louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04364945: Association Between Anesthetic Drugs for General Anesthesia and Postoperative Intelligence/behavioral Assessment Results in Children
Official title: Association Between Anesthetic Drugs for General Anesthesia and Postoperative Intelligence/behavioral Assessment Results in Children
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anesthesia and Neurotoxicity
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 400
Sex: ALL
Minimum age (years): 1
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: In this study, we compared the results of the intelligence and behavioral test performed after surgery between the group using sevoflurane and the group receiving dexmedetomidine and remifentanil, in Korean children under 2 years of age who underwent surgery under general anesthesia.


Eligibility criteria: Inclusion Criteria:

* Children under 2 years of age who underwent general anesthesia for elective surgeries inlcuding urology, surgery, plastic surgery, orthopedics, and otolaryngology, etc, which were non-staged and non-repetitive procedures
* American Society of Anesthesiology Physical Status I, II

Exclusion Criteria:

* Allergies to narcotic analgesics
* With massive bleeding or shock
* Heart, lung, kidney or liver disease
* Central / peripheral nervous system disease and disorder
* Any physical deformity and disorder, genetic disease, chromosomal disease
* Previous history of general anesthesia or sedation
* Developmental delay identified through K-DST results
* Additional exposure to general anesthetics or sedative drugs during follow-up

Primary outcomes:
measure: Wechsler Preschool and Primary Scale of Intelligence-IV at age of 5
timeFrame: When the patient's age is 5 years after surgery
Secondary outcomes:
measure: Leiter International Performance Scale at age of 30 months
timeFrame: When the patient's age is 30 months old after surgery
measure: Wechsler Preschool and Primary Scale of Intelligence-IV at age of 7
timeFrame: When the patient's age is 7 years old after surgery
measure: Child Behavior Checklist results
timeFrame: When the patient's age become 30 months, 5 years and 7 years old after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Other
Study officials:
affiliation: Seoul National University Hospital
name: Ji-Hyun Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02075645: Can Adherence to PALS Guidelines be Improved by Team Training of Pediatric Resuscitation Members?
Official title: Can Adherence to PALS Guidelines be Improved by Team Training of Pediatric Resuscitation Members?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crisis Resource Management
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Canada
name: Canadian Institutes of Health Research (CIHR)
First posted: 2014-03-03
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: A multi-centre prospective cohort study, which examines the effect of a team training educational intervention for pediatric resuscitation team members. The study uses simulation-based training as the primary teaching method to evaluate the effect of team training on team performance, as measured by adherence to PALS guidelines. By re-testing participants again after 6-12 months, the study will examine long-term retention of these skills. Hypothesis: adherence to PALS guidelines is improved following team training of pediatric resuscitation team members.

Detailed description: A multi-centre prospective cohort study, which examines the effect of a team training educational intervention for pediatric resuscitation team members. The study uses simulation-based training as the primary teaching method to evaluate the effect of team training on team performance, as measured by adherence to PALS guidelines. By re-testing participants again after 6-12 months, the study will examine long-term retention of these skills.

The investigator anticipates sustained, improved team performance after team training. If this proves to be true, the long-term goal is to disseminate this training widely across Canada, in order to benefit all paediatric resuscitation teams, and ultimately their patients.

Eligibility criteria: Inclusion Criteria:

* Code Blue certified RN \& RRT
* Pediatric Residents
* Teams must consists of Interprofessional (Resident MD, RN, RRT) resuscitation team members.
* Team composition will reflect actual resuscitation team composition at each site, which will vary slightly from site to site.

Exclusion Criteria:

* Fellows
* Attendings
* Non Code Blue certified staff

Primary outcomes:
measure: Adherence to PALS guidelines, as measured by the Clinical Performance Tool (CPT) by Donoghue et al
timeFrame: up to 3.5 years
Secondary outcomes:
measure: Long-term effect of training on adherence to PALS guidelines (as measured by the CPT) & teamwork performance (as measured by the CTS) at 6-12 months post-training.
timeFrame: up to 3.5 years
Other outcomes:
measure: Teamwork performance as measured by the Clinical Teamwork Scale (CTS) by Guise et al
timeFrame: up to 3.5 years
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
Study officials:
affiliation: University of Calgary
name: Elaine Gilfoyle, MD,MMEd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04303845: Erenumab For Treatment of Hemicrania Continua
Official title: Erenumab For Treatment of Hemicrania Continua
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hemicrania Continua
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-03-11
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This research is being conducting to learn if the study drug erenumab is successful in treating hemicrania continua. The study is also evaluating the safety and tolerability of erenumab in individuals being treated for hemicrania continua.


Eligibility criteria: Inclusion Criteria

* Adults over the age of 18-66
* At least a 12 month history of hemicrania continua (unremitting subtype) according to International Classification of Headache Disorders, 3rd Edition (ICHD-3)1
* Previous or current complete response to indomethacin
* Stable preventive treatment for at least 2 months and no anticipated need to adjust/add current headache prevention treatment

Exclusion Criteria

* Nonresponse to a therapeutic dose of indomethacin for hemicrania continua when used for at least 1 week
* Pregnant or lactating subjects
* Use of barbiturate or opioid \>6 days per month; history of chronic migraine
* History of previous trigeminal-autonomic cephalalgia
* History within previous 2 months of interventional procedure for headache (occipital or other extracranial nerve block, sphenopalatine ganglion block, cervical facet block, facet rhizotomy)
* History of cranial nerve/rhizolysis
* Botulinumtoxin injection with previous 4 months
* Parenteral infusion of or oral corticosteroid use for more than 3 days within 4 weeks prior to screening phase

Primary outcomes:
measure: Headache Days
timeFrame: 4 weeks post erenumab treatment
Secondary outcomes:
measure: Migraine Days
timeFrame: 4 weeks post erenumab treatment
measure: Headache Freedom
timeFrame: 4 weeks post erenumab treatment
measure: Remission Rate
timeFrame: 4 weeks post erenumab treatment
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Rashmi Halker Singh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00173745: Treatment of Drooling With Type A Botulinum Toxin in Children With Cerebral Palsy
Official title: Treatment of Drooling With Type A Botulinum Toxin A in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Drooling
Keywords: cerebral palsy
drooling
botulinum toxin
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2005-09-15
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness of botulinum toxin injection to treat drooling in children with cerebral palsy, and to find the most appropriate dosage, duration of effect and side effects.

Detailed description: Sialorrhea, or drooling, has been reported to be a significant problem in 10%to 37% of patients with cerebral palsy. Excessive drooling may cause skin maceration, increased the burden of caregiver, affect articulation of the patients, and increase the risk of aspiration and dehydration. Many options, including various therapies, medications, surgeries and radiation, have been proposed to treat drooling. Yet none of these is universally successful and many have potential complications. Nerve endings of the parasympathetic post-ganglionic neurons secret aceylcholine. Botulinum toxin should be able to inhibit salivary gland secretion by blocking the release of acetylcholine. Very limited case series had proved fair result of botulinum toxin injection to treat drooling. However, most of the subjects were adult patients with neurological disorders. The purpose of this study is to evaluate the effectiveness of botulinum toxin injection to treat drooling in children with cerebral palsy, and to find the most appropriate dosage, duration of effect and side effects.

Eligibility criteria: Inclusion Criteria:

* diagnosis of cerebral palsy
* severe drooling
* aged 6-21 yrs
* subjects (or their guardian) who are able to understand the requirements of the study and sign the informed consent form

Exclusion Criteria:

* age below 6 yrs or above 21 yrs
* known allergy or sensitivity to the study medication or its component
* diagnosis of myasthenia gravis, amyotrophic lateral sclerosis or any other disease that might interfere with neuromuscular function
* subjects who have prior surgery of the submandibular gland
* subjects who are receiving medication that affect drooling such as anticholinergic drug
* inability to give informed consent

Primary outcomes:
measure: the effectiveness of botulinum toxin in treatment of drooling
Secondary outcomes:
measure: the most appropriated dosage of treatment
measure: duration of effect
measure: side effects
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Jeng Yi Shieh, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03504345: Progesterone Supplementation in Frozen Embryo Transfer Cycles
Official title: Assessing the Optimal Duration of Progesterone Supplementation Prior to Transfer of Frozen Embryos in the Recurrent Implantation Failure Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility Due to Nonimplantation
Infertility
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
First posted: 2018-04-20
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recurrent implantation failure (RIF) occurs after women undergo in vitro fertilization and have multiple embryos transferred but no resulting pregnancies. RIF is a very challenging clinical entity for the reproductive physician and the patient. In fact, there is not even an agreed upon definition in the medical community. Many potential causes have been investigated over the past several years but no clear answer has emerged. Interest has recently turned to the endometrium, or the lining of the uterus. Studies have shown that the genes that are turned on in the endometrium vary based on how long this tissue has been exposed to progesterone, an important hormone that prepares the uterine lining for implantation of the growing embryo. In some women, it seems that they require longer periods of progesterone exposure to reach the same state of readiness. We hypothesize that an even larger proportion of women in RIF population will require longer treatments with progesterone.

In this study, we will randomize women with RIF who are about to undergo a frozen embryo transfer to one of two groups. The first group will have their embryo transfer done on the standard sixth day of progesterone treatment. The other group will have their transfer done on the seventh day of progesterone. We will be comparing the clinical pregnancy rate of the two groups as well as the live birth rate and miscarriage rate. We expect that extending the progesterone treatment by one day will increase the pregnancy rate of women with RIF.


Eligibility criteria: Inclusion Criteria:

* Patient at Mount Sinai Fertility who wants to undertake a frozen embryo transfer
* History of recurrent implantation failure, defined as no pregnancy after three or more embryo transfers of four or more good quality blastocysts

Exclusion Criteria:

* Previous testing with Endometrial Receptivity Assay (ERA)
* Unable understand/communicate in English

Primary outcomes:
measure: clinical pregnancy rate
timeFrame: 6 to 8 weeks after embryo transfer
Secondary outcomes:
measure: Live birth rate
timeFrame: Approximately 9 months after embryo transfer
measure: Miscarriage rate
timeFrame: Approximately 3 months after embryo transfer
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01923545: Phase II Study of DA-3031(PEG-G-CSF) in Chemotherapy-induced Neutropenia
Official title: Multi-Center, Randomized, Open, Phase II Study to Evaluate Efficacy and Safety in Chemotherapy-induced Neutropenia of Once-per-cycle DA-3031(PEG-G-CSF) and Daily G-CSF in Patients With Malignancies Receiving Myelosuppressive Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chemotherapy Induced Neutropenia
Keywords: PEG-G-CSF
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-08-15
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to examine which dose of DA-3031(PEG-G-CSF) has similar efficacy and safety compared to daily G-CSF in chemotherapy-induced neutropenia.

Detailed description: Eligible subjects are randomly assigned to receive once-per-cycle DA-3031(PEG-G-CSF) or daily G-CSF(up to 10 days). This study is conducted for 1 cycles of chemotherapy.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of stage II or III breast cancer
2. Age : ≥18, ≤70
3. TAC regimen as adjuvant therapy
4. ANC≥1,500/mm3, Platelet≥100,000/mm3, ECOG : 0 or 1
5. Creatinine \< 1.5 x ULN
6. Total bilirubin/AST/ALT \< 1.5 x ULN, ALP \< 2.5 x ULN
7. Have given a written, informed consent

Exclusion Criteria:

1. Received any other investigational drugs within 30 days of informed consent date
2. Received systemic antibiotics within 72 hours of chemotherapy into this study or Radiation therapy within 4 weeks of informed consent date
3. Infective symptom before chemotherapy into this study
4. Pregnant or lactating women
5. Prior bone marrow or stem cell transplantation
6. Other malignancy history within 5 years
7. HIV positive
8. Prior exposure to pegfilgrastim or filgrastim or other colony-stimulating factors within 6 weeks of informed consent date
9. Prior chemotherapy

Primary outcomes:
measure: Duration of grade 4 neutropenia in cycle 1
timeFrame: 21 day
Secondary outcomes:
measure: ANC nadir in cycle 1
timeFrame: 21 day
measure: Time to ANC recovery in cycle 1
timeFrame: 21 day
measure: Incidence of febrile neutropenia in cycle 1
timeFrame: 21 day
measure: Incidence of IV antibiotics administration in cycle 1
timeFrame: 21 day
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University GURO hospital
Study officials:
affiliation: Korea University Guro Hospital
name: JaeHong Seo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00568945: Study to Investigate the Effect of the A1 Agonist Capadenoson on Ventricular HR in Patients With Persistent or Permanent Atrial Fibrillation.
Official title: Study to Investigate the Effect of the A1 Agonist Capadenoson on Ventricular HR in Patients With Persistent or Permanent Atrial Fibrillation by Administration of Capadenoson in a Dose of 4 mg Once Daily for Five Days
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Capadenoson
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2007-12-06
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial has the primary goal to show that BAY68-4986 can lower the ventricular rate in patients with the indication persistent atrial fibrillation.


Eligibility criteria: Inclusion Criteria:

* Male and/or female (without childbearing potential) white patients
* History of persistent or permanent atrial fibrillation
* 18 to 75 years of age

Exclusion Criteria:

* Patients with high-risk cardiovascular diseases
* Stroke or myocardial infarction
* Relevant pathological changes in the ECG or echocardiography
* Medication affecting ventricular response in Afib

Primary outcomes:
measure: The effect of capadenoson (BAY68-4986) on rate control in patients with atrial fibrillation
timeFrame: 1 week
Secondary outcomes:
measure: To investigate safety and tolerability of this treatment with capadenoson
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Erfurt
country: Germany
state: Thüringen
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00767247: Analysis of Antihypertensive Treatment Efficacy
Official title: Analysis of Antihypertensive Treatment Efficacy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Arterial Hypertension
Keywords: Arterial Hypertension
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-10-07
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: outpatient clinics

Brief summary: Analysis of antihypertensive treatment efficacy.


Eligibility criteria: Inclusion Criteria:

* arterial hypertension
* intake of Atacand before study enrollment

Exclusion Criteria:

* hypersensitivity to candesartan or any other ingredient of Atacand
* liver function impairment and/or cholestasis
* severe renal insufficiency (serum creatinine \> 265 µmol/L)
* Pregnant and lactating women

Primary outcomes:
measure: Analysis of antihypertensive treatment efficacy.
timeFrame: measurement BP: 3 visits for 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Arhangelsk
country: Russian Federation
facility: Research Site
city: Bryansk
country: Russian Federation
facility: Research Site
city: Domodedovo
country: Russian Federation
facility: Research Site
city: Dzerzhinsk
country: Russian Federation
facility: Research Site
city: Ekaterinburg
country: Russian Federation
facility: Research Site
city: Essentuki
country: Russian Federation
facility: Research Site
city: Georgievsk
country: Russian Federation
facility: Research Site
city: Irkutsk
country: Russian Federation
facility: Research Site
city: Kazan
country: Russian Federation
facility: Research Site
city: Samara
country: Russian Federation
facility: Research Site
city: Severodvinsk
country: Russian Federation
facility: Research Site
city: Vidnoe
country: Russian Federation
facility: Research Site
city: Volgograd
country: Russian Federation
facility: Research Site
Study officials:
affiliation: Federal State Institution of Russian President's General Management Department
name: Dmitry Zateyshchikov, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03212898: Pharmacist Interventions in Rural Elderly Warfarin Patients
Official title: The Influence of Pharmacist Interventions on the Effectiveness of Warfarin Treatment in Elderly Patients From Rural Areas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Thrombosis
Cardiac Failure
Hemorrhage
Keywords: pharmacist interventions, warfarin, elderly rural patients
Lead sponsor: Slaven Falamić
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 131
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The primary study goal is to explore the influence of pharmacist interventions on the effectiveness of warfarin treatment in a specific subpopulation.


Eligibility criteria: Inclusion Criteria:

* Age ≥65 years
* Living site of participant outside the city eg. rural site
* Expected duration of warfarin therapy at least 6 months from the inclusion in the study and 3 months before

Exclusion Criteria:

* Hospitalization
* Vegetarianism
* Patients not able to provide an informed consent
* The use of drug that has an X level of clinical significance of interaction with warfarin according to Lexicomp interact base

Primary outcomes:
measure: Time in therapeutic range (TTR)
timeFrame: 6 months
Secondary outcomes:
measure: Adverse drug reactions
timeFrame: 6 months
measure: Time to adverse drug reaction
timeFrame: 6 months
measure: International randomised ratio
timeFrame: 6 months
measure: Adherence
timeFrame: 6 months
measure: Quality of life
timeFrame: 6 months
measure: Incidence and influence of clinically significant drug interactions
timeFrame: 6 months
measure: Dietary intake of vitamin K
timeFrame: 6 months
measure: Acceptance of pharmacist's intervention by the general practitioners
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Pharmacy Branka Marušić
name: Slaven Falamić, MPharm
role: PRINCIPAL_INVESTIGATOR
References:
citation: Falamic S, Lucijanic M, Ortner-Hadziabdic M, Marusic S, Bacic-Vrca V. Pharmacists' interventions improve health-related quality of life of rural older person on warfarin: a randomized controlled trial. Sci Rep. 2021 Nov 9;11(1):21897. doi: 10.1038/s41598-021-01394-0.