louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00184886: The Influence of Methotrexate on the Metabolism and Vascular Effects of Adenosine in Humans
Official title: The Influence of Methotrexate on the Metabolism and Vascular Effects of Adenosine in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Methotrexate
Vasodilation
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2005-09-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study we aim to determine whether methotrexate influences the metabolism and vascular effects of adenosine in humans in vivo. Adenosine is an endogenous purine-nucleoside with potent anti-inflammatory effects. Also, adenosine receptor stimulation induces vasodilation, ischaemic preconditioning and many other cardiovacular effects. Previous animal studies have provided limited evidence that the anti-inflammatory effects of methotrexate are mediated by adenosine receptor stimulation. In this study, we aim to determine whether also in humans in vivo, methotretate influences endogenous adenosine. Therefore, 10 patients with inflammatory arthritis are treated with methotretxae (15 mg/week orally) for 12 weeks. Before and after treatment, vasodilation to the infusion of adenosine and dipyridamole into the brachial artery is assessed as biomarker for the endogenous adenosine concentration.

Also, blood is drawn for the determination of CRP, ESR, Adenosine deaminase activity adn homocysteine.


Eligibility criteria: Inclusion Criteria:

* 18-75 year
* polyarthritis
* DAS score \> 2.5

Exclusion Criteria:

* previous use of MTX
* concomitant use of dipyridamole/sulfazalasine
* Alcohol \> 21 U/week
* elevated liver enzymes
* pregnancy, breast-feeding, asthma, renal insufficiency, thrombocytopenia, leucocytopenia

Primary outcomes:
measure: Vasodilator response to infusion of adenosine and dipyridamole into the brachial artery
Secondary outcomes:
measure: Adenosine deaminase activity
measure: CRP, BSE, DAS
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
Study officials:
affiliation: Radboud University Medical Center
name: Gerard Rongen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06623786: Cancer Patient Remote Monitoring for Timely Communication Study
Official title: Cancer Patient Remote Monitoring for Timely Communication Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: NSCLC Stage IV
Lead sponsor: Asklepios proresearch
Sponsor class: INDUSTRY
Collaborators: name: Q1.6 B.V.
name: Medical University of Vienna
First posted: 2024-10-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cohort 1: Double immune checkpoint inhibition

* Histologically or cytologically confirmed stage IV NSCLC without EGFR sensitizing mutations or ALK translocations OR
* Histologically or cytologically confirmed advanced, malignant pleural mesothelioma
* Eligible for double immune checkpoint inhibition with an anti PD1/L1 inhibitor and a CTLA-4 inhibitor with or without chemotherapy according to current guidelines and SmPCs

Cohort 2: Immunotherapy with PD1/L1 inhibitor:

* Histologically or cytologically confirmed stage IV NSCLC without EGFR sensitizing mutations or ALK translocations
* Eligible for treatment with an anti-PD-1/L1 inhibitor with or without chemotherapy according to current guidelines and SmPCs

Brief summary: The study is designed as a prospective, single-arm observational, mixed-method study. Patients with stage IV NSCLC or inoperable mesothelioma will be included and will be treated with immunotherapy according to current guidelines and standard of care. Patients may receive either a PD1/L1 inhibitor monotherapy or, if indicated, together with a CTLA4 inhibitor. Immunotherapy may be administered alone or together with chemotherapy as per site standard/physician's choice. Patients will be given access to a mobile app. Patients will receive daily questions via the app to assess immune-related adverse events between clinic visits and their well-being.


Eligibility criteria: Inclusion Criteria:

* Signed Informed Consent Form
* Age \> 18 years at the time of study entry
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Life expectancy \> 6 months
* Patient is able and willing to use smart phone and a wearable device/technology/sensor

Exclusion Criteria:

* Previous systemic treatment for metastatic or locally advanced disease

Primary outcomes:
measure: adherence to use the remote monitoring app
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04682886: Radiomics Analysis of Focal Liver Lesions Based on Contrast-Enhanced Ultrasound Imaging
Official title: Research on Key Techniques for Intelligent Diagnosis and Ablation Decision-making of Liver Cancer and Evolution by Contrast-enhanced Ultrasound
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Focal Liver Lesions
Contrast-enhanced Ultrasound
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with focal liver lesions

Brief summary: Contrast-enhanced ultrasound (CEUS) substantially improves the potential of ultrasound (US) for the identification and characterization of focal liver lesions (FLLs). Compared to contrasted-enhanced MRI and CT, it has some unique advantages, such as the absence of ionizing radiation, and easy operability and repeatability. However, the efficacy of CEUS in diagnosing liver lesions is challenged by several factors including being highly dependent on doctor's experience, low signal-to-noise ratio, and low interobserver agreement. Therefore, it is a beneficial attempt to construct an intelligent CEUS diagnosis system using digital information technology. This study aims to collect standard data of CEUS cines recordings and develop deep learning model for accurate segmentation, detection and classification of liver lesions.


Eligibility criteria: Inclusion Criteria:

1. patients with a solid liver tumor visible during routine ultrasound and received CEUS.
2. disease history and standard of reference of the lesions can be acquired

Exclusion Criteria:

1. hypersensitivity for ultrasound contrast media
2. pregnant or lactating patients
3. previously treated lesions or local relapse from previously treated lesions
4. diffuse tumors

Primary outcomes:
measure: AUC value
timeFrame: through study completion, an average of 7 year
measure: specificity
timeFrame: through study completion, an average of 7 year
measure: sensitivity
timeFrame: through study completion, an average of 3 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT05169086: Comparison of Two Types of Bandages in the Treatment of Lymphoedema
Official title: The Effectiveness of the Elastic Component of the Multilayer Bandage in the Treatment of Patients With Lymphedema at the University Hospital of Montpellier : a Randomised Clinical Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoedema
Keywords: Lymphology
Chronic disease
reduction bandages
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-12-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population corresponds to patients with primary or secondary lymphedema receiving intensive decongestant treatment at the Montpellier University Hospital. Patients must be of legal age and have unilateral stage 2 or 3 lymphedema.

Brief summary: The study is a cohort study of patients at the University Hospital during the first two days of intensive treatment. The patients are randomly divided into two groups (N=10).

Throughout the study, group A is treated with the multilayer elastic bandage while group B is bandaged with contention only. The bandages were applied on the first and second day and were maintained in place. The bandages were applied on the first and second day and were maintained for 24 hours. All patients performed 30 minutes of physical activity in the bandage on both days.

The evaluation is based on the volumetric difference, skin quality and quality of life of these patients


Eligibility criteria: Inclusion criteria:

* Adult with unilateral lower limb lymphoedema
* Stage 2 or 3 lymphoedema
* 1st intensive decongestant treatment
* Ability to sit on a cycloergometer

Exclusion criteria:

* Severe cardiac disease
* Infectious dermoepidermitis
* Bandage unbearable for the patient

Primary outcomes:
measure: Perimetry of the affected limb
timeFrame: day 1
measure: Perimetry of the affected limb
timeFrame: Day 2
measure: Volumetry of the affected limb
timeFrame: day 1
measure: Volumetry of the affected limb
timeFrame: Day 2
Secondary outcomes:
measure: Quality of life questionnaire
timeFrame: day 1
measure: Quality of life questionnaire
timeFrame: one month later
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: nicolas Erdocio, student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01803386: Noninvasive Assessment of Neuromuscular Disease Using Electrical Impedance Myography
Official title: Noninvasive Assessment of Neuromuscular Disease Using Electrical Impedance Myography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amyotrophic Lateral Sclerosis (ALS)
Keywords: ALS
EIM
Lead sponsor: Skulpt, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2013-03-04
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ALS Patients

Brief summary: The purpose of this protocol is to test a new Electrical Impedance Myography (EIM) device and study its reliability and ability to differentiate ALS patients from healthy controls.

Detailed description: Investigators will study 10 ALS patients and at least 10 age-matched healthy controls between the ages of 21 and 85 years old. For all subjects, EIM measurements will be performed on four muscles: two in the upper and two in the lower extremities, using 8 different EIM sensors. Measurements will be repeated one time.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of probable or definite ALS by the El Escorial Criteria

Exclusion Criteria:

* History of superimposed generalized neuromuscular disease
* Primary lateral sclerosis or other atypical motor neuron disorders
* Forced vital capacity of less than 50%
* Presence of disease for greater than 5 years since symptom onset

Primary outcomes:
measure: Muscle health as captured by EIM measurements
timeFrame: One time visit - Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Convergence Medical Devices
state: Massachusetts
Study officials:
affiliation: VA Boston Healthcare System
name: Erik Ensrud, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05462886: Clinical Performance of Masimo INVSENSOR00057 for Heart Rate Measurements
Official title: Clinical Performance of Masimo INVSENSOR00057 for Heart Rate Measurements
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2022-07-18
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study is designed to compare the accuracy of a noninvasive measurement of heart rate compared to reference values obtained by a standard of care ECG monitor.


Eligibility criteria: Inclusion Criteria:

* Subject is 18 to 80 years of age.
* Subject is able to read and communicate in English.

Exclusion Criteria:

* Subject has open wounds, inflamed tattoos or piercings on the area of device placement, and/or has any visible healing wounds that the investigator and/or medical professional determines may place them at an increased risk for participation.
* Subject has any medical condition which in the judgment of the investigator and/or study staff, renders them ineligible for participation in this study or subject is deemed ineligible by the discretion of the investigator/study staff.

Primary outcomes:
measure: Heart Rate Accuracy of Masimo INVSENSOR00057
timeFrame: 1-3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Masimo Corporation
state: California
Study officials:
References:
Clinical trial NCT02619786: Therapy of Ventilator-associated Tracheobronchitis Caused by Gram Negative Bacteria With Nebulized Colistin
Official title: Therapy of Ventilator-associated Tracheobronchitis Caused by Gram Negative Bacteria With Nebulized Colistin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Bronchitis
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2015-12-02
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether inhaled colistin is effective in the treatment of ventilator associated tracheobronchitis due to gram negative organism susceptible to colistin.

Detailed description: Patients diagnosed ventilator-associated tracheobronchitis due to gram negative organism are included to the study.The patients will be received colistin inhalation 75 mg every 12 hours at least 5 days.

The primary objective is to evaluate clinical outcome of inhaled colistin. The secondary objectives are microbiological clearance and toxicity of inhaled colistin.

The sample size was estimated to 62 patients.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of ventilator-associated tracheobronchitis caused by gram negative organism.
* Expected to survive more than 48 hours after enrollment.
* Received intravenous colistin not more than 48 hours prior enrollment.

Exclusion Criteria:

* Pregnancy and Lactation
* Allergy to colistin
* Serum creatinine \> 4 mg/dl or GFR decreased more than 75% from baseline

Primary outcomes:
measure: Number of Patients With Cure, Improved, Failure or Death
timeFrame: through study completion, an average of 2 weeks
Secondary outcomes:
measure: Number of Patients With Eradication, Persistence or Superinfection
timeFrame: through study completion, an average of 2 weeks
measure: Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug, Graded According to NCI CTCAE Version 3.0
timeFrame: through study completion, an average of 2 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Rattanaumpawan P, Lorsutthitham J, Ungprasert P, Angkasekwinai N, Thamlikitkul V. Randomized controlled trial of nebulized colistimethate sodium as adjunctive therapy of ventilator-associated pneumonia caused by Gram-negative bacteria. J Antimicrob Chemother. 2010 Dec;65(12):2645-9. doi: 10.1093/jac/dkq360. Epub 2010 Sep 28.
Clinical trial NCT00451386: Ertapenem Study in Pediatric Patients Who Have Urinary Tract Infections, Skin Infections or Community-acquired Pneumonia (0826-036)
Official title: A Prospective, Multicenter, Double-Blind, Randomized, Comparative Study to Evaluate the Safety, Local Tolerability, and Clinical Outcome of Ertapenem Versus Ceftriaxone in Pediatric Patients With Complicated Urinary Tract Infection, Skin and Soft Tissue Infection, or Community-Acquired Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Urinary Tract Infections
Bacterial Pneumonia
Soft Tissue Infections
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-03-23
Enrollment: 400
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the safety and efficacy of ertapenem versus ceftriaxone in pediatric patients with urinary tract infections, skin infections, or community-acquired pneumonia.


Eligibility criteria: Inclusion Criteria:

* Patients with UTI must have white blood cells and bacteria in the urine with bladder catheterization or urologic abnormality, kidney infection or both
* Patients with SSTI must have a recent infection
* Patients with CAP must have a chest x-ray indicating bacterial pneumonia and a fever

Exclusion Criteria:

* Patients with complete urinary tract blockage or kidney abscess
* Patients with infected burn wounds, bone infection, or bacterial arthritis
* Patients on mechanical ventilation or those with cystic fibrosis, chronic lung disease or puss in the space between the chest wall and lung

Primary outcomes:
measure: To evaluate the incidence of any clinical and/or laboratory drug-related serious adverse experience during the parenteral therapy period in pediatric patients treated with ertapenem.
Secondary outcomes:
measure: To compare the safety of ertapenem versus ceftriaxone during the parenteral therapy period with respect to the proportion of patients with any drug-related adverse experiences in pediatric patients with UTI, SSTI, or CAP.
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Arguedas A, Cespedes J, Botet FA, Blumer J, Yogev R, Gesser R, Wang J, West J, Snyder T, Wimmer W; Protocol 036 Study Group. Safety and tolerability of ertapenem versus ceftriaxone in a double-blind study performed in children with complicated urinary tract infection, community-acquired pneumonia or skin and soft-tissue infection. Int J Antimicrob Agents. 2009 Feb;33(2):163-7. doi: 10.1016/j.ijantimicag.2008.08.005. Epub 2008 Oct 21.
Clinical trial NCT02398786: Myotonic Dystrophy Family Registry
Official title: Myotonic Dystrophy Family Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myotonic Dystrophy
Congenital Myotonic Dystrophy
Myotonic Dystrophy 1
Myotonic Dystrophy 2
Dystrophia Myotonica
Dystrophia Myotonica 1
Dystrophia Myotonica 2
Myotonia Dystrophica
Myotonic Dystrophy, Congenital
Myotonic Myopathy, Proximal
PROMM (Proximal Myotonic Myopathy)
Proximal Myotonic Myopathy
Steinert Disease
Steinert Myotonic Dystrophy
Steinert's Disease
Myotonia Atrophica
Lead sponsor: Myotonic Dystrophy Foundation
Sponsor class: OTHER
First posted: 2015-03-26
Enrollment: 3500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will volunteer to participate in this study and enter their own information. The study will be advertised through neuromuscular disease clinics and the Myotonic Dystrophy Foundation and Myotonic Dystrophy Family Registry websites.

Brief summary: The Myotonic Dystrophy Family Registry (MDFR) is an online, patient-entered database that collects information on myotonic dystrophy (DM) to aid researchers in developing new, effective treatments and help identify participants for research studies and clinical trials.

Detailed description: The Myotonic Dystrophy Family Registry (MDFR) is an online, patient-entered database that collects information on myotonic dystrophy (DM) such as disease symptoms and demographic information to aid researchers in developing new, effective treatments and help identify participants for research studies and clinical trials.

The Registry supports trials and studies, making it easier for researchers to explore data and identify possible trial and study participants. It is the first DM registry that gives community members the opportunity to explore anonymous Registry data, to see what the DM community looks like and what others with DM experience. It also provides information on the community of people living with DM, giving researchers and other medical professionals the opportunity to improve how they treat those affected with DM and learn more about how and why certain treatments work and don't work.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with congenital, juvenile-onset or adult onset DM1 or DM2 (confirmed by clinical exam or genetic test)

Exclusion Criteria:

* Not diagnosed with DM, unaffected family members

Primary outcomes:
measure: Patient reported outcomes
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Myotonic Dystrophy Foundation
state: California
Study officials:
affiliation: Myotonic Dystrophy Foundation
name: Tanya Stevenson, EdD, MPH
role: STUDY_CHAIR
References: