louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05327764: Work-To-Rest Ratios
Official title: Work-To-Rest Ratios
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperthermia
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized counterbalanced study
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to compare physiological responses to two hours of work adhering to two variations of a work-to-rest ratio in a hot environment.


Eligibility criteria: Inclusion Criteria:

* Healthy 18-39 year old individuals
* Physically active

Exclusion Criteria:

* History of cardiovascular, metabolic, respiratory, neural, or renal disease
* Hypertensive or tachycardic during the screening visit (systolic blood pressure ≥ 140 mmHg, diastolic blood pressure ≥ 90 mmHg, resting heart rate ≥ 100 bpm)
* Taking medication or supplements with a known side effect of affecting physiologic responses to exercise (e.g., acetaminophen, beta blockers, statins, aspirin)
* Any form of tobacco or nicotine use in the past six months
* Current musculoskeletal injury impacting physical activity
* A positive pregnancy test at any point in the study
* Study physician discretion based on any other medical condition or medication

Primary outcomes:
measure: Change in core body temperature
timeFrame: Upon completion of 2 hours of the work protocol
measure: Change in heart rate
timeFrame: Upon completion of 80 minutes of work
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
Study officials:
affiliation: University at Buffalo
name: Riana Pryor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05875064: Aesthetic Restorations in Deciduous Anterior Teeth
Official title: Aesthetic Restorations in Deciduous Anterior Teeth - Study Protocol for a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Dental Caries in Children
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 194
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a non-inferiority randomized clinical trial with parallel arms, with an allocation ratio of 1:1
Primary purpose: TREATMENT

Brief summary: This study proposes to conduct a randomized clinical trial (RCT), composed of a sample of 194 deciduous central and lateral incisors with active cavitated lesions, simplified ICDAS C+ score, with involvement of more than two surfaces. This sample will be divided into two experimental groups, both with selective removal of carious tissue: a group in which conventional restoration will be performed using opaque resins; and another group with monochromatic resin with chameleon effect and polyvinyl crowns.


Eligibility criteria: Inclusion Criteria:

* Children ranging in age from 12 to 60 months with at least one active cavitated caries lesion involving more than 2 surfaces (C+ score) in deciduous upper incisors will be included.

Exclusion Criteria:

* Patients with special needs, with general health conditions that may affect the oral cavity, whose guardians do not sign the Inform Consent Form will be excluded. In addition, teeth with pulp exposure, spontaneous pain, mobility, presence of swelling or fistula near the tooth and teeth with previous restorations; less than 2/3 of root (radiographically assessed), teeth without an antagonist, teeth with previous restorations and children with bruxism and/or deep bite.

Primary outcomes:
measure: Change in progression of caries lesion through clinical criteria and longevity of restorations
timeFrame: Baseline and after 6, 12, 18 and 24 months.
Secondary outcomes:
measure: Change in the progression of caries lesion by radiographic criteria
timeFrame: Baseline and after 6, 12, 18 and 24 months.
measure: Change in the perception of parents/guardians
timeFrame: Baseline and after 6, 12, 18 and 24 months.
measure: Change in the satisfaction of parents/guardians
timeFrame: Baseline and after 6, 12, 18 and 24 months.
measure: Change in the impact of treatments on children's oral health-related quality of life
timeFrame: Baseline and after 6, 12, 18 and 24 months.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02163564: Development of an Insomnia Treatment for Depressed Adolescents
Official title: Development of an Insomnia Treatment for Depressed Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Depression
Keywords: Adolescent
Depression
Insomnia
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2014-06-13
Enrollment: 28
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Major depressive disorder (MDD) occurs at least 11% of adolescents and approximately 53-90% of those adolescents have insomnia. If left untreated, insomnia increases the risk of relapse and recurrence of depressive episodes, unintentional injuries, poor school performance, substance use, obesity, and the risk for suicide. This project seeks to develop a nonpharmacological treatment for insomnia in adolescents with depression that is feasible and effective. The specific methodologies that will help accomplish these results are: 1) use of focus groups of adolescents with depression and insomnia to determine how the current standard, nonpharmacological treatment for insomnia (cognitive-behavioral therapy for insomnia; CBTI) among adults can be modified for use by adolescents with depression and 2) determine the preliminary effectiveness, feasibility, and tolerability of group CBTI in adolescents with depression (CBTI-AD) developed using feedback from the focus groups. This project will help to improve the quality and scope of delivery of mental health services in Michigan by a) gaining a greater understanding of how sleep disturbance may perpetuate depression in adolescents and b) to provide mental health professionals with a nonpharmacological treatment option for insomnia in adolescents with depression.


Eligibility criteria: Inclusion Criteria:

* Between 13-19 years of age
* Are depressed
* Have insomnia

Exclusion Criteria:

* Are not depressed
* Do not have insomnia
* Currently using a sleep aid
* Have bipolar depression
* Have psychotic disorder
* Have a sleep disorder other than insomnia

Primary outcomes:
measure: Insomnia Severity Index
timeFrame: Change from baseline in insomnia at 5 weeks
measure: Multidimensional Fatigue Inventory
timeFrame: Change from baseline in fatigue at 5 weeks
measure: Quick Inventory of Depressive Symptomatology
timeFrame: Change from baseline in depression at 5 weeks
Secondary outcomes:
measure: Alcohol and drug use screening test (CRAFFT)
timeFrame: Baseline
measure: Morningness Eveningness Questionnaire -modified
timeFrame: Baseline
Other outcomes:
measure: Sleep diaries
timeFrame: Change from baseline in sleep at 5 weeks
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References:
Clinical trial NCT03662464: ESCAPE Study : Validation of a Specific Tool Scoring Residents at Risk of Escaping/Elopement From Nursing Homes (ESCAPE)
Official title: ESCAPE STUDY : A Specific Tool for Detecting Nursing Home Residents (With or Without Dementia) at Risk of Escaping for the Use of Caregivers: Psychometric Properties and Definition of Risk Levels
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Elopement or Escaping of Nursing Home Resident With or Without Dementia
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2018-09-07
Enrollment: 4050
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Resident of the nursing homes in Provence Alpes Cotes d'Azur Region ( South East of France)

Brief summary: Residents' escapes occur even if most of the nursing homes (NH) have set up specific devices to prevent from this risk. Therefore, the need to develop and validate a specific tool to assess the risk of escaping was obvious to the working group, aim at emphasizing patient centered-care by the nurses' staff and help to develop personalized devices.

Aim of the study: develop and validate a specific tool to score the risk of escaping in NH residents Study design: Observational prospective multicentered cohort study Nursing homes volunteer to participate Location: Provence Alpes Cotes d'Azur Region ( South East of France) Population: 4050 NH residents. Duration: two years, each resident included is followed up for one year Measures: Nursing homes characteristics, residents characteristics ( social and from medical record); Escape Scale (25 items with a Yes/no answer; filled up during a nurses staff meeting for each resident and every three months; 3 sub scales: resident environmental items, social items, and medical items.


Eligibility criteria: Inclusion Criteria:

* Every resident of Nursing home participating to the study
* Living in the NH for three months or more
* With a living prognosis longer than 3 Months

Exclusion Criteria:

* Prognosis less than three months
* Bedridden (not able to move alone from bed to chair)
* Nursing home short stay scheduled \< 3 months

Primary outcomes:
measure: Escape/elopement occurence
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Direction Recherche clinique et Innovation
state: Paca
Study officials:
affiliation: Assitance Publique des Hopitaux de Marseille
name: Jean-Olivier ARNAUD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04747964: A Safety Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor
Official title: A Phase 1,Multi-center, Randomized, Open, Single-dose Escalation Design to Evaluate the Safety, Tolerability and Pharmacodynamics of STSP-0601 for Injection in Patients With Inhibitory Hemophilia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hemophilia
Lead sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd
Sponsor class: INDUSTRY
First posted: 2021-02-10
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study will assess the pharmacokinetics and pharmacodynamics of STSP-0601 at six dose levels. The results will help identify the most optimal doses to treat bleedings in hemophilia patients with inhibitors.


Eligibility criteria: Inclusion Criteria:

* 18 years old ≤age≤65 years of age,male.
* Hemophilia A or B patients with inhibitors.
* Peak historical inhibitor titer ≥ 5 BU and a positive inhibitor test when enrolled.
* Establish proper venous access.
* Provide signed informed consent.

Exclusion Criteria:

* Have any coagulation disorder other than hemophilia A or B.
* Treat with prophylactic treatment of coagulation factor.
* Treat with anticoagulant within 7d of the time of study drug administration.
* Have an active, ongoing bleeding for which the patient is being treated, or treatment for a bleeding was stopped within 7d of the time of study drug administration.
* Have a history of arterial and/or venous thromboembolic events.
* Have platelet count \<100,000/mL.
* Severe liver or kidney disease.
* Accept major operation or blood transfusion within 1 month of the time of screening.
* HIV antibody positive.
* Have a known allergy to Blood product.
* Participate in other clinical research within 1 month of the time of study drug administration.

Primary outcomes:
measure: Number of subjects of adverse events
timeFrame: Baseline to Day 8
measure: Number of subjects With Significant Abnormal Physical Examination
timeFrame: Baseline to Day 8
measure: Number of subjects of Significant Abnormal Vital Signs Findings
timeFrame: Baseline to Day 8
measure: Number of Participants With Significant Abnormal Laboratory Values
timeFrame: Baseline to Day 8
measure: Number of subjects With Significant Abnormal Electrocardiography (ECG) Findings
timeFrame: Baseline,1 hour,4 hour,48 hour,Day 8
Secondary outcomes:
measure: Activated partial thromboplastin time
timeFrame: Baseline to 24 hours
measure: Thrombin production (TG) peak
timeFrame: Baseline to 24 hours
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Study officials:
affiliation: Chinese Academy of Medical Sciences
name: Lei Zhang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03360864: Influence of Therapeutic Education in Patients With Joint Inflammation Treated With a Biological Treatment
Official title: Impact of a Therapeutic Education Program in Patients With Non-radiological Spondyloarthritis Treated With Anti-tumor Necrosis Factor (TNF)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-radiographic Spondyloarthritis
Keywords: Therapeutic education
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2017-12-04
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To describe, with a patient reported score (BIOSECURE), the influence of an approved therapeutic education program (TEP) in patients with joint inflammation requiring a biological treatment initiation.

The hypothesis is that patients attending the TEP will display better cognitive and adaptation competences than patients with no TEP.

Patient's reported quality of life, disease related stress management, treatment adherence, socio-demographic factors, biological home administration modalities and if the biologic treatment is maintained at 12 months, will also be described.


Eligibility criteria: Inclusion Criteria:

* Non-radiological spondyloarthritis diagnosis (ASAS criteria)
* Anti-TNFalpha biological treatment initiation required
* Adult patient (age\>18years)
* Capacity to understand self-questionnaires and address questions
* Patient accepting to attend a therapeutic education program (TEP)

Exclusion Criteria:

* Previous Anti-TNFalpha biological treatment
* Previous attendance to a TEP concerning biological or spondyloarthritis
* Contraindication to Anti-TNFalpha treatment
* Associated and unbalanced diseases

Primary outcomes:
measure: BIOSECURE patient self-questionnaire
timeFrame: Change from Baseline Biosecure's score at 6 months and at 12 month after biological treatment initiation
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: CHU de Strasbourg
name: Christelle SORDET, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02511964: High Intensity Interval Training in 1% or 10% Slope
Official title: Effect of Six Running Sessions of High Intensity Interval Training in Different Slopes on Aerobic Performance: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Aerobic Exercise
HIT,
VO2Max
Performance
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2015-07-30
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective was to determine the effect of six running sessions of high intensity interval training (HIIT) at 1% and 10% incline on VO2max, peak of velocity (VPeak), and time limit of 1% (TLim1%) and 10% (TLim10%) of inclination, as well as the influence of the specificity of training on performance in the different inclines.

Detailed description: Our study is assuming greater activation / muscle overload coming from the uphill running. Accordingly, we believe that in a parallel-group design (1% or 10% gradient) established in controlled and randomized way we could answer the hypothesis that muscle overload provide superior gains to VO2max and aerobic performance. Moreover, considering the first hyphotesis, such developments on the running at 10% slope also promote significant gains in climb performance and also in the plan. Unlike the speculate that the gains from the 1% training does not help performance a 10% incline.

Eligibility criteria: Inclusion Criteria:

* Minimum standards of physical activity proposed by the ACSM
* Perform running activity at high intensities (HIT)

Exclusion Criteria:

* No cardiovascular problems, respiratory or metabolic
* No muscle or joint injuries
* Not to use drugs or ergogenic resources

Primary outcomes:
measure: Maximal oxygen uptake (VO2Max)
timeFrame: 0 week - 3 week (2 sessions for week)
Secondary outcomes:
measure: Time to Exhaustion (TLim 1% and 10%)
timeFrame: 0 week - 3 week (2 sessions for week)
measure: Transfer of performance gains of TLim1% and TLim10% slope
timeFrame: 0 week - 3 week (2 sessions for week)
measure: Peak Velocity
timeFrame: 0 week - 3 week (2 sessions for week)
Other outcomes:
Locations:
Study officials:
affiliation: Universidade Federal do Rio de Janeiro
name: Sérgio Machado, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT07020364: Feasibility and Safety of a Single Working Element for Bipolar and Laser Enucleation in Prostate Surgery: A Prospective Study
Official title: Feasibility and Safety of a Single Working Element for Bipolar and Laser Enucleation in Prostate Surgery: A Prospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate
BPH (Benign Prostatic Hyperplasia)
Keywords: laser enucleation
bipolar enucleation
BPH
prostate
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2025-06-13
Enrollment: 60
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: the study will include male patients aged ≥50 years who are diagnosed with benign prostatic hyperplasia (BPH) , prostate volume ≥40 cc without 4prior history of prostate cancer while patients with ongoing urinary tract infections, prior prostate surgeries, coagulopathy or urethral strictures were excluded.

Brief summary: A prospective feasibility study would be a practical first step, focusing on real-time assessment and ensuring the new working element's integration is safe and effective before broader clinical trials.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with benign prostatic hyperplasia (BPH) requiring surgical intervention.
* Prostate volume ≥40 cc (as assessed by transrectal ultrasound).
* No prior history of prostate cancer.

Exclusion Criteria:

* Patients with ongoing urinary tract infections.
* Prior prostate surgeries.
* Coagulation disorders or patients on long-term anticoagulation therapy.
* Known urethral strictures or other anatomical abnormalities complicating endoscopic procedures.

Primary outcomes:
measure: Feasibility
timeFrame: the operative time
measure: Safety
timeFrame: 1 month
Secondary outcomes:
measure: Efficacy
timeFrame: 1 month
measure: Cost Analysis
timeFrame: the operative time
Other outcomes:
Locations:
city: Shibin Al Kawm
country: Egypt
facility: Menoufia Faculty of Medicine
state: Menoufia
Study officials:
References:
Clinical trial NCT05059964: Circuit Training and Aerobic Exercise Among Sedentary Elderly Population
Official title: Comparison of Circuit Training and Aerobic Exercise on Cardiopulmonary Fitness Among Sedentary Elderly Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Behavior
Old Age; Debility
Keywords: Aerobic Exercise
Circuit Training
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-09-28
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To compare the effects of Circuit training and aerobic exercise on cardiopulmonary fitness among Sedentary elderly population


Eligibility criteria: Inclusion Criteria:

* Participants meeting the below criteria, shall be recruited in the study.
* Sedentary elderly people (Can perform 6 MWT without complication)
* Sedentary elderly population
* No regular exercise or gym activity since last 6 months

Exclusion Criteria:

* Already trained (any gym activity or regular exercise)
* Diagnosed cardiopulmonary disease
* Diabetes
* Any neurological complication

Primary outcomes:
measure: 6 min walk test: Distance (meters)
timeFrame: 4th Week
measure: Step test
timeFrame: 4th Week
measure: Forced Expiratory Volume in 1 second (FEV1)
timeFrame: 4th Week
measure: Forced vital Capacity (FVC)
timeFrame: 4th week
measure: Peak Expiratory Flow (PEF)
timeFrame: 4th week
Secondary outcomes:
Other outcomes:
Locations:
city: Upper dir
country: Pakistan
facility: District Headquarter Hospital - Upper Dir
state: Khyber Pakhtunkhwa
Study officials:
affiliation: Riphah International University
name: Muhammad Iqbal Tariq, MSCPPT
role: PRINCIPAL_INVESTIGATOR
References: