louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04619576: Influence of the COVId-19 Pandemic on STRESS of Occupational Health Workers
Official title: Influence of the COVId-19 Pandemic on STRESS of Occupational Health Workers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Occupational Health
Keywords: COVID-19
Occupational health
Stress
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2020-11-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All volunteers

Brief summary: Coronavirus has caused containment of more than half of the world's population and a major and rapid reorganization of clinical and support services. The spread of coronavirus (COVID-19) has posed significant challenges for occupational health services. However, there is currently no data on the influence of this epidemic on the practice and feelings of dental surgeons and associates

Detailed description: This is an observational study by REDCap questionnaire® via an internet link, which will be distributed to occupational health workers by any means The self-survey will assess stress, working conditions and changes in practices related to the coronavirus outbreak. This questionnaire includes 39 questions.

Eligibility criteria: Inclusion Criteria:

* All volunteers who are screened

Exclusion Criteria:

* None

Primary outcomes:
measure: Stress measures
timeFrame: Day 1
Secondary outcomes:
measure: Sociodemographic characteristics
timeFrame: Day 1
measure: occupation perception
timeFrame: Day 1
measure: work conditions
timeFrame: Day 1
measure: Changes in practices
timeFrame: Day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Clermont-Ferrand University Hospital
state: Aura
Study officials:
References:
Clinical trial NCT00164476: Promoting Clinical Preventive Services Among Adults With Disabilities
Official title: Promoting Prevention Among Adults With Disabilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Physical Disability
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
First posted: 2005-09-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Project SHIELD (Strategies and health Interventions to Enhance Life with Disability) is a participatory action research project to test an intervention package combining a resource kit with peer mentoring in improving consumer education about primary preventive services

Detailed description: Adults with disabilities use primary preventive health care services (basic screenings, immunizations, and hevior health counseling) at rates below those recommended by the US Preventive Services Task Force and Healthy People 2010. This projects is to carry out a community-based campaign to increase preventive care knowledge and service use among adults with physical disabilities. Focus group methodology will be used to determine the specific preventive service priorities of the disability community so that targeted resource materials for consumers and physicians can be developed. Second, a randomized control group experiment will be implemented to evaluate the effectiveness of the targeted resource materials, followed by dissemination of the Preventive Services Resource Kits.

Eligibility criteria: Inclusion Criteria:

* primary residence in Northern Virginia presence of a physical disability at least 18 years old

Exclusion Criteria:

-

Primary outcomes:
measure: Prevention-related knowledge and beliefs
measure: Self-efficacy
measure: Service-seeking intent
measure: Service utilization
Secondary outcomes:
measure: perceptions of the Preventive Service Resource Kit
Other outcomes:
Locations:
city: Washington
country: United States
facility: National Rehabilitation Hospital
state: District of Columbia
Study officials:
affiliation: Medstar Health Research Institute
name: Suzanne L Groah, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01567176: Circulating SIRT6 Expression, Effect on Aging Quality
Official title: Circulating Expression Measurement of a Sirtuin Protein Isoform, Sirt6, as an Early Marker of Aging Quality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: Sirtuins
Aging
Metabolic disease
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2012-03-30
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study follows the results of the COMPALICLAMP study (NCT00951392) where the investigators showed a differential expression of sirtuins protein isoforms, Sirt6, in muscle depending on the quality of aging. The investigators seek to confirm this difference in expression level of circulating leukocytes on a larger sample.


Eligibility criteria: Inclusion Criteria:

* Volunteers from the SUVIMAX 2 aging cohort
* Men and women
* Older than 60
* Subject with a global aging quality score of 1 or 3 in the SU.VI.MAX. 2 study
* Covered by Health Insurance System

Exclusion Criteria:

* Subject not in compliance with the recommendation of French National Law

Primary outcomes:
measure: Sirt6 expression in circulating leukocytes based on the aging quality
timeFrame: participants will be followed for the duration of the visit, an expected average of 1 day
Secondary outcomes:
measure: hand and forearm muscular strength measurement
timeFrame: participants will be followed for the duration of the visit, an expected average of 1 day
measure: Physical examination and anthropometric measurement
timeFrame: participants will be followed for the duration of the visit, an expected average of 1 day
measure: Cognitive assessment
timeFrame: participants will be followed for the duration of the visit, an expected average of 1 day
measure: Physical Activity questionnaire
timeFrame: participants will be followed for the duration of the visit, an expected average of 1 day
Other outcomes:
Locations:
city: Pierre Bénite
country: France
facility: Centre de recherche en nutrition humaine Rhone-Alpes
city: Pierre Bénite
country: France
facility: Centre de Recherche en Nutrition Humaine
Study officials:
affiliation: Centre de recherche en nutrition humaine Rhone-Alpes
name: Martine LAVILLE, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Betry C, Meugnier E, Pflieger M, Grenet G, Hercberg S, Galan P, Kesse-Guyot E, Vidal H, Laville M. High expression of CPT1b in skeletal muscle in metabolically healthy older subjects. Diabetes Metab. 2019 Apr;45(2):152-159. doi: 10.1016/j.diabet.2018.01.018. Epub 2018 Feb 12.
Clinical trial NCT00601276: Comparison of Two Pharmacological Treatments of Pedophilia
Official title: Comparative Controlled Clinical Trial of Two Pharmacological Treatments of Pedophilia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pedophilia
Keywords: pedophilia
antiandrogens
gonadotropin releasing hormone agonists
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
Collaborators: name: Assistance Publique - Hôpitaux de Paris
name: Ministry of Health, France
name: Ministry of Higher Education and Research, France
First posted: 2008-01-28
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sexual abuse committed on children is a major public health problem because of its frequency and its severe consequences on the mental health of victims.

Objective: to compare the therapeutic efficacy of cyproterone acetate (CPA) and leuprolide, with the hypothesis that leuprolide will be more effective.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of pedophilia
* high frequency of sexual urges and deviant behavior as demonstrated by a score equal to 8 on the scale of Rösler \& Witztum (Rösler \& Witztum, 1998) ;
* age: 18-60 years
* informed consent

Exclusion Criteria:

* IQ\<70
* schizophrenia, schizoaffective disorder, or delusional disorder
* already receiving one of the tested drugs
* contraindication for one of the tested drugs
* no current or planned incarceration

Primary outcomes:
measure: Questionnaire on sexual behavior
timeFrame: prospective
Secondary outcomes:
measure: Recidivism
timeFrame: Prospective
Other outcomes:
Locations:
city: Bron
country: France
facility: Federation d'Endocrinologie, Hopital NeuroCardiologique
city: Paris
country: France
facility: Centre MédicoPsychologique CMPG21, EPS Perray Vaucluse
city: Suresnes
country: France
facility: Service de Psychiatrie, Hopital Foch
city: Villejuif
country: France
facility: SMPR, Hopital Paul Guiraud
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Serge Stoleru, MD, PHD
role: STUDY_DIRECTOR
References:
citation: Moulier V, Fonteille V, Pelegrini-Issac M, Cordier B, Baron-Laforet S, Boriasse E, Durand E, Stoleru S. A pilot study of the effects of gonadotropin-releasing hormone agonist therapy on brain activation pattern in a man with pedophilia. Int J Offender Ther Comp Criminol. 2012 Feb;56(1):50-60. doi: 10.1177/0306624X10392191. Epub 2011 Apr 24.
Clinical trial NCT06361576: Real-World Use of Nivolumab for the Treatment of Patients With Metastatic Upper Gastrointestinal Cancer in Canada
Official title: Patients With Upper Gastrointestinal Adenocarcinoma Enrolled in a Patient Support Program to Receive Nivolumab in the Metastatic Setting: Real-World Data From Canada
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Upper Gastrointestinal Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2024-04-12
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is comprised of individuals diagnosed with HER2 negative, unresectable, advanced or metastatic gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma (GC/GEJC/EAC) that participated in the Bristol-Myers Squibb Patient Support Program (PSP) in Canada, GEORgiA PSP (GastroEsophageal Opdivo in non-Resectable, advanced or metastatic Adenocarcinoma)

Brief summary: The purpose of this observational study is to describe the demographics, and disease characteristics of participants with metastatic upper gastrointestinal cancer, along with the treatment characteristics of these patients when treated with nivolumab.


Eligibility criteria: Inclusion Criteria:

* Enrolled in the Bristol-Myers Squibb GastroEsophageal Opdivo in non-Resectable, advanced or metastatic Adenocarcinoma Patient Support Program (GEORgiA PsP) in Canada
* Have consented to the use of their de-identified data generated from information collected during the course of the GEORgiA PsP

Exclusion Criteria:

* Aged \<18 years
* HER2 positive status
* Untreated brain metastases

Primary outcomes:
measure: Particpant sociodemographics
timeFrame: Baseline
measure: Participant Eastern Cooperative Oncology Group (ECOG) score
timeFrame: Baseline
measure: Participant HER2 status
timeFrame: Baseline
measure: Participant comorbidities
timeFrame: Baseline
measure: Participant tumour location
timeFrame: Baseline
measure: Participant treatment history
timeFrame: Baseline
Secondary outcomes:
measure: Initial nivolumab dosage prescribed to participants
timeFrame: Index date
measure: Number of nivolumab treatments received by participants
timeFrame: Up to 75 weeks
measure: Planned combination chemotherapy treatment
timeFrame: Index date
measure: Nivolumab treatment initiation date
timeFrame: Index date
measure: Nivolumab dosage modification
timeFrame: Up to 75 weeks
measure: Participant treatment duration
timeFrame: Up to 75 weeks
measure: Reason for participant discharge
timeFrame: Up to 75 weeks
measure: Participant adverse events (AEs)
timeFrame: Up to 75 weeks
measure: Management of participant adverse events (AEs)
timeFrame: Up to 75 weeks
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Bayshore Specialty Rx Ltd.
state: Ontario
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT04025476: Immune Profile of Acute VKH Patients PBMC
Official title: Clinical Observational Research on Changes of Peripheral Blood Mononuclear Cell（PBMC） Immunity and Expression Profile in Peripheral Blood of Different Course of of Vogt-Hoyanagi-Harada（VKH） Patients.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: VKH Syndrome
Keywords: VKH; immune profile;
Lead sponsor: Aier School of Ophthalmology, Central South University
Sponsor class: OTHER
First posted: 2019-07-19
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: acute primary VKH patients

Brief summary: The investigators will collect blood samples of different courses of VKH patients for investigating immune profile, observe major immune cells number ,functional and membrane molecular changes in the course of treatment, to investigate pathogenesis of VKH. Meanwhile, the investigators will collect clinical data of VKH patients to observe choroid and retina change in different courses.


Eligibility criteria: Inclusion Criteria:

1. Acute VKH patients, meet a criterion of VKH, no recurrence.
2. Age range from 18 to 50 years old.

Exclusion Criteria:

1. Patients with Severe Cardiovascular and Cerebrovascular Diseases
2. Patients allergic to steroid or contrast agents;
3. A history of ocular trauma or intraocular surgery within 3 months; Vaccinated; History of infectious diseases
4. having a history of heredity, immune system correlation, neuroendocrine and digestive system diseases
5. Patients who take health care products for a long time and have heavy alcohol and tobacco addiction.

Primary outcomes:
measure: T/B /NK(natural killer )/monocyte...etc, cell numbers of blood samples in VKH patients
timeFrame: one year
measure: T/B /NK/monocyte...etc cell subtype proportion in blood samples in VKH patients
timeFrame: one year
measure: T/B /NK/monocyte...etc cell functional change in VKH patients
timeFrame: one year
Secondary outcomes:
measure: choroid and retinal thickness change in different course of VKH patients
timeFrame: one year
measure: Use OCTA(optical coherence tomography angiography) to measure macular and optic disc vascular index
timeFrame: one year
measure: Use Maia perimeter to measure macular integrality
timeFrame: one year
measure: measure the Injury degree of choroid and retinal vessels
timeFrame: one year
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan Aier eye hospital
state: Hubei
Study officials:
affiliation: Central-southern university, Aier ophthalmology colleage
name: Qing Zhang, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01305876: Yoga in an Urban School for Children With Emotional Behavioral Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotional Behavioral Disorders
Keywords: yoga
emotional behavioral disorder
intervention
school
meditation
focus: yoga intervention in students with emotional behavioral disorders in an urban school
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
First posted: 2011-03-01
Enrollment: 41
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Yoga is becoming a part of therapies for children with emotional behavioral disorders. The goal is to examine the feasibility and efficacy of yoga sessions for children with emotional behavioral disorders at an urban elementary school.

Detailed description: Participants: children in 4th and 5th grade at an urban elementary school, identified by the special education director and the teaching staff, as having emotional behavioral disorders including anxiety, depression, aggression, conduct disorder, hyperactivity and attention difficulties. These grades have a combined student population of 160 students. Enrolled over two years.

Inclusion/Exclusion criteria:

Eligible if identified by the teaching staff or special education director as having an emotional behavioral disorder. Exclusion criteria: inability to comprehend English sufficiently to complete written assessments and follow the yoga intervention.

Pre- and post-intervention assessments (teachers)

1. Behavior Assessment Scale for Children (BASC).
2. The Swanson, Kotkin, Agler, M-Flynn \& Pelham Rating Scale (SKAMP)

Eligibility criteria: Inclusion Criteria:

* identified by the teaching staff or special education director as having an emotional -behavioral disorder

Exclusion Criteria:

* inability to comprehendread in English sufficiently to complete written assessments and follow the yoga interventionintervention protocols

Primary outcomes:
measure: Behavior Assessment Scale for Children (BASC).
timeFrame: 1 year. The classroom teachers filled out the BASC pre- and post-intervention on each participant. This took place June 2009, after the yoga intervention took place. Has been completed
measure: The Swanson, Kotkin, Agler, M-Flynn & Pelham Rating Scale (SKAMP)
timeFrame: One year. The teachers filled out the SKAMP pre- and post-intervetnion to assess participants focus in class. This took place June 2009, after the yoga interveniton. Has been completed.
Secondary outcomes:
measure: The Swanson, Kotkin, Agler, M-Flynn & Pelham Rating Scale (SKAMP)
timeFrame: The classroom teachers filled out the SKAMP pre- and post-intervention
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center / Tufts University
state: Massachusetts
Study officials:
References:
Clinical trial NCT00754676: Endoscopic Stenting for Chronic Abdominal Pain
Official title: Randomized Single Blind Trial of Endoscopic Stenting for Chronic Pancreatitis-Associated Abdominal Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pancreatitis
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: University of Alabama at Birmingham
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2008-09-18
Enrollment: 2
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women diagnosed with chronic pancreatitis.

Brief summary: The prospective sham randomized study will evaluate the role of endoscopic stenting inpatients with chronic pancreatitis and chronic abdominal pain.

Detailed description: Endoscopic stenting is increasingly used for the treatment of a variety of pancreatic disorders. Although a number of studies suggest that pancreatic stenting relieves abdominal pain in approximately 70% of patients, there has been no randomized study. Since any intervention may improve pain, the effectiveness of endoscopy cannot be ascertained without a true placebo arm or sham therapy group.

The study will aim to determine the effectiveness of pancreatic stents in relieving chronic pain in the setting of chronic pancreatitis. Since these procedures do carry risk, a placebo controlled fashion is used for this study

Eligibility criteria: Inclusion Criteria:

* All patients referred to the principal investigator for chronic pancreatitis will be enrolled.

Exclusion Criteria:

* There are no gender nor racial exclusion.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Alabama at Birmingham
name: Charles M Wilcox, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00653276: MD Ezetimibe Cyclosporine Interaction (0653-057)
Official title: An Open-Label, 2-Period, Crossover Study to Determine the Effect of Multiple Oral Doses of Ezetimibe 20 mg on the Pharmacokinetics of a Single Oral Dose of Cyclosporine in Young, Healthy, Normal, Male and Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cholesterol
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
Collaborators: name: Schering-Plough
First posted: 2008-04-04
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Study to determine the effect of multiple oral doses of ezetimibe on the pharmacokinetics of a single oral dose cyclosporine in young healthy males and females.


Eligibility criteria: Inclusion Criteria:

* Subject is male or female between 18 to 45 years of age
* Subject is judged to be in good health on the basis of history, physical examination, and routine laboratory data

Exclusion Criteria:

* Premenopausal women who are currently pregnant or who are currently nursing
* Subjects with drug or substance abuse, poor mental function, history of major gastrointestinal abnormalities (stomach issues), or high cholesterol
* Subject that has donated blood or has participated in another clinical trial within the last four weeks

Primary outcomes:
measure: To evaluate the safety and tolerability of cyclosporine coadministered with ezetimibe vs. cyclosporine administered alone.
timeFrame: Blood sampling will be conducted for 48 hours starting with the first cyclosporine dosing.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Bergman AJ, Burke J, Larson P, Johnson-Levonas AO, Reyderman L, Statkevich P, Kosoglou T, Greenberg HE, Kraft WK, Frick G, Murphy G, Gottesdiener K, Paolini JF. Effects of ezetimibe on cyclosporine pharmacokinetics in healthy subjects. J Clin Pharmacol. 2006 Mar;46(3):321-7. doi: 10.1177/0091270005284851.