louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03883893: IV Acetaminophen and Post-Tonsillectomy Pain
Official title: Randomized Prospective Study Investigating the Analgesic Efficacy of Intravenous Acetaminophen in Reducing Post-Tonsillectomy Pain in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Tonsillectomy
Adenoidectomy
Keywords: Tonsillectomy
Intravenous Acetaminophen
Pediatric
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2019-03-21
Enrollment: 0
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is a randomized prospective study to compare the post-operative analgesic efficacy of intravenous acetaminophen 15 mg/kg to an equal volume of 0.9% normal saline when all other analgesic interventions have been standardized for all patients enrolled.


Eligibility criteria: Inclusion Criteria:

1. The subject is age 3 to 10 years (inclusive)
2. The subject weighs more than 10.0 kg (inclusive of the tenth kilogram)
3. The subject is scheduled for the following: Elective tonsillectomy or tonsillectomy with adenoidectomy scheduled on an outpatient basis, with acceptable inclusion of patients also having PETs and/or EUA of ear
4. The subject is ASA patient classification I-II
5. The subject's legally authorized representative has given written informed consent to participate in the study and when appropriate, the subject has given assent or consent to participate.

Exclusion Criteria:

1. Additional surgical procedures are being performed concurrently;
2. The subject is ASA classification \> II;
3. The subject has pre-existing allergy or known hypersensitivity to acetaminophen;
4. The subject receives midazolam as a premedication;
5. The subject has a history of chronic malnutrition;
6. The subject has any other condition, which in the opinion of the principal investigator, would not be suitable for participation in the study

Primary outcomes:
measure: Post-operative pain scores
timeFrame: Every 5 minutes after awake in recovery room for 30 minutes
Secondary outcomes:
measure: Quality of emergence from anesthesia
timeFrame: When first spontaneous eye movement occurs in recovery room
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Judy Audas, APRN-CRNA,MSN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02600793: Ceftaroline Diffusion Into Cerebrospinal Fluid of Children
Official title: Ceftaroline Diffusion Into Cerebrospinal Fluid of Children With Ventriculitis Due to Ventriculoperitoneal Shunt (VPS) Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Cerebrospinal Fluid Shunts
Ventriculoperitoneal Shunt
Lead sponsor: Wayne State University
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
First posted: 2015-11-09
Enrollment: 12
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Ceftaroline fosamil is an intravenous (IV) drug that belongs to a group of antibiotics called cephalosporins . Antibiotics are drugs used to treat infections. Clinical studies in adults patient shave shown ceftaroline fosamil to be effective against many bacteria that are resistant to other currently approved antibiotics. Some of these bacteria may be responsible for infections in the central nervous system.The main aim of this study is to gather information to determine how much of a single IV dose of ceftaroline fosamil will enter into a child's CSF so that the benefit of giving ceftaroline fosamil to children with infections can be better determined.

Detailed description: Children 6 months to 17 years of age admitted to the hospital because of infected VPS (ventriculitis) will be eligible for the study. A total of twelve eligible patients will be included in the study. Eligible study subjects would be patients who have undergone VPS removal and placement of EVD tubing and are being treated with standard IV antibiotics for ventriculitis. CSF cultures are obtained before antibiotics treatment is initiated. Standard initial antibiotics regimen is usually IV ceftriaxone and vancomycin. The antibiotics regimen is subsequently adjusted based on the pathogen recovered from the CSF culture. Total IV antibiotic treatment is usually 14 days. Following clearance of the infection the patient undergoes new VPS insertion by neurosurgery service.

Eligibility criteria: Inclusion Criteria:

* Age 6 months - 17 years
* Ventriculitis due to VPS infection (abnormal CSF parameters consistent with meningeal inflammation and/or positive CSF culture)
* VPS is externalized and External Ventriculostomy Drain (EVD) is in place
* Patient has IV access and is receiving antibiotic treatment for VPS infection
* Parent/Guardian signed written informed consent
* Negative urine or serum pregnancy test for females of child-bearing potential

Exclusion Criteria:

* Known Allergy to beta-lactam antibiotics
* Moderate to severe renal impairment (Creatinine clearance \< 50mL/minute)
* Parent/Guardian written consent cannot be obtained
* Positive urine or serum pregnancy test

Primary outcomes:
measure: Pharmacokinetic assessment of Ceftaroline diffusion from blood into the Cerbrospinal fluid.
timeFrame: 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Children's Hospital of Michigan
state: Michigan
Study officials:
References:
Clinical trial NCT04531293: Comparing Pressure Based and Dilution Based Total Lung Capacity Measurements in COPD Patients for Lung Function Diagnostics
Official title: Mono-centred, Controlled Cross-over Study Comparing Pressure Based, and Dilution Based Total Lung Capacity Measurements in COPD Patients and Healthy Subjects Using Two Commercially Available Devices for Lung Function Diagnostics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: COPD
DLCO
spirometry
alveolar volume
body plethysmography
Lead sponsor: ndd Medizintechnik AG
Sponsor class: INDUSTRY
First posted: 2020-08-28
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Total Lung Capacity (TLC) of the lungs can be determined using a pressure based method (i.e. by body plethysmography) or it can be determined using a dilution based method (i.e. by single breath dilution during a CO diffusing capacity test). The results of the two methods differ, especially in patients with higher grades of COPD. The study investigates an improved analysis for the determination of TLC using the dilution method; this method has been suggested in the new ATS/ERS DLCO (diffusion capacity of lung for carbon monoxide) standard published in 2017. This study is based on approx. 120 participants. So far, there has not been a study using commercially available equipment.

Spirometry, lung volume measurement by body plethysmography and DLCO measurements will be performed on reference device (Masterscreen Body/Diff, Vyaire, USA), Spirometry and DLCO will also be performed on the device under test (EasyOne Pro LAB, ndd Medizintechnik AG, Switzerland) in a crossover design. Both devices are CE marked and FDA approved. The tests performed on both devices are standardized tests performed routinely with patients.


Eligibility criteria: Inclusion Criteria:

3 groups

* Healthy subjects, FEV1/FEV1(pred) \> 80%
* COPD GOLD classification 1 or 2, FEV1/FEV1(pred) ≥ 50%
* COPD GOLD classification 3 or 4, FEV1/FEV1(pred) \< 50%

Exclusion Criteria:

* Smoked during 2 hours prior to measurements

Additional exclusion criteria for healthy subjects:

* BMI \> 30
* Any relevant concomitant diseases (investigators decision)
* Any relevant concomitant medication (investigators decision)
* FEV1/FEV1(pred) \<= 80%

Primary outcomes:
measure: Comparison of Total Lung Capacity (TLC) measurement using total-breath method and standard method
timeFrame: single measurement on day 1
Secondary outcomes:
measure: Dependency between primary outcome and COPD disease severity
timeFrame: single measurement on day 1
measure: Device comparison using the same method for both devices.
timeFrame: single measurement on day 1
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: LungenZentrum Hirslanden
Study officials:
References:
Clinical trial NCT05957393: Improving Physician Vaccine Recommendation Using Social Norms, Trust, and Presumptive Language
Official title: Improving Physician Vaccine Recommendation Using Social Norms, Trust, and Presumptive Language
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Physicians
Vaccination Recommendation
Social Norms
Trust
Presumptive Recommendation
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2023-07-24
Enrollment: 447
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: This research examines vaccination recommendation perceptions and behaviors of physicians and advanced practice providers.


Eligibility criteria: Inclusion Criteria:

* Participants must be physicians, advanced practice providers, medical students, nurses/nurse practitioners, or medical fellows.
* Must be in a position to be authorized to recommend vaccines to patients in their official professional capacities/responsibilities.

Exclusion Criteria:

* Students or employees under the supervision of the PI who meet inclusion criteria for the study

Primary outcomes:
measure: Change in proportion of patients that receive a vaccine recommendation
timeFrame: Day 1, Day 30, Day 60, Day 90
measure: Change in self-reported responsibility perception
timeFrame: Day 1, Day 30, Day 60, Day 90
measure: Change in self-reported assessment of patient recommendation acceptance
timeFrame: Day 1, Day 30, Day 60, Day 90
measure: Change in self-reported patient trust
timeFrame: Day 1, Day 30, Day 60, Day 90
measure: Change in self-reported utilization of AIMS
timeFrame: Day 1, Day 30, Day 60, Day 90
measure: Change in self-reported rate of patient vaccine uptake
timeFrame: Day 1, Day 30, Day 60, Day 90
Secondary outcomes:
measure: Change in belief about patient autonomy
timeFrame: Day 1, Day 30, Day 60, Day 90
measure: Change in proportion of patients that accept a recommendation
timeFrame: Day 1, Day 30, Day 60, Day 90
Other outcomes:
Locations:
city: Durham
country: United States
facility: (Any and all facilities) - The study team ask(s)/(ed) professional contacts, friends, and family members who are employed at various US Institutions to forward the recruitment announcement message via their respective networks
state: North Carolina
city: Durham
country: United States
facility: Duke University Health System (all locations)
state: North Carolina
city: Brasília
country: Brazil
facility: (Any and all facilities) - Participants are recruited via market research company "Survey Healthcare Global"
Study officials:
affiliation: Duke University
name: Dan Ariely, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04286893: Improved HRV, Inflammation Markers and Endothelial Function After TAVI
Official title: Improved Heart Rate Variability, Inflammation Markers and Endothelial Function After Transcatheter Aortic Valve Implantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Aortic Stenosis
TAVI
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2020-02-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients eligible for transfemoral transcatheter aortic valve implantation

Brief summary: Severe aortic valve stenosis is known to affect heart haemodynamics, endothelial function and body inflammation markers. Our aim is to investigate the weather transcatheter aortic valve implantation in patients with severe aortic stenosis affects heart rate variability, inflammation markers and endothelial function.


Eligibility criteria: Inclusion Criteria:

* TAVI

Exclusion Criteria:

* stage V chronic kidney disease
* active malignancies

Primary outcomes:
measure: Change of heart rate variability
timeFrame: 3 to 6 months after TAVI
measure: Change of laboratory value of endothelial inflammation markers
timeFrame: 3 to 6 months after TAVI
measure: Change of flow-mediated filatation (FMD) of the brachial artery
timeFrame: 3 to 6 months after TAVI
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: UMC Ljubljana
Study officials:
affiliation: University Medical Centre Ljubljana
name: Borut Jug, PhD
role: STUDY_DIRECTOR
References:
citation: Horn P, Stern D, Veulemans V, Heiss C, Zeus T, Merx MW, Kelm M, Westenfeld R. Improved endothelial function and decreased levels of endothelium-derived microparticles after transcatheter aortic valve implantation. EuroIntervention. 2015 Apr;10(12):1456-63. doi: 10.4244/EIJY14M10_02.
Clinical trial NCT01415193: Tibial Nerve Versus Sciatic Nerve Block
Official title: Selective Tibial Nerve Block vs Popliteal Sciatic Nerve Block in Patients Having Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Analgesia
Lead sponsor: Trinity Health Of New England
Sponsor class: OTHER
First posted: 2011-08-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
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 analyse the ability to selectively block the posterior tibial nerve sparing the function of the common peritoneal nerve. To assess the efficacy of blocking the posterior tibial nerve will give the same post-operative pain relief after total knee surgery compared to a sciatic nerve block.


Eligibility criteria: Inclusion Criteria:

* total knee replacement

Exclusion Criteria:

* History of neuralgia, diabetes, pregnancy, allergy to local anesthetic solutions

Primary outcomes:
measure: To assess if selectively blocking only the tibial nerve component of the sciatic nerve will prevent foot drop.
timeFrame: Upon emergence from general anesthesia and up to 48 hours in the recovery room.
Secondary outcomes:
measure: To assess if levels of pain and analgesic requirements are similar between the two groups.
timeFrame: 24 hours after total knee replacement surgery.
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Saint Francis Hospital and Medical Center
state: Connecticut
Study officials:
affiliation: Saint Francis Hospital
name: Sanjay Sinha, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01750593: Radiofrequency Ablation in Thyroid Nodules
Official title: Efficacy of Radiofrequency Ablation in Thyroid Nodules
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroid Nodules
Keywords: radiofrequency
thyroid
nodule
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2012-12-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Thyroid nodules are common problems and although \> 95% are stated to be benign, they may cause some problems like hyperthyroidism, compression symptoms, and cosmesis associated with their function, size and localization. Especially for these nodules, patients undergo surgery and face up with the problems associated with surgical complications although they are not cancer. In some studies, radiofrequency ablation previously used for intrabdominal tumors like hepatic metastasis...,was stated to be efficient in the treatment of benign thyroid nodules and in some recurrent thyroid cancer cases. Therefore, the investigators decided to use this method in our patients having nodules like previously mentioned and see the efficacy and safety of the technique.


Eligibility criteria: Inclusion Criteria:

1. the presence of subjective symptoms (foreign body sensation, neck discomfort or pain, compressive symptom) or cosmetic problems;
2. a poor surgical candidate or refusal to undergo surgery;
3. fine-needle aspiration cytology and US findings that were compatible with a benign nodule;
4. anxiety about a malignancy.

Exclusion Criteria:

1. a nodule less than 5 mm in size;
2. follicular neoplasm or malignancy on fine needle aspiration cytology (FNAC);
3. a nodule with the sonographic criteria for a malignancy (taller than wide, marked hypoechoic, microcalcifications, ill-defined margins), although FNAC was a benign result;
4. previous radiation or operation history to the head and neck; (5) previous sclerosing therapy.

Primary outcomes:
measure: Shrinkage of the thyroid nodule after radiofrequency ablation
timeFrame: 6 months
Secondary outcomes:
measure: Disappearance of the nodules in follow up
timeFrame: 1 year
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University medical Faculty
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
Study officials:
References:
Clinical trial NCT04229693: Cerebrospinal Fluid Proteom in Dependence of Intranasal Breast Milk
Official title: Proteomics of Cerebrospinal Fluid of Preterm Infants With Posthemorrhagic Hydrocephalus With Focus on Intranasal Breast Milk.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hydrocephalus in Infants
Lead sponsor: University Hospital of Cologne
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 20
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All preterm infants at our neonatologic center with hydrocephalus in need of drainage are eligible.

Brief summary: Investigation of the cerebrospinal fluid proteom in preterm infants with posthemorrhagic hydrocephalus in our neonatology center with analysis for modulation of proteom in dependence of breastmilk feeding and way of application such as via gavage tube, oral or nasal application.

Detailed description: Since the nasal route might be highly effective for neurotrophins and other growth factors the cerebrospinal fluid will be investigated using mass spectrometry to identify modulating effects of intranasal breast milk application on the cerebrospinal fluid proteom.

Eligibility criteria: Inclusion Criteria:

* preterm infant with hydrocephalus and regular drainage

Exclusion Criteria:

* Inborn error of metabolism

Primary outcomes:
measure: Cerebrospinal fluid proteom
timeFrame: weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Neonatology at the University Hospital of Cologne
Study officials:
affiliation: University of Cologne, Children's Hospital
name: Titus Keller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Keller T, Korber F, Oberthuer A, Schafmeyer L, Mehler K, Kuhr K, Kribs A. Intranasal breast milk for premature infants with severe intraventricular hemorrhage-an observation. Eur J Pediatr. 2019 Feb;178(2):199-206. doi: 10.1007/s00431-018-3279-7. Epub 2018 Nov 1.
Clinical trial NCT07024693: DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy
Official title: A Phase 2, Multicenter, Open-Label Study to Assess the Pharmacodynamics, Safety, and Tolerability of DT-168 Ophthalmic Solution in Patients With Fuchs Endothelial Corneal Dystrophy Undergoing Keratoplasty
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Fuchs Endothelial Corneal Dystrophy
Fuchs
Lead sponsor: Design Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2025-06-17
Enrollment: 28
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the pharmacodynamics, safety, and tolerability of DT-168 Ophthalmic Solution in pre-keratoplasty patients with Fuchs endothelial corneal dystrophy.


Eligibility criteria: Inclusion Criteria:

* Participant is scheduled to undergo a keratoplasty for management of FECD independent of this study.
* ≥30 years of age (inclusive).
* Documented diagnosis of FECD in the study eligible eye.
* Confirmation of positive TCF4 allele 18.1 CTG expansion in at least one allele.
* Capable of giving signed informed consent.

Exclusion Criteria:

* Any ocular or medical condition in the study eligible eye which is clinically significant or would confound study results or data interpretation.
* Any clinically significant medical, nonmedical, and psychiatric disorders that could put the participant at higher risk for participation in the study, impair the participant's ability to participate in the study, or interfere with interpretation of the participant's study results, in the opinion of the investigator.
* Concurrent or anticipated need for treatment for FECD, eg, Muro 128 (2% or 5%) during the course of the study in the study eye. Provided the subject undergoes a washout of Muro drops for at least 24 hours prior to the Baseline Visit, they will not be excluded.
* Concurrent or anticipated use of topical corticosteroids in the study eye.
* Concurrent use with Rhopressa®, Rocklatan®, or any other ocular Rho Kinase inhibitor.
* Known contraindication, allergy, or hypersensitivity to any of the treatments, anesthetics, or diagnostic agents or components thereof which may be used during the study.
* Use of contact lenses in the study eye within 7 days prior to the Baseline Visit or planned use during the study.
* Recent (within 30 days of the Screening Visit) or ongoing participation in any other investigational interventional clinical study.
* Female participant is pregnant, planning a pregnancy, or breast-feeding.
* Participant is unwilling to comply with the contraceptive requirements, as per protocol.

Primary outcomes:
measure: FECD Biomarkers: Splicing Panel
timeFrame: Perioperative
Secondary outcomes:
measure: Safety and Tolerability
timeFrame: Through study completion, an average of 4 weeks.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00047593: Phase 3 Study Comparing IOP Lowering in OAG or OH in Japanese Subjects C-01-98
Official title: Phase 3 Study to Compare Two Different IOP Lowering Medications for the Treatment of Open Angle Glaucoma or Ocular Hypertension in Japanese Subjects C-01-98.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Open-Angle Glaucoma
Ocular Hypertension
Keywords: open-angle
glaucoma
ocular
hypertension
POAG
Iris
Pigmentation
Japanese
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2002-10-11
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 evaluate safety and efficacy of two different IOP lowering medications after twelve months of treatment in Japanese subjects.


Eligibility criteria: Adults of Japanese Ethnicity

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Honolulu
country: United States
state: Hawaii
Study officials:
References: