louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01761097: Endocuff Adenoma Detection Rate Pilot Study
Official title: A Pilot Study to Assess the Role for Endocuff© Assisted Colonoscopy in the Detection of Colonic Cancer and Polyps
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Adenoma
Colorectal Cancer
Keywords: Adenoma, polyp, colonoscopy.
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2013-01-04
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Colorectal cancer is the second leading cause of cancer deaths in the UK(1) . Detection of cancer at an early stage, as well as detection and removal of polyps through gold standard colonoscopy examination decreases mortality from the disease. However colonoscopy has a well documented miss rate, with some areas of the bowel difficult to visualise and neoplastic lesions potentially hidden behind folds in the colon.

The Endocuff© is a disposable polymer sleeve with hinged lateral arms. The arms flatten mucosal folds and fix the colonoscope centrally in the bowel lumen allowing controlled withdrawal and improving mucosal visualization. The cap easily attaches to the tip of current colonoscopes without modification. In this single centre, randomised controlled trial, the investigators aim to assess the performance of the current gold standard colonoscopic examination against the current gold standard colonoscopic examination with the Endocuff© attached to the colonoscope.

The investigators aim to recruit 300 patients (150 in each group) who have previously been identified to have colonic polyps or cancers undergoing surveillance colonoscopy following NICE guidelines(2). Colonoscopy will be performed by Joint Advisory Group on gastro-intestinal endoscopy (JAG) certified colonoscopists following quality indicator guidance. All patients undertaking follow up surveillance colonoscopy for previous polyps or cancer will be invited to participate and those agreeing will be randomly allocated to one or other technique.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing surveillance colonoscopy test as part of the colonic adenoma and cancer surveillance programme.
* Ability to understand the nature and requirements of the study and to provide written informed consent.

Exclusion Criteria:

* Contraindication to undergo standard colonoscopy.
* Severe active colitis.
* Known colonic stricture

Primary outcomes:
measure: Proportion of patients with adenomas and cancers detected
timeFrame: immediate
Secondary outcomes:
measure: Caecal intubation time
timeFrame: Immediate
Other outcomes:
measure: Caecal intubation rate
timeFrame: immediate
measure: Polyp detection rate
timeFrame: immediate
Locations:
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
Study officials:
affiliation: Cambridge University Hospitals NHS Foundation Trust
name: Ewen Cameron, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04571697: A Study of Comparing Rates of Dementia and Alzheimer's Disease in Participants Initiating Methotrexate Versus Those Initiating Anti-tumor Necrosis Factor (TNF)-Alpha Therapy
Official title: Comparing Rates of Dementia and Alzheimer's Disease in Patients Initiating Methotrexate Versus Those Initiating Anti-TNF-α Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dementia
Alzheimer Disease
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2020-10-01
Enrollment: 34647
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population consists of participants who are new user of Anti-TNF therapy diagnosed with dementia and alzheimer's disease.

Brief summary: The purpose of the study is to compare the risk of dementia in participants diagnosed with rheumatoid arthritis (RA) exposed to anti-tumor necrosis factor (TNF) therapy versus those exposed to methotrexate.


Eligibility criteria: Inclusion Criteria:

* At least one claim for methotrexate or anti-TNF therapy during the study period. First medication received is the index medication, and date of first receipt is the index date
* 365 days of continuous pre-index observation immediately prior to the index date
* Participants have at least two occurrences of a diagnosis of rheumatoid arthritis within 365 days before and including the index date
* No prior use of methotrexate or an anti- tumor necrosis factor (TNF) therapy at any time prior to the index date
* Cohort follow-up persists until end of continuous observation or filling the comparator drug

Primary outcomes:
measure: Newly Diagnosed Dementia Cases
timeFrame: 365 days
Secondary outcomes:
measure: Newly Diagnosed Alzheimer's Disease (AD) Cases
timeFrame: 365 days
Other outcomes:
Locations:
city: Titusville
country: United States
facility: Janssen R&D
state: New Jersey
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT06190197: Prophylactic Antibiotics in Cystectomy With Diversion
Official title: Prophylactic Antibiotics in Radical Cystectomy With Urinary Diversion
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Muscle-Invasive Bladder Carcinoma
Radical Cystectomy
Ileal Conduit
Neobladder Diversion
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized non-inferiority trial.
Primary purpose: TREATMENT

Brief summary: Using a randomized 2 arm design, this study is being conducted to test for non-inferiority of no prophylactic antibiotic therapy versus the prophylactic oral antibiotic, nitrofurantoin, through comparison of rates of postoperative urinary tract infections within the 90-day postoperative period in patients with muscle invasive bladder cancer who undergo radical cystectomy with urinary diversion.


Eligibility criteria: Inclusion Criteria:

* Presence of muscle invasive bladder cancer and planning to undergo radical cystectomy with either ileal conduit or neobladder diversion.
* 18 years of age or older

Exclusion Criteria:

* Currently receiving antimicrobials for active infection
* Poor renal function with GFR \< 30 ml/min
* Allergy to nitrofurantoin and unable to take an alternative antibiotic (cephalexin, trimethoprim-sulfamethoxazole, or ciprofloxacin)
* Pregnancy
* Unable to provide Informed consent

Primary outcomes:
measure: test for non-inferiority
timeFrame: 90 days
measure: Difference in risk
timeFrame: 30 and 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Hamed Ahmadi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04817397: The Lymphocyte/Neutrophil Ratio as a Prognostic Index for Short Term Outcome in the ICU Admitted COVID-19 Adult Patients
Official title: The Lymphocyte/Neutrophil Ratio as a Prognostic Index for Short Term Outcome in the ICU Admitted COVID-19 Adult Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-03-26
Enrollment: 100
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: The study will conducted on admitted patients that diagnosed as COVID at Assiut university hospitals

Brief summary: 1. ry outcome includes the correlation between lymphocyre /neurtophll ratio (LNR) and mortality rate during hospital stay in the ICU admitted COVID 19 patients.
2. ry outcome(s) include the LNR and its correlation with ICU stay, the need for mechanical ventilation, renal impairment.

Detailed description: In December 2019,the COVID-19 virus has been mainly breaking out in Wuhan in China as pneumonia affecting patients . Common clinical features During hospitalization started to appear including acute respiratory infection , inflammatory reaction , fever, pneumonia, cough, fatigue , anosmia .

The patient known suspected if he has a clinical picture of viral pneumonia, exposure history, and radiographic findings \[CT\] or \[MRI\] chest consistent with COVID-19 pneumonia. the gold standard and the Final diagnosis (PCR) positivity for the presence of coronavirus .

The immune response to respiratory infection causes neutrophils to collect inside the lung especially the alveoli. Neutrophils aggregation may lead to collateral tissue damage and cytotoxicity. According to Previous studies apoptosis of lymphocytes occurred due to the release of anti-inflammatory cytokines resulting in lymphopenia. high levels of circulating neutrophils have been demonstrated in COVID-19 patients(

A lot of literatures and studies have demonstrated the value of what is called neutrophil/ lymphocyte ratio (LNR) as a simple prognostic ratio correlated to morbidity and mortality. Up to our knowledge, there is no study utilized such ratio in COVID-19 ICU admitted patients, so that, this study has been built

Eligibility criteria: Inclusion Criteria:

1. Adult patients (aged ≥18 years)
2. Patients who need non-invasive ventilation (NIV or CPAP) or invasive ventilation (intubation)

Exclusion Criteria:

1. Previous diagnosis of severe liver or kidney failure.
2. Patients with Human Immunodeficiency Virus (HIV) infection.
3. Patients with previous hematological diseases (Leukemia) that condition alterations in blood counts.
4. Consumption of treatments with any type of immunosuppressants prior to admission that conditions low lymphocytes.
5. Patients with bone marrow depression.

Primary outcomes:
measure: The Lymphocyte/neutrophil ratio
timeFrame: up to 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assuit University
Study officials:
References:
Clinical trial NCT03393897: Respiratory Variations of the Diameter of Superior Vena Cava for Predicting Fluid Responsiveness After Cardiac Surgery
Official title: Respiratory Variations of the Diameter of Superior Vena Cava for Predicting Fluid Responsiveness After Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transesophageal Echocardiography
Vena Cava Superior
Keywords: fluid responsiveness
cardiac surgery
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2018-01-09
Enrollment: 56
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 with hemodynamic instability and hypotension

Brief summary: In a recent study (Vignon 2017), respiratory variations of the diameter of superior vena cava had a greater diagnostic accuracy than pulse pressure variations and inferior vena cava respiratory variations in 540 medical and surgical ICU patients. But this indicator has not been investigated yet in cardiac surgery. The investigator aim to study respiratory variations of superior vena cava for predicting fluid responsiveness after cardiac surgery.

In post-operative cardiac surgery patients with hemodynamic failure, the investigator will measure respiratory vena caval variations with TEE (Trans oesophageal echocardiography). Then, the investigator will evaluate fluid responsiveness after a fluid challenge (Trendelenburg).

A ROC curve will be constructed in order to assess the optimal sensitivity and specificity of this parameter.


Eligibility criteria: Inclusion Criteria:

* Hemodynamic instability with hypotension,
* Low cardiac output or norepinephrine requirements in the first 6 post-operative hours.

Exclusion Criteria:

* TEE (Trans oesophageal echocardiography) contra-indication
* Trendelenburg contra-indication

Primary outcomes:
measure: diameter of vena cava superior
timeFrame: at 6 post-operative hours
Secondary outcomes:
measure: % of respiratory variations of maximal Doppler velocity in left ventricular outflow tract
timeFrame: at 6 post-operative hours
measure: % of respiratory variations of maximal Doppler velocity in pulmonary artery
timeFrame: at 6 post-operative hours
measure: % of pulse pressure respiratory variations
timeFrame: at 6 post-operative hours
Other outcomes:
Locations:
city: Saint Etienne
country: France
facility: Centre Hospitalier Universitaire de Saint Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Olivier PEYROUSET, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05008497: Cancer and Literacy in Health
Official title: Validation in French of a Psychometric Tool for Measuring Health Literacy in the Field of Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2021-08-17
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients followed or having been followed for cancer at the Hôpital privé des Peupliers between May 2014 and December 2020

Brief summary: Validation in French of a psychometric tool for measuring health literacy in the field of cancer

Detailed description: Single-centre, non-interventional questionnaire study

Eligibility criteria: Inclusion Criteria:

* Patient aged 18 years or older, having been informed of the research
* Followed or having been followed at the Hôpital privé des Peupliers for a cancer

Exclusion Criteria:

* Patient who has indicated his/her opposition to the use of his/her medical data
* Patient under legal protection, guardianship or curatorship

Primary outcomes:
measure: Validation of a questionnaire
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Privé des Peupliers, Ramsay Santé
Study officials:
affiliation: Hôpital Privé des Peupliers, Ramsay Santé
name: Charlotte NGO, MD PD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00354497: Prostate Cancer Screening and Dietary Heterocyclic Amines in African American Men
Official title: Prostate Cancer Screening and Dietary HA Exposure in African-Americans: Phase II
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: prostate cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-07-20
Enrollment: 800
Sex: MALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Primary purpose: SCREENING

Brief summary: RATIONALE: Screening may help doctors find prostate cancer sooner, when it may be easier to treat. The amount of heterocyclic amines in the diet may affect prostate cancer screening results and the risk of prostate cancer.

PURPOSE: This phase II trial is studying prostate cancer screening and dietary heterocyclic amines in African American men.

Detailed description: OBJECTIVES:

* Estimate dietary heterocyclic amine (HA) exposure in African American men who use HA-forming meats and cooking methods.
* Correlate dietary HA exposure with prostate-specific antigen and digital rectal exam screening results (i.e., higher HA exposure with increased abnormality in prostate cancer screening results) in these participants.

OUTLINE: This is a prospective study.

Participants complete a routine medical questionnaire and undergo a detailed dietary interview that focuses on meat consumption, cooking preferences, and other factors that may be associated with prostate cancer risk. Participants then undergo a digital rectal exam (DRE) and blood collection for prostate-specific antigen (PSA) testing (total PSA and % free PSA). Results of PSA testing and DRE, including follow-up instructions (if needed), are sent to the participant 3-4 weeks later.

Blood samples are also examined by phenotypic assays for UV-damage induced nucleotide excision-repair capacity.

PROJECTED ACCRUAL: A total of 800 participants will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* African American male
* No previous diagnosis of prostate cancer
* Desires prostate cancer screening as a routine preventative medical service

PATIENT CHARACTERISTICS:

* Lives in or near Oakland, California
* Speaks English
* No medical or other disability (e.g., blindness, psychological dysfunction, or amputation) that would preclude study participation

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Dietary heterocyclic amine (HA) exposure in African American men
measure: Correlation of HA exposure with prostate cancer screening results
Secondary outcomes:
Other outcomes:
Locations:
city: Livermore
country: United States
facility: Lawrence Livermore National Laboratory at University of California
state: California
city: Oakland
country: United States
facility: Alta Bates Summit Medical Center - Summit Campus
state: California
Study officials:
affiliation: Lawrence Livermore National Laboratory at University of California
name: Kenneth T. Bogen, DrPH, MPH, MA, ScD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00437697: Thromboprophylaxis in Critically Ill Patients
Official title: Thromboprophylaxis in Critically Ill Patients: a Prospective, Randomized Study Comparing Anti-Xa Activities Following Subcutaneous Administration of 5000 IU and 7500 IU Dalteparin
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Venous Thromboembolism
Keywords: dalteparin, critically ill, thromboprophylaxis
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2007-02-21
Enrollment: 90
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Intensive care patients are at high risk to develop deep venous thrombosis and pulmonary embolism. Despite anticoagulation with heparin 7% of ICU patients suffer from this serious complication. Optimal regimens for prevention of VTE have been established in medical patients only and are not known for ICU patients.

It was therefore the aim of this study to compare the bioavailability of a low molecular weight heparin in ICU patients and in medical patients. Furthermore, we looked wether a 50% dose increase resulted in better bioavailability of this drug.

Detailed description: Background: The optimal dose regimen of low molecular weight heparins (LMWH) for thromboprophylaxis in critically ill patients is unknown.

Objectives: We performed a prospective, randomized study to determine anti-Xa activities following subcutaneous administration of 5000 IU or 7500 IU dalteparin for thromboprophylaxis in ICU patients compared with medical patients receiving the standard dose of 5000 IU.

Patients and Methods: Twenty-five ICU patients received 7500 IU (group 1) and 29 ICU patients received 5000 IU dalteparin subcutaneously (group 2) for thromboprophylaxis. Twenty-nine medical patients receiving 5000 IU dalteparin served as control group (group 3).

Eligibility criteria: Inclusion Criteria:

* Requirement for prophylactic anticoagulation, patient age ³19 years, creatinine clearance within normal range, prothrombin time \>30% and thrombocyte counts \>100 G/l.

Exclusion Criteria:

* Estimated time of admission less than 24 hours, full anticoagulation, renal failure, history of heparin-induced thrombocytopenia, hereditary or acquired coagulation disorders.

Primary outcomes:
measure: Area under the curve of measured anti-Xa activities between baseline and 12 hours (AUC-anti-Xa0-12).
Secondary outcomes:
measure: Peak anti-Xa activities at any time (C-max anti-Xa)
measure: Time of peak anti-Xa-activities (t-max anti-Xa).
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Ute Priglinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00370097: FLOVENT Hydrofluoroalkane (HFA) In 6-12 Month Old Subjects
Official title: PD of Hydrofluoroalkane Propellant of Inhaled Fluticasone Propionate Following Administration in Pediatric Subjects 6-12 Months of Age With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Keywords: Asthma infants FLOVENT spacer
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-08-30
Enrollment: 16
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to address an Food Drug and Administration (FDA) request to provide safety data in pre-asthmatic patients, ages 6 months to \<12 months, following administration of fluticasone propionate HFA.

Detailed description: A repeat-dose, open-label, 2-session study to assess the systemic exposure to, and pharmacodynamics of, fluticasone propionate HFA inhalation aerosol 88mcg administered twice-daily for 28 days delivered via an MDI and valved holding chamber with infant facemask to subjects ages 6 months to \<12 months who have experienced 2 or more wheezing episodes in the preceding 6 months

Eligibility criteria: Inclusion Criteria:

* Subjects who have experienced 2 or more wheezing episodes in the previous 6 months.
* Subjects may not have taken any corticosteroids in the 4 weeks prior to dosing
* Parents/guardians should be able to read and comprehend diary information collected throughout the study
* Parents must be able to demonstrate the ability to use the facemask and spacer used to administer study drug

Exclusion criteria:

* Subjects who weigh less than 7 kg
* Subjects who are taking any drugs that inhibit or induce the cytochrome P450 isoform
* Any parents who have a history of psychiatric disease, intellectual deficiency, substance abuse that would compromise the validity of the consent

Primary outcomes:
measure: Serum cortisol weighted mean(0-12h)
timeFrame: throughout the study
Secondary outcomes:
measure: Serum cortisol Cmin FP Cmaxss, AUClast and tmaxss Adverse events
timeFrame: throughout the study
Other outcomes:
Locations:
city: Huntington Beach
country: United States
facility: GSK Investigational Site
state: California
city: Centennial
country: United States
facility: GSK Investigational Site
state: Colorado
city: Jacksonville
country: United States
facility: GSK Investigational Site
state: Florida
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Normal
country: United States
facility: GSK Investigational Site
state: Illinois
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: