louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06975904: Effect of Modified Constraint-induced Movement Therapy Combined With Virtual Reality on Mobility in Post-stroke Patients: A Randomized Control Trial
Official title: Effect of Modified Constraint-induced Movement Therapy Combined With Virtual Reality on Mobility in Post-stroke Patients: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Stroke
Mobility
Balance
Keywords: Stroke rehabilitation
Hemiplegia therapy
Motor activity
Gait physiology
Neuroplasticity
Movement disorders rehabilitation
Constraint-Induced Movement Therapy
Virtual reality therapy
Lower extremity pathophysiology
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 32
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigates the effectiveness of combining m-CIMT and VR to improve mobility in post-stroke patients. A non-blinded randomized controlled trial will be conducted with 32 participants divided equally into experimental and control groups using purposive sampling. The experimental group will receive m-CIMT with VR training, while the control group will receive m-CIMT with Task-Specific Functional Training. Sessions will be 30 minutes per day, 4 days a week, for 6 weeks. Outcomes will be measured using FMA-LE, BBS, DGI, TUG, and SS-QOL. The study will take place over one year at FFH and FUCP, with ethical approval from ERC FUMC.


Eligibility criteria: Inclusion Criteria:

* Sample Selection Criteria

Inclusion Criteria

* Sub-acute and chronic stroke patient \>3months
* Males and females of 40-60 years.
* Mini-Mental State Examination score ≥24
* FAC Scale = 3
* Limited spasticity (0,1,1⁺) according to modified Ashworth scale
* Adequate balance and walking ability while wearing the constraint to be eligible to participate in CIMT intervention.

Exclusion Criteria

* Patient with Severe Spasticity and pain
* Patient of Epilepsy, Parkinson's disease and stage 4 arthritis
* Patient with Global Aphasia
* Individuals suffering from unstable angina, symptomatic heart failure, or uncontrolled hypertension
* Patients with any traumatic musculoskeletal injury and surgery of lower limb

Primary outcomes:
measure: Motor Control
timeFrame: 6 weeks
measure: Mobility
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Foundation University College of Physical Therapy
Study officials:
References:
Clinical trial NCT02154204: A Validation Study of Near Infrared Fluorescence Imaging of Lymphatic Vessels in Humans.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Focus of Study is: Near Infrared Fluorescence Imaging
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2014-06-03
Enrollment: 10
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants are young healthy males.

Brief summary: The aim of this study is to examine the use of Near Infrared Fluorescence imaging on lymphatic vessels in humans.

Different parameters that reflect lymphatic function will be tested for intra and inter individual reproducibility.

We use 10 healthy test subjects and examine their lymphatic system. All subjects are healthy men between the ages of 20 and 30.

When the fluorescent dye "indocyanine green", has been injected into the skin on the patients feet, it will be transported through the lymph vessels, resulting in clear visualization of the vessels, using a laser and a EM-CCD camera.

On both legs we examine the frequency of vessel contraction and the velocity of lymph moving in vessels. We furthermore use several methods to quantify the vessel function such as the refill time of a vessel, (manually emptied vessel and refill time of 10 cm of a vessel), and pumping pressure (at what pressure lymph can pass a blood pressure cuff).

We investigate the activity of vessels over time, and after several interventions such as exercise, and water baths of the foot at different temperatures.

The patients are examined for approximately 4 hours and wil be examined again 14 days later.


Eligibility criteria: Inclusion Criteria:

Exclusion Criteria:

* lymphedema, edema or vascular disease.

Primary outcomes:
measure: Frequency of contraction in lymph vessels.
timeFrame: At baseline and after 14 days
measure: Pumping pressure
timeFrame: At baseline and after 14 days
measure: refill time
timeFrame: At baseline and after 14 days
measure: velocity
timeFrame: At baseline and after 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Department of cardiothoracic and vascular surgery, Aarhus university hospital.
Study officials:
affiliation: Department of cardiothoracic and vascular surgery, Aarhus university hospita
name: Vibeke E Hjortdal, MD, PhD, DMSc
role: STUDY_DIRECTOR
affiliation: Department of cardiothoracic and vascular surgery, Aarhus university hospita
name: Jacob H Grønlund, bac. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02786004: Image Quality Assessment for Screening and Diagnostic Mammography
Official title: Mammography Image Quality Assessment Reading NextGen Images for Screening and Diagnostic Use (MAGNIFI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Health
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2016-05-30
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study is being conducted to determine the image quality of images using a new investigational medical imaging device.


Eligibility criteria: Inclusion Criteria:

1. Are women aged 40 years or older (≥40 years old);
2. Have had a FFDM (Full Field Digital Mammography) or DBT (Digital Breast Tomosynthesis) breast imaging exam within 30 days prior to enrollment;
3. Have breast sizes compatible with the dimensions of a 24x29 cm image detector without anatomical cut-off;
4. Are able to walk without assistive devices;
5. Are sterile; post-menopausal; or if of childbearing potential, have a negative pregnancy test or is willing to provide urine sample to confirm no pregnancy, within 30 days of imaging exam; and
6. Are willing to provide written informed consent to participate.

Exclusion Criteria:

1. Have been previously included in this study or are participating in another trial expected to interfere with study procedures or outcomes;
2. Have a history of breast biopsy, lumpectomy or mastectomy, or reconstruction on either breast;
3. Are currently lactating;
4. Are currently undergoing radiotherapy or chemotherapy , or have a history of prior radiotherapy treatment on either breast; or
5. If enrolled to the DBT (Digital Breast Tomosynthesis) cohort, have breast implants (breast implants are not exclusionary in the FFDM (Full Field Digital Mammography) cohort).

Primary outcomes:
measure: Number of Participants With Acceptable Overall Clinical Image Quality
timeFrame: At enrollment completion approximately 3 months post initiation
Secondary outcomes:
measure: Number of Subjects Experiencing a Device Related Adverse Events, Serious Adverse Event, Unanticipated Device Effect, and Device Defects by Overall Occurrence.
timeFrame: Through study completion, approximately 3 months
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Carolina Breast Imaging Specialist
state: North Carolina
Study officials:
affiliation: Carolina Breast Imaging Specialists
name: Bruce Schroeder, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01688804: Reducing Sedentary Time in Obese Adults
Official title: A Mobile Health Approach to Reducing Sedentary Time in Bariatric Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Behavior
Keywords: Sedentary behavior
Physical activity
Obesity
Mobile health
Smartphone
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2012-09-20
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Greater time spent in sedentary behaviors, independent of physical activity level, can increase risk of morbidity and mortality. Objective assessments indicate that bariatric surgery patients spend large amounts of time in sedentary behaviors. The present study is the first to test whether a mobile health (mHealth) approach that employs widely adopted smartphone technology to monitor and modify sedentary behaviors as they occur is a feasible and acceptable method of reducing sedentary time in these patients and other obese populations.


Eligibility criteria: Inclusion Criteria:

* Bariatric surgery patients and other obese individuals will be considered
* Body mass index \>= 30 kg/m2

Exclusion Criteria:

* Report being unable to engage in daily activities and walk continuously for \>= 10 minutes without assistance
* Are currently involved in a physical activity intervention.
* Are unable to read or understand the study materials
* Are currently taking medications that cause dizziness and/or feeling faint when sitting or standing.
* Report any condition that in the opinion of investigators would preclude adherence to the intervention protocol including plans to relocate, history of substance abuse or other significant psychiatric problems, or terminal illness.

Primary outcomes:
measure: Average daily sedentary minutes
timeFrame: 4 weeks
Secondary outcomes:
measure: Average daily adherence to prompts to reduce sedentary time delivered via mobile smartphone
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Weight Control and Diabetes Research Center
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital/Brown Alpert Medical School
name: Dale S Bond, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bond DS, Thomas JG, Raynor HA, Moon J, Sieling J, Trautvetter J, Leblond T, Wing RR. B-MOBILE--a smartphone-based intervention to reduce sedentary time in overweight/obese individuals: a within-subjects experimental trial. PLoS One. 2014 Jun 25;9(6):e100821. doi: 10.1371/journal.pone.0100821. eCollection 2014.
Clinical trial NCT00507104: Pituitary Functions After Traumatic Brain Injury (TBI) and/or Subarachnoid Hemorrhage (SAH)
Official title: Prospective Longitudinal Study on Pituitary Functions After TBI and/or SAH
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Subarachnoid Hemorrhage
Hypopituitarism
Keywords: traumatic brain injury
Subarachnoid Hemorrhage
Hypopituitarism
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2007-07-25
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE

Brief summary: This study performs assessments of pituitary functions by basal hormone levels in the acute phase after TBI and/or SAH followed by detailed endocrine tests (insulin-induced hypoglycemia or growth hormone releasing hormone-arginine-corticotropin releasing hormone-leuteinizing hormone releasing hormone \[GHRH-arginine-CRH-LHRH\] test) after 4 and 12 months.

Detailed description: Recent data have demonstrated that hypopituitarism seems to be a frequent finding after traumatic brain injury (TBI) and/or subarachnoid hemorrhage (SAH). However, most of these studies referred to retrospective evaluations. There are only few prospective data, and no longitudinal study routinely taking into account the assessment of anterior pituitary function in the acute phase after TBI or SAH so far.

We prospectively evaluate pituitary functions in patients in the acute phase after TBI or SAH and a control group of patients with trauma not involving the brain. Endocrine data included basal anterior pituitary lobe hormone, IGF-1 and testosterone serum levels (Immulite 2000) within the first 8 hours after TBI or SAH. Further endocrine evaluation was performed by means of either a combined GHRH-arginine-CRH-LHRH test or an insulin-induced hypoglycemia test after 4 months and 12 months. To rule out an assay related bias with regard to GH and IGF-1, all hormone levels were cross-checked by a supersensitive assay in another laboratory.

Eligibility criteria: Inclusion Criteria:

* TBI or SAH
* Control group: injury without involvement of the brain/skull

Exclusion Criteria:

* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Department of Neurosurgery, University of Erlangen
Study officials:
affiliation: Department of Neurosurgery, University of Erlangen
name: Michael Buchfelder, M.D., Ph.D.
role: STUDY_CHAIR
affiliation: Department of Neurosurgery, University of Erlangen
name: Juergen Kreutzer, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Neurosurgery, Division Neuroendocrinology, University of Erlangen
name: Christioph Schöfl, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Neurosurgery, University of Erlangen
name: Andrea Kleindienst, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04404504: Smartphone-App Based Prediction of Large Vessel Occlusion
Official title: Smartphone-App Based Prediction of Large Vessel Occlusion in Suspected Stroke by Emergency Medical Service Using FAST-ED
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Stroke
Keywords: Prehospital Triage
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult patients with suspected acute stroke that are transferred by the Essen emergency service to the university hospital Essen shall be recruited

Brief summary: The aim of this non-interventional study is to evaluate a German version of the triage stroke-score FAST-ED performed by ambulance service personnel in a pre-hospital setting using a smartphone app (Join-Triage, Allm).

Detailed description: The emergency service of the city of Essen (NRW, Germany), which is organised by the Essen fire-department, will perform a prehospital triage stroke-score using a smartphone-app (Join-Triage, Allm) when referring patients with suspected stroke to the university clinic Essen. The triage stroke-score FAST-ED (Field Assessment Stroke Triage for Emergency Destination), as well as the expected time of arrival will be transmitted by an additional smartphone-app in advance of the arrival (Join, Allm). Patients will receive emergency workup to identify stroke etiology and presence of large vessel occlusion. Final diagnosis, presence of large vessel occlusion and type of revascularisation treatment will be registered. Sensitivity, specificity and further criteria for test quality will be calculated for the stroke triage by emergency service in field using the FAST-ED.

Eligibility criteria: All patients above the age of 18 with suspected acute stroke transferred to the university hospital Essen.

Inclusion criteria: suspected acute stroke, age above 18 years and a digitally transmitted FAST-ED by EMS prior to admission.

Exclusion criteria: Known symptom onset beyond 24 Hours.

Primary outcomes:
measure: Presence of large vessel occlusion
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Essen
country: Germany
facility: University Hospital, Essen
state: NRW
Study officials:
affiliation: University Hospital, Essen
name: Martin Köhrmann, Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: Frank B, Lembeck T, Toppe N, Brune B, Bozkurt B, Deuschl C, Nogueira RG, Dudda M, Risse J, Kill C, Forsting M, Kleinschnitz C, Kohrmann M. FAST-ED scale smartphone app-based prediction of large vessel occlusion in suspected stroke by emergency medical service. Ther Adv Neurol Disord. 2021 Nov 14;14:17562864211054962. doi: 10.1177/17562864211054962. eCollection 2021.
Clinical trial NCT06693804: Ophthalmoscope and Otoscope Training in Family Medicine Residency
Official title: Quality Improvement Initiative: Using Digital Ophthalmoscope and Otoscope Visual Arts Observation Training to Improve Family Medicine Residency Training
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Resident Education
Digital Technology
Keywords: otoscope
ophthalmoscope
visual arts
resident
device
instrument
eye exam
ear exam
family medicine
education
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2024-11-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of the study is to evaluate the effectiveness of Welch Allyn PanOptic Plus Ophthalmoscope with smartphone adaptor, and assess residents' opinions on acceptability and usability of the device and curriculum vs the conventional non-digital device used in current clinical practice.


Eligibility criteria: Inclusion Criteria:

* Resident in Penn States Family and Community Medicine Department

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Resident Confidence Survey (Pre)
timeFrame: 0 months
measure: Resident Knowledge Survey (Post)
timeFrame: 3 months
measure: Visual Identification of Images (Pre)
timeFrame: 0 months
measure: Visual Identification of Images (Post)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Harrisburg
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Reading
country: United States
facility: Penn State Health St. Joseph Medical Center
state: Pennsylvania
Study officials:
affiliation: The Pennsylvania State University, College of Medicine, Family and Community Medicine Department
name: Joseph Wiedemer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00975104: AMG 745 in Subjects With Age-associated Muscle Loss
Official title: A Randomized, Double-blind, Placebo-controlled Dose Ranging Study to Evaluate the Safety and Efficacy of AMG 745 in Age-associated Muscle Loss
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Age-associated Muscle Loss
Keywords: Aging
Frailty
Sedentary
Immobilization
Atrophy
Muscle Wasting
Physical Activity
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2009-09-11
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized, Double-blind, Placebo-controlled Dose Ranging Study to Evaluate the Safety and Efficacy of AMG 745 in Age-associated Muscle Loss


Eligibility criteria: Inclusion Criteria:

* Limited exercise tolerance and Rapid Assessment of Physical Activity (RAPA) score ≤ 3
* Hand grip (dominant hand): men ≤ 30.3 kg, women ≤ 19.3 kg
* Walk speed ≤ 0.8 m/s (based on a 4 meter walk)

Exclusion Criteria:

* Subject weight \> 137 kg (300 lbs), or Body Mass Index (BMI) \> 32 kg/m2
* Primary muscle disease or myopathy
* Recent immobilization, or major trauma to the legs within 6 months
* Knee or hip replacement within 12 months or lower extremity amputation
* Significant laboratory abnormalities
* Significant comorbidities or medical history
* Weight loss (intentional or unintentional) of \> 5 kg in 12 weeks
* Unable to complete an MRI scan

Primary outcomes:
measure: To evaluate the effect of AMG 745 weekly IV doses of 0.3 mg/kg, 1.0 mg/kg, or 3.0 mg/kg, compared with weekly IV placebo on thigh muscle CSA in subjects ≥ 65 yrs old with limited exercise tolerance and functional limitations
timeFrame: 12 Weeks
Secondary outcomes:
measure: To evaluate the effect of treatment with AMG 745 on muscle strength (hand grip strength) and function (gait speed, 10-step stair climb power, chair stand and 6 minute walk distance) and to evaluate the PK of AMG 745 following multiple IV administrations
timeFrame: 12 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02103504: DePuy Attune Total Knee Arthroplasty RSA Study
Official title: Roentgen Stereophotogrammetric Analysis (RSA) of the ATTUNETM Posterior Stabilized Fixed Bearing Knee System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Concord Hospital
name: Maisonneuve-Rosemont Hospital
First posted: 2014-04-04
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The DePuy Attune knee system incorporates several key features aimed at improving kinematics of the knee joint, range of motion, and smoothness of use compared to existing total knee replacement technologies. As this is a newly approved medical device, clinical testing in patients using high precision diagnostics is important to evaluate the stability of implant fixation and in vivo function. We propose a multi-centre consecutive series study examining the stability of the Attune posterior-stabilized knee design in 30 patients undergoing total knee arthroplasty for a follow-up period of 2 years. Radiostereometric analysis (RSA) will be utilized to identify the micromotion of the tibial tray with respect to the surrounding bone. Health status and functional outcome measures will be recorded to quantify functional status of subjects before surgery and at follow-up intervals.


Eligibility criteria: Inclusion Criteria:

* Symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty
* Between the ages of 21 and 80 inclusive
* Patients willing and able to comply with follow-up requirements and self-evaluations
* Ability to give informed consent

Exclusion Criteria:

* Active or prior infection
* Medical condition precluding major surgery

Primary outcomes:
measure: Implant migration
timeFrame: 2 years
Secondary outcomes:
measure: Functional range of motion
timeFrame: 2 years
measure: Self-reported health status
timeFrame: 2 years
measure: Self-reported joint status
timeFrame: 2 years
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Concordia Hospital
state: Manitoba
city: Halifax
country: Canada
facility: Capital District Health Authority
state: Nova Scotia
city: Montreal
country: Canada
facility: Hopital Maisonneuve-Rosemont
state: Quebec
Study officials:
affiliation: Capital Health, Canada
name: Michael Dunbar
role: PRINCIPAL_INVESTIGATOR
References: