louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04654923: GERAP's Epidemiological Survey on Perioperative Hypersensitivity Reactions
Official title: Epidemiological Survey on Perioperative Hypersensitivity Reactions in France by the GERAP Network (Groupe d'étude Des réactions Anaphylactiques périopératoires)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypersensitivity, Drug
Keywords: anaphylaxis
perioperative
hypersensitivity reactions
neuromuscular blocking agents
hypnotics
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2020-12-04
Enrollment: 3000
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject having experienced a perioperative hypersensitivity reaction

Brief summary: Perioperative hypersensitivity reactions are still associated with significant morbidity and mortality despite early recognition and use of epinephrine. The epidemiology of these reactions evolves over time and changes with clinical practice. The main objective is to study the epidemiology of these reactions over a 10-year period, including patient phenotype, reaction phenotype and outcome of the allergic work-up.


Eligibility criteria: Inclusion Criteria:

* Minor and major subject
* Subject having experienced a perioperative hypersensitivity reaction between January the 1st 2017 and December the 31st 2027.
* Referred for an allegro-anesthetic workup
* Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.

Exclusion Criteria:

* Subject having expressed opposition to participating in the study
* Inability to provide the subject with research information
* Subject under guardianship or guardianship
* Subject under safeguard of justice

Primary outcomes:
measure: Retrospective analysis of incidence of all perioperative hypersensitivity reactions referred in an allegro-anesthetic
timeFrame: Outcome is analysed every 2 years over a 10 years period
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'anesthésie-réanimation - CHU de Strasbourg - France
Study officials:
affiliation: Strasbourg University Hospitals - Anesthesia-intensive care unit
name: Paul-Michel MERTES, MD, PhD
role: STUDY_DIRECTOR
affiliation: Strasbourg University Hospitals - Anesthesia-intensive care unit
name: Charles TACQUARD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02905123: Brief Internet Intervention for Hazardous Alcohol Use
Official title: Brief Internet Intervention for Hazardous Alcohol Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Consumption
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2016-09-19
Enrollment: 423
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: Amazon's Mechanical Turk (MTurk) is an online platform that has become a popular means of recruiting participants with problem drinking, gambling, or even illicit drug use for the purposes of survey-based research. There is also the possibility that potential participants could be identified through MTurk for online longitudinal studies, including for brief intervention research. The potential to quickly and easily identify large numbers of participants through MTurk is important for research evaluating online interventions during the period that these interventions are being developed and refined. However, before proposing MTurk workers as a viable source for participants in online intervention trials, it is important to evaluate the feasibility of using MTurk for such a purpose. This pilot study proposes to test this feasibility by systematically replicating a trial of an extensively evaluated brief online intervention for hazardous alcohol use (CheckYourDrinking; CYD) and will attempt to recruit and follow-up participants for this replication using people recruited through MTurk.

Participants will be recruited through Amazon's MTurk crowdsourcing platform. Participants identified as problem drinkers based on an initial survey will be invited to complete another survey in 3 months time. Those who are interested will be randomized to receive access to the Check Your Drinking screener (CYD condition) or to a no additional information condition (control condition). At three-months post-baseline, the MTurk portal will be used to send invitation emails that contain a link to the follow-up survey. The primary hypothesis to be tested is that participants receiving access to the CYD intervention will report a greater level of reduction in number of drinks in a typical week between the baseline survey and three-month follow-up as compared to participants in the no information control condition.


Eligibility criteria: Inclusion Criteria:

* Alcohol Use Disorders Identification Test (AUDIT) score of 8 or more
* Willingness to complete a 3-month follow-up survey
* 18 years of age or older

Primary outcomes:
measure: Number of drinks consumed during a typical week
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: John Cunningham, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00312923: Preliminary Study of Safety and Efficacy of Policosanol
Official title: Preliminary Study of Safety and Efficacy of Policosanol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dyslipidemia
HIV Infections
Keywords: HIV
lipids
dyslipidemia
policosanol
treatment experienced
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2006-04-11
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Lay Language Summary: High cholesterol levels are common in persons with HIV infection. However, conventional cholesterol-lowering medications may have harmful side effects when given to HIV-infected persons. Therefore, we plan to evaluate the safety and effectiveness of policosanol, a dietary supplement derived from sugar cane that has cholesterol-lowering properties, to lower cholesterol levels in persons with HIV infection. We hypothesize that policosanol will lower levels of LDL cholesterol ("bad" cholesterol) and raise levels of HDL cholesterol ("good" cholesterol).

Detailed description: As per Brief Summary

Eligibility criteria: Inclusion Criteria:

CD4 count \> 250 Plasma HIV RNA \< 50,000 Currently receiving HAART age 18-60 total cholesterol between 200-240 or triglycerides between 150-400 or LDL cholesterol \> 160

Exclusion Criteria:

kidney or liver disease current use of lipid-lowering drugs pregnancy lactation

-

Primary outcomes:
measure: LDL Cholesterol
timeFrame: 12 weeks
Secondary outcomes:
measure: Triglycerides
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University College of Nursing
name: Barbara A Swanson, DNSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01568723: Betrnet Stem Cells and the Origins of Barrett's Esophagus Project 3 RF Ablation
Official title: Stem Cells And The Origins Of Barrett's Esophagus:Identification Of Novel Biomarkers And Gene Signatures In Barrett's Esophagus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Barrett's Esophagus
Keywords: Barrett's esophagus
high grade dysplasia
ablation
radiofrequency ablation
esophageal cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-04-02
Enrollment: 125
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: Participants must have biopsy proven Barret's esophgus with evidence of specialized intestinal epithelium with high grade dysplasia or early intramucosal carcinoma (mEAC) on histology (confirmed by two pathologists). Patients must have a BE length ≥ 2 cm and ≤ 8 cm.

Brief summary: The purpose of this study is to determine biomarkers which can predict response to ablation therapy in patients with Barretts esophagus.

Detailed description: This Project is designed to identify biologically-based and clinically-useful biomarkers of tissue at risk for neoplastic progression as well as of response to ablation therapy. These results will result in improved risk stratification in BE and better targeting of resources for patients who are candidates for ablative therapy, while simultaneously providing key information regarding the origins of Barrett's esophagus.

Eligibility criteria: Inclusion Criteria:

* Barrett's esophagus with high grade dysplasia or intramucosal (early) adenocarcinoma.
* BE length ≥ 2 cm and ≤ 8 cm.
* Able to return every 3 months for one year after ablation

Exclusion Criteria:

* Patients who are unable to be compliant with follow-up endoscopies
* patients who cannot tolerate Proton Pump inhibitors
* pre-existing esophageal strictures
* pregnant or nursing women

Primary outcomes:
measure: Response to therapy
timeFrame: one year post ablation
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania Perelman School of Medicine
state: Pennsylvania
Study officials:
affiliation: Mayo Clinic
name: Kenneth K Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00770523: Conditioning Regimen Before Infusion of Allogeneic Hematopoietic Stem Cells
Official title: Unrelated Donor Hematopoietic Stem Cell Transplantation After Nonmyeloablative Conditioning for Younger Patients With Hematologic Malignancies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HEMATOLOGIC MALIGNANCIES
Keywords: patients without comorbidity
Lead sponsor: Cooperative Study Group A for Hematology
Sponsor class: NETWORK
First posted: 2008-10-10
Enrollment: 52
Sex: ALL
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: acute leukemia chronic myelogenous leukemia myelodysplastic syndrome

Brief summary: Unrelated Donor Hematopoietic Stem Cell Transplantation After Nonmyeloablative Conditioning for Younger Patients with Hematologic Malignancies.

Detailed description: Primary end points are treatment-related mortality and engraftment. Secondary end points are regimen-related toxicities, graft-versus-host-disease, relapse, and overall survival.

Eligibility criteria: Inclusion Criteria:

-Patients should have an unrelated donor who is matched for HLA-A and -B by serology and for -DRB1 by molecular typing.

Exclusion Criteria:

* Patients should not have major illness or organ failure
* Patients must not have a psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible.
* Patients must not be pregnant or lactating.

Primary outcomes:
measure: treatment-related mortality and engraftment
timeFrame: all cause mortality
Secondary outcomes:
measure: regimen-related toxicities, graft-versus-host-disease, relapse, and overall survival.
timeFrame: Time point(s) at which outcome measure is assessed.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: COSAH
name: Kyoo-hyung Lee, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00683423: BMS-741672 for Diabetic Neuropathic Pain
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Crossover Trial to Evaluate the Efficacy and Safety of BMS-741672 in Patients With Diabetic Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neuropathic Pain
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2008-05-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine whether BMS-741672 improves neuropathic pain in diabetic patients.


Eligibility criteria: Inclusion Criteria:

* Type 1 or 2 diabetics with painful, distal, symmetrical, sensory-motor neuropathy attributed to diabetes, of at least 12 months duration
* Screening HbA1c of ≥ 7% and ≤ 10%
* BMI ≤ 40 kg/m2

Exclusion Criteria:

* Patients with clinically significant, progressive, or potentially unstable disease of any body system including cardiovascular, gastrointestinal, central nervous system (CNS), psychiatric, endocrine (other than diabetes), tuberculosis or renal
* Women of childbearing potential

Primary outcomes:
measure: Reduction in weekly average pain score for BMS drug vs. placebo, computed from diary scores
timeFrame: recorded during the last 7 days of treatment in each period
Secondary outcomes:
measure: Other glycemic, vascular, and mechanism-based biomarkers will be measured
timeFrame: throughout the study
Other outcomes:
Locations:
city: Tustin
country: United States
facility: University Clinical Investigators, Inc.
state: California
city: Palm Beach Gardens
country: United States
facility: Palm Beach Neurological Center
state: Florida
city: St. Petersburg
country: United States
facility: Comprehensive Neurosciences, Inc.
state: Florida
city: Chicago
country: United States
facility: The Pain & Rehabilitation Clinic Of Chicago
state: Illinois
city: Las Vegas
country: United States
facility: Advanced Biomedical Research Of America
state: Nevada
city: Greenville
country: United States
facility: Physicians East P.A.
state: North Carolina
city: Toledo
country: United States
facility: Neurology Center Of Ohio
state: Ohio
city: Dallas
country: United States
facility: Research Institute Of Dallas, P.A.
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00596323: Implantable Antenna Sensors for Continuous Glucose Monitoring
Official title: Implantable Antenna Sensors for Continuous Glucose Monitoring
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes Mellitus
Keywords: antenna
continuous glucose monitoring
electromagnetic
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Juvenile Diabetes Research Foundation
First posted: 2008-01-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults

Brief summary: The researchers' long-term goal is to develop a small implantable device that can continually monitor glucose levels. This will be an antenna. Changes in the glucose levels in will affect the antenna signals and those can be used to predict the patient's glucose levels.

Detailed description: Our goal is to develop a small size implantable device that can continually monitor glucose levels. The scientific objective of this application is to examine the efficacy of using implantable antennas to measure the glucose levels. The central hypothesis of this application is that the changes in the glucose levels in the medium surrounding the antenna will affect the antenna parameters such as input impedance and resonance frequency, and these changes can be used to predict the patient's glucose levels. We have formulated this hypothesis on the basis of our preliminary data, which will be detailed later, in the Preliminary Studies section. The rationale for the proposed research is that, once the correlation between the glucose levels and antenna parameters are determined, the design of a miniaturized long term glucose monitoring device will become a reality.

Eligibility criteria: Inclusion Criteria:

* Healthy adult able to give a blood sample

Exclusion Criteria:

* Adults with diabetes or other glycemic or hematologic disorders.
* Sick adults

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Children's Hospital
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Elaine Moreland, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06724523: Pre- and Post- Descriptive Data of Language Outcomes in Deaf Children
Official title: Pre- and Post- Descriptive Data of Language Outcomes in Deaf Children
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Sign Language Skills
Keywords: sign language
deaf
instruction
Lead sponsor: The University of Tennessee, Knoxville
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2024-12-09
Enrollment: 160
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Deaf children between 4 and 10 years old attending deaf education programs

Brief summary: Deaf children between ages of 4-10 will provide pre and post data by responding to three prompts in sign language and written language at the beginning and end of a year. This data will provide information on the developmental trends and characteristics of deaf children who will receive SISI the following year.


Eligibility criteria: Inclusion Criteria:

* Deaf children between 4 and 10 years old attending deaf education programs

Exclusion Criteria:

* Non-deaf children

Primary outcomes:
measure: Sign Language Skills
timeFrame: From enrollment to the end of treatment 9 academic months later.
Secondary outcomes:
measure: Written Language Skills
timeFrame: From enrollment to the end of treatment 9 academic months later.
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: University of Tennessee, Knoxville
state: Tennessee
Study officials:
References:
Clinical trial NCT01749423: A Retrospective Study to Evaluate the Effectiveness of onabotulinumtoxinA in Preventing Headaches in Patients With Chronic Migraines
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Chronic Migraine, Headache
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-12-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with chronic migraines who received a minimum of two consecutive treatment cycles of 100 units onabotulinumtoxinA and a minimum of two consecutive treatment cycles with the OnabotulinumtoxinA dosing between 155 and 195 units.

Brief summary: This study will evaluate the effectiveness of OnabotulinumtoxinA to prevent headaches in patients with Chronic Migraine.


Eligibility criteria: Inclusion Criteria:

* History of chronic migraines
* 15 or more headache days over a 30 day period
* A minimum of 2 consecutive treatment cycles of 100 units onabotulinumtoxinA and a minimum of 2 consecutive treatment cycles with the onabotulinumtoxinA dosing between 155 and 195 units

Exclusion Criteria:

* Any treatment cycle dose of onabotulinumtoxinA greater than 200 units

Primary outcomes:
measure: Number of Headache Days
timeFrame: Up to 56 Weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00662623: Enabling Sleep Apnea Patient-Centered Care Via an Internet Intervention
Official title: Enabling Sleep Apnea Patient-Centered Care Via an Internet Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Sleep Apnea Syndromes
Keywords: Chronic Obstructive Sleep Apnea
Sleep Apnea
Sleep Apnea Treatment
Lead sponsor: Veterans Medical Research Foundation
Sponsor class: OTHER
First posted: 2008-04-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effect of different methods of providing education about sleep apnea and continuous positive airway pressure therapy (CPAP) use and how that education might help to improve health outcomes and the amount of time CPAP is used.

Detailed description: Poor treatment adherence with CPAP therapy is well-documented. Set against a backdrop of telemedicine applications that have grown as fast in unsubstantiated claims and assumptions of patient satisfaction, diagnostic accuracy, clinical efficacy, and cost-effectiveness as they have in technological sophistication and capabilities, the evaluative aspect of this proposal is designed as as a randomized, controlled clinical trial-Usual Care patients (control) versus i-PAP patients (intervention). An important empirical-methodological advantage of the project is the objective measurement of CPAP adherence, which is measured by internal microprocessor as the "amount of time CPAP is used at the prescribed pressure." This objective measurement allows feedback of treatment adherence and efficacy to both patient and provider, and the i-PAP intervention was designed around this central feature.

Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* confirmed diagnosis of OSA
* being newly prescribed CPAP therapy
* having chronic symptoms as noted on screening symptom checklist
* fluency in English

Exclusion Criteria:

* cognitive impairment sufficient to cause inability to complete the protocol (MMSE \< 24/30)
* residence in a geographical area outside of San Diego County
* fatal comorbidity (life expectancy less than 6 months as indicated by treating physician)
* significant documented substance/chemical abuse or other participant circumstances that, in the opinion of a consensus of study team, would interfere with the safety of a prospective participant or their need for treatment

Primary outcomes:
measure: CPAP Adherence
timeFrame: 4 months
Secondary outcomes:
measure: Quality of patient-centered collaborative care
timeFrame: 4 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Veterans Medical Research Foundation
state: California
Study officials:
affiliation: Veterans Medical Research Foundation
name: Carl J. Stepnowsky, PhD
role: PRINCIPAL_INVESTIGATOR
References: