louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03749694: Investigating Temporal Improvements in Survival Following ST-elevation Myocardial Infarction.
Official title: Investigating Temporal Improvements in Survival Following ST-elevation Myocardial Infarction: A Causal Mediation Analysis Using the Myocardial Ischaemia National Audit Project, 2004-2013.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction
Keywords: Acute Myocardial Infarction
mortality
evidence-based care
Myocardial Ischaemia National Audit Project
ST-elevation myocardial infarction
Lead sponsor: University of Leeds
Sponsor class: OTHER
First posted: 2018-11-21
Enrollment: 232353
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 population comprised of 232,353 in hospital survivors of ST-elevation myocardial infarction recorded in the Myocardial Ischaemia National Audit Project registry between 2004 and June 2013.

Brief summary: The aim of the study was to use data from the Myocardial Ischaemia National Audit Project (MINAP) to investigate whether temporal improvements in survival were associated with changes in patients' baseline clinical risk or use of guideline-indicated treatments for the management of STEMI, and to determine the extent to which associations explained the temporal improvements in survival.


Eligibility criteria: Inclusion Criteria:

* aged 18 years or more
* patients hospitalised with ST-elevation myocardial infarction

Exclusion Criteria:

* patients hospitalised with phenotypes other than ST-elevation myocardial infarction

Primary outcomes:
measure: All cause mortality
timeFrame: one year
Secondary outcomes:
measure: All cause mortality
timeFrame: six months
Other outcomes:
Locations:
Study officials:
affiliation: University of Leeds
name: Chris P Gale, FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Leeds
name: Tatendashe B Dondo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Leeds
name: Marlous Hall, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dondo TB, Hall M, Munyombwe T, Wilkinson C, Yadegarfar ME, Timmis A, Batin PD, Jernberg T, Fox KA, Gale CP. A nationwide causal mediation analysis of survival following ST-elevation myocardial infarction. Heart. 2020 May;106(10):765-771. doi: 10.1136/heartjnl-2019-315760. Epub 2019 Nov 15.
Clinical trial NCT02162394: A Study to Determine the Feasibility of Wireless Electrocardiography
Official title: Study to Determine the Feasibility of Wireless Electrocardiography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Premature Atrial and Ventricular Beats
Conduction Defects
Normal Sinus Rhythm
Lead sponsor: Peerbridge Health, Inc
Sponsor class: INDUSTRY
First posted: 2014-06-12
Enrollment: 14
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: Subjects referred for 24 hour Holter monitoring

Brief summary: The investigators are conducting a prospective, observational study to examine the ECG waveforms captured by the new medical device as compared to a traditional Holter monitor for subsequent use in visual diagnoses of atrial and ventricular arrhythmias as well as cardiac impulse and/or conduction disorders by qualified clinicians.

The hypothesis is that this new medical device prototype is non-inferior to traditional Holter monitoring for capturing ECG waveforms that can be visually assessed for atrial and ventricular arrhythmias as well as disorders of cardiac impulse formation and/or conduction.


Eligibility criteria: Inclusion Criteria:

* Patients must be at least 18 years of age
* Patients must have a medical indication to wear a Holter monitor
* Patients must not be pregnant
* Patients must be able to comply with the study procedures
* Patients must be willing to participate and able to provide informed consent
* Patients must be willing to wear both devices (Holter and the wireless device prototype) simultaneously and continuously for a 2 to 3 hr period

Exclusion Criteria:

* Patients who are not able or willing to comply with study procedures
* Patients with an existing implanted cardioverter-defibrillator and/or pacemaker
* Patients with a known life threatening arrhythmia
* Patients who manifest low voltage on their electrocardiogram
* Patients affected by inflammatory and/or infectious skin disorders

Primary outcomes:
measure: Percent of 8 second ECG strips of sufficient quality for visual diagnosis
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
Study officials:
References:
Clinical trial NCT01607294: A Single Center Study to Evaluate the Efficacy and Safety of ETC 1002 in Subjects With Type 2 Diabetes
Official title: A Placebo-Controlled, Randomized, Double-Blind, Parallel Group, Single Center Study to Evaluate the Efficacy and Safety of ETC 1002 in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperlipidemia
Type 2 Diabetes
Lead sponsor: Esperion Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2012-05-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Phase 2 study will asses the LDL-C lowering efficacy of ETC-1002 versus placebo in subjects with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of type 2 diabetes meeting all of the following:
* Minimum 6 month history of diabetes prior to screening visit;
* Fasting C-peptide ≥ 0.8 ng/mL at screening visit;
* HbA1C at screening visit 7-10%;
* Fasting glucose from 140-270 mg/dL on Day -7 following washout of all glucose regulating drugs and supplements.
* BMI at screening visit from 25-35 kg/m2;
* LDL-C at screening ≥ 100 mg/dL

Primary outcomes:
measure: assess the LDL-C lowering efficacy of ETC-1002 versus placebo in subjects with type 2 diabetes
timeFrame: 4 weeks
Secondary outcomes:
measure: assess the effect of ETC-1002 versus placebo on glycemic parameters including fasting plasma and postprandial glucose and insulin
timeFrame: 4 weeks
measure: assess the effect of ETC-1002 versus placebo on measures of insulin sensitivity in subjects with type 2 diabetes
timeFrame: 4 weeks
measure: assess safety using adverse event reports, physical exams, vital signs, ECGs and clinical laboratory parameters
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Miramar
country: United States
state: Florida
Study officials:
References:
citation: Gutierrez MJ, Rosenberg NL, Macdougall DE, Hanselman JC, Margulies JR, Strange P, Milad MA, McBride SJ, Newton RS. Efficacy and safety of ETC-1002, a novel investigational low-density lipoprotein-cholesterol-lowering therapy for the treatment of patients with hypercholesterolemia and type 2 diabetes mellitus. Arterioscler Thromb Vasc Biol. 2014 Mar;34(3):676-83. doi: 10.1161/ATVBAHA.113.302677. Epub 2014 Jan 2.
Clinical trial NCT04186494: Effect of Liraglutide vs CPAP on Cardiometabolic Outcomes in Obstructive Sleep Apnea
Official title: The Benefit of a Liraglutide-based Weight Management Alone or in Addition to Standard CPAP Therapy on Metabolic Function in Patients With Obstructive Sleep Apnoea (OSA) - an Explorative, Proof-of-concept Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Keywords: Liraglutide
Continuous positive airway pressure
Insulin resistance
Vascular inflammation
Lead sponsor: St Vincent's University Hospital, Ireland
Sponsor class: OTHER
Collaborators: name: University College Dublin
name: Health Research Board, Ireland
First posted: 2019-12-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an explorative, proof-of-concept study exploring the potential therapeutic role of a Liraglutide-based weight loss regimen versus standard CPAP or the combination of both on metabolic parameters, blood pressure, endothelial function, coronary artery calcification, vascular inflammation and apnea/hypopnea index in non-diabetic patients with moderate to severe obstructive sleep apnea


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed moderate-severe OSA (by standard PSG)
* Body mass index between 30 - 40
* Age 18 - 60 years
* Able to provide written, informed consent

Exclusion Criteria:

* Pregnancy
* Requirement for supplemental oxygen
* Previous diagnosis of OSA or previous CPAP treatment
* Diagnosis of Diabetes
* Previous treatment with GLP-1 analogue
* Previous surgical treatment for obesity
* Active treatment for malignancy or severe psychiatric disorder
* Acute coronary syndrome or stroke within 3 months prior to study
* History of decompensated heart failure
* Professional drivers or drivers with a history of road-traffic accident due to sleepiness
* Severe excessive daytime sleepiness defined as Epworth sleepiness scale \>15

Primary outcomes:
measure: Insulin resistance
timeFrame: 6 months
Secondary outcomes:
measure: Weight
timeFrame: 6 months
measure: Glucose tolerance
timeFrame: 6 months
measure: OSA Severity
timeFrame: 6 months
measure: Blood pressure
timeFrame: 6 months
measure: Endothelial function
timeFrame: 6 months
measure: Coronary artery calcification
timeFrame: 6 months
measure: Vascular inflammation
timeFrame: 6 months
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: St Vincent's University Hospital
state: Dublin 4
Study officials:
affiliation: St Vincent's University Hospital, University College Dublin
name: Silke Ryan, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02632994: Master Rollover Protocol for Continued Safety Assessment of Study Drug
Official title: Master Rollover Protocol for Continued Safety Assessment of Study Drug
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2015-12-17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: This study is for patients who have participated in a previous study and who continue to receive benefit to have continued access to study drug and/or treatment.


Eligibility criteria: Inclusion Criteria:

* To be eligible patients must be currently receiving benefit in a concluded Lilly study for a compound that has opened an addendum in the continued access protocol.

Exclusion Criteria:

* Patients must not be concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Torrance
country: United States
facility: UCLA Medical Center
state: California
city: Fort Wayne
country: United States
facility: Fort Wayne Oncology & Hematology
state: Indiana
city: Nashville
country: United States
facility: Sarah Cannon Cancer Center
state: Tennessee
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 NCT05711680: INTERFACE: hIv patieNts TracER For clinicAl assistanCe and rEsearch During COVID 19
Official title: INTERFACE: hIv patieNts TracER For clinicAl assistanCe and rEsearch During COVID 19 Epidemic: a Paradigm for Chronic Conditions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV Infections
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-02-03
Enrollment: 2000
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: All PLWHA on antiretroviral therapy will be enrolled in this study.

Brief summary: The health emergency related to the SARS CoV2 pandemic has highlighted the problems of health management of patients at risk of COVID19 and with chronic diseases, suggesting the need for new methods of patient monitoring. Teleconsultation, and telemedicine in general, are applications that allow, at these times when access to hospitals is by definition limited, to monitor patients with chronic conditions who need regular and consistent care and monitoring. People living with HIV/AIDS (PLWHA) represent a paradigm of chronic patients on whom the development of e-health-based remote monitoring could have a significant impact in terms of maintaining an adequate standard of care. For these reasons, in a large teaching hospital we are planning the creation and use of an application to enable remote monitoring of PLWHA by combining the COVID19 prescreening system and chronicity monitoring.


Eligibility criteria: Inclusion criteria:

* Age of patients\>18 years. Patients able to use apps and smart devices without caregivers or, if the patient is unable to use them, patients with caregivers able to use apps and smart devices.
* Able to provide informed consent

Exclusion criteria:

* Patients unable to use smart devices and apps without the presence of caregivers - Recent diagnosis of HIV infection (\<3 months)
* Any unstable clinical condition requiring hospitalization

Primary outcomes:
measure: A new model for patient follow-up
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: ASST degli Ospedali Civili di Brescia
state: BS
city: Genova
country: Italy
facility: 3. Azienda Ospedaliera Universitaria Policlinico "San Martino" IRCCS di Genova
state: GE
city: Roma
country: Italy
facility: Fondazione PoliclinicoAgostino Gemelli IRCCS
Study officials:
References:
Clinical trial NCT05198180: Treatment of Plantar Warts
Official title: Comparative Study Between Topical30%Potassium Hydroxide Solution and Topical 45% Hydrogen Peroxide Solution in Treatment of Plantar Warts
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Plantar Wart
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-01-20
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to compare the efficacy and safety of topical 30% potassium hydroxide solution and topical 45% hydrogen peroxide solution in treatment of plantar warts.


Eligibility criteria: Inclusion Criteria:

* confirmed diagnosis by clinical and dermoscopic examination of plantar warts

Exclusion Criteria:

* history of hypersensitivity to any component used in this study
* pregnancy and breastfeeding
* patients who receive immune suppressive therapy
* patients who received any wart treatments during the last 2 months before enrollent in the study
* patients who refused participation in the study

Primary outcomes:
measure: Change in the size of the plantar warts
timeFrame: 12 weeks after end of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag faculty of medicine
Study officials:
References:
Clinical trial NCT00823680: A Study of RO5093151 and RO5027838 in Patients With Type 2 Diabetes Mellitus on a Stable Dose of Metformin
Official title: Multi-center, Randomized, Double-blind, 5-arm Parallel Group, Placebo Controlled 4 Week Study to Investigate the Safety, Tolerability and Efficacy of Two Doses Each (Near to Maximum Tolerated Dose and Lower Dose) of RO5093151 Administered Twice Daily (BID Regimen) and RO5027838 Administered Once da
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-01-16
Enrollment: 110
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 5 arm study will evaluate the efficacy and safety of RO5093151 and RO5027838 in patients with type 2 diabetes mellitus on a stable dose of metformin. After a 4 week pre-randomization period for glucose control, patients will be randomized to one of 5 groups to receive a)RO5093151 400mg po bid b)RO5093151 10mg po bid c)RO5027838 200mg po qd d)RO5027838 50mg po qd or e)placebo po bid for 4 weeks. The anticipated time on study treatment is \< 3 months, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, 35-65 years of age;
* type 2 diabetes for \>=3 months;
* treated for \>=3 months with stable dose of metformin \>=1.5g/day or maximum tolerated dose.

Exclusion Criteria:

* history of diabetic ketoacidosis;
* currently or previously treated with insulin;
* currently or within previous 6 months treated with a thiazolidinedione or dual peroxisome proliferator activated receptor (PPAR) agonist;
* treated with lipoprotein-modifying therapy within a month before screening.

Primary outcomes:
measure: Absolute change in mean daily plasma glucose
timeFrame: From baseline to day 27
Secondary outcomes:
measure: Fasting plasma glucose
timeFrame: Baseline, and weeks 1, 2, 3 and 4
measure: Post-prandial glucose and insulin
timeFrame: Baseline, weeks 2 and 4
measure: Insulin sensitivity, beta cell function, lipid profile, HbA1C
timeFrame: At baseline, and at planned visits up to week 4
measure: Adverse events, lab parameters, vital signs, body weight
timeFrame: At baseline, and at planned visits up to week 4
Other outcomes:
Locations:
city: Chula Vista
country: United States
state: California
city: Miami
country: United States
state: Florida
city: Graz
country: Austria
city: München
country: Germany
city: Neuss
country: Germany
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT07014280: Bevacizumab Versus Triamcinolone Acetonide for the Treatment of Keloids.
Official title: Efficacy of Intralesional Bevacizumab Versus Intralesional Triamcinolone Acetonide Injection in the Treatment of Keloids.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Keloids
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 28
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: The study compares the efficacy and safety of intralesional bevacizumab versus corticosteroids for the treatment of keloids. Assessment will be done clinically by the use of Modified Vancouver Scar Scale. Erythema index will be measured by spectrophotometry. The levels of Vascular Endothelial Growth Factor, collagen type 1 and collagen type 3 in the lesions before and after each treatment modality.


Eligibility criteria: Inclusion Criteria:

* Patients with keloids (post-traumatic, any site, any duration)
* Age \>18 years
* Patients who didn't receive any treatment for the lesions in the past 6 weeks

Exclusion Criteria:

* Patients who are pregnant, willing to get pregnant or lactating
* History of any liver or renal disease
* History of any cardiovascular disease
* History of hypertension
* History of thrombo-embolic events
* Known cases of bleeding disorders
* History of peptic ulcer
* Patients who underwent any surgeries in the last month

Primary outcomes:
measure: Modified Vancouver scar scale (mVSS)
timeFrame: 6 months
measure: Erythema Index
timeFrame: 6 months
measure: Vascular Endothelial growth factor (VEGF)
timeFrame: 6 months
measure: Collagen type 1 and 3
timeFrame: 6 months
measure: Histopathological examination
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr El Ainy University Hospital, faculty of medicine, Cairo university
state: El Manial
Study officials:
References:
Clinical trial NCT02461680: Treatment for Partial Lesions of the Fingers Flexor Tendons : Tangential Resection or Direct Suture
Official title: Management Of The Partial Lesions Of The Fingers Flexor Tendons, Prospective Randomized Trial Of 2 Surgical Procedures: Tangential Resection Versus Direct Suture
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Flexor Tendon Injury
Lesions Of The Fingers Flexor Tendons
Keywords: partial section of the flexor tendons
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2015-06-03
Enrollment: 3
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: Flexors tendon injuries are frequent and serious with a potential of definitive functional aftereffects. In the case of partial injury, the treatment is debated. There are 2 techniques of possible repair, the direct suture and the tangential resection. The investigators have already demonstrated that this last technique was favorable for injuries going to 50 %. In the case of partial section between 50 and 75 %, the investigators think that the technique of tangential resection compared with the direct suture would not increase the risks of secondary breaks, would authorize even an immediate mobilization and would decrease the secondary complications.

The main objective is to highlight that the tangential resection is not lower than the classic technique on the clinical plan The secondary objectives are to highlight the non-inferiority of the tangential technique in clinical terms (pains, dexterity, complications), radiologics (MRI, ultrasound) and functional (function, go back to leisures and professional activities)


Eligibility criteria: Inclusion Criteria:

* wound dating less than 48 hours
* partial section from 50 % to 75 % of the flexor tendons (deep and/or superficial flexors, long flexor of the thumb) in zones 1, 2, 3, T1 and T2
* tendinous injuries on a single finger

Exclusion Criteria:

-

Primary outcomes:
measure: Total active motion Grasp
timeFrame: third month,
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: CHU Strasbourg,
Study officials:
affiliation: CHU Strasbourg
name: Sybille FACCA, MD
role: PRINCIPAL_INVESTIGATOR
References: