louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01742182: Circadian Rhythms and Sleep-Wake Cycles in Parkinson's Disease
Official title: Circadian Rhythms and Sleep-Wake Cycles in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease
Excessive Daytime Sleepiness
Circadian Rhythms
Light Therapy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2012-12-05
Enrollment: 70
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Disruption of sleep and alertness is one of the most disabling non-motor symptoms of Parkinson's disease (PD). Mechanisms leading to impaired sleep and alertness in PD are not well understood, and treatment options remain limited. The proposed research will examine markers of the circadian system, sleepiness and sleep quality in PD patients and healthy controls. Further, the project will examine effects of bright light exposure on circadin function, sleep and alertness in PD.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of idiopathic PD as defined by the United Kingdom PD Society Brain Bank Criteria;
2. PD Hoehn and Yahr stage 2-4;
3. Pittsburgh Sleep Quality Index (PSQI) score \>5 in group 1, and ≤5 in group 2;
4. Epworth Sleepiness Scale (ESS) score ≥10 in group 1, and \<10 in group 2;

Control participants will be matched for gender and age with PD participants.

Exclusion Criteria:

1. Atypical or secondary forms of Parkinsonism;
2. Cognitive impairment as determined by the Mini-Mental State Examination (MMSE) score of ≤ 26;
3. Presence of depression defined as the Beck Depression Inventory (BDI) score \>14;
4. Use of hypno-sedative drugs for sleep or stimulants; participants will be allowed to taper these drugs and will become eligible at least 4 weeks after the taper is completed;
5. Use of SSRIs / SNRIs antidepressants, unless the participant has been on a stable dose for at least 3 months prior to the screening;
6. Use of medications known to affect melatonin secretion;
7. Unstable/serious medical illness.

Primary outcomes:
measure: circadian rhythm of melatonin
timeFrame: June 2012- May 2017
measure: Sleep Efficiency
timeFrame: June 2012- May 2017
measure: Daytime Somnolence
timeFrame: June 2012- May 2017
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Aleksandar Videnovic, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03753282: Outcome After Avascular Necrosis of the Femoral Head in Young Patients
Official title: Outcome After Avascular Necrosis of the Femoral Head in Young Patients - Retrospective Analysis With a Min. 10-year Follow-up
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Avascular Necrosis of the Femoral Head
Keywords: Total hip arthroplasty
Total hip replacement
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2018-11-26
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Population 1: Patients with a first AVN-related contact (initial or confirmed diagnosis) at the USB or KSBL Liestal in the years between 1999-2006.

Population 2: Patients with a THA because of AVN at the USB or KSBL Liestal in the years 2000-2007.

Brief summary: 1. The course of AVN between Initial diagnosis and total hip replacement (THA) is analysed. The impact of early interventions versus conservative therapy in AVN before THA will be evaluated.
2. The short and long term outcomes of AVN patients undergoing THA with respect to complications, reoperations and quality of life are investigated. Potential risk factors for adverse outcomes will be investigated.

Detailed description: The study is to describe the course of avascular necrosis (AVN) of the femoral head from initial diagnosis and to collect data on treatment options and the further course in these cases. The duration from initial diagnosis of AVN to joint replacement as total hip arthroplasty (THA) will be analysed and the course after joint replacement with potential short- and long-term complications will be evaluated.

The impact of THA after AVN on activities of daily living will be assessed by Euroquol 5 Dimensions (EQ-5D-5L) and Hip disability and Osteoarthritis Outcome Score (HOOS) questionnaires.

Eligibility criteria: Inclusion Criteria:

* MRI of the hip available from diagnosis at the USB or KSBL Liestal
* Informed Consent

Exclusion Criteria:

* Insufficient knowledge of project languages (English, German, French)

Primary outcomes:
measure: arthroplasty-free interval (time until THA)
timeFrame: single time point assessment at baseline
measure: rate of reoperations after THA
timeFrame: single time point assessment at baseline
Secondary outcomes:
measure: Hip disability and Osteoarthritis Outcome Score (HOOS)
timeFrame: single time point assessment at baseline
measure: Euroquol 5 Dimensions (EQ-5D-5L)
timeFrame: single time point assessment at baseline
Other outcomes:
Locations:
Study officials:
affiliation: Dep. of Orthopedic and Trauma Surgery; University Hospital Basel
name: Franziska Saxer, Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04882982: Caria: Digital Intervention for Menopause Symptom
Official title: Caria: Digital Intervention for Menopause Symptom
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Hot Flashes
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Chorus Health
First posted: 2021-05-12
Enrollment: 150
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Menopause is the time of life when menstrual cycles cease. Women typically spend 30-40% of their lives in menopause. Individual experiences of menopause vary and although some women do not experience any significant symptoms, common symptoms include vasomotor dysfunction, vaginal dryness, mood changes, sleep disturbances, urinary incontinence, cognitive changes, somatic complaints and sexual dysfunction. Reduced quality of life can occur as a result of these symptoms. A mobile app has been developed to reduce the impact of these symptoms using a variety of behavioral change techniques including education, goal setting, motivational enhancement, social support and cognitive behavioral approaches. Participants will complete self report assessments of women's symptoms and QOL at baseline, 3 weeks and 6 weeks of app use.


Eligibility criteria: Inclusion Criteria:

- Women with variable menstrual cycles (menopausal transition) or those who were more than 1 year from their last menstrual period (postmenopause)

Hot flash/night sweats should be experienced as problematic (as indicated by an average score of 2 or higher on three items of the Hot Flush Rating Scale

Elevated score on at least one measure - either depression (PHQ8=10 or greater, sleep (PSQI of 5 or greater) or anxiety (GAD7=10 or greater)

Own an apple device able to run the Caria app

English speaking

Exclusion Criteria:

* None

Primary outcomes:
measure: Hot Flush Rating Scale
timeFrame: 6 weeks
Secondary outcomes:
measure: Women's Health Questionnaire
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Jennifer Duffecy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03880682: Direct Acting Antivirals for HCV Infection in Kidney Transplant Recipients
Official title: Treatment of Chronic Hepatitis C Virus Infection With Direct Acting Antivirals in Kidney Transplant Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplant; Complications
Hepatitis C, Chronic
Keywords: kidney transplant recipients
chronic hepatitis c virus infection
direct acting antivirals
sofosbuvir/ledipasvir
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2019-03-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Kidney transplant recipients with chronic HCV infection who were treated using direct acting antivirals.

Brief summary: Chronic hepatitis C virus (HCV) infection, an important cause of morbidity and mortality worldwide, is a significant problem in kidney transplant recipients (KTRs) given its high prevalence in patients undergoing hemodialysis. Interferon based regimens were cornerstone of treatment of HCV infection in the past; however, due to their low efficacy and high rates of adverse effects, they have been abandoned in the new era of direct acting antivirals (DAAs). Several studies demonstrated the efficacy and safety of DAAs, yet data regarding clinical practice of these agents in KTRs is still needed. Therefore, we conducted a study using our registry data to evaluate the efficacy and safety of DAAs in KTRs.


Eligibility criteria: Inclusion Criteria:

* Being a kidney transplant recipient.
* Having a detectable level of HCV RNA.
* Having direct acting antivirals for 12 or 24 weeks.

Exclusion Criteria:

* Withdrawing or not providing consent.

Primary outcomes:
measure: SVR12
timeFrame: 6 months
Secondary outcomes:
measure: Stable Graft Function
timeFrame: 6-12 months
measure: Stable Serum Trough Levels of Immunosuppressive Agents
timeFrame: 6 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University
Study officials:
affiliation: Department of Internal Medicine, Istanbul Faculty of Medicine
name: Safak Mirioglu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Internal Medicine, Istanbul Faculty of Medicine
name: Halil Yazici, MD
role: STUDY_CHAIR
affiliation: Department of Internal Medicine, Istanbul Faculty of Medicine
name: Sabahattin Kaymakoglu, MD
role: STUDY_CHAIR
References:
citation: Colombo M, Aghemo A, Liu H, Zhang J, Dvory-Sobol H, Hyland R, Yun C, Massetto B, Brainard DM, McHutchison JG, Bourliere M, Peck-Radosavljevic M, Manns M, Pol S. Treatment With Ledipasvir-Sofosbuvir for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic Hepatitis C Virus Genotype 1 or 4 Infection: A Randomized Trial. Ann Intern Med. 2017 Jan 17;166(2):109-117. doi: 10.7326/M16-1205. Epub 2016 Nov 15.
Clinical trial NCT01410682: Oral Care and Gram-negative Pathogen in Children
Official title: Oral Care and Oropharyngeal and Tracheal Colonization by Gram-negative Pathogens in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tracheal and Oropharyngeal Colonization by Gram-negative Pathogens
Keywords: oral hygiene
ventilator-associated pneumonia
infection control
intensive care
pediatric nursing
pediatrics
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2011-08-05
Enrollment: 74
Sex: ALL
Minimum age (years): 29
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Critical care nursing interventions related to oral care can reduce the microorganisms in the oropharynx available for translocation to other sites. THis is a randomized, controlled and double blinded study performed in a pediatric intensive care unit (PICU) from a Brazilian university hospital which objectives were to analyze 0.12% chlorhexidine digluconate influence on Gram-negative pathogens colonization of oropharyngeal and tracheal secretions of mechanically ventilated children.


Eligibility criteria: Inclusion Criteria:

* All the PICU children during 24 months of study were selected for participation.

Exclusion Criteria:

* newborns, those that fulfilled the Centers for Disease Control and Prevention criteria for pneumonia in infants and children at the time of PICU admission, PICU LOS less than 48 hours, presence of tracheostomy and those that declined to participate.

Primary outcomes:
measure: Influence of chlorhexidine digluconate 0.12% on tracheal and oropharyngeal colonization by gram-negative pathogens
Secondary outcomes:
measure: Influence of some demographic characteristics of critically ill children on the oropharynx Gram-negative pathogens identification.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03967782: Effect of the Exercise-meal Timing on Energy Intake and Appetite in Adolescents With Obesity
Official title: Effect of the Exercise-meal Timing on Energy Intake and Appetite in Adolescents With Obesity: the TIMEX 2 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric obésity
Keywords: appetite control
obesity
adolescents
exercise timing
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: AME2P Laboratory, Clermont Auvergne University
First posted: 2019-05-30
Enrollment: 17
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to compare the effect of realizing an exercise right before or right after a meal of on energy intake, appetite feelings and food reward in adolescents with obesity.

Detailed description: The present study will compare the nutritional response to the realisation of an acute exercise right before or right after lunch in adolescents with obesity. 18 adolescents with obesity will be asked to randomly complete three experimental sessions: i) one control session (rest); ii) one session with an acute exercise realized right before lunch; iii) one session with an acute exercise realized right after lunch. Their ad libitum energy intake will be assessed during lunch as well as at dinner time. Appetite feelings will be assessed at regular intervals and their food reward in response to the lunch will also be assessed.

Eligibility criteria: Inclusion Criteria:

* BMI percentile \> 97th percentile according to the french curves.
* ages 12-16 years old
* Signed consent form
* being registered in the national social security system
* no contraindication to physical activity

Exclusion Criteria:

* Previous surgical interventions that is considered as non-compatible with the study.
* Diabetes
* weight loss during the last 6 months
* cardiovascular disease or risks

Primary outcomes:
measure: Change in energy intake measured during an ad libitum buffet meal (in kcal)
timeFrame: day 1 , day 8, day 15
Secondary outcomes:
measure: Hunger feelings
timeFrame: day 1 , day 8, day 15
measure: Food reward
timeFrame: day 1 , day 8, day 15
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Chu Clermont Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: yves Boirie
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fillon A, Beaulieu K, Miguet M, Bailly M, Finlayson G, Julian V, Masurier J, Mathieu ME, Pereira B, Duclos M, Boirie Y, Thivel D. Does exercising before or after a meal affect energy balance in adolescents with obesity? Nutr Metab Cardiovasc Dis. 2020 Jun 25;30(7):1196-1200. doi: 10.1016/j.numecd.2020.04.015. Epub 2020 Apr 23.
Clinical trial NCT05516082: Clinical Evaluation of Two Daily Disposable Lenses in Sphere Design
Official title: Clinical Evaluation of Two Daily Disposable Lenses in Sphere Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ametropia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2022-08-25
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All participants received Lens A and then Lens B in fixed-sequence order.
Primary purpose: TREATMENT

Brief summary: This was a single-blind, interventional, prospective, direct refit, bilateral wear, fixed-sequence crossover study.

Detailed description: The aim of this study was to evaluate the visual performance and subjective experiences of daily disposable hydrogel lens (DDH) when compared to daily disposable silicone hydrogel lens (DDSH) after 15 minutes of daily wear each.

Eligibility criteria: Inclusion Criteria:

* Is at least 18 years of age and has full legal capacity to volunteer.
* Has read and signed an information consent letter.
* Self-reports having a full eye examination in the previous two years.
* Anticipates being able to wear the study lenses for the required time of the study.
* Is willing and able to follow instructions and maintain the appointment schedule.
* Has refractive astigmatism no higher than -0.75 DC.
* Can be fit with the available lens parameters (sphere +8.00 to -10.00D).
* Can achieve binocular distance vision of at least 20/30 Snellen (logMAR 0.18) with the study contact lenses.

Exclusion Criteria:

* Is participating in any concurrent clinical or research study.
* Has any known active ocular disease and/or infection that contraindicates contact lens wear.
* Has a systemic condition that in the opinion of the investigator may affect a study outcome variable.
* Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable.
* Has known sensitivity to the diagnostic sodium fluorescein used in the study.
* Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment.
* Has undergone refractive error surgery or intraocular surgery.

Primary outcomes:
measure: Lens Fit Acceptance
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Dr. Ruben Velazquez Private Practice
Study officials:
affiliation: Dr. Ruben Velazquez Private Practice
name: Rubén V Guerrero, MSc., FIACLE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02952482: Newborn Screening for Adrenoleukodystrophy
Official title: Newborn Screening for Adrenoleukodystrophy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adrenoleukodystrophy
Keywords: adrenoleukodystrophy
C26:0-lyso-PC
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2016-11-02
Enrollment: 45796
Sex: ALL
Minimum age (years): 2
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: newborns whose parents agree to be tested

Brief summary: To test if the routine newborn screening dried blood spots can be used to test if elevation of C26:0 lysophosphatidylcholine (C26:0-lyso-PC), a status indicating adrenoleukodystrophy (ALD)

Detailed description: Parents of newborns will be invited to test if their newborns are affected with ALD. The routine newborn screening dried blood spots sample will be used to test the concentration of C26:0-lyso-PC . If positive of a screening test, further confirmation tests including physical examination and other methodology for ALD confirmation will be provided. Genetic counseling and treatment option will be provided, too.

Eligibility criteria: Inclusion Criteria:

* Babies born in Taiwan receive regular newborn screening suggested by Ministry of Heath and Welfare.
* Parents or Legal Guardian sign in the informed consent form.

Exclusion Criteria:

* Parents or Legal Guardian do not agree to sign in the informed consent form.

Primary outcomes:
measure: numbers of newborn with ALD
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT04381182: Heart Rate Variability and Stress Management Enhancement
Official title: Impact of Heart Rate Variability Modulation on Stress and Performance Among Neurosurgical Residents
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stress
Heart Rate Variability
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Apollo Neuro
First posted: 2020-05-08
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study will be conducted by using two devices (Apollo and Biostrap) for monitoring of baseline physiologic variables and heart rate variability. The biostrap will be worn by residents and will monitor heart rate, heart rate variability, respiratory rate, sleep patterns, steps, etc. The Apollo is a pulse generator device aimed at modulating heart rate variability for (hopefully) reduction in stress and improving performance in and around the hospital. Resident neurosurgeons will wear the biostrap for a two week cycle and follow that with the addition of the Apollo device for heart rate variability modulation.


Eligibility criteria: Inclusion Criteria:

* Neurosurgical Resident (UPMC)

Exclusion Criteria:

* None

Primary outcomes:
measure: Change from baseline to two month heart rate variability
timeFrame: Baseline, Two Month. Analyzed via paired t-test and assessing change between each outcome time point
measure: Change from baseline to two month Perceived Stress Scale
timeFrame: Baseline, Two Month. Analyzed via paired t-test and assessing change between each outcome time point
measure: Change from baseline to two month Quick Inventory of Depressive Symptomatology (QIDS)
timeFrame: Baseline, Two Month. Analyzed via paired t-test and assessing change between each outcome time point
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Presbyterian Hospital Department of Neurological Surgery
state: Pennsylvania
Study officials:
affiliation: Department of Neurological Surgery
name: Joseph Maroon
role: PRINCIPAL_INVESTIGATOR
References: