ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01738646
Conditions: Recurrent Glioblastoma Multiforme Malignant Glioma Adult Brain Tumor
Keywords: vorinostat SAHA bevacizumab AVASTIN malignant glioma GBM glioblastoma multiforme brain tumor
Sponsor: Duke University
Start date: 2013-01-01; Completion date: 2016-02-01
Enrollment: 48 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
It has been shown that bevacizumab has significant anti-tumor activity in patients with recurrent glioblastoma multiforme. Vorinostat has modest anti-tumor activity against malignant glioma and can enhance the action of both chemotherapy and anti-angiogenics. Patients will be treated with a combination of bevacizumab and vorinostat.

Detailed description:
There is no effective therapy for patients with recurrent glioblastoma multiforme (GBM) hence such patients remain a major unmet need in oncology. The investigators have recently demonstrated that bevacizumab (BV), a humanized monoclonal antibody against vascular endothelial growth factor, has significant anti-tumor activity among recurrent glioblastoma multiforme patients. Vorinostat has modest anti-tumor activity against malignant glioma and can potentiate the action of both chemotherapy and anti-angiogenics. The current study is designed to evaluate the anti-tumor activity of vorinostat when combined with BV among recurrent glioblastoma multiforme patients.

Arms: arm 1: Patients will be administered bevacizumab every 2 weeks and vorinostat will be taken on days 1-7 and 15-21 of each 28-day cycle at 400 mg per day.
Interventions: intervention 1: Vorinostat intervention 2: Bevacizumab
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01751126
Conditions: Vernal Keratoconjunctivitis
Keywords: vernal keratoconjunctivitis ciclosporin cyclosporine
Sponsor: Santen SAS
Start date: 2013-04-29; Completion date: 2016-02-01
Enrollment: 169 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to compare the efficacy of two different dosing regimen of NOVA22007 (1mg/ml ciclosporin/cyclosporine) eye drops, emulsion versus placebo (vehicle of the formulation) administered four times a day in patients with severe vernal keratoconjunctivitis after 4 months of treatment.

Detailed description:

Arms: arm 1: One drop of ciclosporin (NOVA22007) 1 mg/ml 4 times a day as monotherapy (morning, noon, afternoon and evening). arm 2: One drop of ciclosporin (NOVA22007) 1 mg/ml twice a day and one drop of placebo twice a day (active study treatment morning and evening and placebo noon and afternoon) as monotherapy. arm 3: One drop of placebo 4 times a day as monotherapy (morning, noon, afternoon and evening).
Interventions: intervention 1: NOVA22007 ''Ciclosporin'' intervention 2: Placebo
Intervention descriptions: intervention 1: Sterile, ophthalmic cationic oil-in-water emulsion containing 1 mg/ml Ciclosporin. intervention 2: Sterile, drug-free, cationic ophthalmic oil-in-water emulsion containing 0 mg/ml Ciclosporin.

Protocol documents:
Clinical trial NCT01751308
Conditions: Malignant Solid Tumor - Malignant Nervous System Neoplasm
Sponsor: Sanofi
Start date: 2013-02-01; Completion date: 2016-02-01
Enrollment: 39 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Primary Objectives:

Phase 1 Part:

To determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) of cabazitaxel as a single agent in pediatric participants with recurrent or refractory solid tumors including tumors of the central nervous system.

Phase 2 Part:

To determine the objective response rate (complete and partial response) and the duration of response to cabazitaxel as a single agent in participants with recurrent or refractory high grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG).

Secondary Objectives:

Phase 1 Part:

To characterize the safety and tolerability of cabazitaxel in participants with recurrent or refractory solid tumors including tumors of the central nervous system.

To characterize the pharmacokinetic (PK) profile of cabazitaxel in participants with recurrent or refractory solid tumors including tumors of the central nervous system.

To evaluate preliminary anti-tumor activity that may be associated with cabazitaxel in participants with recurrent or refractory solid tumors including tumors of the central nervous system.

Phase 2 Part:

To characterize the safety and tolerability of cabazitaxel in participants with recurrent or refractory HGG or DIPG.

To estimate progression free survival in participants with recurrent or refractory HGG or DIPG.

To estimate overall survival in participants with recurrent or refractory HGG or DIPG.

To characterize the plasma PK profile of cabazitaxel in participants with recurrent or refractory HGG or DIPG.

Detailed description:
The study duration will include a period for inclusion of up to 3 weeks and a 3-week treatment cycle(s). The participants may continue treatment until disease progression, unacceptable toxicity or willingness to stop followed by a minimum of 30-day follow-up.

Arms: arm 1: Cabazitaxel 20 mg/m\^2 intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression (DP) or discontinuation due to adverse event (AE) or death (from any cause). arm 2: Cabazitaxel 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause). arm 3: Cabazitaxel 30 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause). arm 4: Cabazitaxel 35 mg/m\^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause). arm 5: Cabazitaxel at the maximum tolerated dose (MTD) as determined in phase 1 (30 mg/m\^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
Interventions: intervention 1: Cabazitaxel (XRP6258)
Intervention descriptions: intervention 1: Pharmaceutical form: Injection Route of administration: Intravenous

Protocol documents:
Clinical trial NCT01836471
Conditions: Asthma
Sponsor: Novartis Pharmaceuticals
Start date: 2013-05-01; Completion date: 2016-02-01
Enrollment: 345 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study was to assess the clinical effect of QAW039 in non-atopic asthmatics taking low dose Inhaled Corticosteroid (ICS) as background therapy.

Detailed description:
This was a multi-centre, randomised, placebo-controlled, double blind, 3-arm study designed to compare the efficacy and safety of a once daily dose of QAW039 with placebo in non-atopic and atopic asthmatics both inadequately controlled despite receiving a low dose ICS background therapy, over a 12 week treatment period. Efficacy and safety of a once daily dose of QAW039 was also compared with an increased dose of ICS in atopic asthmatics taking low dose ICS as background therapy.

Arms: arm 1: QAW039 450 mg (3 capsules of QAW039 150 mg) qd combined with background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1. arm 2: Placebo to QAW039 (3 capsules of Placebo of QAW039 150 mg) combined with background ICS (100 μg fluticasone, bid). Non-atopic randomized in ratio of approximately 1:1. arm 3: QAW039 450 mg (3 capsules of QAW039 150 mg) qd combined with background ICS (100 μg fluticasone, bid). Atopic patients randomized in a ratio of approximate 1:1:1 arm 4: Placebo to QAW039 (3 capsules of Placebo of QAW039 150 mg) combined with 150 μg ICS and with background ICS (100 μg fluticasone, bid). As a consequence total ICS was 250 μg fluticasone bid. Atopic patients randomized in ratio of approximately 1:1:1 arm 5: Placebo to QAW039 (3 capsules of Placebo of QAW039 150 mg) combined with background ICS (100 μg fluticasone, bid). Atopic patients andomized in ratio of approximately 1:1:1
Interventions: intervention 1: QAW039 intervention 2: Placebo QAW039 intervention 3: Fluticasone 250 mcg intervention 4: Fluticasone 100 mcg
Intervention descriptions: intervention 1: QAW039 supplied as hard gelatin capsule in unit dose strength of 150 mg. Patient took 450 mg once daily (3 capsules taken with food in the morning) for the approximate period of the study (12 weeks) intervention 2: Matching placebo for QAW039 supplied as hard gelatin capsule were identical in appearance to their active counterparts. Patients took 3 QAW039 matching placebo capsules once a day ( taken with food in the morning) for the approximate period of the study (12 weeks) intervention 3: Fluticasone was supplied in inhalers with dose strength of 250 mcg. Patients took 250 mcg bid (morning and evening approximately 12 hours between doses) for a total dose of 500 mcg daily for the approximate period of the study (12 weeks). intervention 4: Background therapy - fluticasone was supplied in inhalers with dose strength of 100 mcg. All patients in the study other than the Atopic Fluticasone 150 mcg arm were given the 100 mcg dose strength inhalers and took fluticasone 100 mcg bid (taken morning and evening with approximately 12 hours between doses) as background therapy for the approximate period of the study (12 weeks).

Protocol documents:
Clinical trial NCT01849068
Conditions: Metabolic Syndrome X
Sponsor: Laval University
Start date: 2013-06-01; Completion date: 2016-02-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Ezetimibe has been shown to inhibit cholesterol absorption and several lines of evidence from in vitro systems and animal models suggest that this effect is associated with an increase in low-density lipoprotein (LDL) receptor expression in the small intestine. The impact of a treatment with ezetimibe on intestinal gene expression and protein mass levels of LDL receptor and other key genes involved in intestinal cholesterol homeostasis will be examined in dyslipidemic men with insulin-resistance. In the present study, gene expression studies and protein mass levels will be assessed on duodenal biopsies by real-time polymerase chain reaction (rt-PCR) and liquid chromatography-mass spectrometry (LC-MS/MS), respectively. The primary objective of this proposal is to examine the effects of ezetimibe on intestinal gene expression (rt-PCR) and protein mass levels (LC-MS/MS) of LDL receptor in dyslipidemic men with insulin-resistance. The secondary objective is to examine the impact of ezetimibe treatment on intestinal gene expression and protein mass levels of sterol regulatory element-binding protein (SREBP)-2, Niemann-Pick C1-Like1 (NPC1L1), ATP binding cassette gene (ABCG)-5/8, proprotein convertase subtilisin/kexin type 9 (PCSK9) and 3-hydroxy-3-methyl-glutaryl-CoA (HMG CoA) reductase.

Primary hypothesis Treatment with ezetimibe 10 mg/day will significantly increase duodenal mRNA and protein mass levels of LDL receptor in dyslipidemic men with insulin-resistance.

Secondary hypothesis Treatment with ezetimibe 10 mg/day will significantly increase duodenal mRNA and protein mass levels of SREBP-2, NPC1L1, ABCG5/8, PCSK9 and HMG CoA reductase in dyslipidemic men with insulin-resistance.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ezetimibe intervention 2: Placebo
Intervention descriptions: intervention 1: Ezetimibe 10 mg/d for 12 weeks intervention 2: Placebo for 12 weeks

Protocol documents:
Clinical trial NCT01883804
Conditions: Diabetes Mellitus, Type 1
Keywords: Diabetes Diabetes Mellitus Type 1 Diabetes
Sponsor: University of Colorado, Denver
Start date: 2013-06-01; Completion date: 2016-02-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Type 1 Diabetes is an autoimmune condition in which segments of the immune system cause the destruction of insulin producing cells in the pancreas, leaving individuals with an impaired ability to control blood glucose levels. Currently there is no cure for Type 1 Diabetes and the treatments involve lifelong insulin administration and careful monitoring of blood glucose levels. Long-term complications like cardiovascular disease, nerve damage, and retina damage, may result. Previous studies have shown that improvement in the control of blood glucose can reduce the risks from these long-term complications. Residual insulin production, typically within the first few years following diagnosis, helps to reduce an individual's need to supplement insulin by injection or pump. This effect helps in maintaining the body's ability to regulate blood glucose levels and reducing the needs of external insulin.

Methyldopa, or Aldomet, has been approved by the Food and Drug Administration and is commonly used to treat high blood pressure. This drug has been approved for several decades and has been shown to be safe and effective. This drug has been identified by the researcher to be able to block the communication between two important types of immune cells; which play a critical role in the autoimmune processes of Type 1 Diabetes. The investigators hypothesize that Methyldopa, over a 6 week treatment period, will block this communication and possibly slow down the destruction of insulin producing cells. The investigators hope to assess the appropriate and safe dose to achieve this effect, along with the drug's ability to maintain insulin production and blood glucose control.

Detailed description:

Arms: arm 1: All participants selected to continue with Methyldopa administration.
Interventions: intervention 1: Methyldopa
Intervention descriptions: intervention 1: 6 weeks of Methyldopa administration; where the dose will be increased according to safety of efficacy.

Protocol documents:
Clinical trial NCT01894256
Conditions: Solid Tumours
Keywords: oncology, cancer, neoplasm, anticancer drug, pharmacokinetics, area under curve, olaparib, solid tumour, mild renal impairment, moderate renal impairment
Sponsor: AstraZeneca
Start date: 2013-11-01; Completion date: 2016-02-01
Enrollment: 56 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 2-part study in patients with advanced solid tumours. Part A will investigate the PK of olaparib in patients with mild or moderate renal impairment compared to patients with normal renal function; Part B will allow eligible study patients continued access to olaparib after the PK phase and will provide additional safety data.

Detailed description:

Arms: arm 1: Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). arm 2: Patients with calculated serum creatinine clearance 51-80 mL/min (using Cockcroft-Gault equation). arm 3: Patients with calculated serum creatinine clearance 31-50 mL/min (using Cockcroft-Gault equation).
Interventions: intervention 1: Olaparib tablet dosing
Intervention descriptions: intervention 1: Part A - single 300mg oral dose olaparib (administered as 2x150mg tablets) Part B - 300mg oral dose olaparib (administered as 2x150mg tablets) bd

Protocol documents:
Clinical trial NCT01943864
Conditions: Cancer
Keywords: pharmacokinetics second line monotherapy GSK1120212 (trametinib) MEK inhibitor locally advanced or metastatic biliary tract cancers
Sponsor: GlaxoSmithKline
Start date: 2013-09-19; Completion date: 2016-02-01
Enrollment: 20 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase IIa, open-label, single-arm, multi-center study to evaluate the efficacy and safety of orally administered MEK inhibitor trametinib as the second line in subjects with advanced or metastatic biliary tract cancers (BTC) in Japanese population. The primary endpoint of this study is 12 week non-progressive disease (PD) rate defined as the percentage of subjects without progression at Week 12. As a sub-study, pharmacokinetics (PK) of four tablets of 0.5 milligram (mg) tablet, or one tablet of 2 mg tablet to achieve 2 mg daily regimen will be assessed to evaluate the pharmacokinetics of trametinib in Japanese population.

Eligible subjects will be randomized to receive trametinib at the recommended Phase II dose of 2 mg every day as one 2 mg tablet or four 0.5 mg tablets on Day 1. From Day 2 until disease progression or withdrawal from the study treatment, all subjects will receive one tablet of 2 mg trametinib . Disease assessment will be performed every 8 week. Translational research is also planned to evaluate the potential blood or tumor tissue-derived biomarkers for biological activity, and sensitivity or resistance to treatment with trametinib .

Detailed description:

Arms: arm 1: Subjects will receive, trametinib once daily as a single tablet of 2 mg administered orally with eight ounces of water under fasting conditions either one hour before or 2 hours after a meal. arm 2: Subjects will receive on Day 1, trametinib as four tablets of 0.5 mg administered orally with eight ounces of water under fasting conditions either one hour before or 2 hours after a meal. arm 3: Subjects will receive Day 2 onwards, trametinib once daily as a single tablet of 2 mg administered orally with eight ounces of water under fasting conditions either one hour before or 2 hours after a meal.
Interventions: intervention 1: Trametinib (single tablet) intervention 2: Trametinib (Multiple tablet)
Intervention descriptions: intervention 1: The drug substance is blended with inert intervention 2: The drug substance is blended with inert

Protocol documents:
Clinical trial NCT01974700
Conditions: Intracranial Aneurysms Seizures
Sponsor: Indiana University
Start date: 2013-07-01; Completion date: 2016-02-01
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Seizures are a potential complication of surgical repair of intracranial aneurysms. In order to prevent seizures, many surgeons administer prophylactic anti-epileptic medication during the intra-operative and post-operative period, however, such practice is not supported by clinical data. Retrospective review found the incidence of postoperative seizures was higher in those who received anti-epileptics versus those who did not. The goal is to examine the utility of levetiracetam (Keppra) for seizure prophylaxis in patients undergoing surgical repair of unruptured intracranial aneurysms.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Levetiracetam
Intervention descriptions: intervention 1: 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days

Protocol documents:
Clinical trial NCT01983878
Conditions: Gastric Cancer
Sponsor: Eli Lilly and Company
Start date: 2013-12-01; Completion date: 2016-02-01
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate progression-free survival in participants with gastric or gastroesophageal junction cancer who have had disease progression following first-line therapy who undergo treatment with ramucirumab.

Detailed description:

Arms: arm 1: Ramucirumab 8 milligrams per kilogram (mg/kg) administered intravenously (IV) once every 2 weeks. Treatment will continue until there is evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance or withdrawal of consent.
Interventions: intervention 1: Ramucirumab
Intervention descriptions: intervention 1: Administered IV

Protocol documents:
Clinical trial NCT02002208
Conditions: Atopic Dermatitis
Sponsor: Atopix Therapeutics, Ltd.
Start date: 2013-10-01; Completion date: 2016-02-01
Enrollment: 142 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether OC000459 is in reducing disease severity and preventing flares in people with moderate to severe atopic dermatitis (AD).

Detailed description:
The study will include patients with a Th2 high eosinophilic phenotype who typically have more severe disease and are prone to flare.

Arms: arm 1: 50 mg orally once a day arm 2: Orally once a day
Interventions: intervention 1: OC000459
Intervention descriptions: intervention 1: Oral CRTH2 antagonist

Protocol documents:
Clinical trial NCT02016105
Conditions: Plaque Type Psoriasis
Keywords: plaque type psoriasis equivalent efficacy safety and immunogenicity GP2017 Humira®
Sponsor: Sandoz
Start date: 2013-12-01; Completion date: 2016-02-01
Enrollment: 465 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the study is to demonstrate equivalent efficacy and similarity in the safety profile of GP2017 and Humira® in patients with moderate to severe chronic plaque-type psoriasis.

Detailed description:
The aim of this study (Treatment Period 1) was to demonstrate equivalent efficacy, primarily based on the PASI75 response rate at Week 16, and similar safety of the proposed biosimilar GP2017 and Humira in patients with moderate to severe chronic plaque-type psoriasis at the end of Treatment Period 1, after 17 weeks of study treatment.

The subsequent Treatment Period 2 (Week 17 to Week 35) and the Extension Period (Week 35 to Week 51) were performed to evaluate long-term effects, including immunogenicity (i.e. ADAs), and the effects of repeated switching between GP2017 and Humira.

Arms: arm 1: Study arm with intervention being studied in the protocol. Adalimumab Solution for subcutaneous injection with an initial dose of 80 mg s.c. in Week 0, followed by 40 mg s.c. eow, starting at Week 1 and ending at Week 51. arm 2: Humira® Adalimumab as a subcutaneous injection with an initial dose of 80 mg s.c. in Week 0, followed by 40 mg s.c. eow, starting at Week 1 and ending at Week 51.
Interventions: intervention 1: GP2017 Adalimumab intervention 2: Humira ® Adalimumab
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02044380
Conditions: Carcinoma, Non-Small-Cell Lung
Sponsor: Boehringer Ingelheim
Start date: 2014-03-01; Completion date: 2016-02-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The main aim of this study is to evaluate the safety and tolerability of afatinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring Epidermal Growth Factor Receptor (EGFR) mutation(s) and have never been treated with an EGFR-Tyrosine Kinase Inhibitor (TKI)

Detailed description:

Arms: arm 1: patient to receive a tablet containing 40 mg afatinib once a day, with the option to reduce the dose to 30 or 20 mg/day, based on individual tolerability
Interventions: intervention 1: Afatinib
Intervention descriptions: intervention 1: 40, 30, or 20mg tablets taken once daily, dosage depending on tolerability

Protocol documents: