louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03092921: The Evaluation of a Mask Seal/Mask for the Treatment of Obstructive Sleep Apnea (OSA)
Official title: The Evaluation of a Mask for the Treatment of Obstructive Sleep Apnea (OSA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disordered Breathing
Obstructive Sleep Apnea
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2017-03-28
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This investigation is designed to evaluate the performance as well as the patients overall acceptance of the seal/mask.

Detailed description: A minimum of 15 OSA participants who currently use a Full face mask will be recruited for the trial. Participant will be on the trial for 1 week- The participant will use the trial seal in-home for 1 week.

An additional 5 Participants will be added to the study to use the entire mask in home for 14+-4 days as an extension to the original trial.

Eligibility criteria: Inclusion Criteria:

* Adult (18+ years of age)
* Able to give consent
* Apnea hypopnea Index (AHI)≥ 5 on diagnostic night
* Prescribed PAP for OSA
* Existing oro-nasal mask user

Exclusion Criteria:

* Inability to give consent
* Patients who are in a coma or a decreased level of consciousness
* Anatomical or physiological conditions making automatic positive airway pressure (APAP) therapy inappropriate (e.g. unconsolidated facial structure)
* Commercial drivers who are investigated by New Zealand Transport Agency
* Current diagnosis of carbon dioxide (CO2) retention
* Pregnant or may think they are pregnant

Primary outcomes:
measure: Ease of use
timeFrame: 1 week in home
measure: Acceptability
timeFrame: 1 week in home
measure: Ease of use
timeFrame: 2 weeks in home
measure: Acceptability
timeFrame: 2 weeks in home
Secondary outcomes:
measure: Objective leak data
timeFrame: 1 week in home
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Fisher & Paykel Healthcare
Study officials:
affiliation: Employee
name: Sarah Gunson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04539821: Virtual Pain Care Management (COVID-19)
Official title: Virtual Pain Care for High Risk Veterans on Opioids During COVID19 (and Beyond)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: buprenorphine
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2020-09-07
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This single-arm feasibility study will be conducted in two VA sites.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The COVID-19 pandemic is exacerbating the challenges faced by Veterans at risk of opioid overdose including Veterans prescribed moderate-to-high dose long-term opioid therapy (LTOT) whose usual treatment resources and coping strategies may be inaccessible. This project combines established VA care components to deploy and evaluate virtual models of care for Veterans on high-risk LTOT to meet the dual challenges of maintaining social distancing and delivery high quality care.


Eligibility criteria: Inclusion Criteria:

* Eligible participants must currently receive LTOT for chronic pain at 50 mg morphine equivalent daily dose

Exclusion Criteria:

Exclusion criteria at baseline are:

* dementia diagnosis or moderate-severe cognitive impairment
* unstable or severe untreated psychiatric disorder or medical disease that requires hospitalization
* documentation of suspected controlled substance diversion
* inability to communicate by phone

Primary outcomes:
measure: The Number of Patients Who Agree to Change in Their Opioid Regimen, Including Buprenorphine Transfer
timeFrame: 30 days
Secondary outcomes:
measure: Number of Participants Retained in Care at End of Study
timeFrame: 60 days
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Rocky Mountain Regional VA Medical Center, Aurora, CO
state: Colorado
city: West Haven
country: United States
facility: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
state: Connecticut
Study officials:
affiliation: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
name: Brent Adams Moore, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01804621: RCT to Examine the Effects of Scanning
Official title: An RCT to Examine the Effects of Scanning; a Major Step on the Path Towards Population Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Breast Cancer
Colorectal Cancer
Keywords: Exercise
Nutrition
Mammography
Colorectal screening
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-03-05
Enrollment: 15824
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to implement a randomized control trial testing effects of information scanning on cancer prevention and screening behaviors in a population sample of 50-70 year olds. Participants will receive one of five versions of an e-newsletter once/month for 12 months and will be asked to complete baseline, mid-point, and end-of-project surveys.


Eligibility criteria: Inclusion Criteria:

* US adults, male or female, between 50 and 70 years of age.

Exclusion Criteria:

* Potential subjects will be excluded if they are not between the ages of 50 and 70

Primary outcomes:
measure: Exercise Behavior
timeFrame: 12 months
measure: Fruit & Vegetable Consumption
timeFrame: 12 months
measure: Mammography Screening Behavior
timeFrame: 12 months
measure: Colorectal cancer screening
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Robert Hornik, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02753621: Parkinsonics: A Controlled Study of Group Singing in Parkinson Disease
Official title: Parkinsonics: A Controlled Study of Group Singing for Quality of Life and Voice Outcomes in Parkinson Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson Disease
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2016-04-28
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The overall objective of this study is to observe the effect of group Vocal performance training and performance experience on patients' reported symptoms and quality of life. The effectiveness of PD medications varies significantly in different patients depending on their symptoms. By using music-based interventions to improve symptoms that may be inadequately treated by medications, the investigators hope to improve quality of life in PD patients. "Parkinsonics: A controlled study of group singing for quality of life and voice outcomes in Parkinson disease" (PD) is a controlled crossover behavioral intervention study of once weekly choral classes for patients with idiopathic PD (progressing toward a group performance) and once weekly discussion/support group meetings.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of idiopathic PD based on UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria for PD (Hughes et al. 1992).

Exclusion Criteria:

* Patients unable to consent to the study.
* Patients unable or unwilling to participate in weekly singing classes for 12 weeks, or unwilling to perform in a concert setting.
* Patients with active psychiatric disturbances (agitation, active hallucinations).

Primary outcomes:
measure: Parkinson Disease Quality of Life Questionnaire (PDQ)-39 scores
timeFrame: Change from baseline scores at 30 weeks
Secondary outcomes:
measure: Voice-Related Quality of Life
timeFrame: Change from baseline scores at 30 weeks
measure: Movement Disorder Society-Unified Parkinson Disease Rating Scale Motor scores
timeFrame: Change from baseline scores at 30 weeks
measure: Montreal Cognitive Assessment
timeFrame: Change from baseline scores at 30 weeks
measure: Geriatric Depression Scale-15
timeFrame: Change from baseline scores at 30 weeks
measure: Lorig Self-efficacy scale
timeFrame: Change from baseline scores at 30 weeks
measure: Short Form-36
timeFrame: Change from baseline scores at 30 weeks
measure: Sound pressure level (decibels)
timeFrame: Change from baseline levels at 30 weeks
measure: Voice jitter
timeFrame: Change from baseline values at 30 weeks
measure: Voice shimmer
timeFrame: Change from baseline values at 30 weeks
measure: Harmonic to noise ratio
timeFrame: Change from baseline values at 30 weeks
Other outcomes:
measure: Feasibility
timeFrame: 12 weeks
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Alexander Pantelyat, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06119321: A Study of a Novel Scheimpflug Device in Diagnosing Keratoconus
Official title: Evaluation of a Novel Scheimpflug Device for Detection of Early Keratoconus
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Scansys
Pentacam
Corvis ST
Keratoconus
Subclinical Keratoconus
Lead sponsor: Tianjin Eye Hospital
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients premedicated for refractive surgery

Brief summary: Comparison of the screening and diagnosis ability of the novel Scheimpflug-based tomography device (Scansys) with Pentacam and the Scheimpflug-based biomechanics device (Corvis ST) for keratoconus.


Eligibility criteria: Inclusion criteria:

* Best corrected visual acuity (BCVA) ≥ 20/20;
* No other eye diseases except myopia and astigmatism;
* The cornea was transparent, and there was no cloud or pannus;

Exclusion Criteria:

* The presence of ocular diseases other than myopia and keratoconus;
* Ocular trauma;
* Previous ocular surgery;
* Patients were required to stop wearing soft contact lenses for at least 2 weeks and rigid contact lenses for at least 4 weeks before examination;
* Pregnant and lactating women;

Primary outcomes:
measure: screening and diagnosis ability
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tiajin Eye Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Eye Hospital
name: Yan Wang, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT05903521: BAriatric Surgery Induced Chromosomal Change
Official title: Long-term Impact of Surgically Induced Rapid Weight Loss on Telomere Length and Its Potential Implications in the Genesis and Prevention of Neoplastic Disease Processes in Subjects With Severe Obesity
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity, Morbid
Keywords: Telomere length
Metabolic and bariatric surgery
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population will be divided in two groups; the control group (with obesity) and the treatment group (after Sleeve Gastrectomy or Roux-en-Y Gastric Bypass).

Brief summary: The purpose of this study is to better understand the impact of weight-loss surgery on telomere length. Telomeres are a key marker of biological aging of cells. Telomere shortening is a natural process of aging. Several pathologies and lifestyles are associated with premature telomere shortening, such as obesity, diabetes mellitus or sedentary lifestyle. New evidence supports that telomere shortening can be partially reversed by lifestyle changes such as healthy diet, reduced stress, or increased physical activity.

Detailed description: This study aims to evaluate the impact of metabolic and bariatric surgery on telomere length as well as the role of type 2 diabetes resolution and oxidative stress improvement on telomere lengthening.

The investigators hypothesize that metabolic and bariatric surgery is associated with the lengthening of telomeres as a possible underlying mechanism of cancer risk reduction.

It is a prospective, single-center study including patients with obesity class II or more (Body Mass Index ≥ 35kg/m2) and patients having had metabolic and bariatric surgery more than 12 months ago.

Eligibility criteria: Inclusion Criteria:

* BMI ≥ 35 kg/m2 without previous bariatric surgery (control group) OR
* Having had Sleeve Gastrectomy or Roux-en-Y Gastric Bypass more than 12 months ago and without a weight regain of ≥ 15% of nadir weight (treatment group)

Exclusion Criteria:

* under 18 years of age
* no informed consent

Primary outcomes:
measure: Telomere length
timeFrame: 1 day
Secondary outcomes:
measure: Metabolic disease remission (hypertension and type 2 diabetes remission versus no remission)
timeFrame: 1 day
measure: Excessive weight loss (Weight loss [kg] / excess body weight [kg]) x 100 = Percent of excess body weight loss)
timeFrame: 1 day
measure: Lifestyle (Simple Lifestyle Indicator Questionnaire)
timeFrame: 1 day
measure: Oxidative stress (Interleukin-1β, Interleukin-6, TNF-α)
timeFrame: 1 day
Other outcomes:
Locations:
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
Study officials:
References:
Clinical trial NCT03648021: The Effect of Paracetamol on Brain Temperature
Official title: NEUROTHERM: The Effect of Paracetamol on Brain Temperature in Acute Brain Injury in a Neuro Critical Care Unit: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Brain Injuries
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2018-08-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to compare the effect of intravenous paracetamol administration on mean brain temperature (measured between H0 and H6) in patients with cerebral hyperthermia versus placebo.

The investigators will measure brain temperature using a thermistor that will be connected to the intracranial pressure transducer.


Eligibility criteria: Inclusion Criteria

* 18-year or older patients
* Patient hospitalized in neuro-critical care for:
* Arachnoid hemorrhage
* Intra parenchymatous hematoma
* stroke
* Acute brain Severe injury
* Post-operative complication of an act of neurosurgery or programmed neuroradiology
* Sedation and mechanical ventilation planned \> 2 days
* Monitoring of intracranial temperature and pressure by intraparenchymal sensor (Sophysa®)
* Brain temperature \> 38.5°C for more than 30 minutes

Exclusion Criteria

* Known hypersensitivity to paracetamol or mannitol (excipient with known effect)
* Severe hepatocellular insufficiency (ASAT or ALAT \> 5N, or bilirubin \> 2N)
* Pharmacological intervention (administration of corticosteroids, NSAIDs or paracetamol) or physical intervention (external cooling technique) that may influence temperature in the last 6 hours.
* Pregnant or breastfeeding women
* Previous participation in this study

Primary outcomes:
measure: Comparison of mean brain temperature measured between H0 and H6 following administration of treatment between the two groups (the group treated with paracetamol and the placebo group)
timeFrame: Six hours after administration of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Fondation Adolphe de Rothschild
Study officials:
affiliation: Fondation Ophtalmologique Adolphe de Rothschild
name: Marine de Mesmay, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02738021: Managing PPD at Gouverneur
Official title: Stepped Care for Postpartum Depression in Pediatric Primary Care: A Pilot Project at Gouverneur Health Services
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Post-Partum Depression
Keywords: Psychosocial
Psychotherapy
Maternal
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-04-14
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A Stepped Care pathway for managing postpartum depression (PPD) in pediatric primary care settings will be used to (1) understand context for implementation feasibility (2) evaluate benefits for mother and child.

The proposed pilot project will be conducted as part of a quality improvement effort in the Department of Pediatrics at Gouverneur Health Services to improve management of postpartum depression during pediatric primary care visits. This project will test the feasibility of a stepped care approach to identifying and managing depression among mothers of infants (0-6 months). This study will provide preliminary data on the feasibility of the care management protocol, implementation and fidelity measures, and training/consultation methods within a real world pediatric care practice. These data will inform and support the preparation of a large-scale NIH grant.

Specific research questions include:

1. To pilot the feasibility of using a Stepped Care Approach to identify and mange maternal depression within primary care pediatric care visits, with a focus on mothers of infants 0-6 months.

   1. Train non specialty MH providers to systematically identify maternal depression.
   2. Assess how effective integration of maternal depression intervention is as part of well baby visits.
2. To o examine the impact of STRONG, a brief 3-session IPT-based preventive intervention, on maternal and child health outcomes (e.g., maternal depression symptoms, child receipt of acute care services). Secondary outcomes include maternal social support and parenting practices.


Eligibility criteria: Inclusion Criteria for Subjects

* PHQ-9 scores in the 10-19 range
* Women with infants 6 months and younger at time of screening

Inclusion Criteria for Providers

Exclusion Criteria:

* Active substance use
* Current treatment for depression
* Current/past history of schizophrenia, bipolar or other psychotic disorder;
* Suicidal/Homicidal risks;
* Women with difficulties speaking or understanding English;
* Women under the age of 18.

Primary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: One year
Secondary outcomes:
measure: Maternal Depression Management Inventory
timeFrame: One year
Other outcomes:
Locations:
Study officials:
affiliation: NYU Langone Health
name: Serene Olin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05209321: Predictors of Malnutrition in Patients With Haematological Cancer
Official title: Predictors of Malnutrition in Patients With Haematological Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malnutrition
Lymphoma
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 62
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: Patients over the age of 18 years, with haematological cancer, receiving myelosuppressive chemotherapy.

Brief summary: The primary purpose of this study is to conduct an exploratory study of which predictors are most significant for LBM loss in patients with lymphoma. Patients are measured by weight and bio impedance and furthermore, their physical activity, nutritional status, diet and quality of life during the course are estimated. This is done in order to determine any changes in the aforementioned factors during the course of the cancer treatment that may have a bearing on the loss of LBM.

Detailed description: It was assessed by the National Ethics Committee that the experiment was not subject to notification, cf. section 14 (1) of the Committee Act. 2. The project has been approved by the Ethical Research Committee for SUND and SCIENCE, University of Copenhagen.. The project was also approved by the Danish Data Protection Agency at Region Zealand with case no .: REG-166-2020. A data processor agreement was established between Region Zealand and thesis students.

Data is presented as mean +/- SD. Continuous data are analyzed using Pearson correlation analysis presented by correlation coefficient r and a p-value. Pearson correlation analysis is used to measure the strength of the linear relationship between normally distributed variables. A significance level of 5% is used.

Binary values are assigned for data assessing secondary endpoints. Subsequently, a multiple linear regression analysis is performed to examine the influence of discrete variables on the primary endpoint.

For statistical analysis and design of plots, the programs, R Studio (version 1.4.1106) and Excel (version 16.43) is used.

Eligibility criteria: Inclusion Criteria:

* Patients with haematological cancer
* Patients receiving myelosuppressive chemotherapy for haematological disease
* Adult patients

Exclusion Criteria:

* Patients who cannot understand and speak Danish or English
* Pregnant and breastfeeding
* Patients who suffer from dementia

Primary outcomes:
measure: Loss of Lean Body Mass
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Dept Haematology, Roskilde University Hospital
Study officials:
affiliation: University of Copenhagen
name: Jens R Andersen, MD,MPA
role: STUDY_DIRECTOR
References: