louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02835703: Clinical Assessment of Perfusion Techniques During Repair of Coarctation With Aortic Arch Hypoplasia in Infants
Official title: Clinical Assessment of Perfusion Techniques During Surgical Repair of Coarctation of Aorta With Aortic Arch Hypoplasia in Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coarctation of Aorta
Keywords: Congenital heart disease
Coarctation of aorta
Aortic arch hypoplasia
Cerebral selective antegrade perfusion
Double arterial cannulation
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2016-07-18
Enrollment: 45
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate safety and efficacy of three main perfusion methods in surgical repair of coarctation of aorta with aortic arch hypoplasia in infants.

Detailed description: Three perfusion techniques of visceral protection will be assessed - deep hypothermic circulatory arrest, selective antegrade cerebral perfusion and double arterial cannulation (perfusion of brachiocephalic artery with thoracic descending aorta by two arterial cannulas)

Eligibility criteria: Inclusion Criteria:

* coarctation with severe aortic arch hypoplasia (distal aortic arch z-score \< -2)
* coarctation of aorta with septal defects

Exclusion Criteria:

* coarctation with mild aortic arch hypoplasia (distal aortic arch z-score \> -2)
* complex congenital heart diseases including aortic arch hypoplasia (e.g. transposition of great arteries, double oulet right ventricle, atrioventricular septal defect, Shone's complex)
* univentricular and duct-dependent heart defects
* aortic valve and/or mitral valve stenosis/hypoplasia (aortic valve or mitral valve z-score \< -2.0)
* left ventricular dysfunction (left ventricle ejection fraction \< 60%)
* congenital renal or central nervous system anomalies
* related infectious diseases
* prematurity (gestational age \< 37 weeks)

Primary outcomes:
measure: Adverse events in early postoperative period
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Degree of inotropic support (inotropic score)
timeFrame: through ICU stay, an average of 3 weeks
measure: Intraoperative blood loss (ml)
timeFrame: intraoperatively
measure: Temperature of cooling (C)
timeFrame: intraoperatively
measure: Duration of CPB (min)
timeFrame: intraoperatively
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation
Study officials:
References:
citation: Kulyabin YY, Bogachev-Prokophiev AV, Soynov IA, Omelchenko AY, Zubritskiy AV, Gorbatykh YN. Clinical Assessment of Perfusion Techniques During Surgical Repair of Coarctation of Aorta With Aortic Arch Hypoplasia in Neonates: A Pilot Prospective Randomized Study. Semin Thorac Cardiovasc Surg. 2020 Winter;32(4):860-871. doi: 10.1053/j.semtcvs.2020.04.015. Epub 2020 May 22.
Clinical trial NCT02027103: Metformin and Pioglitazone Effects on Fetuin-A and Osteoprotegrin Concentrations in Type 2 Diabetes Patients
Official title: Comparative Effects of Metformin and Pioglitazone on Fetuin-A and Osteoprotegerin Concentrations in Patients With Newly Diagnosed Diabetes: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Fetuin-A
OPG
Metformin
Pioglitazone
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-01-03
Enrollment: 102
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Oral hypoglycemic agents, along with dietary modification and exercise encompass the mainstay of treatment in early stages of T2DM. Biguanides and thiazolidinediones are two major groups of hypoglycemic medications that while function via different pathways, mare both effective in short- and long-term glucose control. These medications diminish or delay long term micro- and macrovascular complications associated with T2DM although at different rates. Excessive insulin resistance accounts for a sustained increase in cardiovascular incidents in T2DM subjects. Given the shared pathway of insulin resistance/fetuin-A/OPG in atherosclerosis formation, it is conceivable that insulin sensitizing anti-diabetes medications are able to modify successive CAD risk via direct and indirect amelioration of insulin resistance/fetuin-A/OPG. The present study is therefore designed to investigate the effects of metformin and pioglitazone monotherapy on serum concentrations of fetuin-A and OPG in a group of Iranian adults with newly diagnosed T2DM.


Eligibility criteria: Inclusion Criteria:

Newly diagnosed type 2 diabetes patients based on American Diabetes Association criteria (2011) for diagnosis of diabetes

Exclusion Criteria:

Previous intake of oral hypoglycemic agents for treatment of diabetes or other hyperglycemia associated conditions Intake of glucocorticoids in the past one year Major illnesses of heart, lung, kidney, and liver.

Primary outcomes:
measure: Serum concentrations of fetuin-A
timeFrame: 12 weeks
measure: Serum concentrations of osteoprotegrin
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Diabetes Clinic, Vali-Asr Hospital, Tehran University of Medical Sciences
Study officials:
affiliation: Tehran University of Medical Sciences
name: Alireza Esteghamati, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Esteghamati A, Afarideh M, Feyzi S, Noshad S, Nakhjavani M. Comparative effects of metformin and pioglitazone on fetuin-A and osteoprotegerin concentrations in patients with newly diagnosed diabetes: A randomized clinical trial. Diabetes Metab Syndr. 2015 Oct-Dec;9(4):258-65. doi: 10.1016/j.dsx.2014.09.009. Epub 2014 Oct 14.
Clinical trial NCT03735303: Effect of Vitamin D3 and Omega-3FA on Leptin and HbA1C With Vitamin D Deficiency
Official title: The Combined Effect of Vitamin D3 and Omega-3 Supplements on Serum Leptin and Glycated Hemoglobin (Hb A1C) Levels in Jordanian People With Vitamin D Deficiency.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Keywords: vitamin D3
vitamin D deficiency
leptin
A1C
omega-3 fatty acid
Lead sponsor: Applied Science Private University
Sponsor class: OTHER
First posted: 2018-11-08
Enrollment: 146
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The Combined effect of Vitamin D3 and Omega-3 supplements on serum leptin and Glycated hemoglobin (Hb A1C) levels in Jordanian people with vitamin D deficiency.

Detailed description: Nothing is published in the literature about effect of vitamin D3 (VD3) and omega-3 fatty acids (omega-3FA) on serum leptin and glycated hemoglobin ( HbA1C)

This study will be conducted to investigate effect of VD3 and omega-3FA alone and with each other on serum leptin and Glycated hemoglobin (Hb A1C) levels in Jordanian people with vitamin D deficiency.

This randomized, controlled clinical trial will be designed to test effects of 50,000 IU VD3 weekly and 1000 mg omega-3FA daily for eight weeks, separately and with each other, on on serum leptin and Glycated hemoglobin (Hb A1C) levels .

Eligibility criteria: Inclusion Criteria:

* jordanian people aged 25-55
* medical diagnosis of vitamin D deficiency ( VD \<25 ng/ ml)

Exclusion Criteria:

* Blood disorders including
* thalassemia
* sickle cell disease

Primary outcomes:
measure: VD 3
timeFrame: 8 weeks
measure: leptin
timeFrame: 8 weeks
measure: HbA1C
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Applied Science University
Study officials:
affiliation: Applied Science Private University
name: Mahmoud S Abu-Samak, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ross AC. The 2011 report on dietary reference intakes for calcium and vitamin D. Public Health Nutr. 2011 May;14(5):938-9. doi: 10.1017/S1368980011000565. No abstract available.
Clinical trial NCT01713803: Evaluation of BEMA® Buprenorphine NX for Buprenorphine Induction of Opioid Dependent Subjects
Official title: Evaluation of BEMA® Buprenorphine NX for Buprenorphine Induction of Opioid Dependent Subjects
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Opioid Dependence
Lead sponsor: BioDelivery Sciences International
Sponsor class: INDUSTRY
First posted: 2012-10-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This is a randomized, double blind, placebo controlled study in opioid dependent subjects. Subjects meeting entry criteria will be treated with multiple doses of B-BNX or B-Placebo, with non-responders rescued within 6 hours. Open treatment B-BNX will be administered as follow-up therapy. Clinical efficacy assessments include the clinical opioid withdrawal scale (COWS), subject-rated assessments, and a urine drug screen.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent obtained prior to any study procedure being performed
* Subject is a male or non-lactating female with a negative urine pregnancy test
* Subject is aged 18 to 65 years, inclusive
* Current diagnosis of opioid dependence or addiction per the Diagnostic and Statistical Manual of Mental Disorders - 4th edition (text revision) (DSM-IV-TR) criteria including physical dependence on opioids
* Daily short-acting opiate use of at least 60 mg morphine equivalent no opioid use for at least 12 hours prior to Screening with positive opiate result on urine drug screen
* Clinical opioid withdrawal scale (COWS) score ≥9
* Subject is in good general health in the judgment of the Investigator as determined from the physical and oral examination findings.

Exclusion Criteria:

* Use of a long-acting opioid within the last 72 hours
* Use of an investigational drug or device within the last 30 days
* History of hypersensitivity, allergy, or intolerance to buprenorphine, naloxone, or related drugs
* Immediate suicidal risk, as determined by meeting any of the following:

  1. History of suicidal ideation ≤ 3 months prior to Baseline with a score of 4 (intent to act) or 5 (specific plan and intent) on the eC-SSRS
  2. History of suicidal behavior ≤1 year prior to Baseline (actual attempt, interrupted attempt, aborted attempt and/or preparatory acts/behavior) on the eC-SSRS
* A history or current evidence of any clinically significant disorder or any other condition which in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results

Primary outcomes:
measure: The mean change in clinical opioid withdrawal scale (COWS) total score from Baseline to 6 hours following the initial dose
Secondary outcomes:
measure: The percentage of subjects with a negative result on the urine drug screen at Day 7
measure: The percentage of subjects with a clinical opioid withdrawal scale (COWS) total score ≤4 at 6 hours after the initial study drug dose
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
Study officials:
References:
Clinical trial NCT02041403: RENAL RESISTIVE INDEX POST-OPERATIVE COMPLICATIONS IN MAJOR SURGERY?
Official title: MAY RENAL RESISTIVE INDEX BE AN EARLY PREDICTIVE TOOL OF POST-OPERATIVE COMPLICATIONS IN MAJOR SURGERY?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major High Risk Operations
Renal Resistive Index
Outcome
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2014-01-22
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients submitted to major high risk surgery

Brief summary: An observational trial aiming to verify whether does any relationship exist between renal resistive index and postoperative outcome in major high risk surgery

Detailed description: Renal resistive index was measured just after major high risk operations and then patients were observed searching for any surgical and medical-related complications during the first post-operative week

Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* major surgical operations

Exclusion Criteria:

* age \< 18 years

Primary outcomes:
measure: Complications
timeFrame: 7 post-operative days
Secondary outcomes:
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Humanitas Research Hospital - Dept. Anesthesia and Intensive Care Unit
state: Milano
city: Milano
country: Italy
facility: Sant'Ambrogio Clinical Institute - Cardiac Anesthesia Unit
Study officials:
affiliation: Humanitas Research Hospital -Dept. Anesthesia and Intensive Care
name: Enrico Giustiniano, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02421003: Exploratory Study, Prospective, of Volume, Composition and Bacteriology of the Recovered Blood of Multi-perforated Catheter Inserted in the Drapes Thickness of Incisional Sternal Area During Heart Surgery
Official title: Exploratory Study, Prospective, of Volume, Composition and Bacteriology of the Recovered Blood of Multi-perforated Catheter Inserted in the Drapes Thickness of Incisional Sternal Area During Heart Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Surgery
Keywords: heart surgery blood
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2015-04-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The recovered blood into the surgical site at the border of the fields, is very rich in red blood cells, due to the adjacency of the bone marrow and the sternum.

The blood recovered from the surgical site at the border of the fields, is richer in red blood cells than the bloodstream of the patient.

The recovered blood into the surgical site at the border of the fields, is not contaminated and bacteriological cultures are negative.

Consequences: The recovered blood in the surgical site at the edge of fields, can be recovered in the Saver® Cell for reprocessing and re-injected into the patient.

There isn't in our knowledge of published clinical data on the volume and composition of the recovered blood in the surgical site after cardiac surgery.

The analysis of the available literature does not allow to estimate the expected outcomes us. Therefore, this study will be exploratory in nature and will aim to estimate the volume and the content of red blood cells from blood recovered, and generate clinical data to be used in subsequent confirmatory tests.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years;
* Any open heart surgery with or without extracorporeal circulation
* Signature of informed consent
* Affiliation to social security

Exclusion Criteria:

* Subjects legally protected or unable to consent
* Persons deprived of liberty
* Cardiac Surgery extreme emergency (due to difficulties obtaining informed consent)
* Pregnant or breastfeeding women

Primary outcomes:
measure: Measurement of red blood cell numeration from blood collected.
timeFrame: Between the incision and the closure.
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: Centre Hospitalier Universitaire d'Amiens
state: Picardie
Study officials:
affiliation: CHU Amiens
name: Gilles TOUATI, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02410603: Isolating and Testing Circulating Tumor DNA and Soluble Immune Markers During the Course of Treatment for Lung Cancer
Official title: Isolating and Testing Circulating Tumor DNA and Soluble Immune Markers During the Course of Treatment for Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Lung Neoplasms
Cancer of Lung
Cancer of the Lung
Neoplasms, Lung
Neoplasms, Pulmonary
Pulmonary Cancer
Pulmonary Neoplasms
Carcinoma, Non-small-cell Lung
Adenocarcinoma
Squamous Cell Carcinoma
Keywords: Chemotherapy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-04-07
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced stage cancer in the thorax who are scheduled to undergo systemic therapy at the Mayo Clinic in Rochester, MN.

Brief summary: The purpose of this study is to explore the detection of circulating tumor DNA, soluble immune markers, and the evaluation of peripheral blood mononuclear cells (PBMC).

Detailed description: Our plan is to collect blood from patients with advanced stage lung cancer who are scheduled to undergo systemic therapy. In this study we will utilize a novel technology for circulating tumor DNA detection in order to evaluate their presence in patients with lung cancer by comparing blood samples at six time points. We will obtain baseline blood and then collect blood at five time points during the course of the patient's chemotherapy treatments and at the end of treatment. These same blood collections will be used for the detection of soluble immune markers and evaluation of PBMCs.

Eligibility criteria: Inclusion Criteria:

* Advanced (non-resectable) malignancy in the thorax
* Age \>18 years old
* Willing and able to provide consent
* No prior history of neoadjuvant therapy

Exclusion Criteria:

* Age \<18 years old
* Unable to provide consent
* Patients with hemoglobin less than 10 g/dL (to minimize the impact of potential iatrogenic anemia)

Primary outcomes:
measure: The primary end point is the number and type of mutations detectable in the circulating tumor DNA blood samples.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Aaron Mansfield, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02838303: The Use of Self-reported Symptoms as a Proxy for Acute Organophosphate Poisoning Among Nepali Farmers
Official title: The Use of Self-reported Symptoms as a Proxy for Acute Organophosphate Poisoning Among Nepali Farmers: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Organophosphate Poisoning
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Augustinus Fonden
First posted: 2016-07-20
Enrollment: 42
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate self-reported symptoms as a proxy for acute organophosphate poisoning by examining self-reported acute organophosphate poisoning symptoms and PchE activity in response to occupational acute organophosphate exposure among farmers in Nepal.


Eligibility criteria: Inclusion Criteria:

* male
* minimum age 18 years
* hand pressured backpack sprayer usage
* used to spray with moderately to extremely hazardous pesticides according to the World Health Organization's (WHO) Pesticide Hazard Classification

Exclusion Criteria:

* usual personal protective equipment use (respirator/mask with particulate filter, face shield, googles, gloves, boots, plastic poncho)
* unwilling to stay pesticide-free seven days prior to each of the two spray sessions
* medical conditions interfering with PchE activity (liver disease, acute infection, chronic malnutrition, heart attack, cancer, obstructive jaundice, inflammation caused by various diseases, or use of pyridostigmine drugs)

Primary outcomes:
measure: Change in self-reported acute organophosphate poisoning symptoms from baseline to follow up
timeFrame: Obtained just before (baseline) and 30 minutes after (baseline) each spray session
measure: Change in Plasma Cholinesterase (PchE) activity from baseline to follow up
timeFrame: Obtained just before (baseline) and 30 minutes after (baseline) each spray session
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Occupational and Environmental Medicine, Bispebjerg Frederiksberg Hospital, University of Copenhagen
name: Dea H. Kofod, MB
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kofod DH, Jors E, Varma A, Bhatta S, Thomsen JF. The use of self-reported symptoms as a proxy for acute organophosphate poisoning after exposure to chlorpyrifos 50% plus cypermethrin 5% among Nepali farmers: a randomized, double-blind, placebo-controlled, crossover study. Environ Health. 2016 Dec 13;15(1):122. doi: 10.1186/s12940-016-0205-1.
Clinical trial NCT05708703: Assessing the Time Demands of Cancer
Official title: Time Toxicity of Cancer: the Time Demands of Cancer-related Activities and Their Impact on Well-being and Quality of Life
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Metastatic Breast Cancer
Ovarian Cancer
Keywords: ovarian cancer
metastatic breast cancer
time use
quality of life
cancer survivorship
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institutes of Health (NIH)
First posted: 2023-02-01
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals currently undergoing treatment for metastatic breast or advanced stage ovarian cancer.

Brief summary: A total of 80 individuals receiving treatment for metastatic breast or advanced stage ovarian cancer will be asked to complete a baseline survey and install the mobile app on their smartphone; carry the smartphone for 28 consecutive days while outside the home; keep smartphone location and motion services active; confirm and correct (if needed) smartphone-detected activities and trips; use the app interface to provide additional information on activities and trips related to cancer treatment tasks; complete daily surveys regarding well-being; and at the end of the 28 day period, complete an online survey.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Diagnosed with advanced stage (III, IV) ovarian (ovarian, fallopian tube or prmary peritoneal) or metastatic breast cancer \[do not need to be newly diagnosed\]
* Currently receiving any type of therapy for their cancer \[can be front-line, maintenance therapy, or treatment for recurrence\]
* Able to complete study tasks in English
* Able to provide voluntary informed consent
* Own an Android or iOS smartphone on which the operating system is version 9.0 or higher for Android or 10.0 higher for iOS; or willing to use a researcher-provided smartphone

Exclusion Criteria:

* Those who are currently incarcerated
* Have opted out of research contact

Primary outcomes:
measure: Activity and trip types
timeFrame: 28 days
measure: Activity length
timeFrame: 28 days
measure: Activity reoccurrence
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Minneapolis
country: United States
facility: Masonic Cancer Center - University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota Masonic Cancer Center
name: Rachel Vogel, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: