louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01959191: Clinical Significance of Platelet Reactivity on Clopidogrel During Off-pump Coronary Artery Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Platelet activity, CABG, off-pump surgery
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-10-09
Enrollment: 859
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients with indications for surgical myocardial revascularization

Brief summary: Objective: To evaluate the early and late prognoses of patients according to platelet reactivity after clopidogrel administration and determine whether the measurement of platelet inhibition predicted 1-year clinical outcomes after off-pump coronary bypass (OPCAB) Study design

* Prospective, observational, single-center study
* Subjects with OPCAB surgery who meet all inclusion and exclusion criteria will be enrolled.
* Platelet reactivity after 7-days clopidogrel treatment from the day of surgery will be measured by VerifyNow system.
* Dual antiplatelet therapy including aspirin and clopidogrel will be administered for 1 year after surgery and subjects will be followed-up for 1 year about primary endpoint.
* Cutoff value of P2Y12 reactivity units (PRUs) for primary endpoint will be assessed and the cohort will be divided by the PRU cutoff value (low/high platelet reactivity groups).
* The primary and secondary endpoints will be compared between two groups


Eligibility criteria: Inclusion Criteria:

* Patients with indications for surgical myocardial revascularization
* Patients who undergo off-pump coronary artery bypass
* Age between 19\~80 years
* Patients with signed informed consent

Exclusion Criteria:

* Patients with combined surgery with coronary bypass grafting
* On-pump conversion
* Patients with moderate renal dysfunction (creatinine\>2.0mg/dl) or need for dialysis
* Patients with chronic treatment with proton pump inhibitors
* Patients with preoperative bleeding
* Thrombocytopenia (Platelet count 70,000/ml)
* Re-do surgery
* Early death before the measurement of platelet reactivity

Primary outcomes:
measure: Major adverse cardiovascular events (MACEs)
timeFrame: 1 year after off-pump coronary bypass surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiovascular Surgery, Severance Cardiovascular Hospital , Yonsei University College of Medicine
Study officials:
References:
citation: Patti G, Nusca A, Mangiacapra F, Gatto L, D'Ambrosio A, Di Sciascio G. Point-of-care measurement of clopidogrel responsiveness predicts clinical outcome in patients undergoing percutaneous coronary intervention results of the ARMYDA-PRO (Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty-Platelet Reactivity Predicts Outcome) study. J Am Coll Cardiol. 2008 Sep 30;52(14):1128-33. doi: 10.1016/j.jacc.2008.06.038.
Clinical trial NCT01933191: Exercise Treatment of Dental Anxiety
Official title: A Randomised Placebo Controlled Cross-over Trial on Exercise Treatment of Dental Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Anxiety
Keywords: Dental Anxiety, Physical Activity, Dental Phobia
Cortisol, Amylase
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2013-09-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A single bout of physical activity (treadmill)immediately prior to the dental examination reduces anxiety in patients with dental phobia.

Detailed description: The primary objective of the trial is to assess the anxiolytic efficacy of 30 minutes aerobic treadmill exercise versus placebo exercise in subjects experiencing high anxiety prior to a minor dental dental procedure.

Primary efficacy endpoint:

Change in the visual analogue scale (VAS) for anxiety before and after the intervention prior to the elective minor dental procedure

Eligibility criteria: Inclusion Criteria:

* Male or female outpatients 18 years of age or older
* A total score of 12 points or more on the Dental Anxiety Scale at screening and baseline evaluations
* Scheduled appointment for an elective minor dental procedure
* Informed consent

Exclusion Criteria:

* Pregnant or lactating women
* Current diagnosis of any other DSM-IV, with the exception of other phobic disorders, social anxiety disorder or dysthymia
* Serious medical disorders which put subjects at risk if they have to exercise 30 minutes at 70% VO2max

Primary outcomes:
measure: Change from Baseline in VAS - visual analog scale
timeFrame: Baseline and one hour after dental intervention
Secondary outcomes:
measure: Change from Baseline in cortisol level
timeFrame: Baseline and one hour
measure: Change from Baseline in alpha-Amylase
timeFrame: Baseline and one hour after dental intervention
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Psychiatry and Psychotherapy Campus Charité Mitte
Study officials:
affiliation: Department of Psychiatry and Psychotherapie, CCM, Charité-Universitätsmedizin Berlin
name: Andreas Ströhle, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02000791: Does Laryngoscopic Tecnique Facilitate cLMA Insertion?
Official title: Does Laryngoscopic Tecnique Facilitate cLMA Insertion?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Urologic Surgery
Keywords: cLMA
laryngoscopy
fiberoptic
Lead sponsor: Diskapi Yildirim Beyazit Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2013-12-04
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: it is compared that laryngeal mask insertion with standard technique and laryngoscopic technique

Detailed description: Is there any releation between insertion succes rate and difficult intubation criteria. success of the first attempt laryngeal mask insertion, patient response of laryngeal mask placement. And also during the implementation of these two techniques; the effects on heart rate and blood pressure and postoperative complications were investigated.

Eligibility criteria: Inclusion Criteria:

* Over 18 age
* under urologic surgery patient

Exclusion Criteria:

* Uper respiratory infection
* Full stomach
* BMI over 40

Primary outcomes:
measure: İnvestigate to easy of insertion whether standart or laryngoscopic technique
timeFrame: 1 min after insertion
Secondary outcomes:
measure: Fiberoptic view
timeFrame: 1 min after insertion
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Diskapi Yildiim Beyazit Eduation and Research Hospital
Study officials:
name: Tugba Arslan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01940991: Efficacy and Safety of Botulinum Toxin Type A for Moderate to Severe Crow's Feet Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Skin Aging
Lead sponsor: Revance Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2013-09-12
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will confirm the efficacy and safety of a single topical administration of botulinum toxin type A compared to placebo control for the treatment of moderate to severe crow's feet lines


Eligibility criteria: Inclusion Criteria:

* Moderate to severe crow's feet lines
* Female or male, 18 to 65 years of age and in good general health
* Women of childbearing potential (WOCBP) must agree to use an effective method of birth control during the course of the study

Exclusion Criteria:

* Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A
* Muscle weakness or paralysis, particularly in the area receiving study treatment
* Active skin disease or irritation at the treatment area
* Deep dermal scarring, or inability to smooth out the crow's feet lines to be treated by manually spreading the skin apart
* Treatment with Botulinum Toxin Type A for crow's feet lines in the last 6 months or 3 months anywhere in the body

Primary outcomes:
measure: Composite endpoint
timeFrame: Week 4
Secondary outcomes:
measure: Investigator Global Assessment with 2 points or greater improvement from baseline
timeFrame: Week 4
measure: Investigator Global Assessment with 1 point or greater improvement from baseline
timeFrame: Week 4
measure: Patient Severity Assessment with 2 points or greater improvement from baseline
timeFrame: Week 4
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: Dermatology Research Institute
state: Florida
Study officials:
References:
Clinical trial NCT02271191: Effect of Nicardipine on Renal Function in Deliberate Hypotension
Official title: Effect of Nicardipine on Renal Function in Deliberate Hypotension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Spinal Stenosis
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-10-22
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study was to demonstrate the effect of nicardipine on renal function with creatinine clearance, serum cystatin C, urine output and fractional excretion of sodium during deliberate hypotension for spine surgery.

Detailed description: To induce deliberate hypotension, pharmacological agents such as inhalation anesthetics, calcium channel blockers, beta-adrenergic blockers have been used alone or in combination. Nicardipine, classed as a calcium channel blocker, has a peripheral vasodilator effect via relaxation of smooth muscle fiber and sympathetic nerve inhibition. Nicardipine expands the renal artery and increases glomerular filtration rate. Previous studies reported the renal protective effect of nicardipine in cardiac surgery with cardiopulmonary bypass and robot-assisted laparoscopic surgery.

The aim of this study was to demonstrate the effect of nicardipine on renal function with creatinine clearance , serum cystatin C, urine output and fractional excretion of sodium during deliberate hypotension for spine surgery.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing anterior or posterior spine interbody fusion

Exclusion Criteria:

* Patients with American Society of Anesthesiologists physical status III or IV
* Liver dysfunction with aspartate transaminase/alanine transaminase greater than 60/60 IU/L
* Cerebrovascular disease
* Anemia of less than hematocrit 24%
* Diabetes mellitus
* Severe malnutrition
* those diuretics or antihypertensive drugs

Primary outcomes:
measure: creatinine clearance
timeFrame: after deliberate hypotension, and POD1
measure: serum cystatin C
timeFrame: before deliberate hypotension, after deliberate hypotension, and POD1
measure: urine output
timeFrame: after deliberate hypotension, and POD1
measure: fractional excretion of sodium
timeFrame: before deliberate hypotension, after deliberate hypotension, and POD1
Secondary outcomes:
measure: Risk, injury, failure, loss, and end stage renal disease (RIFLE) criteria
timeFrame: before deliberate hypotension, after deliberate hypotension, and POD1
Other outcomes:
Locations:
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, Gangnam Severance Hospital, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, 211 Eonju-ro, Gangnam-gu, Seoul 135-720, Republic of Korea
name: Chul Ho Chang, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00452491: MAXOMAT ® in the Treatment of Severe Early Onset Intrauterine Growth Retardation on Pre-pubertal Children
Official title: A Cohort of Pre-pubertal Children for the Study of Optimization of Methods of Administration of the Biosynthetic Growth Hormone MAXOMAT ® in the Treatment of Severe Early Onset Intrauterine Growth Retardation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fetal Growth Retardation
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-03-27
Enrollment: 306
Sex: ALL
Minimum age (years): 3
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. To test for equivalence in terms of catch-up growth between the 2 therapeutic regimens
2. To specify the best period of treatment
3. To assess the efficacy of treatment based on final adult height of these children


Eligibility criteria: Inclusion Criteria:

* Pre-pubertal children of either sex presenting with severe early onset intrauterine growth retardation (I.U.G.R.)
* Height Less Than or Equal to -3 SD

Exclusion Criteria:

* Age less than 3 years

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Efficacy data : measurement of height
timeFrame: at trimestrial visit
Secondary outcomes:
measure: laboratory test assessment and evaluation of bone age
timeFrame: at every other visit
measure: measurement of anti-GH and anti-ECP antibodies
timeFrame: one visit out of four
measure: Tolerance data : undesirable events
timeFrame: throughout the study
Other outcomes:
Locations:
city: Paris
country: France
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Marie SEBILLE, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT00685191: HIV-1 Viral Dynamics in Subjects Initiating Raltegravir Therapy in Spain
Official title: HIV-1 Viral Dynamics in Subjects Initiating Raltegravir Therapy in Spain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Keywords: Raltegravir
HIV
dynamics
viral load
Treatment Experienced
Lead sponsor: Germans Trias i Pujol Hospital
Sponsor class: OTHER
Collaborators: name: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
First posted: 2008-05-28
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study purpose is to investigate plasma HIV-1 RNA dynamics in subjects initiating raltegravir-based salvage therapy and quantify the corresponding changes in levels of cellular HIV-1 DNA.

Detailed description: First- and second-phase decay rates of plasma HIV-1 RNA and changes in the intracellular levels of HIV-1 proviral DNA and LTR circles will be measured in subjects starting salvage antiretroviral therapy including raltegravir in Spain.

Eligibility criteria: Inclusion Criteria:

* Patients who have limited or no treatment options due to extensive antiretroviral drug resistance or drug intolerance.
* Subjects initiating raltegravir plus another fully active antiretroviral drug.

Exclusion Criteria:

* Pregnancy, or fertile women willing to be pregnant.
* Active substance abuse or major psychiatric disease.

Primary outcomes:
measure: Change in viral load from day 0 to 7
timeFrame: 1 week
Secondary outcomes:
measure: Intracellular levels of HIV-1 proviral DNA and LTR circles
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital U. Germans Trias i Pujol
state: Barcelona
Study officials:
affiliation: Hospital U. Germans Trias i Pujol
name: Bonaventura Clotet, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00240591: Patients With Low-Grade Non-Hodgkin's Lymphoma Previously Treated With Tositumomab and/or Iodine I 131 Tositumomab
Official title: A MULTI-CENTER LONG-TERM FOLLOW-UP STUDY OF PATIENTS WITH LOW-GRADE NON-HODGKIN'S LYMPHOMA PREVIOUSLY TREATED WITH TOSITUMOMAB AND/OR IODINE I 131 TOSITUMOMAB IN STUDIES RIT-I-000, RIT-II-001, RIT-II-002, RIT-II-004, or CP-97-012
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma, Non-Hodgkin
Keywords: BEXXAR
Tositumomab
Iodine I 131 Tositumomab
low-grade follicular lymphomas
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-10-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of patients with NHL previously treated at least 2 years ago with Tositumomab and/or Iodine I 131 Tositumomab on Study RIT-I-000, RIT-II-001, RIT-II-002, RIT-II-004, or CP-97-012.

Brief summary: This is a study for the long-term follow-up of patients who completed at least two years of follow-up after treatment with Tositumomab and/or Iodine I 131 Tositumomab (BEXXAR)on Study RIT-I-000, RIT-II-001, RIT-II-002, RIT-II-004 or CP-97-012. All patients will be assessed for survival and disease status, including subsequent therapy for NHL, and for long term safety. Laboratory evaluations consisting of a TSH level (for all patients) and a complete blood cell (CBC) count with a differential and platelet count (for patients in continuing response only) will be obtained annually through Year 10 post treatment with Tositumomab and/or Iodine I 131 Tositumomab.

Patients that remain in response to their previous treatment with BEXXAR, will additionally be followed radiographically for response and progression.


Eligibility criteria: Inclusion Criteria:

* Patients must have enrolled in one of the following Corixa sponsored clinical trials: RIT-I-000, RIT-II-001, RIT-II-002, RIT II-004 or CP-97-012 and are \>2 years post Tositumomab and/or Iodine I 131 Tositumomab administration.
* Patients must give written informed consent by signing an IRB/ethics committee approved consent form prior to entry on this follow-up study.

Exclusion Criteria:

* Inability to meet the above referenced inclusion criteria.

Primary outcomes:
measure: None - Administrative non interventional study to obtain long term safety and efficacy data.
timeFrame: Subjects enrolled in Study BEX104526 were followed for continued response (as applicable) and safety every 6 months for Years 3 through 5 post-treatment with TST/I-131 TST. Beginning at Year 6, subjects were assessed annually through Year 10 inclusive.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06249880: Pediatric Normative Markerless Movement Analysis
Official title: Pediatric Normative Markerless Movement Analysis Data Collection Project
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pediatric ALL
Adolescent
Keywords: Motion Analysis
Kinetics
Kinematics
Lead sponsor: MultiCare Health System Research Institute
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from the regional community, including convenience sample of children. Subjects will be recruited by word of mouth, posted flyers, and advertised through the RML website and MB social media.

Brief summary: The objective of this project is to collect baseline data from a normative population of children that gender and age matches the population of patients expected to be treated by Mary Bridge Children's Research \& Movement Lab. This project seeks to recruit 20 male and 20 female typically developing individuals, between the ages of 3 and 25 years of age. Non-invasive measurements of movement patterns (motion analysis and force plate data) will be collected during bipedal gait.


Eligibility criteria: Inclusion Criteria:

* Age: 3-25 years of age (with 3 and 25 year olds considered for inclusion).
* Ambulate independently and without the use of assistive devices or orthoses.
* Willing and interested in participating.

Exclusion Criteria:

* Neuromuscular disorders such as cerebral palsy, muscular dystrophy, myotonic dystrophy, spinal muscular atrophy, peripheral neuropathy, or other generalized muscle and/or nerve issues.
* Evidence of developmental delays, muscle weakness, decreased muscle tone, joint stiffness, muscle or bone deformity.
* Currently using or has a history of using assistive technology devices, bracing/orthoses, manual or powered mobility equipment.
* History of premature birth.
* Currently or has a history of taking medication or pharmaceutical treatment related to musculoskeletal side-effects/scenario/diagnosis.

Primary outcomes:
measure: Observation-based movement analyses
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Puyallup
country: United States
facility: Mary Bridge Children's Therapy Unit - Research & Movement Lab
state: Washington
Study officials:
References:
Clinical trial NCT02769780: A Web-based Observational Study of Patient-reported Outcomes in Adults With Narcolepsy
Official title: A Web-based Observational Study of Patient-reported Outcomes in Adults With Narcolepsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Narcolepsy
Lead sponsor: Jazz Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Invitae Corporation
name: Wake Up Narcolepsy
name: Narcolepsy Network
name: ICON plc
First posted: 2016-05-12
Enrollment: 1500
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: All adult patients with narcolepsy

Brief summary: Nexus is a collaboration between academic institutions, advocacy and industry to answer important questions about narcolepsy. It is a web-based observational study of patient-reported outcomes in adult patients with narcolepsy, with follow-up every six months.

Nexus website: www.narcolepsyregistry.com


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Diagnosed with narcolepsy by a doctor

Primary outcomes:
measure: Descriptive epidemiology of type 1 and type 2 narcolepsy
timeFrame: Participants complete a survey every 6 months for 3 years after enrollment
Secondary outcomes:
measure: Medication utilization and treatment outcomes for type 1 and type 2 narcolepsy
timeFrame: Participants complete a survey every 6 months for 3 years after enrollment
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Jazz Pharmaceuticals
state: California
Study officials:
affiliation: Jazz Pharmaceuticals
name: Danielle Hyman, PhD
role: STUDY_DIRECTOR
affiliation: Jazz Pharmaceuticals
name: JeanPierre Coaquira, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thorpy MJ, Ohayon MM, Carls G, Black J, Pasta DJ, Hyman DL, Villa KF. Assessing the impact of sodium oxybate treatment on functioning, productivity, and health-related quality of life in patients with narcolepsy: findings from the Nexus Narcolepsy Registry (waves 1-4). Sleep Med. 2021 Aug;84:380-388. doi: 10.1016/j.sleep.2021.06.010. Epub 2021 Jun 19.