louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00994942: Bioequivalency Study of Morphine Sulfate Injection, Solution and Tablet Under Fasted Conditions
Official title: A Single Dose, Three-Period, Three-Treatment, Six-Sequence, Three-Way Crossover Pharmacokinetic and Comparative Bioavailability Study of Morphine Sulfate Injection, Solution, and Tablet Formulations Under Fasting Conditions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2009-10-14
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Determine the pharmacokinetics and optimize study design for subsequent studies with morphine sulfate tablets and solution.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to morphine sulfate or any comparable or similar product.

Primary outcomes:
measure: bioequivalence determined by statistical comparison Cmax
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: CEDRA Clinical Research
state: Texas
Study officials:
affiliation: CEDRA Clinical Research
name: Fredrick A Bieberdorf, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01153542: Study of VX-770 on Desipramine
Official title: An Open-Label Phase 1 Study to Examine the Effect of VX 770 on Desipramine in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: In Development for Cystic Fibrosis
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2010-06-30
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the effects of VX-770 on Desipramine


Eligibility criteria: Inclusion Criteria:

* Subjects must be male or female and between 18 and 55 years of age
* Subject must have a body mass index (BMI) from 18 to 30 kg/m2
* Subject must be judged to be in good health

Exclusion Criteria:

* History of any illness that, in the opinion of the investigator or the subject's general practitioner, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject
* Subjects who have human immunodeficiency virus, hepatitis C, or active hepatitis B
* Female subjects and male subjects with female partner(s) who are pregnant, nursing, or planning to become pregnant during the study or within 90 days of the last dose of study drug

Primary outcomes:
measure: VX-770 and Desipramine pharmacokinetic parameters
timeFrame: 3 weeks
Secondary outcomes:
measure: Safety as measured by adverse events, vital signs, electrocardiograms (ECGs), and clinically significant laboratory assessments
timeFrame: 3 weeks
measure: Metabolites pharmacokinetic parameters in plasma
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Covance CRU, Inc.
state: Florida
Study officials:
affiliation: Covance CRU, Inc.
name: H. Frank Farmer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00663442: Basic and Clinical Research on Attention Deficit Hyperactivity Disorder (ADHD)
Official title: Dose Response Pharmacogenetic Study of ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: ADHD
Keywords: ADHD
side effects
sleep
dopamine
pharmacogenetics
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2008-04-22
Enrollment: 48
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Children between 6-17 are evaluated for ADHD and and a blood sample is obtained for DNA extraction. If eligible, they participate in a 4 week, double blind, placebo controlled trial with weekly switches. In randomized order, children receive 18, 36, 54 mg. OROS methylphenidate and placebo. Each week, parent report measures, clinical interviews, and safety assessments are conducted.

Hypothesis: Efficacy and adverse events will be dose dependent. Dopamine Transporter Genotype will predict response


Eligibility criteria: Inclusion Criteria:

* 6-17 DSM IV criteria for ADHD Parents willing to complete measures

Exclusion Criteria:

* Mental retardation psychoses seizure disorder

Primary outcomes:
measure: ADHD RS
timeFrame: weekly
Secondary outcomes:
measure: CGI-S
timeFrame: weekly
measure: VItal Signs
timeFrame: weekly
measure: Sleep Questionnaire
timeFrame: weekly
measure: Side Effects rating Scale
timeFrame: weekly
Other outcomes:
Locations:
city: Chicago
country: United States
facility: HALP Clinic, University of Illinois at CHicago
state: Illinois
Study officials:
affiliation: Univesity of Illinois at Chicago
name: Mark A Stein, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stein MA, Sarampote CS, Waldman ID, Robb AS, Conlon C, Pearl PL, Black DO, Seymour KE, Newcorn JH. A dose-response study of OROS methylphenidate in children with attention-deficit/hyperactivity disorder. Pediatrics. 2003 Nov;112(5):e404. doi: 10.1542/peds.112.5.e404.
citation: Stein MA, Waldman ID, Sarampote CS, Seymour KE, Robb AS, Conlon C, Kim SJ, Cook EH. Dopamine transporter genotype and methylphenidate dose response in children with ADHD. Neuropsychopharmacology. 2005 Jul;30(7):1374-82. doi: 10.1038/sj.npp.1300718.
Clinical trial NCT01066442: Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease
Official title: A Randomised, Multicenter 12-Week Double-blind Placebo-controlled Study to Assess the Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson's Disease Followed by a 38 Week Open Label Extension Phase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease
Keywords: Excessive Daytime Sleepiness (EDS)
Parkinson's Disease
Lead sponsor: Bioprojet
Sponsor class: OTHER
First posted: 2010-02-10
Enrollment: 273
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy of BF2.649 over placebo (12 week Double-Blind Phase) and assess the long term safety and the efficacy maintenance(9 months Open-Label Extension Phase) of BF2.649 in the improvement of excessive daytime sleepiness in patients diagnosed with Parkinson's Disease.

Detailed description: As measured by the change from baseline in the Epworth Scale Scores (ESS) at Week 12 and at Week 51, in patients diagnosed with EDS in Parkinson's Disease.

Eligibility criteria: Inclusion Criteria:

* Patients with a documented history of Parkinson's disease according to UPDRS,fluctuator and non-fluctuator patients, Hoehn and Yahr score \<5;
* stabilized on optimal antiparkinsonian treatments unmodified for 4 weeks prior to study entry;
* presenting an Excessive Daytime Sleepiness as indicated by an ESS\>or=12

Exclusion Criteria:

* Patients with a known diagnosis of other degenerative parkinsonian syndromes (e.g. Progressive supra-nuclear palsy, multisystemic atrophy, corticobasal degenerescence, diffuse Lewy's Body dementia)
* Patients who have shift work, chronic or occasional sleep deprivation, circadian rhythm disorders
* Patients with a severe depression indicated by (BDI\>= 16)or at suicidal risk (BDI item G\>0) or depression treated for less than 8 weeks
* Patients with a cognitive impairment

Primary outcomes:
measure: ESS change (Epworth Sleepiness Scale) versus baseline
timeFrame: at week 12 / 51 versus baseline
Secondary outcomes:
measure: Safety
timeFrame: 12-week and 52-week
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: Klinik für Neurologie Universitätsklinikum
Study officials:
affiliation: Bioprojet
name: Kati Gutierrez, PharmD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00824642: Effect of Acu-Transcutaneous Electrical Nerve Stimulation (TENS) on Post-Exercise Expiratory Flow Rate in Subjects With Asthma
Official title: Effect of Acu-TENS on Post-Exercise Expiratory Flow Rate in Subjects With Asthma- A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
Exercise training
TENS
Acupuncture
FEV1
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2009-01-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this study is to investigate the effectiveness of Acu-TENS (Transcutaneous electrical nerve stimulation applied on acupoints) on the post- exercise expiratory flow rate and exercise performance on the subjects with exercise.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis with asthma attending regular follow up at respiratory clinic

Exclusion Criteria:

* Allergic to gel
* Suffered from other neurological or cardiovascular or musculoskeletal disorders that may affect their exercise performance
* Suffered from upper respiratory tract infection prior to the study

Primary outcomes:
measure: Forced expiratory volume in one second (FEV1) and Forced vital capacity (FVC)
timeFrame: measured before exercise, immediately after exercise and at 20, 40 and 60 minutes post exercise
Secondary outcomes:
measure: RPE, Exercise duration
timeFrame: immediately post exercise
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Cardiopulmonary and exercise physiology laboratory, The Hong Kong Polytechnic University
Study officials:
affiliation: Department of Rehabilitation Sciences, Hong Kong Polytechnic University
name: Alice Jones, PhD, FACP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00559442: Susceptibility to High Altitude Pulmonary Edema in Subjects With Increased Hypoxic Pulmonary Vasoconstriction
Official title: Susceptibility to High Altitude Pulmonary Edema in Subjects With Increased Pulmonary Artery Pressure During Exercise in Normoxia and at Rest in Hypoxia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Altitude Pulmonary Edema
Keywords: high altitude pulmonary edema
hypoxic pulmonary vasoconstriction
right ventricular function
hypoxia
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2007-11-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: It has been shown, that subjects susceptible to high altitude pulmonary edema (HAPE)are characterized by an abnormal increase of pulmonary artery pressure at rest in hypoxia and during exercise in normoxia. This abnormal rise of pulmonary artery pressure has also been observed in about 10 % of otherwise healthy subjects without prior altitude exposure. The aim of the study is to investigate the susceptibility to HAPE in unacclimatized subjects with abnormal increase of pulmonary artery pressure at rest in hypoxia and during exercise in normoxia after rapid ascent to high altitude (4559 m).


Eligibility criteria: Inclusion Criteria:

* abnormal increase of pulmonary artery pressure at rest in hypoxia and during exercise in normoxia
* ability to climb Margherita Hut

Exclusion Criteria:

* Birth at or above 1500 m altitude
* any cardiovascular or pulmonary disease
* Infection disease
* Intake of drugs, in particular Acetazolamide, Nifedipine, corticosteroids or PDE-5-inhibitors.
* Pregnancy

Primary outcomes:
measure: Frequency of HAPE after rapid ascent to 4559 m
timeFrame: during the 48 h stay at altitude
Secondary outcomes:
measure: Time course of pulmonary artery pressure
timeFrame: during the 48 h stay at altitude
measure: Assessment of right ventricular function by echocardiography
timeFrame: during the 48 h stay at altitude
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Sports Medicine, University Hospital
Study officials:
affiliation: University Hospital Heidelberg
name: Christoph Dehnert, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Heidelberg
name: Ekkehard Grünig, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dehnert C, Mereles D, Greiner S, Albers D, Scheurlen F, Zugel S, Bohm T, Vock P, Maggiorini M, Grunig E, Bartsch P. Exaggerated hypoxic pulmonary vasoconstriction without susceptibility to high altitude pulmonary edema. High Alt Med Biol. 2015 Mar;16(1):11-7. doi: 10.1089/ham.2014.1117.
Clinical trial NCT01247142: Evaluation of Exhaled Breath Condensate in the Diagnosis of Invasive Pulmonary Aspergillosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Invasive Pulmonary Aspergillosis
Keywords: invasive pulmonary aspergillosis
exhaled breath condensate
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2010-11-24
Enrollment: 24
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospitalized adult patients of the department of Hematology or Intensive Care Unit, University Hospital, Leuven, Belgium

Brief summary: The purpose of this study is to evaluate the diagnostic potential of biomarkers for invasive pulmonary aspergillosis in exhaled breath condensate.

Detailed description: Invasive pulmonary aspergillosis (IPA) is a life-threatening infection in immunocompromised patients. The poor prognosis of the disease is partly attributed to difficulties encountered with the diagnosis of this infection. Invasive sampling procedures are often precluded in these patients. In addition, conventional diagnostic techniques lack sensitivity. Recently there has been increasing interest in the investigation of the lungs by noninvasive means including measurement of biomarkers in exhaled breath (e.g. NO) and those found in the cooled and condensed exhalate,termed EBC. It has been demonstrated that a measurable fraction of the EBC in healthy subjects is derived from aerosolized airway lining fluid. The presence of biomarkers for IPA will be investigated in EBC of patients with IPA, compared to controls.

Eligibility criteria: Inclusion Criteria:

* hospitalisation in the hematology or intensive care department
* age \> 16 years
* informed consent
* proven or probable IPA (EORTC/ MSG criteria)
* galactomannan positivity in BAL or serum

Exclusion Criteria:

* age \< 16 years

Primary outcomes:
measure: The identification of biomarkers for invasive pulmonary aspergillosis (IPA) in exhaled breath condensate (EBC)
timeFrame: 15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
References:
Clinical trial NCT00877370: Pharmacokinetics of Ertapenem in Continuous Venovenous Hemodialysis
Official title: Pharmacokinetics of Invanz® (Ertapenem) in Critically Ill Patients Receiving Continuous Venovenous Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Kidney Failure
Keywords: ertapenem
continuous hemodialysis
pharmacokinetics
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2009-04-07
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Critically ill patients in the intensive care unit often receive continuous hemodialysis to treat their kidney failure. Ertapenem is an antibiotic often used in these patients. Continuous dialysis may remove ertapenem, putting patients at risk for inappropriate treatment of their infection. This study will determine how much ertapenem is removed by continuous hemodialysis.

Detailed description: Subjects receiving CVVHD will receive a one gram dose of ertapenem. Serial blood samples over 24 hours will be taken to assess the ertapenem blood concentrations over time. Spent dialysate and urine samples (if any) will also be measured for ertapenem content to determine how much drug is removed by CVVHD and kidneys. A pharmacokinetic evaluation will be made to determine what is the most appropriate dose for this drug in patients receiving CVVHD to achieve pharmacokinetic and pharmacodynamic goals.

Eligibility criteria: Inclusion Criteria:

* Hospitalized in ICU
* Receiving Continuous hemodialysis
* Prescribed ertapenem
* Informed consent granted

Exclusion Criteria:

* \< 18 years of age
* Allergy to ertapenem or other carbapenem antibiotic
* Severe, life-threatening reaction to penicillin or cephalosporins
* Patients experiencing or with history of CNS disorders (eg: seizure, stroke)
* Patients experiencing CNS infection
* Inability to complete 24 hours of CVVHD
* Concurrent use of other extracorporeal therapies such as extracorporeal membrane oxygenation, plasmapheresis or intermittent hemodialysis
* Inability to obtain informed consent
* Pregnant and/or breastfeeding women

Primary outcomes:
measure: Ertapenem Transmembrane Clearance by Continuous Hemodialysis.
timeFrame: 24 hours after receiving first 1 gram dose
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan University Hospital
state: Michigan
Study officials:
affiliation: University of Michigan
name: Bruce A Mueller, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eyler RF, Vilay AM, Nader AM, Heung M, Pleva M, Sowinski KM, DePestel DD, Sorgel F, Kinzig M, Mueller BA. Pharmacokinetics of ertapenem in critically ill patients receiving continuous venovenous hemodialysis or hemodiafiltration. Antimicrob Agents Chemother. 2014;58(3):1320-6. doi: 10.1128/AAC.02090-12. Epub 2013 Dec 9.
Clinical trial NCT01505270: The Prevalence of Psychological and Medical Comorbidities Among Children Suffering From Autistic Spectrum Disorder and the Differences Between Ethnic Groups in Israel
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Autism
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-01-06
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: It is known that several psychological and medical comorbidities are frequently found among children suffering from autistic spectrum disorders. Our aim is to investigate which comorbidities are most common among those children and whether there are differences among the different ethnic groups found in Israel.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with autism

Exclusion Criteria:

Primary outcomes:
measure: Percentage of autistic children with comorbidities
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT00825370: Protocolized vs Discretionary Use of Opioids in Acute Pain
Official title: Protocolized vs Discretionary Use of Opioids in Acute Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: Hydromorphone
acute pain
Protocolized
Efficacy
Safety
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2009-01-21
Enrollment: 350
Sex: ALL
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We are testing whether patients who received protocolized pain management (1 mg of IV hydromorphone followed by an additional 1 mg Intravenous (IV) hydromorphone 15 minutes later if the patients wants more) will have better pain relief and no more adverse events than patients receiving discretionary care, in which the patients receives whatever IV opioid the treating physician wants to give, in whatever dose.


Eligibility criteria: Inclusion Criteria:

1. Age 21 to 64 years.
2. Pain with onset within 7 days.
3. Emergency Department attending physician's judgment that patient's pain warrants use of intravenous opioids.
4. Normal mental status.

Exclusion Criteria:

1. Prior use of methadone.
2. Use of other opioids, tramadol, or heroin in the past seven days.
3. Prior adverse reaction to morphine, hydromorphone, or other opioids.
4. Chronic pain syndrome.
5. Alcohol intoxication.
6. Systolic Blood Pressure \< 90 mm Hg.
7. Use of monoamine oxidase (MAO) inhibitors in past 30 days.
8. Weight less than 100 pounds.
9. Baseline room air oxygen saturation less than 95%.
10. C02 measurement greater than 46: In accordance with a number of similar studies that we have performed, four subsets of patients will have their CO2 measured using a handheld capnometer prior to enrollment in the study. If the CO2 measurement is greater than 46, then the patient will be excluded from the study. The 4 subsets are as follows:

    1. All patients who have a history of chronic obstructive pulmonary disease (COPD)
    2. All patients who have a history of sleep apnea
    3. All patients who report a history of asthma together with greater than a 20 pack-year smoking history
    4. All patients reporting less than a 20 pack-year smoking history who are having an asthma exacerbation

Primary outcomes:
measure: Percentage of Patients With Successful Treatment
timeFrame: 60 minutes
Secondary outcomes:
measure: Percentage of Patients Who Did Not Want Additional Pain Medication at 15 Minutes
timeFrame: 15 min
measure: Percentage of Patients Who Did Not Want Additional Pain Medication at 60 Minutes
timeFrame: 60 minutes
measure: Changes in Pain Intensity From Baseline to Other Pain Assessment Times (15 and 60 Minutes).
timeFrame: Up to 60 minutes
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center Emergency Department
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Andrew K Chang, MD
role: PRINCIPAL_INVESTIGATOR
References: