ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01207102
Conditions: Metastatic Breast Cancer
Keywords: Breast cancer Triple negative
Sponsor: Duke University
Start date: 2011-08-01; Completion date: 2014-06-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Taxanes (such as paclitaxel) are highly active to treat breast cancer. Abraxane® (nanoparticle albumin-bound paclitaxel) compared to standard paclitaxel improves efficacy and tolerability. When combined with a taxane, platinum agents improve response in metastatic breast cancer, with carboplatin conferring less toxicity than cisplatin. The investigators hypothesize that the combination of weekly Abraxane® and carboplatin will lengthen time to progression without producing intolerable toxicity.

Detailed description:
Paclitaxel and cisplatin are well-recognized for their activity in treating a variety of tumors including breast cancer. As cytotoxins, they have been studied alone and in combination with other chemotherapeutic agents, and have been incorporated into treatment regimens for women who fail previous anthracycline-based therapies. Although both agents are notable for favorable response rates, they are also associated with a variety of adverse events, some of which may be dose-limiting and having a negative effect on quality of life: myelosuppression, nausea and vomiting, diarrhea, stomatitis/mucositis, short- and long-term neuropathy, nephrotoxicity, alopecia and hypersensitivity reactions.

As second-generation compounds, Abraxane® and carboplatin have been shown to improve response rates and may mediate some of the toxicities associated with paclitaxel and cisplatin, respectively. Of particular interest is Abraxane's potential to reduce allergic reactions associated with other taxanes.

This study combines these two agents: primarily, to evaluate progression-free survival; and secondarily, to assess the feasibility and tolerability of this regimen to treat poor prognosis metastatic breast cancer patients.

Arms: arm 1: Abraxane 100mg/m2 IV days 1, 8 and 15 of a 28 day cycle Carboplatin area under the concentration curve, (AUC)2 IV days 1,8, and 15 of a 28 day Cycle
Interventions: intervention 1: Abraxane intervention 2: Carboplatin
Intervention descriptions: intervention 1: Abraxane® 100 mg/m2 IV over 30 min days 1,8,15 every 28 days intervention 2: area under curve(AUC)=2 over 15 minutes days 1,8,15 every 28 days

Protocol documents:
Clinical trial NCT01212874
Conditions: Hypertension
Sponsor: Loma Linda University
Start date: 2010-12-01; Completion date: 2014-06-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an investigator initiated, sponsored, open label, prospective randomized controlled trial to be performed in adult patients undergoing scheduled cardiac surgery. Patients will be randomized to esmolol infusion or nitroglycerin infusion for control of hypertension that occurs during cardiac surgery from induction of anesthesia to initiation of cardiopulmonary bypass (CPB).

Detailed description:

Arms: arm 1: nitroglycerin titrated to control hypertension between anesthesia induction and initiation of cardiopulmonary bypass arm 2: esmolol titrated to control hypertension between anesthesia induction and initiation of cardiopulmonary bypass
Interventions: intervention 1: nitroglycerin intervention 2: esmolol
Intervention descriptions: intervention 1: nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery. intervention 2: esmolol will be administered by infusion following a step up / step down protocol to control hypertension.

Protocol documents:
Clinical trial NCT01226732
Conditions: Metastatic or Unresectable Solid Tumor Malignancy
Keywords: Solid tumor Capecitabine Hsp90 inhibitor AUY922
Sponsor: SCRI Development Innovations, LLC
Start date: 2010-11-01; Completion date: 2014-06-01
Enrollment: 23 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The investigators propose this Phase I trial of the combination of AUY922 and capecitabine to determine the maximum tolerated dose (MTD) in patients with advanced solid tumors. This combination treatment has potential applicability in tumor types where capecitabine or fluorouracil is a treatment option, including colorectal and breast cancer.

Detailed description:

Arms: arm 1: Hsp90 Inhibitor AUY922: 22mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles arm 2: Hsp90 Inhibitor AUY922: 28mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles arm 3: Hsp90 Inhibitor AUY922: 40mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles arm 4: Hsp90 Inhibitor AUY922: 55mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles arm 5: Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles arm 6: Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1250mg/m2 PO BID d 1-14 of 21-day cycles
Interventions: intervention 1: Capecitabine intervention 2: Hsp90 Inhibitor AUY 922
Intervention descriptions: intervention 1: Taken orally twice daily on Days 1 through 14 of 21 day cycle. intervention 2: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle

Protocol documents:
Clinical trial NCT01242813
Conditions: TNF-receptor Associated Periodic Syndromes (TRAPS)
Keywords: TNF-receptor associated periodic syndrome fevers rashes musculoskeletal and abdominal pain periorbital edema TNFR1
Sponsor: Novartis Pharmaceuticals
Start date: 2010-10-01; Completion date: 2014-06-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This trial will assess the safety and efficacy of ACZ885 in patients with active recurrent or chronic TNF-receptor associated periodic syndrome (TRAPS).

Detailed description:

Arms: arm 1: This was an open-label, single treatment arm, multicenter study of monthly canakinumab 150 mg (2 mg/kg for patient ≤ 40 kg) subcutaneous injections in patients with active recurrent or chronic TRAPS.
Interventions: intervention 1: ACZ885
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01249417
Conditions: Cerebral Palsy Muscle Spasticity Children
Sponsor: Ipsen
Start date: 2011-07-01; Completion date: 2014-06-01
Enrollment: 241 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to determine whether Dysport® is effective in the treatment of increased stiffness of the calf muscles and to evaluate the safety of this treatment in children with Cerebral Palsy. In addition this study will also check whether Dysport® can lessen the pain caused by spasticity and improve the child's wellbeing.

Detailed description:

Arms: arm 1: 10 U/Kg per lower limb. Either one or both lower limbs can be treated. Total volume injected, 2ml per leg. arm 2: 15 U/Kg per lower limb. Either one or both lower limbs can be treated. Total volume injected, 2ml per leg. arm 3: Total volume to be injected per lower limb - 2ml. Either one or both lower limbs can be treated.
Interventions: intervention 1: Botulinum toxin type A intervention 2: Placebo
Intervention descriptions: intervention 1: I.M. (in the muscle) injection on day 1 of a single treatment cycle. intervention 2: I.M. injection on day 1 of a single treatment cycle.

Protocol documents:
Clinical trial NCT01281917
Conditions: Non-Hodgkins Lymphoma
Keywords: velcade temsirolimus non-hodgkins lymphoma
Sponsor: University of Wisconsin, Madison
Start date: 2011-02-01; Completion date: 2014-06-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The investigators want to find out if the drugs Velcade and temsirolimus given together are effective in treating cancer. Velcade and temsirolimus are each FDA approved individually for certain types of cancer (Velcade for multiple myeloma and mantle cell lymphoma, and temsirolimus for renal cell carcinoma) but are not currently approved in combination for B-cell non-Hodgkin lymphoma. The investigators are trying to find out if giving these 2 drugs together will improve the period of time that the patient's cancer is stopped or slowed from growing and causing symptoms.

Detailed description:

Arms: arm 1: Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)

Treat for up to 6 cycles, cycles are 35 days long.
Interventions: intervention 1: Velcade intervention 2: Temsirolimus
Intervention descriptions: intervention 1: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22) intervention 2: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)

Protocol documents:
Clinical trial NCT01286441
Conditions: Common Warts
Keywords: Verruca vulgaris
Sponsor: ViroXis Corporation
Start date: 2012-11-01; Completion date: 2014-06-01
Enrollment: 183 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Nonclinical studies have shown sandalwood oil to have anti-inflammatory, anti-fungal, antiviral, and anti-bacterial activities. Previous clinical studies have shown East Indian Sandalwood oil to be promising as a treatment for common warts in adults and children.

The primary objective of this study is to evaluate the efficacy and safety of 10%, 20%, and 30% East Indian Sandalwood Oil (EISO) ointment compared with the ointment placebo administered twice daily (bid) for 12 weeks for the treatment of common warts (Verruca vulgaris).

Detailed description:

Arms: arm 1: Placebo for East Indian Sandalwood Oil ointment administered topically twice daily arm 2: East Indian Sandalwood Oil ointment, 10% (w/w), applied topically twice daily arm 3: East Indian Sandalwood Oil ointment, 20% (w/w), applied topically twice daily arm 4: East Indian Sandalwood Oil ointment, 30% (w/w), applied topically twice daily
Interventions: intervention 1: 10% EISO intervention 2: Placebo intervention 3: 20% EISO intervention 4: 30% EISO
Intervention descriptions: intervention 1: During the Treatment Period, subjects will apply study medication (10% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks. intervention 2: During the Treatment Period, subjects will apply placebo to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks. intervention 3: During the Treatment Period, subjects will apply study medication (20% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks. intervention 4: During the Treatment Period, subjects will apply study medication (30% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks.

Protocol documents:
Clinical trial NCT01289821
Conditions: Colorectal Neoplasms
Sponsor: Bayer
Start date: 2011-02-01; Completion date: 2014-06-01
Enrollment: 54 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a study to evaluate the efficacy (effectiveness) and the safety of regorafenib when given in combination with chemotherapy mFOLFOX6 as first line therapy in patients with metastatic colorectal cancer (CRC). mFOLFOX6 is an approved chemotherapy. Regorafenib is an oral (i.e. taken by mouth) multi-targeted kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. By specifically targeting these proteins, regorafenib may stop cancer growth. The growth of the tumor may be decreased by preventing these specific proteins from functioning.

The primary endpoint (the most meaningful result to be tracked) of this study is based on the rate of response, i.e. the disease getting smaller. The aim is to show that the therapy of colorectal cancer with mFOLFOX6 in combination with regorafenib improves the response rate observed for the standard therapy only.

Detailed description:

Arms: arm 1: On Day 1, participants received 85 mg/m\^2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m\^2 D/L-folinic acid or 200 mg/m\^2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m\^2 IV bolus injection immediately followed by a 5-FU 2400 mg/m\^2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
Interventions: intervention 1: Regorafenib (Stivarga, BAY73-4506) intervention 2: Oxaliplatin intervention 3: Folinic acid intervention 4: 5-FU (mFOLFOX6)
Intervention descriptions: intervention 1: Subjects will receive regorafenib 160 mg od on days 4 to 10 and days 18 to 24 as four 40 mg coprecipitate tablets. In case of administration as a single agent during the study, regorafenib will be administered 160 mg od for 3 weeks on/1 week off. Each cycle consists of 28 days. intervention 2: On day 1 and day 15 of each cycle, participants will receive 85 mg/m\^2 oxaliplatin as a 2 hour i.v. infusion. intervention 3: On day 1 and day 15 of each cycle, participants will receive folinic acid (either 400 mg/m\^2 D/L-folinic acid or 200 mg/m\^2 L-folinic acid) as a 2 hour i.v. infusion. intervention 4: Participants will receive a 400 mg/m\^2 5 FU i.v. bolus injection immediately followed by a 2400 mg/m\^2 5 FU 46 hour i.v. infusion.

Protocol documents:
Clinical trial NCT01306331
Conditions: Contraception
Sponsor: Evofem Inc.
Start date: 2011-04-01; Completion date: 2014-06-01
Enrollment: 3389 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a research study of a new experimental vaginal gel that helps in vaginal pH regulation and results in immobilization of spermatozoa by maintaining the normally low vaginal pH, even in the presence of semen. This vaginal gel is called Phexxi™ (previously known as Amphora) and was compared to a commercially available spermicide called Conceptrol®, which contains nonoxynol 9; commonly abbreviated as N-9. Conceptrol® can help prevent pregnancy. This study objective was to determine if this product prevents pregnancy when inserted into the vagina before intercourse.

Detailed description:
Clinical Trial Design

This is a multicenter, open-label, randomized, controlled, Phase III study of repeated use of Amphora™ gel compared to Conceptrol® Vaginal Gel as the method of contraception over seven cycles of use. In addition, there is an opportunity for Amphora™ gel subjects to continue with study treatment for up to 13 cycles of treatment upon completion of the first seven cycles of treatment.

A subset of subjects (Amphora™ gel and Conceptrol® Vaginal Gel) will undergo colposcopy at the Admission Visit and at the visits after Cycles 1, 3, and 7 (Treatment Exit). Subjects participating for 13 cycles will also undergo colposcopy after Cycles 10 and 13. Colposcopic photographs will be taken at all visits independent of presence of any suspicious areas. Any suspicious areas and clinical findings will be recorded on the colposcopy case report form. The colposcopy evaluator for the subset will be blinded regarding the treatment group of the subject. If at any time during the study the investigator deems colposcopy necessary, colposcopy will be performed on any subject and will not be limited to subjects in the colposcopy subset.

A subset of subjects (Amphora™ gel and Conceptrol® Vaginal Gel) will also have semi-quantitative cultures for E. coli and clinical yeast performed at the Admission Visit and after Cycles 1, 3, and 7 (Treatment Exit) Visits. Subjects participating for 13 cycles will also undergo the assessments after Cycles 10 and 13. Another subgroup will have quantitative vaginal cultures performed after Cycles 1 and 7 (Treatment Exit) Visits, and also after Cycle 13 for subjects participating in the extension.

Selected research centers will also recruit subjects into the subset of women 36-45 years of age at enrollment.

Arms: arm 1: 100 mg (4% concentration) of nonoxynol-9 in 2.5 mL volume of gel arm 2: Citric acid USP, potassium bitartrate USP, and L-lactic acid USP
Interventions: intervention 1: Conceptrol intervention 2: Amphora
Intervention descriptions: intervention 1: • Conceptrol® Vaginal Gel, which contains 100 mg (4% concentration) of nonoxynol-9 (N-9) in 2.5 mL volume of gel. intervention 2: • Amphora™ gel, which will be delivered in 5 mL doses, is a clear, water-based, petroleum-free gel.

Protocol documents:
Clinical trial NCT01313780
Conditions: Cancer
Keywords: cancer related pain
Sponsor: Mundipharma Korea Ltd
Start date: 2011-05-01; Completion date: 2014-06-01
Enrollment: 128 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Objectives:

To prove non-inferiority of Targin compared to Oxycontin in terms of change of pain intensity

1. Primary objective: Change of pain intensity (NRS 0-10) score (average pain over 24 hours obtained each evening) within 4 weeks
2. Secondary objectives: Bowel Habit (worsening/no change/improving), Total dose and frequency of rescue medication, Quality of Life (QOL; EORTC QLQ-C30), Duration to need of laxative use and Adverse events

Detailed description:
This will be a 4-week multicentre, randomized, open label, parallel group, active control study to evaluate efficacy and safety of Targin in comparison with Oxycontin in Korean patients with cancer pain who are administered weak opioid or naïve patients including patient not on the long term strong opioid medication within 3 months.

Arms: arm 1: Trade name is Targin(fixed combination drug). arm 2: Trade name is Oxycontin(single compound).
Interventions: intervention 1: Oxycodone/Naloxone intervention 2: Oxycodone(single compound)
Intervention descriptions: intervention 1: Dose and administration : Upto 40mg B.I.D per daily. intervention 2: Dose and administration : Upto 40mg B.I.D per daily.

Protocol documents:
Clinical trial NCT01317004
Conditions: Relapsing Remitting Multiple Sclerosis
Keywords: Multiple sclerosis Fingolimod Disease Modifying Therapy TSQM-9
Sponsor: Novartis Pharmaceuticals
Start date: 2011-05-01; Completion date: 2014-06-01
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the change in patient-reported treatment satisfaction after 6 months of treatment with fingolimod 0.5mg/day vs. DMT standard of care, using the global satisfaction subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM-9).

Detailed description:

Arms: arm 1: Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period. arm 2: Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
Interventions: intervention 1: Fingolimod intervention 2: Standard MS DMT
Intervention descriptions: intervention 1: 0.5 mg/day oral capsule intervention 2: Interferon beta 1a or interferon beta 1b or Glatiramer Acetate

Protocol documents:
Clinical trial NCT01330316
Conditions: Hepatitis C
Sponsor: Boehringer Ingelheim
Start date: 2011-07-01; Completion date: 2014-06-01
Enrollment: 119 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this trial is to collect evidence for the safety and efficacy of 24 weeks of treatment with BI 201335 240 mg in combination with 24 or 48 weeks of Pegylated Interferon (PegIFN) and ribavirin (RBV) in treatment experienced patients who have been withdrawn from PegIFN and RBV treatment due to lack of efficacy in the 1220.7, 1220.30 and 1220.47 trials.

Detailed description:

Arms: arm 1: BI 201335 once daily dose for 24 weeks in combination with PegIFN/RBV for 24 or 48 weeks
Interventions: intervention 1: BI 201335 intervention 2: PegIFN/RBV
Intervention descriptions: intervention 1: BI 201335 for 24 weeks intervention 2: PegIFN/RBV for 48 weeks

Protocol documents:
Clinical trial NCT01332149
Conditions: Diabetic Neuropathy, Painful
Keywords: Diabetic Neuropathies Pain Efficacy of pregabalin Placebo controlled
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2011-07-01; Completion date: 2014-06-01
Enrollment: 626 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Pregabalin has proven effective in previous clinical trails in other countries in relieving neuropathic pain associated with postherpetic neuralgia and painful diabetic neuropathy.

This study is being conducted according to China registration requirement to submit a reapplication with new local diabetic peripheral neuropathy study as a commitment plus the existing data to apply for Lyrica "pain associated with postherpetic neuralgia" indication after Lyrica "pain associated with postherpetic neuralgia" is approved.

Detailed description:

Arms: arm 1: Patient take pregabalin capsule twice a day arm 2: None
Interventions: intervention 1: Pregabalin intervention 2: Placebo matched with pregabalin
Intervention descriptions: intervention 1: Subjects in the pregabalin group will start treatment with pregabalin capsule 150 mg/day for 1 week, then their dose will be increased to 300mg/day. After 1-week titration period, dose must be stable during study, no dose adjustment is permitted, and subject who cannot tolerate 300 mg/day pregabalin will be withdrawn.

At the completion of the dose maintenance phase subjects will taper off study medication over a 1-week period. 300 mg/ day subjects will taper to 150 mg/ day. intervention 2: Subject will take placebo matched with pregabalin twice a day.

Protocol documents: