louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01409070: Head to Head Comparison of Azacitidine and Decitabine in Myelodysplastic Syndrome
Official title: Head to Head Comparison of Azacitidine and Decitabine in Myelodysplastic Syndrome: Retrospective, Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myelodysplastic Syndromes
Keywords: MDS
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-08-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: MDS patients who are diagnosed at SNUH

Brief summary: In Myelodysplastic syndrome, epigenetic treatments such as Azacitidine and Decitabine have been highlighted in phase 3 studies. However, as the 1st line treatment, it has not been evaluated the head to head comparison of two drugs. This study is a retrospective study to compare the efficacy of two drugs.

Detailed description: Among 300 MDS patient, 200 of them have been taking Azacitidine and 100 of them have been taking Decitabine. Medical chart of these patients will be reviewed to assess the efficacy and safety between two agents.

Eligibility criteria: Inclusion Criteria:

* Confirmed MDS by bone marrow examination
* Receiving azacitidine and decitabine as a first line chemotherapy
* Adequate hepatic, cardiac, and renal function

Exclusion Criteria:

* Previously treated with another anti-cancer therapy due to MDS
* Not available for clinical information

Primary outcomes:
measure: Response rate
timeFrame: 6 months
Secondary outcomes:
measure: Efficacy
timeFrame: 6 months
measure: Survival rate
timeFrame: 6 months
measure: Number of participants with non-hematologic toxicities
timeFrame: 6 months
measure: infection rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SNUH
Study officials:
References:
citation: Lee YG, Kim I, Yoon SS, Park S, Cheong JW, Min YH, Lee JO, Bang SM, Yi HG, Kim CS, Park Y, Kim BS, Mun YC, Seong CM, Park J, Lee JH, Kim SY, Lee HG, Kim YK, Kim HJ; Korean Society of Haematology AML/MDS working party. Comparative analysis between azacitidine and decitabine for the treatment of myelodysplastic syndromes. Br J Haematol. 2013 May;161(3):339-47. doi: 10.1111/bjh.12256. Epub 2013 Feb 21.
Clinical trial NCT02449070: Effects of Nicorandil on Cardiac Infarct Size in Patients With ST-segment Elevation Acute Myocardial Infarction
Official title: Effects of Nicorandil on Cardiac Infarct Size in Patients With ST-segment Elevation Acute Myocardial Infarction : A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Myocardial Infarction
Keywords: Nicorandil
Cardiac MRI
Lead sponsor: Pusan National University Hospital
Sponsor class: OTHER
Collaborators: name: JW Pharmaceutical
First posted: 2015-05-20
Enrollment: 86
Sex: ALL
Minimum age (years): 20
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 to determine whether nicorandil reduce cardiac infarct size in patient with ST-segment elevation acute myocardial infarction.

Detailed description: Study objective :

To investiage whether nicorandil treatment reduce infarct size measured by cardiac MRI at 6 months after primary PCI

Allocation :

1. Nicorandil arm :

   Recieve nicorandil 4 mg i.v. before undergoing PCI, additionall 2mg i.c. just before 1st ballooning, additionall 2mg i.c. just before stenting, After successful PCI, 10 mg/day (or 5 mg/day) p.o. for 6 months.
2. Control arm :

Recieve standard treatment including PCI, but avoid nicoranil and adenosine.

Follow-up and Measurement :

Cardiac MRI scans are scheduled at 5 days and 6 months after primary PCI. Clinically followed upto 6 months after parimary PCI.

Eligibility criteria: Inclusion Criteria:

* STEMI patients presenting within 12 hours after symptom onset
* Undergoing primary PCI

Exclusion Criteria:

* Previous myocardial infarction
* Atrial fibrillation
* RV infarction
* Cardiogenic shock
* Serum creatinine \>2.0 mg/dL
* Narrow angle glaucoma
* Taking PDE-5 inhibitors

Primary outcomes:
measure: Infarct size as measured by cardiac MRI
timeFrame: Six months after primary PCI
Secondary outcomes:
measure: LVEF(%) as measured by cardiac MRI
timeFrame: Five days and 6 months after primary PCI
measure: MVO as measured by cardiac MRI
timeFrame: Five days after primary PCI
measure: ST-segment resolution
timeFrame: One hour after primary PCI
measure: MACE (Death, Spontaneous MI, Stroke)
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
Study officials:
affiliation: Pusan National University Hospital
name: Jun-Hyok Oh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06719570: A Study of Doravirine and Islatravir as a Single Entity or Combination Therapy and the Effect of Food in Healthy Adult Participants (MK-8591A-055)
Official title: An Open-Label Study to Evaluate the Effect of a High-Fat Meal on the Pharmacokinetics of Doravirine/Islatravir (100 mg/0.25 mg) Fixed-dose Combination Tablet and to Compare the Pharmacokinetics of Doravirine/Islatravir to Doravirine and Islatravir Single Entities in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-12-06
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to learn what happens to MK-8591A in a person's body over time. Researchers will compare what happens to MK-8591A in the body when it is given with and without food.


Eligibility criteria: Inclusion Criteria:

Inclusion Criteria include, but are not limited to:

* Has a body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m\^2
* Is medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and electrocardiograms (ECGs)

Exclusion Criteria:

Exclusion Criteria include, but are not limited to:

* Has a history or presence of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
* Has a history of cancer (malignancy)

Primary outcomes:
measure: Area under the curve from time 0-infinity (AUC0-inf) of DOR
timeFrame: At designated time points up to ~30 days
measure: Area under the curve from time 0 to last measurable concentration (AUC0-last) of Doravine
timeFrame: At designated time points up to ~30 days
measure: Maximum plasma concentration (Cmax) of doravine
timeFrame: At designated time points up to ~30 days
measure: Plasma concentration at 24 hours postdose (C24) of DOR
timeFrame: At designated time points up to ~24 hours postdose
measure: AUC0-inf of ISL
timeFrame: At designated time points up to ~30 days
measure: AUC0-last of ISL
timeFrame: At designated time points up to ~30 days
measure: Cmax of ISL
timeFrame: At designated time points up to ~30 days
Secondary outcomes:
measure: Number of participants who experienced an adverse event (AE)
timeFrame: Up to ~44 days
measure: Number of participants who discontinued study intervention due to an AE
timeFrame: Up to ~30 days
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion (Site 0001)
state: Nebraska
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05752370: Improving Outcomes of Respiratory Patients With Exertional Hypoxemia
Official title: Improving Post-hospitalization Outcomes of Respiratory Patients With Exertional Hypoxemia by Early Pulmonary Rehabilitation Using High Flow Nasal Oxygen- a Pilot Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Rehabilitation
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 56
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of this pilot randomized controlled trial is to determine feasibility of the proposed pulmonary rehabilitation intervention.

Detailed description: In this pilot randomized controlled trial, our primary aim is to determine feasibility of the proposed intervention.

Eligibility criteria: Inclusion Criteria:

* 21 years and above
* Presence of exertional hypoxemia during 1-minute sit-to-stand test
* diagnosis of acute COPD exacerbation or Covid-19 pneumonia or exacerbation of bronchiectasis or exacerbation of interstitial lung disease
* physically fit to participate in exercise therapy as determined by both the patient's physician and physiotherapist

Exclusion Criteria:

* uncontrolled severe medical conditions
* currently enrolled in a pulmonary rehabilitation trial
* unsuitable for randomization as determined by the patient's physician

Primary outcomes:
measure: Changes in 1-minute sit to stand test
timeFrame: 1 month
Secondary outcomes:
measure: Changes in 30-second sit to stand test
timeFrame: 1 month, 3 month
measure: Changes in respiratory symptoms
timeFrame: 1 month, 3 months
measure: Changes in mood
timeFrame: 1 month, 3 month
measure: changes in quality of life
timeFrame: 1 month, 3 month
measure: Changes in lung function
timeFrame: 1 month, 3 month
measure: Changes in lung function
timeFrame: 1 month, 3 month
measure: Proportion of patients who still have exertional hypoxemia
timeFrame: 1 month, 3 month
measure: Adherence rates
timeFrame: 3 week
measure: Changes in 1-minute sit to stand test
timeFrame: 3 month
Other outcomes:
measure: Qualitative interview
timeFrame: Upon completion of study, or when patients end participation in the study
Locations:
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
affiliation: Changi General Hospital
name: Yingjuan Mok
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02105870: A Randomized Trial of Intracoronary Reopro to Improve Coronary Microvascular Function
Official title: A Randomized Control Trial of Intracoronary Reopro to Improve Coronary Microvascular Function
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myocardial Infarction
Coronary Artery Disease
Lead sponsor: University of Melbourne
Sponsor class: OTHER
First posted: 2014-04-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Microvascular dysfunction is a key determinant of pathogenesis and outcome in patients suffering an acute myocardial infarction.

The investigators hypothesise that treatment with intracoronary abciximab, a potent anti platelet agent, at the time of coronary stent insertion, will improve microvascular function.

Detailed description: The index of microcirculatory resistance (IMR), an invasive measure of coronary microvascular function, correlates with clinical outcomes in patients with stable angina and ST elevation myocardial infarction. The glycoprotein IIb/IIIa receptor inhibitor, abciximab, improves coronary microvascular function and reduces major cardiac adverse events in patients with acute coronary syndromes. This study will investigate whether an intracoronary bolus of abciximab in patients with non-ST elevation myocardial infarction decreases IMR and improves microvascular function.

Eligibility criteria: Inclusion Criteria:

* Patient with acute coronary syndromes

Exclusion Criteria:

* Patient with untreated malignancy, disseminated malignancy, active inflammatory diseases, active infectious diseases patients unable to give informed consent Patients with STEMI

Primary outcomes:
measure: Index of Microvascular Resistance
timeFrame: within 3 hours
Secondary outcomes:
measure: Incidence of periprocedural myocardial infarction
timeFrame: within 24 hours
Other outcomes:
Locations:
city: Fitzroy
country: Australia
facility: St Vincent's Hospital
state: Victoria
Study officials:
affiliation: University of Melbourne
name: Andrew Wilson, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004770: Pilot Compassionate Use Study of Thioctic Acid Treatment in Mitochondrial Myopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mitochondrial Myopathy
Keywords: inborn errors of metabolism
mitochondrial myopathy
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: University of Rochester
First posted: 2000-02-25
Enrollment: 1
Sex: MALE
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Assess the efficacy of thioctic acid in treating a single patient with mitochondrial myopathy.

Detailed description: PROTOCOL OUTLINE: The patient receives one thioctic acid tablet 3 times a day. If patient experiences no side effects after 1 week, 2 tablets are administered and given 3 times a day over 3 months for compassionate use.

The patient is followed at weeks 3, 8, and 12.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Long standing ophthalmoparesis and fatiguable weakness of the limbs
* Mild ataxia and no central nervous system involvement
* History of mitochondrial DNA deletion and a measurable biochemical defect of the respiratory chain
* Steady deterioration in skeletal muscle mass and power over 5 years

--Prior/Concurrent Therapy--

* Previous participation in studies of muscle disease natural history (CRC Protocol 183A)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Rochester
name: Robert Griggs
role: STUDY_CHAIR
References:
Clinical trial NCT02848170: Study of CS-3150 Compared to Olmesartan in Patients With Essential Hypertension
Official title: An Exploratory Study of CS-3150 to Evaluate the Relation Between Antihypertensive Effect and Baseline Factors Compared to Olmesartan Medoxomil in Patients With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Essential Hypertension
Keywords: essential hypertension
mineralocorticoid receptor antagonist
Developmental Phase III
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2016-07-28
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Phase 3 study to examine the relation between antihypertensive effect and baseline factors exploratively, compared to olmesartan medoxomil in patients with essential hypertension.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects aged 20 years or older at informed consent
* Subjects with essential hypertension during run-in period (mean 24 hour systolic blood pressure SBP ≥ 130 and diastolic blood pressure DBP ≥ 80 mmHg and Sitting systolic blood pressure (SBP) ≥ 140 mmHg and \< 180 mmHg, Sitting diastolic blood pressure (DBP) ≥ 90 mmHg and \< 110 mmHg)

Exclusion Criteria:

* Secondary hypertension or malignant hypertension
* Diabetes mellitus with albuminuria
* Serum potassium level \< 3.5 or ≥ 5.1 milliequivalent (mEq)/L
* Reversed day-night life cycle including overnight workers
* estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m\^2.

Primary outcomes:
measure: Change from baseline in 24 hr blood pressure
timeFrame: baseline to end of Week 12
Secondary outcomes:
measure: Change from baseline in morning, evening, and night blood pressure.
timeFrame: baseline to week 12
measure: Change from baseline in sitting blood pressure
timeFrame: baseline to week 12
measure: Time course of 24 hr blood pressure and sitting blood pressure
timeFrame: week 12
measure: Proportion of patients achieving 24 hr and sitting blood pressure control
timeFrame: week 12
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
affiliation: Daiichi Sankyo
name: Global Clinical Leader
role: STUDY_DIRECTOR
References:
Clinical trial NCT06893770: The Effect of the Quran on Quality of Life and Quality of Sleep in Breast Cancer
Official title: Effect of Quran Recital on Quality of Life and Quality of Sleep in Patients Receiving Chemotherapy Due to Breast Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Carcinoma
Keywords: breast cancer
Quran recital
life of quality
sleep of quality
Lead sponsor: Ardahan University
Sponsor class: OTHER
Collaborators: name: Erzurum Technical University
First posted: 2025-03-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled design
Primary purpose: TREATMENT

Brief summary: Objective: This study aims to investigate the effects of Quran on quality of life and sleep in patients receiving chemotherapy due to breast cancer.

Method: This study will be conducted with 40 patients with breast cancer receiving chemotherapy at Erzurum City Hospital Outpatient Chemotherapy Unit in a randomized controlled experimental design. Block randomization will be used in group assignment. The breast cancer patient identification form, European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Scale (QLQ-C30) and Pittsburg Sleep Quality Index (PSQI) will be used to collect research data. It is planned to collect research data with a total of four measurements during the application of the first, second, third and last protocols of chemotherapy.

Expected Results: As a result of the study, it is expected that Quran recitation will have a positive effect on quality of life and sleep in patients receiving chemotherapy due to breast cancer.


Eligibility criteria: Inclusion Criteria:

* Having breast cancer
* Being on chemotherapy
* Being on a chemotherapy protocol every 21 days
* Being over the age of 18
* Not having communication problems
* Being willing to participate in the study

Exclusion Criteria:

* Having a hearing problem
* Having an ear infection or any condition that prevents hearing
* Having other types of cancer other than breast cancer

Primary outcomes:
measure: The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Scale (QLQ-C30), Version 3.0 (EORTC QLQ C-30)
timeFrame: From registration to the end of treatment at week 12
Secondary outcomes:
measure: Pittsburg Sleep Quality Index
timeFrame: From registration to the end of treatment at week 12
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Erzurum Technical Universitesi
Study officials:
affiliation: Ardahan University
name: DERYA ŞİMŞEKLİ
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03139175: Association Between TMD and LBP Back Pain
Official title: Association Between Temporomadibular Disorder and Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Conditions
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2017-05-03
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Investigate the relationships between temporomandibular disorder and low back pain

Detailed description: Some patients with chronic low back pain reveal temporomandibular disorder,and others do not. So the aims of my study were to find out the risk factors that contribute to the concurrence of temporomandibular disorder.

Eligibility criteria: Inclusion Criteria:

* unilateral LBP for more than 1 year

Exclusion Criteria:

* sensory or neurologic disorders; structural defect of the spine or lower extremities; a history of spine or TMD surgery; recent hip, knee, or ankle pain; any medication that could affect balance; a history of uncorrected visual impairment; and vestibular disorders.

Primary outcomes:
measure: balance assesment
timeFrame: only measure the balance performance before the treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
Study officials:
affiliation: Tri-Service General Hospital
name: Kuei-Chen Lee, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06094075: Dynamic Strength Index-based Intervention in Basketball.
Official title: Effectiveness of an Individualized Training Based on Dynamic Strength Index on Sprinting, Jumping and Change of Direction Performance in Basketball Players: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sports
Basketball
Strength Training
Lead sponsor: University of Primorska
Sponsor class: OTHER
Collaborators: name: Middlesex University
First posted: 2023-10-23
Enrollment: 46
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups (randomization used for allocation), tested before and after the intervention.
Primary purpose: OTHER

Brief summary: The goal of this randomized controlled trial will be to determine the effectiveness of the dynamic strength index (DSI) in optimizing training programs to improve physical performance proxies (sprinting, jumping, and CoD) in basketball players. Subjects will be randomly allocated to one of two groups: the intervention group and the control group. Measurement and intervention will occur during a 7-week in-season period, right before the play off starts. Throughout this period, all participants will engage in an average of 10 hours of basketball training per week, which will comprise 5 basketball sessions and 2 strength training sessions. In addition, they are anticipated to play 2 games weekly. A pre-test will be performed one week before the first training session, and post-tests will be performed in the week after the training sessions have finished. Athletes will perform both testing sessions at the same time of the day (± 2 hours). Each athlete will perform a 20-m sprint test, with timing gates positioned at every 5 m distance, a 505 CoD test, countermovement jump (CMJ), and isometric mid-thigh pull (IMTP). Based on CMJ peak force and IMTP peak force data, we will calculate DSI. Based on the average DSI value, the participants in the intervention group will be divided into two groups - strength group and ballistic group.


Eligibility criteria: Inclusion Criteria:

* Perform basketball training for at least 5 years
* Plays in professional regional, national or international league

Exclusion Criteria:

* Any musculoskeletal injury in the past 6 months
* Any neurological issues
* Any chronic non-communicable diseases

Primary outcomes:
measure: 20 m Sprint performance
timeFrame: Baseline and after 5 weeks.
measure: Change of direction performance
timeFrame: Baseline and after 5 weeks.
measure: Jumping ability
timeFrame: Baseline and after 5 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Izola
country: Slovenia
facility: University of Primorska, Faculty of Health Sciences
Study officials:
References: