louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03629366: Supported Employment for Refugees
Official title: Supported Employment for Refugees
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refugees
Keywords: Refugees
Supported Employment
Individual Placement and Support
Employment
Vocational Rehabilitation
Mental Health
Lead sponsor: NORCE Norwegian Research Centre AS
Sponsor class: OTHER
Collaborators: name: Norwegian Labour and Welfare Administration
First posted: 2018-08-14
Enrollment: 66
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Humanitarian crises related to the Syrian conflict have led to a large increase in refugees in Europe in the recent years. There is need for effective approaches to increase labor market participation among refugees, and to reduce the impact of unfavorable exclusion mechanisms among this group. The Supported Employment for Refugees (the SER-trial) is a randomized controlled trial investigating the effectiveness of Supported Employment (SE) for newly arrived refugees who are involved in the mandatory introduction program provided for all refugees in Norway. SE is an intervention that has proved effective in promoting competitive employment among patients with severe mental illness in over twenty international randomized controlled trials, and is currently being evaluated for various new patient groups in ongoing trials. The SER-trial is however the first trial to evaluate the effect of SE for the target group of refugees (who may or may not have mental illness).


Eligibility criteria: Inclusion Criteria:

* Refugees in the city of Bergen, Norway
* Expressed desire to work
* Able to have a simple conversation in Norwegian or English

Exclusion Criteria:

* No expressed desire to work
* Unable to have a simple conversation in Norwegian or English

Primary outcomes:
measure: Competitive employment (register data and log books)
timeFrame: 12 months
Secondary outcomes:
measure: Acculturation (survey data)
timeFrame: 12 months
measure: Psychological distress (survey data)
timeFrame: 12 months
measure: Posttraumatic stress (survey data)
timeFrame: 12 months
measure: Global well-being (survey data)
timeFrame: 12 months
measure: Health-related quality of life (survey data)
timeFrame: 12 months
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: NORCE Norwegian Research Centre
Study officials:
affiliation: NORCE Norwegian Research Centre
name: Vigdis Sveinsdottir, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: NORCE Norwegian Research Centre
name: Tonje Fyhn
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01957566: The Utility of Pretracheal Stethoscope in Detecting Respiratory Abnormalities in Sedated Children
Official title: The Utility of Amplified Pretracheal Stethoscope in Detecting Ventilatory Abnormalities During Propofol Sedation of Non Intubated Children: a Validation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedation
Keywords: propofol sedation
children
procedure sedation
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 105
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The purpose of the study is to validate the diagnostic performance of the amplified pretracheal stethoscope (APS) to detect sedation-related adverse acute respiratory events in propofol sedated nonintubated children. To determine the sensitivity/specificity and positive/negative predictive value of the APS in detecting sedation-related adverse acute respiratory events in propofol sedated nonintubated children.


Eligibility criteria: Inclusion Criteria:

* Patients 2 years to 18 years of age undergoing induction and maintenance of propofol sedation at the American Family Children's Hospital (AFCH) Pediatric Sedation Clinic
* American Society of Anesthesiology score (ASA) of 1-2

Exclusion Criteria:

* ASA scoring \> 3
* Oxygen requirement and cardiorespiratory instability
* Allergy to propofol or its components
* Patients requiring propofol sedation outside the AFCH Pediatric Sedation Clinic

Primary outcomes:
measure: An auscultation of a stridor score greater than or equal to 2 will be defined as a sedation-related adverse acute respiratory event
timeFrame: Day 1 of propofol sedation.
measure: A stridor score of less than 2 will be defined as not sedation-related event.
timeFrame: Day 1 of sedation.
Secondary outcomes:
measure: The positive predictive value and negative predictive value of the APS for predicting airway obstruction.
timeFrame: Day 1 of propofol sedation.
Other outcomes:
Locations:
city: Madison
country: United States
facility: American Family Children's Hospital (AFCH)
state: Wisconsin
Study officials:
affiliation: UW Madison
name: Juan Boriosi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05028166: Individual Patient Compassionate Use of Mirdametinib
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Neurofibromatosis Type 1-Associated Plexiform Neurofibromas
Histiocytic Neoplasm
Other MAP-K Pathway Driven Diseases
Keywords: RASopathies
NF1
Neurofibromatosis
Plexiform Neurofibromas
Langerhans
Lead sponsor: SpringWorks Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-31
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: This program is being offered on a patient by patient basis and will require company, Institutional Review Board/Independent Ethics Committee, and applicable competent authority approval.


Eligibility criteria: Inclusion Criteria:

* Patient has a serious, debilitating or life-threatening medical condition that cannot be treated satisfactorily with an authorized medicinal product or other available standard treatment options, or all other treatment options have been exhausted.
* Patient does not qualify to participate in an ongoing clinical trial.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01453426: Phase 1 Study to Evaluate the PK, Safety, and Tolerability of BG00012 in Chinese, Japanese, and Caucasian Healthy Volunteers
Official title: An Open-Label, Parallel-Group, Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BG00012 in Chinese, Japanese, and Caucasian Adult Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2011-10-17
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This is an open-label, parallel-group study to evaluate the PK, safety, and tolerability of two different dose regimens of BG00012 over a 24-hour period to adult Chinese, Japanese, and Caucasian healthy volunteers.

Detailed description: The purpose of this healthy volunteer study is to provide pharmacokinetic and safety data for two different dose regimens of BG00012. The study will evaluate BG00012 administered over a 24-hour period.

The study will be conducted in male and female Chinese, Japanese, and Caucasian healthy volunteers.

Eligibility criteria: Inclusion Criteria:

* Must give written informed consent and any authorizations required by local law
* All subjects must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.

Exclusion Criteria:

* History of any clinically significant cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator.
* History of malignancy (subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible)
* History of severe allergic or anaphylactic reactions
* Known history of or positive test result for Human Immunodeficiency Virus (HIV)
* Serious infection (e.g., pneumonia, septicemia) within 2 months prior to Screening.
* Female subjects who are pregnant or currently breastfeeding

Primary outcomes:
measure: AUC of BG00012
timeFrame: First dose to 24 hours
measure: Cmax of BG00012
timeFrame: First dose to 24 hours
Secondary outcomes:
measure: Number of Adverse Events, as a measure of safety and tolerability
timeFrame: Subjects will be followed for the duration of the study, an expected 20 days
measure: Number of Serious Adverse Events, as a measure of safety and tolerability
timeFrame: Subjects will be followed for the duration of the study, an expected 20 days
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Research Site
state: Victoria
city: Hong Kong
country: China
facility: Research Site
state: Hong Kong
Study officials:
References:
Clinical trial NCT03151226: OSA Screen Negative With Spinal Duramorph
Official title: A Prospective, Observational, Double-blind (Black-Box) Study Evaluating Incidence, Severity and Predictive Factors of Respiratory Depression and Sleep Disorder Pattern During Postoperative Neuraxial Opioid Analgesia in OSA Screened Negative With BMI>=35 Kg/m2 Obstetric Patients After Cesarean Delivery Using Current Standard Intermittent Postoperative Monitoring Compared to Continuous Pulse Oximetry/Capnography
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Respiratory Depression
Keywords: obstructive sleep apnea screen negative
respiratory depression
cesarean section
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Non emergent scheduled cesarean sections will be consented to participate in this study of patients who have screened negative for obstructive sleep apnea and who are also BMI\>/= 35 to have capnography monitoring postoperatively. The capnography and pulse oximetry will be initiated in the post anesthesia care unit and be worn for 12-24 hours after delivery. Data will be retrieved after that time period in a deidentified fashion. Medication usage will be reviewed as well as the standard of care information from the duramorph monitoring will be retrieved.


Eligibility criteria: Inclusion Criteria:

* OSA screen negative per hospital protocol
* age 18 or greater
* BMI\>35
* consent to participate to wear capnography and pulse oximetry monitoring devices post delivery

Exclusion Criteria:

* Spanish speaking only
* under age 18
* contraindication to receiving drugs utilized in delivery anesthetic

Primary outcomes:
measure: Respiratory Depression/Suppression
timeFrame: up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Novant Health Forsyth Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Peter H Pan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00514826: Study to Investigate Sleep Apnea Patients at Altitude
Official title: Study to Investigate Sleep Apnea Patients at Altitude
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea Syndrome
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2007-08-10
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of the study is to investigate the effect of an altitude sojourn on patients with the obstructive sleep apnea syndrome

Detailed description: Previous observations do not allow to draw firm conclusions on the effect of altitude sojourn on sleep, breathing and daytime performance in patients with the obstructive sleep apnea syndrome. Furthermore, the susceptibility of sleep apnea patients to high altitude related illness is not known. Therefore, the purpose is to study untreated patients with obstructive sleep apnea syndrome living at low altitude during a sojourn of a few days at moderate altitude in order to evaluate the physiologic effects of hypobaric hypoxia in these patients. We hypothesize that: 1. Sleep and nocturnal breathing disturbances in untreated OSA patients are more pronounced at moderate altitude compared to low altitude. 2. The increase in sleep related breathing disturbances at moderate altitude is due to an increase in central apnea/hypopnea

Eligibility criteria: Inclusion Criteria:

* Obstructive sleep apnea syndrome based on symptoms and a sleep study

Exclusion Criteria:

* Sleep disorders other than obstructive sleep apnea syndrome
* Other than mild, stable cardiovascular disease
* Other than mild lung disease
* Chronic rhinitis, previous uvulopalatopharyngoplasty
* Treatment with drugs that affect respiratory center drive
* Internal, neurologic or psychiatric disease that interferes with sleep quality
* Previous intolerance to moderate or low altitude \< 2600m

Primary outcomes:
measure: Prevalence and severity of sleep disordered breathing
timeFrame: during altitude sojourn
Secondary outcomes:
measure: alterations in sleep structure and vigilance; high altitude related illness
timeFrame: during altitude sojourn
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Pulmonary Division, University Hospital Zurich, Switzerland
Study officials:
affiliation: Pulmonary Division, University Hospital Zurich, Switzerland
name: Konrad E. Bloch, MD
role: STUDY_DIRECTOR
References:
citation: Nussbaumer-Ochsner Y, Schuepfer N, Ulrich S, Bloch KE. Exacerbation of sleep apnoea by frequent central events in patients with the obstructive sleep apnoea syndrome at altitude: a randomised trial. Thorax. 2010 May;65(5):429-35. doi: 10.1136/thx.2009.125849.
citation: Bloch KE, Latshang TD, Turk AJ, Hess T, Hefti U, Merz TM, Bosch MM, Barthelmes D, Hefti JP, Maggiorini M, Schoch OD. Nocturnal periodic breathing during acclimatization at very high altitude at Mount Muztagh Ata (7,546 m). Am J Respir Crit Care Med. 2010 Aug 15;182(4):562-8. doi: 10.1164/rccm.200911-1694OC. Epub 2010 May 4.
Clinical trial NCT02811926: Incidence and Risk Factors of Parastomal Bulging in Patients With Ileostomy or Colostomy
Official title: Incidence and Risk Factors of Parastomal Bulging in Patients With Ileostomy or Colostomy: a Register-based Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colostomy
Ileostomy - Stoma
Enterostomy
Keywords: parastomal bulging
peristomal bulging
ileostomy
colostomy
enterostomy
incidence
risk factor
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Herlev Hospital
First posted: 2016-06-23
Enrollment: 5019
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with an ileostomy or colostomy in the Danish Stoma Database Capital Region

Brief summary: The purpose of this study is to use routinely-collected health data from registers to examine the incidence of parastomal bulging (PB) at different time points in the first year after surgery for ileostomy or colostomy. Additionally, the purpose is to investigate risk factors for development of PB.

Detailed description: Parastomal bulging (PB) in patients with ileostomy and colostomy in the Capital Region of Denmark up to one year after surgery is the primary outcome in this study. The investigators will use a register-based study design to evaluate routinely-collected health data from the Danish Stoma Database Capital Region (DSDCR). Incidence of PB one year post surgery and at different points of follow-up during the first year will be investigated using survival analysis. Potential risk factors will be investigated controlling for potential confounders. In order to include relevant variables on lifestyle, comorbidity, and physical status, data from the DSDCR will be linked to data from the Danish Anaesthesia Database.

Eligibility criteria: Inclusion Criteria:

* Subject is registered in the Danish Stoma Database Capital Region
* Is registered as having either ileostomy, jejunostomy, sigmoidostomy, or transversostomy

Exclusion Criteria:

* Patients with urostomy or unknown stoma type

Primary outcomes:
measure: Number of patients with the incidence of parastomal bulging
timeFrame: Up to 1 year after primary surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00460226: Lamictal Bipolar Observational Study
Official title: A Multi-centre, Observational Study to Evaluate the Incidence of Non-serious Rash in Korean Bipolar I Patients With Lamotrigine Therapy in Real World Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder
Keywords: Korean
Bipolar I disorder
Non-serious rash
Lamotrigine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-04-13
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient setting and reflecting usual clinical practice in general hospital

Brief summary: This is multi-center, prospective, observational stud. This study is designed to evaluate the rate of non-serious rash in Korean bipolar I patients.


Eligibility criteria: Inclusion criteria:

* A subject will be eligible for inclusion in this study only if all of the following criteria apply:
* Provides written informed consent
* Male or female age 18 years or older A female subject is eligible to enter and participate in the study if she is of;
* Non-childbearing potential
* Childbearing potential, has a negative pregnancy test at screen
* Diagnosis of bipolar I disorder using DSM-IV criteria

Exclusion criteria:

* A subject will not be eligible for inclusion in this study if any of the following criteria apply:
* Previous or current treatment with lamotrigine
* Presence of a clinically significant psychiatric or physiologic comorbidity, including significant substance abuse, severe depression or mania which is of an unstable or progressive nature that could, in the opinion of the investigator, interfere with participation in this study
* Presence of untreated thyroid disease
* Have active suicidality or homicidality, history of recent suicide attempts within the past year, or, in the investigator's opinion, a marked risk for suicide
* History of severe hepatic or renal insufficiency or significant hematologic disease or other significant medical or psychiatric condition that would interfere with subjects' participation in the study
* Currently participating in another clinical trial, or plans to enroll in another trial while participating in this study
* Currently pregnant or is breastfeeding

Primary outcomes:
measure: Occurrence of non-serious rash during 12 weeks of treatment with lamotrigine in patients with bipolar I in Korea
timeFrame: 12 weeks
Secondary outcomes:
measure: CGI-BP at Week 12 and occurrence of adverse events at Week 12
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Woo YS, Bahk WM, Jon DI, Joo YH, Kim W, Seo JS, Ahn YM, Chung SK, Won SH, Shin YC, Yoon BH, Jung SH, Seok JH, Lee YS, Kim Y, Min KJ. Rash in adult patients receiving lamotrigine to treat bipolar I disorder in Korea: a multicenter, prospective, naturalistic, open-label trial. Prog Neuropsychopharmacol Biol Psychiatry. 2009 Oct 1;33(7):1147-52. doi: 10.1016/j.pnpbp.2009.06.010. Epub 2009 Jun 18.
Clinical trial NCT06449365: Comparison of Intravenous V/S Nasal Atomizer Delivery of Midazolam for Conscious Sedation for No-scalpel Vasectomy
Official title: Comparison of Intravenous V/S Nasal Atomizer Delivery of Midazolam for Conscious Sedation for No-scalpel Vasectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vasectomy
Sedation
Lead sponsor: University of Tennessee Graduate School of Medicine
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 35
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized control
Primary purpose: OTHER

Brief summary: Purpose: This study compared administration of midazolam via intravenous route with nasal atomizer route for moderate sedation in an office-based vasectomy clinic.

Detailed description: Purpose: This study compares administration of midazolam via intravenous route with nasal atomizer route for moderate sedation in an office-based vasectomy clinic.

Patients and methods: Patients will be randomly assigned to one of two groups: midazolam given via traditional intravenous route or midazolam via a nasal atomizer. Outcomes are patient perception of anxiety with the drug delivery method, discomfort with administration, pain during the procedure, and length of sedation effects. Medical personnel rated ease of use, efficacy, time to sedation and time to transport after procedure.

Eligibility criteria: Inclusion Criteria:

* all men who request no-scalpel vasectomy procedure

Exclusion Criteria:

* anyone not eligible for no-scalpel vasectomy procedure

Primary outcomes:
measure: Patient Questionnaire (generated by institution)
timeFrame: 1 year
Secondary outcomes:
measure: Nursing Questionnaire (generated by institution)
timeFrame: 1 year
Other outcomes:
measure: Surgeon Questionnaire (generated by institution)
timeFrame: 1 year
Locations:
city: Knoxville
country: United States
facility: UTGSM
state: Tennessee
Study officials:
affiliation: UTGSM
name: Jennifer Ferris, Phd
role: STUDY_DIRECTOR
References: