louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04169516: Localization of Microvascular Dysfunction
Official title: Different Microcirculation Response to Ischemic Injury of Culprit and Non-culprit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Keywords: microcirculation
Lead sponsor: Dong-A University
Sponsor class: OTHER
First posted: 2019-11-20
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute coronary syndrome

Brief summary: Microvascular dysfunction is an independent predictor of poor prognosis. Such response in the culprit vessel is common even after successful revascularization. This study investigated whether the microvascular dysfunction differed between culprit and non-culprit vessels in patients with acute coronary syndrome (ACS) who underwent percutaneous coronary intervention (PCI).

Detailed description: The prospective study included 115 patients with ACS. In this study, after successful PCI, culprit and non-culprit intracoronary hemodynamic measurements were performed and repeated at 6-month follow-up. 13N-ammonia positron emission tomography (PET) was performed at 6-month follow-up visit to determine absolute myocardial blood flow (MBF). The resistance values of each vessel were calculated using the coronary pressure data and the MBF values obtained from 13N-ammonia PET data. Such physiological measures were compared between culprit and non-culprit vessels in baseline and 6-month follow-up.

Eligibility criteria: Inclusion Criteria:

* Individuals were eligible for inclusion if they underwent PCI for ACS, if the target lesion was found in the proximal or middle segments of a major epicardial coronary artery, and if the lesion was successfully treated with a coronary stent.

Exclusion Criteria:

* a previous infarction other than in the vessel of interest or a history of coronary artery bypass surgery, cardiogenic shock requiring inotropic support, chronic kidney disease requiring renal replacement therapy, hypertrophic cardiomyopathy, collateral flow to the target vessel greater than angiographic grade 1, or statin or ticagrelor use within 1 year.

Primary outcomes:
measure: Change from Baseline index of microcirculatory resistance at 6 months
timeFrame: baseline and 6-month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Jo YS, Moon H, Park K. Different Microcirculation Response Between Culprit and Non-Culprit Vessels in Patients With Acute Coronary Syndrome. J Am Heart Assoc. 2020 May 18;9(10):e015507. doi: 10.1161/JAHA.119.015507. Epub 2020 May 15.
Clinical trial NCT03214016: Effects of Pilates Method and Aerobic Training in Hypertensive Subjects
Official title: Effects of Pilates Method and Aerobic Training in Hypertensive Subjects: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Pilates Training
Aerobic Exercises
Hypertension
Clinical trial
Lead sponsor: Universidade Federal de Santa Maria
Sponsor class: OTHER
First posted: 2017-07-11
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: This study evaluates the effects of Pilates method and aerobic training in hypertensive subjects. Half of participants will be trained with Pilates, while the other half will be trained with aerobic exercise during 8 weeks.


Eligibility criteria: Inclusion Criteria:

* subjects with high blood pressure controled by medication;
* sedentary.

Exclusion Criteria:

* IMC≥30 kg/m²
* using beta blockers
* smokers or that interrupted the routine less than 6 months
* musculoskeletal diseases in evolution or with current symptomatic
* rheumatological diseases
* other cardiovascular disease
* renal disease due to hypertension
* endocrine, neurological, oncological, immunological, hematological and psychiatric diseases.

Primary outcomes:
measure: Change from baseline casual systolic blood pressure at 8 weeks
timeFrame: baseline and 8 weeks
measure: Change from baseline 24-hour systolic blood pressure at 8 weeks
timeFrame: baseline and 8 weeks
Secondary outcomes:
measure: Casual diastolic blood pressure
timeFrame: baseline and 8 weeks
measure: Heart rate variability
timeFrame: baseline and 8 weeks
measure: Diastolic and mean blood pressure
timeFrame: baseline and 8 weeks
measure: Functional capacity
timeFrame: baseline and 8 weeks
measure: Respiratory muscle strength
timeFrame: baseline and 8 weeks
measure: Muscle strength
timeFrame: baseline and 8 weeks
measure: Flexibility
timeFrame: baseline and 8 weeks
measure: Body Mass Index
timeFrame: baseline and 8 weeks
measure: Oxidative damage
timeFrame: baseline and 8 weeks
measure: Antioxidant capacity
timeFrame: baseline and 8 weeks
measure: Lipid profile
timeFrame: baseline and 8 weeks
measure: Endothelial function
timeFrame: baseline and 8 weeks
measure: Inflammation
timeFrame: baseline and 8 weeks
measure: Creatinine
timeFrame: baseline and 8 weeks
measure: Lactate
timeFrame: baselina and 8 weeks
measure: Creatine kinase
timeFrame: baseline and 8 weeks
measure: Questionnaire of Quality of life
timeFrame: baseline and 8 weeks
Other outcomes:
Locations:
city: Santa Maria
country: Brazil
facility: University Federal of Santa Maria
state: RS
Study officials:
References:
Clinical trial NCT01547416: The Effect of Combined General/Epidural Anesthesia Versus General Anesthesia on Diaphragmatic Function
Official title: The Effect of Combined General/Epidural Anesthesia Versus General Anesthesia on Diaphragmatic Function After Robot-assisted Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prostate Cancer
Keywords: Diaphragmatic dysfunction
General anesthesia
Epidural Anesthesia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-03-07
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to investigate whether robot assisted laparoscopic radical prostatectomy give rise to the impairment of diaphragmatic function postoperatively, and whether combined general/epidural anesthesia could provide better postoperative diaphragmatic function.

Detailed description: Diaphragmatic dysfunction after abdominal surgery can result in extended hospital stay and increased medical costs, because it is related with atelectasis, lung collapse or pneumonia. The mechanism of diaphragm dysfunction is thought to be from not only direct injury to abdominal wall and viscera but inhibitory reflexes of phrenic activity. Thoracic or upper abdominal surgery is suggested as a risk factor of postoperative diaphragm dysfunction, and perioperative analgesic modality is also known to affect diaphragm movements. But there has been no trial to investigate the effect of laparoscopic pelvic surgery such as prostatectomy on diaphragm movement. Moreover, it is not clear if minimally invasive Robot-assisted laparoscopic radical prostatectomy (RALRP) has any influence on respiratory and diaphragm functions.

Eligibility criteria: Inclusion Criteria:

* Patients of over 18 years of age undergoing elective Robot-assisted laparoscopic radical prostatectomy

Exclusion Criteria:

* Patients with previous history of smoking, cardiopulmonary or neuromuscular disease or obesity (body mass index \> 30 kg.m-2)

Primary outcomes:
measure: Change of diaphragm movement using sonography (diaphragm inspiratory amplitude, diaphragm inspiratory and expiratory velocity)on postoperative day 1 and 2 from baseline (day before surgery)
timeFrame: on the day before surgery until postoperative day 2
Secondary outcomes:
measure: Change in pulmonary function test on postoperative day 1 and 2 from baseline (day before surgery)
timeFrame: on the day before surgery until postoperative day 2
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severence Hospital, Yonsei University Health System
Study officials:
affiliation: Severance Hospital, Yonsi University Health System
name: Young Jun Oh, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01167816: Phase I Trial of 5-Azacitidine Plus Gemcitabine in Patients With Advanced Pancreatic Cancer
Official title: Phase I Trial of 5-Azacitidine Plus Gemcitabine in Patients With Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Pancreatic Cancer
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: Celgene Corporation
First posted: 2010-07-22
Enrollment: 9
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: The primary objective is to determine the maximum tolerated dose (MTD) of azacitidine and gemcitabine in subjects with previously untreated and unresectable pancreatic cancer. Also to determine the effect of azacitidine therapy on DNA methylation in peripheral blood cells.

Detailed description: This is a Phase I single arm study designed for subjects with newly diagnosed, unresectable pancreatic cancer who have received no prior chemotherapy, radiation therapy, or surgery with curative intent for pancreatic cancer.

Eligibility criteria: Inclusion Criteria:

* Patient must have pathologically confirmed diagnosis of pancreatic adenocarcinoma
* Must have measurable disease as defined by RECIST. RECIST evaluation must have occurred within 4 weeks prior to study entry
* Must have newly diagnosed, unresectable disease and have received no prior chemotherapy, radiation therapy or surgery with curative intent for pancreatic cancer
* Karnofsky performance status of greater than or equal to 70%
* Other significant medical conditions must be well controlled and stable in the opinion of the investigator for at least 30 days prior to Study Day 1
* Women of child bearing age must have negative serum pregnancy test prior to treatment

Exclusion Criteria:

* Known central nervous system tumor involvement
* Evidence of other active malignancy requiring treatment
* Clinically significant heart disease
* Active serious systemic disease, including active bacterial or fungal infection
* Active viral hepatitis or symptomatic HIV infection. Positive serology alone is not exclusionary
* Prior surgery with curative intent for pancreatic cancer
* Prior or current chemotherapy or radiation therapy for pancreatic cancer. Palliative radiation for distant metastases (excluding metastases in the abdominal region) is allowed
* Breast feeding, pregnant, or likely to become pregnant during the study
* known or suspected hypersensitivity to azacitidine or mannitol

Primary outcomes:
measure: Determine maximum tolerated dose
timeFrame: 28 days
measure: Toxicity
timeFrame: 28 days
Secondary outcomes:
measure: Determine the effect of azacitidine therapy on DNA methylation in peripheral blood cells
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Stephenson Cancer Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Osama Qubaiah, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01308216: Transcranial Laser Therapy in the Rehabilitation of Hemiplegic Patients From Ischemic Stroke
Official title: Efficacy of Transcranial Laser Therapy for Improving Upper Extremity Functional Recovery in Hemiplegic Patients From Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Hemiplegia
Keywords: Transcranial Laser Therapy
Hemiplegia
Rehabilitation
Physiotherapy
Ischemic stroke
Lead sponsor: Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
First posted: 2011-03-04
Enrollment: 25
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine the efficacy of transcranial laser therapy applied in automatic noncontact scanning mode for improving functional disability in patients with hemiplegia from ischemic stroke undergoing a rehabilitation program.

Detailed description: Transcranial laser therapy is applied with an InGa(Al)As diode laser.The laser in automatic scanning is applied over both cerebral hemisphere during 15 sessions. Patients simultaneously performed a program of therapeutic exercises 3 days a week. Outcome measures were the Fugl-Meyer Upper Extremity scale, which assessed upper limb motor function, and the Barthel index, which assessed general functional disability.

Eligibility criteria: Inclusion Criteria:

1. Patients with hemiplegia secondary to cerebral stroke ischemic.
2. Requirement of shaving the scalp area.
3. Initiation of the TLT procedure begins between 70 and 100 days after stroke onset.
4. Informed written consent before enrolling in the study.

Exclusion Criteria:

1. Hemiplegia secondary to hemorrhagic stroke.
2. Metallic brain implants.
3. Neurodegenerative disorders.
4. Bilateral motor problems.

Primary outcomes:
measure: Fugl-Meyer Scale
timeFrame: 20 minutes
Secondary outcomes:
measure: Barthel index
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
Study officials:
affiliation: Hospital University Ramon y Cajal. IRYCIS.Madrid
name: Ramón Montes-Molina, PT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00910416: The Comparability of Bispectral Index and Neurosense During Anesthesia
Official title: The Comparability of Bispectral Index and Neurosense During Total Intravenous Anesthesia and Balanced Anesthesia
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Anesthesia
Keywords: Anesthesia
Monitoring, Intraoperative
Electroencephalography/*drug effects
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2009-05-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surgical patients

Brief summary: The assessment of anesthesia depth was based, until recently, on the evolution of hemodynamic parameters. Nowadays it can be evaluated by several monitoring methods, derived from electroencephalogram analysis, namely the Bispectral Index (Aspect Medical Systems, Newton, USA). A new modality is currently under development: the NeuroSENSE (Cleveland Medical Devices Inc., Cleveland, OH 44103, USA). The goal of this study is to compare both monitoring modalities during anesthesia.


Eligibility criteria: Inclusion Criteria:

* Patients requiring either intravenous anesthesia or balanced anesthesia (including sevoflurane)

Exclusion Criteria:

* Pregnant women,
* Allergy to propofol, remifentanil, morphine, muscle relaxant, or to a component,
* Hypersensibility to sufentanil, remifentanil or to a derivate of fentanyl,
* History of neurological disorder or central brain lesion, of muscle disease,
* Patient carrying a pacemaker,
* Patients receiving a psychotropic treatment or a morphine agonist-antagonist,
* Alcoholic patients and patients taking opiates,
* Surgery with extracorporeal circulation,
* Surgical position incompatible with an adequate positioning of the probe.

Primary outcomes:
measure: Concordance between pairs of Bispectral Index and Neurosense indices during maintenance of anesthesia
timeFrame: at the end of each case
Secondary outcomes:
measure: Concordance between pairs of Bispectral Index and Neurosense indices during induction and emergence
timeFrame: at the end of each case
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Dept of Anesthesia, Hôpital Foch
Study officials:
affiliation: Hôpital Foch
name: Marc Fischler, MD
role: STUDY_CHAIR
References:
citation: Zikov T, Bibian S, Dumont GA, Huzmezan M, Ries CR. Quantifying cortical activity during general anesthesia using wavelet analysis. IEEE Trans Biomed Eng. 2006 Apr;53(4):617-32. doi: 10.1109/TBME.2006.870255.
Clinical trial NCT01098916: The RAD-HOME Project: a Pilot Study of Domiciliary Teleradiology
Official title: The RAD-HOME Project: a Randomized Pilot Study of a Domiciliary Teleradiology Program for Frail Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Congestive Heart Failure
Exacerbation of COPD
Pneumonia
Fractures
Osteomyelitis
Keywords: hospital at home
radiology at home
frail elderly
Lead sponsor: Azienda Ospedaliera San Giovanni Battista
Sponsor class: OTHER
Collaborators: name: FondazioneCRT
First posted: 2010-04-05
Enrollment: 69
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Aim of the study is to assess feasibility and safety of a public territorial radiology service for home hospitalized frail elderly patients whose health conditions discourage the transportation to hospital.


Eligibility criteria: Inclusion Criteria:

* immobilization or chairbound,
* need for chest, pelvis/hips, joints, upper and lower limbs, hands and feet X-rays,
* absence of definite delirium at enrollment according to the Confusion Assessment Method, and
* intermediate or high risk of delirium according to the criteria of Inouye.

Exclusion Criteria:

* need of urgent examination (within 24 hours),
* need of X-ray examinations not suitable at home.

Primary outcomes:
measure: Comparison of episodes of delirium related to the radiological procedure at home and in hospital, using the Confusion Assessment Method (CAM)
timeFrame: 24 hours after the radiological procedure
Secondary outcomes:
measure: Evaluation of direct and indirect costs of the radiological procedures performed at home or in hospital
timeFrame: 1 year
measure: Satisfaction of patients and/or families
timeFrame: within 1 month after the procedure
Other outcomes:
Locations:
city: Torino
country: Italy
facility: San Giovanni Battista Hospital
Study officials:
affiliation: Fifth Radiology Department, San Giovanni Battista Hospital of Torino
name: Teresa Cammarota, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ricauda NA, Tibaldi V, Bertone P, Quagliotti E, Tizzani A, Zanocchi M, Isaia GC, Grosso M, Cammarota T, Davini O. The RAD-HOME project: a pilot study of home delivery of radiology services. Arch Intern Med. 2011 Oct 10;171(18):1678-80. doi: 10.1001/archinternmed.2011.336. Epub 2011 Aug 8. No abstract available.
Clinical trial NCT02577016: Double-blind Sitagliptin Add-on Study in Japanese Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Ipragliflozin (MK-0431J-842)
Official title: A Phase III, Multicenter, Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Trial to Assess the Safety and Efficacy of Addition of Sitagliptin in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Ipragliflozin Monotherapy in Addition to Diet and Exercise Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2015-10-15
Enrollment: 141
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: This is a study to assess the safety and efficacy of the addition of sitagliptin in Japanese participants with Type 2 diabetes mellitus (T2DM) who have inadequate glycemic control on ipragliflozin, diet, and exercise therapy. The primary hypothesis of the study is that the addition of sitagliptin once daily compared with placebo provides greater reduction in hemoglobin A1C (HbA1c) as assessed by change from baseline (Week 0) to Week 24.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus
* Inadequate glycemic control on diet/exercise therapy and ipragliflozin monotherapy
* HbA1c ≥7.0% and ≤10.0% before study start

Exclusion Criteria:

* History of type 1 diabetes mellitus or a history of ketoacidosis
* History of any of the following medications: thiazolidinediones (TZD) and/or insulin within 12 weeks prior to study participation, sitagliptin within 8 weeks prior to study participation.
* Currently has a urinary tract infection or genital infection with subjective symptom

Primary outcomes:
measure: Change From Baseline in HbA1c at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants Who Experienced at Least One Adverse Event (AE)
timeFrame: Up to 26 weeks
measure: Percentage of Participants Who Discontinued Study Drug Due to an AE
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Change From Baseline in 2-hr PMG at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Glucose Total Area Under the Plasma Concentration Curve From Hour 0 to Hour 2 (AUC0-2hr) After Meal at Week 24
timeFrame: Baseline and Week 24 (just before loading meal [0 min], 30 min, 60 min and 120 min)
measure: Change From Baseline in FPG at Week 24
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Seino Y, Kaku K, Kadowaki T, Okamoto T, Sato A, Shirakawa M, O'Neill EA, Engel SS, Kaufman KD. A randomized, placebo-controlled trial to assess the efficacy and safety of sitagliptin in Japanese patients with type 2 diabetes and inadequate glycaemic control on ipragliflozin. Diabetes Obes Metab. 2021 Jun;23(6):1342-1350. doi: 10.1111/dom.14346. Epub 2021 Feb 28.