louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01432093: Intensive Glycemic Management and Outcomes Following Liver Transplantation
Official title: Intensive Glycemic Management and Outcomes Following Liver Transplantation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hospital Hyperglycemia
Post-transplant Hyperglycemia
Keywords: liver transplant
high blood sugars
hospital hyperglycemia
post-transplant hyperglycemia
post liver transplant
post liver-kidney transplant
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2011-09-12
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Most people develop high blood sugars following liver transplant that requires treatment with insulin in the hospital, even if they don't have diabetes, due to stress and use of steroid medications. High blood sugar levels can be treated with a hormone that the body makes called insulin. This study is being done to determine if maintaining normal blood sugar levels after transplant for as long as needed while in the hospital results in a lesser incidence of death, infections, transplanted liver rejection or failure or need for rehospitalization within 90 days after transplant.


Eligibility criteria: Inclusion Criteria:

* 18 years of age and older
* Undergoing liver transplant or combined liver-kidney transplant

Exclusion Criteria:

* Unable to grant informed consent or comply with study procedure
* Allergic to any of the excipients in insulin

Primary outcomes:
measure: Conduct a randomized controlled trial to compare outcomes with two management strategies to control hospital hyperglycemia in adult patients following liver transplantation.
timeFrame: 90 days following liver transplantation.
Secondary outcomes:
measure: Compare length of stay in the ICU and hospital in the two study groups.
timeFrame: 90 days following liver transplantation.
measure: Compare the incidence of hypoglycemia in the ICU and hospital in the two study groups.
timeFrame: 90 days following liver transplantation.
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Gunjan Y. Gandhi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00473993: Hepatitis C Among Opioid Addicts in Opioid Maintenance Treatment in Zurich, Switzerland
Official title: Hepatitis C Bei Opioidabhängigen in Der Praxis, Eine Querschnittsuntersuchung
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Substance Abuse Treatment Centers
Opioid-Related Disorders
Keywords: Hepatitis C
Opioid Maintenance Treatment
Methadone
Buprenorphine
Heroin
Interferon, pegylated
Lead sponsor: Seidenberg, Arztpraxis A., M.D.
Sponsor class: INDIV
Collaborators: name: University of Zurich
First posted: 2007-05-16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Time perspective: RETROSPECTIVE
Study population: Patients in opioid maintenance treatment in the kanton of Zurich, Switzerland

Brief summary: Hepatitis C viral infection is common among opioid addicts in Zurich, Switzerland. The majority undergoes a maintenance treatment with methadone, heroin or buprenorphine. While stabilized by an opioid maintenance treatment (OMT)chronic hepatitis C can be treated with pegylated interferon plus ribavirin. As not sufficiently known, the results are comparable to the results of the treatment of nonaddicts.

Our crossectional study investigates how many patients undergoing OMT are adequately investigated concerning hepatitis C. If not, why are they not adequately investigated and treated? Representative data are collected in the local clinics and medical practices involved in OMT in the Kanton of Zurich. The patients files are revised and the involved doctors are asked through a structured interview.

Detailed description: www.seidenberg.ch/hepcop.pdf

Eligibility criteria: Inclusion Criteria:

* Medical practices and clinics involved in opioid maintenance treatment in the Kanton of Zurich, Switzerland

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: research fellow EHAM, University of Zurich
name: André Seidenberg, Dr.med.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03608293: Smoker Extracellular Vesicles Influence on Human Bronchial Epithelial Cells
Official title: Particulate Air Pollution : Smoker Extracellular Vesicles Influence on Human Bronchial Epithelial Cells
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smokers
Human Bronchial Epithelial Cells
Lung Pathogenesis
Biomarkers
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
Collaborators: name: Universite du Littoral Cote d'Opale
First posted: 2018-07-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Cigarette smoking is a habit that has spread all over the world and is a significant risk factor for many diseases including cardiovascular disease, chronic obstructive pulmonary disease(COPD),asthma and lung cancer.

Evaluation and understanding of tobacco health effects are of major interest worldwide and answer to important societal concerns.

Identification of new biomarkers of exposure to tobacco smoke potentially implicated in COPD or lung carcinogenesis would allow a better observation of tobacco exposed population, thanks to screening establishment at reversible stages of pathological processes.

In this study, we question whether cigarettes smoking alters miRNA profiles of extracellular vesicles (EVs) present in human broncho alveolar lavages (BALs), which could affect surrounding normal bronchial epithelial cells status.

Detailed description: Extracellular vesicles (EVs) include a variety of nanoscale membranous vesicles (exosomes, microvesicles, microparticles). EVs are released into the interstitial fluid from a wide variety of normal or diseased cells.

Analysis of EVs and their content maybe useful as disease biomarkers as they reflect the contents of cells of origin, differ between normal and diseased tissue and can be reliably detected.

EVs may thus act as biomarkers of diverse pathologies like cancer, and detection of these biomarkers maybe applied to early diagnosis or assessment of prognosis in patients with cancer. EVs indeed contain both mRNAs and non-coding RNAs, such as small regulatory microRNAs (miRNAs).

Eligibility criteria: Inclusion Criteria:

* \>18 year-old

Exclusion Criteria:

* Lack of informed consent
* Drug treatment
* Professional exposure
* Evolutive pregnancy
* Bradycardia
* Respiratory assistance required,
* Diagnosed respiratory distress (e.g. COPD, asthma)
* Infectious pneumopathy
* Bronchial cancer

Primary outcomes:
measure: Quantification of target mRNA expression in human bronchial epithelial cells (BEAS-2 B) exposed to EVs isolated from LBA of patients
timeFrame: Through the study completion, an average of 48 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GHICL
name: Pierre Gosset, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06209593: Acceptability and Tolerance Study of a Plant-based Tube Feed
Official title: Acceptability (including Gastrointestinal Tolerance and Compliance) of a Plant Based High Energy Adult Enteral Formula
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nutrition Disorders
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2024-01-17
Enrollment: 15
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients established on a tube feed

Brief summary: This is a single arm, prospective, multi-centre study to evaluate the gastrointestinal tolerance and compliance over a 7-day period with a plant based tube feed.

Detailed description: Enterally fed adults who are assessed by the Health Care Professional/dietitian as requiring an adult plant- based high-energy, enteral formula will be recruited. Data from 15 participants are required in order to submit an application to the UK Advisory Committee on Borderline Substances (ACBS) for product registration

Eligibility criteria: Inclusion Criteria:

* Patients 16 years and over and adults requiring a plant- based enteral tube feed (taking 50% or more of energy needs from their feeding tube) as part of their dietary management for disease related malnutrition
* Patients well-established and stable on current polymeric enteral tube feed.
* Willingly given, written, informed consent from patient

Exclusion Criteria:

* Inability to comply with the study protocol, in the opinion of the investigator
* Under 16 years of age
* Patients on total parenteral nutrition
* Known food allergies to any ingredients including patients who have an allergy to milk protein e.g IgE and non- mediated as product contains traces of milk and allergy to peanuts due to the pea protein
* Patients with significant renal or hepatic impairment
* Participation in another interventional study within 2 weeks of this study.
* Patients with known or suspected ileus or mechanical bowel obstruction

Primary outcomes:
measure: Baseline assessment and daily recording during intervention up to day 7 measuring Gastrointestinal tolerance
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Nu
Study officials:
affiliation: University College London Hospitals
name: James Evans
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04802993: Survival Among Patients With Pancreatic Cancer Depending on Surgical Resection Rate
Official title: Survival Among Elderly Patients in Sweden With Right-sided Pancreatic Adenocarcinoma Depending on Resection Rate of Pancreaticoduodenectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Ductal Adenocarcinoma
Keywords: pancreaticoduodenectomy
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2021-03-17
Enrollment: 5123
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients registered in the Swedish National Registry for tumours in the pancreatic and periampullary region diagnosed with right-sided pancreatic adenocarcinoma or resected with pancreaticoduodenectomy

Brief summary: The primary aim of this population-based study is to investigate how a high resection rate of pancreaticoduodenectomy affects overall survival among patients aged ≥70 years with pancreatic ductal adenocarcinoma. The secondary aim is to determine if a high resection rate of pancreaticoduodenectomy increases perioperative morbidity.


Eligibility criteria: Inclusion Criteria:

* Diagnosed between 1 January 2010 and 31 December 2018
* Registered in the Swedish National Registry for tumours in the pancreatic and periampullary region
* Either a diagnosis of pancreatic ductal adenocarcinoma of the pancreatic head or having been resected with pancreaticoduodenectomy

Exclusion Criteria:

* None

Primary outcomes:
measure: Overall survival
timeFrame: A little more than 10 years (from first patient to vital status)
Secondary outcomes:
measure: Severe complications after pancreaticoduodenectomy
timeFrame: Around 10 years (patients diagnosed between 1 January 2010 and 31 December 2018, latest dismissal from hospital january 2020)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01309893: A Study to Evaluate a New Silicone Hydrogel Contact Lens
Official title: A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Contact Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: Contact lens
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2011-03-07
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The objective of this study is to determine the clinical feasibility and to evaluate the product performance of investigational contact lenses.


Eligibility criteria: Inclusion Criteria:

* Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
* Be myopic and require lens correction from -0.50 D to -5.50 D in each eye.

Exclusion Criteria:

* Any systemic disease affecting ocular health.
* Using any systemic or topical medications that will affect ocular physiology or lens performance.
* An active ocular disease, any corneal infiltrative response or are using any ocular medications.
* Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
* Allergic to any component in the study care products.

Primary outcomes:
measure: Distance High Contrast logMAR Visual Acuity at 1 Week
timeFrame: Baseline & 1 week
Secondary outcomes:
measure: Slit Lamp Findings ≥ Grade 2
timeFrame: 1 week
measure: Overall Comfort
timeFrame: 1 week
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Robert Steffen, OD, MS
role: STUDY_DIRECTOR
References:
Clinical trial NCT02275793: The Regulation of Pulmonary Vascular Resistance in Patients With Heart Failure
Official title: The Regulation of Pulmonary Vascular Resistance in Patients With Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diastolic Heart Failure
Pulmonary Hypertension
Lead sponsor: University of Toledo
Sponsor class: OTHER
First posted: 2014-10-27
Enrollment: 90
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: We will study a cohort of patients that will be recruited from the cath lab during diagnositic heart catheterization

Brief summary: Peripheral blood and blood following a pulmonary wedge pressure will be obtained from patients undergoing right heart catheterizations.

Detailed description: It is well known that left sided heart disease can lead to pulmonary hypertension via a number of proposed mechanisms. The purpose in this study is to identify biomarkers in pulmonary hypertension to further understand the pathophysiology of this disease in patients with heart disease.Patients are recruited in the cardiac catheterization lab, which are undergoing right heart catheterization as per their plan of care established by their primary cardiologist. During the procedure, we will ask the performing cardiologist to obtain a blood sample of 40-50 milliliters from the catheter that they are using during the procedure. These blood samples will be sent for analysis of biomarkers. The patient will then have an echocardiogram done 1 year from their heart catheterization.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Ability to provide informed consent.
* Presenting for cardiac catheterization for evaluation of heart disease
* Ejection Fraction \> 50%

Exclusion Criteria:

* Unable to provide informed consent.
* Unable or unwilling to comply with the protocol and follow up.
* Infiltrative cardiomyopathy
* Constrictive pericarditis
* Severe valvular disease
* Comorbid status with life expectancy \<3 years
* Right ventricular dysplasia
* Congenital heart disease
* On immunosuppressive drugs.
* Patients who has heart transplant.
* Ejection Fraction \< 50%
* Mean Pulmonary Artery Pressure \<25
* Wedge pressure \<15

Primary outcomes:
measure: Mortality
timeFrame: 1 year
Secondary outcomes:
measure: Morbidity
timeFrame: 1 year
Other outcomes:
Locations:
city: Toledo
country: United States
facility: University of Toledo, Health Science Campus
state: Ohio
Study officials:
affiliation: University of Toledo Health Science Campus
name: Samer Khouri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01442493: Reengineering Methadone Treatment Study of Patient-centered Methadone Treatment
Official title: Reengineering Methadone Treatment: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opiate Dependence
Keywords: Methadone Treatment
Opiate dependence
Services research
Lead sponsor: Friends Research Institute, Inc.
Sponsor class: OTHER
First posted: 2011-09-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of the study is to determine whether a change in the rules and staff roles in methadone treatment programs will result in greater lengths of stay in treatment and lower rates of heroin and cocaine use, crime and HIV-risk behavior as compared to methadone treatment as usual.

Detailed description: Early drop-out and premature discharge from methadone treatment is common in the United States and may be associated with drug use and its associated problems. The purpose of this study is to evaluate the effectiveness of a novel approach to the organization methadone treatment in which the patient rules and staff roles of the clinic will be modified for study participants as compared to patients receiving standard methadone treatment.

Eligibility criteria: Inclusion Criteria:

* opiate dependence
* newly admitted to methadone treatment

Exclusion Criteria:

* pregnancy

Primary outcomes:
measure: Number of Participants With Opiate Positive Urine Tests
timeFrame: 12-months post-baseline
Secondary outcomes:
measure: Number of Participants With Cocaine Positive Urine Tests
timeFrame: 12-months post-baseline
measure: Drug Use HIV Risk Behavior
timeFrame: 12-months post-baseline
measure: Criminal Behavior
timeFrame: 12-months post-baseline
measure: Global Score on the World Health Organization Quality of Life Measure
timeFrame: 12-months post-baseline
measure: Number of Participants Meeting DSM-IV Opiate Dependence Criteria
timeFrame: 12-months post-baseline
measure: Number of Participants Meeting DSM-IV Cocaine Dependence Criteria
timeFrame: 12-months post-baseline
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Institutes for Behavior Resources REACH
state: Maryland
city: Baltimore
country: United States
facility: University of Maryland Drug Treatment Center
state: Maryland
Study officials:
affiliation: Friends Research Institute, Inc.
name: Robert P Schwartz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mitchell SG, Monico LB, Lertch E, Kelly SM, Gryczynski J, Jaffe JH, O'Grady KE, Schwartz RP. Counseling Staff's Views of Patient-Centered Methadone Treatment: Changing Program Rules and Staff Roles. J Behav Health Serv Res. 2018 Jul;45(3):506-515. doi: 10.1007/s11414-018-9603-1.
Clinical trial NCT00863993: Energy Expenditure and Gastric Bypass Surgery
Official title: Energy Expenditure and Gastric Bypass Surgery
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Gastric Bypass Surgery
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2009-03-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 40 healthy patients (M=F, aged 18-60 years) undergoing gastric bypass bariatric surgery will be recruited.

Brief summary: The aim of this study is to assess whether activity thermogenesis increases in patients undergoing bariatric surgery post-operatively compared to pre-operatively. The investigators will assess non-exercise activity thermogenesis using a validated Physical Activity Monitoring System and doubly labeled water, immediately pre-operatively and again at 6 and 18 months post-operatively. PAMS has been validated in lean and obese individuals. This is to assess energy expenditure, activity thermogenesis and NEAT during the phase of greatest weight loss and once weight loss has plateaued. This will permit us to address our primary hypothesis that activity thermogenesis as a fraction of total daily energy expenditure increases in patients undergoing bariatric surgery 6 and 18 months post-operatively, compared to pre-operatively.


Eligibility criteria: Inclusion Criteria:

* Undergoing gastric bypass surgery, 18-60 years

Exclusion Criteria:

* Eligible subjects will be excluded who cannot walk at 2.4 mph for 15 minutes, or weigh greater than 227 kg at the screening visit.

Primary outcomes:
measure: TDEE (total daily energy expenditure)
timeFrame: March 2009 to October 2013
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05399693: Platelet Transfusion Refractoriness
Official title: Characterization of Anti-HLA I Antibodies Involved in Platelet Transfusion Refractoriness: Optimization of the Transfusion Management of Patients With Severe Thrombocytopenia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Platelet Transfusion Refractoriness
Lead sponsor: Institut de cancérologie Strasbourg Europe
Sponsor class: OTHER
First posted: 2022-06-01
Enrollment: 50
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: Adult patient :

* with Hematopoietic stem cells graft (autograft or allograft)
* or with acute leukemia with the indication of platelet transfusion.

Brief summary: Platelet Transfusion Refractoriness is one of the severe complications after multiple transfusions in patients with severe thrombopenia. Platelet Transfusion Refractoriness is characterized by inefficient transfusion and arise from allo-antibodies specific of platelets antigenes, mostly carried by HLA-I molecules.

Detailed description: A preliminary study has shown different isotypes of anti-HLA I in patients with Platelet Transfusion Refractoriness. Our hypothesis is that the type of anti-HLA I antibodies (recognised epitope, quantity, isotype) should establish predictive and diagnostic criteria for Platelet Transfusion Refractoriness.

Eligibility criteria: Inclusion Criteria:

* Adult patient with Hematopoietic stem cells graft (autograft or allograft) or with acute leukemia with the indication of platelet transfusion.

Exclusion Criteria:

* Patient under guardianship
* Minor patient

Primary outcomes:
measure: Research of predictive criteria of Platelet transfusion refractoriness
timeFrame: blood samples before the transfusion of each chemotherapy cycle
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Institut de cancérologie Strasbourg Europe
Study officials:
affiliation: Institut de cancérologie Strasbourg Europe
name: Luc FORNECKER
role: PRINCIPAL_INVESTIGATOR
References: