ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01250379
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2011-02-01; Completion date: 2015-03-01
Enrollment: 494 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized, open-label, parallel-group study will assess the efficacy and s afety of Avastin (bevacizumab) in combination with chemotherapy versus chemother apy alone as second- and third-line therapy in patients with locally recurrent o r metastatic breast cancer progressing after first-line therapy with Avastin and chemotherapy. Patients will be randomized to receive either Avastin (15 mg/kg e very 3 weeks or 10 mg/kg every 2 weeks intravenously) plus standard chemotherapy or chemotherapy alone. Anticipated time on study treatment is until third-line disease progression or unacceptable toxicity occurs.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: bevacizumab [Avastin] intervention 2: Chemotherapy
Intervention descriptions: intervention 1: 10 mg/ kg iv every 2 weeks or 15 mg/kg iv every 3 weeks intervention 2: Standard chemotherapy (doublets not allowed)

Protocol documents:
Clinical trial NCT01281007
Conditions: GENITAL HERPES
Keywords: Herpes Simplex Virus
Sponsor: EMS
Start date: 2012-07-01; Completion date: 2015-03-01
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Recurrent genital herpes is a commonly occurring sexually transmitted disease caused by herpes simplex virus (HSV). There are effective oral prescription antiviral medicines available to reduce the discomfort of symptoms, such as famciclovir and aciclovir.

This is a phase III, multicenter, randomized, parallel-group study to compare the efficacy and safety of treatment with famciclovir (125 mg) versus aciclovir (200 mg) in patients with active recurrent genital herpes.

Detailed description:
STUDY DESIGN

* Open-label, prospective, parallel group, intent to treat trial
* Experiment duration: 5 days
* 2 visits (days 1, and 5)
* Reduction of symptoms
* Adverse events evaluation

Arms: arm 1: 1 tablet every 12 hours for 5 days arm 2: 1 tablet every 4 hours (excluding nocturnal dose) for 5 days
Interventions: intervention 1: Famciclovir intervention 2: Aciclovir
Intervention descriptions: intervention 1: Famciclovir 125 mg every 12 hours for 5 days intervention 2: Aciclovir 200 mg every 4 hours fo 5 days

Protocol documents:
Clinical trial NCT01291511
Conditions: Schizophrenia
Keywords: Schizophrenia Mental Disorders Antipsychotic Agents Iloperidone Relapse Prevention
Sponsor: Vanda Pharmaceuticals
Start date: 2011-02-01; Completion date: 2015-03-01
Enrollment: 635 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether Iloperidone is effective in the prevention of relapse in patients with schizophrenia

Detailed description:

Arms: arm 1: After meeting all entry criteria, completing a 1-week open-label iloperidone titation period (up to 12 mg/day), followed by a 14-24 week open-label iloperidone flexible dose-stabilization period (up to 24 mg/day), approximately 260 patients will be randomized to one of two arms in a 1:1 ratio of iloperidone (flexible dosing 8-24 mg/day) to placebo. Post-randomization double-blind study medication will be administered orally twice daily for up to 26 weeks to evaluate relapse prevention. Subsequently, during the extension period, after a 1-week mock double-blind titration, open-label iloperidone (8-24 mg/day) is administered for up to 51 weeks to evaluate long-term safety. arm 2: Post-randomization matching placebo is administered orally bid during the double-blind period.
Interventions: intervention 1: Iloperidone intervention 2: Placebo
Intervention descriptions: intervention 1: Over-encapsulated iloperidone tablets were administered orally using a bid schedule; the strengths used include 1, 2, 4, 6, 8, 10, and 12 mg. intervention 2: Matching placebo capsules were administered orally using a bid schedule during the double-blind period.

Protocol documents:
Clinical trial NCT01317615
Conditions: Carcinoma, Large Cell Neuroendocrine Tumors
Keywords: Large cell carcinoma, Lung cancer, Neuroendocrine Tumors, RAD001
Sponsor: Novartis Pharmaceuticals
Start date: 2011-04-01; Completion date: 2015-03-01
Enrollment: 49 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a multi-centric, open-label study evaluating the efficacy and safety of RAD001 in patients with advanced (stage IV) Lung Cancer (Large Cell) with neuroendocrine differentiation treated with a combination of RAD001 with paclitaxel and carboplatin.

Detailed description:

Arms: arm 1: Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
Interventions: intervention 1: RAD001 intervention 2: Paclitaxel intervention 3: Carboplatin
Intervention descriptions: intervention 1: Participants started RAD001 treatment with a dose of 5 mg/day once daily. A dose decrease to 5 mg every other day was allowed if tolerability issues arose. intervention 2: Paclitaxel was started at doses of 175 mg/m². Dose reductions of Paclitaxel to 135 mg/m2 was permitted if tolerability issues arose. intervention 3: Carboplatin was started at doses of Area under the Curve 5 (AUC 5). Dose reductions of carboplatin to AUC 4 was permitted if tolerability issues arose.

Protocol documents:
Clinical trial NCT01320293
Conditions: Psoriasis
Keywords: Moderate to Severe Chronic plaque type psoriasis
Sponsor: University of North Carolina, Chapel Hill
Start date: 2011-03-01; Completion date: 2015-03-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Severe psoriasis has been demonstrated to be associated with decreased endothelial function and an increase risk of future coronary events. Although systemic therapy with immunomodulatory agents has been shown to improve psoriatic symptoms, its effects on systemic inflammation and endothelial function are unknown.

In this study we want to assess the cardiovascular risks factors, endothelial dysfunction and inflammatory markers before and after treatment of moderate to severe psoriasis with an FDA-approved biologic agent, adalimumab (Humira).

Detailed description:

Arms: arm 1: Adalimumab 40 MG/0.8 ML Subcutaneous Solution \[HUMIRA\] Dose administered every other week for 6 months
Interventions: intervention 1: Adalimumab 40 MG/0.8 ML Subcutaneous Solution [HUMIRA]
Intervention descriptions: intervention 1: 40mg subcutaneously, every other week for 6 months

Protocol documents:
Clinical trial NCT01328054
Conditions: Cancer
Keywords: cancer cardiac repolarization Holter monitor pharmacokinetics GW572016 lapatinib QTc interval safety ECG
Sponsor: GlaxoSmithKline
Start date: 2011-12-01; Completion date: 2015-03-01
Enrollment: 58 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will estimate the effect of lapatinib on cardiac repolarization (QTc interval duration) in subjects with advanced solid tumors. The study treatment period will occur over five days and an End of Study visit will be conducted on Day 8 (or no later than 3 days beyond Day 8). Subjects will receive placebo that mimics lapatinib for 2 days as three separate doses given 12 hours apart (8 tablets/dose) and lapatinib (2000mg) for 2 days as three separate doses given 12 hours apart (8 tablets/dose). Subjects will not know when they are receiving placebo vs. lapatinib. Digital 12-lead ECG recordings will be extracted from continuous ECG recordings obtained via a Holter monitor to measure QTc interval duration. Triplicate ECG measurements of QTc interval will be taken at pre-specified times at Day 1 (Baseline) and pre-dose and up to 24 hours after the third dose of placebo or lapatinib on Study Days 2 and 4. Pharmacokinetic sampling will occur immediately following each pre-specified QTc measurement in subjects dosed with placebo or lapatinib. Subjects who complete participation in this study, if they are eligible, will be offered the option to continue treatment with lapatinib, either alone or in combination with other oncology drugs in pre-selected anticancer regimens, in a continuation protocol, EGF111767.

Detailed description:

Arms: arm 1: This is a crossover study where subjects will receive placebo that mimics lapatinib for 2 days and lapatinib for 2 days. Subjects will not know when they are receiving placebo vs. lapatinib.
Interventions: intervention 1: lapatinib intervention 2: placebo matching lapatinib
Intervention descriptions: intervention 1: lapatinib commercial tablet, 2000mg, will be given as three separate doses (8 tablets/dose) given 12 hours apart over a 2 day period intervention 2: placebo matching lapatinib will be given as three separate doses (8 tablets/dose) given 12 hours apart over a 2 day period

Protocol documents:
Clinical trial NCT01349595
Conditions: Disorder of Transplanted Kidney
Sponsor: Mark Stegall
Start date: 2011-12-01; Completion date: 2015-03-01
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to see if treating patients who have high levels of donor specific alloantibodies post-transplant with bortezomib might prevent the development of transplant glomerulopathy and preserve allograft function.

Detailed description:

Arms: arm 1: Bortezomib is a type of targeted chemotherapy arm 2: Mayo Clinic standard post kidney transplant follow-up.
Interventions: intervention 1: Bortezomib
Intervention descriptions: intervention 1: Patients randomized to bortezomib treatment will receive 2, 4-dose cycles of drug followed by a 2 month "hiatus". At the end of this time, subjects will be re-evaluated for the appropriateness of receiving a 3rd and 4th cycle of bortezomib. Bortezomib will be given subcutaneously (under the skin). If unable to give subcutaneously, bortezomib will be given as a single IV (injection into vein) over a time of 3 to 5 seconds. Patients will receive up to 4, four-dose cycles of 1.3 mg/m(2) (based on body surface area).

Protocol documents:
Clinical trial NCT01380535
Conditions: Chronic Graft Versus Host Disease
Keywords: Extracorporeal photopheresis therapy Methoxsalen cGVHD hematopoietic stem cell transplantation
Sponsor: Mallinckrodt
Start date: 2011-11-01; Completion date: 2015-03-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Chronic graft-versus-host disease (cGVHD) is a long-lasting complication that can occur after transplants. The transplanted cells seem to fight with the patient's own cells.

Extracorporeal photopheresis (ECP) is a fairly new procedure for cGVHD. The participant gets a port to hook up to a machine. The machine removes the white blood cells, mixes them with a light-sensitive drug, shines light on it, and puts all the blood back in.

This study will find out if patients respond better if they get ECP with methoxsalen, in addition to the pills normally used to treat cGVHD.

Detailed description:
The investigation of extracorporeal photopheresis (ECP) plus standard of care (SoC) (SoC+ECP) in chronic graft-versus-host disease (cGVHD) within prospective, randomized clinical studies is limited, despite its frequent clinical use.

This phase 1/pilot study was the first randomized, prospective study to investigate ECP use as first-line therapy in cGVHD, based on the 2015 National Institutes of Health (NIH) consensus criteria for diagnosis and response assessment.

Adult patients with new-onset (≤3 years of hematopoietic stem cell transplantation) moderate or severe cGVHD were randomized 1:1 to 26 weeks of SoC+ECP vs SoC (corticosteroids and cyclosporine A/tacrolimus) between 2011 and 2015. The primary endpoint was overall response rate (ORR), defined as complete or partial response, at week 28 in the intention-to-treat population (ITT).

Arms: arm 1: Participants receive methoxsalen administered via ECP in addition to standard of care arm 2: Participants receive standard of care only
Interventions: intervention 1: ECP Methoxsalen intervention 2: Standard of Care
Intervention descriptions: intervention 1: Methoxsalen delivered by ECP intervention 2: Tapered prednisone with cyclosporine or tacrolimus via oral administration, consistent with local institutional practice (corticosteroids and cyclosporine A/tacrolimus)

Protocol documents:
Clinical trial NCT01432015
Conditions: Ovarian Cancer Uterine Cancer
Keywords: aprepitant fosaprepitant gynecologic cancer emesis
Sponsor: Gynecologic Oncology Associates
Start date: 2011-09-01; Completion date: 2015-03-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Nausea and vomiting are two of the more concerning adverse outcomes associated with chemotherapy in the treatment of gynecologic malignancies. In fact, nearly 90% of cancer patients develop chemotherapy induced nausea and vomiting (CINV) following treatment with carboplatin and paclitaxel. The successful control of chemotherapy induced nausea and vomiting (CINV) is thus, of paramount importance in ensuring optimal treatment and sustaining a cancer patient's quality of life.

Detailed description:
Studies have indicated that oral and intravenous anti-emetics are equivalent with regard to efficacy; when evaluating cost and convenience, the intravenous route may be preferable. Fosaprepitant, a water-soluble phosphoryl prodrug for aprepitant, is converted to aprepitant via phosphatases following intravenous administration. Given the rapid conversion of fosaprepitant to the active form (i.e., aprepitant), the two medications appear to provide a similarly effective antiemetic impact. Clinical reports have additionally suggested that fosaprepitant could be appropriate as an intravenous alternative to the oral aprepitant.

Arms: arm 1: Fosaprepitant for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy. Oral Placebo given on days 1-3 arm 2: Aprepitant 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3. 100 cc of IV placebo administered on day 1
Interventions: intervention 1: fosaprepitant intervention 2: aprepitant intervention 3: Oral Placebo intervention 4: IV placebo
Intervention descriptions: intervention 1: Fosaprepitant for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy. Patient will receive standard pre-medications intervention 2: Aprepitant 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3. patient will receive standard pre-medications intervention 3: One pill administered on days 1-3 in conjunction with Fosaprepitant. intervention 4: 100 cc of IV placebo administered on day in conjunction with Aprepitant

Protocol documents:
Clinical trial NCT01466881
Conditions: Adult Nasal Type Extranodal NK/T-Cell Lymphoma Anaplastic Large Cell Lymphoma Angioimmunoblastic T-Cell Lymphoma Hepatosplenic T-Cell Lymphoma Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma Recurrent Adult Non-Hodgkin Lymphoma Recurrent Adult T-Cell Leukemia/Lymphoma
Sponsor: National Cancer Institute (NCI)
Start date: 2011-10-01; Completion date: 2015-03-01
Enrollment: 42 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well alisertib works in treating patients with peripheral T-cell non-Hodgkin lymphoma that has come back after a period of improvement or has not responded to treatment. Alisertib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To estimate the objective response rate (complete responses + partial responses) after treatment with alisertib (MLN8237) in patients with relapsed or refractory peripheral T-cell non-Hodgkin lymphoma.

II. To assess overall survival (OS) and progression-free survival (PFS) in this patient population.

III. To evaluate the safety and tolerability of MLN8237 treatment for this patient population.

IV. To explore the association between pre-treatment aurora kinase A expression in tumor biopsies as measured by fluorescence in situ hybridization (FISH) and objective response rate in patients with peripheral T-cell lymphomas (PTCL) treated with MLN8237.

IV. To investigate the copy number, mutational status, expression of aurora kinase (A, B, and C) and associated signaling pathways in PTCL utilizing tissue microarray analysis (TMA) before and after treatment with MLN8237.

V. To investigate changes in the serum cytokine profile pre- and post- aurora kinase Inhibitor treatment.

VI. To evaluate serum markers of apoptosis pre- and post- aurora kinase inhibitor treatment as pharmacodynamic markers of efficacy.

OUTLINE:

Patients receive alisertib orally (PO) twice daily (BID) on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 4 months for 2 years.

Arms: arm 1: Patients receive alisertib PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Alisertib intervention 2: Laboratory Biomarker Analysis intervention 3: Pharmacological Study
Intervention descriptions: intervention 1: Given PO intervention 2: Correlative studies intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT01467700
Conditions: Acute Depressive Episode
Keywords: Drug Therapy
Sponsor: Takeda
Start date: 2011-12-01; Completion date: 2015-03-01
Enrollment: 490 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the efficacy and safety of Ramelteon, once daily (QD), sublingual (SL), in adult participants with acute depressive episodes associated with Bipolar I disorder.

Detailed description:
Ramelteon sublingual formulation is being developed by Takeda Pharmaceutical Company Limited for maintenance therapy of Bipolar I disorder.

Participants will be seen twice during the first week of treatment, weekly during the first 2 weeks of treatment and then every 2 weeks up to the end of the 8-week treatment period. Participants who complete the 8-week treatment period will have a follow-up visit approximately seven days after the last visit. A safety follow-up phone call will be made 30 days after completion of the 8-week treatment period.

Based on the recommendation of the Independent Data Monitoring Committee which determined that the study data had met pre-determined criteria for futility, Takeda has made a decision to terminate the study. No safety concerns were identified by the Independent Data Monitoring Committee

Arms: arm 1: Ramelteon SL 0.1 mg, tablets, sublingual (SL) \[dissolved under the tongue\], once daily (QD), every night at bedtime for up to 8 weeks. arm 2: Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 8 weeks. arm 3: Ramelteon SL 0.8 mg tablets, sublingual, once daily, every night at bedtime for up to 8 weeks. arm 4: Ramelteon SL placebo-matching, tablets, sublingual, once daily, every night at bedtime for up to 8 weeks.
Interventions: intervention 1: Ramelteon SL intervention 2: Placebo
Intervention descriptions: intervention 1: Ramelteon SL tablets intervention 2: Ramelteon placebo-matching tablets

Protocol documents:
Clinical trial NCT01467713
Conditions: Bipolar Disorder
Keywords: Drug Therapy
Sponsor: Takeda
Start date: 2011-12-01; Completion date: 2015-03-01
Enrollment: 642 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the efficacy and safety of ramelteon, once nightly before bedtime (QHS), sublingual (SL), in the maintenance treatment of Bipolar I Disorder in adult patients.

Detailed description:
TAK-375SL (ramelteon sublingual formulation) is being developed by Takeda Pharmaceutical Company Limited as an adjunctive treatment in the maintenance therapy of bipolar I disorder.

Participants will be seen twice a month for the first two months and then once every month up to the end of the 9-month treatment period. Participants who complete the 9-month treatment period will have a follow-up visit approximately seven days after the last visit. A safety followup phone call will be made 30 days after completion of the 9-month treatment period.

Based on the recommendation of the Independent Data Monitoring Committee which determined that the study data had met pre-determined criteria for futility, Takeda has made a decision to terminate the study. No safety concerns were identified by the Independent Data Monitoring Committee

Arms: arm 1: Ramelteon SL placebo-matching, tablets, sublingual (SL) \[dissolved under the tongue\], once daily, every night at bedtime for up to 9 months. arm 2: Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months. arm 3: Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months. arm 4: Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
Interventions: intervention 1: Ramelteon SL intervention 2: Placebo
Intervention descriptions: intervention 1: Ramelteon sublingual (SL) tablets intervention 2: Ramelteon sublingual (SL) placebo-matching tablets

Protocol documents:
Clinical trial NCT01484873
Conditions: Obesity Overweight Craniopharyngioma
Keywords: Exenatide Byetta Hypothalamic Obesity Obesity Craniopharyngioma
Sponsor: Vanderbilt University Medical Center
Start date: 2012-06-01; Completion date: 2015-03-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether exenatide can cause weight loss in patients with a history of craniopharyngioma or other brain lesion.

Detailed description:
Hypothalamic obesity occurs in up to 60% of patients with tumors in the hypothalamic region, most commonly craniopharyngiomas. Hypothalamic dysfunction can be due to tumor infiltration and as a consequence of surgery or radiation therapy. Survivors who develop obesity have greater morbidity and mortality than normal weight survivors. Prevention and treatment of obesity in this population is vital in order to decrease the morbidity and mortality from diabetes, stroke and myocardial infarction.

Exenatide (Byetta®) is a GLP-1 homologue that was FDA approved for treatment of type 2 diabetes in 2005. It also decreases the rate of gastric emptying and increases satiety and has been shown to cause weight loss in some people. Exenatide may improve insulin sensitivity and satiety in patients with hypothalamic obesity but without the risks of bariatric surgery. The investigators hypothesize that treatment with exenatide will lead to weight loss in patients with hypothalamic obesity.

Arms: arm 1: All patients received exenatide 10mcg BID x 50 weeks
Interventions: intervention 1: Exenatide
Intervention descriptions: intervention 1: Treatment with exenatide 5 mcg twice daily for 4 weeks, then 10 mcg twice daily for 46 weeks.

Protocol documents: