louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02876432: Evaluating Acupuncture Relationship With the Catecholaminergic Pathway
Official title: Evaluating Acupuncture in the Treatment of Low Back Pain in Athletes and the Relationship With the Catecholaminergic Pathway
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Universidad Autónoma Benito Juárez de Oaxaca
Sponsor class: OTHER
First posted: 2016-08-23
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Activation of the sympathetic nervous system attenuates inflammation via catecholamines, recent advances in electroacupuncture allow activating critical neuronal networks with the release of catecholamines the aim of this research was to evaluate de effect of electroacupuncture in the activation of sympathetic nervous system and the control of low back pain in athletes

Detailed description: Activation of the sympathetic nervous system attenuates inflammation via activation of β2-adrenoreceptors by catecholamines, Electrical stimulation of vagus nerve limits the inflammatory response in several animal models of inflammatory diseases, In addition, voluntary activation of the sympathetic nervous system by meditation, training or breathing techniques limits production of proinflammatory cytokines in vivo during experimental endotoxemia in healthy human volunteers.

Currently there are therapies that effectively antagonize proinflammatory cytokines and control pain, as non-steroidal anti-inflammatory drugs and opioid analgesics, but had serious side effects if used chronically. Therefore, alternative therapies as electroacupuncture, which may limit inflammatory cytokine production more physiologically, are warranted. The aim of this study was to evaluate de effect of electroacupuncture used for attenuation of low back pain in the activation of sympathetic nervous system and leukocyte inflammatory potential.

Eligibility criteria: Inclusion Criteria:

(Controls)

* Healthy
* Non Smokers
* Athletes

(Cases)

* Acute Low Back Pain (less than 1 month)
* Athletes
* Non Smokers

Exclusion Criteria:

* Sciatic Pain
* Smokers
* Chronic Low Back Pain

Primary outcomes:
measure: Visual analogue scale
timeFrame: before Electroacupuncture Time "0"
measure: Levels of catecholamines in serum
timeFrame: five minutes before Electroacupuncture
Secondary outcomes:
measure: Levels of catecholamines in serum
timeFrame: five minutes after Electroacupuncture
measure: Visual analogue scale
timeFrame: Five days after Electroacupuncture
Other outcomes:
Locations:
Study officials:
affiliation: IMSS
name: Lourdes Arriaga Pizano, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05527132: Understanding the Phenomena of Aging and Rupture of Breast Implants
Official title: Understanding the Phenomena of Aging and Rupture of Breast Implants
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aging of Breast Implants
Keywords: Breast Prosthesis Implantation
Aging of breast implants
Rupture of breast implants
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-09-02
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female adult (≥18 years old) operated on at the HUS for a change of breast prosthesis, aesthetic or reconstruction, between 2022 and 2024

Brief summary: Breast implants, like all implantable medical devices, are subject to wear and tear as they age in the body. In addition to this wear and tear, they are subject to external trauma, whether accidental during daily life, during insertion or during mammography.

The kinetics and mechanisms of aging are poorly studied and the phenomenon of implant rupture is not elucidated. However, studies of older generation implants have shown that implant rupture is correlated with the duration of implantation.


Eligibility criteria: Inclusion criteria:

* Female adult (≥18 years old)
* operated on at the HUS for a change of breast prosthesis, aesthetic or reconstruction, between 2022 and 2024
* having not expressed, after information, her opposition to participate in this research.

Exclusion criteria:

* Women who have expressed their opposition to participating in the study
* ruptured prosthesis, associated with a LAGC-AIM, excessive perspiration
* interfering treatments and associated diseases, history

Primary outcomes:
measure: The mechanical properties of breast implants will be evaluated by uniaxial tensile tests
timeFrame: After extraction of breast implants
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie Plastique Esthétique et Reconstructrice - CHU de Strasbourg - France
Study officials:
affiliation: Service de Chirurgie Plastique Esthétique et Reconstructrice - CHU de Strasbourg - France
name: laetitia RUFFENACH, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03162432: High Dose Interval Vitamin D Supplementation in Patients With IBD Receiving Remicade
Official title: High Dose Interval Vitamin D Supplementation in Patients With IBD Receiving Remicade
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: IBD
Ulcerative Colitis
Crohn Disease
Keywords: IBD
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2017-05-22
Enrollment: 50
Sex: ALL
Minimum age (years): 7
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study will be to assess the safety and efficacy of high-dose interval Vitamin D3 therapy in children and young adults with Inflammatory Bowel Disease being treated with serial Remicade infusions.

Detailed description: Study subjects will receiving 50,000 units of Vitamin D3 if they receive Remicade infusions every 4-6 weeks. Study subjects will receiving 100,000 units of Vitamin D3 if they receive Remicade infusions every 6-8 weeks.

Eligibility criteria: Inclusion Criteria:

* Existing diagnosis of IBD
* Age 0-25 years
* Measured serum level of 25-OH Vitamin D of 15-29 ng/ml in the last 8 weeks and no changes in Vitamin D supplementation in the interim

Exclusion Criteria:

* Pregnant Women
* History of underlying kidney disease
* History of granulomatous disease
* Inability to take oral Vitamin D
* History of hypercalcemia or hypercalciuria
* Currently taking an anti-epileptic medication
* History of pre-existing liver disease (excluding primary sclerosing cholangitis, non-alcoholic fatty liver disease, or steatohepatitis)

Primary outcomes:
measure: Ability of intervention to maintain 25-OH Vitamin D levels in the 35-80 range
timeFrame: Patients will continue to receive oral Vitamin D therapy for one year. We will be assessing the efficacy of oral Vitamin D therapy, in this dosing schema, to result in 25-OH Vitamin D levels during and at the conclusion of this one-year study.
Secondary outcomes:
measure: Assess risk of kidney stones development in patients treated with high-dose interval Vitamin D
timeFrame: Patients will be monitored for urinary symptoms and complete serial urine assessments as outlined in the protocol. The impact of oral Vitamin D administration on calcium excretion will be evaluated during and at the conclusion of this one-year study.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
References:
citation: Gordon RJ, Wells R, Johansen C, Liu S, Dahlberg SE, Snapper SB, Rufo PA. Efficacy and Safety of High-dose Cholecalciferol in Patients With Inflammatory Bowel Disease Receiving Infliximab. J Pediatr Gastroenterol Nutr. 2022 Apr 1;74(4):476-483. doi: 10.1097/MPG.0000000000003386. Epub 2022 Jan 18.
Clinical trial NCT02855632: The Efficacy of G-CSF Against Adhesion Reformation After Hysteroscopic Adhesiolysis
Official title: The Efficacy of G-CSF Against Adhesion Reformation After Hysteroscopic Adhesiolysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intrauterine Adhesion
Keywords: G-CSF
adhesion reformation
Asherman syndrome
Lead sponsor: Sir Run Run Shaw Hospital
Sponsor class: OTHER
Collaborators: name: Wenzhou people's hospital，zhejiang province,China
name: Ningbo Women & Children's Hospital
First posted: 2016-08-04
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate the efficacy of Granulocyte Colony Stimulating Factor(G-CSF) on decreasing adhesion reformation and improving fertility outcomes after hysteroscopic adhesiolysis in patients with moderate to severe intrauterine adhesions.

Detailed description: After hysteroscopic adhesiolysis, patients with moderate to severe intrauterine adhesions will be allocated into 2 groups randomly, with COOK ballon and estrogen and progesterone sequential therapy given to prevent adhesion routinely. 7 day later, G-CSF or normal saline will be injected into the uterine cavity by Tom catheter after removing the balloon respectively. A second hysteroscopic examination will be performed in 2 months to check up the adhesion reformation. In addition, the endometrial thickness after surgery and fertility outcome will be followed up.

Eligibility criteria: Inclusion Criteria:

* Moderate and severe intrauterine adhesion patients(AFS score ≥5)
* age 18-40
* first time receiving hysteroscopic adhesiolysis
* provided COOK balloon as adjuvant adhesion prevention treatment
* accepting randomized trial

Exclusion Criteria:

* Mild adhesion patients
* uterine shape can't be restored in the end of surgery
* abnormal chromosome phenotype
* systemic disease
* no fertility desire
* contradiction of G-CSF injection.

Primary outcomes:
measure: Adhesion reformation rate
timeFrame: 2 months after first surgery
Secondary outcomes:
measure: Pregnancy rate
timeFrame: 3 years after first surgery
measure: Live birth rate
timeFrame: 4 years after first surgery
Other outcomes:
measure: Endometrial thickness
timeFrame: 1 months after G-CSF injection
Locations:
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
state: Zhejiang
Study officials:
affiliation: Sir Run Run Shaw Hospital
name: Xiaona Lin, Doctor
role: STUDY_DIRECTOR
References:
citation: Zhang Y, Chen X, Chen S, Wei C, Li B, Wang Z, Shen X, Lin X. Intrauterine administration of G-CSF for promoting endometrial growth after hysteroscopic adhesiolysis: a randomized controlled trial. Hum Reprod. 2022 Apr 1;37(4):725-733. doi: 10.1093/humrep/deac023.
Clinical trial NCT02903732: Autism Registry for French Guiana
Official title: Autism Registry for French Guiana
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Autism Spectrum Disorder
Lead sponsor: Centre Hospitalier de Cayenne
Sponsor class: OTHER
First posted: 2016-09-16
Enrollment: 400
Sex: ALL
Minimum age (years): 8
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children aged 8 years will be the denominator. the numerator is children who are seeking assistance for care or educational purposes at the unique administration dealing with handicap in French Guiana

Brief summary: The objective of the autism registry is to estimate the prevalence of autism in French Guiana in the cohort of children aged 8 years. Secondary objectives are to determine the prevalence of comorbidities, and to determine the theoretical and actual orientation of these children regarding care and education in a territory with significant structural deficits relative to mainland France. The outcomes of this registry will be to guide decision makers in their funding priorities to improve, screening, diagnosis, care and education for children on the autistic spectrum


Eligibility criteria: Inclusion Criteria:

* children aged 8 years with a diagnosis of autism spectrum disorder

Exclusion Criteria:

* refusal to participate

Primary outcomes:
measure: autism spectrum disorder
timeFrame: 1 year (the year at age 8)
Secondary outcomes:
Other outcomes:
Locations:
city: Cayenne
country: France
facility: Centre Hospitalier de Cayenne
state: French Guiana
Study officials:
References:
Clinical trial NCT00221832: Molecular Genetic Screening and Identification of Congenital Arrhythmogenic Diseases
Official title: Molecular Genetic Screening and Identification of Congenital Arrhythmogenic Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Long QT Syndrome
Hypertrophic Cardiomyopathy
Arrhythmogenic Right Ventricular Dysplasia
Keywords: Long QT Syndrome
Hypertrophic cardiomyopathy
arrhythmogenic right ventricular dysplasia
Short QT Syndrome
Brugada Syndrome
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patient sampling with history of syncope, aborted SCD, familial sudden cardiac death, high suspicion of familial cardiac arrhythmias.

Brief summary: The aim of this study is the identification of familial congenital arrhythmogenic disorders and their clinical follow-up.

Detailed description: Molecular genetic screening in patients with:

* supraventricular
* ventricular arrhythmia
* syncopes of unknown origin and/or suspicion of an arrhythmogenic origin
* family members of patients with sudden cardiac death and aborted sudden cardiac death

Examination of patients includes routine testing like electrocardiogram (ECG), sequential ECGs, exercise testing, invasive electrophysiological stimulation, cardiac magnetic resonance imaging, intravenous drug challenge for identification/exclusion of eg Brugada syndrome. Examples are patients with Long QT Syndrome, Short QT Syndrome, Brugada Syndrome, familial atrial fibrillation, WPW-syndrome, arrhythmias due to familial hypertrophic cardiomyopathy or arrhythmogenic right ventricular dysplasia. Blood samples are taken for further molecular genetic screening.

Eligibility criteria: Inclusion Criteria:

* Patients with a history of syncope, abnormal ECG and suspicion of an arrhythmogenic disease
* Patients with long QT syndrome
* Patients with short QT syndrome, shortened QT intervals, borderline shortened QT intervals
* Patients with Brugada syndrome
* Patients with hypertrophic cardiomyopathy
* Patients with arrhythmogenic right ventricular dysplasia

Exclusion Criteria:

* Inability to understand study protocol

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: University Hospital Mannheim, I. Department of Medicine
Study officials:
affiliation: I. Department of Medicine-Cardiology
name: Martin Borggrefe, Prof., MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04302532: Coenzyme q 10 and Fertility Outcome in Women With Clomiphene Resistant PCOS
Official title: Combined Coenzyme Q10 and Clomiphene Citrate for Ovulation Induction in Clomiphene-citrate-resistant Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coenzyme q10
Keywords: ovulation induction
coenzyme q10
pregnancy rate
Lead sponsor: Karachi Medical and Dental College
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 149
Sex: FEMALE
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: The study evaluates the effect of coenzyme q 10 on ovulation and subsequent pregnancy in women with polycystic ovarian syndrome. Half of the participants will receive coq10 and ovulation induction with clomiphene and other half would receive a placebo with clomiphene.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of polycystic ovarian syndrome PCOS based on the revised 2003 consensus on diagnostic criteria and long-term health risks related to PCOS (2003).
* All women were previously treated with 100 mg of CC daily for 5 days per cycle, for two to three cycles with persistent anovulation or ovulate with very thin endometrium \<5 mm at the time of hCG administration

Exclusion Criteria:

* Non-consenting.
* known autoimmune disorders
* prior treatment of endometriosis or surgery to reproductive tract
* prior history of pelvic inflammatory disease
* those with tubal factors and uterine factors as assessed on history and confirmed by normal hysterosalpingogram.
* Thyroid disorder as assessed by history examination and TSH level
* Patients with raised FSH

Primary outcomes:
measure: number of ovulating women
timeFrame: 1-2 months
measure: number of pregnancies
timeFrame: 1-2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aziz medical center
state: Sindh
Study officials:
affiliation: Aziz Medical Center
name: Rubina Izhar
role: STUDY_DIRECTOR
References:
Clinical trial NCT04195932: Exercise as a Modulator of Immune Risk Factors for Ischemic Heart Disease
Official title: Exercise as a Modulator of Immune Risk Factors for Ischemic Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Diseases
Keywords: exercise
hyperlipidemia
TNF-alpha
atherogenesis
LDL-cholesterol
oxidized LDL-C
Lead sponsor: East Tennessee State University
Sponsor class: OTHER
First posted: 2019-12-12
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Before and after study
Primary purpose: BASIC_SCIENCE

Brief summary: A before and after study involving 43 adult subjects at risk of having ischemic heart disease. Subjects underwent 6 months of supervised moderate intensity aerobic and resistive exercise training. Blood samples were obtained at entry and at 6 months for measurement of complement (C3), CRP, blood lipid levels, lymphocyte phenotypes, and for the isolation, culture, and measurement of the spontaneous and phytohemagglutinin-induced secretion of proatherogenic and antiatherogenic cytokines by their peripheral blood mononuclear cells (PBMC).

Detailed description: A before and after study involving 43 adult subjects at risk of having ischemic heart disease. Subjects underwent 6 months of supervised moderate intensity aerobic and resistive exercise training. Blood samples were obtained at entry and at 6 months for measurement of complement (C3), CRP, blood lipid levels, lymphocyte phenotypes, and for the isolation, culture, and measurement of the spontaneous and phytohemagglutinin-induced secretion of proatherogenic and antiatherogenic cytokines by their peripheral blood mononuclear cells (PBMC

Eligibility criteria: Inclusion criteria:

* normal EKG
* normal stress test

Exclusion Criteria:

* abnormal EKG
* abnormal stress test
* presence of a chronic inflammatory disease
* presence of malignancy
* immunosuppressive therapy

Primary outcomes:
measure: Effect of exercise on atherogenic cytokine production by mitogen-stimulated peripheral blood mononuclear cells
timeFrame: 1 year
measure: Effect of exercise on plasma lipids and oxidizable low density lipoprotein cholesterol levels
timeFrame: 1 year
Secondary outcomes:
measure: Effect of exercise on blood lymphocyte phenotypes
timeFrame: 1 year
Other outcomes:
Locations:
city: Johnson City
country: United States
facility: James H. Quillen College of Medicine
state: Tennessee
Study officials:
affiliation: East Tennessee State University
name: John K Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01302132: Mass Balance Study of ASP1941
Official title: An Open Label Study to Evaluate the Pharmacokinetics of ASP1941 After a Single Oral Dose of 14C-labeled ASP1941 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: Mass Balance
ASP1941
Pharmacokinetics
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2011-02-23
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This study investigates the pharmacokinetics, in particular the routes and extent of metabolism and excretion, of ASP1941 after a single oral dose.


Eligibility criteria: Inclusion Criteria:

* Body weight between 60-100kg, BMI between 18.5-30 kg/m2, inclusive

Exclusion Criteria:

* Pulse \<40 or \>90 bpm; Systolic Blood Pressure \> 140 mmHg; Diastolic Blood Pressure \>90 mmHg

Primary outcomes:
measure: Pharmacokinetics of ASP1941 to evaluate metabolism and excretion
timeFrame: up to 216 hours
Secondary outcomes:
measure: Identification of metabolic profile of ASP1941
timeFrame: up to 216 hours
Other outcomes:
Locations:
city: Zuidlaren
country: Netherlands
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Use Central Contact
role: STUDY_DIRECTOR
References:
Clinical trial NCT03479632: Aerobic Walking Exercise for Non-Ambulatory Stroke Survivors
Official title: Aerobic Walking Exercise for Non-Ambulatory Stroke Survivors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2018-03-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: By doing this study, researchers hope to learn the effects of aerobic exercise on heart, lung, and bone health in people who cannot walk after a stroke.


Eligibility criteria: Inclusion Criteria:

* Independent ambulation before stroke
* Be able to understand and follow verbal commands in English
* Have physicians' approval for exercise, and be in stable medical condition
* Participant's first stroke
* Unable to walk independently according to Functional Ambulation Category (FAC) (\<2) after in-patient rehabilitation treatment
* Between 6 weeks to 5 years after stroke onset

Exclusion Criteria:

* Current cardiovascular abnormalities other than stroke such as ischemic cardiovascular event or coronary artery bypass surgery less than 3 months ago
* Musculoskeletal disorder which prevents subjects from participating in the exercise
* Resting blood pressure more than 200/110 mm Hg
* Current or previous pulmonary diseases in the past two years
* Osteoporosis and restricted passive movement in the major joints of the lower limbs
* Subjects will be excluded if they are unable to speak or understand English and/or unable to travel to the University of Kansas Medical Center (KUMC) Neuromuscular Research Laboratory

Primary outcomes:
measure: Resting Heart Rate
timeFrame: Change from Baseline to Week 8
Secondary outcomes:
measure: Resting blood pressure
timeFrame: Change from Baseline to Week 8
measure: Change in vital capacity (VC)
timeFrame: Change from Baseline to Week 8
measure: Change in forced vital capacity (FVC)
timeFrame: Change from Baseline to Week 8
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Wen Liu
role: PRINCIPAL_INVESTIGATOR
References: