louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01790009: Influence of Age on the Absorption and Metabolism of Cocoa Flavanols
Official title: Influence of Age on the Absorption and Metabolism of Cocoa Flavanols
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: ADME
Flavanols
Age
Pharmacokinetics
Lead sponsor: University of Reading
Sponsor class: OTHER
First posted: 2013-02-12
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Accumulating evidence suggests that regular consumption of foods and beverages rich in flavanols, such as cocoa, tea, apples and wine, may have cardiovascular benefits. Several well-controlled randomised human intervention studies have shown that cocoa flavanols have beneficial effects on blood pressure, endothelial function and other biomarkers of cardiovascular health. These vascular improvements have been correlated in time with changes in plasma flavanol metabolites. The health benefits of flavanol consumption are therefore likely dependent on changes in their absorption, distribution, metabolism and excretion (ADME). Recent studies have provided detailed information regarding the absorption and metabolism of cocoa flavanols. However, there is a lack of information on whether there are changes in flavanol absorption and metabolism with increasing age.


Eligibility criteria: Inclusion Criteria:

* signed consent form
* Caucasian
* Good general health
* No allergy to milk products or sensitivity to alkaloids/caffeine,
* No gastrointestinal disorders (e.g., chronic constipation, diarrhoea, inflammatory bowel disease, irritable bowel syndrome, or other chronic gastrointestinal complaints)
* Not diabetic or suffering from hypertension (140/90 mm Hg),
* No anaemia or gall bladder problems.

Exclusion Criteria:

* those on a weight reducing dietary regimen
* Taking any dietary supplements
* Consuming more than 15 units (120g) of alcohol per week
* Taking anti-inflammatory medication
* Smokers
* Those with sensitivities to chocolate, reduced calorie sweeteners, dairy, nuts or gluten,
* Vegetarians or vegans.

Primary outcomes:
measure: Plasma and urine flavanol metabolites
timeFrame: 24 hours
Secondary outcomes:
measure: Paracetamol and methylxanthine plasma and urine levels
timeFrame: 24 h
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: Department of Food and Nutritional Sciences
state: Berkshire
Study officials:
affiliation: University of Reading
name: Jeremy Spencer, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05379309: Compliance in Non Invasive Mechanical Ventilation
Official title: Compliance in Non Invasive Mechanical Ventilation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Insufficiency
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic respiratory failure

Brief summary: Database study of the adherence to treatment to non-invasive mechanical ventilation


Eligibility criteria: Inclusion Criteria:

* patients in non invasive mechanical ventilation and affiliated by the respiratory centre of the East of Denmark
* registered in telemedical solution in the period from 01.01.2020 to 04.01.2022
* Age above 18 years

Exclusion Criteria:

-

Primary outcomes:
measure: Use of treatment more than 4 hr. per day
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Rigshospitalet Glostrup
Study officials:
References:
Clinical trial NCT00959309: Media Use in Preschooler Study (MUPS)
Official title: Media Use in Preschooler Study (MUPS) An Office Based Intervention to Improve Media Use in Preschool Children: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Keywords: pediatrics
media
MUPS
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2009-08-14
Enrollment: 160
Sex: ALL
Minimum age (years): 3
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Childhood obesity is an epidemic and increasing. There are very few effective treatments for obesity in children. Recent studies have shown an association between obesity and sedentary behaviors such as television, video viewing and playing video games ('screen time') in preschool aged children. A school based intervention to reduce screen time in older children has been effective in preventing obesity.

The reduction of screen time may lead to the prevention of obesity and its complications in preschool children.

Detailed description: There have been no trials examining an intervention to decrease screen time in preschool children in the physician office setting. This setting is appealing for interventions directed to preschool children because of accessibility. In addition, other public health interventions implemented in a physician office setting, such as home safety advice, have been effective.

The proposed study design will be a randomized controlled trial. The intervention group will receive the study intervention, which is a 15 minute session about the health impact of screen time in children and strategies to decrease screen time.

The objective of this study is to determine if an office based intervention is effective in decreasing screen time (television, video viewing and playing video games) in preschool children.

Eligibility criteria: Inclusion Criteria:

* registered to attend a 3 year old well child visit

Exclusion Criteria:

* children with limitations in ambulation or cognitive delay will be excluded from the study.

Primary outcomes:
measure: Parent reported number of hours screen time on the previous weekday and previous weekend day
timeFrame: 6 and 12 months
Secondary outcomes:
measure: Number of meals in front of the TV
timeFrame: 6 and 12 months
measure: Activity levels
timeFrame: 6 and 12 months
measure: Anthropometric measures
timeFrame: 12 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto Canada
name: Catherine Birken, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03664609: Deep Brain Stimulation (DBS) Retrospective Outcomes Study
Official title: Deep Brain Stimulation (DBS) Retrospective Outcomes Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease
Essential Tremor
Dystonia
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2018-09-10
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects' chart data will be drawn from the Investigator's standard patient pool treated at his/her practice.

Brief summary: The primary objective of this study is to characterize real-world clinical outcomes of Deep Brain Stimulation (DBS) using retrospective review of de-identified patient records.

Detailed description: The purpose of this study is to characterize

1. real-world clinical outcomes of Deep Brain Stimulation (DBS) using retrospective review of de-identified patient records.

Eligibility criteria: Inclusion Criteria:

* Must be previously treated with or eligible for implantation with a deep brain stimulation system

Exclusion Criteria:

* No Exclusion Criteria

Primary outcomes:
measure: Mean Change in Unified Parkinson's Disease Rating Scale (UPDRS III) at up to 5 years post implant compared to baseline
timeFrame: 5 yrs. post implant
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Joseph's Hospital & Medical Center
state: Arizona
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Boise
country: United States
facility: St. Luke's Regional Medical Center
state: Idaho
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Seattle
country: United States
facility: Swedish Neuroscience Institute
state: Washington
city: Gent
country: Belgium
facility: AZ St. Lucas
city: Roeselare
country: Belgium
facility: AZ Delta
city: Düsseldorf
country: Germany
facility: Universitaetsklinikum Dusseldorf
city: Jena
country: Germany
facility: Uniklinikum Jena
city: Köln
country: Germany
facility: Uniklinik Köln
city: Lübeck
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein
city: Würzburg
country: Germany
facility: Universitaetsklinikum Wuerzburg
city: Pavia
country: Italy
facility: Fondazione Istituto Neurologico Casimiro Mondino
city: Sevilla
country: Spain
facility: Hospital Virgen Del Rocio
Study officials:
affiliation: Boston Scientific Neuromodulation Corporation
name: Natalie Bloom Lyons
role: STUDY_DIRECTOR
References:
Clinical trial NCT06440109: The Effect of Therapeutic Touch and Emotional Freedom Technique on Postpartum Mood and Fatigue in Postpartum Women
Official title: The Effect of Therapeutic Touch and Emotional Freedom Technique on Postpartum Mood and Fatigue in Postpartum Women
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fatigue
Emotion Regulation
Keywords: emotional freedom technic
therapeutic touch
fatigue
mood state level
Lead sponsor: KTO Karatay University
Sponsor class: OTHER
First posted: 2024-06-03
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Therapeutic touch (TD) is a non-pharmacological/integrated treatment method used to balance the body by regulating the imbalanced energy field in the individual or resolving blockages in energy flow. Emotional freedom technique (EFT) is a psychophysiological intervention that combines elements of somatic stimulation using acupuncture points. This research will be conducted as a randomized controlled experimental study to determine the effect of TD and EFT intervention on postpartum mood and fatigue in postpartum women. The research will be conducted between November 2023 and November 2024 with women who gave birth normally and are registered at Karakulak Family Health Center in Konya. This research; It was planned to be carried out with three groups: TD intervention, EFT intervention and control group. The population of the research consists of women who gave birth vaginally and those who gave birth vaginally in the relevant hospital.


Eligibility criteria: Inclusion Criteria:

* Having a vaginal birth at term
* Being primiparous
* Postpartum 3rd-5th. to be in the days
* Being able to speak and understand Turkish
* Being 18 years or older
* Having a single and viable fetus
* Volunteering to participate in research
* Not having experienced TD or EFT treatment before

Exclusion Criteria:

* A psychiatric diagnosis has been made,
* Having a chronic systemic disease,
* The newborn's need for treatment
* Having postpartum complications in the mother or baby
* Those who have sensitivity or problems with touch,
* Wounds, infections, etc. in places that need to be touched. existence of situations,
* Women who have any disability that would prevent communication (deafness, hearing impairment, etc., use of languages other than Turkish) will be excluded from the research.

Primary outcomes:
measure: Postpartum 3rd-5th. EFT intervention will be applied to women who are between
timeFrame: six weeks
measure: Postpartum 3rd-5th. TD intervention will be applied to women who are between
timeFrame: six weeks
measure: 3rd-5th postpartum Pre- and post-test will be given to women between
timeFrame: six weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Karatay
country: Turkey
facility: KTO Karatay University
state: Konya
Study officials:
affiliation: KTO Karatay University
name: Aslıhan Turan, PhD (c)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05342909: Two Time a Week vs. Five Time a Week Blood Flow Restriction Training Program for the Lower Extremity.
Official title: Blood Flow Restriction Training for the Quad: Comparing Daily Training vs. Training Twice a Week
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blood Flow Restriction Training
Lead sponsor: George Fox University
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will randomize healthy adults who regularly perform resistance training exercises for the lower extremities (2x a week) to one of three groups: a blood flow restriction (BFR) exercise group that trains 2x a week, a BFR exercise group that trains 5x a week, and a control group that does not perform any additional BFR exercise. Those randomized to the BFR groups will perform the unilateral 90-0 knee extension exercise followed by the bilateral squat. Subjects will have the BFR applied to their dominant lower extremity and will perform 4 sets (30/15/15/15 reps) per exercise. Training will initial start at 30% of 1RM with training intensity increased by 5% every 2 weeks. The training program will last 8 weeks.

Pre- and posttests include ultrasound imaging of the dominant leg rectus femoris and strength testing via hand held dynamometry.


Eligibility criteria: Inclusion Criteria: healthy adults 18 years of age who currently perform weight-lifting (i.e., resistance training) exercise 2x a week.

-

Exclusion Criteria: current musculoskeletal injury; surgery to the low back or lower extremities during the prior year; one or more contraindications to blood flow restriction training.

-

Primary outcomes:
measure: Muscular strength
timeFrame: 8 weeks
measure: Cross-sectional area of the rectus femoris
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Newberg
country: United States
facility: George Fox University School of Physical Therapy
state: Oregon
city: Newberg
country: United States
facility: George Fox University
state: Oregon
Study officials:
affiliation: College of Physical Therapy; George Fox University
name: JASON BRUMITT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00978809: Effects of Physical Treatment on Postural Stability in Benign Paroxysmal Positional Vertigo (BPPV) Patients
Official title: Epley Maneuver vs. Semont Maneuver for Benign Paroxysmal Positional Vertigo (BPPV): Evaluating Treatment Effectiveness by Postural Stability - a Double Blinded Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Benign Paroxysmal Positional Vertigo
Keywords: BPPV
postural stability
Epley
Semont
Lead sponsor: Assuta Hospital Systems
Sponsor class: OTHER
Collaborators: name: Ben-Gurion University of the Negev
First posted: 2009-09-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The propose of this study is to compare two methods of physical treatment for benign paroxysmal positional vertigo, by evaluating treatment effects on postural stability.

The trail design is a double blinded randomized controlled trail, with each patient going through three evaluations: before treatment, 1 week after treatment and 60 days after treatment.


Eligibility criteria: Inclusion Criteria:

* medical referral for treating "vertigo"
* subject has short episodes of rotatory vertigo (up to 1 minute)
* subject has positive Hallpike-Dix test with typical nystagmus
* repeated Hallpike-dix test will show fatigability

Exclusion Criteria:

* Hallpike-Dix test produces vertigo without nystagmus
* subject has BPPV of the horizontal or anterior semi-circular canal
* subject has other known vestibular or neurologic condition
* subject has nystagmus of a different type
* subject has a cervical spine problem which prevents the utilization of Epley or Semont maneuvers
* subject is unable to stand for 1 minute
* subject gets pharmacologic treatment for vertigo while doing the postural stability evaluation
* subject is under 18 years old or a pregnant female or cannot obtain informed concent

Primary outcomes:
measure: postural stability
timeFrame: 60 days post treatment
Secondary outcomes:
measure: subjective vertigo
timeFrame: 60 days post treatment
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: Maccabi health services
Study officials:
affiliation: Ben-Gurion University of the Negev
name: Itshak Melzer, Dr
role: STUDY_CHAIR
affiliation: Soroka University Medical Center
name: Moshe Puterman, Dr
role: STUDY_DIRECTOR
References:
citation: Blatt PJ, Georgakakis GA, Herdman SJ, Clendaniel RA, Tusa RJ. The effect of the canalith repositioning maneuver on resolving postural instability in patients with benign paroxysmal positional vertigo. Am J Otol. 2000 May;21(3):356-63. doi: 10.1016/s0196-0709(00)80045-9.
citation: Di Girolamo S, Paludetti G, Briglia G, Cosenza A, Santarelli R, Di Nardo W. Postural control in benign paroxysmal positional vertigo before and after recovery. Acta Otolaryngol. 1998 Jun;118(3):289-93. doi: 10.1080/00016489850183340.
Clinical trial NCT04171609: Expressive Writing for Cancer Survivors
Official title: Expressive Writing for Resilience in Adult Cancer Survivors.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Survivors
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2019-11-21
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether a 1-day expressive writing intervention for adult cancer survivors improves resilience scores as measured by the Connor-Davidson Resilience Scale (CD-RISC).

Detailed description: The purpose of this study is to determine whether a 1-day expressive writing intervention for adult cancer survivors improves resilience scores as measured by the Connor-Davidson Resilience Scale (CD-RISC).

Eligibility criteria: Inclusion Criteria:

* Have ever received a cancer diagnosis
* Have completed cancer treatment (e.g., surgery, radiation, or chemotherapy)
* Are able to speak, read, write, and understand English
* Are cognitively able to provide consent
* Are able to travel to Durham to participate in the 1-day writing intervention

Exclusion Criteria:

-Cancer diagnosis was skin cancer that did not require additional treatment after surgical removal

Primary outcomes:
measure: Change in resilience as measured by the Connor-Davidson Resilience Scale
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Post-writing survey
timeFrame: 1 day (collected during the 1-day intervention)
measure: Change in quality of life as measured by the Quality of Life Patient/Cancer Survivor Version (QOL-CSV)
timeFrame: Baseline, 6 months
measure: Change in perceived stress as measured by Perceived Stress Scale (PSS-10)
timeFrame: Baseline, 6 months
measure: Change in depression as measured by Center for Epidemiological Studies Depression Scale Revised (CESD-R)
timeFrame: Baseline, 6 months
measure: Qualitative follow-up questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Integrative Medicine
state: North Carolina
Study officials:
affiliation: Duke University
name: Oliver Glass, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01167309: LEO 27847 - Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Secondary Hyperparathyroidism Patients
Official title: LEO 27847 - Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Secondary Hyperparathyroidism Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Secondary Hyperparathyroidism
Keywords: Safety and tolerability of LEO 27847
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2010-07-22
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this trial is to determine the safety and tolerability of ascending single and multiple oral doses of LEO 27847 in secondary hyperparathyroidism patients.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 to 75 years (inclusive) at screening.
* Patients with body mass index within 18 to 34 kg/m2 (inclusive).
* Haemoglobin is stable (≥9 g/dL or 5.6 mmol/L)
* Parathyroid hormone (PTH) is ≥200 pg/mL and \<800 pg/mL.
* Screening serum albumin is ≥30 g/L.
* C-reactive protein \<25 mg/L.

Exclusion Criteria:

* Adjustment of vitamin D sterols within 14 days before the screening visit and patients for whom adjustment of vitamin D sterols is planned from screening until end of study.
* Adjustment of calcium supplements within 14 days before the screening visit and patients for whom adjustment of calcium supplements is planned from screening until end of study.
* Adjustment of phosphate binder within 14 days before the screening visit and patients or whom adjustment of phosphate binder is planned from screening until end of study.

Primary outcomes:
measure: Safety and Tolerability
timeFrame: 7 days after last dosing
Secondary outcomes:
measure: Pharmacokinetics and Pharmacodynamics
timeFrame: 7 days after last dosing
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: CRS Clinical Research Services Kiel GmbH
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny MON
Study officials:
affiliation: LEO Pharma
name: Medical Expert
role: STUDY_DIRECTOR
References: