louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03898999: Relationship of de Ankle ROM With Balance and Falls in Older Adults
Official title: Relationship of the Ankle ROM With Balance and Falls in Older Adults: Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aging Problems
Keywords: Ankle
Balance
Falls
Older Adult
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2019-04-02
Enrollment: 87
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects must belong to the population of older adults, who must not present serious pathologies that make their balance or mobility difficult, although they can use aids.

Brief summary: The ankle is an important joint to maintain a good balance within the population of the older adult. As people get older, problems appear in this joint. Many of these problems affect the correct joint range of the ankle. There is evidence to suggest that a lower range of motion in the ankle can negatively affect balance and, consequently, increase the risk of falls in the elderly. It would be interesting to assess if this relationship is true. The aim of the study will be to study if the state of the joint range of the ankle is related in some way to balance and falls in the elderly.


Eligibility criteria: Inclusion Criteria:

* Be 60 years old or older

Exclusion Criteria:

* Do not sign the informed consent
* Lower limb injury in the previous three months
* Presenting severe pathology that affects balance or mobility

Primary outcomes:
measure: Lunge Test (°)
timeFrame: Baseline
measure: Active Ankle Range of Movement
timeFrame: Baseline
Secondary outcomes:
measure: Pressure Platform - Open Eyes
timeFrame: Baseline
measure: Pressure Platform - Closed Eyes
timeFrame: Baseline
measure: One Leg Balance
timeFrame: Baseline
measure: Timed "Up and Go" Test
timeFrame: Baseline
measure: Functional Reach
timeFrame: Baseline
measure: Falls Efficacy Scale-International
timeFrame: Baseline
measure: Register of falls
timeFrame: Baseline
measure: Ankle plantar flexion strength
timeFrame: Baseline
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Universidad de Valencia
Study officials:
affiliation: University of Valencia
name: David Hernández-Guillén, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Valencia
name: Jose M Blasco, PhD, PT
role: STUDY_DIRECTOR
References:
Clinical trial NCT02493699: Martial Arts Therapy in Autism Spectrum Disorders
Official title: The Effect of Karate Techniques Training on Communication Deficit of Children With Autism Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorders
Lead sponsor: University of Isfahan
Sponsor class: OTHER
First posted: 2015-07-09
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the present study was to determine whether teaching Karate techniques training leads to reduction in communication deficit of children with autism spectrum disorders.


Eligibility criteria: Inclusion Criteria:

* Individuals diagnosed as autism spectrum disorders according to the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition, Text Revision.
* Age range in 5 to 16.

Exclusion Criteria:

* Not participating in up to 3 intervention sessions.

Primary outcomes:
measure: Raw score of communication subscale of Gilliam Autism Rating Scale-Second Edition (GARS-2) as the measure of communication deficit
timeFrame: within the first 30 days after termination of intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Isfahan
name: Fatimah Bahrami, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06290999: Study of Multifrequential Impedancemetry in Pulsatile Tinnitus
Official title: Study of Multifrequential Impedancemetry in Pulsatile Tinnitus
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulsatile Tinnitus
Keywords: Pulsatile Tinnitus
multifrequency admittancemetry
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Unilateral or bilateral pulsatile tinnitus

Brief summary: This study intended to search for a relationship between the multifrequential admittancemetry and the pulsatile tinnitus.

Detailed description: The multifrequency admittancemetry is known to reflect several parameters of the middle ear and the external ear. More recently it appears to also reflect some parameters of the inner ear, such as the perilymph pressure. Furthermore, investigators do not know exactly the physiopathology of pulsatile tinnitus that are from veinous etiology. Modifications of the perilymphatic pressure could be implicated. Investigators intended to search for a relationship between these both theories.

Investigators will include every patient that consult to Ear, Nose and Throat unit of Bordeaux University Hospital with a pulsatile tinnitus trouble, and perform multifrequential admittancemetry. If a radio-surgical intervention is scheduled for a venous stenosis, the test will also be performed test after the surgery.

If there is no surgical intervention, no follow-up will be required.

Eligibility criteria: Inclusion Criteria:

* Adult patient
* Unilateral or bilateral pulsatile tinnitus
* Pulsatile tinnitus \> 1 month old
* Affiliated or beneficiary of by social security system

Exclusion Criteria:

* Otological surgery, excluding trans-tympanic aerators in childhood with closed eardrum
* Middle ear abnormality (any type of partial or total filling of the middle ear) noted on otoscopy or subsequent MRI scan
* Abnormal eardrums excluding tympanosclerosis
* Non-pulsatile tinnitus
* Conductive hearing loss with abolition of stapedial reflexes
* Minor patient
* Major protected
* Abnormal tympanometry at 226 Hz
* Presence of rotatory vertigo
* Opposition to participation expressed by patient

Primary outcomes:
measure: Multifrequency admittancemetry
timeFrame: At Day 0 (inclusion)
Secondary outcomes:
measure: compression maneuvers
timeFrame: At Day 0 (inclusion)
measure: Evaluation of the effect of interventional radiology
timeFrame: up to 3 month after inclusion (M3)
measure: success of radiointerventional treatment
timeFrame: up to 3 month after inclusion (M3)
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Bordeaux University Hospital
Study officials:
References:
Clinical trial NCT01200199: Validity of Electronic Diary for Monitoring Varicose Veins Symptoms
Official title: Performance of Daily Electronic Diary to Capture Venous Symptoms Before and After Intervention for Great Saphenous Vein Incompetence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Varicose Veins
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2010-09-13
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Varicose veins

Brief summary: The purpose of this study is to contribute to the validation of an electronic daily diary to assess symptoms in patients with varicose veins.


Eligibility criteria: Inclusion Criteria:

* Sign informed consent and complete study assessments in written English
* Male or female age 18 to 75
* Patients having Saphenofemoral Junction (SFJ) incompetence and scheduled to receive foam sclerotherapy treatment for varicose veins in one leg
* Screening Symptom score of 7 points or more as measured by Question 1 on the modified VEINES-QOL/Sym questionnaire

Exclusion Criteria:

* Unable to comply with completing a daily diary for a total of 24 days
* Participation in any other investigational pharmaceutical product, or device study within the 3 months prior to Visit 1
* Current venous leg ulcer in either leg

Primary outcomes:
measure: To assess the feasibility, variability, validity and sensitivity of patient's varicose vein symptoms using a disease-specific symptom questionnaire, administered as a daily electronic diary in patients undergoing treatment for varicose veins
timeFrame: 8 weeks
Secondary outcomes:
measure: To establish the treatment effect size of foam sclerotherapy treatment
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
Study officials:
affiliation: BTG International Inc.
name: David Wright, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00186199: Determination of Voiding Patterns of Children With Vesicoureteral Reflux
Official title: Determination of Voiding Patterns of Children With Vesicoureteral Reflux
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vesicoureteral Reflux
Keywords: voiding patterns
flow rate
ultrasound
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 38
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with history of vesicoureteral reflux, toilet trained, ambulatory, and able to void on command. Children scheduled to have procedural correction of vesicoureteral reflux

Brief summary: Determine if the pattern of voiding differs in children with vesicoureteral reflux (VUR) compared to those who do not have VUR.

Detailed description: We hope to determine the statistical difference between the flow rate and volume of urination in children with VUR compared to those without.

Eligibility criteria: Inclusion Criteria:

* Children with or without vesicoureteral reflux (history of VUR)
* Toilet trained and can void on command

Exclusion Criteria:

* Any voiding disorder, musculoskeletal neurologic disorders, other congenital or acquired genitourinary problems, growth disorders, recent UTI

Primary outcomes:
measure: Uroflow rate
timeFrame: 3 months
Secondary outcomes:
measure: PVR
timeFrame: 3 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Lucile Packard Childrens Hospital
state: California
Study officials:
affiliation: Department of Urology, Stanford University
name: Linda Shortliffe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00745199: Evaluating the Effect of Cromolyn Sodium in Uremic Pruritus
Official title: Phase II Study of the Effect of Oral Cromolyn Sodium on Uremic Pruritus and Serum Tryptase Levels of Hemodialysed Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: End Stage Renal Disease
Pruritus
Keywords: End Stage Renal Disease
Cromolyn Sodium
Pruritus
Tryptase
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2008-09-03
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pruritus is a major disorder among the skin derangements in advanced renal failure. Recent information suggests that interactions between dermal mast cells and distal ends of nonmyelinated C fibers may be important in the precipitation and regulation of the sensory stimuli.Patients having uremic pruritus have been noted to have increased levels of plasma histamine and tryptase as well as increased numbers of dermal mast cells.Cromolyn sodium is a mast cell stabilizing agent that inhibits degranulation of mast cells and the release of histamine, tryptase, and leukotrienes. It is hypothesized that oral cromolyn sodium may attenuate uremic pruritus by decreasing serum tryptase level.


Eligibility criteria: Inclusion Criteria:

* Hemodialysis patients \> 18 yo suffering from pruritus for at least 6 weeks, and who have not responded to other drugs
* Willing and able to give informed concent

Exclusion Criteria:

* Known dermatologic, liver, metabolic disease, or any other disease or condition other than ESRD that causes pruritus
* Lactase deficiency

Primary outcomes:
measure: pruritus
timeFrame: 3 months
Secondary outcomes:
measure: serum tryptase level
timeFrame: 4 months
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Shiraz University of Medical sciences, Nemazi and Faghihi Hospital
state: Fars
Study officials:
affiliation: Shiraz University of Medical Sciences
name: Ghazal Vessal, PharmD, BCPS
role: STUDY_DIRECTOR
affiliation: Shiraz University of Medical Sciences
name: Mohammad Mahdi Sagheb, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shiraz University of Medical Sciences
name: Saman Shilian, Pharm student
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.
Clinical trial NCT00162799: Efficacy Pilot Study of Triflusal in the Attenuation of Insulin Resistance in Human Obesity
Official title: Phase IIa Study of Triflusal in the Attenuation of Insulin Resistance in Men and Woman With Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Insulin Resistance
Keywords: insulin resistance and inflamation
insulin sensitibity
obesity-induced insuline resistence
obesity-diabetes link
salicylate
insulin resistance in obesity health adults
Lead sponsor: J. Uriach and Company
Sponsor class: INDUSTRY
First posted: 2005-09-13
Enrollment: 30
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To explore the efficacy of triflusal in the attenuation of insulin resistance in human obesity. Triflusal is a salicylate compound approved in several countries as antithrombotic agent (antiplatelet). The hypothesis is to explore if there is a reduction of obesity-induced insulin resistance by triflusal.

Detailed description: Double-blind, randomized, cross-over (three periods) with two dose levels of triflusal, placebo-controlled.

Interventions: treatment periods Triflusal 600 mg/d, 15 days Triflusal 900 mg/d , 15 days placebo, 15 days

Washout period: 30 days

Eligibility criteria: Inclusion Criteria:

* Ages 35 to 60 years old

Primary outcomes:
measure: Increase of insulin sensitivity in apparently healthy men and woman evaluate by means of i.v. glucose tolerance test (PTEVGMR).
Secondary outcomes:
measure: Reduction antropometric measures associated with insulin resistance and arterial hypertension.
Other outcomes:
Locations:
city: Girona
country: Spain
facility: Unitat de Diabetologia, Endocrinologia y Nutrición Hosp Josep Trueta
Study officials:
affiliation: Unidad Diabetología. Serv Endocrino Hosp Josep Trueta
name: Jose Manuel Fernández del Real, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01553799: Use of Ultrasound Technology to Check Proper Placement of Tracheal and Endobronchial Tubes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Focus of Study
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2012-03-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all adult of both sexes

Brief summary: tracheal and endobronchial misplaced will be checked quickly qith US


Eligibility criteria: Inclusion Criteria:

* all general anesthesia with trachea and endobronchial intubation

Exclusion Criteria:

* regional anesthesia

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01574599: Use of Repetitive Facilitative Exercise Program in Established Stroke
Official title: A Randomized Controlled Evaluation of a Repetitive Facilitative Exercise Program for Adults With an Established Stroke and Upper Extremity Impairment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Keywords: Stroke
weakness
rehabilitation
chronic stroke
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-04-10
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess whether a novel therapy approach (repetitive facilitative exercise (RFE)) is more effective than conventional rehabilitation in facilitating the recovery of upper extremity function following stroke.


Eligibility criteria: Inclusion Criteria:

* Age greater than 18 years
* Having a single ischemic or hemorrhagic hemispheric stroke of more than 6 months duration
* The ability to selectively demonstrate active extension of at least 10 degrees at the metacarpo-phalangeal joint and the interphalangeal joints and 20 degrees at the wrist
* Capable of effectively participating in the study

Exclusion Criteria:

* Upper extremity contracture/pain that interfere with study technique
* Pre-existing upper extremity neurologic or orthopedic disorders
* Unstable medical condition
* BMI \> 35
* Active treatment of condition during 3 months prior to enrollment in study (botulinum toxin, therapy, tendon release, etc.)
* Language or cognitive/perceptual deficits or scheduling problems that would limit participation
* Inability to provide informed consent

Primary outcomes:
measure: Fugl-Meyer Arm score
timeFrame: baseline, immediate post-intervention and 3 month post-intervention
Secondary outcomes:
measure: Motor Activity Log
timeFrame: baseline, immediate post-intervention and 3 month post-intervention
measure: 9-Hole Peg Test
timeFrame: baseline, immediate post-intervention and 3 month post-intervention
measure: Box and Block test
timeFrame: baseline, immediate post-intervention and 3 month post-intervention
measure: Grasp strength
timeFrame: baseline, immediate post-intervention and 3 month post-intervention
measure: Active Range of motion of shoulder flexion, wrist extension, and index finger extension
timeFrame: baseline, immediate post-intervention and 3 month post-intervention
measure: Overall patient satisfaction
timeFrame: baseline, immediate post-intervention and 3 month post-intervention
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Billie Schultz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03484299: Chemotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma
Official title: Chemotherapy and Irreversible Electroporation (IRE) in the Treatment of Advanced Pancreatic Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Pancreas Cancer
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2018-03-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subjects undergoing IRE will receive treatment with either FOLFIRINOX or gemcitabine (based on which regimen was received prior to IRE)
Primary purpose: TREATMENT

Brief summary: Compare the efficacy and tolerability of IRE in combination with either FOLFIRINOX or gemcitabine in patients with locally advanced pancreatic cancer.

Detailed description: Phase II study in which all patients undergoing IRE for the treatment of locally advanced pancreatic carcinoma will receive either FOLFIRINOX or gemcitabine as peri-ablation treatment.

Eligibility criteria: Inclusion Criteria:

* greater than or equal to 18 years of age
* diagnosed with stage III pancreatic cancer
* tumor is measurable
* GFR \> mL/min/1.73m2
* willing and able to comply with protocol requirements
* AST/ALT \>3 times upper limit of normal
* stable surgical post-operative course as defined by operative surgeon

Exclusion Criteria:

* participating in another clinical trial for the treatment of cancer at the time of screening
* pregnant or currently breast feeding
* have a cardiac pacemaker or ICD implanted that cannot be deactivated during IRE procedure
* have non-removable implants with metal parts within 1 cm of the target lesion
* had a myocardial infarction within 3 months prior to enrollment

Primary outcomes:
measure: Incidence of Adverse and Serious Adverse events will be captured (safety and tolerability)
timeFrame: Time from first dose until subject has reached 90 days post last active study treatment
Secondary outcomes:
measure: Progression free survival
timeFrame: Time from first dose date to first date of confirmed disease progression, assessed for 90 days
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Robert Martin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bhutiani N, Li Y, Zheng Q, Pandit H, Shi X, Chen Y, Yu Y, Pulliam ZR, Tan M, Martin RCG 2nd. Electrochemotherapy with Irreversible Electroporation and FOLFIRINOX Improves Survival in Murine Models of Pancreatic Adenocarcinoma. Ann Surg Oncol. 2020 Oct;27(11):4348-4359. doi: 10.1245/s10434-020-08782-2. Epub 2020 Jul 17.