louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05294224: The Relationship Between Disease Severity and Various Lower Extremity Parameters in Individuals With Knee Osteoarthritis
Official title: The Relationship Between Disease Severity and Various Lower Extremity Parameters in Individuals With Knee Osteoarthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Osteoarthritis
Knee Injuries
Keywords: muscle thikness
cartilage thickness
balance
postural stability
kinesiophobia
gait
degeneration
function
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
Collaborators: name: Muğla Sıtkı Koçman University
First posted: 2022-03-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Volunteer patients who applied to the Physical therapy and Rehabilitation department with knee pain

Brief summary: This study perform to investigate the relationship between quadriceps femoris (QF) strength, QF thickness, femoral cartilage thickness, knee function, balance, kinesiophobia and gait of the patients with knee osteoarthritis.

Detailed description: Osteoarthritis (OA) is one of the most common chronic degenerative diseases in the world, which progresses slowly, can cause pain, stiffness and dysfunction, and reduces the quality of life.

OA is particularly common in weight-bearing joints such as the knee and the functional status of patients with OA is adversely affected various factors such as immobility due to pain, decrease in muscle strength and joint range of motion, etc.

In relation to this, walking difficulty and decrease in walking speed, balance problems and an increase in the risk of falling are a picture that can be encountered in the later stages of the disease.

The aim of this study is to investigate the relationship between QF strength, QF thickness, femoral cartilage thickness, knee function, balance, kinesiophobia and gait of the patients with knee OA.

Eligibility criteria: Inclusion Criteria:

* Volunteer patients who applied to the Physical therapy and Rehabilitation department with knee pain

Exclusion Criteria:

* Individuals who have received intra-articular therapy for gonarthrosis in the last 6 months, who have undergone arthroscopic surgery, and who have additional pathologies in their lower extremities
* Individuals with physical, mental and/or psychological disorders that may affect participation in the study

Primary outcomes:
measure: QF muscle thickness
timeFrame: Day 1
measure: QF muscle strength
timeFrame: Day 1
measure: Femoral cartilage thickness
timeFrame: Day 1
measure: Knee function
timeFrame: Day 1
measure: Kellgreen-Lawrence Radiological Stages
timeFrame: Day 1
measure: Kinesiophobia
timeFrame: Day 1
measure: Balance and gait
timeFrame: Day 1
measure: Low Extremity Functionality and Fall Risk
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Muğla
country: Turkey
facility: Mugla Sıtkı Koçman University
Study officials:
References:
Clinical trial NCT04741724: TEDS in Prolonged Mechanical Ventilation
Official title: Effect of Transcutaneous Electrical Diaphragmatic Stimulation in Prolonged Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Ventilation
Keywords: electrical stimulation
diaphragmatic
weaning
Lead sponsor: Chang Gung University
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 59
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Muscle atrophy and diaphragm dysfunction are common with prolonged mechanical ventilation (PMV). Electrical stimulation has been shown to be beneficial in severe chronic heart failure and chronic obstructive pulmonary disease. However, its effect on PMV is unclear. This study examined the effects of transcutaneous electrical diaphragmatic stimulation (TEDS) on respiratory muscle strength and weaning outcomes in patients with PMV.

Detailed description: Subjects on ventilation for ≥21 days were randomly assigned to TEDS or control groups. The TEDS group received muscle electrical stimulation for 30 min/session/day throughout the intervention. Weaning parameters and respiratory muscle strength (Pimax, Pemax) were assessed. The hospitalization outcome, including weaning rate and length of stay, was followed up until discharge.

Eligibility criteria: Inclusion Criteria:

1. age ≥ 20 years;
2. MV for \> 6 h/day for \> 21 days;
3. medical stability

Exclusion Criteria:

1. acute lung or systemic infection,
2. hemodynamic instability,
3. abdominal distention,
4. pregnancy.

Primary outcomes:
measure: breathing frequency
timeFrame: through study completion, an average of 2 weeks
measure: Pimax
timeFrame: through study completion, an average of 2 weeks
measure: Vt
timeFrame: through study completion, an average of 2 weeks
Secondary outcomes:
measure: RCC days
timeFrame: through study completion, an average of 6 weeks
measure: weaning rate
timeFrame: through study completion, an average of 6 weeks
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Dept of Respiratory therapy, Chang Gung University
Study officials:
affiliation: Chang Gung University
name: Yen-Huey Chen, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02533024: Preoperative Prevalence of Ulnar Neuropathy and Changes in Ulnar Nerve Latency During Surgery
Official title: Preoperative Prevalence of Ulnar Neuropathy and Changes in Ulnar Nerve Latency During Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulnar Neuropathy
Lead sponsor: University of Toledo
Sponsor class: OTHER
First posted: 2015-08-26
Enrollment: 4
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is to investigate the incidence of undiagnosed ulnar neuropathy in patients undergoing surgery. The investigators hope to determine if patients with ulnar neuropathy have changes in nerve conduction latency during surgery.

Detailed description: After obtaining an informed consent, the participating subjects will be asked a few questions relating to ulnar nerve dysfunction. Following this the investigators will do a focused physical exam looking for decrement of sensation in the distribution of the ulnar nerve and muscle strength of the hand muscles supplied by the ulnar nerve. After this the subjects will undergo an EMG exam to measure the conduction velocity of the ulnar nerve. Basically the nerve will be stimulated with a small current and the resultant muscle activity of the hand muscle will be picked up using an EKG like patch applied to the skin over the hand. If a subject is diagnosed to have ulnar neuropathy preoperatively the investigators would study the EMG based nerve conduction during surgery at 30-60 minute intervals for the duration of surgery. For purposes of comparison the investigators would measure the ulnar nerve conduction during surgery in age and sex matched controls.

Eligibility criteria: Inclusion Criteria:

* 50 yrs of age or older
* Scheduled to undergo a surgical procedure at UTMC with an anticipated length of 2hours or greater

Exclusion Criteria:

* Less than 50yrs
* Not scheduled for a surgical procedure at UTMC or scheduled for a surgical procedure with an anticipated length of less than 2hours

Primary outcomes:
measure: Prevalence of ulnar neuropathy in patients scheduled to undergo anesthesia and surgery as measured by electromyography
timeFrame: Day 1
Secondary outcomes:
measure: Amplitude (mV)
timeFrame: Day 1
measure: Latency (ms)
timeFrame: Day 1
measure: Velocity (m/s)
timeFrame: Day 1
Other outcomes:
Locations:
city: Toledo
country: United States
facility: University of Toledo
state: Ohio
Study officials:
affiliation: University of Toledo
name: Andrew B Casabianca, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05754424: AT278, NovoRapid® and Humulin® R (U500) in Glucose Clamp Study
Official title: A Phase 1, Single Centre, Single Dose, Randomised, Double-blind, Two-way Crossover, Glucose Clamp Study Investigating the Pharmacodynamics, Pharmacokinetics, and Safety of Ultra-rapid-acting Concentrated Insulin Aspart AT278 in Comparison to Standard Insulin Aspart NovoRapid® With an Additional Open Comparison to Humulin® R U-500 in Participants With Type 2 Diabetes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Arecor Limited
Sponsor class: INDUSTRY
First posted: 2023-03-03
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a phase 1, single dose, randomised, double-blind, two-way crossover study to compare ultra-rapid-acting concentrated insulin aspart AT278 (U500/mL) with standard insulin aspart NovoRapid® (U100/mL) in participants with T2D. Participants and Investigators will be blinded to both study interventions. Humulin® R U-500 (U500/mL), a highly concentrated regular human insulin, will be used as an open-label comparator.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of type 2 diabetes for at least 180 days prior to the day of screening
* Haemoglobin A1C (HbA1c) concentration of ≤9.5% (≤80 mmol/mol) at screening.
* BMI within the range of 25 - 45 kg/m2 (both inclusive)

Exclusion Criteria:

* Known or suspected hypersensitivity to IMPs or related products
* Clinically significant concomitant disease or abnormal lab values
* Severe asthma or chronic obstructive pulmonary disease (GOLD III and IV), or lower if requiring high dose of corticosteroids or beta2-adrenergic agonists

Primary outcomes:
measure: Area under the glucose infusion rate-time curve of insulin aspart
timeFrame: 0 to 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Clinical Trials Unit, Medical University of Graz
Study officials:
References:
Clinical trial NCT05517824: Needle Radiofrequency Treatment for Submental Fat
Official title: Efficacy and Safety of the Micro-insulated Needle Radiofrequency Device for Reduction of Submental Fat
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obese
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2022-08-26
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: prospective, single-blinded, pre-post comparative study
Primary purpose: TREATMENT

Brief summary: The investigators aimed to evaluate the efficacy and safety of a fractional radiofrequency device with a micro-insulated needle to reduce submental fat.


Eligibility criteria: Inclusion Criteria:

* Patients with excess submental fat on a grade of 1\~4, as assessed by the Physician-Assisted Submental Fat Rating Scale

Exclusion Criteria:

* mental impairment, infectious disease
* history of keloid development
* pregnancy, pacemaker
* use of anticoagulants
* undergoing a facelift procedure within the prior 6 months.

Primary outcomes:
measure: Physician-Assisted Submental Fat Rating Scale score from 0 (nothing) to 4 (very severe)
timeFrame: 1 month after the treatment
Secondary outcomes:
measure: submental fat volume (cc)
timeFrame: 1 month after the treatment
measure: patient satisfaction score from 0 (not satisfied) to 10 (most satisfied)
timeFrame: 1 month after the treatment
measure: any adverse effects at any time during or after treatment
timeFrame: assessed through study completion, an average of 2 months
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Chang-Hun Huh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02288624: The Effects of Whole Versus Processed Orange Consumption on Satiety
Official title: A Randomized, Double Blind and Crossover Study Investigating the Effect of Whole Versus Processed Orange Consumption on Satiety in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Satiety Response
Lead sponsor: University of Reading
Sponsor class: OTHER
Collaborators: name: PepsiCo Global R&D
First posted: 2014-11-11
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This is a human dietary intervention study that is randomized and crossover in design with 4 treatment arms consisting of control, orange juice,whole orange, and processed whole orange to investigate the satiety effects of the treatments in healthy volunteers. Self reported hunger and fullness scores by Visual Analogue Scale (VAS) form were collected at different time points prior to and post consumption of each treatment.

Detailed description: This is a human dietary intervention study that is randomized and crossover in design with 4 treatment arms consisting of control, orange juice,whole orange, and processed whole orange to investigate the satiety effects of the treatments in healthy volunteers. Self reported hunger and fullness scores by Visual Analogue Scale (VAS) form were collected at different time points prior to and post consumption of each treatment.

Eligibility criteria: Inclusion Criteria:

* Gender: male or female(postmenopausal women only)
* Age at start of the study: males ≥ 21and ≤ 65 years and females ≥ 50 and ≤ 65 years
* Body Mass Index (BMI) ≥ 18.5 and ≤ 27 kg/m2
* Apparently healthy: measured by questionnaire, no reported current or previous metabolic diseases or chronic gastrointestinal disorders
* Reported dietary habits: no medically prescribed diet, no slimming diet, used to eating 3 meals a day
* Reported intense sporting activities ≤ 10h/w
* Reported alcohol consumption ≤21 units/w
* Informed consent signed
* Recruitment form filled out

Exclusion Criteria:

* Smoking
* Dislike, allergy or intolerance to test products
* Possible eating disorder (measured by SCOFF questionnaire score \>1)
* Eating habits questionnaire score \>14
* Reported medical treatment that may affect eating habits/satiety
* Pre menopausal women

Primary outcomes:
measure: Self reported hunger and fullness score by Visual Analogue Scale
timeFrame: baseline to 2 hours
Secondary outcomes:
measure: Overall liking by '9 point hedonic scale'
timeFrame: baseline to 2 hours
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: Hugh Sinclair Unit of Human Nutrition
state: Berkshire
Study officials:
affiliation: University of Reading
name: Jeremy P Spencer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01885624: Open Label Phase 1 Pharmacokinetics and Tolerability Study of Single TAB08 Administration in Healthy Volunteers
Official title: Open Label Phase 1 Pharmacokinetics and Tolerability Study of Single TAB08 Administration in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Adult Healthy Volunteers
Keywords: TAB08
healthy volunteers
Lead sponsor: Theramab LLC
Sponsor class: INDUSTRY
First posted: 2013-06-25
Enrollment: 31
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to assess safety and tolerability of ascending dosed of TAB08 after single i.v. infusion to the adult healthy volunteers. Additionally were assessed infusion speed tolerability, pharmacokinetics and pharmacodynamics of TAB08 after single i.v. infusion and to explore TAB mechanism-of-action biomarkers.


Eligibility criteria: Inclusion Criteria:

* Adult man aged from 18 to 40 years, who agreed to use adequate contraception.
* Body mass is at least 60 kg and BMI is within 20-27
* Volunteer is in good physical and mental health, as per his medical history and assessment results
* Volunteer's laboratory values are normal (or not clinically significant as per Investigator discretion) at screening, including baseline cytokines levels as per RESTORE test results
* Volunteer has signed the informed concent.

Exclusion Criteria:

* Any chronic or relapsing illness in the medical history
* Any abnormal assessment or laboratory result at screening, which is clinically significant as per Investigator discretion
* Active tuberculosis at the time of screening
* Any acute illness at the time of study enrollment
* Any blood donation within 4 weeks before Study Day 1
* Positive result for HBsAG, Hepatitis C, HIV
* Continuous use af any medications
* Use of any medications within 72 hours before study drug infusion
* Use of an investigational treatment within 4 weeks before screening, or within a period of 5 half-lives of the investigational treatment, whichever is longer
* High inflammatory cytokines levels as per RESTORE test results after ex vivo PBMC testing

Primary outcomes:
measure: Incidence of dose-limiting toxicity in every dose cohort
timeFrame: From study drug infusion (Day 1) untill the end of study (Day 71/141)
Secondary outcomes:
Other outcomes:
Locations:
city: Yaroslavl
country: Russian Federation
facility: Clinical Emergency Hospital of Yaroslavl
Study officials:
affiliation: Clinical Emergency Hospital of Yaroslavl
name: Olga B Ershova, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04819334: Effect of Amino Acid Addition to a Drink on the Appearance of Ingested Water in Body Fluids1
Official title: Effect of Amino Acid Addition to a Drink on the Appearance of Ingested Water in Body Fluids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rate of Water Appearance/Delivery in the Blood Water Balance
Lead sponsor: Loughborough University
Sponsor class: OTHER
Collaborators: name: Entrinsic Beverage Company LLC
First posted: 2021-03-26
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double-blind, randomised, crossover design
Primary purpose: BASIC_SCIENCE

Brief summary: To determine the effects of a moderate amount of amino acids on the rate of water absorption and availability as a precursor fluid for sweat. Young and healthy (male or female) volunteers will take part in three experimental trials. In each trial, volunteers will be given one of two commercially available sports drinks or a commercially available sport drink with added amino acids in a double-blinded, randomised, crossover design. Each drink will be a single 600 mL bolus. All beverages will be labelled with deuterium (D2O). Trials will be compared for temporal accumulation of deuterium in plasma over the course of 60 minutes. Whole blood measurements of haemoglobin and haematocrit will also be made and plasma volume changes calculated. It is hypothesised that the amino acid trial will increase the rate of fluid absorption.


Eligibility criteria: Inclusion Criteria:

* Generally fit and healthy (determined by health screen questionnaire)
* Recreationally active (minimum 3 hours of physical activity per week including walking)

Exclusion Criteria:

* Any cardiovascular, gastrointestinal, renal or acute/chronic health conditions that may influence the outcomes
* Smoking (including vaping)
* BMI of greater than 30 (combined with a body fat percentage greater than 20%) or BMI lower than 17.5

Primary outcomes:
measure: Time at which drink absorption rate was maximum (t1)
timeFrame: 60 minutes
measure: Time at which drink absorption rate returned to 0 (t2)
timeFrame: 60 minutes
measure: Time at which 50% of drink was absorbed (t1/2)
timeFrame: 60 minutes
measure: Maximum absorption rate of drink
timeFrame: 60 minutes
measure: Area under the curve for D2O
timeFrame: 60 minutes
Secondary outcomes:
measure: Plasma volume
timeFrame: 60 minutes
measure: Plasma osmolality
timeFrame: 60 minutes
measure: Plasma glucose concentration
timeFrame: 60 minutes
measure: Plasma lactate concentration
timeFrame: 60 minutes
measure: Plasma creatinine concentration
timeFrame: 60 minutes
measure: Plasma amino acid concentration
timeFrame: 60 minutes
measure: Urinary specific gravity
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Loughborough
country: United Kingdom
facility: Loughborough University
state: Leicestershire
Study officials:
References:
Clinical trial NCT04290234: Childhood Trauma and Escape Decision Dynamics
Official title: The Influence of Childhood Maltreatment on Cognitive and Reactive Fear
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Child Abuse
Fear
Keywords: cognitive fear
fMRI
reactive fear
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
Collaborators: name: Prof. Dean Mobbs
First posted: 2020-02-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from a community sample and childhood maltreatment will be assessed with the Childhood Trauma Questionnaire.

Brief summary: The purpose of this study is to evaluate the effects of childhood maltreatment on cognitive and reactive fear.

Detailed description: Childhood maltreatment dramatically increases the risk for psychiatric disorders accompanied by profound difficulties in social interactions. However, it is still unclear how childhood maltreatment affects social interactions in adulthood. In this study, we examine how childhood maltreatment may modulate threat sensitivity assessed by the distance at which an individual flees from an approaching threat. While rapid escape decisions rely on "reactive fear" circuits, slower escape decisions are associated with "cognitive fear" circuits. Based on previous observations of altered early sensory processing, we expect that childhood maltreatment affects both cognitive and reactive fear circuits.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects with varying levels of childhood maltreatment

Exclusion Criteria:

* current psychiatric illness
* current psychiatric medication or psychotherapy
* MRI contraindication (e.g. metal in body, claustrophobia)
* pregnancy

Primary outcomes:
measure: Neural responses in the flight initiation distance (FID) task
timeFrame: fMRI paradigm with an average duration of 45 minutes
measure: Flight distance in the flight initiation distance (FID) task
timeFrame: fMRI paradigm with an average duration of 45 minutes
measure: Difficulty ratings in the flight initiation distance (FID) task
timeFrame: fMRI paradigm with an average duration of 45 minutes
measure: Confidence ratings in the flight initiation distance (FID) task
timeFrame: fMRI paradigm with an average duration of 45 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Department of Psychiatry, University of Bonn
Study officials:
affiliation: University of Bonn
name: Dirk Scheele, PhD
role: PRINCIPAL_INVESTIGATOR
References: