louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02452996: Safety Study of GNbAC1 Monoclonal Antibody in Healthy Male Volunteers
Official title: A Randomised, Double-Blind, Placebo Controlled, Single Ascending Doses Study With GNbAC1 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: GNbAC1
Multiple Sclerosis
Multiple Sclerosis Associated Retrovirus (MSRV)
MSRV-Envelope protein
Monoclonal antibody
Temelimab
Lead sponsor: GeNeuro SA
Sponsor class: INDUSTRY
First posted: 2015-05-25
Enrollment: 21
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: In this clinical study, the safety and tolerability of GNbAC1 as a treatment for MS patients will be evaluated in healthy male volunteers.

Detailed description: The monoclonal antibody, GNbAC1, targets the envelope protein (Env) of the human endogenous retrovirus (HERV), also called multiple sclerosis associated retrovirus (MSRV), which is considered as a critical factor in the development of multiple sclerosis.

This study will assess the pharmacokinetics, safety and tolerability of GNbAC1 following single ascending doses (6, 18, and 36 mg/kg) administered via IV infusion.

Eligibility criteria: Inclusion Criteria:

* Healthy male subjects as determined by past medical history, physical examination, vital signs, ECG and laboratory tests at Screening and confirmed at Day -1 who have signed the informed consent.
* Aged from 18 to 55 years, both inclusive.

Exclusion Criteria:

* History of serious adverse reactions or hypersensitivity to any drug.
* Presence or history of any allergy requiring acute or chronic treatment (seasonal allergic rhinitis that requires no treatment may be tolerated).
* Need of any prescription medication within 15 days prior to the administration of the study drug and/or non-prescription medication within 7 days prior to the administration of the study drug or anticipated need for any concomitant medication during the study.
* Participation in a clinical trial during the previous 3 months, i.e. from completion of the previous trial to the planned first administration of the current trial.

NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: safety and tolerability of single ascending doses of GNbAC1 in healthy male subjects
timeFrame: 57 days
Secondary outcomes:
measure: PK characteristics: GNbAC1 serum concentrations
timeFrame: 57 days
measure: immunogenicity in terms of antibodies against GNbAC1 (anti-drug antibodies)
timeFrame: 57 days
measure: ratio of serum to CSF GNbAC1 concentration
timeFrame: 29 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: PAREXEL Early Phase Clinical Unit
Study officials:
affiliation: Parexel
name: Georg Golor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03135496: Evaluation of Endothelial Dysfunction During Aortic Valvular Replacement by Bioprosthesis With and Without Extracorporeal Circulation
Official title: Evaluation of Endothelial Dysfunction During Aortic Valvular Replacement by Bioprosthesis With and Without Extracorporeal Circulation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endothelial Dysfunction
Aortic Valve Disease
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2017-05-01
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: (Angiopoietin 1 and 2) in two types of populations: one with CEC and one without CEC (TAVI).

Brief summary: Patients with aortic stenosis present many risk factors for endothelial dysfunction (arterial hypertension, arteriosclerosis, dyslipidemia, chronic renal insufficiency, etc.). It is likely that a significant number of patients suffer from pre-existing endothelial dysfunction that can be evaluated by a molecular approach.

To date, the replacement of the aortic valve can be performed by surgery with extracorporeal circulation (CEC) or percutaneous (Transcatheter Aortic Valve ImplantationTAVI) without CEC.

Two recent studies have demonstrated a sustained improvement in endothelial function with TAVI. On the contrary, studies have demonstrated that post-operative complications (coagulopathy, capillary leak syndrome, acute vasoplastic disorder and acute renal failure) after surgery with extracorporeal circulation (CEC) could be the result of the interaction between pre-existing endothelial dysfunction And the "operative" aggression associated with the CEC.

Thus, patients with preexisting involvement of endothelial function would develop vascular dysfunction after valvular replacement due to "endothelial activation" related to CEC. This phenomenon would not exist in TAVI, and would explain the absence of so-called vascular dysfunction complications (Systemic inflammatory response syndrome, vasoplastic syndrome, disseminated intravascular coagulation).


Eligibility criteria: Inclusion Criteria:

* Patient ≥ 18 years.
* Patient operated on aortic valvular replacement by bioprosthesis in surgery + CEC or TAVI
* Signed consent.
* Affiliation to Social Security

Exclusion Criteria:

* Any other cardiac surgery
* Mechanical aortic valve replacement
* Permanent Ac / Fa.
* Pregnant woman.
* Curative anticoagulation (AVK, NANCO, heparin).
* Patient under tutelage or curatelle.
* Refusal of the patient.
* Participation in another study.
* Preoperative sepsis
* Minor or adult, under guardianship or curatorship

Primary outcomes:
measure: Analysis of the variation of the following endothelial function markers: angiopoetin 1 and 2 depending on whether or not extracorporeal circulation
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
state: Picardie
Study officials:
References:
Clinical trial NCT01779596: ET-blockade and Exercise Induced Blood Flow in T2DM
Official title: Effect of a Dual ET-blocker on Exercise Induced Blood Flow and Endothelial Function in T2DM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes
endothelial function
exercise
blood flow
bosentan
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2013-01-30
Enrollment: 22
Sex: MALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to establish the effect of ET blockade on the acute exercise induced blood flow and endothelial function in subjects with T2DM. We hypothesize that combining ET - blockade with exercise training leads to an acute increase of exercise induced blood flow when compared with exercise alone. We expect that this will lead to an optimization of vascular training effect in T2DM.


Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes Mellitus (\>2 years since diagnosis) OR controls

Exclusion Criteria:

* \<40 years of age
* \>65 years of age
* smoking
* cardiovascular disease
* diabetes related manifest vascular complications
* Type 1 Diabetes Mellitus
* use of Glibenclamide
* use of HIV drugs
* use of calcineurin inhibitors
* use of drugs that interfere with CYP3A4 and CYP2C19

Primary outcomes:
measure: exercise induced blood flow
timeFrame: 2 hours
Secondary outcomes:
measure: exercise induced Flow Mediated Dilation
timeFrame: 2 hours
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
state: Gelderland
Study officials:
References:
citation: Schreuder TH, van Lotringen JH, Hopman MT, Thijssen DH. Impact of endothelin blockade on acute exercise-induced changes in blood flow and endothelial function in type 2 diabetes mellitus. Exp Physiol. 2014 Sep;99(9):1253-64. doi: 10.1113/expphysiol.2013.077297. Epub 2014 May 16.
Clinical trial NCT01190696: Titanium Elastic Nailing Versus Hip Spica Cast in Treatment of Femoral Fractures in Children
Official title: Study of Surgical Method Versus Casting for Treatment of Femoral Fracture in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Femoral Shaft Fracture
Keywords: Spica Cast
TEN
Femoral Shaft Fracture
Children
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2010-08-30
Enrollment: 46
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine which method is better for treatment of femoral fracture in children in outcomes.

Detailed description: There is no consensus on treatment of closed femoral shaft fractures in children 6-12years old. We aimed to compare hip spica cast with titanium elastic nailing (TEN) in the treatment of femoral shaft fractures in children.

Eligibility criteria: Inclusion Criteria:

* patients 6-12 years old with femoral shaft fracture without exclusion criteria

Exclusion Criteria:

* Segmental, Winquist type III and IV comminuted fractures, previously diagnosed neuromuscular disease (e.g., cerebral palsy), metabolic bone disorders (e.g. osteomalacia), or pathological fractures.

Primary outcomes:
measure: Length of hospital stay
timeFrame: at 1 months post-operatively
Secondary outcomes:
measure: the time to walking with aids
timeFrame: at 1 months post-operatively
measure: parent's satisfaction
timeFrame: at 1 months post-operatively
measure: the time absent from school
timeFrame: at 1 months post-operatively
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Al-zahra university hospital
Study officials:
affiliation: MD,research comittee
name: hamidreza shemshaki, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05618496: Multi-centre, Open-label, First-in-man Study With Epipad Used in Adult Patients
Official title: Multi-centre, Open-label, First-in-man Study With Epipad Used in Adult Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound
Lead sponsor: Contipro Pharma a.s.
Sponsor class: OTHER
First posted: 2022-11-16
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main objective of the trial is to confirm safety of a new product - Epipad. The main impact of the device is to provide good environment for the healing of chronic wounds and wounds in the last healing phase (granulation and epithelisation).


Eligibility criteria: Inclusion Criteria:

* Patient suffered from superficial wound of different etiology
* Wounds in terminal phase of healing
* Wounds without visible sign of infection
* Max. size of the wound: 10 x 20 cm (i.e. two pieces of the product)
* Duration of wound treatment of at least 6 weeks
* Subject willing and able to provide written informed consent
* Ability to communicate well with the investigator in local language, and to understand and comply with the requirements of the study

Exclusion Criteria:

* Sloughy or necrotic wound bed
* Severely contaminated or infected wound
* Age \< 18 years
* Pregnant or lactating woman
* Subject in terminal stage of living
* Subject with cancer disease
* Subject with known hypersensitivity or allergy to any component of the investigational device
* Subject participating in other interventional clinical trial
* Alcohol and/or drug abuse

Primary outcomes:
measure: Change in the wound dimensions (width x length)
timeFrame: Week 3
Secondary outcomes:
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Fakultni nemocnice u sv. Anny
city: Hořice
country: Czechia
facility: Levitovo centrum nasledne pece
city: Olomouc
country: Czechia
facility: Vojenska nemocnice Olomouc
city: Vsetín
country: Czechia
facility: Vsetinska nemocnice
Study officials:
References:
Clinical trial NCT01557296: Evaluation of Diagnostic Methods and Dietary Treatment of Diabetic Gastroparesis
Official title: Comparing Treatment With Food of Small Particle Size and Food of Large Particle Size in Subjects With Diabetic Gastroparesis. Evaluation of Diagnostic Methods. Determination of the Motility of Gastric Emptying After Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Gastroparesis
Keywords: Diet
Dietary treatment
Particle size
Gastroparesis
Diabetes Mellitus
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2012-03-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study is in subjects with Insulin Treated Diabetes Mellitus type 1 or 2 and gastroparesis:

* validate radiopaque markers with fluoroscopy with gastric scintigraphy method
* study the difference of metabolic control including the frequents of hypoglycaemia, gastrointestinal symptoms, quality of life and nutrition state during dietary treatment of food of small particle size compared with food of large particle size
* validate the radiopaque markers method and measurement of the blood glucose and gastrointestinal symptoms after a test meal, against the gastric scintigraphy
* determine if the function of gastric emptying can be improved after intervention


Eligibility criteria: Inclusion Criteria:

* diabetes type 1 or 2 and gastroparesis
* must be able to understand oral and verbal instructions

Exclusion Criteria:

* gastrointestinal surgery
* other gastrointestinal disease
* S-Creatinine \>150 umol/L
* mental disease
* cerebral disease
* collagen disease
* untreated endocrine disease
* anticholinergic drugs
* psychopharmacologic drugs
* opiates
* addiction to drugs as alcohol and narcotics
* vegetarian

Primary outcomes:
measure: Metabolic Control - HbA1c
timeFrame: 22 weeks
Secondary outcomes:
measure: gastrointestinal symptoms - Questionnaire: Patient Assessment of upper Gastrointestinal Disorders Symptoms, Gastrointestinal Symptom Rating Scale
timeFrame: 22 weeks
Other outcomes:
Locations:
city: Goteborg
country: Sweden
facility: Goteborg Universitet, Sahlgrenska Academy, Sahlgrenska University Hospital
Study officials:
affiliation: Inst of Medicine, Sahlgrenska Academy, Göteborg University
name: Magnus Simrén, M.D., Ph.D.
role: STUDY_CHAIR
References:
citation: Olausson EA, Storsrud S, Grundin H, Isaksson M, Attvall S, Simren M. A small particle size diet reduces upper gastrointestinal symptoms in patients with diabetic gastroparesis: a randomized controlled trial. Am J Gastroenterol. 2014 Mar;109(3):375-85. doi: 10.1038/ajg.2013.453. Epub 2014 Jan 14.
Clinical trial NCT02441296: Carbohydrate and Metabolism: a Pilot Study
Official title: Postprandial Serum Responses to Various Infant Formulas and Breast Milk in Infants- a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant
Metabolism
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: University of California, Davis
name: Mead Johnson Nutrition
First posted: 2015-05-12
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The optimal choice of carbohydrate in infant formula needs to be assessed in more detail. Lactose has conventionally been used in most milk-based infant formulas, but more recently lactose-free formulas based on corn syrup solids/maltodextrins have gained in popularity. However, the metabolic consequences have not been examined.

In a pilot study, the investigators will assess the postprandial metabolic response to a meal of formula with either lactose or maltodextrins. A breastfed reference group is also included.


Eligibility criteria: Inclusion Criteria:

* Healthy
* Term infants (gestational age 37-42 weeks)
* Birth weight 2500-4500g

Exclusion Criteria:

* Infant illness
* Maternal diabetes
* Maternal pregnancy complications

Primary outcomes:
measure: Glucose levels
timeFrame: 2 hours (Change from baseline to 15 min, 30 min, 60 min, 90 min and 120 min)
Secondary outcomes:
measure: Insulin levels
timeFrame: 2 hours (Change from baseline to 15 min, 30 min, 60 min, 90 min and 120 min)
measure: Metabolite levels
timeFrame: 2 hours (Change from baseline to 15 min, 30 min, 60 min, 90 min and 120 min)
Other outcomes:
Locations:
Study officials:
References:
citation: Slupsky CM, He X, Hernell O, Andersson Y, Rudolph C, Lonnerdal B, West CE. Postprandial metabolic response of breast-fed infants and infants fed lactose-free vs regular infant formula: A randomized controlled trial. Sci Rep. 2017 Jun 16;7(1):3640. doi: 10.1038/s41598-017-03975-4.
Clinical trial NCT04773717: The Effect of High Dose Parenteral Ascorbic Acid On Microcirculation In Sepsis
Official title: The Effect of High Dose Parenteral Ascorbic Acid On Microcirculation In Sepsis. Randomized Double-Blind Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Septic Shock
Keywords: Sepsis
Microcirculation
Ascorbic acid
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 60
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: The purpose of this study is to evaluate the effect of high-dose ascorbic acid on microcirculation in sepsis.

Detailed description: Adult patients with septic shock were enrolled within 24 hours following admission to the Central Department of Intensive Care in Lithuanian University of Health Sciences Hospital Kaunas Clinics.

Participants were randomly assigned to a placebo or ascorbic acid group in a 1:1 ratio. They were resuscitated according to Surviving Sepsis Campaign Guidelines. Additionally, they received an intravenous infusion of ascorbic acid either placebo. The dose of ascorbic acid was 200mg/kg/24h divided into four equal parts for 96 hours. Sublingual microcirculatory measurements were obtained, using an incident dark field (IDF) device.

Eligibility criteria: Inclusion Criteria:

* Patients with sepsis or septic shock within the first 24 hours after ICU admission.

Exclusion Criteria:

* Age \< 18 years,
* Pregnancy,
* Advanced malignancy,
* History of kidney stone, glucose-6-phosphate deficiency, hemochromatosis, or solid organ transplantation,
* Oral mucosal inflammation or injury or technical difficulties in obtaining sublingual images.

Primary outcomes:
measure: Microvascular flow index (MFI)
timeFrame: Baseline, after 0.5, 6, 12, 24, 48, 72 and 96 hours
measure: Proportion of perfused small vessels (PPV)
timeFrame: Baseline, after 0.5, 6, 12, 24, 48, 72 and 96 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Lithuanian University of Health Sciences Hospital Kaunas Clinics
Study officials:
References:
Clinical trial NCT00204217: Monitoring of Intubation and Ventilation During Resuscitation
Official title: Monitoring of Intubation and Ventilation During Resuscitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cardiac Arrest
Keywords: cardiac arrest
resuscitation
ventilation
impedance
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Laerdal Medical
name: Ullevaal University Hospital
name: Health Region East, Norway
name: Norwegian Air Ambulance Foundation
name: University of Stavanger
First posted: 2005-09-20
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Airway control and ventilation is vital during cardiopulmonary resuscitation (CPR) in cardiac arrest. Endotracheal intubation is the gold standard for airway control, but several studies have shown high rates of unrecognized placements of the tube in the esophagus instead of in the airway out-of-hospital. This is lethal. There are no failproof technique for recognising such mistakes clinically in the cardiac arrest situation. Changes on the air volume in the lungs with ventilation changes the impedance (resistance to alternating current) through the thorax. This impedance is already measured routinely by the defibrillators used during CPR. We propose that we can measure ventilation volumes and also discover failed intubations by monitoring this impedance during CPR with the possibility of giving feedback on both to the rescuers.

Detailed description: On the anesthesiologist manned ambulance in Oslo ventilation volumes during CPR will be controlled with a ventilator, the tidal volume varied in random order between 500, 700 and 100 ml, and the volumes be measured continuously as will the impedance between the defibrillator electrodes. In case of failed CPR, the patient will be declared dead. Thereafter the lungs will be ventilated with 700 ml followed by removal of the endotracheal tube, placement of an endotracheal tube in the esophagus and ventilation of this tube, again with monitoring of the impedance.

Eligibility criteria: Inclusion Criteria:

* Cardiac arrest

Exclusion Criteria:

* \<18 years old trauma pregnancy

Primary outcomes:
measure: sensitivity/specificity for lung ventilation detection
measure: correlation ventilation volume - impedance change
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Ulleval University Hospital
Study officials:
affiliation: Ulleval University Hospital, University of Oslo
name: Elizabeth Dorph
role: PRINCIPAL_INVESTIGATOR
References: