louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02566291: Observational Study With Investigation of Two Second Generation Laryngeal Masks
Official title: Supraglottic Airways LMA Supreme and Ambu AuraGain in Clinical Practice: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Airway Remodeling
Keywords: laryngeal mask
airway leakage
airway morbidity
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2015-10-02
Enrollment: 364
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Inclusion criteria:

Age \> 18 Years informed consent elective surgery undergoing general anesthesia non-pregnant

Brief summary: In a observational study the second-generation laryngeal masks LMA Supreme and Ambu AuraGain are investigated.

Detailed description: After approval from the local ethics committee, data were collected in a prospective, non- randomised study over a three-month period. When contra-indications for laryngeal mask use were absent anaesthesiologists used either Supreme (Teleflex Medical GmbH, Germany) or Gain (Ambu GmbH, Germany). Endpoints were the success rate and time to insertion.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 Years
* No concurrent participation in another study
* capacity to consent
* Present written informed consent of the research participant
* Elective surgery under general anesthesia

Exclusion Criteria:

* Age \<18 years
* Existing pregnancy
* Lack of consent
* inability to consent
* emergency patients
* Emergency situations in the context of a Difficult Airway Management
* ASA classification\> 3
* situations where the possibility of accumulated gastric contents
* Participation in another study

Primary outcomes:
measure: Success rate
timeFrame: 70-98 Percent
Secondary outcomes:
measure: Time for insertion
timeFrame: 5-120 seconds
measure: Leakage in ml.min
timeFrame: 0-300 ml.min
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Department of Anaesthesiology;
state: Rhineland-Palatinate
Study officials:
affiliation: University JG, Mainz
name: Marc MK Kriege, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Russo SG, Cremer S, Galli T, Eich C, Brauer A, Crozier TA, Bauer M, Strack M. Randomized comparison of the i-gel, the LMA Supreme, and the Laryngeal Tube Suction-D using clinical and fibreoptic assessments in elective patients. BMC Anesthesiol. 2012 Aug 7;12:18. doi: 10.1186/1471-2253-12-18.
Clinical trial NCT04912791: Obstetric Anaesthesia And Analgesia Month Attributes - in COVID-19
Official title: A National Survey on Obstetric Anesthesia and Analgesia Care: Obstetric Anaesthesia And Analgesia Month Attributes - in COVID-19 (OBAAMA-COV)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obstetric Anesthesia Care
Keywords: Obstetric anesthesia
Survey
COVID-19
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
Collaborators: name: Masaryk University
name: Institute of Biostatistics and Analyses, Masaryk University Brno
name: Czech Society of Anaesthesiology, resuscitation and intensive care (ČSARIM)
First posted: 2021-06-03
Enrollment: 5000
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women in labor undergoing anesthesia care

Brief summary: A national survey of current practices, preferred drug and technique choices for obstetric anesthesia and analgesia and to evaluate the impact of COVID-19 pandemic on obstetric anesthesia and analgesia in Czech Republic and Slovak Republic

Detailed description: A one month-long project monitoring an obstetric anesthesia practices in obstetric/anesthesia departments throughout the Czech Republic and Slovak Republic.

Electronic Case Report Form (eCRF) is used to collect data on all obstetric anesthesia procedures in peripartal period and obstetric and anesthesia complications. All consecutive cases in each participating center during the study period are recorded. Each record is related to parturient and contains the following sections: history, form of labour analgesia, type of anesthesia for Cesarean section and anesthesia in third stage of labor.

Eligibility criteria: Inclusion Criteria:

* Women in labor undergoing anesthesia care

Exclusion Criteria:

* not meeting inclusion criteria

Primary outcomes:
measure: A national survey of current practice of obstetric anesthesia and analgesia in Czech Republic and Slovak Republic
timeFrame: Parturition period, up to 24 hours after labor
Secondary outcomes:
measure: Types of anesthesia a analgesia in peripartal period
timeFrame: Parturition period, up to 24 hours after labor
measure: Complications related to obstetric anesthesia care
timeFrame: Parturition period, up to 24 hours after labor
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Brno University Hospital
state: South Moravian Region
Study officials:
affiliation: University Hospital Brno
name: Petr Stourac, prof. MD., Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT01398891: Development of a Positive Psychology Intervention to Reduce Suicide Risk
Official title: Development of a Positive Psychology Intervention to Reduce Suicide Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicidal Ideation
Suicide Attempt
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2011-07-21
Enrollment: 60
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: This pilot study will recruit patients admitted to the inpatient psychiatric unit at MGH for suicidal ideation or a suicide attempt. Inclusion criteria will be broad to increase enrollment rates and obtain information for patients with a wide range of diagnoses and illness severity. Enrolled subjects will complete randomly-selected positive psychology exercises daily (on weekdays) until discharge and will rate the exercises in multiple domains. Subjects' participation will be complete at the end of their admission or when all exercises have been completed, whichever comes first.

Overall, our goal is to assess the acceptability and utility of eight possible positive psychology interventions related to gratitude, optimism, kindness, mindfulness, recollection, and forgiveness in suicidal inpatients.

This is a single-arm study, completed with patients who have been admitted to the hospital for suicidal ideation or a suicide attempt. It is aimed at developing a positive psychology treatment aimed at suicidal patients. The study consists of serial completion of different positive psychology exercises, once daily, during admission, to get subjects' input on their feasibility and impact. This will allow us to work collaboratively to identify the specific exercises that best fit this population. Subjects' participation ends when they are discharged from the hospital. The investigators plan to enroll 30 subjects at MGH (and total) in this study.


Eligibility criteria: Inclusion Criteria:

* Adult (age 18 and older) admitted to inpatient psychiatric unit at Massachusetts General Hospital
* Suicidal ideation at time of admission OR
* Admission occurring in context of suicide attempt
* Ability to read and write in English

Exclusion Criteria:

* Psychotic symptoms
* Cognitive disorder

Primary outcomes:
measure: Completion of exercises
timeFrame: Every 24 hours until all exercises administered or discharge occurs
Secondary outcomes:
measure: Optimism
timeFrame: Baseline and on the date of discharge (average length of admission= 2 weeks)
measure: Feasibility and utility of exercises
timeFrame: Assessed within 24 hours of exercise completion
measure: Hopelessness
timeFrame: Baseline and on the date of discharge (average length of admission=2 weeks)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jeff C Huffman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00665691: Pilot Test for a Newly Developed Nutrition Screening Method: Pediatric Subjective Global Assessment
Official title: Pilot Test for a Newly Developed Nutrition Screening Method: Pediatric Subjective Global Assessment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Compare Two Nutrition Screening Tools
Keywords: All Malignancies
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2008-04-24
Enrollment: 132
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Participant is between 2 and 16 years of age and receiving treatment for a hematologic or solid malignancy at St. Jude Children's Research Hospital.

Brief summary: Researchers are studying ways to predict if cancer patients are at risk for poor nutrition during their chemotherapy treatment. They hope to identify children with nutrition problems early in treatment. This may help prevent weight loss and other nutrition problems later in treatment.

Detailed description: The PEDSGA is a newly developed nutrition tool that includes a training manual that be used to teach health care professionals to identify at-risk patients by doing a nutrition physical exam. The PEDSGA also includes questions that the patient/caregiver answers regarding appetite, recent treatment, and activity level. This method of screening is new and may be able to identify at-risk patients better than the standard method. This study will use both methods and evaluate the two, in hope of determining which method works best to identify at-risk patients.

Eligibility criteria: Inclusion Criteria:

* St. Jude Children's Research Hospital patient between 2 and 16 years of age who is actively receiving treatment for a hematologic or solid tumor malignancy
* Patient is not admitted to the transplant service
* Patient is able to read English or Spanish

Primary outcomes:
measure: To compare the ability of two nutrition screening tools to identify nutritionally at risk patients
timeFrame: Within 90 days of study completion
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Karen Smith, RD, MS, LDN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01847391: A Phase 1 Study to Assess the Safety,Tolerability, and Pharmacokinetics of GS-6615 in Healthy Subjects
Official title: A Phase 1, Single-Blind, Randomized, Placebo-Controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of GS-6615 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ischemic Heart Disease
Keywords: Ischemic Heart Disease
Heart Disease
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2013-05-06
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This is a phase 1, single-blind, randomized, placebo-controlled, multiple ascending dose study aimed to assess the safety, tolerability, and pharmacokinetics of GS-6615 in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Weight of at least 50 kg with body mass index (BMI) between 18 and 30 kg/m2
* Female subjects must be of non-childbearing potential as defined per the protocol
* Male subjects with female partners of childbearing potential must be using protocol acceptable methods of contraception
* Willing and able to comply with the requirements of the protocol and directions
* Willing to avoid consumption of grapefruit, grapefruit juice and Seville oranges
* Willing to avoid consumption of nicotine (including nicotine gum) and alcoholic beverages

Exclusion Criteria:

* Ongoing or history of any medical or surgical condition that, in the judgment of the Investigator, might jeopardize the subject's safety or interfere with the study objectives
* History of meningitis or encephalitis, seizures, migraines, tremors, myoclonic jerks, sleep disorder, anxiety, syncope, head injuries or a family history of seizures
* Any abnormal ECG findings, abnormal laboratory value, or physical examination findings at Screening judged to be clinically significant
* Any abnormal neurological examination findings at Screening that is judged as clinically significant
* Hemoglobin \< 12 g/dL
* Serology test positive for HIV, or hepatitis B or C
* Positive urine drug test (including cotinine or ethanol)
* Use of systemic prescription medications or over the counter (OTC) medication, including multivitamins, and dietary and herbal supplement
* Use of any experimental or investigational drug or device within 30 days
* Female subjects who are of childbearing potential, pregnant or lactating
* Donation or loss of blood within 8 weeks and/or donation of plasma within 7 days
* History of drug or alcohol abuse
* Psychosocial or addictive disorders

Primary outcomes:
measure: Safety and tolerability of GS-6615
timeFrame: Up to 65 days
measure: Pharmacokinetic (PK) profile of GS-6615
timeFrame: Up to 65 days
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: Investigational Site
state: Wisconsin
Study officials:
affiliation: Gilead Sciences
name: Elizabeth Layug, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04287491: Use Of Virtual Reality For Pain Control in Dermatological Bedside Procedures
Official title: Use Of Virtual Reality For Pain Control in Dermatological Bedside Procedures
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pain
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2020-02-27
Enrollment: 0
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research study is to explore the impact of virtual reality (VR) on pain perception during out-patient procedures such as wart removal, wound debridement, and lidocaine injections.


Eligibility criteria: Inclusion Criteria:

* Patients 13 years and older.
* Patient (or health care proxy when applicable) must sign an ICF.
* Patient requiring any painful dermatological bedside procedure including: wound debridement, injections and liquid nitrogen application.
* Patients willing to participate and parents able to consent.

Exclusion Criteria:

* Subjects with a diagnosis of vertigo, inner ear diseases or seizures are excluded due to the uncertainty of performance under VR conditions.
* Subjects requiring procedures on the head are also excluded to the interference of the VR headset.

Primary outcomes:
measure: Change in average pain as assessed by the visual analog scale (VAS)
timeFrame: Baseline, up to 2 hours
measure: Change in maximum pain level as assessed by VAS
timeFrame: Baseline, up to 2 hours
Secondary outcomes:
measure: Change in heart rate
timeFrame: Baseline, up to 2 hours
measure: Change in oxygen saturation
timeFrame: Baseline, up to 2 hours
measure: Incidence of intervention related adverse events
timeFrame: Baseline, up to 2 hours
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Hadar Lev-Tov, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03441594: Psychological Mechanisms Linking Food Insecurity and Obesity
Official title: Psychological Mechanisms Linking Food Insecurity and Obesity (Food Mind Pilot Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Psychological
Keywords: Food Insecurity
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2018-02-22
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The target study sample will be 56 food secure and food insecure women and men aged 18 to 49 years with a BMI of 20.0 kg/m2 or greater.

Brief summary: The current pilot study will examine emergent hypotheses by investigating the role of psychological mechanisms in the relationship between food insecurity and obesity. This objective will be achieved via a cross-sectional, observational pilot study collecting quantitative and qualitative data.

Detailed description: This pilot study will investigate an emergent risk factor for obesity: food insecurity, which is defined as the limited or uncertain availability of nutritionally adequate and safe foods. While paradoxically linked, numerous studies have shown a significant association between food insecurity and obesity. Moreover, recent narrative works have developed new, untested hypotheses linking food insecurity and obesity positing the causal role of psychological mechanisms. Given this, this mixed method pilot study will collect new psychological data in a sample of food secure and food insecure adults with and without obesity to examine the connections between food insecurity, body weight, and psychological constructs. The overarching objective of the study is to gather pilot data to identify potentially new intervention targets that will be used in future studies to more rigorously investigate the relationship between food insecurity and obesity.

Eligibility criteria: Inclusion Criteria:

* Age 18-49 years
* BMI ≥ 20.0 kg/m2
* Able to read and write using the English language
* Willing to provide written informed consent

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Delay Discounting
timeFrame: Through study completion, an average of 1 hour and 30 minutes at Study Visit 1
Secondary outcomes:
measure: Grit
timeFrame: Through study completion, an average of 1 hour and 30 minutes at Study Visit 1
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedicial Research Center
name: Candice A Myers, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Myers CA, Beyl RA, Martin CK, Broyles ST, Katzmarzyk PT. Psychological mechanisms associated with food security status and BMI in adults: a mixed methods study. Public Health Nutr. 2020 Oct;23(14):2501-2511. doi: 10.1017/S1368980020000889. Epub 2020 Jun 29.
Clinical trial NCT00213694: PROSTACOX : Metastatic Prostate Chemotherapy
Official title: Efficacy of Docetaxel (J 15) and Celecoxib in Metastatic Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Prostate Cancer
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 52
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: Clinical response to chemotherapy. Biological parameter (PSA) and RECIST evaluation. Association of Docetaxel (J 15) and Celecoxib.

Detailed description: Association Docetaxel (J 15) and celecoxib Patient survival Biological parameter : PSA Clinical status RECIST evaluation

Eligibility criteria: Inclusion Criteria:

* metastatic prostate cancer
* ASCO progression criteria

Exclusion Criteria:

* other prostate chemotherapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: Charles Nicolle, University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Christian PFISTER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00282594: The Effect of Intensive Insulin Therapy in the Surgical Critical Care Unit
Official title: No Outcome Benefit for the Use of Intensive Insulin Therapy in the Critically Ill General and Vascular Surgical Patient. A Randomized Prospective Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Respiratory Failure
Renal Failure
Surgical Site Infection
Keywords: Intensive Insulin Therapy
General Surgical
Vascular Surgical
Tight Glycemic Control
Lead sponsor: Genesys
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
First posted: 2006-01-27
Enrollment: 317
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: We sought to determine if there is a benefit to using an insulin drip to control hyperglycemia in the surgical critical care unit for patients who undergo general and vascular surgery.

Detailed description: While evidence exists for using tight glycemic control in the critically ill cardiac surgical patient, other patient populations have yet to be studied. We performed a prospective randomized trial for using intensive insulin therapy in the general and vascular critically ill surgical patient population. We will compare tight glycemic control versus conventional glycemic control to determine if there is a benefit to the normalization of blood glucose levels in this patient population

Eligibility criteria: Inclusion Criteria: Patients undergoing a general or vascular surgical procedure requiring admission to the surgical intensive care unit as a result of ventilatory requirement, vasopressor support, or physiologic instability

-

Exclusion Criteria:

* Under age 18

Primary outcomes:
measure: Mortality
Secondary outcomes:
measure: Length of ICU Stay
measure: Ventilatory Requirement
measure: Vasopressor Support
measure: Incidence of Renal Failure
measure: Incidence of Wound Infection
Other outcomes:
Locations:
city: Grand Blanc
country: United States
facility: Genesys Regional Medical Center
state: Michigan
Study officials:
affiliation: Ascension Health
name: Michael Kia, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67. doi: 10.1056/NEJMoa011300.