louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02724813: Tele-Rehabilitation Study for People With a History of Stroke
Official title: Tele-rehabilitation for Cognitive Disability Post Stroke: Enhancing Function in the Face of Geographical Disparities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Baycrest
Sponsor class: OTHER
Collaborators: name: Health and Stroke Foundation-Canadian Partnership for Stroke recovery
First posted: 2016-03-31
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stroke results in long-term disability for many people, and particularly for survivors of stroke who have cognitive impairments. However, a decreasing proportion of stroke patients are able to access or receive publicly funded rehabilitation. The investigators have shown in previous studies that in-person delivery of the Cognitive Orientation to daily Occupational Performance (CO-OP) rehabilitation approach to promoting attainment of everyday life goals has resulted in improvements in functional independence and executive function. In a small pilot study of tele-CO-OP with people with chronic traumatic brain injury (TBI) (n=3), the investigators found the delivery method was feasible and that participants were satisfied with the treatment and demonstrated clinically significant improvements on personally meaningful activities. The investigators will investigate the feasibility, preliminary efficacy, and cost-effectiveness of delivering CO-OP in an online format to reduce disability post-stroke. The study design is a single-blind (assessor), randomized wait-list control trial with a one-month retention follow-up. All therapy and testing sessions will be delivered online. We hypothesize that participants will demonstrate improvement in everyday activities and community participation.


Eligibility criteria: Inclusion Criteria:

* Community-dwelling adults at least three months post-stroke
* Fluent in written and spoken English
* Impairment of executive cognitive functions
* Ability to self-identify specific areas of difficulty in their everyday life that they would like to improve
* Access to a computer or tablet with a high-speed internet connection

Exclusion Criteria:

* Presence of dementia
* Severe concurrent depression
* Severe aphasia
* Concurrent substance abuse

Primary outcomes:
measure: Changes in Canadian Occupational Performance Measure (COPM)
timeFrame: 10 weeks and 14 weeks
measure: Changes in Reintegration to Normal Living Index (RNL)
timeFrame: 10 weeks and 14 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Baycrest Health Sciences
state: Ontario
Study officials:
affiliation: Baycrest Health Sciences
name: Deirdre Dawson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04999319: Morphine Consumption in Thoracotomy
Official title: Comparison of Morphine Consumption at Postoperative 24th Hour in Thoracotomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: Postoperative pain
Thoracotomy
Paravertebral block
Erector spina plane block
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2021-08-10
Enrollment: 44
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: PREVENTION

Brief summary: Importance of effective postoperative pain management is well known. The undesired effects of pain can be prevented with multimodal analgesia for the patient. Thoracotomy operations are associated with high levels of pain. With the use of ultrasound, many regional anesthesia techniques were described to provide effective postoperative analgesia. The aim of this study was to compare the postoperative effect of paravertebral block (PVB) and erector spinal plane block (ESPB) in thoracotomies.


Eligibility criteria: Inclusion Criteria:

* ASA I-III patients undergo elective thoracotomy surgeries.

Exclusion Criteria:

* Obesity (BMI \> 35 kg/m2)
* Infection of the skin at the site of the needle puncture area
* Patients with known allergies to any of the study drugs
* Coagulopathy

Primary outcomes:
measure: Morphine consumption
timeFrame: Postoperative 24th hour
measure: NRS score
timeFrame: Postoperative 24th hour
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli Unversity
Study officials:
References:
Clinical trial NCT01077219: Study on Energy Cost Prediction of Cycle Ergometer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Obesity
Keywords: healthy female
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2010-03-01
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy female

Brief summary: This study purpose is (1) to develop the new energy expenditure equation; (2) to increase accuracy of energy cost prediction of cycle ergometer; (3) to find out some dependent factors.

Detailed description: Oxygen consumption (ml/min) was measured while subjects were at rest and exercised at four submaximal workloads in steady state on cycle ergometer. Bioelectrical impedance analysis was used to estimate the body fats and skeletal muscle mass.

Eligibility criteria: Inclusion Criteria:

* Healthy female
* Never received bicycle training

Exclusion Criteria:

* Exercise testing contraindications

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
name: Ying-Tai Wu, Assoc Prof
role: STUDY_CHAIR
References:
Clinical trial NCT06780319: Digital Rehabilitation After Hip Arthroplasty: a Randomized Controlled Trial
Official title: Digital Rehabilitation After Hip Arthroplasty: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hip Arthroplasty, Total
Lead sponsor: Clinique du Sport, Bordeaux Mérignac
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 60
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: The study aims to compare the effectiveness of tele-rehabilitation versus no physical therapy after total hip arthroplasty (THA) in improving patient-reported outcomes and functional recovery. THR is a common surgical procedure to relieve pain and improve function in patients with a variety of hip conditions. Traditional physical therapy is a standard component of the post-operative care pathway for PTH patients, but can be hampered by logistical obstacles. Tele-rehabilitation is emerging as a promising alternative, offering the potential to overcome these barriers and improve access to care. The study uses a prospective monocentric design with two arms and a follow-up time of 6 months. The primary objective is assessed using the Timed up and go Test (TUG), while secondary objectives include patient-reported outcome measures, patient satisfaction, healthcare utilization, and return to physical activity.


Eligibility criteria: Inclusion Criteria:

* Have an email address and a smartphone
* Patient speaking and writing French
* Patient covered by a social security scheme

Exclusion Criteria:

* Hip revision surgery, significant comorbidities (Parkinson's disease, multiple sclerosis, stroke) or psychiatric disorders (substance use) that could interfere with rehabilitation
* Patients with disorders that make it difficult for them to express their feelings
* Pregnant or breast-feeding patients
* Patient under protective supervision
* Patient not covered by a social security scheme

Primary outcomes:
measure: Time Up and Go test
timeFrame: 6 weeks and 6 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Merignac
country: France
facility: Clinique du Sport
Study officials:
References:
Clinical trial NCT03295019: "Hyaluronan" Formulation for Dry Mouth in Sleep Apnea Patients
Official title: Clinical Evaluation of the Efficacy of "Hyaluronan" Formulation for Dry Mouth in Sleep Apnea Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dry Mouth
Xerostomia
OSA
Sleep Apnea
Lead sponsor: You First Services
Sponsor class: INDUSTRY
First posted: 2017-09-27
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: During routine clinical practice, it is observed that patients with suspected obstructive sleep apnea (OSA) often reported waking up with a dry mouth during the night or in the morning. This 9 week, cross-over group, randomized, single center, study will evaluate the efficacy of a proprietary formulation in comforting dry mouth in Sleep Apnea patients.


Eligibility criteria: Inclusion Criteria:

1. Patient should be above 18 years of age.
2. Patients who have been initiated on CPAP therapy after an initial diagnosis of OSAS and have developed dry mouth or have worsening of pre-existing dry mouth condition, as an effect of CPAP therapy.
3. Ability to attend visits at the research site
4. Patient should be able to read and/or understand and sign the consent form and be willing to participate in the research study
5. Have a negative history of radiation therapy to head and neck
6. Agree to abstain from the use of any products for xerostomia other than those provided in the study.
7. Agree to comply with the conditions and schedule of the study.

Exclusion Criteria:

1. Subjects with open mouth sores at study entry.
2. Any pathology that, based on the judgement of the researcher, could negatively affect the oral mucosa and subsequent treatment for xerostomia (immune disorders, etc.)
3. Subjects who are nursing, becoming pregnant or plan to become pregnant during the study period
4. Subjects currently on medication or treatment for dry mouth/xerostomia
5. Subjects \< 18 years of age
6. Hypersensitivity to any of the following ingredients- HA ,xylitol and Sodium Benzoate.
7. Subjects with soft or hard tissue tumor of the oral cavity.
8. Presence of severe gingivitis
9. Chronic disease with concomitant oral manifestations other than xerostomia
10. Subjects with conditions the investigator may feel will interfere with the condition under study.

Primary outcomes:
measure: Relief from dry mouth survey using questionnaires.
timeFrame: 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: VA WNY Healthcare System
state: New York
Study officials:
References:
Clinical trial NCT06625619: On the BRINK: PhotoBiomodulation (PBM) for Mucositis in Patients Undergoing Allogeneic Hematopoietic Stem Cell TRansplant (HSCT) - Implementing the Evidence & Discovering New Knowledge
Official title: On the BRINK: PhotoBiomodulation (PBM) for Mucositis in Patients Undergoing Allogeneic Hematopoietic Stem Cell TRansplant (HSCT) - Implementing the Evidence &Amp; Discovering New Knowledge
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-10-03
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are undergoing HSCT and nurses who administer PBM

Brief summary: This study evaluates mucositis and other oral symptoms in patients undergoing photobiomodulation in patients undergoing hematopoietic stem cell transplantation.

Detailed description: PRIMARY OBJECTIVE:

I. Examine mucositis severity, oral pain, taste changes, and xerostomia in patients undergoing PBM, a new standard of care for oral mucositis.

OUTLINE: This is an observational study. Participants are assigned to 1 of 2 groups.

GROUP I: Patients have their medical records reviewed on study.

GROUP II: Nurses complete surveys on study.

Eligibility criteria: Inclusion Criteria:

* PATIENTS:

  * Age: ≥ 18 years
  * Undergoing allogeneic HSCT - cases where PBM was used and cases where PBM was not used

NURSES:

* Nurses who administer PBM

Primary outcomes:
measure: Mucositis according to the World Health Organization (WHO) Scale
timeFrame: Up to 22 days or until discharge, whichever came first
measure: Average oral pain
timeFrame: Up to 22 days or until discharge, whichever came first
measure: Taste
timeFrame: Up to 22 days or until discharge, whichever came first
measure: Xerostomia
timeFrame: Up to 22 days or until discharge, whichever came first
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Annette Isozaki, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03776019: Efficacy of Audio-Visual-Perception-Enhancement (AVWF®) Method in Chronic Pain Patients
Official title: Efficacy of Audio-Visual-Perception-Enhancement (AVWF®) Method in Chronic Pain Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Stress
Keywords: Pain
Stress
AVWF
Audio-Visual-Perception-Enhancement
Lead sponsor: Klinikum Klagenfurt am Wörthersee
Sponsor class: OTHER
First posted: 2018-12-14
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is anticipated that Audio-Visual-Perception-Enhancement (AVWF®) method leads to pain reduction and a decrease of inflammatory markers in chronic pain patients. Also an improvement of quality of life, self-perceived disability and depression in chronic pain patients is expected.


Eligibility criteria: Inclusion Criteria:

* chronic low back pain with a numeric rating scale of pain \>= 4 for \> 6 month
* patients \>18 years

Exclusion Criteria:

* psychosis
* drug addiction
* pension process
* pregnant women
* epilepsy

Primary outcomes:
measure: Change in Numeric Rating Scale of Pain Severity
timeFrame: Change from baseline Numeric Rating Scale of Pain Severity after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention
Secondary outcomes:
measure: Health related quality of life
timeFrame: Change from baseline health related quality of life after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention
measure: Hospital Anxiety and Depression Scale
timeFrame: Change from baseline Hospital Anxiety and Depression Scale after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention
measure: Pittsburgh Sleep Quality Index
timeFrame: Change from baseline Pittsburgh Sleep Quality Index after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention
measure: Depression Anxiety Stress Scales
timeFrame: Change from baseline Depression Anxiety Stress Scales after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention
measure: Pain Disability Index
timeFrame: Change from baseline Pain Disability Index after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention
measure: Salival Cortisol level
timeFrame: Change from baseline salival cortisol level after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention
Other outcomes:
Locations:
city: Klagenfurt
country: Austria
facility: Klinikum Klagenfurt am Wörthersee
Study officials:
affiliation: Head of department
name: Rudolf Likar
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01155219: Safety, Efficacy Assessment of Geltim LP® 1 mg/g in Ocular Hypertensive or Glaucomatous Patients.
Official title: Safety and Efficacy Assessment of Geltim LP® 1 mg/g (Unpreserved Timolol Gel - TG1030) in Ocular Hypertensive or Glaucomatous Patients Stabilized by Xalatan® With Ocular Intolerance Signs.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Keywords: Bilateral Glaucoma
Bilateral ocular hypertension
Bilateral primary open angle glaucoma
Bilateral ocular hypertension already treated and controlled by mono-therapy of Xalatan® (1drop per day)
With local intolerance signs in at least one eye
Lead sponsor: Laboratoires Thea
Sponsor class: INDUSTRY
First posted: 2010-07-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This phase IV study aims to assess the safety and the efficacy in intra ocular pressure of Geltim LP® 1 mg/g (0.1% unpreserved timolol maleate gel) in glaucomatous patients initially treated and stabilised by monotherapy of Xalatan® with ocular objective signs of intolerance to prostaglandin eye drops.

Detailed description: The primary objectives are to compare the safety and the efficacy of Geltim LP® 1mg/g eye drops versus Xalatan® eye drops with respect to:

The assessment of the ocular tolerance:

* Ocular symptoms
* Objective ocular signs.

The maintain of the IOP efficient lowering effect. Comparison between the 2 study products of the mean basal IOP after a 12 weeks treatment period (84 days ±7).

Eligibility criteria: Inclusion Criteria:

* Written informed consent.
* Association of the 4 following criteria:

  1. - Bilateral primary open angle glaucoma or bilateral ocular hypertension already treated and controlled by mono-therapy of Xalatan® (1drop per day),
  2. - With local intolerance signs.

Exclusion Criteria:

* Presence of severe objective ocular sign.
* Any ocular hypertension other than primary ocular hypertension or primary chronic open angle glaucoma (such as congenital, angle closure glaucoma, secondary glaucoma).
* Absolute defect in the ten degrees central point of the visual field.
* Best far corrected visual acuity ≤ 1/10.

Primary outcomes:
measure: Ocular Tolerance
timeFrame: Day 84
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
Study officials:
References:
Clinical trial NCT03400319: Obstructive Sleep Apnoea in Adolescents With Thoracic Aortic Aneurysm
Official title: Obstructive Sleep Apnoea in Adolescents With Thoracic Aortic Aneurysm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Aortic Aneurysm Without Rupture
Obstructive Sleep Apnea
Keywords: Thoracic Aortic Aneurysm
Obstructive Sleep Apnea
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with and without Thoracic Aortic Aneurysm

Brief summary: The objective of this prospective cohort study is to determine the prevalence of obstructive sleep apnoea (OSA) in patients with and without thoracic aortic aneurysm.

Detailed description: The objective of this prospective cohort study is to determine the prevalence of obstructive sleep apnoea (OSA) in patients with and without thoracic aortic aneurysm.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years.
* Diagnosis of thoracic aortic aneurysm defined by the following parameters:

Women: at the level of the sinus of valsalva ≥39mm, or ascending aorta ≥42mm. (for controls: \<39mm and \<42mm respectively); Men: at the level of the sinus of valsalva ≥44mm, or ascending aorta ≥46mm. (for controls: \<44mm and \<46mm respectively)

Exclusion Criteria:

* Patients on continuous positive airway pressure (CPAP) therapy for OSA at baseline.
* Patients with known central sleep apnoea.
* Patients on morphine or other opioid medication, heroin addiction, alcohol addiction.
* Patients with moderate or severe aortic regurgitation.
* Patients with moderate or severe aortic stenosis.
* Pregnant patients.

Primary outcomes:
measure: Prevalence of Obstructive Sleep Apnea
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Pulmonary Division
Study officials:
References:
Clinical trial NCT00069719: Phase II Safety and Efficacy Study to Evaluate a Glaucoma Therapy in Open-Angle Glaucoma or Ocular Hypertension Patients
Official title: Phase II Safety and Efficacy Study to Evaluate a Glaucoma Therapy in Open-Angle Glaucoma or Ocular Hypertension Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Open-Angle Glaucoma
Ocular Hypertension
Keywords: open-angle
glaucoma
ocular
hypertension
POAG
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2003-10-06
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: To determine the safety and IOP-lowering ability of a test compound in patients with open-angle glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* Adult subjects of either sex and any race with open-angle glaucoma or ocular hypertension;
* logMAR visual acuity not worse than 0.6.

Exclusion Criteria:

* Clinically relevant ophthalmic or systemic conditions may be excluded.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Multiple Locations Throughout the US Sponsored by Alcon of
country: United States
facility: Alcon Clinical Trial Sites
state: Texas
Study officials:
References:
Clinical trial NCT03734419: The Use of Aging Biomarkers in Saliva, Based on DNA Methylation Status in Elovl2 to Predict Biological Age
Official title: Clinical Trials on Prediction of Biological Age Using Saliva Samples of Healthy Population, Based on DNA Methylation Status in ELOVL2 Gene
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Healthy
Keywords: epiaging
biological age
chronological age
DNA methylation
ELOVL2-AS1
ELOVL2
Lead sponsor: HKGepitherapeutics
Sponsor class: INDUSTRY
First posted: 2018-11-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of men and women aged from 18 to 100 years old of different ethnicities living in Kazakhstan.

Brief summary: There is a big change in our understanding of aging in recent years. Recent researches has revealed clock-like patterns of epigenetic change across in humans. The aging involves a timed epigenetic reprogramming. However, this biological clock which ticks in our DNA is affected by our experience, diet, stress, etc. and it could be changed by experience and life style potentially.

The purpose of this study is to develop and test non-invasive biomarkers based on methylation changes in ELOVL2-AS1 gene in saliva samples using a next generation sequencing.


Eligibility criteria: Inclusion Criteria:

* Healthy population

Exclusion Criteria:

* Chronic diseases

Primary outcomes:
measure: The Use of Aging Biomarkers in Saliva, Based on DNA Methylation Status in Elovl2 to Predict Biological Age.
timeFrame: 6 months to 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: