louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02521636: Clinical Trial Assessing the Value of an Antibiotic Protocol Guided by Serum Procalcitonin in Acute Exacerbations of Chronic Obstructive Pulmonary Disease in Intensive Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2015-08-13
Enrollment: 300
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: Investigators propose to conduct a prospective, randomized, controlled, multicenter assessing the interests of an antibiotic protocol guided by serum procalcitonin (PCT) on morbidity and mortality in patients with chronic obstructive pulmonary disease (COPD) hospitalized in intensive care unit (ICU) for acute exacerbation with or without associated pneumonia. The main objective is to show in patients hospitalized in intensive care for acute exacerbation of COPD with or without pneumonia, safety, defined as a lack of difference in mortality at 3 months, an antibiotic strategy guided by the PCT in the ICU.


Eligibility criteria: Inclusion Criteria:

* patients over 18 years
* Documented or suspected clinically COPD according to the criteria of GOLD
* In acute exacerbation
* Suspect of lower respiratory tract infection
* With or without pulmonary criteria defined as the presence of a radiological infiltrates consistent with an infectious site and associated with one or more of the following items: dyspnea, cough, sputum, fever above 38 ° C, fireplace clinical auscultation, higher leukocytosis at 10,000 / mm³ or leukopenia below 4000 / mm³
* Admitted to the hospital for less than 48 hours
* ICU Admission
* Informed Consent signed by the patient or his representative

Exclusion Criteria:

* Other than acute exacerbation etiology with or without pulmonary disease as suspected cause of ICU admission
* Patient immunocompromised neutropenia neutrophil count below 500 / mm³ secondary to chemotherapy, corticosteroids greater than 0.5 mg / kg / day for more than 10 days, HIV seropositivity
* Severe Acute Asthma
* Moribund patient or a disease with an estimated survival time of less than three months
* Therapeutic limitation Existence
* minor patient or under guardianship or custody
* Pregnant woman
* Refusal to participate in the study
* The inclusion of the subject in another biomedical research protocol in progress or for less than 30 days

Primary outcomes:
measure: mortality
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Medical Intensive Care Unit, CHU Caen
Study officials:
References:
Clinical trial NCT01948336: The Effects of Dexmedetomidine on Early Stage Renal Functions in Pediatric Patients
Official title: Phase 4 THE EFFECTS OF DEXMEDETOMIDINE ON EARLY STAGE RENAL FUNCTIONS IN PEDIATRIC PATIENTS UNDERGOING CARDIAC ANGIOGRAPHY USING NON- IONIC CONTRAST MEDIA: A DOUBLE- BLIND, RANDOMIZED CLINICAL TRIAL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Function Disorder
Hemodynamic Instability
Keywords: Contrast-induced nephropathy, Dexmedetomidine, Endothelin-1
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2013-09-23
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to evaluate the effect of dexmedetomidine infusion on early stage renal function.

Detailed description: Background: Contrast-induced nephropathy is the third most common cause of acute renal failure in hospitalized patients in all age groups. In this study we aimed to investigate the effects of dexmedetomidine on early stage renal function in pediatric patients undergoing cardiac angiography.

Methods: 60 pediatric patients between 6 and 72 months of age undergoing cardiac angiography were included in the study. Patients were divided into two groups. The patients in both groups were administered 1mgkg-1 ketamine, 1mgkg-1 propofol as bolus and followed by 1 mgkg-1hour-1 ketamine and 50 µgkg-1min-1 propofol infusion. Additionally, a loading dose of 1 µgkg-1 dexmedetomidine given over 10 minutes followed by 0.5 µgkg-1hour-1 dexmedetomidine infusion to patients in group D. The patients were evaluated for NGAL, creatinine, renin, endothelin-1, TAS and TOS blood levels before the procedure and 6th and 24th hours after the procedure. pRIFLE criteria were used to define CIN and its incidence in the study.

Eligibility criteria: Inclusion Criteria:

* 6 and 72 months children
* scheduled for cardiac angiography

Exclusion Criteria:

* patients with renal failure or diabetes mellitus, patients who were on nephrotoxic and vasoactive drugs simultaneously, patients with decompensated congestive heart failure and patients who had been administered contrast media in the last two weeks

Primary outcomes:
measure: Renal Functions,
timeFrame: Baseline, changes from baseline at 6th and 24th hours after the cardiac angiography
Secondary outcomes:
measure: Blood Pressure
timeFrame: Up to 24 hours
measure: Heart rate
timeFrame: Up to 24 hours
measure: peripheral oxygen saturation
timeFrame: Up to 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: TC Erciyes University
name: Adnan Bayram, Asst. Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT06263036: Morphometric Examination of the Larynx
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laryngeal Dimensions in Males and Females
Keywords: larynx, measurement, cadaver, Turkish population
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2024-02-16
Enrollment: 102
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Turkish cadavers including males and females of various ages and heights

Brief summary: Objective: To measure laryngeal dimensions in a sample of Turkish cadavers including males and females of various ages and heights.

Patients and Methods: Morphological measurement was performed on 102 laryngeal specimens. Laryngeal cartilages were collected from human cadavers. All dimensions of the cartilages were measured using a thread and vernier calipers. Age, sex, and height were recorded. Results for men and women were compared.


Eligibility criteria: Inclusion Criteria:human cadavers -

Exclusion Criteria:

-

Primary outcomes:
measure: To measure laryngeal dimensions in cadavers
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04683536: Bakircay University Cigli Training and Research Hospital
Official title: Bakircay University Cigli Training and Research Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Keywords: obturator nerve blockade
bladder cancer
non-muscle invasive bladder cancer
adductor contraction
bladder perforation
Lead sponsor: Recep Tayyip Erdogan University Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 106
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with lateral wall localized non muscle invasive bladder cancer underwent TUR-BT under spinal anesthesia combined with ultrasound guided obturator nerve blockade

Brief summary: The aim of the study is to investigate the oncological outcomes of obturator nerve blockade in patients with lateral wall localized non-muscle invasive bladder cancer

Detailed description: Patient divided into two group.First group includes patients underwent TUR-BT under only spinal anesthesia and second group includes patients underwent TUR-BT under spinal anesthesia combined with ultrasound guided obturator nerve blockade.

Eligibility criteria: Inclusion Criteria:

* patients with lateral wall localized non muscle invasive bladder cancer

Exclusion Criteria:

* history of previous TUR-BT
* diagnosis of non-urothelial carcinoma
* coagulopathy
* history of allergic reaction to the local anesthtetic agent
* presence of muscle-invasive bladder cancer
* history of chemotherapy or radiotherapy before TUR-BT
* precence of variant histopathology
* using bipolar energy for the resection of bladder tumor
* presence of concomittant upper urothelial tract urothelial carcinoma
* patients with the neuromusculer disease
* pregnancy
* history of medication effecting immune system

Primary outcomes:
measure: Oncological outcomes
timeFrame: 5 year
Secondary outcomes:
measure: Complications
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06169436: Translational Cancer Observational Protocol
Official title: 2014 Transizionali - Observational Study on the Occurrence of Relapses and on the Quality of Life in Patients Who Underwent Nephroureterectomy Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Upper Urinary Tract Urothelial Carcinoma
Keywords: Upper Urinary Tract Urothelial Carcinoma
Nephroureterectomy surgery
Relapse
Quality of life
Diagnosis and Treatment strategies
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 1250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with upper tract urothelial cancer who underwent nephroureterectomy surgery.

Brief summary: Observational study on relapse occurrence and on the quality of life in patients who underwent nephroureterectomy surgery

Detailed description: Monocentric prospective and retrospective observational study on the quality of life and on the pathological status in patients who underwent nephroureterectomy surgery. Oncological, psychological, sexual and quality of life-related data will be collected within a specifically created database that will allow us an easy and secure data extraction for the statistical analysis required by the clinical trial in terms of oncological relapse, clinical progression and improve the assistance and therapeutic strategy for each patient. Retrospective data for patients who underwent surgery between 1987 and today will be available in the form of clinical report stored in the hospital archives.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Upper tract urothelial cancer diagnosis
* Indication to cancer removal through nephroureterectomy surgery
* Ability to read and sign the informed consent

Exclusion Criteria:

* Age \< 18 years
* Absence of upper tract urothelial cancer
* Inability to read and sign the informed consent

Primary outcomes:
measure: Clinical progression data collection
timeFrame: 50 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
state: MI
Study officials:
affiliation: IRCCS Ospedale San Raffaele
name: Francesco Montorsi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03250936: Descriptive Study of Trampoline Accidents in the Pediatric Emergency Department of Rennes
Official title: Descriptive Study of Trampoline Accidents in the Pediatric Emergency Department of Rennes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma
Emergencies
Child, Only
Keywords: trampoline
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2017-08-16
Enrollment: 4000
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children between 2 and 16 years old consulting in pediatric emergencies for a trauma related to trampoline Children between 2 and 16 years old consulting in pediatric emergencies for a trauma related to others sport

Brief summary: The aim of this study is to compare trauma related to others sport to trauma due to trampoline in pediatric emergencies of Rennes.

Detailed description: Trampoline accidents are increasing since a few years. In Rennes hospital, pediatric emergencies are experiencing a subjective increase in admissions for trampoline trauma with increasingly early ages and severe trauma. The aim of this study is to compare trauma related to others sport to trauma due to trampoline in pediatric emergencies of Rennes.

In parallel, retrospective data analysis will be performed on the same data during the year 2008, to compare with a period before the explosion of trampoline sales.

Eligibility criteria: Inclusion Criteria:

* Child from 2 to 16 years old
* Childs admitted in emergencies unit for a trauma
* Parents not opposed in their child's participation to the study

Exclusion Criteria:

* Child under 2 years old (before learning to walk)
* Single wounds and head injuries not related to sports activities (Fall from a bed or from its height, simple wound with sharp objects)

Primary outcomes:
measure: Types of trauma related to trampoline compared to trauma related to others sport in pediatric emergencies of Rennes.
timeFrame: 6 months
Secondary outcomes:
measure: Arguments for preventive management in the general practitioner
timeFrame: 6 months
Other outcomes:
Locations:
city: Rennes
country: France
facility: Pediatric and orthopedic surgery division
Study officials:
affiliation: Rennes University Hospital
name: Bernard Fraisse, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01326936: Online Primary Care Physician (PCP) Training in Screening, Brief Intervention, Referral, and Treatment
Official title: Fast Track SBIR Study Online PCP Training in Screening, Brief Intervention, Referral, and Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medical Education
Keywords: Online education
Medical education
Substance abuse training
Drug abuse training
Lead sponsor: Medical Directions, Inc
Sponsor class: INDUSTRY
Collaborators: name: University of Miami
name: Cleveland Clinic Florida
name: University of Arizona
name: Contra Costa County Regional Medical Center
name: Valley Family Medicine Residency, UC Davis Network
First posted: 2011-03-31
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This project seeks to develop a comprehensive, computer-based education program for primary care physicians that will improve their skills in structured substance abuse screening, brief interventions, and referral and treatment (SBIRT). The investigators will develop two online education programs based on virtual patient (VP) technology. One program will include five typical, interactive, problem-solving VPs and the second will include five identical VPs except that two VPs will have been "worked" by substance abuse experts and presented as case studies. The remaining three VPs will be "unworked" (typical VPs). The investigators hypothesize that both education programs will significantly improve educational outcomes, compared to no training, as measured by a validated survey tool. A secondary hypothesis is that physicians using the "worked" (guided learning) program will achieve similar educational results as those using the typical VP approach, but will require less training time.


Eligibility criteria: Inclusion Criteria:

* Physician in primary care training program
* Faculty member in primary care training program

Exclusion Criteria:

* Advanced medical training in substance abuse management

Primary outcomes:
measure: Scores on The Physicians' Competence in Substance Abuse Test (P-CSAT)
timeFrame: Following completion of education program and 2 months later
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Medical Directions, Inc.
state: Arizona
Study officials:
affiliation: Medical Directions, Inc
name: John M Harris, Jr., MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Harris JM Jr, Sun H. The Physicians' Competence in Substance Abuse Test (P-CSAT): a multidimensional educational measurement tool for substance abuse training programs. Drug Alcohol Depend. 2012 May 1;122(3):236-40. doi: 10.1016/j.drugalcdep.2011.10.006. Epub 2011 Nov 4.
Clinical trial NCT00809536: Investigation Of How PD 0332334 And Metformin Are Eliminated From The Body When They Are Administered At The Same Time
Official title: A Phase 1, Open-Label, Randomized, Cross-Over Study To Estimate The Pharmacokinetics Of PD 0332334 And Metformin When Administered Concurrently In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Generalized Anxiety Disorder
Keywords: metformin, PD 0332334, organic cation transporter, OCT2, pharmacokinetics
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-12-17
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: 1. To estimate the effects of multiple doses of PD 0332334 on the elimination of a single dose of metformin from the body
2. To estimate the effects of multiple doses of metformin on the elimination of a single dose of PD 0332334 from the body
3. To evaluate the safety and tolerability when PD 0332334 and metformin are administered at the same time.

Detailed description: Detailed Description:

Additional Study Purpose Details: To assess the pharmacokinetics of metformin and PD 0332334 with concurrent administration.

On February 18th 2009, a decision to terminate further development for PD 0332334 was communicated to investigators in this study. The decision to terminate this study was not based on any safety concerns.

Eligibility criteria: Inclusion Criteria:

* Nonsmokers
* Male or female adults

Exclusion Criteria:

* Current or history of significant medical illness
* Smokers
* Illicit drug use

Primary outcomes:
measure: Metformin and PD 0332334 area under the curve (AUC) from time 0 to infinity (AUCinf)
timeFrame: Days 1 through 7
measure: Metformin and PD 0332334 AUC from 0 to last quantifiable concentration (AUClast)
timeFrame: Days 1 through 7
measure: Metformin and PD 0332334 half-life (t1/2)
timeFrame: Days 1 through 7
measure: Metformin and PD 0332334 maximum plasma concentration
timeFrame: Days 1 through 7
Secondary outcomes:
measure: Clinical safety laboratories
timeFrame: Days 1 through 7
measure: Incidence, duration and severity of adverse events when study medications administered alone and concurrently
timeFrame: Days 1 through 7
measure: Discontinuation due to adverse events when study medications administered alone and concurrently
timeFrame: Days 1 through 7
measure: 12-lead ECGs
timeFrame: Days 1 through 7
measure: Vital signs
timeFrame: Days 1 through 7
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06621836: Analgesic Efficacy of Intermediate Cervical Plexus Block in Patients Undergoing Neck Surgeries: A Comparison Between Two Bupivacaine Concentrations
Official title: Analgesic Efficacy of Intermediate Cervical Plexus Block in Patients Undergoing Neck Surgeries: A Comparison Between Two Bupivacaine Concentrations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cervical Plexus Block
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cervical plexus blocks (CPB) have been widely used to provide effective anesthesia and analgesia during various head and neck procedures. The ICPB was considered a good alternative to the deep CPB with an easier technique and fewer adverse events such as intravascular, epidural, subarachnoid injection, and phrenic nerve palsy. A recent randomized trial investigated the analgesic efficacy of superficial vs intermediate CPB combined with GA during total thyroidectomy. Authors used 10 ml bupivacaine 0.25% bilaterally, and they revealed a lower pain score and prolonged duration of analgesia with ICPB compared to superficial CPB; however, the authors did not assess the influence of this bupivacaine concentration on the diaphragmatic motion. \[5\] This randomized comparative trial is designed to investigate the analgesic efficacy of ICPB combined GA using two bupivacaine concentrations in patients undergoing neck surgeries (total thyroidectomy or total laryngectomy). We hypothesize that a smaller concentration of bupivacaine (0.185%) could provide an equivalent analgesic effect to a larger concentration (0.25%) with less impact on the diaphragmatic motion. The primary endpoint is the duration of postoperative analgesia. The secondary endpoints are the intraoperative hemodynamics, the postoperative pain score, total postoperative opioid consumption over 24 hours, diaphragmatic motions, and hemi-diaphragmic paresis.


Eligibility criteria: Inclusion Criteria:

* ASA physical status I-III,
* scheduled for total thyroidectomy or total laryngectomy

Exclusion Criteria:

* Heart failure,
* A history of arrhythmias or treatment with antiarrhythmic drugs,
* Impaired pulmonary, liver or kidney functions,
* Neck infection or rash

Primary outcomes:
measure: The duration of analgesia
timeFrame: Time elapsed from the end of the ICPB block procedure till VAS ≥ 4 over 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Anesthesia department - Faculty of medicine- Cairo University
Study officials:
References: