ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01795638
Conditions: Extreme Immaturity
Keywords: anthropometrics weight nutrition
Sponsor: Children's Hospital Medical Center, Cincinnati
Start date: 2009-10-01; Completion date: 2011-01-01
Enrollment: 53 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Adequate growth during the neonatal period is critical for optimal long term outcomes. Despite maximal calorie intake, sixty percent of very low birth weight infants still fail to thrive suggesting that factors other than total calorie intake are important in ensuring consistent weight gain. Several reports have indicated a positive sodium balance is critical in ensuring good weight gain in very low birth weight infants, however these infants are susceptible to low serum sodium concentrations. Urine sodium values are sometimes used to diagnosis of hyponatremia or negative sodium balance after the first two weeks of life, but there is no evidence for this practice in preterm neonates. Our central hypothesis is that early supplementation with sodium will ensure positive sodium balance in very low birth weight infants and will result in optimal weight gain and enhanced long term outcomes. Secondarily we hypothesize that low sodium concentrations in the urine will not correlate with low serum sodium values.

Detailed description:
This is a randomized, blinded, placebo-controlled trial in infants born at less than 32 weeks gestation, who are admitted to the Newborn Intensive Care Unit at University of Cincinnati Medical Center, Cincinnati, Ohio. Infants are randomized to receive either 4 meq/kg/day supplemental sodium or an equal amount of sterile water on days of life 7-35. Institutional data from 2008 revealed that a sample size of 56 infants completing the study will detect a 15% difference in the primary outcome of weight gain with 80% power and an alpha error of 0.05. Allowing that 33% drop-out rate (infants may be transferred to another hospital, expire, or be discharged prior to day of life 35), we choose to randomize 75 infants. Calorie intake, serum sodium, weight gain, urine sodium were monitored weekly till 35 days of life or discharge. Infants were assessed for common morbidities associated with prematurity including bronchopulmonary dysplasia, systemic hypertension, late-onset sepsis, necrotizing enterocolitis and retinopathy of prematurity.

Arms: arm 1: Sodium chloride 1 meq/kg (0.4 ml/kg of 2.5meq/ml formulation for injection)q6hrs on days of life 7-35. Intervention was given enterally if feedings were at least 100 ml/kg/day; otherwise medication was diluted in equal amounts of dextrose 5% water and administered intravenously. arm 2: Sterile water, 0.4 ml/kg q6hrs on days of life 7-35. Placebo is given enterally when infant is tolerating at least 100 ml/kg/day; otherwise the product is diluted in equal amounts of dextrose 5% water and administered intravenously.
Interventions: intervention 1: Sodium chloride intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: sterile water, 0.4 ml/kg every 6 hours on days of life 7-35.

Protocol documents:
Clinical trial NCT03231371
Conditions: Orthotopic Heart Transplant
Keywords: Orthotopic Heart Transplant
Sponsor: Bryan Goldstein
Start date: 2008-11-01; Completion date: 2011-01-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Heart transplantation is a life-sustaining therapy that allows patients with either congenital or acquired heart disease and severe cardiac dysfunction to survive. Over time, however, the transplanted heart can develop problems. One of the more common and troubling problems is the development of stenoses, or narrowings, within the coronary arteries. These narrowings, technically referred to as coronary artery vasculopathy (CAV for short), account for the single most common cause of death or need for repeat heart transplant in persons more than one year post-transplant. Traditionally, CAV has been diagnosed at cardiac catheterization using coronary angiography (where dye is directly injected into the coronary blood vessels and viewed using special x-ray equipment called fluoroscopy). There is no good treatment for CAV aside from treatment of symptoms and listing for repeat heart transplantation. The goal of this study is to test several newer methods of diagnosing CAV. The first is called coronary flow reserve (catheterization test). The second is called Endo-PAT (a finger probe test) and the third is called contrast-enhanced cardiac MRI (MRI test, only for patients 12 and older). The older method (coronary angiography) will still be used in all cases, in addition to the new tests The goal is, one day, to be able to diagnose patients with CAV earlier in the course, prior to a patient's development of abnormal angiograms. If this can be done, it is possible that better therapies will be able to be used to stop or even reverse the development of CAV, perhaps reducing, or at least delaying, the need for repeat heart transplantation.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Adenosine
Intervention descriptions: intervention 1: Administration of intravenous adenosine infusion over 3 minutes (0.14 ml/kg, 3mg/ml concentration, total dose).

Protocol documents:
Clinical trial NCT00757042
Conditions: Atopic Dermatitis Healthy Volunteers
Keywords: atopic dermatitis skin diseases healthy volunteer
Sponsor: Amgen
Start date: 2008-09-18; Completion date: 2011-01-05
Enrollment: 78 participants; Allocation: RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
This study is a single dose escalation study of tezepelumab (AMG 157) in healthy adults (Part A) and adults with moderate to severe atopic dermatitis (Part B). The purpose of the study is to evaluate the safety, tolerability, immunogenicity and pharmacokinetics of tezepelumab.

Detailed description:

Arms: arm 1: Participants will receive a single dose of tezepelumab administered subcutaneously or intravenously. The starting dose will be 2.1 mg tezepelumab. arm 2: Participants will receive matching placebo administered subcutaneously or intravenously.
Interventions: intervention 1: Tezepelumab intervention 2: Placebo
Intervention descriptions: intervention 1: Administered by subcutaneous or intravenous injection intervention 2: Matching placebo administered by subcutaneous or intravenous injection.

Protocol documents:
Clinical trial NCT00656487
Conditions: Cannabis Dependence Cannabis Withdrawal
Keywords: Cannabis Dependence Marijuana Dependence Cannabis Withdrawal Rimonabant cannabinoid receptor type 1 (CB1) inverse agonist Neuropsychology functional magnetic resonance imaging (fMRI) Endocannabinoids Cortisol
Sponsor: The Scripps Research Institute
Start date: 2008-04-30; Completion date: 2011-01-06
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to find out more about cognitive functioning in people who are cannabis dependent, relative to people who do not use cannabis, and how their brains process information after one month of not using cannabis. An additional goal is to characterize the severity of cannabis dependence using precipitated and naturalistic withdrawal with a double blind, placebo controlled, single administration of rimonabant. Research assessments occur bi-weekly throughout this 28 day study.

Detailed description:

Arms: arm 1: Cannabis dependent young adults administered rimonabant 90 mg at Day 0 and followed for 28 days post. arm 2: Cannabis dependent young adults administered matched placebo at Day 0 and followed for 28 days post. arm 3: Non-cannabis using demographically similar young adults followed for 28 days.
Interventions: intervention 1: rimonabant intervention 2: placebo
Intervention descriptions: intervention 1: double blind, placebo controlled, single 90 mg dose intervention 2: matched placebo

Protocol documents:
Clinical trial NCT00632203
Conditions: Carcinoma, Non-Small-Cell Lung Adenocarcinoma Carcinoma, Large Cell Carcinoma, Squamous Cell
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-03-04; Completion date: 2011-01-07
Enrollment: 53 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main objective of this study is to investigate whether administration of maintenance temozolomide following standard treatment could possibly prevent or delay the onset of brain metastases in patients with controlled non-small cell lung cancer (NSCLC).

Detailed description:
This is a Phase 2, open-label, randomized, multicenter study of maintenance temozolomide versus observation in subjects with stable or responding stage III/IV NSCLC to be conducted in conformance with Good Clinical Practices. Subjects will be randomly assigned to a study drug (temozolomide) or observation arm. The study drug will be administered at a dose of 75 mg/m\^2 PO daily for 21 consecutive days, followed by a 7-day rest period, until progression or up to a maximum of 6 cycles, whichever occurs first. Subjects completing 6 cycles of treatment will be followed up for incidence of brain metastasis for up to 2 years, or until progression.

Arms: arm 1: Subjects will receive temozolomide at a dose of 75 mg/m\^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period, until progression or up to a maximum of 6 cycles, whichever occurs first. arm 2: Observation
Interventions: intervention 1: Temozolomide
Intervention descriptions: intervention 1: 5-mg, 20-mg, and 100-mg gel capsules, 75 mg/m\^2 PO daily for 21 consecutive days, followed by a 7-day rest period, until progression or up to a maximum of 6 cycles, whichever occurs first.

Protocol documents:
Clinical trial NCT00799058
Conditions: HIV-1 Infections
Keywords: HIV-1 infections
Sponsor: International Partnership for Microbicides, Inc.
Start date: 2009-07-06; Completion date: 2011-01-08
Enrollment: 128 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A double-blind, randomized, placebo-controlled Phase I/II trial to evaluate the safety of dapivirine Gel 4759, 0.05% 2.5 g and dapivirine Gel 4789, 0.05% 2.5 g formulations as compared to the vaginal HEC-based Universal placebo gel, 2.5 g in healthy HIV-negative women

Detailed description:
This was a double-blind, randomized, placebo-controlled trial, to be conducted over 10 months at five research centers in the USA among 180 healthy, sexually active women, to assess the safety and acceptability of dapivirine Gel 4759, 0.05% 2.5 g, and dapivirine Gel 4789, 0.05% 2.5 g, both vaginal microbicides containing dapivirine, compared to the vaginal HEC-based Universal placebo gel, 2.5 g, containing no active ingredient, used once daily for a period of 12 weeks.

Arms: arm 1: will be applied by participants once daily for 12-weeks treatment period arm 2: Will be applied by participants once daily for12-weeks treatment period arm 3: Will be applied once daily for 12-weeks treatment period
Interventions: intervention 1: dapivirine 4789 intervention 2: dapivirine gel 4759 intervention 3: Drug placebo
Intervention descriptions: intervention 1: dapivirine gel 4789, 0.05%, 2.5g applied once daily intervention 2: dapivirine gel 4759, 0.05%, 2.5g applied once daily intervention 3: HEC-based universal placebo gel, 2.5g applied once daily

Protocol documents:
Clinical trial NCT00972179
Conditions: Healthy Volunteers
Keywords: healthy volunteers
Sponsor: Amgen
Start date: 2009-09-15; Completion date: 2011-01-09
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The primary objective is to evaluate the safety, tolerability, and immunogenicity of multiple-dose administration of tezepelumab in healthy adults.

Detailed description:
This study will follow a randomized, multiple-dose, double-blind, placebo-controlled, sequential dose-escalation study design. The study will consist of five subcutaneous (SC) cohorts and one intravenous (IV) cohort. Each dose cohort is planned to enroll 8 participants, randomized such that 6 participants will receive tezepelumab and 2 will receive placebo (3:1 ratio).

Arms: arm 1: Tezepelumab will be administered subcutaneously (SC) at doses from 35 mg once every 28 days (Q28D) (cohort 1) up to 210 mg once every 7 days (Q7D) (cohort 5) and an intravenous (IV) dose cohort of 700 mg Q28D (cohort 6). arm 2: Two participants in each cohort (cohorts 1 to 6) will receive matching placebo administered subcutaneously (cohorts 1-5) or intravenously (cohort 6), matching the treatment regiment of tezepelumab.
Interventions: intervention 1: Placebo intervention 2: Tezepelumab
Intervention descriptions: intervention 1: Administered by subcutaneous or intravenous injection. intervention 2: Administered by subcutaneous or intravenous injection

Protocol documents:
Clinical trial NCT00809354
Conditions: Osteoarthritis Arthritis
Keywords: monoclonal antibody nerve growth factor (NGF) anti-NGF tanezumab PF-04383119 RN624 osteoarthritis (OA)
Sponsor: Pfizer
Start date: 2009-02-12; Completion date: 2011-01-12
Enrollment: 2720 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the long-term analgesic efficacy and safety of tanezumab for patients with osteoarthritis (OA) of the knee or hip currently experiencing partial benefit from, and are tolerating, non-steroidal anti-inflammatory drug (NSAID) therapy.

Detailed description:
This study was terminated on 28 October 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.

Arms: arm 1: Oral NSAID arm 2: IV tanezumab 5 mg every 8 weeks (through Week 48) arm 3: IV tanezumab 10 mg every 8 weeks (through Week 48) arm 4: IV doses of tanezumab 5 mg every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks arm 5: IV doses of tanezumab 10 mg every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks
Interventions: intervention 1: NSAID intervention 2: tanezumab intervention 3: tanezumab intervention 4: tanezumab intervention 5: NSAID intervention 6: tanezumab intervention 7: NSAID
Intervention descriptions: intervention 1: IV doses of placebo (to match tanezumab) every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks intervention 2: IV tanezumab 5 mg every 8 weeks (through Week 48) and oral placebo for NSAID BID from Weeks 2 through 56 intervention 3: IV tanezumab 10 mg every 8 weeks (through Week 56) and oral placebo for NSAID BID from Weeks 2 through 56 intervention 4: IV tanezumab 5 mg every 8 weeks (through Week 48) intervention 5: Oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks intervention 6: IV tanezumab 10 mg every 8 weeks (through Week 48) intervention 7: Oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks

Protocol documents:
Clinical trial NCT01063062
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2010-02-28; Completion date: 2011-01-17
Enrollment: 107 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This single-arm, open-label, multicenter study evaluated the safety and tolerability and the efficacy in reducing disease activity of tocilizumab \[RoActemra/Actemra\] as monotherapy or in combination with methotrexate in patients with active moderate to severe rheumatoid arthritis (RA). Patients were eligible to participate in this study if they are currently experiencing an inadequate response to a stable dose of a non-biologic disease-modifying antirheumatic drug (DMARD). Patients received 8 mg/kg tocilizumab \[RoActemra/Actemra\] as an intravenous infusion every 4 weeks for a total of 6 infusions. The anticipated time on study treatment was 24 weeks. The target sample size was 50-200 patients.

Detailed description:

Arms: arm 1: Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
Interventions: intervention 1: tocilizumab [RoActemra/Actemra] intervention 2: Methotrexate
Intervention descriptions: intervention 1: 8 mg/kg intravenous infusion every 4 weeks. intervention 2: methotrexate as per standard of care in clinical practice.

Protocol documents:
Clinical trial NCT01235338
Conditions: Healthy
Sponsor: Shire
Start date: 2010-10-28; Completion date: 2011-01-17
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will examine the effects of co-administration of SPD489 and the antidepressant EFFEXOR XR on the pharmacokinetics of lisdexamfetamine, d-amphetamine, and EFFEXOR XR. In addition, serial blood pressure and pulse measures will be obtained and examined to ensure that there are no unexpected changes in vital signs following co administration of SPD489 and EFFEXOR XR that would impact the further study of this drug combination. The hypothesis is that a drug drug interaction could possibly exist.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: LDX + Venlafaxine XR intervention 2: Venlafaxine XR + LDX
Intervention descriptions: intervention 1: * Day 1-5 LDX 30mg
* Day 6-10 LDX 50mg
* Day 11-15 LDX 70mg
* Day 16-20 LDX 70mg and Venlafaxine XR 75mg daily
* Day 21-25 LDX 70mg and Venlafaxine XR 150mg daily
* Day 26-30 LDX 70mg and Venlafaxine XR 225mg daily
* Day 31-34 Venlafaxine XR 150mg daily
* Day 35-38 Venlafaxine XR 75mg daily. intervention 2: * Day 1-5 Venlafaxine XR 75mg
* Day 6-10 Venlafaxine XR 150mg
* Day 11-15 Venlafaxine XR 225mg
* Day 16-20 Venlafaxine XR 225mg and LDX 30mg daily
* Day 21-25 Venlafaxine XR and LDX 50mg daily
* Day 26-30 Venlafaxine XR 225mg and LDX 70mg daily
* Day 31-34 Venlafaxine XR 150mg
* Day 35-38 Venlafaxine XR 75mg.

Protocol documents:
Clinical trial NCT01209078
Conditions: Skin Infections, Bacterial
Keywords: methicillin-resistant Staphylococcus aureus linezolid repeat dose GSK1322322
Sponsor: GlaxoSmithKline
Start date: 2010-08-17; Completion date: 2011-01-18
Enrollment: 84 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will determine the safety, tolerability and efficacy of GSK1322322 verses Linezolid in subjects with Acute Bacterial Skin and Skin Structure Infection (ABSSSI).

Detailed description:
This is a phase IIa, multicenter, randomized, parallel group, double-blind, double dummy study to assess the safety, tolerability, and efficacy of GSK1322322 when given as 1500mg twice daily over a 10-day period versus linezolid (600mg twice daily for 10 days) in adults with suspected Gram positive Acute Bacterial Skin and Skin Structure Infection who are not currently receiving antibacterial therapy. Subjects will be randomized (2:1) to GSK1322322 or linezolid. This study consists of a screening visit, a 10-day treatment period, and follow-up evaluations 7 and 28 days following the last dose.

Arms: arm 1: GSK1322322 1500mg and Placebo Linezolid given twice a day (BID) for 10 days arm 2: Linezolid 600mg and placebo GSK1322322 given BID for 10 days
Interventions: intervention 1: GSK1322322 intervention 2: Linezolid intervention 3: GSK1322322 placebo intervention 4: Linezolid placebo
Intervention descriptions: intervention 1: GSK1322322 1500mg BID intervention 2: Linezolid 600mg intervention 3: Placebo intervention 4: placebo

Protocol documents:
Clinical trial NCT00670202
Conditions: Carotid Stenosis
Keywords: Patients scheduled for elective carotid endarterectomy
Sponsor: Brigham and Women's Hospital
Start date: 2008-03-13; Completion date: 2011-01-20
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the causal relationship between Rho/Rho kinase overactivity and mechanisms of vascular dysfunction in patients with atherosclerosis.

Detailed description:

Arms: arm 1: Fasudil hydrochloride 40 mg three times a day X 14 days arm 2: Placebo 1 tablet three times daily x 14 days
Interventions: intervention 1: Fasudil Hydrochloride intervention 2: Placebo Oral Tablet
Intervention descriptions: intervention 1: Fasudil 40 mg three times a day x 14 days intervention 2: Placebo oral tablet manufactured to mimic fasudil three times a day x 14 days

Protocol documents:
Clinical trial NCT00922272
Conditions: Schizophrenia and Predominant Negative Symptoms
Keywords: Schizophrenia
Sponsor: Shire
Start date: 2009-09-14; Completion date: 2011-01-20
Enrollment: 92 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To explore the efficacy of SPD489, as adjunctive therapy to a stable dose of atypical antipsychotic medication, on negative symptoms in adult subjects with clinically stable schizophrenia and predominant negative symptoms, as measured by the Scale for the Assessment of Negative Symptoms (SANS).

Detailed description:

Arms: arm 1: None arm 2: Placebo
Interventions: intervention 1: SPD489 (lisdexamfetamine dimesylate) intervention 2: Placebo matching SPD489 (lisdexamfetamine dimesylate)
Intervention descriptions: intervention 1: oral, 20, 30, 40, 50, 60, or 70 mg once daily intervention 2: oral, once daily

Protocol documents:
Clinical trial NCT01059825
Conditions: Diabetes Mellitus, Type 2
Keywords: Phase 2 safety and efficacy study with ertugliflozin (PF-04971729, MK-8835) Type 2 diabetes mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2010-02-24; Completion date: 2011-01-20
Enrollment: 375 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
MK-8835-016 (B1521006) is designed to evaluate the safety and efficacy of an investigational drug, ertugliflozin (MK-8835, PF-04971729) in participants with Type 2 diabetes mellitus. Participants in the study will receive 1 of 6 treatments for 12 weeks including 1 treatment with an approved drug (sitagliptin) for the treatment of Type 2 diabetes mellitus.

Detailed description:

Arms: arm 1: Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days arm 2: Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days arm 3: Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days arm 4: Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days arm 5: Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days arm 6: Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
Interventions: intervention 1: Placebo to Ertugliflozin intervention 2: Ertugliflozin 1 mg intervention 3: Ertugliflozin 5 mg intervention 4: Ertugliflozin 25 mg intervention 5: Sitagliptin 100 mg intervention 6: Placebo to Sitagliptin intervention 7: Metformin
Intervention descriptions: intervention 1: Tablet(s), 1 or 2, matching placebo to 1-mg, 5-mg and/or 25-mg tablets, once daily for 84 days intervention 2: Tablet, 1 mg, once daily for 84 days intervention 3: Tablet(s), 1 or 2, 5-mg tablets once daily for 84 days intervention 4: Tablet, 25 mg, once daily for 84 days intervention 5: Tablet, 100 mg, once daily for 84 days intervention 6: Tablet, matching placebo to 100 mg, once daily for 84 days intervention 7: Participants continued pre-study stable doses of metformin during the run-in and treatment periods of the study (maximum dose up to 2500 mg/day or 3000 mg/day where the maximum metformin dose per the local country product labels was 3000 mg/day).

Protocol documents: