louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02133560: Use of Mobile Technology for Intensive Training in Medication Management
Official title: Use of Mobile Technology for Intensive Training in Medication Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Disease
Thalassemia
Keywords: Sickle cell
Thalassemia
Adherence
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Sicklesoft Inc
First posted: 2014-05-08
Enrollment: 46
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Purpose: Assess whether intensive training with education and daily remote monitoring with provider involvement has a lasting positive impact on adherence to medication management. The study will seek to enroll 25 subjects with sickle cell disease or thalassemia, and less than 100% compliance for taking iron chelators in the previous three month prior to participation in the study. Subjects will be asked to monitor their daily iron chelator administration by taking a video recording of preparing it and ingesting at least one sip. Subjects will also use a medication log to record daily administration of medication, and meet with study staff monthly for educational activities. The data collected will be analyzed to describe patient adherence and comfort level with the process of daily recording of medication management. Mean percent adherence in the pre-study periods and each of the study periods will be analyzed and compared.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of sickle cell or thalassemia
* History of iron overload

Exclusion Criteria:

* None

Primary outcomes:
measure: Increase adherence to medication regimen
timeFrame: Baseline, 3 month, 6 month, 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Nirmish Shah, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04113460: The Effectiveness Yoga@Work Among Office Workers With Chronic Nonspecific Neck Pain (CNNP)
Official title: The Effectiveness Yoga@Work Among Office Workers With Chronic Nonspecific Neck Pain (CNNP): A Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Non-Specific Neck Pain
Lead sponsor: NMP Medical Research Institute
Sponsor class: OTHER
Collaborators: name: Yog-Kulam
First posted: 2019-10-02
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic nonspecific neck pain (CNNP) is a public health issues with a 50% life prevalence. CNNP is a leading cause of disability which contributes to higher costs due to loss of productivity, disability, and increased absenteeism from work. Yoga has been found effective managing neck pain but there has been no study at work setting for chronic non-specific neck pain.

To determine the effectiveness of Yoga@work program for chronic non specific neck pain among office workers, present randomised controlled trial was undertaken.


Eligibility criteria: Inclusion Criteria:

* Participants who gave written informed consent
* Having neck pain for more than 3 month

Exclusion Criteria:

* Systematic disorder
* Neck or spine injuries
* Recent surgery

Primary outcomes:
measure: Neck Pain
timeFrame: Change from baseline to 8 weeks
Secondary outcomes:
measure: Health related quality of life
timeFrame: Change from baseline to 8 weeks
measure: Neck function
timeFrame: change from baseline to 8 weeks
Other outcomes:
Locations:
city: Jaipur
country: India
facility: Yog Bhawan
Study officials:
affiliation: Yog-Kulam
name: Neha Sharma, PhD
role: STUDY_DIRECTOR
affiliation: NMP Medical Research Institute, India
name: Shekhar Sharma
role: PRINCIPAL_INVESTIGATOR
affiliation: Yog-Kulam
name: Jaydeep Joshi
role: STUDY_CHAIR
References:
Clinical trial NCT05698160: Biomarkers and Prediction of Tigecycline Induced Coagulation Dysfunction
Official title: Biomarkers and Prediction of Tigecycline Induced Coagulation Dysfunction Based on Multi-omics and Machine Learning Techbology
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Blood Coagulation Disorder
Keywords: Tigecycline
Blood Coagulation Disorder
multi-omics
machine learning techbology
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The critically ill patients treated with tigecycline in the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Brief summary: This study is to screen out the biomarkers and establish the model to predict coagulation dysfunction induced tigecycline

Detailed description: The critically ill patients treated with tigecycline in in tensive care unit will be recruited and divided into tigecycline-induced coagulation dysfunction group and non-coagulation dysfunction group. The multi-omics will be used to screen out biomarkers for early prediction of coagulation dysfunction caused by tigecycline. Afterwards, machine learning methods will be adopted to establish the the early prediction model of tigecycline-induced coagulation dysfunction.

Eligibility criteria: Inclusion Criteria:

* Inpatients receiving tigecycline treatment in the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
* Intravenous tigecycline ≥ 3 days
* Monitoring the plasma concentration of tigecycline

Exclusion Criteria:

* Missing clinical data

Primary outcomes:
measure: Biomarkers associated with the coagulation dysfunction induced tigecycline
timeFrame: January 2023-December 2025
Secondary outcomes:
measure: Prediction model for coagulation dysfunction induced by tigecycline
timeFrame: January 2023-December 2025
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01461460: A Thorough QT Study of TR-701free Acid (FA) in Healthy Subjects
Official title: A Phase 1 Blinded, Placebo-controlled Crossover Study to Evaluate the Effects of Oral TR 701 Free Acid on the Electrocardiogram
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: volunteer
Lead sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
First posted: 2011-10-28
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to assess the effects of oral TR-701 free acid (FA) versus placebo on QTcF.

Detailed description: To assess the effects of a single therapeutic (200 mg) and supratherapeutic of oral TR-701 free acid (FA) versus placebo on QT interval corrected for heart rate using Fridericia's formula (QTcF) in healthy subjects.

Eligibility criteria: Inclusion Criteria:

* Male or female subjects between 18 and 45 years of age, inclusive.
* Healthy males and females with no clinically significant abnormalities.
* Body mass index ≥18.0 kg/m2 and ≤30.0 kg/m2

Exclusion Criteria:

* Sustained supine systolic blood pressure \>140 or \<100 mmHg or a diastolic blood pressure \>90 or \<60 mmHg at the Screening and Day 1 Visit.
* Abnormal ECG at Screening or Day -1 Visits indicating a second or third-degree atrioventricular block, or QRS \>110 msec, QTcF \>450 msec for males and \>470 msec for females, PR interval \>200 msec, or any rhythm other than sinus rhythm which is interpreted by the Investigator as clinically significant - History of unexplained infections or current signs of infection
* History of risk factors for Torsades de Pointes, including unexplained syncope, known Long QT Syndrome, heart failure, myocardial infarction, angina, or clinically significant abnormal laboratory assessments including hypokalemia, hypercalcemia, hypomagnesemia, or family history of Long QT Syndrome or Brugada Syndrome

Primary outcomes:
measure: QTcF Change from Baseline
timeFrame: 24 Hours
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Trius Investigator
state: Texas
Study officials:
affiliation: Trius Therapeutics
name: Philippe G Prokocimer, MD
role: STUDY_CHAIR
References:
citation: Flanagan S, Litwin J, Fang E, Prokocimer P. Effects of therapeutic and supratherapeutic doses of oral tedizolid phosphate on cardiac repolarisation in healthy volunteers: a randomised controlled study. Int J Antimicrob Agents. 2016 Jul;48(1):33-40. doi: 10.1016/j.ijantimicag.2015.12.015. Epub 2016 Jun 2.
Clinical trial NCT06229860: Impact of Personality on Adherence to Tyrosine Kinase Inhibitor Therapy in Pts W/Chronic Myeloid Leukemia
Official title: Impact of Personality on Adherence to Tyrosine Kinase Inhibitor Therapy in Patients with Chronic Myeloid Leukemia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Myeloid Leukemia
Chronic Phase Chronic Myelogenous Leukemia
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study populations include adult patients with CML in chronic phase (CML-CP) who are being treated with one of the four TKIs - imatinib, dasatinib, bosutinib, and nilotinib

Brief summary: This is an observational pilot study to examine the association between a patient's personality and adherence to tyrosine kinase inhibitor therapy in patients with chronic myeloid leukemia.

Detailed description: The purpose of this pilot study is to explore the association between personality and adherence to a specific type of oral cancer medication - tyrosine kinase inhibitor (TKI) - in patients with chronic myeloid leukemia (CML). 75 individuals with chronic phase CML who are being treated with TKIs will be recruited. Consenting patients will participate in a focused interview where TKI adherence, personality type, and quality of life and symptom burden will be assessed using validated questionnaires. Information on treatment response and the treating physician's perception of TKI adherence will be obtained from the electronic health record.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Diagnosed with chronic myeloid leukemia (CML) and in the chronic phase (CML-CP)
* Currently being treated with one of four cancer medications - imatinib, dasatinib, bosutinib, or nilotinib
* A patient at the UCI Chao Family Comprehensive Cancer Center (CFCCC), or
* A member of a patient support group organized by the CML Buster Foundation
* Do not meet any of the criteria listed under "Exclusion Requirements"

Exclusion Criteria:

* Unable to read and speak English
* Impaired decisional capacity to consent

Primary outcomes:
measure: Assessment of adherence to TKI medication
timeFrame: Up to 1 year
measure: Personality assessment
timeFrame: Up to 1 year
measure: Assessment of quality of Life
timeFrame: Up to 1 year
measure: Assessment of quality of Life and symptom burden
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: Chao Family Comprehensive Cancer Center University of California, Irvine
state: California
Study officials:
affiliation: Chao Family Comprehensive Cancer Center
name: Mahtab Jafari, Pharm.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01352260: Near-Infrared Spectroscopy Comparison Study
Official title: Validation of Near-Infrared Spectroscopy for Neuromonitoring During Moderate Hypothermic Circulatory Arrest for Total Aortic Arch Replacement: A Comparison of Two Technologies With Jugular Venous Bulb Oximetry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Aortic Arch Replacement
Keywords: Near Infrared Spectroscopy
Neuromonitoring
Aortic Arch Replacement
Lead sponsor: Nonin Medical, Inc
Sponsor class: INDUSTRY
Collaborators: name: Baylor College of Medicine
First posted: 2011-05-11
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Baylor College of Medicine and affiliated Hospitals

Brief summary: The objective of this study is to validate Near-Infrared (NIRS) monitoring in patients undergoing circulatory arrest. This study will compare two-wavelength NIRS INVOS System, Somanetics; Troy, MI) with four-wavelength NIRS (Nonin Medical, Inc; Plymouth, MN) to determine which modality best correlates with jugular venous oxygen saturation


Eligibility criteria: Inclusion Criteria:

1. Provide written informed consent from patient or legally authorized representative before surgery
2. Adult patients 18-65 years of age
3. Presenting for elective or urgent total aortic arch repair under moderate hypothermic circulatory arrest (Nasopharyngeal temperature 20 - 24 ºC) with selective antegrade cerebral perfusion -

Exclusion Criteria:

1. Patients will be excluded from this study if they are age less than 18
2. Are undergoing an emergent procedure
3. Have a history of insulin-dependent diabetes mellitus
4. Have a history of stroke
5. Are undergoing a redo sternotomy during which major bleeding occurs necessitating transfusion of \> 4 units of packed red blood cells prior to the institution of circulatory arrest
6. Patients in whom a left jugular venous bulb cannula cannot successfully be placed

Primary outcomes:
measure: Linear correlation between absolute value of cerebral oxygen saturation (rSO2) compared to Jugular Venous Oxygen Saturation (SjvO2). Sensitivity and specificity to detect < 60% desaturation.
timeFrame: At the end of the surgical case approximately 6 to 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine and affiliated Hospitals
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Wei Pan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01478360: Safety, Tolerability, and Efficacy of AIN457 in Patients With Uncontrolled Asthma
Official title: A Randomized, Double-blind, Placebo Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, and Efficacy of Intravenous Administration of Secukinumab (AIN457) in Patients With Asthma Not Adequately Controlled With Inhaled Corticosteroids and Long Acting Beta-agonists.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Asthma
Keywords: Asthma
Secukinumab
Therapeutic Uses
Respiratory
Lung
Pulmonary
inhaled
corticosteroids
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-11-23
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a preliminary proof of efficacy study of AIN457 in patients with bronchial asthma that is poorly controlled with the current standard of care.


Eligibility criteria: Inclusion Criteria:

* Adult patients with asthma \>1 year duration diagnosed according to the GINA guidelines (GINA 2010).
* Daily treatment with \> 1000μg beclomethasone dipropionate or equivalent, plus a long acting beta agonist for ≥ 3 months prior to Day 1, that has been stable for at least 4 weeks prior to screening.
* Asthma which is not adequately controlled on current treatment
* Peripheral blood eosinophil count \< 400/μl at screening

Exclusion Criteria:

* Women of child-bearing potential unwilling to use effective contraception during the study and for 16 weeks after stopping treatment.
* Use of other investigational drugs at the time of screening, or within 30 days of screening.
* Smokers

Primary outcomes:
measure: Improvement in the Severity of Asthma as Measured by Change in the Asthma Control Questionnaire (ACQ) Score
timeFrame: Baseline and 85 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Grosshansdorf
country: Germany
facility: Novartis Investigative Site
city: Mainz
country: Germany
facility: Novartis Investigative Site
city: Wiesbaden
country: Germany
facility: Novartis Investigative Site
city: Leicester
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Manchester
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT06217276: Respiratory Muscle Fatigue and Lower Extremity Muscle Oxygenation
Official title: Examining the Relationship Between Respiratory Muscle Fatigue and Lower Extremity Muscle Oxygenation in Chronic Obstructive Pulmonary Disease Patients.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COPD
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: In our study, changes in vastus lateralis muscle oxygenation will be evaluated with the Moxy device, a functional infrared oxygen measurement device, during the inspiratory muscle fatigue protocol in COPD cases and the healthy control group.


Eligibility criteria: Inclusion Criteria:

* Having a diagnosis of Stage 2-3 COPD according to the following clinical diagnostic criteria according to the American Thoracic and European Respiratory Societies (ATS-ERS).
* Having been using the same medications for the last 4 weeks

Exclusion Criteria:

* Patients with severe comorbid diseases, unstable coronary artery disease, collagen vascular diseases and requiring high-flow oxygen therapy (˃ 3-4 L\\min).
* Presence of any vascular problem that may affect lower extremity muscle oxygenation
* Presence of another respiratory system disease other than COPD
* Patients who have had an acute COPD exacerbation in the last 4 weeks
* Patients experiencing COPD exacerbations during the study protocol
* Presence of fatty tissue or scar tissue at the measurement points, which may impair the measurement quality.
* Have already participated in another clinical trial within the last 30 days that may affect the results of the study.

Inclusion Criteria for Healthy Cases

* Being over 18 years of age
* Not having any diagnosed chronic disease
* Not being a smoker

Primary outcomes:
measure: Lower extremity muscle oxygenation level measurement
timeFrame: 20 minutes
measure: Lower extremity muscle total hemoglobin amount level measurement
timeFrame: 20 minutes
Secondary outcomes:
measure: Peripheral oxygen saturation measurement
timeFrame: 20 minutes
measure: Forced vital capacity (FVC),
timeFrame: 5 minutes
measure: Respiratory muscle strength
timeFrame: 10 minutes
measure: Forced expiratory volum in one second (FEV1)
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Yedikule Chest Disease Hospital
state: Zeytinburnu
Study officials:
References:
Clinical trial NCT01834976: Cardiac Biomarker in Pediatric Heart Disease
Official title: Observational Study of Cardiac Biomarker During Perioperative Management in Pediatric Heart Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Keywords: cardiac biomarker
congenital heart disease
surgery
Lead sponsor: Okayama University
Sponsor class: OTHER
First posted: 2013-04-18
Enrollment: 74
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric patients who receive surgery for congenital heart disease under 18 years old

Brief summary: The purpose of this study is to investigate cardiac biomarker during perioperative management in pediatric cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* children who receive surgery for congenital heart disease
* require cardiopulmonary bypass for surgery
* under 18 years old

Exclusion Criteria:

* simple congenital heart disease (atrial septal defect, ventricle septal defect, patent ductus arteriosus)

Primary outcomes:
measure: serious adverse events
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Okayama
country: Japan
facility: Okayama University Hospital
Study officials:
References: