louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00715390: Dysrhythmias During General Anesthesia in Children
Official title: Dysrhythmias During General Anesthesia in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arrhythmias, Cardiac
Keywords: Children
Cardiac Arrhythmia
General Anesthesia
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Children's Anesthesiology Associates, Ltd.
First posted: 2008-07-15
Enrollment: 234
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who have undergone anesthesia at the Children's Hospital of Philadelphia or at one of CHOP's satellite surgicenters, and whose anesthetic record was recorded electronically into the Compurecord system will be screened.

Brief summary: To describe the types and incidence of cardiac dysrhythmias that occur under anesthesia in the present anesthesia environment.

Detailed description: It is unclear what the current state of anesthesia associated dysrhythmias is in the pediatric population. This was last investigated retrospectively in 1992 when the predominant volatile agent used for inhalation induction was halothane. Sevoflurane was approved by the Food and Drug Administration in 1995. Since that time, Sevoflurane has displaced halothane as the agent of choice for inhalation induction and has relegated halothane to be used in a narrow niche which primarily involves patients with very specific congenital heart diseases. It has been described that halothane has a larger proarrhythmic effect than sevoflurane for ventricular dysrhythmias. With the transition from the halothane to the sevoflurane era, a reassessment of the incidence and types of dysrhythmias occurring in non-cardiac pediatric patients is important.

Eligibility criteria: Inclusion Criteria:

Children, while under anesthesia, having

1. circumstances of tachycardia and bradycardia,
2. administration of medications used in the treatment of dysrhythmias,
3. the commentary which includes comment about the heart rhythm or therapy for dysrhythmia,
4. in the quality assurance database for evidence of dysrhythmia

Exclusion Criteria:

Children with a known pre-operative:

1. prior history of dysrhythmia and/or
2. residual congenital heart disease
3. anti/pro dysrhythmic medications

Primary outcomes:
measure: Arrhythmias During General Anesthesia in Children
timeFrame: July 1998 through July 2004
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Ronald S Litman, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02813590: Ascitic Fluid Microbiome in Liver Cirrhosis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Ascitic Fluid, Microbiota
Microbiota
Sequence Analysis
Polymerase Chain Reaction
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: CBmed - Center for biomarker research in medicine
First posted: 2016-06-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with underlying liver cirrhosis and ascitic fluid that is routinley punctured.

Brief summary: Ascitic fluid microbiome is going to be investigated in this study by using internal transcripted spacer (ITS) and 16S ribosomal RNA (rRNA) polymerase chain reaction (PCR) and sequencing as conventional culture methods are lacking sensitivity regarding diagnosis of spontaneous bacterial peritonitis (SBP).

All patients with routinely performed ascitic fluid puncture and underlying liver cirrhosis are included in this study. Next generation sequencing (NGS) in ascitic fluid, skin swaps from puncture side and stool samples as well as conventional culture methods are performed to investigate the difference in the microbiome between patients with and without SBP.


Eligibility criteria: Inclusion Criteria:

* Underlying decompensated liver cirrhosis
* routinely performed ascitic fluid puncture
* informed consent

Exclusion Criteria:

-

Primary outcomes:
measure: Next generation sequencing results from ascitic fluid samples
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
state: Styria
Study officials:
References:
Clinical trial NCT02816190: PROne POsition and Volumetric CAPnography
Official title: PROne POsition and Volumetric CAPnography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prone Position
Mechanical Ventilation
Volumetric Capnography
Lead sponsor: Hopital of Melun
Sponsor class: OTHER
First posted: 2016-06-28
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All prone positionned patients

Brief summary: Beneficial effect of prone position in ARDS on mortality is not linked to increase in PF ratio. It is probably due to improvement in ventilation-perfusion ratio (V/Q). Volumetric capnography allows assessment of dead space and homogeneity of V/Q. All prone positionned patients will be included in the study with usual monitoring (i.e. respiratory system basic mechanics, volumetric capnography, blood gas samples). Epidemiologic and monitoring data will be collected during all prone position sessions.


Eligibility criteria: Inclusion Criteria:

* all prone positioned patients

Exclusion Criteria:

* age below 18 y, dependant patients, participation reject

Primary outcomes:
measure: P3Slp
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Melun
country: France
facility: Melun Hospital ICU
Study officials:
affiliation: Clinical Research Unit, Melun Hospital
name: sebastien jochmans, MD
role: STUDY_DIRECTOR
References:
citation: Jochmans S, Mazerand S, Chelly J, Pourcine F, Sy O, Thieulot-Rolin N, Ellrodt O, Mercier Des Rochettes E, Michaud G, Serbource-Goguel J, Vinsonneau C, Vong LVP, Monchi M. Duration of prone position sessions: a prospective cohort study. Ann Intensive Care. 2020 May 24;10(1):66. doi: 10.1186/s13613-020-00683-7.
Clinical trial NCT05665790: Primary Lesion Treatment for Bone Metastases
Official title: Study on Primary Lesion Treatment for Patients With Bone Metastases
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bone Metastases
Lead sponsor: Shanghai 6th People's Hospital
Sponsor class: OTHER
First posted: 2022-12-27
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will carry out a prospective cohort study to study the effect of different primary leison treatment modes on disease control, quality of life, economic cost and survival period of patients with bone metastases from breast cancer and lung cancer by giving radiotherapy or palliative surgery or not giving local treatment for the primary lesion in patients with bone metastases from breast cancer or lung cancer


Eligibility criteria: Inclusion Criteria:

1. HR positive breast cancer patients with bone metastasis or Non-small-cell lung cancer patients with bone metastasis；
2. Aged over 18;
3. ECOG：0-1；
4. Patients who benefit clinically(CR+PR) after 6 months of treatment.

Exclusion Criteria:

1. The expected life span is less than 3 months;
2. Have serious cardiovascular and cerebrovascular diseases, blood coagulation dysfunction, and cannot tolerate surgery;
3. Allergies to narcotic drugs;
4. The patient refused the treatment decision of the integrated team.

Primary outcomes:
measure: Disease control rate at 1 year
timeFrame: 1 year
Secondary outcomes:
measure: Progression-Free Survival
timeFrame: 1 year
measure: Overall Survival
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00894790: Celecoxib Efficacy And Safety Versus Diclofenac In Acute Pain Due To Cervical Sprain Related To A Traffic Accident
Official title: A Phase IV Open Label Randomized Multicenter Comparative Study Of Celecoxib Efficacy And Safety Versus Standard Doses Of Oral Diclofenac In Acute Pain Due To Cervical Sprain Related To Motor Vehicle Accident
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pain
Keywords: Treatment of the acute pain due to cervical
sprain
Celecoxib
NSAID
Diclofenac
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-05-07
Enrollment: 8
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: This Study Will Evaluate Celecoxib Efficacy And Safety Versus Standard Doses Of Diclofenac In Acute Pain Due To Cervical Injury (Due To A Sprain) Related To A Motor Vehicle Accident

Detailed description: On 21Oct2010 study was prematurely terminated due to poor enrollment with subsequent low number of participants. No safety or efficacy issues were involved in the decision to terminate prematurely.

Eligibility criteria: Inclusion Criteria:

* Patients That Had Suffered A Car Accident And Due To It Suffered A Cervical Sprain

Exclusion Criteria:

* Recent Cervical Sprains Or Other Cervical Conditions

Primary outcomes:
measure: Change From Baseline to Day 7 of Participant's Assessment of Cervical Pain Due to Cervical Sprain
timeFrame: Baseline, Day 7
Secondary outcomes:
measure: Change From Baseline on VAS-pain at Day 3 and Day 14
timeFrame: Baseline, Days 3, 14
measure: Percentage of Participants With at Least a 20 mm Improvement on VAS-pain (Responder Rates)
timeFrame: Baseline, Days 7, 14
measure: Change From Baseline in Patient Global Assessment of Cervical Injury
timeFrame: Baseline, Days 7, 14
measure: Change From Baseline on Physician's Global Assessment of Cervical Injury
timeFrame: Baseline, Days 7, 14
measure: Change From Baseline in Modified Brief Pain Inventory-Short From (m-BPI-sf): Pain Interference Score
timeFrame: Baseline, Days 7, 14
measure: Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores
timeFrame: Baseline, Days 7, 14
measure: Change From Baseline in Categorical Responses to Participant's Gastrointestinal (GI) Symptom Questionnaire
timeFrame: Baseline, Days 7, 14
measure: Change From Baseline in Participant's Responses to Neck Disability Index (NDI)
timeFrame: Baseline, Days 7, 14
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Pfizer Investigational Site
state: D.f.
city: Mexico
country: Mexico
facility: Pfizer Investigational Site
state: D.f.
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00912990: Pediatric Elective Intubation With and Without Muscle Relaxation Utilizing the Shikani Optical Stylet
Official title: Pediatric Elective Intubation With and Without Muscle Relaxation Utilizing the Shikani Optical Stylet
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Intubation,Endotracheal
Keywords: Pediatric
Lead sponsor: Rady Children's Hospital, San Diego
Sponsor class: OTHER
First posted: 2009-06-03
Enrollment: 34
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators' primary specific aims are to demonstrate that:

1. Pediatric patients with normal airways, undergoing elective surgical procedures, can be successfully intubated when deeply sedated, without the use of muscle relaxants using the Shikani Optical Stylet.
2. Shikani intubation of pediatric patients is equally effective in children that are deeply sedated or paralyzed as evidenced by a non-significant difference in:

   * Time to intubation (defined as no more than a 30 second time difference between the two groups);
   * Incidence of adverse events.


Eligibility criteria: Inclusion Criteria:

* 6 months of age to 17 years of age (not yet 18)
* Male or female
* English or Spanish speaking
* Normal airway (Mallampati Classification )
* American Society of Anesthesiology Physical Status Classification I or II
* Elective surgical procedure expected to last at least 45 minutes in length
* Written informed consent/assent for participation given by the parent legal guardian and subject (if applicable)

Exclusion Criteria:

* \< 6 months of age, \> 17 years of age
* Difficult airway (Mallampati Classification)
* History of previous difficult intubation, suspected abnormal airway: \*micrognathia

  * facial trauma
  * airway tumor
  * epiglottitis
  * retropharyngeal abscess
  * foreign body, etc.
  * Scheduled for non-elective, emergent OR procedure
  * Parent, legal guardian, or subject is unavailable or unwilling to consent for study participation

Primary outcomes:
measure: Time to Intubation
timeFrame: Confirmed by the visualization of three carbon dioxide waveforms.
Secondary outcomes:
measure: The Number of Adverse Events
timeFrame: Recorded from the start of the intubation procedure to the time of successful endotracheal intubation
Other outcomes:
measure: Number of Intubation Attempts for Each Enrolled Subject
timeFrame: The number is totaled after successful endotracheal intubation is documented
Locations:
city: San Diego
country: United States
facility: Rady Children's Hospital
state: California
Study officials:
References:
Clinical trial NCT04383821: Comparison of the Non-rebreather Mask With the Double-trunk Mask
Official title: Comparison of the Effects of Two Oxygen Delivery Systems on Arterial Blood Gases: Non-rebreather Mask Versus Double-trunk Mask
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxemia
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will compare the impact of the Double-Trunk Mask (DTM) with the Non-Rebreather Mask (NRM) on the blood gases of patients with severe hypoxemia.

Detailed description: The Double-Trunk Mask (DTM) is a device designed to increase the fraction of inspired oxygen in patients who receive oxygen therapy. The mask is composed of a regular aerosol mask with corrugated tubing (15 cm length) inserted into two lateral holes.

Each included patient will wear the standard Non-Rebreather Mask (NRM) which is the standard delivery oxygen system for patients with acute severe hypoxemia. Then the patients will wear the DTM for 30 minutes. Finally the DTM will be replaced by the NRM for the next 30 minutes. The impact of both oxygen delivery system will be assessed by measuring the change of blood gases with each system.

Eligibility criteria: Inclusion Criteria:

• Acute hypoxemia not corrected with nasal cannula

Exclusion Criteria:

* Chronic obstructive pulmonary disease or other chronic respiratory disease with hypercapnia
* Confusion
* Contra-indications to arterial blood gas sampling (peripheral arteriopathy, bleeding disorder)

Primary outcomes:
measure: Changes in PaO2
timeFrame: At baseline and 30 minutes after wearing DTM
Secondary outcomes:
measure: Changes in PaCO2
timeFrame: At baseline and 30 minutes after wearing DTM
measure: Changes in pH
timeFrame: At baseline and 30 minutes after wearing DTM
measure: Changes in respiratory rate
timeFrame: At baseline and 30 minutes after wearing both systems
measure: Comfort with the oxygen delivery systems
timeFrame: 30 minutes after wearing both systems
measure: Dyspnea with the oxygen delivery systems
timeFrame: 30 minutes after wearing both systems
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
state: Brussels Capital
city: Hornu
country: Belgium
facility: Epicura
city: La Louvière
country: Belgium
facility: Centre Hospitalier Universitaire de Tivoli
Study officials:
References:
Clinical trial NCT06669364: A Retrospective Study to Validate BioEP as an Assessment Aid for Seizure Susceptibility
Official title: Retrospective Analysis of Routine EEG to Validate a Computational Biomarker (BioEP) as an Assessment Aid for Seizure Susceptibility.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Epilepsy
Lead sponsor: Neuronostics Ltd
Sponsor class: INDUSTRY
First posted: 2024-11-01
Enrollment: 400
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult population with a diagnosis of epilepsy

Brief summary: The goal of this retrospective study is to validate BioEP during routine adult EEG recording in an outpatient setting, using patients with a known epilepsy diagnosis. The main objectives of the study are:

* To validate BioEP during routine adult EEG recording in an outpatient setting, using patients with a known diagnosis
* To examine whether the use of BioEP could support a more efficient patient pathway to diagnosis (thus adding economic value), by reducing time to final diagnosis and/or the number of clinical appointments needed.


Eligibility criteria: Inclusion Criteria:

* Adults (age 22 and above) who had a routine EEG in an outpatient setting, following a suspected seizure.
* A diagnosis of epilepsy or alternate condition has been reached. A period of at least 3 years has passed since ultimate diagnosis, which itself has remained stable.
* EEGs performed to ABRET \& IFCN standards using a minimum of 19 electrodes and additional technical requirements.

Exclusion Criteria:

* Subject was not suspected of having had a seizure or epilepsy.
* Subject has a dual diagnosis of epilepsy AND non-epileptic seizures.
* Subject's final diagnosis unknown, unstable, or less than three years passed since an unchanged diagnosis was made.
* Incomplete or unreliable metadata, such as the age, sex, and treatment status at the time of the EEG recording.
* Sleep deprived EEG recordings in the outpatient setting.
* Encephalopathic subjects.
* Poor quality EEGs (multiple artefacts) that do not fulfil technical criteria for analysis.
* Known structural abnormalities or skull breaches, including historical cases, or with people with metal or plastic implants in their brain or skull.

Primary outcomes:
measure: To validate BioEP during routine adult EEG recording in an outpatient setting, using patients with a known diagnosis
timeFrame: 6 months
Secondary outcomes:
measure: To examine whether the use of BioEP could support a more efficient patient pathway to diagnosis
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Neuronostics Ltd
name: Milaana Mainstone
role: STUDY_DIRECTOR
References:
Clinical trial NCT00144664: Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)
Official title: An Open-Label, Phase III Study to Evaluate the Efficacy, Safety and PK of MRA in Patients With pJIA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Systemic Juvenile Idiopathic Arthritis
Lead sponsor: Chugai Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2005-09-05
Enrollment: 19
Sex: ALL
Minimum age (years): 2
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, Phase III study to evaluate the efficacy, safety and PK of MRA in patients with pJIA.


Eligibility criteria: Inclusion criteria

* Patients who are diagnosed with rheumatoid factor (RF) positive or negative polyarthritic or oligoarthritic JIA according to the ILAR standards (1997)
* Patients aged at least 2 years old and less than 20.
* Patients aged less than 16 years old at time of onset

Exclusion criteria

* Patients with Class IV Steinbrocker functional disorder at evaluation within 2 weeks before initiation of treatment with the investigational product
* Patients who have been treated for the underlying disease with a biological agent, such as infliximab or etanercept, within 12 weeks before initiation of treatment with the investigational product

Primary outcomes:
measure: Efficacy:Percentage of patients showing 30% improvement in the JIA core set on LOBS
timeFrame: whole period
measure: Safety:Incidence and severity of adverse events and adverse drug reactions
timeFrame: whole period
measure: Pharmacokinetics:The Cmax, trough values, AUC, Kel, CL, Vd, Vdss, and t1/2 for serum MRA concentration
timeFrame: whole period
Secondary outcomes:
measure: Efficacy:The time course of the percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, each evaluation endpoint in the JIA core set, CRP, pain up to LOBS
timeFrame: whole period
Other outcomes:
Locations:
Study officials:
affiliation: Chugai Pharmaceutical
name: Takahiro Kakehi
role: STUDY_DIRECTOR
References: