louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00162591: Bispectral Index as an Analgesia Monitoring in Severely Ill Patient: Effect of Remifentanyl
Official title: Bispectral Index as an Analgesia Monitoring in Severely Ill Patient: Effect of Remifentanyl
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Keywords: Bispectral index
sedation
remifentanyl
Bronchoalveolar lavage
Intensive care
Nociceptive stimuli
Sedated patient
BIS variation
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2005-09-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this protocol is to study the prophylactic effect of remifentanil on bispectral index variation during a nociceptive stimuli.

Detailed description: Pain is difficult to estimate in ICU because most of the patients are sedated. Bispectral index could be helpful in detecting this pain in ICU patients. Remifentanil is a morphinomimetic product with short half life that could be interesting for short nociceptive stimuli, as bronchoalveolar lavage.

The purpose of this study is to evaluate the impact of remifentanil infusion on bispectral index (BIS) variations during bronchoalveolar lavage.

It is a prospective, double blind study, versus placebo on 40 sedated and critically ill patients.

The hypothesis is that BIS can study analgesia in sedated patient.

Eligibility criteria: Inclusion Criteria:

* Sedated patient with mechanical ventilation with suspected nosocomial pneumonia

Exclusion Criteria:

* Pace maker
* Neurologic illness
* Hemodynamic instability
* Hypothermia

Primary outcomes:
measure: BIS variation during bronchoalveolar lavage
Secondary outcomes:
measure: Systolic blood pressure, diastolic blood pressure, heart rate viation
Other outcomes:
Locations:
city: Paris
country: France
facility: Surgical ICU Bichat Claude Bernard
Study officials:
affiliation: Surgical ICU Bichat Claude Bernard (Paris, France)
name: QUINTARD H Hervé, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Quintard H, Pavlakovic I, Mantz J, Ichai C. Adjunctive remifentanil infusion in deeply sedated and paralyzed ICU patients during fiberoptic bronchoscopy procedure: a prospective, randomized, controlled study. Ann Intensive Care. 2012 Jul 16;2(1):29. doi: 10.1186/2110-5820-2-29.
Clinical trial NCT05617391: An Evaluation of Concordance of Smartwatch ECG and One Clinical ECG and Comparison of The Two ECGS in Terms of Predictive Risks
Official title: An Evaluation of Concordance of Smartwatch ECG and One Clinical ECG and Comparison of The Two ECGS in Terms of Predictive Risks
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Childhood Cancer
Cardiomyopathy, Primary
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2022-11-15
Enrollment: 1300
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants who meet eligibility criteria and consent to enrollment on the study.

Brief summary: The participant is being asked to take part in this trial, because the participant is a survivor of childhood cancer.

Primary Objective

To evaluate remote cardiomyopathy prediction via smartwatch and one clinical ECG and assess the concordance of the two ECGs in terms of predicted risk.

Secondary Objective

To build a novel predictive model solely on smartwatch ECG to predict risk for cardiomyopathy.

Detailed description: The proposed study is looking to compare the 30 second ECG read from a smartwatch to the clinical ECG during a SJLIFE scheduled ECG appointment.

Eligibility criteria: Inclusion Criteria:

* SJLIFE participant and 22 years of age or older at time of enrollment
* Participant or legal guardian is able and willing to give informed consent
* At least 5 years after childhood cancer diagnosis

Exclusion Criteria:

* Been diagnosed with cardiomyopathy on previous SJLIFE ECG
* Currently on heart medication

Primary outcomes:
measure: Standard 12-lead ECG
timeFrame: Baseline
measure: Apple Smartwatch ECG 30-second recording
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Melissa Hudson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01426191: Study on Cefotaxime and Sulbactam Sodium for Injection (2:1) for Treatment of Respiratory and Urinary Tract Infection
Official title: A Open Multi-center Clinical Study on Cefotaxime Sodium and Sulbactam Sodium for Injection(2:1) for Treatment of Respiratory and Urinary Tract Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Tract Infections
Urinary Tract Infections
Keywords: Cefotaxime sulbactam sodium
Phase IV clinical studies
Respiratory and urinary tract infections
Lead sponsor: Xiangbei Welman Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2011-08-31
Enrollment: 2032
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hospitalized patients or outpatients

Brief summary: In the proposed study, the investigators plan to evaluate the efficacy and safety of Cefotaxime sodium and sulbactam sodium for injection (2:1)for the treatment of respiratory and urinary tract acute bacterial infection under the widely used in clinical conditions.

Detailed description: Cefotaxime is a third-generation cephalosporins.Cefotaxime sodium and sulbactam sodium for injection (2:1)plays a therapeutic role by the former inhibiting bacterial cell wall synthesis by irreversible competitive inhibition of β-lactamase.The antimicrobial effect of cefotaxime can be enhanced by the two combined.The compound specifically aims to the mechanism of bacterial resistance, extending the life of cefotaxime in the treatment-resistant pathogen infections.

Eligibility criteria: Inclusion Criteria:

1. patients who qualify for moderate and severe acute respiratory or urinary tract bacterial infection of acute bacterial infections need for systemic antibiotic therapy.
2. Age\>18 years old, Gender: both
3. Women of childbearing age were to be negative pregnancy test and agree to take contraceptive measures during the trial;
4. patients were volunteers and signed informed consent form;
5. patients did not participate in other clinical trials.

Exclusion Criteria:

1. Patients were hypersusceptibility to the test drug or other penicillins ,β-lactamase inhibitor
2. Pregnant and Lactating women
3. Patients have severe liver,kidney,cardiovascular,cerebrovascular,endocrine and hematopoietic system of primary diseases and that of immunodeficiency,advanced cancer or mental illness.
4. Patients who were complicated by other diseases and thought to affect efficacy evaluations or poor compliance.

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: day0-day22-28
Secondary outcomes:
measure: Clinical Effect
timeFrame: at weeks 4,day22-28
Other outcomes:
Locations:
Study officials:
affiliation: Zhejiang University
name: lanjuan lj li, docter
role: PRINCIPAL_INVESTIGATOR
affiliation: Chongqing Red Cross Hospital
name: changqing cq li, doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02549391: Phase 3 Study of KHK7580
Official title: Phase 3 Study of KHK7580 (A Randomized, Double-Blind, Intra-Subject Dose-Adjustment, Parallel-Group Study of KHK7580 and Cinacalcet Hydrochloride in Subjects With Secondary Hyperparathyroidism Receiving Hemodialysis)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Secondary Hyperparathyroidism
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-09-15
Enrollment: 634
Sex: ALL
Minimum age (years): 20
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 KHK7580 orally administered once daily for 30 weeks in subjects with secondary hyperparathyroidism (SHPT) receiving hemodialysis in a randomized, double-blind, intra-subject dose-adjustment, parallel-group design with cinacalcet hydrochloride as an active control.


Eligibility criteria: Inclusion Criteria:

* Personally submitted written voluntary informed consent to participate in the study
* Stable chronic renal disease treated with hemodialysis 3 times weekly for at least 12 weeks before screening
* Mean intact PTH level of \> 240 pg/ml at screening, at 2 weeks and 1 week before the start of study treatment

Exclusion Criteria:

* Treatment with cinacalcet hydrochloride within 2 weeks before screening;
* Change in dose or dosing regimen of an activated vitamin D drug or its derivative, phosphate binder, or calcium preparation within 2 weeks before screening; or start of treatment with such drugs within 2 weeks before screening;
* Parathyroidectomy and/or parathyroid intervention within 24 weeks before screening;
* Severe heart disease;
* Severe hepatic dysfunction;
* Uncontrolled hypertension and/or diabetes;
* Treatment with an investigational product (drug or medical device) in a clinical study or any study equivalent to clinical study within 12 weeks before screening;
* Primary hyperparathyroidism;
* Other conditions unfit for participation in this study at the discretion of the investigator or subinvestigator.

Primary outcomes:
measure: Percentage of subjects in the evaluation period achieving a mean intact parathyroid hormone (PTH) level of ≥ 60 pg/mL and ≤ 240 pg/mL
timeFrame: Weeks 28-30
Secondary outcomes:
measure: Percentage of subjects in the evaluation period achieving a mean percent decrease in intact PTH level of ≥ 30% (percent change ≤ -30%) from baseline
timeFrame: Weeks 28-30
measure: Mean percent change in the evaluation period in intact PTH level from baseline
timeFrame: Weeks 28-30
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin
Study officials:
References:
citation: Shigematsu T, Asada S, Endo Y, Kawata T, Fukagawa M, Akizawa T. Evocalcet with vitamin D receptor activator treatment for secondary hyperparathyroidism. PLoS One. 2022 Feb 17;17(2):e0262829. doi: 10.1371/journal.pone.0262829. eCollection 2022.
Clinical trial NCT01090791: FLOTRAC/VIGILEO in Acute Circulatory Failure
Official title: Assessment of the FLOTRAC/VIGILEO Third Generation Software to Predict Fluid Responsiveness in Critically Ill Patient With Acute Circulatory Failure
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Critically Ill
Acute Circulatory Failure
Fluid Loading
Keywords: critically ill patient
Lead sponsor: Hôpital Européen Marseille
Sponsor class: OTHER
First posted: 2010-03-23
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients with acute circulatory failure, as defined by two or more of the inclusion criteria.

Brief summary: Acute circulatory failure may be related to hypovolemia. Fluid loading increases stroke volume in approximatively half of challenges. Determining fluid responsiveness prevents unnecessary fluid loading. Passive leg raising (PLR) provides a transient increase of 300 ml in venous return for a short time. The measurement of stroke volume (SV) before and after a PLR test allows physician to detect fluid responsiveness, when stroke volume increases is higher than 15 %. Beside thermodilution, the use of non invasive device to measure stroke volume becomes largely employed. Arterial Pressure based Cardiac Output (APCO), provided by the Flotrac/Vigileo system, does not required specific materials nor repeated calibration. The third generation software is believed to be more accurate and more precise for SV measurement. The aim of this study is to test the performance of the Flotrac/Vigileo device in a situation of rapid venous return changes induced by PLR and then by fluid loading. Patients will be classify posteriorly in responders and non responders, according to the magnitude of the fluid loading-induced SV changes measured by transthoracic echocardiography.


Eligibility criteria: Inclusion Criteria:

* Systolic arterial pressure \< 90 mmHg or Mean arterial pressure \< 60 mmHg
* Heart rate \> 100 bpm
* Norepinephrine infusion
* Urine output \< 0.5 ml/kg/h during at least two consecutive hours
* skin mottling
* Capillary refill time \> 3 sec

Exclusion Criteria:

* Acute cor pulmonale
* Ongoing renal replacement therapy
* Lack of echogenicity during transthoracic echocardiography

Primary outcomes:
measure: Stroke volume measurement between Flotrac/Vigileo device and transthoracic echocardiography
timeFrame: 30 min
Secondary outcomes:
measure: SV cut-off with Flotrac/Vigileo and with TEE to predict fluid responsiveness
timeFrame: 30 min
measure: SVV cut-off with Flotrac/Vigileo to predict fluid responsiveness
timeFrame: 30 min
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hopital Paul Desbief
city: Marseille
country: France
facility: Hopital Ambroise Paré
Study officials:
affiliation: Fondation Hôpital Ambroise Paré
name: Jérôme Allardet-Servent, MD,MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05138991: Reproducibility and Accuracy of a Portable System for Early Detection of Cardiac Dysfunction in Childhood Cancer Survivors
Official title: Assessment of the Reproducibility and Accuracy of a Portable System for Early Detection of Cardiac Dysfunction in Childhood Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-12-01
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The clinical trial compares the reproducibility and accuracy of cardiac tonometry-based portable systems that may detect early cardiac dysfunction (SphygmoCor® Xcel and Oscar 2™ ambulatory blood pressure monitor) at home and in the clinic to currently available screening tests for heart failure including echocardiogram (echo) and cardiovascular magnetic resonance (CMR). The SphygmoCor® Xcel and Oscar 2™ systems may help detect cardiac dysfunction earlier than other available screening tests because it can be self-administered outside of the clinic. This study aims to test the accuracy and practicality of these devices in the clinic setting and at home.

Detailed description: Primary Objective(s)

Validate the accuracy of ejection fraction, as measured using a tonometry-based system (SphygmoCor® Xcel), in the clinic setting, and determine the reproducibility (Oscar 2™) at home.

Secondary Objective(s)

Determine the cost-effectiveness of tonometry-based screening in the clinic setting and at home.

Eligibility criteria: Inclusion Criteria:

* Previously enrolled in IRB# 14154.
* Able to understand and sign the study specific informed consent form (ICF).

Exclusion Criteria:

* Participants cannot be actively receiving cancer-directed therapy.
* Standard exclusion criteria for CMR imaging will be incorporated, and these include: implanted pacemaker or defibrillator, insulin pump, cochlear implant, central nervous system aneurismal clips, implanted neural stimulator, ocular foreign body (metal), other implanted medical devices (e.g.: drug infusion ports).

Primary outcomes:
measure: Accuracy of ejection fraction (EF) in the clinic setting, and determine its reproducibility at home.
timeFrame: Up to 2 years
Secondary outcomes:
measure: Cost-effectiveness of tonometry-based screening in the clinic setting and at home.
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Saro H Armenian
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00204191: Comparison of the Two Immunosuppressive Regimens Based on Tacrolimus and Cyclosporine Following Kidney Transplantation
Official title: Open, Prospective, Randomized Study to Compare the Efficacy and Safety of Immunosuppression Regimens Based on Cyclosporine (Neoral®) and Tacrolimus (Prograf®) in Renal Transplant Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Kidney Transplantation
Keywords: kidney transplantation
Immunosuppression
Cyclosporine
Tacrolimus
Lead sponsor: Uniwersytet Mikolaja Kopernika w Toruniu
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Inc
First posted: 2005-09-20
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate and compare, in the single center setting, the safety, efficacy and cost-effectiveness of the two standard immunosuppressive regimens based on tacrolimus and cyclosporine.

Detailed description: Despite several multicenter studies, there is no hard evidence on the superiority of a cyclosporine or tacrolimus based immunosuppressive regimen following kidney transplantation, in a single-center setting. Existing studies concentrated on benefits in safety and efficacy, but seldomly evaluated the cost-effectiveness of one treatment.

The study has been designed in a fashion as close to the daily clinical practice as possible. Patients are randomized in pairs, receiving kidneys from the same donor, thus avoiding donor-related bias. Those having specific indications or contraindications for one of the study medications were not entered into the study. All other study-related decisions are made only on a clinical basis and according to the standard practice of the center. Patients are followed on the intention-to-treat rule. Cost-effectiveness will be calculated on 12-month treatment for each patient entered into the study.

Eligibility criteria: Inclusion Criteria:

* First or second cadaveric kidney transplantation
* Age over 18 years old
* Specific indications or contraindications for cyclosporine or tacrolimus are absent
* Informed consent

Exclusion Criteria:

* Specific indications for use of cyclosporine or tacrolimus
* Specific contraindications for use of cyclosporine or tacrolimus
* Participation in another interventional clinical trial
* Pregnancy or lactation

Primary outcomes:
measure: graft survival
timeFrame: at one year
measure: patient survival
timeFrame: at one year
Secondary outcomes:
measure: renal function measured by serum creatinine (SCr)
timeFrame: at one year
measure: lipid profile
timeFrame: throughout the study
measure: total cost of the treatment
Other outcomes:
Locations:
city: Bydgoszcz
country: Poland
facility: Klinika Transplantologii, Szpital Uniwersytecki, ul. M. Sklodowskiej-Curie 9
Study officials:
affiliation: Klinika Transplantologii, Collegium Medicum UMK Torun
name: Zbigniew Wlodarczyk, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00119691: Nesiritide Infusion for the Treatment of Decompensated Heart Failure and Renal Dysfunction
Official title: Nesiritide Infusion for the Treatment of Decompensated Heart Failure and Renal Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Congestive Heart Failure
Renal Insufficiency
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Scios, Inc.
First posted: 2005-07-14
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The researchers hypothesize that the addition of nesiritide to standard therapy will prevent worsening of renal function in patients admitted to the hospital with decompensated heart failure and renal dysfunction relative to standard therapy alone.


Eligibility criteria: Inclusion Criteria:

* Decompensated heart failure hospitalization with at least 1 symptom and 1 sign of elevated filling pressures
* Admission estimated creatinine clearance =\< 50 cc/min.

Exclusion Criteria:

* Systolic blood pressure \< 85 mm Hg
* Cardiogenic shock
* Volume depletion
* Myocardial infarction, unstable angina within last 30 days
* Significant valvular stenosis, hypertrophic/restrictive cardiomyopathy, or constrictive pericarditis
* Chronic hemodialysis
* Anticipated major procedure during hospitalization i.e. left heart catheterization, surgery, or transplantation
* Enrolled in another research protocol within last 30 days.

Primary outcomes:
measure: Renal function
timeFrame: within 7 days after randomization
Secondary outcomes:
measure: Weight loss
timeFrame: Within 7 days from randomization
measure: Days to optimal volume status
timeFrame: From randomization till day 7 or sooner
measure: Concomitant diuretic use
timeFrame: Within 7 days from randomization
measure: Global symptom assessment
timeFrame: 24 hrs and 3 days after randomization
measure: Length of stay
timeFrame: From admission to discharge or day 7
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Anju Nohria, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02185391: Interactive Education of Patients With Coronary Heart Disease
Official title: Development of Sustainable Methods in Interactive Patient Education to Improve Adherence After Cardiac Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Disease
Keywords: Coronary Disease
Audience Response System
Lead sponsor: Paracelsus Harz Clinic Bad Suderode.
Sponsor class: OTHER
Collaborators: name: The German Heart Foundation
First posted: 2014-07-09
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Coronary Heart Diseases are responsible for a high number of deaths in Germany. To determine the risk factors secondary prevention is of great importance. After their residence in rehabilitation centers patients often get rid of newly required skills. In addition to that parameters like BMI, blood pressure and cholesterol level return to their initial value.

Using an Audience Response System (ARS) during oral presentations in rehabilitation centers should improve the learning effect of patients. Furthermore patients will receive motivating telephone calls in the follow-up. These methods should lead to a sustainable improvement of learning effects, health care behavior and quality of life.


Eligibility criteria: Inclusion Criteria:

* Cardiovascular disease

Exclusion Criteria:

* Inability or refusal to give written informed consent

Primary outcomes:
measure: Training content as a measure of success
timeFrame: 3 - 4 weeks
Secondary outcomes:
measure: BMI and / or abdominal circumference
timeFrame: 12 months
measure: Blood Cholesterol Values
timeFrame: 12 months
measure: Depression Score
timeFrame: 12 months
measure: Health Related Quality of Living
timeFrame: 12 months
measure: Stroke
timeFrame: 12 months
measure: Myocardial Infarction
timeFrame: 12 months
Other outcomes:
Locations:
city: Quedlinburg
country: Germany
facility: Paracelsus Harz Clinic Bad Suderode
state: Saxony-Anhalt
Study officials:
References: