louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01748630: Effects of Dexmedetomidine on the Postoperative Experience in Children
Official title: Pain, Fentanyl Consumption, and Delirium in Children After Scoliosis Surgery: Dexmedetomidine Versus Midazolam
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Failed Moderate Sedation During Procedure
Keywords: scoliosis, sedation, children, fentanyl consumption, pain
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2012-12-12
Enrollment: 42
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: The study aim was to compare the efficacy of dexmedetomidine versus midazolam for sedation during the early postoperative period in children who underwent scoliosis surgery.

Methods: We performed a prospective, randomized trial in an intensive care unit (ICU) in a tertiary care center. In this study, 42 patients (American Society of Anesthesiology physical status I and II) who underwent scoliosis surgery were divided into 2 groups according to sedation protocols: group DEX (n = 22) and group MDZ (n = 20). Children (12-18 years) requiring mechanical ventilation underwent a continuous infusion of either dexmedetomidine (group DEX; starting dose, 0.4 μg•kg-1•h-1) or midazolam (group MDZ; starting dose, 0.1 mg•kg-1•h-1) with intermittent fentanyl, as needed. The efficacy of sedation was assessed using the Richmond Agitation Sedation Scale (RASS). Quality of pain relief was measured using the Numeric Visual Analog Scale (NVAS). During the arousal assessment, delirium was determined in patients in the RASS range of -2 to +1 using the Confusion Assessment Method for the ICU (CAM-ICU). Fentanyl consumption, incidence of delirium, NVAS scores, and hemodynamics were recorded postoperatively at 2, 4, 6, and 24 h in the ICU.


Eligibility criteria: Inclusion Criteria:

admittance to the ICU and a requirement of mechanical ventilation with an endotracheal tube.

Exclusion Criteria:

Patients who had a history of allergies to midazolam and/or dexmedetomidine; delirium, developmental delay, or mental retardation, as reported by parents; an American Society of Anesthesiologists classification greater than III; any known previous reactions to anesthesia; or a history of asthma or an anticipated difficult airway and concomitant disease (neuromuscular scoliosis or neurodegenerative disease) were excluded from the study.

Primary outcomes:
measure: fentanyl consumption
timeFrame: 1 hour
measure: fentanyl consumption
timeFrame: 2 hours
measure: fentanyl consumption
timeFrame: 4 hours
measure: fentanyl consumption
timeFrame: 6 hours
measure: fentanyl consumption
timeFrame: 24 hours
Secondary outcomes:
measure: incidence of delirium
timeFrame: 1, 2, 4 ,6 and 24 hours
Other outcomes:
measure: heart rate
timeFrame: 1, 2, 4 ,6 and 24 hours
Locations:
city: Malatya
country: Turkey
facility: Inonu University Turgut Ozal Medical Center
Study officials:
References:
Clinical trial NCT00650130: Whole Blood-plasma-oral Fluid Ratios of Psychoactive Drugs and Medicines
Official title: DRUID Sub-study: Substance Concentration Ratio/Impairment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Driving Under the Influence
Keywords: driving under the influence
psychoactive substances
oral fluid
whole blood
plasma
Ratio of psychoactive substances in whole blood-plasma-oral fluid
Prevalence of psychoactive substances in road traffic
Lead sponsor: Finnish Institute for Health and Welfare
Sponsor class: OTHER_GOV
Collaborators: name: University of Helsinki
name: Ministry of Internal Affairs, Finland
name: European Commission
First posted: 2008-04-01
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: drivers of motorised vehicles in general road traffic

Brief summary: The aim of this study is to get new information on the whole blood-plasma-oral fluid ratios of psychoactive drugs which are encountered in traffic.

Samples are taken from drivers suspected of being under the influence of drugs or medicines. The samples are analysed with immunological methods and GC-MS.

Observations from Police and a physician on impairment are combined with the results of the different bodily fluids. Observational evaluations and substance concentrations are compared.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* driver of a motorised vehicle

Exclusion Criteria:

* 17 years or younger
* not the driver of a motorised vehicle

Primary outcomes:
measure: ratio of psychoactive drugs/medicines in whole blood-plasma-saliva and correlation to symptoms of impairment
timeFrame: 1 year
Secondary outcomes:
measure: prevalence of psychoactive substances in the general driving population
timeFrame: three years
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: National Public Health Institute
Study officials:
affiliation: National Public Health Institute, Helsinki, Finland
name: Pirjo Lillsunde, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05119530: POC Study to Evaluate the Performance of the AcuVid COVID-19 Rapid Antigen Saliva Test
Official title: U.S. POC Study to Evaluate the Performance of the AcuVid COVID-19 Rapid Antigen Saliva Test
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Lead sponsor: Therma Bright Inc
Sponsor class: INDUSTRY
First posted: 2021-11-15
Enrollment: 300
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Study population will come from individuals visiting COVID-19 testing Centers for the purpose of obtaining a COVID-19 RT-PCR test results. Individuals will be approached to determine eligibility and obtain consent after they have provided a NP swab sample for their COVID-19 RT-PCR test.

Brief summary: The AcuVid COVID-19 Rapid Antigen Saliva Test is a lateral flow immunoassay to detect SARS-CoV-2 nucleocapsid antigens in human saliva specimens from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset, or from individuals without symptoms or other epidemiological reasons to suspect.

The AcuVid COVID-19 Rapid Antigen Saliva Test performance will be compared to a high sensitivity FDA EUA approved RT-PCR COVID-19 test. Nasopharyngeal (for RT-PCR) swab results will be collected from subjects by healthcare providers at CLIA Waived COVID-19 Testing Centers, and on the same day the subjects will also provide saliva samples which will be tested and interpreted by the healthcare providers.

This prospective, observational, study will test up to 300 participants to establish the performance characteristics of the AcuVid test on saliva specimens.


Eligibility criteria: Inclusion Criteria:

* Participant is willing to sign verbal informed consent form.
* Age ≥12 and parents or legal guardians must consent as required by law.
* Participant is attending COVID-19 testing centre to provide a nasopharyngeal swab sample.
* Participant is willing to provide a self-collected saliva sample.

Exclusion Criteria:

* Participant has previously tested positive for COVID-19 within the past 90 days.

Primary outcomes:
measure: Establish performance of AcuVid COVID-19 Rapid Antigen Saliva Test
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Modesto
country: United States
facility: Covid Clinic Inc.
state: California
Study officials:
References:
Clinical trial NCT00264030: Distal Protection Combined With PTCA in AMI Patients
Official title: Distal Protection Combined With PTCA in AMI Patients -- The DIPLOMAT Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Artery Disease
Lead sponsor: Cordis Corporation
Sponsor class: INDUSTRY
First posted: 2005-12-12
Enrollment: 56
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 primary objective is to evaluate if use of the AngioGuard™ XP improves myocardial reperfusion after PTCA as assessed by ST segment resolution at the end of PTCA.

Detailed description: This is a prospective, randomized, multicenter trial. Patients will be randomized either to be treated by PTCA only or in combination with the An-gioGuard™ XP device. The patients will be followed for six-months post-procedure.

Eligibility criteria: Inclusion Criteria:

* Acute myocardial infarction \< 12 hours with ST segment elevation \> 2 mm in at least 2 contiguous leads;
* Clinical indication of primary PTCA;
* De novo or restenotic lesions in native coronary vessel, single vessel treatment only;
* Target lesion stenosis is \> 80% (by visual estimation).

Exclusion Criteria:

* Patient has unprotected left main coronary disease with \> 50% stenosis in case left coronary artery is treated;
* Patient has an ostial target lesion;
* Killip class \> 3.

Primary outcomes:
measure: Absolute ST segment resolution.
timeFrame: post-PTCA
Secondary outcomes:
measure: ST segment resolution (> 50% decrease).
timeFrame: pre- and post-PTCA
measure: TIMI Frame Count
timeFrame: post PTCA
measure: Composite endpoint of slow flow, no reflow or distal embolization.
timeFrame: at anytime
measure: Regional wall motion index by echocardiography.
timeFrame: discharge and 6 month follow-up
measure: Clinical success evaluation; qualitative evaluation of device and delivery system characteristics.
timeFrame: post-procedure
measure: Cardiac function assessed by echocardiography.
timeFrame: before discharge and at 6 month follow-up
Other outcomes:
Locations:
city: Massy
country: France
facility: Institut Cardiovasculaire Paris Sud
Study officials:
affiliation: Hopital Tarnier-Cochin
name: Thierry LEFEVRE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04392830: A Study to Investigate the Safety, Tolerability, Pharmacokinetics of ALZ002 DS in Healthy Volunteers
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study, to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses (SAD-MAD) of ALZ002 DS in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: AnnJi Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-05-19
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single-ascending and multiple-ascending doses of ALZ002 DS.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or non-childbearing potential female subjects, non-smoker (no use of tobacco or nicotine products within 3 months prior to screening), ≥18 and ≤55 years of age at screening.
* Body mass index \> 18.5 and \< 30.0 kg/m2, and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females at screening visit.
* Capable of consent.

Exclusion Criteria:

* Any clinically significant abnormality or abnormal laboratory test results
* Positive urine drug screen, alcohol breath test, or urine cotinine test
* History of significant allergic reactions to any drug.
* Participation in a clinical research study involving the administration of an investigational or marketed drug or device
* History of clinically significant opportunistic infection
* Presence of fever (body temperature \> 38°C)

Primary outcomes:
measure: Incidence of SAEs and treatment-related adverse events
timeFrame: Baseline through Study Completion (up to Day 14)
Secondary outcomes:
measure: Maximum Plasma Concentration (Cmax) will be assessed
timeFrame: predose, 0.5, 1, 2, 4, 8, 12, 16, and 24 hours postdose; Day 3: predose; Day 4:predose; Day 5:predose; Day 6: predose; Day7: predose, 0.5, 1, 2, 4, 8, 12, 16, and 24 hours postdose
measure: Area Under the Curve (AUC) will be assessed
timeFrame: predose, 0.5, 1, 2, 4, 8, 12, 16, and 24 hours postdose; Day 3: predose; Day 4:predose; Day 5:predose; Day 6: predose; Day7: predose, 0.5, 1, 2, 4, 8, 12, 16, and 24 hours postdose
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Cmax clinical research
Study officials:
References:
Clinical trial NCT06154330: Safety and Efficacy of Suprachoroidal Tube Shunt in Patients With Primary Open and Pseudoexfoliation Glaucomas
Official title: Safety and Efficacy of Suprachoroidal Tube Shunt in Patients With Primary Open and Pseudoexfoliation Glaucomas
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Glaucoma, Open-Angle
Suprachoroidal Space
Pseudo Exfoliation Syndrome
Keywords: MIGS
Suprachoroidal Space
Glaucoma, Open-Angle
Suprachoroidal Silicone Tube
Suprachoroidal Shunt
Glaucoma Shunt
Lead sponsor: Davinci LTD
Sponsor class: OTHER
First posted: 2023-12-04
Enrollment: 91
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All study patients were Caucasian

Brief summary: To assess safety and efficacy of a novel suprachoroidal silicone tube (SST) shunt for the treatment of primary open angle and exfoliative glaucomas.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects from 40 years up to 90 years old
* Diagnosis of primary open angle glaucoma (POAG) and pseudo-exfoliative glaucoma
* Subject is able to understand and sign a written informed consent form
* Subject who underwent SST implantation and agreed to come for the cross-sectional follow-up

Exclusion Criteria:

* Close angle forms of glaucoma
* Congenital or developmental glaucoma
* Pseudophakic with an anterior chamber intraocular lens (IOL), iris fixed IOL, or implantable contact lens (ICL)
* Prior glaucoma procedures such as Selective Laser Trabeculoplasty (SLT), Microinvasive Glaucoma Surgery (MIGS) or Episcleral Shunts
* History of corneal transplant, corneal refractive surgery, corneal dystrophy, or corneal ectasia (such as either keratoconus or keratoglobus) in the study eye
* Chronic ocular inflammatory disease, or clinically significant ocular inflammation or infection (e.g., uveitis, iritis, iridocyclitis, retinitis).
* Any condition that, in the Investigator´s opinion, can interfere with full participation in the study, including study treatment and attending required visits; can pose a significant risk to the participant, or interfere with interpretation of study data.

Primary outcomes:
measure: Main outcome measures
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Tbilisi
country: Georgia
facility: Davinci Eye Center, LTD
Study officials:
References:
Clinical trial NCT05126030: The TRICURE First in Human Trial
Official title: TRiCares Topaz Transfemoral Tricuspid Heart Valve Replacement System First in Human Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tricuspid Regurgitation
Lead sponsor: TRiCares
Sponsor class: INDUSTRY
First posted: 2021-11-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Topaz TTVR System
Primary purpose: TREATMENT

Brief summary: The objective of this first in human study is to gain early clinical insight into the safety profile and performance of the Topaz transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve.

Detailed description: The TRiCares Topaz Prosthesis is intended to replace a diseased tricuspid heart valve via a transcatheter approach without removing the native valve.

Eligibility criteria: Inclusion Criteria:

* Subject of age \>18 years.
* Subject with severe symptomatic tricuspid regurgitation presenting following conditions:

  1. TR severity of at least 3 (severe) on a scale of 0 (none) to 5 (torrential), assessed by independent core lab and/or
  2. symptoms requiring use of diuretics.
* Subject presenting with New York Heart Association Class NYHA ≥II.
* Subject is not eligible for open tricuspid valve surgery due to high operative risk, as determined by a Heart Team decision.

Exclusion Criteria:

* Subject in need of emergent or urgent intervention or any planned cardiac intervention within the next 12 months.
* Subject undergoing cardiac interventions within 30 days prior to index procedure.
* Subject with concomitant clinically relevant mitral, aortic, pulmonary regurgitation/stenosis.
* Subject who had previous tricuspid valve replacement or repair and a device is still in situ.

Primary outcomes:
measure: Hierarchical composite endpoint
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Algemeen Stedelijk Ziekenhuis,
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc UCL
city: Liège
country: Belgium
facility: Centre hospitalier universitaire CHU de Liège
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Bron Cedex
country: France
facility: Hospices Civils de Lyon, Hôpital Cardiothoracique Louis Pradel
city: Créteil
country: France
facility: CHU Henri Mondor
city: Lille
country: France
facility: University Hospital Lille, Institut Cœur Poumon
city: Marseille
country: France
facility: Hôpital Saint Joseph
city: Rennes
country: France
facility: CHU Pontchaillou
city: Saint-Denis
country: France
facility: Centre Cardiologique du Nord
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Jean-Louis Vanoverschelde, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Henri Mondor
name: Emmanuel Teiger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04785430: Incarceration Risk Factors in Inguinal Hernia.
Official title: Incarceration Risk Factors in Inguinal Hernia.Prospective Observational Clinical Trial.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Incarcerated Inguinal Hernia
Strangulated Inguinal Hernia
Inguinal Hernia
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2021-03-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have applied to the general surgery outpatient clinic of Bakırköy Dr Sadi Konuk Training and Research Hospital, diagnosed with inguinal hernia, and who have applied to the emergency diagnosed with incarcerated inguinal hernia and underwent hernia repair surgery.

Brief summary: It is known that strangulation or necrosis of the intestine within the hernia sac of inguinal hernia increases mortality and morbidity in patients. However, the risks of incarceration in hernias have not been fully revealed.To better understand the factors associated with incarceration in inguinal hernia, the investigators will examine patients who will apply to our clinic for inguinal hernia and undergo elective and emergency inguinal hernia surgery.

Detailed description: A prospective study will be conducted for 2 years, involving all adult patients who have applied to the general surgery outpatient clinic of Bakırköy Dr Sadi Konuk Training and Research Hospital, diagnosed with inguinal hernia, and who have applied to the emergency diagnosed with incarcerated inguinal hernia and underwent hernia repair surgery.

Eligibility criteria: Inclusion Criteria:

* Ages between 18-80
* Primary and recurrent inguinal hernias
* Incarcerated / strangulated inguinal hernias

Exclusion Criteria:

* Younger than 18, older than 80
* Pregnancy
* Mental retardation

Primary outcomes:
measure: Hernia defect size
timeFrame: 2 hours after physical examination
Secondary outcomes:
measure: Constipation
timeFrame: 1 years
measure: Age
timeFrame: up to 24 weeks
measure: Body Mass Index
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bakırkoy Dr.Sadi Konuk Training and Research Hospital
Study officials:
affiliation: Bakırkoy Dr. Sadi Konuk Training and Research Hospital
name: Turgut Donmez
role: STUDY_DIRECTOR
References:
citation: Sneiders D, Yurtkap Y, Kroese LF, Kleinrensink GJ, Lange JF, Gillion JF; Hernia-Club Members. Risk Factors for Incarceration in Patients with Primary Abdominal Wall and Incisional Hernias: A Prospective Study in 4472 Patients. World J Surg. 2019 Aug;43(8):1906-1913. doi: 10.1007/s00268-019-04989-x.
citation: Kunduz E, Sormaz IC, Yapalak Y, Bektasoglu HK, Gok AF. Comparison of surgical techniques and results for emergency or elective femoral hernia repair. Ulus Travma Acil Cerrahi Derg. 2019 Nov;25(6):611-615. doi: 10.14744/tjtes.2019.04524.
Clinical trial NCT06657430: A Study on the Preference of Risperidone Dosage Forms
Official title: A Study on the Preference of Risperidone Dosage Forms
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Schizophrenia
Bipolar Affective Disorder
Autism Spectrum Disorder
Conduct Disorder
Mental Retardation
Keywords: risperidone
patch
cross-sectional study
preference
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2024-10-24
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with schizophrenia, bipolar disorder, autism spectrum disorder, mental retardation or their primary caregivers who voluntarily participate in the study.

Brief summary: This study aimed to understand patients' needs and preferences for antipsychotic dosage forms.

Detailed description: This study aims to understand patients' needs and preferences for antipsychotic dosage forms and to clarify the clinical value of patch-form antipsychotics.

Eligibility criteria: Inclusion Criteria:

* Patients with schizophrenia, bipolar disorder, autism spectrum disorder, mental retardation or their primary caregivers who voluntarily participate in the study.

Exclusion Criteria:

* Have difficulty reading and understanding Chinese or refuse to participate in the study.

Primary outcomes:
measure: Proportion of patients (and their caregivers) who prefer risperidone patch-form medicine
timeFrame: "through study completion, an average of 6 months
Secondary outcomes:
measure: Factors related to patients' preference for risperidone patch-form medicines
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
References: