louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06340009: MIME THERAPY vs MOTOR IMAGERY TECHNIQUE in Bell's Palsy
Official title: Comparison of Mime Therapy and Motor Imagery Technique on Facial Disability in Bell's Palsy.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bell Palsy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Bell's palsy, characterized by unilateral paralysis/paresis of facial muscles, is a condition with a significant impact on individuals' lives. It was first identified by scientist Sir Charles Bell, and its sudden onset can lead to social, psychological, and emotional distress. Left untreated, Bell's palsy can have long-lasting effects on a patient's quality of life, including loss of facial muscle control, emotional stress, and communication difficulties. Rehabilitation protocols encompass various physical therapy techniques, among which Mime therapy and Motor imagery technique have shown promise.

Detailed description: While rehabilitation protocols have shown promise in enhancing facial muscle control, reducing disability, and preventing long-term complications, there remains a critical gap in the literature regarding the comparative effectiveness of various rehabilitation techniques. Currently, there is limited empirical evidence to guide healthcare professionals in selecting the most suitable rehabilitation approach for individual patients. The purpose of this study is to address this gap in knowledge by comparing two specific rehabilitation techniques: Mime therapy and Motor imagery technique. Understanding which of these rehabilitation techniques is more effective can significantly influence clinical practice and patient care. By conducting a systematic comparison, this study aims to provide evidence-based recommendations to healthcare professionals in selection of appropriate rehabilitation protocol for Bell's palsy patients.

Eligibility criteria: Inclusion Criteria:

* Age 20-40 years
* Both male and female
* Patients diagnosed with Bell's Palsy
* Paralysis/paresis of all muscle groups of one side of face

Exclusion Criteria:

* Patients diagnosed with facial palsy
* Patients with impaired cognition
* Patients diagnosed with other neurological diseases

Primary outcomes:
measure: House-Brackmann Scale (HBS)
timeFrame: week 6
measure: Facial Disability Index (FDI)
timeFrame: week 6
measure: Sunnybrook Facial Grading System
timeFrame: week 6
measure: Synkinesis Assessment Questionnaire (SAQ)
timeFrame: week 6
Secondary outcomes:
Other outcomes:
Locations:
city: Sargodha
country: Pakistan
facility: Muzaffar Hospital
Study officials:
affiliation: Riphah International University
name: Ayesha Afridi, PhD*
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03808909: Providing Expanded Continuous Labor Support to Pregnant Women in New Mexico With Substance Use Disorders
Official title: Providing Expanded Continuous Labor Support to Pregnant Women in New Mexico With Substance Use Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Substance Use Disorders
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2019-01-18
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will determine the feasibility of offering expanded continuous labor support by trauma- and addiction-trained medical paraprofessionals (i.e. doulas) at no cost to pregnant women receiving care for substance use disorders (SUD). The long-term goal of this transdisciplinary multilevel intervention is ultimately to reduce a major existing behavioral health disparity in the state. This cross-campus multi-disciplinary collaboration, is in partnership with Young Women United (a research and policy organization in NM) and doulas of the UNM Birth Companion Program. Through this partnership, women receiving combined OB/SUD treatment at the Milagro Program at UNMHSC will be offered expanded doula services.


Eligibility criteria: Inclusion Criteria:

* at least 18 years old
* able to participate in informed consent
* able to read, write, and speak English
* gestation of at least 26 weeks at baseline (necessary because of short duration of study)
* plan to give birth at UNM.

Exclusion Criteria:

* active psychosis
* current incarceration
* identified by medical staff as unable for medical reasons to currently participate in the study
* not interested in having doula support

Primary outcomes:
measure: Number of Participants Who Remain in the Study
timeFrame: 2 week postpartum follow-up assessment
Secondary outcomes:
measure: Alternative Birth Outcome
timeFrame: birth
measure: Postpartum Posttraumatic Stress Disorder Checklist
timeFrame: 2 week postpartum follow-up assessment
measure: Participant Satisfaction
timeFrame: 2 week postpartum follow-up assessment
Other outcomes:
measure: Percentage of Days With Drinking or Substance Use
timeFrame: 2 week postpartum follow-up assessment
measure: Mother's Autonomy During Birth
timeFrame: queries feelings during labor and birth but is administered at 2 week follow-up
measure: Postpartum Depression
timeFrame: 2 week postpartum follow-up assessment
measure: Breastfeeding Update
timeFrame: 2 week postpartum follow-up assessment
measure: Neonatal Abstinence Syndrome
timeFrame: neonatal
measure: Length of NICU Stay
timeFrame: from birth through study completion, an average of 3 months
measure: Social Support - NIH Toolbox
timeFrame: 2 week postpartum follow-up assessment
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
References:
Clinical trial NCT00994409: Patient Satisfaction in Stroke Patients
Official title: Berliner Schlaganfallregister - Nachbefragung Von Patienten Mit Schlaganfall
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: Stroke
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Center for Stroke Research Berlin
name: German Federal Ministry of Education and Research
First posted: 2009-10-14
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stroke and TIA patients treated at the Charite with acute stroke or TIA onset less than 7 days

Brief summary: The objective of this trial is to guarantee a follow-up of all stroke and transient ischemic attack (TIA) patients. With this follow-up assessment long term effects of therapy and prevention measures can be detected and monitored. It is part of quality assurance.

Detailed description: Primary efficacy endpoint: Number of patients who state that they received all the information they want about the causes and nature of their illness Key secondary endpoint(s): Compliance/adherence with discharge medication. Re-events. Degree of Disability. Activities of daily living. Mortality.

Eligibility criteria: Inclusion Criteria:

* all patients eligible

Exclusion Criteria:

* none

Primary outcomes:
measure: Primary efficacy endpoint: Number of patients who state that they received all the information they want about the causes and nature of their illness.
timeFrame: September 2010
Secondary outcomes:
measure: Compliance/adherence with discharge medication Activities of daily living
timeFrame: September 2010
measure: Re-events
timeFrame: September 2010
measure: Degree of Disability
timeFrame: September 2010
measure: Mortality
timeFrame: September 2010
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Dept. Neurology, Charité Campus Benjamin Franklin
Study officials:
affiliation: Center for Stroke Research Berlin
name: Peter U Heuschmann, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03893409: GIRH Chronic Obstructive Pulmonary Disease Observational Study
Official title: A Observational Study in Chinese Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2019-03-28
Enrollment: 10000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This is a observational prospective longitudinal cohort study to to establish the large COPD cohort and biological database in China, including COPD subjects( n= 5000) and healthy subjects (n= 5000). Sites Investigators will be respiratory physicians working in the respiratory department of our sites, which must be tier 2 or tier 3 hospitals in China, with the equipment and ability to conduct pulmonary function test, HRCT. Patients must meet all the inclusion criteria and none of the exclusion criteria. No additional investigational drugs will be applied to the patients. Statistical analysis will be conducted by epidemiology \& statistics work group from Chinese Academy of Sciences, using SAS and R software. Paper-based questionnaire administration will also be used. Questionnaire variables will be checked before data entry. During the study, PI will be in charge of the monitoring of the whole procedure.

Brief summary: The purpose of this study is to establish the large COPD cohort and biological database in China, aiming for precision medicine to optimize diagnosis and treatment choices.


Eligibility criteria: Inclusion Criteria:

-Aged 40-70 years COPD group: baseline post-bronchodilator FEV1/FVC \< 0.7 Signed informed consent obtained prior to participations with the ability to comply with protocol and be available for study visits over 5 years

Exclusion Criteria:

* Acute exacerbation in the past 3 months Having other respiratory diseases with massive lung tissue destruction such as severe bronchiectasis and tuberculosis, etc The usual criteria of serious uncontrolled diseases thoracic or abdominal surgery in the last 3 months eye surgery in the last three months retinal detachment myocardial infarction in the last 3 months admission to hospital for any cardiac condition in the last month heart rate over 120 beats per minute antibacterial chemotherapy for tuberculosis pregnant or breast feeding

Primary outcomes:
measure: difference of FEV1 at 12 months from baseline
timeFrame: at 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
References:
Clinical trial NCT05721209: Virtual Reality Treadmill Training in Individuals with Traumatic Brain Injury
Official title: Virtual Reality Treadmill Training in Individuals with Traumatic Brain Injur : a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Traumatic Brain Injury
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2023-02-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This pilot study aims to determine the feasibility of a virtual reality treadmill training intervention in individuals with Traumatic Brain Injury (TBI). Participants will be stratified based on age into adults' group or older adults' group and then randomized into the virtual reality treadmill training (intervention) group with feedback or the treadmill training (control) group. This pilot study will also provide preliminary evidence on the impact of the virtual reality treadmill training on mobility, balance, fear of falls, fall risk, attention and physical activity in the community in individuals with TBI. The data collected in this pilot study will also help to estimate sample size for subsequent large clinical trial.


Eligibility criteria: Inclusion Criteria:

1. 18 to 90 years old
2. diagnosed with a non-penetrating TBI
3. at least 12 months post most recent injury
4. self-reported balance deficits and fear of falls or at least 2 falls in the last one year
5. Able to understand and speak English language to respond, understand and comply with study procedures throughout the 10-week study period and fill out the study questionnaires in English
6. Able to walk with minimal assistance or less (with bracing and assistive devices as needed)

Exclusion Criteria:

1. history of severe cardiac disease
2. neuromuscular or neurological pathologies other than TBI that limit study participation
3. uncontrolled seizure disorder
4. weight greater than 135 kg or less than 25 kg
5. height greater than 6' 2''
6. severe cognitive, visual or hearing impairment where the patient is not able to follow the study instructions
7. open skin lesion or bandage in the area of C-Mill harness contact

Primary outcomes:
measure: Recruitment Rate
timeFrame: Up to Week 10
measure: Enrollment Rate
timeFrame: Up to Week 10
measure: Retention Rate
timeFrame: Up to Week 10
measure: Percentage of Participants who Adhere to 100% of Study Procedures
timeFrame: Up to Week 10
Secondary outcomes:
measure: Change from Baseline in Falls Self-Efficacy Scale (FES-I) Score by Final Intervention Visit
timeFrame: Baseline, Week 7
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Akhila Veerubhotla, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02987309: Indirect Calorimetry: SensorMedics Vmax vs GE Carescape - a Method Comparison Study
Official title: Indirect Calorimetry: SensorMedics Vmax vs GE Carescape - a Method Comparison Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Nutrition Assessment
Critical Illness
Children
Keywords: indirect calorimetry
method comparison
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2016-12-08
Enrollment: 6
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children undergoing intensive care treatment

Brief summary: Dosing of nutrition in PICUs is mainly based on patient weight and assumptions on clinical status. There is however poor correlation between these calculations and actual energy consumption measured with indirect calorimetry (IC). Available equipment for IC has however been too cumbersome to use in daily clinical practice. Of relative new date is IC integrated in modern ventilators. This functionality is easy to use, but we do not know if the results are reliable for children. This study is a method comparison study comparing measurements done with SensorMedics Vmax ("gold standard") vs GE Carescape (modern ventilator with Integrated IC) in children undergoing intensive care treatment.


Eligibility criteria: Inclusion Criteria:

* \< 18 years of age,
* endotracheally intubated.
* FiO2 \< 0,6, tube leak \< 10%, tidal volume \> 50 ml.

Exclusion Criteria:

* Ventilatory and hemodynamically unstable during 2 hours prior to inclusion.

Primary outcomes:
measure: MEE (measured energy expenditure) kcal/kg/day, RQ (respiratory quotient)
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Rikshospitalet
Study officials:
affiliation: Oslo University Hospital
name: Gunnar Bentsen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05298709: Functional Magnetic Resonance Imaging (fMRI) Vascular Reactivity in Cerebral Cavernous Malformations (CCM)
Official title: Functional Magnetic Resonance Imaging (fMRI) Vascular Reactivity in Cerebral Cavernous Malformations (CCM)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cerebral Cavernous Malformation
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
First posted: 2022-03-28
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal is to characterize vascular reactivity and cardiac pulsatility of normal appearing white matter in patients with CCM during hypercarbia/hypocarbia using quantitative real-time high-speed multi-echo fMRI to develop prognostic biomarkers for CCM formation


Eligibility criteria: Inclusion Criteria:

1. All familial CCM subjects presenting at UNMH who can consent to our study.
2. Adult Male/Female patients ages \>18 years old

Exclusion Criteria:

1. Individuals ages \<18 year
2. Subjects with a known fear of dyspnea or enclosed spaces will be excluded from this study as well as those with metal implants, COPD, heart conditions, and hypercapnia.
3. Subjects who have contraindications to MRI such as harboring incompatible ferromagnetic objects implanted in the body.
4. Pregnant women (screening for pregnancy will be performed by oral questionnaire. MRI is safe in pregnancy but the study will exclude pregnant subjects, as the effects of respiratory challenge cannot be predicted in such subjects. Since these effects are proportional to the stage of gestation, oral history will be sufficient to assure safety.)
5. Prisoners.
6. People unable to consent.
7. People unable to participate due to prior neurological deficits.
8. Subjects with underlying pre-existing pulmonary illness; such as asthma, COPD, pulmonary hypertension, will be excluded.
9. Cognitively impaired and/or participants not able to speak English language will not be included in the study (This pilot study involves performing motor and verbal tasks while in the MRI, in addition to undergoing a respiratory challenge, that requires understanding instructions clearly. We do not have current capabilities to include a translator who would be available at all stages of the study to include subjects who do not speak English.)

Primary outcomes:
measure: Hemodynamic Response
timeFrame: 12 Months
measure: Resting state connectivity
timeFrame: 12 month
Secondary outcomes:
measure: Cardiac Pulsatility
timeFrame: 12 Months
measure: First Harmonic
timeFrame: 12 Months
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Neurology Research Center
state: New Mexico
Study officials:
References:
Clinical trial NCT02732509: Chronic Inflammation and Exercise Responsiveness
Official title: Chronic Inflammation and Exercise Responsiveness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Syndrome
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-04-08
Enrollment: 146
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Men and women between the ages of 30-55 years will be recruited for this study. Fifteen individuals will be lean, defined as a body mass index (BMI) between 19 and 24 kg/m2. Thirty individuals will be overweight/obese, defined as a BMI between 25 and 45 kg/m2.

Brief summary: The purpose of this study is to determine how chronic inflammation influences skeletal muscle protein metabolism and metabolic function in humans. The investigators will evaluate acute responsiveness to a single bout of exercise in men and women who are either lean or overweight/obese. The investigators will explore the relationship between circulating inflammatory markers and anabolic, proteomic, and transcriptional responses to acute exercise. The investigators will measure skeletal muscle protein synthesis in the postabsorptive state and in response to a single bout of exercise.


Eligibility criteria: Inclusion Criteria:

* Age 30-55 years
* BMI 19-45 kg/m2

Exclusion Criteria:

* Anemia (female subjects hemoglobin of \<11 g/dl and male subjects hemoglobin \<12 g/dl)
* Active coronary artery disease or history of unstable macrovascular disease (unstable angina, myocardial infarction, stroke, and revascularization of coronary, peripheral or carotid artery within 3 months of recruitment)
* Renal insufficiency/failure (serum creatinine \> 1.5mg/dl)
* Oral warfarin group medications or history of blood clotting disorders.
* Pregnancy or breastfeeding
* Alcohol consumption greater than 2 glasses/day or other substance abuse
* Untreated or uncontrolled thyroid disorders
* Debilitating chronic disease (at the discretion of the investigators)

Primary outcomes:
measure: Maximal oxygen consumption rates in mitochondria isolated from skeletal muscles
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Ian R Lanza, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vanderboom P, Zhang X, Hart CR, Kunz HE, Gries KJ, Heppelmann CJ, Liu Y, Dasari S, Lanza IR. Impact of obesity on the molecular response to a single bout of exercise in a preliminary human cohort. Obesity (Silver Spring). 2022 May;30(5):1091-1104. doi: 10.1002/oby.23419.