ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00858234
Conditions: Multiple Myeloma
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-02-13; Completion date: 2012-04-19
Enrollment: 9 participants; Allocation: NA; Intervention model: SEQUENTIAL

Brief summary:
The primary purpose of this clinical study is to determine the recommended clinical doses of vorinostat (MK-0683) and bortezomib administered in combination to participants with relapsed and/or refractory multiple myeloma (MM). It was hypothesized that administration of vorinostat in combination with bortezomib is sufficiently safe and tolerated well enough to permit further study in participants with relapsed and/or refractory MM. Study results are based on data collected up to the data cut-off date of 20-March-2011.

Detailed description:

Arms: arm 1: Participants undergo up to 3 successive 21-day treatment cycles. During Cycle 1, participants receive vorinostat (400 mg once daily \[QD\] on Days 1 through 14) + bortezomib (1.3 mg/m\^2 intravenous \[IV\] on Days 1, 4, 8, and 11). If that dose is not well tolerated, during Cycle 2 participants receive vorinostat (400 mg QD on Days 1 through 14) + bortezomib (1.0 mg/m\^2 IV on Days 1, 4, 8, and 11). If that dose is not well tolerated, during Cycle 3 participants receive vorinostat (300 mg QD on Days 1 through 14) + bortezomib (1.0 mg/m\^2 IV on Days 1, 4, 8, and 11).
Interventions: intervention 1: Vorinostat intervention 2: Bortezomib
Intervention descriptions: intervention 1: Vorinostat (MK-0683) three or four 100 mg capsules taken by mouth with food. intervention 2: Bortezomib (1.0 or 1.3 mg/m\^2) intravenous infusion.

Protocol documents:
Clinical trial NCT00702052
Conditions: Lymphoma, Mantle- Cell
Keywords: Mantle Cell Lymphoma Lymphoma B-Cell Lymphoma Mantle Zone Lymphoma Refractory Lymphoma Aggressive Lymphoma PILLAR-1
Sponsor: Novartis Pharmaceuticals
Start date: 2008-08-22; Completion date: 2012-04-20
Enrollment: 58 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study was to evaluate the safety and efficacy of a daily, oral dose of 10 mg RAD001 in participants with Mantle Cell Lymphoma who were refractory or intolerant to Velcade® therapy and who had received at least one prior antineoplastic agent other than Velcade®, either separately or in combination with Velcade® (see inclusion criteria). Intolerance to Velcade® therapy was determined by the study investigator based on clinical evaluations. Participants were considered refractory to Velcade® if they have documented radiological progression on or within 12 months of the last dose of Velcade® when given alone or, on or within 12 months of the last dose of the last component of a combination therapy which included Velcade®.

Detailed description:

Arms: arm 1: Participants received everolimus tablets, 10 mg, orally, once daily during each 28 day cycle until determination of objective tumor progression or unacceptable toxicity, or death, or consent withdrawal, or discontinuation from the study for any other reason.
Interventions: intervention 1: Everolimus
Intervention descriptions: intervention 1: Everolimus tablets

Protocol documents:
Clinical trial NCT00442572
Conditions: Hepatitis B, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2006-07-03; Completion date: 2012-04-23
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study will evaluate the efficacy and safety of intermittent treatment with PEGASYS in HBeAg negative patients with chronic hepatitis B who have demonstrated virological and biochemical response after treatment with interferon alfa. After 48 weeks therapy with interferon alfa, and 24 weeks treatment-free follow-up, eligible patients will be randomized into the PEGASYS or the observational group. Those in the PEGASYS group will receive 4 therapeutic cycles of long term intermittent treatment with PEGASYS (135 micrograms sc weekly for 12 weeks, followed by a treatment-free period of 12 weeks) and those in the observational arm will receive no specific antiviral treatment. The anticipated time on study treatment is 1-2 years, and the target sample size is 100 individuals.

Detailed description:

Arms: arm 1: Participants received 4 treatment cycles of continuous intermittent treatment with PEGASYS® (Peginterferon alfa-2a) . Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 micrograms in 0.5 ml solution in prefilled syringes, applied once weekly subcutaneously and followed by 12 weeks period without treatment. arm 2: Participants were on non- specific anti-viral treatment.
Interventions: intervention 1: PEGASYS [peginterferon alfa-2a]
Intervention descriptions: intervention 1: There were 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 micrograms in 0.5 ml solution in prefilled syringes, applied once weekly subcutaneously and followed by 12 weeks period without treatment.

Protocol documents:
Clinical trial NCT01512693
Conditions: Hepatic Insufficiency
Sponsor: Merck Sharp & Dohme LLC
Start date: 2012-02-23; Completion date: 2012-04-24
Enrollment: 17 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This open-label, non-randomized study was designed to compare pharmacokinetics of a single 50 milligram (mg) dose of MK-0822 in participants with and without moderate hepatic insufficiency (abnormal liver function) in order to determine to what degree hepatic dysfunction may impact therapeutic blood levels of MK-0822. The primary hypothesis is that plasma AUC0-∞ of odanacatib in participants with moderate hepatic insufficiency is similar to that in matched healthy participants following a single 50 mg oral dose.

Detailed description:

Arms: arm 1: Single-dose administration of odanacatib 50 mg to participants with moderate hepatic insufficiency. arm 2: Single-dose administration of odanacatib 50 mg to healthy matched control participants.
Interventions: intervention 1: MK-0822
Intervention descriptions: intervention 1: A single oral dose (50 mg tablet) of MK 0822 will be administered on Day 1 after an overnight fast.

Protocol documents:
Clinical trial NCT05167370
Conditions: Solid Tumors Brain Tumors
Keywords: Solid Tumors Brain Tumors
Sponsor: Children's Hospital Medical Center, Cincinnati
Start date: 2010-12-13; Completion date: 2012-04-24
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a study of amifostine to determine how effective it is in the reduction of infection in a high dose chemotherapy regimen with autologous stem cell rescue in children with high risk, relapsed or refractory pediatric solid tumors.

Detailed description:
Autologous stem cell transplant (ASCT) permits chemotherapy dose-escalation to exploit the steep dose-response of solid tumors to alkylating agents. Although ASCT regimens have activity in some high risk pediatric solid tumors, non-hematological regimen-related morbidity and mortality are major barriers to additional dose escalation. We hypothesized that the chemoprotectant amifostine (Ethyol®) would reduce the toxicity of ASCT without compromising anti-tumor efficacy. This is a study of amifostine at 1125 mg/m2 to determine the efficacy of it's chemoprotection in the reduction of bacteremia in a high dose busulfan, melphalan and thiotepa chemotherapy regimen with autologous stem cell rescue in children with high risk, relapsed or refractory pediatric solid tumors.

Arms: arm 1: None
Interventions: intervention 1: Amifostine
Intervention descriptions: intervention 1: Amifostine (Ethyol) 1125 mg/m2 will be given intravenously daily over 5 minutes starting 30 minutes prior to chemotherapy (melphalan or thiotepa) on days -5, -4, -3, -2, and on day -1 twenty four hours after prior dose of amifostine.

Protocol documents:
Clinical trial NCT00817063
Conditions: Eczema
Keywords: retinoid treatment fingertip dermatitis hyperkeratotic hand eczema vesicular hand eczema pompholyx
Sponsor: Stiefel, a GSK Company
Start date: 2009-01-08; Completion date: 2012-04-26
Enrollment: 599 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the safety and efficacy of alitretinoin in the treatment of severe chronic hand eczema that does not respond to treatment with potent topical steroids.

Detailed description:
Chronic hand eczema (CHE)is a distressing disease that poses difficult problems for dermatologists. CHE leads to considerable work-absenteeism, disability and exclusion from labour market. Conventional treatments, including highly potent topical steroids, yield often unsatisfactory results. This study investigates the efficacy and safety of oral alitretinoin, a retinoid, in patients who have not responded to avoidance of causative factors, such as contact allergens and skin irritants, non-medicated skin care and highly potent topical steroids. Eligible patients are randomly assigned to receive alitretinoin or a placebo.

Arms: arm 1: Patients will receive alitretinoin 30mg capsule for up to 24 weeks arm 2: Patients will receive placebo 30mg capsule for up to 24 weeks
Interventions: intervention 1: alitretinoin intervention 2: Placebo
Intervention descriptions: intervention 1: Patients receive alitretinoin 30mg one capsule daily for up to 24 weeks intervention 2: Patients receive matching placebo for up to 24 weeks

Protocol documents:
Clinical trial NCT01217229
Conditions: Hodgkin Lymphoma
Keywords: Hodgkin Lymphoma
Sponsor: Daiichi Sankyo
Start date: 2011-03-03; Completion date: 2012-04-26
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
PLX3397 is a selective inhibitor of Fms, Kit, and oncogenic Flt3 activity.The primary objective of this study is to evaluate the efficacy, as measured by overall response rate, of orally administered PLX3397 in patients with relapsed or refractory classical Hodgkin lymphoma (HL). Secondary objectives include safety, the duration of response, the disease control rate, progression free survival, and how the drug affects your body.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: PLX3397
Intervention descriptions: intervention 1: Capsules administered once or twice daily, continuous dosing. Subjects will begin with 900 mg/day, but should safety data allow in our PLX108-01 study, subject may dose at 1200 mg/day.

Protocol documents:
Clinical trial NCT01455181
Conditions: Hypoparathyroidism
Keywords: PTH 1-84 Hypoparathyroidism NPSP558 Parathyroid Hormone 1-84
Sponsor: Shire
Start date: 2011-08-19; Completion date: 2012-04-26
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is designed to evaluate the effect of 6-months of treatment with NPSP558 in reducing requirements for supplemental oral calcium and active vitamin D, while maintaining stable total serum calcium levels in adult subjects with hypoparathyroidism.

Detailed description:
Subjects either must have previously completed NPSP558 Study CL1-11-040 (REPLACE) including 24 weeks of active therapy and 4 weeks of follow-up to Week 28 prior to enrolling in this study or have enrolled in REPLACE and dropped out during optimization, but currently meet inclusion/exclusion criteria for REPLACE.

Arms: arm 1: None
Interventions: intervention 1: NPSP558
Intervention descriptions: intervention 1: 50, 75, 100 μg

Protocol documents:
Clinical trial NCT01421498
Conditions: Keratoconjunctivitis Sicca Dry Eye Disease
Keywords: ophthalmic delivery Dry Eye
Sponsor: Shire
Start date: 2011-08-29; Completion date: 2012-04-28
Enrollment: 588 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the efficacy of SAR 1118 Ophthalmic Solution (5.0%) compared to placebo in the treatment of Dry Eye. The safety and tolerability of SAR 1118 Ophthalmic Solution (5.0%) compared to placebo in subjects with dry eye when administered BID for 12 weeks will also be evaluated.

Detailed description:

Arms: arm 1: Lifitegrast arm 2: Placebo
Interventions: intervention 1: Lifitegrast intervention 2: Placebo
Intervention descriptions: intervention 1: Dosage Form: Ophthalmic Solution Dosage: 5.0% Frequency: BID Duration: 12 weeks intervention 2: Dosage Form: Ophthalmic Solution Frequency: BID Duration: 12 weeks

Protocol documents:
Clinical trial NCT00089479
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2002-08-01; Completion date: 2012-05-01
Enrollment: 2611 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study will compare the efficacy and safety of Taxotere + Xeloda, versus Taxotere alone, following a regimen of Adriamycin plus Cytoxan in women with high-risk breast cancer. Following 4 cycles of Adriamycin and Cytoxan, patients will be randomized to receive either 1)Taxotere 75mg/m2 iv on day 1 and Xeloda 825mg/m2 po bid on days 1-14 of each 3 week cycle or 2) Taxotere 100mg/m2 iv alone on day 1 of each 3 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: capecitabine [Xeloda] intervention 2: Taxotere intervention 3: Taxotere
Intervention descriptions: intervention 1: 825mg/m2 po bid on days 1-14 of each 3 week cycle intervention 2: 75mg/m2 iv on day 1 of each 3 week cycle intervention 3: 100mg/m2 iv on day 1 of each 3 week cycle

Protocol documents:
Clinical trial NCT00148798
Conditions: Non Small Cell Lung Cancer (NSCLC)
Keywords: Cetuximab Non small cell lung cancer Lung cancer Cisplatin/vinorelbine Monoclonal antibody Erbitux
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2004-10-01; Completion date: 2012-05-01
Enrollment: 1861 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to investigate the efficacy of cetuximab in combination with chemotherapy in comparison to chemotherapy alone in patients with advanced non small cell lung cancer who did not received prior chemotherapy. Overall survival will be taken as primary measure of efficacy.

Detailed description:

Arms: arm 1: cetuximab + cisplatin + vinorelbine arm 2: cisplatin + vinorelbine alone
Interventions: intervention 1: cetuximab + cisplatin + vinorelbine intervention 2: cisplatin + vinorelbine
Intervention descriptions: intervention 1: cetuximab given as an intravenous (i.v.) infusion every week (400mg/m\^2 initial dose and 250mg/m\^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m\^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m\^2 i.v. infusion on days 1 and 8 of each 3-week cycle. intervention 2: cisplatin 80mg/m\^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m\^2 i.v. infusion on days 1 and 8 of each 3-week cycle.

Protocol documents:
Clinical trial NCT00439517
Conditions: Previously Untreated Metastatic Colorectal Cancer
Keywords: Cancer Colorectal Metastatic Untreated
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2007-02-01; Completion date: 2012-05-01
Enrollment: 302 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an exploratory study to compare activity and safety in 400 patients with previously untreated metastatic carcinoma of the colon treated with UFOX (a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin, Folinic Acid) plus Cetuximab or FOLFOX-4 (a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid) plus Cetuximab)

Detailed description:

Arms: arm 1: UFOX + Cetuximab arm 2: FOLFOX4 + Cetuximab
Interventions: intervention 1: UFOX + Cetuximab intervention 2: FOLFOX4 + Cetuximab
Intervention descriptions: intervention 1: * Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22)
* Oxaliplatin infusion (85mg/m\^2) on days 1 and 15 (every 2 weeks)
* Oral UFT® (250mg/m\^2 tegafur + 560 mg/m\^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21
* Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21 intervention 2: * Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22)
* Oxaliplatin infusion (85 mg/m\^2) on days 1 and 15 (every 2 weeks)
* 5-FU bolus + infusions (400 mg/m\^2) on days 1, 2, 15 and 16
* Folinic Acid infusions (200 mg/m\^2) on days 1, 2, 15 and 16

Protocol documents:
Clinical trial NCT00460265
Conditions: Recurrent and/or Metastatic Head and Neck Cancer
Keywords: Squamous Cell Carcinoma Epidermal Growth Factor Epidermal Growth Factor Receptor SCCHN Metastatic Head and Neck Cancer EGFr Head and Neck Cancer Recurrent Head and Neck Cancer
Sponsor: Amgen
Start date: 2007-05-01; Completion date: 2012-05-01
Enrollment: 658 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the treatment effect of Panitumumab in combination with chemotherapy versus chemotherapy alone as first line therapy for metastatic and/or recurrent squamous cell carcinoma of the head and neck.

Detailed description:

Arms: arm 1: Arm 2 consists of Cisplatin and 5-FU arm 2: ARM 1 Consists of Panitumumab plus Cisplatin and 5-FU
Interventions: intervention 1: ARM 2 intervention 2: ARM 1
Intervention descriptions: intervention 1: Subjects will receive Cisplatin plus 5FU intervention 2: Subjects will receive Panitumumab plus cisplatin and 5FU

Protocol documents:
Clinical trial NCT00537238
Conditions: Partial Seizures
Keywords: Epilepsies partial Partial Seizure Disorder Complex Partial Seizure Disorder Epilepsy
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2007-10-01; Completion date: 2012-05-01
Enrollment: 509 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare pregabalin and levetiracetam in patients with partial seizures. It will also evaluate the safety and tolerability of pregabalin and levetiracetam in these patients.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: pregabalin intervention 2: levetiracetam
Intervention descriptions: intervention 1: 300, 450, 600 mg/day administered orally, BID until seizure control/improvement or intolerable side effects intervention 2: 1000, 2000, 3000 mg/day administered orally, BID until seizure control/improvement or intolerable side effects

Protocol documents:
Clinical trial NCT00748566
Conditions: Schizophrenia and Disorders With Psychotic Features
Keywords: Ziprasidone metabolic syndrome risk factors schizophrenia psychotic disorders.
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2008-12-01; Completion date: 2012-05-01
Enrollment: 172 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to explore the impact of ziprasidone on the distribution of metabolic syndrome risk factors in a population of patients presenting with glucose intolerance, dyslipidemia and/or elevated waist circumference associated with their current antipsychotic medication.

Detailed description:
The trial was terminated prematurely on May 24, 2012, due to changes in organizational strategy and resources. The decision to terminate the trial was not based on any safety or efficacy concerns.

Arms: arm 1: None
Interventions: intervention 1: Ziprasidone HCL (oral)
Intervention descriptions: intervention 1: Ziprasidone Hydrochloride 20 to 80 mg administered orally twice a day (40 to 160 mg total daily dose) for up to 1 year.

Protocol documents:
Clinical trial NCT00890097
Conditions: Geographic Atrophy Age-Related Macular Degeneration
Keywords: Geographic Atrophy GA Age-Related Macular Degeneration AMD
Sponsor: Alcon Research
Start date: 2009-04-01; Completion date: 2012-05-01
Enrollment: 772 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to evaluate the safety and efficacy of AL-8309B Ophthalmic Solution versus Vehicle administered as a topical ocular drop for the treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Detailed description:

Arms: arm 1: AL-8309B 1.0% Ophthalmic Solution, 1 drop in each eye twice daily for 30 months, up to a maximum of 36 months arm 2: AL-8309B 1.75% Ophthalmic Solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months arm 3: AL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
Interventions: intervention 1: AL-8309B Ophthalmic Solution intervention 2: AL-8309B Vehicle
Intervention descriptions: intervention 1: None intervention 2: Inactive ingredients used as placebo comparator

Protocol documents:
Clinical trial NCT01011868
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2009-11-01; Completion date: 2012-05-01
Enrollment: 494 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the current study is to investigate the efficacy, safety and tolerability of BI 10773 at two different doses compared to placebo during long term treatment (78 weeks) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.

Detailed description:

Arms: arm 1: Patients receive BI 10773 low dose daily arm 2: Patients receive BI 10773 high dose daily arm 3: Patients receive placebo to match BI 10773 daily
Interventions: intervention 1: BI 10773 placebo intervention 2: BI 10773 low dose intervention 3: BI 10773 high dose intervention 4: BI 10773 placebo
Intervention descriptions: intervention 1: BI 10773 placebo intervention 2: BI 10773 low dose intervention 3: BI 10773 high dose intervention 4: BI 10773 placebo

Protocol documents: