louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01492777: Pharmacogenetics of Acenocoumarol
Official title: Stabilization of Anticoagulation by Acenocoumarol: Role of Genetic Vulnerability and Risk of Drug Interactions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thromboembolic Diseases
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2011-12-15
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients starting acenocoumarol therapy

Brief summary: The use of oral anticoagulation is marked by an elevated risk of adverse drug events (ADE) due to a narrow therapeutic window leading to important medical and economical consequences. The risk of ADE is increased partly by drug interactions and recently identified genetic factors influencing the metabolism of coumarins (polymorphism of the cytochrome P450 CYP2C9) as well as the target enzyme of the coumarins (polymorphism of the vitamin K epoxide reductase complex subunit 1 (VKORC1).

The objective is to determine the impact of several genotypes on acenocoumarol treatment and on vulnerability to drug-drug interactions.


Eligibility criteria: Inclusion Criteria:

* Every patients with requiring acenocoumarol therapy for at least 4 weeks and a target INR in the low intensity range (INR range 2-3)
* Age ≥ 18 years
* Signed informed consent

Exclusion Criteria:

* Severe cognitive impairment
* Previous or current treatment with any coumarin

Primary outcomes:
measure: Time to achieve stable dosing in days, since the beginning of the anticoagulation
timeFrame: 5 weeks
Secondary outcomes:
measure: Number of patients with INR > or = 4.0, which indicates overanticoagulation
timeFrame: 5 weeks
measure: Time to achieve two consecutive therapeutic INRs
timeFrame: 5 weeks
measure: Mean daily dosage of acenocoumarol
timeFrame: 5 weeks
measure: Major bleedings and minor bleedings
timeFrame: 5 weeks
measure: Thromboembolic events due to infratherapeutic anticoagulation
timeFrame: 5 weeks
measure: Length of hospitalisation in days
timeFrame: 5 weeks
measure: Potential of other drug interactions, linked to the observed genotype and phenotype of the patient
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Geneva 14
country: Switzerland
facility: University Hospitals
Study officials:
affiliation: University Hospital, Geneva
name: Jules A Desmeules, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gschwind L, Rollason V, Boehlen F, Rebsamen M, Combescure C, Matthey A, Bonnabry P, Dayer P, Desmeules JA. P-glycoprotein: a clue to vitamin K antagonist stabilization. Pharmacogenomics. 2015 Jan;16(2):129-36. doi: 10.2217/pgs.14.164.
Clinical trial NCT01674777: A Study to Investigate the Effect of Food on the Absorption, Distribution and Elimination of ASP1941
Official title: A Pharmacokinetic Study to Investigate the Effect of Food on the Pharmacokinetics of ASP1941
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Pharmacokinetics of ASP1941
Keywords: ASP1941
Food effect
Pharmacokinetics
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2012-08-29
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study is to investigate the effect of food on the pharmacokinetics, the pharmacodynamics and safety of ASP1941 after administration of ASP1941 in healthy non-elderly adult male subjects.

Detailed description: This will be a randomized, open-label, 3-way crossover design study to investigate the effect of food on the pharmacokinetics, the pharmacodynamics and safety of ASP1941 after administration of ASP1941 in healthy non-elderly adult male subjects. Each subject will receive a single dose of ASP1941 "under fasting condition", "before meal" and "after meal".

Eligibility criteria: Inclusion Criteria:

* Healthy as judged by the investigator/subinvestigator based on the results of physical examinations and laboratory tests
* Body weight ; ≥50.0 kg, \<80.0 kg
* Body Mass Index ; ≥17.6, \<26.4
* Written informed consent has been obtained

Exclusion Criteria:

* Received any investigational drugs within 120 days before the screening assessment
* Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or d components within 14 days before the screening assessment
* Received medication within 7 days before hospital admission
* A deviation from the assessment criteria of physical examinations or laboratory tests at screening or upon admission
* History of drug allergies
* With renal, hepatic, gastrointestinal, heart, cerebrovascular or respiratory diseases

Primary outcomes:
measure: Pharmacokinetics (PK) profiles of ASP1941 (in plasma): AUCinf, AUClast and Cmax
timeFrame: For 72 hours after each administration
Secondary outcomes:
measure: Pharmacokinetics (PK) profiles of ASP1941 (in plasma): tmax, t1/2, apparent distribution volume, apparent body clearance
timeFrame: For 72 hours after each administration
measure: Safety assessed by incidence of adverse event, vital signs, 12-lead ECG and laboratory tests
timeFrame: For 72 hours after each administration
measure: Changes in urinary glucose excretion
timeFrame: Before and for 72 hours after each administration
Other outcomes:
Locations:
city: Kantou
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT03718377: The Effects of Ultrasound-guided Serratus Plane Block During Video-assisted Thoracoscopic Lobectomy
Official title: The Effects of Ultrasound-guided Serratus Plane Block in Combination With General Anesthesia on Intraoperative Opioid Consumption, Emergence Time and Hemodynamic Stability During Video-assisted Thoracoscopic Lobectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia, Conduction
Pain Management
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2018-10-24
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the effects of serratus plane block on intraoperative opioid consumption, emergence time and hemodynamic stability in patients undergoing video-assisted thoracic surgery.

Detailed description: Thoracotomy is known as one of the most painful surgery. Thus, there is a development to reduce surgical stress in terms of operation technique, which is video-assisted thoracoscopic surgery. Although it has reduced postoperative pain and complications compared with thoracotomy, VATS is still quite painful operation.

Serratus plane block is a novel technique which provide analgesic effect for lateral chest wall by blocking lateral branch of intercostal nerve. It has been reported to be used for pain management including rib fracture, herpes zoster, and postoperative pain. It has become a popular analgesic modality because it is easy to perform and relatively safe. However, the effect of serratus plane block during intraoperative period has not yet been studied.

In this study, therefore, the investigators decided to assess the effect of serratus plane block on intraoperative opioid consumption, emergence time and hemodynamic stability in patients undergoing video-assisted thoracic surgery.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status classification I-III for three port video-assisted thoracic surgery lobectomy under general anesthesia

Exclusion Criteria:

* History of allergic reaction to local anesthetics, coagulopathy, local infection at the injection site, and systemic infection.

Primary outcomes:
measure: Intraoperative remifentanil consumption
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Emergence time
timeFrame: through study completion, an average of 1 year
measure: Systolic blood pressure
timeFrame: through study completion, an average of 1 year
measure: Heart rate
timeFrame: through study completion, an average of 1 year
measure: Dose of rescue drugs used to control blood pressure and HR
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook national university hospital
Study officials:
affiliation: Kyungpook National University Hospital
name: Saeyoung Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01768377: Comparison of Intubation With Nerve Block and With Sedation in Awake Patients
Official title: Comparison of in Intubation With Nerve Block and Intubation With Sedation in Awake Patients in Terms of Efficacy, Complications and Physician's Satisfaction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Intubation Complication
Keywords: Awake intubation
Nerve block
Sedation
Physician satisfaction
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-01-15
Enrollment: 70
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: The purpose of this study is to compare intubation with nerve block with intubation with sedation in awake patients in terms of efficacy, ease, and the rate of complications and physician satisfaction


Eligibility criteria: Inclusion Criteria:

* Candidate for intubation with methods other than RSI
* Age\>= 18 years
* Patient or patient's guardian's consent

Exclusion Criteria:

* Need for RSI or crash intubation
* Allergy to Lidocain in block group
* Allergy to opioid drugs in sedation group
* Allergy to midazolam in either group

Primary outcomes:
measure: Time required for intubation in seconds
timeFrame: From start of the intubation attempt for an average of one minutes
Secondary outcomes:
measure: physicians' perception of the difficulty of the procedure
timeFrame: Within an average of 30 minutes after completion of the procedure
measure: Number of Participants with Adverse Events
timeFrame: From the start of the procedure until 30 minutes after the procedure is completed
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Imam Khomeini Hospital
Study officials:
affiliation: TUMS
name: Mohammad Jalili, MD
role: STUDY_DIRECTOR
affiliation: TUMS
name: Amir Nejati, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02426177: Comparison of Tab.Labetalol and Tab.Nifedipine for Management of Postpartum Hypertension
Official title: Comparison of Oral Labetalol and Oral Nifedipine for Postpartum Hypertension Management
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Postnatal Hypertension
Keywords: postpartum hypertension
labetalol in postpartum hypertension
nifedipine in postpartum hypertension
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2015-04-24
Enrollment: 98
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare effectiveness of oral labetalol and oral nifedipine for management of postpartum hypertension.

Detailed description: A comparison of oral labetalol and oral nifedipine for management of postpartum hypertension. Which drug is more effective in lowering blood pressures in patient with postpartum hypertension.

Eligibility criteria: Inclusion Criteria:

* all women with postpartum hypertension as a continuation of pregnancy induced hypertension,eclampsia, pre-eclampsia or new onset de-novo postpartum hypertension,of any parity.
* age group between 18-48.
* after informed consent.

Exclusion Criteria:

* all women with chronic hypertension, uncontrolled and un treated medical disorders will be excluded.
* conditions in which drugs labetalol and nifedipine is contraindicated.

Primary outcomes:
measure: Blood Pressure less than 140/90 mm of hg
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Dow University of Health Sciences
name: fariha javed, mbbs
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04357977: A Human Clinical Study to Collect Calibration and Performance Data for the RBA-2 Device
Official title: A Human Clinical Study to Collect Calibration and Performance Data for the RBA-2 Device
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronavirus
COVID
Lead sponsor: Kaligia Biosciences, LLC
Sponsor class: INDUSTRY
Collaborators: name: University of South Florida
First posted: 2020-04-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from patients and study staff at the testing site who have been flagged for COVID-19 testing or who are being treated for COVID-19.

Brief summary: The current available diagnostic methods used for the detection of COVID-19 takes up to 4 hours. In some cases, these diagnostics tests make take up to a couple of days. As it is highly contagious, people who are in close contact with the infected person are at high risk of being infected. COVID-19 is transmitted through respiratory droplets produced when an infected person coughs or sneezes. The desire for rapid detection of COVID-19 has become an immediate necessity. The purpose of Kaligia Biosciences' saliva monitoring device (RBA-2) is to detect the presence of the COVID-19 virus in human saliva. The RBA-2 uses Raman Spectros-copy to detect the coronavirus. Once the sample is scanned successfully, the spectra contains the response of the component present in human saliva and provide results in a matter of minutes, rather than hours or days.

Detailed description: The purpose of this study is to calibrate the performance of RBA-2 using people by comparing the results against a standard diagnostics test. The objective of this study is to collect non-invasive in vivo saliva from confirmed cases of both infected and non-infected COVID-19 patients or site staff at the testing site and compare the test results using the RBA-2 against the standard test results used for diagnosis.

The comparison of the results obtained from the current testing methods will be used to calibrate machine learning algorithms of the RBA-2.

Eligibility criteria: Inclusion Criteria:

Participants can be patients or staff members at the testing site.

Potential participants may be enrolled if:

1. They are identified as requiring a standard diagnostic test for COVID-19 or are being treated after testing positive for COVID-19;
2. They are age ≥ 18 years old;
3. They are willing and able to provide verbal informed consent.

Exclusion Criteria:

* Patients receiving active treatment with antivirals, chloroquine or immune modulators.

Primary outcomes:
measure: Covid +
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Tampa
country: United States
facility: AdventHealth Tampa
state: Florida
Study officials:
References:
Clinical trial NCT06137677: Child Sweet and Savory Snack Study
Official title: Child Sweet and Savory Snack Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Eating Behavior
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 14
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine how consumption of a snack food affects the hedonic ratings of that snack food compared to other foods. The results will have implications for guidance about the provision of snacks for preschool children and may help in identifying strategies for the prevention of obesity in children.


Eligibility criteria: Inclusion Criteria:

* Children who are enrolled in a scheduled classroom of the participating childcare centers
* Children who are between the ages of 4 and 6 years old at the time of enrollment

Exclusion Criteria:

* Children who are allergic to any of the foods served
* Children whose diets exclude any of the foods served
* Children who are absent from the childcare center on the acclimation day or both study days
* Children who are not able to complete study measures (e.g. only use the anchors or have low variability for their liking ratings)

Primary outcomes:
measure: Change between interventions in liking of each test food
timeFrame: Study weeks 1 and 2
measure: Change between interventions in ranked preference of each test food from before to after consumption
timeFrame: Study weeks 1 and 2
Secondary outcomes:
measure: Change between interventions of intake by weight
timeFrame: Study weeks 1 and 2
measure: Change between interventions of intake by energy
timeFrame: Study weeks 1 and 2
measure: Change between interventions in fullness ratings from before to after consumption
timeFrame: Study weeks 1 and 2
Other outcomes:
Locations:
city: University Park
country: United States
facility: The Pennsylvania State University
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00213577: NEUROTOX: Two Dosages of Type A Botulinic Toxin in Neurogenic Overactive Bladder
Official title: Evaluation of the Efficacy and Tolerance of 2 Dosages of Type A Botulinic Toxin in Neurogenic Areactive Bladder Resistant to Oral Medical Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Overactive Bladder
Keywords: overactive neurogenic bladder
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 80
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: The purpose of this study is to determine the efficacy and tolerance of 2 dosages (750 versus 500 units) of the Dysport type A botulinic toxin for patient suffering from neurogenic urinary incontinence by an overactive bladder and the failure of anticholinergic drugs.


Eligibility criteria: Inclusion Criteria:

* Neurogenic urinary incontinence with urodynamic overactivity resistant to anticholinergic

Exclusion Criteria:

* Pregnancy
* Bladder cancer
* Symptomatic urinary infection

Primary outcomes:
measure: complete urinary continence at baseline, and days 30, 90, 180, and 360
Secondary outcomes:
measure: number of mictions or self catheterizations a day
measure: number of leakages, urgency adverse events
measure: guarding times
measure: urodynamics: bladder capacity, reflex volume, residual maximal capacity detrusor pressure, flow detrusor pressure
Other outcomes:
Locations:
city: Rouen
country: France
facility: CHU-Rouen
Study officials:
affiliation: University Hospital, Rouen
name: Philippe GRISE, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grise P, Ruffion A, Denys P, Egon G, Chartier Kastler E. Efficacy and tolerability of botulinum toxin type A in patients with neurogenic detrusor overactivity and without concomitant anticholinergic therapy: comparison of two doses. Eur Urol. 2010 Nov;58(5):759-66. doi: 10.1016/j.eururo.2010.06.035. Epub 2010 Jul 3.
Clinical trial NCT01156077: Pharmacokinetic (PK) Study of Oral and IV TR-701 FA in Adolescent Patients
Official title: A Phase 1, Open-Label, Multi-Center, Two-Part, Single-Dose, Parallel Design, Safety, Tolerance, and Pharmacokinetic Study of Orally and Intravenously Administered TR-701 FA in 12 to 17 Year Old Adolescent Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bacterial Infection
Keywords: antibiotic
Adolescents receiving antibiotics
Lead sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
First posted: 2010-07-02
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This is an open-label, multi-center, two-part, parallel-design study to assess the PK, safety, and tolerability of TR-701 FA and its active metabolite, TR-700, following a single oral dose (Part A) or IV dose (Part B) of TR-701 FA in 12 to 17 year old adolescent patients.


Eligibility criteria: Inclusion Criteria:

* males and females, between 12 and 17 years of age, inclusive;
* receiving prophylaxis for or have a confirmed or suspected infection with Gram positive bacteria and receiving concurrent antibiotic treatment with Gram positive antibacterial activity
* in stable condition
* females must be premenarchal, surgically sterile, abstinent, or practicing an effective method of birth control
* males will either be surgically sterile, abstinent, or practicing an effective method of birth control

Exclusion Criteria:

* relevant history of seizures, clinically significant cardiac arrhythmia, cystic fibrosis, moderate or severe renal impairment, or any physical condition that could interfere with the interpretation of the study results
* any acute or chronic condition that, in the opinion of the Investigator, would limit the patient's ability to complete and/or participate in this clinical study
* physician-diagnosed migraine headaches
* history of infection with hepatitis or other significant hepatic disease
* females who are pregnant or breast feeding

Primary outcomes:
measure: Adolescent PK
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Bradley JS, Flanagan SD, Arrieta AC, Jacobs R, Capparelli E, Prokocimer P. Pharmacokinetics, Safety and Tolerability of Single Oral or Intravenous Administration of 200 mg Tedizolid Phosphate in Adolescents. Pediatr Infect Dis J. 2016 Jun;35(6):628-33. doi: 10.1097/INF.0000000000001096.
Clinical trial NCT02531477: Intra-carotid Anesthetic Agent Delivery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2015-08-24
Enrollment: 5
Sex: ALL
Minimum age (years): 10
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Intra-Carotid delivery of propofol.

Detailed description: Propofol injection into carotid artery . detection of response of experimental subjects to pain

Eligibility criteria: Inclusion Criteria:

* 5 experimental animals (rabbits)

Exclusion Criteria:

* none

Primary outcomes:
measure: effect on painful stimulus perception on HR measurement
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura university
state: Dakahleya
Study officials:
References: