ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00147498
Conditions: Rheumatoid Arthritis
Keywords: oral JAK inhibitor clinical trial joint diseases anti-Inflammatory agents rheumatic diseases DMARD Antirheumatic Agents Autoimmune Diseases Immune System Diseases
Sponsor: Pfizer
Start date: 2005-01-01; Completion date: 2006-06-01
Enrollment: 264 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study's objective is to compare the efficacy of 3 dose levels of oral CP-690,550 monotherapy (5 mg, 15 mg, and 30 mg twice daily \[BID\]) versus placebo administered over 6 weeks for the treatment of the signs and symptoms of subjects with active rheumatoid arthritis (RA).

Detailed description:

Arms: arm 1: CP 690,550 5 mg BID arm 2: CP 690,550 15 mg BID arm 3: Oral tablets administered at a dose of 30 mg BID for 6 weeks arm 4: Placebo
Interventions: intervention 1: CP-690,550 intervention 2: CP-690,550 intervention 3: CP-690,550 intervention 4: Placebo
Intervention descriptions: intervention 1: Oral tablets administered at a dose of 5 mg BID for 6 weeks intervention 2: Oral tablets administered at a dose of 15 mg BID for 6 weeks intervention 3: 30 mg BID for 6 weeks intervention 4: Placebo tablets

Protocol documents:
Clinical trial NCT00154063
Conditions: Migraine Prophylaxis
Sponsor: Eisai Inc.
Start date: 2005-01-01; Completion date: 2006-06-01
Enrollment: 206 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a 22-week, prospective, randomized, double-blind, placebo-controlled, multicenter, parallel-group study that included a 4-week Baseline Phase at the beginning and a 4-week single-blind placebo Safety Phase at the end of the study.

Detailed description:

Arms: arm 1: During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase). arm 2: During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
Interventions: intervention 1: E2007 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00160680
Conditions: Rhinitis, Allergic, Perennial
Keywords: Persistent Allergic Rhinitis HDM Parietaria sneezing rhinorrhea ocular pruritus Rhinasthma inflammatory cells ICAM-1 ATAREAL Xyzal Levocetirizine
Sponsor: UCB S.A. - Pharma Sector
Start date: 2005-03-01; Completion date: 2006-06-01
Enrollment: 62 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Comparison of clinical efficacy and safety of levocetirizine in PER continuous versus on demand, measured by evolution of individual symptom scores during 6 months.

Detailed description:

Arms: arm 1: 5 mg of Levocetirizine (LCTZ) was taken orally once a day. arm 2: 5 mg of Levocetirizine (LCTZ) was taken whenever needed.
Interventions: intervention 1: Levocetirizine
Intervention descriptions: intervention 1: * Pharmaceutical form: Tablet
* Concentration: 5 mg
* Route of administration: Oral use

Protocol documents:
Clinical trial NCT00203294
Conditions: Migraine
Sponsor: Thomas Jefferson University
Start date: 2005-06-01; Completion date: 2006-06-01
Enrollment: 45 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Subjects are scheduled to undergo a Greater Occipital Nerve Block (GONB) as treatment for your chronic daily headache (CDH). GONB has been used for many years in the treatment of headaches. The nerve block is done by injecting a liquid drug through the skin of the back of the head to the area of the greater occipital nerve. The nerve runs superficially in this area, therefore the drugs are injected just under the skin. The injected drugs block electrical transmission through the nerve, resulting in reduced head pain. There are treatment options for patients receiving a GONB, however, some clinicians use local anesthetics (lidocaine and /or bupivicaine) alone, and some use local anesthetics with local steroid injection. The purpose of this study is to evaluate whether or not there is an observed difference between these two treatment approaches for GONB. We expect to enroll 60 patients into this research study at Thomas Jefferson University only.

Detailed description:

Arms: arm 1: Adult patients with CDH, and headache of at least moderate intensity at time of treatment, were randomized to receive bilateral GONB and trigger point injections in the cervical paraspinal and the trapezius muscles bilaterally. arm 2: Adult patients with CDH, and headache of at least moderate intensity at time of treatment, were randomized to receive bilateral GONB and trigger point injections in the cervical paraspinal and the trapezius muscles bilaterally.
Interventions: intervention 1: lidocaine, bupivicaine and saline intervention 2: lidocaine plus bupivicaine plus triamcinolone (steroid)
Intervention descriptions: intervention 1: lidocaine, bupivicaine and saline-2 cc were injected to each GON and 0.5 cc to each trigger point. Total injected volume = 10 cc. intervention 2: lidocaine, bupivicaine and triamcinolone (steroid)-2 cc were injected to each GON and 0.5 cc to each trigger point. Total injected volume = 10 cc.

Protocol documents:
Clinical trial NCT00203307
Conditions: Migraine
Sponsor: Thomas Jefferson University
Start date: 2004-05-01; Completion date: 2006-06-01
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Olanzapine (o-lan-zah-peen) is a medication that has been approved by the Food and Drug Administration (FDA) for the treatment of patients with schizophrenia and/ or bipolar disorder. The trade name for this drug is Zyprexa®. Olanzapine has not been approved by the FDA for the prevention of migraine and is experimental for the purposes of this research study.

The Jefferson Headache Center at Thomas Jefferson University has developed this clinical study to evaluate the safety and effectiveness of Olanzapine in preventing migraine headaches.

Detailed description:

Arms: arm 1: Olazepam arm 2: None
Interventions: intervention 1: Olanzapine during first intervention period and placebo during second intervention period intervention 2: Placebo during first intervention period, then olanzapine during second intervention period
Intervention descriptions: intervention 1: Olanzapine (5-10 mg) daily during first intervention period, then placebo(matching)druing second intervention period (after a washout period) intervention 2: Placebo (matching) during first intervention period, then olanzapine (5-10 mg. daily) during the second intervention period (after a washout phase).

Protocol documents:
Clinical trial NCT00220740
Conditions: Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Keywords: Immunoglobulin G
Sponsor: Grifols Therapeutics LLC
Start date: 2004-04-01; Completion date: 2006-06-01
Enrollment: 117 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The intent of this study is to demonstrate the efficacy and safety of Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in newly or previously diagnosed CIDP subjects. Eight courses of treatment with either placebo or IGIV-C will occur every 3 weeks. Neurological function will be measured by Inflammatory Neuropathy Cause and Treatment (INCAT) scores. Patients who deteriorate or show no improvement between day 16 and month 6 will receive the alternate study drug for an additional 6 months.

Detailed description:
110 subjects, 55 per treatment group, with newly or previously diagnosed CIDP defined by INCAT neurophysiological diagnostic criteria will be enrolled into the trial. Patients will not be replaced if they discontinue prematurely.

Arms: arm 1: IGIV-C arm 2: None
Interventions: intervention 1: Immune Globulin IV (Human), 10% Caprylate/Chromatography Purified intervention 2: Albumin (Human) 25%, United States Pharmacopeia (USP)
Intervention descriptions: intervention 1: 2 g/kg body weight ideally over 2-4 days . Thereafter, study drug infusion (IGIV-C) will be administered every 3 weeks at a dose of 1 g/kg bw, given over 1-2 days for a total of 7 additional infusions intervention 2: Albumin 25%, USP diluted with dextrose 5% to a final concentration of 0.1% as an intravenous infusion. Alternatively, it may be a bottled placebo of 0.1% Albumin (Human) in 0.2 M Glycine, 1.1 mm sodium caprylate, 0.25% sodium chloride. 2 g/kg body weight ideally over 2-4 days . Thereafter, infusion (placebo) will be administered every 3 weeks at a dose of 1 g/kg bw, given over 1-2 days for a total of 7 additional infusions

Protocol documents:
Clinical trial NCT00296192
Conditions: Parkinson's Disease
Keywords: Rotigotine Rotigotine nasal spray Efficacy, safety and tolerability Parkinson's disease
Sponsor: UCB Pharma
Start date: 2006-02-01; Completion date: 2006-06-01
Enrollment: 82 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this trial is to evaluate safety and efficacy of rotigotine nasal spray (SPM 952) in a single dose application scheme.

Subjects will undergo a 2 - 28 days screening period in which eligibility criteria will be checked. Subjects will then be hospitalized for one night. In the morning of the next day, subjects will be randomly assigned either to rotigotine or placebo nasal spray and will then receive a single dose of trial medication. Safety assessments after application include adverse events, 12-lead electrocardiograms, blood pressure and heart rate assessments, and laboratory checks. Efficacy will be assessed by application of motor examination scores.

The first subject is planned to be enrolled in February 2006. The last subject is planned to be enrolled in May 2006. Last subject out is expected for August 2006.

Detailed description:
The objective of this trial is to evaluate safety and efficacy of rotigotine nasal spray (SPM 952)in a single dose application scheme. Subjects will undergo a 2-28 days screening period in which eligibility criteria will be checked. Subjects will then be hospitalized for one night. In the morning of the next day, subjects will be randomly assigned either to rotigotine or placebo nasal spray and will then receive a single dose of trial medication. Safety assessments after application include adverse events, 12-lead electrocardiograms, blood pressure and heart rate assessments, and laboratory checks. Efficacy will be assessed by application of motor examination scores.

Arms: arm 1: Placebo nasal spray 1 - 4 puffs arm 2: Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine) arm 3: Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine) arm 4: Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine) arm 5: Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
Interventions: intervention 1: Rotigotine nasal spray intervention 2: Placebo
Intervention descriptions: intervention 1: Rotigotine- HCl 2.5mg/mL nasal spray, dosage per puff of 275µg per 110µg administered in up to 4 deliveries intervention 2: placebo nasal spray 1, 2 3, and 4 puffs

Protocol documents:
Clinical trial NCT00395993
Conditions: Anemia
Keywords: anemia heavy uterine bleeding menorrhagia Anemia secondary to heavy uterine bleeding
Sponsor: American Regent, Inc.
Start date: 2005-05-01; Completion date: 2006-06-01
Enrollment: 456 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study compares of the safety and efficacy of intravenous iron vs oral iron in the treatment of anemia secondary to heavy uterine bleeding

Detailed description:
This is an open-label, randomized, Phase III, active-control, study of the efficacy and safety of IV iron vs oral iron in patients with anemia secondary to heavy uterine bleeding.

Arms: arm 1: Maximum of 1,000 mg of iron as IV FCM given at weekly intervals until the individual's calculated cumulative dose has been reached or a maximum of 2,500 mg has been administered arm 2: 325 mg tablets TID on Days 0 through Day 42
Interventions: intervention 1: Ferric Carboxymaltose (FCM) intervention 2: Ferrous Sulfate tablets
Intervention descriptions: intervention 1: Maximum of 1,000 mg of iron as IV FCM given at weekly intervals until the individual's calculated cumulative dose has been reached or a maximum of 2,500 mg has been administered intervention 2: 325 mg tablets TID on Days 0 through Day 42

Protocol documents:
Clinical trial NCT00710424
Conditions: Pain Diabetic Neuropathy
Keywords: Pain diabetic neuropathy
Sponsor: Jazz Pharmaceuticals
Start date: 2005-07-01; Completion date: 2006-06-01
Enrollment: 297 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy of Sativex® compared with placebo in relieving pain due to Diabetic Neuropathy.

Detailed description:
This was a 15 week (one week baseline and fourteen weeks treatment period), multicentre, double blind, randomised, placebo controlled, parallel group study to evaluate the efficacy of Sativex in subjects with pain due to diabetic neuropathy. Subjects were screened to determine eligibility and completed a seven-day baseline period. Subjects then returned to the centre for assessment, randomisation and dose introduction. Visits occurred at the end of weeks two, six, ten and at the end of the study (treatment week 14) or earlier if they withdrew. A follow up visit occurred 28 days after completion or withdrawal. Subjects in this study were given the opportunity to be enrolled in an open label extension study.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Sativex intervention 2: Placebo
Intervention descriptions: intervention 1: containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours intervention 2: containing peppermint oil, 0.05% (v/v), quinoline yellow, 0.005% (w/v), sunset yellow, 0.0025% (w/v), in ethanol:propylene glycol (50:50) excipient.

Protocol documents:
Clinical trial NCT00712530
Conditions: HIV Infection
Keywords: HIV Vaccine Immune Therapy DermaVir
Sponsor: Genetic Immunity
Start date: 2005-01-01; Completion date: 2006-06-01
Enrollment: 9 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
* DermaVir is a plasmid DNA-containing synthetic nanomedicine. It is administered topically with DermaPrep to target Langerhans cells. Langerhans cells with DermaVir migrate to lymph nodes and express HIV-like particles that induce immune responses to kill HIV-infected cells.
* Hypothesis: Single DermaVir immunization is safe and immunogenic measured by induction of HIV-specific precursor/memory T cell responses.
* GIHU004 was a phase I dose escalation study conducted in Hungary. It evaluated the safety and immunogenicity of three dosing regimens of topical DermaVir immunization for the treatment of HIV-infected individuals on fully suppressive highly active antiretroviral therapy (HAART).

Detailed description:
This study enrolled nine HIV-infected adult subjects in three sequential dose cohorts. All had durable suppression of HIV-RNA on HAART over the previous 6 months and CD4 count over 300 cells/mm3. Subjects, received on study Day 0 a single DermaVir immunization:

* Low dose: 0.1 mg pDNA, 0.8 mL DermaVir administered under two DermaPrep patches.
* Medium dose: 0.4 mg pDNA, 3.2 mL DermaVir administered under four DermaPrep patches.
* High dose: 0.8 mg pDNA, 6.4 mL DermaVir administered under eight DermaPrep patches.

Subjects were on study for a total of 28 days followed by a post-treatment safety follow-up for 48 weeks. HAART was not interrupted. All subjects completed the 28-day treatment and 48 weeks safety follow up phase.

Arms: arm 1: Single low-dose DermaVir immunization

* 0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir
* Administered topically with DermaPrep under two skin patches (0.4 mL/patch) arm 2: Single medium-dose DermaVir immunization

* 0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir
* Administered topically with DermaPrep under four skin patches (0.8 mL/patch) arm 3: Single high-dose DermaVir immunization

* 0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir
* Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)
Interventions: intervention 1: DermaVir intervention 2: HAART
Intervention descriptions: intervention 1: DermaVir is a synthetic pathogen-like nanomedicine. The active pharmaceutical ingredient is a plasmid DNA expressing fifteen HIV proteins that assemble into HIV-like particles. These particles are safe, cannot replicate, integrate or reverse transcribed. DermaVir is targeted to Langerhans cells with DermaPrep medical device. These DermaVir-containing Langerhans cells migrate to the lymph nodes, where induce HIV-specific cytotoxic T cells that can recognize and kill HIV-infected cells. intervention 2: Three or more antiretroviral drugs that can fully suppress HIV RNA

Protocol documents:
Clinical trial NCT01745055
Conditions: Rheumatoid Arthritis
Keywords: Pharmacokinetics oral JAK inhibitor methotrexate (MTX) rheumatoid arthritis (RA)
Sponsor: Pfizer
Start date: 2005-04-01; Completion date: 2006-06-01
Enrollment: 12 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study was designed to estimate the effects of methotrexate (MTX) on the pharmacokinetics (PK) of CP-690,550 when administered to subjects with rheumatoid arthritis (RA), to estimate the effects of CP-690,550 on the PK of MTX and to evaluate the short-term safety and tolerability of co-administration of CP-690,550 and MTX.

Detailed description:

Arms: arm 1: Individual dose of methotrexate with the addition of CP-690,550 30 mg q12h
Interventions: intervention 1: CP-690,550 (tofacitinib) intervention 2: Methotrexate (MTX)
Intervention descriptions: intervention 1: CP-690,550 30 mg q12h for 5 days intervention 2: individual dose of methotrexate (stably dosed)

Protocol documents:
Clinical trial NCT02281422
Conditions: Epilepsy
Sponsor: Bial - Portela C S.A.
Start date: 2005-03-01; Completion date: 2006-06-01
Enrollment: 40 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Open-label, single-dose (BIA 2-093 800 mg tablet), single-centre study in five groups of subjects with various degrees of renal function based on creatinine clearance

Detailed description:
This was an open-label, single-dose (BIA 2-093 800 mg tablet), single-centre study in five groups of subjects with various degrees of renal function based on creatinine clearance (stages of renal function according to the Food and Drug Administration and the European Agency for the Evaluation of Medicinal Products Guidelines) for the evaluation of pharmacokinetics in patients with impaired renal function.

The trial commenced with Groups 1 and 2. An interim safety evaluation was conducted and, as there were no safety concerns, the trial continued with Groups 3 and 4. After another interim safety evaluation with the data from Groups 3 and 4, the trial commenced with Group 5.

Arms: arm 1: normal renal function (creatinine clearance \> 80 mL/min) arm 2: mild renal impairment (creatinine clearance 50-80 mL/min) arm 3: moderate renal impairment (creatinine clearance 30-50 mL/min) arm 4: severe renal impairment (creatinine clearance \<30 mL/min) arm 5: end stage renal disease, requiring haemodialysis (ESRD)
Interventions: intervention 1: BIA 2-093
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00421148
Conditions: Anesthesia
Sponsor: Merck Sharp & Dohme LLC
Start date: 2005-05-30; Completion date: 2006-06-02
Enrollment: 94 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is:

* to explore the dose-response relation of sugammadex (Org 25969, MK-8616, SCH 900616) given as a reversal agent at reappearance of T2 after 0.6 mg.kg-1 rocuronium in pediatric and adult participants
* to explore the pharmacokinetics (PK) of sugammadex in pediatric and adult participants, and to evaluate the safety of sugammadex in pediatric and adult participants.

Detailed description:

Arms: arm 1: Participants are to receive an intravenous (IV) single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 0.5 mg/kg sugammadex is to be given. arm 2: Participants are to receive an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex is to be given. arm 3: Participants are to receive an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex is to be given. arm 4: Participants are to receive an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex is to be given. arm 5: Participants are to receive an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single 3-mL bolus dose of placebo (sodium chloride 0.9% solution) is to be given.
Interventions: intervention 1: Sugammadex 0.5 mg/kg intervention 2: Sugammadex 1 mg/kg intervention 3: Sugammadex 2 mg/kg intervention 4: Sugammadex 4 mg/kg intervention 5: Placebo intervention 6: Rocuronium bromide
Intervention descriptions: intervention 1: IV infusion intervention 2: IV infusion intervention 3: IV infusion intervention 4: IV infusion intervention 5: IV infusion intervention 6: IV infusion

Protocol documents:
Clinical trial NCT00372957
Conditions: Diabetes Mellitus, Type 2
Keywords: pharmacodynamics Diabetes pharmacokinetics
Sponsor: GlaxoSmithKline
Start date: 2006-03-22; Completion date: 2006-06-28
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate the preliminary pharmacokinetics, pharmacodynamics, safety and tolerability of GW823093 at doses of 15mg and 30mg given once daily for 7 days in Japanese Type 2 diabetes mellitus (T2DM) patients.

Detailed description:

Arms: arm 1: Participants received two capsules of matching placebo orally once daily in the morning with 150 milliliter (mL) of water at least 15 minutes prior to breakfast for 7 Days. arm 2: Participants received one 15 milligrams (mg) of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days. arm 3: Participants received 30 mg (2x15 mg) of GW823093C capsules orally once daily in the morning with 150 mL of water at least 15 minutes prior to breakfast for 7 Days.
Interventions: intervention 1: GW823093 15mg intervention 2: GW823093 placebo capsule intervention 3: GW823093 30mg
Intervention descriptions: intervention 1: White opaque capsule containing 15mg of GW823093 as free base intervention 2: Matching placebo of GW823093 capsule or 15mg capsule intervention 3: White opaque capsule containing 15mg of GW823093 as free base

Protocol documents: