louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01784445: Post ERCP Pancreatitis Prevention in Average Risk Patients
Official title: Diclophenac Potassium Versus Ceftazidime for Reduction of Post ERCP Pancreatitis in Average Risk Patients-double Blind, Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pancreatitis
Keywords: Endoscopic Retrograde Cholangiopancreatography,
Lead sponsor: University Hospital Rijeka
Sponsor class: OTHER
First posted: 2013-02-05
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Diclophenac potassium and ceftazidime are commercially available drugs that are used in various clinical situations. They are safe and known for years. Diclophenac potassium and Ceftazidime have been used in some studies for the prophylaxis and treatment of pancreatitis and Post-ERCP Pancreatitis (PEP). Diclophenac potassium, together with indometacin is currently standard treatment for prevention of (PEP) while ceftazidime is possible alternative treatment for patients with contraindications for nonsteroidal medicines. The aim of the study is to evaluate the efficacy of Ceftazidime for the prophylaxis of PEP.

Detailed description: Study type:

Interventional Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: only Investigator Primary Purpose: Prevention Study Phase: Phase 4

Conditions or Focus of the study: Post ERCP pancreatitis

Intervention information

* Intervention Names ERCP
* Arm Information

  * Arm 1:Ceftazidime
  * Arm 2 (active comparator): Diclophenac potassium

Eligibility criteria: Inclusion Criteria:

* o All patients undergone to ERCP irrespectively about the diagnosis

Exclusion Criteria:

* o Unwillingness or inability to consent for the study

  * Age \< 18 years
  * Previous ERCP (papillotomy)
  * Intrauterine pregnancy
  * Breast feeding mother
  * Allergy to Aspirin or NSAIDs and Ceftazidime
  * NSAID or antibiotic use within 1 week (ASA 325 mg daily or less acceptable)
  * Renal failure (Cr \> 1.4)
  * Active or recent (within 4 weeks) gastrointestinal hemorrhage
  * Existing acute pancreatitis (lipase peak) within 72 hours prior to ERCP
  * Anticipated inability to follow protocol

Primary outcomes:
measure: Incidence of PEP in the group of patients receiving Ceftazidime versus incidence of PEP in the group of patients receiving Diclophenac potassium
timeFrame: One year
Secondary outcomes:
Other outcomes:
measure: Time to discharge from hospital
timeFrame: One year
Locations:
city: Rijeka
country: Croatia
facility: Clinical Hospital Centre
state: Kresimirova 42
Study officials:
affiliation: University Hospital Rijeka
name: Goran Hauser, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04036045: Approaches to Identify Early Biomarkers and Pathogenesis of Anthracycline Cardiotoxicity
Official title: Integrated Basis and Translational Approaches to Identify Early Biomarkers and Pathogenesis of Anthracycline Cardiotoxicity
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Childhood Cancer
Keywords: Anthracycline induced cardiotoxicity
Lead sponsor: Connecticut Children's Medical Center
Sponsor class: OTHER
Collaborators: name: Nationwide Children's Hospital
First posted: 2019-07-29
Enrollment: 0
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are \> or equal to 9 years of age who are newly diagnosed with cancer who will receive anthracycline (s) as part of the their treatment regimen.

Brief summary: Early microRNAs (miRs) and Cardiac Magnetic Resonance (CMR)-derived strain analysis and detection of genes contributing to Anthracycline-Induced Cardiotoxicity (AIC) sensitivity and resistance will identify pediatric cancer patients most and least likely to develop AIC.

Detailed description: Plan is to enroll 110 children and adults (≥9 years old) newly diagnosed at CCMC and Nationwide Children's Hospital (55 per institution) who will receive anthracyclines as part of their chemotherapy regimen.

The duration of study participation will be approximately a year.

Patients will have a total of four study visits:

Baseline

1 week after patient's anthracycline cumulative dose hits between 60 and 100 mg/m2 After the patient has completed maximal therapy One year after completion of anthracycline treatments

Study tasks for all four visits will be:

Collection of clinical data Blood draw for micro RNA and Biomarkers Cardiac MRI Echocardiogram One time blood draw for genetics

Eligibility criteria: Inclusion Criteria:

* Age (≥ 9years old)
* Newly diagnosed with a malignancy that will receive ACs as part of their chemotherapy.
* Parental/caregiver consent and subject assent to enrollment.

Exclusion Criteria:

* Subject has contraindications to CMR.\*
* Subject requiring sedation for CMR
* Subject too large to be safely accommodated by CMR
* Pregnancy tests are done routinely prior to chemotherapy, if test is positive the patient will be excluded
* Subject's serum creatinine above guidelines for adequate renal function. See table below:

Age (years) Male Female 6-10 1.0 mg/dL 1.0 mg/dL 10-13 1.2 mg/dL 1.2 mg/dL 13-16 1.5 mg/dL 1.4 mg/dL \>16 1.7 mg/dL 1.4 mg/dL

Primary outcomes:
measure: CMR
timeFrame: From Baseline to one year after anthracycline therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Olga Salazar
state: Connecticut
Study officials:
affiliation: Connecticut Children's Medical Center
name: Olga Salazar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04055545: High Intensity Interval Training VS Moderate Intensity Continuous Training in Chronic Low Back Pain Subjects
Official title: 12 Week High Intensity Interval Training VS Moderate Intensity Continuous Training in Chronic Low Back Pain Subjects: a Randomized Single-blinded Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: HES-SO Valais-Wallis
Sponsor class: OTHER
Collaborators: name: Schulthess Klinik
First posted: 2019-08-13
Enrollment: 30
Sex: ALL
Minimum age (years): 29
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The current guidelines for non-specific CLBP, recommend a conservative approach with exercise therapy, as first line treatment. Endurance and resistance training are two examples of recommended exercise therapies. However, it appears that none is recommended as superior over the other.

Detailed description: The lack of studies using HIIT in CLBP subjects, is the reason why it is needed to conduct an investigation about its effects.

However, firstly it is needed to assess the feasibility and safety of the HIIT protocol, to integrate it in the daily practise and future research.

In a single-center, single-blinded randomized feasiblity study, the investigators aim to prove the feasibility and safety of a 12 week HIIT programm.

Eligibility criteria: Inclusion Criteria:

* Oswestry disability index (ODI) Score ≥ 14%
* Low back pain for at least 3 months.
* Declared suitable by their physician or hospital consultant to start an exercise programme and to perform a graded exercise testing to determine the heart rate peak.
* Good understanding of German or English, written and spoken.
* Age between 29 - 69
* No or stopped physical therapy.

Exclusion Criteria:

* Pre-existing unstable heart disease or suspected angina pectoris, cardiac dysrhythmias, heart failure, aneurysm or aortic stenosis.
* Known pregnancy.
* Previous low back spinal surgery in the last 2 years.
* Tumour, spinal stenosis, spinal fractures or radiculopathy.
* Comorbid health conditions like diabetes mellitus, rheumatoid arthritis or other systemic inflammatory diseases.

Primary outcomes:
measure: Adherence
timeFrame: 13 weeks
Secondary outcomes:
measure: Enjoyability
timeFrame: 13 week
measure: Willingness to continue the training
timeFrame: 13 weeks
measure: Number of Adverse Events & Dropout rate
timeFrame: 13 weeks
measure: Recruited rate
timeFrame: 3 months
Other outcomes:
measure: Oswestry disability index
timeFrame: 13 weeks
measure: Numeric Pain Rate Scale
timeFrame: 13 weeks
Locations:
city: Zürich
country: Switzerland
facility: Schulthess Klinik
Study officials:
References:
citation: Cerini T, Hilfiker R, Riegler TF, Felsch QTM. 12 weeks high intensity interval training versus moderate intensity continuous training in chronic low back pain subjects: a randomised single-blinded feasibility study. Arch Physiother. 2022 May 2;12(1):12. doi: 10.1186/s40945-022-00136-3.
Clinical trial NCT05525845: Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI
Official title: Physiological Regulation of Energy Intake - the FOOD-PRINT Study Identifying the Hormonal and Neural Footprints of the Visceroceptive, Homeostatic, and Hedonic Components of Food Intake Regulation in Humans
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-09-02
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to investigate how gut hormones and brain areas respond differently to gastric distention, tasteless calories, or palatable food and how this alters appetite.


Eligibility criteria: Inclusion Criteria:

* BMI 18-25 kg/m\^2.
* Weight stable for 3 months prior to study entry.
* For females: study days will be scheduled during the follicular phase of their menstrual cycle (i.e., the first 13 days (about 2 weeks) of the cycle).
* Able to provide written informed consent prior to any study procedures and be willing and able to follow study procedures..
* Ability to perform light to moderate physical activity.

Exclusion Criteria:

* Any contraindication for MRI scanning.
* Any history of childhood (\> 95th percentile) or adult obesity (BMI \>30 kg/m\^2).
* Claustrophobia.
* High intensity training or physical activity.
* Any contraindication for intragastric balloon insertion.
* Any allergies to the study meals.
* Any history of eating disorder.
* Any substance abuse disorder (including alcohol and tobacco).
* Any history of psychiatric disorders.
* Any cardiovascular, endocrine, pulmonary, neurological, or gastrointestinal comorbidities.
* Pregnancy or nursing.
* Any history of bariatric surgery or endoscopic bariatric procedure.
* Use of any medication or supplement that alters appetite.
* Patient has a known history of any condition or factor judged by the investigator to prevent participation in the study or which might hinder study adherence.

Primary outcomes:
measure: Difference in Cerebral Blood Flow related to hypothalamus
timeFrame: 1 month
Secondary outcomes:
measure: Cerebral Bloodflow related in multiple brain areas
timeFrame: 1 month
measure: Cerebral Blood Flow between three stimuli
timeFrame: 1 month
measure: Hormone level
timeFrame: 1 month
measure: comparison of calories
timeFrame: 1 month
measure: calorie corellation to hormones
timeFrame: 1 month
measure: hormone level comparison
timeFrame: 1 month
measure: Time differences in stimuli
timeFrame: 1 month
measure: Caloric consumption differences in stimuli
timeFrame: 1 month
measure: FitBit measured Physical Activity
timeFrame: 1 month
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Andres Acosta, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00670345: Tranexamic Acid in Urologic Surgery
Official title: Efficacy of Tranexamic Acid in Reducing Perioperative Bleeding in Patients Undergoing Radical Prostatectomy. A Randomized Controlled Double-blind Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bleeding
Prostatectomy
Keywords: tranexamic acid
prostatectomy
surgery
Lead sponsor: Università Vita-Salute San Raffaele
Sponsor class: OTHER
First posted: 2008-05-01
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This prospective randomized double-blind placebo vs control study aims at verifying the efficacy of tranexamic acid administration in reducing perioperative bleeding in patients undergoing open radical prostatectomy. Two recent meta-analysis confirmed that tranexamic acid administration does not increase mortality, myocardial infarction, deep venous thrombosis, pulmonary embolism, stroke and renal failure.

200 patients undergoing open radical prostatectomy will be enrolled. Patients will receive a slow endovenous infusion of 500 mg of tranexamic acid before surgical incision, followed by 250 mg/h of tranexamic acid by continuous infusion.

Patients belonging to the control group will receive the same volume of saline infusions.


Eligibility criteria: Inclusion Criteria:

* Adult patients
* Patients undergoing open radical prostatectomy

Exclusion Criteria:

* Age \< 18 years
* Patients with drug eluting stent with a double antiplatelet therapy
* Atrial fibrillation
* Thrombophilic diathesis
* Allergy to tranexamic acid

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia
Study officials:
affiliation: Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia
name: Giovanni Landoni, MD
role: STUDY_DIRECTOR
affiliation: Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia
name: Antonella Crescenti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Crescenti A, Borghi G, Bignami E, Bertarelli G, Landoni G, Casiraghi GM, Briganti A, Montorsi F, Rigatti P, Zangrillo A. Intraoperative use of tranexamic acid to reduce transfusion rate in patients undergoing radical retropubic prostatectomy: double blind, randomised, placebo controlled trial. BMJ. 2011 Oct 19;343:d5701. doi: 10.1136/bmj.d5701.
Clinical trial NCT02702245: Effects of Two Doses of Thylakoids on OGTT
Official title: Thylakoids' Effect on Glucose Homeostasis and Appetite Regulation After an Oral Glucose Tolerance Test in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glucose Intolerance
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Lund University
First posted: 2016-03-08
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This cross-over intervention study aims to investigate the effect of two doses of thylakoids to an oral glucose tolerance test (OGTT) on glucose and insulin homeostasis as well as appetite regulating hormones in healthy volunteers.

Detailed description: A minimum of twenty healthy volunteers are recruited to participate in an OGTT at three different occasions separated by one week. At two of the occasions a green leaf extract, thylakoids, is added to a glucose solution; 5 gram or 10 gram in randomized order. The third occasion, without added thylakoids, serve as control.

Blood samples are taken fasting and 15, 30, 45, 60, 90, 120 and 180 minutes after the glucose load.

Blood samples are analysed for p-glucose, p-insulin, p-C-peptide, p-ghrelin, p-CCK and p-GLP-1.

Eligibility criteria: Inclusion Criteria:

* Healthy
* Adult
* Normal-weight and weight stable
* Not pregnant or breast-feeding
* No use of medication that can affect glucose- and insulin homeostasis (for example corticosteroids).

Exclusion Criteria:

* Diabetes,
* Impaired glucose tolerance and/or insulin resistance
* Anaemia
* Use of tobacco or drugs.

Primary outcomes:
measure: Insulin sensitivity
timeFrame: 180 minutes, repeated at three occasions
Secondary outcomes:
measure: p-GLP-1
timeFrame: 180 minutes, repeated at three occasions
measure: p-ghrelin
timeFrame: 180 minutes, repeated at three occasions
Other outcomes:
Locations:
Study officials:
affiliation: Lund University, Region Skane
name: Eva-Lena Stenblom, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02171845: Mechanisms and Factors Responsible for the Inhibition of Transposons During Fetal Gonad Development in Humans
Official title: Mechanisms and Factors Responsible for the Inhibition of Transposons During Fetal Gonad Development in Humans
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Medical Termination of Pregnancy
Voluntary Termination of Pregnancy
Keywords: Male foetuses of 10 to 37 weeks
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2014-06-24
Enrollment: 30
Sex: MALE
Minimum age (years): 10
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male foetuses of 10 to 37 weeks of amenorrhea obtained following medical termination of pregnancy or voluntary termination of pregnancy.

Brief summary: This is a single-centre study over 36 months for the inclusion of 30 patients. The selection and inclusion of patients will take place according to the criterion of Medical Termination of Pregnancy at 4 different gestational ages (8-12 weeks of gestation (WG)), 13-16 WG, 17-23 WG and 25-35 WG. The tissue analysed will principally be the gonads, other somatic tissue will also be systematically harvested in parallel (liver and psoas muscle) for control purposes. The gonads will be subjected to molecular biology analyses destined to quantify the expression of transposons and their inhibitors.


Eligibility criteria: Inclusion Criteria:

* Couple or mother who has provided written informed consent
* Foetus between 10 and 37 weeks of amenorrhea (WA)
* Male foetus
* Foetus obtained following medical termination of pregnancy or voluntary termination of pregnancy

Exclusion Criteria:

* persons without national health insurance cover
* foetus presenting aneuploidy
* foetus presenting a malformation of the genital organs

Primary outcomes:
measure: Spatio-temporal analysis of the activity of TEs by RT-qPCR and immunostaining
timeFrame: Baselines
Secondary outcomes:
measure: Promoter methylation profile by pyrosequencing
timeFrame: Baselines
Other outcomes:
measure: Spatiotemporal analysis piARN way: RT qPCR, Small RNA Seq, and immunoprecipitation of proteins PIWI
timeFrame: Baselines
Locations:
city: Dijon
country: France
facility: CHU de DIJON
Study officials:
References:
Clinical trial NCT00246545: Effect Evaluation of Early Exercise Training After Myocardial Infarction
Official title: Effect Evaluation of Early Exercise Training After Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myocardial Infarction
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2005-10-30
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The aim of the study is to evaluate the effect of early onset of exercise training (ET) after myocardial infarction (MI) in a randomized controlled trial. Usual care is to wait 4-6 weeks after onset of MI, and our hypotheses are that early ET will prevent a fall in VO2peak and contribute to better quality of life.

Detailed description: Exercise training is well documented as effective treatment for myocardial infarction(MI) patients. However, the long time effect of early onset is more unclear, and it is needed to provide knowledge about to which extend early onset of ET contribute to reduce risk factors, increase oxygen consumption and influence on quality of life.

A RCT is conducted, 60 persons with recently MI is invited to participate. The subjects participating is hospitalised in St. Olavs Hospital. The participants are randomised to either a training group or a control group. The training group will be offered hospital out-patient group exercise training of moderate intensity twice a week for four weeks. The training is leaded by a physiotherapist. The control group will wait four weeks before both groups continue ET twice a week for 12 weeks (high intensity training).

Eligibility criteria: Inclusion Criteria:

* Myocardiac infarction, 2 weeks ago
* over 18 years
* able to participate i exercise groups

Exclusion Criteria:

* unstable angina
* heart failure
* failure to reach a maximal pretest
* drug abuse

Primary outcomes:
measure: Change in maximal oxygen consumption
Secondary outcomes:
measure: quality of life
measure: change in risk factors (smoking habits, physical activity)
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs Hospital
state: Sør-Trøndelag
Study officials:
affiliation: NTNU, St.Olavs hospital
name: Asbjørn Støylen, Dr.med
role: STUDY_DIRECTOR
affiliation: St. Olavs Hospital
name: Ingerlise Aamot, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aamot IL, Moholdt T, Amundsen BH, Solberg HS, Morkved S, Stoylen A. Onset of exercise training 14 days after uncomplicated myocardial infarction: a randomized controlled trial. Eur J Cardiovasc Prev Rehabil. 2010 Aug;17(4):387-92. doi: 10.1097/HJR.0b013e328333edf9.
Clinical trial NCT04686045: Stroke Prevention in Atrial Fibrillation Patients Between 2004 and 2020
Official title: Stroke Prevention in Atrial Fibrillation Patients Between 2004 and 2020
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation; Stroke Prevention
Lead sponsor: Jan Kochanowski University
Sponsor class: OTHER
First posted: 2020-12-28
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with AF treated in hospital.

Brief summary: Prevention of thromboembolic complications is an important part in the management of patients with atrial fibrillation (AF). European and American guidelines recommend the use of non-vitamin K antagonist oral anticoagulants (NOACs) over therapy with vitamin K antagonists (VKA) in most AF patients. The number of patients treated with NOACs has increased significantly during the last few years. In the primary randomized controlled trials leading to their approval, compared to warfarin, NOACs were shown to be either noninferior or superior for stroke prevention in AF, with similar or reduced rates of bleeding, especially intracranial haemorrhage.

The aim of this study was to assess the frequency of oral anticoagulants using, espescially apixaban, dabigatran, and rivaroxaban, and the predictors of their prescription in a group of hospitalised patients with AF.


Eligibility criteria: Inclusion Criteria:

- non-valvular atrial fibrillation

Exclusion Criteria:

* valvular atrial fibrillation
* death during hospitalization

Primary outcomes:
measure: oral anticoagulant treatment
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Kielce
country: Poland
facility: 1st Clinic of Cardiology and Electotherapy
state: Grunwaldzka 45
city: Kielce
country: Poland
facility: Iwona Gorczyca
Study officials:
References: