louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04719936: Superior and Inferior Capsulotomy in Bipolar Hemiarthroplasty Using Posterior Approach
Official title: Comparison Between Superior and Inferior Capsulotomy in Bipolar Hemiarthroplasty Using Posterior Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Femoral Neck Fractures
Keywords: Femoral Neck Fractures
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Ajou University School of Medicine
name: Nowon Eulji Medical Center
name: Dankook University
name: Konkuk University Medical Center
name: Gyeongsang National University Hospital
name: Semyeong Christianity Hospital
First posted: 2021-01-22
Enrollment: 3502
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Inferior capsulotomy in bipolar hemiarthroplasty will be performed in 25 patients.

As control group, historical group of patients who received bipolar hemiarthroplasty using superior capsulotomy from January 2010 to December 2020 will be included. A total of 5500 patients are to be included in multicenters.
Primary purpose: TREATMENT

Brief summary: Investigators will compared the clinical outcomes between superior capulotomy and inferior capsulotomy in bipolar hemiarthropalsty using posterior approach.

Detailed description: primary clinical outcome will be dislocation within 1 year after surgery.

Eligibility criteria: Inclusion Criteria:

* more than 50 years old
* displaced femoral neck fractgure

Exclusion Criteria:

* less than 50 years old

Primary outcomes:
measure: dislocation
timeFrame: 12 months
Secondary outcomes:
measure: mobility change
timeFrame: 12 months
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT02894736: Home-Administered Trial of Direct Current Stimulation
Official title: Home-administered Transcranial Direct Current Stimulation (tDCS) Treatment for Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depression
Lead sponsor: The University of New South Wales
Sponsor class: OTHER
First posted: 2016-09-09
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Transcranial Direct Current Stimulation (tDCS) is a novel non-invasive brain stimulation treatment that is effective with no significant side effects. It can potentially be self-administered by patients in their own homes with remote monitoring, substantially reducing treatment costs and increasing accessibility, including to remote areas. This study will evaluate the feasibility and efficacy of home-administered tDCS treatment for depression.


Eligibility criteria: Inclusion Criteria:

* Subject meets criteria for a DSM-IV Major Depressive Episode, lasting more than 4 weeks
* Total MADRS score ≥ 20

Exclusion Criteria:

* Diagnosis of any DSM-IV psychotic disorder
* History of drug or alcohol abuse or dependence in the preceding 3 months
* High suicide risk
* Clinically defined neurological disorder or insult
* Metal in the cranium or skull defects
* Skin lesions on the scalp (e.g. cuts, abrasions, rashes) at the proposed electrode sites
* Pregnancy

Primary outcomes:
measure: Montgomery Asberg Depression Rating Scale for Depression (MADRS)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Randwick, Sydney
country: Australia
facility: Black Dog Institute
state: New South Wales
Study officials:
affiliation: University of New South Wales / Black Dog Institute
name: Angelo Alonzo, BSc(Hons)/BA, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04159636: Pulmonary Aspiration in Elderly Patients
Official title: Comparison of the Risk of Pulmonary Aspiration Assessed by Gastric Ultrasound in Elderly Patients in Fasting Group vs. Carbohydrate Loading Group
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
First posted: 2019-11-12
Enrollment: 58
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study was to compare the risk of pulmonary aspiration assessed with gastric ultrasonography in elderly patients, undergoing elective surgery.

Detailed description: Recently, carbohydrate loading is suggested for enhanced recovery after surgery.

Aging process often accompanies gastrointestinal dysmotility. Therefore, elderly patients might have undiagnosed gastro-esophageal reflux disease, or other gastrointestinal disorders. Moreover, because of their co-morbid underlying diseases and multi-drug effects, gastric emptying might be further delayed in the elderly patients.

This study was designated to compared the risk of pulmonary aspiration in elderly patients, with gastric ultrasound between fasting group and carbohydrate loading group.

Eligibility criteria: Inclusion Criteria:

* aged from 65
* scheduled for elective surgery
* American Society of Anesthesiologists physical status 1 or 2

Exclusion Criteria:

* Diagnosed for diseases that might delay gastric emptying (obesity, diabetes, hiatal hernia, gastro-esophageal reflux disease, ileus)
* psychiatric or mental disorders
* delirium
* dementia
* parkinsonism
* alcoholism
* drug abuse

Primary outcomes:
measure: Incidence of risk of pulmonary aspiration assessed by gastric ultrasound defined by Perlas grade 2
timeFrame: 2 hours after intake of last allowable carbohydrate drink time
Secondary outcomes:
measure: cross-sectional area of gastric antrum in supine position
timeFrame: 2 hours after intake of last allowable carbohydrate drink time
measure: cross-sectional area of gastric antrum in right decubitus position
timeFrame: 2 hours after intake of last allowable carbohydrate drink time
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
Study officials:
References:
Clinical trial NCT03852641: Feeding Premature Infants During Non-invasive Respiratory Support
Official title: Feeding Very-low-birth-weight (VLBW) Premature Infants (<1500g) During Non-invasive Respiratory Support- Continuous Drip Vs. Bolus Gavage Feeding
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Premature Infant
Non-invasive Respiratory Support
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2019-02-25
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A randomized control trial comparing bolus gavage feeds to continuous feed among premature infants supported by non-invasive respiratory support


Eligibility criteria: Inclusion Criteria:

* Infants \<1500gr, on non-invasive respiratory support
* Feeding\>20 ml/kg/day

Exclusion Criteria:

* Major congenital malformations
* Unstable infants because of sepsis, central nervous system, cardiac or other significant morbidities
* Gastrointestinal morbidity such as spontaneous intestinal perforation (SIP) and necrotising enterocolitis (NEC).

Primary outcomes:
measure: Oxygenation instability as documented by oxygen saturation histograms
timeFrame: before dischatge home at an average of 40 weeks gestation
measure: Time to full feeds (TFF) defined as full enteral gavage feeding of 150 cc/Kg/day
timeFrame: before dischatge home at an average of 40 weeks gestation
Secondary outcomes:
measure: Respiratory-length of respiratory support
timeFrame: before dischatge home at an average of 40 weeks gestation
measure: Incidence of Necrotising enterocolitis (NEC) as defined by the medical team
timeFrame: before dischatge home at an average of 40 weeks gestation
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
affiliation: Rambam Health Care Campus
name: Liron Borenstein-Levin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05646641: Strength Training in Fibromyalgia on Balance, Neuromuscular Performance and Symptoms
Official title: Does Strength Training in Fibromyalgia Affect Balance, Neuromuscular Performance and Symptoms? A 12 Week of a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: University of Beira Interior
Sponsor class: OTHER
Collaborators: name: Universidade Federal de Pernambuco
First posted: 2022-12-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is verify the effects of a 8 weeks strength training, on balance, neuromuscular performance and symptomatology of fibromyalgia.

Detailed description: Thirty participants will be recruited. Volunteers will be randomly assigned to the control group or experimental group. Before the training period, symptoms, balance and neuromuscular performance will be assessed. Participants in the experimental group will perform strength training twice a week (50 min each) for eight weeks. Then, four weeks of detraining will be completed.

Eligibility criteria: Inclusion Criteria:

* medical diagnosis of fibromyalgia according to the American College of Rheumatology criteria
* at least 18 years old

Exclusion Criteria:

* severe comorbidity or any other type of condition that negatively influences participation in the training program
* cognitive disorders
* heart problems
* surgeries or fractures in the last 6 months
* regular practice of physical exercises in the least 3 months before program.

Primary outcomes:
measure: Balance
timeFrame: Change from Baseline balance at week 9
measure: Balance
timeFrame: Change from Baseline balance at week 12
measure: Balance
timeFrame: Change from week 9 balance at week 12
measure: Neuromuscular performance
timeFrame: Change from Baseline neuromuscular performance at week 9
measure: Neuromuscular performance
timeFrame: Change from Baseline neuromuscular performance at week 12
measure: Neuromuscular performance
timeFrame: Change from week 9 neuromuscular performance at week 12
Secondary outcomes:
measure: Fibromyalgia impact questionnaire
timeFrame: Baseline, week 9, week 12
measure: Pain intensity
timeFrame: baseline and everyday until the week 12
measure: Anxiety
timeFrame: baseline and everyday until the week 12
measure: Quality of sleep
timeFrame: baseline and everyday until the week 12
measure: Fatigue
timeFrame: baseline and everyday until the week 12
measure: Mood state
timeFrame: baseline and everyday until the week 12
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Federal University of Pernambuco
state: Pernambuco
Study officials:
affiliation: University of Beira Interior
name: Investigator
role: STUDY_DIRECTOR
References:
Clinical trial NCT04645641: Evaluation of the Safety and Effectiveness of the Dexcom Glucose Monitoring (CGM) System
Official title: Evaluation of the Safety and Effectiveness of the Dexcom Glucose Monitoring (CGM)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: DexCom, Inc.
Sponsor class: INDUSTRY
First posted: 2020-11-27
Enrollment: 150
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Evaluation of the Safety and Effectiveness of the Dexcom Glucose Monitoring (CGM) System

Detailed description: The objective of the study is to establish performance of the Dexcom CGM System (System) in comparison to a blood glucose comparator method.

Eligibility criteria: Inclusion Criteria:

* Ages 2 or older
* Diagnosis of Type 1 diabetes or Type 2 diabetes
* Willing to wear the required number of Systems for the total duration of study wear
* Willing to participate in Clinic Session(s) during study wear

Exclusion Criteria:

* Presence of extensive skin changes/diseases at sensor wear site(s) that preclude wearing the sensor(s) on skin
* Known allergy to medical-grade adhesives
* Pregnancy
* Hematocrit outside specification
* ≥ 18 years of age:

  * Male: 36.0%;
  * Female: 33.0%;
* 13-17 years of age: 35.0%;
* 7 years - 12 years of age: 32.0%;
* End stage renal disease and currently managed by dialysis or anticipating initiating dialysis during the study wear period
* Required or scheduled to have a Magnetic Resonance Imaging (MRI) scan, Computed Tomography (CT) scan, or diathermy during the study wear period

Primary outcomes:
measure: System Performance
timeFrame: 10 days
Secondary outcomes:
measure: System Related Adverse Device Effects
timeFrame: 10 days
Other outcomes:
Locations:
city: Escondido
country: United States
facility: AMCR Institute
state: California
city: Aurora
country: United States
facility: Barbara Davis Center
state: Colorado
city: Idaho Falls
country: United States
facility: Rocky Mountain Clinical Research
state: Idaho
city: San Antonio
country: United States
facility: Endeavor Clinical Trials
state: Texas
Study officials:
References:
Clinical trial NCT02599441: Computed Tomography for Evaluating Supination-external Rotation Type Ankle Fractures
Official title: Comparison of a Novel Weight Bearing Cone-beam Computed Tomography (CT) Scan to Gravity Stress X-ray for Determining Instability of Supination-external Rotation Type Ankle Fractures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Supination-external Rotation Ankle Fractures
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2015-11-06
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have been diagnosed with unstable supination-external rotation type ankle fractures

Brief summary: To compare measures of ankle stability from an investigational cone beam computed tomography scanner to gravity stress X-ray in patients who have unstable supination-external rotation ankle fractures.


Eligibility criteria: Inclusion Criteria:

* willing \& able to provide written informed consent
* at least 18 years-old
* have medial clear space measuring less than 5 mm with clinical suspicion of instability and would normally require a gravity stress X-ray

Exclusion Criteria:

* pregnant (females)
* prisoners
* open fracture
* clinical signs of foot deformity
* previous foot trauma or surgery on the affected foot
* significant osteoarthritis or pre-existing ligamentous instability or pain in the affected foot
* unable to stand in the weight bearing position during the CT scan

Primary outcomes:
measure: Medial Clear Space Distance in the Ankle Joint
timeFrame: Baseline- single-day study
Secondary outcomes:
measure: Medial Clear Space on Gravity Stress Xray
timeFrame: Baseline
measure: Medial Clear Space on Standard Xray
timeFrame: Baseline
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: UBMD Orthopaedics & Sports Medicine
state: New York
Study officials:
affiliation: UBMB Orthopaedics & Sports Medicine
name: John Marzo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02540941: Protocols Development for Single Cells Genomics and Their Implementation for Molecular Diversity Between Cells
Official title: Protocols Development for Single Cells Genomics and Their Implementation for Molecular Diversity Between Cells
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2015-09-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will obtain human single and bulk cells from healthy donors. Volunteers will be sperm donors who shall designate part or full donation to the proposed research. Egg donors who shall designate part of the eggs to the proposed research; for women who come to the clinics of fertility problems. Reaching the donors will be using advertisements in sperm banks and in women's health centers or asking for student volunteers.

Brief summary: The investigators will extract single cells and analyze the molecular composition of single cells as well as bulks using the latest protocols for single cell and bulk genomics analyses including genetic, epigenetic, transcriptomic and proteomic analyses using the latest available protocols. A broad list of such example protocols are listed below.

The samples and their molecular characterization (including sequencing \& molecular levels) will serve as the basis for development of methods for single cells analysis. The developed methods are aimed at genomic transcriptomic, epigenetic, or proteomics analysis of single cells and share the same structure: the measured feature will be translated to a DNA library which will represent the feature by a dedicated assay.

This library alongside with proper mathematical analysis of the sequencing results will be performed in order to conclude the desired feature. The general structure of such protocols is described in our review paper (Single-cell sequencing-based technologies will revolutionize whole-organism science, E. Shapiro, T. Biezuner \& S.Linnarsson, Nature Reviews Genetics 14, 618-630, 2013) which is attached to our proposal.

In addition, the researchers will use sequencing based methods (existing and future developed) in order to compare single cells and bulks from different tissues and/or different time points from the same donor in order to measure genetic, epigenetic, transcriptomic, and proteomic diversity.


Eligibility criteria: Inclusion Criteria:

Adults

Exclusion Criteria:

* Non

Primary outcomes:
measure: Measuring single-cell variability using single-cell genomics
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01209741: Bioavailability of Variably Aged MK-0974 Tablets (MK-0974-038)(COMPLETED)
Official title: An Open Label, Randomized, 3-Period Crossover Study to Evaluate the Comparative Bioavailability of Variably Aged MK-0974 Capsules Administered Orally as Single Doses in Healthy Male and Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Migraine
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-09-27
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will evaluate the comparative bioavailability of three capsule formulations of MK-0974.


Eligibility criteria: Inclusion Criteria:

* Subject is in good health
* Subject is a nonsmoker
* Subject is willing to comply with the study restrictions

Exclusion Criteria:

* Subject has a history of stroke, chronic seizures, or major neurological disorder
* Subject has a history of cancer
* Subject is a nursing mother
* Subject has or has a history of any illness that might make participation in the study unsafe or confound the results of the study

Primary outcomes:
measure: Area under the curve (AUC(0 to infinity) following single dose administration of MK-0974 12Mo5C and 5Mo5C formulations
timeFrame: Through 48 hours postdose
measure: Peak plasma concentration (Cmax) following single dose administration of MK-0974 12Mo5C and 5Mo5C formulations
timeFrame: Through 48 hours postdose
Secondary outcomes:
measure: Area under the curve (AUC(0 to infinity) following single dose administration of MK-0974 12MoRT and 5Mo5C formulations
timeFrame: Through 48 hours postdose
measure: Peak plasma concentration (Cmax) following single dose administration of MK-0974 12MoRT and 5Mo5C formulations
timeFrame: Through 48 hours postdose
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00883441: Implementation Research of New Dengue Vector Control Tools
Official title: Implementation Research of New Dengue Vector Control Tools
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: DENGUE
Keywords: IMPLEMENTATION RESEARCH
AEDES
VECTOR CONTROL
Lead sponsor: Institute of Tropical Medicine, Belgium
Sponsor class: OTHER
Collaborators: name: European Union
name: Mahidol University
name: Universidad de los Andes, Chile
First posted: 2009-04-17
Enrollment: 22
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This project will provide new insights concerning how to reduce dengue transmission by means of cost-effective and sustainable implementation strategies of vector control methods.

The research will assess key strategies which deliver new vector control tools with respect to their cost-effectiveness, acceptability and sustainability in contrasting environments.


Eligibility criteria: Inclusion Criteria:

* No patients, but communities were included, with as inclusion criteria: neighborhoods of Lam Chabang, Thailand and Valera and San Rafael de Carvajal, Venezuela after obtaining community approval

Exclusion Criteria:

* Neighborhoods without community approval

Primary outcomes:
measure: Aedes aegypti entomological indices
timeFrame: every 6 months
Secondary outcomes:
measure: uptake and acceptance of tools
timeFrame: 6 and 18 months after distribution
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Tropical Medicine, Mahidol University,
city: Trujillo
country: Venezuela
facility: Universidad de Los Andes, Research Centre, Trujillo
Study officials:
References: