ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01844817
Conditions: Pancreatic Cancer
Keywords: untreated metastatic OGX-427
Sponsor: SCRI Development Innovations, LLC
Start date: 2013-09-01; Completion date: 2016-03-01
Enrollment: 132 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the overall survival in patients with previously untreated metastatic pancreatic cancer receiving gemcitabine/nab-paclitaxel plus OGX-427 or gemcitabine/nab-paclitaxel plus placebo.

Detailed description:
Patients with pancreatic cancer usually present with inoperable disease and systemic therapy becomes the primary form of treatment. The combination of gemcitabine plus nab-paclitaxel represents an appropriate front-line standard of care for patients with metastatic pancreatic cancer. However, poor outcomes with this disease warrant exploration of novel drugs with unique mechanisms of action. Preclinical evidence suggests that OGX-427 has shown promising activity in pancreatic cancer. In this trial, we will compare the overall survival of patients with previously untreated metastatic pancreatic cancer using OGX-427 with either gemcitabine/nab-paclitaxel or a placebo with gemcitabine/nab-paclitaxel.

Arms: arm 1: Three loading doses of OGX-427 at 600mg IV will be administered Days -9 to -1. Following the loading dose period, OGX-427 will be administered at 600mg IV weekly Days 1, 8, 15, and 22 of each 28 day cycle during the Treatment Phase. arm 2: Three loading doses of placebo will be administered Days -9 to -1. Following the loading dose period, placebo will be administered weekly Days 1, 8, 15, and 22 of each 28 day cycle.
Interventions: intervention 1: OGX-427 intervention 2: Placebo
Intervention descriptions: intervention 1: Three separate administrations of OGX-427 will be given during the 9-day Loading Dose Period. Following the Loading Dose Period, patients will receive 600mg OGX-427 prior to the administration of nab-paclitaxel (125mg/m2 IV)and gemcitabine (1000mg/m2 IV)administration on Day 1, 8, and 15 of each cycle. OGX-427 will also be administered on Day 22 during each cycle (i.e., weekly). Patients will continue 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment. intervention 2: Three separate administrations of Placebo will be given during the 9-day Loading Dose Period. Following the Loading Dose Period, patients will receive placebo prior to the administration of nab-paclitaxel (125mg/m2 IV)and gemcitabine (1000mg/m2 IV)administration on Day 1, 8, and 15 of each cycle. Placebo will also be administered on Day 22 during each cycle (i.e., weekly). Patients will continue 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment.

Protocol documents:
Clinical trial NCT01850030
Conditions: Female Infertility
Sponsor: Abbott
Start date: 2013-08-01; Completion date: 2016-03-01
Enrollment: 1070 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Female inability to conceive a child. The purpose of this randomized, two-arm and double blind, double dummy study is to demonstrate that the treatment of a daily dose of 3x10mg dydrogesterone orally is as effective and safe as the daily dose of 3x200 mg micronized progesterone capsules administered intravaginally for the luteal support in patients undergoing IVF. The treatment will start on the day of oocyte retrieval and continue until pregnancy is negative or until week 12 gestation.Patients will be followed after treatment until 30 days after delivery to record any safety and tolerability data of the patient and their newborn(s).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Dydrogesterone 30 mg intervention 2: Micronized Progesterone 600 mg intervention 3: Placebo progesterone intervention 4: Placebo dydrogesterone
Intervention descriptions: intervention 1: Oral Dydrogesterone 10 mg tablets tid intervention 2: Intravaginal micronized progesterone 200 mg capsules tid intervention 3: Placebo intravaginal micronized progesterone 200 mg capsules tid intervention 4: placebo oral dydrogesterone 10 mg tablets tid

Protocol documents:
Clinical trial NCT01865084
Conditions: Muscular Dystrophy, Duchenne
Sponsor: Eli Lilly and Company
Start date: 2013-09-01; Completion date: 2016-03-01
Enrollment: 331 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to determine if tadalafil can slow the decline in walking ability of boys who have Duchenne muscular dystrophy (DMD). The study will also assess the safety of tadalafil and any side effects that might be associated with it in boys who have DMD. Participants will receive study treatment (tadalafil or placebo) for the first 48 weeks of the study, and can then continue into an open label extension (OLE) that consists of two periods during which all participants will receive tadalafil. In OLE period 1, all participants will receive tadalafil for 48 weeks. Participants completing OLE period 1 will continue into OLE period 2 and will receive tadalafil for at least another 48 weeks.

Detailed description:

Arms: arm 1: Placebo taken orally once daily. arm 2: 0.3 milligram per kilogram (mg/kg) tadalafil taken orally once daily. arm 3: 0.6 mg/kg tadalafil taken orally once daily.
Interventions: intervention 1: Tadalafil intervention 2: Placebo
Intervention descriptions: intervention 1: Administered orally intervention 2: None

Protocol documents:
Clinical trial NCT01879618
Conditions: Chronic Renal Failure
Keywords: Fragmin dalteparin hemodialysis anticoagulation Renal Failure
Sponsor: Pfizer
Start date: 2013-10-01; Completion date: 2016-03-01
Enrollment: 152 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study will determine if the Fragmin dose can be adjusted to suit the clinical needs of patients during dialysis.

Detailed description:

Arms: arm 1: Fragmin given according to the flexible dosing regimen outlined in the protocol
Interventions: intervention 1: Fragmin
Intervention descriptions: intervention 1: variable dosing regimen

Protocol documents:
Clinical trial NCT01882829
Conditions: Major Depressive Disorder Treatment Resistant
Keywords: depression major depressive disorder treatment resistant Nuedexta dextromethorphan antidepressant glutamate NMDA receptor
Sponsor: James Murrough
Start date: 2013-07-01; Completion date: 2016-03-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
There is an urgent need, therefore, to identify well-tolerated, orally available compounds that target the NMDA receptor as a novel treatment approach for TRD. The current project aims to test the safety, tolerability and efficacy of Nuedexta - containing the NMDA antagonist dextromethorphan.

Detailed description:
Approximately one-third of patients with major depressive disorder do not achieve adequate symptom control despite a series of multiple treatment trials with currently available antidepressant medication (for example a serotonin-selective reuptake inhibitor). This group of patients - representing treatment-resistant depression (TRD) - accounts for an alarmingly high public health burden and signifies a critical area of need in pharmaceutical treatment development. While current treatments are slow to act and only partially effective, new basic and clinical research focusing on the glutamate system is yielding promising new avenues for novel drug discovery. Ketamine - a glutamate N-methyl-d-aspartate (NMDA) receptor antagonist - has now been demonstrated in several studies to bring about a rapid and robust antidepressant effect, even in patients suffering from TRD. Ketamine is limited as a treatment for TRD by the need for intravenous administration and the potential for untoward medical or psychiatric adverse effects. There is an urgent need, therefore, to identify well-tolerated, orally available compounds that target the NMDA receptor as a novel treatment approach for TRD. The current project aims to test the safety, tolerability and efficacy of Nuedexta - containing the NMDA antagonist dextromethorphan.

Arms: arm 1: 45/10 mg every 12 hours x 8 weeks
Interventions: intervention 1: dextromethorphan/quinidine
Intervention descriptions: intervention 1: up to 45/10 mg every 12 hours in patients with TRD with a short 7 day tapering period in which subjects are tapered off 45/10 mg dose from twice a day to once daily for an additional 7 days at post 8-week treatment period to minimize the potential for discontinuation effects

Protocol documents:
Clinical trial NCT01895361
Conditions: Sickle Cell Disease
Keywords: SelG1 P-selectin monoclonal antibody sickle cell disease sickle cell anemia sickle cell pain crisis pain crises vasoocclusion vaso-occlusion priapism hepatic sequestration splenic sequestration chest syndrome SCD
Sponsor: Reprixys Pharmaceutical Corporation
Start date: 2013-07-01; Completion date: 2016-03-01
Enrollment: 198 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to determine whether the investigational drug SelG1 when given to sickle cell disease patients either taking or not taking hydroxyurea was effective in preventing or reducing the occurrence of pain crises. SelG1 prevents various cells in the bloodstream from sticking together. By stopping these cell-cell interactions, SelG1 may prevent small blood vessels from becoming blocked and therefore reduce the occurrence and severity of pain crises. Other effects of SelG1 was evaluated, as well as the safety of the drug and how long it stayed in the blood stream.

Funding Source - FDA Office of Orphan Products Development (OOPD)

Detailed description:

Arms: arm 1: IV Infusion, once every 4 weeks through Week 50 arm 2: IV Infusion, once every 4 weeks through Week 50 arm 3: IV Infusion, once every 4 weeks through Week 50
Interventions: intervention 1: SelG1 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01900652
Conditions: Carcinoma, Non-Small-Cell Lung
Sponsor: Eli Lilly and Company
Start date: 2013-08-01; Completion date: 2016-03-01
Enrollment: 111 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to evaluate the efficacy of the study drug known as LY2875358, administered alone or in combination with a second drug named Erlotinib, in participants affected by a defined type of lung cancer (MET biomarker diagnostic positive Non-Small-Cell Lung Cancer) that experienced a disease progression during the most recent treatment with Erlotinib.

Detailed description:

Arms: arm 1: 750 milligram (mg) Emibetuzumab flat dose given as a 1.5 hour intravenous (IV) infusion on Days 1 and 15 of a 28-day cycle and Erlotinib 150 mg given orally once daily on a 28-day cycle. arm 2: 750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle.
Interventions: intervention 1: Emibetuzumab intervention 2: Erlotinib
Intervention descriptions: intervention 1: Administered IV intervention 2: Administered Orally

Protocol documents:
Clinical trial NCT01908205
Conditions: Autism Spectrum Disorder
Keywords: Autism Social Functioning Cognition Repetitive Behaviors Anxiety Quality of Life
Sponsor: Holland Bloorview Kids Rehabilitation Hospital
Start date: 2013-09-01; Completion date: 2016-03-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
We are studying an investigational drug called intranasal oxytocin (Syntocinon®). Syntocinon® has been approved by the U.S. Food and Drug Administration for use in helping women breastfeed, but it has not been approved for use in children with ASD. However, there is previous research conducted that has indicated that after administration of oxytocin, adults with ASD demonstrated improvements in social cognition, and reduced repetitive behaviours and anxiety. There is also early research to suggest that children may also benefit in these areas. The purpose of this study is to test if oxytocin works to help children and adolescents with ASD.

Detailed description:
Extensive data has been accumulated to suggest that central release of oxytocin is important for social cognition and function, as well as likely involved in anxiety modulation and repetitive behaviors. The Principal Investigator and Co-Principal Investigator of this study have previously documented: 1) an association between ASD and a single nuclear polymorphism of the oxytocin receptor gene, 2) ability to measure oxytocin levels in the blood by enzyme immunoassay and 3) preliminary data to support safety and efficacy of intranasal oxytocin in the treatment of social deficits and repetitive behaviors in adults with autism. A medication treatment targeting the core deficits of ASD in childhood is highly valuable because it could influence the developmental trajectory and make further psychosocial interventions possible. In this context, we propose a randomized placebo controlled trial of intranasal oxytocin in children and adolescents with ASD.

Arms: arm 1: The proposed dosing schedule is 0.4 IU/kg, taken twice daily, for a maximum of 24 IUs per dose arm 2: The proposed dosing schedule is 0.4 IU/kg, taken twice daily, for a maximum of 24 IUs per dose
Interventions: intervention 1: Intranasal Oxytocin intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01914159
Conditions: Age Related Macular Degeneration
Sponsor: University Hospital, Bonn
Start date: 2013-02-01; Completion date: 2016-03-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The Ranibizumab in Pigment Epithelium Tears Secondary To Age-Related Macular Degeneration (RIP) Study is a prospective, multicenter, uncontrolled, interventional phase 2 clinical trial that investigates the effect of fixed monthly intravitreal injections of ranibizumab (Lucentis, Novartis Pharma, Germany) on visual acuity and retinal morphology over a study period of 12 months in 30 patients.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany)
Intervention descriptions: intervention 1: Monthly intravitreal injections

Protocol documents:
Clinical trial NCT01919697
Conditions: Chronic Idiopathic Constipation
Keywords: Plecantaide Chronic Idiopathic Constipation Chronic Idiopathic Constipation Synergy CIC CIC study CIC OLE CIC OLE study OLE OLE CIC OLE CIC3 Open label Open label study Long term Long term study Extension Extension study
Sponsor: Bausch Health Americas, Inc.
Start date: 2013-08-01; Completion date: 2016-03-01
Enrollment: 2370 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-center, open-label, 52-week safety and tolerability study of plecanatide in patients with Chronic Idiopathic Constipation (CIC).

Detailed description:
This is an open-label extension study of plecanatide in the treatment of patients with CIC who previously completed Synergy Protocols SP304-20210 and SP304203-00 (The CIC3 Study).

The planned duration of each patient's study participation is up to 411 days, including up to 33 days of screening, 8 study visits over 52 weeks of treatment and a follow-up visit 2 weeks after the last dose of study drug.

Arms: arm 1: Plecanatide 3.0 mg, one tablet by mouth daily for 52 weeks arm 2: Plecanatide 6.0 mg, one tablet by mouth daily for 52 weeks
Interventions: intervention 1: Plecanatide
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01928927
Conditions: HIV-1 Infection
Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Start date: 2014-01-01; Completion date: 2016-03-01
Enrollment: 58 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main goal of this study was to see if a drug called telmisartan would decrease fibrosis (scarring) and inflammation (irritation) in people who are infected with HIV and doing well on their HIV medications. The study was also done to see what effects telmisartan has on other signs of disease and inflammation in the body, and to see whether people who have HIV can take telmisartan safely and without side effects that make them want to stop the drug. Telmisartan is FDA-approved for treating high blood pressure and decreasing the chance of heart attacks and strokes in people over the age of 55 years of age who are at high risk for these events.

Detailed description:
This was a multicenter, randomized, open label, phase IIb, two-arm study to evaluate the effects of telmisartan on fibrotic and inflammatory contributors to end-organ disease in HIV-infected subjects well controlled on antiretroviral therapy (ART). Participants were randomized 2:1 to the telmisartan and control arms. The participants on telmisartan took 40 mg telmisartan daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. The participants in the control arm did not take any study medication, but did undergo all evaluations. All participants were followed for 48 weeks after randomization.

The study clinic visits included Step 1 entry, Step 2 entry, and weeks 4, 12, 24, 36, 48. Biopsies for the primary outcomes were collected at Step 1 entry and Week 48. The evaluations of safety (clinical assessment for signs and symptoms, diagnoses, laboratory tests) were done at Step 2 entry and weeks 4, 12, 24, 36, 48.

The co-primary objectives assessed the effects of telmisartan for 48weeks on lymph node and adipose tissue collagen I deposition.

Currently, the results are entered for the primary outcome measures only. The results on the secondary outcomes will be posted when they become available.

Arms: arm 1: None arm 2: Participants received no study drug and followed the week 0-48 evaluation schedule.
Interventions: intervention 1: Telmisartan
Intervention descriptions: intervention 1: Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Protocol documents:
Clinical trial NCT01980589
Conditions: Multiple Myeloma
Keywords: multiple myeloma
Sponsor: Amgen
Start date: 2013-08-01; Completion date: 2016-03-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective was to determine the maximum tolerated dose of carfilzomib given twice weekly in combination with cyclophosphamide and dexamethasone for patients with newly diagnosed multiple myeloma.

Detailed description:

Arms: arm 1: Participants received carfilzomib, cyclophosphamide and dexamethasone for up to eight 28-day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
Interventions: intervention 1: Carfilzomib intervention 2: Cyclophosphamide intervention 3: Dexamethasone
Intervention descriptions: intervention 1: Carfilzomib administered as a 30-minute intravenous (IV) infusion on Days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. On Days 1 and 2 of Cycle 1, all participants received carfilzomib at 20 mg/m². intervention 2: Cyclophosphamide administered orally (PO) at the dose of 300 mg/m² on Days 1, 8, and 15 of each 28-day cycle. intervention 3: Dexamethasone administered PO or IV at 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle.

Protocol documents:
Clinical trial NCT01995201
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2013-09-01; Completion date: 2016-03-01
Enrollment: 401 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This multicenter, open-label study will evaluate the efficacy and safety of subcutaneously administered RoActemra/Actemra (tocilizumab) as monotherapy or in combination with methotrexate or other non-biologic DMARDs in patients with active rheumatoid arthritis and an inadequate response to non-biologic DMARDs or to one anti-TNF. In Phase 1, all patients will receive RoActemra/Actemra 162 mg subcutaneously (sc) weekly for Weeks 1 to 24, with or without methotrexate or other non-biologic DMARDs. For Part 2, patients who achieve sustained clinical DAS28-ESR remission at Weeks 20 and 24 will be randomized to receive RoActemra/Actemra 162 mg sc either weekly or every 2 weeks for Weeks 24 to 48, with or without methotrexate or other non-biologic DMARDs. Patients who do not achieve sustained clinical remission but achieve low disease activity (DAS-ESR \</= 3.2) will continue the initial treatment of RoActemra/Actemra 162 mg sc weekly for Weeks 24 to 48, with or without methotrexate or other non-biologic DMARDs.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: DMARD intervention 2: methotrexate intervention 3: tocilizumab [RoActemra/Actemra] intervention 4: tocilizumab [RoActemra/Actemra] intervention 5: tocilizumab [RoActemra/Actemra]
Intervention descriptions: intervention 1: non-biological disease-modifying antirheumatic drugs at stable dose intervention 2: stable dose intervention 3: 162 mg subcutaneously (SC) qw, Weeks 1-24 intervention 4: 162 mg SC qw or q2w, Weeks 24-48 intervention 5: 162 mg SC qw, Weeks 24-48

Protocol documents:
Clinical trial NCT02031770
Conditions: Metabolic Acidosis Chronic Kidney Disease
Keywords: vascular endothelial cells
Sponsor: University of Colorado, Denver
Start date: 2014-01-01; Completion date: 2016-03-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Cardiovascular disease (CVD) is the leading cause of death in patients with chronic kidney disease (CKD) and large artery damage is a major factor that contributes to death. Metabolic acidosis is a common complication of CKD resulting from an inability of the diseased kidney to excrete the daily dietary acid load and it is associated with all-cause mortality in patients with CKD. However, the effect of treatment of metabolic acidosis with oral sodium bicarbonate on endothelial dysfunction and arterial stiffness in patients with CKD has not been evaluated. The investigators propose a prospective, randomized, controlled, open-label 14-week crossover pilot study examining the effect of treatment of metabolic acidosis with oral sodium bicarbonate on vascular endothelial function in 20 patients with CKD stage IV with metabolic acidosis.

Detailed description:

Arms: arm 1: Patients will start with sodium bicarbonate treatment then switch to control (no treatment) arm 2: Patients will start with control (no treatment) then switch to sodium bicarbonate treatment
Interventions: intervention 1: Sodium bicarbonate intervention 2: Control
Intervention descriptions: intervention 1: Subjects will be treated with oral sodium bicarbonate two to three times per day for a goal serum bicarbonate (HCO3-) of ≥ 23 meq/L. intervention 2: subjects will receive no treatment

Protocol documents: