louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02299752: Unnoticed Gloves Perforation
Official title: Double Gloves: A Randomized Trial to Evaluate a Simple Strategy to Reduce Contamination During Resuscitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Catheterization
Contamination
Lead sponsor: International Institute of Rescue Research and Education
Sponsor class: OTHER
First posted: 2014-11-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study was to investigate the incidence of glove perforation in cannulation of blood vessels (CBV) during resuscitation and compare perforation rates between single and double-gloves.

Detailed description: Exposure to blood pathogens among medical staff is a serious problem that should be first and foremost prevented . The risk of acquiring a virus from one percutaneous needle stick is 0.3% to 0.4% for human immunodeficiency virus (HIV), 6% to 30% for hepatitis B (HBV), and 2.7% to 10% for hepatitis C (HCV). The prevention of blood-borne infections is particularly important during cases when emergency medical attention is needed. Emergency Response Personnel that work in this profession have taken medical rescue courses to prepare for situations of sudden health threats, hence the majority of procedures is associated with direct contact with body fluids of the patient.

Eligibility criteria: Inclusion Criteria:

* Give voluntary consent to participate in the study
* Medical profession (paramedics, nurses, physicians) or medical students (nurses, paramedics, physicians)

Exclusion Criteria:

* Not meet the above criteria
* Wrist or low back diseases

Primary outcomes:
measure: visible puncture
timeFrame: 1 day
Secondary outcomes:
measure: WLT
timeFrame: 1 day
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: International Institute of Rescue Research and Education
state: Masovia
Study officials:
affiliation: Institute of Cardiology
name: Lukasz Szarpak
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06488352: Enhancing Care Study in Patients After CABG
Official title: Enhancing Care in Patients After Coronary Artery Bypass Graft Surgery (CABG)： OptiCABG Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Bypass
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 40000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who accepted coronary artery bypass graft and met the eligibility criteria are enrolled for this study.

Brief summary: Review the data of patients who underwent coronary artery bypass grafting (CABG) at the National Center for Cardiovascular Disease, Fuwai Hospital from January 2013 to June 2023 including medical history, head CT scan, and postoperative, including 30-day mortality, arrhythmia, cerebrovascular disease and intracerebral haemorrhage, etc. Case-control and retrospective cohort studies were conducted to explore the risk factors associated with early postoperative complications, examine their relationship with postoperative management, explore independent risk factors of compound complications, and build predictive models.


Eligibility criteria: Inclusion Criteria:

* patients accepted CABG enrolled from January 2013 to June 2023

Exclusion Criteria:

* patients discharged within 72 hours of admission
* patients with an admission diagnosis of atrial fibrillation
* patients underwent CABG as emergency surgery
* patients underwent concurrent surgical treatments
* patients with repeat admissions

Primary outcomes:
measure: 30-day mortality
timeFrame: 30 days
Secondary outcomes:
measure: post-operative atrial fibrillation
timeFrame: Around the second postoperative day.
measure: MACE
timeFrame: Around the second postoperative day.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Structral Heart Disease Center, Fuwai Hospital
state: Beijing
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Xiangbin Pan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00097552: A Study to Evaluate Subjects With Turner Syndrome Treated With Growth Hormone
Official title: Characterization of Subjects With Turner Syndrome Treated With Growth Hormone in the National Cooperative Growth Study (NCGS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Turner Syndrome
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2004-11-25
Enrollment: 1696
Sex: FEMALE
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: This study is a multicenter, open-label, observational, postmarketing surveillance study of Genentech growth hormone (GH) products in the treatment of girls with Turner syndrome in the United States and Canada.


Eligibility criteria: Inclusion Criteria:

* Are girls with Turner syndrome who are being or will be treated with Nutropin, Nutropin AQ, or Protropin
* Are willing to keep follow-up appointments throughout study participation
* Are girls with Turner syndrome who have submitted Form 4 upon discontinuation and may also submit Form 9

Exclusion Criteria:

* Have Noonan syndrome
* Subjects treated within the last 6 months with a non-Genentech GH preparation
* Have closed epiphyses prior to NCGS enrollment
* Have active neoplasia

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: Barbara Lippe, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04724252: Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children
Official title: Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Pain, Postoperative
Keywords: thoracic surgery
cardiac surgery via a sternotomy or thoracotomy
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 60
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Children meeting criteria will be randomized in a 1:1 ratio using 4 blocked randomization to either gabapentin or placebo (in addition to standard of care pain control treatment):
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to determine if the peri and post operative use of gabapentin in children reduces the need for narcotics after thoracic surgery.

We hypothesize that patients who are given gabapentin will need fewer morphine equivalents postoperatively than those who were not given gabapentin

Detailed description: This study is a double-blind, placebo controlled, randomized study to explore the effects of gabapentin peri and post operatively. Physician and families will be blinded to the treatment.

60 subjects will be randomized in a 1:1 ratio to either:

* Gabapentin treatment group
* Placebo - control group

We aim to understand the impact that gabapentin use peri and post operatively has on:

1. opioid use based of IV morphine
2. pain scores
3. opioid related complications such as withdrawal
4. effects on the level of sedation
5. Possible adverse effects associated with use of gabapentin
6. Time to extubating

The duration of an individual subject's participation in the study will be 7 days or until the patient is discharged from UC Davis Hospital, whichever occurs first.

Eligibility criteria: Inclusion Criteria:

1. Age newborn to \< 18 years.
2. Gestational age to be minimum 38 weeks.
3. Undergo cardiac surgery via a sternotomy or thoracotomy.
4. Any Thoracic Surgery
5. Planned noncardiac surgery via a thoracotomy or Video Assisted Thoracotomy (VATS).
6. Surgery will result in an inpatient stay of at least 48 hours.

Exclusion Criteria:

1. Use of opioids within 30 days prior to study entry.
2. Renal Failure as defined by RIFLE Criteria.
3. History of seizures requiring active treatment.
4. History of chronic pain treated medically.
5. Diagnosis of Autism.
6. Unable to tolerate enteral medications.
7. Hematology/Oncology patients.
8. Parents/legal guardians unable to consent.
9. Participation in another clinical study presently or within the last 30 days
10. Pregnancy
11. Prisoners

Primary outcomes:
measure: Amount of pain medication needed.
timeFrame: 7 days post-operative or until discharge, whichever came first
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
Study officials:
References:
Clinical trial NCT04059952: Mechanism of Action of Electroconvulsive Therapy
Official title: Mechanism of Action of Electroconvulsive Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Unipolar Depression
Bipolar Depression
Keywords: Electroconvulsive Therapy
Magnetic Resonance Imaging
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2019-08-16
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and Female Patients with Unipolar or Bipolar Depression Between the Ages of 18 and 65 Being Treated with ECT as Part of Outpatient Psychiatric Care, or Healthy Controls.

Brief summary: This is an observational neuroimaging study assessing the effects of ECT on the brains of patients with unipolar and bipolar depression.

Detailed description: This project aims to use functional connectivity magnetic resonance imaging (fcMRI) to study patients with unipolar and bipolar depression receiving ECT. Patients will be scanned before and after a full course of ECT and clinical measures for depression severity and memory will be obtained at the same times.The project has the following aims and hypothesis: (1) to determine the therapeutic antidepressant mechanism of action of ECT at the circuit level (2) to determine the mechanism of action of iatrogenic amnesia caused by ECT at the circuit level (3) to study the use of fcMRI as a state biomarker for depression (4) to study the use of fcMRI as a predictor of response for depression.

Eligibility criteria: Inclusion Criteria:

* Males and Females Between Ages of 18 and 65
* Diagnosis of Major Depressive Disorder without Psychotic Features or Bipolar I/II
* Requiring ECT Treatment as Part of Psychiatric Care

Exclusion Criteria:

* Comorbid diagnoses of Major Depressive Disorder with Psychotic Features, Schizoaffective Disorder, Schizophrenia or Dementia
* History of Psychosis
* Substance Use Disorder (Abuse or Dependence) with Active Use Within Last 6 Months
* Severe or Unstable Medical Illness
* Medical Contraindication to Anesthesia or ECT (e.g., Recent Myocardial Infarction)

Primary outcomes:
measure: Changes in Functional Connectivity of Key Nodes
timeFrame: Through Treatment Completion, Average of 2 Months
Secondary outcomes:
measure: Changes in Functional Connectivity of Memory Circuits
timeFrame: Through Treatment Completion, Average of 2 Months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Joan Camprodon, MD MPH PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00140452: Phase II Study Using Thalidomide for the Treatment of ALS
Official title: Phase II Study Using Thalidomide for the Treatment of Amyotrophic Lateral Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Amyotrophic Lateral Sclerosis
ALS
Keywords: ALS
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Celgene Corporation
First posted: 2005-09-01
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The use of Thalidomide in patients with ALS who have disease progression.

Detailed description: Phase II open labeled trial testing the efficacy of thalidomide for ALS in the setting of disease progression.

Eligibility criteria: Inclusion Criteria:

* Clinically proven ALS
* Disease duration less than or equal to 5 years
* ALSFRS-R score equal to or greater then 30

Exclusion Criteria:

* Patients with known deep venous thrombosis or hyper coagulable state will be excluded
* Patients with FVC less than 80%

Primary outcomes:
measure: To evaluate the effect of Thalidomide in the rate of progression in ALS at 9 months and hence determine preliminary efficacy in the treatment of ALS
timeFrame: Efficacy will be gauged according to the slopeof the expected average decline at nine months after starting Thalidomide
Secondary outcomes:
measure: To evaluate 1) toxicity 2) quality of life 3) cytokine profile 4) PFT's 5) sleep questionnaire and 6) survival of thalidomide in the treatment of ALS
timeFrame: survival and progression free suvival will be assessed from the date of initial therapy on study to date od death. Survival and progresion free survival wil be analyzed using the Kaplan Meier method
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hichcock Medical Center
state: New Hampshire
Study officials:
name: Elijah Stommel
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04500652: Mental Health Status and Related Factors Among Physical Medicine & Rehabilitation Physicians in the Covid-19 Pandemic
Official title: Evaluation of Mental Health Status and Related Factors Among Physical Medicine & Rehabilitation Physicians During the Covid-19 Pandemic
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anxiety
Depression
Insomnia
Covid19
Coronavirus
Keywords: depression
anxiety
insomnia
Covid-19
coronavirus
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 310
Sex: ALL
Minimum age (years): 24
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Physical medicine and rehabilitation physicians in Turkey who worked during COVID-19 pandemic in specialty outpatient/inpatient clinic or pandemic outpatient/inpatient clinic.

Brief summary: In December 2019, a highly infectious disease caused by a novel coronavirus (SARS-CoV-2) emerged in Wuhan, China. On March 11th 2020, the World Health Organization (WHO) declared COVID-19 a pandemic. Facing this critical situation, health care workers on the front line are at risk of developing psychological distress and other mental health symptoms. Physical medicine and rehabilitation (PM\&R) physicians works both in specialty outpateint/inpatient clinic and pandemic outpatient/inpatient clinics during the outbreak. Accordingly, PM\&R physicians are expected to be mentally affected by COVID-19 pandemic. In this study we aimed to evaluate mental health status of PM\&R physicians and related factors during COVID-19 pandemic. This study is a cross-sectional survey which is conducted on an online platform. Demographic data, working conditions of PM\&R physicians and factors that may be related to mental health status is questioned in the survey. The Depression, Anxiety and Stress Scale - 21 (DASS-21) is used to measure the emotional states of depression, anxiety and stress.The Insomnia Severity Index (ISI) is used to assess the severity of both nighttime and daytime components of insomnia.


Eligibility criteria: Inclusion Criteria:

* Being a physical medicine and rehabilitation physician
* Worked during COVID-19 pandemic in specialty outpatient/inpatient clinic or pandemic outpatient/inpatient clinic.

Exclusion Criteria:

* Being a specialist in a branch other than physical medicine and rehabilitation

Primary outcomes:
measure: Depression, Anxiety and Stress Scales 21 Score
timeFrame: 5 months
measure: Insomnia severity index score
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Dokuz Eylul University
Study officials:
References:
Clinical trial NCT01116700: Dexmedetomidine in Seizure Patients
Official title: The Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Patients With Seizure Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Seizure Disorders
Keywords: Epilepsy
Dexmedetomidine
Seizure
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2010-05-05
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Dexmedetomidine is an alpha-2 agonist commonly used during neurosurgery due to its unique properties as a sedative and anxiolytic with minimal respiratory depression. Neurosurgical patients frequently come to the operating room on anticonvulsant therapy with a history of seizures. The investigators clinical experience suggests that these patients are resistant to the sedative effects of dexmedetomidine. This effect may represent a pharmacokinetic interaction between the anticonvulsant medications and dexmedetomidine or the higher dexmedetomidine dose requirement could result from abnormal pharmacodynamics due to the underlying seizure disorder. The investigators study aims to investigate the pharmacokinetic and pharmacodynamic differences of dexmedetomidine between patients receiving and not receiving enzyme-inducing anticonvulsant therapy and to identify a potential mechanism for these differences.


Eligibility criteria: Inclusion Criteria:

* Age 18-65, BMI 20-25 kg/m2
* Anticonvulsant Group: Diagnosis of seizure disorder taking carbamazepine or phenytoin for a minimum of 2 weeks
* Control Group: Healthy volunteers taking no medications

Exclusion Criteria:

* Positive urine pregnancy test or lactating
* History of allergy to dexmedetomidine or alpha -2 agonists
* History of liver, renal or thyroid disease
* History of cardiovascular disease including history of arrhythmia or congestive heart failure
* History of drug or alcohol abuse

Primary outcomes:
measure: Serum level of dexmedetomidine
timeFrame: 0-8 hour period
Secondary outcomes:
measure: Patient State Index (PSI) and Entropy
timeFrame: 0-8h
measure: Visual Analog Scale score
timeFrame: 0-8h
measure: Ramsay Sedation Score
timeFrame: 0-8h
measure: Observer's Assessment of Alertness/Sedation Score (OAA/S)
timeFrame: 0-8h
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: UCSF Department of Anesthesia
name: Alana M Flexman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UCSF Department of Anesthesia
name: Pekka Talke, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UCSF Department of Neurology
name: Paul Garcia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sleigh JW, Vacas S, Flexman AM, Talke PO. Electroencephalographic Arousal Patterns Under Dexmedetomidine Sedation. Anesth Analg. 2018 Oct;127(4):951-959. doi: 10.1213/ANE.0000000000003590.
Clinical trial NCT04969952: Evaluation of an Interventional Module to Assist Physicians Introducing ACP to Cancer Patients
Official title: National Taiwan University Hospital,Taiwan (R.O.C)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Patients
Keywords: ACP brochure
Interventional Module
Advance directive
cancer patients
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 384
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Shared decision making (SDM) process through Advance Care Planning (ACP) consultation with cancer patients
Primary purpose: SUPPORTIVE_CARE

Brief summary: Evaluation of an Interventional module to assist physicians introducing ACP to cancer patients

Detailed description: Investigators hypothesize that compared to ACP brochure alone, educational module plus ACP brochure is effective in assisting the physicians to introduce ACP to the patients and completion of AD documentation

Eligibility criteria: "Inclusion Criteria" and "Exclusion Criteria"

Inclusion Criteria

1. Older than 20-years-old
2. Diagnosed with cancer
3. Have not signed any form of AD or DNR

Exclusion Criteria

1. Under 20-years-old
2. Can not speak or listen, difficult communication
3. Signed AD or DNR

Primary outcomes:
measure: Sign DNR (Do-Not-Resuscitate)
timeFrame: 3 month
Secondary outcomes:
measure: Completion AD(Advance directive) documentation
timeFrame: 3 month
Other outcomes:
measure: Explain and predict health behaviors(Sign DNR / Completion AD)
timeFrame: 3 month
Locations:
city: Taipei county
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Nation Taiwan University Hospital
Study officials:
affiliation: Shao-Yi Cheng
name: Shao-Yi Cheng Shao-Yi, PHD
role: PRINCIPAL_INVESTIGATOR
References: