louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01935076: miRNA in Fetal Overgrowth
Official title: Placental miRNA (microRNA) Profile in Fetal Overgrowth Related to Maternal Obesity Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: Maternal obesity
Macrosomic
miRNA
Fetal overgrowth
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2013-09-04
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients delivering in the labor and delivery unit at the Hospital of the University of Pennsylvania.

Brief summary: The purpose of this study is to determine whether placental and umbilical cord blood miRNA expression is altered in women with obesity with macrosomic neonates to when compared to miRNA expression from control patients.

Detailed description: MicroRNA's are a class of non-coding RNA's that function as translational repressors and are thought to modulate tissue development, proliferation, differentiation and function. Differential expression of certain placental miRNA's has been associated with preeclampsia.

The fetal origins of adult disease hypothesis suggests that risk factors from intrauterine environmental exposures affect the fetus' development during sensitive periods, and increases the risk of specific diseases in adult life. Our aim is to understand factors that predispose fetuses to fetal overgrowth in utero, especially in women with obesity. The objective of the study is to identify miRNA which are differentially expressed in the placenta and cord blood of pregnancies that are affected by fetal macrosomia to determine factors that may predispose fetuses to fetal overgrowth.

Eligibility criteria: Inclusion Criteria:

* singleton pregnancy
* prenatal care \& delivery at the Hospital of the University of Pennsylvania system
* Normal glucose tolerance test results (less than 120 mg/dl)

Exclusion Criteria:

* Multiple gestation
* under 18 years old, or over 45 years old
* chronic hypertension
* preeclampsia
* chronic steroid use
* diabetes
* major fetal anomaly
* connective tissue disorder requiring medication
* active HIV
* Hepatitis C

Primary outcomes:
measure: Fetal Overgrowth
timeFrame: Delivery date to up to 6 weeks post partum
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Celeste P Durnwald, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02078076: IRM Cardiaque en Respiration Libre Pour Des Patients Atteints de Dystrophinopathie sévère
Official title: IRM Cardiaque en Respiration Libre Pour Des Patients Atteints de Dystrophinopathie sévère
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Duchenne or Severe Becker Myopathy
Keywords: MRI
free-breathing acquisitions
myopathy
fibrosis assessment
function
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2014-03-05
Enrollment: 22
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Clinical, prospective and monocentric study aiming at assessing the feasibility of fibrosis detection and quantification (and of function assessment) during MRI without breath-holds in a population of adults and children with Duchenne myopathy.


Eligibility criteria: Inclusion Criteria:

* Dystophinopathy (Duchenne or severe Becker)
* \>8yo
* with social insurance
* informed consent

Exclusion Criteria:

* arythmia
* impossibility to undergo an MRI (pacemaker, ....)

Primary outcomes:
measure: Number of exams correctly acquired (feasabiliy of the exam)
timeFrame: after the last inclusion
measure: Number of exams allowing a qualitative assessment of images by the physician
timeFrame: after the last MRI exam
measure: Number of exams allowing a quantitative assessment of the diagnosis
timeFrame: after the last MRI examination
Secondary outcomes:
measure: Number of anatomic cardiac segments with significant fibrosis according to the assessment methods (conventional LGE, qualitative detection with GRICS, and quantiative measure with GRICS)
timeFrame: after the last inclusion
measure: Number of cardiac segments with fibrosis and/or regional dysfunction
timeFrame: after the last inclusion
Other outcomes:
Locations:
city: Vandoeuvre
country: France
facility: Service de médecin nucléaire / CHU Nancy Brabois
Study officials:
References:
Clinical trial NCT04311476: Autologous Cord Blood Cells for Prevention of BPD in Preterm
Official title: Autologous Cord Blood Cells for Prevention of BPD in Preterm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Safety Issues
BPD - Bronchopulmonary Dysplasia
Neonatal Death
Keywords: ACBMNC
very premature infants
BPD
Lead sponsor: Guangdong Women and Children Hospital
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 62
Sex: ALL
Minimum age (years): 28
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To study the effect of Autologous cord blood cells infusion on prevention of bronchopulmonary dysplasia in very preterm neonates

Detailed description: We did a randomized, double-blind, placebo-controlled trial to assess effect of one intravenous dose of cord blood MNCs compared with placebo in reducing incidence of BPD in very preterm neonates.We enrolled preterm neonates less than 32 weeks of GA at neonatal intensive care units (NICUs) in Guangdong Women and Children Hospital within the first 24 postnatal hours. Patients were randomly assigned by 1:1 to receive either (5×107cells/kg ACBMNC or normal saline intravenously within 24 hours after birth according to a computer-generated schedule. The primary endpoint was efficacy at 36 GA or discharge home and all analyses were done by intention to prevent.MNCs viability was also tested before transfusion

Eligibility criteria: Inclusion Criteria:

* born in the study hospital;
* singleton birth;
* less than 32 weeks GA
* Without congenital malformations or known chromosomal aberrations;
* Without clinical chorioamnionitis;
* the mother was negative for hepatitis B (HBsAg and/or HBeAg) and C virus (anti-HCV), syphilis, HIV (anti-HIV-1 and -2) and IgM against cytomegalovirus, rubella, toxoplasma and herpes simplex virus;
* consents were obtained from their parents or guardians;
* the umbilical cord blood cells after processing were available.

Exclusion Criteria:

* birth-weight was less than the third percentile for gestational age according to Fenton curve,
* if they had severe perinatal asphyxia (defined as an Apgarscore of 0-3 for more than 5 minutes, a cord blood pH of less than 7.00, or both) and were expected to die shortly after birth.

Primary outcomes:
measure: number of patients without bronchopulmonary dysplasia
timeFrame: at 36 weeks of postmenstrual age or discharge home, whichever came first
Secondary outcomes:
measure: number of patients who died， severe bronchopulmonary dysplasia
timeFrame: at 36 weeks of postmenstrual age
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Jie Yang
state: Guangdong
Study officials:
affiliation: Guangdong Women and Children Hospital
name: Jie Yang, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01669876: Study to Evaluate Dietary Supplementation With a Version of Anatabloc(R) in Subjects With Alzheimer's Disease
Official title: 3-Month, Single Site or Multi-Site, Double Blind, Randomized, Placebo-Controlled, Parallel-Group Trial to Evaluate the Safety Tolerability and Potential Effects of the Dietary Supplement Anatabloc(R) in Subjects With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Alzheimer Disease
Keywords: Randomized
Double-Blind
Dietary Supplements
Lead sponsor: Rock Creek Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Roskamp Institute Inc.
First posted: 2012-08-21
Enrollment: 85
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To explore whether dietary supplementation with a version of Anatabloc(R) exerts an effect on blood levels of amyloid beta (Aβ), or impacts global or functional measures of Alzheimer's Disease (AD) in subjects with mild to moderate AD.


Eligibility criteria: Inclusion Criteria:

* At least 65 years old.
* Have a diagnosis of probable AD or a concurrent diagnosis of probable AD and possible or probable vascular dementia.
* Score 16 or more on the Mini-Mental State Examination (MMSE).
* Otherwise stable medical history and general health.
* Weigh between 45 kg and 120 kg inclusive.

Exclusion Criteria:

* Have contra-indications, allergy, or sensitivity to the study products or their components.
* Be currently taking any of the following medications: systemic (oral or injectable) glucocorticoids; interferon-alpha; anti-CD20 antibody (e.g., rituximab); or anti-CTLA-4 antibody (e.g., ipilimumab).
* Be a current smoker or smokeless tobacco user.

Primary outcomes:
measure: Number of subjects experiencing adverse effects when using the supplement
timeFrame: 3 months
Secondary outcomes:
measure: Measured changes in blood markers of AD
timeFrame: 3 months
measure: Changes in global or functional measures of AD in subjects during the course of the study
timeFrame: 3 months
Other outcomes:
Locations:
city: Sarasota
country: United States
facility: Roskamp Institute
state: Florida
Study officials:
affiliation: Roskamp Institute
name: A Keegan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05118776: Study to Evaluate the Safety and Efficacy of ASC40 Tablets in Combination With Bevacizumab in Subjects With rGBM
Official title: A Phase III Randomized, Double-blind, Placebo-controlled, Multi-center Trial to Evaluate Safety and Efficacy pf ASC40 Tablets Combined With Bevacizumab in Subjects With Recurrent Glioblastoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Recurrent Glioblastoma
Keywords: ASC40
Recurrent Glioblastoma
Lead sponsor: Ascletis Pharma Inc
Sponsor class: INDUSTRY
First posted: 2021-11-12
Enrollment: 136
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: This is a randomized, double-blind, controlled and multi-center Phase III clinical trial to evaluate the safety and efficacy of ASC40 tablets combined with bevacizumab in the treatment of adult patients with recurrent glioblastoma. After standard radiotherapy and chemotherapy (temozolomide), the subject first experienced clinical recurrence or progression.


Eligibility criteria: Inclusion Criteria:

* 1. Age ≥18 years old, both male and female;
* 2. Histologically confirmed glioblastoma;
* 3. Patients with glioblastoma who have failed standard treatment (surgery, Stupp regimen), were diagnosed by MRI and evaluated by RANO standard to support the first recurrence. Stupp regimen needs to complete at least 6 medication cycles.

Exclusion Criteria:

* 1. Use low molecular weight heparin and warfarin within 35 days before randomization;
* 2. Arterial or venous thrombosis (such as cerebral infarction, myocardial infarction, venous thrombosis of lower limbs, arterial embolism of lower limbs, pulmonary embolism, etc.) occurred within 6 months before randomization

Primary outcomes:
measure: Progression-free survival
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
measure: Total survival
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 months
Secondary outcomes:
measure: Objective remission rate
timeFrame: Week 4 to Month 6 (every 8 weeks)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital，Capital Medical University
state: Beijing
Study officials:
References:
Clinical trial NCT00623376: Randomized Double Blind Cross Over Study for Nabilone in Spasticity in Spinal Cord Injury Persons
Official title: Randomized Double Blind Cross Over Study Assessing the Effect of Cannabiniods on Spasticity in Spinal Cord Injured Persons :A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Spasticity in Spinal Cord Injured Persons
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Valeant Canada Limited
First posted: 2008-02-26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Objectives: To determine whether nabilone, a synthetic cannabinoid, alleviates spasticity in people with spinal cord injury (SCI).

Methods: Twelve subjects were enrolled in this double-blind, placebo-controlled, crossover study. They received either nabilone or placebo during the first four-week period (0.5mg OD with option to increase to 0.5mg BID), then outcome measures were assessed. After a two-week washout, subjects were crossed-over to the opposite arm.

The primary outcome was the Ashworth scale for spasticity in the most involved muscle group, chosen by the subject and clinician. The secondary outcomes included Spasm Frequency Scale, Visual Analog Scale, Wartenberg Pendulum Test, sum of the Ashworth Scale in eight muscle groups of each side of the body, and the Clinician's and Subject's Global Impression of Change .


Eligibility criteria: Inclusion Criteria:

* Patients with spinal cord injury were eligible for the study if they are 18-65 years old, have C5 (ASIA A-D) and below and the injury occurred greater than 1 year previously. They had to have stable neurological level of injury with moderate spasticity (Ashworth \>/= 3) and no cognitive impairments. The spasticity medications needed to be unchanged for at least 30 days before inclusion, and no botulinum toxin injections for \> 4 months.

Exclusion Criteria:

They were excluded if they had:

* Heart disease as cannabinoids can reduce heart rate and blood pressure
* History of psychotic disorders, schizophrenia or any active psychological disorder
* Previously documented sensitivity to marijuana or other cannabinoid agents
* Severe liver dysfunction
* Cognitive impairment
* Major illness in another body area
* If they were pregnant or nursing mother
* Had history of drug dependency
* Used smoked cannabis \< 30 days before the onset of the study or were unwilling not to smoke during the study; OR
* If they fixed tendon contractures

Primary outcomes:
measure: Ashworth scale in most involved group muscles
timeFrame: 10 weeks
Secondary outcomes:
measure: The secondary outcomes included Spasm Frequency Scale, Visual Analog Scale, Wartenberg Pendulum Test, sum of the Ashworth Scale in eight muscle groups of each side of the body, and the Clinician's and Subject's Global Impression of Change .
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Rehabilitation hospital ,800 sherbrook St.
state: Manitoba
Study officials:
References:
Clinical trial NCT01560676: Reducing Obesity and Type 2 Diabetes in High Risk Youth
Official title: A School-based Internet Obesity Prevention Program for Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Obesity
Type 2 Diabetes
Keywords: Internet
School based
Obesity Prevention Program
Adolescents
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2012-03-22
Enrollment: 384
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Compare the effect of the HEALT\[e\]TEEN program and a HEALTH\[e\]TEEN plus coping skills training delivered to high school students on BMI, nutrition and physical activity behaviors, and self-efficacy over 6 months.


Eligibility criteria: Inclusion Criteria:

* Student enrolled in Health, Biology, or Public Health course

Exclusion Criteria:

* Cognitive ability unable to read or respond to questions in program

Primary outcomes:
measure: BMI
timeFrame: 6 months
Secondary outcomes:
measure: Dietary behavior
timeFrame: 6 months
measure: Sedentary behavior
timeFrame: 6 months
measure: Physical activity
timeFrame: 6 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale
state: Connecticut
Study officials:
affiliation: Yale University
name: Robin Whittemore, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Margaret Grey, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Whittemore R, Jeon S, Grey M. An internet obesity prevention program for adolescents. J Adolesc Health. 2013 Apr;52(4):439-47. doi: 10.1016/j.jadohealth.2012.07.014. Epub 2012 Sep 27.
Clinical trial NCT04563676: Physiopathology and Sequelae of COVID-19 Infection
Official title: Physiopathology and Sequelae of COVID-19 Infection
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Covid19
TSH
Cortisol
Keywords: Covid19
TSH
cortisol
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The data obtained from Covid-19 infections seem to suggest that the immunogenesis of Covid-19 could in some cases be the result of immune dysregulation. On the other hand, endocrine damage is possible at the tile of Covid-19 infection (mainly thyroid,adrenal, and hypothalamus). These disorders are autoimmune or linked to degeneration.

The main objective is to assess the thyroid function (thyrotropic axis) as well as the corticotropic adrenal function of patients who have had Copvid-19 pneumonia. The secondary objectives is to describe the pathophysiological mechanisms of pulmonary and vasculothrombotic involvement of Covid-19


Eligibility criteria: Inclusion Criteria:

* patient having a covid19 infection hospitalized at the Amiens Picardie University Hospital
* Patient who is seen in Pneumology consultation for a respiratory assessment at 3 months of his hospitalization (between M2 and M4) to evaluate presence of respiratory sequelae
* Patient who agreed to participate in the protocol
* Patient affiliated to a Social Security

Exclusion Criteria:

* patient under guardianship or curators
* patient refusing to participate

Primary outcomes:
measure: 8-hour cortisol level in patients with Covid19 pneumonia
timeFrame: day 0
measure: TSH level in patients with Covid19 pneumonia
timeFrame: day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT06017076: Effect of Preoperative Oral Energy Drinks Compared to Warming Matress on Body Temperature During Combined Spinal-epidural Anesthesia for Elective Cesarean Delivery.
Official title: Effect of Preoperative Oral Energy Drinks Compared to Warming Matress on Body Temperature During Combined Spinal-epidural Anesthesia for Elective Cesarean Delivery: a Randomised Non-inferiority Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cesarean Section Complications
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2023-08-30
Enrollment: 280
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: It is not known which is better for intraoperative temperature protection, warming matress or preoperative oral functional drinks in elective cesarean section. We plan to conduct a non inferiority randomized trial to clarify this problem.


Eligibility criteria: Inclusion Criteria:

* Women pregnant with a single fetus;
* American Society of Anesthesiologists (ASA) physical status II;
* Willingness to undergo elective cesarean delivery under CSEA;
* An age of 20-40 years;
* A body mass index (BMI) of 19-30 kg·m-2;
* A gestational age of 38-40 weeks.

Exclusion Criteria:

* Contraindications for CSEA;
* A diagnosis of delayed gastric emptying, hyperemesis gravidarum until late pregnancy, or consumption of drugs that affect gastrointestinal motility within 3 days before surgery;
* Preoperative body temperature \>38°C or \<36°C or the use of drugs that affect body temperature;
* Pregnancy combined with diabetes, hypertension, or metabolic disorders (eg, hypothyroidism or hyperthyroidism);
* Ear diseases (eg, otitis media, tympanic membrane perforation, etc) affecting measurement of ear temperature .
* Patients who were simultaneously undergoing other operations (eg, removal of uterine fibroids and ovarian cysts) or had a surgical time \>1.5 hours;
* Patients with blood transfusion or autologous blood transfusion intraoperatively;
* Patients who did not receive the anesthetic specified in the protocol;
* Patients who failed to drink adequate energy drinks as prescribed before surgery.

Primary outcomes:
measure: Core temperature change
timeFrame: Before the operation, and every 10 minutes during the operation until the end of the operation.
Secondary outcomes:
measure: Skin temperature changes
timeFrame: Before the operation, and every 10 minutes during the operation until the end of the operation.
measure: hypotension
timeFrame: Intraoperative
measure: The incidence of nausea in pregnant women
timeFrame: Intraoperative
measure: Umbilical artery blood base excess
timeFrame: 30sec after delivery
measure: The incidence of vomiting in pregnant women
timeFrame: Intraoperative
measure: The incidence of shivering in pregnant women
timeFrame: Intraoperative
Other outcomes:
Locations:
Study officials:
References: