louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00098046: Famciclovir Oral Pediatric Formulation in Children 1-12 Years of Age With Varicella Zoster Infection
Official title: Pharmacokinetics and Safety of Famciclovir Oral Pediatric Formulation in Children 1-12 Years of Age With Varicella Zoster Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chickenpox
Herpes Zoster
Keywords: chickenpox
herpes zoster
children
Famvir
varicella zoster virus
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2004-12-03
Enrollment: 76
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Varicella zoster virus causes chickenpox in children and shingles in adults. Chickenpox is usually a self-limiting illness characterized by fever and a rash. Serious complications can include secondary bacterial infections, pneumonia, and encephalitis. Anti-viral treatment is not a standard of care in immunocompetent children, but is recommended whenever a risk of complication exists. This study will evaluate the safety and blood levels of a new formulation of famciclovir in children 1-12 years of age.


Eligibility criteria: Inclusion Criteria:

* Male or female children 1-12 years of age
* Clinical or laboratory evidence of varicella zoster infection
* Patients suspected of having varicella zoster infection

Exclusion Criteria:

* Patients unable to swallow
* Concomitant use of probenecid
* Positive pregnancy

Additional protocol-defined inclusion/exclusion criterial may apply. For detailed information on eligibility, please contact the study center nearest to you (see below), or call the following number 1-862-778-3544 or 1-434-951-3228

Primary outcomes:
measure: Step A: Single-dose safety and pharmacokinetics
measure: Step B: Safety and tolerability of pediatric formulation administered 3 times daily over 7 days
Secondary outcomes:
measure: Steps A & B: Acceptability of pediatric formulation by patients
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: San Jose
country: Costa Rica
facility: Novartis Investigational Site
city: Cuidad de Guatemala
country: Guatemala
facility: Novartis Investigational Site
city: Ciudad de Panama
country: Panama
facility: Novartis Investigational Site
city: David, Chiriqui
country: Panama
facility: Novartis Investigational Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References:
citation: Saez-Llorens X, Yogev R, Arguedas A, Rodriguez A, Spigarelli MG, De Leon Castrejon T, Bomgaars L, Roberts M, Abrams B, Zhou W, Looby M, Kaiser G, Hamed K. Pharmacokinetics and safety of famciclovir in children with herpes simplex or varicella-zoster virus infection. Antimicrob Agents Chemother. 2009 May;53(5):1912-20. doi: 10.1128/AAC.01054-08. Epub 2009 Mar 9.
Clinical trial NCT01858246: A Randomised Controlled Trial Comparing Bone Anchored Hearing Aid With Bonebridge
Official title: A Randomised Controlled Trial Comparing Bone Anchored Hearing Aid With Bonebridge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss, Conductive
Bone Conduction Deafness
Keywords: Hearing Loss, Conductive
Bone Conduction
bone conduction thresholds better than 45 dBHL
Lead sponsor: Ninewells Hospital
Sponsor class: OTHER
First posted: 2013-05-21
Enrollment: 3
Sex: ALL
Minimum age (years): 16
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Bonebridge is a new bone conducting implantable hearing aid. The investigators plan to randomize patients to receive either the Bonebridge or a conventional bone conducting hearing device. The investigators will then compare the surgical and audiological outcomes of the two groups.

Detailed description: The new Bonebridge fully implanted, except for an external sound processor. It does not have any percutaneous parts like the Bone Anchored Hearing Aid. The investigators believe that this may improve wound healing and reduce problems with wound infection and skin overgrowth seen in Bone Anchored Hearing Aids.

There may also be audiological improvements by the use of the Bonebridge as the physical separation of the vibrating part from the sound processor should reduce feedback. The company also claims other audiological improvements in the Bonebridge.

The investigators wish to demonstrate whether this is actually the case by performing a study directly comparing the outcomes of the two groups.

Eligibility criteria: Inclusion Criteria:

* Conductive Hearing Loss within criteria for Bonebridge
* Adults

Exclusion Criteria:

* Children
* Pregnancy

Primary outcomes:
measure: Speech audiogram result at 6 months after switch on at 60 dBA in quiet using AB word lists
timeFrame: Up to 1 year post-operatively
Secondary outcomes:
measure: Speech audiogram result at 60 dB A in noise using AB word lists
timeFrame: Up to 1 year after implantation
measure: Patient reported outcome data
timeFrame: Up to 1 year following implantation
measure: Time from surgery to device switch-on
timeFrame: Up to 3 months
measure: Number of patient episodes required during study period
timeFrame: 1 year from implantation
measure: Time to complete wound healing
timeFrame: Up to 3 months from implantation
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: Ninewells Hospital and Medical School
Study officials:
affiliation: NHS Tayside
name: Stephen EM Jones
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04667546: Assessment of the Efficacy on the 5th Day of Antibiotic Therapy for Febrile Urinary Tract Infections Among Children From 3 Months to 18 Years Old
Official title: Assessment of the Efficacy on the 5th Day of Antibiotic Therapy for Febrile Urinary Tract Infections Among Children From 3 Months to 18 Years Old
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Tract Infections
Pediatric Disorder
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2020-12-14
Enrollment: 54
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The main objective is to describe the rate of asymptomatic patients after 5 days of effective antibiotic therapy in an uncomplicated febrile urinary tract infection in children between 3 months and 18 years of age.

Detailed description: This is a non-randomised prospective monocentric pilot study whose main objective is to describe the proportion of asymptomatic patients after 5 days of effective antibiotic therapy in an uncomplicated febrile urinary tract infection, in children between 3 months and 18 years of age. After being informed about the study, all patient meeting inclusion criteria will respond to a survey at D2, D5, D10 and D28 to evaluate the persistence of symptoms to determine the effectiveness of a 5-day course of antibiotic treatment. All patients will be treated in accordance to the French guidelines.

Eligibility criteria: Inclusion Criteria:

* Child between 3 months and 18 years old
* Diagnosis of uncomplicated febrile urinary tract infection certain and defined by :

  * Naked fever (without an identifiable source of infection) for at least 24 hours for boys and 48 hours for girls.
  * A urine test strip with at least 2 crosses of leukocyturia ≥ or 1 cross of leukocyturia ≥ with positive nitrituria
  * A cytobacteriological urine test with leukocyturia greater than 10/mm3 in the case of catheterisation or Clean catch or greater than 100/mm3 if the collection is performed by bag (Urinocol®).
  * Positive bacteriological urine culture
  * Response to antibiotic therapy
  * Absence of other diagnoses that could explain the clinical picture

Exclusion Criteria:

* Children under 3 months old
* Immunodepression
* Underlying uropathy or known neurological bladder disease

Primary outcomes:
measure: Effectiveness of treatment
timeFrame: Day 5
Secondary outcomes:
measure: Leukocyte count
timeFrame: Day 1
measure: Mode of sampling
timeFrame: Day 1
measure: Rate of failure
timeFrame: Day 28
measure: Procalcitonin levels
timeFrame: Day 1
measure: CRP levels
timeFrame: Day 1
measure: Polynuclear cell count
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06289946: Topical Nitro or Placebo Pre-Cath
Official title: Topical Nitroglycerin Prior to Trans-radial Coronary Angiography: a Phase 2, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Coronary Artery Disease
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase 2, single-center, randomized, blinded clinical study to assess the safety and efficacy of topical nitroglycerin on ease of TRA during scheduled PCI. We will compare topical nitroglycerin to placebo applied prior to planned, non-urgent PCI to determine if nitroglycerin is associated with decreased number of arterial puncture attempts made, decreased time to radial access, and lower crossover rate to TFA. Subjects will be randomized to receive either topical nitroglycerin ointment or placebo prior to scheduled PCI. There will be 256 subjects enrolled in this study with 1:1 randomization.

Detailed description: Percutaneous coronary intervention (PCI) procedures performed by entering the radial artery, or the transradial approach (TRA), is associated with reduced vascular access site complications, bleeding, and length of hospital stay, as well as greater patient satisfaction when compared to the transfemoral approach. One of the major challenges to a successful TRA remains the small size of the radial artery. The potential need for larger catheters during PCI has been one factor limiting broader adoption of TRA and a common reason for crossover from TRA to femoral access intraprocedurally. Additionally, multiple unsuccessful attempts to access the radial artery leads to unnecessary bleeding and may lead to severe arterial vasospasms. Nitroglycerin, a vasodilator, is available in a topical form and may be used prior to PCI to dilate the radial artery and potentially increase the rate of successful TRA.

Eligibility criteria: Inclusion Criteria:

1. Male or non-pregnant female \> 18 years of age at the time of consent
2. Scheduled to undergo PCI using TRA in the cardiac catheterization laboratory
3. Able to provide informed consent with capacity, given in English.

Exclusion Criteria

Patients with any of the following characteristics or conditions will not be included in the study:

1. Known nitrate allergy
2. Allergy to CeraVe Moisturizing lotion
3. Baseline hypotension with systolic blood pressure \<90mmHg
4. Absence of radial artery blood flow in one or both arms
5. Presence or history of liver, rheumatologic, or chronic kidney disease
6. Current treatment with any vasodilator therapy (eg. Sildenafil)
7. Radial artery catheterization \<30 days prior to enrollment
8. Active site infection
9. AV-fistula or prior radial artery harvest for bypass surgery

Primary outcomes:
measure: Crossover rate
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03635346: Medicinal Dependence and Chronic Pain: Addictive Evaluation in CETD
Official title: Medicinal Dependence and Chronic Pain: Addictive Evaluation in CETD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opiate Dependence
Chronic Pain
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: analysis of SUD criteria in a population with a chronic pain (non cancer) , consulting a center specialized in pain mangement

Brief summary: prescription opioid misuse in chronic pain is a growing public health concern. few studies got interested in prevalence of misuse and of opiate use disorder in a population of patients with a non cancer chronic pain.

the investigators analyzed during 3 months opiate misuse and opiate ude disorder in a population of patients consulting a center specialized in pain management.


Eligibility criteria: Inclusion Criteria:

* patient with a non cancer chronic pain
* consulting a CETD center

Exclusion Criteria:

* non understanding of french

Primary outcomes:
measure: DSM 5 criteria of SUD
timeFrame: Day 0 (at the inclusion)
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References:
Clinical trial NCT04538846: Culinary Art Therapy Group for Adults With Eating Disorders.
Official title: Culinary Art Therapy Group for Adults With Eating Disorders: Assessment of Influence on Thinking, Patterns and Behaviour Related to Food.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Eating Disorders
Behavior, Eating
Relationship, Family
Cognitive Change
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: University of Haifa
First posted: 2020-09-04
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Quasi-Experimental Study
Primary purpose: TREATMENT

Brief summary: The study will assess the influence of culinary art therapy group (a new therapeutic tool) for adults with eating disorders. It will assess changes in thinking patterns and behavioural patterns associated with food and eating.


Eligibility criteria: Inclusion Criteria:

* A diagnosis of eating disorder
* Body Mass Index (BMI) \> 15

Exclusion Criteria:

* No active participation in three group sessions
* Refusal to take an active part in the sessions

Primary outcomes:
measure: Eating Attitudes Test (EAT-26)
timeFrame: 3 months
measure: Eating & Meal Preparation Skills Questionnaire (EMPSA)
timeFrame: 3 months
measure: Rosenberg Self-Esteem Scale (RSES)
timeFrame: 3 months
Secondary outcomes:
measure: Assessment of Communication and Interaction Skills (ACIS)
timeFrame: 3 months
measure: Individual semi-structured interview
timeFrame: 3 months
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Eating disorders outpatients department, Hadassah Medical Center
Study officials:
affiliation: University of Haifa
name: Adi Stern, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03021746: Fostering Sustainability Through Diabetes Self-Management Support
Official title: Fostering Sustainability Through Diabetes Self-Management Support
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: African-American
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2017-01-16
Enrollment: 358
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To understand the effectiveness of three approaches to address diabetes self-management support compared to enhanced usual care in church-based settings.

Detailed description: To understand the effectiveness of three approaches to address diabetes self-management support compared to enhanced usual care in church-based settings.

Eligibility criteria: Inclusion Criteria:

* Have Type 2 diabetes for at least 6 months
* Be Black/African American
* Be a resident of metro-Detroit, Toledo, or Flint
* Be at least 21 years old
* Be under the care of a physician for diabetes
* Have transportation to attend the program

Exclusion Criteria:

* Have Type 2 diabetes for less than 6 months
* Under 21 years of age
* Not under care of physician
* Lack of transportation to attend the program

Primary outcomes:
measure: Change in A1C Blood Glucose level
timeFrame: During this study, A1c will be measured at five time points; baseline, 6 months, 9 months, 21 months, and 33 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Gretchen Piatt, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04663646: Optokinetic Stimulation for Hemineglect
Official title: Application of Optokinetic Stimulation in the Treatment of Hemineglect
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Perceptual Disorders
Unilateral Spatial Neglect
Keywords: Perceptual Disorders
Unilateral spatial neglect
Optokinetic stimulation
Photic stimulation
Lead sponsor: University of Salamanca
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial in which an intervention group will undergo optokinetic stimulation with virtual reality glasses, and the control group will receive placebo sessions.
Primary purpose: TREATMENT

Brief summary: Hemineglect is a sequel to stroke, which appears more frequently when the injury occurs in the right cerebral hemisphere. Hemineglect refers to those patients who do not pay attention to their left side, presenting movement disorders that do not allow them to participate spontaneously in their activities of daily life.

There are different methodologies for the treatment of hemineglect. Among them, we find optokinetic stimulation (OKS), which consists of creating an illusory movement to the left to center the patient's frame of reference and thus, make them pay more attention to their left side. In recent years, the effect that this therapy has on motor movement disorders has begun to be explored, although the parameters for its correct application still seem to be unclear.

For this reason, our aim is to describe the effect that the OKS has on balance, posture, spatial representation and conscience, and movement disorders in hemineglect. Patients with hemineglect will undergo OKS to see its influence on the recovery of this sequel of stroke.


Eligibility criteria: Inclusion Criteria:

* 18 year old or older
* Diagnosis of right stroke
* Diagnosis of left heminegligence

Exclusion Criteria:

* No cooperation and comunication problems
* Uncontrolled epileptic seizures or migraines

Primary outcomes:
measure: Posture
timeFrame: 60 minutes
measure: Stability
timeFrame: 60 minutes
measure: Fluff Test
timeFrame: 60 minutes
measure: Bisection of the line
timeFrame: 60 minutes
measure: Fugl Meyer Assessment Scale
timeFrame: 60 minutes
measure: Fullerton Advance Balance Test
timeFrame: 60 minutes
measure: Diller's cancelation test
timeFrame: 60 minutes
Secondary outcomes:
measure: Sex
timeFrame: 1 minute
measure: Date of birth
timeFrame: 1 minute
measure: Date of injury
timeFrame: 1 minute
measure: Type of injury
timeFrame: 1 minute
measure: Admission time
timeFrame: 1 minute
measure: National Institutes of Health Stroke Scale
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Universidad de Salamanca
Study officials:
References:
Clinical trial NCT04583046: Effects of Iloprost on Pulmonary Oxygenation in Obese Patients During One-lung Ventilation
Official title: Effects of Iloprost on Pulmonary Oxygenation in Obese Patients During One-lung Ventilation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer (Including Metastatic Cancer)
Pulmonary Infection
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2020-10-12
Enrollment: 78
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: One lung ventilation (OLV) is essential during thoracic surgery. During OLV, intrapulmonary shunt can be increased resulting hypoxemia. Although OLV technique had been advanced so far, hypoxemia during OLV reaches about 10% in spite of inspired oxygen fraction 100%. Iloprost is a prostaglandin analogue used for pulmonary hypertension, which can decrease pulmonary artery resistance by selectively dilating pulmonary artery. In this prospective, randomized, double blind study, the investigator is planning to investigate the effects of iloprost on respiratory physiology (intrapulmonary shunt, deadspace, oxygenation, etc) in obese patients.


Eligibility criteria: Inclusion Criteria:

1. scheduled for VATS lobectomy
2. 40 \< age \< 80
3. American Society of Anaesthesiologists(ASA) physical status classification I\~III
4. BMI \> 30 kg /m2

Exclusion Criteria:

1. American Society of Anaesthesiologists(ASA) physical status classification IV or more
2. NYHA class III\~IV
3. Severe obstructive lung disease and/or restrictive lung disease patients
4. patients with end-organ diseases (i.e. heart failure, respiratory failure, hepatic failure, renal failure)
5. arrhythmia
6. pregnant women
7. pulmonary edema or pulmonary arterial hypertension
8. cerebrovascular disease
9. unstable angina or myocardial infarction within 6 months
10. patients with allergic reaction at iloprost

Primary outcomes:
measure: Result of arterial blood gas analysis : partial pressure of oxygen(PaO2)
timeFrame: 20 minutes after iloprost inhalation (T2)
measure: Result of arterial blood gas analysis : partial pressure of oxygen in the arterial blood(PaO2)/Fraction of inspired oxygen(FiO2) ratio (P/F ratio)
timeFrame: 20 minutes after iloprost inhalation (T2)
measure: Result of arterial blood gas analysis : Oxygen saturation in arterial blood(SaO2)
timeFrame: 20 minutes after iloprost inhalation (T2)
Secondary outcomes:
measure: deadspace
timeFrame: 20 minutes after iloprost inhalation (T2)
measure: intrapulmonary shunt
timeFrame: 20 minutes after iloprost inhalation (T2)
Other outcomes:
Locations:
Study officials:
affiliation: Severance Hospital
name: Young Jun Oh
role: PRINCIPAL_INVESTIGATOR
References: