louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02487680: Effects of an Amino Acid and Chromium-picolinate Containing Drink on Glucose Metabolism on Healthy Subjects
Official title: Effect of a Table Water Enriched With Amino Acids and Chromium on Blood Glucose and Insulin Levels After a Meal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: DoubleGood AB
Sponsor class: INDUSTRY
Collaborators: name: Lund University
First posted: 2015-07-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: It has previously been shown in healthy overweight subjects, that table water including a defined amount of amino acids and chromium can decrease the postprandial glucose. In this study, the effect of this table water on glucose excursions after a test meal containing a defined amount of available carbohydrates, protein and fat will be studied in healthy subjects. The study will be conducted in a cross -over design, double blinded and placebo controlled including 20 participants. The primary endpoint of the study is the incremental area under the curve for plasma glucose (iAUCgluc) within 180 minutes after ingestion of the meal.


Eligibility criteria: Inclusion Criteria:

* Stable body weight (no changes above 3 kg during the last 2 months)
* Good general health
* Body mass index 19 - 30 kg/m2 (normal to overweight)
* Fasting blood glucose below 6.1 mmol/L

Exclusion Criteria:

* Any medication that could influence the study. Such as medication against diabetes, hypoglycemia, hypertension or hypercholesterolemia
* Psychiatric Disease
* Alcohol or drug abuse
* Smokers or people consuming snus
* Acute infections
* Vegetarians/vegans
* Suffering from Lactose or Gluten intolerance
* Pregnancy or Lactation
* Participation in another study at the same time
* Any other parameter that the PI will judge as inadequate

Primary outcomes:
measure: Area under the curve for Glucose after ingestion of a test meal
timeFrame: 180 min
Secondary outcomes:
measure: Area under the curve for insulin after ingestion of a test meal
timeFrame: 180 min
Other outcomes:
Locations:
Study officials:
affiliation: Stoffwechselzentrum Rhein Pfalts, Mannheim, Germany and Department of internal medicine, University of Heidelberg, Germany
name: Per Humpert, MD, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Food for Health Science Center, Lund University, Sweden
name: Ana Rascón, PhD, Prof
role: STUDY_DIRECTOR
affiliation: Experimental Medical Science, Lund University, Sweden
name: Kristina Andersson, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03203980: Bleeding Events After Triple Antithrombotic Therapy Initiation.
Official title: Bleeding Events After Triple Antithrombotic Therapy Initiation: a Prospective Observational Study in Real Life
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bleeding
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2017-06-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from the cardiology care unit of Nancy Central Hospital, hospitalised for coronary stenting and requiring oral anticoagulation (except VKA)

Brief summary: The optimal antithrombotic therapy for patients requiring anticoagulation after coronary stenting is unknown. Double platelets suppressive agents combined with oral anticoagulation (triple antithrombotic therapy) remains the Gold standard.

Our study aims at studying bleeding events occurring until 6 months after the initiation of triple antithrombotic therapy.


Eligibility criteria: Inclusion Criteria:

* patients requiring triple antithrombotic therapy, including double antiplatelets agents and oral anticoagulation

Exclusion Criteria:

* history of bleeding
* patients already under triple antithrombotic therapy
* patients under vitamin K antagonists

Primary outcomes:
measure: Bleeding events
timeFrame: within 6 months since the initiation of triple antithrombotic therapy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00120380: Combination Therapy of Bosentan and Aerosolized Iloprost in Idiopathic Pulmonary Arterial Hypertension (IPAH)
Official title: Combination Therapy of Bosentan and Aerosolized Iloprost in Idiopathic Pulmonary Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hypertension
Keywords: Idiopathic pulmonary arterial hypertension
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2005-07-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 test whether the addition of inhaled iloprost is safe and effective in patients with idiopathic pulmonary arterial hypertension who are already being treated with the endothelin receptor antagonist bosentan.


Eligibility criteria: Inclusion Criteria:

* IPAH
* \> 3 months treatment with bosentan
* 6 minute walk distance 150 - 425 m

Exclusion Criteria:

* other forms of pulmonary hypertension
* severe comorbidities
* cotreatment with sildenafil or investigational drugs

Primary outcomes:
measure: 6 minute walk test
Secondary outcomes:
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School
Study officials:
affiliation: Hannover Medical School
name: Marius M Hoeper, MD
role: STUDY_CHAIR
References:
citation: Hoeper MM, Leuchte H, Halank M, Wilkens H, Meyer FJ, Seyfarth HJ, Wensel R, Ripken F, Bremer H, Kluge S, Hoeffken G, Behr J. Combining inhaled iloprost with bosentan in patients with idiopathic pulmonary arterial hypertension. Eur Respir J. 2006 Oct;28(4):691-4. doi: 10.1183/09031936.06.00057906.
Clinical trial NCT05784480: Relevance of Reversible Causes During OHCA (Rebecca Study)
Official title: Relevance of Reversible Causes During OHCA (Rebecca Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Out-Of-Hospital Cardiac Arrest
Cardiopulmonary Arrest
Keywords: Intoxication
Prehospital POCUS
CPR
Sonography
Blood gas analysis
Cardiac arrest
OHCA
Reversible causes
Tele-support
Checklist
Prehospital emergency physician
Emergency medicine
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Seibersdorf Labor GmbH
name: Ludwig Boltzmann Institute for Digital Health and Prevention
First posted: 2023-03-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Management of the reversible causes in cardiac arrest is fundamental for successful treatment of out-of-hospital cardiac arrests. Point-of-care diagnostics as prehospital emergency ultrasound, blood gas analysis and toxicological screening support the diagnostic process of evaluating potential reversible causes. Digital tools provide support of a structured approach. This study aims to evaluate the frequency of reversible causes during OHCA as well as specific interventions due to these findings. Furthermore, CPR performance (hands-off, ROSC, 30-day mortality) and cognitive load of the prehospital emergency physician will be investigated. In total 100 patients with OHCA will be included in this study. Identification of reversible causes will be performed upon a structured protocol using an interactive checklist. Cognitive load of emergency physician as well as CPR parameter (frequency of reversible causes, hands-off, ROSC, 30-day mortality) will be analysed.


Eligibility criteria: Inclusion Criteria:

* Patients with prehospital cardiac arrest, where POCUS, blood gas analysis as well as screening for intoxication can integrated in ALS rhythm without delay of life-saving treatment or transportation will be included.

Exclusion Criteria:

* Patients will be excluded under the age of 18, or if POCUS, blood gas analysis will lead to a delay of live-saving treatment or transportation. Furthermore, pregnant patients will be excluded.

Primary outcomes:
measure: Frequency of reversible causes in OHCA and alterations of treatment
timeFrame: up to 30 days
Secondary outcomes:
measure: Frequency of ROSC
timeFrame: up to 30 days
measure: 30-day mortality
timeFrame: up to 30 days
measure: Hands-off time
timeFrame: During study completion, up to 120 min
measure: Cognitive load
timeFrame: 1 year (evaluation in documentation phase after CPR)
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Anesthesiology and Intensive Care Medicine Department - Medical University of Vienna
city: Vienna
country: Austria
facility: Department of Anesthesia, General Intensive Care and Pain Management,Medical University of Vienna
Study officials:
References:
Clinical trial NCT04644380: Assessment of the INVOcell Culture Device When Used for up to Five-Day Incubation
Official title: Assessment of the INVOcell Culture Device When Used for up to Five-Day Incubation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Lead sponsor: INVO Bioscience, Inc.
Sponsor class: INDUSTRY
First posted: 2020-11-25
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The INVOcell Culture Device received de novo request for 3-day intravaginal incubation. The device is held in place with the intravaginal cavity by a Retention Device. The clinical study will assess the ability of a modified Retention Device to hold INVOcell in place during 5-day vaginal incubation as well as comfort and vaginal irritation as secondary endpoints.

Detailed description: This is a single center, open label non-comparative prospective trial to evaluate the retention of the INVOcell IVC with the Retention Device over the vaginal incubation period of up to 5 days.

The purpose of this study is to assess the retention of the INVOcell IVC device with the Retention Device over the vaginal incubation period of up to 5 days.

Primary Endpoint

• Retention of the INVOcell IVC device with the Retention Device over the vaginal incubation period of up to 5 days.

Secondary Endpoint

* Comfort of the INVOcell IVC and Retention Device
* Vaginal tissue reactions during the vaginal incubation
* Optical clarity and the ability to visualize the embryos after the incubation

Eligibility criteria: Inclusion Criteria:

* Have been informed about the study and have given their written consent.
* Patients 18 years to 42 years
* Women who are scheduled for an oocyte retrieval in anticipation of INVOcell IVF.

Exclusion Criteria:

* Inability to read and speak English fluently
* Identified vaginal infection
* Recent pelvic surgery based on clinical history and physical examination.
* History of toxic shock syndrome
* Inability to tolerate the placement or wearing of the INVOcell IVC or INVOcell Retention Device.
* Inability to tolerate a speculum examination
* Unwilling or unable to wear the INVO Retention (diaphragm) during the incubation.
* Unable or unwilling to sign informed consent or abide by study follow up assessment requirements.

Primary outcomes:
measure: Device Retention
timeFrame: 5 days
Secondary outcomes:
measure: Comfort
timeFrame: 5 days
measure: Vaginal tissue reactions
timeFrame: 5 days
measure: Optical clarity
timeFrame: 5 days
Other outcomes:
Locations:
city: Homewood
country: United States
facility: American Institute of Reproductive Medicine/IVF Alabama (AIRM)
state: Alabama
Study officials:
affiliation: American Institute of Reproductive Medicine/IVD Alabama (AIRM)
name: Karen Hammond, DNP, CRNP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00479180: Safety of Vascugel Treatment After Creation of Arteriovenous Access for Hemodialysis Use
Official title: Safety of Vascugel Treatment After Creation of Arteriovenous Access for Hemodialysis Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hemodialysis Access
Keywords: Hemodialysis access
Arteriovenous graft
Arteriovenous fistula
End stage renal disease
Lead sponsor: Pervasis Therapeutics, Inc
Sponsor class: INDUSTRY
First posted: 2007-05-28
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Vascugel™ is safe when placed at the anastomotic site at the time of surgery during creation of an AV graft or fistula for hemodialysis access.

Detailed description: Randomized, double-blind, parallel group, Phase I/II clinical trial of Vascugel™ treatment vs. Gelfoam® in patients undergoing creation of an arteriovenous graft or fistula for hemodialysis access.

All patients will undergo preoperative duplex ultrasound imaging and/or angiography (whatever is the standard of care at the research site) of the vein and artery to evaluate the optimal site for vascular access placement in the upper extremity.

Patients will be examined with Doppler ultrasound or standard of care immediately after surgery to verify patency of the AV graft or fistula.

During the follow-up period, each patient will undergo a physical examination and imaging of the vascular access at specified intervals.

Eligibility criteria: Inclusion Criteria:

* Adult male or female patients (ages of 18 to 89, inclusive) who are undergoing placement of an AV graft or fistula for hemodialysis access

Exclusion Criteria:

* Patient is currently on an active transplant list for a kidney from a deceased donor OR is undergoing assessment and expects to be placed on the active transplant list within the next twenty-four weeks OR expects to receive a living donor kidney within twenty-four weeks.
* Patient is expecting another solid organ transplant or a bone marrow transplant.
* Patient has had more than one access surgery (defined as a new access, not a revision) in the target limb.
* Patient is currently on chronic, systemic immunosuppressant medication other than locally or topically applied steroids.

Primary outcomes:
measure: Safety of vascugel
timeFrame: 6 months followed by 2.5 year extension
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT03328780: Anemia in Orthopedic Surgery - Determination of Hb
Official title: Prevalence of Anemia in Orthopedic Surgery, Data Collection From Classical Laboratory Determination of Hemoglobin, by Non-invasive Hemoglobin Measurement (Rad-67™) and by HemoCue®.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Keywords: preoperative
orthopedic surgery
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
First posted: 2017-11-01
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients scheduled for elective orthopedic surgery.

Brief summary: Anemia prevalence in orthopedic surgery is up to 30 %. Identifying those patients prior to surgery and treating them would be ideal. Different ways of determining hemoglobin Levels are available. In this study classical laboratory determination, determination with HemoCue® and Rad-67™ will be performed to compare precision of those three methods as well as their correlation.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Scheduled for elective orthopedic surgery
* Written informed consent.

Exclusion Criteria:

• Not able to speak the german language

Primary outcomes:
measure: Precision
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Anemia
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Hopsital Balgrist
Study officials:
affiliation: Balgrist University Hospital
name: Oliver M Theusinger, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03678480: A Study of HTD1801 in Adolescents With Primary Sclerosing Cholangitis (PSC)
Official title: A Phase 2, Randomized, Double-Blind Study of HTD1801 vs Ursodeoxycholic Acid (UDCA) in Adolescents With Primary Sclerosing Cholangitis (PSC)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Primary Sclerosing Cholangitis
Cholangitis
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Adolescent
Lead sponsor: HighTide Biopharma Pty Ltd
Sponsor class: INDUSTRY
First posted: 2018-09-19
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized, double-blind, active-controlled, parallel-group study of HTD1801 in adolescents.


Eligibility criteria: Inclusion Criteria:

* Weight ≥ 35 kg
* Previous cholangiographic evidence of PSC by magnetic resonance cholangiopancreatography (MRCP) or direct cholangiography or liver biopsy findings
* Serum GGT ≥ 2 × upper limit of normal (ULN)
* On a stable UDCA treatment regimen for ≥ 8 weeks

Exclusion Criteria:

* Secondary sclerosing cholangitis
* Percutaneous or endoscopically-placed biliary drain or stent
* History of cholangiocarcinoma or clinical suspicion of new dominant stricture within 1 year
* Ascending cholangitis requiring intravenous antibiotic therapy within 60 days prior to Screening
* Concomitant overlap syndrome with primary biliary cholangitis (PBC)
* Significant hepatic decompensation
* Alternative causes of chronic liver disease
* Hospitalization for colitis within 30 days prior to Screening
* Serum creatinine \> 1.2 x ULN
* Hemoglobin \< 10 g/dL
* Glucose-6-phosphate dehydrogenase (G6PD) deficiency

Primary outcomes:
measure: change in gamma-glutamyl transferase (GGT)
timeFrame: 18 weeks
Secondary outcomes:
measure: percentage of patients whose GGT normalizes to <50 units/liter
timeFrame: 18 weeks
measure: change in aspartate aminotransferase (AST)
timeFrame: 18 weeks
measure: change in alanine aminotransferase (ALT)
timeFrame: 18 weeks
measure: change in alkaline phosphatase (ALP)
timeFrame: 18 weeks
measure: change in total bilirubin
timeFrame: 18 weeks
measure: change in C-reactive protein (CRP)
timeFrame: 18 weeks
measure: incidence of adverse events
timeFrame: 18 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04346680: Intraoperative ADSC Administration During Nerve Release
Official title: Intraoperative Adipose-Derived Stem Cells Administration During the Secondary Release (Neurolysis) of a Reconstructed Nerve
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neurotmesis of Peripheral Nerve (Disorder)
Keywords: ADSC
nerve release
neurolysis
stem cells
scar
peripheral nerves
Lead sponsor: Mossakowski Medical Research Centre Polish Academy of Sciences
Sponsor class: OTHER
Collaborators: name: Centre of Postgraduate Medical Education
First posted: 2020-04-15
Enrollment: 6
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of the investigator's observational, nonrandomized, open label study is to investigate the safety and efficacy of autologous adipose derived mesenchymal cells (ADSC) transplantation into the individuals with faiure in reconstruction of peripheral nerves. ADSC will be used during a last-chance surgery (neurolysis, nerve release) on a previously reconstructed nerve. All enrolled patients will have a documented at least 2-years clinical and electrophisiological observation. Each patient will recive once 10 microinjections of ADSC along the injured nerve, directly after nerve neurolysis. Safety, adverse events and efficacy will be confirmed by clinical, elecrophisiological (EMG, Sensory Thyreshold) and DASH survey.

Detailed description: The aim of the study will be an evaluation of undifferentiated Adipose-Derived Stromal/Stem Cells (ADSC) usage during a last-chance surgery (neurolysis, nerve release) on a previously reconstructed nerve. Patients who experienced failure of nerve reconstruction will be included in the study. During the revisional surgery, nerve fascicles will be released, and ADSCs will be isolated from harvested fat with enzymatic method in a standarized conditions. Cells will be administered through microinjections along the fascicles and around the adjacent tissues after external neurolysis. The follow-up will be continued at least 36 months.

Eligibility criteria: Inclusion Criteria:

* clinically definite failure nerve reconstructed patients
* lack of improvement after previous treatment
* without severe, unstable chronic diseases
* Polish citizens

Exclusion Criteria:

* INR \> 2 before liposuction
* primary haematological disease, including hypercoagulable states
* previous/current history of neoplasm or comorbidity that could impact upon patient's survival
* pregnancy /lactation
* alcohol abuse, cocaine amphetamine, etc.

Primary outcomes:
measure: Electrophysiological improvement
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00349180: Total Hip Replacement Study With XRP4563 (Enoxaparin Sodium)
Official title: Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Enoxaparin Sodium（RP54563）20mg qd and 20mg Bid for 14 Days in Patients With Total Hip Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthroplasty, Replacement, Hip
Keywords: Total Hip Replacement
Enoxaparin
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-07-06
Enrollment: 156
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is performed to confirm the optimal dose for THR (total hip replacement).


Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective primary THR (total hip replacement) surgery

Exclusion Criteria:

* Patient with risk of clinical significant bleeding

Primary outcomes:
measure: Incidence of VTE
Secondary outcomes:
measure: Incidence of bleeding
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Yoshihiro IKEDA
role: STUDY_DIRECTOR
References: