louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00767507: Maintenance of Platelet Inhibition With Cangrelor
Official title: BRIDGE: Maintenance of Platelet inihiBition With cangRelor After dIscontinuation of ThienopyriDines in Patients Undergoing surGEry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Coronary Syndrome (ACS)
Lead sponsor: The Medicines Company
Sponsor class: INDUSTRY
First posted: 2008-10-07
Enrollment: 221
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: The purpose of this study is to demonstrate that patients receiving cangrelor infusion before coronary artery bypass grafting have an acceptable safety profile and can undergo surgery without excessive bleeding peri-operatively.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* 18 Years of Age
* Non emergent coronary bypass graft surgery
* Received a thienopyridine within 48 hours prior to enrollment

Exclusion Criteria:

* Confirmed or suspected pregnancy
* Cerebrovascular accident within one yar
* Intracranial neoplasm
* History of bleeding diathesis
* Thrombocytopenia

Primary outcomes:
measure: Stage I: Percentage of Patient Samples That Maintained Platelet Inhibition Levels of Greater Than or Equal to 60% as Reported by the VerifyNow P2Y12 Point of Care Assay.
timeFrame: During study drug infusion up to 1-6 hours prior to surgery
measure: Stage II: The Percentage of Patients That Maintained Platelet Reaction Units (PRU) < 240, as Determined by the VerifyNow P2Y12 Point of Care Assay, Measured During Study Drug Infusion Pre-surgery.
timeFrame: During study drug infusion up to 1-6 hours prior to surgery
Secondary outcomes:
measure: Stage II: Analysis of Platelet Reactivity (ITT Population) / Patients With Platelet Reactivity < 240 PRU
timeFrame: baseline until just prior to surgery (post infusion)
measure: Incidence of Excessive Coronary Artery Bypass Graft (CABG)-Related Bleeding
timeFrame: Randomization through Hospital discharge
measure: Non-CABG (Preoperative) Bleeding - Protocol-defined GUSTO Severe/Life-threatening, Moderate and Mild
timeFrame: Randomization until start of CABG surgery
measure: Patients With Blood Product Transfusions up to 7 Days After Surgery or Discharge, Whichever Was Sooner
timeFrame: Through 7 days or hospital discharge, whichever was sooner
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Clinic / Scripps Green Hospital
state: California
Study officials:
affiliation: Scripps
name: Eric Topol, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Angiolillo DJ, Firstenberg MS, Price MJ, Tummala PE, Hutyra M, Welsby IJ, Voeltz MD, Chandna H, Ramaiah C, Brtko M, Cannon L, Dyke C, Liu T, Montalescot G, Manoukian SV, Prats J, Topol EJ; BRIDGE Investigators. Bridging antiplatelet therapy with cangrelor in patients undergoing cardiac surgery: a randomized controlled trial. JAMA. 2012 Jan 18;307(3):265-74. doi: 10.1001/jama.2011.2002.
Clinical trial NCT05495607: Continous Renal Replacement Therapy With the CARPEDIEM® in a French National Cohort of 25 Neonates and Small Infants
Official title: Dialysis With CARPEDIEM®: French Multicentric Experience in 25 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoxic-Ischemic Encephalopathy
Sepsis
Kidney Diseases
Metabolic Disease
Twin to Twin Transfusion Syndrome
Cardiac Disease
Pulmonary Disease
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2022-08-10
Enrollment: 25
Sex: ALL
Minimum age (years): 0
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population will be selected in a department of pediatric and neonatal unit intensive care and whom need a renal replacement therapy

Brief summary: Historically, CKRT and hemodialysis were performed in small infants and newborns with devices developed for adults with high rates of complications and mortality.

We aim to retrospectively report the first multicenter French experience of CARPEDIEM® use and evaluate the efficacy, feasibility, outcomes, and technical considerations of this new device in a population of neonates and small infant. Compared to adult's device continuous renal replacement therapy with an adapted machine allowed successful blood purification without severe complications even in low birth weight neonates.


Eligibility criteria: Inclusion criteria:

* Children and neonates including premature and low birth weight neonates
* Have a diagnosis of acute kidney injury, end stage renal disease, metabolic disease, electrolyte abnormality
* Require renal replacement therapy

Exclusion Criteria:

-Renal replacement therapy with another device than Carpediem machine

Primary outcomes:
measure: Survival
timeFrame: 3 years
measure: Serum creatinine
timeFrame: 3 years
measure: Serum potassium
timeFrame: 3 years
measure: Blood urea nitrogen
timeFrame: 3 years
measure: Ammonia levels
timeFrame: 3 years
Secondary outcomes:
measure: Ultrafiltration flow
timeFrame: 3 years
measure: Blood flow
timeFrame: 3 years
measure: Anticoagulation
timeFrame: 3 years
measure: Number of sessions
timeFrame: 3 years
measure: Time of treatments
timeFrame: 3 years
measure: CKRT modality
timeFrame: 3 years
measure: Vascular access
timeFrame: 3 years
measure: Priming circuit
timeFrame: 3 years
measure: Size of the circuit
timeFrame: 3 years
measure: Death
timeFrame: 3 years
measure: Clotting circuit and other dysfunction circuit
timeFrame: 3 years
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
References:
Clinical trial NCT02471807: Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System
Official title: Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tricuspid Valve Regurgitation
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2015-06-15
Enrollment: 34
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 study is a multi-center, prospective, early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function, provide guidance for future clinical study designs and development efforts of the Edwards FORMA Tricuspid Transcatheter Repair System.

Detailed description: The early feasibility study of the Edwards FORMA Tricuspid Transcatheter Repair System is a multi-center, prospective, early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function, provide guidance for future clinical study designs and development efforts of the Edwards FORMA Tricuspid Transcatheter Repair System.

Data collected in this clinical study will include safety and function of the investigational system as well as up to 3 year clinical outcomes.

Eligibility criteria: Inclusion Criteria:

1. ≥ 18 years old
2. Clinically significant, symptomatic, functional, tricuspid regurgitation (per applicable guidelines) requiring transcatheter tricuspid valve repair as assessed by the local Heart Team

Exclusion Criteria:

1. Tricuspid valve/right heart anatomy not suitable for the study device
2. Moderate or greater tricuspid valve stenosis
3. Severe RV dysfunction

Primary outcomes:
measure: Major Adverse Event Rate : Count and Percentage of Patients Who Experienced at Least One MAE
timeFrame: 30 days
Secondary outcomes:
measure: Device Success : Count and Percentage of Patients Who Experienced Device Success
timeFrame: Intraprocedural
measure: Procedure Success: Count and Percentage of Patients Who Experienced Procedural Success
timeFrame: Discharge (2-8 days)
measure: Clinical Success: Count and Percentage of Patients Who Experienced Clinical Success
timeFrame: 30 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
References:
Clinical trial NCT04462107: Longitudinal Study Evaluating Recovery After Scheduled Cesarean Delivery
Official title: Longitudinal Study Evaluating Postpartum Recovery After Scheduled Cesarean Delivery With the Obstetric Quality of Recovery Tool
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cesarean Section
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-07-08
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parturients scheduled for cesarean delivery at Mayo Clinic Hospital Family Birth Center

Brief summary: The purpose of this research is to describe how patients recover after scheduled C-section for the first 3 months.


Eligibility criteria: Inclusion Criteria:

* Women 18 years of age or older who receive neuraxial anesthesia for elective cesarean delivery

Exclusion Criteria:

* Less than 18 years of age
* Gestational age less than 32 weeks
* Women whose infants have died or are in the neonatal intensive care unit after delivery
* Inability to read or understand written English
* Failed neuraxial anesthesia requiring general anesthesia

Primary outcomes:
measure: Longitudinal evaluation of global health visual analog scale
timeFrame: Baseline, 24 h, 48 h, 1 week, 3 weeks, 6 weeks, 12 weeks postpartum
Secondary outcomes:
measure: To determine change in pain levels post C-section using the Visual Analog Scale (VAS)
timeFrame: Baseline, 24 hour, 48 hour, 1 week, 3 weeks, 6 weeks, 12 weeks, and 3 months
measure: Compare opioid consumption post partum
timeFrame: 24 hours, 48 hours, 1 week, 3 weeks, 6 weeks, and 3months post partum
measure: Compare non-maternal reasons for delayed hospital discharge
timeFrame: Hospital discharge, approximately 3 days
measure: Compare frequency of activities of daily living
timeFrame: Baseline
measure: Compare frequency of activities of daily living
timeFrame: 6 weeks postpartum
measure: Compare Edinburgh Postnatal Depression Scale
timeFrame: 6 weeks postpartum
measure: Compare a modified recovery after delivery questionnaire
timeFrame: 6 weeks postpartum
measure: Correlation between postpartum ObsQOR-10 and EQ-5D
timeFrame: 6 weeks postpartum
measure: Correlation between postpartum ObsQOR-10 and EQ-5D
timeFrame: 12 weeks postpartum
measure: Correlation between ObsQOR-10 scores at multiple time points
timeFrame: 24 hours, 48 hours, 1 week postpartum
measure: Correlation between postpartum ObsQOR-10 and EQ-5D
timeFrame: 3 weeks post partum
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Emily E Sharpe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06204107: A Clinical Trial to Evaluate the Food Effect on Pharmacokinetic Profiles and Safety of CKD-379
Official title: A Randomized, Open-label, Single Dose, Crossover, Phase Ⅰ Trial to Evaluate the Food Effect on Pharmacokinetic Profiles and Safety of CKD-379 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2024-01-12
Enrollment: 28
Sex: ALL
Minimum age (years): 19
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a randomized, open-label, single dose, crossover, phase Ⅰ trial to evaluate the food effect on pharmacokinetic profiles and safety of CKD-379 in healthy volunteers

Detailed description: Participants were randomly assigned in a 1:1 ratio. The patients are prescribed oral administration of the appropriate IP(2 tablets in single dose: actual medication)

Eligibility criteria: Inclusion Criteria:

* Healthy adults aged 19 to 54 years
* BMI measurement result is 18.0 kg/m2 to 30 kg/m2
* Written informed consent
* Other inclusion criteria, as defined in the protocol

Exclusion Criteria:

* History of clinically significant liver, kidney, blood, digestive, respiratory, endocrine, cardiovascular, neurological, mental, or immune system disorders
* AST or ALT or total bilirubin \> 1.5 times the upper limit of normal range
* History of regular alcohol consumption \> 21 units/week within 6 months at the time of screening
* Participated in a clinical trial within 6 months prior to 1st IP dosing
* Other exclusive inclusion criteria, as defined in the protocol

Primary outcomes:
measure: AUCt of Empagliflozin, sitagliptin, metformin
timeFrame: 0 hour ~ 48 hour after drug administration
measure: Cmax of Empagliflozin, sitagliptin, metformin
timeFrame: 0 hour ~ 48 hour after drug administration
Secondary outcomes:
measure: AUCinf of Empagliflozin, sitagliptin, metformin
timeFrame: 0 hour ~ 48 hour after drug administration
measure: Tmax of Empagliflozin, sitagliptin, metformin
timeFrame: 0 hour ~ 48 hour after drug administration
measure: t1/2 of Empagliflozin, sitagliptin, metformin
timeFrame: 0 hour ~ 48 hour after drug administration
measure: CL/F of Empagliflozin, sitagliptin, metformin
timeFrame: 0 hour ~ 48 hour after drug administration
measure: Vd/F of Empagliflozin, sitagliptin, metformin
timeFrame: 0 hour ~ 48 hour after drug administration
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jaeyong Jeong
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04507607: Efficacy and Safety of TAF in Pregnant Women With Chronic Hepatitis B Infection
Official title: Efficacy and Safety of TAF in Pregnant Women With Chronic Hepatitis B Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Chronic Hepatitis B
Mother-to-child Block
Antiviral Treatment
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2020-08-11
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The effectiveness of mother-to-child block of CHB in pregnant women in the middle and later stages of pregnancy has been recognized by the guidelines. TAF, as a newly marketed antiviral drug, has not been conclusively concluded in terms of its efficacy and postpartum safety in preventing mother-to-child transmission in pregnant women.Our purpose is to explore the TAF for CHB the curative effect of pregnant and postnatal security.

Detailed description: After diagnosis at the infection clinic of the Third Affiliated Hospital of Sun Yat-sen University, the eligible patients were enrolled into the group.Each person will sign the informed consent prior to enrollment.

Eligibility criteria: Inclusion Criteria:

* 25 pregnant women with HBeAg (+), HBV DNA ≥ 2\*10\^6IU/mL who met the diagnostic criteria in the guidelines for the prevention and treatment of chronic hepatitis B were pregnant women at 24-28 weeks of pregnancy.
* 25 non-pregnant women with HBeAg (+), HBV DNA ≥ 2\*10\^6IU/mL who met the diagnostic criteria in the guidelines for the prevention and treatment of chronic hepatitis B.
* The enrolled patients were all newly admitted patients without treatment, and if they did not meet the standard after completing the relevant examination, they would be removed.

Exclusion Criteria:

* Coinfection with HAV, HCV, HDV, HEV or HIV;
* A history of antiviral therapy or concurrent treatment with immunoregulatory drugs, antitumor drugs, cytotoxic drugs or immunosuppressive steroids;
* Three-dimensional ultrasonography showed fetal malformation;
* The spouse is infected with HBV;
* History of decompensated liver disease (e.g., decompensated liver disease with coagulation disorders, hyperbilirubinemia, hepatic encephalopathy, hypoalbuminemia, ascites and esophageal varicose bleeding), history of liver cancer or other chronic liver disease (e.g., autoimmune hepatitis) or clinical symptoms;
* History of immune diseases;
* A history of serious cardiovascular disease;
* Other reasons the researchers considered it inappropriate to participate in the trial.

Primary outcomes:
measure: Liver indicators of intrapartum
timeFrame: intrapartum
measure: Liver indicators of postpartum
timeFrame: 12 months postpartum
Secondary outcomes:
measure: Liver indicators of pregnancy
timeFrame: 24 weeks gestation until delivery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: LinChaoshuang
Study officials:
References:
Clinical trial NCT01953107: Oral Iron vs. Placebo in Newly Diagnosed Gynecologic Oncology Patients Who Are Surgical Candidates.
Official title: A Randomized Controlled Trial of Pre-Operative Treatment With Ferrous Fumarate 300 mg Once Daily Versus Placebo in Newly Diagnoses Gynecologic Oncology Patients Who Are Primary Surgical Candidates.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ovarian Cancer
Cervical Cancer
Uterine Cancer
Anemia
Keywords: Anemia
Ovarian cancer
Uterine cancer
Cervical cancer
Oral iron
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2013-09-30
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The prevalence of anemia in gynecologic oncology new patients has been seen in previous studies to be as high as 35-59%. this population includes women with several types of gynecologic malignancies. Therefore, it is assumed that the origin of the anemia can be due to anemia of chronic disease and iron deficiency anemia. No previous studies have looked at the efficacy of oral iron supplementation with concurrent Vitamin C in women with newly diagnosed gynecologic malignancies.

Hypothesis: In newly diagnosed gynecologic oncology patients who are surgical candidates does treatment with 3-6 weeks of oral ferrous fumarate 300 mg once a day improve the mean change in hemoglobin levels, from baseline to pre-operative, in comparison to placebo.


Eligibility criteria: Inclusion Criteria:

* Over the age of 18
* Scheduled for primary operative procedure within 3-6 weeks of initial consult clinic visit with endometrial cancer, uterine sarcoma, cervical cancer, ovarian/fallopian tube cancer or patients with pelvic mass and a high suspicion of a gynecologic malignancy.

Exclusion Criteria:

* Patient with known allergy to ferrous fumarate.
* Patient's on IV Iron or erythropoietin treatment at the time of recruitment
* Patient's who are not primary surgical candidates.
* Patient's with a known hemoglobinopathy or a hypoproliferative hematologic disorder
* Patient who have significant active vaginal bleeding
* Patient who have a hemoglobin \< 80 g/L will be removed from randomization and referred to blood conservation at Sunnybrook Health SCiences Centre.

Primary outcomes:
measure: Mean Difference in Hemoglobin
timeFrame: Pre-surgery (4-6 weeks)
Secondary outcomes:
measure: Quality of life
timeFrame: Baseline to Pre-surgery (4-6 weeks)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Odette Cancer Centre
state: Ontario
Study officials:
affiliation: Odette Cancer Centre
name: Danielle Vicus, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04122807: Cryoablation of the Retrograde Fast Pathway as Treatment for AVNRT
Official title: Cryoablation of the Retrograde Fast Pathway as Treatment for AVNRT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Atrioventricular Node Arrhythmia
Keywords: AVNRT
Cryoablation
PR interval
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: University of Western Ontario, Canada
First posted: 2019-10-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective model with two groups based on PR interval on ECG, normal and prolonged PR
Primary purpose: TREATMENT

Brief summary: In this study a new technique for ablation in atrioventricular nodal reentrant tachycardia using cryo-energy will be studied in cases where the standard approach has higher risk.

Detailed description: Atrioventricular nodal reentrant tachycardia (AVNRT) is the most common cause of fast heartbeats in young people. People with AVNRT have two pathways within the heart, the fast pathway (FP) and slow pathway (SP). A treatment for AVNRT is ablation (burning or freezing) of the SP. This can be done with either radiofrequency or cryo-energy. A complication which occurs in 1% of cases is AV block (AVB), meaning the person needs a pacemaker.

Slow pathway ablation is a problem in people when the electrocardiogram (ECG) shows a long PR interval, with greater rates of AVB. This accounts for 5% of AVNRT cases. A possible solution is to treat the FP with cryo-energy and leave the SP intact. This pilot study aims to show this is safe and effective.

Eligibility criteria: Inclusion Criteria:

* Documented supraventricular tachycardia (SVT)
* Planned to undergo electrophysiology (EP) study and ablation
* PR interval on ECG \<220ms (Group 1) or \>220ms (Group 2)

Exclusion Criteria:

* Pregnancy
* Age \<18 years
* Inability to provide consent
* High likelihood of tachycardia mechanism other than AVNRT (e.g. Pre-excitation on surface ECG, atrial tachycardia)

Primary outcomes:
measure: Termination of AVNRT
timeFrame: One day
Secondary outcomes:
measure: Freedom from recurrence
timeFrame: 1 year
measure: Incidence of AV block
timeFrame: 1 year
measure: Cardiac tamponade
timeFrame: 1 year
measure: Vascular complications
timeFrame: 1 year
Other outcomes:
measure: Procedural time
timeFrame: Immediate
measure: Fluoroscopy time
timeFrame: Immediate
Locations:
city: London
country: Canada
facility: Lawson Health Research Institute
state: Ontario
Study officials:
References: