louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04636645: Effects of Lower Limb Positive Pressure on the Balance of Community-dwelling Older Adults
Official title: Effects of Lower Limb Positive Pressure on the Balance of Community-dwelling Older Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Old Age
Fall
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 90
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: With the onset of the sixth decade in life, degenerative processes affect the neuromuscular system in terms of losses in muscle strength (dynapenia) and muscle mass (sarcopenia). Neural (e.g., numerical loss of alpha motoneurons) and morphological factors. Borde et al. 123 number and size of particularly type-II muscle fibers), as well as their interaction, are responsible for age-related declines in muscle strength and mass. There is evidence that muscular weakness is highly associated with impaired mobility and an increased risk for falls. Moreover, lower extremity muscle weakness was identified as the dominant intrinsic fall-risk factor with a five-fold increase in the risk of falling. An anti-gravity treadmill allows users to walk or run in a reduced body weight environment. The user walks or runs on a treadmill belt surrounded by an enclosed, air-filled chamber. When air pressure increases, an upward force offloads the weight of the runner and decreases the percentage of body weight (BW%) experienced upon foot impact. So, a research question was developed in our mind after the literature review. Is there any effect of AGT training on fall risk of older adults?


Eligibility criteria: Inclusion Criteria:

1. Community-dwelling adults aged 55 years and above.
2. Berg balance score should be from 46 to 54.
3. Able to follow instructions in Urdu.
4. No neurological conditions, and no musculoskeletal injuries within the past year.
5. Both male and female.

Exclusion Criteria:

1. Pain with ambulation or dizziness when standing or walking.
2. Contraindications to treadmill walking and LBPP such as cardiovascular conditions.
3. Severe osteoporosis, fractures, when loading of the abdominal region, hip or pelvis is contraindicated (such as groin infections, skin graft in the groin region, gastrointestinal tubes, colostomy, compromised skin integrity), orthopedic conditions in the past year or neurological conditions.

Primary outcomes:
measure: Timed up and go test (TUG)
timeFrame: 12 week
measure: Berg balance scale
timeFrame: 12 week
measure: Functional reach test
timeFrame: 12 week
measure: Fall risk score
timeFrame: 12 week
measure: Balance App
timeFrame: 12 week
Secondary outcomes:
measure: Force Plate
timeFrame: 12 week.
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Fauji Foundation Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Waqar Ahmed Awan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00214045: Rigid Versus Flexible Cystoscopy in Women
Official title: Rigid Versus Flexible Cystoscopy in Women in Outpatient Clinic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematuria
Urination Disorders
Voiding Dysfunction
Recurrent Urinary Tract Infection
Keywords: Bladder cancer surveillance
Voiding dysfunction
Cystoscopy
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study will help define the best tolerated approach to cystoscopy in women by randomly comparing flexible to rigid cystoscopy. Previous randomized studies evaluated rigid cystoscopy under general anesthesia versus flexible cystoscopy under local anesthesia. As a result of these studies, flexible cystoscopy is performed in the clinic setting generally in males. However, many women have rigid cystoscopy performed in the clinic while the men have flexible cystoscopy. No studies to date have evaluated whether flexible cystoscopy is better tolerated in women compared to rigid cystoscopy in women in the clinic setting.


Eligibility criteria: Inclusion Criteria:

* Female

Exclusion Criteria:

* Minors
* Incarcerated individuals

Primary outcomes:
measure: Visual Analog Scale for Pain
timeFrame: During procedure and 1 week post-procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Stephen Nakada, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04415645: Absorption, Metabolism, Excretion, and Mass Balance Study of [14C]-VVZ-149 in Healthy Adult Male Subjects
Official title: Phase 1, Open-Label Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of a Single Intravenous Dose of [14C]-VVZ-149 in Healthy Adult Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adult Male
Lead sponsor: Vivozon, Inc.
Sponsor class: INDUSTRY
First posted: 2020-06-04
Enrollment: 6
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is an open-label, single-dose, absorption, metabolism, excretion, and mass balance study following a single IV infusion of \[14C\]-VVZ-149 in healthy adult male subjects. Whole blood, plasma, urine, and fecal samples will be analyzed for at least 72 hours following the start of infusion to measure total radioactivity and plasma drug concentrations.


Eligibility criteria: Key Inclusion Criteria:

* Healthy, adult, male, 19-55 years of age, inclusive
* Continuous non-smoker
* BMI ≥ 18.0 and ≤ 32.0 kg/m2
* Medically healthy with no clinically significant medical history or findings
* Must agree to adhere to the contraception requirements

Key Exclusion Criteria:

* History or presence of clinically significant medical or psychiatric condition or disease
* History or presence of alcohol or drug abuse within the past 2 years
* History, presence or evidence of cardiovascular, renal or hepatic impairment
* Less or abnormal bowel movements
* Unable to refrain from or anticipates the use of any prohibited drugs
* Recent donation of blood/plasma or significant blood loss
* Radiation exposure within 12 months
* Participation in another clinical study within 30 days

Primary outcomes:
measure: Mass balance
timeFrame: Day 15
measure: Total radioactivity (TRA) concentration equivalents in plasma
timeFrame: Day 15
measure: TRA concentration equivalents in urine
timeFrame: Day 15
measure: TRA concentration equivalents in feces
timeFrame: Day 15
measure: Drug concentrations in plasma
timeFrame: Hour 48
Secondary outcomes:
measure: Treatment-emergent adverse events
timeFrame: Day 15
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion
state: Nebraska
Study officials:
References:
Clinical trial NCT02984345: Does the Ingestion of Mycoprotein Elicit an Optimal Anabolic Response in Resting and Exercised Skeletal Muscle?
Official title: Does the Ingestion of Mycoprotein Elicit an Optimal Anabolic Response in Resting and Exercised Skeletal Muscle?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Exeter
Sponsor class: OTHER
First posted: 2016-12-06
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The present study will seek to quantify the muscle protein synthetic response to mycoprotein feeding, comparing it to milk protein as a gold standard and heavily researched positive control


Eligibility criteria: Inclusion Criteria:

• BMI between 18 and 30 -

Exclusion Criteria:

* Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes)
* Any diagnosed cardiovascular disease or hypertension.
* Elevated blood pressure at the time of screening (e.g. blood pressure of ≥140/90mmHg).
* Chronic use of any prescribed or over the counter pharmaceuticals.
* A personal or family history of epilepsy, seizures or schizophrenia.
* Anyone with previous motor disorders.
* An allergy to mycoprotein / Quorn, penicillin, or milk.

Primary outcomes:
measure: Muscle fractional synthetic rate (muscle protein synthesis)
timeFrame: 7.5 hours
Secondary outcomes:
measure: Plasma amino acid concentration
timeFrame: 7.5 hours
measure: Serum insulin concentration
timeFrame: 7.5 hours
measure: Molecular markers of muscle anabolism
timeFrame: 7.5 hours
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: University of Exeter, Sports & Health Sciences, College of Life & Environmental Sciences
state: Devon
Study officials:
References:
Clinical trial NCT01984645: Primary-care-provider Identification And Notification
Official title: Identifying Primary Care Providers and Notifying Them Upon Admission of Their Patients to New York-Presbyterian Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emergency
Keywords: Emergency Visit
Secure Health messaging
Inpatient
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2013-11-15
Enrollment: 7023
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: New York-Presbyterian Hospital has created a system that notifies its primary care providers whenever their patients are admitted to the hospital. In this study, the investigators want to evaluate how accurate this system is and how it is affecting the primary providers and their health care delivery.

Detailed description: The investigators will interview the participating providers to understand if they were aware of the admission of their patients, and how they want to get involved in the care of that patient while he/she is in hospital. The investigators will also look at the data in the Electronic Health Record system to understand how providers are acting in response to the notifications.

Lastly, the investigators will determine if the notifications have resulted in any change in the care of the patients, specifically in terms of the number of days from discharge until the next clinic visit.

Eligibility criteria: Inclusion Criteria:

* Primary Care Provider at the New York Presbyterian.

Exclusion Criteria:

* No clinic rotation during the study period

Primary outcomes:
measure: Mean duration until first post-discharge outpatient visit
timeFrame: 1 year
Secondary outcomes:
measure: Mean number of secure health messages (SHMs)
timeFrame: 1-7 days after each admission
Other outcomes:
measure: Average rate of readmission to inpatient setting
timeFrame: 1 year
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: David K Vawdrey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05477745: The Correlation Between Femoral Component Implanting Flexion Angle and Posterior Condyle Offset in Cruciate Retaining Total Knee Arthroplasty
Official title: The Correlation Between Femoral Component Implanting Flexion Angle and Posterior Condyle Offset in Cruciate Retaining Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Knee Osteoarthritis
Keywords: Sagittal flexion angle
Posterior femoral offset
Cruciate-retaining total knee arthroplasty
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2022-07-28
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the patients were treated with primary total knee arthroplasty in Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine.

Brief summary: The main aim and scope is making measurement and comparison about the femoral component posterior offset under different femoral component implanting flexion angle in cruciate retaining total knee arthroplasty. The results may identify the influence of the flexion component implanting flexion angle on the femoral component posterior offset.


Eligibility criteria: Inclusion Criteria:

* The patients undertaken the primary cruciate retaining total knee arthroplasty;
* using the curiate retaining total knee arthroplasty prothesis from Biomet and Smith\&Nephew;
* Complete surgery documents and radiologic data,such as standard X-ray postoperative both at antirior-posterior position and medial-lateral position(overlap of the medial and lateral femoral condyle).

Exclusion Criteria:

* The patients without standard X-ray postoperative both at antirior-posterior position and medial-lateral position(poor overlap of the medial and lateral femoral condyle);
* Complex primary total knee arthroplasty, using extra component such as trabecular metal,stem or et al.

Primary outcomes:
measure: Posterior Femoral Offset
timeFrame: 1 week after the surgery
measure: Posterior Femoral Offset Ratio
timeFrame: 1 week after the surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: RenJi Hospital
name: Lin Du
role: STUDY_CHAIR
References:
Clinical trial NCT06119945: Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1568 in Healthy Adult Volunteers
Official title: An Open-label, Randomized, 2x4 Crossover Study to Compare the Pharmacokinetics and Safety Following Administration of DWJ1568 and DWC202215 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2023-11-07
Enrollment: 44
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study aims to compare the pharmacokinetics and safety following administration of DWJ1568 and DWC202215 in healthy volunteers

Detailed description: The study design is a Randomized, Open-label, Oral, Single-dose, Four-way crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUCt of DWJ1568 and DWC202215. Secondary endpoints were AUCinf, Tmax, t1/2 of DWJ1568 and DWC202215.

Eligibility criteria: Inclusion Criteria:

* over 19 year old

Exclusion Criteria:

* Galactose intolerance
* Lapp lactase deficiency

Primary outcomes:
measure: Cmax,ss of DWJ1568 and DWC202215
timeFrame: At pre-dose (0 hour), and post-dose 0 to 72 hour.
measure: AUCt of DWJ1568 and DWC202215
timeFrame: At pre-dose (0 hour), and post-dose 0 to 72 hour.
Secondary outcomes:
measure: AUCinf of DWJ1568 and DWC202215
timeFrame: At pre-dose (0 hour), and post-dose 0 to 72 hour.
measure: Tmax of DWJ1568 and DWC202215
timeFrame: At pre-dose (0 hour), and post-dose 0 to 72 hour.
measure: AUCt/AUCinf of DWJ1568 and DWC202215
timeFrame: At pre-dose (0 hour), and post-dose 0 to 72 hour.
measure: t1/2 of DWJ1568 and DWC202215
timeFrame: At pre-dose (0 hour), and post-dose 0 to 72 hour.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: H Plus YANGJI Hospital
Study officials:
References:
Clinical trial NCT01731145: Assessment of Tremor Using SNUMAP Motion Sensing System
Official title: Quantitative Assessment of Tremor Using Portable Six-axis (Tri-axial Accelerometer and Tri-axial Gyroscope) Motion Sensing System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tremor
Keywords: Tremor
SNUMAP
accelerometry
gyroscope
clinical rating scale
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Life Science Technology Inc.
First posted: 2012-11-21
Enrollment: 187
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to record and measure tremor using portable six-axis (tri-axial accelerometer and tri-axial gyroscope) motion sensing system.

Detailed description: SNUMAP system is portable, finger-worn, battery powered device that contains MEMS (micro-electro-mechanical system) hybrid motion sensor (three-axis accelerometer and three-axis gyroscope). The SNUMAP device consists of a wrist module and finger module, which attaches to an patients's finger and transmits three dimensional motions to a wrist module for storage and further analysis. The aims of this study is to assess tremor severity using tri-axial accelerometry and gyroscope to determine the reliability and the correlation with clinical measurements.

Eligibility criteria: Inclusion Criteria:

* Age: 20-80 years
* Patients with tremor (involuntary, rhythmic, oscillatory movement in one or more body part)
* Subject who signed an informed consent

Exclusion Criteria:

* Pregnant or nursing woman.
* Comorbid neurologic illnesses that impact the ability to perform the study tasks.
* Subjects with medical condition that in the opinion of the investigator would affect his/her ability to participate in this study.

Primary outcomes:
measure: 3-D Accelerometric and gyroscope variables measured
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Neurology, Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Beom S Jeon, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02652247: Serial, Non-invasive Analysis of Exhaled Breath Condensate in Ventilated Trauma Patients
Official title: Serial, Non-invasive Molecular Analysis of Exhaled Breath Condensate to Define the Pulmonary Flora in Critically Injured, Ventilated Adults: The Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ventilator Associated Pneumonia (VAP)
Keywords: trauma
ventilator
surgical ICU
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2016-01-11
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To determine if the analysis of exhaled breath condensate correlates with the development \& resolution of pneumonia.

Detailed description: This proposal investigates the utility of exhaled breath condensate fluid (EBCF) collected from heat moisture exchange (HME) filters connected to patient's endotracheal tubes for early, non-invasive detection of ventilator-associated pneumonia (VAP) in critically ill or injured ICU patients. The development of pneumonia during mechanical ventilation is the most common healthcare-associated infection in severely injured patients, accounting for substantial morbidity, excess ICU and hospital stay, additional cost and increased mortality.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Admitted to the Vanderbilt Trauma (TICU) and Surgical Intensive Care Units (SICU)
* Mechanically ventilated for ≥2 successive days (without planned extubation within 24 hours of enrollment)

Exclusion Criteria:

* Less than 18 years of age
* Expected survival less than 24 hours
* Anticipated extubation within 24 hours of enrollment
* Conditions limiting the subject's ability to tolerate collection of lavage specimens, including: FIO2 \> 80%; PEEP \> 16 cmH2O; Intracranial pressure \>20 cmH2O; Tracheal or mucosal bleeding; Platelet count \< 20,000 cells/uL; INR \> 2.0
* Known prisoners
* Pneumonia diagnosis at the time of ICU admission

Primary outcomes:
measure: The number of patients with a positive association between the exhaled breath condensate fluid and BAL fluid in in patients suspected of pneumonia.
timeFrame: enrollment to hospital day 15
measure: The per cent of positive correlation for the development & resolution of pneumonia based on changes in bacteria found in the exhaled breath condensate.
timeFrame: enrollment to hospital day 15
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Addison K May, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03407547: A Study Exploring Brain Activity in Relation to Sensory Arm Impairments in the Early Stages of Stroke
Official title: Neural Correlates of Upper Limb Somatosensory Impairments and Recovery in the Acute Phase After Stroke: an EEG Investigation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke
Keywords: upper limb
recovery
somatosensory
impairment
electroencephalography
acute phase
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This clinical study is organized for people with stroke often experience difficulties with their sensation in their upper limb. New technologies may be able to help these important problems. However, there is currently not enough knowledge about how the brain recovers in people with sensory impairments in their arm and hand. Using a non-invasive technique of recording brain activity, known as electroencephalography (EEG), brain activity in combination with somatosensation of the hand will be measured. Therefore, the purpose of this study will be to analyse brain activity in relation to somatosensory impairments after stroke during the first two weeks after stroke.


Eligibility criteria: Participants will be recruited during the first 2-3 days post-stroke. They should have:

1. a first-ever unilateral, supra-tentorial stroke, as defined by Wold Health Organisation;
2. admission to the acute hospital,
3. deficit in distal pinprick somatosensory measured by Rivermead assessment of somatosensory performance (score of ≤4) and/or motor impairment measured by Fugl Meyer Assessment (score of ≤12 out of 14),
4. the age of \> 18 years and
5. the ability to provide informed consent.

Healthy adults will also be recruited and they should have:

1. no history of sensory impairments in their hands
2. the age of \> 18 years and
3. the ability to provide informed consent.

Primary outcomes:
measure: Sensory Evoked Potential Latency
timeFrame: First 2 weeks post-stroke
measure: Sensory Evoked Potential Amplitude
timeFrame: First 2 weeks post-stroke
Secondary outcomes:
measure: Fugl Meyer Assessment
timeFrame: First 2 weeks post-stroke
measure: Wolf Motor Function Test
timeFrame: First 2 weeks post-stroke
measure: Perceptual Threshold of Touch
timeFrame: First 2 weeks post-stroke
measure: Erasmus modified Nottingham Sensory Assessment
timeFrame: First 2 weeks post-stroke
measure: Nottingham Sensory Assessment
timeFrame: First 2 weeks post-stroke
measure: Montreal Cognitive Assessment
timeFrame: First 2 weeks post-stroke
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Saint Luc Hospital
Study officials:
References: