louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02220062: Randomized, Controlled Trial of Endoscopic Ultrasound-Guided Bilateral Celiac Plexus Neurolysis vs Celiac Ganglia Neurolysis to Control Pain in Inoperable Pancreatic Cancer Patients With Inadequate Pain Control by Pain Killer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Neoplasms
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2014-08-19
Enrollment: 166
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pancreatic cancer related pain can be difficult to control, even with high doses of narcotics, whose adverse effects may further impair quality of life. So EUS-CPN(endoscopic ultrasound guided celiac plexus neurolysis) is well established as an effective technique for controlling pain and reducing narcotic requirements in patients with pancreatic cancer. Recently, celiac ganglia can be visualized and accessed by endoscopic ultrasound. So it allows for direct injection into individual celiac ganglia to perform celiac ganglia neurolysis. This more precise delivery of therapeutic drug will offers the potential for enhanced efficacy and safety. To evaluate this hypothesis, this randomized controlled trial aimed to compare the efficacy and safety of EUS-CGN(Endoscopic ultrasound guided celiac ganglia neurolysis) vs. Bilateral EUS-CPN(Endoscopic ultrasound guided celiac plexus neurolysis) in providing relief from pancreas cancer-related pain.


Eligibility criteria: Inclusion Criteria:

1. At least 19 years old age (above 70 years old age, need the consent of the legal representative)
2. Inoperable pancreatic cancer patients
3. Pancreatic cancer patients with inadequate pain control by pain killer (VAS score 4 points or more)
4. Patient who agree to participate in this study

Exclusion Criteria:

1. Abnormal clotting (international normalized ratio ≥1.5)
2. Reduced platelet count (≤50000/μL)
3. Use of anticoagulation agents
4. Presence of gastric and/or esophageal varices
5. Anatomical deformity due to past surgery

Primary outcomes:
measure: percentage of participants with 50% decrease or less than 3 points in Pain Visual Analogue Scale (VAS)
timeFrame: 1 week after procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00631462: A Dose-escalation Study of the Safety and Tolerability of Orally Administered TG101348 in Patients With Myelofibrosis
Official title: A Phase 1, Open-label, Dose-escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered TG101348 in Patients With Primary, Post-polycythemia Vera, or Post-essential Thrombocythemia Myelofibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Myelofibrosis
Keywords: primary myelofibrosis
post-polycythemia vera myelofibrosis
post-essential thrombocythemia myelofibrosis
Lead sponsor: TargeGen
Sponsor class: INDUSTRY
First posted: 2008-03-07
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and tolerability of orally administered TG101348 in patients with myelofibrosis.

Detailed description: TG101348 is a potent small molecule inhibitor of Janus kinase 2 (JAK2). This is a first-in-human study that will include a dose-escalation phase, to establish the maximum tolerated dose, and an expanded cohort, dose-confirmation phase. The safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of TG101348 in patients with myelofibrosis will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of myelofibrosis (primary, post-polycythemia vera, or post-essential thrombocythemia)
* At least 18 years of age.
* ECOG PS 0, 1, or 2.

Exclusion Criteria:

* Any chemotherapy, immunomodulatory therapy, immunosuppressive therapy, corticosteroids, or growth factor treatment within 14 days prior to initiation of study drug.
* Major surgery or radiation therapy within 28 days prior to initiation of study drug.

Primary outcomes:
measure: Safety (i.e., adverse events; effects on laboratory parameters, vital signs, and ECGs; dose-limiting toxicities), tolerability, and MTD
timeFrame: 28 days
Secondary outcomes:
measure: Pharmacokinetics and pharmacodynamics
timeFrame: 28 days
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD Moores Cancer Center
state: California
city: Stanford
country: United States
facility: Stanford Comprehensive Cancer Center
state: California
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic, Rochester
state: Minnesota
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Mayo Clinic
name: Ayalew Tefferi, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06027762: Assessment of vGRF Measurement During Walking With Feetme® Insoles in Healthy Adults
Official title: Assessment of Vertical Ground Reaction Force Measurement During Walking With Feetme® Insoles in Healthy Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Volunteers
Lead sponsor: FeetMe
Sponsor class: INDUSTRY
Collaborators: name: Hopitaux de Saint-Maurice
First posted: 2023-09-07
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Adults between 18 and 85 years old without gait pathologies

Brief summary: The objective of the present study is to demonstrate the validity and reliability of vGRF and other gait parameters measurement in healthy adults while walking with FeetMe® insoles compared to force plates (AMTI BP400600) and video motion capture system (Vicon NEXUS and MX-T40) .


Eligibility criteria: Inclusion Criteria.

Volunteers with following criteria satisfied:

* Between the ages of 18 and 80.
* Shoe size between 35 to 46.
* Body weight from 40kg to 120kg.
* Able to walk for 30 mins without assistance.
* Comfortable with using a smartphone.

Non-inclusion Criteria.

A volunteer will not be included if one of the following conditions is met:

* cognitive or behavioral problems limiting communication or participation in the study
* deprivation of liberty by a legal or administrative decision
* adults subject to a legal protection measure or unable to express their consent
* pregnant, parturient and nursing mothers
* people admitted to a health or social establishment for purposes other than research
* Past or planned surgery with the possibility of impacting walking in the past 3 months or which had an impact on walking: orthopedic surgery, trauma to the lower limbs and spine, urological or gynecological surgery, brain and spinal cord surgery .
* Chronic disease affecting walking: Rheumatological, orthopedic, painful, neurological pathology.

Primary outcomes:
measure: precision of measurement of 'maximum weight acceptance' and 'push-off' peaks in healthy adults by FeetMe® insoles
timeFrame: between February 2022 and November 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Maurice
country: France
facility: Hopitaux Saint-Maurice
state: Ile-de-France
Study officials:
References:
Clinical trial NCT06485362: Use of Thermography for the Prevention and Diagnosis of Diabetic Foot
Official title: Use of Thermography for the Prevention and Diagnosis of Diabetic Foot
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diabetic Foot
Diabetic Neuropathies
Diabetic Angiopathy
Keywords: diabetic foot
neuropaty
angiopaty
termography
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy subjects or those with type 2 diabetes mellitus for more than 5 years who wish to participate in the study voluntarily, who will undergo a thermography of both feet.

Brief summary: Diabetic foot is a serious complication of diabetes mellitus that can lead to ulcerations, infections and, in extreme cases, amputations. Early detection of changes in skin temperature can help prevent these complications. Infrared thermography is a noninvasive technique that allows the visualization and quantification of skin temperature and could be an effective tool for the early detection of alterations in diabetic foot.

Objective

To evaluate the effectiveness of infrared thermography in the early detection and diagnosis of diabetic foot, comparing the temperatures of the feet of healthy subjects and subjects with diabetic foot.

Detailed description: Significant differences in foot temperatures are expected to be found between subjects with diabetic foot and healthy subjects. It is anticipated that areas of the foot at higher risk of ulceration in subjects with diabetic foot will show higher temperatures due to inflammation and changes in blood perfusion.

The results of the study could validate the use of thermography as an early detection and monitoring tool in patients at risk of developing diabetic foot. This could allow early and personalized interventions to prevent serious complications.

Eligibility criteria: Inclusion Criteria:

Subjects of both sexes. Age between 40 and 80 years. Diagnosis of type 1 or type 2 diabetes mellitus (for the case group). Absence of acute inflammatory diseases in the control group. Signed informed consent.

Exclusion Criteria:

Skin diseases that affect the interpretation of thermography. Recent treatment with medications that affect peripheral circulation. History of lower limb amputation.

Primary outcomes:
measure: Temperature maximun
timeFrame: One measurement will be taken at the start of the study and another measurement the following year.
measure: Temperature minimum
timeFrame: One measurement will be taken at the start of the study and another measurement the following year.
Secondary outcomes:
Other outcomes:
Locations:
city: Seville
country: Spain
facility: University of Seville
Study officials:
affiliation: University of Seville
name: RAQUEL GARCIA DE LA PEÑA, DOCTOR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03859362: Ertapenem in Patients With Urosepsis
Official title: Pharmacodynamics of Ertapenem in Patients With Urosepsis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Patients With Urosepis and Received Ertapenem for Treatment
Keywords: pharmacokinetic, pharmacodynamic, ertapenem, urosepsis
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2019-03-01
Enrollment: 12
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: Ertapenem, a broad-spectrum carbapenem antibiotic, has shown promising in vitro activity agenst ESBL-producing Enterobacteriacae. This agent was licensed in United State of America and Europe for several clinical use in complicated intraabdominal infections, complicated skin and skin-structure infections, acute pelvic infections, complicated urinary tract infections and community-acquired pneumonia. In common with other beta-lactams, ertapenem exhibits primarily time-dependent activity, and the percentage of the exposure time during which the free drug concentration remain above the MIC (%T\>MIC) is the pharmacokinetic/pharmacodynamics (PK/PD) index that best correlates with efficacy. Pathophysiological changes in critically ill patients with severe infections resulting in altered PK patterns that may affect therapeutic plasma concentrations and achievement of PD have been found with several antimicrobial agents. The aim of the study was to determine the PK of ertapenem in patients with urosepsis.


Eligibility criteria: Inclusion Criteria:

* \>18 years of age
* Diagnosis of urosepsis

Exclusion Criteria:

* They were pregnant
* Circulatory shock (defined as a systolic blood pressure of \< 90 mmHg and pour tissue perfusion)
* Documented hypersensitivity to carbapenems
* Estimated creatinine clearance (CLcr) (determined by the Crockcroft-Goult method) of \< 30 mL/min

Primary outcomes:
measure: Concentration of ertapenem in plasma
timeFrame: 48 hours after the ertapenem dose
Secondary outcomes:
Other outcomes:
Locations:
city: Hat Yai
country: Thailand
facility: Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University
state: Songkla
Study officials:
References:
Clinical trial NCT02074462: Effect of Inflammation on Voriconazole Concentration
Official title: Managing Voriconazole Exposure During Severe Infection; Effect of Inflammation on Voriconazole Metabolic Ratio
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammation
Fungal Infection
Keywords: Voriconazole
CRP
Inflammation
Pharmacokinetics
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2014-02-28
Enrollment: 36
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 patients admitted to the University Medical Center Groningen who receive voriconazole

Brief summary: Voriconazole is a broad-spectrum antifungal agent. There is evidence for a relation between the efficacy and safety of voriconazole and voriconazole trough concentrations. There are several factors that could influence voriconazole concentrations. Inflammation could be one of these factors. In a retrospective study was observed that reduced metabolism of voriconazole was related to inflammation in patients with severe infections. Reduced metabolism of voriconazole resulted in high voriconazole levels and low N-oxide metabolite (inactive metabolite of voriconazole) levels. The purpose of this study is to determine an algorithm to guide dosing of voriconazole during severe inflammation and to develop a multiple linear regression model to describe the contribution of CRP concentrations to the variability in voriconazole levels and metabolic ratio.


Eligibility criteria: Inclusion Criteria:

* age ≥ 18 yrs
* treatment with voriconazole
* written informed consent

Exclusion Criteria:

* concomitantly using a strong inhibitor or inducer of CYP P450

Primary outcomes:
measure: Plamsa concentration of voriconazole and voriconazole N-oxide in patients during a severe inflammation
timeFrame: Up to 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
References:
Clinical trial NCT04606862: A Clinical Trial to Evaluate the Efficacy of the Morley Medical Sepsis (MMS) Software Device in Predicting Sepsis in Adult Patients Using Artificial Intelligence (AI) Machine Learning Algorithms
Official title: A Non-Randomized Clinical Trial to Investigate the Efficacy of the Morley Medical Sepsis (MMS) Software Device in the Prediction and Early Detection of Sepsis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sepsis
Lead sponsor: Morley Medical
Sponsor class: INDUSTRY
Collaborators: name: Morley Research Consortium
First posted: 2020-10-28
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a pivotal medical device clinical trial comparing the clinical outcomes in hospitalized patients monitored with the MMS Software Device for the prediction and early detection of sepsis versus patients monitored with current standard sepsis scoring systems at participating clinical trial sites. This will be conducted through a non-randomized multi-center, non-blinded, clinical trial.
Primary purpose: DIAGNOSTIC

Brief summary: This is a pivotal medical device clinical trial evaluating the clinical outcomes in hospitalized patients monitored with the Morley Medical Sepsis Software Device. The device uses unique AI machine learning algorithms to analyze patient data in real time and generate clinical decision support sepsis risk predictions for clinicians.


Eligibility criteria: Inclusion Criteria:

* Male or female patient 18 years of age or older
* Patient is admitted or had been admitted to a participating healthcare facility

Exclusion Criteria:

* Sepsis diagnosis present on admission
* Involvement in a clinical trial of another investigational product with similar purpose

Primary outcomes:
measure: In-hospital sepsis prevalence
timeFrame: Up to 8 weeks
measure: In-hospital sepsis related 30-day mortality
timeFrame: 30 days
Secondary outcomes:
measure: In-hospital all-cause 30-day mortality
timeFrame: 30 days
measure: Hospital length of stay
timeFrame: Up to 8 weeks
measure: Hospital re-admission
timeFrame: Up to 8 weeks
measure: Time of initial IV fluids administration
timeFrame: Day 1 to Day 30, or until discharge
measure: Time of initial vasopressors administration
timeFrame: Day 1 to Day 30, or until discharge
measure: Time of initial antibiotics administration
timeFrame: Day 1 to Day 30, or until discharge
measure: Time of initial blood microbiology culture
timeFrame: Day 1 to Day 30, or until discharge
measure: Sepsis related adverse outcomes (septic shock)
timeFrame: Day 1 to Day 30, or until discharge
measure: Sepsis prediction to onset time
timeFrame: Day 1 to Day 30, or until discharge
measure: Sensitivity and specificity of sepsis prediction
timeFrame: Day 1 to Day 30, or until discharge
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00510562: Effect of Cranial Osteopathy on Visual Function
Official title: Effect of Cranial Osteopathy on Visual Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Function
Keywords: Cranial manipulation
Visual function
Lead sponsor: Nova Southeastern University
Sponsor class: OTHER
First posted: 2007-08-02
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is the purpose of this study to attempt to determine if there is an immediate, measurable change in visual function as a direct result following a session of cranial osteopathic manipulation.


Eligibility criteria: Inclusion Criteria:

* Free of active ocular or systemic disease
* Refractive error between six diopters of myopia and five diopters of hyperopia with regular astigmatism of any amount
* Normal best-corrected visual acuity at 20/40 or better
* Normal amplitude of accommodation
* Willing to undergo cranial osteopathic manipulation

Exclusion Criteria:

* Pregnancy
* History of previous closed head trauma or brain injury
* Students from the Nova Southeastern University Colleges of Osteopathic Medicine and Optometry
* Prior cranial manipulative treatment/craniosacral therapy

Primary outcomes:
measure: Accommodative system testing Visual acuity testing Stereoacuity testing Vergence system testing Pupillary testing
timeFrame: Immediately after intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Ft. Lauderdale
country: United States
facility: Nova Southeastern University Davie Health Center
state: Florida
Study officials:
affiliation: Nova Southeastern University
name: Mark Sandhouse, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sandhouse ME, Shechtman D, Sorkin R, Drowos JL, Caban-Martinez AJ 3rd, Patterson MM, Shallo-Hoffmann J, Hardigan P, Snyder A. Effect of osteopathy in the cranial field on visual function--a pilot study. J Am Osteopath Assoc. 2010 Apr;110(4):239-43.
Clinical trial NCT06361862: Does Continuous Vital Sign Monitoring Increase Investigations and Interventions in Complication-free Patients?
Official title: Does Continuous Vital Sign Monitoring Increase Investigations and Interventions in Complication-free Patients? - a Sub-study of Randomized Clinical Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Chronic Obstructive Pulmonary Disease
Surgery-Complications
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Bispebjerg Hospital
First posted: 2024-04-12
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This aim of this study is to investigate whether active alerts during CVSM result in an increased number of diagnostic tests and treatments in complication free patients, hypothesizing that more interventions are performed in the CVSM-group than standard of care (EWS) group.


Eligibility criteria: Inclusion Criteria:

* • Patients from WARD - RCT.

Exclusion Criteria:

-

Primary outcomes:
measure: Frequency of patients having at least one of the following tests/treatments:
timeFrame: 72 hours
Secondary outcomes:
measure: The frequency of individual treatments and diagnostics:
timeFrame: 72 hours
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Eske Kvanner Aasvang
Study officials:
References:
Clinical trial NCT01514162: Post-Approval Study Protocol of the St. Jude Medical Trifecta Valve
Official title: Post-Approval Study Protocol of the St. Jude Medical Trifecta Valve
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Valve Diseases
Keywords: Trifecta Valve
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2012-01-20
Enrollment: 245
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: To further evaluate the long term clinical safety and effectiveness of the Trifecta valve

Detailed description: To further evaluate the long term clinical safety and effectiveness of the Trifecta valve in subjects who had a Trifecta valve implanted during the IDE study.

Eligibility criteria: Inclusion Criteria:

* Subjects implanted with a Trifecta valve at one of the US sites of the IDE study.
* Subject met eligibility criteria of IDE study
* Subject agrees to complete study follow-up visits
* Subject provides written informed consent

Exclusion Criteria:

* Subject currently participating in another device or drug study
* Subject unable or unwilling to return for study follow-up visits

Primary outcomes:
measure: Late Adverse Event Incidence
timeFrame: 5 years
Secondary outcomes:
measure: Characterize Patient NYHA Functional Classification Status
timeFrame: 5 years
measure: Report the Hemodynamic Performance of the Valve
timeFrame: 5 years
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital Cardiac Surgical Associates
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Asheville
country: United States
facility: Mission Hospital
state: North Carolina
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt Heart Institute
state: Tennessee
city: Murray
country: United States
facility: Intermountain Heart & Lung Surgical Associates
state: Utah
Study officials:
References: