louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04895501: Effects of Shoe Longitudinal Bending Stiffness
Official title: Effects of Shoe Longitudinal Bending Stiffness on Changes in Energy Cost of Running During a 21 km Run
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Runners
Keywords: NEUROMUSCULAR FATIGUE
ENERGETIC COST OF RUNNING
LONGITUDINAL BENDING STIFFNESS
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2021-05-20
Enrollment: 21
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Carbon plates inserted in competitive running shoes have been increasingly used in the past 2-3 years and several investigations have shown that these plates increase the longitudinal bending stiffness (LBS) of the shoe. It leads to a redistribution of muscle work and to a modification of the force generation conditions, which may reduce the energy cost of running (Cr) and improve performance.

Detailed description: Only one study has investigated the effects of LBS in running bouts longer than 8 minutes but on the biomechanics part, and their effects on neuromuscular fatigue and prolonged running performance. The aim of this study is to compare shoes with and without carbon plates during a prolonged (21 km) running exercise on Cr, plantar flexor neuromuscular fatigue and running kinetics and kinematics to estimate the changes high-LBS may induce on fatigue and subsequent performance.

Eligibility criteria: Inclusion Criteria:

* aged ≥ 18 and ≤ 50 years.
* men
* experienced, well-trained endurance runners with the capacity to run 21km in less than 1h 40 and who train more than 5h a week.
* free from muscular, bone or joint injuries
* free from neurologic disease
* approval received from a physician

Exclusion Criteria:

* currently participating in a structured exercise program
* injury in the 3 months prior to the protocol
* chronic joint pathologies (e.g.: repetitive sprains, patellar or ligament problems)
* the intake of corticosteroids within 3 months (inhalation, infiltration or history of prolonged corticosteroid therapy).

Primary outcomes:
measure: energy cost of running
timeFrame: during the last 4 minutes of a 21km race
Secondary outcomes:
measure: ankle plantar flexors
timeFrame: during the last 4 minutes of a 21km race
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Unités de Myologie et de Médecine du Sport
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Léonard FEASSON, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01375101: Therapeutic Effect of Quercetin and the Current Treatment of Erosive and Atrophic Oral Lichen Planus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Atrophic Oral Lichen Planus
Erosive Oral Lichen Planus
Keywords: lichen planus
quercetin
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-06-17
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Lichen planus (LP) is a common chronic inflammatory mucocutaneous disease with an immunologic etiology ,which has number of different clinical forms. Alternative natural or herbal origine drugs with antioxidant and anti-inflammatory properties have been used individually or in combination with systemic corticosteroids in order to decrease adverse drug reactions.

This study was conducted to evaluate the effect of quercetin on treatment of erosive -atrophic lesions of oral lichen planus (OLP).


Eligibility criteria: Inclusion Criteria:

* confirmation of clinical diagnosis of Atrophic and erosive lichen planus by histological examination
* two weeks wash out periods after the last treatment
* having the experience of atrophic and erosive lesion greater than 1 cm having the experience of pain and burning greater than 3.5 in VAS Score

Exclusion Criteria:

* confirmation of dysplasia and malignancy in histologic examination
* confirmation of lichenoid reaction in histologic examination
* pregnancy and breast feeding
* using fluorokinolon and cyclosporin which interact with quercetin

Primary outcomes:
measure: the effects of this Drug on OLP measured with VAS scale for pain and evaluation of intensity of lesions.
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mashhad
country: Iran, Islamic Republic of
facility: Mashhad university of Medical science, Research Center of oral and maxillofacial medicine
state: Khorasan Razavi
Study officials:
References:
Clinical trial NCT02272101: Rhinitis in the Elderly: The Role of Vitamin D
Official title: "Rhinitis in the Elderly: A Randomized, Double-Blind, Placebo Controlled, Cross-Over Study of the Effect of Vitamin D Supplementation on Nasal Symptoms and Rhinitis Related Quality of Life"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis
Lead sponsor: Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.
Sponsor class: OTHER
First posted: 2014-10-22
Enrollment: 15
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A study of the role of vitamin D in elderly subjects with perennial and/or nonallergic rhinitis. The hypothesis is that vitamin D supplementation will improve rhinitis symptoms and rhinitis related quality of life.

Detailed description: Rhinitis in the elderly is poorly understood as this group of patients has been ignored in almost all rhinitis studies. Vitamin D deficiency and insufficiency are very common, especially in the elderly. Vitamin D may play an important role in respiratory disease as shown by studies in asthma. This is a randomized, double-blind, placebo controlled, cross-over study. The investigators will look for the effect of vitamin D 4,000 I.U/day vs. placebo for six weeks on symptom scores and rhinitis related quality of life. This study will be performed in the period Nov. 1, 2013 and March 31, 2014, to try to avoid seasonal fluctuations of serum vitamin D due to sun exposure. The investigators will also look for possible associations between serum vitamin D at baseline and study subjects demographics, treatment, and symptom scores.

Eligibility criteria: Inclusion Criteria:

* Subjects 65 years old and older with perennial and/or nonallergic rhinitis

Exclusion Criteria:

* Current smokers, digoxin, liver disease, anticoagulants (except for aspirin), planning a surgical procedure during the study period.

Primary outcomes:
measure: Effect of vitamin D on rhinitis symptoms and rhinitis related quality of life measured by standardized questionnaire.
timeFrame: 6 weeks
Secondary outcomes:
measure: Associations between baseline serum vitamin D and subjects' demographics and treatment
timeFrame: 6 weeks
Other outcomes:
measure: Safety of vitamin D supplementation in the elderly
timeFrame: 6 weeks
Locations:
city: Bryn Mawr
country: United States
facility: Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.
state: Pennsylvania
city: Bryn Mawr
country: United States
facility: Rohr and Columbo Asthma, Allergy and Immunology Specialists
state: Pennsylvania
Study officials:
affiliation: Rohr and Columbo Associates
name: Michele Columbo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01284101: Prospective Randomized Study Comparing Endothelial Cell Loss Using the Tan EndoGlide With Forceps for Insertion of the Donor Graft in DSAEK
Official title: Prospective Randomized Study Comparing Endothelial Cell Loss Using the Tan EndoGlide With Forceps for Insertion of the Donor Graft in DSAEK
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endothelial Cell Loss With Different Insertion Devices
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2011-01-26
Enrollment: 42
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 Tan EndoGlide device results in less endothelial cell trauma during insertion of the donor corneal graft indicated by reduced endothelial cell loss at 1 year follow-up compared to the Forceps.


Eligibility criteria: Inclusion Criteria:

* Patients presenting with corneal decompensation requiring DSAEK with or without cataract surgery for visual rehabilitation.
* Clinical diagnosis include endothelial cell dysfunction secondary to Fuchs endothelial dystrophy, pseudophakic or aphakic bullous keratopathy, failed penetrating keratoplasty or DSAEK, iridocorneal endothelial syndrome or trauma.
* Ability to understand the nature of the procedure and give full informed consent.
* Patients who are able to comply with the standard DSAEK follow-up protocol at the Toronto Western Hospital.

Exclusion Criteria:

* Patients with late stage corneal decompensation with stromal scarring unsuitable for DSAEK and therefore requiring penetrating keratoplasty.
* Patients with complex anterior segment pathology precluding successful DSAEK procedure.
* Patients not giving full informed consent to participate in the trial

Primary outcomes:
measure: Donor Graft Endothelial cell counts
timeFrame: 1 year
measure: Best corrected visual acuity
timeFrame: 1 year
Secondary outcomes:
measure: Complications of surgery
timeFrame: 1 year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
References:
Clinical trial NCT02400801: Gonadotropin-releasing Hormone (GnRH) Downregulation Versus Oral Anticonception Prior to ART in Postoperative Endometriosis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometriosis
Infertility
Keywords: endometriosis
infertility
assisted reproductive technology
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2015-03-27
Enrollment: 166
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Does prolonged GnRH downregulation prior to ART improve the clinical pregnancy rate in postoperative endometriosis patients? (A single centre randomised controlled trial)


Eligibility criteria: Inclusion Criteria:

* histologically proven endometriosis with complete treatment of all endometriosis lesions during laparoscopy
* only first three ART cycles
* normal uterine cavity
* Eligible for ovarian stimulation with long agonist protocol

Exclusion Criteria:

* FSH\>20 IU/L
* presence of large intramural fibroids (\> 3 cm)
* \<4 oocytes obtained in any previous fresh ART cycle
* ART with sperm derived from testicular biopsy
* ART with Preimplantation Genetic Diagnosis/Screening

Primary outcomes:
measure: clinical pregnancy rate per initiated ART cycle
timeFrame: participants will be followed for the duration of the ART cycle including the pregnancy test, an expected average of 10 weeks in the active comparator group and an expected average of 18 weeks in the experimental group
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: UZ Leuven
name: Thomas M D'Hooghe, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tomassetti C, Beukeleirs T, Conforti A, Debrock S, Peeraer K, Meuleman C, D'Hooghe T. The ultra-long study: a randomized controlled trial evaluating long-term GnRH downregulation prior to ART in women with endometriosis. Hum Reprod. 2021 Sep 18;36(10):2676-2686. doi: 10.1093/humrep/deab163.
Clinical trial NCT00835601: Resistive/Cardiovascular Training Study
Official title: An Integrated Musculoskeletal Countermeasure Battery for Long-Duration Lunar Missions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Muscular Atrophy
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2009-02-03
Enrollment: 36
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy men and women 25-55 years of age who are not exercisers

Brief summary: This is a training study in healthy volunteers to characterize gains in lower-body resistive strength and cardiovascular capacity with exercise on a Combined Countermeasure Device (CCD) we have developed for the National Space Biomedical Research Institute. The CCD is a single platform which contains interchangeable modules for cardiovascular stepping exercises and lower body resistive exercises including squats, heel raises, abductor and adductor exercises and knee extension and flexion. The platform has the capability to tilt, yaw and pitch, and to translate in three dimensions in order to challenge the neurovestibular system. The underlying goal of the project is to provide a compact and efficient exercise modality that will prevent deterioration of the cardiovascular and musculoskeletal systems, and the neurovestibular system, in long-duration spaceflights. The goal of the current study is simply to test the hypothesis that in healthy volunteers, the exercise prescription proposed for the device will improve strength and VO2 max. Subjects are tested for lower body resistive strength and V02max at baseline, then are trained for 12 weeks, and tested again at followup to test for a change. 36 subjects, allowing for a 20% attrition rate, allows sufficient power to detect 95% percent confidence intervals in the changes in the strength and V02max measures of roughly 10-20%. If we observe gains in these indices which are similar to those reported in the literature for simultaneous cardiovascular and resistive strength protocols, then we believe that there is sufficient evidence to test CCD in a bedrest model of long-duration spaceflight.


Eligibility criteria: Inclusion Criteria:

* Healthy men and women
* 25-55 years old
* Do not exercise on a regular basis

Exclusion Criteria:

Have not been diagnosed with hypertension, diabetes, high cholesterol, cardiovascular disease or asthma and other pulmonary disorders

Primary outcomes:
measure: VO2max
timeFrame: 6-12 weeks
measure: Leg Press Strength
timeFrame: 6-12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02381301: Biomarkers and Cardiac CT
Official title: Biomarkers and Cardiac Computed Tomography: Relationship Between Cardiovascular Biomarkers and Coronary Artery Disease in Patients Undergoing Cardiac Computed Tomography
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Atherosclerosis
Keywords: Biological Markers
Multidetector Computed Tomography
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2015-03-06
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients referred from the Cardiology clinic for routine CCTA for diagnostic purposes, will be included in this study, after given written informed consent.

Brief summary: Coronary artery disease (CAD) is the leading cause of morbidity and mortality in developed countries. In addition, many patients suffer from valvular and aortic disease. Although various tools are available to identify patients with cardiovascular (CV) disease at risk for major adverse cardiac events (MACE), the identification of these patients remains a clinical challenge.

One promising avenue is the use of different serum biomarkers involved in atherothrombosis which could provide an easy and cost-effective step in risk stratification.


Eligibility criteria: Inclusion Criteria:

* Patients referred from the Cardiology clinic for routine CCTA.

Exclusion Criteria:

* Pregnancy
* Severe renal insufficiency
* Severe allergy to contrast medium
* Inability to obtain informed consent
* Age below 18 years

Primary outcomes:
measure: Data registration of patients undergoing CCTA and given written informed consent.
timeFrame: 15 years.
measure: To detect these patients for cardiovascular disease and Long term CV outcome (MACE).
timeFrame: 15 years.
Secondary outcomes:
measure: The relationship of novel blood biomarkers with CCTA findings.
timeFrame: 15 years.
measure: The predictive value of these biomarkers to predict CAD in patients undergoing CCTA.
timeFrame: 15 years.
measure: The prognostic value of these biomarkers (in combination) to predict MACE.
timeFrame: 15 years.
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Harry J Crijns, MD, PhD
role: STUDY_CHAIR
affiliation: Maastricht University Medical Center
name: Bas Kietselaer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06820801: Assessment of PFM Strength and Function After Radiotherapy Treatment in Women With Pelvic Cancers
Official title: Assessment of Pelvic Floor Muscles Strength and Function After Radiotherapy Treatment in Women With Pelvic Cancers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Muscle Strength and Function
Keywords: pelvic floor muscles - radiotherapy - pelvic cancers
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 60
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: women aged between 30 and 50 years old diagnosed with cervix or rectal cancers and will be treated with preoperative radiotherapy for 5 weeks

Brief summary: Assessment the effect of radiotherapy treatment on pelvic floor muscles in women with pelvic cancers

Detailed description: Evaluate the impact of radiotherapy treament on pelvic floor muscles strength and function in women with cervical and rectal cancers

Eligibility criteria: Inclusion Criteria:

* women between 30 -50 years old
* diagnosed with cervix or rectal cancers
* married
* will be treated with preoperative radiotherapy for at least 5 weeks
* had not any pelvic operations in the past

Exclusion Criteria:

* un married women
* Age below 30 or above 50 years old
* has another type of pelvic tumors
* has any metastasis
* had any pelvic surgeries
* will be treated with short course radiotherapy

Primary outcomes:
measure: PFM strength and function
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazeg
country: Egypt
facility: Elahrar oncology center and zagazeg university oncology center
state: Alsharkia
Study officials:
name: Elham Shahat Hassan, Lecturer of physical therapy
role: STUDY_DIRECTOR
References:
Clinical trial NCT04848701: Uterocervical Angle: a Screening Tool That Estimates the Latent Phase Duration in Post Term Pregnancies
Official title: Anterior Uterocervical Angle for Latent Phase Duration in Post Term Pregnancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Term Pregnancy
Lead sponsor: Sanliurfa Mehmet Akif Inan Education and Research Hospital
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: To evaluate the performance of uterocervical angle (UCA) in the prediction of latent phase duration in post term pregnancies


Eligibility criteria: Inclusion Criteria:

* Patients with singleton pregnancies
* Post term pregnancies
* Patients with vertex presentation,
* Patients with intact membranes
* Patients with no uterine contractions

Exclusion Criteria:

* women with BMI \>30,
* multiparity and multiple pregnancies,
* patients with macrosomia (\>4500 gr),
* patients with major fetal congenital abnormality or fetal death and any contraindications to vaginal birth (e.g. active genital herpes),
* patients with abnormal Pap smears,
* patients with a history of previous cesarean section, myomectomy, hysteroscopic surgeries, dilatation and curettages, loop electrosurgical excision procedures, and cervical conization.

Primary outcomes:
measure: prediction of latent phase duration by uterocervical angle in post term pregnancies
timeFrame: 5 months
Secondary outcomes:
measure: the relative success of UCA in active phase and duration of labor prediction in post term pregnancies
timeFrame: 5 months
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Nefise Nazlı Yenigül
Study officials:
References: