louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04682132: Polk COVID-19 and Flu Response
Official title: County-wide Emergency Personnel Assessment of COVID-19 and Influenza Status
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Lead sponsor: Polk County Fire Rescue
Sponsor class: OTHER_GOV
First posted: 2020-12-23
Enrollment: 686
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: Volunteers of Polk County (FL) emergency personnel

Brief summary: Study Objectives:

To perform COVID-19 diagnostic and serologic testing on emergency medical personnel in Polk County to determine:

1. COVID-19 prevalence
2. Rate of convalesced personnel (+antibodies)
3. Rate of asymptomatic carriers

Detailed description: This observational study involves a community wide program offering free COVID-19 testing to county front line workers, including EMS personnel, board of county commissioners and sheriffs' office personnel. These personnel will also be asked to fill out a survey that asks about their medical history and which of any symptoms they have experienced in the prior three weeks. The survey is voluntary and written informed consent is obtained . EMS personnel can still get the free testing even if they do not want to fill out the survey.

The primary objective of the study is to describe the prevalence of COVID-19 antigen and IgM and IgG markers amongst our county/EMS workers.

The secondary objective is to describe whether the antigen/antibody markers are significantly correlated to the presence of a set of symptoms in the prior 3 weeks, and/or to the baseline demographics such as age, sex, and presence of co-morbidities.

Eligibility criteria: Inclusion Criteria:

Polk County (FL) emergency personnel including EMS, Fire Rescue, Board of County Commissioners, and Sheriff's office

Exclusion Criteria:

Age \< 18

Primary outcomes:
measure: Prevalence of COVID-19 amongst county emergency personnel
timeFrame: May-December 2020
Secondary outcomes:
measure: Correlation of common COVID-19 symptoms with result of COVID-19 test
timeFrame: May-December 2020
measure: Co-existence of influenza and COVID-19 positive test results
timeFrame: May-December 2020
Other outcomes:
Locations:
city: Bartow
country: United States
facility: Polk County Fire Rescue
state: Florida
Study officials:
affiliation: Polk County Fire Rescue
name: Campion, Breanna <breannacampion@polk-county.net> Campion
role: STUDY_DIRECTOR
References:
Clinical trial NCT05463432: A Study of HR19024 in Subjects With Advanced Solid Tumor
Official title: An Open-label Phase 1a Study of the Safety and Tolerability of HR19024 Injection in Subjects With Advanced Solid Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumor
Lead sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-07-19
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: HR19024 for all enrolled subjects
Primary purpose: TREATMENT

Brief summary: To evaluate the safety，tolerability，pharmacokinetic characteristics and preliminary efficacy of HR19024 injection in the treatment of advanced solid tumor


Eligibility criteria: Inclusion Criteria:

1. ECOG performance status 0 or 1
2. Histologically confirmed advanced solid tumor
3. Life expectancy of greater than or equal to (\>=) 12 weeks
4. At least one measurable lesion is present according to the efficacy evaluation criteria for solid tumors (RECIST 1.1)
5. Able and willing to provide a written informed consent

Exclusion Criteria:

1. Subjects with unresolved toxicity （\> CTCAE G1）of prior therapy at the time of enrolment
2. Subjects who had received anti-tumor treatments such as surgery, chemotherapy, radiotherapy recently

Primary outcomes:
measure: Maximum tolerated dose (MTD) of HR19024
timeFrame: 21-day cycle (tri-weekly)
Secondary outcomes:
measure: Response rate (RR)
timeFrame: up to 6 months following the date the last patient was randomized
measure: Disease Control Rate
timeFrame: up to 6 months following the date the last patient was randomized
measure: Duration of Response
timeFrame: up to 6 months following the date the last patient was randomized
measure: Progression free survival (PFS)
timeFrame: up to 6 months following the date the last patient was randomized
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References:
Clinical trial NCT01945632: Effect of Root Planing on Surface Topography.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Periodontitis
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2013-09-18
Enrollment: 19
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: In a clinical trial of 19 patients, 44 single-rooted teeth will be randomly assigned to one of four groups for: 1) no treatment, 2) manual root planing with curettes; 3) root planing with piezoelectric ultrasonic scraper \[PU\]; or 4) root planing with vertically oscillating ultrasonic device \[VOU\]. Post-treatment, the teeth will be extracted and their topography analyzed in 124 observations with white light confocal microscopy, measuring the roughness parameters Rp, Rv, Rt, Ra, Rq, Rku, and Rsk.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing programmed tooth extraction for chronic advanced periodontitis.

Exclusion Criteria:

* Patients with no advanced periodontitis or patients that refused the treatment.

Primary outcomes:
measure: Surface roughness
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Granada
country: Spain
facility: School of Dentistry, University of Granada
Study officials:
References:
Clinical trial NCT00723632: Pharmacoeconomic Study Assessing the Cost of Chronic Hepatitis C Treatment With Peginterferon Alfa-2b (PegIntron) and Ribavirin (Rebetol) in the Czech Republic (Study P04588)(COMPLETED)
Official title: Cost of Treatment of Chronic Hepatitis C Using Combination of Peginterferon α-2b Plus Ribavirin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Hepatitis C
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-07-29
Enrollment: 901
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with chronic hepatitis C treated with peginterferon alfa-2b and ribavirin at approximately 81 sites in the Czech Republic.

Brief summary: The objective of the study is to evaluate the costs associated with peginterferon alfa-2b (PegIntron) plus ribavirin (Rebetol) treatment for chronic hepatitis C in the Czech Republic. Only costs associated with rescue medication, concomitant therapy, disease monitoring, and medical intervention costs recognized by the treating institution as treatment-related expenses will be included in the analysis. The study will also evaluate the correlation between hepatitis C virus (HCV) therapy-related costs with ribavirin dosing and participant history.


Eligibility criteria: Inclusion Criteria:

* Participants with chronic hepatitis C
* At least 18 years old
* Eligibility determined based on the diagnosis and medical judgment only.

Exclusion Criteria:

* None

Primary outcomes:
measure: Average Cost Per Participant With Sustained Virologic Response (SVR) Stratified by Weight Category
timeFrame: From enrollment up to 48 weeks for participants with hepatitis C virus (HCV) genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3
Secondary outcomes:
measure: Average Cost Per Participant With SVR Stratified by Ribavirin Dosage
timeFrame: From enrollment up to 48 weeks for participants with HCV genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3
measure: Average Cost Per Participant With SVR Stratified by Prior Treatment Status
timeFrame: From enrollment up to 48 weeks for participants with HCV genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01074632: Effect of Calories and Fat Content on the Pharmacokinetics of Lurasidone HCl
Official title: A Phase 1, Open-Label Study to Determine the Effect of Calories and Fat Content on the Pharmacokinetics of Repeated Dose Lurasidone 120 mg in Subjects With Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2010-02-24
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The objective of this study is to evaluate the effect of calorie and fat content on the pharmacokinetics of Lurasidone HCl in subjects with schizophrenia, schizoaffective disorder, or schizophreniform disorder.


Eligibility criteria: Inclusion Criteria:

* Male and female 18 to 65 years of age
* BMI \>= 19.5 and \<= 37 kg/m2
* No clinically relevant abnormal laboratory values

Exclusion Criteria:

* History or presence of renal or hepatic insufficiency
* Participated in a clinical trial in the past 30 days
* Use of con meds that prolong the QT/QTc taken within 14 days prior to study drug administration

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: California Clinical Trials
state: California
city: Wichita
country: United States
facility: Clinical Research Institute
state: Kansas
Study officials:
References:
Clinical trial NCT02492932: The Second Try During Landmark Approach of the Internal Jugular Vein: an Ultrasonographic Prelocation Study
Official title: The Second Try During Landmark Approach of the Internal Jugular Vein: an Ultrasonographic Prelocation Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Jugular Veins
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-07-09
Enrollment: 323
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Two approaches are possible when the first finder needle attempt of the internal jugular vein cannulation fails; the needle can be turned slightly laterally or the puncture point can be moved slightly medially. This study is an ultrasonographic stimulation study to evaluate the success rate of turning the needle laterally and moving the puncture point medially, and to determine the proper angle or distance for the second try of internal jugular vein cannulation.

Detailed description: Immediately after induction of general anesthesia, the patient's head is turned slightly, and the table is tilted at 10 degrees, and the puncture point estimated by the anatomical landmarks are marked on the patient's skin. The investigators obtain a sonographic view at the estimated puncture point. It is recorded "success" when the internal jugular vein is visualized on the ultrasonography, and the estimated needle path passes the internal jugular vein. It is recorded "failure" if the internal jugular vein is not visualized on the ultrasonography, and the estimated needle path does not pass the internal jugular vein. After "failure" of the first attempt, the probe is either turned laterally or moved medially until the internal jugular vein is visualized on the ultrasonography, and the estimated needle path passes the internal jugular vein. The angle and distance is recorded. The location of the carotid artery is always marked on the ultrasonography for evaluation of complications.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for general anesthesia

Exclusion Criteria:

* Refusal of consent
* Patients with C-spine injuries
* Patients with atlanto-axial instability
* Patients at risk of increased intracranial pressure

Primary outcomes:
measure: Success rate of internal jugular vein cannulation at the second attempt after failure of first attempt on ultrasonographic simulation
timeFrame: intraoperative
Secondary outcomes:
measure: Degree of lateral rotation or medial movement for successful puncture of second attemp
timeFrame: intraoperative
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Chul-Woo Jung
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03872232: Evaluating the Efficacy and Safety of Co-administrated Rosuvastatin/Ezetimibe and Telmisartan
Official title: A Randomized, Double-blind, Active-controlled, Multicenter Phase3 Trial to Evaluate the Efficacy and Safety of Co-administrated Rosuvastatin/Ezetimibe and Telmisartan in Patients With Primary Hypercholesterolemia and Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Hypertension
Lead sponsor: Addpharma Inc.
Sponsor class: INDUSTRY
First posted: 2019-03-13
Enrollment: 180
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: The purpose of this study is to evaluate the efficacy and safety of co-administrated Rosuvastatin/Ezetimibe and Telmisartan in patients with primary hypercholesterolemia and essential hypertension.

Detailed description: This trial is a phase 3 study to evaluate efficacy and safety of co-administrated Rosuvastatin/Ezetimibe and Telmisartan in patients with primary hypercholesterolemia and essential hypertension.

In "Rosuvastatin/Ezetimibe+Telmisartan" treatment group, 60 subjects will be assigned and the subjects administer "Rosuvastatin/Ezetimibe+Telmisartan" for 8 weeks.

In "Rosuvastatin/Ezetimibe" treatment group, 60 subjects will be assigned and the subjects administer "Rosuvastatin/Ezetimibe" for 8 weeks.

In "Telmisartan" treatment group, 60 subjects will be assigned and the subjects administer "Telmisartan" for 8 weeks.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Subjects with hypertension and hyperlipidemia

Exclusion Criteria:

* Patient with known or suspected secondary hypertension
* Other exclusions applied

Primary outcomes:
measure: Low density lipoprotein cholesterol (LDL-C)
timeFrame: Baseline, Week 8
measure: Mean sitting systolic blood pressure (MSSBP)
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Mean sitting systolic blood pressure (MSSBP)
timeFrame: Baseline, Week 4
measure: Low density lipoprotein cholesterol (LDL-C)
timeFrame: Baseline, Week 4
measure: Mean sitting diastolic blood pressure (MSDBP)
timeFrame: Baseline, Week 4, Week 8
measure: Total Cholesterol (TC)
timeFrame: Baseline, Week 4, Week 8
measure: High density lipoprotein cholesterol (HDL-C)
timeFrame: Baseline, Week 4, Week 8
measure: Triglyceride (TG)
timeFrame: Baseline, Week 4, Week 8
measure: Low density lipoprotein cholesterol/High density lipoprotein cholesterol (LDL-C/HDL-C)
timeFrame: Baseline, Week 4, Week 8
measure: Total Cholesterol/High density lipoprotein cholesterol (TC/HDL-C)
timeFrame: Baseline, Week 4, Week 8
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hyo Soo Kim, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01615432: Comparison of Synchrony Between 4 NIV Ventilators
Official title: Comparison of Four Different Ventilators for Noninvasive Ventilation in Terms of Patient-ventilator Synchrony and Comfort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratoy Failure Requiring NIV Treatment
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2012-06-08
Enrollment: 22
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: Comparison of the effects of 4 ventilators dedicated to NIV (2 home ventilators and 2 ventilators designed for NIV) on patient-ventilator synchrony and comfort in patients admitted in the intensive care unit for respiratory failure and treated with NIV.


Eligibility criteria: Inclusion Criteria:

* respiratory failure

Exclusion Criteria:

* Severe hypoxemia requiring an FiO2 \> 0.6
* Hemodynamic instability : defined as a variation of \> 20% in mean arterial pressure (MAP) and heart rate (HR) during the previous 2 hours; the need for high doses of catecholamines (namely \> 0.5 mcg/kg/min) and/or the need of major volume resuscitation (more than 2 liters of fluids in 2 hours)
* Impaired consciousness or absence of patient cooperation;
* Facial or laryngeal lesions contraindicating the use of NIV;
* Poor short term prognosis.
* Age \< 18 years old

Primary outcomes:
measure: Patient-ventilator synchrony
Secondary outcomes:
measure: comfort of patient under NIV
measure: Ventilatory parameters
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Intensive care and burn unit / CHUV
state: Vaud
Study officials:
References:
Clinical trial NCT06470932: Outcome of Patients Admitted to Pediatric Intensive Care for Acute Respiratory Failure
Official title: Outcome of Patients Admitted to Pediatric Intensive Care for Acute Respiratory Failure
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pediatric Respiratory Diseases
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to assess the quality of life of patients six months after admission to a pediatric intensive care unit for acute respiratory failure. Children's quality of life will be assessed using the PedsQL scale at 6 months. This is a prospective cohort diagnostic and prognostic study.


Eligibility criteria: Inclusion Criteria:

* admitted in the PICU of Grenoble-Alps University Hospital
* for acute respiratory failure (code J960) requiring mechanical ventilation for at least 48hrs

Exclusion Criteria:

* already followed-up by a pediatric pulmonologist
* with congenital disease
* with long term ventilation
* still admitted at 3 months

Primary outcomes:
measure: Quality of life at 3 months
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01485432: Goal Directed Hemodynamic Management and Renal Outcome After Renal Transplant Surgery
Official title: Can Goal Directed Hemodynamic Management Improve Renal Outcome After Renal Transplant Surgery?
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Renal Transplant Surgery
Keywords: Renal transplant surgery
hemodynamic management
PiCCO
delayed graft function
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2011-12-05
Enrollment: 1
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing renal transplant surgery

Brief summary: This study is designed to compare the incidence of delayed graft function in patients following renal transplant surgery with different perioperative hemodynamic managements: a goal directed hemodynamic management group (using PiCCO) and a control group.

Detailed description: Volume assessment and management during renal transplantation is one of the most challenging problems the anesthetist has to deal with. It seems sensible that individualized volume management and hydration therapy during the operation and during the stay at the intensive care unit could improve perfusion of the transplanted organ resulting in a better transplant function. Aim of this study is to investigate the impact of a goal directed hemodynamic management on incidence of delayed graft function (DGF) after renal transplant surgery.

Therefore patients will be randomized in one of two groups, the PiCCO group with goal directed hemodynamic management during operation and during the ICU-stay and the control group with hemodynamic management performed according to heart rate, blood pressure and central venous pressure.

Eligibility criteria: Inclusion Criteria:

* Renal Transplant Surgery
* Age ≥ 65 years
* Written informed consent

Exclusion Criteria:

* Contraindications for an arterial line in the femoral artery:

  * stents
  * bypasses
  * severe peripheral artery occlusive disease

Primary outcomes:
measure: delayed graft function
timeFrame: Start of anesthesia until day 7 after the operation
Secondary outcomes:
Other outcomes:
Locations:
city: Munic
country: Germany
facility: Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München
state: Bavaria
Study officials:
affiliation: Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München, Ismaninger Str. 22, 81675 München
name: Bettina Jungwirth, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goepfert MS, Reuter DA, Akyol D, Lamm P, Kilger E, Goetz AE. Goal-directed fluid management reduces vasopressor and catecholamine use in cardiac surgery patients. Intensive Care Med. 2007 Jan;33(1):96-103. doi: 10.1007/s00134-006-0404-2. Epub 2006 Nov 21.
citation: Boom H, Mallat MJ, de Fijter JW, Zwinderman AH, Paul LC. Delayed graft function influences renal function, but not survival. Kidney Int. 2000 Aug;58(2):859-66. doi: 10.1046/j.1523-1755.2000.00235.x.