louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03899389: Plasma TMAO (Trimethylamine N-oxide) as a Predictive Marker in Coronary Disease Patients
Official title: Plasma TMAO (Trimethylamine N-oxide) as a Predictive Marker in Coronary Disease Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Disease
Keywords: trimethylamine-N-oxide
Lead sponsor: Gdansk University of Physical Education and Sport
Sponsor class: OTHER
First posted: 2019-04-02
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from the Pomeranian Cardiology Centers in Wejherowo

Brief summary: The primary aim of the current research project is to determine whether the TMAO concentration in the blood can serve as a prognostic indicator of myocardial infarction.

The hypothesis is that in patients with recent myocardial infarction, TMAO concentration in blood is higher than in patients undergoing scheduled coronarography.

Detailed description: To the study will be included volunteers - patients with stable angina (SA), who were scheduled for conventional coronary angiography, and patients with acute coronary syndrome (ACS) who were admitted to the hospital with chest pain and undergoing coronography surgery. Blood samples will be taken from volunteers once - before the coronography surgery by qualified medical personnel.

Eligibility criteria: Inclusion Criteria:

* diagnosed stable angina (SA) or acute coronary syndrome (ACS) and planned coronography

Exclusion Criteria:

* unconscious patient

Primary outcomes:
measure: Trimethylamine-N-oxidec(TMAO) blood concentration
timeFrame: Immediately before coronography.
Secondary outcomes:
Other outcomes:
Locations:
city: Gdansk
country: Poland
facility: University of Physical Education and Sport
state: Pomorskie
Study officials:
affiliation: University of Physical Education and Sport in Gdansk
name: Robert A Olek, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01476189: A Study to Compare to the Pharmacokinetic Profile of Two Paracetamol Formulations
Official title: A Repeat Dose PK Study Investigating the Extent of Paracetamol Absorption From Two Sustained Release Paracetamol Formulations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: pharmacokinetic
paracetamol
Healthy volunteer
steady state
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-11-22
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: A repeat dose pharmacokinetic study investigating two paracetamol formulations


Eligibility criteria: Inclusion Criteria:

* Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination.

Exclusion Criteria:

* Subject does not agree to refrain from alcohol consumption for the 10-day period prior to visit 2 and throughout the study.
* Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
* Current (within 14 days of screening) or regular use of any prescription, over-the-counter drugs including paracetamol/acetaminophen, herbal medicine or drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to dosing (e.g. barbiturates, theophylline, cimetidine, or erythromycin), excluding prescription birth control, if applicable.

Primary outcomes:
measure: Bioequivalence as measured by Area Under the Curve (AUC)
timeFrame: last 24 hours of dosing
Secondary outcomes:
measure: Time duration at or above minimal therapeutic plasma paracetamol concentration
timeFrame: last 24 hours of dosing
measure: To assess pharmacokinetic parameters (Cmax, AUC, Tmax and Kel)
timeFrame: last 24 hours of dosing
measure: Adverse events
timeFrame: Baseline to 72 hours post dosing
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: MDS Pharma Services NEBRASKA
state: Nebraska
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02284789: Colorado Adult Joint Assessment Scale (CAJAS) Validation
Official title: Content and Psychometric Validation Study of the Colorado Adult Joint Assessment Scale (CAJAS) in Subjects With Moderate to Severe Hemophilia A Treated on Prophylaxis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemophilia A
Keywords: Hemophilia
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2014-11-06
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: To obtain evidence of content validity and reliability of the Colorado Adult Joint Assessment Scale (CAJAS), a clinician-reported outcome (ClinRO) measure, as adapted for use in a population of adults with moderate to severe hemophilia A treated with coagulation factor VIII (FVIII) therapy as secondary prophylaxis or episodic treatment.


Eligibility criteria: Inclusion Criteria:

* Male, 18 to 50 years of age
* Diagnosis of moderate to severe hemophilia A (documented \<1-2% Factor VIII Concentration \[FVIII:C\])
* Willing to maintain current FVIII treatment regimen, whether prophylactic or on-demand, for the duration of the study

Exclusion Criteria:

* Routine need for wheelchair or routine need for two canes or crutches
* Diagnosis of another bleeding disorder such as von Willebrand Disease
* Known event that would interfere with the scheduled CAJAS evaluations (e.g., elective joint surgery, vacation)

Primary outcomes:
measure: Colorado Adult Joint Assessment Score (CAJAS)
timeFrame: Up to 25 days
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Indianapolis
country: United States
state: Indiana
city: Portland
country: United States
state: Oregon
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02391389: VentFirst Pilot: Ventilating Preterm Infants During Delayed Cord Clamping
Official title: VentFirst Pilot: Ventilating Preterm Infants During Delayed Cord Clamping
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant, Premature, Diseases
Keywords: preterm infant
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2015-03-18
Enrollment: 28
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Delayed clamping of the umbilical cord (DCC) has been shown to have some benefits for preterm infants. Initiation of breathing before cord clamping is also thought to be beneficial. Since some preterm infants do not breathe well on their own immediately after birth, assisting ventilation during delayed cord clamping might have additional benefit beyond DCC alone. "VentFirst Pilot" will assess feasibility and safety of assisting ventilation of preterm infants during 90 seconds of DCC which is essential before proceeding to a randomized clinical trial.

Detailed description: Mothers expected to deliver an infant at 24-32 completed weeks' gestation will be approached for consent. When the infant is delivered, members of the neonatology team will be at the mother's side and will provide initial steps of resuscitation (position, suction, stimulate) per guidelines of the Neonatology Resuscitation Program (NRP). At 30 seconds after birth, the infant will receive continuous positive airway pressure (CPAP) if breathing well, or positive pressure ventilation (PPV) if not breathing well. At 90 seconds, the umbilical cord will be cut and the remainder of the resuscitation and stabilization will be carried out in the usual location.

Eligibility criteria: Inclusion Criteria:

- 24 0/7 to 32 6/7 weeks gestation at birth

Exclusion Criteria:

* major congenital anomalies
* monochorionic twins
* twin-twin transfusion syndrome
* hydrops fetalis

Primary outcomes:
measure: Number of deliveries in which providing ventilatory assistance during delayed cord clamping is achieved
timeFrame: 90 seconds after birth
Secondary outcomes:
measure: Number of unanticipated complications of neonatal resuscitation during delayed cord clamping (neonatal temperature, hematocrit, bilirubin,maternal infection, and other clinical variables)
timeFrame: 7 days from birth
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia School of Medicine
state: Virginia
Study officials:
affiliation: University of Virginia SOM
name: Karen D Fairchild, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Winter J, Kattwinkel J, Chisholm C, Blackman A, Wilson S, Fairchild K. Ventilation of Preterm Infants during Delayed Cord Clamping (VentFirst): A Pilot Study of Feasibility and Safety. Am J Perinatol. 2017 Jan;34(2):111-116. doi: 10.1055/s-0036-1584521. Epub 2016 Jun 15.
Clinical trial NCT04698889: Effect of Ingestion of Human, Cow, and Modified-cow Milk, on Glucose and Hormone Responses in Humans.
Official title: Study of the Effects of Ingestion of Natural Human, Natural Cow, and Modified-cow Milk, on Glucose, Amino Acids, Insulin, and Incretin Responses in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Tolerance
Hormone
Aminoacidaemia
Keywords: cow milk
human milk
incretins
casein
whey proteins
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2021-01-07
Enrollment: 17
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Subjects allocated to receive one or more milk types in random order on different occasions, spaced by at least two weeks
Primary purpose: BASIC_SCIENCE

Brief summary: Human milk, despite a much lower protein content, is as effective as cow milk on insulin stimulation under iso-lactose conditions. The causes for such a similar potency are unknown. This effect could be due to incretin and amino-acid responses, and/or to milk-protein interactions.In this study the investigators will address the above question(s) by testing, in young healthy volunteers, the effects of natural cow and human milk, as well as of the manipulation of the casein and whey protein content in cow milk, on insulin, C-peptide, GLP-1 and GIP secretion, as well as on circulating amino acids.

Detailed description: Objective: To determine plasma glucose, insulin, C-peptide, glucagon-like polypeptide-1 (GLP-1), glucose-inhibitory-polypeptide (GIP) and amino-acid responses, following administration of human and cow milk, either natural or with experimentally-modified casein and whey-protein content(s).

Design. Young healthy volunteers of both sexes will receive iso-lactose loads (0.36 g lactose / kg body weight) of: natural cow milk; natural human milk; and of cow milk with modified casein and whey protein contents. Blood samples will be frequently collected over 4 hours. Plasma glucose, amino acids, insulin and incretin concentrations will be measured.

Eligibility criteria: Inclusion Criteria:

* Age 20-35 yrs
* Both sexes
* Healthy
* In post-absorptive state
* Hemoglobin Hb1c values within normal values.
* Previous regular, moderate physical activity
* Stable body weight and regular dietary habits.

Exclusion Criteria:

* Familial or personal history of diabetes.
* Altered fasting glucose and/ or impaired glucose tolerance.
* Any metabolic, hormonal, hepatic, renal, and cardiovascular disease.
* Current drug treatments

Primary outcomes:
measure: Plasma insulin and c-peptide
timeFrame: 1 year
measure: Plasma GIP: glucose-inhibitory polypeptide and GLP-1: glucagon-like-polypeptide-1
timeFrame: 1 year
Secondary outcomes:
measure: Plasma Amino acids
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01996189: Arterial Puncture Using Insulin Syringe is Less Painful Than Standard Syringe
Official title: Arterial Puncture Using Insulin Syringe is Less Painful Than Standard Syringe, a Randomized Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2013-11-27
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary objective is to compare the difference in the pain score in radial arterial puncture using the insulin needle versus the standard 23G hypodermic needle.

Detailed description: In a randomised, crossover design, healthy volunteers were recruited to receive bilateral radial arterial punctures. They were assigned to receive either the insulin or the standard needle as the first puncture using block randomisation. The primary outcome was the pain score measured on a 100mm visual analogue scale (VAS) and the secondary outcomes were procedural complications and rate of haemolysis.

Eligibility criteria: Inclusion Criteria:

* age above 21

Exclusion Criteria:

* concurrent antipyretic use in the last 24 hrs,
* presence of painful conditions eg fracture, rheumatoid arthritis
* history of peripheral vascular disease

Primary outcomes:
measure: Visual analogue scale (VAS) score in millimetres
timeFrame: Immediately after each puncture ( average within 5 minutes)
Secondary outcomes:
measure: blood haemolysis
timeFrame: Immediately after collection
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: National Unversity Health Systems
name: Irwani Ibrahim, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: National University Health Systems
name: Yau Ying Wei, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00328289: Effect of Intradialytic Electrical Muscle Stimulation and Passive Leg Mobilisation on Blood Pressure and Dialysis Efficacy
Official title: Effect of Intradialytic Electrical Muscle Stimulation and Passive Leg Mobilisation on Blood Pressure and Dialysis Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypotension
Keywords: Dialysis associated hypotension
Urea removal
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2006-05-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Hypothesis: Intradialytic blood pressure and dialysis efficacy (in terms of urea removal) improve under electrical muscle stimulation or passive leg movement on a treadmill.


Eligibility criteria: Inclusion Criteria:

* Dialysis patients able to put legs on a treadmill

Exclusion Criteria:

* Dialysis duration shorter than 3 months

Primary outcomes:
measure: Blood pressure
measure: Urea removal
Secondary outcomes:
measure: Number of hypotensive episodes on dialysis
Other outcomes:
Locations:
city: Berne
country: Switzerland
facility: Department of Nephrology and Hypertension, University Hospital of Berne
Study officials:
affiliation: Department of Nephrology and Hypertension, University Hospital of Berne
name: Dominik Uehlinger, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04936789: Clinical Feasibility of the IMES Transradial Prosthesis
Official title: Clinical Feasibility of the IMES Transradial Prosthesis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amputation
Lead sponsor: Össur Iceland ehf
Sponsor class: INDUSTRY
First posted: 2021-06-23
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This study will evaluate the feasibility of using implanted myoelectric sensors (IMES) to control a transradial prosthesis

Detailed description: The study assesses the feasibility of an implantable myoelectric prosthesis control system to control a transradial prosthesis. Implantable Myoelectric Sensors (IMES) will be implanted into the residual forearm muscles of three transradial amputee subjects. These devices wirelessly transmit electrical muscle signals to an electromechanical prosthetic wrist and hand.

Following a two-week recovery from implantation of up to 16 IMES into residual forearm muscles, subjects will begin a two week training phase. When they receive their custom-fit IMES Transradial Prosthesis (including electromechanical wrist and hand) subjects initiate approximately four months of home use. Subjects will be offered up to five post-study follow-up visits. The usability and functionality of the prosthetic system will be evaluated throughout the study.

Eligibility criteria: Inclusion Criteria:

* (unilateral acquired transradial) amputation
* residual limb size requirements to fit investigational device componentry
* at least 6 residual muscle locations available for implantation
* good compliance with health service (rehabilitation)
* willing to undergo surgical implantation of IMES Sensor implants
* experience with myoelectric upper limb prostheses
* using own myoelectric device approximately 6-8h/day
* able to provide informed consent and attend the study visits

Exclusion Criteria:

* any condition which in the opinion of the investigator poses a risk to health
* neurological disorder that may prohibit accurate control
* major injury proximal to the level of amputation
* neuromuscular disorder
* nerve transection or palsy that may cause de-innervation of muscles planned for implantation
* allergy to implanted materials
* existing active implant

Primary outcomes:
measure: Grip Accuracy
timeFrame: The measure will be carried out 11 times during the study, at Baseline with the subject's own device for comparison, and at 10 study visits with the investigational device conducted over approximately 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde
Study officials:
affiliation: NHS; University of Edinburgh
name: Aidan Roche, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01542489: Observational Study of the Predictability of Levemir® in Terms of Metabolic Control, Change of Body Weight and Hypos
Official title: An Observational 3 Months Study to Evaluate the Effect of Insulin Levemir® on Glycaemic Control, Weight and Incidence of Hypoglycaemic Events in Insulin Treated Subjects With Type 1 or Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-03-02
Enrollment: 480
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any subject with type 1 or type 2 diabetes treated with insulin in whom at the discretion of the participating physicians it was decide to switch insulin treatment to the long-acting insulin analogue Levemir® in combination with either insulin aspart (NovoRapid®) or human insulin (Actrapid®)

Brief summary: This trial is conducted in Europe. The aim of this trial is to evaluate the effect of Levemir® (insulin detemir) on glycaemic control, weight and incidence of hypoglycaemic events in insulin treated subjects with type 1 or type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Any subject with type 1 or type 2 diabetes treated with insulin in whom at the discretion of the participating physicians it was decide to switch insulin treatment to the long-acting insulin analogue insulin detemir (Levemir®) in combination with either insulin aspart (NovoRapid®) or human insulin (Actrapid®)

Primary outcomes:
measure: Change in HbA1c (glycosylated haemoglobin)
Secondary outcomes:
measure: Change in 7-point blood glucose variability
measure: Change in body weight
measure: Insulin dose
measure: Number of injections
measure: Number of hypoglycaemic episodes
measure: Number of adverse events
Other outcomes:
Locations:
city: Bratislava
country: Slovakia
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Emil Martinka; Improved Glycemic Control and Weight Loss in Slovakian Patients Switching from NPH to Insulin Detemir; 2049-PO; 69th Scientific Sessions (2009); American Diabetes Association
Clinical trial NCT04444089: Perioperative Fluid Therapy in Pediatric Patients Undergoing Penile Hypospadias Repair
Official title: Role of Lung Ultrasound in Comparison of Different Fluid Replacement Regimens in Pediatric Patients Undergoing Penile Hypospadias Repair, Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Volume Overload
Keywords: Conventional regimen
restrictive regimen
lactated Ringer's solution
lung ultrasound
fluid management
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-06-23
Enrollment: 80
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Optimization of perioperative fluid management is important for preventing adverse events, such as hypovolemia, cardiogenic shock, volume overload, and pulmonary edema, in both adult and pediatric patients. If the intravascular (IV) fluid volume is not optimized, pediatric patients are at risk of dehydration or volume overload. Perioperative IV fluid therapy is important during and after induction of general anesthesia (GA).The aim of this study is to investigate the difference between conventional and restrictive fluid replacement regimens using lung ultrasound in pediatric patients undergoing penile hypospadias repair, as a surgery with minor fluid loss.


Eligibility criteria: Inclusion Criteria:

* scheduled for repair of penile hypospadias with American Society of Anaesthesiologists' physical status of class I-II.

Exclusion Criteria:

* Patients with pulmonary, cardiovascular, or hematological disorders or a family history of allergy to local anesthetics or lung disease

Primary outcomes:
measure: volume overload using lung ultrasound
timeFrame: intraoperative duration that is approximately 110 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: anesthesia department at Cairo University
state: Elmanial
Study officials:
affiliation: Cairo University
name: Mohamed Elsonbaty, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 1. Joshua IS. Perioperative fluid restriction. Clin Colon Rectal Surg 2013;26:197-202. 2. Feldheiser A, Aziz O, Baldini G, Cox BP, Fearon KC, Feldman LS, et al. Enhanced Recovery After Surgery (ERAS) for gastrointestinal surgery, part 2: Consensus statement for anaesthesia practice. Acta Anaesthesiol Scand 2016;60:289-334. 3. Varadhan KK, Lobo DN. A meta-analysis of randomised controlled trials of intravenous fluid therapy in major elective open abdominal surgery: Getting the balance right. Proc Nutr Soc 2010;69:488-9. 4. Shin CH, Long DR, McLean D, Grabitz SD, Ladha K, Timm FP, et al. Effects of intraoperative fluid management on postoperative outcomes: A hospital registry study. Ann Surg 2018;267:1084-92.