louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00316368: A Study to Determine the Effect of Bi-Ventricular Pacing on Cardiac Hemodynamics After Coronary Artery Bypass Graft
Official title: A Study to Determine the Effect of Bi-Ventricular Pacing on Cardiac Hemodynamics After Coronary Artery Bypass Graft
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Coronary Disease
Keywords: Bi-Ventricular pacing post coronary artery bypass graft
coronary artery bypass graft
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2006-04-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to determine, using echocardiography, whether bi-ventricular pacing improves the contractile force by resynchronizing both ventricles, thereby improving and/or correcting the paradoxical septal movement.

Primary Hypothesis:

* Bi-ventricular pacing post cardiac surgery will result in at least a 10% increase in cardiac index (CI) as compared with standard atrio-right ventricular pacing.

Secondary Hypothesis:

* Bi-ventricular pacing post cardiac surgery will result in at least a 10% increase in cardiac index (CI) as compared with atrio-left ventricular pacing and right atrium pacing.

Detailed description: Clinical trials done to date have focused on the efficacy of biventricular pacing (BVP) in the treatment of patients with congestive heart failure, Intraventricular conduction delay, dilated cardiomyopathies, and post cardiac surgery. However, studies done in post cardiac surgery patients are limited by their small sample size (4-22 patients with overall of 51 patients), non-randomized pacing protocol and by their inability to determine a definitive mechanism for the improved hemodynamics observed with BVP. Therefore, we propose to complete a pilot study aimed at determining both the magnitude of the hemodynamic benefit associated with BVP, if any. In addition, we will investigate changes in intra-ventricular septal motion as a possible mechanism for the previously observed changes in cardiac hemodynamics.

Eligibility criteria: Inclusion Criteria:

* All elective/emergent patients requiring isolated coronary artery bypass graft (CABG) at St. Michael's Hospital.

Exclusion Criteria:

* Patient's age \< 18 years.
* Known atrial fibrillation.
* Sinus tachycardia \> 100 beats per minute (bpm).
* Post-operative CI \< 2.
* High inotrope dosage post-operation:

  * Dopamine (Intropin) if \> 10 µg/kg/min.
  * Dobutamine (Dobutrex) if \> 10 µg/kg/min.
  * Norepinephrine (Levophed) if \> 0.1 µg/kg/min.
  * Epinephrine if \> 0.1 µg/kg/min.
* Need for intraaortic balloon pump (IABP).
* Unable or unwilling to give informed consent.
* Already participating in another clinical trial.

Primary outcomes:
measure: Cardiac index
Secondary outcomes:
measure: Intraventricular motion
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: University of Toronto
name: David Latter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05840068: IGF Level in Breast Cancer Patients Treated With Metformin
Official title: Metformin Effect as a Chemotherapeutic Adjuvant on Level of IGF in Non-diabetic Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Cancer Female
Keywords: Metformin
Breast cancer
IGF
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 107
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the impact of metformin as an adjuvant to chemotherapy on IGF levels in both progressing and non progressing cases of metastatic breast cancer in female patients.

Detailed description: One hundred and seven women with metastatic breast cancer (MBC) are randomly assigned to either a metformin (500 mg twice daily) or placebo (placebo) group during chemotherapy. All patients followed the standard chemotherapy protocol developed by the South Egypt Cancer Institute (SECI). Blood IGF-1 levels were measured at the start of treatment (baseline) and again six months later.

Eligibility criteria: Inclusion Criteria:

* Female patients with MBC
* patients older than 18
* nondiabetic patients
* patients who received only chemotherapy

Exclusion Criteria:

* patients with non-metastatic breast cancer
* patients receiving hormonal therapy or radiotherapy
* patients with diabetes
* history of cardiac diseases
* hypersensitivity, or allergy to metformin.

Primary outcomes:
measure: IGF-1 levels
timeFrame: 6 months.
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 1 Year
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Marian S. Boshra
Study officials:
References:
citation: Ko KP, Ma SH, Yang JJ, Hwang Y, Ahn C, Cho YM, Noh DY, Park BJ, Han W, Park SK. Metformin intervention in obese non-diabetic patients with breast cancer: phase II randomized, double-blind, placebo-controlled trial. Breast Cancer Res Treat. 2015 Sep;153(2):361-70. doi: 10.1007/s10549-015-3519-8. Epub 2015 Aug 21.
citation: Essa NM, Salem HF, Elgendy MO, Gabr A, Omran MM, Hassan NA, Tashkandi HM, Harakeh S, Boshra MS. Efficacy of Metformin as Adjuvant Therapy in Metastatic Breast Cancer Treatment. J Clin Med. 2022 Sep 20;11(19):5505. doi: 10.3390/jcm11195505.
citation: Pollak M. Insulin and insulin-like growth factor signalling in neoplasia. Nat Rev Cancer. 2008 Dec;8(12):915-28. doi: 10.1038/nrc2536.
Clinical trial NCT00550368: Clinical Experiment of Helicobacter Pylori Transmission
Official title: Effect of Gastric Acid and H. Pylori Infection on Infection With Enteropathogenic E. Coli
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection
Achlorhydria
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2007-10-29
Enrollment: 45
Sex: ALL
Minimum age (years): 35
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The study proposes to test whether chronic infection with Helicobacter pylori protects individuals from symptomatic infection with enteropathogenic E. coli. The study will also evaluate the effect of gastric acidity in this relationship.

Detailed description: Because H. pylori is an enteric infection, its prevalence may be linked to exposure to other enteric pathogens. Results of observational studies on the association between H. pylori and gastroenteritis, however, have been conflicting. Some have shown increased incidence of diarrhea in children with H. pylori infection, with one study attributing 11% of diarrhea cases to H. pylori. Other studies found no association, and still others found a protective effect of H. pylori against gastroenteritis. Dissecting out confounding from true physiological associations can be difficult in observational studies. To better elucidate the association between H. pylori and gastroenteritis, we performed a direct challenge experiment with a well-characterized gastrointestinal pathogen, enteropathogenic Escherichia coli (EPEC). EPEC is a leading cause of infantile gastroenteritis in the world and has a long history of safe use in human experiments. It is also acid sensitive: in our laboratory less than 0.001% of inoculated EPEC organisms survived at pH 2.5. Our goal was to test the hypothesis that chronic infection with H. pylori increases the risk of diarrheal illness after direct challenge with EPEC.

Eligibility criteria: Inclusion Criteria:Healthy Exclusion Criteria:prior gastrointestinal disease prior treatment of H. pylori infection immune suppression or deficiency history of cancer, diabetes, or other co-morbidity

Primary outcomes:
measure: Development of Diarrhea
timeFrame: 48 hours
Secondary outcomes:
measure: Intensity of Gastrointestinal Symptoms
timeFrame: 48 hours
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Julie Parsonnet
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04991168: Relationship Between Oral Health and Diabetes
Official title: Oral Health and Diabetes: Relationship Between Knowledge, Practices and Oral Health Status in Patients Followed in the Diabetes Department at the Montpellier University Hospital.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes
Keywords: Oral hygiene
Public Health
Patients coming to the CHU Lapeyronie for consultation or those being hospitalised there
Prevention
Telemedicine
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-08-05
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Diabetic patients over 18 coming to the CHU Lapeyronie

Brief summary: The aim of this study is to assess the state of knowledge and practices in oral health of diabetic patients through the use of two questionnaires. It is also to analyse the link between the oral health status and the profile of diabetic patient, by carrying out an oral assessment for voluntary patients.


Eligibility criteria: Inclusion criteria:

- All diabetic patients over 18 coming to the CHU Lapeyronie

Exclusion criteria:

-Non diabetic patients, diabetic patients under 18

Primary outcomes:
measure: Oral health knowledge and practice questionnaire score.
timeFrame: 1 day
measure: Number of missing and decayed teeth on the oral examination and clinical signs in diabetology.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Camille INQUIMBERT, PhD
role: STUDY_DIRECTOR
affiliation: UH MONTPELLIER
name: Amir MEZIANE, resident
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00815568: Feasibility and Efficacy Study of Conditioning Regimen for Allogeneic Hematopoietic Cell Transplantation (HCT) With Fludarabine, Busulfan, and Total Body Irradiation (TBI)
Official title: Prospective Phase II Clinical Trial of Myeloablative Conditioning Regimen With Fludarabine and Busulfan Plus 400 cGy Total Body Irradiation for Hematologic Malignancies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: AML
MDS
ALL
CML
Lymphoma
Keywords: fludarabine
busulfan
total body irradiation
conditioning regimen
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2008-12-30
Enrollment: 114
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the OS, RFS, and TRM after HCT with low-dose total body irradiation, fludarabine, and busulfan conditioning.

Detailed description: Conventional allogeneic hematopoietic cell transplantation (HCT) for patients with hematological malignancies involves conditioning with high doses of systemic chemo/radiation therapy such as cyclophosphamide (CY) plus 1200 or 1000 cGy total body irradiation (TBI; CY/TBI) or busulfan (Bu) / CY (BuCy). Unfortunately, such regimens have been associated with significant toxicities, limiting their use to otherwise healthy, relatively young patients.

Recently, Fludarabine plus 4 day dose of busulfan (FluBu4) containing myeloablative regimen has been introduced successfully without increasing transplant-related mortality (TRM). To improve transplant outcomes without increasing the risk of recurrence, Russell et al introduced 400cGy of TBI with antithymocyte (ATG, 4.5mg/Kg) into FluBu4 regimen with successful outcomes.

Eligibility criteria: Inclusion Criteria:

* At least 15 years old and not more than 65 years old.
* ECOG performance status 0-2.
* Patients with AML or MDS with intermediate/unfavorable cytogenetics.
* Patients with ALL and CML ineligible for Cy/TBI conditioning.
* Patients with NHL or HD eligible to myeloablative HCT.
* Patients receiving unrelated BMT for AML, MDS, ALL, CML, NHL or HD.
* Consent form signed and dated prior to study specific procedures.
* Subject able to comply with the scheduled follow-up and with the management of toxicities.

Exclusion Criteria:

-

Primary outcomes:
measure: progression free survival
timeFrame: one year
Secondary outcomes:
measure: relapse of primary disease, overall survival, and occurrence of acute/chronic GVHD
timeFrame: one year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Dong Hwan Kim
Study officials:
affiliation: Samsung Medical Center
name: Dong Hwan Kim
role: STUDY_DIRECTOR
References:
Clinical trial NCT02792868: Biological Phosphocalcic Metabolism and Coronary Artery Calcifications
Official title: Biological Phosphocalcic Metabolism and Coronary Artery Calcifications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Disease
Lead sponsor: French Cardiology Society
Sponsor class: OTHER
First posted: 2016-06-08
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patient with cardiovascular risk

Brief summary: Study a sample of patients in primary prevention, moderate cardiovascular risk (n = 83 patients), with normal, non-diabetic renal function. The investigators quantify the phophocalcic intake and excretion, realizing a food examination and a urine collection of 24 particular. The investigators will measure plasma levels of FGF23 serum calcium, phosphatemia, the investigators will calculate the tubular reabsorption of phosphate. The investigators will conduct a quantitative assessment of coronary calcification by a non-injected CT scan, measuring semi automated way Agatston calcium score. There will be an analysis of collinearity. An adjustment will be made for confounding variables in a generalized linear regression model.


Eligibility criteria: Inclusion Criteria:

* Hospitalization for a cardiovascular check in the Detection Centre and the Atherosclerosis Prevention (CHU Rangueil Toulouse)
* In primary prevention of coronary heart disease
* Introducing an intermediate cardiovascular risk according to the European SCORE equation, that is to say, a risk of cardiovascular death at 10 years greater than or equal to 1% and less than 5%
* signed the informed consent,

Exclusion Criteria:

* Chronic renal failure patients with an estimated GFR less than 60 mL / min / 1.73m2, due to alterations in phosphate metabolism,
* Patients receiving glucose-lowering therapy,
* Patients with a fasting blood glucose greater capillary or equal to 1.10 g / l, confirmed by a plasma glucose greater than or equal to 1.10g / l.
* The diuretic therapy patients (due to a change in urinary electrolytes)
* HIV-positive patients for HIV, antiretroviral (due to a change in urinary electrolytes)
* Pregnant women,
* Patients under judicial protection, guardianship or trusteeship.

Primary outcomes:
measure: plasma levels of FGF23 according to the calcium score, determined by an ELISA method
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Chu Rangueil
Study officials:
affiliation: CHU RANGUEIL
name: Jean FERRIERES
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04930068: Ultrasonic Cavitation on Abdominal Obesity in Adolescent Females
Official title: Ultrasonic Cavitation on Abdominal Obesity in Adolescent Females
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ultrasonic
Keywords: Ultrasonic
aerobic exercise
Diet
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Ghada ebrahim El Refaye - Department of Physical Therapy for Women's Health, Faculty of Physical Therapy, Cairo University, Egypt
First posted: 2021-06-18
Enrollment: 40
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group (A) consisted of 25 females who treated by ultrasonic cavitation, group (B) consisted of 25 females who performed aerobic exercise.
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine the effect of ultrasonic cavitation on abdominal obesity in females. Fifty volunteer females with abdominal obesity participated in the study.

Detailed description: The purpose of this study was to determine the effectiveness of ultrasonic cavitation on abdominal obesity in adolescent females. Fifty volunteer females with abdominal obesity participated in the study.

Group (A) consisted of 25 females who treated by ultrasonic cavitation on abdominal region for 30 minutes and aerobic exercises for 30 minutes, 2 times per week for 6 weeks ; group (B) consisted of 25 females who performed aerobic exercise and low caloric diet.

Eligibility criteria: Inclusion Criteria:

* Their ages were range from 17 to 21 years old.
* Their body mass index less than 35kg/m2.

Exclusion Criteria:

* Females with BMI exceed 35kg/m2.
* Females have psychological disorders.
* cardiac diseases.
* hypertension

Primary outcomes:
measure: Bioelectrical impedance analysis
timeFrame: 6 weeks
Secondary outcomes:
measure: skin fold caliper
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of physical therapy- Cairo University
state: Dokki
Study officials:
affiliation: Cairo University
name: Ghada E Elrefaye, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01903668: Determination of the Nature of the Endogenous Ligand of TREM-1 and Its Use as a New Diagnostic Biomarker in Sepsis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Sepsis
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2013-07-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Blood samples used for this study come from a collection being created as part of the research entitled "The combined determination STREM-1/PCT/CD64 it allows the diagnosis of sepsis in intensive care" - No. IDRCB 2009 - A00870-57 and led by Professor Sebastian GIBOT CHU Nancy.

Brief summary: Step 1: Identification and characterisation of the TREM1L protein from samples already available characterised at the hospital Central of Nancy Step 2: Study of the isoforms of TREM1L in correlation with the prognosis of sepsis, Step 3: implementation of assay methods for TREM1L (ELISA or SUPRA MS) Step 4: Validation of assays for TREM1L and its isoforms in a larger number of subjects (inclusion of samples from Dijon CHU and Besançon CHU)


Eligibility criteria: Inclusion Criteria:

* patients hospitalised in a Medical Intensive Care unit whatever the reason
* written informed consent obtained

Exclusion Criteria:

* patients less than 18 years old or under guardianship, persons without national health insurance.

Primary outcomes:
measure: plasma concentrations of sTREM-1
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03685968: King Vision® and GlideScope® in Difficult Airways
Official title: A Comparison of the King Vision® Channeled, King Vision® Non-Channeled, and Glidescope® Video Intubation Systems in Patients at Risk for Difficult Intubation - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Management
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: King Systems Corporation
First posted: 2018-09-26
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There are several advantages of video laryngoscopy; especially their ability to provide superior glottis visualization, as compared to traditional laryngoscopy.1-3 The purpose of this three arm study was to compare the safety and efficacy of the King Vision® Video Intubation Systems (AMBU-King Systems, Denmark) to the Cobalt GlideScope® (Verathon Medical Inc., USA) in patients with anticipated difficult airways.


Eligibility criteria: Inclusion Criteria:

* Over 18 years of age
* Mallampati III-IV
* Neck circumference \> 43cm
* Reduced mouth opening (\< 4cm) or 3 Finger breath's (patient's own)
* Thyromental distance \< 6cm

Exclusion Criteria:

* Mallampati I-II
* Neck circumference \< 43cm
* Documented 'easy' intubation
* Previous history of failed intubation and failed bag-mask ventilation
* Under 18 years of age
* ASA IV
* Known unstable cervical spine injury
* Presentation for an emergency surgical procedure

Primary outcomes:
measure: Overall Successful Tracheal Intubation for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL
timeFrame: During laryngoscopy and endotracheal tube placement
Secondary outcomes:
measure: First-attempt Successful Intubation for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL
timeFrame: During laryngoscopy and endotracheal tube placement
Other outcomes:
measure: Final Intubation Time for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL
timeFrame: During laryngoscopy and endotracheal tube placement
Locations:
Study officials:
affiliation: The University of Texas MD Anderson Cancer Center
name: Carin A Hagberg, MD
role: STUDY_CHAIR
References:
citation: Hagberg CA, Iannucci D, Goodrich A. A comparison of the glottic view obtained with the Macintosh Video Laryngoscope in anesthetized, paralyzed, apneic patients. Direct view vs video monitor. Anesthesiology 2003; 103: A1501.
citation: Hagberg C, Matuszczak M, Ellis S, et al. A randomized comparison of laryngoscopy techniques using the video laryngoscope and the traditional Macintosh laryngoscope in obese patients. Anesthesiology 2005; 103: A1420.
citation: Hagberg C, Vogt-Harenkamp C, Bogomolny Y, et al. A comparison of laryngoscopy techniques using the video laryngoscope and the traditional Macintosh laryngoscope in potentially difficult to intubate patients. Anesth Analg 2005; 100: S-212.