louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02560207: Randomized Trial of Continuous Versus Intermittent Cefotaxime Infusion on ICU.
Official title: Does Continuous Cefotaxime Administration Improve Time to Attainment and Maintenance of Target Drug Levels in Critically Ill Patients?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Critically Ill
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2015-09-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study evaluates target attainment after either intermittent intravenous bolus or intravenous continuous infusion of cefotaxime in critically ill patients. Critically ill patients will be randomized to intermittent infusion or continuous infusion of cefotaxime.

Detailed description: Critically ill patients have other pharmacokinetic/pharmacodynamic profiles than healthy volunteers. Suboptimal, both under- and overdosing of antibiotics is an important threat in this patient category. Given the time-dependent character of beta-lactam antibiotics continuous dosing as opposed to traditional intermittent dosing is likely to render better target attainment and maintenance and might improve clinical outcome.

Eligibility criteria: Inclusion Criteria:

* Admitted to intensive care
* Able to give informed consent by themselves or informed consent can be obtained via next of kin
* Indication for treatment with cefotaxime (as judged by treating physician) in the context of our standard treatment protocol of Selective decontamination of the digestive tract (SDD).

Exclusion Criteria:

* Renal replacement therapy
* Contra-indication for cefotaxime, including known or suspected allergy to cefotaxime
* No indication for an arterial line; an arterial line will not be placed solely for the purpose of this study; thus, only patients with an indication for an arterial line outside this protocol are eligible.

Primary outcomes:
measure: Cefotaxim serum concentrations
timeFrame: 40 min, 1 hour, 2, 4, 8, 12 and 24 hours; 36h; 48 h; 60h; 72h; 84h and 96h post administration
Secondary outcomes:
measure: Area under the curve of cefotaxim
timeFrame: 0-96h post administration
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: Department of Critical Care, UMCG
name: Jan G Zijlstra, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aardema H, Bult W, van Hateren K, Dieperink W, Touw DJ, Alffenaar JC, Zijlstra JG. Continuous versus intermittent infusion of cefotaxime in critically ill patients: a randomized controlled trial comparing plasma concentrations. J Antimicrob Chemother. 2020 Feb 1;75(2):441-448. doi: 10.1093/jac/dkz463.
Clinical trial NCT00090207: Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) Associated With Highly Emetogenic Chemotherapy (0869-801)(COMPLETED)
Official title: A Randomized, Double-Blind, Parallel-Group Study Conducted Under In-House Blinding Conditions to Determine the Safety, Tolerability and Efficacy of Aprepitant Regimen Compared to Ondansetron Regimen for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) Associated With High Dose Cisplatin in Cycle 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nausea
Vomiting
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2004-08-27
Enrollment: 477
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A multicenter trial to assess the safety and efficacy of an investigational drug in the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with confirmed solid tumors who will be treated with a chemotherapy regimen that includes cisplatin. The study will evaluate the investigational drug for the treatment of CINV during the first cycle of treatment with cisplatin.


Eligibility criteria: Inclusion Criteria:

* Patient is greater than 18 years of age.
* Patient is scheduled to receive his/her first

course of cisplatin chemotherapy for a solid tumor.

* Patient has a prognosis (life expectancy) greater than or equal to 3 months.

Primary outcomes:
measure: Patient vomiting
Secondary outcomes:
measure: Number of rescue therapies
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Schmoll HJ, Aapro MS, Poli-Bigelli S, Kim HK, Park K, Jordan K, von Pawel J, Giezek H, Ahmed T, Chan CY. Comparison of an aprepitant regimen with a multiple-day ondansetron regimen, both with dexamethasone, for antiemetic efficacy in high-dose cisplatin treatment. Ann Oncol. 2006 Jun;17(6):1000-6. doi: 10.1093/annonc/mdl019. Epub 2006 Mar 8.
Clinical trial NCT01362907: Clinical Comparison of Silicone Hydrogel and HEMA-based Daily Disposable Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-06-01
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this trial was to compare the performance of an investigational daily disposable contact lens to a commercially available daily disposable contact lens.


Eligibility criteria: Inclusion Criteria:

* Normal eyes with no use of ocular medications.
* Be of legal age of consent and sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and subject must sign Assent document.
* Willing and able to wear spherical contact lenses for protocol-specified timeframe within the available range of powers (-1.00 D to -6.00D in 0.25D steps).
* Visual acuity with study lenses 20/25 or better.
* Cylinder less than or equal to 0.75 D.
* Currently wearing daily disposable lenses.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Anterior segment infection, inflammation, or abnormality.
* Any active anterior segment ocular disease that would contraindicate contact lens wear.
* Any use of systemic medications for which contact lens wear could be contraindicated as determined by the investigator.
* History of refractive surgery or irregular cornea.
* Eye injury within twelve weeks immediately prior to enrollment for this trial.
* Currently enrolled in any clinical trial.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Corrected Distance Monocular Visual Measurement Reported as Visual Acuity (VA)
timeFrame: 1 week of wear, replacing lenses daily
measure: Overall Comfort
timeFrame: 1 week of wear, replacing lenses daily
measure: Overall Vision Quality
timeFrame: 1 week of wear, replacing lenses daily
measure: Overall Handling
timeFrame: 1 week of wear, replacing lenses daily
Secondary outcomes:
measure: Overall Lens Fit
timeFrame: 1 week of wear, replacing lenses daily
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05673707: The Effect of Thyromental Height and Other Difficult Airway Evaluation Parameters
Official title: The Effect of Thyromental Height and Other Difficult Airway Evaluation Parameters on Laryngeal Mask Placement Success Rate in Elderly Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Airway Complication of Anesthesia
Lead sponsor: Diskapi Yildirim Beyazit Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-01-06
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all patients between 65-90 years old who had urological procedure

Brief summary: Many changes occur in the body with age. There are difficulties in endotracheal intubation and the placement of supraglottic airway devices (LMA) in elderly patients due to changes in the tooth and facial structure, and a decrease in temporomandibular joint and neck movements. In the literature, there are studies on the relationship between thyromental height measurement and endotracheal intubation difficulty, but there is no study on the relationship between thyromental height measurement and laryngeal mask placement difficulty.

Detailed description: Age, gender, height, body weight, body mass index, type of operation, and Mallampati score are recorded in the preoperative evaluations of all patients. For anthropometric measurements, thyromental height, thyromental distance, sterno-mental distance, neck circumference, and mouth opening are measured. After the laryngeal mask is placed after the induction of anesthesia, the location of the LMA is checked with the FOB (fiberoptic bronchoscopy). Ease of insertion was subjectively assessed using a grading score of 1-4 (1, no resistance; 2, mild resistance; 3, moderate resistance; 4, inability to insert the device) by the attending anesthesiologist who inserted the device. After successful placement of the device, the adjustable pressure limiting (APL) valve is adjusted to 30 cm H2O at 3L/minute fresh gas flow, and the airway pressure and leakage amount are measured.

Eligibility criteria: Inclusion Criteria:

* over 65 years old
* elective operation
* using laryngeal mask device

Exclusion Criteria:

* younger than 65 years old
* urgent or emergency operation
* morbidity obese
* contraindications of all laryngeal mask devices using

Primary outcomes:
measure: laryngeal mask placement success
timeFrame: during insertion
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Department of Anesthesiology and Reanimation, University of Health Sciences, Diskapi Yıldırım Beyazit Training and Research Hospital
Study officials:
References:
Clinical trial NCT03738007: Clinical Study to Evaluate the Correction of Facial Wrinkles and Folds and Safety of YVOIRE Volume Versus Perlane in Nasolabial Fold Injection
Official title: A Randomized, Multi Center, Single-blind, Active-controlled, Matched Pairs Design Clinical Study to Evaluate the Correction of Facial Wrinkles and Folds and Safety of HA IDF II Versus Perlane in Nasolabial Fold Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporary Correction of Wrinkles
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
First posted: 2018-11-13
Enrollment: 57
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was purposed to evaluate the non-inferiority of YVOIRE volume, a hyaluronic acid product, in terms of correction of wrinkles and safety in nasolabial fold deep-dermal injection, compared to Perlane, the control preparation.


Eligibility criteria: Inclusion Criteria:

1. Age: Women in 30\~55 years.
2. Those whose wrinkle scores in the treatment site (nasolabial fold) at the screening visit were Stage 3 or 4 in the 5-stage Wrinkle Severity Rating Scale (WSRS) symmetrically
3. Those who were informed on this study in detail, understood it completely, decided to participate in the study own their own and signed on the informed consent form.

Exclusion Criteria:

1. Those with a skin disease in the face (skin infection, eczema, psoriasis, rosacea, herpes etc.)
2. Those with a history of severe allergy
3. Those with hypertrophic scar or a history of kelloid
4. Patients with an autoimmune disease
5. Those with hepatic dysfunction or abnormality in coagulation, or those administering an anticoagulant (aspirin, warfarin etc.) concomitantly
6. Those who had used a local topical preparation (steroid, retinoid) within 4 weeks prior to the study
7. Those who had underwent a chemical peeling, laser procedure (including IPL) or insertion of other bioadaptive materials (however, those who had been treated with HA filler could participate in the study if the date of treatment was known and the investigator judged that the filler effect had disappeared).
8. Patients with a malignant tumor
9. Women in pregnancy or lactation
10. Hepatitis carriers or VDRL/HIV positive patients
11. Those with a hypersensitivity to the investigational medical device of this study
12. Other persons including those considered as difficult to perform this study by the principal investigator

Primary outcomes:
measure: Average of Wrinkle Severity Rating Scale (WSRS) score evaluated by the evaluating investigator at Week 26 (Visit 7) after the final treatment with the investigational medical device.
timeFrame: Week 26 (Visit 7)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00766207: Electronic Notification of Teratogenic Risks
Official title: Preconception Risk Evaluation Via Electronic Medical Record Notification of Teratogenic Risks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Teratogens
Abnormalities, Drug-Induced
Contraception
Keywords: Teratogens
Abnormalities, Drug-Induced
Contraception
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2008-10-03
Enrollment: 2593
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will use a factorial design randomized controlled trial to (1)compare multi-faceted decision support (intervention) to streamlined clinical alerts (control) and (2) evaluate whether collecting information about women's risk of pregnancy using a networked tablet computer (intervention) is superior to the way clinicians usually collect this information (control).

Over the course of 1 year, we will abstract data from the electronic medical record when study clinicians prescribe teratogenic medications, conduct phone interviews with women prescribed medications by participating clinicians, and survey participating clinicians about their satisfaction with the decision support they receive. We will use this data to confirm our hypotheses that clinicians in the intervention groups will (1) prescribe fewer teratogenic medications, (2) be more likely to prescribe contraception when a teratogenic medication is prescribed, (3) have more patients report satisfaction with the counseling they received, and (4) report more satisfaction with the decision support they received.


Eligibility criteria: Inclusion Criteria:

* Women aged 18-45 seen at a participating primary care clinic

Exclusion Criteria:

* Non-English speakers

Primary outcomes:
measure: Proportion of women prescribed potentially teratogenic medications with documented use of contraception
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Delmont
country: United States
facility: Partners in Health
state: Pennsylvania
city: Level Green
country: United States
facility: Partners in Health
state: Pennsylvania
city: Murrysville
country: United States
facility: Partners in Health
state: Pennsylvania
city: Pittsburgh
country: United States
facility: General Internal Medicine Oakland (GIMO) Practice
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Eleanor B Schwarz, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schwarz EB, Parisi SM, Handler SM, Koren G, Cohen ED, Shevchik GJ, Fischer GS. Clinical decision support to promote safe prescribing to women of reproductive age: a cluster-randomized trial. J Gen Intern Med. 2012 Jul;27(7):831-8. doi: 10.1007/s11606-012-1991-y.
Clinical trial NCT01180907: The Biodistribution of 1-[2 Deoxy-2, -18 Fluroarabinfuranosyl]Cytosine [18FAC] in Healthy Subjects and Patients With Cancer, Autoimmune/Inflammatory Diseases
Official title: The Biodistribution of 1-[2 Deoxy-2, -18 Fluroarabinfuranosyl]Cytosine [18FAC] in Healthy Subjects and Patients With Cancer, Autoimmune/Inflammatory Diseases: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Inflammation
Keywords: 18F-FAC
imaging
cancer
inflammation
PET
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2010-08-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with cancer, autoimmune diseases and healthy subjects

Brief summary: The purpose of the study is to determine whether positron emission tomography using the new imaging agent 18F-FAC can be used for imaging cancer and/or inflammation.


Eligibility criteria: Inclusion Criteria:

* \> 18 years of age
* women of childbearing potential will undergo a pregnancy test free of charge
* patients with cancer or autoimmune diseases or healthy subjects

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Christiaan Schiepers, M.D. Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01226407: Examine Maximum Tolerated Dose and Pharmacokinetic and Pharmacodynamic Profile
Official title: Phase I Study of CG200745 to Examine the Maximum Tolerate Dose, Pharmacokinetic and Pharmacodynamic Profiles, and Safety Among Patients With Progressive Solid Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Solid Tumour
Keywords: Solid Tumour
Lead sponsor: CrystalGenomics, Inc.
Sponsor class: INDUSTRY
First posted: 2010-10-22
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Open label, single dose and phase I study.

The primary objective: To determine the maximum tolerated dose in Single dose

The secondary objective: to evaluate the toxicity in administration to determine desirable dosing amount for phase II to evaluate tumor response in progressive solid cancer patients to evaluate pharmacokinetic/ pharmacodynamic profile.

Detailed description: 1. Number of Subjects: 28\~36, dose escalation (2\~6 subject of each step)
2. Adverse Events will be coded to preferred therm and body system using the CTCAE

Eligibility criteria: Inclusion Criteria:

* from 20 years old to 69 years old
* diagnosed with progressive solid cancer
* In spite of standard chemotherapies, the efficacy of the treatment or life extension cannot be expected.
* Evaluated 0-1 of ECOG
* Expected life duration is within 3 months

Exclusion Criteria:

* Major surgery except tumor-removal surgery received within 2 weeks of screening.
* history of CNS metasis
* hyper-sensitivy of study drug
* pregancy or lactating
* administered other HDAC inhibitor within 4 weeks of screening

Primary outcomes:
measure: To determine the maximum tolerated dose in Single dose
timeFrame: On 22 days after administration
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Asan Medical Center
Study officials:
affiliation: Seoul Asan medical Center
name: Tae Won Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04304807: Effect of Melatonin on Feeding Intolerance and Incidence of Necrotizing Enterocolitis in Preterm Infants
Official title: Effect of Melatonin on Feeding Intolerance and Incidence of Necrotizing Enterocolitis in Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Preterm Infant
Feeding Intolerance
Necrotizing Enterocolitis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-03-11
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assesses the efficacy of melatonin in treatment of feeding intolerance in preterm infants, the time needed to reach full enteral intake, the incidence of necrotizing enterocolitis and measures the level of tumor necrosis factor-alpha as a marker of oxidative stress.

Detailed description: This is a prospective study held on ninety preterm infants in Ain Shams University neonatal intensive care units. All enrolled neonates were suffering from feeding intolerance in the form of abdominal distension, gastric residuals or bloody stools. The first group of forty five infants were given melatonin in addition to traditional antibiotic treatment. The second group of forty five infants were given traditional antibiotic treatment only. Both groups were followed up clinically as regards improvement of clinical signs of feeding intolerance and laboratory results till they reached full enteral intake. Both groups were compared as regards incidence of necrotizing enterocolitis and level of tumor necrosis factor-alpha after 72 hours of starting treatment as a marker of oxidative stress.

Eligibility criteria: Inclusion Criteria:

* Preterm infants (\<37 weeks of gestation)
* Evidence of feeding intolerance

Exclusion Criteria:

* Infants with hypoxic ischemic encephalopathy
* Infants on nothing per os
* Infants with high oxygen needs wither on invasive or non-invasive mechanical ventilation
* Major congenital anomalies
* Intracranial hemorrhage
* Respiratory distress syndrome

Primary outcomes:
measure: Melatonin as an antioxidant and free radical scavenger in feeding intolerance in preterm infants
timeFrame: 3 days
measure: Melatonin efficacy in reducing incidence of necrotizing enterocolitis in preterm infants
timeFrame: 1 week
measure: Effect of melatonin on time needed to reach full enteral intake in preterm infants with feeding intolerance
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Pediatrics Department
state: Abbasia
Study officials:
References: