louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02580240: Initiation of Hydrocortisone for the Treatment of Septic Shock
Official title: Early Initiation of Low-dose Hydrocortisone Treatment for Septic Shock in Adults: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Septic Shock
Keywords: septic shock
hydrocortisone
mortality
Lead sponsor: Northern Jiangsu People's Hospital
Sponsor class: OTHER
First posted: 2015-10-20
Enrollment: 118
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 this study : 1）to determine whether hydrocortisone is effective in the treatment of septic shock and 2) to identify the role of timing of low dose hydrocortisone administration in septic shock patients.


Eligibility criteria: Inclusion Criteria:

1. age 18 years old or older;
2. onset of septic shock within 6 h

Exclusion Criteria:

1. Systemic corticosteroid therapy within the last 3 months before septic shock;
2. high-dose steroid therapy;
3. immunosuppression;
4. refusal of the attending staff or patient family.

Primary outcomes:
measure: 28-day Mortality
timeFrame: 28 days
Secondary outcomes:
measure: All Cause Mortality
timeFrame: 90 days
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: Northern Jiangsu Province people's hospital
state: Jiangsu
Study officials:
affiliation: Department of Critical Care Medicine, Northern Jiangsu Province people's hospital
name: Qingquan Lv, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lv QQ, Gu XH, Chen QH, Yu JQ, Zheng RQ. Early initiation of low-dose hydrocortisone treatment for septic shock in adults: A randomized clinical trial. Am J Emerg Med. 2017 Dec;35(12):1810-1814. doi: 10.1016/j.ajem.2017.06.004. Epub 2017 Jun 5.
Clinical trial NCT01284140: Improving the Sleep and Circadian Rhythms of Mechanically Ventilated Patients
Official title: Improving the Sleep and Circadian Rhythms of Mechanically Ventilated Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Sleep Deprivation
Respiratory Failure
Sleep Disorders, Circadian Rhythm
Keywords: Critical illness
Sleep
Polysomnography
Respiratory failure
Circadian rhythm
Sedation
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2011-01-26
Enrollment: 24
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 goal of this project is to determine whether the sleep and circadian rhythms of critically ill patients undergoing mechanical ventilation can be improved through practical strategies that can be employed at the bedside.

Detailed description: Nearly 1 million patients develop respiratory failure annually in the United States; yet, the sleep of patients undergoing mechanical ventilation has received little attention. This project is designed to characterize sleep and circadian rhythmicity in critically ill patients and to explore the efficacy of a non-pharmacological intervention to improve sleep and normalize circadian phase. The study will examine the effect of a protocol employing noise reduction and enforcement of a robust light-dark cycle on sleep quality and circadian rhythmicity. A secondary analysis will examine the relationship between delirium and sleep disruption and loss of circadian rhythmicity. Circadian rhythmicity will be characterized through the measurement of urinary 6-sulfatoxymelatonin levels at frequent intervals, while sleep will be assessed using continuous polysomnography.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Receiving mechanical ventilation and intravenous sedation

Exclusion Criteria:

* Debilitating central nervous system disease or degenerative disorder
* Active seizures
* Persistent coma
* Renal failure requiring dialysis
* Expected to be extubated within 24 hours
* Currently receiving neuromuscular blocker

Primary outcomes:
measure: Circadian Timing
timeFrame: Day 1 to Day 3
Secondary outcomes:
measure: Normal Circadian Timing
timeFrame: Day 3
measure: Circadian Amplitude
timeFrame: Day 3
measure: Spectral Edge Frequency 95%
timeFrame: Day 2
measure: Delirium
timeFrame: Day 3
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
affiliation: University of Iowa
name: Brian K Gehlbach, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04352140: Electromyographic and Acceleromyographic Monitoring in Restricted Arm Movement Surgical Setting
Official title: Electromyographic and Acceleromyographic Monitoring in Restricted Arm Movement Surgical Setting. A Prospective, Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Residual Neuromuscular Blockade
Keywords: Neuromuscular Blockade
Tetragraph
AMG
EMG
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-04-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Researchers are comparing the ease of use and repeatability of the force vs electrical activity produced by a muscle after it has undergone nerve stimulation during a surgical procedure in which the patients' arm movement is restricted (placed under surgical drapes) in laparoscopic or robotic procedures.


Eligibility criteria: Inclusion Criteria:

* Age \> or = 18 years old
* Patients willing to participate and provide an informed consent
* Patients undergoing an elective laparoscopic or robotic surgical procedure that requires use of NMBA agents administered intraoperatively.

Exclusion Criteria:

* Patients with disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, Dupuytren contracture, or any similar wrist injury.
* Patients with systemic neuromuscular diseases such as myasthenia gravis
* Patients with significant organ dysfunction that can significantly affect pharmacokinetics of neuromuscular blocking and reversal agents, i.e., severe renal impairment or end-stage liver disease.
* Patients having surgery that would involve prepping the arm or leg into the sterile field

Primary outcomes:
measure: Accuracy of Values Between Tetragraph and ToFscan
timeFrame: Up to 1 hour postoperatively
Secondary outcomes:
measure: Incidence of Residual Neuromuscular Blockade
timeFrame: Up to 1 hour postoperatively
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Vandœuvre-lès-Nancy
country: France
facility: Université de Lorraine, CHU de Brabois
city: Debrecen
country: Hungary
facility: University of Debrecen
Study officials:
affiliation: Mayo Clinic
name: J.Ross Renew, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04176640: Quantifying Brain Injury on Computed Tomography in Hospitalized Children
Official title: Quantifying Brain Injury on Computed Tomography in Hospitalized Children: a Prospective Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Trauma, Brain
Pediatric
Keywords: pediatric traumatic brain injury
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2019-11-25
Enrollment: 425
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized children with traumatic brain injury

Brief summary: Lay Summary:

To evaluate a novel early diagnostic tool for hospitalized children with traumatic brain injury.

The Problem: Children who present with decreased level of consciousness after injury require urgent medical attention determined by the type and the severity of injury. Unfortunately, history and physical findings are often unreliable in the first hours after hospitalization, the period in which urgent management decisions must be made for their treatment.

The Solution: A promising tool developed for measuring detectable evidence of traumatic brain injury on routine brain scans. The tool combines features invisible to the human eye but detectable by computer software with expert knowledge.This study will evaluate how well the tool can perform in a real health care setting. It is believed that it will greatly improve the efficacy and quality of care provided to children after traumatic brain injury.

Detailed description: To evaluate a novel early neuroimaging diagnostic tool for hospitalized children with traumatic brain injury.

This tool is used to detect evidence of traumatic brain injury on routine brain scans. The tool combines features invisible to the human eye but detectable by computer software with expert knowledge.This study will evaluate how well the tool can perform in a real health care setting. It is believed that it will greatly improve the efficacy and quality of care provided to children after traumatic brain injury.

Eligibility criteria: Inclusion Criteria:

* Hospitalized with TBI
* Age: less than 18 years of age who undergoes routine head CT in the acute period with any severity of injury based on Glasgow Coma Scale score (3 to15).

Exclusion Criteria:

* Non hospitalized
* Non traumatic brain injury

Primary outcomes:
measure: To measure if QBIct predicts the development of new cerebral dysfunction measured on the Glasgow Outcome Scale Extended for Pediatrics score
timeFrame: 30 days
Secondary outcomes:
measure: To determine if QBIct tool predicts secondary clinical outcomes
timeFrame: 90 days
measure: To determine if QBIct tool predicts recovery endpoints.
timeFrame: 90 days
Other outcomes:
Locations:
Study officials:
affiliation: The Hospital for Sick Children, University of Toronto
name: Anne-Marie Guerguerian
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02264340: Effects of Exercise and Relaxation Techniques on Tension Headache Pain Parameters of University Students
Official title: EFFECTS OF EXERCISE AND RELAXATION TECHNIQUES ON TENSION-TYPE HEADACHE PAIN PARAMETERS OF UNIVERSITY STUDENTS; A RANDOMIZED AND CONTROLLED CLINICAL TRIAL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tension-Type Headache
Keywords: Tension-type headache
relaxation techniques
physiotherapy
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2014-10-15
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Tension headache is a common disabling disease and a worldwide public health problem. This research tries to demonstrate the efficacy of physical therapy, based on cervical training and postural self-correction instructions, which aims to increase the positive results obtained from traditional relaxation techniques (Schultz Autogenic Training). University students are selected, because headaches are very common in this sector of the population. The design is a non-pharmacological randomized controlled trial, with blinded evaluation of the response variables. The investigators compare two independent samples. One of them receives an only treatment (Autogenic Training) and the other group receives a combined program (Autogenic Training + specific cervical exercises and postural correction). Pain parameters (frequency, intensity and duration) and drug consumption are measured before treatment, and then, at 4 weeks and 3 months, to value the results.


Eligibility criteria: Inclusion Criteria:

* College students of Complutense University of Madrid, diagnosed with frequent episodic or chronic tension-type headache (according to the criteria of International Headache Society (IHS)).

Exclusion Criteria:

* Cases with other headaches
* Students with excessive state anxiety and / or trait anxiety (≥ 85 percentile, State-Trait Anxiety Inventory )
* Students that had received treatment for tension headache, based on physical exercise or relaxation techniques, in the last 6 months.

Primary outcomes:
measure: Frequency
timeFrame: 4 weeks
Secondary outcomes:
measure: Intensity
timeFrame: 4 weeks
measure: Duration
timeFrame: 4 weeks
measure: Medication
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Universidad Complutense de Madrid
name: Ángela Álvarez Melcón, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03509740: Intravenous Tramadol Versus Intravenous Paracetamol in Patients With Dysmenorrhea
Official title: Efficacy and Safety of Intravenous Tramadol Versus Intravenous Paracetamol for Relief of Acute Pain of Primary Dysmenorrhea: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dysmenorrhea
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Algazeerah hospital
First posted: 2018-04-26
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients presented with primary dysmenorrhea composed the study population. One gram paracetamol and 100 mg tramadol in 100 ml saline with a slow infusion were compared in ceasing dysmenorrhea in the emergency department

Detailed description: Patients over 18 years old who presented with dysmenorrhea composed the study population. Patients received painkiller within the last six hours, physical findings consistent with peritoneal irritation, allergy to the study drugs, renal or liver failure, drug addiction, pregnancy or woman with lactation and denied to give inform consent were the exclusion criteria. The pain of the study patients is measured with the visual analogue scale at baseline, 15th and 30th minutes and 1 hour after study drug administration. At the end of the 60 minutes, rescue drug need is also recorded.

Eligibility criteria: Inclusion Criteria:

* Patients with moderate to severe primary dysmenorrhea and visual analog scale (VAS) pain scores ≥40
* Patients over 18 years old

Exclusion Criteria:

* denied to give inform consent, irregular menstrual cycles, known or suspected secondary dysmenorrhea
* Renal or liver failure
* Allergy to the study drugs
* Receiving pain killer within the last 6 hours.
* Physical examination findings consistent with peritoneal irritation
* Pregnancy or patients with lactation
* Drug or Alcohol Abuse

Primary outcomes:
measure: acute pain of dysmenorrhea measured by visual analogue scale
timeFrame: 15 minutes
measure: pain of dysmenorrhea measured by visual analogue scale
timeFrame: 30 minutes
measure: pain of dysmenorrhea measured by visual analogue scale
timeFrame: 60 minutes
Secondary outcomes:
measure: Rescue drug need
timeFrame: 30 minutes.
measure: adverse effects.
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Aljazeerah Hospital
Study officials:
affiliation: Cairo University
name: AHMED SAMY, MD
role: STUDY_DIRECTOR
affiliation: National Research Center
name: mahmoud alalfy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: faculty of medicine al-azhar university
name: Ahmed Ali, mbbch
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01843140: Assessing Reproductive Outcomes in Young Female Cancer Survivors Through a National Fertility Preservation Registry
Official title: Fertility Information Research Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cancer
Infertilty
Keywords: cancer
fertility preservation
infertility
pregnancy
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2013-04-30
Enrollment: 55
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Young women ages 18-44 who have been diagnosed with cancer or exposed to cancer treatment

Brief summary: The FIRST project is a national fertility preservation registry for young women facing cancer treatments. The investigators will examine how different cancers and treatments affect the reproductive health of young survivors. This prospective cohort study seeks to recruit young women close to time of cancer diagnosis and treatment. Participants will answer a yearly questionnaire on their current health. A subset of participants will provide dried blood spots to measure reproductive hormones. The primary goal of the study is to determine the risk of infertility and time to pregnancy in young female cancer survivors.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with cancer or exposure to cancer treatment
* English speaking
* Ability to consent to the study

Primary outcomes:
measure: Risk of infertility
timeFrame: Annually up to 10 years
Secondary outcomes:
measure: Time to pregnancy
timeFrame: Annually up to 10 years
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD Moores Cancer Center
state: California
Study officials:
References:
citation: Dominick SA, McLean MR, Whitcomb BW, Gorman JR, Mersereau JE, Bouknight JM, Su HI. Contraceptive Practices Among Female Cancer Survivors of Reproductive Age. Obstet Gynecol. 2015 Sep;126(3):498-507. doi: 10.1097/AOG.0000000000000963.
Clinical trial NCT00873340: Physical Disability in Patients Treated With Betaferon
Official title: Physical Disability Observational Study in Patients Treated With Betaferon in Daily Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: MS
Multiple Sclerosis
Betaferon
Colombia
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-04-01
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MS community sample

Brief summary: To gather Observation data about physical disability progression, safety and adherence during the use of Betaferon in daily practice. Patients with any type of Multiple Sclerosis (MS) (MRRS) (PSMS), under treatment with Betaferon.Open Multicentric Observational study.24 months.Evaluation of physical disability in patients treated with Betaferon, using Kurtzke's expanded disability scale (EDSS) in biannual periods


Eligibility criteria: Inclusion Criteria:

* Patients with a first demyelinating event suggestive of MS, as well as patients with remittent recurrent MS (RRMS), secondary progressive MS (SPMS) and primary progressive MS (PPMS) will be able to join the study.

Exclusion Criteria:

* Pregnancy
* Patients with a history of hypersensitivity to natural or recombinant interferon-beta, human albumin or to any of the excipients
* Patients with a history of severe depressive disorders and/or suicidal ideation
* Patient with decompensated liver disease
* Patient with epilepsy not adequately controlled by treatment

Primary outcomes:
measure: To collect observational local data about effectivity related to physical disability progression on the daily routine basis in patients treated with Betaferon
timeFrame: Every 6 months for 2 years
Secondary outcomes:
measure: To evaluate Betaferon safety on the daily routine basis
timeFrame: Every 6 months
measure: To evaluate patient adherence to Betaferon treatment
timeFrame: Every 6 months
Other outcomes:
Locations:
city: Many Locations
country: Colombia
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01042340: Energy Dense Oleic Acid Formula to Geriatric Patients
Official title: Energy Dense Oleic Acid Rich Formula to Newly Admitted Geriatric Patients - Feasibility and Effects on Energy Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutritional Intervention
Keywords: nutrition
geriatric
supplement
energy
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2010-01-05
Enrollment: 71
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background and aims:

Old patients seldom reach energy requirements. The effects of an oleic-acid rich formula on energy intake and appetite were studied.

Methods: Recently admitted geriatric patients (n=71), likely to stay more than 1 week were randomised to receive a fat emulsion (Calogen, intervention group (IG)) or to standard care (control group (CG)). Thirty ml of the emulsion were given 3 times daily, i.e. 420 kcal, and was distributed at the regular medication rounds. Food intake and self-rated appetite were registered 2-3 days after admission and on day 8 or the day prior to discharge. Nutritional risk screening (NRS) 2002 and serum lipids and fatty acid profiles were analysed.


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria were: likely to stay at the ward more than one week, \>65 years old and able to give informed consent.

Exclusion Criteria:

* Exclusion criteria were: pancreatitis, fat malabsorption, overweight (BMI \>30) and non-consent for participation.

Primary outcomes:
measure: To detect a significant difference in energy intake of 48kJ/200 kcal between the groups at 5% significance level and with 80% power.
timeFrame: 5 days to 3 weeks intervention
Secondary outcomes:
measure: Effects on serum lipids and appetite
timeFrame: 5 days to 3 weeks treatment
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Dep of Geriatrics, Karolinska University Hospital, Huddinge
Study officials:
affiliation: Dep of Clinical Nutrition and dietetics Karolinska University Hospital and section of Clinical Nutrition/NVS/Karolinska Institute
name: Gerd Faxén Irving, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Milne AC, Potter J, Avenell A. Protein and energy supplementation in elderly people at risk from malnutrition. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD003288. doi: 10.1002/14651858.CD003288.pub2.
citation: Faxen-Irving G, Cederholm T. Energy dense oleic acid rich formula to newly admitted geriatric patients--feasibility and effects on energy intake. Clin Nutr. 2011 Apr;30(2):202-8. doi: 10.1016/j.clnu.2010.08.007. Epub 2010 Sep 19.