louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04082624: Workplace Wellness: Improving Your Experience at Work
Official title: Workplace Wellness: Improving Your Experience at Work
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Behavior
Obesity
Lead sponsor: University of Victoria
Sponsor class: OTHER
Collaborators: name: Social Sciences and Humanities Research Council of Canada
First posted: 2019-09-09
Enrollment: 116
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: The primary objective of study was to compare affective (i.e., highlighted emotional benefits), instrumental (i.e., highlighted other health benefits), and self-regulation (i.e., demonstrated ways to plan, set goals, etc.) interventions in terms of their ability to motivate less sitting in the workplace. Research of this type is important because people sit for long periods of time at work which adversely affects their health and productivity.

It was hypothesized that the affective and self-regulation groups would sit less than the instrumental and control groups based on evidence indicating that affective attitude (i.e., emotional evaluation of the behavior) and self-regulation techniques tend to predict behavior.


Eligibility criteria: Inclusion Criteria:

* From a local workplace in Victoria
* Full-time employee (i.e., greater than 35 hours per week)
* Reported over 5.5 hours of sitting per day at work
* Agreed to attend the 3 intervention sessions

Exclusion Criteria:

* Not from a local workplace in Victoria
* Not a full-time employee (i.e., 35 hours or less per week)
* Reported less than 5.5 hours of sitting per day at work
* Did not agree to attend the 3 intervention sessions

Primary outcomes:
measure: Sitting time
timeFrame: Twelve weeks post-baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Victoria
country: Canada
facility: Behavioural Medicine Laboratory
state: British Columbia
Study officials:
References:
citation: Lithopoulos A, Kaushal N, Beauchamp MR, Conner M, de Bruijn GJ, Latimer-Cheung AE, Rhodes RE. Changing Sedentary Behavior in the Office: A Randomised Controlled Trial Comparing the Effect of Affective, Instrumental, and Self-Regulatory Messaging on Sitting. Appl Psychol Health Well Being. 2020 Nov;12(3):687-702. doi: 10.1111/aphw.12202. Epub 2020 May 19.
Clinical trial NCT06097624: Effectiveness of Synchronized Tele-exercise
Official title: Effectiveness of Synchronized Tele-exercise on Sleep Quality and Quality of Life for Healthy Young Adults: A Randomized Double-blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Okan University
Sponsor class: OTHER
Collaborators: name: Ankara Medipol University
name: Istanbul University - Cerrahpasa
name: Duha Saydam Physical Therapy and Clinical Pilates Center (name of the center)
name: Ozel Uç Ufuk Çizgisi Special Education and Rehabilitation Center (name of the center
First posted: 2023-10-24
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine the effect of telehealth-synchronized group exercise on sleep and quality of life, and secondarily, on the health and body perception of healthy young adults. This study is planned as a randomized double-blind controlled clinical study.

Detailed description: The aim of this study is to determine the effect of telehealth-synchronized group exercise on sleep and quality of life, and secondarily, on the health and body perception of healthy young adults. This study is planned as a randomized double-blind controlled clinical study. The sample size was calculated using G\*power 3.1.9.2, which required 42 patients and a size effect of 0.8, 80% power, 1:1 allocation ratio, and an error probability of 0.05. Forty-eight participants were planned to be included in the study, based on the probability that 15% of the patients could be excluded.

Eligibility criteria: Inclusion Criteria:

* being a volunteer,
* being in the age range of 18-25,
* having no barriers to online sessions through a computer,
* having no visual impairment.

Exclusion Criteria:

* having experienced a physical injury in the last 3 months
* having any major disorder,
* learning difficulty,
* having a mental disorder that could affect the results

Primary outcomes:
measure: The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 0th week
measure: The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 4th week
measure: World Health Organization Quality of Life-Brief Form
timeFrame: 0th week
measure: World Health Organization Quality of Life-Brief Form
timeFrame: 4th week
Secondary outcomes:
measure: Body Perception
timeFrame: 0th week
measure: Body Perception
timeFrame: 4th week
measure: Perception of General Health
timeFrame: 0th week
measure: Perception of General Health
timeFrame: 4th week
measure: Perception of Physical Fitness
timeFrame: 0th week
measure: Perception of Physical Fitness
timeFrame: 4th week
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Okan University
Study officials:
References:
Clinical trial NCT05640024: Prospective Cohort Study for Validation of Predictive Immune Biomarkers of Response to PAPR Inhibitors
Official title: Prospective Cohort Study for Validation of Predictive Immune Biomarkers of Response to PAPR Inhibitors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ovarian Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2022-12-07
Enrollment: 54
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ovarian cancer patients who receive PARP inhibitor

Brief summary: Increasing number of ovarian cancer patients are receiving PARP inhibitor as maintenance therapy. Predictive factors to PARP inhibitor other than BRCA mutation or HRD status are unknown. Previous study, we analyzed the dynamic immunological changes in peripheral T cells during PARP inhibitor maintenance therapy and found predictive biomarkers. The purpose of this study is to prospectively validate the biomarkers for predicting response to PAPR inhibitors in ovarian cancer. We collect serial blood samples (before initiation of therapy and after 1, 3, and 6 months) in ovarian cancer patients who receive PARP inhibitor and analyze immunological characteristics of peripheral CD8 and regulatory T cells. Through assessment of the baseline properties and dynamic changes in T cells, we aim to validate the predictive biomarker and develope promising novel targets to enhancing survival outcomes of high-risk patients.


Eligibility criteria: Inclusion Criteria:

1. Pathological diagnosis of epithelial ovarian cancer, 2. Presence of germline or somatic BRCA mutational status result, 3. Advanced or recurrent ovarian cancer patients who responded to their most recent platinum-based chemotherapy and plan to start PARPi (olaparib or niraparib) maintenance therapy.

Exclusion Criteria:

1. Patients who refuse to participate, 2. Patients having difficulty understanding the protocol due to language barrier

Primary outcomes:
measure: Validation of biomarkers for predicting response to PAPR inhibitor
timeFrame: The primary endpont will be accessed 12 months after last patient registration.
Secondary outcomes:
measure: Identify dynamic immunological changes during PAPR inhibitor therapy
timeFrame: Immunological changes (Time Frame: 6 months
measure: Identify promising novel targets to enhance survivla outcomes of high-risk pateints in PAPR inhibitor therapy.
timeFrame: Identify promising novel targets (Time Frame: 12 months)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
affiliation: Yonsei University College of Medicine Department of Obstetrics and Gynecology
name: Jung-Yun Lee
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01067924: Motivational Interviewing to Promote Maintenance of Physical Activity in People With Type 2 Diabetes
Official title: Motivational Interviewing to Promote Maintenance of Physical Activity in People With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes, motivational interviewing, physical activity maintenance, physical activity adherence
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2010-02-12
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to assess the effectiveness of motivational interviewing in promoting maintenance of physical activity in people with Type 2 diabetes (T2D) upon the completion of a structured exercise program.

Participants with T2D who are new graduates of a supervised exercise program will be randomly assigned to either standard care (SC) or to standard care and in addition, participate in two individual motivational interview (MI) sessions (SC + MI).

The primary outcome will be change in physical activity behavior assessed by the Godin Leisure and Exercise questionnaire. Secondary outcomes will include change in blood glucose control (A1C), BMI, six minute walk-test, QoL, and self-efficacy.

Outcomes will be measured in groups at baseline, end of program, 3 months and 6 months post-program.


Eligibility criteria: Inclusion Criteria:

* a) self-reported physician diagnosed T2D, included are those who are treated with diet alone, oral medication and insulin
* b) clearance by Living Well clinical staff to exercise through GXT algorithm and triaged to "Keep Going" level class,
* c) at least 18 years of age,
* d) ability to read and write in English.

Exclusion Criteria:

* a) insulin therapy that began less than 2 years after T2D diagnosis,
* b) changes during the previous 2 months in oral hypoglycemic

Primary outcomes:
measure: Change in physical activity as measured by the GODIN physical activity questionnaire
timeFrame: baseline, 3, 6 months post program
Secondary outcomes:
measure: Change in Hemoglobin A1C, BMI, six minute walk-test, QoL, and self-efficacy.
timeFrame: Baseline, 3, 6 months post-program
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Ronald Sigal
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02076724: Reinforcement of the Abdominal Wall After Breast Reconstruction With the Pedicled TRAM-flap
Official title: Reinforcement of the Abdominal Wall With Acellular Dermal Matrix (Strattice™) After Breast Reconstruction With the Pedicled TRAM-flap
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Donor-site
Keywords: Abdominal donor-site
Breast reconstruction
Synthetic mesh
Biological mesh
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: LifeCell
name: Novo Nordisk A/S
name: University of Aarhus
First posted: 2014-03-04
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare two methods for reinforcement of the abdominal donor-site after breast reconstruction with the pedicled TRAM-flap. Reinforcement of the abdominal donor-site is performed, after randomization, with either a porcine derived biological mesh or a synthetic mesh. The patient and the investigator is blinded.

The aim is to identify the most optimal method for reinforcement of the abdominal donor-site and thereby contribute to fast and complete rehabilitation of women undergoing breast reconstruction with the pedicled TRAM-flap after surgical removal of the breast tissue due to breast cancer, precursors to breast cancer or an increased risk of developing breast cancer and thereby following preventive removal of the breast tissue.

The patients visit the outpatient clinic 4, 12 and 24 months after operation and abdominal wall function, the donor site morbidity, the frequency of postoperative complications, the aesthetic appearance of the reconstructed breast and the abdominal wall and costs are evaluated.


Eligibility criteria: Inclusion Criteria:

* Immediate or delayed breast reconstruction using the pedicled TRAM-flap
* Older than 18 years of age
* Understand enough Danish to comprehend the given information and to complete the study questionnaire
* Verbal and written informed consent

Exclusion Criteria:

* Current smokers
* Not eligible patients, assessed by surgeon
* High level of co-morbidity, assessed by surgeon or anesthesiologist

Primary outcomes:
measure: Abdominal wall function change
timeFrame: Change from before surgery to 12 and 24 months after surgery
Secondary outcomes:
measure: Abdominal donor site morbidity
timeFrame: 24 months
measure: Aesthetics at the abdominal wall
timeFrame: 24 months
measure: Costs
timeFrame: 24 months
measure: Postoperative complications
timeFrame: Acute <1 month, ≥ 1 month-24 months
Other outcomes:
Locations:
city: Aarhus C.
country: Denmark
facility: Department of Plastic and Reconstructive Surgery, Aarhus University Hospital
state: Aarhus
Study officials:
affiliation: Aarhus University Hospital and Aarhus University
name: Mette Eline Brunbjerg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05459324: Intraoperative Neuromonitoring Recording With a Novel SCS Paddle: Phase II
Official title: Effects of Novel SCS Paddle on Intraoperative Neuromonitoring Recording: Phase II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Neuropathic Pain
Failed Back Surgery Syndrome
Complex Regional Pain Syndromes
Keywords: Spinal cord stimulation
chronic pain
Lead sponsor: Albany Medical College
Sponsor class: OTHER
First posted: 2022-07-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Statistics will be performed comparing the HR-SCS to commercial SCS devices. Additionally, we will correlate patient reported outcomes and spinal measurements to IONM outcomes to determine overall device capabilities.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this study is to demonstrate safety and efficacy of a new spinal cord stimulation paddle electrode which is able to target the dorsal horns, dorsal nerve roots, and dorsal columns. The research electrode ("Study Electrode") is designed to answer basic physiological clinical research questions. It may inform future device therapy development, but the Study Electrode is not a product that will be marketed or sold. The Investigators believe the protocol is a Non-Significant Risk study answering basic physiological research questions, which may be performed under hospital IRB approval.


Eligibility criteria: Inclusion Criteria:

* patients undergoing a spinal cord stimulation procedure for neuropathic pain.
* have undergone a successful SCS trial and are determined eligible for a permanent SCS implant.
* Patients must be fluent in English as well as mentally competent to read and answer the questionnaires, as well as complete pain assessment exams.-
* subjects must be able to give informed consent.

Exclusion Criteria:

* patients who are not undergoing thoracic spinal cord stimulation for chronic neuropathic pain

Primary outcomes:
measure: Numeric Rating Scale
timeFrame: 3 months
Secondary outcomes:
measure: McGill Pain Questionnaire (MPQ)
timeFrame: 3 month
measure: Oswestry Disability Index (ODI)
timeFrame: 3 months
measure: Pain Catastrophizing Scale (PCS)
timeFrame: 3 months
measure: Beck Depression Index (BDI)
timeFrame: 3 months
Other outcomes:
measure: PainDetect
timeFrame: Baseline
Locations:
city: Albany
country: United States
facility: Albany Medical College
state: New York
Study officials:
References:
Clinical trial NCT04563624: Clinical Assessment of Indirect Restoration Fabricated From Nano Hybrid Composite Blocks Versus Ceramic Blocks in Badly Broken Teeth One Year Follow up
Official title: Clinical Assessment Accourding to Modified Usphs"of Indirect Restoration Fabricated From Nano Hybrid Composite Blocks Versus Ceramic Blocks in Badly Broken Teeth One Year Follow up Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Teeth Restoration
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 42
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare one-year clinical performance of indirect restoration fabricated from nano hybrid composite CAD CAM blocks and ceramic blocks

Detailed description: This research is conducted for comparing the clinical efficacy of nano hybrid composite blocks and ceramic blocks ., the choice of nano hybrid composite blocks based on the claim of the manufacturer, as it's considered to be promising , nano hybrid composite blocks has the highest fillers content (86% by weight), resembles natural teeth perfectly , Excellent physical values for flexural strength and abrasion, No firing required (a real one step ), can be processed using any conventional milling unit, can be finished and polished optimally, Ideal for grinding even in cases with thin edges.

Eligibility criteria: Inclusion Criteria:

* Patients with badly broken vital teeth
* Young adult Males or female
* Good oral hygiene measures
* Cooperative patients approving to participate in the study

Exclusion Criteria:

* Patients with a compromised medical history.
* Severe or active periodontal disease
* Severe medical complications
* Lack of compliance
* Endodontically treated teeth

Primary outcomes:
measure: marginal integrity
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06605924: Oral Nicotine Pouch Marketing Features Influence on Perceptions
Official title: Aim 2 Study - Novel "Tobacco-Free" Oral Nicotine Pouches: The Impact of Product Features and Marketing Influences on Abuse Liability, Perceptions, and Use Behavior in Smokers and Non-Nicotine Users
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Tobacco Use
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-09-20
Enrollment: 5000
Sex: ALL
Minimum age (years): 13
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will view ads in each of four conditions manipulating presence of different marketing features.
Primary purpose: OTHER

Brief summary: This study tests the effects of three oral nicotine marketing features on product perceptions.


Eligibility criteria: Inclusion Criteria:

* Live in the US
* For youth age \<21: Never used any nicotine pouch
* For adults: Smoked greater than or equal to 100 cigarettes in during lifetime
* For adults: Currently smoke some or all days
* For adults: No regular use of oral nicotine pouches
* For adults: No past 30-day pouch use

Exclusion Criteria:

* Do not live in the US
* For youth age \<21: Ever used nicotine pouches
* For youth age \<21: Greater than or equal to 100 lifetime uses of any other nicotine or tobacco product
* For adults: Smoked \<100 cigarettes in life
* For adults: Does not currently smoke some or all days
* For adults: Regular use of oral nicotine pouches
* For adults: Past 30-day pouch use

Primary outcomes:
measure: Absolute perceived harm
timeFrame: Immediately after viewing ad
measure: Relative perceived harm
timeFrame: Immediately after viewing ad
measure: Absolute perceived addictiveness
timeFrame: Immediately after viewing ad
measure: Relative perceived addictiveness
timeFrame: Immediately after viewing ad
measure: Product appeal
timeFrame: Immediately after viewing ad
measure: Use intention
timeFrame: Immediately after viewing ad
Secondary outcomes:
measure: Perceived ability to satisfy nicotine cravings
timeFrame: Immediately after viewing ad
measure: Perceived ability to help one quit smoking
timeFrame: Immediately after viewing ad
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: 2213 McElderry St.
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Meghan Moran, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01153724: Relative Bioavailability of Olodaterol and Fluconazole
Official title: Relative Bioavailability of 10 mcg Olodaterol (Solution for Inhalation Administered With the Respimat) at Steady State Alone or in Combination With Multiple Doses of 400 mg q.d. Fluconazole (Hard Capsule) in Healthy Male and Female Volunteers (an Open Label, Fixed Sequence, Phase I Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2010-06-30
Enrollment: 35
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial is intended to investigate a possible effect of the CYP 2C9 inhibitor fluconazole on the bioavailability of olodaterol


Eligibility criteria: Inclusion criteria:

Healthy male and female volunteers

Primary outcomes:
measure: Area Under Curve From 0 to 6 Hours at Steady State (AUC0-6,ss)
timeFrame: Day 8 of period 1 and day 14 of period 2
measure: Maximum Concentration at Steady State (Cmax,ss)
timeFrame: Day 8 of period 1 and day 14 of period 2
Secondary outcomes:
measure: Time From Dosing to the Maximum Concentration at Steady State (Tmax,ss)
timeFrame: Day 8 of period 1 and day 14 of period 2
measure: Fraction of Urine Excretion From 0 to 24 Hours at Steady State (fe0-24,ss)
timeFrame: Day 8 of period 1 and day 14 of period 2
measure: Amount of the Analyte Excreted in Urine From 0 to 24 Hours at Steady State (Ae0-24,ss)
timeFrame: Day 8 of period 1 and day 14 of period 2
measure: Area Under Curve From 0 to 12 Hours at Steady State (AUC0-12,ss)
timeFrame: Day 8 of period 1 and day 14 of period 2
measure: Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG
timeFrame: First administration of trial medication until 6 days after last administration of trial medication
measure: Assessment of Tolerability by the Investigator
timeFrame: End of period 1 and end of period 2
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: 1222.48.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: