ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01156363
Conditions: Anemia
Sponsor: Hoffmann-La Roche
Start date: 2010-10-01; Completion date: 2013-01-01
Enrollment: 86 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open label, single arm study will assess the efficacy for long-term maintenance of haemoglobin levels and the safety and tolerability of methoxy polyethylene glycol-epoetin beta \[Mircera\] in dialysis patients with chronic renal anaemia. Patients on regular long-term haemodialysis or peritoneal dialysis will receive monthly subcutaneous or intravenous Mircera for 6 months. Target sample size is \<200 patients.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Dialysis intervention 2: methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention descriptions: intervention 1: regular haemodialysis or peritoneal dialysis intervention 2: once monthly, subcutaneously or intravenously, for 32 weeks

Protocol documents:
Clinical trial NCT01175395
Conditions: Age-Related Macular Degeneration Choroidal Neovascularization
Keywords: Choroidal neovascular membranes CNV AMD Age-relate Macular Degeneration CNVM subfoveal
Sponsor: University of Illinois at Chicago
Start date: 2010-09-01; Completion date: 2013-01-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose of this study is to assess the safety \& tolerability of an investigational drug 20089 TA (6.9 mg or 13.8 mg) when used adjunctively with Lucentis 0.5 mg in subjects with sub-foveal neovascular AMD.

Detailed description:
The study is being done to test the safety and effectiveness of an investigational drug 20089 TA that will be used in combination with Lucentis for the treatment of CNVM. In CNVM, tiny abnormal blood vessels grow through the retinal layers in the eye. These vessels are very fragile and can leak or bleed. The severity of the symptoms depends on the size of the CNVM and its proximity to the macula (the center of visual field). Symptoms may be mild such as a blurry or distorted area of vision, or more severe, like a central blind spot. Although Lucentis has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of CNVM, the study drug 20089 TA has not yet been approved, and therefore is considered an investigational drug.

Triamcinolone Acetonide (TA) is a corticosteroid (an anti-inflammatory drug) that is used to treat many eye diseases, such as: macular edema (where inflammation causes thickening of the macula), diabetic eye disease, and age-related macular degeneration. TA has also been shown to be effective in treating neovascular AMD (also known as "wet AMD") where there is an abnormal growth of blood vessels in the macula.

Study drug 20089 is an experimental form of the corticosteroid, Triamcinolone Acetonide(TA). 20089 is a new slow-release formula (longer lasting) for intravitreal (into the eye) delivery of TA. This drug releases the active agent TA over a period of approximately 6 months thereby allowing for the improvement of inflammation and/or complications following neovascular AMD.

Although intravitreal Lucentis has been shown to prevent the loss of vision in most neovascular AMD patients and help gain visual acuity (how well we can see), results can only be assured if monthly injections are given. Since monthly injections are a burden on the patient and caregiver, attempts are being made to reduce the burden by combining available treatment options. We hope that by combining 20089 TA with Lucentis a decrease in retinal inflammation, closure of the leaky vessels with a decrease in the number of monthly injections could be achieved.

Arms: arm 1: Alternate treatment of either 6.9 mg IBI-20089/Lucentis or 13.8 mg IBI-20089/Lucentis
Interventions: intervention 1: IBI-20089/Lucentis
Intervention descriptions: intervention 1: Combining a single dose of IBI-20089 (6.9 mg or 13.8 mg) intravitreal injection adjunctively with Lucentis 0.5 mg intravitreal injection at baseline and monthly intravitreal Lucentis injection PRN based on clinical and OCT results.

Protocol documents:
Clinical trial NCT01179399
Conditions: Advanced Nonhematological Malignancies
Sponsor: Millennium Pharmaceuticals, Inc.
Start date: 2010-09-01; Completion date: 2013-01-01
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Overview of Study Design: This is a phase 1, multicenter, open-label, multiple-dose, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of TAK-960 in patients with advanced nonhematologic malignancies. This study will be the first to administer TAK-960 to humans. The patient population will consist of adults with a nonhematologic malignancy for which standard treatment is no longer effective or does not offer curative or life-prolonging potential, or for which no standard treatment is available.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: TAK-960
Intervention descriptions: intervention 1: TAK-960 administered orally once a day for 21-days of a 28-day treatment cycle. A 3 + 3 dose escalation scheme will be employed.

Protocol documents:
Clinical trial NCT01179737
Conditions: Pulmonary Arterial Hypertension
Keywords: Pulmonary Arterial Hypertension Nilotinib 6MWD Pulmonary Hypertension
Sponsor: Novartis Pharmaceuticals
Start date: 2010-07-01; Completion date: 2013-01-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial was to establish the safety, tolerability and PK of nilotinib in this population and to test the hypothesis that 6 months treatment with nilotinib will significantly reduce pulmonary artery resistance.

Detailed description:
The purpose of this trial was to establish the safety, tolerability and PK of nilotinib in this population and to test the hypothesis that 6 months

Arms: arm 1: Participants in cohort 1 were assigned to receive nilotinib 50 mg during 14 days, followed by 150 mg during 14 days, followed by 300 mg during 140 days. Participants in cohort 2 were assigned to receive nilotinib 300 mg during 168 days arm 2: Participants were assigned to receive placebo to nilotinib to match 50 mg and 150 mg capsules during 168 days.
Interventions: intervention 1: Nilotinib intervention 2: Placebo to nilotinib
Intervention descriptions: intervention 1: Nilotinib capsules for oral administration at 50 mg, 150 mg twice a day and 300 mg (2 capsules of 150 mg) twice a day. intervention 2: Placebo to nilotinib capsules for oral administration to match 50 mg, 150 mg and 300 mg capsules twice a day

Protocol documents:
Clinical trial NCT01185288
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Sponsor: AbbVie (prior sponsor, Abbott)
Start date: 2010-09-01; Completion date: 2013-01-01
Enrollment: 309 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate the efficacy of both low and high doses of methotrexate (MTX) in combination with open-label adalimumab (ADA) in patients who have had an inadequate response to high dose of MTX. The study will also evaluate the pharmacokinetics and safety of the two regimens of MTX in combination with ADA in participants with rheumatoid arthritis (RA).

Detailed description:

Arms: arm 1: Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly). arm 2: Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
Interventions: intervention 1: Adalimumab intervention 2: Methotrexate
Intervention descriptions: intervention 1: Adalimumab in pre-filled syringes intervention 2: Methotrexate capsule

Protocol documents:
Clinical trial NCT01186744
Conditions: Psoriasis
Keywords: OPT Retreatment OPT chronic moderate severe treatment safety treatment withdrawal retreatment retreatment withdrawal CP-690,550 Psoriasis Vulgaris Plaque Psoriasis tofacitinib Xeljanz nail psoriasis Jak-inhibitor oral treatment Pruritus Itch DLQI rebound intermittent retreat
Sponsor: Pfizer
Start date: 2010-09-01; Completion date: 2013-01-01
Enrollment: 666 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objectives of the study are to 1) compare the efficacy responses of CP 690,550 (5 mg BID and 10 mg BID) versus placebo following 24 weeks of CP 690,550 treatment and subsequent withdrawal of active treatment at various timepoints during the 16 week double blind active or placebo treatment period; 2) evaluate the regain of efficacy responses of CP 690,550 (5 mg BID and 10 mg BID) following 4 -16 weeks of CP 690,550 treatment withdrawal and subsequent re treatment; and 3) evaluate the safety and tolerability of CP 690,550 (5 mg BID and 10 mg BID) in subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.

Detailed description:

Arms: arm 1: Continuous active treatment (CP-690,550) for 24 weeks, followed by treatment withdrawal (placebo treatment) for 4-16 weeks, followed by active treatment (CP-690,550) for 16-28 weeks arm 2: Continuous active treatment (CP-690,550) for 56 weeks arm 3: Continuous active treatment (CP-690,550) for 24 weeks, followed by treatment withdrawal (placebo treatment) for 4-16 weeks, followed by active treatment (CP-690,550) for 16-28 weeks arm 4: Continuous active treatment (CP-690,550) for 56 weeks
Interventions: intervention 1: CP-690,550 intervention 2: CP-690,550 intervention 3: CP-690,550 intervention 4: CP-690,550
Intervention descriptions: intervention 1: 10 mg of CP-690,550 oral BID or placebo oral BID, as appropriate based on treatment withdrawal/retreatment design intervention 2: 10 mg oral BID intervention 3: 5 mg of CP-690,550 oral BID or Placebo oral BID, as appropriate based on treatment withdrawal/retreatment design intervention 4: 5 mg oral BID

Protocol documents:
Clinical trial NCT01220414
Conditions: Pain
Sponsor: University of Wisconsin, Madison
Start date: 2010-09-01; Completion date: 2013-01-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to examine opioid and endocannabinoid mechanisms of exercise-induced analgesia in men and women.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Naltrexone, then placebo intervention 2: Placebo, then Naltrexone
Intervention descriptions: intervention 1: 50 mg of naltrexone intervention 2: sugar pill

Protocol documents:
Clinical trial NCT01222286
Conditions: Smoldering Multiple Myeloma
Keywords: Smoldering Multiple Myeloma
Sponsor: Innate Pharma
Start date: 2010-09-01; Completion date: 2013-01-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the anti-tumor activity, safety and pharmacology of two dose regimens (0.2 and 2 mg/kg)of IPH2101 in patients with Smoldering Multiple Myeloma.

Detailed description:
This is a randomized Phase II, open label, multi-centre study, with two independent arms.

Patients receive 6 injections of IPH2101, at the dose of 0.2 mg/kg or 2 mg/kg (according to their randomization) administered over one hour infusion at four weeks intervals.

A patient whose disease achieves at least a minimal response to study treatment at any time during the initial period of 6 cycles can be treated with an additional period of treatment of 6 cycles.

Patients are followed 6 months after treatment completion or until a KIR occupancy level \< 30% (i.e if the time required for KIR desaturation was \> 6 months), whichever is longer.

Arms: arm 1: 0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles arm 2: 2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
Interventions: intervention 1: IPH2101
Intervention descriptions: intervention 1: 0.2 mg/Kg or 2mg/Kg, every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles

Protocol documents:
Clinical trial NCT01236118
Conditions: Rheumatoid Arthritis
Sponsor: Eli Lilly and Company
Start date: 2010-12-01; Completion date: 2013-01-01
Enrollment: 28 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and tolerability of LY2439821 subcutaneously administered for 48 weeks in Japanese participants with rheumatoid arthritis who have completed Study I1F-JE-RHAL (NCT01253265).

Detailed description:

Arms: arm 1: Participants will start receiving LY2439821 30 mg once every week for the first 3 doses and then once every 2 weeks until week 44. Investigators or its designees will increase the LY2439821 dose to 160 mg at any visit once the safety of LY2439821 180 mg is confirmed by the Data Review Meeting in Study I1F-JE-RHAL (NCT01253265). arm 2: Participants will start receiving LY2439821 80 mg once every week for the first 3 doses and then once every 2 weeks until week 44. Investigators or its designees will increase the LY2439821 dose to 160 mg at any visit once the safety of LY2439821 180 mg is confirmed by the Data Review Meeting in Study I1F-JE-RHAL (NCT01253265). arm 3: Participants will start receiving LY2439821 160 mg once every 2 weeks for the first 3 doses and then once every 4 weeks until Week 44.
Interventions: intervention 1: LY2439821
Intervention descriptions: intervention 1: Administered subcutaneously

Protocol documents:
Clinical trial NCT01241591
Conditions: Psoriasis
Keywords: CP-690,550 Etanercept Moderate Severe Chronic Plaque Psoriasis Efficacy Safety Tofacitinib Xeljanz OPT Compare OPT head-to-head non-inferiority Psoriasis vulgaris short-term Itch Pruritus Plaque psoriasis DLQI
Sponsor: Pfizer
Start date: 2010-11-01; Completion date: 2013-01-01
Enrollment: 1101 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy of CP-690,550 as compared to etanercept and the safety of CP-690,550 for treatment of moderate to severe chronic plaque psoriasis.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: CP 690,550 5 mg intervention 2: CP 690,550 10 mg intervention 3: Etanercept 50 mg intervention 4: Placebo
Intervention descriptions: intervention 1: CP-690,550 5 mg orally dosed twice daily and placebo subcutaneously dosed twice weekly for 12 weeks intervention 2: CP-690,550 10 mg orally dosed twice daily and placebo subcutaneously dosed twice weekly for 12 weeks intervention 3: Placebo orally dosed twice daily and etanercept 50 mg subcutaneously dosed twice weekly for 12 weeks intervention 4: Placebo orally dosed twice daily and placebo subcutaneously dosed twice weekly for 12 weeks.

Protocol documents:
Clinical trial NCT01243775
Conditions: Non-Small Cell Lung Cancer
Keywords: NSCLC
Sponsor: Chonnam National University Hospital
Start date: 2010-11-01; Completion date: 2013-01-01
Enrollment: 33 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Lung cancer is the leading cause of cancer death in Korea as well as in other countries. About 80% of lung cancer is non-small cell lung cancer(NSCLC). The majority of patients with NSCLC require cytotoxic chemotherapy in the course of their illness. Combination chemotherapy using third generation anticancer drugs (paclitaxel, docetaxel, gemcitabine) with platinums(cisplatin or carboplatin) reached a plateau in their efficacy. Oxaliplatin, another platinum being used for colorectal, gastric and pancreatic cancer has lower adverse effects such as nausea and nephrotoxicity. In this phase II trial, we will observe efficacy and safety of docetaxel and oxaliplatin for patients with NSCLC.

Detailed description:

Arms: arm 1: Belotaxel 60 mg/m2 3 weekly (day 1) Belloxa 70 mg/m2 3 weekly (day 2)
Interventions: intervention 1: Belotaxel intervention 2: Belloxa
Intervention descriptions: intervention 1: 60 mg/m2 3 weekly (day 1) intervention 2: 70 mg/m2 3 weekly (day 2)

Protocol documents:
Clinical trial NCT01251120
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2011-11-01; Completion date: 2013-01-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized, open-label, parallel-group study will assess the effect on disease remission of RoActemra/Actemra (tocilizumab) in combination with disease-modifying antirheumatic drugs (DMARDs) versus current best practice non-biologic DMARD therapy in patients with moderate-to-severe active rheumatoid arthritis. Patients who are randomly assigned to the RoActemra/Actemra treatment group will receive 8 mg/kg RoActemra/Actemra intravenously every 4 weeks. The anticipated time on study treatment is 12 months.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: tocilizumab [RoActemra/Actemra] intervention 2: DMARD
Intervention descriptions: intervention 1: 8 mg/kg intravenously every 4 weeks plus background DMARDs (including methotrexate) intervention 2: Non-biologic DMARDs (including methotrexate) according to current best practice

Protocol documents:
Clinical trial NCT01280604
Conditions: Hyperlipidemias
Sponsor: Kaiser Permanente
Start date: 2010-10-01; Completion date: 2013-01-01
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this randomized trial is to measure the impact of converting patients on statin therapy from fenofibrate 160mg to 54mg per day compared to patients who continue fenofibrate 160mg per day for triglycerides.

Detailed description:
Hypothesis: Study subjects receiving fenofibrate 54mg will maintain similar triglyceride levels as patients on 160mg of fenofibrate.

The primary objective of this randomized trial is to measure the impact of converting patients on statin therapy from fenofibrate 160mg to 54mg per day compared to patients who continue fenofibrate 160mg per day for triglycerides. Secondary objectives include evaluating effect of the dosage change on low-density lipoprotein (LDL), HDL, alanine aminotransferase (ALT), aspartate aminotransferase (AST), and serum creatinine (SCr), and the potential cost savings associated with prescribing 54mg instead of 160mg. Electronic medical records will be used to identify subjects and gather data on demographics, comorbid conditions, and concomitant lipid lowering therapy. Subjects will be recruited for enrollment via telephone by the principal investigator (PI), co-principal investigators (Co-PIs), or provider referral after eligibility screening and approval from their primary care physician. Subjects must provide written informed consent and Health Insurance Privacy and Accountability Act (HIPAA) privacy rule authorization prior to participation in this study. Subjects will be randomized to either the intervention arm (conversion to 54mg of fenofibrate) or to the control arm (remain on 160mg of fenofibrate). Subjects in both study arms will have fasting lipid panels, ALT/AST, and SCr evaluated at baseline. All subjects will have repeat labs approximately 8 weeks after enrollment. All subjects will continue to receive standard care based on lipid values. The study period will begin approximately October 29, 2010 and run to June 30, 2011.

Arms: arm 1: Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks. arm 2: Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
Interventions: intervention 1: Fenofibrate 54mg
Intervention descriptions: intervention 1: Subjects will receive fenofibrate 54mg daily.

Protocol documents:
Clinical trial NCT01286012
Conditions: End Stage Renal Disease
Keywords: End Stage Renal Disease, Hemodialysis, SFP
Sponsor: Rockwell Medical Technologies, Inc.
Start date: 2011-01-01; Completion date: 2013-01-01
Enrollment: 108 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the clinical safety and efficacy of SFP in sparing the need for erythropoiesis stimulating agents (ESAs) required to maintain hemoglobin (hgb) levels in chronic hemodialysis subjects who receive SFP via the dialysate versus subjects who receive conventional dialysate without iron.

Detailed description:

Arms: arm 1: None arm 2: Control concentrate lacking SFP does not contain SFP (total iron = 0)
Interventions: intervention 1: Soluble Ferric Pyrophosphate in liquid bicarbonate intervention 2: Placebo: Conventional liquid bicarbonate intervention 3: Erythrocyte Stimulating Agent (ESA) intervention 4: Intravenous (IV) Iron
Intervention descriptions: intervention 1: Subjects will receive hemodialysis containing SFP at 2 µM (11 µg iron/dL of dialysate) at every dialysis session, for a total duration of 36 weeks. intervention 2: Subjects will receive hemodialysis containing conventional liquid bicarbonate lacking SFP at every dialysis session, for a total duration of 36 weeks. intervention 3: ESA was administered according to the recommendation of a blinded central anemia management center (CAMC) based on the weekly hemoglobin value and its rate of change. intervention 4: Approved IV iron preparations were administered per a protocol driven algorithm when patients serum ferritin value decreased below 200 ug/L.

Protocol documents:
Clinical trial NCT01287221
Conditions: Multiple System Atrophy
Sponsor: Phillip Low
Start date: 2011-03-01; Completion date: 2013-01-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to determine whether Rifampicin was effective in slowing or reversing the progression of multiple system atrophy (MSA). Research studies indicate that there is an abnormality in protein synthesis and structure in parts of the brain responsible for MSA (protein misfolding) and the drug Rifampicin could potentially prevent or reverse this protein alteration. The study was done on participants with early MSA. The study consisted of taking the drug 2 times a day for 12 months. Participants underwent an evaluation of symptoms and function and will underwent a neurologic examination at the beginning of the study, at 6 months and at 12 months. They were also be contacted at 3 and 9 months by telephone. Studies were done at 10 participating sites.

Detailed description:
MSA is a progressive, fatal disorder characterized by autonomic failure and parkinsonism and/or cerebellar involvement. Neuropathologically, MSA is characterized by glial cytoplasmic inclusions (GCI) of abnormally aggregated α-synuclein (α-syn). This was a study to test the hypothesis that Rifampicin, because of its ability to inhibit the formation of α-synuclein fibrils and disaggregate fibrils already formed, will delay progression or reverse neurologic and autonomic functions and symptoms in MSA. This approach has been proposed as a potential approach to treat parkinsonism and specifically, MSA. In an experimental model of MSA, it was hypothesized that Rifampicin would improve behavioral abnormalities of MSA and halt or reverse the pathological changes. The primary objective was to undertake a double-blind placebo-controlled clinical trial on the effect of Rifampicin on progression of neurological and autonomic failure in MSA.

The Data Safety Monitoring Board (DSMB) recommended stopping the study after an interim analysis of the primary endpoint revealed that futility criteria were met.

Arms: arm 1: Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months. arm 2: Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
Interventions: intervention 1: Rifampicin intervention 2: placebo
Intervention descriptions: intervention 1: 300 mg, 2 times daily intervention 2: placebo

Protocol documents: