louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06294977: Impact of COVID-19 Pandemic on Epilepsy Evaluations in the Pediatric Emergency Department
Official title: Impact of COVID-19 Pandemic on Epilepsy Evaluations in the Pediatric Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Emergency Services, Hospital
COVID-19
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2024-03-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All children under the age of 18 years who had at least one access to the Pediatric ED of the hospital for seizures

Brief summary: Background. Seizures are a common cause of evaluation in the pediatric emergency department (ED). Several studies about the impact of COVID-19 pandemic on ED attendances report a considerable reduction in general pediatric care. The aim of our study was to evaluate the impact of COVID-19 on the admission to the pediatric ED for seizures.

Materials and methods. We performed a retrospective study to assess the rate of ED admission for seizures at the pediatric ED of the Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico of Milan between January 2017 and December 2021, comparing the pre-pandemic (from January 2017 to February 2020) and pandemic periods (from March 2020 to December 2021).


Eligibility criteria: Inclusion Criteria:

* age: 1 months to 17 years
* sex: all
* with at least one access to the Pediatric ED of the hospital for seizures

Exclusion Criteria:

* children who received a diagnosis of seizure on admission in triage that was not confirmed at discharge (breath-holding spell, fainting...).

Primary outcomes:
measure: During the study period, 1,091 patients with seizures were admitted to pediatric ED, 776 before the pandemic and 315 during the pandemic. In particular, the evaluation rates per month were 20.4 before the pandemic and 14.3 afterward
timeFrame: the pre-pandemic (from January 2017 to February 2020) and pandemic periods (from March 2020 to December 2021)
Secondary outcomes:
measure: Patients with a history of previous seizures showed a greater decrease in the monthly number of ED visits compared to those with a first seizure. An increased rate of unprovoked seizures and a decreased rate of provoked ones were observed in the pandemic
timeFrame: the pre-pandemic (from January 2017 to February 2020) and pandemic periods (from March 2020 to December 2021)
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Pediatric Emergency Department Clinica de Marchi, Foundation IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Study officials:
References:
Clinical trial NCT02641977: Longterm Followup of Patients With Rheumatoid Arthritis Treated With Methotrexate
Official title: Longterm Followup of Patients With Rheumatoid Arthritis Treated With Methotrexate Enroled in the Ratingener Rheuma-Kohorte
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: External Causes of Morbidity and Mortality
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2015-12-30
Enrollment: 271
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with rheumatoid arthritis

Brief summary: Longterm followup of patients with rheumatoid arthritis 30 years after starting a baseline treatment with Methotrexate.

Detailed description: Objective. 30-year follow-up of rheumatoid arthritis (RA) patients treated with methotrexate (MTX) in the 1980s to analyze the association of the degree of response to MTX with long-term mortality.

Methods. In this observational cohort study, 271 RA patients who had started treatment with MTX between 1980 and 1987 were included (mean age 58 years, mean disease duration 8.5 years). One year after baseline, the treatment response to MTX was evaluated. Responders were defined as patients with at least 20% improvement. Thereafter, assessments were performed at 10 and 18 years after baseline. This re-evaluation was done to provide the data after 30 years of follow-up. Standardized mortality ratios (SMR) are calculated, Cox regression and logistic regression are performed.

Eligibility criteria: Inclusion Criteria:

* rheumatoid arthritis
* treatment with methotrexate
* active disease

Exclusion Criteria:

* low disease activity
* previous treatment with methotrexate

Primary outcomes:
measure: mortality
timeFrame: 30 years
Secondary outcomes:
Other outcomes:
Locations:
city: Gladbeck
country: Germany
facility: Internistische und rheumatologische Praxis Gladbeck
Study officials:
affiliation: University Bochum, Germany
name: Dietmar MJ Krause, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05379777: Effective Dose of Remimazolam for Sedation in Patients Undergoing Lower Extremity Surgery Under Spinal Anesthesia
Official title: Determination of Effective Dose 90 of Remimazolam That Can Maintain Loos of Consciousness From Sedation With Remimazolam in Adult Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Remimazolam
Orthopedic Procedures
Sedatives
Anesthesia, Spinal
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 51
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Currently used drugs for monitored general anesthesia include propofol, midazolam, and dexmedetomidine. Each drug has diﬀerent advantages and disadvantages. Remimazolam causes a relatively small decrease in blood pressure, and it has no injection pain. In addition, remimazolam has a very short onset time, and even after the continuous infusion, the onset of remimazolam is fast, and even after continuous injection, the eﬀect disappeared very quickly due to the short context-sensitive half time. and through continuous infusion, the patient's depth of anesthesia can be maintained constant. In addition, the short duration of action and the ability to quickly reverse the eﬀect of ﬂumazenil suggest that remimazolam can be used eﬀectively under general anesthesia as well as under general anesthesia. Remimazolam can be used as a continuous infusion for general anesthesia. However, it has also been reported to be used for sedation by continuous infusion or divided intravenous infusion. However, the eﬀective infusion dose of remimazolam for supervised general anesthesia without mechanical ventilation has not been established.

In this study, the ED90 of the maintenance dose that maintain loss of consciousness in patients when supervised general anesthesia is performed through continuous infusion of remimazolam after spinal anesthesia is obtained.


Eligibility criteria: Inclusion Criteria:

* ASA PS 1-3
* Patients undergoing lower extremity surgery under spinal anesthesia and sedation using remimazolam

Exclusion Criteria:

* Patients who refuse to participate in this study
* Patients with hypersensitivity to benzodiazepine or flumazenil
* Patients with severe renal/hepatic disease
* Patients with drug/alcohol abuse
* Patients who take antidepressants, anticonvulsants, psychoactive drugs chronically
* Patients with difficulty in communication
* Patients with severe obstructive sleep apnea or other airway problems
* Patients contraindicated to regional anesthesia
* Patients judged to be inappropriate for this study

Primary outcomes:
measure: success or failure of sedation maintenace
timeFrame: throughout the surgery
Secondary outcomes:
measure: Frequency of respiratory depression
timeFrame: throughout the surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
Clinical trial NCT06946277: Assessing the Time-Course of Dexmedetomidine-Induced Analgesia Via EEG
Official title: Mapping the Temporal Profile of Dexmedetomidine-Induced Analgesia Via EEG Signatures in Brain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Total Hip Arthroplasty (THA)
Intrathecal Anesthesia
Hip Osteoarthritis
Lead sponsor: China International Neuroscience Institution
Sponsor class: OTHER
First posted: 2025-04-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Objective: To investigate the temporal dynamics of dexmedetomidine's analgesic effects in the brain using EEG.

Methods: Eligible patients scheduled for total hip arthroplasty under intrathecal anesthesia received a continuous infusion of DEX at 1.5 μg/(kg·h) for 15 minutes before neuraxial puncture, followed by an additional 15-minute infusion. The study was divided into three phases:

Phase 1: Non-dosing phase (Baseline). Phase 2: DEX preemptive analgesia phase (DEX infusion). Phase 3: DEX cessation phase (Post-infusion).

Outcomes:

Primary safety outcome: EEG spectral analysis at different phases. Secondary outcomes: NRS scores, postoperative nausea and vomiting (PONV), dizziness, agitation, and time to intestinal exhaust within 48 hours. Intraoperative hemodynamics were also monitored.

Detailed description: Objective: To investigate the temporal dynamics of dexmedetomidine's analgesic effects in the brain using EEG.

Methods: Eligible patients scheduled for total hip arthroplasty under intrathecal anesthesia received a continuous infusion of DEX at 1.5 μg/(kg·h) for 15 minutes before neuraxial puncture, followed by an additional 15-minute infusion. The study was divided into three phases:

Phase 1: Non-dosing phase (Baseline). Phase 2: DEX preemptive analgesia phase (DEX infusion). Phase 3: DEX cessation phase (Post-infusion).

Outcomes:

Primary safety outcome: EEG spectral analysis at different phases. Secondary outcomes: NRS scores, postoperative nausea and vomiting (PONV), dizziness, agitation, and time to intestinal exhaust within 48 hours. Intraoperative hemodynamic monitoring was performed.

EEG/ERP monitoring: The 64-site EEG and ERP were recorded at different phases

Eligibility criteria: Inclusion Criteria:

Patients with hip osteoarthritis scheduled for total hip arthroplasty under intrathecal anesthesia; Age 18-70 years; American Society of Anesthesiologists (ASA) physical status classification I-III; Body mass index (BMI) 22-30 kg/m².

Exclusion Criteria:

Pre-existing peripheral or central nervous system disorders; Mental disorders; Cognitive impairment; Emergency surgery; or Hearing impairment.

Primary outcomes:
measure: Resting EEG
timeFrame: During the whole operation
Secondary outcomes:
measure: ERP
timeFrame: During the whole operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu hospital
state: Beijing
Study officials:
References:
Clinical trial NCT01526577: Study of LC23-1306 in Healthy Male Subjects
Official title: A Dose Blocked-randomized, Double-blind, Active and Placebo Controlled, Single and Multiple Dosing, Dose-escalation Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Characteristics and Food Effect
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Coronary Syndrome
Keywords: phase1
healthy subjects
antiplatelet agent
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
First posted: 2012-02-06
Enrollment: 113
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This will be a dose block-randomized, double-blind, active and placebo controlled, single and multiple dosing, dose-escalation study to evaluate tolerability, safety and pharmacokinetic/pharmacodynamic characteristics. Adverse events, physical examinations, vital signs, ECG and laboratory tests will be conducted for safety/tolerability evaluation and serial blood samples and urine collections for pharmacokinetic and pharmacodynamic evaluations will be conducted at specified time points.


Eligibility criteria: Inclusion Criteria:

1. Healthy male subjects between the ages of 20 and 50 years at screening
2. Subjects with Body Mass Index (BMI) between 18.0 (inclusive) and 27.0 kg/m2 (exclusive); and a total body weight between 55 kg (inclusive) and 90 kg (exclusive). BMI (kg/m2) = body weight (kg)/ {height (m)}2.
3. Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB) - approved informed consent prior to performing any of the screening procedures.
4. Findings within the range of clinical acceptability in medical history and physical examination, and laboratory results within the laboratory reference ranges for the relevant laboratory tests

Primary outcomes:
measure: Adverse Events of LC23-1306
timeFrame: 7 days (plus or minus 1 day)
measure: Pharmacodynamic Measurement
timeFrame: 1D 0, 2, 8, 24h for single dose study / 1D and 7D 0, 2, 8, 12, 24h for multiple dose study
measure: Platelet Aggregation Test, Bleeding Test
timeFrame: pre-dose, up to 1 day post-dose
Secondary outcomes:
measure: AUC
timeFrame: pre-dose, up to 3 days post-dose
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT03834077: Tissue Flossing in Tennis Elbow Patients
Official title: The Effect of Tissue Flossing in Patients With Tennis Elbow
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tennis Elbow
Keywords: physiotherapy
Lead sponsor: University of Jaén
Sponsor class: OTHER
First posted: 2019-02-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: The aim of the present intervention is to determine the effectiveness of the application of tissue flossing in patients with tennis elbow

Detailed description: The application of tissue flossing has been deemed to provide beneficial results in patients with ankle range of motion limitation. Although, tissue flossing is widely extended among athletes due to its effectiveness in pain, function and range of motion, the evidence is limited.

The aim of the present protocol is to determine the effectiveness of tissue flossing in patients with tennis elbow.

Eligibility criteria: Inclusion Criteria:

* Elbow pain for at least 6 weeks and satisfy the widely accepted diagnostic criteria of lateral epicondylalgia.
* Diagnostic criteria are pain over the lateral humeral epicondyle that is provoked by gripping activities.
* Reduced grip strength and increased sensitivity to manual palpation over the lateral epicondyle.
* Pain with stretching or contraction of the wrist extensor muscles.

Exclusion Criteria:

* Upper limb fractures, surgery or concomitant disease.
* Red flags presence.
* Mental disorders.

Primary outcomes:
measure: Patient-related Tennis Elbow Questionnaire change
timeFrame: At baseline, after 1 week and after 4 week.
Secondary outcomes:
measure: Numeric rating scale change
timeFrame: At baseline, after 1 week and after 4 week.
measure: Pressure Pain Threshold change
timeFrame: At baseline, after 1 week and after 4 week.
Other outcomes:
Locations:
city: Jaen
country: Spain
facility: University of Jaen
Study officials:
affiliation: University of Jaen
name: David Cruz-Diaz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02764177: Resistance Exercise, Recovery Drinks and Appetite
Official title: Effect of Recovery Drink Composition Consumed After Resistance Exercise on Subsequent Appetite and Energy Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Active Population
Lead sponsor: Loughborough University
Sponsor class: OTHER
First posted: 2016-05-06
Enrollment: 15
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Whilst the effects of manipulating the macronutrient content of foods on appetite and energy intake has been relatively well studied at rest, little is known about these responses in a post-exercise context. The effect of post-exercise nutrition on recovery from or adaptation to exercise has been well studied. However, many exercisers do so for weight management and thus any post-exercise nutrition might impact on energy balance and might need to be carefully considered. This study will examine the impact of manipulating the composition of a recovery drink consumed after resistance exercise on subsequent appetite and energy intake.

Detailed description: Subjects perform a bout of lower body resistance exercise lasting \~50 min and immediately post-exercise they consume one of two recovery drinks over a 5 min period. Over the next 60 min subjective appetite responses will be measured and then 60 min after drink ingestion, subjects will consume an ad-libitum meal.

Eligibility criteria: Inclusion Criteria:

* Generally fit and healthy
* Use resistance exercise as part of weekly training
* Weight stable in previous 6 months

Exclusion Criteria:

* Smoker
* History of gastric, digestive, cardiovascular or renal disease
* Lactose, dairy, gluten intolerances or allergies

Primary outcomes:
measure: Ad-libitum energy intake
timeFrame: 65 min post-exercise
measure: Subjective appetite (hunger)
timeFrame: 150 min
measure: Subjective appetite (fullness)
timeFrame: 150 min
measure: Subjective appetite (desire to eat)
timeFrame: 150 min
measure: Subjective appetite (prospective food consumption)
timeFrame: 150 min
Secondary outcomes:
measure: Pleasantness of study drinks
timeFrame: Immediately after drinking
measure: Aftertaste of study drinks
timeFrame: Immediately after drinking
measure: Saltiness of study drinks
timeFrame: Immediately after drinking
measure: Bitterness of study drinks
timeFrame: Immediately after drinking
measure: Sweetness of study drinks
timeFrame: Immediately after drinking
measure: Creaminess of study drinks
timeFrame: Immediately after drinking
measure: Thickness of study drinks
timeFrame: Immediately after drinking
measure: Stickiness of study drinks
timeFrame: Immediately after drinking
measure: Fruitiness of study drinks
timeFrame: Immediately after drinking
measure: Refreshment of study drinks
timeFrame: Immediately after drinking
measure: Eating rate
timeFrame: 65 min post-exercise
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01913977: Clinical Study to Determine the Optimal Operation Parameters During CO2 Removal With the Abylcap® System
Official title: Clinical Study to Determine the Optimal Operation Parameters During CO2 Removal With the Abylcap® System.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ARDS (Acute Respiratory Distress Syndrome)
Respiratory Acidosis
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2013-08-01
Enrollment: 4
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: This prospective study includes 5 patients with ARDS (Acute Respiratory Distress Syndrome) treated by mechanical ventilation. In case of respiratory acidosis, extracorporeal CO2 (carbon dioxide)removal might be necessary. We hereby work with the Abylcap system with the oxygenator Lilliput2 as CO2 remover (Bellco, Italy).

The patients (M/V) are older than 18, not pregnant, have a BMI\<30, and no contraindication for anticoagulation therapy.

Under standard conditions patients are treated with a blood flow of QB=300mL/min and a gas flow (100% 02) of QG=7L/min. Blood sampling is performed from the arterial bloodline in the patients at 0, 1h, 3h, 24h, 48h, 72h, 96h, and 120h.

A parameter study is also performed to optimise CO2 removal. Herewith, blood samples (1mL) are taken from the inlet and outlet line of the Lilliput2 at the previously mentioned time points and for different flow setting: Blood flow (QB) 200-300-400mL/min and gas flow (QG) 1.5, 3, 6, 7, 8L/min

Blood samples are analysed for the different blood gases from which the extraction in the CO2 remover can be calculated for each setting of QB (blood flow) and QG (gas flow).


Eligibility criteria: Inclusion Criteria:

* Patients with ARDS and respiratory acidosis on the intensive care unit
* Treated with the Abylcap system (Bellco, Italy)
* Not pregnant

Primary outcomes:
measure: calculation of CO2 extraction in blood samples during mechanical ventilation
timeFrame: during mechanical ventilation with CO2 removal (max up to 120h)
Secondary outcomes:
measure: Based on the extraction rates, the optimum parameter settings are derived
timeFrame: During mechanical ventilation with CO2 removal (max up to 120h)
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Ghent University Hospital
state: Oost-Vlaanderen
Study officials:
affiliation: University Hospital, Ghent
name: Sunny Eloot, PhD, MScBME, MScCivE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01474577: Prognostic Value of Rb-82 PET Myocardial Perfusion Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Health
Keywords: stress test
cardiac issues
Rb-82 PET Myocardial Perfusion Imaging
11-150
one or more 82Rb myocardial perfusion stress tests
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2011-11-18
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with one or more 82Rb myocardial perfusion stress tests performed at MSKCC, 2008-2011.

Brief summary: The physician would like to see if nuclear cardiac stress tests can predict cardiac health. For example, if a patient has an abnormal stress test, is he or she more likely to have cardiac problems in the future?


Eligibility criteria: Inclusion Criteria:

* Patient \> or = to 18 years of age
* Registered patient at MSKCC
* Patient with one or more 82Rb myocardial perfusion stress tests performed at MSKCC, 2008-2011

Exclusion Criteria:

* Patient is unwilling to participate

Primary outcomes:
measure: correlate scan findings with clinical outcomes
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Heiko Schöder, MD
role: PRINCIPAL_INVESTIGATOR
References: