louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04615676: Prospective Evaluation of the Predictive Criteria of Severity for Respiratory Infection Due to COVID-19 Virus
Official title: Prospective Evaluation of the Predictive Criteria of Severity Related to Patient Calling Emergency Centre for Low or High Respiratory Infection With or Without Fever and Suspected to be COVID-19.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV2
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2020-11-04
Enrollment: 4734
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patient (more than 15 years old) calling the emergency call center (15 center) for Low or High Respiratory Infection With or Without Fever and Suspected

Brief summary: Emergency call centers are very solicited in epidemic situations. It is necessary to detect early Predictive Criteria of Severity in COVID respiratory infection to identify patients at risk of complication or aggravation from an emergency call center in order to adapt their orientation and their medical management.


Eligibility criteria: Inclusion Criteria:

* patient (more than 15 years old) calling the emergency call center (15 center) for Low or High Respiratory Infection With or Without Fever and Suspected to be COVID

Exclusion Criteria:

* unknown contact facility
* call not regulated by a practitioner from the medical emergency help team

Primary outcomes:
measure: Hospitalization
timeFrame: Month 1
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital of Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Charles-Henri HOUZE-CERFON
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04347876: Outcome of COVID-19 Cases Based on Tuberculin Test: Can Previous BCG Alter the Prognosis?
Official title: Outcome of COVID-19 Cases Admitted to Hospital and ICU With Positive Tuberculin Test: Can Previous BCG Alter the Prognosis?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
BCG Vaccination
Keywords: Outcome
COVID-19 pneumonia
BCG
Tuberculin test positive
Egypt
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All cases admitted with proven COVID-19 positive disease will be included, tested with tuberculin test positive and negative ( History of previous BCG or not)

Brief summary: There is no evidence that the Bacille Calmette-Guérin vaccine (BCG) protects people against infection with COVID-19 virus. Two clinical trials addressing this question are underway, and WHO will evaluate the evidence when it is available. In the absence of evidence, WHO does not recommend BCG vaccination for the prevention of COVID-19. WHO continues to recommend neonatal BCG vaccination in countries or settings with a high incidence of tuberculosis. There is experimental evidence from both animal and human studies that the BCG vaccine has non-specific effects on the immune system. These effects have not been well characterized and their clinical relevance is unknown


Eligibility criteria: Inclusion Criteria:

* COVID-19 positive cases admitted to hospitals in Upper Egypt

Exclusion Criteria:

* None

Primary outcomes:
measure: Pneumonia severity index
timeFrame: 2 weeks
measure: Need for ICU admission
timeFrame: 2 weeks
Secondary outcomes:
measure: COVID -19 test conversion
timeFrame: 2 weeks
measure: Mortality
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: AssiutU
Study officials:
References:
Clinical trial NCT04393376: PSA Glycomics Assay for Early Detection of Prostate Cancer
Official title: Evaluation of Prostate-Specific Antigen Glycomics Assay for the Early Detection of Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
PSA
Keywords: Prostate Cancer
PSA
Glycomics Assay
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Amsterdam UMC, location VUmc
name: The Netherlands Cancer Institute
name: Radboud University Medical Center
name: Leiden University Medical Center
First posted: 2020-05-19
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The principal aim of this pilot study is to test whether the PSA Glycomics Assay on urine and serum samples can provide insights regarding the disease state of patients with elevated PSA concentrations, as well as to accurately identify if the patient has prostate cancer and, in the case of prostate cancer, to determine its level of aggressiveness.


Eligibility criteria: Inclusion Criteria:

* Patients with elevated PSA (\>3 ng/mL)
* Signed informed consent

Exclusion Criteria:

* Patients that have a cystitis (bladder infection)
* Patients under chemotherapy
* Patients using 5-alpha reductase inhibitors
* History or presence of cancers, or non-prostate urological disorders.

Primary outcomes:
measure: PSA Glycomics Assay
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, location AMC
state: Noord Holland
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, location VUmc
city: Leiden
country: Netherlands
facility: Leiden University Medical Centre
Study officials:
References:
Clinical trial NCT04622176: Magnetomotoric Ultrasound for Diagnostic Purposes in Rectal Cancer
Official title: Magnetomotoric Ultrasound for Diagnostic Purposes in Rectal Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rectal Cancer
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
Collaborators: name: Lund University
First posted: 2020-11-09
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with rectal cancer undergoing abdominoperineal excision.

Brief summary: A magnetomotive ultrasound combines standard diagnostic ultrasound equipment with the application of an external time-varying magnetic field. The investigators aim to use this equipment to improve preoperative diagnostics in rectal cancer.

Detailed description: The investigators will compare magnetomotive ultrasound with MRI and pathology report on specimens extracted during surgery.

Eligibility criteria: Inclusion Criteria:

* Rectal cancer
* Surgery with abdominoperineal resection

Exclusion Criteria:

* No informed consent
* Not fulfilling inclusion criteria
* No rectal cancer

Primary outcomes:
measure: Accuracy of lymph node diagnosis compared to pathology report
timeFrame: 1 hour postoperatively
measure: Accuracy of lymph node diagnosis compared to MRI
timeFrame: 1 hour postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Dept. of Surgery, Sahlgrenska University Hospital/Ostra
Study officials:
affiliation: Sahlgrenska Universitetssjukhuset
name: Eva Angenete
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00482976: Effect of LY333531 on Vascular and Neural Functions
Official title: The Effects of a Protein Kinase C Beta Inhibitor, LY333531, on Vascular and Neural Functions in Type 2 Diabetes Mellitus - Study B7A-MC-MBDM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus
Lead sponsor: Chromaderm, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Joslin Diabetes Center
First posted: 2007-06-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To determine if protein kinase C beta plays a significant role in vascular endothelial dysfunction, small fiber neural dysfunction, and oxidative stress associated with diabetes mellitus.

Detailed description: 32mg Ruboxistaurin; 4 week cross-over treatment.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes diagnosed for at least 1 mo and less than 10 yrs prior to visit 1
* HbA1c less than 9% and fasting plasma glucose less than 260mg/dl
* Blood pressure less than 160/100 mmHg
* Total cholesterol less than 300 mg/dl and/or triglycerides less than 600 mg/dl

Exclusion Criteria:

* Subjects treated with a thiazolidinedione (TZD) in 12 weeks prior to visit 1.
* History of heart disease (MI, unstable angina, CVA, TIA, CABG, or percutaneous transluminal coronary angioplasty) w/in 6 months of visit 1 or subjects with BYHA class III or IV congestive heart failure.
* Female subjects of child-bearing potential that are pregnant or intend to become pregnant (i.e. not practicing an acceptable method of birth control)
* TSH greater than 1.5 times upper limit of normal at V1 or other endocrine disease.
* ALT greater than 1.5 times upper limit of normal at V1; Serum creatinine greater than 2.0mg/dl at V1; micro-albumin greater than 300.

Primary outcomes:
measure: Improvement in endothelium-dependent vasodilation of the microcirculation of the skin and nerve axon-related reflex vasodilation.
timeFrame: 4 weeks
measure: Improvement in endothelium-dependent vasodilation of the brachial artery (flow mediated dilation)
timeFrame: 4 weeks
measure: Improvement in selective measurements of oxidative stress, endothelial activity and vascular abnormalities which will correlate with PKC activity in the peripheral monocytes.
timeFrame: 4 weeks
Secondary outcomes:
measure: Safety of ruboxistaurin
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Massachusetts
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02906176: Influence of SLCO2B1 Polymorphism on the PK of Voriconazole in CYP2C19 PM
Official title: A Clinical Trail to Investigate the Influence of SLCO2B1 Polymorphism on the Pharmacokinetic Characteristics of Voriconazole in CYP2C19 Poor Metabolizers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-09-19
Enrollment: 12
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: A clinical trail to investigate the influence of SLCO2B1 polymorphism on the pharmacokinetic characteristics of voriconazole in CYP2C19 poor metabolizers


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteer who is a CYP2C19 Poor metabolizer with rs3781727 SNP wild or variant genotype

Exclusion Criteria:

* History of clinically significant respiratory, cardiovascular, renal, hepatic, hematologic, neurological disorder

Primary outcomes:
measure: Pharmacokinetic outcome - Maximum plasma concentration (Cmax)
timeFrame: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose
measure: Pharmacokinetic outcome - Area under the plasma concentration versus time curve (AUC)
timeFrame: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital Clinical Trial Center
Study officials:
affiliation: Seoul National University Hospital
name: SeungHwan Lee, MD., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01248676: An Evaluation of the Usability and Usefulness of a Multi-language Online Patient Education Module
Official title: An Evaluation of the Usability and Usefulness of a Multi-language Online Patient Education Module: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: cancer radiation patient education
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2010-11-25
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to determine if multi-language patients will find the multi-language capabilities of the online modules useful for better understanding of the general information regarding radiation therapy.

Detailed description: Research shows that treatment-related information is the most important informational need of cancer patients and online media sources are gaining popularity as a cancer communication method. It is important to know whether having multi-language online education modules are usable for and beneficial to the multicultural cancer patient population at Sunnybrook Hospital, given that recent research suggests that this cancer population in general faces many barriers to effective online cancer communication. Approximately 10 new patients from the radiation oncology clinic at Sunnybrook Hospital will be screened to participate in the study. Usability testing will involve a combination of interviewing, observation, think-aloud methodology and a short survey.Results will be analyzed by assessing the percentage of patients identifying with a certain level of the Likert scale on the survey as well as through content analysis of responses to the interview and open-ended survey questions.

Eligibility criteria: Inclusion Criteria:

* first/second language in one of the module languages with the ability to understand and communicate English to an understandable degree, basic computer skills, and the ability to complete 20-30 minutes of testing.

Exclusion Criteria:

* inability to participate in 20-30 minutes of usability testing.

Primary outcomes:
measure: Patients will be asked to give their rating (Likert scale) on the usefulness of the information on the patient education site with regard to their upcoming radiation simulation and treatment.
timeFrame: Within one month of patients initial consultation with the Radiation Oncologist
Secondary outcomes:
measure: Patients will be asked to give their rating (Likert scale) on how easily the online patient education module is to navigate.
timeFrame: Within one month of patients initial consultation with the Radiation Oncologist
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Odette Cancer Centre at Sunnybrook Health Sciences
state: Ontario
Study officials:
affiliation: Odette Cancer Centre at Sunnybrook Health Sciences Centre
name: Lisa S Di Prospero, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00092976: Study Evaluating ReFacto® in Hemophilia A Undergoing Major Surgery
Official title: A Phase IV Study of the Safety and Efficacy of ReFacto® (Moroctocog Alfa, B-Domain Deleted Recombinant Factor VIII) in Subjects With Hemophilia A Undergoing Major Surgery Monitored Using the Chromogenic Substrate Assay at the Local Laboratory
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hemophilia A
Keywords: Hemophilia A
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2004-09-29
Enrollment: 15
Sex: MALE
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this clinical research study is to evaluate the safety and efficacy of ReFacto in subjects with hemophilia A undergoing major surgery monitored using the chromogenic substrate assay at the local laboratory.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 6 years
* Male previously treated patients (≥150 Exposure Days) with moderate or severe hemophilia A (i.e. ≤ 5% FVIII:C) who will undergo elective major surgery that is anticipated to require at least 6 consecutive days of daily factor VIII (FVIII) infusions (surgical and post-surgical prophylaxis)
* Ability to adhere to the protocol requirements

Exclusion Criteria:

* Hypersensitivity to ReFacto, murine allergen, or hamster allergen 2 History of FVIII inhibitor or current inhibitor, defined as \> 0.6 BU
* Prior participation in this study
* Any concomitant bleeding disorder other than hemophilia A

Primary outcomes:
measure: To evaluate the safety and efficacy of ReFacto in subjects with Hemophilia A undergoing major surgery monitored using the chromogenic substrate assay at the local laboratory.
Secondary outcomes:
measure: To compare FVIII:C levels determined using the one-stage and the chromogenic substrate assays at a central laboratory
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: New Brunswick
country: United States
state: New Jersey
city: Cincinnati
country: United States
state: Ohio
city: Hershey
country: United States
state: Pennsylvania
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00910676: Study About Preventive Treatment of Folliculitis Induced by Epidermal Growth Factor Receptor Inhibitors
Official title: Phase II Multicentric Study About Preventive Treatment of Folliculitis Induced by the EGF-R Inhibitors in Patients With Metastatic Colorectal Cancer and Treated by Cetuximab or With Non-small-cell Lung Carcinoma Treated by Erlotinib
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Colorectal Cancer
Non-Small-Cell Lung Carcinoma
Keywords: EGF-R inhibitors
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2009-06-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Patients will receive local prophylactic treatment (Diprosone cream) during 8 weeks from the beginning of the EGF-R inhibitors treatment, on the areas of the body susceptible to be affected by folliculitis.


Eligibility criteria: Inclusion Criteria:

* Indication of Cetuximab in patients with metastatic colorectal cancer in association or not with irinotecan, after failure of a chemotherapy treatment with Irinotecan OR
* Indication of Erlotinib, in patients with metastatic Non-Small-Cell Lung Carcinoma, after failure of at least one chemotherapy treatment
* No pre-existing cutaneous toxicity

Exclusion Criteria:

* Contraindication to local corticotherapy
* Previous history of severe hypersensibility reactions (Grade III or IV) due to Cetuximab, Irinotecan or Erlotinib
* Betamethasone or one of excipient product allergy

Primary outcomes:
measure: To reduce by 30 % the frequency of folliculitis by a local corticotherapy beginning at the same time that the treatment by EGF-R inhibitors began
timeFrame: 2 months of treatment by corticotherapy
Secondary outcomes:
measure: To assess the frequency of grade I, II and III folliculitis under Cetuximab and under Erlotinib
timeFrame: 2 months of treatment
measure: To list the cutaneous side effects of the EGF-R inhibitors
timeFrame: 2 months of treatment
measure: To assess the patient quality of life with the DLQI questionnaire
timeFrame: 2 months of treatment
Other outcomes:
Locations:
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lille
country: France
facility: Centre Hospitalier Regional
city: Lille
country: France
facility: Centre Hospitalier Régional
Study officials:
affiliation: Centre Hospitalier Régional et Universitaire de LILLE
name: Laurent MORTIER, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03523676: Use of Red Cell Distribution Width for Prediction of New-onset Atrial Fibrillation in Critically Ill Sepsis Patients
Official title: Evaluation of Red Cell Distribution Width to Predict New-onset Atrial Fibrillation in Critically Ill Sepsis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation New Onset
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-05-14
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 70 patients of both sexes were enrolled in this study. They were admitted to the general ICU of Ain Shams University Hospitals with sepsis or septic shock

Brief summary: Red cell distribution width variations are increased in a variety of medical conditions such as congestive heart failure, acute myocardial infarction, pulmonary embolism, pneumonia, critical illness, and cardiac arrest , and is a predictor of mortality in the general population..

Detailed description: This study was done retrospectively on sepsis patients admitted to intensive care units. data will be retrieved from patient medical records. The primay end point will be occurrence of new-onset AF during ICU stay. The secondary outcomes will be 28-day mortality.

The presence of anisocytosis or RDW variations has been classicaly used as a test for iron deficiency anemia. Increasing evidence points to its potential as a predictor for various conditions such as heart failure , malignancy, ischemic heart disease and sepsis.

Study investigators will examine the relationship between RDW levels and incidence of atrial fibrillation in critically ill sepsis patients as well as 28-day mortality.

Eligibility criteria: Inclusion Criteria:

* For all patients According to Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) , adult patients with suspected infection are identified, having quickSOFA (qSOFA) score meeting ≥2 of the following criteria: respiratory rate of 22/min or greater, altered mentation, or systolic blood pressure of 100 mmHg or less
* Sepsis patients with newly developed Atrial fibrillation during ICU stay.

Exclusion Criteria:

All patients with concomitant valvular disease, cardiomyopathy, cardiac dysrhythmias, previous cardiac surgery, secondary hypertension, hyperthyroidism, severe head injury, stroke, coma, acute coronary artery disease or underlying cardiac dysfunction\[cardiac index (CI) \<2.2 l/min/m 2 \], severe liver disease (Child-Pugh grade C), chronic renal failure were excluded from the study. In addition, pregnant patients were excluded.

Primary outcomes:
measure: New-Onset atrial fibrillation , confirmed by electrocardiographical assessment
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ain Shams University
name: Diaaeldein Ibrahim, MD
role: STUDY_DIRECTOR
References: