louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03726164: Remote Ischaemic Postconditioning in the Clinical Setting of NSTEACS and Urgent PCI
Official title: A Study Investigating the Cardioprotective Benefits of Remote Ischaemic Postconditioning in Patients Presenting With Non ST Elevation Acute Coronary Syndromes Undergoing In-hospital Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Procedural Myocardial Infarction
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: University College London Hospitals
name: Surrey and Sussex Healthcare NHS Trust
First posted: 2018-10-31
Enrollment: 626
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigates the cardioprotective effect of remote ischaemic pre-/postconditioning in patients presenting with a NSTEMI/Unstable angina undergoing PCI.

Detailed description: Patients presenting with Non ST elevation acute coronary syndromes (NSTEACS) - NSTEMI and Unstable angina patients are enrolled in this study.

Eligible patients are approached, with patient information sheets and are consented for involvement into the study. Patients are randomised to intervention or control. Patients randomised to intervention will receive 3 x 5 minutes of forearm ischaemia (with the cuff inflated to 200 mmHg) separated by 5 minutes of reperfusion between each cuff inflation, prior coronary angiography.

This protocol of episodic forearm ischaemia/reperfusion has been demonstrated to confer remote ischaemic preconditioning-induced protection.

Prior to the intervention, a blood sample will be taken to measure serum troponin T and CK-MB (baseline level). Following PCI patients will be reviewed on the wards and their ongoing recovery will be assessed and reviewed prior to discharge from the study. Troponin T and CK-MB levels will be measured for the 24 hours after PCI, at various time points (6 hour, 12 hour, 24 hour) as a measure of the degree of myocardial damage, and levels compared between the different treatment groups.

Primary end point

Myocardial injury (Peri-procedural Myocardial Infarction and Injury) measured by cTnT and CK-MB release over 24 hours after primary PCI.

Eligibility criteria: Inclusion Criteria:

* Patients admitted with NSTEMI/ Unstable angina undergoing percutaneous intervention

Exclusion Criteria:

* Known renal failure
* Known liver disease
* Peripheral vascular disease involving upper limbs
* Inability to consent

Primary outcomes:
measure: Peri-Procedural Myocardial Injury
timeFrame: 24 hours post PCI
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University College, London
name: Derek M Yellon, PhD, FACC
role: STUDY_DIRECTOR
References:
Clinical trial NCT04251364: Treatment of Chronic Mountain Sickness
Official title: Acetazolamide and Statins for the Treatment of Chronic Mountain Sickness in Highlanders: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypoxia, Altitude
Lead sponsor: Centre d'Expertise sur l'Altitude EXALT
Sponsor class: OTHER
First posted: 2020-01-31
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to assess the effect of two drugs for the treatment of chronic mountain sickness in highlanders.

Detailed description: About 100 million individuals reside at high altitude (\>2500m) worldwide, with the largest populations of highlanders being found in South America (Andean), central Asia (Tibetan and Sherpa) and East Africa (Ethiopian). Despite unique adaptations to hypoxia in these populations, chronic mountain sickness (CMS) is a clinical syndrome which is observed in 5-33% of individuals residing permanently at high altitude.Several pharmacological approaches have been proposed in the treatment of EE and CMS. However, few studies show sufficient clinical evidence for safety and efficacy in CMS treatment and most highlanders with CMS remain untreated. The present project aims to better characterize chronic hypoxic responses in highlanders and to evaluate the interest of acetazolamide and statins as potential treatments for chronic mountain sickness.

Eligibility criteria: Inclusion Criteria:

* Male
* Age between 18 and 55 yrs
* Body mass index \<30kg/m²
* Born at \>3500 m, living for \>3 years at the local high altitude
* No diagnosis of cardiorespiratory, metabolic or neurological diseases
* No drug intake
* No smoker
* Chronic mountain sickness score ≥6

Exclusion Criteria:

* Diagnosis of cardiorespiratory, metabolic and neurological diseases
* Systolic \> 130 mmHg and/or diastolic \> 85 mmHg blood pressure
* Drug intake
* Smoker
* Chronic mountain sickness score \<6

Primary outcomes:
measure: Change in hematocrit
timeFrame: Change from before to after 9 months of treatment
Secondary outcomes:
measure: Chronic mountain sickness score
timeFrame: Change from before to after 9 months of treatment
measure: Macrovascular reactivity
timeFrame: Change from before to after 9 months of treatment
measure: Microvascular reactivity
timeFrame: Change from before to after 9 months of treatment
measure: Hemoglobin mass
timeFrame: Change from before to after 9 months of treatment
measure: Pulmonary arterial pressure
timeFrame: Change from before to after 9 months of treatment
measure: Blood pressure
timeFrame: Change from before to after 9 months of treatment
measure: Sleep recording
timeFrame: Change from before to after 9 months of treatment
Other outcomes:
Locations:
city: Échirolles
country: France
facility: Association EXALT, UM Sport Pathologies, Hôpital Sud, Avenue Kimberley
Study officials:
affiliation: EXAL
name: Samuel Verges, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02024321: Study on Blood Glucose Variations in Tumor Patients Before and After Total Parenteral Nutrition
Official title: Phase 1: Select Tumor Patients to be Observed Phase 2: Observe the Blood Glucose Values During TPN Phase 3: Sort Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Surgery
Nutrition Related Cancer
Keywords: abdominal surgery
TPN
blood glucose
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2013-12-31
Enrollment: 86
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Tumor patients using TPN in abdominal surgery department in Cancer Hospital.

Brief summary: The purpose of this study is to determine the relationship among TPN, tumor and blood glucose.

Detailed description: Select the tumor patients in abdominal department after surgery with TPN. Monitor the blood glucose variation after TPN.

Eligibility criteria: Inclusion Criteria:

* 1.tumor patients,2.use TPN after surgery

Exclusion Criteria:

* without using TPN

Primary outcomes:
measure: Glycemic Variations during TPN
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Jincheng Yang, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pasquel FJ, Spiegelman R, McCauley M, Smiley D, Umpierrez D, Johnson R, Rhee M, Gatcliffe C, Lin E, Umpierrez E, Peng L, Umpierrez GE. Hyperglycemia during total parenteral nutrition: an important marker of poor outcome and mortality in hospitalized patients. Diabetes Care. 2010 Apr;33(4):739-41. doi: 10.2337/dc09-1748. Epub 2009 Dec 29.
citation: Yang JC, Dai YY, Wang LM, Xie YB, Zhou HY, Li GH. Glycemic Variation in Tumor Patients with Total Parenteral Nutrition. Chin Med J (Engl). 2015 Aug 5;128(15):2034-9. doi: 10.4103/0366-6999.161358.
Clinical trial NCT06218264: BCAAs, Muscle Protein Synthesis and Glucose Uptake
Official title: The Role of Branched-chain Amino Acids (BCAAs) in the Stimulation of Skeletal Muscle Protein Synthesis and Glucose Uptake in Healthy Young Volunteers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Lead sponsor: Wageningen University
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The present study aims to quantify the insulin sensitivity and the skeletal muscle protein synthetic response to consuming a test drink containing all amino acids or all amino acids except for BCAAs.

Detailed description: Twenty-eight healthy, young volunteers will receive a stable isotope tracer infusion (7.5h) combined with repeated blood and muscle sampling, to measure muscle protein synthesis rate in the postabsorptive state following ingestion of a drink containing all amino acids (n=14) or all amino acids except for BCAAs (n=14).

Eligibility criteria: Inclusion Criteria:

* Aged from 18-35 years
* 18.5 \< Body mass index \< 30 kg·m2
* Recreationally active (performing non-competitive physical exercise at least one time per week for minimally 30 minutes)

Exclusion Criteria:

* Smoking
* Diabetes (Type 1, Type 2, or genetic form of diabetes)
* Any diagnosed cardiovascular (heart) disease or high blood pressure (≥140 mmHg systolic and/or ≥90 mmHg diastolic)
* Chronic use of any prescribed or over the counter pharmaceuticals (excluding oral contraceptives and contraceptive devices)
* Known allergy to lidocaine
* Regular use of dietary protein and/or amino acid supplements (\>3 times per week)
* Currently involved in a structured progressive resistance training programme (\>3 times per week)
* A personal or family history of thrombosis (clots), epilepsy, seizures, or schizophrenia.
* Any previous motor disorders or disorders in muscle and/or lipid metabolism
* Presence of an ulcer in the stomach or gut and/or strong history of indigestion
* Known severe kidney problems
* Pregnant or breastfeeding
* Unable to give consent

Primary outcomes:
measure: Postprandial muscle protein synthesis
timeFrame: 4 hours
Secondary outcomes:
measure: Forearm muscle glucose uptake
timeFrame: 7.5 hours
measure: Whole-body insulin sensitivity
timeFrame: Four hours following ingestion of an amino acid drink
measure: Forearm amino acid kinetics
timeFrame: Prior to and for 4 hours following amino acid intake
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University and Research
state: Gelderland
Study officials:
References:
Clinical trial NCT04191564: Effect of Anesthetic Conditions on Stapling Thickness and Quality
Official title: Impact of Low Perfusion by High Intraabdominal Pressure and Low Blood Pressure on Stapling Quality Measured as Thickness Difference Between Staples and Stomach Wall and by Bursting Pressure of Excluded Stomach
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastrectomy
Lead sponsor: AZ Sint-Jan AV
Sponsor class: OTHER
First posted: 2019-12-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: low perfusion
Primary purpose: DIAGNOSTIC

Brief summary: the excluded stomach during sleeve gastrectomy can be investigated post removal outside the patient. During stapling it is common to reduce systolic arterial blood pressure (SAP) below 100 mmHg to reduce peritoneal perfusion and have better compression. Higher intra abdominal pressures reduce also the peritoneal and mucosal perfusion and might help to improve stapling compression. Stapling compression can be evaluated by measuring stapling thickness and compare it with stomach wall thickness or by measuring leaks during leak test or better outside the patient on the excised stomach with a bursting pressure.

Detailed description: Patients are randomized to two groups: group standard perfusion means that the SAP is kept between 100 and 140 mmHg by adapting depth of anesthesia, by level of post expiratory pressure or by giving vasoconstriction.

low perfusion group means that

1. systolic blood pressure is kept below 100 mmHg from the first linear staple till the last by using a Clevidipine infusion to regulate the blood pressure accurate just below 100 mmHg for a short time while needed.
2. goal directed fluid therapy using 100 ml/h fluid intravenous and extra load of fluid if pulse pressure variation \> 20 %
3. increase intra abdominal pressure (IAP) up to 20 mmHg inly during stapling and return to minimum IAP needed to achieve 3 liter workspace.

The resected stomach is removed and analyzed outside the body before throwing away:

Eligibility criteria: Inclusion Criteria:

* primary sleeve gastrectomy

Exclusion Criteria:

* allergy to one of the drugs used intra operative
* liver, renal, cardiac or lung disease with limited function

Primary outcomes:
measure: staple thickness in mm
timeFrame: on excised stomach before being discarded within 1 hour after surgery
measure: stomach thickness in mm close to staple measurement
timeFrame: on excised stomach before being discarded within 1 hour after surgery
measure: bursting pressure in mmHg
timeFrame: on excised stomach before being discarded within 1 hour after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: Azsintjan
Study officials:
affiliation: AZSint Jan AV
name: Jan Paul Mulier
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01843764: Rapid Diagnostic Tests for Assessment of Initial Clearance and Detection of Recurrent Malaria Infections
Official title: Efficacy of Plasmodium Falciparum Specific Rapid Diagnostic Tests for Assessment of Initial Clearance and Detection of Recurrent Infections After Antimalarial Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Plasmodium Falciparum Malaria
Keywords: RDT
malaria
treatment follow up
diagnosis
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Muhimbili University of Health and Allied Sciences
First posted: 2013-05-01
Enrollment: 53
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with fever visiting primary health care units in malaria endemic area

Brief summary: The aim of the study was to follow clearance of malaria infections and detection of new malaria episodes after initiation of antimalarial treatment in Tanzanian children. For this purpose the investigators used five diagnostic tools, 2 Rapid Diagnostic tests based on Histidine Rich Protein 2(HRP2) and Lactate dehydrogenase(LDH), 2 microscopical methods and one polymerase chain reaction (PCR). The investigators followed the 53 enrolled children during 42 days.


Eligibility criteria: Inclusion Criteria:

* children between 6-59 months
* fever (≤37.5 C) or history of fever during the preceding 24 hours
* confirmed P.falciparum monoinfection
* uncomplicated malaria
* parasite density between 2000-250.000/µL
* willing/able to comply with the 42 day follow up
* informed concent from patient/guardian

Exclusion Criteria:

* children with history of antimalaria drug intake within the last two weeks
* symptoms / signs of severe disease

Primary outcomes:
measure: Clearance time with five diagnostic tests
timeFrame: 2009 June to 2012 May (up to day 42)
measure: Detection of recurrent infection with HRP2 and LDH-based Rapid diagnostic tests during follow up
timeFrame: 2009 June to 2012 May (up to day 42)
Secondary outcomes:
measure: Efficiency of P.falciparum specific rapid diagnostic tests
timeFrame: 2009 June to 2012 May (up to day 42)
Other outcomes:
Locations:
city: Dar es Salaam
country: Tanzania
facility: Mlandizi Health Centre and Fukayosi dispencary
state: Kibaha and Bagamoyo district
city: Dar es Salaam
country: Tanzania
facility: Muhimbili University of Health Allied Science
Study officials:
affiliation: Karolinska Institutet
name: Anders Björkman, Professor
role: STUDY_DIRECTOR
References:
citation: Aydin-Schmidt B, Mubi M, Morris U, Petzold M, Ngasala BE, Premji Z, Bjorkman A, Martensson A. Usefulness of Plasmodium falciparum-specific rapid diagnostic tests for assessment of parasite clearance and detection of recurrent infections after artemisinin-based combination therapy. Malar J. 2013 Oct 1;12:349. doi: 10.1186/1475-2875-12-349.
Clinical trial NCT01235364: Assessment of Pain With Insertion of the Foley Catheter for Induction of Labour
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Foley catheter
induction
labour
skin conductance
visual analogue scale
mechanical method
Lead sponsor: Uppsala University Hospital
Sponsor class: OTHER
First posted: 2010-11-05
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess pain in women randomised to digital or speculum placement of a Foley catheter. Pain during cervical ripening with the Foley catheter is also to be evaluated as well as maternal satisfaction with induction of labour.

Detailed description: The most common method described for placing the Foley catheter is under direct visualisation of the cervix during a sterile speculum examination. Another method is to place the catheter during a digital cervical examination.

Maternal discomfort/pain during speculum placement of the catheter has been evaluated in a few studies whereas studies that compare the digital method with the speculum method of placement are lacking.

The visual analogue scale is used to subjectively assess pain. With a skin conductance algesimeter an objective assessment of pain is possible.

Eligibility criteria: Inclusion Criteria:

* singleton fetus in cephalic presentation with a Bishop score of 3-5 and
* indication for induction of labour

Exclusion Criteria:

* low-lying placenta,
* undiagnosed vaginal bleeding,
* more than one previous caesarean section,
* previous use of an induction or pre-induction agent during the same pregnancy,
* signs of infection (maternal fever)
* non- proficiency in the Swedish language.

Primary outcomes:
measure: Pain assessed by VAS and SCA, in women randomised to digital or speculum placement of a Foley catheter.
timeFrame: At insertion of Foley catheter
Secondary outcomes:
measure: To assess pain with VAS and SCA during cervical ripening with the Foley catheter and to evaluate maternal satisfaction. To evaluate if markers of stress in blood and amniotic fluid correlate with VAS and SCA.
timeFrame: During treatment with Foley catheter. At expulsion of Foley catehter
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Department of obstetrics and gynecology, Uppsala university hospital
Study officials:
References:
Clinical trial NCT02041364: Biomarkers of Fatigue Related to Adjuvant Chemotherapy for Breast Cancer
Official title: Biomarkers of Fatigue Related to Adjuvant Chemotherapy for Breast Cancer: Evaluation of Plasma and Lymphocyte Expression.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fatigue
Breast Cancer
Keywords: Fatigue
Biomarkers
Breast Cancer
Lead sponsor: Faculdade de Medicina do ABC
Sponsor class: OTHER
First posted: 2014-01-22
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with stage I, II and III breast cancer undergoing adjuvant systemic chemotherapy based on the use of anthracyclines will be screened before the start of their treatment.

Brief summary: Fatigue is common in cancer patients receiving adjuvant chemotherapy. To further understand the mechanism of fatigue and search for potential biomarkers, we will conduct a prospective study with breast cancer patients receiving adjuvant chemotherapy.

Detailed description: Patients with breast cancer undergoing adjuvant systemic chemotherapy based on the use of anthracyclines will be screened before the start of chemotherapy.

Patients whose scores on the brief fatigue inventory (BFI) increase after having received the first cycle of chemotherapy will be considered as having manifested fatigue. The patients whose fatigue won't worse following the first cycle of chemotherapy will be used as controls. We will collect blood samples of both groups before and 21 days after the start of chemotherapy. We will analyze the following biomarkers: IL2, IL10, TNF and TGFB-1 measured by amplification reaction; FSH, LH, estradiol, DHEA, DHEAS and cortisol hormones measured by chemiluminescent enzyme immunometric assay

Eligibility criteria: Inclusion Criteria:

* Non metastatic breast cancer;
* Patients undergoing adjuvant chemotherapy

Exclusion Criteria:

* hypothyroidism;
* Depression;
* anemia;
* heart disease or decompensated hypertension

Primary outcomes:
measure: Potential biomarkers related to chemotherapy induced fatigue
timeFrame: 21 days after the start of chemotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Santo Andre
country: Brazil
facility: Cepho-Fmabc
state: Sao Paulo
Study officials:
affiliation: 551134744249
name: Felipe M Cruz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cruz FM, Munhoz BA, Alves BC, Gehrke FS, Fonseca FL, Kuniyoshi RK, Cubero D, Peppone LJ, Del Giglio A. Biomarkers of fatigue related to adjuvant chemotherapy for breast cancer: evaluation of plasma and lymphocyte expression. Clin Transl Med. 2015 Feb 14;4:4. doi: 10.1186/s40169-015-0051-8. eCollection 2015.
Clinical trial NCT01560364: Bundle Evaluation in Extra Renal Epuration, Incidence of Thrombosis
Official title: Bundle Evaluation in Extra Renal Epuration, Incidence of Thrombosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adults Receiving Renal Replacement Therapy
Keywords: Renal replacement therapy
Hemofilter clotting
Clotting risk factor
Hemofilter clotting prevention
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2012-03-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults receiving renal replacement therapy

Brief summary: This is a prospective observational clinical multicentric study in ICU with acute renal failure requiring renal replacement therapy.

Detailed description: Prospective before / after observational clinical multicentric study on ICU acute kidney injury during renal replacement therapy. Evaluation of incidence and exposure to hemofilter clotting.

The after phase will consist in medical measures (help for prescription) and paramedical measures (stop the filtration flow during the patient's mobilization).

Eligibility criteria: Inclusion Criteria:

* Adult (age \> 18 years)
* Renal replacement therapy (continuous veino-veinous hemofiltration or continuous veino-veinous hemodiafiltration)
* Consent of patients

Exclusion Criteria:

* Use citrate anticoagulation
* Age below 18 years

Primary outcomes:
measure: Hemofilter lifetime
timeFrame: at day 1
Secondary outcomes:
measure: Hemofilter clotting risk factors
timeFrame: at day 1
measure: hemofiltration duration
timeFrame: at day 1
measure: down time value
timeFrame: at day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Sébastien PERBET
role: PRINCIPAL_INVESTIGATOR
References: