louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02205957: Training Quality in Anaesthesia and Intensive Care: Tunisian Residents Feed Back
Official title: Training Quality in Anesthesia and Intensive Care : Tunisians Residents' Feed Back
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Training Objectives Achievement
Keywords: anesthesiology and intensive care, quality, training
Lead sponsor: University Hospital, Mahdia
Sponsor class: OTHER
First posted: 2014-08-01
Enrollment: 160
Sex: ALL
Minimum age (years): 30
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents in anesthesiology and intensive care

Brief summary: Opinion survey to assess the level of satisfaction and the expectations of the residents in anesthesiology and intensive care in Tunisia ( North Africa)

Detailed description: The first national anonymous survey to assess the theoretical and practical training quality in anesthesia and intensive care and the improvements propositions.

Eligibility criteria: Inclusion Criteria:

* Tunisian nationality
* Resident in anesthesiology and intensive care
* training period : 6 months to four year

Exclusion Criteria:

* training done outside tunisia

Primary outcomes:
measure: the approval of theoretical and practical teaching
timeFrame: up to four year of training
Secondary outcomes:
measure: Improvement propositions
timeFrame: up to 4th year
Other outcomes:
Locations:
city: Mahdia
country: Tunisia
facility: Mahdia University Hospital
Study officials:
affiliation: Mahdia UNiversity Hospital
name: Kolsi Abdessalem, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04028557: An Implementation Model for Clinical Decision Support for Heart Failure Prescribing
Official title: Development and Validation of an Integrated Implementation Model for Clinical Decision Support for Heart Failure Prescribing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Decision Support Systems, Clinical
Heart Failure
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2019-07-22
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of this proposal is to compare clinical outcomes, implementation metrics (i.e., patient reach and clinician adoption), and clinician preferences of two designs (customized vs. commercial) of a clinical decision support (CDS). Beta blocker prescribing for patients with heart failure will be used as a test case. The best practices in CDS design, including the user-centered design will be incorporated into the customized CDS and compared to a commercially-available CDS in the electronic health record using a cluster randomized trial.


Eligibility criteria: Study subjects are providers

Inclusion Criteria:

* Prescribing primary care clinicians at University of Colorado Health (UCHealth) who provide care for patients with heart failure and reduced ejection fraction

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in prescription of Beta blocker (BB)
timeFrame: 6 months post CDS implementation
Secondary outcomes:
measure: Patient Reach
timeFrame: 6 months post CDS implementation
measure: Clinician Adoption
timeFrame: 6 months post CDS implementation
measure: Factors Influencing Clinician Adoption of the CDS per Qualitative Interviews
timeFrame: 6 months post CDS implementation
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Health
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Katy E Trinkley, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Trinkley KE, Kroehl ME, Kahn MG, Allen LA, Bennett TD, Hale G, Haugen H, Heckman S, Kao DP, Kim J, Matlock DM, Malone DC, Page Nd RL, Stine J, Suresh K, Wells L, Lin CT. Applying Clinical Decision Support Design Best Practices With the Practical Robust Implementation and Sustainability Model Versus Reliance on Commercially Available Clinical Decision Support Tools: Randomized Controlled Trial. JMIR Med Inform. 2021 Mar 22;9(3):e24359. doi: 10.2196/24359.
Clinical trial NCT01515657: Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated and Immediate Release Aspirin in Diabetic Patients
Official title: A Randomized, Actively Controlled, Crossover Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated and Immediate Release Aspirin in Patients With Type II Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: PLx Pharma
Sponsor class: INDUSTRY
First posted: 2012-01-24
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study will determine if aspirin from PL2200, an investigational product, gets into the blood stream as quickly as plain aspirin and enteric coated aspirin, and to test whether PL2200 is able to prevent blood clots as effectively as these other products, when administered to patients with diabetes.


Eligibility criteria: Inclusion Criteria:

* Adults 21-79
* Body mass index (BMI) of 30-40 kg/m2
* Non-insulin-dependent type-2 diabetics (as confirmed by hemoglobin A1c (HbA1c) of \> 6.4% and/or fasting plasma glucose of \>125 mg/dL or current anti-diabetic medication)
* AA-induced platelet aggregation response of \>60% within 3 hours prior to initial dose of study drug administration

Exclusion Criteria:

* Contraindications to aspirin
* Previous history of vascular disease
* Patient requires insulin
* Use of non-steroidal anti-inflammatory drugs, anti-secretory agents, antacids, and salicylate-containing nutritional supplements within 2 weeks of randomization

Primary outcomes:
measure: Time to 99% Inhibition of Serum Thromboxane (TxB2)
timeFrame: 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: MedPace Clinical Pharmacology
state: Ohio
Study officials:
References:
citation: Bhatt DL, Grosser T, Dong JF, Logan D, Jeske W, Angiolillo DJ, Frelinger AL 3rd, Lei L, Liang J, Moore JE, Cryer B, Marathi U. Enteric Coating and Aspirin Nonresponsiveness in Patients With Type 2 Diabetes Mellitus. J Am Coll Cardiol. 2017 Feb 14;69(6):603-612. doi: 10.1016/j.jacc.2016.11.050. Epub 2017 Jan 11.
Clinical trial NCT00180557: Austria Study - Analysis of Difference Between Active and Passive Fixation Leads
Official title: Analyse Der Unterschiede Zwischen Aktiv-fixierenden Und Passiv-fixierenden Stimulations-Elektroden Hinsichtlich Implantationsdauer Und Elektrischer Parameter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bradycardia
Heart Block
Sick Sinus Syndrome
Lead sponsor: Guidant Corporation
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 120
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: In this study the difference between screw in leads actively fixed in the septum and tined leads passively fixed in the apex concerning electrical parameters and implantation time will be evaluated. In addition the influence of the stimulation location by type of lead on QRS width, ejection fraction and NYHA class will be evaluated using and electrocardiogram and echocardiogram.


Eligibility criteria: Inclusion Criteria:

Age \< 18 years, indication for pacemaker implantation according to current guidelines, written consent of the patient

Exclusion Criteria:

Live expectancy \< 6 months, pregnancy or women without contraception in birth bearing age, inability or refusal to sign consent form, simultaneous participation in another clinical trial, contraindication for any procedure required during pacemaker implantation, patients who need other pacemaker systems including pacing leads than those required by the protocol, heart failure (LVEF \<35%, QRS-Width\>150ms), functional (rate dependent) bundle branch bloc

Primary outcomes:
measure: QRS width
measure: Ejection fraction
measure: NYHA class
Secondary outcomes:
Other outcomes:
Locations:
city: Ried im Innkreis
country: Austria
facility: Krankenhaus der barmherzigen Schwestern
Study officials:
affiliation: Krankenhaus der barmherzigen Schwestern Ried im Innkreis
name: C Nimeth, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04778657: National Exhaustive Cohort of Hereditary Stomatocytoses and Other Channelopathies Affecting the Red Blood Cell
Official title: National Exhaustive Cohort of Hereditary Stomatocytoses and Other Channelopathies Affecting the Red Blood Cell
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stomatocytosis
Keywords: rare genetic disease
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 150
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 for whom the diagnosis of hereditary stomatocytosis has been made or confirmed by ektacytometry

Brief summary: Hereditary stomatocytosis is a heterogeneous group of rare constitutional diseases of dominant transmission in the vast majority of cases. The data concerning their clinical and biological presentation, and their evolution are few, and come from about thirty clinical cases. The constitution of an exhaustive French cohort of hereditary stomatocytosis will improve the establishment of the diagnosis and the management of patients

Detailed description: The patient is prospectively included. The referring hematologist will inform the patient about participation in the cohort, give him the information note and obtain his non-objection agreement to the use of his data for research purposes.

The data will be collected from the medical file of each patient as part of his usual annual follow-up.

Eligibility criteria: Inclusion Criteria:

* Any patient with a diagnosis of stomatocytosis without age limit
* Patient affiliated or beneficiary of french Social Security
* No objection from the patient or legal representative

Exclusion Criteria:

* Diagnosis of stomatocytosis excluded by ektacytometry and / or genetics
* Patient under guardianship, with curators or legal protection

Primary outcomes:
measure: Obtain a description of the clinical and laboratory data of patients at the time of diagnosis of stomatocytosis
timeFrame: Baseline
Secondary outcomes:
measure: Determine the proportion of recurrent genetic mutations and private mutations within our cohort
timeFrame: Baseline
measure: Establish phenotypes-genotypes relationships
timeFrame: through study completion, an average of 15years
measure: Describe the appearance of complications
timeFrame: through study completion, an average of 15years
measure: Describe possible new phenotypic presentations of hereditary stomatocytosis
timeFrame: through study completion, an average of 15years
Other outcomes:
Locations:
city: Le Kremlin Bicêtre
country: France
facility: AP-HP, Bicêtre Hospital, Pediatrics - Hematology - Reference center for Sickle cell anemia, Thalassemia and other constitutional diseases of the red blood cell
Study officials:
affiliation: APHP
name: Corinne GUITTON
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04414657: USZ BioResource COVID-19
Official title: Development of a SARS-CoV-2 Research Biobank and Databank
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: COVID19
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 150
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: SARS-CoV-2 infektion (according to WHO guideline)

Brief summary: Mono-centric. Blood sampling for biobank development, including linkage to patient data (resource for research on COVID19).


Eligibility criteria: Inclusion Criteria:

* m/f age \> 18 years
* SARS-CoV-2 infektion (according to WHO guideline)
* hospitalisation, general ward
* acceptable language knowledge
* voluntary IFC and biobank appendix

Exclusion Criteria:

* contra indication for blood sampling

Primary outcomes:
measure: blood sampling for biobank
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Clinical Trials Center
Study officials:
affiliation: Head of Clinical Trials Center University Hospital Zurich
name: Regina Grossmann, Dr med
role: STUDY_DIRECTOR
References:
Clinical trial NCT06057857: Oral Cancer Screening in Workplace: a Cross-sectional Study
Official title: An Experience of Oral Cancer Screening in Workplace: a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Cancer
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all employees working in ACU

Brief summary: Employees are to be all screened for oral cancer in work place.


Eligibility criteria: Inclusion Criteria:

* adults

Exclusion Criteria:

* refusal to participate

Primary outcomes:
measure: Presence of lesion: oral cancer or oral potentially malignant lesions
timeFrame: upon study completion; an average of 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Ahram Candian University
Study officials:
References:
Clinical trial NCT00469157: Refractive Surgery and Optive Compatibility Study
Official title: Refractive Surgery and Optive Compatibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye Syndromes
Keywords: compatibility of Optive after PRK or LASIK
Lead sponsor: Innovative Medical
Sponsor class: INDUSTRY
First posted: 2007-05-04
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: To assess the compatibility of Optive with refractive surgery (PRK and LASIK) post-operatively.


Eligibility criteria: Inclusion Criteria:

* Men and women 18 and over
* Patients undergoing refractive surgery

Exclusion Criteria:

* Concurrent ocular conditions or pathology that could affect patient's ability to complete study
* Concurrent use of topical medications other than study medications
* Use of systemic medications with ocular drying sequelae:

  * Antihistamines
  * Decongestants
  * Antispasmotics
  * Antidepressants

Primary outcomes:
measure: Assess compatibility
timeFrame: 8 months
Secondary outcomes:
measure: comfort
timeFrame: 8 months
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: TLC
state: California
Study officials:
affiliation: TLC
name: Loren Rude, OD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01411657: NT-501 CNTF Implant for Ischemic Optic Neuropathy: Safety, Neuroprotection and Neuroenhancement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ischemic Optic Neuropathy/Optic Nerve Stroke
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2011-08-08
Enrollment: 11
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Ciliary Neurotrophic Factor (CNTF) has been demonstrated in multiple preclinical models to enhance survival and regeneration of retinal ganglion cells, the retinal neurons injured in diseases like ischemic optic neuropathy/optic nerve stroke. We hypothesize that CNTF delivery to the human eye will provide neuroprotection (prevent loss of vision) and neuroenhancement (improve vision indices) in ischemic optic neuropathy. Patients in the trial will receive an NT-501 CNTF implant (made by Neurotech) into one eye, and will be carefully followed to evaluate safety and efficacy.


Eligibility criteria: Inclusion Criteria:

* age 40 years or older
* must understand and sign the informed consent
* must be medically able to undergo ophthalmic surgery for the NT-501 device insertion and possible removal, as well as the testing required.
* diagnosis of ischemic optic neuropathy characterized by (a) non-arteritic subtype, including a normal ESR and CRP; (b) syndrome of acute unilateral visual loss with documented optic nerve head edema but without significant pain; (c) a relative afferent papillary defect in the affected eye, and a decrease of best-corrected visual acuity to 20/40 or worse in the affected eye, and detectable loss on visual field testing consistent with nerve fiber visual field defect but retaining measurable residual visual field preservation.

Exclusion Criteria:

* other corneal, lens, optic nerve or retinal disease causing vision loss,
* blind in one eye
* requirement of acyclovir and/or related products during study
* receiving systemic steroids or other immunosuppressive medications.
* pregnant or lactating.
* considered immunodeficient or has a known history of human immunodeficiency virus (HIV)
* on chemotherapy, or a history of malignancy, UNLESS it was treated successfully 2 years prior to inclusion in the trial.

Primary outcomes:
measure: Safety: Number of patients with adverse events
timeFrame: 18 months
Secondary outcomes:
measure: Functional Efficacy: Vision, Visual Field, Pattern Electroretinogram, Visual Field Questionnaire-25
timeFrame: 18 months
measure: Structural efficacy: Nerve fiber layer, optic nerve topography
timeFrame: 18 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: Bascom Palmer Eye Institute, University of Miami Miller School of Medicine
state: Florida
Study officials:
References:
Clinical trial NCT03447457: Early Initiation of High-flow Nasal Cannula Oxygen Therapy in Patients With Acute Respiratory Failure in the Emergency Department: A Before-after Study
Official title: Early Initiation of High-flow Nasal Cannula Oxygen Therapy in Patients With Acute Respiratory Failure in the Emergency Department: A Before-after Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Failure
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier de Niort
First posted: 2018-02-27
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: FLORAL-ER is a before/after study
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study is to compare the efficiency on respiratory failure regression of high-flow nasal oxygen therapy versus standard oxygen in patients admitted to the ED for de novo acute respiratory failure.

Detailed description: Prospective observational before-after study at the ED in two French centers.

Selection of patients with acute hypoxemic respiratory failure at the ED.

Application of oxygen strategy according to the period:

* before period: standard oxygen delivered through nasal cannula, face mask or non-rebreathing reservoir mask, with a flow rate adjusted to maintain a pulse oxymetry of at least 92%.
* after period: high-flow oxygen therapy continuously applied via large-bore nasal prongs with a gas flow rate of 50 L/min and a FiO2 adjusted to maintain a pulse oxymetry at least 92%.

Eligibility criteria: Inclusion Criteria:

* de novo acute respiratory failure cowith the following criteria: a respiratory rate \> 25 b/min, or signs of increased work of breathing.

Main exclusion Criteria:

* cardiogenic pulmonary edema,
* acute exacerbation of chronic lung disease, respiratory acidosis (pH \< 7.35 and PaCO2 \> 50 mm Hg),
* hemodynamic instability
* Glasgow Coma Scale score of 12 points or less,
* an urgent need for endotracheal intubation,

Primary outcomes:
measure: complete regression of respiratory failure
timeFrame: one hour after initiation of oxygen strategies
Secondary outcomes:
Other outcomes:
Locations:
city: Niort
country: France
facility: CHG de Niort
city: Poitiers
country: France
facility: CHU Poitiers
Study officials:
affiliation: Centre Hospitalier de Niort
name: Jean MACE, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02186457: Antibiotic Irrigation for Pancreatoduodenectomy
Official title: Routine Antibiotic Irrigation in Patients Undergoing Pancreatoduodenectomy to Reduce Infection and Fistula Rates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Infection
Keywords: Pancreatoduodenectomy
Whipple
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2014-07-10
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if the routine use of antibiotic irrigation during pancreas surgery (Whipple procedure) will decrease superficial and organ space infections.

Detailed description: The primary aim of this study is to test the efficacy of routine antibiotic irrigation in reducing superficial and organ space infections among patients undergoing pancreatoduodenectomy.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age and older;
* Open pancreatoduodenectomy for any diagnosis

Exclusion Criteria:

* Pregnant;
* Prisoners;
* Patients undergoing concomitant colectomy;
* Antibiotic allergy to study medication;
* Serum creatinine \> 2.0;
* Unable to provide informed consent

Primary outcomes:
measure: The Number of Patients With Infections
timeFrame: 30 Days
Secondary outcomes:
measure: The Number of Patients With Fistulas
timeFrame: 5 Days
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University
name: Michael House, MD
role: PRINCIPAL_INVESTIGATOR
References: