louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05629819: Effect of Early Non-invasive Phrenic Nerve Stimulation on Weaning in Mechanically Ventilated Patients
Official title: Effect of Early Non-invasive Phrenic Nerve Stimulation on Weaning in Mechanically Ventilated Patients：A Multicenter, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mechanical Ventilation
Weaning
Keywords: phrenic nerve stimulation
diaphragm function
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2022-11-29
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: the early application of non-invasive PNS in MV patients can increase the number of days without mechanical ventilation, delay disuse phrenic atrophy, and improve the strength of inspiratory muscle.

Detailed description: A prospective randomized controlled study included 104 patients with MV who met inclusion criteria in multiple hospital ICU units and were randomly divided 1:1 into PNS and conventional groups. The PNS group received neuromuscular electrical stimulation in addition to routine airway management, early activity and respiratory muscle training. It was verified that early non-invasive PNS could increase the number of days without mechanical ventilation for 28 days, delay disused diaphragm atrophy and improve inspiratory muscle strength.

Eligibility criteria: Inclusion Criteria:

* Age ≥18years and ≤80years;
* MV time ≤48h;
* MV duration is expected to be ≥72h;
* The sternocleidomastoid region and pectoralis major region were completely exposed.
* Patients or family members are willing to sign informed consent and participate in the study.

Exclusion Criteria:

* There are contraindications to PNS in vitro (Pneumothorax, active tuberculosis, pleural adhesions, installation of pacemakers and defibrillators, etc.);
* Neuromuscular disease (myasthenia gravis, etc.) or known anatomical abnormalities of the diaphragm;
* ECMO status;
* Hemodynamic instability;
* Uncorrected arrhythmias;
* Be pregnant;
* Clinical end-stage and palliative care patients.

Primary outcomes:
measure: Ventilator-free days
timeFrame: 28 days
Secondary outcomes:
measure: mechanical ventilation days
timeFrame: 28 days
measure: re-intubation rate
timeFrame: 28 days
measure: ICU mortality
timeFrame: 28 days
measure: 60/90-day survival rate
timeFrame: 28 days
measure: Maximal Inspiratory Pressure
timeFrame: up to 28 days
measure: Diaphragm thickness
timeFrame: up to 28 days
measure: diaphragm thickening fraction
timeFrame: up to 28 days
measure: Transdiaphragmatic Pressure
timeFrame: up to 28 days
Other outcomes:
measure: The incidence of adverse events
timeFrame: up to 28 days
measure: Medical expenses
timeFrame: through study completion, an average of 30 days
Locations:
city: Beijing
country: China
facility: Bing Sun
state: Beijing
Study officials:
affiliation: Beijing Chao Yang Hospital
name: Bing Sun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01235819: Comparison Between GLP 1 Analogues and DPP 4 Inhibitors in Type 1 Diabetes Mellitus
Official title: Comparison Between GLP 1 Analogues and DPP 4 Inhibitors in Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 1 Diabetes
Keywords: type 1 diabetes
exenatide
sitagliptin
Lead sponsor: Command Hospital, India
Sponsor class: OTHER_GOV
First posted: 2010-11-08
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the effects of GLP 1 analogues and DPP 4 inhibitors on newly detected type 1 diabetes patients.

Detailed description: Inclusion criteria T1DM \<3 months GAD Antibody+ Stimulated C peptide\<0.5ng/ml Ketosis at onset Age \< 30 yr Exclusion criteria Age \> 30 yr Pancreatic disease significant systemic complication

Eligibility criteria: Inclusion Criteria:

* T1DM \<3 months
* GAD Antibody+ or Stimulated C peptide\<0.5 ng/ml
* Ketosis at onset
* Age \< 30 yr

Exclusion Criteria:

* Age \> 30 yr
* Pancreas disease
* Significant systemic disease

Primary outcomes:
measure: change in insulin requirement
timeFrame: one year
Secondary outcomes:
measure: C peptide response
timeFrame: at the end of one year
Other outcomes:
Locations:
city: Lucknow
country: India
facility: Command Hospital
state: UP
Study officials:
affiliation: Command Hospital
name: The Commandant, MD
role: STUDY_DIRECTOR
References:
citation: Hari Kumar KV, Shaikh A, Prusty P. Addition of exenatide or sitagliptin to insulin in new onset type 1 diabetes: a randomized, open label study. Diabetes Res Clin Pract. 2013 May;100(2):e55-8. doi: 10.1016/j.diabres.2013.01.020. Epub 2013 Mar 13.
Clinical trial NCT01735019: Estimating EC95 of Remifentanil for Cough Prevention During Emergence From Total Intravenous Anesthesia With Propofol and Remifentanil in Patients Undergoing Transsphenoidal Hypophysectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypophysectomy
Keywords: EC95, effective concentration in 95% of subjects
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-11-28
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: In patients undergoing hypophysectomy through transsphenoidal approach, preventing cough during anesthetic emergence is important to avoid hemorrhage and cerebrospinal fluid leakage. Previous reports demonstrated that administration of remifentanil during anesthetic emergence could reduce the incidence and severity of cough during anesthetic emergence. Therefore, the objective of this study is to determine EC95 of remifentanil for preventing cough during anesthetic emergence in patients undergoing hypophysectomy with transsphenoidal approach.


Eligibility criteria: Inclusion Criteria:

* scheduled to undergo hypophysectomy with transsphenoidal approach
* American Society of Anesthesiologists physical status I or II
* more than 20 years old

Exclusion Criteria:

* acute or chronic respiratory disease
* uncontrolled hypertension
* taking sedatives or anti-tussive
* gastro-esophageal reflux
* pregnant or breast feeding
* patients who cannot understand statements for subjects or this study itself

Primary outcomes:
measure: The occurrence of cough during anesthetic emergence
timeFrame: 5 min after extubation
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT02344719: Effect of Taurine on Portal Hemodynamics in Patients With Advanced Liver Cirrhosis
Official title: The Effect of Oral Taurine on Portal Hemodynamics in Patients With Advanced
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cirrhosis
Portal Hypertension
Keywords: cirrhosis
portal hypertension
taurin
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2015-01-26
Enrollment: 30
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 want to analyze the effect of Taurin on portal hemodynamics in patients with advanced liver cirrhosis.

Detailed description: 28 days of 6 grams Taurine versus Placebo (randomization 1:1).

Eligibility criteria: Inclusion Criteria:

* Patients (male and female) aged older than 18 years with advanced liver cirrhosis (Child's Grade B and Child's Grade C), regardless of the disease origin (viral, alcoholic, idiopathic), who are scheduled for hepatic hemodynamic investigation
* Negative pregnancy test of women with childbearing potential
* Patient without beta blocker therapy: due to: intolerance of the medication, preexisting contraindication against beta blocker therapy, endoscopic band ligation as prophylaxis

Exclusion Criteria:

* History of variceal bleeding without endoscopic band ligation
* History of endoscopically diagnosed large varices with red spots without previous bleeding and without endoscopic band ligation
* HVPG \< 10 mmHg
* HVPG \> 20 mmHg and varices, unless ligated and treated in an eradication program within 6 months
* Beta Blocker therapy
* History of hypersensitivity to the trial drugs and contrast agent or to drugs with similar chemical structure
* Treatment with vasoactive or non-steroidal anti-inflammatory drugs or systematic antibiotics one week before the study
* Exclusion criteria for hepatic hemodynamic investigation
* Cardiac, renal or respiratory failure
* Previous surgical or transjugular intrahepatic portosystemic shunt
* Breast-feeding or pregnant women

Primary outcomes:
measure: HVPG change in mmHg after 28 days with Taurin 6g or placebo
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Dept. of Internal Medicine III, Gastroenterology and Hepatology, Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Arnulf Ferlitsch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03436719: Antibiotic Prophylaxis in Rectal Cancer Surgery: Oral With Intravenous Versus Intravenous Antibiotics.
Official title: Randomized Controlled Trial of Antibiotic Prophylaxis in Rectal Cancer Surgery: Oral With Intravenous Versus Intravenous Antibiotics.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Cancer
Keywords: Surgical Site Infection
Rectal Cancer Surgery
Oral Antibiotic
Antibiotic Prophylaxis
Lead sponsor: State Scientific Centre of Coloproctology, Russian Federation
Sponsor class: OTHER_GOV
First posted: 2018-02-19
Enrollment: 280
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: This is a randomized, controlled, parallel study to determine the efficiency of oral antibiotics in reduction of surgical site infection (SSI) in rectal cancer surgery.

Detailed description: Patients undergoing rectal cancer surgery in a single centre will assigned randomly to combined preoperative oral antibiotics (metronidazole and erythromycin) and perioperative intravenous antibiotics (cefmetazole) (oral+intravenous group) or to perioperative intravenous antibiotics (cefmetazole) alone (intravenous group). The primary endpoint is the overall rate of SSI.

Eligibility criteria: Inclusion Criteria:

* Have a planned of resection of rectum
* Have signed approved informed consent form for the study.

Exclusion Criteria:

* Significant simultaneous surgical procedure (e.g., liver resection of metastasis)
* Bacterial infection at the time of surgery or antimicrobial therapy up to 4 weeks before surgery
* Preoperative severe impairment in renal function (creatinine clearance (MDRD) \< 30 ml/min)
* Allergy on the study drugs .

Primary outcomes:
measure: Rate of Surgical Site Infection
timeFrame: 0 to 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: State Scientific Centre of Coloproctology
Study officials:
References:
Clinical trial NCT04114019: The Effect of Pelvic Floor Physiotherapy on Vaginal Elasticity
Official title: The Effect of Pelvic Floor Physiotherapy on Vaginal Elasticity as Measured by a Vaginal Tactile Imager
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Stress Urinary Incontinence
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2019-10-03
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women between 18-70 years of age, suffering from stress urinary incontinence, referred to pelvic floor physiotherapy.

Brief summary: Women suffering from stress urinary incontinence are offered pelvic floor physiotherapy as an optional treatment. Strengthening of the pelvic floor is measured to date by manual examination and lacks precise evaluation. The vaginal tactile imager assists in evaluation of the changes in the pelvic floor after physiotherapy.

Detailed description: Women with stress urinary incontinence will undergo 6-10 pelvic floor strengthening physiotherapy sessions. The participants will undergo a short examination of vaginal elasticity using a vaginal tactile imager prior to beginning physiotherapy and additional examinations after 6 treatments, 10 treatments and 3 and 6 months post-treatment cessation.

Eligibility criteria: Inclusion Criteria:

* women suffering from stress urinary incontinence.

Exclusion Criteria:

* women suffering from urge urinary incontinence.
* women suffering of mixed urinary incontinence.

Primary outcomes:
measure: Vaginal Elasticity
timeFrame: From the treatment cessation up to 6 months post-treatment
Secondary outcomes:
measure: Stress urinary incontinence
timeFrame: From the treatment cessation up to 6 months post-treatment
Other outcomes:
Locations:
Study officials:
affiliation: Rambam Health Care Campus
name: Roy Lauterbach, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02747719: Effects of Light and Exercise on Human Circadian Rhythms and Performance
Official title: Effects of Light and Exercise on Human Circadian Rhythms and Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Circadian Rhythm
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: NSBRI
First posted: 2016-04-22
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Both light and exercise are effective countermeasures for space and ground-based crews for circadian phase resetting and alertness levels. The investigators propose to test the combined effects of these two countermeasures to determine whether adding exercise to light stimuli will further improve circadian phase resetting and alertness.


Eligibility criteria: Inclusion Criteria:

* healthy by history, physical exam, laboratory studies of blood and urine, and psychological screening
* moderate-intensity exercise for at least 150 minutes per week

Exclusion Criteria:

* color blind
* no prescription medications, except hormonal birth control in females

Primary outcomes:
measure: Circadian Phase
timeFrame: 8 days
Secondary outcomes:
measure: Subjective alertness
timeFrame: 8 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Associate Professor
name: Elizabeth B Klerman, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01568619: Validation of Electrical Cardiometry Versus Fick Method in Cardiac Output Measurement
Official title: Validation of Electrical Cardiometry Versus Fick Method to Measure Stroke Volume and Cardiac Output in Patients With or Suspected of Having Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: cardiopulmonary exercise test
cardiac output
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2012-04-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients of 18 years or older who undergo cardiopulmonary exercise testing (CPET) with invasive hemodynamic monitoring for their routine care.

Brief summary: The investigators would like to find out if AESCULON®, a new device that non-invasively and continuously measures cardiac output using electrical cardiometry, works as well as one existing method--Fick method in patients undergoing cardiopulmonary exercise testing.


Eligibility criteria: Inclusion Criteria:

* Age \>= 18 yd;
* Level 3 cardiopulmonary exercise testing.

Exclusion Criteria:

* Proven or suspected disease involving severe aortic regurgitation;
* Implanted with a rate-responsive cardiac pacemaker;
* Pneumothorax or pleural effusion;
* Skin lesion(s) at the place where the electrode is supposed to be applied;
* Allergic to adhesive of ECG electrodes.

Primary outcomes:
measure: difference in CO measurements with two methods
timeFrame: two weeks after finishing the exercise test
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Yandong Jiang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04927819: Extra-short vs. Non-extra-short Dental Implants Splinted on the Same Prosthesis
Official title: Prospective Observational Study on Evolution of Extra-short Implants (<6.5 mm) Compared to Non-extra-short Implants (≥ 6.5 mm) Splinted on the Same Prosthesis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Partial-edentulism
Lead sponsor: Fundación Eduardo Anitua
Sponsor class: OTHER
First posted: 2021-06-16
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Partial edentulism

Brief summary: The main aim of this prospective study is to analyze the survival rate of short-length implants (\<6.5 mm) in subjects with partial edentulism. Non-short length implant will be used as control arm. Additionally, others clinical parameters (marginal bone loss and prosthetic associated complications) will be measured.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Have planned a fixed multiple prosthesis supported by implants \<6.5 mm in length and implants ≥ 6.5 mm in length within 15 days before the inclusion of the patient in the study.
* Planning of supported prostheses from 2 to 4 implants dental
* Have a previously performed CBCT (Cone Beam Computed Tomography)
* Availability to be observed during the period of tracing
* Signature of the informed consent

Exclusion Criteria:

* Smokers\> 10 cigarettes / day
* Complete prostheses
* Unitary prostheses

Primary outcomes:
measure: Survival of dental implants
timeFrame: 1 year
Secondary outcomes:
measure: Marginal bone loss
timeFrame: 1 year
measure: Incidence of prosthetic or implant complications
timeFrame: 1 year
Other outcomes:
Locations:
city: Vitoria
country: Spain
facility: Clinica Eduardo Anitua
Study officials:
affiliation: Clinica Eduardo Anitua
name: Eduardo Anitua, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06342219: Chronic Migraines and Neurofdeeback Mindfulness
Official title: Study Protocol for a Randomized Controlled Trial of Neurofeedback Mindfulness in Chronic Migraines
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Migraine, Headache
Keywords: neurofeedback mindfulness
headache management self-efficacy
chronic migraines
dependence behaviours
migraine severity
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
Collaborators: name: Saskatchewan Health Research Foundation
First posted: 2024-04-02
Enrollment: 135
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: As the second phase of our study on migraine headaches and neurofeedback mindfulness, we will explore how chronic migraineurs will benefit from a long term practice (8 weeks) of neurofeedback mindfulness compared to a similar attention group and a waitlisted group. This randomized controlled trial will also explore if migrianuers could decrease their dependence on medicine intake after completion of the study.


Eligibility criteria: Inclusion Criteria:

* have a diagnosis of chronic migraine from a clinician or have met the criteria for a chronic migraine diagnosis based on ICHD-3
* reside in Saskatoon area
* have a smartphone and internet connection for accessing the MUSE app
* have no frequent background experience of meditation

Exclusion Criteria:

* Comorbidity of Raynaud's syndrome or diabetes
* Current use of a preventative migraine treatment over 6 months

Primary outcomes:
measure: Migraine Disability
timeFrame: 8 weeks
measure: Migraine Severity
timeFrame: 8 weeks
measure: Headache management self-efficacy
timeFrame: 8 weeks
measure: Dependence on medicine
timeFrame: 8 weeks
Secondary outcomes:
measure: Anxiety
timeFrame: 8 weeks
measure: Depression
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
Study officials:
References: