louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01384019: Distal Protection Device in ST-elevation Myocardial Infarction (STEMI)
Official title: Distal Protection Device Did Not Improve Microvascular Obstruction Evaluated by Cardiac MR After Primary Percutaneous Intervention for ST-elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: ST-segment Elevation Myocardial Infarction
Keywords: ST-elevation myocardial infarction
percutaneous coronary intervention
cardiac magnetic resonance imaging
microvascular occlusion
myocardial salvage
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2011-06-28
Enrollment: 126
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators examined the mechanism underlying the lack of benefit from distal protection and thrombus aspiration (DP-TA) in 126 patients with ST-elevation Myocardial Infarction (STEMI) in a prospective, randomized trial.

Detailed description: Patients with first-diagnosed STEMI were randomly assigned to distal protection and thrombus aspiration (DP-TA) pretreatment during percutaneous coronary intervention (PCI) or conventional PCI (c-PCI).

The primary endpoint was the remodeling index (RI), measured by cardiac magnetic resonance imaging (CMR) post-PCI and 6 months after PCI.

Secondary endpoints, determined by CMR within 3 to 5 days after PCI, included the infarct ratio (infarct size to entire left ventricular \[LV\] size ) by delayed-enhancement (DE), area at risk (AAR) ratio (AAR to LV size) by T2 high-signal intensity , microvascular occlusion index (MVO) ratio (MVO to LV size) by DE, and myocardial salvage index (MSI, \[AAR-infarct size\] x 100/AAR).

Eligibility criteria: Inclusion Criteria:

* 30 and less than 80 years presenting with STEMI
* more than 30 minutes but less than 12 hours after symptom onset
* with ≥ 2 mm of ST-segment elevation in 2 or more contiguous leads or with a presumably new left bundle-branch block
* for whom primary PCI was intended

Exclusion Criteria:

* included thrombolytic therapy before PCI;
* spontaneous restoration of coronary flow (\> TIMI grade II or III);
* cardiogenic shock (Killip class IV);
* major surgery or active bleeding within 6 weeks;
* aspirin, thienopyridine, or heparin allergy;
* neutropenia (\<1000 neutrophils/mm3), thrombocytopenia (\<100000 platelets/mm3), hepatic dysfunction, or renal insufficiency (serum creatinine level \>2.5 mg/dL \[221 μmol/L\]);
* noncardiac condition with expected survival less than 1 year;
* current participation in other investigations.

Primary outcomes:
measure: Postinfarct Remodeling
timeFrame: 6 months
Secondary outcomes:
measure: Reperfusion Success
timeFrame: 3-5 days
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul Natioinal University Bundang Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Dong-ju Choi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01503619: Studying Biomarkers in Tumor Tissue and Blood Samples From Patients With Small Cell Lung Cancer Registered on CALGB-140202
Official title: Genomics of Small Cell Lung Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: small cell lung cancer
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-01-04
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with small cell lung cancer enrolled on the Cancer and Leukemia Group B (CALGB) 140202 study

Brief summary: RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in tumor tissue and blood samples from patients with small cell lung cancer registered on CALGB-140202.

Detailed description: OBJECTIVES:

Primary

* To identify the major genetic alterations in human small cell lung cancer (SCLC) using next-generation sequencing and focusing on mutations in coding sequence.

Secondary

* To follow up with in-depth assessment of candidate oncogenes and tumor suppressor genes using gene expression analysis, cell culture systems, and murine models of SCLC.

OUTLINE: DNA isolated from archived tumor tissue and blood samples are analyzed for genetic mutations and gene expression profiling using Illumina exome sequencing. Results are compared with transcriptome of tumors (or cell lines) with and without the specific mutation. Cell culture studies overexpressing or inhibiting the genes of interest are also performed in a mouse model to identified potential drivers of small cell lung cancer.

Eligibility criteria: * Patients must have been registered to CALGB-140202 trial in which tumor material (frozen tissue and paired blood specimens) is available
* Institutional Review Board (IRB) review and approval at the institution where the laboratory work will be performed is required

Primary outcomes:
measure: Identification of genetic alterations in human SCLC (driver or passenger mutations)
timeFrame: Baseline
Secondary outcomes:
measure: Gene expression between samples with or without mutations
timeFrame: Baseline
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: David MacPherson, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01255618: The Measurement Of Cerebral Oxygenisation With NIRS Method İn Polycythaemic Infants Might Add A Criterion To Indicate PPET?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Oxygenation
Peripheric Oxygenation
Polycythaemic Infants
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor class: OTHER
First posted: 2010-12-07
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Preterm infants who admitted to neonatal intensive care unit.

Brief summary: Near infrared spectrophotometry (NIRS) offers the possibility of noninvasive and continuous bedside investigation of cerebral , renal, mesenteric and peripheric oxygenation and hemodynamics, and changes in newborn period.The aim of the present study is to investigate cerebral oxygenation with NIRS method in polycythaemic infants who underwent partial exchange transfusion.


Eligibility criteria: Inclusion Criteria:

term (≥37wk) infants whom determined ≥ 65% haematocrit(Hct) levels

Exclusion Criteria:

Infants with severe congenital malformation, sepsis, intracranial hemorrhage, birth asphyxia were excluded from the study.

Primary outcomes:
measure: cerebral oxygenation measurement
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Zekai Tahir Maternity Teaching Hospital
state: Altındag
Study officials:
References:
Clinical trial NCT01956318: Crenobalneotherapy in the Treatment of Chronic Venous Insufficiency
Official title: Crenobalneotherapy in the Treatment of Chronic Venous Insufficiency. A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Balneology
Keywords: Chronic venous insufficiency
Varicose vein
Crenobalneotherapy
Balneotherapy
Spa therapy
Lead sponsor: Centre de Recherche Rhumatologique et Thermal
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: At 3 months, crenobalneotherapy session is superior to waiting list for patients with chronic venous insufficiency.


Eligibility criteria: Inclusion Criteria:

* patients aged 18 to 80 years with chronic venous insufficiency regardless of etiology stages 3 or 4 according to the CEAP classification (Clinical severity, Etiology or cause, Anatomy, Pathophysiology)
* Patients available to participate in a 3 weeks session in the spa center and to be followed for 6 months

Exclusion Criteria:

* pregnant women,
* contra-indication for the spa treatment (chronic infectious diseases, cancer, heart failure, serious liver or kidney disease, open leg ulcer, psychiatric disorders, immune deficiency, phlebitis, erysipelas or history of erysipelas);
* surgery in the next three months,
* spa treatment in the previous 6 months,
* professional involvement with a spa resort

Primary outcomes:
measure: number of patient with 20% improvement of CIVIC scale at 3 months
timeFrame: 3 months
Secondary outcomes:
measure: CIVIC
timeFrame: 1 month
measure: civic
timeFrame: 1 & 3 months
measure: Rutherford severity score
timeFrame: 1 & 3 months
measure: PASS
timeFrame: 1 & 3 months
measure: opinion of patient and practitionner
timeFrame: 1 & 3 months
measure: associated treatment
timeFrame: 1 & 3 months
measure: side effects
timeFrame: week 1 & 3. 1 & 3 months
Other outcomes:
Locations:
Study officials:
References:
citation: Forestier RJ, Briancon G, Francon A, Erol FB, Mollard JM. Balneohydrotherapy in the treatment of chronic venous insufficiency. Vasa. 2014 Sep;43(5):365-71. doi: 10.1024/0301-1526/a000374.
Clinical trial NCT01697618: Pharmacokinetics, Pharmacodynamics and Safety of Biphasic Insulin Aspart 30 in Type 2 Diabetes
Official title: A Randomised, Double-blind, Single Centre, Two-way Cross-over Trial Comparing the Pharmacokinetics, Pharmacodynamics and Safety of the Biphasic Insulin Aspart 30 and Insulin Mixtard 30/70 After Multiple Dosing With a Twice Daily Dose Regimen in Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-10-02
Enrollment: 13
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to investigate pharmacokinetics, pharmacodynamics and safety of biphasic insulin aspart 30 in subjects with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes for at least 12 months
* Treated with a combination of soluble/protracted human insulin in the ratio of 30/70 in a twice-daily regimen for at least 6 months
* BMI (body mass index) below 39 kg/m\^2
* HbA1c (glycosylated haemoglobin) below 12%

Primary outcomes:
measure: Area under the serum insulin curve
Secondary outcomes:
measure: Overall shape of the 24 hour serum insulin profile
measure: Cmax (maximum plasma concentration)
measure: tmax (time to reach maximum)
measure: Area under the curve following each injections derived from 24 hours serum insulin profiles
measure: Overall shape of the 24 hour serum glucose profile
measure: Serum glucose excursions (EXC)
Other outcomes:
Locations:
city: Alphen a/d Rijn
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Crawley
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR,1452)
role: STUDY_DIRECTOR
References:
citation: McSorley PT, Bell PM, Jacobsen LV, Kristensen A, Lindholm A. Twice-daily biphasic insulin aspart 30 versus biphasic human insulin 30: a double-blind crossover study in adults with type 2 diabetes mellitus. Clin Ther. 2002 Apr;24(4):530-9. doi: 10.1016/s0149-2918(02)85129-3.
Clinical trial NCT06575218: The Effectiveness of Virtual Reality Training Program
Official title: The Effectiveness of Virtual Reality Training Program in Community Dwelling Older Adults With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Lead sponsor: Yeditepe University
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 45
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Alzheimer's disease is the most common type of dementia, accounting for 50% of all cases. Advanced age is a significant risk factor for AD. Virtual Reality (VR) is an interactive video game technology that provides computer-generated environments that include physical activity and provide users with experiences similar to those in the real world. VR technology can be used for rehabilitation purposes in individuals with various orthopedic and neurological disorders due to its ability to enhance motor, cognitive learning and neural plasticity (1,2). The aim of our study was to examine the effect of the Virtual Reality Training Program on cognition in individuals with Alzheimer's disease living in the community.

Detailed description: The aim of our study was to examine the effect of the Virtual Reality Training Program on cognition in individuals with Alzheimer's disease living in the community. Prospective Randomized Controlled Single Blind Study After the patients and their relatives are informed in detail before the study, they will be asked whether they want to participate in the study and the individuals or relatives of the patients who approve of participating in the study will be asked to sign the informed consent form. Individuals who meet the inclusion criteria will be randomly divided into three groups by a single researcher: Virtual reality training program, cognitive exercise with traditional balance exercises, and traditional balance exercises only.

Eligibility criteria: Inclusion Criteria:

* ≥ 55 years and older Diagnosed with AD according to DSM-IV diagnostic criteria by a neurologist, MOCA ≥ 16 Clinical Dementia Rating Scale \< 2

Exclusion Criteria:

* Various mobility restrictions, musculoskeletal disorders, (wheelchair use, etc.) Clinically significant aphasia (must be able to understand the therapist's commands) Significant visual or sensory impairment

Primary outcomes:
measure: Montreal cognitive assessment scale
timeFrame: 12 weeks
measure: Berg Balance Scale
timeFrame: 12 weeks
measure: Time up and Go Test
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Ebru Akbuğa Koç
Study officials:
References:
Clinical trial NCT04239118: New Technologies for Endoscopic Treatment of Bleeding Gastroduodenal Ulcers
Official title: New Technologies for Endoscopic Treatment of Bleeding Gastroduodenal Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulcer Hemorrhage
Keywords: ulcer
bleeding
treatment
aseptisorb-A
Lead sponsor: Voronezh N.N. Burdenko State Medical Academy
Sponsor class: OTHER
First posted: 2020-01-23
Enrollment: 112
Sex: ALL
Minimum age (years): 44
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study was to improve treatment results of patients with bleeding gastroduodenal ulcers by endoscopic applications of autoplasma, enriched with platelets and granular sorbent aseptisorb-A.

Detailed description: The clinical study was conducted on the basis of the Voronezh city specialized Center for the treatment of patients with gastrointestinal bleeding. The study included 112 patients with ulcerative gastroduodenal bleeding. All patients were divided into two groups by random sampling: the main group (n=57 people) and the comparison group (n=55 people). In the treatment of patients of the main group (57 people), an individual approach was used with the use of granular sorbent aseptisorb-A and autoplasm enriched with platelets, in the complex endoscopic treatment of bleeding-complicated gastroduodenal ulcers (Patent Russian Federation (RF) № 2632771). In the comparison group (55 people), traditional methods of endoscopic hemostasis were used.

Eligibility criteria: Inclusion Criteria:

* Gastroduodenal ulcers with bleeding

Exclusion Criteria:

* Bleedings of other etiology

Primary outcomes:
measure: the timing of final hemostasis
timeFrame: a week
Secondary outcomes:
measure: the frequency of recurrent bleeding
timeFrame: 1 year
measure: mortality rates
timeFrame: 1 year
measure: healing of ulcerative defects
timeFrame: 1 year
Other outcomes:
Locations:
city: Voronezh
country: Russian Federation
facility: Voronezh State Medical University
Study officials:
References:
Clinical trial NCT04259918: Effect of Alveolar Recruitment Maneuver on Postoperative Pain
Official title: Effect of Alveolar Recruitment Maneuver on Postoperative Pain After Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2020-02-07
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Control group: no additional procedure Low ARM group : recruitment maneuver of 30cmH2O High ARM group: recruitment maneuver of 60cmH2O

Detailed description: After random assignment of group, Control group: no additional procedure apply, Low ARM group : after surgical trocha out after bariatric surgery, applying 30cmH2O recruitment maneuver 5 times every 5 seconds, High ARM group: after surgical trocha out after bariatric surgery, applying 60cmH2O recruitment maneuver 5 times every 5 seconds

Eligibility criteria: Inclusion Criteria:

* Patients who scheduled for elective bariatric surgery

Exclusion Criteria:

* uncontrolled cardio-vascular disease, active pulmonary disorder

Primary outcomes:
measure: numeric rating scale for postoperative pain
timeFrame: up to postoperative 24 hour
measure: Quality of recovery (QoR40) for Postoperative comfort
timeFrame: up to postoperative 24 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04570618: Early Prediction of Sepsis
Official title: Early Prediction of Sepsis in Hospitalized Patients Using a Machine Learning Algorithm, a Randomized Clinical Validation Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Keywords: Prediction
Lead sponsor: AlgoDx
Sponsor class: INDUSTRY
First posted: 2020-09-30
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: In this clinical trial a novel Medical Device Software will be validated prospectively. The software incorporates a machine learning algorithm capable of predicting sepsis by using routine clinical variables in adult patients at Intensive Care Units.


Eligibility criteria: Inclusion Criteria:

1. Adult patient (age ≥18 years).
2. Patient is admitted to the ICU during the recruitment period of the trial.

Exclusion Criteria:

1. Patient is participating in another interventional clinical trial which, as judged by the investigator, could potentially impact variables used by the sepsis prediction algorithm or has participated in such interventional clinical trial within the last 30 days.
2. Patient is known to be pregnant.
3. Death is deemed imminent and inevitable, at the investigator's discretion.
4. Patient has, due to chronic reduced mental capacity, been assessed by the investigator as incapable of making an informed decision
5. Patient has previously been enrolled in this trial.

Primary outcomes:
measure: Validate the prognostic accuracy of the algorithm at predicting sepsis.
timeFrame: Up to 30 days (ICU hospitalization period)
Secondary outcomes:
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Intensiv- och perioperativ vård
Study officials:
References:
Clinical trial NCT06576518: Exercise Intervention in Patients With Metabolic Syndrome and Renal Disease: a Prospective Study
Official title: Exercise Intervention in Patients With Metabolic Syndrome and Renal Disease: a Prospective Study (EXRED)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
CKD
Keywords: Adherence
Chronic Kidney Disease
Metabolic Syndrome
Obesity
Therapeutic Exercise
Lead sponsor: University of La Laguna
Sponsor class: OTHER
Collaborators: name: Fundacion Canaria Instituto de Investigacion Sanitaria de Canarias
First posted: 2024-08-28
Enrollment: 50
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: INTRODUCTION: Obesity (OB) and metabolic syndrome (MetS) are risk and progression factors for chronic kidney disease (CKD). However, the effect of OB/MetS intervention with exercise on renal function progression and proteinuria is unknown.

OBJECTIVE: To analyse the effect of therapeutic exercise on MetS and main renal outcomes in patients with CKD.

METHODOLOGY: This is a 6-month prospective exploratory study. Patients with stablished CKD (1-4) and MetS were treated with individualised incremental exercise (aerobic and resistance). Simultaneously, a plan of adherence was set up to promote compliance. Renal and metabolic outcomes were collected. The main renal parameters were: proteinuria, in isolated urine samples, and glomerular filtration rate (GFR), measured by iohexol DBS, at 0, 3 and 6 months. At the same time points, metabolic outcomes were measured: weight, dyslipidemia, insulin resistance and hypertension.


Eligibility criteria: Inclusion Criteria:

* age \>18 years
* CKD of diverse aetiologies
* estimated GFR ≥ 30 ml/min
* BMI ≥ 27 kg/m2 associated to MetS or diabetes mellitus (DM)
* stable renal function for at least 6 months before screening
* ability to perform exercise

Exclusion Criteria:

* clinical conditions that exclude exercise therapy such as clinical instability, active infection, cancer, acute cardiovascular disease, advanced CKD, pulmonary hypertension, or limb amputations
* inability to understand the protocol
* severe psychiatric illness
* allergy to iodine

Primary outcomes:
measure: Changes in Glomerular filtration rate (GFR) and urine abulmin-creatinine ratio (UACR).
timeFrame: Baseline, 3 and 6 months
Secondary outcomes:
measure: Changes in body weight and MetS traits (Analytics).
timeFrame: Baseline, month 3 and 6.
measure: Compliance-adherence
timeFrame: Monthly
Other outcomes:
Locations:
city: San Cristobal de La laguna
country: Spain
facility: Universidad de La Laguna
state: Santa Cruz De Tenerife
Study officials:
References: