ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01244828
Conditions: Schizophrenia
Sponsor: Organon and Co
Start date: 2011-04-05; Completion date: 2014-08-21
Enrollment: 157 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a multi-site, open-label fixed-flexible dose long-term study of asenapine in participants with schizophrenia. Participants in this study consist of schizophrenia with residual subtype or receiving high dose/multiple antipsychotic drugs, treatment refractory, or elderly participants with schizophrenia. The treatment period is up to 52 weeks.

Detailed description:

Arms: arm 1: Asenapine 5 mg twice daily (BID) for the first week of treatment, then either 5 mg or 10 mg BID.
Interventions: intervention 1: Asenapine
Intervention descriptions: intervention 1: 5 mg or 10 mg fast-dissolving sublingual tablets BID for up to 52 weeks

Protocol documents:
Clinical trial NCT00555152
Conditions: Ductal Breast Carcinoma In Situ HER2/Neu Positive
Sponsor: National Cancer Institute (NCI)
Start date: 2009-08-19; Completion date: 2014-08-28
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase I/II trial studies the side effects and best dose of lapatinib ditosylate and to see how well it works in treating patients with ductal breast carcinoma in situ. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. Determine whether lapatinib (lapatinib ditosylate) therapy at the dose of 1000 mg results in a statistically significantly lower rate of proliferation in ductal carcinoma in situ (DCIS) breast cancer cells as measured by Ki67 when compared to placebo.

II. Determine the toxicity profile and frequency of adverse events in women with DCIS breast cancer taking lapatinib at 1000 mg as compared to women taking placebo.

SECONDARY OBJECTIVES:

I. Determine whether lapatinib treatment affects the incidence of DCIS seen at the time of surgical excision.

II. Determine whether treatment with lapatinib will modulate breast tissue histology or the expression of specific biomarkers in normal and DCIS breast cancer cells.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive lapatinib ditosylate orally (PO) once daily (QD) for 2-6 weeks until the time of surgery.

ARM II: Patients receive placebo PO QD for 2-6 weeks until the time of surgery.

After completion of study treatment, patients are followed for 4-5 weeks.

Arms: arm 1: Patients receive lapatinib ditosylate PO once QD for 2-6 weeks until the time of surgery. arm 2: Patients receive placebo PO QD for 2-6 weeks until the time of surgery.
Interventions: intervention 1: Laboratory Biomarker Analysis intervention 2: Lapatinib Ditosylate intervention 3: Placebo
Intervention descriptions: intervention 1: Correlative studies intervention 2: Given PO intervention 3: Given PO

Protocol documents:
Clinical trial NCT02701296
Conditions: Posterior Knee Infiltration
Keywords: Infiltration between popliteal artery and capsule of knee (iPACK)
Sponsor: Trinity Health Of New England
Start date: 2011-11-07; Completion date: 2014-08-31
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess pain control after total knee replacement surgery using two different nerve block techniques. The 2 methods are:

1. Continuous femoral nerve block with ultrasound guided posterior capsular injection
2. Continuous femoral nerve block with ultrasound selective tibial nerve block.

Detailed description:
Patients undergoing total knee replacement surgery experience severe post-operative pain. Continuous femoral nerve block combined with selective tibial nerve block provides optimal pain control in the anterior and posterior aspect of the knee respectively. However, in patients with pre-existing neuropathy of the sciatic nerve, the blockade of tibial nerve is contraindicated because of increased risk of nerve damage that may lead to exacerbation of neurologic symptoms. In such patients where selective tibial nerve block cannot be offered, ultrasound guided posterior knee capsular injection may be an alternative technique for controlling posterior knee pain after surgery. Posterior capsular injection by surgeons intraoperatively, when combined with femoral nerve block has been shown to provide pain control after total knee replacement. With posterior capsular injection, the main trunk of the tibial nerve is spared and only the terminal nerve endings innervating the posterior knee joint is blocked providing effective pain control. In this study, the efficacy of ultrasound guided posterior capsular injections performed pre-operatively will be compared to tibial nerve block in controlling knee pain after surgery.

The results of this study may help establish the efficacy of ultrasound guided posterior capsular injection as an alternative to tibial nerve block in patients undergoing total knee arthroplasty.

Arms: arm 1: Ultrasound guided posterior capsular injection of ropivacaine with epinephrine arm 2: Ultrasound selective tibial nerve block of ropivacaine
Interventions: intervention 1: Ropivacaine with Epinephrine intervention 2: Ropivacaine
Intervention descriptions: intervention 1: Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles intervention 2: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa

Protocol documents:
Clinical trial NCT00114777
Conditions: Renal Transplantation
Sponsor: Bristol-Myers Squibb
Start date: 2005-02-01; Completion date: 2014-09-01
Enrollment: 595 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to learn if Belatacept is effective and safe as a first line of immunosuppression treatment in patients undergoing a renal transplant where the donor kidney is obtained in patients with extended criteria.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Cyclosporin A intervention 2: Belatacept Less Intensive Regimen (LI) intervention 3: Belatacept More Intensive Regimen (MI)
Intervention descriptions: intervention 1: tablet, oral, 1st month target: 150-300 ng/mL, after 1st month target: 100-250 ng/mL, daily, 36 months, 100-250 ng/mL, daily, 84 months intervention 2: solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months months, 5 mg/kg every 4 weeks, q 4 weeks, 84 months intervention 3: solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months, 5 mg/kg every 4 weeks, q 4 weeks, 84 months

Protocol documents:
Clinical trial NCT00248170
Conditions: Breast Cancer
Keywords: Breast cancer letrozole anastrozole adjuvant postmenopausal FACE
Sponsor: Novartis Pharmaceuticals
Start date: 2005-12-01; Completion date: 2014-09-01
Enrollment: 4172 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Eligible patients will be post-menopausal hormone receptor- and lymph node-positive females who recently underwent primary surgery for breast cancer. Patients will be randomized to letrozole (2.5 mg per day for 5 years) vs anastrozole (1 mg per day for 5 years). Follow up will occur for 5 years after the completion of enrollment for survival and disease status updates.

Detailed description:

Arms: arm 1: 2.5 mg by mouth (p.o.) once daily arm 2: 1 mg p.o. once daily
Interventions: intervention 1: Letrozole intervention 2: Anastrozole
Intervention descriptions: intervention 1: 2.5 mg tablets intervention 2: 1 mg tablets

Protocol documents:
Clinical trial NCT00559585
Conditions: Rheumatoid Arthritis (RA)
Sponsor: Bristol-Myers Squibb
Start date: 2008-01-01; Completion date: 2014-09-01
Enrollment: 2492 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether a weekly subcutaneous dose of abatacept yields clinical efficacy comparable to that of monthly intravenous doses of abatacept in participants with rheumatoid arthritis and an inadequate response to current methotrexate therapy.

Detailed description:

Arms: arm 1: Participants received 125 mg weekly SC abatacept injections (with an intravenous \[IV\] abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. arm 2: Participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo).
Interventions: intervention 1: Subcutaneous (SC) Abatacept intervention 2: Intravenous (IV) Abatacept
Intervention descriptions: intervention 1: Participants received 125 mg weekly SC abatacept injections (with an intravenous \[IV\] abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. intervention 2: Participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo).

500mg (for body weight up to 60 kg)

750 mg (body weight between 61 and 100 kg)

1g (body weight above 100 kg)infusions

Protocol documents:
Clinical trial NCT00735397
Conditions: Epilepsy
Keywords: Partial onset seizures
Sponsor: Eisai Inc.
Start date: 2008-10-01; Completion date: 2014-09-01
Enrollment: 1218 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to evaluate the safety and tolerability of perampanel (up to 12 mg/day) given as adjunctive treatment in subjects with refractory partial seizures and to evaluate the maintenance of effect of perampanel for the control of refractory partial seizures.

Detailed description:
This was an open-label extension (OLE) study for subjects who completed one of the following double-blind, placebo-controlled, Phase 3 studies: E2007-G000-304 (NCT00699972), E2007-G000-305 (NCT00699582), and E2007-G000-306 (NCT00700310). This OLE study consisted of 2 phases: an Open-label Treatment Phase (comprised of a 16-week blinded Conversion Period and a 256-week Maintenance Period) and a Follow-up Phase (4 weeks). During the Conversion Period, subjects and investigators remained blinded to the treatment received in the previous DB study. To achieve this, all subjects continued to take 6 tablets of study medication (2 mg perampanel or matching placebo) or fewer as they were instructed during the core Double-Blind (DB) study. During the open-label Maintenance Period, subjects were treated with the perampanel dose that provided the best combination of individual efficacy and tolerability.

Arms: arm 1: Participants previously receiving perampanel/placebo in the double blind-study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study up to approximately 5 years.
Interventions: intervention 1: perampanel
Intervention descriptions: intervention 1: Perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study up to approximately 5 years

Protocol documents:
Clinical trial NCT01095796
Conditions: HIV HIV Infections
Keywords: Treatment Naive HIV 1 Infected
Sponsor: Gilead Sciences
Start date: 2010-03-01; Completion date: 2014-09-01
Enrollment: 707 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the safety and efficacy of Stribild®, a single tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/cobicistat (COBI \[GS-9350\])/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus efavirenz (EFV)/FTC/TDF (Atripla®) in HIV-1 infected, antiretroviral treatment-naive adults. Stribild offers an alternative STR for patients who are not candidates for non-nucleoside reverse transcriptor-based STRs.

Detailed description:

Arms: arm 1: Stribild plus placebo to match Atripla arm 2: Atripla plus placebo to match Stribild
Interventions: intervention 1: Stribild intervention 2: Atripla intervention 3: Stribild Placebo intervention 4: Atripla Placebo
Intervention descriptions: intervention 1: Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR administered orally once daily intervention 2: Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet administered orally once daily prior to bedtime intervention 3: Placebo to match Stribild STR administered orally once daily intervention 4: Placebo to match Atripla tablet administered orally once daily prior to bedtime

Protocol documents:
Clinical trial NCT01106586
Conditions: HIV HIV Infections
Keywords: HIV 1 Infection Treatment Naive
Sponsor: Gilead Sciences
Start date: 2010-04-01; Completion date: 2014-09-01
Enrollment: 708 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the safety and efficacy of Stribild®, a single tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/cobicistat (COBI \[GS-9350\])/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus ritonavir-boosted atazanavir (ATV/r) plus the standard of care nucleoside reverse transcriptase inhibitor (NRTI) backbone FTC/TDF (Truvada®). ATV/r + FTC/TDF was selected as the active comparator for this study as it is a preferred protease inhibitor-based regimen in guidelines for the treatment of HIV-1 infected, antiretroviral treatment-naive adults.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Stribild intervention 2: ATV intervention 3: Ritonavir intervention 4: FTC/TDF intervention 5: Stribild Placebo intervention 6: ATV Placebo intervention 7: RTV Placebo intervention 8: FTC/TDF Placebo
Intervention descriptions: intervention 1: Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR administered orally once daily intervention 2: Atazanavir 300 mg capsule administered orally once daily intervention 3: Ritonavir (RTV; /r) 100 mg tablet administered orally once daily intervention 4: FTC/TDF 200/300 mg tablet administered orally once daily intervention 5: Placebo to match Stribild administered orally once daily intervention 6: Placebo to match ATV administered orally once daily intervention 7: Placebo to match RTV administered orally once daily intervention 8: Placebo to match FTC/TDF administered orally once daily

Protocol documents:
Clinical trial NCT01122927
Conditions: Adolescent Schizophrenia Child or Adolescent Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features
Keywords: schizophrenia adolescent bipolar
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2010-07-01; Completion date: 2014-09-01
Enrollment: 524 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label study consisting of a screening period, a conversion/titration phase (Phase 1), an open-label treatment phase (Phase 2), and a follow-up period.

The study will enroll new subjects (hereafter referred as "de novo" subjects) with schizophrenia, or bipolar I disorder, manic or mixed episode with or without psychotic features, and rollover subjects with schizophrenia from 31-09-266 (hereafter referred to as "Study 266"). All de novo subjects must enter the screening period of the study. Subjects who are screened and are not required to go through Phase 1 will complete a Phase 2 baseline visit prior to their participation in Phase 2.

Study Design: Treatment, Single Group Assignment, Open Label, Active Control, Safety/Efficacy Study

Detailed description:

Arms: arm 1: Aripiprazole (2-mg, 5-mg, 10-mg, 15-mg, 20-mg, 25-mg or 30-mg)
Interventions: intervention 1: Aripiprazole
Intervention descriptions: intervention 1: Aripiprazole (2-mg, 5-mg, 10-mg, 15-mg, 20-mg, 25-mg or 30-mg) pill taken orally once per day

Protocol documents:
Clinical trial NCT01151046
Conditions: Her2 Negative Breast Cancer Patients
Keywords: Breast Cancer Her2 negative Estrogen Receptor Positive Progesterone Receptor Positive MM-121 Exemestane Postmenopausal Women
Sponsor: Merrimack Pharmaceuticals
Start date: 2010-06-01; Completion date: 2014-09-01
Enrollment: 118 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine whether the combination MM-121 + Exemestane in ER+ and/or PR+ breast cancer patients is more effective than Exemestane alone

Detailed description:
The study is a double-blind, randomized Phase 2 trial of Exemestane +/- MM-121. The trial is designed to demonstrate whether MM-121 + Exemestane is more effective than Exemestane alone in ER+ and/or PR+ and Her2 negative breast cancer patients that have failed first-line anti-estrogen therapy in the locally advanced or metastatic setting and patients that have progressed during (or within 6 months of completing) adjuvant treatment with a non-steroidal aromatase inhibitor (AI)and/or tamoxifen. Patients will be treated until radiologic or clinical progression of their disease is documented. Local radiologist and/or PI assessment is accepted.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: MM-121 intervention 2: Placebo intervention 3: Exemestane
Intervention descriptions: intervention 1: MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week intervention 2: Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week and exemestane (25 mg) administered orally once per day intervention 3: Exemestane (25 mg) administered orally once per day

Protocol documents:
Clinical trial NCT01727713
Conditions: Tourette's Disorder Tic Disorder
Keywords: Tourette Syndrome Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Tic Disorders Tics Movement Disorders Mental Disorders Aripiprazole
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2013-01-01; Completion date: 2014-09-01
Enrollment: 110 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of the current trial is to determine safety of Once-daily aripiprazole in reducing Total Tic Severity in children and adolescents with Tourette's Disorder.

Detailed description:
Tourette's Disorder is a neuropsychiatric condition that is characterized by the appearance of tics that can be simple or complex in nature. A tic is a sudden, rapid, recurrent, non-rhythmic, stereotyped motor movement or vocalization. There are a very limited number of medications approved for the treatment of Tourette's Disorder. The goal of the current trial is to obtain additional efficacy, safety, and tolerability data in a controlled condition of a Once-daily aripiprazole formulation in children and adolescents with Tourette's Disorder. The trial is a 52-week extension to the double-blind trial.

The Once-daily tablet formulation that will be evaluated in this trial represents a daily dosage regimen that is intended to be administered to children and adolescents.

Arms: arm 1: Aripiprazole Immediate Release Once-Daily
Interventions: intervention 1: Aripiprazole
Intervention descriptions: intervention 1: Open Label: Once-Daily formulation of aripiprazole flex dose regimine

Protocol documents:
Clinical trial NCT01795547
Conditions: Schizophrenia
Sponsor: H. Lundbeck A/S
Start date: 2013-02-01; Completion date: 2014-09-01
Enrollment: 295 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the effectiveness of aripiprazole once-monthly in the maintenance treatment of patients with a diagnosis of schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR®), in a naturalistic care setting by comparing it to an existing long-acting antipsychotic, paliperidone palmitate.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Aripiprazole and aripiprazole once-monthly intervention 2: Paliperidone and paliperidone palmitate
Intervention descriptions: intervention 1: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection at the end of Week 4. Oral tablets were taken for 2 more weeks after the 1st injection. Starting at the end of Week 8, additional injections were given every 4 weeks until Week 24. intervention 2: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by 2 paliperidone palmitate IM injections at Weeks 3 and 4, respectively. Starting at the end of Week 8, additional injections were given every 4 weeks until Week 24.

Protocol documents:
Clinical trial NCT01903005
Conditions: Opioid Dependence, on Agonist Therapy
Keywords: Opioid, Dependence, agonist, Buprenorphine, Naloxone
Sponsor: Orexo AB
Start date: 2013-07-01; Completion date: 2014-09-01
Enrollment: 668 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to assess safety, efficacy, and treatment retention following extended treatment with OX219, a higher-bioavailability buprenorphine/naloxone (BNX) sublingual tablet formulation in opioid-dependent patients who completed 1 of 2 primary efficacy and safety studies of OX219.

Detailed description:
This was a multicenter, open-label, uncontrolled, single-arm, 24-week, extension study to assess safety, efficacy, and treatment retention during maintenance treatment.

Eligible patients had completed 1 of 2 primary efficacy and safety studies of the higher-bioavailability BNX sublingual tablet formulation (primary study OX219-006 \[NCT01908842\] or OX219-007 \[NCT01848054\]). The total duration of study treatment was 24 weeks.

Arms: arm 1: Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
Interventions: intervention 1: Higher bioavailability BNX sublingual tablets
Intervention descriptions: intervention 1: Once daily, open-label treatment with higher bioavailability BNX sublingual tablets for 24 weeks

Protocol documents: