louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00785746: Improving Balance in Frail Elderly
Official title: Improving Balance in Frail Elderly: A Randomized Clinical Trial of Two Methods to Enhance Strength (Stretch and Strength Versus Core Strength)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Elderly
Frail
Keywords: elderly, balance, core, strength
Lead sponsor: McGill University
Sponsor class: OTHER
First posted: 2008-11-05
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The objective of this pilot study is to estimate, for a frail elderly population, the extent to which balance improves following a Core-Strength training program in comparison to a Stretch \& Strength program. A secondary objective is to explore the impact of core strength training on urinary incontinence.

Detailed description: Participants will be randomized to one of the two exercise groups, Core-Strength training group or the Stretch \& Strength group. The exercises will consist of 15-20 minute session for every day they attend the GDH. Measures will be made at admission, after 6 weeks of the program and at discharge if more than past 6 weeks.

Eligibility criteria: Inclusion Criteria:

* elderly persons attending the geriatric day hospital at the royal victoria hospital

Exclusion Criteria:

* persons who are not medically fit to participate in the Geriatric day hospital physiotherapy component.
* the individuals at high risk for falls

Primary outcomes:
measure: Berg balance scale
timeFrame: baseline, 6 weeks, discharge
Secondary outcomes:
measure: Functional walking capacity 6 minute walk test
timeFrame: baseline, 6 weeks, discharge
measure: Gait speed
timeFrame: baseline, 6 weeks, discharge
measure: Bridge Test
timeFrame: Baseline, 6 weeks, discharge
measure: Activities-Specific Balance Confidence Scale (ABC Scale)
timeFrame: Baseline, 6 weeks, Discharge
measure: International Consultation on Urinary Incontinence Questionnaire- Urinary Incontinence Short Form (ICIQ-UI)
timeFrame: Baseline, 6 weeks, discharge
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University-Royal Victoria Hospital Site
state: Quebec
Study officials:
affiliation: McGill University, Division of Clinical Epidemiology
name: Nancy E Mayo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02191046: Effect of Squeezable Bottle Nasal Irrigation Device in Children With Sinusitis
Official title: A Randomized- Controlled Study Comparing the Effect of Squeezable Bottle Nasal Irrigation Device With Syringe in Children With Sinusitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sinusitis
Keywords: nasal irrigation
sinusitis
children
buffered hypertonic saline
nasal irrigation device
Lead sponsor: Thammasat University
Sponsor class: OTHER
First posted: 2014-07-15
Enrollment: 80
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to the effect of squeezable bottle nasal irrigation device with syringe in children with sinusitis in symptom score and satisfaction to nasal irrigation

Detailed description: sinusitis is the one of common diseases in Thailand. Nasal irrigation has been used as an adjunctive treatment.In previous study shown that buffer hypertonic nasal irrigation have more effective to decrease symptom in patient sinonasal disease when compare to normal saline.Until now, there are no clear data comparing the effectiveness on sinonasal symptom of the various devices use in children with sinusitis. The purpose of this study was to compare the effect of squeezable bottle nasal irrigation device with syringe in children with sinusitis in symptom score and satisfaction to nasal irrigation.

Eligibility criteria: Inclusion Criteria:

1. age 3-15 years
2. diagnose sinusitis by each of following criteria 2.1 persistent upper respiratory infection symptoms \> or = 10 days 2.2. severe upper respiratory infection symptom with greenish discharge per nose or periorbital swelling 2.3 double sickening of upper respiratory infection symptoms

Exclusion Criteria:

1. patient who has history of penicillin allergy
2. patient who has complication of sinusitis
3. patient with a history of nasal anatomical defects
4. patient who has immune deficiency or primary ciliary dyskinesia

Primary outcomes:
measure: the Effect of Squeezable Bottle and Syringe on Clinical Effectiveness in Sinusitis Children
timeFrame: compare 5S-score of both group at 2 week and at baseline visit .compare the mean 5S-score and satisfaction score between both group at 2 weeks after treatment
Secondary outcomes:
measure: the Contamination in Nasal Irrigation Devices
timeFrame: at second week after treatment
Other outcomes:
Locations:
city: Klongluang
country: Thailand
facility: Araya Satdhabudha
state: Pratumthanee
Study officials:
affiliation: Thammasat University
name: Araya Satdhabudha, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05049304: Prevention With Oleanolic Acid of Insulin Resistance
Official title: Prevention With Oleanolic Acid of Insulin Resistance and Metabolic Syndrome in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Metabolic Syndrome
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2021-09-20
Enrollment: 22
Sex: ALL
Minimum age (years): 16
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Oleanolic acid (OA), a triterpene that is highly present in olive leaves, has been proposed as component of functional foods in the prevention of metabolic syndrome due to its anti-inflammatory activity. In this research project we will study the presence of OA in postprandial TRL in healthy adolescents and in normal weight. Moreover, THP-1 macrophages will be incubated with LPS for 48h after pretreatment with OA at different concentrations. Also, TRL will be isolated from healthy adolescents before and 2 and 5h postprandially after the intake of a meal containing the functional olive oil or common olive oil and incubated with THP-1 macrophages.


Eligibility criteria: Inclusion Criteria:

-Participants without digestive, metabolic or oncologic disorders or any other pathology

Exclusion Criteria:

-Not having the informed consent signed by the parents

Primary outcomes:
measure: Pro-inflammatory cytokines
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Faculty of Health Sciences (University of Granada)
Study officials:
References:
Clinical trial NCT00938704: Study to Compare the Efficacy and Safety of Two Non-Preserved Artificial Tears for the Treatment of Dry Eye Signs and Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye Syndromes
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2009-07-14
Enrollment: 71
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: To compare the efficacy and safety of two non-preserved artificial tears, (carboxymethylcellulose 0.5%, + glycerin 0.9% vs. sodium hyaluronate 0.18%) eye drops for the treatment of the signs and symptoms of dry eye disease.


Eligibility criteria: Inclusion Criteria:

* Current use of an artificial tear product at least 2 times per day (e.g. for relief of dry eye symptoms of dryness).
* Be likely to complete the entire course of study and to comply with appropriate instructions

Exclusion Criteria:

* Have undergone refractive surgery (e.g., cataract surgery, PRK, LASIK, or any surgery involving a limbal or corneal incision) within the last 12 months.
* Have uncontrolled systemic disease
* Are currently using, or have used within 14 days of study enrollment, any ocular medications other than artificial tears
* Have anticipated contact lens wear during the study
* Have an active ocular infection

Primary outcomes:
measure: Change From Baseline in Ocular Surface Disease Index (OSDI) at Week 2
timeFrame: Baseline, Week 2
Secondary outcomes:
measure: Change From Baseline in Tear Breakup Time (TBUT) at Week 2
timeFrame: Baseline, Week 2
measure: Change From Baseline in Corneal Staining at Week 2
timeFrame: Baseline, Week 2
measure: Change From Baseline in Conjunctival Staining (Temporal) at Week 2
timeFrame: Baseline, Week 2
measure: Change From Baseline in Conjunctival Staining (Nasal) at Week 2
timeFrame: Baseline, Week 2
Other outcomes:
Locations:
city: Ulm
country: Germany
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04097704: Pharmacogenetics Sampling of the CC-90007-CP-003 Study Cohort
Official title: An Observational Follow-on Study to Describe the Pharmacogenetics of the CC-90007-CP-003 Study Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatic Insufficiency
Keywords: Hepatic impairment
CC-90007-CP-003
Healthy Subject
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2019-09-20
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 28 subjects from the CC-90007-CP-003 study (from any race, males or non-pregnant and non-nursing females) will be enrolled. The study will be conducted at approximately 3 sites in the US that participated in the CC-90007-CP-003 study. Subjects may not be replaced with subjects that did not participate in the CC-90007-CP-003 study.

Brief summary: This is a multi-center observational follow-up study to collect saliva samples that allow pharmacogenetic analysis of the subjects that participated in the CC-90007-CP-003 study.

Approximately 28 subjects with moderate and severe hepatic impairment and healthy control subjects with normal hepatic function will be enrolled.


Eligibility criteria: Inclusion Criteria:

Each subject must satisfy all of the following criteria to be enrolled in this study:

1. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
2. Subject is able to communicate with the Investigator, understand and comply with the requirements of the study, and agree to adhere to restrictions and examination schedules and other protocol requirements.
3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
4. Subject participated in the CC-90007-CP-003 study.

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

1. Subject has any condition which places the subject at unacceptable risk if he/she were to participate in the study.
2. Subject has any condition that confounds the ability to interpret data from the study.

Sponsor's medical monitor should be consulted on suspected conditions under this exclusion criterion, prior to exclusion.

Primary outcomes:
measure: Percentage of subjects whose primary saliva sample yields DNA that meets modified PharmacoScan® workflow acceptability criteria
timeFrame: Day 1
Secondary outcomes:
measure: Adverse Events (AEs)
timeFrame: Time from ICF to Day 1
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Pharmacology of Miami, LLC
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center OCRC
state: Florida
city: Knoxville
country: United States
facility: Volunteer Research Group and New Orleans Center for Clinical Research - Knoxville
state: Tennessee
Study officials:
affiliation: Celgene Corporation
name: Leon Carayannopoulos, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02212704: Verticality Perception - Multisensory Contribution
Official title: Verticality Perception - Dissociating Head and Trunk Contributors in Healthy Human Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Verticality Perception in Healthy Human Subjects
Individual Contribution of Different Sensory Systems
Keywords: vestibular
proprioception
spatial orientation
bayesian
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2014-08-08
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the relative contribution of head- and trunk-based sensory systems to internal estimates of direction of gravity in healthy human subjects. To implement this assessment experimentally, the investigators will use a motor-driven 3D-turntable and a thermoplastic mask to keep the head in a stable, either roll-tilted (±30°) or aligned with the trunk. The investigators will then obtain measurements of the subjective visual vertical in seven different whole-body roll positions (max. 90° roll-tilt). Analysis will be driven by a state-of-the art Bayesian integration model. The investigators hypothesize that different sensory input signals are combined in a statistically optimal fashion.


Eligibility criteria: Inclusion Criteria:

* ages 18-60 years
* informed consent
* absence of exclusion criteria

Exclusion Criteria:

* peripheral-vestibular deficit
* disturbed consciousness
* history of sensory deficits
* visual field deficits
* other neurological or systemic disorder which can cause dementia or cognitive dysfunction
* intake of antidepressants, sedatives, or neuroleptics
* pregnancy, unless excluded by a negative pregnancy test
* known neck pain or status post neck trauma

Primary outcomes:
measure: Accuracy and precision of SVV adjustments in different head and trunk roll-tilt positions
timeFrame: During the turntable measurement (90 minutes)
Secondary outcomes:
measure: relative contribution of head- and trunk-based sensory systems based on Bayesian modelling
timeFrame: while on the turntable (1.5 hours)
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Dept. of Neurology
state: ZH
Study officials:
affiliation: University Hospital Zurich, Dept. of Neurology
name: Dominik Straumann, Prof, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004404: Study of Clotrimazole and Hydroxyurea in Patients With Sickle Cell Syndromes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Anemia
Keywords: genetic diseases and dysmorphic syndromes
hematologic disorders
rare disease
sickle cell anemia
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
First posted: 1999-10-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

Determine the effectiveness of the combined use of clotrimazole and hydroxyurea on a specific panel of red cell characteristics in patients with sickle cell syndromes.

Detailed description: PROTOCOL OUTLINE:

Patients receive oral hydroxyurea either once or twice daily plus oral clotrimazole twice daily after meals for 6 months. Patients are assessed at 3 and 6 months during treatment.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Sickle cell syndromes characterized by vaso-occlusive crises sufficiently severe to require prophylactic therapy Three or more crises per year sufficiently severe to require hospitalization Stable dose of hydroxyurea for at least 4 months required --Prior/Concurrent Therapy-- No treatment with any other antisickling agents within the past 4 months Biologic therapy: No transfusion within 90 days No concurrent chronic transfusions allowed (defined as more than one transfusion per month for 2 or more months) Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No chronic medications that alter neurologic, renal, or hepatic functions

* Patient Characteristics-- Performance status: Karnofsky 70-100% Hematopoietic: WBC within normal limits Platelet count within normal limits Hepatic: No history of chronic liver disease Bilirubin less than 2 times normal SGOT and SGPT less than 2.5 times normal No severe hepatic damage Renal: Creatinine within normal limits No severe renal damage Neurologic: No severe neurologic impairment No recent or progressive neurologic impairment Other: Not pregnant Fertile patients must use effective contraception No allergies to hydroxyurea or clotrimazole

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Children's Hospital - Boston
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Carlo Brugnara
role: STUDY_CHAIR
References:
Clinical trial NCT07013604: Sarcopenia and Intervention Physical Therapy
Official title: Effectiveness of Neuromuscular Electrical Stimulation Versus Low-load Resistance Training With Blood Flow Restriction in Elderly Individuals With Sarcopenia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sarcopenia
Lead sponsor: Pharos University in Alexandria
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study follows a randomised controlled trial (RCT) design involving 60 elderly participants aged 60-75 years diagnosed with sarcopenia according to EWGSOP2 criteria. Participants will be randomly assigned to three groups (n = 20 each).
Primary purpose: TREATMENT

Brief summary: To evaluate and compare the effectiveness of neuromuscular electrical stimulation (NMES) and low-load resistance training with blood flow restriction (BFR) in improving muscle mass, strength, functional performance, and quality of life in elderly individuals diagnosed with sarcopenia

Detailed description: Sarcopenia, the age-related decline in muscle mass, strength, and function, significantly affects the health and independence of elderly individuals. It increases the risk of frailty, falls, and disability. Neuromuscular electrical stimulation (NMES) and low-load resistance training with blood flow restriction (BFR) are promising rehabilitation strategies for older adults with limited physical capacity. This study aims to compare the effectiveness of NMES and BFR in managing sarcopenia and improving physical and functional outcomes in the elderly

Eligibility criteria: Inclusion Criteria:

* Older age (≥ 60-75 years)

Low muscle strength (e.g., low handgrip strength)

Low muscle mass (e.g., ASM/height² below cutoff)

Exclusion Criteria:

* heart disese
* kidny disese
* autoimune disese
* cognetive disorder
* sever form of sarcopenia

Primary outcomes:
measure: Change in Muscle Mass
timeFrame: 2 month
Secondary outcomes:
measure: Muscle Strength Handheld dynamometer (e.g., MicroFET)
timeFrame: 2 month
measure: Timed Up and Go (TUG) Test
timeFrame: 2 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06814704: Effect of Intraabdominal Hypopressive Exercises on Postnatal Backache and Functional Disability
Official title: Effect of Intraabdominal Hypopressive Exercises on Postnatal Backache and Functional Disability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: postpartum
low back pain
Quality of life
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 38
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the effectiveness of hypopressive exercise in postpartum females with abnormal hyperlordosis and back pain.

Hypopressive exercises are safe and beneficial for new moms, as they can be started soon after delivery. They help strengthen postural muscles, reduce back pain, and manage pain by reducing intra-abdominal pressure, increasing activity of postural musculature, and normalizing myofascial tension.

Detailed description: 38 postpartum women with abnormal hyperlordosis. The women were then divided into two equal groups. Group A(n=19) received hypopressive abdominal exercise along with traditional treatment for lower back pain (LBP), while Group B(n=19) received the same treatment without hypopressive exercise. The main outcomes measured were the the Revised Short McGill Pain Questionnaire Version-2, the lumbar lordotic angle, and the patient-specific functional scale.

Eligibility criteria: Inclusion Criteria:

- participants must have a healthy pregnancy, a typical vaginal birth, LBP that existed 24 weeks after giving birth, and functional limitations in daily activities. The study only allowed women aged 20-35 with no more than two prior pregnancies and a BMI of less than 25 kg/m2 to participate.

Exclusion Criteria:

* women who under pharmacological or psychological treatment, had pelvic tumors, lumbar disk herniation, heart disease, hypertension, lumbar spine tumors, chronic uterine prolapse, chronic pelvic pain, lumbar spondylosis, or lumbar spondylolisthesis.

Primary outcomes:
measure: Pain assessment
timeFrame: Pain assessment at the end of the study up to 8 weeks
Secondary outcomes:
measure: Assessment of functional disability
timeFrame: This scale will be done for each case at the end of the study up to 8 weeks
Other outcomes:
measure: Assessment of lumbar lordotic angle
timeFrame: It will be done for each case at the end of the study up to 8 weeks
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Kafrelsheikh university
Study officials:
References: