louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02915562: Influence of Depressive Mood on Rehab Outcome
Official title: Influence of Depressive Mood on Short Term Rehab Outcome at an Acute Geriatrics Unit
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depressive Mood
Keywords: rehabilitation
exercise
outcome measurement
Lead sponsor: Johannes Kepler University of Linz
Sponsor class: OTHER
Collaborators: name: Kepler University Hospital
First posted: 2016-09-27
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the effects of depressive mood on outcomes of an in-house rehabilitation program.


Eligibility criteria: Inclusion Criteria:

* 2-week in-house-rehab at an acute geriatric unit
* ability to take part in assessments
* understanding German language
* Informed Consent

Exclusion Criteria:

* anti-depressive medication shorter than 4 weeks before enrollment
* In-house rehab \< 14 days
* advanced stage of dementia

Primary outcomes:
measure: Physical Performance Test
timeFrame: Change from baseline at day 14 +/-1
measure: de Morton Mobility Index
timeFrame: Change from baseline at day 14 +/-1
measure: Performance Orientated Mobility Assessment (POMA)
timeFrame: Change from baseline at day 14 +/-1
measure: Barthel Index
timeFrame: Change from baseline at day 14 +/-1
measure: Function Index Physiotherapy
timeFrame: Change from baseline at day 14 +/-1
measure: Function Index Occupational Therapy
timeFrame: Change from baseline at day 14 +/-1
measure: Grip strength measurement
timeFrame: Change from baseline at day 14 +/-1
Secondary outcomes:
measure: Charlson Comorbidity Index
timeFrame: Day 1+/-1
measure: Timed Test of Money Counting
timeFrame: Day 1+/-1
measure: Geriatric Depression Scale (GDS-15)
timeFrame: Day 1+/-1 and day 14+/-1
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Kepler University Hospital
Study officials:
References:
Clinical trial NCT05349162: Epicardial vs. Transvenous ICDs in Children
Official title: Epicardial Versus Transvenous Implantable Cardioverter Defibrillators in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Implantable Cardioverter Defibrillator Complications
Implantable Defibrillator User
Lead sponsor: Paris Cardiovascular Research Center (Inserm U970)
Sponsor class: OTHER_GOV
Collaborators: name: Hôpital Necker-Enfants Malades
First posted: 2022-04-27
Enrollment: 131
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All children implanted with an ICD at necker hospital, Paris, France

Brief summary: This observational study included all patients \<18-year-old implanted with an Implantable cardioverter defibrillator (ICD) at Necker Hospital, Paris, France, from January 2003 to January 2021. Outcomes (ICD-related complications and reinterventions) were compared between epicardial and transvenous ICDs using Cox proportional hazard models.


Eligibility criteria: Inclusion Criteria:

* ICD implantation
* Age \< 18 years

Exclusion Criteria:

- Absence of patient's consent

Primary outcomes:
measure: Number of patients with implantable cardioverter defibrillator system dysfunction (lead dysfunction requiring reintervention)
timeFrame: up to 15 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00920062: Measurement of Recirculation During Venovenous Extracorporeal Membrane Oxygenation (VV ECMO)
Official title: Ultrasound Dilution Measurement of Recirculation During Venovenous Extracorporeal Membrane Oxygenation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venovenous Extracorporeal Membrane Oxygenation
Recirculation
Keywords: recirculation
ultrasound dilution
venovenous extracorporeal membrane oxygenation
Lead sponsor: Transonic Systems Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2009-06-15
Enrollment: 16
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonatal and/or pediatric patients receiving venovenous extracorporeal membrane oxygenation as treatment.

Brief summary: This study is to test the usefulness of ultrasound dilution recirculation measurements in patients receiving venovenous extracorporeal membrane oxygenation as therapy. The ultrasound dilution measurements determine the efficiency of support provided by venovenous extracorporeal membrane oxygenation. At the present time there are no other devices available to make recirculation measurements.

Detailed description: At the present time there are no devices available to measure recirculation in patients on venovenous extracorporeal membrane oxygenation. The study uses an external monitor, laptop computer, clamp on flowsensors and ultrasound dilution technology to measure blood flow. Measurements are made by injecting 0.5 - 1 ml/kg of sterile isotonic saline into the patient's extracorporeal circuit. The subject will be monitored throughout the measurements. The measurements will be coordinated with the regular care of the patient and their extracorporeal circuit.

Eligibility criteria: Inclusion Criteria:

* Patients between 0 and 21 years of age
* Patients receiving venovenous extracorporeal membrane oxygenation as treatment.

Exclusion Criteria:

* Patients over 21 years of age
* Patients not receiving venovenous extracorporeal membrane oxygenation.

Primary outcomes:
measure: Recirculation measurements made in patients receiving venovenous extracorporeal membrane oxygenation.
timeFrame: Duration of venovenous extracorporeal membrane oxygenation
Secondary outcomes:
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: Crouse Hospital
state: New York
Study officials:
affiliation: Transonic Systems Inc.
name: Nikolai M Krivitski, PhD, DSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Crouse Hospital
name: Bonnie L Marr, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Clements D, Primmer J, Ryman P, Marr B, Searles B, Darling E. Measurements of recirculation during neonatal veno-venous extracorporeal membrane oxygenation: clinical application of the ultrasound dilution technique. J Extra Corpor Technol. 2008 Sep;40(3):184-7.
Clinical trial NCT00731562: An Investigation Of The Effects Of Food On The Absorption Of A Varenicline Controlled Release Formulation
Official title: Phase 1, Open-Label, Randomized, Single-Dose, Two-Way Crossover Study To Evaluate The Effect Of Food On The Oral Bioavailability Of A Varenicline Controlled Release Formulation In Healthy Adult Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Bioavailability
Smoking Cessation
Keywords: food, varenicline, pharmacokinetics, bioavailability
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-08-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: 1. To estimate the absorption of a single oral dose of a controlled release varenicline tablet under fed and fasted conditions.
2. To evaluate the pharmacokinetics, safety, and tolerability of a single dose of a varenicline controlled release tablet under fed and fasted conditions.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female adult smokers
* 18 to 55 years of age

Exclusion Criteria:

* Sensitivity to varenicline
* Illegal drug use
* Pregnant or nursing females

Primary outcomes:
measure: Varenicline area under the curve (AUC) from time of study medication administration to last quantifiable plasma concentration (AUClast) and AUC from time of study medication administration to infinity (AUCinf).
timeFrame: 5 days
measure: Maximum plasma concentration of varenicline
timeFrame: 1 day
Secondary outcomes:
measure: Safety measures including adverse events
timeFrame: 5 days
Other outcomes:
Locations:
city: East Grand Forks
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Fargo
country: United States
facility: Pfizer Investigational Site
state: North Dakota
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00549562: Study of Paliperidone ER in Adolescents and Young Adults With Autism
Official title: A Prospective, Open-Label Study of Paliperidone ER in Adolescents and Young Adults With Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Autism
Keywords: Autistic Disorder
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Ortho-McNeil Janssen Scientific Affairs, LLC
First posted: 2007-10-26
Enrollment: 25
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This 8-week, prospective open-label study will investigate the effectiveness and tolerability of paliperidone ER in adolescents and young adults with autism. Hypothesis:Paliperidone Er will be well tolerated and efficacious for reducing aggression, self-injury, and irritability in adolescents and young adults.


Eligibility criteria: Inclusion Criteria:

* Males and females between ages of 12 and 21 years
* Tanner Sage III or IV (post-pubertal)
* Diagnostic and Statistical Manual Fourth Edition Text-Revised (DSM-IV-TR) diagnosis of autism
* Outpatient
* Ability to swallow pills
* Antipsychotic medication-free for at least 2 weeks
* Score of 4 or more on the Clinical Global Impressions Severity Scale
* Score of 18 or higher on the Aberrant Behavior Checklist Irritability Scale
* Mental age of 18 months or greater based on testing
* Subjects must be in good physical health

Exclusion Criteria:

* Asperger's Disorder, Pervasive Developmental Disorder Not Otherwise Specified (PDD NOS), Rett's Disorder, childhood disintegrative disorder, schizophrenia, bipolar disorder, Fragile X Syndrome, Tuberous Sclerosis
* A significant medical condition
* An active seizure disorder
* Females who are pregnant
* Evidence of a prior adequate trial of paliperidone ER
* History of neuroleptic malignant syndrome
* Hypersensitivity to paliperidone ER

Primary outcomes:
measure: The Clinical Global Impression-Improvement(CGI-I)
timeFrame: Week 8
measure: The Aberrant Behavior Checklist
timeFrame: Week 8
Secondary outcomes:
measure: The Children's Yale-Brown Obsessive Compulsive Scale Modified for Pervasive Developmental Disorders
timeFrame: Week 8
measure: The Social Responsiveness Scale
timeFrame: Week 8
measure: The Vineland Adaptive Behavior Scales (VABS) - Maladaptive Behavior Domain
timeFrame: Week 8
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Riley Child & Adolescent Psychiatry Clinic- Riley Hospital
state: Indiana
Study officials:
affiliation: Indiana Univerity School of Medicine
name: David Dunn, MD
role: STUDY_DIRECTOR
References:
citation: Stigler KA, Mullett JE, Erickson CA, Posey DJ, McDougle CJ. Paliperidone for irritability in adolescents and young adults with autistic disorder. Psychopharmacology (Berl). 2012 Sep;223(2):237-45. doi: 10.1007/s00213-012-2711-3. Epub 2012 May 3.
Clinical trial NCT03778762: Re-evaluation of Blind Intubation Through the Air-Q Intubating Laryngeal Airway
Official title: Blind Tracheal Intubation Through the Air-Q Intubating Laryngeal Airway in Pediatric Patients. Re-evaluation. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Techniques of Endotracheal Intubation in Pediatrics
Keywords: air-Q, blind intubation, correction maneuvers, fiberoptic guided intubation
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 126
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To compare the success rate of blind technique with correction manoeuvres versus fiber optic- guided Intubation through the air Q laryngeal airway in pediatric patients

Detailed description: A prior G-power analysis was done to estimate the sample size. The primary outcome of this study was the first trial success rate. Using fibre exact test and assuming alpha (type I error) = 0.05 and beta (type II error) = 0.2 (power =80%), 58 patients per group would be sufficient to detect a difference 10 % in success rate among the groups. A drop out 10% of cases was expected; therefore 63 patients were required in each group to detect the difference.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status I-II
* Body weight from 4 to 30 kg

Exclusion Criteria:

* Obesity
* History of gastroesophageal reflux
* History of hyperactive airway
* Patients with congenital disorders associated with difficult airway

Primary outcomes:
measure: The first trial success rate
timeFrame: during first trial of intubation procedure
Secondary outcomes:
measure: The total success rate
timeFrame: from beginning of manipulation of the endotracheal tube till end of second trial either by successful intubation or failed intubation procedure
measure: Time to ventilation
timeFrame: procedure (Time from beginning of air-Q insertion till full capno-graphic wave)
measure: Time to intubation
timeFrame: procedure (Time from beginning of manipulation of the ETT till full capno-graphic wave)
measure: Heart rate
timeFrame: After induction of anesthesia till 10 minutes after intubation
measure: Mean arterial blood pressure
timeFrame: After induction of anesthesia till 10 minutes after intubation
measure: blood staining of the device
timeFrame: from extubation till 24 hours after extubation
measure: post-intubation croup
timeFrame: from extubation till 24 hours after extubation
measure: hoarsenes
timeFrame: from extubation till 24 hours after extubation
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Enas A Abd el Motlb
state: DK
Study officials:
affiliation: Associate Professor
name: Enas A Abd el Motlb, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03378362: Pain Relief and Functional Outcome After Partial Denervation of the Wrist
Official title: A Prospective Study on Pain Relief and Functional Outcome After Partial Denervation of the Wrist
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wrist Arthritis
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2017-12-19
Enrollment: 60
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: Prospective study on the effect of partial wrist denervation (ie combined anterior and posterior interosseous neurectomy) on pain relief on functional outcome in patient with wrist osteoarthritis. The impact of psychological factors on postoperative outcome will be studied.


Eligibility criteria: Inclusion criteria

1. Chronic wrist pain (≥6 months) due to posttraumatic arthritis after distal radius fracture or SLAC/SNAC arthritis or arthritis due to Mb Preiser/Mb Kienböck where surgical unloading of the bone isn't possible.
2. Pain is refractory to nonsurgical management such as bracing, corticosteroid injection, oral analgesics, NSAIDs, physiotherapy.

Exclusion criteria

1. Rheumatoid or other inflammatory arthritis.
2. Previous wrist surgery with simultaneous PIN/AIN neurectomy.
3. Simultaneous arthritis or symptomatic instability of the distal radio ulnar (DRU) joint on the ipsilateral side.
4. Inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction).
5. Patient's wish for a definite procedure.

Primary outcomes:
measure: Change in Disability of the Arm, Shoulder and Hand score (DASH)
timeFrame: peroperatively, 3, 6 and 12 months postoperatively
Secondary outcomes:
measure: Change in Patient Related Wrist Evaluation (PRWE)
timeFrame: peroperatively, 3, 6 and 12 months postoperatively
measure: Change in EQ5D
timeFrame: peroperatively, 3, 6 and 12 months postoperatively
measure: Change in Hospital Anxiety and Depression Scale (HADS)
timeFrame: peroperatively, 3, 6 and 12 months postoperatively
measure: Change in range of motion, grip strength
timeFrame: peroperatively, 3, 6 and 12 months postoperatively
measure: Change in Sence Of Coherence -13 (SOC13)
timeFrame: peroperatively, 3, 6 and 12 months postoperatively
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Handkirurgiska kliniken Södersjukhuset
Study officials:
affiliation: Karolinska Institutet
name: Maria Wilcke, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05414591: Pharmacokinetics and Safety Following Administration of DWP16001
Official title: A Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of DWP16001 Drug A and DWP16001 Drug B in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2022-06-10
Enrollment: 38
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To compare and evaluate the safety and pharmacokinetic characteristics after administration of DWP16001 Drug A and DWP16001 Drug B in healthy adult volunteers


Eligibility criteria: Inclusion Criteria:

* Healthy adult volunteers aged ≥ 19 years at screening
* Subjects with a body weight of ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 30.0 kg/m2
* Subjects with no congenital or chronic disease that requires treatment, and no clinical symptoms or findings based on medical examination
* Subjects who are determined eligible to participate in this study based on results of laboratory tests, vital signs, physical examination etc at screening.

Exclusion Criteria:

* Current or history of clinically significant hepatic, renal, nervous, respiratory, endocrine, hemato-oncology, cardiovascular, urogenital, psychosis disorder
* Current or history of gastrointestinal disorders or prior history of gastrointestinal surgery that may affect safety and PK/PD assessment of the study drug
* Clinical laboratory test values are outside the accepted normal range at screening
* Other exclusive inclusion criteria, as defined in the protocol

Primary outcomes:
measure: AUC0_t of DWP16001
timeFrame: 0-72 hours
measure: Cmax of DWP16001
timeFrame: 0-72 hours
Secondary outcomes:
measure: Tmax Tmax
timeFrame: 0-72 hours
measure: AUC of DWP16001
timeFrame: 0-72 hours
measure: T 1/2 of DWP16001
timeFrame: 0-72 hours
measure: CL/F of DWP16001
timeFrame: 0-72 hours
measure: Vd/F of DWP16001
timeFrame: 0-72 hours
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT00170391: Do People With Insomnia Sleep Better After Psychological Treatment?
Official title: Does CBT for Insomnia Improve the PSG Sleep of Patients Treated in Primary Care?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia
Keywords: Insomnia
Sleep
PSG
Behavioural treatment
Lead sponsor: NHS Greater Clyde and Glasgow
Sponsor class: OTHER
First posted: 2005-09-15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The principal aim of the study is to evaluate if CBT for insomnia is associated with improvement in the PSG sleep of patients treated in primary care. Furthermore,the relationship between subjectively-assessed sleep and PSG sleep are investigated(at pre-treatment, at post-treatment, in relation to treatment change.


Eligibility criteria: Inclusion Criteria:

Meets clinical/RDC criteria for primary insomnia Healthy Adult (18+ years)

Exclusion Criteria:

Evidence of sleep disorders other than insomnia Use of sleeping pills Major Psychopathologies

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Sackler Foundation of Psychobiological Research
state: Lanarkshire
Study officials:
affiliation: University of Glasgow
name: Colin A Espie, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01528891: Dexmedetomidine as a Rapid Bolus in Children for Emergence Agitation
Official title: Dexmedetomidine as a Rapid Bolus for Treatment and Prophylactic Prevention of Emergence Agitation in Anesthetized Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tonsillectomy
Keywords: tonsillectomy
emergence agitation
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Hospira, now a wholly owned subsidiary of Pfizer
First posted: 2012-02-08
Enrollment: 418
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To Determine The Efficacy of a Rapid Bolus Injection of Dexmedetomidine on the Incidence of Emergence Agitation in Anesthetized Children and the Cardiovascular Profile of a Rapid Bolus Injection of Dexmedetomidine.


Eligibility criteria: Inclusion Criteria:

* children undergoing tonsillectomy with and without adenoidectomy and myringotomy and tube insertion
* ASA 1,2,3
* females who have started menses but have a negative urine pregnancy test

Exclusion Criteria:

* patients with known dysrhythmias,
* not recovering in the ICU
* developmental delay,
* autism communication disorder
* bleeding disorder
* PI discretion

Primary outcomes:
measure: Heart Rate (HR)
timeFrame: Heart rate was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. Heart rate was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU).
measure: Systolic Blood Pressure (SBP)
timeFrame: Systolic blood pressure (SBP) was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. SBP was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU).
measure: Diastolic Blood Pressure (DBP)
timeFrame: Diastolic blood pressure (DBP) was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. DBP was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU).
Secondary outcomes:
measure: Incidence of Emergence Agitation (EA)
timeFrame: The highest PAED score for each patient within the first 30 minutes after waking up was recorded.
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Childrens Hospital of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Peter J Davis, MD
role: PRINCIPAL_INVESTIGATOR
References: