louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02378831: Comparison of In-lab PSG to WP200 for Assessing Sleep Parameters
Official title: Testing for Sleep Apnea in Adolescence Subjects With the WP200/WP200U Compared to an In-lab Overnight PSG Testing
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Sleep
Keywords: diagnosing sleep
Lead sponsor: Itamar-Medical, Israel
Sponsor class: INDUSTRY
First posted: 2015-03-04
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will include adolescence subjects, age 12-17, referred to the clinical sleep laboratory for an overnight sleep study

Brief summary: The WP200 and/or WP200U will be compared with a PSG system which is a digital physiological recorder system, cleared for use for clinical sleep studies. The manual scoring of the PSG data, performed by a trained and authorized scorer, according to the AASM (American Academy of Sleep Medicine) guidelines, serves as a "gold standard" for all determinations of efficacy.


Eligibility criteria: Inclusion Criteria:

* Age between 12-17
* Subjects with a legal guardian that is able to read understand and sign the informed consent form
* Willing to sleep with the WP200/WP200U and PSG simultaneously in the sleep lab

Exclusion Criteria:

* Permanent pacemaker: atrial pacing or VVI without sinus rhythm.
* Use of one of the following medications: alpha blockers, short acting nitrates (less than 3 hours before the study)

Primary outcomes:
measure: sensitivity, specificity, obtained by the WP200/WP200U device automatic-computerized analysis as compared to the manual scoring of the PSG that is considered the "gold standard"
timeFrame: 1 night
measure: correlation obtained by the WP200/WP200U device automatic-computerized analysis as compared to the manual scoring of the PSG that is considered the "gold standard"
timeFrame: 1 night
measure: Agreement obtained by the WP200/WP200U device automatic-computerized analysis as compared to the manual scoring of the PSG that is considered the "gold standard"
timeFrame: 1 night
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06150131: Exercise Intervention After Lung Cancer Surgery
Official title: Combination of Supervised and Non-supervised Exercise After Lung Cancer Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rehabilitation After Lung Cancer Surgery
Lead sponsor: Region Örebro County
Sponsor class: OTHER
First posted: 2023-11-29
Enrollment: 90
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: A combination of supervised and un-supervised exercise in patients after lung cancer surgery is evaluated with regards to aerobic capacity, strength, physical activity and health-related quality of life.


Eligibility criteria: Inclusion Criteria:

* Elective lung cancer surgery
* Ability to perform tests
* Able to communicate in Swedish
* Willing to participate in supervised exercise

Exclusion Criteria:

-

Primary outcomes:
measure: Six-minute walk test
timeFrame: 30 minutes
Secondary outcomes:
measure: EORTC QLQ-C30/LC13
timeFrame: 10 minutes
measure: 30 s chair stands test
timeFrame: 5 minutes
measure: OMPAQ
timeFrame: 2 minutes
measure: Actigraph GT3X
timeFrame: 7 days
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Örebro University Hospital
Study officials:
References:
Clinical trial NCT06902727: Effects of Virtual Reality Exercise on Promoting Physical Activity and Health Among College Students
Official title: Effects of Virtual Reality Exercise on Promoting Physical Activity and Health Among College Students: A 4-week Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity Levels
Cardiovascular Fitness
Body Composition
Situational Motivation
Situational Interest
Mood States
Depressive Symptoms
Keywords: Exergaming
Physical Activity
Virtual Reality
Video games
VR games
Physical Activity Levels
Cardiovascular fitness
Lead sponsor: The University of Tennessee, Knoxville
Sponsor class: OTHER
Collaborators: name: University of Minnesota
First posted: 2025-03-30
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this research is to examine the effectiveness of a 4-week immersive-virtual reality (VR) exercise bike intervention on college students' physiological outcomes (physical activity levels, cardiovascular fitness, and body composition) and psychological outcomes (situational motivation, situational interest, mood states, and depressive symptoms).


Eligibility criteria: Inclusion Criteria:

* College students age from 18 to 35 years old who are currently enrolled in the university
* College students without diagnosed physical and/or mental disabilities
* Must be willing to provide informed consent and compete the PA Readiness Questionnaire (PAR-Q)
* Must be willing to be randomized into an intervention or control group
* no self-reported motion sickness symptoms during immersive VR-based exercise

Exclusion Criteria:

* Students under the age of 18 or over the age of 35 years old or not currently enrolled in the university
* Having self-reported physical and/or mental disabilities
* Contradictions to PA participation as determined by PAR-Q responses
* having motion sickness reaction when exercising under VR-based condition.

Primary outcomes:
measure: Exercise Motivation
timeFrame: Baseline, and 4 weeks
measure: Mood States
timeFrame: Baseline, and 4 weeks
measure: Depressive Symptoms
timeFrame: Baseline, and 4 weeks
Secondary outcomes:
measure: Cardiovascular fitness levels
timeFrame: Baseline, and 4 weeks
measure: Physical activity levels
timeFrame: Baseline, and 4 weeks
measure: Body Mass Index
timeFrame: Baseline, and 4 weeks
measure: Percent of body fat
timeFrame: Baseline, and 4 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota, Twin Cities
state: Minnesota
Study officials:
References:
Clinical trial NCT02157727: Cost-effectiveness of Tele-expertise for Premature Infants for Retinopathy
Official title: Effectiveness and Cost-effectiveness of Tele-expertise for the Screening Examination of Premature Infants for Retinopathy of Prematurity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinopathy of Prematurity
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Agence Regionale de Sante d'Ile de France
First posted: 2014-06-06
Enrollment: 843
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants hospitalized in neonatology unit

Brief summary: The purpose of this study is to determine whether telemedicine would be as effective as having a pediatrics ophthalmologist on site for screening examination of retinopathy in premature infants and would be cost-effective.


Eligibility criteria: Inclusion Criteria:

* Born before 32 WA or having a birth weight under 1500g

Exclusion Criteria:

* Brain malformations

Primary outcomes:
measure: Proportion of premature infants being screened for retinopathy following recommendations
timeFrame: 4 weeks in average
Secondary outcomes:
measure: Delay before the first screening of retinopathy
timeFrame: 4 weeks in average
measure: Cost of telemedicine
timeFrame: 6 months after enrollment of the first patient
Other outcomes:
Locations:
city: Corbeil-Essonnes
country: France
facility: Service de réanimation néonatale. Centre Hospitalier Sud Francilien
city: Paris
country: France
facility: Service de réanimation néonatale. Maternité de Port-Royal
Study officials:
affiliation: DRCD URC Eco. Assistance Publique, Hôpitaux de Paris
name: Isabelle Durand-Zaleski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Sud Francilien
name: Michele Granier, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kidholm K, Ekeland AG, Jensen LK, Rasmussen J, Pedersen CD, Bowes A, Flottorp SA, Bech M. A model for assessment of telemedicine applications: mast. Int J Technol Assess Health Care. 2012 Jan;28(1):44-51. doi: 10.1017/S0266462311000638.
citation: Fierson WM; American Academy of Pediatrics Section on Ophthalmology; American Academy of Ophthalmology; American Association for Pediatric Ophthalmology and Strabismus; American Association of Certified Orthoptists. Screening examination of premature infants for retinopathy of prematurity. Pediatrics. 2013 Jan;131(1):189-95. doi: 10.1542/peds.2012-2996. Epub 2012 Dec 31.
citation: Charrier N, Zarca K, Durand-Zaleski I, Calinaud C; ARS Ile de France telemedicine group. Efficacy and cost effectiveness of telemedicine for improving access to care in the Paris region: study protocols for eight trials. BMC Health Serv Res. 2016 Feb 8;16:45. doi: 10.1186/s12913-016-1281-1.
Clinical trial NCT06564727: Uniportal VATS Resection for Pulmonary Aspergilloma : Evaluation of Prognostic Factors in a Single Center Experience
Official title: Uniportal VATS Resection for Pulmonary Aspergilloma : Evaluation of Prognostic Factors in a Single Center Experience
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Aspergillosis
Surgery-Complications
Thoracic Diseases
Lead sponsor: Hassan II University
Sponsor class: OTHER
First posted: 2024-08-21
Enrollment: 51
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: study the effect of a treatment and evaluate outcome postoperatively
Primary purpose: TREATMENT

Brief summary: The objective of this study was to report our experience with U-VATS resection and to evaluate our surgical outcomes with an analysis of postoperative complications. The investigators also estimate the prognostic factors that influence the morbidity and the conversion.

Detailed description: Evaluation of prognostic factors Tuberculosis Hemoptysis Type of aspergilloma presence of complete adherence Procedure

Eligibility criteria: Inclusion Criteria:

- Treatment using uniportal VATS

Exclusion Criteria:

- Resection using thoracotomy

Primary outcomes:
measure: postoperative complications
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Casablanca
country: Morocco
facility: Hassan II University
Study officials:
affiliation: Hassan II University
name: sara WAGUAF
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03844373: Tolerance and Acceptability Evaluation of STOCKHOLM
Official title: Tolerance and Acceptability Evaluation of STOCKHOLM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Lead sponsor: Aymes International Limited
Sponsor class: INDUSTRY
First posted: 2019-02-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Tolerance and Acceptability of new oral nutritional supplement - STOCKHOLM.

Detailed description: To evaluate tolerance and acceptability of 'STOCKHOLM' in patients requiring supplementary oral nutritional support compared with currently available alternatives.

To obtain data to support an ACBS submissions for 'STOCKHOLM' (to allow for prescription in the community at NHS expense).

Eligibility criteria: Inclusion Criteria:

* Patients who are able to communicate their views regarding acceptability.
* Patients established on an oral nutritional supplement, being prescribed ONS providing approximately 300 kcal/day
* Patients expected to require oral nutritional supplementation for at least 2 further weeks.
* Informed consent obtained.

Exclusion Criteria:

* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
* Patients requiring a milk free diet
* Patients with medical or dietary contraindication to any feed ingredients (see appendix 2 of protocol for full list)
* Patients with significant renal or hepatic impairment
* Patients with dysphagia requiring stage 1,2 or 3 thickened fluids
* Patients with uncontrolled inflammatory bowel disease or previous bowel resection with ongoing gastrointestinal symptoms.

Primary outcomes:
measure: GI Tolerance
timeFrame: 9 Days
Secondary outcomes:
measure: Acceptability and Palatability of Consuming the Nutritional Supplement: Questionnaire
timeFrame: 9 days
measure: Compliance with Prescription of STOCKHOLM
timeFrame: 9 days
Other outcomes:
Locations:
city: Haywards Heath
country: United Kingdom
facility: Gemma Fry
Study officials:
References:
Clinical trial NCT06118073: Effect of Mindfulness on Pain After Total Knee Arthroplasty
Official title: The Effect of Utilizing Mindfulness Perioperatively on Pain, Opioid Consumption, and Functional Outcomes in Patients With Depression and Anxiety Undergoing Total Knee Arthroplasty: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Total Knee Replacement
Post Operative Pain
Opioid Use
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will be a prospective randomized controlled trial evaluating the effectiveness of using Headspace before and after undergoing total knee replacement surgery. The purpose of this study will be to determine whether using Headspace will help to improve functional outcome scores, decrease pain, and decrease opioid medication use after total knee replacement in patients with depression and/or anxiety. Headspace is a smartphone-based application that guides individuals through various mindfulness sessions and has been shown to reduce symptoms of depression, anxiety, and pain.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing unilateral primary TKA

AND

* Patients with MDD who take medication for MDD and/or Patients with GAD who take medication for GAD
* Patients with MDD and/or Patients with GAD who are being treated for those conditions with psychotherapy by a psychologist or psychiatrist
* Patients with an SF-12 Mental Health Score less than 45.6
* Owning a smartphone (Apple or Android) to be able to download the mindfulness application

Exclusion Criteria:

* Patients undergoing bilateral TKA
* Patients undergoing revision TKA
* Patients with mental health conditions other than MDD and/or GAD
* Patients currently utilizing a mindfulness application

Primary outcomes:
measure: Postoperative pain
timeFrame: 6 weeks
measure: Participant satisfaction #1
timeFrame: 6 weeks
measure: Participant satisfaction #2
timeFrame: 6 weeks
measure: Participant mental health
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Orthopaedic Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT06027073: Biologics and Sublingual Immunotherapy
Official title: Adding Biological Therapy to Asthmatic Patients on Allergen Immunotherapy to House Dust Mites
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Asthma, Allergic
Keywords: IgE
asthma
omalizumab
immunotherapy
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
Collaborators: name: Centrum Medyczne Andrzej Bożek
First posted: 2023-09-07
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The randomization procedure with random selection will rely on computer-generated numbers using a computer program (Excel, version 14.2.0, 2020 Microsoft Corporation). The patients will be randomized into four groups 1:1:1:1 as follows:

Group A: Xolair® Group B: Actair® Group C: Actair® and Xolair® Group D: Standard of Care (no interventional therapy).
Primary purpose: TREATMENT

Brief summary: Most current studies involve using a biological drug to increase the safety of allergen immunotherapy (AIT) especially in the treatment of food allergies, to avoid the risk of anaphylaxis. However, adding Xolair® to AIT may improve the therapy's effectiveness. There are still few observations on this topic, especially in patients with house dust mite (HDM)-driven asthma.

Detailed description: Assess the effectiveness of combined therapy Actair® plus Xolair compared to monotherapy with Actair® or Xolair® or standard symptomatic therapy in patients with mild or moderate allergic asthma to HDM.

Treatment duration: 24 months Follow-up duration:12 months Total duration: 36 months (not including screening and randomization period) May 2024 - March 2028 Consisting of a 4 to 5 months screening phase (with 1 month observation period prior to randomization) a treatment phase of 24 months and post-treatment follow-up phase 12 months

Eligibility criteria: Inclusion Criteria:• \>18 years old

* A total IgE between 30-700 IU/mL
* Moderate asthma with perennial symptoms confirmed as HDM-driven asthma based on medical history and positive nasal provocation tests, partially controlled asthma;
* FEV1 \>70% at baseline;
* Positive skin prick test results for D. pteronyssinus, D. farinae

Exclusion Criteria:

* Sensitisation to other allergens with clinical signs not related to HDM
* Uncontrolled asthma,
* Other serious diseases or chronic unstable diseases
* Allergen immunotherapy during the past 5 years
* Contraindicating allergen immunotherapy and omalizumab treatment.

Primary outcomes:
measure: Assess the effectiveness of combined therapy : omalizumab+ immunotherapy
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06348173: Response and Remission to Treatment With Anti-IL5/IL5R Antagonists
Official title: Response and Remission to Treatment With Anti-IL5/IL5R Antagonists in a Real-world Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: Université de Montréal
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2024-04-04
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 18 years and older who were followed at the outpatient asthma clinic of Sacre-Cœur Hospital and have been treated with anti-IL5/il5R between 2016 and 2020.

Brief summary: The aim of this retrospective observational study is to compare the response and remission rate after treatment with IL5/IL5-R antagonists in asthmatics who would and would have not met the inclusion criteria of the original randomized clinical trials.

This study will be performed using the charts of the patients.

Detailed description: Objective To compare the response and remission rate after treatment with IL5/IL5-R antagonists in asthmatics who would and would have not met the inclusion criteria of the original RCTs.

After having obtained authorization from the ethics committee of the CIUSSS du nord de l'île de Montréal and from the director of the Professional Services, all the charts of patients who received anti IL5/IL-5R at the tertiary asthma clinic of the Hôpital du Sacré-Coeur de Montréal will be reviewed.

Patients aged 75 years or younger, with a smoking history of less than 10 pack-year, and a FEV1 \<80% predicted with reversibility in the previous year will be considered to fulfill the RCTs criteria. Response to treatment was defined by at least a 50% reduction in asthma exacerbations or in oral corticosteroids (OCS) doses in the year following the initiation of IL5/IL5R antagonists. Clinical remission on treatment at one year was defined as no exacerbation, no OCS and la 10% or less decrease in pre-bronchodilator FEV1 compared with baseline value.

Eligibility criteria: Inclusion Criteria:

Patients 18 years and older who were followed at the outpatient asthma clinic of Sacre-Cœur Hospital and have been treated with anti-IL5/il5R between 2016 and 2020.

Exclusion Criteria:

None

Primary outcomes:
measure: Response to IL5/IL5R antagonists one year after cohort entry among subjects fulfilling and not fulfilling the original RCT inclusion criteria
timeFrame: one year
measure: Remission rate with IL5/IL5R antagonists one year after cohort entry in subjects fulfilling and not fulfilling the original RCT inclusion criteria
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Hôpital du Sacré-Coeur de Montréal
state: Quebec
Study officials:
affiliation: Université de Montréal
name: Catherine Lemiere, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06180473: Evaluation of Tolerability, Efficacy and Adherence to Treatment With Wynzora Cream
Official title: Evaluation of Tolerability, Efficacy and Adherence to Treatment With Wynzora Cream in Patients With Psoriasis Previously Treated With Enstilar Foam.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Psoriasis
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-12-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with psoriasis will be enrolled, who will be according to clinical practice will be prescribed treatment with Wynzora cream for 30 consecutive days, referring to the Dermatology and Venereology outpatient clinics of the Fondazione Policlinico Universitario A. Gemelli, IRCCS Rome

Brief summary: The primary objective is to assess with the PPQ questionnaire the patient preference for Wynzora compared with therapy carried out previously with Enstilar spray foam. Secondary objectives Assess satisfaction with the treatment. Assess adherence to therapy. Evaluate the impact of various clinical and demographic factors on treatment adherence. Evaluate the efficacy of Wynzora cream therapy.


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years of age, of either sex;
* Patients diagnosed with mild-to-moderate psoriasis (PASI and BSA \&lt;10) requiring monotherapy topical with Wynzora;
* Patients who have stopped treatment with Enstilar foam for any reason for at least 30 days; and
* Patients whose medical records are accessible and record all demographic parameters, anthropometric and clinical parameters during the treatment period
* Signature of written informed consent;

Exclusion Criteria:

* Patients with palmoplantar, inverse, erythrodermic, guttate, and scalp psoriasis.
* Patients who are taking concomitant systemic therapies for psoriasis, such as. cyclosporine, methotrexate, acitretin, phototherapy or biologic therapies.
* Women who are pregnant or planning to become pregnant.
* Patients with disabilities or other motor problems that could complicate self-medication.

Primary outcomes:
measure: preference of wynzora cream
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: