louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00856882: The Effects of Soy Protein and Isoflavones on Glycemic Control, Insulin Sensitivity and Cardiovascular Risk Factors
Official title: The Effects of Soy Protein and/or Isoflavones on Glycemic Control, Insulin Sensitivity and Cardiovascular Risk Factors-a Six Months RCT Among Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Cardiovascular Risk
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2009-03-06
Sex: FEMALE
Minimum age (years): 46
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: The investigators propose to perform a double-blind, randomized placebo-controlled trial to examine the hypothesis that soy protein with isoflavones could improve glycemic control, insulin sensitivity and decrease cardiovascular risk factors in postmenopausal women with prediabetes.


Eligibility criteria: Inclusion Criteria:

* Hong Kong Chinese menopausal women aged 46-70 years with prediabetes or early untreated diabetes

Exclusion Criteria:

* Women with breast, ovary or other cancers in recent 5-year
* Severe renal or liver dysfunction
* Women with androgen excess
* Smokers
* Current use or recent (3-month)use of any drug or treatment for glycemic control, lipid improvement, weight reduction; Subjects with known soy or milk allergy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Liu ZM, Ho CS, Chen YM, Woo J. Can soy intake affect serum uric acid level? Pooled analysis from two 6-month randomized controlled trials among Chinese postmenopausal women with prediabetes or prehypertension. Eur J Nutr. 2015 Feb;54(1):51-8. doi: 10.1007/s00394-014-0684-1.
citation: Liu ZM, Ho SC, Chen YM, Ho YP. A mild favorable effect of soy protein with isoflavones on body composition--a 6-month double-blind randomized placebo-controlled trial among Chinese postmenopausal women. Int J Obes (Lond). 2010 Feb;34(2):309-18. doi: 10.1038/ijo.2009.236. Epub 2009 Nov 17.
Clinical trial NCT03293082: Preschool CGM Use and Glucose Variability in Type 1 Diabetes
Official title: The Effect of Continuous Glucose Monitoring Use on Glucose Variability in Preschool Children With Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: University of Ljubljana, Faculty of Medicine
Sponsor class: OTHER
First posted: 2017-09-26
Enrollment: 40
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population of preschool children with type 1 diabetes aged up to 7 years that were prescribed sensor use in the observational period.

Brief summary: The objectives of this clinical study is to evaluate the efficacy continuous glucose monitoring (CGM) use on glucose variability (GV) in preschool children with T1D treated with CSII.

Downloads from CGM and CSII saved in pdf from will be retrospectively reviewed and analysed for all preschool children with type 1 diabetes in Slovenia. Glucose variability and other glycemic parameters will be analyzed separately for periods when CGM was used (CGM and SMBG data) and compared to periods when CGM was not used (SMBG only data).


Eligibility criteria: Inclusion Criteria:

1. Subject with Type 1 diabetes (\&gt; 6 months since diagnosis)
2. Insulin infusion pump CSII therapy for at least 3 months
3. Age ≤ 7 years
4. HbA1c at inclusion ≥ 6.5 and \< 10
5. BMI SDS - below the 95th percentile for age

Exclusion Criteria:

1. Concomitant diseases that influence metabolic control
2. Participation in any other interventional study
3. Known or suspected allergy to trial products

Primary outcomes:
measure: Glucose variability
timeFrame: Three years
Secondary outcomes:
measure: Mean intersticial glucose
timeFrame: Three years
measure: Mean blood glucose
timeFrame: Three years
measure: HbA1c
timeFrame: Three years
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: UMC - University Children's Hospital Ljubljana
Study officials:
References:
Clinical trial NCT00754182: Subcuticular Suture Versus Synthetic Glue in Thyroidectomy Incision
Official title: Comparison of Esthetic Results Between Subcuticular Suture and Synthetic Glue in Thyroidectomy Incision: a RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Goiter
Thyroid Neoplasms
Parathyroid Pathologies
Keywords: thyroidectomy
surgery
synthetic glue
subcuticular suture
Lead sponsor: Azienda Ospedaliero-Universitaria di Modena
Sponsor class: OTHER
First posted: 2008-09-17
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The aim of this study is to compare aesthetic results of two different type of sutures (subcuticular versus synthetic glue) in post-thyroidectomy incisions. It is a randomized clinical trial (single blinded) designed as a superiority study, since in the authors' hypotheses glue can give better results compared with subcuticular suture in this particular district. Secondary objective is to investigate if other factors (like the use of cold/warm blade, the sex, the presence of diabetes, the lenght of incision) can influence aesthetic results.


Eligibility criteria: Inclusion Criteria:

* Patients underwent thyroidectomy, emithyroidectomy, parathyroidectomy

Exclusion Criteria:

* Former neck operations with external incisions
* Post-operative bleeding
* Cervical nodes involvement (with the necessity of widened incisions)

Primary outcomes:
measure: Scar evaluation scale for short term esthetic results (Hollander, J. E., Singer, A. J., Valentine, S., and Henry, M. C. Wound registry: Development and validation. Ann. Emerg. Med. 25: 675, 1995.)
timeFrame: 10 days
Secondary outcomes:
measure: Scar Evaluation Scale (by Adam J. Singer, M.D. et al. "Development and Validation of a Novel Scar Evaluation Scale" Plastic and Reconstructive Surgery ,December 2007 Volume 120, Number 7 ,1892-1897)
timeFrame: 3 months
Other outcomes:
Locations:
city: Modena
country: Italy
facility: Policlinico di Modena
Study officials:
affiliation: Otorinolaringoiatria, Policlinico di Modena
name: Matteo Alicandri-Ciufelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03610282: EEG Study of IV Methylphenidate-Induced Emergence From Propofol Sedation
Official title: Electroencephalogram Study of Intravenous Methylphenidate-Induced Emergence From Propofol Sedation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Anesthesia
Keywords: Propofol
Methylphenidate
Ritalin
Anesthetics
Anesthetics, Intravenous
Molecular Mechanisms of Pharmacological Action
Anesthetics, General
Neurotransmitter Agents
Physiological Effects of Drugs
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators are performing this research study to find out if intravenous (IV) methylphenidate (commonly known as Ritalin) can help people recover faster from propofol sedation. The investigators also want to know how IV methylphenidate acts in the brain and whether IV methylphenidate is safe to take with an anesthetic (a drug or agent used to decrease or eliminate the feeling of pain by causing unconsciousness) without causing too many side effects. The brain's electrical activity will be studied and recorded using a machine called an electroencephalogram (EEG).

Detailed description: During this research study, participants will receive propofol, and propofol and IV methylphenidate together, at a high enough dose to achieve unconsciousness (make study participants "fall asleep"). During one visit participants will receive propofol and a saline placebo; during another visit participants will be given both propofol and IV methylphenidate together. The investigators will record EEG the entire time, The investigators will also ask some questions related to cognitive function.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 18 to 45
* Normal body weight and habitus, BMI ≤ 30
* Non-smoker
* No history of taking stimulants
* American Society of Anesthesiologists (ASA) physical status classification P1

Exclusion Criteria:

• Chronic health conditions

Primary outcomes:
measure: Change in multitaper spectral estimates of EEG power during a continuous infusion of propofol.
timeFrame: Up to 100 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Ken Solt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02162082: Coronary and Structural Interventions Ulm - Coronary Chronic Total Occlusions
Official title: Coronary and Structural Interventions Ulm - Coronary Chronic Total Occlusions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Ischemic Heart Disease
Stable Angina
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2014-06-12
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the long-term results after recanalization of coronary chronic total occlusions.

Detailed description: Patients with successful recanalization of coronary chronic total occlusions are followed during a period of 5 years to demonstrate safety and efficacy.

Eligibility criteria: Inclusion Criteria:

* coronary artery disease
* chronic total occlusion

Exclusion Criteria:

* no written informed consent

Primary outcomes:
measure: Major adverse cardiac events
timeFrame: 1-5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: University of Ulm
Study officials:
affiliation: University of Ulm, Ulm, Germany
name: Jochen Wöhrle, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kugler C, Markovic S, Rottbauer W, Wohrle J. Bioresorbable scaffolds compared with everolimus-eluting stents for the treatment of chronic coronary total occlusion: clinical and angiographic results of a matched paired comparison. Coron Artery Dis. 2017 Mar;28(2):120-125. doi: 10.1097/MCA.0000000000000449.
Clinical trial NCT03649282: HFNC and NCPAP in Extremely Preterm Infants
Official title: Comparisons of the Dynamic of the Cardiorespiratory System Behavior of Extreme Preterm Infants Receiving Nasal CPAP or High Flow Nasal Cannula During the Immediate Post-extubation Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Extreme Prematurity
Keywords: NCPAP
HFNC
Preterm infants
Cardiorespiratory behaviour
Non-invasive respiratory support
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2018-08-28
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: To avoid or decrease the rate of complications in preterm infants after disconnection from a mechanical ventilation (extubation), non-invasive respiratory support is routinely used. While infants are most commonly extubated to nasal continuous positive airway pressure (NCPAP), high flow nasal cannula (HFNC) has emerged as an attractive alternative. However, research regarding the safety and efficacy of HFNC in the most extreme preterm infants is limited. Therefore, we hypothesize that immediately after extubation, measures of heart rate and respiratory behavior may be useful to investigate for any differences between HFNC and NCPAP.

Detailed description: Infants will be studied 30 min after extubation on both modes of support, provided in a random order. A transition period of 15 min between modes will be given. For each mode, recordings will be performed for 40 minutes. Analysis of these recordings will be done off line.

Eligibility criteria: Inclusion Criteria:

* Infants with birth weight ≤ 1250 grams
* Infants that have been mechanically ventilated and undergoing their first elective extubation attempt

Exclusion Criteria:

* Major congenital anomalies, neuromuscular disease, hemodynamic instability (use of vasopressors or hypotension).
* Infants reintubated before initiation or during data collection.
* Parental/legal guardian consent not obtained.

Primary outcomes:
measure: Differences on Heart Rate Variability in extremely preterm infants receiving HFNC and NCPAP
timeFrame: Immediate post-extubation period
measure: Differences on Respiratory Variability in extremely preterm infants receiving HFNC and NCPAP
timeFrame: Immediate post-extubation period
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal Children's Hospital
state: Quebec
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Guilherme M Sant'Anna, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05764382: Remote Tai Ji for Low Back Pain
Official title: Remote Tai Ji for Low Back Pain: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Keywords: Tai Chi
Qigong
Lead sponsor: New York Presbyterian Hospital
Sponsor class: OTHER
Collaborators: name: Center for Taiji and Qigong Studies & Wa-Qi.com
First posted: 2023-03-10
Enrollment: 300
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 purpose of the study is to examine the implementation strategy, in terms of feasibility and the possible benefits, of a free online Zoom t'ai chi and qigong gentle movement and meditation program to reduce back pain and to improve sleep and quality of life among those with chronic back pain. The primary objective of this study is to examine whether a safe and moderate online t'ai chi and qigong exercise program, offered without cost to individuals with chronic back pain, improves pain levels, sleep, and quality of life; The secondary objective is to explore whether improvements in pain levels are different among smokers and those with unhealthy BMI than among others.


Eligibility criteria: Inclusion Criteria:

* 18 years and older
* Have experienced low back pain for the last 6 weeks or longer
* Understands written and spoken English
* Be willing to complete the initial survey and 3 additional ones emailed baseline and January 2023
* Be willing and able to provide consent to participate in the survey

Exclusion Criteria:

* pregnany
* previously has taken t'ai chi classes
* spine surgery within the last 6 months

Primary outcomes:
measure: Change in the Oswestry Disability Index 3 months after intervention
timeFrame: baseline, 3 months
Secondary outcomes:
measure: Change in visual analogue scale (VAS) for low back pain
timeFrame: baseline, 3 months
measure: Change in VAS leg pain
timeFrame: baseline, 3 months
measure: The "SF-36," Short Form Health Survey questionnaire
timeFrame: baseline, 3 months
measure: 9-Item Pittsburgh Sleep Quality Index
timeFrame: baseline, 3 months
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbytarian Hospital
state: New York
Study officials:
affiliation: Director Center for Taiji and Qigong Studies & Wa-Qi.com https://www.wa-qi.com
name: Yang Yang, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05555420: BMP-2 and ALP Levels Following Laser Therapy With Scaling and Root Planing in Periodontitis- RCT.
Official title: Assessment of BMP-2 and ALP Levels Following Laser Therapy as an Adjunct to Scaling and Root Planing for Treatment of Periodontitis- A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periodontitis, Laser
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-09-26
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with periodontitis will be treated by either SRP only or SRP in combination with laser.

Samples from GCF will be collected immediately after treatment and at 3 months follow-up time. Levels of BMP-2 and ALP will be assessed at these time points.

Statistical analysis to compare the results will be performed.


Eligibility criteria: Inclusion Criteria:

* Periodontitis

Exclusion Criteria:

* Uncontrolled medical condition

Primary outcomes:
measure: Amount of attachment gain
timeFrame: 3 months
Secondary outcomes:
measure: Level of BMP-2 in GCF
timeFrame: 3 months
measure: Level of ALP in GCF
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06323720: Signs of Central Sensitization in Tension-type Headache
Official title: Are Signs of Central Sensitization Present in Tension-type Headache?
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tension-Type Headache
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2024-03-21
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: This study will involve participation from various populations, specifically patients with episodic tension headache, patients with chronic tension headache, and healthy pain-free controls.

Brief summary: The goal of this observational study is to assess the pain sensitivity in tension-type headache patients. The main question it aims to answer is:

- Are signs of central sensitization present in tension-type headache?

Participants will be asked to fill out baseline questionnaires and they will be assessed during 1 test moment (static and dynamic quantitative sensory testing).

Researchers will compare tension-type headache patients with healthy controls to see if signs of central sensitization are only present in the tension-type headache group.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of tension headache according to globally recognized criteria (ICHD-3) or verified by a physician
2. Diagnosis of tension headache confirmed by a questionnaire (Headache Screening Questionnaire)
3. Not pregnant or given birth in the past year since a change in hormone levels can affect pain experience
4. Adults between the ages of 18 and 65
5. Proficient in the Dutch language

Exclusion Criteria:

1. Other diagnosis of headache or a mixed form
2. Other existing condition involving central nervous system sensitivity
3. Other structural neurological syndromes
4. Any condition involving the brain in the past
5. Procedure on the head, neck, or shoulder in the past 3 years
6. Currently suffering from a psychiatric condition
7. Athletes competing at a competitive level
8. Not proficient in the Dutch language
9. Currently pregnant.

Primary outcomes:
measure: Pain sensitivity for heat stimuli
timeFrame: Baseline
measure: Pain sensitivity for cold stimuli
timeFrame: Baseline
measure: Pain sensitivity for electrical stimuli
timeFrame: Baseline
measure: Pain sensitivity for pressure
timeFrame: Baseline
measure: Function of the pain facilitating pathways
timeFrame: Baseline
measure: Function of the pain inhibiting pathways
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University
state: East-Flanders
Study officials:
affiliation: Revalidatiewetenschappen en kinesitherapie
name: Jessica Van Oosterwijck, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03303820: Analysis of the Impact of the Undernutrition on the Cerebral Infarct in Thrombolized Patients
Official title: Analysis of the Impact of the Undernutrition on the Cerebral Infarct in Thrombolized Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thrombosis
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2017-10-06
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patient admitted in hospital for vascular cerebral accident in 2015 with thrombolytic treatment

Brief summary: Many clinical trials show that 30 to 50 % of the hospitalized patients are undernourished in various degrees. This prevalence didn't change since 15-20 years The fact is that the present undernutrition in the admission deteriorates during the hospitalization.

Besides, the cerebral vascular accident (AVC) complicates the first days, in at least 50 % of the cases, the disorders of the gulp, which are a risk factor of acquired undernutrition. The nutrition holds an important place in the therapeutic coverage of the AVC. Nevertheless, the link between the undernutrition the entrance and the evolution of the AVC is at the moment only little known. The purpose is to study the impact of the undernutrition in the entrance to the hospital (undernutrition previous to the AVC), on the gravity and the evolution


Eligibility criteria: Inclusion Criteria:

* patient admitted in hospital for vascular cerebral accident in 2015
* thrombolytic treatment

Exclusion Criteria:

* no thrombolytic treatment
* transcient ischaemic attack

Primary outcomes:
measure: Rankin score
timeFrame: Day 1; last day of hospitalisation
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
affiliation: GHPSJ
name: ZUBER Mathieu, Professor
role: STUDY_DIRECTOR
References: