louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05684393: Anatomy-based Fitting in Unexperienced Cochlear Implant Users
Official title: Anatomy-based Fitting in Unexperienced Cochlear Implant Users
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Influence of Anatomy Based Frequency Mapping on Speech Outcomes and Hearing Related Measures
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2023-01-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The performance with the CI is investigated over time in two groups of freshly implanted CI users. The first group is fitted using the standard frequency-band distribution as implemented in MAESTRO 9 fitting software. In the second group of users, an anatomy-based frequency distribution is used as per anatomy-based fitting in MAESTRO 9.
Primary purpose: BASIC_SCIENCE

Brief summary: The present study investigates CI users' potential differences in speech tests, other performance measures (i.e. pitch-matching, perception of timbre and melodic intervals, consonance perception), and patient-reported outcome (i.e. questionnaires) between the clinical fitting map and anatomy-based fitting in two groups of CI users (one with standard fitting and one with anatomy-based fitting).


Eligibility criteria: Inclusion Criteria:

* Post-lingual onset of severe to profound sensory-neural hearing loss in the implanted ear(s)
* Post-OP CT scan of the CI electrode available
* Subject implanted with MED-EL cochlear implant(s)
* Subjects received a Flex28, FlexSoft and Standard electrode
* Subject planned to receive a SONNET 2 or RONDO 3 audio processor on the newly implanted side
* Audio processor not yet activated on the newly implanted side
* The most apical active electrode contact has to be inserted at least 450°
* Minimum of 10 active channels can be activated
* Fluent in the language of the test centre
* Signed and dated ICF before the start of any study-specific procedure

Exclusion Criteria:

* Lack of compliance with any inclusion criteria
* EAS user (user of an EAS audio processor)
* Implanted with C40+, C40X and C40C
* Implanted with an ABI or Split electrode array
* Anything that, in the opinion of the Investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study

Primary outcomes:
measure: Word recognition score (WRS)
timeFrame: 6 months
Secondary outcomes:
measure: Speech reception threshold (SRT)
timeFrame: 6 months
measure: Pitch ranking
timeFrame: 6 months
measure: Perception of timbre
timeFrame: 6 months
measure: Phoneme categorization
timeFrame: 6 months
measure: Consonance/difference rating
timeFrame: 6 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
Clinical trial NCT00524693: Montelukast in Acute RSV Bronchiolitis
Official title: A Double-Blind Placebo Controlled Randomized Trial of Montelukast in Acute Respiratory Syncytial Virus Bronchiolitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiolitis
Keywords: Bronchiolitis
controlled clinical trial
pediatrics
Infants
montelukast
Respiratory syncytial virus
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Wolfson Medical Center
First posted: 2007-09-05
Enrollment: 51
Sex: ALL
Minimum age (years): 4
Maximum age (years): 2
Standard ages: CHILD
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is evidence of inflammatory mechanisms in RSV bronchiolitis with increased cysteinyl-leukotrienes (cys-LT). Recently, specific cys-LT receptor antagonists - montelukast (Singulair©) approved for use in infants as granule sachets, have become available. We evaluated the effect of Singulair© on clinical progress and on cytokine profiles in the acute phase of RSV bronchiolitis.


Eligibility criteria: Inclusion Criteria:

* Age \> 4 weeks \< 2 years
* Duration of respiratory symptoms \< 4 days
* Signs of bronchiolitis: prodromal rhinorrhea and cough, followed by at least two of the following signs: chest retractions, tachypnea, wheezing, or rales
* First episode of wheezing or shortness of breath
* Randomization within 12 hours of admission
* No need for steroid treatment in the ward
* Informed consent

Exclusion Criteria:

* A history of asthma symptoms or any previous hospital admissions with respiratory tract illnesses and if they had ever been treated with anti-asthma medications (prior to the current illness).
* Underlying cardiopulmonary disease such as bronchopulmonary dysplasia, congenital heart disease, immunodeficiency, or cystic fibrosis.

Primary outcomes:
measure: Length of stay
timeFrame: hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ziv Medical Center
name: Israel Amirav, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amirav I, Luder AS, Kruger N, Borovitch Y, Babai I, Miron D, Zuker M, Tal G, Mandelberg A. A double-blind, placebo-controlled, randomized trial of montelukast for acute bronchiolitis. Pediatrics. 2008 Dec;122(6):e1249-55. doi: 10.1542/peds.2008-1744. Epub 2008 Nov 4.
Clinical trial NCT02915211: Evaluation of Keyo in Children With Epilepsy
Official title: A Feasibility Study to Evaluate the Acceptability of Keyo, a Food for Special Medical Purposes (FSMP) for Use in the Ketogenic Diet (KD) With Regard to Product Tolerance, Compliance and Acceptability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intractable Epilepsy
Glucose Transporter Type 1 Deficiency Syndrome
Ketogenic Dieting
Keywords: Epilepsy
Glut
Ketogenic
Glucose
Lead sponsor: Vitaflo International, Ltd
Sponsor class: INDUSTRY
First posted: 2016-09-26
Enrollment: 17
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the tolerance, acceptability and compliance of Keyo in 20 subjects aged 3 years and over, with intractable epilepsy or Glut-1 DS on a KD.

Detailed description: Qualitative assessments from subject questionnaires that allow evaluation of the acceptability and ease of use of the study product.

Collection of daily data about the gastro-intestinal tolerance of the study product.

Collection of daily data about compliance with the study product i.e. actual versus prescribed intake.

Improve quality of life by increasing range of foods available for use in a ketogenic diet.

Eligibility criteria: Inclusion Criteria:

* 3 years and over
* Confirmed diagnosis of intractable epilepsy or Glut-1 DS
* Children must be currently established on a KD for at least 3 months, taken orally
* Written, informed consent by participant/carer

Exclusion Criteria:

-

Primary outcomes:
measure: Palatability questionnaire
timeFrame: Day 8
measure: Ease of use daily diary
timeFrame: Days 1-7
measure: GI tolerance daily diary
timeFrame: Days 1-7
measure: Product compliance daily diary
timeFrame: Days 1-7
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Central Manchester University Hospitals NHS Foundation Trust
state: Greater Manchester
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
state: West Yorkshire
Study officials:
affiliation: Leeds Teaching Hospitals NHS Trust
name: Helen McCullagh, BSc, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01088711: Evaluation of Omarigliptin (MK-3102) in Obese Participants and in Participants With Type 2 Diabetes (MK-3102-004)
Official title: A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK3102 in Obese Subjects and in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes (T2D)
Keywords: Type 2 diabetes (T2D)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-03-17
Enrollment: 32
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will test the safety and tolerability of omarigliptin. It is hypothesized that administration of once-weekly omarigliptin in obese but otherwise healthy participants, and in obese participants with Type 2 diabetes (T2D) will be sufficiently safe and well tolerated to permit continued clinical investigation.


Eligibility criteria: Inclusion Criteria:

* obese (body mass index \[BMI\] ≥30 kg/m² and ≤40 kg/m²) male participants and female participants of non-childbearing potential
* has been diagnosed with T2D (Panel B)
* is not actively participating in a weight loss program

Exclusion Criteria:

* has a history of clinically-significant disease (other than T2D)
* has a history of cancer
* has estimated creatinine clearance ≤60 mL/min
* is unable to refrain from or anticipates the use of any prescription or non-prescription medication
* consumes excessive amounts of alcohol or caffeine
* has participated in a previous omarigliptin study

Primary outcomes:
measure: Number of Participants Experiencing an Adverse Event (AE)
timeFrame: Up to Day 36
measure: Number of Participants Withdrawing From Study Therapy Due to an AE
timeFrame: Up to Day 22
Secondary outcomes:
measure: Percent Inhibition of Dipeptidyl Peptidase-4 (DPP-4) After Day 15
timeFrame: 168 hours post-dose on Day 15
measure: Percent Inhibition of DPP-4 After Day 22
timeFrame: 168 hours post dose on Day 22
measure: WAA Active Glucagon-like Peptide-1 (GLP-1) Concentration
timeFrame: Through 4 hours post dose on Day 21
measure: WAA Total GLP-1 Concentration
timeFrame: Through 4 hours post dose on Day 21
measure: Plasma Glucose Concentration
timeFrame: Through 4 hours post dose on Day 21
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Addy C, Tatosian D, Glasgow XS, Gendrano IN 3rd, Kauh E, Martucci A, Johnson-Levonas AO, Selverian D, Matthews CZ, Gutierrez M, Wagner JA, Aubrey Stoch S. Pharmacokinetic and Pharmacodynamic Effects of Multiple-dose Administration of Omarigliptin, a Once-weekly Dipeptidyl Peptidase-4 Inhibitor, in Obese Participants With and Without Type 2 Diabetes Mellitus. Clin Ther. 2016 Mar;38(3):516-30. doi: 10.1016/j.clinthera.2015.12.020. Epub 2016 Feb 9.
Clinical trial NCT02852811: Reducing Menopausal Symptoms for Women During Menopause Using Group Education in a Primary Health Care Setting
Official title: Reducing Menopausal Symptoms for Women During Menopause Using Group Education in a Primary Health Care Setting: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Keywords: Climacteric
Education
Mental health
Menopause
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2016-08-02
Enrollment: 131
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate if group education about the topic menopause to women in PHC can improve women's menopausal symptoms and reduce depression.

Detailed description: One hundred twenty women will be included in the study. The survey population consists of Swedish-speaking women aged 45-55 years and seek care at Distriktsköterskemottagningen in Skene and at the Antenatal clinic in Svenljunga. The selection is done consecutively.

Method:

Grouping:The women will be randomly allocated to intervention group and control group (60/60).

The intervention:

The project includes the implementation of a total of four equivalent group treatments. Two of the group education will be at Skene Medical center and two Svenljunga Medical center. Group treatments are carried out by the district nurse and midwife in common. Each treatment group includes 15 women. A total of 60 women will thus participate in group education..Each treatment group consists of two information sessions of 2 hours.

The first information contains information about the menstrual cycle, hormonal shift, urogenital symptoms, and information on prevention and health promotion self-care.

The other information currently contains information about cardiovascular risk factors during menopause, relations, mental health, information about depressive symptoms and for preventive measures and health-promoting self-care.

The control group did not obtain any group education or any other intervention.

Eligibility criteria: Inclusion Criteria:

* female gender, 45 to 55 years of age, comprehension and fluency in the Swedish language.

Exclusion Criteria:

* that the patient did not any longer want to participate in the study.

Primary outcomes:
measure: Change in menopause symptoms during baseline to four month follow up. The measurement that be used were The Menopause Rating Scale (MRS).
timeFrame: from baseline to four month follow up
measure: Change in depression symptoms during baseline to four month follow up. The measurement that be used was The Montgomery-Asberg Depression Rating Scale (MADRS).
timeFrame: from baseline to four month follow up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Research and Development Center Södra Älvsborg, Närhälsan, Research and Development, Primary Health Care Region, Västra Götaland, Sweden,
name: Gun Rembeck, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02707211: Anti-oxLDL IgM Antibodies as a Novel Therapy for Metabolic Lipid Diseases
Official title: Immunization Against oxLDL in Patients With Lysosomal Lipid Diseases and Associated Metabolic Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Lipid Metabolism, Inborn Errors
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2016-03-14
Enrollment: 20
Sex: ALL
Minimum age (years): 2
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To test whether active pneumococci immunization can alleviate inflammation and improve cholesterol metabolism in lysosomal lipid storage diseases and associated metabolic disorders.

Detailed description: Growing evidence describes the central role of oxidized low density lipoproteins (oxLDL) in diseases related to lipid metabolism. Moreover, oxLDL has been shown to be involved in pathological processes such as an inappropriate inflammatory response, disturbance of cholesterol metabolism and dysfunction of the lysosomal apparatus. Relevantly, it has been shown that immunizing mice with Streptococcus pneumoniae results in higher serum titers of anti-oxLDL IgM antibodies due to molecular mimicry.

Eligibility criteria: Inclusion Criteria:

* Patients of following diseases (characterized by lysosomal lipid storage or associated metabolic pathology)

  * Familial hypercholesterolemia,
  * NPB,
  * NPC
  * Partial lipodystrophy (PPARg mutations and laminin A/C mutations)
* Intention to be treated and participate to the treatment - Written informed consent

Exclusion Criteria:

* Medical conditions that may interfere with the study procedures: cancer Hodgkin lymphoma (all related to immune cells); autoimmune diseases; immune deficiency; splenectomy syndrome
* Alcohol abuse (quantitative limit \>20g/day for men and \>10g for women)
* Illiteracy
* Patients younger than 10 years.
* Any condition which in the opinion of the (co-) investigator might interfere with the evaluation of the study objectives.

Primary outcomes:
measure: The level of inflammation
timeFrame: 4 weeks
Secondary outcomes:
measure: Levels of lysosomal enzymes
timeFrame: 4 weeks
measure: the level of cholesterol metabolism
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-brabant
Study officials:
References:
Clinical trial NCT02013011: Effects of Recruitment Maneuver in Patients Undergoing Robotic Assisted Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effects of Recruitment Maneuver During Intraoperative and Postoperative Period
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-12-17
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to evaluate effects of recruitment maneuver in patients undergoing robotic assisted radical prostatectomy.


Eligibility criteria: Inclusion Criteria:

* 60\~80 yr
* American Society of Anesthesiologists physical status 1 or 2
* scheduled for elective robotic assisted radical prostatectomy

Exclusion Criteria:

* heavy smoker
* severe respiratory or cardiac disease
* hepatic or renal function impairment
* neurologic disease
* BMI \> 31kg/m2

Primary outcomes:
measure: rate of perioperative complication
timeFrame: perioperative period
Secondary outcomes:
measure: respiratory index
timeFrame: intraoperative respiratory index
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Ah-young Oh
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT00092911: Study Evaluating DVS-233 SR in Adult Outpatients With Major Depressive Disorder
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy And Safety Study of a Flexible Dose of DVS-233 SR in Adult Outpatients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depression
Depressive Disorder
Major Depressive Disorder
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2004-09-28
Enrollment: 244
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 main objective of this study is to compare the antidepressant efficacy and safety of DVS-233 SR versus placebo in adult outpatients with Major Depressive Disorder.


Eligibility criteria: Inclusion Criteria:

* Outpatients
* Men and women age 18 years of age and older
* Women of childbearing potential participating in the study must have a negative serum pregnancy test result at screening and use a medically acceptable form of contraception

Exclusion Criteria:

* Treatment with DVS-233 SR at any time in the past
* Treatment with venlafaxine (immediate release \[IR\] or extended release \[ER\]) within 90 days of study day 1
* Known hypersensitivity to venlafaxine (IR or ER)
* Significant risk of suicide based on clinical judgment, including common

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05603611: Implementation of the HELIOSTARTM in Real-world Clinical Practice at a High-volume Center
Official title: Implementation of the HELIOSTARTM in Real-world Clinical Practice at a High-volume Center - Operator Learning Curve and Procedural Outcome Parameters
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
Collaborators: name: Biosense Webster, Inc.
First posted: 2022-11-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients presenting at Heidelberg University Hospital with an indication for AF ablation via the clinical routine.

Brief summary: The HELIOSTARTM catheter (Biosense Webster) is a new technology for pulmonary vein isolation (PVI) in atrial fibrillation (AF), combining radiofrequency (RF)-ablation and 3D-mapping visualization with the concept of "single-shot"-ablation device. This study evaluates the operator learning curve und procedural outcome during implementation of the HELIOSTARTM.

Detailed description: The first patients undergoing PVI by HELIOSTARTM at Heidelberg University Hospital are included in this prospective study. Procedures are performed by an operator proficient in CB-ablation. Procedural outcome was analyzed over the course of increasing experience with the device and in comparison to a previous cohort investigated during implementation of the Arctic FrontTM-cryoballoon (Medtronic).

Eligibility criteria: Inclusion Criteria:

* age ≥18 years, ability to provide informed consent and at least one episode of documented paroxysmal or persistent AF

Exclusion Criteria:

* history of prior AF ablation, left atrial thrombus, suspected irregular PV-anatomy in pre-procedural transesophageal echocardiography (TOE) or contraindication for peri-procedural anticoagulation therapy

Primary outcomes:
measure: Procedure duration
timeFrame: Day of index procedure, number of minutes
measure: LA dwell time
timeFrame: Day of index procedure, number of minutes
measure: Fluoroscopy duration
timeFrame: Day of index procedure, number of minutes
Secondary outcomes:
measure: Short-term AF arrhythmia recurrence
timeFrame: 3 months
measure: Procedural complications
timeFrame: 3 months
measure: Long-term arrhythmia recurrence
timeFrame: 12 months
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg, Department of Cardiology
Study officials:
References:
Clinical trial NCT05578911: Medical Follow-up and Self-medication Among Medical Students
Official title: Medical Follow-up and Self-medication Among Medical Students
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medical Student
Keywords: medical student
medical follow-up
self medication
Lead sponsor: Université de Reims Champagne-Ardenne
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: medical student in general practice or in specialty medicine

Brief summary: As health actors, medical students educate patients to have regular medical follow-up and give them justified medical prescriptions. Regarding their own health, medical students do not seem to apply these same principles.

The medical follow-up of medical students seems insufficient, which can be explained by the lack of medical follow-up by occupational medicine, a consequent work time, but also the fear of judgment by colleagues Moreover, medical student have an easy access to all types of prescriptions and therefore the ease of self-prescription and self-medication. Medical students may also overestimate their medical knowledge and may not be objective about their symptomatology.

Detailed description: The aim of the study will be to describe medical follow-up and self-medication among medical students

Eligibility criteria: Inclusion Criteria:

* medical student in general practice or in specialty medicine
* agreeing to participate in the study

Exclusion Criteria:

* none

Primary outcomes:
measure: self-medication
timeFrame: Day 0
Secondary outcomes:
measure: self-prescription
timeFrame: Day 0
Other outcomes:
Locations:
city: Reims
country: France
facility: Ufr Medecine Urca
Study officials:
References: