louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04826380: Thumb Basal Joint (CMC I) Arthritis - Preoperative Anxiety/Depression, Outcome Instruments, Carpal Cinematics and Cost-utility
Official title: Thumb Basal Joint (CMC I) Arthritis - Preoperative Anxiety/Depression, Outcome Instruments, Carpal Kinematics and Cost-utility
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arthritis
Thumb Osteoarthritis
Arthropathy
Quality of Life
Lead sponsor: Töölö Hospital
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A project aiming to promote evidence based practice when treating thumb basal joint (CMC I) arthritis. We will aim to: 1) provide the minimal clinical difference of two general outcome instruments, 2) evaluate the association between pre-operative anxiety and/or depression and outcomes following trapeziectomy, 3) evaluate the effect of trapziectomy on carpal cinematics, 4) determine the cost-utility-ratio of trapeziectomy


Eligibility criteria: Inclusion Criteria:

* Eaton-Glickel \>2 arhritis
* Symptom duration \>3 months
* Pain VAS \>30mm
* No significant comorbidities, ASA I-II
* Fluent in Finnish language

Exclusion Criteria:

* Eaton-Glickel \<2
* Duration of symptoms \<3 months
* VAS \<30mm
* ASA \>II
* Inflammatory joint disease
* Systemic corticosteroid or immunomodulatory medication
* Upper limb symptoms not explained with CMC I artritis
* Heavy smoking (\> 20 cigarettes per day)
* Alcohol or drug abuse
* Neurological condition affecting upper limb function
* Other ipsilateral upper limb condition requiring surgery

Primary outcomes:
measure: Patient-Rated Wrist Evaluation
timeFrame: 12 months
measure: Michigan Hand Outcome Questionnaire
timeFrame: 12 months
Secondary outcomes:
measure: Pain Catastrophizing Scale
timeFrame: 12 months
measure: Pain (Visual Analogue Scale)
timeFrame: 12 months
measure: Global improvemen
timeFrame: 12 months
measure: Grip strength
timeFrame: 12 months
measure: Wrist and hand (thumb) range of motion (ROM)
timeFrame: 12 months
measure: Cost-utility
timeFrame: 12 months
measure: Carpal Kinematics
timeFrame: 12 months
measure: Beck Depression Inventory
timeFrame: 12 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Töölö Hospital (Helsinki University Hospital)
Study officials:
References:
Clinical trial NCT05387980: A Study to Learn About the Study Medicine (CIBINQO) in People With Atopic Dermatitis.
Official title: Special Investigation for CIBINQO （Long Term）
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atopic Dermatitis
Keywords: JAK Inhibitor
Atopic Dermatitis (AD)
Abrocitinib
Eczema
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-05-24
Enrollment: 1200
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adolescent participants diagnosed with atopic dermatitis in Japan.

Brief summary: The purpose of this study is to learn about the safety and effectiveness (how well the study treatment works) of the study medicine (CIBINQO) for the potential treatment of atopic dermatitis in people under Japanese medical practice.


Eligibility criteria: Inclusion Criteria:

1. Participants receiving this Product for treatment of AD.
2. Participants start receiving this Product (commercial product) for the first time and no earlier than the contract date of this Study, or Participants who continues to receive this drug after hospital transfer can be registered retrospectively.

Exclusion Criteria:

1. Participants previously enrolled in this Study at the same site.

Primary outcomes:
measure: Number of Participants with adverse drug reactions
timeFrame: 156 weeks
measure: Number of Participants with Discontinuation of Treatment
timeFrame: 156 weeks
Secondary outcomes:
measure: Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score
timeFrame: Baseline, 156 weeks
measure: Percentage of Participants with Change From Baseline in Eczema Area and Severity Index (EASI)
timeFrame: Baseline, 156 weeks
measure: Percentage of Participants with Change From Baseline in Affected % Body Surface Area (BSA)
timeFrame: Baseline, 156 weeks
measure: Percentage of Participants with Change From Baseline in Pruritus Assessment
timeFrame: Baseline, 156 weeks
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Pfizer Local Country Office
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01558180: Telephone Care Management to Address Sleep Problems in Young Children With Autism
Official title: Telephone Care Management to Address Sleep Problems in Young Children With Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Autism Spectrum Disorders
Insomnia
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: The Ingram Foundation is funding this work.
First posted: 2012-03-20
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators will conduct a randomized controlled trial comparing a telephone based intervention (TCM) to usual care (UC). TCM will feature a registered nurse providing a series of phone calls to assist caregivers in learning and modifying behavioral strategies that may help young children with autism to sleep better. Objective (activity monitors) and subjective (rating scales) data will be collected by an independent research assistant at the end of the project. The investigators hypothesize that TCM improves sleep duration and decreases sleep problems relative to a usual care control condition (UC).

Detailed description: Please see brief summary.

Eligibility criteria: Inclusion Criteria:

1. Insomnia
2. Autism Spectrum Disorder
3. Regular telephone service for caregiver
4. Stable dose of medication

Exclusion Criteria:

1. Signs of obstructive sleep apnea (e.g., turning blue or stop breathing at night, recurrent snoring)
2. Receptive language skills under 18 months

Primary outcomes:
measure: Children's Sleep Habits Questionnaire
timeFrame: 2 month follow-up
Secondary outcomes:
measure: Actigraphy (Activity Monitoring)
timeFrame: 2 month follow up
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Jack Stevens, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03105180: Irrigating Fluid and Blood Coagulation
Official title: The Effect of a Mixture of 2.7% Sorbitol-0.54% Mannitol Solution on Blood Coagulation: In-vitro, Observational Healthy-volunteer Study Using Rotational Thromboelastometry (ROTEM®)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Coagulation Disorder
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2017-04-07
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers

Brief summary: Irrigating fluid absorbed during the endoscopic surgery may alter whole blood coagulation. However, little is known about the dose-response relationships of hemodilution. The investigators have therefore performed the present study to measure the effect of a mixture of 2.7% sorbitol-0.54% mannitol solution on the coagulation pathway according to the hemodilution level using a rotational thromboelastometry (ROTEM®) tests.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* age: 20 to 65 years
* Body weight \> 50 kg
* Volunteers who provided informed consent

Exclusion Criteria:

* Hematologic disease
* Anticoagulant medication

Primary outcomes:
measure: FIBTEM
timeFrame: during the rotational thromboelastometry analysis/ an average of 1 hour
Secondary outcomes:
measure: INTEM
timeFrame: during the rotational thromboelastometry analysis/ an average of 1 hour
measure: EXTEM
timeFrame: during the rotational thromboelastometry analysis/ an average of 1 hour
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Hyo-Seok Na, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02267980: Effect of the Addition of Ketamine to Sevoflurane Anesthesia in Electroconvulsive Therapy
Official title: Turgut Ozal Medical Center Department of Anesthesiology and Reanimation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Depressive Disorder
Keywords: Electroconvulsive therapy; sevoflurane; ketamine
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2014-10-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators evaluate the effects of a subanesthetic dose of ketamine, administered as an adjunct to sevoflurane, on duration of seizure activity, hemodynamic profile and recovery times during electroconvulsive therapy (ECT) in patients with major depression.

Detailed description: Patients will randomly allocate, to either a sevoflurane-ketamine (Group SK), sevoflurane-saline (Group SS) receiving group. Mean arterial pressure (MAP) and heart rate (HR) will record prior to anesthetic induction (T1); following anesthetic induction (T2); and 0, 1, 3, and 10 min after the seizure has ended (T3, T4, T5, and T6, respectively). Motor and EEG seizure durations will be recorded.

Eligibility criteria: Inclusion Criteria:

* Major depressive patients

Exclusion Criteria:

* Pregnancy
* Have a history of myocardial infarction in the previous six months
* Atrial fibrillation or flutter
* Heart block
* Unregulated hypertension
* Cerebrovascular diseases
* A known drug allergy

Primary outcomes:
measure: seizure duration
timeFrame: During electroconvulsive therapy (30 minutes)
Secondary outcomes:
measure: Mean arterial pressure (MAP)
timeFrame: During Electroconvulsive therapy (30 minutes)
measure: Heart rate (HR)
timeFrame: During Electroconvulsive therapy (30 minutes)
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Turgut Ozal Medical Center
Study officials:
affiliation: MD
name: Feray Erdil, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yalcin S, Aydogan H, Selek S, Kucuk A, Yuce HH, Karababa F, Bilgic T. Ketofol in electroconvulsive therapy anesthesia: two stones for one bird. J Anesth. 2012 Aug;26(4):562-7. doi: 10.1007/s00540-012-1378-6. Epub 2012 May 24.
Clinical trial NCT05147480: Online Mother-Baby Yoga With Preterm Infants and Their Mothers
Official title: The Effects of Online Mother-Baby Yoga on Preterm Infants and Their Mothers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Birth
Anxiety
Development, Infant
Keywords: premature infants
yoga
motor performance
COVID-19
Lead sponsor: Halic University
Sponsor class: OTHER
First posted: 2021-12-07
Enrollment: 29
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention group (yoga) and control group (standardized protocol)
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to examine the effects of internet-based mother-baby yoga on preterm infants and their mothers.

Detailed description: Mother-infant pairs were enrolled in the study. Interventions applied as group sessions (maximum of 5 mother-infant pairs) for 6 weeks, once a week. Yoga sessions Before-after evaluations were done for both mother and infant outcomes.

Eligibility criteria: Inclusion Criteria:

* The infants whose gestational age between 32 0/7-36 6/7 week and corrected age's older than 6 weeks and their mothers
* Caregivers who have at least one smartphone or/and laptop or/and Ipad
* Mothers and their babies who accept to register to the study

Exclusion Criteria:

* The infants who have a severe pathological sign in cranial screening
* The infants who had IVH
* The infants who have congenital abnormalities
* The infants who have a metabolic or genetic diagnosis
* The infants who have hearing or visual impairment
* The mothers who had chronic depression history and/or mental retardation
* The mothers who have a neurological or orthopedic diagnosis to the contraindication of exercise
* The mothers who are pregnant

Primary outcomes:
measure: Motor performance of infants
timeFrame: 15 minutes
Secondary outcomes:
measure: Anxiety levels of mothers
timeFrame: 15 minutes
measure: Postpartum bonding of mothers
timeFrame: 15 minutes
measure: Nordic Musculoskeletal Questionnaire (NMQ)
timeFrame: 10 minutes
measure: Health-related quality of life of mothers
timeFrame: 15 minutes
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Dilara Bozgan
Study officials:
affiliation: Istanbul University
name: dilara bozgan
role: STUDY_DIRECTOR
affiliation: Istanbul University
name: mine çalışkan, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04782180: PrEP at a Syringe Services Program
Official title: Mobile Delivery of PrEP at a Syringe Services Program-A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hiv
Substance Use Disorders
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to see if providing participants with pre-exposure prophylaxis (PrEP) medicine right away at the IDEA Exchange will help participants remain in HIV negative.


Eligibility criteria: Inclusion Criteria:

1. over the age of 18
2. speak either English or Spanish
3. ability to provide informed consent
4. currently enrolled in the syringe services program
5. have a negative HIV rapid test result
6. estimated creatinine clearance \> 30 ml/minute

Exclusion Criteria:

1. do not meet the above criteria of inclusion
2. decline to participate
3. test positive for HIV via rapid test
4. are pregnant or plan on becoming pregnant
5. have symptoms acute HIV.
6. Any other comorbidities that at the discretion of the investigator would prevent the participant from participating in the study.

Primary outcomes:
measure: Intracellular level of tenofovir diphosphate
timeFrame: 6 months
Secondary outcomes:
measure: time to PrEP initiation post negative HIV rapid test
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Hansel Tookes
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00221780: Role of Left Ventricular Pacing Site
Official title: Importance of Left Ventricular Pacing Site in Biventricular Resynchronization Therapy for Severe Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Cardiomyopathy, Dilated
Coronary Disease
Keywords: Heart failure
Cardiomyopathy, dilated
Coronary disease
Cardiac Pacing, Artificial
Hemodynamics
Randomized Controlled Trials
Single-Blind Study
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2005-09-22
Enrollment: 33
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: Cardiac resynchronization therapy has been shown to be effective in reducing symptoms and mortality in heart failure patients. However, very few is known about the importance of the left ventricular pacing site. We study in a random order 11 different left ventricular pacing sites and compare their hemodynamics using pressure-volume catheters. The consequences on the surface ECG are also assessed.

Detailed description: Background. Cardiac resynchronization therapy has been shown to be effective in reducing symptoms and mortality in heart failure patients. However, very few is known about the importance of the left ventricular pacing site.

Design. Single-blind, monocentric, randomized cross-over study comparing 11 left ventricular pacing sites in a random order.

Intervention. Left ventricular DDD pacing on 11 ventricular sites, prior to the implantation. At each pacing site, a control hemodynamics will be obtained in AAI pacing at the same pacing rate. At each pacing site, 2 AV delays, a short and a long one, will be assessed.

Eligibility criteria. Patients referred for cardiac resynchronization therapy for heart failure

Outcomes. Hemodynamic measures using pressure-volume catheters.

Eligibility criteria: Inclusion Criteria:

* Heart failure referred for cardiac resynchronization therapy
* NYHA Class III or IV
* Informed consent form signed

Exclusion Criteria:

* Hypertension not controlled by treatment
* Coronary ischemia not controlled by treatment

Primary outcomes:
measure: Variation in left ventricular dp/dt max
Secondary outcomes:
measure: pressures and volumes of the left ventricle
measure: stroke work
measure: surface ECG repolarisation
Other outcomes:
Locations:
city: Pessac
country: France
facility: Hôpital Cardiologique du Haut Lévêque, Rythmology department, Pr CLEMENTY, 3rd Floor
Study officials:
affiliation: University Hospital, Bordeaux
name: Pierre Jaïs, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Paul Perez, Dr
role: STUDY_CHAIR
References:
Clinical trial NCT03779880: Examining Parkinson's Disease-Related Retirement: Results of Turkey
Official title: Examining Parkinson's Disease-Related Retirement: Results of Turkey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Keywords: Parkinson Disease, Early Retirement,
Lead sponsor: Istanbul Kültür University
Sponsor class: OTHER
Collaborators: name: Marmara University
name: Istanbul University
First posted: 2018-12-19
Enrollment: 75
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants were chosen from among retired Parkinson's patients who met the inclusion criteria and are applied Istanbul Cerrahpaşa University, has largest movement disorders unit of Turkey, between May and December 2018.

Brief summary: Although Parkinson Disease's (PD) is usually associated with an older patient population, 5% of patients are diagnosed at age 50 and 30% before 65 years of age. This shows that many patients with PD have diagnosed during the active study and have long periods of normal retirement. After the diagnosis of Parkinson's patients, the duration of leaving of employment vary between 0 and 25 years. It was found that patients' full-time working capacity decreased by up to 80% and they quitted earlier than the general population. The disability associated with PD is thought to be a factor in this situation. Nevertheless, the reasons for early retirement are not fully known and more information is needed on the specific problems of PD in order for patients to continue their career. The aim of our study is to examine the impact of Parkinson's disease on retirement and to contribute to Turkey's data. Patients with PD admitted to the Parkinson's disease outpatient clinic, which is the biggest clinic of Turkey about neurology, are included in the study. It is planned to meet with 75 patients on 31/12/2018 and to reach the end of the data collection phase.


Eligibility criteria: Inclusion Criteria:

* To be between 30-85 aged
* Parkinson Disease diagnosis according to the United Kingdom Brain Bank criteria
* To be treated with antiparkinson

Exclusion Criteria:

* Dementia
* Severe cognitive impairment
* Not willing to participate in the study

Primary outcomes:
measure: Qualitative interview
timeFrame: The researcher interviewed for about half an hour at once time with each participant.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Cerrahpaşa University
Study officials:
affiliation: Istanbul Kültür University
name: Gamze Ertürk, GRAD ASST
role: STUDY_CHAIR
affiliation: Marmara University
name: Semra Oğuz, ASST PROF
role: STUDY_DIRECTOR
References:
Clinical trial NCT05105880: Auscultation and Pulse Oximetry Combined Screening of Neonatal Congenital Heart Disease
Official title: The Effectiveness of Cardio-auscultation and Pulse Oximetry Combined Screening of Congenital Heart Disease in Newborns
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Keywords: Pulse oximetry
Auscultation
Congenital Heart Disease
Screening
Lead sponsor: Women and Children's Hospital of Linyi City
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 40000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population focus on the neonates delivered in the two campuses of the study center which is the largest maternal facility in a municipality of 11 million population.

Brief summary: The investigators conducted this retrospective study in a large single center with an annual birth of more than 20,000 newborns, from January 1, 2018 to December 31, 2019, to confirm the applicability and accuracy of pulse oximetry (POX) combined cardio-auscultation to screen congenital heart disease for neonates.

Detailed description: All consecutive newborn babies were eligible, irrespective of gestational age, NICU admission, symptom presence or prenatal diagnosis.

This study was approved by institutional ethical review board of Linyi Maternal and Child Healthcare Hospital. Spoken informed consent was obtained from the participating babies' parents.

Physicians from departments of neonatal medicine and developmental medicine undertake auscultation screening. When abnormal murmur occurred, an echocardiography would be requested to confirm if the newborn has CHD or not.

Physicians from obstetrics department and nursing staff from neonatal department undertake POX measurement. If a positive POX occurred, an echocardiography would be requested to confirm if the newborn has CHD or not.

Physicians from department of ultrasonography undertake echocardiography confirmation for newborns deemed positive by auscultation or POX.

Eligibility criteria: Inclusion Criteria:

* All consecutive newborn babies delivered in the study center were eligible, irrespective of gestational age, NICU admission, symptom presence or prenatal diagnosis.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Severe congenital heart disease
timeFrame: The first 24 hours after birth.
Secondary outcomes:
Other outcomes:
Locations:
city: Linyi
country: China
facility: Women and Children's Hospital of Linyi City
state: Shandong Provicne
Study officials:
References: