louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01912170: Effect of Omega-3 Fatty Acids on Insulin Sensitivity in Chinese Gestational Diabetic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gestational Diabetes
Keywords: omega-3 fatty acid
gestational diabetes
insulin sensitivity
Lead sponsor: Zhejiang University
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2013-07-30
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to examine the change of fasting insulin, glucose, insulin sensitivity and related traits in response to the 14 wk treatment of omega-3 fatty acids, including fish oil (n=25) and flaxseed oil(n=25), in Chinese gestational diabetic patients. Corn oil(n=25), rich in omega-6 fatty acids, will be selected as a controlled oil. The intervention will start from the third trimester of these pregnant women and finish at the 4wk after the birth of their children. The investigators hypothesize that omega-3 fatty acids could improve insulin sensitivity and glucose metabolism in these patients.


Eligibility criteria: Inclusion Criteria:

* 1)gestational diabetes 2) female, \<40 years old 3)willing to participant in the trial

Exclusion Criteria:

* 1）type 1 diabetes or type 2 diabetes before pregnancy 2）Deny to sign the informed consent 3）Family history of hypertriglyceridemia or fasting triglyceride\>4.56 mmol/L 4）Have severe liver disease, kidney disease or cancer 5)Participating in the other clinical trial within 30 days 6)Other diseases or conditions, for which the doctor of the patients do not agree his or her participating

Primary outcomes:
measure: fasting glucose
timeFrame: 14 weeks
measure: Fasting insulin
timeFrame: 14 weeks
Secondary outcomes:
measure: birth weight, length of children
timeFrame: 10 weeks
Other outcomes:
measure: blood lipids, inflammatory markers
timeFrame: 14 weeks
Locations:
city: Jiaxing
country: China
facility: Jiaxing Women's and Children's Hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT05869370: The Effects Of Low Intensity Training With Blood Flow Restriction In Rheumatoid Arthritis Patients
Official title: The Effects Of Low Intensity Training With Blood Flow Restriction In The Lower And Upper Limbs On Muscle Strength, Muscle Mass, Biochemical Parameters And Markers Of Systemic Inflammation In Rheumatoid Arthritis Patients: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Kaatsu
Blood Flow Restriction Training
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
Collaborators: name: Hospital de Clínicas de Porto Alegre
First posted: 2023-05-22
Enrollment: 28
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Rheumatoid arthritis (RA) patients showed systemic manifestations that may lead to a reduction in muscle strength, muscle mass and, consequently, to a reduction in physical function. On the other hand, high intensity resistance training (HIRT) are able to improve muscle strength and muscle mass in RA without affecting the disease course. However, due to the articular manifestations caused by this disease, these patients may present intolerance to HIRT. Thus, the low intensity resistance training with blood flow restriction (TBFR) may be a new training strategy for these populations. In this sense, the investigators speculate that TBFR could be beneficial in RA patients, as well as, HIRT.


Eligibility criteria: Inclusion Criteria:

* Female;
* Rheumatoid arthritis patients;
* All individuals will undergo an ergospirometry to ensure cardiorespiratory conditions.

Exclusion Criteria:

* Fibromyalgia;
* Cardiovascular disease;

Primary outcomes:
measure: Muscle strength
timeFrame: Twelve weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Universidade Federal do Rio Grande do Sul - Faculdade de Medicina - Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
References:
citation: Dos Santos LP, Santo RCDE, Ramis TR, Portes JKS, Chakr RMDS, Xavier RM. The effects of resistance training with blood flow restriction on muscle strength, muscle hypertrophy and functionality in patients with osteoarthritis and rheumatoid arthritis: A systematic review with meta-analysis. PLoS One. 2021 Nov 10;16(11):e0259574. doi: 10.1371/journal.pone.0259574. eCollection 2021.
Clinical trial NCT03954470: Factors Influencing Risk of Progression of Chronic Kidney Disease
Official title: Factors Influencing Risk of Progression of Chronic Kidney Disease in Patients With Severe Renal Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease stage4
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2019-05-17
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult population with chronic renal failure, before replacement therapy, followed in 9 nephrology departments of Bourgogne Franche-Comté.

Brief summary: The aim of this study is to identify typical patterns of renal function evolution in patients with stage 4 chronic kidney disease, regularly followed in nephrology consultation and included in a French cohort.


Eligibility criteria: Inclusion Criteria:

* Patients meeting the inclusion criteria of the ND-CRIS cohort (long-term follow-up in one of the centers participating in the research, with a GFR \<60mL/min /1.73m2)
* Patients included in the ND-CRIS cohort on the date when the estimate of their GFR is strictly less than 30mL/min/1.73m2 and greater than or equal to 15mL/min/1.73m2 (MDRD equation).

Patients should have at least two measurements of GFR \<30mL/min/1.73m2 to be included, at least one of them greater than or equal to 15mL/min/1.73m2. The date of the first GFR \<30mL/min/ 1.73m2 will be considered as the date of origin.

Exclusion Criteria:

* Patients with GFR ≥30mL / min / 1.73m2 or \<15mL / min / 1.73m2
* Patients who do not meet the inclusion criteria of ND-CRIS cohort (dialysis patients, transplant patients, unfollowed patients)

Primary outcomes:
measure: Evolution of estimated Glomerular Filtration Rate (GFR) according to MDRD equation (modification of diet in renal disease) at each visit
timeFrame: up to 3 years
measure: Time between inclusion and occurrence of the "progression" event
timeFrame: up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre Hospitalier Universitaire de Besançon
Study officials:
References:
Clinical trial NCT01786070: Effect of Nebulized Budesonide on Preventing Postextubation Complications in Critically Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Sounds
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-02-07
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is evaluation of the effect of administration nebulized budesonide after extubation. The specific objectives of our study are to determine whether multiple doses of nebulized budesonide are effective to reduce or prevent postextubation edema.

In this double-blind randomized clinical trial study, 70 patients (age between 18 to 65) who are intubated (at least for 48 hours) and now are ready for extubation will be enrolled in the study after obtaining a written informed consent from their parents or guardians.

The investigators divide our patients randomly into two equal groups.

-Patients who are in budesonide group will receive nebulized budesonide (1 mg-every 12 hours; n=35) and patients in placebo group receive placebo (normal saline; n=35) until 48 hours after extubation. If patient have extubation criteria the investigators will extubate him and for 24 hours after, another anesthesiologist who is unaware about kind of medication, will evaluate the patients for severity of stridor. We will record the vital sings and grade of stridor every 6 hour. Respiratory rate (RR), heart rate (HR), blood pressure (BP) and oxygen saturation (SPO2) were recorded for each patient immediately before aerosol administration (time 0) and at 30 and 60 min; and 2,4,8,12,24,36 and 48 hrs. After extubation then the presence of stridor (heard with the aid of stethoscope) was recorded within 48 hr of extubation.


Eligibility criteria: Inclusion Criteria:

1. Patients' age 18-55 years old
2. Intubated for more than 48 hours after surgery
3. Met the weaning criteria defined as respiratory rate \< 30 breaths / min, negative tidal volume \> 5 ml/kg ideal body weight, and shallow index (respiratory rate/tidal volume) \< 105 breaths / min/L

Exclusion Criteria:

1. Any history of corticosteroid therapy in previous week
2. Nasal or throat disease / surgery
3. Pulmonary airway disease
4. Gastrointestinal bleeding

Primary outcomes:
measure: post extubation stridor
timeFrame: After extubation until 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Alzahra University Hospital
Study officials:
References:
Clinical trial NCT02618070: Cognitive Modulation of Dyspeptic Symptom During Food Ingestion in Functional Dyspepsia Patients Cognitive Modulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Imaging
Functional Dyspepsia
Food
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2015-12-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In this functional magnetic resonance imaging study, effects of different information of fat content of high or low fat will be examined in FD patients and healthy volunteers (n=30, respectively). These data will provide a better understanding of symptom generation following food ingestion in general as well as in patients with respective functional gastrointestinal disorders.


Eligibility criteria: Inclusion Criteria:

* Male and female, volunteering adults BMI: 18-25 kg/m² right-handed Age: 18-65 years Capacity to give informed consent

For FD patients, Diagnosis of functional dyspepsia over the last 12 months certified by a medical record Inconspicuous gastroscopy during the last 6 months certified by a medical record

Exclusion Criteria:

* Subjects which have a non-removable metal object in or at their body, such as, for example:
* Heart pace-maker,
* Artificial heart valve,
* Metal prosthesis,
* Metallic implants (screws, plates from operations, etc.),
* Interuterine Spiral,
* Metalsplinters / grenade fragments
* Non-removable dental braces,
* Acupuncture needles,
* Insulin pump,
* Intraport, etc., Pregnant women or pregnancy cannot be excluded Nursing women Subjects with limited temperature perception and/or increased sensitivity to warming of the body A circulatory disease cannot be excluded Subjects with hearing-disease or an increased sensitivity to loud noises Subjects with fear of closed-in places (claustrophobia) Subjects which were operated less than three month ago Acute illness or infection Neurological disorder or injury (e.g. epilepsy) Moderate or severe head injury Severe psychotic illness (e.g. schizophrenia, depression) Intake of antidepressants / antipsychotics Vegetarians/Vegans Food allergies Self-reported eating disorder

Primary outcomes:
measure: functional brain activity
timeFrame: 1-2 years
measure: subjective rating
timeFrame: 1-2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: Psychosomatic Medicine and Psychotherapy Department, University of Tübingen, Tübingen, Germany
Study officials:
affiliation: Psychosomatic Medicine and Psychotherapy Department, University of Tübingen, Tübingen, Germany
name: Paul Enck, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee IS, Kullmann S, Scheffler K, Preissl H, Enck P. Fat label compared with fat content: gastrointestinal symptoms and brain activity in functional dyspepsia patients and healthy controls. Am J Clin Nutr. 2018 Jul 1;108(1):127-135. doi: 10.1093/ajcn/nqy077.
Clinical trial NCT04204070: Accuro and the Use of Real Time Ultra Sound With Acoustic Puncture Assisted Device to Confirm Epidural Space End Point
Official title: Comparing Between Ultrasound Assisted Epidural Catheter Placement Using Accuro and the Use of Ultra Sound Real Time With Acoustic Puncture Assisted Device to Confirm Epidural Space End Point
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Two Different Techniques to Perform Epidural Using Ultrasound
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2019-12-18
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aim of the work:

To compare the use of the Accuro ultrasound and a real time ultrasound guided epidural combined with the acoustic puncture assisted device to perform the epidural anesthesia Secondary aim is to compare the incidence of complications associated with each technique.

Patient's selection:

This study will be performed on 100 pregnant patients scheduled for normal vaginal delivery under epidural analgesia.

The sample size was calculated by taking success rate of conventional LOR to be 98% in the patients; assuming 80% power, with 95% confidence interval (CI) of two techniques and 30% margin of error.

The study protocol will be reviewed and approved by the Ethics Committee of the Alexandria Main University Hospitals.

A written consent will be obtained from all the patients participating in this study.

Complete history will be taken from all the patients and will be subjected to thorough examination and routine laboratory investigations. Patients will be randomly divided into two equal groups using a computer-generated program.

Group I consists of 50 patients scheduled for epidural catheter insertion using the Accuro ultrasound imaging assisted technique.

Group II consists of 50 patients scheduled for epidural catheter insertion using the real time ultrasound guided technique combined with the use of the acoustic puncture assist device (APAD) technique.


Eligibility criteria: Inclusion Criteria:

* pregnant patients scheduled for normal vaginal delivery under epidural analgesia.

Exclusion Criteria:

* • Any contraindication for epidural analgesia

  * High risk pregnancy or precious baby.
  * Patients not willing for participation.

Primary outcomes:
measure: the depth of the EDS from skin,
timeFrame: the procedure time
measure: the number of attempts to perform the epidural anesthesia, the repositioning of the epidural needle either in the same space or in different space
timeFrame: the procedure time
measure: , the time taken for space localisation .
timeFrame: the procedure time
measure: the total time of the procedure
timeFrame: the procedure time
Secondary outcomes:
measure: compare the incidence of complications associated with each technique.
timeFrame: the procedure time
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria university
Study officials:
References:
Clinical trial NCT01182870: Vitamin D and the Influenza Epidemic
Official title: Vitamin D and the Influenza Epidemic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: vitamin D
influenza
prevention
Lead sponsor: University of Tromso
Sponsor class: OTHER
First posted: 2010-08-17
Enrollment: 569
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Subjects included in ongoing vitamin d intervention trials were asked by questionnaire if they were ill with influenza during the winter season 2009/2010 to see if vitamin d supplementation prevented flu like disease.


Eligibility criteria: Inclusion Criteria:

* participant in vitamin D versus placebo study

Exclusion Criteria:

* none

Primary outcomes:
measure: influenza during the winter season 2009/2010
timeFrame: up to 30 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University of Tromsø
Study officials:
affiliation: University of Tromso, Norway
name: rolf Jorde, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01401270: Prize Contingency Management for Cocaine-Dependent Methadone Patients
Official title: Prize Contingency Management for Cocaine-Dependent Methadone Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cocaine Abuse
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-07-25
Enrollment: 280
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 investigators will randomize 300 cocaine-dependent methadone patients to 1 of 6 conditions: (a) a control group, (b) a contingency management condition that arranges a 100% probability of winning a prize with each draw and has 3 prize categories, (c) a contingency management condition that arranges a 31% probability of winning and has 3 prize categories, (d) a contingency management condition that arranges a 100% probability of winning and has 7 prize categories, (e) a contingency management condition that arranges a 31% probability of winning and has 7 prize categories, or (f) usual prize contingency management with a 50% probability of winning from 3 prize categories. Magnitudes of reinforcement will be identical across conditions, but lower overall probability conditions arrange for greater chances of winning larger magnitude prizes. The investigators expect that the new contingency management conditions will reduce cocaine use relative to the control condition, that 31% probability conditions will decrease drug use relative to 100% conditions, and that 7-prize category conditions will reduce drug use compared to 3-prize category conditions. In addition, the 31%/7-category condition is expected to be most efficacious. Results will be instrumental for further developing prize contingency management to improve outcomes of cocaine-dependent methadone patients.


Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* current DSM-IV diagnosis of cocaine dependence
* enrolled at the clinic for \>3 months
* on a stable dose of methadone (no changes) for \>1 month and not requesting a dose alteration
* submitted \>1 clinic cocaine positive sample in the last 6 months
* English speaking
* pass a quiz related to understanding the informed consent form

Exclusion Criteria:

* serious, uncontrolled psychiatric illness
* significant cognitive impairment
* in recovery from pathological gambling

Primary outcomes:
measure: longest continuous period of cocaine abstinence
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
Study officials:
affiliation: UConn Health
name: Sheila M Alessi, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04577170: Pulsatility Index, Vasomotor Reactivity and Leukoencephalopathy in Fabry Patients
Official title: Association of the Pulsatility Index and Vasomotor Reactivity With White Matter Lesions in Brain MRI of Fabry Disease Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fabry Disease
Keywords: pulsatility index
vasomotor reactivity
leukoencephalopathy
transcranial ultrasound
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2020-10-06
Enrollment: 45
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients with genetically confirmed FD and healthy individuals will be prospectively enrolled as part of routine clinical examination.

Brief summary: We hypothesize that Fabry disease - FD is associated with elevated vascular resistance induced by cerebral small-vessel disease, indicating increased distal resistance to blood flow. The findings of this study may be used as a precursor for neuroimaging manifestations related to stroke in FD patients.


Eligibility criteria: Inclusion Criteria:

Fabry disease diagnosis, genetically confirmed Age\> 16 years

Exclusion Criteria:

Insufficient temporal bone window MRI contra-indication Inability to cooperate for breath-holding test Detection of atrial fibrillation Refuse to sing informed consent

Primary outcomes:
measure: Prevalence of elevated pulsatility index of FD patients
timeFrame: 2 years
measure: Prevalence of elevated vasomotor reactivity in FD patients.
timeFrame: 2 years
Secondary outcomes:
measure: Association of pulsalitily index with leukoencephalopathy in FD patients.
timeFrame: 2 years
measure: Association of vasomotor reactivity with leukoencephalopathy in FD patients.
timeFrame: 2 years
measure: Τo compare the pulsatility index measured in FD patients against corresponding prospectively collected data from healthy individuals, stratified by age and sex.
timeFrame: 2 years
measure: Τo compare vasomotor reactivity measured in FD patients against corresponding prospectively collected data from healthy individuals, stratified by age and sex.
timeFrame: 2 years
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Second Department of Neurology, "Attikon" University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece
Study officials:
References: