louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04233541: Frailty Status and Increased Risk for Falls
Official title: Frailty Status and Increased Risk for Falls: The Role of Anticholinergic Burden
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Frailty
Fall
Anticholinergic Toxicity
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 1000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Community-dwelling older subjects admitted to the Geriatrics Outpatient Clinic

Brief summary: We hypothesized that the use of anticholinergic medications may precipitate falls differently by frailty status in older adults. Community-dwelling older subjects admitted to the Geriatrics Outpatient Clinic prospectively enter into the study. Frailty status is defined according to the Physical Frailty Phenotype. The drugs are categorized according to the ACB scale

Detailed description: Previous studies have found that the use of drugs with anticholinergic properties relate to increased prevalence of falls in older women and men. Frailty is associated with serious health outcomes including falls, hip fractures, and death. Frailty can be a relevant target to investigate its association with the risk of falls among the users of drugs with anticholinergic properties. A recent evidence suggests that the interaction between being frail and adverse outcomes in older adults receiving polypharmacy or centrally acting drugs is complex and not straightforward across all frailty phenotypes.

We classify the participants frail if they met at least three of five criteria, while those having one or two criteria were pre-frail, and others were non-frail. We determine the anticholinergic burden by using the Anticholinergic Cognitive Burden (ACB) Scale developed by Boustani et al.

Eligibility criteria: Inclusion Criteria:

* Community-dwelling older adults

Exclusion Criteria:

* a history of dementia,
* current delirium or psychotic symptoms,
* taking antipsychotic medications,
* being functionally dependent to others,
* difficulty in communicating with the interviewer,
* terminal illness,
* being bedridden or wheelchair bound (≥2 weeks),
* difficulty in standing or walking,
* incomplete data

Primary outcomes:
measure: Fall assessment
timeFrame: 1-2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gulhane Faculty of Medicine & Gulhane Training and Research Hospital
Study officials:
affiliation: Gulhane Faculty of Medicine & Gulhane Training and Research Hospital
name: Ilker Tasci, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05212441: ADJUNCTIVE EFFECT OF LIGHT EMITTING DIODE ON HAND GRIP STRENGTH IN BURN PATIENTS
Official title: ADJUNCTIVE EFFECT OF LIGHT EMITTING DIODE ON HAND GRIP STRENGTH IN BURN PATIENTS: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Burns
Hand Burn
Hand Grasp
Hand Injuries
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be done to evaluate effect of applying LED before hand exercise on hand grip strength. Sixty male patients with subacute partial thickness burn of hand will be randomly allocated into two equal groups of 30 patients. The following equipment and tools will be used

Measurement equipments:

* For total active motion of fingers (TAM): Goniometer.
* For hand grip strength: Hand grip dynamometer.

Therapeutic equipment:

Light emitting diode therapy (LED) device.


Eligibility criteria: Inclusion Criteria:

The subject selection will be according to the following criteria:

* Burn caused by thermal injury (flame or scald) with involvement of the wrist and hand and other parts of the body not including shoulder and elbow.
* Age range between 20-35 years.
* Male gender.
* Subacute Partial-thickness burn " From 3rd day of burn".
* Recent discharge of in patient acute care, spontaneous healing.
* All patients enrolled to the study will have their informed consent.

Exclusion Criteria:

The potential participants will be excluded if they meet one of the following criteria:

* Cardiac diseases.
* Perception of persistent respiratory problem related to a previous inhalation injury
* Signs of burn infection (i.e., unclear fluid oozing from the wound, increased pain, expanded redness and swelling)
* Exposed tendons.
* Nerve, muscle injury.
* Scar contracture of hand.
* Cognitive disorders.
* Presence of fractures.
* Patients who suffer from skin diseases, diabetes, varicose veins, and peripheral vascular diseases.
* Patients with life threatening disorders as renal failure, myocardial infarction or other similar diseases will be excluded from the study.

Primary outcomes:
measure: Changes in Total active ROM from baseline to 6 weeks posttreatment
timeFrame: baseline and 6 weeks posttreatment
measure: Changes in hand grip strength from baseline to 6 weeks posttreatment
timeFrame: baseline and 6 weeks posttreatment
Secondary outcomes:
Other outcomes:
Locations:
city: Al Ḩayy Ath Thāmin
country: Egypt
facility: October 6 University Hospital
state: Giza
Study officials:
References:
Clinical trial NCT02210741: Next-generation Sequencing (NGS) of Peripheral Blood Immune Repertoire in Graves' Disease
Official title: Next-generation Sequencing (NGS) of Peripheral Blood Immune Repertoire in Graves' Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Graves Disease
Keywords: immune repertoire
Graves' disease
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2014-08-07
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient from our hospital, National Taiwan University Hospital

Brief summary: Graves' disease (MIM 27500) is the leading cause of hyperthyroidism worldwide. The prevalence of Graves' disease is quite high (2.7% in women), and there is solid evidence of genetic predisposition. Despite its clinical and scientific significance, Graves' disease is still mysterious in terms of its susceptibility genes or pathophysiological mechanisms. The immune repertoire, being the sum of T and B lymphocytes in a body at any given time, is both a snapshot and a historical record of a person's immune function. Thanks to the power of next-generation sequencing (NGS), massively parallel sequencing of the B cell and T cell receptors suddenly becomes plausible, and opens a door for many creative approaches to study immune related diseases. The ultimate goal of this project is to use both the NGS deep sequencing and immune repertoire experiment to perform Graves' disease sub-group genetic fine mapping, and to identify Graves' disease-specific T cell and B cell receptors. Furthermore, using the immune repertoire approach, investigators want to study the critical epitopes of thyroid auto-antigens, and to delineate the pathophysiological steps in various disease stages and in various sub-groups. Investigators expect to solve the immune repertoire of Graves' disease of different sub-group presentations and at various disease activity stages.


Eligibility criteria: Patients with Graves disease

Primary outcomes:
measure: B lymphocyte and T lymphocyte receptor profiles of Graves' disease patients
timeFrame: Three years
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Professor of Department of Internal Medicine, National Taiwan University
name: Tien-Chun Chang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02626741: Effect of a Meal Replacement on Weight Loss Obesity Patients With Metabolic Syndrome
Official title: Effect of a Meal Replacement on Weight Loss Obesity Patients With Metabolic Syndrome : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Abdominal Obesity-Metabolic Syndrome
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2015-12-10
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether meal replacement, SlimWell ®, is effective in the treatment of obesity patients with metabolic syndrome.

Detailed description: The participants are divided into two groups: intervention group and control group. In the intervention group, the participants receive a meal replacement plus life style modification. In the control group, the participants receive only life style modification.

Sample size calculation is 69 participants per group. Primary outcome is to compare the weight loss between the intervention group and control group.

Eligibility criteria: Inclusion Criteria:

* Body mass index more than or equal to 25 kg/m2
* Patients with metabolic syndrome
* Patients who are on anti-hypertensive drugs, oral hypoglycemic drugs and lipid lowering drugs.

Exclusion Criteria:

* Uncontrolled diabetes patients
* Patients with gastrointestinal abnormalities
* Patients with cardiovascular diseases
* Patients with hematologic disorders
* Patients with Glomerular filtration rate less than 60 ml/min/1.73m2
* Patients with drug or alcohol abuse
* Pregnancy and lactation

Primary outcomes:
measure: Participants with weight loss unit in kilograms
timeFrame: 3 months
Secondary outcomes:
measure: Participants with waist circumference change in centimeters
timeFrame: 3 months
measure: Participants with triglyceride change in mg/dl.
timeFrame: 3 months
measure: Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study meal replacement, Graded According to NCI CTCAE Version 3.0
timeFrame: 3 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital, Mahidol University
Study officials:
affiliation: Mahidol University
name: Kusuma Chaiyasoot, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leader NJ, Ryan L, Molyneaux L, Yue DK. How best to use partial meal replacement in managing overweight or obese patients with poorly controlled type 2 diabetes. Obesity (Silver Spring). 2013 Feb;21(2):251-3. doi: 10.1002/oby.20057.
Clinical trial NCT00606541: An Open Label, Double-blind Discontinuation Study of Quetiapine Extended Release(XR)
Official title: An Open Label, Double-blind Discontinuation Study of Quetiapine (Extended Release) XR in Social Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Social Anxiety Disorder
Keywords: Social Anxiety Disorder
Quetiapine XR
Prevention
tolerability
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2008-02-04
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Purpose of Study: To examine 1) the short and long-term effectiveness and tolerability of quetiapine (extended release) XR for the treatment of social anxiety disorder (SAD); and 2) continuation effects of quetiapine XR in preventing SAD relapse.


Eligibility criteria: Inclusion Criteria:

* Adults 18-65 years of age
* A primary diagnosis of SAD,using Diagnostic Standard Manual IV(DSM-IV) criteria
* Minimum CGI severity score of 4 and minimum Brief Social Phobia Scale (BSPS) score of 20 at baseline
* Written informed consent
* A negative serum pregnancy test for women of childbearing potential.

Exclusion Criteria:

* Current DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, mental retardation or other pervasive developmental disorder, or cognitive disorder due to a general medical condition
* Any current primary anxiety disorder other than SAD or current primary depression
* History of substance abuse or dependence within the last 6 months
* Suicide risk or serious suicide attempt within the last year
* Clinically significant medical condition or laboratory abnormality
* Women of childbearing potential who are unwilling to practice an acceptable method of contraception
* Subjects needing concurrent use of psychotropic medications
* History of hypersensitivity to quetiapine
* History of cataracts.

Primary outcomes:
measure: Kaplan Meier survival of Clinical Global Impression of Improvement (CGI-I)
timeFrame: 20 weeks
Secondary outcomes:
measure: Percentage of CGI-I, BSPS, SPIN
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Wei Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03473041: Autologous Rectus Sheath Fascia Versus Midurethral Transobturator Tension Free Vaginal
Official title: Surgeon Tailored Hybrid Autologus Rectus Sheath Fascia Versus Midurethral Transobturator Tension Free Vaginal Tape For Treatment Of Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Stress Urinary Incontinence
Keywords: female stress incontinence
Transobturator tension free vaginal tape TVTO
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2018-03-21
Enrollment: 140
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: a hybrid sling formed of a central part of autologus rectus sheath (2×6 cm) and two arms of polypropylene mesh (2×10cm) versus transobturator tension free vaginal tape(TVT-O)

Detailed description: a surgeon tailored hybrid sling formed of a central part of autologus rectus sheath (2×6 cm) and two arms of polypropylene mesh (2×10cm) is used for treatment of urinary stree incontinence and its efficacy is compared to transobturator tension free vaginal tape (TVT-O) conventional mid urethral sling

Eligibility criteria: Inclusion Criteria:

* stress urinary incontinence

Exclusion Criteria:

* previous surgery for stress incontinence

Primary outcomes:
measure: cure rate
timeFrame: 1 year follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr El Ainiy Hospital
Study officials:
References:
Clinical trial NCT04297241: Nitrate Effect on Exercise Capacitance
Official title: Nitrate Effect on Exercise Capacitance and Hemodynamic Profile Prior to Fontan Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fontan
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2020-03-05
Enrollment: 20
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators will investigate the safety and preliminary efficacy of ISDN therapy to reduce venous congestion and improve exercise tolerance in children and adults after the Fontan operation. This will be accomplished by recruiting 15 Fontan physiology patients from the Cincinnati Children's Fontan clinic and University of Kentucky Pediatric Cardiology clinic for the investigation. The investigators will non-invasively measure both central venous pressures at rest and during graded cardiopulmonary exercise testing. In addition the study team will obtain a measurement of liver stiffness before and after a 4-week regimen of ISDN therapy. Patients will be seen twice in clinic, once before and after ISDN therapy, and phone calls will be made to ensure safety, compliance, and make appropriate alterations to medications throughout the study period. Pre- and post-intervention central venous pressure and exercise tolerance will be compared.


Eligibility criteria: Inclusion Criteria:

* Underlying Fontan physiology
* On a stable medication regimen for the past 3 months
* Nine years of age or older

Exclusion Criteria:

* Pregnant or nursing
* Prior hospitalization for heart failure in past year
* Presence of uncontrolled arrhythmias within the past 6 months
* Non-cardiac conditions which significantly limited exercise
* Moderate or severe ventricular dysfunction by echocardiogram or cardiac MRI
* Currently treated with a phosphodiesterase-5 inhibitor or organic nitrates
* Concurrent enrollment in other investigational drug trial
* End stage Liver Disease (ESLD)

Primary outcomes:
measure: Number of Participants Who Experience an Adverse Reaction to the Study Medication During the Study Enrollment Period.
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Effect of Isosorbide Dinitrate on Liver Stiffness Levels
timeFrame: Baseline and 6 weeks
measure: Effect of Isosorbide Dinitrate on Central Venous Pressure
timeFrame: Baseline and 6 weeks
measure: Effect of Isosorbide Dinitrate on Maximal Exercise Capacity VO2 Max
timeFrame: Baseline and 6 weeks
measure: Effect of Isosorbide Dinitrate on Maximal Exercise Capacity Heart Rate Response
timeFrame: Baseline and 6 weeks
measure: Effect of Isosorbide Dinitrate on Maximal Exercise Capacity Respiratory Rate Response
timeFrame: Baseline and 6 weeks
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Childrens Hospital Medical Center
state: Ohio
Study officials:
References:
Clinical trial NCT03547141: Pharmacodynamic and Safety of MBA-P01 in Healthy Male Volunteers
Official title: A Randomized, Double-blind, Active-controlled, Single-center, Phase 1 Study to Determine the Pharmacodynamic and Safety of MBA-P01 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Medy-Tox
Sponsor class: INDUSTRY
First posted: 2018-06-06
Enrollment: 28
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To determine the pharmacodynamic and safety of MBA-P01 in Healthy Male Volunteers


Eligibility criteria: Inclusion Criteria:

* Male adults aged between 20 and 45 years

Exclusion Criteria:

* Subjects not appropriate for participating in this study according to the investigator's opinion

Primary outcomes:
measure: to estimate the pharmacodynamic aspects of muscle
timeFrame: day 3, 14, week 4, 8, 12
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, St. Paul's Hospital
Study officials:
affiliation: The Catholic University, St. Paul's Hospital
name: Myungeun Chung
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04618341: A Clinical Study of Online Active Play Program With Adolescents
Official title: A Clinical Study of Online Active Play Program With Adolescents During COVID-19 Lockdown
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety
Depression
Keywords: Adolescents
Online Active Revival Program
Lead sponsor: Revival Active
Sponsor class: OTHER
Collaborators: name: L.E.A.D
name: Aarogyam UK
First posted: 2020-11-05
Enrollment: 32
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children who has attended online Revival Active Program (RAP) during COVID-19 lockdown

Brief summary: To assess the efficacy of an online, active play program (Revival Active Program) in reducing the symptoms of anxiety and depression in community-based adolescents,, a retrospective community based participatory research was conducted with 32 adolescents aged between 11-17 years old.

Program was conducted during Covid-19 lockdown from March 2020 to June 2020 to support children and families in isolation.


Eligibility criteria: Inclusion Criteria:

* Children at the online program for whole duration
* indicating a symptom level of, at minimum, above mean on anxiety and/or depression on self-report measures
* Parental consent before stating the program

Exclusion Criteria:

* Children at normal levels of mental health screening
* Children who did not complete the intervention period

Primary outcomes:
measure: Anxiety
timeFrame: Change from baseline anxiety at 6 weeks
measure: Depression
timeFrame: Change from baseline depression at 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: Revival Active
state: Leicestershire
Study officials:
affiliation: Revival Active Limited
name: Rakesh Patel
role: STUDY_DIRECTOR
affiliation: Revival Active Limited
name: Tejal Patel
role: STUDY_DIRECTOR
affiliation: Aarogyam UK
name: Nagamani Krishnamurthy
role: PRINCIPAL_INVESTIGATOR
References: