louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03834545: Improved Motivation for Physical Activity in an Institutionalized Geriatric Population Through a Virtual Environment
Official title: Improvement of Motivation for Physical Activity in an Institutionalized Geriatric Population Thanks to a Virtual Environment: Comparison of Motivation Between Classic Bike and Bike With Virtual Environment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Motivation
Fall
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2019-02-08
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Institutionalized older adults over 65 years

Brief summary: The purpose of this study is to test the interest of a virtual environment with cycling to increase the motivation of physical activity practice in institutionalized older adults.

Detailed description: The World Health Organization (WHO) recommends for people aged 65 years and over a weekly practice of at least 150 minutes of moderate-intensity endurance activities or at least 75 minutes of activity. endurance of sustained intensity, or an equivalent combination of moderate and sustained activity. However, the attractiveness for physical activity fades over the years limiting the practice of physical activity. Several types of unconventional approaches have already shown their effectiveness in the prevention of falls in the elderly but these practices find their limits in the lack of adherence to this type of exercise, especially in nursing homes. New virtual reality and gaming technologies have recently emerged and are being used as tools to prevent the risk of falling. The use of these new tools has advantages over conventional exercises: motivating.

The investigators aimed to test the interest of a virtual environment with cycling to increase the motivation of physical activity practice in institutionalized older adults.

Eligibility criteria: Inclusion Criteria:

* age over 65
* ability to cycle

Exclusion Criteria:

* unstable cardiopathy
* New York Heart Association classification III or IV
* severe cognitive disorders with inability to follow simple orders (follow investigator, ride on the ergometric bicycles, pedal)
* visual disturbance preventing counting fingers at 5m

Primary outcomes:
measure: Cycling distance in meters
timeFrame: 3 months
Secondary outcomes:
measure: Time spent pedaling in seconds per session
timeFrame: 3 months
measure: The average speed in meters per second per session
timeFrame: 3 months
measure: Mean pedaling cadence per session in revolutions per minute
timeFrame: 3 months
measure: Borg rating of perceived exertion scale
timeFrame: 3 months
measure: Mean pedaling power per session in Watts
timeFrame: 3 months
measure: Closed-ended question to know which condition they would prefer for a futur exercise session.
timeFrame: 3 months
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
state: Normandy
Study officials:
References:
Clinical trial NCT03283345: Effect of Menstrual Cycle on Traumatic Systemic Response
Official title: ASSESSMENT OF SYSTEMIC RESPONSES TO TRAUMA IN DIFFERENT PHASES OF THE MENSTRUAL CYCLE: IN PATIENTS UNDERWENT MODIFIED RADICAL MASTECTOMY A Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Systemic Inflammatory Response Syndrome
Keywords: breast cancer
menstrual cycle
breast surgery
systemic responses to trauma
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2017-09-14
Enrollment: 89
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: It is aimed to evaluate pathophysiology of systemic responses to trauma via using interleukin (IL) -1 and IL-6 levels and determining timing of surgery through phases of menstrual cycle.

Detailed description: 89 female breast cancer patient who underwent modified radical mastectomy included into study. Menstrual history and hormone levels were used to determine menstrual phase: luteal, follicular, and other. IL-1β and IL-6 levels, which are related to severeness of inflammation, were measured one day before and one day after surgery. Those are statistically analysed to show effect of timing of breast surgery on responses to trauma in postmenopausal and premenopausal women during different phases of their menstrual cycles

Eligibility criteria: Inclusion Criteria:

* female patients
* who underwent modified radical mastectomy for breast cancer
* who signed informed consent forms

Exclusion Criteria:

* For premenopausal patients taking oral contraceptives
* for postmenopausal patients taking hormone replacement therapy.

Primary outcomes:
measure: IL-1 and IL-6 levels
timeFrame: 5 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Kocaeli University
name: Cantürk
role: STUDY_DIRECTOR
References:
Clinical trial NCT03153345: The Efficacy of Bedside Respiratory Muscle Training in Stroke Patients
Official title: The Efficacy of Bedside Respiratory Muscle Training in Stroke Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Rehabilitation
Breathing Exercise
Pneumonia
Respiration
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
First posted: 2017-05-15
Enrollment: 40
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: Objectives: To investigate the efficacy of bedside respiratory muscle training on pulmonary function and stroke-related disabilities in stroke patients.

Design: Prospective randomized controlled trial

Setting: A single physical medicine and rehabilitation department at a university hospital

Participants: Stroke patients in a rehabilitation unit were recruited and randomly assigned to either the intervention group or the control group.

Intervention: Both groups participated in a conventional stroke rehabilitation program. During the study period, the intervention group received bedside respiratory muscle training twice a day for three weeks. The respiratory muscle training consisted of (1) a breath stacking exercise, (2) inspiratory muscle training and (3) expiratory muscle training. The participants were evaluated at baseline and again at the end of the study (3 weeks later).

Main Outcome Measures: The primary outcomes were measures of pulmonary function: functional vital capacity (FVC), forced expiratory volume in one second (FEV1) and peak flow.

Secondary outcomes were stroke-related disabilities assessed by the following: National Institutes of Health Stroke Scale, Modified Barthel Index, Berg Balance Scale, Fugl-Meyer Assessment, the Korean Mini-Mental State Examination, and the incidence of pneumonia.


Eligibility criteria: Inclusion Criteria:

1. older than 18 years of age,
2. first episode of stroke within three months,
3. moderate to severe stroke impairment, defined as a NIHSS score from 5-36, and
4. the ability to follow instructions and engage in the study program.

Exclusion Criteria:

1. a medical history of persistent cardiopulmonary disease,
2. other coexisting brain disorders, such as brain tumor,
3. poorly controlled hypertension, which was defined as a blood pressure higher than 180/100 mmHg during the preceding 24 hours,
4. severe facial palsy or other oropharyngeal structural abnormality,
5. severe oral apraxia, and (6) having a tracheostomy.

Primary outcomes:
measure: functional vital capacity
timeFrame: 21 days
measure: Forced expiratory volume
timeFrame: 21 days
measure: Peak flow
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Physical Medicine and Rehabilitation, Korea University Anam Hospital, Korea University College of Medicine
name: Sung-Bom Pyun, M.D, Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT02373345: Clinical and Neuromechanical Predictors for the Evolution of Chronic Non-specific Low Back Pain
Official title: Clinical and Neuromechanical Predictors for the Evolution of Chronic Non-specific Low Back Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Keywords: psychological factors
functional disability
pain thresholds
tolerance thresholds
motor adaptations
natural course
Lead sponsor: Université du Québec à Trois-Rivières
Sponsor class: OTHER
Collaborators: name: Institut de Recherche Robert-Sauvé en Santé et en Sécurité du Travail
name: Chaire de recherche en chiropratique FRCQ
First posted: 2015-02-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with a history of nonspecific low back pain

Brief summary: The purpose of the present study is to determine the association between factors known to be associated with the development of chronic low back pain (psychological and biological) and the evolution of functional disability in individuals with a history of low back pain. To do so, 100 individuals with a history of nonspecific low back pain will be followed over a period of 18 months. During this time frame, participants will be evaluated three times in the laboratory (initial, at 6 months and at 18 months) to determine pain and tolerance thresholds, pain inhibition processes as well as neuromuscular activation. Moreover, these participants will be assessed every three months (initial, 3, 6, 9 12, 15 and 18 months) for functional disability and pain intensity levels of their low back pain as well as for psychological symptoms usually associated with the development of chronic low back pain. It is hypothesized that high psychological symptoms measured initially will be associated with high functional disability throughout the study .


Eligibility criteria: Inclusion Criteria:

* To have experienced at least one episode of disabling (resulting in loss of work or modified tasks at work) nonspecific low back pain in the past three years.

Exclusion Criteria:

* Specific causes of low back pain, arthritic conditions, other chronic pain conditions

Primary outcomes:
measure: Change from baseline in disability (Roland-Morris Disability Questionnaire)
timeFrame: baseline, 3 months, 6, months. 9 months, 12 months, 15 months, 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Trois-Rivières
country: Canada
facility: Université du Québec à Trois-Rivières
state: Quebec
Study officials:
affiliation: Université du Québec à Trois-Rivières
name: Martin Descarreaux, DC, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05499845: Effects of Different Anesthesia on Odor Memory
Official title: Comparison of the Effects of TIVA and Inhalation Anesthesia Methods on Olfactory Functions and Olfactory Memory
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smell Functions
Odor Memory
Keywords: General anesthesia management
propofol
sevoflurane
odor memory
smell functions
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2022-08-12
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 97

Brief summary: This study aimed to research the effect of different general anesthesia administration on postoperative smell functions and memory.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) I-II risk groups
* operated under elective conditions with general anesthesia requiring intubation
* operation durations of 40-180 minutes.

Exclusion Criteria:

* intracranial,
* endocrine or nasal surgery,
* pregnant cases,
* those with history of respiratory tract diseases and psychiatric disease, with disorder of odor reception and perception,
* with smoking and chronic alcohol use,
* requiring a nasogastric probe

Primary outcomes:
measure: Butanol Threshold Test
timeFrame: during 24 hour after surgery
measure: Odor Identification Test
timeFrame: during 24 hour after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Gamze Küçükosman
Study officials:
References:
Clinical trial NCT03869047: Dexmedetomidine Added to Bupivacaine Versus Bupivacaine inTransincisionalU/S Guided Quadratus Lumborum Block in Open Renal Surgeries , A New Technique
Official title: Dexmedetomidine Added to Bupivacaine Versus Bupivacaine inTransincisionalU/S Guided Quadratus Lumborum Block in Open Renal Surgeries , A New Technique :Prospective, Randomized Double- Blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-03-11
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the addition of dexmedetomidine to bupivacaine versus bupivacaine only in anterior QLblock(transincisional) , where the local anesthetic will be applied before wound closure at the end of surgery through the wound . in combination with general anesthesia in elective open renal surgery with regard to Postoperative pain control,hemodynamic stability, and adverse effects.


Eligibility criteria: Inclusion Criteria:

* physical status American Society of Anesthesiologist (ASA) I or II

Exclusion Criteria:

* Patients refusal
* A body mass index (BMI) \>30 kg/m2
* ASA physical status \>II
* major illnesses (e.g., cardiac, respiratory, renal, hepatic or neurological)
* Coagulation abnormalities
* Infection at the injection site
* Allergy or contraindications to the drugs used in the study
* History of drug addiction or alcohol abuse
* A psychiatric illness, or mental retardation interfering with the evaluation of pain scores or PCA programs .

Primary outcomes:
measure: First time to analgesic requirement
timeFrame: 1st 24 hour postoperatively
Secondary outcomes:
measure: the secondary outcomes will be the total opioid consumption postoperatively
timeFrame: 1st 24 hour
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University hospitals
Study officials:
References:
Clinical trial NCT02054247: Continuous And Pulsed Ultrasound Treatments On Carpal Tunnel Syndrome
Official title: The Placebo-Controlled Continuous And Pulsed Ultrasound Treatments on Carpal Tunnel Syndrome : A Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: Carpal tunnel syndrome,ultrasound,pulsed ultrasound
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2014-02-04
Enrollment: 46
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The aim of this placebo-controlled study was to evaluate the effects of pulsed and continuous ultrasound treatments combined with splint therapy on patients with mild and moderate idiopathic carpal tunnel syndrome

Detailed description: The study included 36 carpal tunnel syndrome patients who were randomly divided into 3 groups.The first group received 0 W/cm2 placebo ultrasound treatment. second group received 1.0 W/cm2 continuous ultrasound treatment and the third group received 1.0 W/cm2 1:4 pulsed ultrasound treatment 5 days a week for a total of 15 sessions. All patients were also treated with night splints during the treatment. Pretreatment and posttreatment Visual Analogue Scale scores, Symptom Severity Scale scores, Functional Status Scale scores, median nerve motor conduction velocity. and distal latency and sensory conduction velocity of median nerve in the 2nd finger and palm were compared.

Eligibility criteria: Inclusion Criteria:

* Mild or moderate idiopathic carpal tunnel syndrome (without thenar atrophy or spontaneous activity on electrophysiological examination of the abductor pollicis brevis (APB) muscle)

Exclusion Criteria:

* Secondary entrapment neuropathies
* Cervical radiculopathy
* Systemic diseases with increased risk of the carpal tunnel syndrome
* Gained surgical relief of the syndrome
* Treated with ultrasound for the syndrome
* A history of steroid injections into the carpal tunnel and of physical therapy within the last 3 months
* Patients with either thenar atrophy or spontaneous activity (fibrillation potentials and positive sharp waves) on electrophysiological examination

Primary outcomes:
measure: Change From Baseline in Symptom Severity With Symptom Severity Scale
timeFrame: three weeks
Secondary outcomes:
measure: Change From Baseline in Pain With Visual Analogue Scale
timeFrame: Three weeks
measure: Change From Baseline in Functional Status With Functional Status Scale
timeFrame: Three weeks
measure: Changes From Baseline Nervus Medianus Motor Conduction Velocity
timeFrame: Three weeks
Other outcomes:
Locations:
Study officials:
affiliation: Eskisehir Osmangazi University
name: Onur ARMAGAN, ass. prof.
role: STUDY_DIRECTOR
References:
citation: Armagan O, Bakilan F, Ozgen M, Mehmetoglu O, Oner S. Effects of placebo-controlled continuous and pulsed ultrasound treatments on carpal tunnel syndrome: a randomized trial. Clinics (Sao Paulo). 2014 Aug;69(8):524-8. doi: 10.6061/clinics/2014(08)04.
Clinical trial NCT03161847: Natural History Study of Oculopharyngeal Muscular Dystrophy
Official title: Natural History Study of Oculopharyngeal Muscular Dystrophy
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Oculopharyngeal Muscular Dystrophy
Keywords: OPMD
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: University of Florida
First posted: 2017-05-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Genetically Confirmed Oculopharyngeal Muscular Dystrophy

Brief summary: The objective of this study is to test a set of clinical outcome measures longitudinally in a cohort of OPMD patients to identify ones that show quantifiable change over time as the disease progresses. The investigators' goal is to delineate the natural history of OPMD.

Detailed description: OPMD patients will undergo a screening evaluation and testing to confirm the participants carry the OPMD mutation. Subjects fulfilling the inclusion/exclusion criteria will be enrolled and followed prospectively at regular intervals to determine the natural history of this disease. Measures of muscle function and swallowing will be made at baseline and at follow-up visits to measure natural clinical progression.

Eligibility criteria: Inclusion Criteria:

* OPMD by genetic criteria
* ≥ 18 years old
* English-speaking

Exclusion Criteria:

* Another medical condition that precludes safe completion of study tasks (such as severe cardiac or respiratory disease)
* Another medical condition that causes symptoms similar to OPMD (i.e., ptosis, dysphagia \[trouble swallowing\] or limb weakness).
* History of head or neck cancer, or history of radiation to the head or neck
* A videofluoroscopic swallow study within the 12 months prior to study enrollment

Primary outcomes:
measure: Muscle Strength over time
timeFrame: Baseline and every 9 months for 3 years
Secondary outcomes:
measure: Dysphagia severity over time
timeFrame: Baseline and every 9 months for 3 years
Other outcomes:
Locations:
Study officials:
affiliation: New Mexico Neuromuscular Center
name: Sarah Youssof, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06723847: Navigating the Learning Curve of Robotic Pancreatoduodenectomy: Feasibility, Proficiency, and Mastery in a First-generation Surgeon
Official title: Navigating the Learning Curve of Robotic Pancreatoduodenectomy: Feasibility, Proficiency, and Mastery in a First-generation Surgeon
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Robotic Pancreaticoduodenectomy
Keywords: learning curve
robotic pancreaticoduodenectomy
Lead sponsor: University of Pisa
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 313
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patient underwent robotic pancreaticoduodenectomy at our institution regardless for the pathology

Brief summary: This study delineates the learning curve of robotic pancreatoduodenectomy (RPD) for first-generation surgeons, using the Comprehensive Complication Index (CCI) to assess patient outcomes and the PD-ROBOSCORE to stratify patients for their risk to develop post-operative complications.

Detailed description: This study aims to define the learning curve of a first-generation surgeon who implemented robotic pancreatoduodenectomy. When compared to previous studies on the same issue, the current study has several distinctive features. Firstly, the learning curve was defined using the cumulative sum method, with the comprehensive complication index as the main outcome metric. The comprehensive complication index provides a holistic view of the burden of postoperative complications in each individual patient, correlating with key outcome measures such as length of hospital stay, use of hospital resources, and ultimately mortality. Secondly, outcomes were adjusted by procedure complexity based on the newly described PD-ROBOSCORE (Surgery. 2023;173:1438-1446). This is the first study assessing the learning curve of robotic pancreatoduodenectomy while incorporating difficulty levels.

Eligibility criteria: Inclusion Criteria:

All patients underwent robotic pancreaticoduodenectomy.

Exclusion Criteria:

None.

Primary outcomes:
measure: Post-operative complications
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: