaluate the effect of Rhythmic Auditory Stimulation (RAS) on balance in children with cerebral palsy.


Eligibility criteria: Inclusion Criteria:

* Patients with cerebral palsy at 7-15 years old with Gross motor function classification system 1-3.
* Patients can understand and follow to command.

Exclusion Criteria:

* Patients who received surgery/chemo-denervation injection/injury at spine/pelvic/lower extremities in last 6 months.
* Patients with intrathecal baclofen pump implantation.
* Patients with other signs and/or symptoms of neurological deficit that effect ability to ambulation.

Primary outcomes:
measure: Timed up and go - in children
timeFrame: Change from baseline Timed up and go - in children at after intervention 3 weeks
Secondary outcomes:
measure: Pediatric Balance Scale
timeFrame: Change from baseline Pediatric Balance Scale at after intervention 3 weeks
measure: Gross Motor Function Measure
timeFrame: Change from baseline Gross Motor Function Measure at after intervention 3 weeks
measure: Gait Velocity
timeFrame: Change from baseline Gait Velocity at after intervention 3 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Physical medicine and rehabilitation
Study officials:
References:
Clinical trial NCT02228070: Strabismus Measurements Using Automated 3D Video Oculography
Official title: Strabismus Measurements Using Automated 3D Video Oculography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Strabismus
Keywords: strabismus
oculomotor palsy
abducens palsy
trochlear palsy
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Albert Bruppacher-Stiftung
name: Stiftung OPOS zugunsten von Wahrnehmungsbehinderten
First posted: 2014-08-28
Enrollment: 58
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Measuring ocular motility and alignment is important for diagnosing different causes of strabismus, following patients recovering from cranial nerve palsies, preparing patients for strabismus surgery and follow-up post surgery. The current clinical gold standards for measuring ocular alignment are the Hess screen and the Harms tangent screen. These tests are accurate, but require patient cooperation, and are not objective because the patient has to indicate the position of the light he sees on the screen. Our objective is to develop an accurate and easy to use goggles system to measure ocular alignment and motility using 3D video oculography.


Eligibility criteria: Inclusion Criteria:

* Patients 11 years or older
* congenital strabismus
* acquired strabismus
* paretic strabismus (oculomotor, abducens and trochlear nerves)
* before and after strabismus surgery
* normal controls

Exclusion Criteria:

* Patients unable to sign informed consent
* Patients with significantly impaired vision
* Patients unable to cooperate with standard strabismus workup (including Hess and Harms tests)
* For sub-study: intolerance to scleral search coils

Primary outcomes:
measure: Validation of video goggles against Hess/Harms screen
timeFrame: initial visit
Secondary outcomes:
measure: Accuracy of video goggles in comparison to scleral search coils
timeFrame: initial visit
Other outcomes:
measure: Follow-up squint angle measures post-OP and after recovery from cranial nerve palsy with 3D video goggles and Hess/Harms screen
timeFrame: initial visit, 3 months after surgery, recovery from cranial nerve palsy after 3 months
Locations:
city: Zurich
country: Switzerland
facility: Ophthalmology Department, University Hospital Zurich
Study officials:
References:
citation: Weber KP, Rappoport D, Dysli M, Schmuckle Meier T, Marks GB, Bockisch CJ, Landau K, MacDougall HG. Strabismus Measurements with Novel Video Goggles. Ophthalmology. 2017 Dec;124(12):1849-1856. doi: 10.1016/j.ophtha.2017.06.020. Epub 2017 Jul 17.
Clinical trial NCT02393170: Home-based -Virtual Reality Intervention for Stroke Rehabilitation
Official title: Virtual Reality Intervention for Stroke Rehabilitation - Home Based (Stage 2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: European Commission
First posted: 2015-03-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: On-going rehabilitation is needed to maintain and improve the weaker upper extremity following stroke. Community rehabilitation programs for stroke individuals in the chronic stage are often difficult to be implement. Consequently, many individuals remain without structured interventional programs. Self-training programs, where individuals can independently continue to exercise at home, might answer this challenge. However, since exercising alone is boring and not motivating, individuals often stop the prescribed exercises and remain inactive. The use of video-games for self-training might answer this challenge.

Therefore, the investigators aimed to assess the feasibility of using video-games for self-training after stroke. Specifically the investigators aim to compare the (1) training time, (2) satisfaction and (3) effectiveness of a self-training program using video-games compared to a traditional self-training program.

Detailed description: This is a single-blind randomized controlled trial with four assessments; two before and two following the 5-week self training intervention.

Individuals are requested to perform the self training (video-games or traditional exercises) 60 minutes a day for 5 weeks.

Eligibility criteria: Inclusion Criteria:

* 6 to 36 months after stroke onset
* lived in the community with family or a caregiver
* mild to moderate weakness the affected upper extremity
* without significant cognitive deficit
* able to walk at least 10-meters (with or without assistance).

Exclusion Criteria:

* Other neurological conditions
* Epilepsy

Primary outcomes:
measure: self-training time
timeFrame: week 9
measure: Change in Action Research Arm Test
timeFrame: week 0, week 4, week 9, week 13
Secondary outcomes:
measure: Change in Box and Block Test
timeFrame: week 0, week 4, week 9, week 13
measure: Change in The Functional Reach Test
timeFrame: week 4, week 9, week 13
measure: Daily enjoyment from the self-training
timeFrame: week 9
measure: Change in the Motor Activity Log (MAL)
timeFrame: week 0, week 4, week 9, week 13
measure: Daily exertion from the self-training
timeFrame: week 9
measure: Satisfaction from the self-training program
timeFrame: week 9
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Tel Aviv University
name: Debbie Rand, OT, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02810470: Acceptability Study of Nutritional Supplements in Hospitalized Elderly Patients
Official title: Acceptability Study of Nutritional Supplements in Hospitalized Elderly Patients Aged for More Than 65 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-06-23
Enrollment: 107
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Malnutrition is a major health problem with serious consequences for the quality of life of elderly people: it increases the number of hospitalizations and lengths of stay, worsens functional dependency and increases morbidity and mortality rates There are numerous recommendations and tools to detect or to manage malnutrition and the prescription of Oral Nutritional Supplements (ONS) can be a solution. As the elderly suffer from food monotony, as well as age-related changes, which may or may not be associated with the presence of disease, it is necessary to ensure full ingestion of the prescribed supplements to optimize the benefits provided by these products. To achieve this it is necessary to know the chemosensory characteristics of foods enjoyed by hospitalized elderly people who are malnourished or at risk of malnutrition. The investigators make the hypothesis that by further optimizing taste and energy content of foods, consumption by the elderly and the health benefits would be improved.


Eligibility criteria: Inclusion Criteria:

* Person who have given their written informed consent
* Person aged more than 65 years
* Person cognitively able to participate in tests and to answer questionnaires (Mini Mental Statement Estimation score (MMSE) equal to or greater than 21)
* Person with an Mini Nutritional Status score (MNA) lower than 23.5/30 for risk of malnutrition or malnourished
* Person without known unstable cardiac disease
* Person without high blood pressure

Exclusion Criteria:

* Person who are not covered by national health insurance
* Person suffering from severe illness during the test
* Person with a life expectancy lower than 6 months or with a cancer
* Every person with proven anosmia (total loss of olfaction) from birth or due to physical trauma (head trauma) or disease (acute rhinitis)
* Person with allergy (soya milk) or severe aversion to one of the foods that will be used during the study
* Person with swallowing disorders
* Person with a prescribed strict food diet
* Person with an instable diabetes

Primary outcomes:
measure: Acceptability of the different tested Oral Nutrition Supplement with different flavors
timeFrame: Hedonic scale after testing at day 2
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00766870: Efficacy and Safety of Lu AA34893 in Patients With Major Depressive Disorder
Official title: A Randomised, Double-blind, Parallel-group, Placebo-controlled, and Active-referenced Study Evaluating the Efficacy and Safety of Three Fixed Dose Regimens of Lu AA34893 in the Treatment of Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Major Depressive Disorder
Keywords: Efficacy
Safety
Depression
Interventional
Placebo
Short-term
Major Depressive Disorder
Major Depressive Episode
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2008-10-06
Enrollment: 35
Sex: ALL
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: The purpose of the study is to evaluate the efficacy, safety and tolerability of three fixed dosages of Lu AA34893 compared to placebo in the treatment of patients with Major Depressive Disorder.

Detailed description: Major Depressive Disorder (MDD) is reported to be the most common mood disorder, with a lifetime prevalence of about 15% and as high as 25% in women. MDD is characterised by the presence of one or more Major Depressive Episodes (MDEs) that presents with depressed mood, loss of interest or pleasure, disturbed sleep or appetite, low energy, feelings of guilt or low self-worth, and poor concentration. MDD is a disabling, severe illness that tends to be chronic, and repeated episodes are common. Despite the availability of a range of effective treatments in MDD, a significant proportion of patients do not respond or achieve remission and many relapse despite continued treatment. Lu AA34893 has a novel mechanism of action and this could be of clinical relevance in addressing currently unmet needs in MDD.

Eligibility criteria: In- and out-patients with moderate to severe Major Depressive Disorder

Inclusion Criteria:

* Major Depressive Episode (MDE) as primary diagnosis according to DSM-IV (classification code 296.xx)
* Moderate to severe depression
* Current MDE duration of at least 3 months

Exclusion Criteria:

* Any current psychiatric disorder other than MDD as defined in the DSM-IV TR
* Any substance disorder within the previous 6 months
* Females of childbearing potential and not using adequate contraception
* Use of any psychoactive medication within 2 weeks before randomisation and during the study

Primary outcomes:
measure: Depressive symptoms as measured by the change from baseline in MADRS total score
timeFrame: 8 weeks
Secondary outcomes:
measure: HAM-D, CGI, responders and remitters, HAM-A, adverse events, clinical safety laboratory tests, vital signs, weight, ECG, physical examination
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: CA009
state: Ontario
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
Clinical trial NCT01565070: Osteoarthritis in Older Adults: Recovery of Mobility and Pain With a Topical Analgesic
Official title: Osteoarthritis in Older Adults: Recovery of Mobility and Pain With a Topical Analgesic
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Knee Osteoarthritis
Keywords: Osteoarthritis
Pain
Quality of life
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2012-03-28
Enrollment: 0
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Biofreeze® is a topical ointment that has menthol and alcamphor. Its analgesic effect lies in the stimulation of A and C fibers by cold and nociceptive stimulation, respectively, which is produced by menthol, apparently through the newly discovered receptor TRPM8 (Transient Receptor Potential melastatin-8) The aim of this study is to investigate if BIOFREEZE ® treatment (Performance Health Inc., Export, PA) improves symptoms associated with moderate knee osteoarthritis, which would decrease the immobility and isolation in older adults.


Eligibility criteria: Inclusion Criteria:

* Moderate osteoarthritis of the knee
* Age 60 to 80 years
* Ambulatory

Exclusion Criteria:

* Other conditions that affect mobility
* Severe chronic diseases such as cardiac or renal failure
* Cancer
* Presence of gout
* Cognitive impairment

Primary outcomes:
measure: WOMAC score
timeFrame: 60 days
Secondary outcomes:
measure: Quality of life measured using SF 36
timeFrame: 60 days
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Institute of Nutrition and Food Technology
state: Met
Study officials:
affiliation: INTA University of Chile
name: Daniel Bunout, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang J, Enix D, Snyder B, Giggey K, Tepe R. Effects of Biofreeze and chiropractic adjustments on acute low back pain: a pilot study. J Chiropr Med. 2008 Jun;7(2):59-65. doi: 10.1016/j.jcme.2008.02.004.
Clinical trial NCT03820570: Comparison Open Lichtenstein Repair and Totally Extraperitoneal Herniorrhaphy
Official title: Comparison of Early and Long Term Outcomes of Open Lichtenstein Repair and Totally Extraperitoneal Herniorrhaphy for Primary Inguinal Hernias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Lead sponsor: Uşak University
Sponsor class: OTHER
First posted: 2019-01-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: comparison of early and long term results of open lichtenstein repair and totally extraperitoneal herniorrhaphy for primary inguinal hernias.

Detailed description: Early results such as postoperative pain, operation time and long term results such as chronic pain and recurrence will be compared.

Eligibility criteria: Inclusion Criteria:

* inguinal hernia

Exclusion Criteria:

* recurrent hernia

Primary outcomes:
measure: recurrence
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05953870: This is a Study to Evaluate if Music Therapy Can Reduce Stress and Increase Satisfaction of Patients Undergoing Ambulatory Surgery
Official title: Music Therapy to Reduce Perioperative Stress and Increase Satisfaction in Patients Undergoing Ambulatory Surgery: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Personal Satisfaction
Lead sponsor: Ente Ospedaliero Cantonale, Bellinzona
Sponsor class: OTHER
First posted: 2023-07-20
Enrollment: 34
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: Patients who undergo outpatient surgery according to normal practice will be divided into two groups.

The first group (17 patients), before and after their surgery, will listen to relaxing music, namely a slower tempo music that can quiet mind and make patients feel soothed.

The second group (17 patients) will follow the standard surgical pathways according to normal clinical practice, in particular they will not listen to relaxing music.

A questionnaire to evaluate stress and satisfaction will be administered to all the patients before their discharge


Eligibility criteria: Inclusion Criteria:

* Patients undergoing outpatient surgery
* Age ≥ 18 years
* Signed informed consent

Exclusion Criteria:

* Pregnant or lactating women

Primary outcomes:
measure: Concern
timeFrame: during hospitalization, 1 day
Secondary outcomes:
measure: Personal satisfaction
timeFrame: during hospitalization, 1 day
measure: Length of hospital stay
timeFrame: during hospitalization, 1 day
Other outcomes:
Locations:
city: Bellinzona
country: Switzerland
facility: Ospedale Regionale Bellinzona e Valli, Ente Ospedaliero Cantonale
Study officials:
affiliation: Ente Ospedaliero Cantonale, Bellinzona
name: Davide La Regina, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00794170: Interactive Study to Increase Glaucoma Adherence to Treatment
Official title: I-SIGHT: Interactive Study to Increase Glaucoma adHerence to Treatment Phase 2: Participant Recruitment & Intervention Delivery and Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Keywords: Treatment Compliance
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2008-11-19
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Study participants who receive the I-SIGHT intervention will have higher rates of glaucoma treatment compliance (e.g., medication-taking and refill compliance, return for clinical follow-up) and more positive eye health outcomes at 12-month follow-up than participants who receive the control group intervention.

Detailed description: The intervention is telephone-based and individually-tailored to participants' compliance knowledge, attitudes, and behaviors; psychosocial predictors of compliance; health literacy; race and culture; and prescribed medication regimen. The intervention calls utilize interactive voice recognition technology to facilitate interest, participation, and interaction with call recipients. We evaluated the intervention in a randomized controlled trial with telephone interviews administered to all participants at baseline, 6, 9, and 12-months

Eligibility criteria: Inclusion Criteria:

* Receive treatment at the Atlanta VA Medical Center or Grady Eye clinic for their eye condition
* Be between the ages of 18-80
* Be Caucasian or African American
* Possess a telephone (home telephone or cellular phone)
* Speak and understand English
* Be diagnosed with open angle glaucoma, be glaucoma suspect, or be ocular hypertensive for at least one year
* Be prescribed daily doses of topical treatments for at least one year
* Be able to read or have someone who can help the participant with reading written materials that we give to the participant

Exclusion Criteria:

* Having eye surgery within 3 months of baseline interview and enrollment
* Being legally blind (20/200 or worse)

Primary outcomes:
measure: Data on Prescription Drug Renewals, Appointment Compliance and Medication Taking (e.g. Physician Notes)
timeFrame: Baseline and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Atlanta VA Medical Center
state: Georgia
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
Study officials:
affiliation: Emory University
name: Karen Glanz, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Glanz K, Beck AD, Bundy L, Primo S, Lynn MJ, Cleveland J, Wold JA, Echt KV. Impact of a health communication intervention to improve glaucoma treatment adherence. Results of the interactive study to increase glaucoma adherence to treatment trial. Arch Ophthalmol. 2012 Oct;130(10):1252-8. doi: 10.1001/archophthalmol.2012.1607.