louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00575549: Prospective Analysis and Comparison of Stress Echo to Real-Time Myocardial Contrast Stress Echo
Official title: Prospective Analysis and Comparison of Conventional Stress Echocardiograms and Real-Time Myocardial Contrast Stress Echocardiogram; for Bristol-Myers Squibb Medical Imaging: The Definity RT-P During DSE Database
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Evaluation of Troponin I Levels
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2007-12-18
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of this study is to prospectively analyze and compare conventional stress echocardiograms and real-time myocardial contrast stress echocardiograms; and to determine the effect of contrast agents used during real-time myocardial contrast stress echocardiograms on serum troponin I levels.

Detailed description: To compare two different stress echocardiograms (conventional Stress echocardiograms or Real-time Myocardial Contrast Stress Echocardiograms) that are in routine clinical use. The information, including the digital images that are collected during the stress tests is used to determine if the usse of specialized imaging techniques and ultrasound contrast can better detect blockage in blood flow to the heart and predict how patients outcome may be affected by this detection of a blockage.

Eligibility criteria: Inclusion Criteria:

* Male or female
* Age \> 19 years
* Scheduled for a stress echocardiography
* Are conscious and coherent, and able to communicate effectively with trial personnel
* For troponin evaluation, only hospitalized patients who had a troponin level drawn in the morning of and prior to stress echocardiogram will be included.

Exclusion Criteria:

* Pregnant and breast feeding women are excluded from participation because of the possibility of a bias as CSE is routinely used in pregnant patients secondary to lack of human studies to determine the fetal risk of use of Definity.
* Age \< 19 years old
* Known or suspected hypersensitivity to ultrasound contrast agents or other drugs used for the study
* Possibility that potential subject may be pregnant
* Studies where RT-MCE was specifically requested by the ordering physician

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Thomas R Porter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05767749: Split Face Study of the Duration of Local Anesthetics
Official title: Characterizing and Comparing the Duration of Local Anesthetic in Dermatologic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthetics, Local
Keywords: Anesthesia
Mohs
lidocaine
ropivacaine
bupivacaine
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2023-03-14
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a research study to compare how long injectable pain medications (anesthetics) commonly used in dermatologic surgery are effective for. This study will compare a short-acting anesthetic, lidocaine with epinephrine, to one of two long-acting anesthetics (ropivacaine or bupivacaine). This study will also directly compare the duration of actions of ropivacaine and bupivacaine. The investigators hypothesize that the duration of anesthesia of short-acting anesthetics will not differ significantly from long-acting anesthetics at a single site and there will not be a significant difference between the two long-acting anesthetics at a single site.

Detailed description: This study will compare the relative durations of local anesthetics within the same subject at a highly vascularized anatomic region of skin, the nasal ala. This study will test and compare the relative durations and efficacy of commonly used long acting (ropivacaine or bupivacaine) and short acting local anesthetics (lidocaine with epinephrine), delivered via local anesthesia. This study will use a modification of a previously published approach of non-invasive pinprick testing to assess the duration of local anesthetic.

Eligibility criteria: Inclusion Criteria:

* Male or female ≥ 18 years of age
* Normal skin sensation at both nasal ala assessed by pinprick
* Ability to provide informed consent

Exclusion Criteria:

* Previous adverse reaction to local anesthetic or any components of the local anesthetics being evaluated
* Pregnant or breastfeeding volunteers (assessed by self-report)
* Patients taking monoamineoxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types

Primary outcomes:
measure: Time to Return to Baseline Sensation, as Determined by Binary Outcomes (Yes/no) in 15 Minute Increments
timeFrame: Up to 4 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Kira Minkis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03959449: Action Observation and Motor Imagery Induced Hypoalgesia in Asymptomatic Subjects
Official title: Action Observation and Motor Imagery Induced Hypoalgesia in Asymptomatic Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Exercise
Keywords: Motor imagery
Action observation
Hypoalgesia
Lead sponsor: Universidad Autonoma de Madrid
Sponsor class: OTHER
First posted: 2019-05-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the influence of motor imagery and the observation of actions on pain perception. Participants in this study are asymptomatic subjects who will perform an IM and AO protocol of an aerobic exercise.

Detailed description: Motor Imagery (MI) is defined as a dynamic mental process that involves the representation of an action, in an internal way, without its actual motor execution. The Action Observation (AO) evokes an internal, real-time motor simulation of the movements that the observer is perceiving visually. Both mental processes trigger the activation of the neurocognitive mechanisms that underlie the planning and execution of voluntary movements in a manner that resembles how the action is performed in a real manner. The phenomenon of exercise-induced hypoalgesia is well known. This is why it has been suggested that these techniques could produce pain modulation similar to that produced by real exercise.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 60
* Healthy and with no pain subjects

Exclusion Criteria:

* Any cognitive impairment that hindered viewing of audiovisual material.
* Difficulty understanding or communicating.
* Presence of systemic pathology, Central Nervous System or rheumatic disease.
* Inadequate understanding of the Spanish language to follow instructions for measuring and treatment.
* Collaboration of pregnant women.
* Underage subjects
* Subjects with pain at the time of the study.

Primary outcomes:
measure: Pain pressure threshold
timeFrame: Change from baseline and immediately post-intervention
Secondary outcomes:
measure: Visual and Kinesthetic Motor Imagery Ability
timeFrame: Immediately before the intervention
measure: The degree of physical activity
timeFrame: Immediately before the intervention
measure: Kinesiophobia
timeFrame: Immediately before the intervention
measure: Electrodermal Activity
timeFrame: Change in electrodermal activity after 5 minutes post-intervention
measure: Respiration Rate
timeFrame: Change in electrodermal activity after 5 minutes post-intervention
measure: Respiration Rate
timeFrame: Change in electrodermal activity after 5 minutes post-intervention
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: CSEU La Salle
Study officials:
References:
Clinical trial NCT03076749: Predictive Models for Betalactam Allergy
Official title: Designing Predictive Models for Betalactam Allergy Using the Drug Allergy and Hypersensitivity Database®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Drug Hypersensitivity
Keywords: Betalactam
Decision tree
Drug hypersensitivity
Logistic regression
Predictive modelling
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2017-03-10
Enrollment: 1200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients seen in consultation in allergology department for suspicion of allergy to beta lactamines

Brief summary: Background: ß-lactam (BL) antibiotics represent the main cause of allergic reactions to drugs, inducing both immediate and non-immediate reactions. The diagnosis is well established, usually based upon skin tests and drug provocation tests, but cumbersome.

Objectives: To design predictive models for the diagnosis of BL allergy, based on the clinical history of patients with suspicions of allergic reactions to BL.

Methods: The study included a retrospective phase in which records of patients consulting and explored for a suspicion of BL allergy (in the Allergy Unit of the University Hospital of Montpellier between September 1996 and September 2012) where used to construct predictive models; a prospective phase, in which we performed an external validation of the chosen models, in patients with suspicion of BL allergy recruited from 3 allergy centres (Montpellier, Nîmes, Narbonne), between March and November 2013. Data related to clinical history and allergy work-up results were retrieved and analysed. Logistic regression and decision tree method were used to design two models to predict the diagnosis of allergy to BL.


Eligibility criteria: Inclusion Criteria:

* Patients seen in consultation in allergology department for suspicion of allergy to beta lactamines

Exclusion Criteria:

* patient refusal to take part in the study
* pregnancy
* breast feeding women
* contraindication to provocation test

Primary outcomes:
measure: Provocation test
timeFrame: 18 months
Secondary outcomes:
measure: Questionnaire SF36
timeFrame: 18 months
measure: Questionnaire ENDA
timeFrame: 18 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02880306: Hepatocellular Carcinoma and Rheumatoid Arthritis
Official title: Hepatocellular Carcinoma and Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Hepatocellular
Lead sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Sponsor class: OTHER
First posted: 2016-08-26
Enrollment: 741379
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All individuals were enrolled prospectively in Taiwan's national health insurance between Jan 1, 1999, and June 30, 2009, and had follow-up data until Dec 31, 2009

Brief summary: Rheumatoid arthritis(RA) is a disorder with altered immunologic function and increased risk of developing malignancies, while studies examining the association between hepatocellular carcinoma (HCC) and RA remain lacking. The investigators aimed to investigate the risk of HCC between participants with and without RA.

Detailed description: The investigators did a retrospective, observational, nested case-control study in a cohort that was previously recruited from a population-based RA survey. All participants were enrolled prospectively in Taiwan's national health insurance between Jan 1, 1999, and June 30, 2009, and had follow-up data until Dec 31, 2009. RA was diagnosed based on the 1987 American College of Rheumatology diagnostic criteria. The investigators matched RA and non-RA subjects by propensity score in a 1:1 ratio. The primary outcome was the risk of developing HCC. Cox proportional hazards regression was applied to estimate the hazard ratio (HR) and 95% confidence interval (CI) of HCC for RA and non-RA cohort.

Eligibility criteria: Inclusion Criteria:

* subjects were required to have ≥2 RA diagnosis (International Classification of Diseases, Ninth Revision \[ICD-9-CM\]-codes 714.0x), and to be ≥18 years of age on the date of first diagnosis. And inclusion in the Registry for Catastrophic Illness Patient Database (RCIPD)

Exclusion Criteria:

* who were diagnosed with RA only once during the study interval, \<18 years of age when first diagnosed with RA, first diagnosed with RA after July 1, 2009, or not registered in the RCIPD were excluded

Primary outcomes:
measure: the risk of developing hepatocellular carcinoma
timeFrame: between Jan 1, 1999 and Dec 31, 2009
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Hsu CS, Lang HC, Huang KY, Chao YC, Chen CL. Risks of hepatocellular carcinoma and cirrhosis-associated complications in patients with rheumatoid arthritis: a 10-year population-based cohort study in Taiwan. Hepatol Int. 2018 Nov;12(6):531-543. doi: 10.1007/s12072-018-9905-7. Epub 2018 Nov 14.
Clinical trial NCT05112406: Early Diagnostic Biomarkers of Sepsis
Official title: A Comparison Between CRP, Ferritin and Serum Zinc as Early Diagnostic Biomarkers of Sepsis in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critically Ill
Sepsis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-11-08
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients above 18 years old with systemic infection that may lead to sepsis.

Brief summary: A Comparison between CRP, ferritin, and serum zinc as early diagnostic biomarkers of sepsis in critically ill patients


Eligibility criteria: Inclusion Criteria:

* All patients with chest infection and UTI.

Exclusion Criteria:

* children

Primary outcomes:
measure: Study of some biomarkers as indicators of sepsis.
timeFrame: about 2 years
measure: Study of some biomarkers as indicators of sepsis.
timeFrame: about 2 years
measure: Study of some biomarkers as indicators of sepsis.
timeFrame: about 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00375206: A Safety and Immunology Study of a DNA Trivalent Influenza Vaccine
Official title: A Phase I Study to Assess Safety, Tolerability and Immunogenicity of a Trivalent Influenza Vaccine Administered by Particle Mediated Epidermal Delivery (PMED) to Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Influenza
Keywords: PowderMed, DNA vaccine, influenza
Lead sponsor: PowderMed
Sponsor class: INDUSTRY
First posted: 2006-09-12
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate how well the vaccine is tolerated at sites where administrations are given and any effects it may have on subjects' wellbeing. The study will also test the ability of vaccine to cause particular immune responses in the body.

Detailed description: Influenza is a contagious disease of the upper airways and the lungs. It rapidly spreads around the world in seasonal epidemics, killing hundreds of thousands of people and having high economic consequences due to healthcare costs and lost productivity. Each year governments recommend groups who are at risk of influenza or its complications to receive influenza vaccination. Current vaccine supply is not sufficient to meet the demand if this recommendation were to be taken up by all. This study is part of the clinical development of a particle mediated epidermal delivery (PMED) trivalent DNA vaccine for the prevention of influenza.This study will investigate the safety and tolerability of this vaccine as well as assess the humoral and cellular immunogenicity of the vaccine in healthy subjects.

Eligibility criteria: Ages Eligible for Study:

* 18 Years - 50 Years
* Genders Eligible for Study: Both
* Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

* Healthy adult volunteers (women must be of non child-bearing potential)
* Provided written informed consent

Exclusion Criteria:

* No significant concomitant illness
* No allergy to gold
* No immunosuppression due to disease or treatment
* No previous flu vaccination in 2005 or 2006

Primary outcomes:
measure: Safety, tolerability and local reactogenicity - AEs and laboratory parameters
Secondary outcomes:
measure: Immunogenicity of the vaccine
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: Quintiles Lenexa (QLX)
state: Kansas
city: Springfield
country: United States
facility: Biokinetic
state: Missouri
Study officials:
affiliation: Quintiles, Inc.
name: Philip Leese, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05325606: Registry-based Stroke in Tunisia
Official title: Registry-based Stroke Research in Tunisia: Multicenter Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke, Ischemic
Strokes Thrombotic
Stroke
Keywords: stroke
thrombolysis
Tunisia
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with stroke symptoms and accept to enroll the study .

Brief summary: Study the prevalence of strokes in the emergency department (ED) and their possible eligibility for thrombolysis.

Detailed description: The diagnosis and management of strokes represent a great emergency that requires multidisciplinary teams and an organization of the care chain from the collection of patients at the site of the stroke to follow-up care.

That is why it is necessary to identify the prevalence of stroke in the ED in Tunisia and to evaluate their eligibility for thrombolysis.

Eligibility criteria: Inclusion Criteria:

* All patients with stroke symptoms.

Exclusion Criteria:

* Refusal of inclusion

Primary outcomes:
measure: Stroke prevalence
timeFrame: 1day
measure: Modified Rankin Scale (MRS) score change
timeFrame: After a month , six month , 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Nouira Semir
Study officials:
affiliation: University of Monastir
name: Nouira Semir, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05820906: Cadonilimab Plus Regorafenib and Gem-Cis Chemotherapy in Advanced Biliary Tract Cancer
Official title: Cadonilimab Plus Regorafenib and Gem-Cis Chemotherapy in Advanced Biliary Tract Cancer: A Single Center, Single Arm, Phase II Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Advanced Biliary Tract Cancer
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2023-04-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of Cadonilimab in combination with Regorafenib and Gem-Cis chemotherapy in advanced biliary tract Cancer


Eligibility criteria: Main Inclusion Criteria:

1. subjects with a histopathological or cytologically diagnosis of BTC
2. The participants must be required to sign an informed consent
3. At least one measurable lesion (RECIST 1.1)
4. No previous systematic treatment for BTC
5. Child-Pugh Score, Class A
6. ECOG performance status 0 or 1
7. Adequate organ function
8. Life expectancy of at least 3 months

Exclusion Criteria:

1. Diagnosis of mixed ampullary, hepatocellular and cholangiocarcinoma
2. Known history of serious allergy to any monoclonal antibody
3. Known central nervous system metastases and/or leptomeningeal disease prior to treatment
4. Portal hypertension with esophageal or gastric varices within 6 months prior to initiation of treatment
5. Any bleeding or thrombotic disorder within 6 months prior to initiation of treatment
6. Any active malignancy prior to the start of treatment
7. Active or history of autoimmune disease
8. Other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation
9. Pregnant or lactating women

Primary outcomes:
measure: Overall response rate ( ORR) per RECIST 1.1
timeFrame: Up to 1 year
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: Up to two years
measure: Progress Free Survival (PFS)
timeFrame: Up to two years
measure: Adverse Events (AEs)
timeFrame: Up to two years
measure: Disease control rate (DCR) per RECIST 1.1
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Cancer Hospital Airport Hospital
state: Tianjin
Study officials:
References: