louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03261908: A Pharmacogenomics Study of Simvastatin-Induced Adverse Drug Reaction
Official title: A Pharmacogenomics Study of Simvastatin-Induced Adverse Drug Reaction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Simvastatin Adverse Reaction
Pharmacogenomics
Accurate Medication
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2017-08-25
Enrollment: 2200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese Patients:In accordance with anti-hyperlipemia indications of simvastatin

Brief summary: Adverse reactions of simvastatin are mostly slight and transient, however, the incidence of simvastatin-induced hepatic impairment and myopathy are obviously higher in Chinese population than other racial groups. There is still lack of research data in Chinese. In this study, we will investigate whether there are specific genotypes which may predict the incidence of simvastatin-induced hepatic impairment and myopathy in Chinese so as to provide a basis for developing guidelines on precise medication in simvastatin therapy apply to Chinese population.


Eligibility criteria: Inclusion Criteria:

* Patients taking simvastatin therapy
* Signed informed consent.

Exclusion Criteria:

* Patients not taking simvastatin therapy
* Intolerance or unwillingness to blood sample collection.

Primary outcomes:
measure: Incidence of hepatic impairment
timeFrame: At 2 years
measure: Incidence of myopathy
timeFrame: At 2 years
Secondary outcomes:
measure: Genotype detected by next generation sequencing
timeFrame: pre-dose of simvastatin(Baseline)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT01244308: Effectiveness and Reliability of VectSelect™ Feature for Avoidance of Phrenic Nerve Stimulation in Cardiac Resynchronisation Therapy (CRT) Patients
Official title: Effectiveness and Reliability of VectSelect™ Feature for Avoidance of Phrenic Nerve Stimulation in CRT Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Phrenic nerve stimulation
LV pacing configuration
CRT
Cardiac resynchronisation therapy
Heart failure
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2010-11-19
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with indication for implantation of CRT-D device

Brief summary: It's the aim of this study to analyse efficacy and reliability of VectSelect Feature for avoidance of phrenic nerve stimulation in cardiac resynchronisation therapy (CRT) patients.


Eligibility criteria: Inclusion Criteria:

* indication for CRT-D implantation / upgrade
* written informed consent

Exclusion Criteria:

* pregnancy
* age \< 18 years
* patients, who cannot visit the routine follow ups (within first 3.5months)
* participants to other studies with active treatment arm

Primary outcomes:
measure: Amount of patients with at least one acceptable LV pacing configuration.
timeFrame: First Follow Up after hospital discharge (approx. 1-3 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Medizinische Einrichtungen der RWTH Aachen
city: Bad Langensalza
country: Germany
facility: Hufeland Klinikum GmbH
city: Frankfurt am Main
country: Germany
facility: Cardioangiologisches Centrum Bethanien
city: Gießen
country: Germany
facility: Universitätsklinikum Gießen und Marburg GmbH Sitz Gießen
city: Hamburg
country: Germany
facility: Universitäres Herzzentrum Hamburg GmbH (UHZ)
city: Herne
country: Germany
facility: Katholisches Krankenhaus Marienhospital Universitätsklinik
city: Kassel
country: Germany
facility: Klinikum Kassel gGmbH
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig AÖR
city: Osnabrück
country: Germany
facility: Niels-Stensen-Kliniken Marienhospital
city: Quedlinburg
country: Germany
facility: Klinikum Dorothea Christiane Erxleben GmbH
Study officials:
affiliation: Universitätsklinikum Leipzig AÖR
name: Norbert Klein, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Klein N, Klein M, Weglage H, Przibille O, Fischer S, Trappe HJ, Birkenhauer F, Pfeiffer D; Efface Phrenic Stim Study Group. Clinical efficacy of left ventricular pacing vector programmability in cardiac resynchronization therapy defibrillator patients for management of phrenic nerve stimulation and/or elevated left ventricular pacing thresholds: insights from the Efface Phrenic Stim study. Europace. 2012 Jun;14(6):826-32. doi: 10.1093/europace/eur412. Epub 2012 Jan 25.
Clinical trial NCT05643508: A Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of DWC202206 and DWC202207 in Patients With Concomitant Hypertension and Hyperlipidemia
Official title: A Randomized, Double-blind, Multicenter Phase 3 Trial to Evaluate the Efficacy and Safety of Co-administration of DWC202206 and DWC202207 in Patients With Hypertension and Dyslipidemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hypertension
Hyperlipidemias
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2022-12-08
Enrollment: 192
Sex: ALL
Minimum age (years): 19
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 aims to evaluate the efficacy and safety of co-administration of DWC202206 and DWC202207 in patients with concomitant hypertension and hyperlipidemia.

Detailed description: The study design is a randomized, double-blind, multicenter clinical trial. The patients were randomly assigned to each group. Primary endpoint was the change of MSSBP based on baseline between Treatment arm and control 1 arm and the change of LDL-C based on baseline between arm and control 2 arm.

Eligibility criteria: Inclusion Criteria:

* Age 19 to 80 years
* Patients with hypertension and hyperlipidemias

Exclusion Criteria:

* Orthostatic hypotension
* History of ventricular tachycardia, atrial fibrillation
* Uncontrolled diabetes mellitus

Primary outcomes:
measure: The change of MSSBP (Mean Sitting Systolic Blood Pressure) based on baseline between treatment arm and control 1 arm
timeFrame: 8 weeks
measure: The change of LDL-C based on baseline between treatment arm and control 2 arm
timeFrame: 8 weeks
Secondary outcomes:
measure: The change of MSSBP (Mean Sitting Systolic Blood Pressure) based on baseline between treatment arm and control 1 arm
timeFrame: 4 weeks
measure: The change of LDL-C based on baseline between treatment arm and control 2 arm
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02777008: Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CTP-543 in Healthy Subjects
Official title: A Two-Part Single Center, Randomized, Sequential, Single and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CTP-543 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Concert Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2016-05-19
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Single- and multiple-ascending dose study of CTP-543 in healthy volunteers.

Detailed description: This two-part study will assess, in healthy volunteers, under fasted conditions, and in a sequential manner, the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single- and multiple-ascending doses of CTP-543.

Eligibility criteria: Inclusion Criteria:

* Healthy adult males and females between 18 and 50 years of age, inclusive
* Body weight ≥ 50 kg and BMI within the range of 18 to 30 kg/m2, inclusive

Exclusion Criteria:

* History of clinically significant central nervous system (eg, seizures), cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal (GI) conditions
* PR interval \> 220 msec or QRS duration \> 120 msec or QTcF interval \> 450 msec obtained at screening visit or prior to the first dose of study drug
* History of herpes zoster
* Hemoglobin, white blood cell, or platelet levels below the lower reference limit at screening or prior to the first dose of study drug
* Liver function tests greater than the upper limit of normal
* Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, or hepatitis C virus antibody
* Urinalysis positive for protein or glucose
* A positive screen for alcohol, drugs of abuse, or tobacco use
* Donation of blood, plasma or other blood products prior to screening
* A positive tuberculosis test

Primary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 24 hours
measure: Measurement of CTP-543 exposure in plasma under fasted conditions
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
measure: The relationship between CTP-543 drug concentration and effect
timeFrame: 7 days
Locations:
city: Adelaide
country: Australia
state: South Australia
Study officials:
affiliation: Concert Pharmaceuticals, Inc.
name: Colleen Hamilton
role: STUDY_DIRECTOR
References:
Clinical trial NCT04409808: IRIS Alfa Clinical Trial A Monocentric, Academic Clinical Trial Safety Study of a Prototype of a New Vitrectomy Device.
Official title: IRIS Alfa Clinical Trial. A Safety Study of a Prototype of a New Vitrectomy Device.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Vitrectomy
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To perform a safety study on the prototype IRIS vitrectomy device.

Detailed description: to determine the safety and effectiveness of the device.

Eligibility criteria: Inclusion Criteria:

* Patients that are scheduled for vitrectomy surgery, regardless of the indication
* Both vitrectomy-only and combined phaco-vitrectomy surgeries
* Primary or repeat vitrectomy
* General or local anesthesia, or combination
* All ages
* Informed consent (from parents in patients \<18 years old)

Exclusion Criteria:

* Unable to obtain informed consent from patient (or from parents in children)
* No post-operative 8 week visit is anticipated

Primary outcomes:
measure: incidence of intra-operative adverse events that determine the safety of the surgery
timeFrame: Intraoperative (surgery day)
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams Brabant
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Peter Stalmans, PHd MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02955108: The Effect of Distractive Auditory Stimuli (Music) on Dyspnea and Anxiety During Exercise in Adults With Chronic Respiratory Diseases
Official title: The Effect of Distractive Auditory Stimuli (Music) on Dyspnea and Anxiety During Exercise in Adults With Chronic Respiratory Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-11-04
Enrollment: 8
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this study is to look at the effects of distractive auditory stimuli (DAS) on reducing dyspnea intensity and related anxiety and increasing exercise tolerance. Investigators hope that compared to a no-music control condition, that under a music condition participants with COPD will (a) demonstrate increased self-paced walk distance and enjoyment; (b) have less dyspnea intensity, (c) experience less dyspnea anxiety; (d) have less fatigue and state anxiety; and (e) higher maximum heart rate. The upbeat music with a tempo of 90 - 100 bpm (an average-to-moderate walking tempo) is expected to have distractive and performance enhancing effects in order to increase tolerance to dyspnea and exercise. The long-term goal of this study is to increase physical activity in adults with COPD and RLD by promoting dyspnea and fatigue management through use of distractive auditory stimuli in the form of music.

Detailed description: This randomized clinical trial will use a cross-over design. The research will include two within-subject factors, music versus no music and time. Each subject will be randomized a single time to receive either music first then no music, or alternatively, no music first then music during two walk tests.

Eligibility criteria: Inclusion Criteria:

* English speaking
* aged 40 years or older, with physician-diagnosed COPD
* a flow volume loop with a FEV1/FVC of \< 0.70 in the past 12 months

  * medically cleared to participate in NYULMC's pulmonary rehabilitation program.

Exclusion Criteria:

* Inability to exercise due to musculoskeletalor neurological dysfunction
* Inability to walk independently (unaided)
* deafness or severe hearing impairment requiring hearing aids
* mMRC score = 0 ("I only get breathlessness with strenuous exercise").

Primary outcomes:
measure: Dyspnea Intensity (DI)
timeFrame: 60 Minutes
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Anna Maria Norweg
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03121508: Taking on Diabetes to Advance You (TODAY)
Official title: Taking on Diabetes to Advance You
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Colorado State University
Sponsor class: OTHER
First posted: 2017-04-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The investigators will utilize an evidence-based self-management program, and all individuals will be assigned to the prevention group to promote healthy lifestyles.
Primary purpose: PREVENTION

Brief summary: The program will consist of diabetes self-management sessions, led by an occupational therapist. The sessions will be held in an individualized format. Sessions will focus on diabetes education, self-management education, and education on behaviors and adaptive techniques to optimize participation in daily life with type II diabetes. As occupational therapists, the investigators and facilitator, aim to focus on establishing healthy habits, roles, and routines for individuals with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* type 2 diabetes
* 18 or older
* patient at the Family Medicine Center in Fort Collins

Exclusion Criteria:

* reading level below 6th grade
* inability to understand written or verbal instructions regarding questionnaires

Primary outcomes:
measure: The Diabetes Self-Management Questionnaire
timeFrame: through the end of the intervention period, up to one year
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Family Medicine Center
state: Colorado
Study officials:
affiliation: Colorado State University
name: Matt Malcolm, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01626508: Prospective Evaluation in Older Premature, Untreated Breast Milk and Milk Processed by the Breast-milk Bank
Official title: Directed Donation of Untreated Milk or Milk Processed by the Breast-milk : Prospective Evaluation in Older Premature
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant, Premature, Diseases
Fatty Acid Deficiency
Keywords: breast milk
breast-milk bank
plasma profile
essential fatty acids
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire Saint Pierre
First posted: 2012-06-22
Enrollment: 9
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: for both groups, the gestational age at birth must be less than 33 weeks gestation and at the time of inclusion the child must be hospitalized in neonatal resuscitation

Brief summary: The purpose of this study is to evaluate the impact of the enteral nutrition type (untreated breast milk, or breast milk processed by the breast-milk bank) on the longitudinal evolution of the total content and plasma profile of essential fatty acids (EFA) in a population of premature infants.


Eligibility criteria: Inclusion Criteria:

* Parent's written informed consent
* Gestational age less than 33 weeks of amenorrhea
* Hospitalisation in an NICU at the time of inclusion
* Intended enteral nutrition with breast milk

Exclusion Criteria:

* Persons not covered by the French social security system
* Major congenital malformation
* Participation in other biomedical study protocols
* Babies that are likely to be transferred to another hospital during the study period

Primary outcomes:
measure: Measurement of the effects of the milk-treatment process at the milk bank on the composition of the milk in terms of FA
timeFrame: 3 weeks after the establishment of enteral nutrition
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Centre Hospitalier Universitaire
state: Bourgogne
city: Saint Pierre
country: France
facility: Centre Hospitalier Regional
state: LA Reunion
Study officials:
References:
Clinical trial NCT03468608: Development and Validation of a Pediatric Procedural Sedation Satisfaction Survey
Official title: Development and Validation of a Pediatric Procedural Sedation Satisfaction Survey
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Satisfaction
Keywords: procedural sedation
paediatric
parental satisfaction
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2018-03-16
Enrollment: 650
Sex: ALL
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parent population will be based on those receiving services within our central unit.

Brief summary: The quality of care associated with medical procedures, such as procedural sedation, has historically been assessed from the perspective of the healthcare professional, wherein the appropriateness of the services provided and the skill with which this care was performed were considered. However, more recently, the perspectives of consumers of healthcare services (i.e. the patients) have also been sought in the form of patient satisfaction. A review of the literature shows that patient satisfaction is routinely assessed when determining the effectiveness of sedation; however, it is less frequently assessed as the primary outcome. In child-specific, validated studies, limitations are noted with respect to being validated in a language other than English and failing to encompass a variety of procedures. As a result, these validated tools are not appropriate for use with pediatric populations undergoing procedural sedation in North America, nor are these validated tools amenable to comparison with our proposed tool.

Detailed description: Due to the central unit procedural sedation team servicing several areas of specialty, a varied patient satisfaction tool is required to ensure all concerns pertaining to sedation in each specialty are addressed, as well as allowing consistency between specialties to be examined. Therefore, the objective is to develop and validate a procedural sedation satisfaction tool for use with a variety of specialties requiring pediatric procedural sedation.

Eligibility criteria: Inclusion Criteria for Parents:

* child is receiving procedural sedation within the central unit at our facility
* child is aged 0-8 years

Exclusion Criteria for Parents:

* parent self-identifies as not being able to speak or read English

Inclusion Criteria for Healthcare Team Members:

* work within the central unit providing procedural sedation at our facility

Exclusion Criteria for Healthcare Team Members:

* none

Primary outcomes:
measure: Parental Satisfaction with Procedural Sedation
timeFrame: immediately proceeding procedural sedation experience
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: Anesthesiologist-in-Cheif
name: Mark Crawford
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02153008: Strep A FIA Field Study, Sofia
Official title: Sofia Strep A FIA Field Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Group A Streptococcus
Keywords: Strep throat
Lead sponsor: Quidel Corporation
Sponsor class: INDUSTRY
First posted: 2014-06-02
Enrollment: 1708
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from the general population as they present to the clinical facility. Subjects must be exhibiting symptoms characteristic of pharyngitis, possibly GAS.

Brief summary: To demonstrate the clinical performance of the Strep A FIA and Sofia, using throat swabs collected from symptomatic subjects.


Eligibility criteria: Inclusion Criteria:

1. Male and Female, 3 years of age or older
2. Must currently be exhibiting one or more of the symptoms characteristic of pharyngitis to be eligible for inclusion in this study.

For example:

1. Acute onset of sore throat
2. Redness of the posterior pharyngeal wall
3. Difficulty/pain on swallowing
4. Fever, \> 37.8º C (100ºF) at presentation or within past 24 hours
5. Pharyngeal exudate
6. Tender cervical lymphadenopathy
7. Absence of cough, runny nose or other upper respiratory symptoms.\*
8. Other, symptoms specific to Strep A not listed above.

   * Must include at least one additional symptom from a-f and cannot be the only criteria used to meet inclusion for enrollment in the study.

Exclusion Criteria:

1. Subjects currently under treatment with antibiotics are not to be included in this study.
2. At clinical sites requiring informed consent, unable to understand and consent to participation; for minors this includes parent or legal guardian.

Primary outcomes:
measure: Detection of Group A Streptococcus
timeFrame: Within 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Best Medical Group, LLC
state: Arizona
city: Boynton Beach
country: United States
facility: Gentle Medical Associates
state: Florida
city: Delray Beach
country: United States
facility: Pediatrics by the Sea
state: Florida
city: Tampa
country: United States
facility: Teena Hughes, MD
state: Florida
city: Rochester
country: United States
facility: Twelve Corners Pediatrics
state: New York
city: Belton
country: United States
facility: Veritas, PA
state: Texas
city: Vienna
country: United States
facility: Advanced Pediatrics
state: Virginia
Study officials:
affiliation: Quidel Corporation
name: John D. Tamerius, PhD
role: STUDY_DIRECTOR
References: