louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00952913: Study Evaluating The Potential Effect Of Lansoprazole On The Pharmacokinetics Of Bosutinib In Healthy Subjects
Official title: A Study to Examine The Potential Effect Of Lansoprazole On The Pharmacokinetics Of Bosutinib When Administered Concomitantly To Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2009-08-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if there is an effect on the pharmacokinetics of bosutinib when administered with lansoprazole.


Eligibility criteria: Inclusion Criteria:

* Healthy men and women of nonchildbearing potential, between the ages of 18 to 50 years old.

Exclusion Criteria:

* Any cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.

Primary outcomes:
measure: Pharmacokinetics as measured by Cmax, AUC, tmax, t1/2
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Abbas R, Leister C, Sonnichsen D. A clinical study to examine the potential effect of lansoprazole on the pharmacokinetics of bosutinib when administered concomitantly to healthy subjects. Clin Drug Investig. 2013 Aug;33(8):589-95. doi: 10.1007/s40261-013-0103-z.
Clinical trial NCT04303013: Guided Meditation During Radiotherapy.
Official title: A Randomized Controlled Trial of Guided Mindfulness Intervention During Radiotherapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Quality of Life
Relaxation During Radiation Therapy
Cancer
Radiation Toxicity
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research is to gather information on the effects of Mindfulness-Based Intervention (MBI) on quality of life during and after radiation treatment.

This study involves randomization. There is a 50 percent chance (like a flip of the coin) that you will be randomized to attend meditation sessions during treatment.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Prescribed a course of at least 15 daily fractions of RT for curative intent of any malignancy
* Willing to attend MBI sessions weekly during RT
* Able to transport themselves to scheduled MBI sessions in the DAHLC
* Able to complete questionnaire(s) by themselves
* Native English speaker (MBI sessions, videos, and QOL questionnaires are only available in English)
* ECOG Performance Status 0-2

Exclusion Criteria:

* Prescribed a course of RT with fewer than 15 consecutive, daily fractions
* Unable or unwilling to attend required MBI sessions

Primary outcomes:
measure: Effectiveness of Meditation Sessions
timeFrame: Before radiation treatment.
measure: Effectiveness of Meditation Sessions
timeFrame: During radiation treatment
measure: Effectiveness of Meditation Sessions
timeFrame: 3 months and 12 months post radiation treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Kimberly S. Corbin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02416713: Way to Safety Cellphone Blocking
Official title: Way to Safety: Cellphone Blocking Technology to Reduce Cellphone Use While Driving Among Teens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Teen Drivers
Motor Vehicle Accident
Keywords: Driving
Teens
Texting
Cellphone
DriveID
Motor vehicle accident
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
First posted: 2015-04-15
Enrollment: 35
Sex: ALL
Minimum age (years): 16
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Research participants will be recruited to take part in a randomized control trial. Participants' cellphone use will be observed during an initial baseline period. Participants will then be randomly assigned to one of four conditions: education only (control), opt-in blocking, opt-out blocking, and opt-out blocking with parental notification.

Detailed description: Motor vehicle crashes are the leading cause of death in teens in the United State and for drivers aged 15-19 involved in fatal crashes, 21% of distracted drivers were distracted by the use of cellphones. Nearly 90% of teens expect a response to a text message within 5 minutes, and the compulsion to respond is stronger for messages from close social contacts. This suggests that behavioral-economic interventions such as immediate and frequent incentives are needed to offset the disutility caused by not being able to communicate by cellphone while driving. If proven to be effective, incentives could be scaled up via auto insurance discount contributions, school programs, and parental contributions.

Eligibility criteria: Inclusion Criteria:

1. High school student
2. 16 or 17 at start of the study
3. Have a valid driver's license
4. Lives in parent's/guardian's home
5. Drives to school
6. Primarily drive one car
7. Has their own iPhone 4S or newer or Android 4.3 or newer smartphone with data plan
8. Parent/guardian is willing to assist with installation
9. Admit to texting while driving \>1 time in the last 30 days

Exclusion Criteria:

1. Already uses a smartphone app or hardware device to limit cellphone use while driving

Primary outcomes:
measure: Change in Frequency of Cellphone Unlocks
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Catherine McDonald, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01339013: Rebreathing of Carbon Dioxide With a Device Used for Giving Inhalational Anaesthesia
Official title: Dead Space Effect of an Anaesthesia Gas Reflector (AnaConDa)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthetic Ventilatory Requirements
Keywords: Quantification
ventilatory requirements
charcoal filter
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2011-04-20
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The anesthesia gas reflector (AnaConDa) is built on the adsorptive capacity of active carbon which also adsorbs carbon dioxide in exhaled air. Rebreathing of carbon dioxide thus occurs and must be compensated for by increased ventilation. This study aims at determining how much compensation must be given, based on the hypothesis that rebreathing depends on carbon dioxide level in blood and exhaled air.


Eligibility criteria: Inclusion Criteria:

* elective coronary artery by-pass graft surgery
* elective valve replacement surgery
* normal left ventricular ejection fraction on preoperative echocardiography

Exclusion Criteria:

* obstructive lung disease
* restrictive lung disease

Primary outcomes:
measure: Airway Dead Space With Devices for Heat and Moisture Exchange of Respiratory Gas.
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: University Hospital, Cardiothoracic Intensive Care
Study officials:
affiliation: Division of Surgery, Department of Anaesthesia, Skane University Hospital, Lund, Sweden
name: Mikael Bodelsson, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sturesson LW, Bodelsson M, Johansson A, Jonson B, Malmkvist G. Apparent dead space with the anesthetic conserving device, AnaConDa(R): a clinical and laboratory investigation. Anesth Analg. 2013 Dec;117(6):1319-24. doi: 10.1213/ANE.0b013e3182a7778e.
Clinical trial NCT03330613: Emergence Delirium and Recovery Time in Children
Official title: Emergence Delirium and Recovery Time in Children: a Randomized Trial to Compare Total Intravenous Anesthesia With Propofol to Inhalational Sevoflurane Anesthesia for Ambulatory Dental Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Emergence Delirium
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 120
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: In this study, inhalation anesthesia procedure and intravenous anesthesia method will be compared in terms of emergence delirium and recovery time in children who are scheduled for dental treatment under general anesthesia.

Detailed description: Pediatric Anesthesia Early Delirium Scale (PAEDS) will be used to evaluate postoperative emergence delirium.

Eligibility criteria: Inclusion Criteria:

1. Indication of dental treatment under general anesthesia.
2. No systemic disease (ASA1).
3. Child and parent agree to participate in the work

Exclusion Criteria:

1. Do not accept to participate in the work.
2. The child is not systemically healthy.
3. Children with allergies to general anesthetic drugs.
4. Contraindicated children to take general anesthesia
5. Children with upper respiratory tract infection on the day of operation

Primary outcomes:
measure: Emergence delirium
timeFrame: 6 hours
Secondary outcomes:
measure: Recovery time
timeFrame: 6 hours
Other outcomes:
Locations:
city: Aydin
country: Turkey
facility: Ozlem Kocaturk
Study officials:
affiliation: Faculty of Dentistry, Adnan Menderes University
name: Ozlem Kocaturk
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chandler JR, Myers D, Mehta D, Whyte E, Groberman MK, Montgomery CJ, Ansermino JM. Emergence delirium in children: a randomized trial to compare total intravenous anesthesia with propofol and remifentanil to inhalational sevoflurane anesthesia. Paediatr Anaesth. 2013 Apr;23(4):309-15. doi: 10.1111/pan.12090.
citation: Konig MW, Varughese AM, Brennen KA, Barclay S, Shackleford TM, Samuels PJ, Gorman K, Ellis J, Wang Y, Nick TG. Quality of recovery from two types of general anesthesia for ambulatory dental surgery in children: a double-blind, randomized trial. Paediatr Anaesth. 2009 Aug;19(8):748-55. doi: 10.1111/j.1460-9592.2009.03054.x. Epub 2009 Jun 15.
Clinical trial NCT02029313: Safety and the Pharmacokinetic Study of Characteristics of MKT-N2 (Montelukast) and Singulair® (Montelukast Sodium)to Treat Asthma
Official title: A Randomized, Open-label, Single-Dose, 2-Treatment, 2-Way, 2-Period Crossover Study to Compare the Safety and the Pharmacokinetic Characteristics of MKT-N2 (Montelukast) and Singulair® (Montelukast Sodium) Tablet 10mg in Healthy Male Korean Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma and Allergic Rhinitis
Lead sponsor: PharmaKing
Sponsor class: INDUSTRY
First posted: 2014-01-07
Enrollment: 40
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The Purpose of A center, Randomized, Open label, single dose, Placebo-controlled, 2-Treatment, 2-Way, 2-Period Crossover Study to Compare the Safety and the Pharmacokinetic Characteristics of MKT-N2 (Montelukast) and Singulair® (montelukast sodium) tablet 10mg in Healthy Male Korean Subjects


Eligibility criteria: Inclusion Criteria:

* Healthy Korean Male over20, under 45 years old
* 55kg over weight, IBW +-20% range male

Exclusion Criteria:

* Males who have gotten a clinically significant of liver, pancreas, kidneys, nervous system, respiratory system, endocrine system, blood cancer, mental illness, cardiovascular, urinary tract disease, or a history corresponding
* Males who have gotten a history of gastrointestinal disease
* Males who have gotten a history of hypersensitivity to montelukast or reaction to other drugs(aspirin, antibiotics)

Primary outcomes:
measure: Number of participants with Adverse event
timeFrame: 1day
Secondary outcomes:
measure: Pharmacokinetic profiles
timeFrame: 1day
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
state: Junggu
Study officials:
References:
Clinical trial NCT00759213: Discharge Planning Assessment of Family Needs
Official title: Discharge Planning Assessment of Family Needs and Concerns at the Time of Infant's Discharge in the NICU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Family Needs / Concerns
Keywords: Discharge planning
Family needs
Family concerns
NICU
Infants
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
Collaborators: name: Alfred I. duPont Hospital for Children
First posted: 2008-09-25
Enrollment: 250
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants in the NICU

Brief summary: It is well established within pediatric and neonatal medicine that social and traditionally "non-medical" aspects of the home environment and conditions after discharge influence neonatal health both in the acute and long-term setting. Government programs and laws exist that are designed for the provision of basic pediatric health needs. Unfortunately, deficits in obtaining those services lead to preventable poor health outcomes. Hospital social workers and discharge planners are able to identify appropriate services, while lawyers are experts in ensuring those rights and services are actually obtained and delivered.

West Side Health of CCHS has implemented a medical-legal partnership along the pathways advocated by the Medical Legal Partnership for Children as part of their clinical care services. Before implementing a similar system in the NICU, a needs assessment will be performed first.

The purpose of this study is to determine what the health care team (physicians, nurses, social workers, discharge planners, etc) through our discharge planning practice establishes as the legal needs. We will collect information which is normally collected by the health care team as a part of their usual care and assessment for discharge planning. The families will not be approached directly by study staff.


Eligibility criteria: Inclusion Criteria:

* Infants admitted to the NICU
* Length of stay \> 6 days
* Discharge to home

Exclusion Criteria:

* Length of stay \</= 6 days
* Discharge to another hospital

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Care Health Systems
state: Delaware
city: Wilmington
country: United States
facility: Alfred I. duPont Hospital for Children
state: Delaware
Study officials:
affiliation: Christiana Care Health Services
name: Robert G. Locke, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02935413: Combined tDCS and Vision Restoration Training in Subacute Stroke Rehabilitation: A Pilot Study
Official title: Combined tDCS and Vision Restoration Training in Subacute Stroke Rehabilitation: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hemianopia
Stroke
Lead sponsor: University of Magdeburg
Sponsor class: OTHER
Collaborators: name: Neurologisches Therapiezentrum Gmundnerberg
First posted: 2016-10-17
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this Study is to determine whether non-invasive transcranial direct current stimulation (tDCS) is effective in increasing rehabilitation effects after stroke in visual Cortex.

Detailed description: Visual field defects after posterior cerebral artery stroke can be improved by vision restoration training (VRT), but when combined with transcranial direct current stimulation (tDCS) which alters brain excitability, vision restoration can be potentiated in the chronic stage. Because it is possible that such therapy may be more effective during the early recovery phase after the stroke and can reach patients during the rehabilitation phase, investigators wished to explore the applicability, efficacy and safety of early intervention with a combined tDCS/VRT treatment.

Seven post-acute stroke homonymous hemianopia patients were assigned to 10 sessions of combined tDCS (2mA, 10 daily sessions of 15-20 min) and VRT. The primary outcome criterion was the pre-post change in perimetric detection thresholds in percent. The results were compared to 7 age and stroke lesion matched controls of our patient data pool who received standard rehabilitation.

Eligibility criteria: Inclusion Criteria:

* Posterior Cerebral Artery Stroke
* Visual Field Defect
* Lesion age 4 weeks up to 6 month max

Exclusion Criteria:

* Electrical Implants
* Metal artefacts in head
* Epilepsy
* Visual Neglect

Primary outcomes:
measure: Change of mean sensitivity (in dB) detection threshold from baseline to post-intervention
timeFrame: 14-20 days post treatment,
Secondary outcomes:
Other outcomes:
Locations:
city: Altmuenster
country: Austria
facility: Neurologisches Therapiezentrum Gmundnerberg
city: Magdeburg
country: Germany
facility: Inst. f. Medical Psychology, Univ. of Magdeburg
Study officials:
affiliation: Neurologisches Therapiezentrum Gmundnerberg
name: Raimund Alber, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alber R, Moser H, Gall C, Sabel BA. Combined Transcranial Direct Current Stimulation and Vision Restoration Training in Subacute Stroke Rehabilitation: A Pilot Study. PM R. 2017 Aug;9(8):787-794. doi: 10.1016/j.pmrj.2016.12.003. Epub 2017 Jan 8.
Clinical trial NCT01803113: Sofia hCG FIA Field Study
Official title: Sofia hCG FIA Field Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy, Early Detection
Keywords: Pregnancy
hCG
Lead sponsor: Quidel Corporation
Sponsor class: INDUSTRY
First posted: 2013-03-04
Enrollment: 975
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any female of childbearing potential being screened for pregnancy

Brief summary: The objective of this field study is to demonstrate the clinical performance of the Sofia hCG FIA Test, using urine specimens from females of childbearing age.

Detailed description: Subjects presenting for pregnancy testing will provide urine specimens that will be tested with the Sofia hCG FIA test and the comparator pregnancy test that will detect levels of hCG of 20mIU as positive for pregnancy.

Eligibility criteria: Inclusion Criteria:

* Female subjects of childbearing age, who are being screened for pregnancy and who have signed the informed consent

Exclusion Criteria:

* Subject is post-menopausal.
* Subject within the past six weeks has experienced any of the following: delivered a newborn; had an abortion or a natural termination (miscarriage); or, received hCG supplements.
* Subject has had a hysterectomy.
* Unable to understand and consent to participation.

Primary outcomes:
measure: Determination of presence of hCG in urine
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Boynton Beach
country: United States
facility: Jose Castaneda, MD
state: Florida
city: Fall River
country: United States
facility: NECCR of Massachusetts, LLC
state: Massachusetts
city: Fall River
country: United States
facility: New England Center for Clinical Research Fall River,LLC (NECCR)
state: Massachusetts
city: Pawtucket
country: United States
facility: Partners In Obstetrics and Gynecology, Inc.
state: Rhode Island
city: Houston
country: United States
facility: Planned Parenthood Gulf Coast
state: Texas
Study officials:
References:
Clinical trial NCT04730713: The Morphology and Parameter Estimation of Cranial Ultrasound Spectrum Based on Cerebral Artery
Official title: The Morphology and Parameter Estimation of Cranial Ultrasound Spectrum Based on Cerebral Artery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intracranial Pressure Increase
Keywords: Transcranial Doppler（TCD）,Intracranial pressure(ICP)
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2021-01-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Age over 18 years old, \<85 Years old; patients who need lumbar puncture.

Brief summary: 1. Observe the changes of TCD/TCCD spectrum shape before and after lumbar puncture in patients with severe neurological disease.
2. Discuss the TCD/TCCD spectrum shape and parameters of cerebral arteries and neurocritical patients Correlation of intracranial pressure.

Detailed description: After entering the ICU, the subjects who meet the standards will undergo a full-body physical examination and basic vital signs assessment and monitoring, which mainly include specialized examinations of the nervous system, multimodal brain function testing, respiratory system monitoring and management, hemodynamic monitoring, and APACHEⅡ Score, GCS score, and perform routine general circulation, breathing management, sedation and analgesia management, temperature management, osmotic pressure management, lumbar puncture pressure measurement

Eligibility criteria: Inclusion Criteria:

Aneurysmal subarachnoid hemorrhage (aSAH), traumatic brain injury (TBI), acute deficiency Blood stroke (AIS), acute cerebral hemorrhage (ICH), hypoxic ischemic encephalopathy (HIE), Sepsis-associated encephalopathy (SAE), intracranial tumor surgery; older than 18 years old, \<85 Years old; patients who need lumbar puncture.

Exclusion Criteria:

1. Age \<18 years old;
2. Pregnancy;
3. The condition of the temporal window is limited and the image cannot be obtained;
4. The frequency spectrum of bilateral cerebral arteries shows stenosis;
5. Patients with cerebral artery stenosis
6. Patients who have not obtained informed consent;

Primary outcomes:
measure: The TCD/TCCD spectrum shape and parameters of cerebral arteries are related to the intracranial pressure of neurocritical patients
timeFrame: January 26, 2021 to December 30, 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: medical Ethics committee of Xiangya Hospital Central South University
state: Hunan
Study officials:
affiliation: Department of Critical Care Medicine, Central South University
name: li na li na, PhD Tutor
role: STUDY_CHAIR
References: