louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02840123: Safety Study of DIPG Treatment With Autologous Dendritic Cells Pulsed With Lysated Allegenic Tumor Lines
Official title: Phase Ib Clinical Trial on the Safety of Immunotherapy With Autologous Dendritic Cells Primed With Lysate Allogeneic Tumor Lines in Patients With Diffuse Intrinsic Pontine Glioma (DIPG)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Diffuse Intrinsic Pontine Glioma
Lead sponsor: Fundació Sant Joan de Déu
Sponsor class: OTHER
Collaborators: name: Institut d'Investigacions Biomèdiques August Pi i Sunyer
First posted: 2016-07-21
Enrollment: 10
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to asses safety of diffuse intrinsic pontine glioma (DIPG) treatment with autologous dendritic cells pulsed with lysated allegenic tumor lines

Evaluate the nonspecific immune response generated in peripheral blood and Cerebral Spinal Fluid (CSF) by proposed treatment Evaluate the specific antitumor immunity response generated in peripheral blood and CSF Assess overall survival and progression free survival Correlate the neuroradiological changes with the clinical course and immune response generated in peripheral blood and CSF Quality of life evaluation


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed DIPG Patients without progressive disease
* Aged between 3 and 18 yo Lansky scale \>50 (Karnofsky for patients aged more than 16 yr)
* Life expectancy \> 8 weeks
* Preserved bone marrow function Normal hepatic and renal function

Exclusion Criteria:

* Impossibility to perform aphaeresis
* Patient participation of other experimental study within the last 3 months
* Patient under antitumor treatment in the last 4 weeks
* Co-morbidity that does not allow the study treatment
* Patients requiring \> 2mg/day of dexamethasone treatment Corticoid-dependent patients
* Patients under uncontrolled infection
* Positive serologies of HIV, hepatitis C virus (HCV) or hepatitis B virus (HBV)

Primary outcomes:
measure: Number of serious adverse events per patient (after treatment administration
timeFrame: 2 years
Secondary outcomes:
measure: Overall survival Progression free survival
timeFrame: 1 year
measure: Time to first Serious Adverse Event (SAE)(after treatment)
timeFrame: 1 year
Other outcomes:
Locations:
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan de Deu
state: Barcelona
Study officials:
References:
Clinical trial NCT00905723: The Effects of Isoflavone and Estrogen in Sex Response in Climacteric Women
Official title: Effects of Isoflavone and Estrogen in Sex Response in Climacteric Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Postmenopausal Symptoms
Keywords: climacterium
sexual life
isoflavone
estrogen
McCoy's sexual questionnaire
Kupperman index
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2009-05-20
Enrollment: 60
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Climacterium is marked by hypoestrogenism and it is associated to drastic vasomotors symptoms, genital atrophy and humor alteration. Additionally, these symptoms impair sexual life and life quality. These effects can be counteracted by administration of estrogen therapy. However, estrogen therapy has side effects and isoflavone has been proposed as an estrogen substitute in reposition therapy. The aim of the randomized controlled trial is to evaluate the effects of isoflavone in the sex life assessed by a modified McCoy's sexual questionnaire.


Eligibility criteria: Inclusion Criteria:

* women aged 45-65 years old
* presenting climacteric symptoms
* sexual complaints

Exclusion Criteria:

* hormonal therapy
* counter indication to hormonal therapy
* uncontrolled comorbidities

Primary outcomes:
measure: McCoy's sexual questionnaire
timeFrame: at recruitment and six months later
Secondary outcomes:
measure: Kupperman's index
timeFrame: at recruitment and six months later
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Ambulatório de Ginecologia Endócrina
Study officials:
affiliation: Universidade Federal de São Paulo
name: Mauro A Aidar, M.D., PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01216423: Pulmonary Embolism and Stroke in Patient With Patent Foramen Ovale
Official title: Is There a Link Between Venous Thromboembolism and Stroke in Patient With Patent Foramen Ovale ? Research for Stroke in Hospitalized Patients With Pulmonary Embolism.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recent Stroke
Pulmonary Embolism
Patent Foramen Ovale
Keywords: Patent Foramen Ovale
Pulmonary embolism
Stroke
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2010-10-07
Enrollment: 374
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive series of hospitalized patients with pulmonary embolism

Brief summary: The cause of ischemic stroke remains frequently unknown. In patients with patent foramen ovale (PFO), the link between PFO and Stroke is unclear. The investigators hypothesize that the main mechanism is paradoxical embolism and decided to look for clinically apparent and silent cerebral embolism in patients with a recent pulmonary embolism.

Detailed description: Inclusion criteria :

* age \> 18 years old
* confirmed pulmonary embolism
* informed consent
* social ensured

Exclusion criteria :

* pregnancy
* age \< 18 years old
* protected major person (in sense of public health)
* consent refused
* MRI contraindications

Eligibility criteria: Inclusion Criteria:

* age \> 18 years old
* confirmed pulmonary embolism
* informed consent
* social ensured

Exclusion Criteria:

* pregnancy
* age \< 18 years old
* protected major person (in sense of public health)
* consent refused
* MRI contraindications

Primary outcomes:
measure: Incidence of recent ischemic stroke in patients hospitalized for a recent pulmonary embolism with comparison in two groups with and without PFO
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: Brest University Hospital
city: Brest
country: France
facility: Army Hospital
city: Dijon
country: France
facility: CHU Dijon de Bocage
city: Quimper
country: France
facility: Centre Hospitalier de Cornouaille
Study officials:
affiliation: University Hospital, Brest
name: Emmanuelle LE MOIGNE, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Le Moigne E, Timsit S, Ben Salem D, Didier R, Jobic Y, Paleiron N, Le Mao R, Joseph T, Hoffmann C, Dion A, Rousset J, Le Gal G, Lacut K, Leroyer C, Mottier D, Couturaud F. Patent Foramen Ovale and Ischemic Stroke in Patients With Pulmonary Embolism: A Prospective Cohort Study. Ann Intern Med. 2019 Jun 4;170(11):756-763. doi: 10.7326/M18-3485. Epub 2019 May 7.
Clinical trial NCT02568423: A Study of Mirikizumab (LY3074828) in Healthy Participants
Official title: A Single-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of LY3074828 in Japanese and Caucasian Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2015-10-05
Enrollment: 51
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to explore the safety and tolerability of mirikizumab in healthy Japanese and Caucasian participants. The study will also estimate how much mirikizumab gets into the blood stream and how long it takes the body to remove it. The study is expected to last about 16 weeks for each participant.


Eligibility criteria: Inclusion Criteria:

* Are overtly healthy males or females, as determined by medical history and physical examination.
* Are first generation Japanese or are Caucasian.
* Have a body mass index (BMI) of 18.0 kilograms per square meter (kg/m2) to 32.0 kg/m2, inclusive, at screening.
* Have a body weight of 40.0 kg or higher for Cohorts 1, 2, 3 and 4, and 48.0 kg or higher for Cohort 5 and 6.

Exclusion Criteria:

* Have had symptomatic herpes zoster within 3 months of screening.
* Show evidence of active or latent tuberculosis (TB), as documented by medical history and examination, chest x-rays (posterior anterior and lateral), and TB testing.
* Have received live vaccine(s) within 1 month of screening or intend to during the study.
* Are immunocompromised.
* Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing.

Primary outcomes:
measure: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline through Day 85
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab
timeFrame: Day 1: 0 (pre dose), end of infusion, 2, 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016 hr post dose for IV administration; Day 1: 0 (pre dose), 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016 hr post dose for SC administration
measure: Pharmacokinetics: Area Under the Concentration (AUC) Curve From Time Zero to Infinity of Mirikizumab
timeFrame: Day 1: 0 (pre dose), end of infusion, 2, 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016 hr post dose for IV administration; Day 1: 0 (pre dose), 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016 hr post dose for SC administration
Other outcomes:
Locations:
city: Cypress
country: United States
facility: WCCT Global
state: California
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02369523: Multimodal Pain Management Following Primary TKA
Official title: Periarticular Infusion With Liposomal Bupivacaine or a Ropivacaine Cocktail Versus Continuous Femoral Nerve Catheters for Multimodal Pain Management Following Primary TKA: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Pain
Keywords: Primary Total Knee Arthroplasty
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2015-02-24
Enrollment: 84
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The investigators plan to evaluate the length of time to discharge readiness between the groups (continuous femoral nerve blocks (cFNB) vs. liposomal bupivacaine (LB) vs. periarticular infusion cocktails (PIC) following primary total knee arthroplasty (TKA). In addition, the investigators will compare quadriceps strength recovery over time and exploratory variables between the groups.


Eligibility criteria: Inclusion Criteria:

* ≥ 40 Years Old
* Scheduled for Primary Total Knee Arthroplasty

Exclusion Criteria:

* Opiate Tolerant (≥60mg/day oral morphine/equivalent for ≥1 week)
* Neuromuscular deficit affecting the lower limbs

  * Peripheral neuropathy
  * Radiculopathy/Sciatica
* Known allergy or intolerance to Bupivacaine or Ropivacaine
* Hepatic Disease
* Renal Disease/Patients needing Dialysis
* Planned unicompartmental knee replacement
* Less than 90 degree of knee flexion preoperatively.
* Patients who lack the capacity to consent or are unwilling to do so
* At the discretion of the PI, patients who may have difficulty complying with standard of care (SOC) followup may also be excluded

Primary outcomes:
measure: Time to Discharge Readiness
timeFrame: Participants will be followed for the duration of hospital stay, an average of 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Orthopaedic Center
state: Utah
Study officials:
affiliation: University of Utah
name: Christopher Pelt, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03590223: Glycosylated Hemoglobin and Risk of Perioperative Major Cardiovascular Events in Diabetic Patients Undergoing Coronary Bypass Revascularization (HbA1c)
Official title: Glycosylated Hemoglobin and the Risk of Perioperative Major Cardiovascular Events in Diabetic Patients Undergoing Coronary Bypass Revascularization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Event
Coronary Artery Bypass Graft
Diabetes Mellitus
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2018-07-18
Enrollment: 589
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all patients with diabetes mellitus

* undergoing coronary bypass revascularization at the Klinik für Herzchirurgie, Universitätsspital Basel, Spitalstrasse 21, CH 4031-Basel since 2012
* who did not disapprove of use of data for research purposes
* statistic stratification in serum level of glycosylated hemoglobin (HbA1c) \> 6.5% and \</= 6.5%

Brief summary: Glycosylated Hemoglobin (HbA1c) is considered as one of the best markers to assess the glycaemia treatment over a period of 3 to 4 months, and is considered as predictive marker for perioperative mortality and morbidity. The impact of the elevated HbA1c on the risk of perioperative major cardiovascular events in patients undergoing coronary bypass revascularization (by retrospective analysis of perioperative cardiovascular events and preoperative HbA1c) is evaluated.


Eligibility criteria: Inclusion Criteria:

* patients with Diabetes mellitus undergoing coronary bypass revascularization since 2012

Exclusion Criteria:

* disapproval of use of data for research purposes

Primary outcomes:
measure: occurence of Major adverse cardiac events
timeFrame: perioperative = in hospital
Secondary outcomes:
measure: occurence of severe renal insufficiency
timeFrame: perioperative = in hospital
measure: occurence of sternal wound infection
timeFrame: perioperative = in hospital
measure: mortality
timeFrame: perioperative = in hospital
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Herzchirurgie University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Denis Berdajs, PD Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
citation: https://www.pulsus.com/scholarly-articles/glycosylated-hemoglobin-and-adverse-events-following-elective-coronary-bypass-revascularization-4682.html
Clinical trial NCT00491023: Examining Macrophage Influx and Vascularization in Chronic Pancreatitis
Official title: Examining Macrophage Influx and Vascularization in Chronic Pancreatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatitis
Diabetes
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2007-06-25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Time perspective: RETROSPECTIVE

Brief summary: Our aim in this study is to find out if we can locate the similar reduction in the recruitment of macrophages, remodeling of vasculature and do they correlate in the number and area of the islets in pancreas as in the mouse model.


Eligibility criteria: Inclusion Criteria:

* Pancreas tissue sections from preparates from pancreatic surgery.
* Patients having chronic pancreatitis with or without diabetes

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: James DeGregori, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03932123: Antibiotic Therapy for Early Onset Neonatal Sepsis
Official title: Efficacy and Safety of Antibiotics in the Treatment of Early Onset Neonatal Sepsis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Early Onset Neonatal Sepsis
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: Tianjin Central Hospital of Gynecology Obstetrics
name: Shandong Provincial Hospital
name: Qianfoshan Hospital
First posted: 2019-04-30
Enrollment: 500
Sex: ALL
Minimum age (years): 0
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates suffered from early onset neonatal sepsis

Brief summary: Antibiotic therapy for early onset neonatal sepsis recommended by international guidelines and relevant studies is only kind of treatment regimen that penicillin G/ penicillin/ampicillin combined with gentamicin as the first-line treatment regimen. However, it is not applicable to the clinical practice in many countries and regions. We aim to study efficacy and safety of antibiotics in the treatment of early onset neonatal sepsis.


Eligibility criteria: Inclusion Criteria:

* Age: postnatal age ≤ 72h;
* Meets NICE guidelines for using antibiotics to treat EONS;
* Azlocillin used as part of antimicrobial treatment;
* Parental written consent.

Exclusion Criteria:

* Expected survival time less than the treatment cycle;
* Major congenital malformations;
* Undergoing surgery within the first week of life;
* Receiving other systemic trial drug therapy;
* Other factors that the researcher considers unsuitable for inclusion.

Primary outcomes:
measure: Treatment failure
timeFrame: 72 hours after ending initial antibiotic therapy
Secondary outcomes:
measure: Treatment duration
timeFrame: Through study completion, an average of 3 days
measure: Duration of hospitalization
timeFrame: In the first month of patients' life
measure: PD target
timeFrame: Through study completion, an average of 3 days
measure: White blood cell count
timeFrame: Through study completion, an average of 3 days
measure: Procalcitonin
timeFrame: Through study completion, an average of 3 days
measure: C-reactive protein
timeFrame: Through study completion, an average of 3 days
measure: Death
timeFrame: In the first month of patients' life
measure: Adverse events
timeFrame: Through study completion, an average of 3 days
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Central Hospital of Gynecology Obstetrics
state: Tianjin
Study officials:
References:
citation: Wu YE, Wang T, Yang HL, Tang BH, Kong L, Li X, Gao Q, Li X, Yao BF, Shi HY, Huang X, Wang WQ, Jacqz-Aigrain E, Allegaert K, van den Anker J, Tian XY, Zhao W. Population pharmacokinetics and dosing optimization of azlocillin in neonates with early-onset sepsis: a real-world study. J Antimicrob Chemother. 2021 Feb 11;76(3):699-709. doi: 10.1093/jac/dkaa468.
Clinical trial NCT00488423: Glucose Metabolism in the Immediate and Short Term Follow up After Bariatric Surgery
Official title: Glucose Metabolism in the Immediate and Short Term Follow up From Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Gastric Bypass
Keywords: diabetes
MIDAS
gut hormones
gastric bypass
lap band
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Ethicon Endo-Surgery
First posted: 2007-06-20
Enrollment: 21
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: MIDAS involves an assessment of glucose levels obtained before and after bariatric surgery. There are two different procedural tests involved; an oral glucose tolerance test (mixed meal) and a hyperglycemic clamp test. Two tests are performed preoperatively and five more are performed postoperatively for a one year period. The associated labwork drawn with the mixed meal and clamp tests are demonstrating changes in glucose, insulin and gut hormone levels.

Detailed description: Tests performed are the Mixed Meal tolerance test, the Hyperglycemic Clamp test, c-peptide, free fatty acids, adipocyte hormone profile levels.

Eligibility criteria: Inclusion Criteria:

* Negative pregnancy test if female
* ADA criteria for diabetes type II
* Hematocrit \> 35 creatinine \< 1.9, AST \< 3X upper limit of normal, ALT \< 3X upper limit of normal, alkaline phos \<3X upper limit of normal
* Eligibility for bariatric surgery based on the NIH and clinical criteria
* Mentally and legally capable of providing consent

Exclusion Criteria:

* Lactating females
* Must not have type I diabetes
* Systemic steroids taken within 6 months
* Clinically significant heart disease
* Recent pulmonary embolism, untreated proliferative retinopathy, renal failure, uncontrolled hypertension, autonomic neuropathy, resting heart rate \> 100, neuromuscular or musculoskeletal disease.

Primary outcomes:
measure: To assess the effect of gastric by-pass surgery to decrease lipotoxicity.
timeFrame: One year
Secondary outcomes:
measure: To examine the effect of roux-en-Y compared to gastric banding on pancreatic B cell recovery or insulin secretion in response to oral and IV glucose.
timeFrame: One Year
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Sangeeta R. Kashyap, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Philip R. Schauer, M.D.
role: PRINCIPAL_INVESTIGATOR
References: