louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02739711: Glycoprotein IIb/IIIa Inhibitors Versus Standard Therapy in Patients with Myocardial Infarction and No-reflow
Official title: Prospective RandomizEd Study Comparing Glycoprotein IIb/IIIa Inhibitors VERsus Standard Therapy in PatientS with Myocardial Infarction and Angiographic Evidence of No-reFLOW
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Acute Myocardial Infarction
Lead sponsor: University of Luebeck
Sponsor class: OTHER
First posted: 2016-04-15
Enrollment: 120
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: Aim of the study is to examine the effects of glycoprotein IIb/IIIa inhibitors on reperfusion success assessed by cardiac magnetic resonance imaging in patients with myocardial infarction and angiographic evidence of no-reflow.


Eligibility criteria: Inclusion Criteria:

* ST-elevation myocardial infarction and non-ST-elevation myocardial infarction \<48 h after symptom onset
* Angiographic evidence of no-reflow (Thrombolysis in Myocardial Infarction-flow grade ≤2) after primary percutaneous coronary intervention
* Age ≥18 years
* Informed consent

Exclusion Criteria:

* ST-elevation myocardial infarction and non-ST-elevation myocardial infarction patients with Thrombolysis in Myocardial Infarction-flow 3 after primary percutaneous coronary intervention
* Age ≤18 years
* Known pregnancy, breast-feeding or intend to become pregnant during the study period
* Contraindication for treatment with platelet inhibitors
* Known allergy to glycoprotein IIb/IIIa inhibitors, aspirin, or heparin
* Active peptic gastric or duodenal ulcer
* History of major surgery (including intracranial or intraspinal) \<4 weeks
* Active bleeding or bleeding diathesis
* Stroke \<2 years (ischemic and hemorrhagic)
* Known coagulation defect or relevant thrombocytopenia
* Arteriovenous malformations or aneurysm
* Severe liver insufficiency
* Renal insufficiency requiring dialysis
* Uncontrolled hypertension
* Hypertensive retinopathy
* Vasculitis
* Fibrinolysis \<12 hours
* Contraindication for cardiac magnetic resonance imaging at study entry
* Patients without informed consent
* Participation in another trial

Primary outcomes:
measure: Infarct size assessed by cardiac magnetic resonance imaging
timeFrame: Day 1-10 after myocardial infarction
Secondary outcomes:
Other outcomes:
Locations:
city: Luebeck
country: Germany
facility: University of Luebeck
Study officials:
References:
Clinical trial NCT04507711: Palonosetron and Blood Coagulation
Official title: The Effect of a Palonosetron on Blood Coagulation: In Vitro, Volunteer Study Using Thromboelastography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blood Coagulation Disorder
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2020-08-11
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Palonosetron may alter whole blood coagulation. However, little is known about the dose-response relationships according to the blood concentration of palonosetron. The investigators therefore will perform the present study to measure the effect of palonosetron levels using thromboelastography.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Age: 20 to 65 years
* Body weight \> 50 kg
* Volunteers who provided informed consent

Exclusion Criteria:

* Hematologic disease
* Anticoagulant medication

Primary outcomes:
measure: Citrated Functional Fibrinogen
timeFrame: During the thromboelastography analysis/ an average of 1 hour
Secondary outcomes:
measure: Citrated Kaolin
timeFrame: During the thromboelastography analysis/ an average of 1 hour
measure: Citrated Kaolin Heparinase
timeFrame: During the thromboelastography analysis/ an average of 1 hour
measure: Citrated Rapid Thromboelastography
timeFrame: During the thromboelastography analysis/ an average of 1 hour
measure: Heparinized Kaloin Heprinase
timeFrame: During the thromboelastography analysis/ an average of 1 hour
measure: Activator F
timeFrame: During the thromboelastography analysis/ an average of 1 hour
measure: Adenosine diphosphate
timeFrame: During the thromboelastography analysis/ an average of 1 hour
measure: Arachidonic acid
timeFrame: During the thromboelastography analysis/ an average of 1 hour
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National Univ. Bundang Hospital
state: Gyeonggi
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Hyo-Seok Na, MD., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05227911: Incidental Findings in Abdominal Surgery
Official title: The Incidence of Incidental Findings in All Abdominal Surgeries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: General Surgery
Keywords: Surgery, General surgery, Incidental findings
Lead sponsor: University of Aleppo
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 543
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing abdominal surgery whether performed by laparotomy or laparoscopy for any indication, however, the procedure must include proper inspection of the abdominal cavity

Brief summary: Despite the recent advancement in diagnostic modalities, many surgeons experience till this day unexpected findings during the course of surgery. Very few information is available in the medical literature in order to assist the surgeon with the anticipation and preparation to deal with Incidental Findings (IFs). Such valuable information can be of great benefit to the surgeon, as the surgical team can prepare himself better -technically and scientifically- to deal with the common expected IFs. The authors aim to examine the incidence of all IFs in abdominal surgery -laparoscopy or laparotomy- and identify possible associations through a cross-sectional designed study conducted in Aleppo University Hospital - Department of Surgery. The authors collected patients' data who underwent abdominal surgery during the period of the two-consecutive years 2018-2019.


Eligibility criteria: Inclusion Criteria:

* patients older than 13 y/o
* patients undergoing laparoscopy or laparotomy that must include a proper inspection of the abdominal cavity

Exclusion Criteria:

* patients aged 13 y/o or less
* patients with incomplete data
* gynecological procedures even if it involves laparotomy or laparoscopy.

Primary outcomes:
measure: The Incidence of IFs detection
timeFrame: Detection during the time of the procedure itself
measure: IFs identification
timeFrame: Detection during the time of the procedure itself
Secondary outcomes:
measure: The incidence of misdiagnosis events
timeFrame: Detection during the time of the procedure itself
measure: The association between procedure type in IF detection
timeFrame: Detection during the time of the procedure itself
measure: The association between gender in IF detection
timeFrame: Detection during the time of the procedure itself
Other outcomes:
Locations:
city: Aleppo
country: Syrian Arab Republic
facility: Aleppo University Hospital
state: Aleppo Provice
Study officials:
References:
Clinical trial NCT03716128: Diagnosis of Renal Osteodystrophy in Patients With Reduced Renal Function
Official title: Diagnosis of Renal Osteodystrophy in Patients With Reduced Renal Function Can 18F-PET Replace Bone Histomorphometry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Renal Osteodystrophy
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: Universiteit Antwerpen
First posted: 2018-10-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients under investigation for prostate cancer are recruited as bone healthy controls Patients with reduced renal function and suspected high or low bone turnover are recruited for bone biopsy, blood and urin samples and 18F-PET scan

Brief summary: The aim of the study is to

1. To describe the bone morphology in patients with reduced renal function and high or low parathyroid hormone (PTH) respectively.
2. To investigate if the non-invasive method 18-Fluoride Positron Emission Tomography (18F-PET) can describe the bone turnover and reflect the bone histomorphologic changes
3. To investigate if non-oxidized PTH reflects bone turnover

Detailed description: Patients with reduced renal function and suspected high turnover or low turnover bone disease are recruited.

A bone biopsy and a 18F-PET scan are performed and it is investigated if the 18F-PET can discriminate high turnover from low turnover bone disease

Eligibility criteria: Patients with reduced renal function:

Inclusion Criteria:

-≥ 18 years

* estimated Glomerular Filtration Rate (eGFR) ≤ 20 ml/min/1,73m2
* PTH \< 150 pg/ml or PTH \> 300 pg/ml

Exclusion Criteria:

* ongoing malignancy
* Allergy towards tetracyclin
* Pregnancy

Control Group:

Inclusion Criteria:

-≥ 18 years

* eGFR \>= 60 ml/min
* under examination for c prostata
* Prostatic Specific Antigen (PSA) total \<40 µg/l

Exclusion:

* Former kidney disease
* ionized calcium or PTH outside normal range
* Known metabolic bone disease
* treatment with anticoagulants
* Disturbed thrombosis and hemostasis

Primary outcomes:
measure: Can 18F-PET-CT describe bone formation rate?
timeFrame: The bone biopsy and 18F-PET will be performed during two month for each participant
measure: Can non-oxidized PTH describe bone formation rate?
timeFrame: Blood sample and bone biopsy will be performed during two month for each participant
Secondary outcomes:
measure: Can 18F-PET-CT describe mineral apposition rate?
timeFrame: The bone biopsy and 18F-PET will be performed during two month for each participant
measure: Can non-oxidized PTH describe mineral apposition rate?
timeFrame: Blood sample and bone biopsy will be performed during two month for each participant
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital
Study officials:
References:
Clinical trial NCT01296828: Lips and Tongue of Mouth Breathing Children
Official title: Posture, Tone and Mobility of Lips and Tongue of Mouth Breathing Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mouth Breathing
Lead sponsor: Pontificia Universidade Catolica de Sao Paulo
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2011-02-16
Enrollment: 40
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 40 mouth breathing children, 26 (65%) male and 14 (35%) female, aging between 7 and 10 years old, were involved in this research realized in Instituto CEFAC, São Paulo, SP, Brazil.

Brief summary: Purpose: to characterize the posture, tone and mobility of lips and tongue of mouth breathing children.

Methods: 40 mouth breathing children, 26 (65%) male and 14 (35%) female, aging between 7 and 10 years old, were involved in this research realized in São Paulo, SP, Brazil . It was used the MBGR protocol to evaluate the posture, tone and mobility of lips and tongue of mouth breathing children.


Eligibility criteria: Inclusion Criteria:

* Mouth breathing children diagnosed by doctor.

Exclusion Criteria:

* Children with mental, neurological or hearing diseases, or with cold or flu at the examination day.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto CEFAC
state: SP
Study officials:
affiliation: CEFAC Educação e Saúde
name: Irene Q Marchesan
role: STUDY_CHAIR
References:
Clinical trial NCT03374228: A Study to Evaluate the Bioavailability of BMS-986205
Official title: A Study to Evaluate the Absolute Bioavailability of BMS-986205 Tablet Formulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-12-15
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Assess the absolute bioavailability of a tablet formulation of BMS-986205 following simultaneous oral administration of BMS-986205 and intravenous infusion of \[13C\]BMS-986205 solution for intravenous administration in healthy participants.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) 18.0 to 32.0 kg/m2, inclusive
* Must have normal renal function demonstrated by an estimated glomerular filtration rate, calculated by Chronic Kidney Disease Epidemiology Collaboration formula
* Women must not be of childbearing potential (cannot become pregnant)

Exclusion Criteria:

* Women who are of childbearing potential or breastfeeding
* Any significant acute or chronic medical illness
* Active tuberculosis (TB) requiring treatment or documented latent TB at screening

Other protocol defined inclusion / exclusion criteria could apply

Primary outcomes:
measure: Absolute oral bioavailability (F)
timeFrame: Up to 15 days
Secondary outcomes:
measure: Occurrence of adverse events (AEs)
timeFrame: Up to 15 days
measure: Occurrence of serious adverse events (SAEs)
timeFrame: Up to 15 days
measure: Occurrence of adverse events (AEs) leading to discontinuation
timeFrame: Up to 15 days
measure: Number of participants with vital sign measurement abnormalities
timeFrame: Up to 15 days
measure: Number of participants with electrocardiogram abnormalities
timeFrame: Up to 15 days
measure: Number of participants with physical examination abnormalities
timeFrame: Up to 15 days
measure: Number of participants with clinical laboratory test abnormalities
timeFrame: Up to 15 days
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient Clinical
state: Ruddington Fields
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00483028: A Randomized, Placebo-Controlled Trial to Examine the Efficacy of Oral Donepezil in Subjects With MCI
Official title: A Randomized Double-Blind, Parallel, Placebo-Controlled Trial to Examine the Efficacy of Oral Donepezil (5 mg QD for 6 Weeks) After Single Dose and Steady State Therapy (2 Weeks and 6 Weeks) in Subjects With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-06-06
Enrollment: 38
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: To purpose of this study is to estimate the effect of donepezil on Neuropsychological Testing (NPT) and brain Proton Magnetic Resonance Spectroscopy.


Eligibility criteria: Inclusion Criteria:

* Healthy males or females ages 55-90 inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and heart rate measurement, 12-lead ECG and clinical laboratory tests)
* Body Mass Index (BMI) between 18 to 34 kg/m2, inclusive; and a total body weight
* Subjects with mild cognitive impairment (MCI) must have a reliable informant who has an average of 10 hours per week or more contact with the subject.
* Memory complaints and memory difficulties, which are verified by an informant
* Mini-mental status exam (MMSE) score of 24-30

Exclusion Criteria:

* Subjects with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives
* Insulin-requiring diabetes or uncontrolled diabetes mellitus
* Subjects with a current diagnosis of depression or other psychiatric illnesses

Primary outcomes:
measure: Neuropsychologic test scores: GMLT, DSST, Cog State TM including PAL test, RAVLT, ADAS-cog at baseline (pre-dose) 5 and 8 hours after the first dose and 2 and 6 weeks. (Continues in next bullet.)
measure: MRS (Magnetic Resonance Spectroscopy) profile including but not limited to NAA (N-acetyl-aspartate), NAA/Cr (N-acetyl-aspartate/creatinine ratio), MI (Myoinositol) and MI/Cr (Myoinositol/creatinine ratio).
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Albany
country: United States
facility: Pfizer Investigational Site
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03851328: Best Possible Medication History at USB
Official title: Best Possible Medication History at Universitätsspital Basel (USB)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Best Possible Medication History
Keywords: Adverse Drug Events (ADEs)
Medication Accuracy
Medication Discrepancy
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2019-02-22
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to Emergency Department of University Hospital Basel and being transfered to medical ward

Brief summary: This pilot project investigates the use of a structured medication history (Best Possible Medication History, BPMH) in patients (primarily admitted at the emergency department of University Hospital Basel) after transfer to a medical ward. Unintentional medication discrepancies are analyzed comparing outpatient and inpatient medication therapy.


Eligibility criteria: Inclusion Criteria:

* Admission to Emergency Department of University Hospital Basel and transfer to medical ward

Exclusion Criteria:

* medication history taken at Emergency Department of University Hospital Basel not present

Primary outcomes:
measure: unintended medication discrepancy
timeFrame: single time point (1 day after admission to hospital)
Secondary outcomes:
measure: Categorisation ( Class1, Class2, Class3) for clinical relevance of unintended medication discrepancy
timeFrame: during 7 days after admission to hospital
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Spitalpharmazie Universitätsspital Basel (USB)
Study officials:
affiliation: Spitalpharmazie Universitätsspital Basel (USB)
name: Stephan Gut
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01599728: Effect of Urocortins in Patients With Heart Failure
Official title: Urocortins 2 & 3-Effects on Forearm Arterial Blood Flow in Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Endothelium
Keywords: Urocortin 2
Urocortin 3
Forearm venous occlusion plethysmography
Heart failure
Endothelium
Substance P
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: NHS Lothian
First posted: 2012-05-16
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Despite modern advances in treatment, heart failure continues to carry a poor prognosis with high morbidity and mortality rates. Hence, there remains a major interest in the development of novel therapeutic agents for this debilitating condition. Urocortins have recently shot into limelight with their potential role in the pathophysiology and treatment of heart failure.

Recent studies by the investigators group (REC no: 09/S1103/41) have confirmed that Urocortin 2 and 3 are potent arterial vasodilators, the effects of which are reproducible and well tolerated in healthy male volunteers. Previous studies using heart failure models in animals1-7, as well studies in heart failure patients (Urocortin 2), suggest that there is great scope for Urocortins as novel biomarkers and as potential therapeutic agents in heart failure. With this in mind, the investigators wish to study the local vasomotor effects of these peptides in greater detail in patients with heart failure.


Eligibility criteria: Inclusion Criteria:

Patients with heart failure:

1. Patients with stable heart failure (NYHA class II-IV) on maximum tolerated doses of an ACE inhibitor and beta-blocker for at least 3 months.
2. Baseline echocardiographic parameters (echo performed within last 12 months) at recruitment: ejection fraction (EF) \<35%, left ventricular end dimension \>5.5cm and fractional shortening \<20%
3. Age 18-80 years (inclusive) at recruitment

Healthy volunteers:

* Age and sex-matched healthy volunteers

Exclusion Criteria:

1. Lack of informed consent
2. Age \<18 years and \> 80 years
3. Current involvement in a clinical trial
4. Systolic blood pressure \>190 mmHg or \<90 mmHg, untreated malignant arrhythmias
5. Haemodynamically significant valvular heart disease
6. Severe or significant co-morbidity including bleeding diathesis, renal or hepatic failure
7. History of anaemia
8. Recent infective/inflammatory condition
9. Recent blood donation (prior 3 months)
10. Women of child bearing potential

Primary outcomes:
measure: Forearm blood flow
timeFrame: 3 hours
Secondary outcomes:
measure: Absolute forearm blood flow
timeFrame: 3 hours
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Wellcome Trust Clinical Research Facility, Royal Infirmary of Edinburgh
Study officials:
affiliation: University of Edinburgh
name: David E Newby, PhD, FRCP
role: PRINCIPAL_INVESTIGATOR
References: