ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01441414
Conditions: Metastatic Renal Cell Carcinoma
Keywords: CVX-060 PF-04856884 AG-013736 axitinib mRCC metastatic renal cell cancer second line anti-angiogenic Ang-2
Sponsor: Pfizer
Start date: 2011-11-21; Completion date: 2014-03-27
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: 

Brief summary:
To evaluate the combination of PF-04856884 (CVX-060) in combination with Axitinib (AG-013736) in patients that have received one prior systemic regimen for metastatic renal cell carcinoma (mRCC) vs. axitinib alone.

Detailed description:
The study was prematurely discontinued on 06Nov2012 due to tolerability findings in patients treated in Part I of the study that have prompted the Sponsor to re-evaluate the strategic development of the program. An unexpected frequency of arterial thrombotic events (ATEs) and venous thrombotic events (VTEs) were reported in patients treated in Part I.

Arms: arm 1: PF-04856884 in combination with AG-013736 arm 2: AG-013736 alone
Interventions: intervention 1: PF-04856884 intervention 2: Axitinib (AG-013736) intervention 3: Axitinib (AG-013736)
Intervention descriptions: intervention 1: 15 mg/kg/week intravenously \[IV\] until toxicity or disease progression intervention 2: 5 mg PO BID intervention 3: 5 mg PO BID

Protocol documents:
Clinical trial NCT01232556
Conditions: Lymphoma, Non-Hodgkin
Keywords: inotuzumab ozogamicin aggressive Non-Hodgkin lymphoma diffuse large b-cell lymphoma relapsed/refractory lymphoma
Sponsor: Pfizer
Start date: 2011-04-04; Completion date: 2014-03-28
Enrollment: 338 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy of inotuzumab ozogamicin plus rituximab in relapsed/refractory aggressive Non-Hodgkin lymphoma patients who are not candidates for intensive high-dose chemotherapy. Specifically, the goal is to demonstrate the superiority of this combination compared with an active comparator arm (investigator's choice of rituximab+bendamustine or rituximab+gemcitabine) using the primary endpoint of overall survival.

Detailed description:

Arms: arm 1: Inotuzumab ozogamicin+rituximab arm 2: Investigator's choice of (1) rituximab+gemcitabine, or (2) rituximab+bendamustine
Interventions: intervention 1: Inotuzumab ozogamicin intervention 2: Rituximab intervention 3: rituximab + gemcitabine intervention 4: rituximab +bendamustine
Intervention descriptions: intervention 1: 1.8 mg/m2 on day 2 every 28 days by IV infusion, 3 to 6 cycles intervention 2: 375 mg/m2 on day 1 every 28 days by IV infusion, 3 to 6 cycles intervention 3: rituximab 375 mg/m2 on days 1, 8, 15, and 22 of cycle 1, and day 1 of cycles 2 to 6, every 28 days by IV infusion, 3 to 6 cycles; gemcitabine 1000 mg/m2 on days 1, 8, and 15 every 28 days, 3 to 6 cycles intervention 4: rituximab 375 mg/m2 on day 1 every 28 days by IV infusion, 3 to 6 cycles; bendamustine 120 mg/m2 on days 1 and 2 by IV infusion every 28 days, 3 to 6 cycles

Protocol documents:
Clinical trial NCT00955253
Conditions: Stroke Hemispatial Neglect
Keywords: Neglect Attention Vigilance Stroke Hemineglect Unilateral Neglect Spatial Neglect
Sponsor: Imperial College London
Start date: 2010-04-01; Completion date: 2014-03-28
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To find out if spatial neglect following stroke and brain injury can be reduced using guanfacine, a drug that was shown to improve neglect in two stroke patients in a previous pilot study (Malhotra et al, 2006). In this trial, the effects of guanfacine will be examined in a larger number of patients, and there will also be a systematic assessment of whether the drug is only effective in patients with particular patterns of brain damage.

Detailed description:
The current study has a double-blind crossover design where patients will receive a single 2mg dose of oral guanfacine and a single dose of placebo. They will receive one of these on Day 2 of the study period and the other on Day 4.

They will be tested daily on Days 1 to 5 so that any test repetition or long-term drug effects can be gauged.

On days 2 and 4 they will be tested twice-once prior to drug/placebo administration and again 90 minutes after drug/placebo administration.

Tests will include standard pen-and-paper tasks for neglect as well as computerised tests of sustained attention and visual exploration. In our published pilot study (Malhotra et al, 2006) there was a suggestion that patients without damage to frontal cortex were more likely to respond to guanfacine. In the current study we intend to test 10 patients with and 10 patients without frontal damage in order to test this further.

Arms: arm 1: All patients received a single dose of guanfacine on Day 2 and a single dose of placebo on Day 4. arm 2: All patients received a single dose of placebo on Day 2 and a single dose of guanfacine on Day 4.
Interventions: intervention 1: Guanfacine intervention 2: Placebo
Intervention descriptions: intervention 1: 2mg oral guanfacine (encapsulated) intervention 2: placebo

Protocol documents:
Clinical trial NCT01576575
Conditions: Healthy
Keywords: buprenorphine CYP3A
Sponsor: Washington University School of Medicine
Start date: 2010-06-01; Completion date: 2014-03-29
Enrollment: 21 participants; Allocation: ; Intervention model: SEQUENTIAL

Brief summary:
To evaluate role of CYP3A in buprenorphine disposition and effect

Detailed description:
Subjects will be studied during a maximum of seven occasions.

Study drugs are intravenous buprenorphine (0.025-0.2 mg infused over 1 hr) and sublingual buprenorphine (2-4 mg), with 1-3 week washout between sessions.

Sessions 1\&2: Control (no pretreatment) - intravenous and sublingual buprenorphine. Some subjects will only undergo session 1 (IV)

Sessions 3\&4: Liver and gut CYP3A induction (rifampin 600 mg daily), intravenous and sublingual buprenorphine

Session 5: Gut only CYP3A inhibition (grapefruit juice the night before), sublingual buprenorphine

Sessions 6\&7: Liver and gut CYP3A inhibition (ketoconazole 400 mg daily), intravenous and sublingual buprenorphine

Arms: arm 1: Subjects will be studied during a maximum of seven occasions.

Study drugs are intravenous buprenorphine (0.025-0.2 mg infused over 1 hr) and sublingual buprenorphine (2-4 mg), with 1-3 week washout between sessions.

Sessions 1\&2: Control (no pretreatment) - intravenous and sublingual buprenorphine. Some subjects will only undergo session 1 (IV)

Sessions 3\&4: Liver and gut CYP3A induction (rifampin 600 mg daily), intravenous and sublingual buprenorphine

Session 5: Gut only CYP3A inhibition (grapefruit juice the night before), sublingual buprenorphine

Sessions 6\&7: Liver and gut CYP3A inhibition (ketoconazole 400 mg daily), intravenous and sublingual buprenorphine
Interventions: intervention 1: Buprenorphine Control intervention 2: Buprenorphine + Rifampin intervention 3: Buprenorphine + Grapefruit juice intervention 4: Buprenorphine + Ketoconazole
Intervention descriptions: intervention 1: Control (no pretreatment) - intravenous and sublingual buprenorphine. Some subjects will only undergo session 1 (IV) intervention 2: Liver and gut CYP3A induction (rifampin 600 mg daily), intravenous and sublingual buprenorphine intervention 3: Gut only CYP3A inhibition (grapefruit juice the night before), sublingual buprenorphine intervention 4: Liver and gut CYP3A inhibition (ketoconazole 400 mg daily), intravenous and sublingual buprenorphine

Protocol documents:
Clinical trial NCT01794923
Conditions: Pain
Keywords: Delayed onset muscle soreness ibuprofen topical
Sponsor: Pfizer
Start date: 2013-06-13; Completion date: 2014-03-29
Enrollment: 205 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to compare the efficacy and safety of Ibuprofen 5% Topical Gel versus placebo administered two or three times daily for the treatment of pain associated with delayed onset muscle soreness following intense eccentric exercise of the elbow flexor muscles.

Detailed description:

Arms: arm 1: IBU BID (Treatment A) arm 2: Placebo BID (Treatment B) arm 3: IBU TID (Treatment C) arm 4: Placebo TID (Treatment D)
Interventions: intervention 1: IBU BID intervention 2: Placebo BID intervention 3: IBU TID intervention 4: Placebo TID
Intervention descriptions: intervention 1: 10-cm strip of IBU 5% topical gel applied to the affected area BID (twice daily) x 3 days intervention 2: 10-cm strip of placebo topical gel applied to the affected area BID (twice daily) x 3 days intervention 3: 10-cm strip of IBU 5% topical gel applied to the affected area TID (three times daily) x 3 days intervention 4: 10-cm strip of placebo topical gel applied to the affected area TID (three times daily) x 3 days

Protocol documents:
Clinical trial NCT01395810
Conditions: Congenital Bleeding Disorder Haemophilia B
Sponsor: Novo Nordisk A/S
Start date: 2012-04-15; Completion date: 2014-03-30
Enrollment: 71 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Asia, Europe, Japan, North America and South Africa. The aim is to evaluate the safety and efficacy of nonacog beta pegol (NNC-0156-0000-0009) after long-term exposure in patients with haemophilia B.

This trial is an extension to trials NN7999-3747 (NCT01333111/paradigm™ 2) and NN7999-3773 (NCT01386528/paradigm™ 3).

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: nonacog beta pegol intervention 2: nonacog beta pegol intervention 3: nonacog beta pegol
Intervention descriptions: intervention 1: One single dose administered intravenously (into the vein) once weekly. Patients will receive instruction on how to treat any bleeding episode they may experience. intervention 2: One single dose administered intravenously (into the vein). Patients will treat themselves with either a low or a high dose dependent on the severity of the bleeding episode. intervention 3: One single dose administered intravenously (into the vein) every second week. Patients will receive instruction on how to treat any bleeding episode they may experience.

Protocol documents:
Clinical trial NCT02605395
Conditions: Gastrointestinal Diseases
Keywords: Bioequivalence Fed condition PARIET 20 mg IDIAZOLE 20mg Rabeprazole
Sponsor: GlaxoSmithKline
Start date: 2014-03-22; Completion date: 2014-03-30
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is an open-label, randomized, single dose, two-sequence, two-periods crossover study, separated by 7 days washout interval from the first Study Drug Administration. This study is conducted to determine the bioequivalence of Rabeprazole from IDIAZOLE 20mg Delayed-Release (DR) tablets (tabs) and PARIET 20 mg DR tabs after a single oral dose administration of each to healthy adults fed under conditions.

In Period 1, subjects will be randomized to either Idiazole 20mg DR tabs or PARIET 20 mg DR tabs. Following a washout of at least 7 days, subjects will be crossed over in Period 2 to receive the treatment that they did not receive in Period 1.

PARIET is a registered trademark of EISAI Co. Limited.

Detailed description:

Arms: arm 1: Subjects will receive a single oral dose of IDIAZOLE 20mg DR tabs under fed condition in treatment period 1 followed by 7 days washout interval from the first study drug administration. After the washout interval the subjects will receive a single dose of PARIET 20 mg DR tabs under fed condition in treatment period 2. arm 2: Subjects will receive a single oral dose of PARIET 20 mg DR tabs under fed condition in treatment period 1 followed by 7 days washout interval from the first study drug administration. After the washout interval the subjects will receive a single dose of Idiazole 20mg DR tabs under fed condition in treatment period 2.
Interventions: intervention 1: IDIAZOLE 20mg DR tabs intervention 2: PARIET 20 mg DR tabs
Intervention descriptions: intervention 1: IDIAZOLE 20mg DR tabs is a delayed-release, enteric-coated tablets containing 20 mg of rabeprazole sodium. intervention 2: PARIET 20 mg DR tabs is a delayed-release, enteric-coated tablets containing 20 mg rabeprazole sodium.

Protocol documents:
Clinical trial NCT01629966
Conditions: Generalized Anxiety Disorder
Keywords: Generalized Anxiety Disorder GAD
Sponsor: Forest Laboratories
Start date: 2012-06-30; Completion date: 2014-03-31
Enrollment: 680 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy, safety and tolerability of vilazodone relative to placebo in the treatment of generalized anxiety disorder (GAD)

Detailed description:

Arms: arm 1: Dose-matched placebo one per day, oral administration arm 2: Vilazodone 20mg once per day, oral administration. arm 3: Vilazodone 40mg once per day, oral administration
Interventions: intervention 1: Placebo intervention 2: Vilazodone intervention 3: Vilazodone
Intervention descriptions: intervention 1: Matching 10 mg and 20 mg placebo tablets, once per day, oral administration, intervention 2: Vilazodone, 20mg, oral administration once per day. intervention 3: Vilazodone, 40mg, oral administration once per day.

Protocol documents:
Clinical trial NCT00297232
Conditions: Relapsing-Remitting Multiple Sclerosis
Keywords: Multiple Sclerosis MS
Sponsor: Biogen
Start date: 2006-03-01; Completion date: 2014-04-01
Enrollment: 1094 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objectives for the initial treatment period of this study are to further evaluate the safety of natalizumab monotherapy by evaluating the risk of hypersensitivity reactions and immunogenicity following re-exposure to natalizumab and confirming the safety of switching from interferon (IFN), glatiramer acetate, or other multiple sclerosis (MS) therapies to natalizumab. The primary objective for the long-term treatment period of this study is to evaluate the long-term impact of natalizumab monotherapy on the progression of disability measured by Expanded Disability Status Scale (EDSS) changes over time.

Detailed description:
Study 101-MS-322 (NCT00306592) was conducted to evaluate the safety of natalizumab monotherapy following re-exposure to natalizumab in former clinical trial participants in Studies C-1801 (NCT00027300), C-1802 (NCT00030966), and C-1803 (NCT00097760) and included subjects in North America. In parallel with the conduct of that study, this study (101-MS-321 \[NCT00297232\]) was initiated for participants in Europe and the rest of the world. In addition, after 48 weeks, participants from 101-MS-322 (NCT00306592) could enter study 101-MS-321 (NCT 00297232), which was considered the Long-Term Treatment Period of 101-MS-322 (NCT00306592).

The primary purpose and primary outcome for both studies are identical; therefore, the combined long-term data from both studies are presented. (Combined Week 48 data from both studies are presented in the 101-MS-322 \[NCT00306592\] record.)

Arms: arm 1: 300 mg intravenous (IV) infusions once every 4 weeks for up to 480 weeks
Interventions: intervention 1: Natalizumab
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00778830
Conditions: Metastatic Colorectal Cancer
Keywords: mCRC
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2009-02-01; Completion date: 2014-04-01
Enrollment: 289 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an open-label, non-randomized, multicenter Phase II study evaluating folinic acid + fluorouracil + irinotecan (FOLFIRI) plus cetuximab (Erbitux) or folinic acid + fluorouracil + oxaliplatin (FOLFOX) plus cetuximab as first-line therapy of patients with KRAS wild-type metastatic colorectal cancer.

Only subjects with k-ras oncogene (KRAS) wild-type tumors are eligible. Efficacy will be assessed every 8 weeks. Treatment will be continued until progressive disease or unacceptable adverse events occur. After the end of study treatment, information on further anticancer treatment and survival will be collected every 3 months.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Cetuximab intervention 2: FOLFIRI intervention 3: FOLFOX
Intervention descriptions: intervention 1: Cetuximab will be administered intravenously at a dose of 500 milligram per square meter (mg/m\^2) biweekly on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent. intervention 2: Irinotecan will be administered intravenously at a dose of 180 mg/m\^2 along with folinic acid administration intravenously at a dose of 400 mg/m\^2 (racemic) or 200 mg/m\^2 (L-form) and 5-fluorouracil will be administered intravenously at a dose of 400 mg/m\^2 bolus followed by a 46-hour continuous infusion of 2,400 mg/m\^2 given biweekly until disease progression, death, or consent withdrawal. intervention 3: Oxaliplatin will be administered intravenously at a dose of 100 mg/m\^2 along with folinic acid administration intravenously at a dose of 400 mg/m\^2 (racemic) or 200 mg/m\^2 (L-form) and 5-fluorouracil administration intravenously at a dose of 400 mg/m\^2 bolus followed by a 46-hour continuous infusion of 2,400 mg/m\^2 given biweekly until disease progression, death, or consent withdrawal.

Protocol documents:
Clinical trial NCT00833417
Conditions: Basal Cell Carcinoma
Keywords: BCC Hedgehog Pathway Inhibitor Hedgehog Basal Cell Cancer
Sponsor: Genentech, Inc.
Start date: 2009-02-01; Completion date: 2014-04-01
Enrollment: 104 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This was a Phase II, single-arm, two-cohort multicenter clinical trial evaluating the efficacy and safety of vismodegib (GDC-0449) in patients with advanced basal cell carcinoma. All patients received vismodegib until evidence of progression, intolerable toxicities most probably attributable to vismodegib, or withdrawal from the study.

Detailed description:

Arms: arm 1: Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
Interventions: intervention 1: Vismodegib 150 mg
Intervention descriptions: intervention 1: Vismodegib 150 mg was provided in hard gelatin capsules.

Protocol documents:
Clinical trial NCT01117987
Conditions: Pulmonary Arterial Hypertension
Keywords: Pulmonary arterial hypertension, imatinib, 6MWD, pulmonary hypertension
Sponsor: Novartis Pharmaceuticals
Start date: 2010-04-01; Completion date: 2014-04-01
Enrollment: 144 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a multinational, multi center extension study. This study will provide data on the long-term safety, tolerability, and efficacy of imatinib in the treatment of severe pulmonary arterial hypertension.

Detailed description:

Arms: arm 1: Depending on the participants' randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated. arm 2: Depending on the participants' randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
Interventions: intervention 1: Imatinib intervention 2: Placebo
Intervention descriptions: intervention 1: Participants, who received imatinib 200 mg in the core study, CQTI571A2301 (NCT00902174), and completed the core study, received imatinib 200 mg every day (qd) in the extension. Participants, who were randomized to receive imatinib 400 mg in the core study and completed the core study, received imatinib 400 mg qd in the extension. Participants, who terminated early from the core study or who were randomized to placebo and completed the core study, started the extension with imatinib 200 mg qd. After 2 weeks, the dose was increased to 400 mg qd if tolerated. intervention 2: To preserve the blind of the core study until the core study, CQTI571A2301 (NCT00902174), was completed, participants received a blinded study drug package containing a 70-tablet bottle of imatinib and a 70-tablet bottle of matching placebo.

Protocol documents:
Clinical trial NCT01193348
Conditions: Atypical Hemolytic-Uremic Syndrome
Keywords: Atypical Hemolytic-Uremic Syndrome
Sponsor: Alexion Pharmaceuticals, Inc.
Start date: 2010-09-01; Completion date: 2014-04-01
Enrollment: 22 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose is to assess the efficacy and safety of eculizumab in pediatric patients with aHUS to control TMA as characterized by thrombocytopenia, hemolysis and renal impairment.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Eculizumab
Intervention descriptions: intervention 1: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.

Protocol documents:
Clinical trial NCT01297270
Conditions: Hepatitis C
Sponsor: Boehringer Ingelheim
Start date: 2011-04-01; Completion date: 2014-04-01
Enrollment: 658 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this trial is to evaluate the efficacy and safety of two different treatment regimens with BI 201335, both in combination with PegIFN/RBV) as compared to standard of care (SOC) with PegIFN/RBV alone.

Detailed description:

Arms: arm 1: 48 weeks arm 2: BI 201 335 QD dosing in combination with IFN/RBV arm 3: BI 201335 QD doing in combination with PEFG IFN/RBV arm 4: None
Interventions: intervention 1: BI201335 intervention 2: PegIFN/RBV intervention 3: BI201335 intervention 4: Placebo
Intervention descriptions: intervention 1: QD BI 201335 intervention 2: None intervention 3: QD (once daily) BI 201335 intervention 4: None

Protocol documents: