louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01654055: International Prospective Study on Morphine-induced Adverse Drug Reactions in Emergency Departments.
Official title: International Multicentre Prospective Study on Morphine-induced Adverse Drug Reactions in Emergency Departments: Description and Predictive Factors.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergencies
Keywords: Morphine
Adverse events
Predictive factors
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2012-07-31
Enrollment: 1128
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: Patients aged 18 years or older who require treatment with morphine for pain control

Brief summary: Morphine is the gold standard for treatment of severe acute pain but it has a number of adverse effects.

No study has so far managed to identify the morphine-induced adverse drug reactions. The primary objective of this study is to determine predictive factors of morphine-induced adverse drug reaction when it is used in emergency departments.

Detailed description: We want to study a large cohort of morphine-induced adverse drug reactions patients, the consequences for patients, mainly in terms of severity, and predictive criteria. This will allow us to identify some patients most at risk of morphine-induced adverse drug reactions, and thus to adapt morphine titration and monitoring of these patients. Leading to a better understanding and a better prediction of adverse effects in patients, it is possible that part of the "opiophobia" which persists in emergency services disappear. Finally, it is toward a better security but also a better efficiency in the management of pain patients in emergencies that leads this study.

The secondary objectives are:

To determine the frequency and severity of adverse events related to morphine. To establish an inventory of morphine use in emergency departments in the different centres studied.

Eligibility criteria: Inclusion Criteria:

All patients aged 18 years or older who require treatment with morphine for pain control will be considered for entry into the study.

Conscious without life threatening at the inclusion

Exclusion Criteria:

Patients who receive morphine during or after an orotracheal intubation, altered level of consciousness, inability to give consent or refusal of patient.

Primary outcomes:
measure: Occurrence of morphine related adverse-event
timeFrame: From the administration of morphine until 6 hours after this first administration
Secondary outcomes:
measure: Description of adverse effects caused by morphine
timeFrame: For each side effects of morphine from the first administration of morphine until 6 hours after.
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital Toulouse
state: Midi-Pyrénées
Study officials:
name: Vincent Bounes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02600455: Use-Results Survey for ORENCIA® Subcutaneous Injection 125mg Syringe 1mL
Official title: Outline of Use-Results Survey for ORENCIA® Subcutaneous Injection 125mg Syringe 1mL
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2015-11-09
Enrollment: 505
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: Patients who are treated with ORENCIA according to the approved indications, and dosage and administration.

Brief summary: The purpose of this study to collect information on the safety, especially localized injection site reactions, and efficacy of ORENCIA Subcutaneous Injection 125mg Syringe 1mL in patients with rheumatoid arthritis.


Eligibility criteria: Inclusion Criteria:

* Patients who are beginning to receive the treatment with ORENCIA Subcutaneous Injection 125mg Syringe 1mL under the approved indications, dosage, and administration

Primary outcomes:
measure: Safety measured by number of Adverse events and laboratory abnormalities associated with adverse events
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shinjuku-ku
country: Japan
facility: Local Institution
state: Tokyo
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT02699255: Ventricular Arrhythmias After Pulmonary Vein Isolation
Official title: A Single-center Observational Study to Examine the Occurrence of Ventricular Arrhythmias After Pulmonary Vein Isolation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventricular Arrhythmias
Atrial Fibrillation
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2016-03-04
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with paroxysmal atrial fibrillation scheduled to undergo pulmonary vein isolation

Brief summary: The investigators study aimed to observe the occurrence of new premature ventricular complexes and other ventricular arrhythmias after pulmonary vein isolation.

Detailed description: Atrial fibrillation is the most common arrhythmia with a lifetime risk for development of over 20%. Pulmonary vein isolation is now established as therapy of choice for patients with symptomatic atrial fibrillation. It is well known that this interventional therapy inevitably modulates the intracardiac autonomic nervous system. While this ablation might alter atrial electrophysiology beneficially, the impact on ventricular electrophysiology remains unclear.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Paroxysmal atrial fibrillation scheduled to undergo pulmonary vein isolation

Exclusion Criteria:

* Age \< 18 years
* Persistent atrial fibrillation
* Life expectancy less than 12 months
* Acute myocardial infarction, coronary artery bypass graft surgery, open heart surgery, or percutaneous transluminal coronary angioplasty within less than 3 months prior to inclusion
* Documentation of \>30 premature ventricular complexes per hour, salvos or ventricular tachycardias prior to atrial fibrillation ablation

Primary outcomes:
measure: Ventricular arrhythmias
timeFrame: one year
Secondary outcomes:
measure: Arrhythmia recurrence
timeFrame: one year
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Department of Cardiology - Electrophysiology, University Heart Centre, University Hospital Hamburg-Eppendorf
Study officials:
affiliation: Department of Cardiology - Electrophysiology, University Heart Centre
name: Christian Meyer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05057455: Effectiveness of the Cytokine Hemadsorption on Sepsis
Official title: Effectiveness of the Cytokine Hemadsorption on the Clinical Progression and Mortality of Intensive Care Patients With Sepsis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Interleukin-6
Lead sponsor: Biruni University
Sponsor class: OTHER
First posted: 2021-09-27
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In this one-centered study, we prospectively analyzed the outcomes and laboratory findings of 39 patients diagnosed with sepsis from 01 Jan 2020 to 30 December 2020 hospitalized in ICU.

Brief summary: In this prospective study, we aimed to compare the laboratory and clinical results of cytokine hemadsorption as an immunomodulation therapy in ICU patients diagnosed with sepsis or septic shock.


Eligibility criteria: Inclusion Criteria:

* the patients were the available data of clinical and laboratory diagnosis of sepsis and septic shock
* detection of gram-negative bacterial agent in blood or sputum culture.
* patients who had the shock symptoms such as hypotension, tachycardia or fever during the course of sepsis.

Exclusion Criteria:

* had uncontrolled hemorrhage,
* diagnosed with cardiac failure at stage 4 or renal failure at stage 4 or hepatic liver failure at stage 4
* cancer at the end stage or admitted with acute coronary syndrome.

Primary outcomes:
measure: IL-6
timeFrame: 1 YEARS
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Ilke Kupeli
Study officials:
References:
citation: Bahar I, Oksuz H, Senoglu N, Demirkiran H, Aydogan M, Tomak Y, Comez M, Bayrakci S, Gonullu E, Berktas M. Compliance With the Surviving Sepsis Campaign Bundle: A Multicenter Study From Turkey. Cureus. 2021 May 12;13(5):e14989. doi: 10.7759/cureus.14989.
citation: Houschyar KS, Pyles MN, Rein S, Nietzschmann I, Duscher D, Maan ZN, Weissenberg K, Philipps HM, Strauss C, Reichelt B, Siemers F. Continuous hemoadsorption with a cytokine adsorber during sepsis - a review of the literature. Int J Artif Organs. 2017 May 29;40(5):205-211. doi: 10.5301/ijao.5000591. Epub 2017 May 19.
citation: Ye Q, Wang B, Mao J. The pathogenesis and treatment of the ;Cytokine Storm' in COVID-19. J Infect. 2020 Jun;80(6):607-613. doi: 10.1016/j.jinf.2020.03.037. Epub 2020 Apr 10.
citation: Bonavia A, Groff A, Karamchandani K, Singbartl K. Clinical Utility of Extracorporeal Cytokine Hemoadsorption Therapy: A Literature Review. Blood Purif. 2018;46(4):337-349. doi: 10.1159/000492379. Epub 2018 Sep 3.
Clinical trial NCT05646355: Flatbush FHC Proactive Colorectal Cancer Screening and Navigation
Official title: Colorectal Cancer Screening Through Proactive Outreach and Navigation in a Federally Qualified Health Care Center in Brooklyn
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-12-12
Enrollment: 109
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The proposed study is a randomized controlled pilot trial designed to assess the effectiveness and acceptability of a proactive screening outreach program on colorectal cancer screening rates on eligible patients in the Flatbush Family Health Center medical practice.

Detailed description: The proposed study is a randomized controlled pilot trial designed to assess the effectiveness and acceptability of a proactive screening outreach program on colorectal cancer screening rates on eligible patients in the Flatbush Family Health Center medical practice, which provides free and subsidized health services to underrepresented minorities. The investigators will randomize patients to the proactive screening outreach arm which will include mailed letters providing patients with information regarding their eligibility for and instructions for performing colorectal cancer screening with FIT testing or colonoscopy. Colorectal cancer screening rates via FIT testing or colonoscopy will be compared in the proactive outreach group and the usual care group. The investigators hypothesize that rates of colorectal cancer screening will improve in underserved populations with the implementation of a proactive approach that incorporates a mailed outreach invitation to screen, followed by active assistance to a colonoscopy completion if preferred or indicated.

Eligibility criteria: Inclusion Criteria:

* Receiving medical care at Flatbush FHC
* Due or overdue for CRC screening

Exclusion Criteria:

* Age younger than 45 years old or greater than 75 years old
* Up-to-date with colorectal cancer screening (FIT within 1 year or colonoscopy within 10 years)
* History of colorectal cancer, inflammatory bowel disease or colorectal polyps
* No address or phone number on file
* FIT test ordered within 6 months

Primary outcomes:
measure: Number of Participants Who Complete Initial Fecal Immunochemical Test (FIT) at 6 Months
timeFrame: Up to Month 6
measure: Number of Participants Who Completed Colonoscopy at 6 Months
timeFrame: Up to Month 6
Secondary outcomes:
measure: Number of Participants With Positive FIT Test Who Complete Colonoscopy at 6 Months
timeFrame: Up to Month 6
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: NYU Brooklyn Family Health Centers
state: New York
Study officials:
affiliation: NYU Langone Health
name: Aasma Shaukat
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01771055: Direct Peritoneal Resuscitation Effects in the Damage Control Patient
Official title: Direct Peritoneal Resuscitation Effects in the Damage Control Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Injury
Keywords: Trauma
Hypovolemia
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2013-01-18
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Galactose versus standard care
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find if direct peritoneal resuscitation helps blood flow through important organs in a person's body after they have had a traumatic injury with massive blood loss. Sometimes after severe injuries requiring operation, surgeons cannot close the muscles and skin of a patient's belly, because of swelling. This study will also try to find if direct peritoneal resuscitation decreases tissue swelling and allows for quicker closure of of a patient's belly.

Detailed description: Standard methods of controlling bleeding and increasing blood flow to vital organs will be used. These methods include giving blood and fluids and surgically repairing the vessels that are causing the bleeding which are standard ways physicians treat injuries with massive blood loss. A drain (a small plastic tube) will be placed inside the belly.

Subjects will randomly (like flipping a coin) be placed into a group of patients who either get a sugar solution dripped into the belly after surgery or do not get this treatment. The drain will be used to drip a high glucose solution into the abdomen in patients be part of that group. The fluid will continue to be dripped into the belly until it is possible to close the skin and underlying layers.

Eligibility criteria: Inclusion Criteria:

* All trauma patients age 18 years or greater with massive blood loss
* Patients requiring a damage control procedure
* Traumatic injury within the last 24 hours

Exclusion Criteria:

* Patients who are pregnant
* Less than 18 years of age
* Known chronic renal disease
* Moribund

Primary outcomes:
measure: Number of Participants With Morbidity
timeFrame: 1 Month
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville Hospital
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Jason Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04924855: Immunity After COVID-19 Vaccination
Official title: Estimation of Dynamics of Humoral Immunity in COVID-19 Vaccined Health Care Workers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tunis Military Hospital Staff Vaccinated Against Covid 19
Lead sponsor: General Administration of Military Health, Tunisia
Sponsor class: NETWORK
First posted: 2021-06-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: military health personnel vaccinated at tunis military hospital

Brief summary: The purpose of the research is to evaluate kinetic after vaccination to the COVID-19 coronavirus by measurements of specific and neutralizant antibodies for spike antigenic sequences .

This work will allow us to follow the efficacy and tolerance of the vaccine over a year, to evaluate the antibody profile, their kinetics, the fraction of neutralising antibodies and will also allow us to understand the attitudes to be taken to ensure the best protection for our staff

Detailed description: Our objective is to follow the hospital staff after vaccination, for this we will include two groups of participants:

G1: vaccinated staff who did not contract the virus (at the date of vaccination) and who had a serology \<0 at least at D7 of the date of vaccination dose 1 (known serological value) G2: vaccinated personnel who have contracted the virus with a PCR + and who have positive serology at least at D7 of the date of vaccination (known serological value)

Eligibility criteria: Inclusion Criteria:

RB-approved informed consent, age 18 years or older, male or female, anyone considering COVID-19 vaccination or anyone that has received COVID-19 vaccination.

Subjects can enroll at anytime after vaccination even though they may not have enrolled before vaccination.

Sampling Frequency and timing: Up to 8 total samples in 12 months -

Exclusion Criteria:

Exclusion: Failure to provide informed consent

-

Primary outcomes:
measure: Vaccine effectiveness
timeFrame: 1 year
measure: Vaccine effectiveness
timeFrame: 1 year
Secondary outcomes:
measure: the tolerance of the vaccine
timeFrame: 1 year
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: HMPIT vaccination committee
state: Please Select...
Study officials:
References:
Clinical trial NCT03017755: Scoliosis Survey to Development Treatment Decision Tool
Official title: Your Scoliosis Journey: a Survey for Patients Treated for Scoliosis and Their Families
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Scoliosis; Adolescence
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-01-11
Enrollment: 5000
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolecent Idiopathic Scoliosis (AIS) patients and their families

Brief summary: This is a survey to help understand the influences related to the decision for Adolescent Idiopathic Scoliosis treatment (observation vs. bracing vs. surgery). The investigator then plans to create a decision aid to help families when making a decision about the treatment choice being presented to them.

Detailed description: This survey is designed to help understand the factors that families consider to help make treatment decisions related to Adolescent Idiopathic Scoliosis (AIS). The surveys will then be used to help create a shared decision making tool to help families better understand the treatment options and optimize clinical conversations surrounding AIS treatment.

Eligibility criteria: Inclusion Criteria:

* Subject (and/or parent of subject) who has previously been treated for Adolescent Idiopathic Scoliosis (AIS)

Exclusion Criteria:

* Age less than or equal to 12 years

Primary outcomes:
measure: Number of subjects who completed the survey
timeFrame: Baseline, approximately 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Todd A Milbrandt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05097755: The Time Delay Correlated With LV Functions and Heart Failure Incidence in STEMI?!
Official title: In Non-diabetic Patients With STEMI Treated With Primary PCI: is the Time Delay Correlated With LV Functions and Heart Failure Incidence?!
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myocardial Infarction
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-10-28
Enrollment: 345
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * All patients will be subjected to:
* Calculation of time from the first medical contact to time of primary PCI.

  * Full history taking: including age, sex, history of HTN, Smoking, dyslipidemia, IHD

Brief summary: To find out if the time delays between the first medical contacts till the device has an impact on LV functions estimated by transthoracic Echocardiography and if it's correlated to heart failure incidence in non-diabetic patients with STEMI treated with primary PCI


Eligibility criteria: Inclusion Criteria:

* Subjects with anterior STEMI according to ESC guidelines 2017.
* Subjects undergoing PPCI for the first time .
* Non diabetic patients.

Exclusion Criteria:

* • Patients with previous PCI.

  * Patients with previous CABG.
  * Patients with TIMI flow II or less .
  * Cardiogenic shock.

Primary outcomes:
measure: to what extent could the time be relevant to the incidence of Heart failure
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00116155: Trial of IV Injection of CV787 in Hormone Refractory Metastatic Prostate Cancer
Official title: A Phase I/II Dose Finding Trial of the Intravenous Injection of CV787, a Prostate-Specific Antigen Cytolytic Adenovirus, in Patients With Hormone Refractory Metastatic Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Keywords: Hormone Refractory Metastatic Prostate Cancer
Lead sponsor: Cell Genesys
Sponsor class: INDUSTRY
First posted: 2005-06-28
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multi-center, open-label, dose finding study of CV787 adenovirus in patients with hormone refractory metastatic prostate cancer. Patients will receive treatment intravenously at one of up to nine dose levels, each containing three to six patients.



Primary outcomes:
measure: To determine the safety, tolerability, and the maximum tolerated dose of CG7870 when administered intravenously to patients with progressive metastatic hormone refractory prostate cancer
Secondary outcomes:
measure: To evaluate prostate-specific antigen (PSA) response rates, duration of response, and time to disease progression
measure: To evaluate other clinical efficacy responses observed
measure: To evaluate the systemic pharmacokinetics of CG7870 after intravenous administration
measure: To monitor the immune response to CG7870
Other outcomes:
Locations:
Study officials:
References: