louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05073094: Esmolol for Myocardial Protection in Hypertrophic Obstructive Cardiomyopathy
Official title: Myocardial Protection With Esmolol in Patients With Hypertrophic Obstructive Cardiomyopathy Undergoing Surgery Under Cardiopulmonary Bypass
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypertrophic Obstructive Cardiomyopathy
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2021-10-11
Enrollment: 80
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: Perioperative blockage of beta-adrenoreceptors is widely used in cardiac and non-cardiac surgery to reduce the rate of cardiovascular complications. Several randomized-controlled studies and meta-analysis showed that esmolol reduces the incidence of myocardial ischemia and arrhythmias in cardiac surgery as well as enhances postoperative cardiac performance. No studies assessed the influence of esmolol in patients with hypertrophic obstructive cardiomyopathy undergoing cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Signed informed consent
* Patient with hypertrophic obstructive cardiomyopathy undergoing surgery under cardiopulmonary bypass

Exclusion Criteria:

* History of adverse effects on esmolol
* Urgent/emergent surgery
* Administration of esmolol in 30 days before randomization
* Participation in other randomized trial during same hospitalization

Primary outcomes:
measure: Peak concentration of Troponin I
timeFrame: From the randomization to the postoperative day 3 (POD 3)
Secondary outcomes:
measure: The need for (yes/no) inotropic agents
timeFrame: through study completion, an average of 4 weeks
measure: The need for (yes/no) defibrillation
timeFrame: through study completion, an average of 4 weeks
measure: The incidence of new-onset moderate and severe arrhythmias of cardiac arrest
timeFrame: through study completion, an average of 4 weeks
measure: Left ventricular ejection fraction
timeFrame: through study completion, an average of 4 weeks
measure: Peak serum creatinine concentration
timeFrame: through study completion, an average of 4 weeks
measure: The incidence of acute kidney injury
timeFrame: through study completion, an average of 4 weeks
measure: Duration of mechanical ventilation
timeFrame: through study completion, an average of 4 weeks
measure: Duration of ICU stay
timeFrame: through study completion, an average of 4 weeks
measure: Duration of hospital stay
timeFrame: through study completion, an average of 4 weeks
measure: 30-day all-cause mortality
timeFrame: through study completion, an average of 4 weeks
measure: Presence of diastolic dysfunction
timeFrame: through study completion, an average of 4 weeks
measure: The dosage of inotropic agents (inotropic score)
timeFrame: through study completion, an average of 4 weeks
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: E. Meshalkin National Medical Research Center
Study officials:
References:
Clinical trial NCT04781894: Application of Transthoracic Shear-wave Ultrasound Elastography in Pleural Lesions
Official title: Application of Transthoracic Shear-wave Ultrasound Elastography in Pleural Lesions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Elasticity Imaging Techniques
Keywords: Shear wave ultrasound elastography
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving chest ultrasonography in National Taiwan University Hospital

Brief summary: This study aims to provide the information of tissue elasticity in different etiologies of pleural lesions and to validate the predictive value of shear-wave elastography in differentiating benign pleural lesions from malignant lesions.


Eligibility criteria: Inclusion Criteria:

* Patients with radiographic evidence of pleural lesions or effusion

Exclusion Criteria:

* Age \< 20 y/o
* Patients who cannot hold their breath for 5 seconds

Primary outcomes:
measure: Application of transthoracic shear-wave ultrasound elastography in pleural lesions
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yao-Wen Kuo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05879094: Orthopaedic Simulation of Morton's Extension to Test the Effect on Plantar Pressures of Each Metatarsal Head in Patients Without Deformity: A Pre-post-test Study.
Official title: Orthopaedic Simulation of Morton's Extension to Test the Effect on Plantar Pressures of Each Metatarsal Head in Patients Without Deformity: A Pre-post-test Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Keywords: metatarsalgia
foot
orthopedics
Lead sponsor: Mayuben Private Clinic
Sponsor class: OTHER
First posted: 2023-05-30
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to simulate the orthopedic treatment called Morton's extension on non-deformed patients to check the effects on each metatarsal head on its static footprint.

Detailed description: The objective of this study is to perform an assimilation of the orthopedic treatment called morton extension on non-deformed patients to verify the effects on each metatarsal head on its static footprint, specifically the mean pressures and before and after the application of the morton extension.

Eligibility criteria: Inclusion Criteria:

* no history of trauma to the foot;
* the presence of at least 10° of dorsiflexion at the ankle with the knee fully dorsiflexed;
* unrestricted motion of the functional subtalar joint of 30°;
* unrestricted motion along the longitudinal axis of the midtarsal joint of 15°;
* unrestricted nonweight-bearing motion of the first ray of at least 8 mm;
* greater than 50° of dorsiflexion of the hallux to the first metatarsal bisection during nonweight-bearing;
* age greater than 18 years and younger than 60 years;
* at the time of data collection, no lower limb dysfunction or chronic injury; and
* no evidence of a non-fixed deformity at first MTP and first metatarsal cuneiform joints.

Exclusion Criteria:

* plantar corns and calluses,
* hallux valgus and lesser toe deformities,
* diabetes,
* any abnormality in the lower extremity that may affect gait.

Primary outcomes:
measure: Before Morton Extension Medium pressure
timeFrame: Through study completion, an average of 1 week
measure: Before Morton Extension Maximum pressure
timeFrame: Through study completion, an average of 1 week
measure: After Morton Extension Medium pressure
timeFrame: Through study completion, an average of 1 week
measure: After Morton Extension Maximum pressure
timeFrame: Through study completion, an average of 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Eva María Martínez-Jimenez
Study officials:
affiliation: Mayuben Private Clinic
name: Eva María Martínez-Jimenez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00985894: Comparison Between Asynchronous Online Care Model With Usual In Office Care for the Management of Atopic Dermatitis
Official title: Comparison Between Asynchronous Online Care Model for the Management of Atopic Dermatitis With That of Face-to-Face, Office Visits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Keywords: Teledermatology
Telemedicine
Atopic Dermatitis
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2009-09-29
Enrollment: 183
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine if an asynchronous online model of teledermatology can achieve similar clinical outcomes as compared to conventional in-office care for the management of atopic dermatitis. The investigators also aim to determine the effects of this online care model on patient quality of life as well as patient and physician satisfaction.

The investigators' hypotheses include the following:

1. Compared to in-person visits, the online care model will result in similar clinical improvement in atopic dermatitis disease severity.
2. Compared to in-person visits, the online care model will result in similar improvements in quality of life.
3. Providers and subjects in the online group will achieve a similar level of overall satisfaction as those in the in-person group.


Eligibility criteria: Inclusion Criteria:

* Patients aged 4 years or older at time of consent, may be male or female.
* Meet the Hanifin diagnostic criteria for atopic dermatitis.
* Capable of giving informed consent (for patients less than 18 years of age, assent will be obtained from the minor and informed consent will be obtained from a legal guardian).
* Able to image their skin or have someone do it for them.
* Able to adhere to the study visit schedule and other protocol requirements.
* Have access to a computer with internet connection, a digital camera, and an e-mail address.

Exclusion Criteria:

* Non English speaking patients.
* Patients requiring systemic treatment (e.g., cyclosporine, phototherapy).
* Patients requiring close laboratory monitoring.

Primary outcomes:
measure: Eczema Area and Severity Index (EASI)
timeFrame: Every 8 weeks
measure: Patient-oriented Eczema Measure (POEM)
timeFrame: Every 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Department of Dermatology
state: California
Study officials:
affiliation: UC Davis Department of Dermatology
name: April W Armstrong, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Armstrong AW, Johnson MA, Lin S, Maverakis E, Fazel N, Liu FT. Patient-centered, direct-access online care for management of atopic dermatitis: a randomized clinical trial. JAMA Dermatol. 2015 Feb;151(2):154-60. doi: 10.1001/jamadermatol.2014.2299.
Clinical trial NCT05083494: Real-time Monitoring of Concentration and Size Variations of Circulating Plasma Free DNA to Predict Early Response to Immunotherapies in Patients With Different Types of Cancer.
Official title: Real-time Monitoring of Concentration and Size Variations of Circulating Plasma Free DNA to Predict Early Response to Immunotherapies in Patients With Different Types of Cancer.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2021-10-19
Enrollment: 260
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 starting a cancer treatment, as part of marketing treatment (alone or in combination) in five type of cancer (melanoma, clear cell renal cancer, urothelial carcinomas of the bladder, squamous cell carcinomas of the head and neck and non-small cell lung cancer).

Brief summary: Immunotherapy, which can be represented by the immune checkpoint blockade, is a milestone in the progress of the ongoing struggle against cancer. However, the emergence of unexpected tumor response patterns, such as pseudo-progression or hyper-progression, might complicate the management of patients receiving these immune checkpoint inhibitors. A reliable standardized biomarker that can be used in clinical practice for predicting response to treatment, monitoring tumor evolution and evaluating treatment efficacy has not yet been established.

The general aim of this study is to assess the interest of the plasmatic free circulating DNA (cfDNA) on the clinical response for patients with different types of cancer treated with immunotherapies. The primary objective is to assess the performance of the plasmatic free circulating DNA using the estimation of the receiver operating characteristic (ROC) curve and calculation of the area under the curve (AUC) on the response rate.


Eligibility criteria: Inclusion Criteria:

* Patients starting anti-PD1 immunotherapy as part of marketing authorization alone or in combination (melanoma, clear cell renal cancer, urothelial carcinomas of the bladder, squamous cell carcinomas of the head and neck and non-small cell lung cancer).
* No contraindications to immunotherapy
* Non-pregnant patient
* Patient not opposed to participation in this study

Exclusion Criteria:

* HIV seropositivity
* Patient with psychiatric or other conditions that may compromise his or her ability to give non opposition or to follow study procedures

Primary outcomes:
measure: Interest of the plasmatic free circulating DNA (cfDNA)
timeFrame: At first evaluation, then 1 administration over 2 for 1 year then at 18 months and an additional sample will be taken at the time of recurrence
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: APHM
Study officials:
References:
Clinical trial NCT02870894: Electrical Impedance Tomography for Quantification of Pulmonary Edema in Acute Respiratory Distress Syndrome Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Respiratory Distress Syndrome
Lead sponsor: Sichuan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2016-08-17
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult ICU patients with ARDS will be enrolled between August 2016 and August 2017 when they fulfilled the inclusion criteria,and unfulfilled the exclusion criteria below

Brief summary: Evaluation of pulmonary edema is a key factor in monitoring and guidance of therapy in acute respiratory distress syndrome (ARDS) patients. To date, methods available at the bedside for estimating the physiologic correlate of pulmonary edema, extravascular lung water(EVLW), often are unreliable or require invasive measurements. The purpose of the this study is to develop a novel approach to reliably assess extravascular lung water by electrical impedance tomography(EIT).


Eligibility criteria: Inclusion Criteria:

Patients will be included in this study if the following criteria have been met:

1. Males and females \> 18 years old and \<85 years old (non-pregnant, non-lactating females).
2. Patients fulfilled the Berlin diagnostic criteria of ARDS
3. Signed written informed consent has been obtained
4. Patients had monitoring system Pulse-Induced Contour Cardiac Output (PiCCO)

Exclusion Criteria:

1. Females who are pregnant or lactating.
2. Patients with contraindication of EIT(Skin abrasions or wounds in the chest area.Patients with pacemakers or paced EKG rhythms.Thoracic deformity. Severe subcutaneous emphysema)
3. Patients \<18 years old or \> 85 years old
4. Patients Without monitoring system Pulse-Induced Contour Cardiac Output (PiCCO)
5. Patients with Cardiac function of grade 4 or patients with acute myocardial infarction or acute coronary syndrome

Primary outcomes:
measure: Comparison between a novel EIT-based method to estimate pulmonary edema (lung water ratio-EIT ) with a conventional measurement for EVLW using trans-cardiopulmonary thermodilution technique
timeFrame: once the patient was consented and enrolled
Secondary outcomes:
Other outcomes:
Locations:
city: Cheng Du
country: China
facility: Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
state: Sichuan
Study officials:
affiliation: Sichuan Academy of Medical Sciences
name: Xiaobo Huang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhao Z, He H, Luo J, Adler A, Zhang X, Liu R, Lan Y, Lu S, Luo X, Lei Y, Frerichs I, Huang X, Moller K. Detection of pulmonary oedema by electrical impedance tomography: validation of previously proposed approaches in a clinical setting. Physiol Meas. 2019 Jun 4;40(5):054008. doi: 10.1088/1361-6579/ab1d90.
Clinical trial NCT01193894: Trial on Profermin and Fresubin in Ulcerative Colitis
Official title: A Randomized Trial on Profermin and Fresubin for Dietetic Treatment of Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Ulcerative Colitis
Keywords: IBD
UC
Profermin
Fresubin
Probiotics
Dietetic
Lead sponsor: Nordisk Rebalance A/S
Sponsor class: INDUSTRY
Collaborators: name: Hvidovre University Hospital
First posted: 2010-09-02
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study aim to investigate the effect of Profermin versus Fresubin in the dietetic treatment of active ulcerative colitis.


Eligibility criteria: Inclusion Criteria:

* Active ulcerative colitis (SCCAI =\>5 and \<=11)
* Access to Internet

Exclusion Criteria:

* Stoma or intestinal resections
* Recent changes in UC medication
* Treatment with antibiotics
* Diabetes
* Celiac disease
* Lactose malabsorption

Primary outcomes:
measure: Development in Simple Clinical Colitis Activity Index (SCCAI) score
timeFrame: 8 and 16 weeks
Secondary outcomes:
measure: Reduction in SCCAI score
timeFrame: 8 and 16 weeks
measure: Clinical remission
timeFrame: 8 and 16 weeks
measure: Safety - Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Allerod
country: Denmark
facility: Noreba
state: Capital region
Study officials:
affiliation: Nordisk Rebalance A/S
name: Hans Israelsen, PhD
role: STUDY_DIRECTOR
affiliation: Hvidovre University Hospital
name: Aleksander Krag, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hvidovre University Hospital
name: Flemming Bendtsen, MD, DMSci
role: STUDY_CHAIR
References:
Clinical trial NCT02967094: Mucolytic Solution Before Upper Endoscopy
Official title: The Use of Mucolytic Solution Before Upper Endoscopy: A Randomized, Double-blinded Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastroscopy; Gastric Cancer
Lead sponsor: Vitkovice Hospital
Sponsor class: OTHER
First posted: 2016-11-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Study was designed to evaluate efficacy of mucolytic solution ingested before upper endoscopy on visibility of gastric mucosa.

Detailed description: Residual gastric content containing mucus, bubbles, bile and food particles may limit visibility of gastric mucosa and therefore diagnostic yield of upper endoscopy, especially in cases of early neoplastic lesions. Data on benefit of peroral mucolytic solution administered before upper endoscopy are limited.

Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* signed informed consent
* diagnostic gastroscopy

Exclusion Criteria:

* age \< 18 years
* interventional gastroscopy
* known disease of the upper GI tract and/or history of surgery of GI tract
* gastroscopy indicated of bleeding, dysphagia or ileus
* liver cirrhosis
* general anesthesia

Primary outcomes:
measure: "Visibility score" evaluated by blinded performing endoscopist
timeFrame: through study completion, an average of 3 months
Secondary outcomes:
measure: "Visibility score" evaluated by three blinded endoscopists using 11 endoscopic images captured during endoscopy.
timeFrame: through study completion, an average of 3 months
measure: Residual fluid in the stomach evaluated by blinded performing endoscopist
timeFrame: through study completion, an average of 3 months
measure: Duration of endoscopy
timeFrame: through study completion, an average of 3 months
Other outcomes:
Locations:
city: Ostrava
country: Czech Republic
facility: Digestive Diseases Center
Study officials:
affiliation: Digestive Diseases Center, Vítkovice Hospital
name: Premysl Falt, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stepan M, Falt P, Pipek B, Fojtik P, Hanousek M, Hill M, Urban O. Administration of mucolytic solution before upper endoscopy - double-blind, monocentric, randomized study. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2023 Mar;167(1):69-73. doi: 10.5507/bp.2021.038. Epub 2021 Jun 22.
Clinical trial NCT02428894: Characterization of the Plasma Proteome Following Left Ventricular Assist Device Implantation
Official title: Characterization of the Plasma Proteome Following Left Ventricular Assist Device Implantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventricular Dysfunction, Left
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2015-04-29
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants will be recruited from the University of Colorado Hospital Advanced Heart Failure Program.

Brief summary: The purpose of this study is to characterize changes in the plasma proteome over time following left ventricular assist device (LVAD) implantation.


Eligibility criteria: Inclusion Criteria:

* Planned HeartMate II LVAD implantation
* Planned warfarin (goal INR, 2.0-3.0) and low-dose aspirin therapy post-LVAD placement

Exclusion Criteria:

* Prior history of mechanical circulatory support;
* Body weight \< 110 lbs;
* Pre-existing hemolytic, bleeding, or immunologic disorders prior to LVAD implantation;
* Severe aortic stenosis;
* Renal failure requiring dialysis;
* Hepatic dysfunction resulting in severe coagulopathies;
* Recent serious infection;
* Current need for prolonged ventilatory support;
* Prior organ transplantation;
* Blood transfusion within 14 days of the first planned study blood draw;
* Concomitant immunosuppressant or chemotherapeutic agents;
* Pregnant women;
* Decisionally challenged or prisoners;
* Unwilling to provide written informed consent

Primary outcomes:
measure: Quantitative differences in plasma protein abundance
timeFrame: Days 7, 14, 30, 60, 90, and 180 post-LVAD implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Christina Aquilante, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References: