louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05026463: Use of Pressure Muscle Index to Avoid Over-assistance During Pressure Support Ventilation
Official title: Use of Pressure Muscle Index to Avoid Over-assistance During Pressure Support Ventilation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mechanical Ventilation
Keywords: mechanical ventilation
pressure support
inspiratory effort
work of breathing
lung injury
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2021-08-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Pressure support ventilation (PSV) is the most commonly used mode in mechanical ventilated patients. Studies have shown that over-assistance was prevalent in patients undergoing PSV. Up to now, no reliable method has been recommended to select an "optimal" inspiratory support level. Pressure muscle index (PMI) was introduced recently to evaluate the degree of spontaneous breathing effort. We hypothesize that PMI might be used as an indicator for over-assistance during PSV. In this randomized crossover study, inspiratory support is set at three levels according to negative, positive and zero PMI. Inspiratory effort, work of breathing, and respiratory mechanics are compared among the three inspiratory pressure support levels.


Eligibility criteria: Inclusion Criteria:

* Mechanical ventilated patients within 48 hours after the transition from a controlled mode to PSV

Exclusion Criteria:

* History of neuromuscular disease
* History of diaphragm dysfunction and surgery
* History of esophageal, gastric or lung surgery
* Decreased level of consciousness
* Central respiratory drive dysfunction
* Considered withholding of life support

Primary outcomes:
measure: Inspiratory effort
timeFrame: 30 minutes
measure: Work of breathing
timeFrame: 30 minutes
Secondary outcomes:
measure: Respiratory system compliance (ml/cmH2O)
timeFrame: 30 minutes
measure: Partial pressure of oxygen in arterial blood (mmHg)
timeFrame: Partial pressure of oxygen in arterial blood
measure: Partial pressure of carbon dioxide in arterial blood (mmHg)
timeFrame: 30 minutes
measure: Respiratory rate (breaths/min)
timeFrame: 30 minutes
measure: Tidal volume (ml)
timeFrame: 30 minutes
measure: Rapid shallow breathing index
timeFrame: 30 minutes
measure: The use of accessory respiratory muscle
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT04204863: Status Epilepticus Population Study (STEPS)
Official title: Status Epilepticus Population Study (STEPS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Epileptic Seizures
Keywords: Status epilepticus
Electroencephalogram
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2019-12-19
Enrollment: 1000
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 patients (i.e., patients ≥18 years of age) with SE treated at the University Hospital Basel and the Cantonal Hospital Aarau.

Brief summary: The aim of this observational multicenter cohort study is to gain a deeper understanding regarding the effects of treatment adaption based on information from outcome prediction models, risk stratification, as well as treatment monitoring, detection, prevention, and management of complications on course and outcome of adult patients with status epilepticus (SE).


Eligibility criteria: Inclusion Criteria:

* Adult patients (i.e., patients ≥18 years of age) with diagnosed SE between 2005 and 2023 who have been treated at the University Hospital of Basel or the Cantonal Hospital Aarau.

Exclusion Criteria:

* Patients younger than 18 years.
* Patients with repetitive epileptic seizures not qualifying for SE.
* Patients with documented refusal of the general consent.

Primary outcomes:
measure: Demographics
timeFrame: between 01.01.2005 and 31.12.2023
measure: Data from acute prehospital management by the emergency medical services (EMS)
timeFrame: between 01.01.2005 and 31.12.2023
measure: Duration of ICU (intensive care unit) and hospital stay, and destination at discharge
timeFrame: between 01.01.2005 and 31.12.2023
measure: Date(s) of seizure(s) captured by electroencephalographic (EEG) data
timeFrame: between 01.01.2005 and 31.12.2023
measure: Seizure history and etiology
timeFrame: between 01.01.2005 and 31.12.2023
measure: Number and Duration of SE episodes
timeFrame: between 01.01.2005 and 31.12.2023
measure: Types of SE
timeFrame: between 01.01.2005 and 31.12.2023
measure: Additional features of the seizure
timeFrame: between 01.01.2005 and 31.12.2023
measure: ICU Scoring Systems
timeFrame: between 01.01.2005 and 31.12.2023
measure: Clinical neurologic monitoring scores
timeFrame: between 01.01.2005 and 31.12.2023
measure: Laboratory parameters
timeFrame: between 01.01.2005 and 31.12.2023
measure: Outcome measure
timeFrame: between 01.01.2005 and 31.12.2023
measure: Therapeutic features
timeFrame: between 01.01.2005 and 31.12.2023
measure: Monitoring of vital signs
timeFrame: between 01.01.2005 and 31.12.2023
Secondary outcomes:
Other outcomes:
Locations:
city: Aarau
country: Switzerland
facility: Cantonal Hospital Aarau (KSA)
city: Basel
country: Switzerland
facility: Clinic for Intensive Care Medicine, University Hospital Basel
Study officials:
affiliation: Clinic for Intensive Care Medicine, University Hospital Basel
name: Raoul Sutter, PD Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05100563: Participant(s) With Autism and High Pain Tolerance Treated With High Dose Naltrexone
Official title: Participant(s) With Autism and High Pain Tolerance Treated With High Dose Naltrexone
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autism Spectrum Disorder
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 1
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents and adults with autism spectrum disorder

Brief summary: High dose naltrexone with response gauged by pain tolerance as measured by the cold pressor test may help treat autism.

Detailed description: Clinical Trial: Cause and Treatment of High Opioid Tone Autism Key Words: autism, neurobiological systems engineering, opioid tone, cold pressor time, clinical trial Abstract Introduction: Neurobiological systems engineering models are useful for treating patients. We show a model of "high opioid tone" autism and present a hypothesis about how autism is caused by administration of opioids during childbirth.

Main Symptoms: Clinical diagnosis of autism in a 25 year old man was confirmed by a Social Responsiveness Scale (SRS) self - rating of 79, severe, and a Social Communications Questionnaire (SCQ - 2) by the patient's father scoring 27. Cold pressor time is a measure of pain tolerance obtained by having the subject submerge their normal forearm in a painful ice water bath. Cold pressor time (CPT) was 190 seconds - unusually long, consonant with the high pain tolerance of autism.

Therapeutic Intervention and Outcome Measure:

Primary Outcome Measure is the Cold Pressor Time (CPT). At naltrexone 50 mg/day CPT fell to 28, repeat 39 seconds.

Secondary outcome measures are Social Responsiveness Scale (SRS) and Social Communications Questionnaire (SCQ-2). SRS fell to 54 and SCQ - 2 to 9; both non - significant for autism.

Change in relatedness was experienced ambivalently, understood as feelings never before experienced - causing pain. Non - compliance with naltrexone was followed by cutting open his palm and drinking alcoholically. Transference focused psychotherapy has helped him remain naltrexone - compliant while he works on issues of identity and relatedness.

Conclusion: The model suggests studies that could be conducted to both prevent and treat this form of autism.

Eligibility criteria: Inclusion Criteria: Diagnosis of autism -

Exclusion Criteria: Lack of ability to give informed consent

-

Primary outcomes:
measure: improvement of social responsiveness scale (SRS) and social communication questionnaire (SCQ)
timeFrame: After two weeks at optimal naltrexone dose
Secondary outcomes:
measure: Cold Pressor Time
timeFrame: After a week on optimized naltrexone dose with repeat two weeks later
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: Upstate Medical University
state: New York
Study officials:
References:
Clinical trial NCT00606463: Gen2 Isthmus-Dependent Atrial Flutter Ablation Study
Official title: Gen2 Cardiac Ablation System Isthmus-Dependent Atrial Flutter Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atrial Flutter
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2008-02-04
Enrollment: 30
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: Irrigated catheter for ablation of isthmus-dependent atrial flutter

Detailed description: This study intends to use an investigational irrigated catheter for ablation of isthmus-dependent atrial flutter

Eligibility criteria: Inclusion Criteria:

* Scheduled for ablation of isthmus-dependent atrial flutter

Exclusion Criteria:

* Prior ablation of isthmus-dependent atrial flutter
* Atypical or scar flutter
* Significant heart disease
* Intracardiac thrombus
* Prior cardiac surgery (within 1 month)
* Contraindication to heparin

Primary outcomes:
measure: Incidence of intraprocedural, serious cardiac adverse event
timeFrame: 7 days post-procedure
Secondary outcomes:
Other outcomes:
measure: Bi-direction block and non-inducibility of atrial flutter
timeFrame: Procedural
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: West Orange
country: United States
facility: St. Barnabus Medical Center
state: New Jersey
city: Doylestown
country: United States
facility: Doylestown Hospital
state: Pennsylvania
Study officials:
affiliation: University of Alabama at Birmingham
name: Vance Plumb, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03944863: Impact of Antibiotic Prophylaxis in Per-oral Endoscopic Myotomy for Esophageal Motor Disorders
Official title: Impact of Antibiotic Prophylaxis and Conditioning Modalities in Per Oral Endoscopic Myotomy for Esophageal Motor Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophagus Disorder
Esophageal Achalasia
Keywords: antibiotic prophylaxis
per oral endoscopic myotomy
Lead sponsor: Société Française d'Endoscopie Digestive
Sponsor class: OTHER
First posted: 2019-05-10
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults patients presenting a major esophageal motor disorder confirmed by prior manometry according to the Chicago classification and treated by per-oral endoscopic myotomy after a multidisciplinary meeting decision. Under-age patients were excluded.

Brief summary: No recommendation regarding antibiotic prophylaxis and preparation modalities are available for patients with esophageal motor disorders who benefit from Per-Oral Endoscopic Myotomy (POEM). The aim of our study was to evaluate the impact of antibiotic prophylaxis on the POEM's safety.

This study was a comparative and multicentric retrospective analysis of a database prospectively maintained. Patients over 18 year's old with esophageal motor disorders confirmed by prior manometry, who underwent POEM were included. The primary endpoint was the occurrence of complications, as classified by Cotton, based on whether or not antibiotic prophylaxis was administered.


Eligibility criteria: Inclusion Criteria:

* Adults patients presenting a major esophageal motor disorder confirmed by prior manometry according to the Chicago classification and treated by per-oral endoscopic myotomy after a multidisciplinary meeting decision

Exclusion Criteria:

* Under-age patients were excluded

Primary outcomes:
measure: The occurence of postoperative complications, according to Cotton's classification
timeFrame: 7 Days
Secondary outcomes:
measure: The evaluation of the efficacy of the procedure
timeFrame: 1 Month
measure: The occurence of perioperative and postoperative complications
timeFrame: 7 Days
measure: The C-Reactive Protein and white blood cells count sampled
timeFrame: 1 Day
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05903963: Evaluation of Renal Protection Of Dexmedetomidine Versus Midazolam As a Sedative For Septic Patients In Intensive Care Unit
Official title: Evaluation of Renal Protection Of Dexmedetomidine Versus Midazolam As a Sedative For Septic Patients In Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Renal Failure
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 40
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: SUPPORTIVE_CARE

Brief summary: Evaluation of Renal Protection Of Dexmedetomidine Versus Midazolam As a Sedative For Septic Patients In Intensive Care Unit


Eligibility criteria: Inclusion Criteria:

* Age (18-80) years old. sex:both male and female.
* intubated and mechanically ventilated patients.

Exclusion Criteria:

* 1.Patient's relatives refusal. 2. burns as admitting diagnoses. 3.patients with any renal pathology(such as chronic glomerulonephritis, pyelonephritis and diabetic nephropathy).

  4. pregnancy or lactation. 5. serious central nervous system pathology (acute stroke, uncontrolled seizures, severe dementia).

  6. acute hepatitis or severe liver disease (Child-Pugh class C). 7. unstable angina or acute myocardial infarction, left ventricular ejection fraction less than 30%, heart rate less than 50/min, second- or third-degree heart block, or systolic blood pressure less than 90 mm Hg despite continuous infusions of 2 vasopressors before the start of study drug infusion.

Primary outcomes:
measure: Incidence of acute kidney injury
timeFrame: 5 days
Secondary outcomes:
measure: length of ICU stay
timeFrame: 10 days
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Marlin Zarif Shehata
Study officials:
References:
Clinical trial NCT00147563: Compare Effectiveness of Eplerenone vs Atenolol in Reversing the Remodelling Resistance Arteries in Subjects With HT
Official title: A Double-Blind, Parallel Design Study to Compare the Effectiveness of Eplerenone Versus Atenolol in Reversing the Remodeling of Resistance Arteries in Subjects With Mild to Moderate Primary Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-07
Enrollment: 34
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the impact of antihypertensive therapy with the selective mineralocorticoid receptor blocker, eplerenone, on small resistance artery remodeling, compared to the effect of equivalent blood pressure control achieved with a b-blocker, atenolol.


Eligibility criteria: Inclusion Criteria:

* Pt with essential hypertension who have never been treated or untreated within the previous 6 months

Exclusion Criteria:

* History of Malignant Hypertension
* Sitting diastolic blood pressure \> 115mmHg or sitting Systolic blood pressure \> 200mmHg

Primary outcomes:
measure: The change from baseline to week 52 in the media/lumen ratio and the maximum % relaxation response to acetylcholine of gluteal subcutaneous resistance vessels, measured from the gluteal biopsy.
Secondary outcomes:
measure: Will be done for both the Intent to Treat and per protocol populations, and use both the LOCF and OC methods
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Savoia C, Touyz RM, Amiri F, Schiffrin EL. Selective mineralocorticoid receptor blocker eplerenone reduces resistance artery stiffness in hypertensive patients. Hypertension. 2008 Feb;51(2):432-9. doi: 10.1161/HYPERTENSIONAHA.107.103267. Epub 2008 Jan 14.
Clinical trial NCT01130363: Fundic Gland Polyps and Proton Pump Inhibitor (PPI) Drugs
Official title: Determination of a Possible Association of Fundic Gland Polyps With the Use of Proton Pump Inhibitor Drugs
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Fundic Gland Polyps
Keywords: Proton Pump Inhibitor
Gastric carcinoid tumors
Gastric cancer
Fundic Gland Polyps
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2010-05-26
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals found to have fundic gland polyps on endoscopic evaluation and are on proton pump inhibitor (PPI), individuals found to have fundic gland polyps on endoscopic evaluation but are not on PPI or patients on PPI but had no fundic gland polyps found on endoscopic evaluation (control group).

Brief summary: The class of proton pump inhibitor (PPI) medications such as omeprazole has proven extremely effective in the treatment and prevention of gastric and duodenal ulcers. Although the FDA approval for PPI therapy is limited to 6-8 weeks, many individuals remain on these agents for years, and human studies have suggested that long-term use of a PPI can result in enterochromaffin-like (ECL) cell hyperplasia, as well as being associated with the development of fundic-gland polyps of the stomach. These findings raise the concern of the possibility that long-term use of PPIs may predispose to the development of neuroendocrine tumors in patients. The investigators aim to examine clinical parameters, including history of PPI use and fasting gastrin levels, as well as histologic characteristics (particularly the presence of ECL-cell hyperplasia) of patients found to have fundic gland polyps during endoscopy. The investigators hypothesize that there is a correlation between fundic gland polyps of the stomach and the use of proton pump inhibiter medications.


Eligibility criteria: Inclusion Criteria:

* Age 18 and above.
* Able and willing to sign informed consent.
* The patient had a gastric fundic gland polyp detected on EGD that was removed and sent to pathology or patient had no fundic gland polyps on EGD but are on PPIs and will serve as controls.

Exclusion Criteria:

* Unwilling or unable to sign informed consent for the study.

Primary outcomes:
measure: Number of patients with fundic gland polyps and PPI use that have a higher gastric pH
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Harold Frucht, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00508963: Compassionate Use of Sodium Stibogluconate (Pentostam) for Cutaneous and Mucocutaneous New World Leishmaniasis
Official title: Compassionate Use of Sodium Stibogluconate (Pentostam) for Cutaneous and Mucocutaneous New World Leishmaniasis
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Leishmaniasis, Cutaneous
Leishmaniasis, Mucocutaneous
Keywords: New World Cutaneous or Mucocutaneous Leishmaniasis
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2007-07-30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: Patients with biopsy proven new world cutaneous or mucocutaneous leishmaniasis will be treated with sodium stibogluconate (Pentostam).


Eligibility criteria: Inclusion Criteria:

* Biopsy proven new world cutaneous or mucocutaneous leishmania

Exclusion Criteria:

* Prolonged QT
* Liver disease
* Pancreatitis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of CA at San Francisco Hospitals and Clinics
state: California
Study officials:
affiliation: University of CA at San Francisco
name: Brian Schwartz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of CA at San Francisco
name: Kanade Shinkai, MD
role: PRINCIPAL_INVESTIGATOR
References: