ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01661972
Conditions: Metastatic Colorectal Cancer
Keywords: colorectal cancer all solid tumors metastatic refractory advanced solid tumors
Sponsor: John Strickler, M.D.
Start date: 2012-08-01; Completion date: 2016-06-12
Enrollment: 63 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The Primary Phase I objectives are to determine the recommended phase II dose for the capecitabine and aflibercept doublet combination; and to describe any dose limiting and non-dose limiting toxicities. The Phase II Primary objective is to determine progression free survival associated with this regimen. The Phase II secondary objectives are to determine response rate associated with this regimen; to determine overall survival associated with this regimen; and to explore any correlation of clinical outcome with baseline and on treatment changes in blood-based angiogenesis biomarkers.

This open-label, non-randomized phase I/II trial is designed to assess the safety, tolerability and RPTD of capecitabine plus aflibercept in adult subjects with metastatic colorectal cancer.

Detailed description:

Arms: arm 1: A standard 3+3 dose escalation format will be used. Capecitabine will start at 850mg/m2 to be given on days 1-14 and off days 15-21. If tolerated, the dose will then be escalated to 1000mg/m2 for the next cohort, given on the same schedule. The dose of aflibercept will be held constant at 6 mg/kg, given intravenously every 3 weeks. arm 2: Once the RPTD of the doublet combination has been identified, an additional 50 subjects with metastatic colorectal cancer will be added to a single, Phase 2 arm
Interventions: intervention 1: Capecitabine and aflibercept
Intervention descriptions: intervention 1: Capecitabine given on days 1-14 and off days 15-21. Dose: Phase 1 cohort 1 850mg/m2 Phase 1 cohort 2 1000mg/m2, Phase 2 RPTD.

Aflibercept will be held constant at 6 mg/kg, given intravenously every 3 weeks.

Both agents will be administered on a 21-day cycle.

Protocol documents:
Clinical trial NCT02557945
Conditions: Clinical High Risk for Psychosis
Sponsor: New York State Psychiatric Institute
Start date: 2015-08-01; Completion date: 2016-06-12
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test the effects of the drug gabapentin on brain function thought to be important in the development of schizophrenia. Researchers think that treating a brain region with gabapentin (the hippocampus) may reduce the risk for developing schizophrenia.

Detailed description:
Six week, single site, proof-of concept, randomized double-blind placebo-controlled pilot study to examine the effects of moderate dose gabapentin (3600mg) in n= 100 putatively prodromal patients on hippocampal activity.

Arms: arm 1: Gabapentin 3600mg PO daily arm 2: Matching placebo PO daily
Interventions: intervention 1: Gabapentin intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects will be treated with 400mg pills of gabapentin , titrating up to 3600mg per day, or 9 tablets (3 tabs tid) intervention 2: Subjects will be treated with 400mg pills of placebo, titrating up to 3600mg per day, or 9 tablets (3 tabs tid)

Protocol documents:
Clinical trial NCT02281773
Conditions: Schizophrenia
Sponsor: Boehringer Ingelheim
Start date: 2014-11-10; Completion date: 2016-06-13
Enrollment: 518 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the study is to investigate the efficacy, safety and tolerability of four different doses of BI 409306 once daily compared to placebo given for 12 weeks in patients with schizophrenia on stable antipsychotic treatment.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: BI 409306 100 mg QD intervention 2: BI 498306 50 mg QD intervention 3: Placebo intervention 4: BI 498306 25 mg QD intervention 5: BI 409306 10 mg QD
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None

Protocol documents:
Clinical trial NCT02365506
Conditions: LQT2 Syndrome
Keywords: Congenital Long QT Syndrome LQTS Sudden Cardiac Death
Sponsor: Gilead Sciences
Start date: 2015-07-20; Completion date: 2016-06-13
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to evaluate the effect of oral eleclazine (formerly GS-6615) on corrected QT (QTc) interval in participants with long QT2 syndrome.

Detailed description:

Arms: arm 1: Participants will receive placebo to match eleclazine on Days 1 and 4, eleclazine 24 mg on Day 2 and eleclazine 48 mg on Day 3. arm 2: Participants will receive placebo to match eleclazine on Days 1, 2 and 4, and eleclazine 48 mg on Day 3. arm 3: Participants will receive placebo to match eleclazine on Days 1 to 4.
Interventions: intervention 1: Eleclazine intervention 2: Placebo
Intervention descriptions: intervention 1: Tablets administered orally in a single dose intervention 2: Placebo to match tablets administered orally in a single dose

Protocol documents:
Clinical trial NCT02706925
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2016-03-22; Completion date: 2016-06-13
Enrollment: 63 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate safety, tolerability and pharmacokinetics, following single doses of BI 443651

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: BI 443651 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01457885
Conditions: Acute Myeloblastic Leukemia
Keywords: AML
Sponsor: University of Michigan Rogel Cancer Center
Start date: 2011-11-01; Completion date: 2016-06-14
Enrollment: 75 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Although transplant results for AML in complete remission (CR) at the time of transplant have improved, transplant results for non-remission AML have been quite poor. Most multi-center studies have focused on standard risk AML patients and not many studies have been done in this population of patients with non-remission AML. There are a large number of older patients with non-remission AML because the complete remission rate with induction chemotherapy decreases with age. Such older patients do not tolerate conventional full intensity conditioning regimens. Thus, an effective and tolerable conditioning regimen for non-remission AML is a great unmet need for current transplant practice.

From the investigators earlier study, it is suggested that replacing Fludarabine of standard FluBu4 regimen by Clofarabine (a related drug with much more potent anti-leukemia effect) in the transplant conditioning regimen may potentiate the anti-tumor activity of the conditioning regimen without adding significant toxicity, a goal of new conditioning regimen development.

The investigators expect to enroll a total of 75 patients from about fifteen sites. The investigators main objective is to confirm both the safety and efficacy as measured by one-year overall survival, of the CloBu4 combination as full intensity conditioning for non-remission acute myelogenous leukemia.

Detailed description:

Arms: arm 1: After pre-conditioning with CloBu4 (Clofarabine/Busulfan x 4), subjects will receive a peripheral blood stem cell transplant
Interventions: intervention 1: Clofarabine/Busulfan x 4 intervention 2: Peripheral blood stem cell transplant
Intervention descriptions: intervention 1: * Clofarabine IV dose level: 40 mg/m2/day x 5 days
* Busulfan IV dose level: 3.2 mg/kg daily x 4 days intervention 2: Peripheral blood stem cell transplant, after pre-conditioning drug treatment

Protocol documents:
Clinical trial NCT02131272
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2014-06-11; Completion date: 2016-06-14
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted globally. The aim of the trial is to investigate the efficacy and safety of insulin detemir versus insulin Neutral Protamine Hagedorn (NPH) in combination with the maximum tolerated dose of metformin and diet/exercise on glycaemic control in children and adolescents with type 2 diabetes insufficiently controlled on the maximum tolerated dose of metformin with or without other oral antidiabetic drug(s) with or without basal insulin.

Detailed description:

Arms: arm 1: Current OADs i.e. metformin or other OADs are continued unchanged arm 2: Current OADs i.e. metformin or other OADs are continued unchanged
Interventions: intervention 1: Insulin detemir intervention 2: Insulin NPH intervention 3: Diet/exercise
Intervention descriptions: intervention 1: Administered subcutaneously (s.c., under the skin) once or twice daily. The subjects' pre-trial OAD's i.e. metformin treatment should continue unchanged during the treatment period. intervention 2: Administered subcutaneously (s.c., under the skin) once or twice daily. The subjects' pre-trial OADs i.e. metformin treatment should continue unchanged during the treatment period. intervention 3: Intervention will be performed through family based changes in eating and activity behaviours.

Protocol documents:
Clinical trial NCT02203578
Conditions: Graft Versus Host Disease
Sponsor: Rutgers, The State University of New Jersey
Start date: 2014-11-01; Completion date: 2016-06-14
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This pilot clinical trial studies romidepsin in treating patients with graft-versus-host disease (GVHD) that has not responded to treatment with steroids. Romidepsin may be an effective treatment for graft-versus-host disease caused by a bone marrow or stem cell transplant.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine if romidepsin should be developed as a therapy for patients with steroid-refractory GVHD.

OUTLINE:

Patients receive romidepsin intravenously (IV) over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 3 and 6 months.

Arms: arm 1: Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: romidepsin intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given IV intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT02252016
Conditions: Hepatitis C
Sponsor: Merck Sharp & Dohme LLC
Start date: 2014-10-22; Completion date: 2016-06-14
Enrollment: 159 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, multi-site, placebo-controlled trial of a fixed dose combination (FDC) of grazoprevir (MK-5172) 100 mg + elbasvir (MK-8742) 50 mg in participants with chronic Hepatitis C Virus (HCV) genotype (GT) 1, GT4 or GT6 with inherited blood disorders. The primary hypothesis is that the proportion of participants treated with grazoprevir+elbasvir achieving Sustained Virologic Response (SVR) 12 weeks after the end of all study therapy (SVR12) will be greater than the reference rate of 40%.

Detailed description:

Arms: arm 1: Participants will take grazoprevir 100 mg + elbasvir 50 mg once daily during the 12-week treatment period and then will be monitored for safety during a 24-week follow-up period. arm 2: Participants will take placebo tablets once daily during the 12-week treatment period and will then be monitored for safety during a 4-week follow-up period. Participants will then begin open-label treatment with grazoprevir 100 mg + elbasvir 50 mg for a 12-week treatment period and will then be monitored for safety during a 24-week follow-up period.
Interventions: intervention 1: Grazoprevir + Elbasvir intervention 2: Placebo
Intervention descriptions: intervention 1: FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken once daily by mouth. intervention 2: Placebo tablets matching grazoprevir + elbasvir FDC tablets taken once daily by mouth.

Protocol documents:
Clinical trial NCT02642614
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2016-01-25; Completion date: 2016-06-14
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main objective of the current trial is to investigate safety, tolerability, pharmacokinetics and effect on inflammation of oral BI 1026706 administered twice daily for 4 weeks in patients with COPD.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: BI 1026706 intervention 2: Placebo intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: For blinding purposes

Protocol documents:
Clinical trial NCT00790036
Conditions: Diffuse Large B-cell Lymphoma
Keywords: Diffuse large B cell lymphoma DLBCL poor risk R-IPI 3-5 adjuvant therapy after R-CHOP or R-EPOCH after R-CHOP B-cell lymphoma lymphoma b cells blood cancer lymph nodes Hodgkin's non-Hodgkin
Sponsor: Novartis Pharmaceuticals
Start date: 2009-07-24; Completion date: 2016-06-15
Enrollment: 742 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Phase III study of RAD001 adjuvant therapy in poor risk patients with Diffuse Large B-Cell Lymphoma (DLBCL) of RAD001 versus matching placebo after patients had achieved complete response with first-line rituximab-chemotherapy

Detailed description:

Arms: arm 1: Participants who received Everolimus 10 mg (two 5 mg tablets), daily for 12 months arm 2: Participants who received Everolimus placebo 10 mg (two 5 mg tablets), daily for 12 months
Interventions: intervention 1: Everolimus intervention 2: Everolimus Placebo
Intervention descriptions: intervention 1: Everolimus was formulated as tablets of 5 mg strength, blister-packed under aluminum foil in units of 10 tablets. intervention 2: Everolimus placebo was formulated as tablets of 5 mg strength, blister-packed under aluminum foil in units of 10 tablets.

Protocol documents:
Clinical trial NCT01986907
Conditions: Wet Age Related Macular Degeneration
Keywords: wet AMD macular degeneration ranibizumab mono-bilateral poor visual acuity retinal disease eye disease Angiogenesis Inhibitors Angiogenesis Modulating Agents
Sponsor: Novartis Pharmaceuticals
Start date: 2014-03-04; Completion date: 2016-06-15
Enrollment: 1049 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of ranibizumab in patients affected by wet age related macular degeneration (wAMD).

Detailed description:

Arms: arm 1: Administered as an Intravitreal injection
Interventions: intervention 1: ranibizumab
Intervention descriptions: intervention 1: All patients will receive ranibizumab 0.5 mg/0.05 ml according to approved label: treatment is given monthly until maximum VA is achieved (i.e. stable VA for three consecutive monthly assessments performed while on ranibizumab treatment). Thereafter according to approved label, patients should be monitored monthly for visual acuity and treatment is to be resumed when monitoring indicates loss of visual acuity due to disease activity. Monthly injections should then be administered until stable visual acuity is reached again for three consecutive monthly assessments (implying a minimum of two injections).

Protocol documents:
Clinical trial NCT02346721
Conditions: Hepatitis C Virus Infection
Keywords: Sofosbuvir SOF/GS-5816 GS-5816 Hepatitis C HCV Cirrhosis Velpatasvir
Sponsor: Gilead Sciences
Start date: 2015-02-23; Completion date: 2016-06-15
Enrollment: 111 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) in participants with chronic genotype 1, 2, 4, 6 or indeterminate HCV infection who received placebo in the Gilead-sponsored study GS-US-342-1138.

Detailed description:

Arms: arm 1: SOF/VEL for 12 weeks
Interventions: intervention 1: SOF/VEL
Intervention descriptions: intervention 1: 400/100 mg tablet administered orally once daily

Protocol documents:
Clinical trial NCT02432105
Conditions: Otitis Media With Effusion in Children Otitis Media Recurrent
Sponsor: Alcon Research
Start date: 2015-06-25; Completion date: 2016-06-15
Enrollment: 470 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate EXE844 plus tympanostomy tubes compared to tympanostomy tubes only based on sustained clinical cure at end-of-therapy (EOT).

Detailed description:

Arms: arm 1: EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops, twice daily (BID) in each ear for 7 days after Tympanostomy Tube Insertion arm 2: EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion arm 3: Bilateral myringotomy and tympanostomy tube insertion
Interventions: intervention 1: EXE844 Sterile Otic Suspension, 0.3% intervention 2: Tympanostomy Tube Insertion
Intervention descriptions: intervention 1: None intervention 2: Surgical procedure for treating pediatric cases of recurrent or chronic otitis media

Protocol documents:
Clinical trial NCT01415427
Conditions: Mucopolysaccharidosis IV A Morquio A Syndrome MPS IVA
Keywords: Mucopolysaccharidosis IV type A MPS IV Type A Mucopolysaccharidosis IVA MPS IVA Morquio A Syndrome Lysosomal Storage Disorder LSD N-acetylgalactosamine-6-sulfatase N-acetylgalactosamine-6-sulfate sulfatase galactose-6-sulfatase GALNS enzyme replacement therapy ERT
Sponsor: BioMarin Pharmaceutical
Start date: 2011-07-01; Completion date: 2016-06-16
Enrollment: 173 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase 3 extension study will evaluate the long-term efficacy and safety of BMN 110 2.0 mg/kg/week and/or BMN 110 2.0 mg/kg/every other week in patients with mucopolysaccharidosis IVA (Morquio A Syndrome).

Detailed description:
This is a multi-center, multinational, extension study to evaluate 2 dose regimens of BMN 110 treatment in patients with MPS IVA who completed MOR-004.

The last study visit assessments for MOR-004 will constitute Baseline for this study. The first study drug dose of this protocol will occur on Week 0 of MOR-005, which is the same as the last visit (Week 24) of MOR-004. Initially, the study will be double-blind with patients previously randomized to BMN 110 in MOR-004 remaining on their assigned BMN 110 dose regimen (qw or qow dosing). The MOR-004 placebo patients will be re-randomized (1:1 ratio) to one of the 2 BMN 110 dose regimen groups: 2.0 mg/kg/qw or 2.0 mg/kg/qow.

There will be two study parts:

* Part 1 - randomized double-blind until the optimal BMN 110 dose regimen has been determined, based on the final primary efficacy analysis from MOR-004
* Part 2 - open-label BMN 110 treatment with the single optimal dose regimen

Arms: arm 1: BMN 110 Weekly: In Part 1, patients will receive an intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours once a week. arm 2: BMN 110 Every Other Week: In Part 1, patients will receive an intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours every other week and will receive infusions of placebo on alternating weeks.
Interventions: intervention 1: BMN 110 - Weekly intervention 2: BMN 110 - Every Other Week
Intervention descriptions: intervention 1: In Part 1, patients will receive intravenous (IV) infusions of study drug at a dose of 2.0 mg/kg/qw administered over a period of approximately 4 hours once a week.

In Part 2, patients will continue to receive 2.0 mg/kg of BMN 110 every week, with no placebo. intervention 2: In Part 1, patients will receive intravenous (IV) infusions of study drug at a dose of 2.0 mg/kg administered over a period of approximately 4 hours every other week. Patients randomized to the 2.0 mg/kg/qow arm will receive infusions of placebo on alternating weeks, to mask active drug weeks.

In Part 2, patients will receive 2.0 mg/kg of BMN 110 every week, with no placebo.

Protocol documents:
Clinical trial NCT01671332
Conditions: Carcinoma, Non Small Cell Lung
Keywords: Carcinoma, non small cell lung Second line Third line
Sponsor: University of Wisconsin, Madison
Start date: 2012-06-01; Completion date: 2016-06-16
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The overall purpose of the study is to determine whether or not the inclusion of suramin to standard treatment with docetaxel improves progression-free survival for patients with advanced non-small cell lung cancer in the second and third line settings.

Detailed description:
The overall purpose of the study is to determine whether or not the inclusion of suramin to standard treatment with docetaxel improves progression-free survival for patients with advanced non-small cell lung cancer in the second and third line settings.

Secondary objectives include:

* To compare response rate of patients in both treatment arms
* To compare overall survival of patients in both treatment arms
* To compare toxicity in both treatment arms
* To determine whether the survival benefit from suramin is associated with reduced M-phase entry in peripheral blood lymphocytes

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Docetaxel intervention 2: Suramin intervention 3: Docetaxel
Intervention descriptions: intervention 1: IV over 60 minutes, 75 mg/m2 intervention 2: IV over 30 minutes intervention 3: IV over 60 minutes. 56 mg/m2

Protocol documents:
Clinical trial NCT01980888
Conditions: Chronic Lymphocytic Leukemia
Sponsor: Gilead Sciences
Start date: 2014-02-05; Completion date: 2016-06-16
Enrollment: 311 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the progression-free survival in participants with previously untreated chronic lymphocytic leukemia (CLL) who would otherwise be suitable for bendamustine and rituximab treatment as standard of care.

An increased rate of deaths and serious adverse events (SAEs) among participants with front-line CLL and early-line indolent non-Hodgkin lymphoma (iNHL) treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA).

Detailed description:

Arms: arm 1: Participants will receive idelalisib for 96 weeks plus bendamustine+rituximab for 21 weeks. arm 2: Participants will receive placebo to match idelalisib for 96 weeks plus bendamustine+rituximab for 21 weeks.
Interventions: intervention 1: Idelalisib intervention 2: Bendamustine intervention 3: Rituximab intervention 4: Placebo
Intervention descriptions: intervention 1: 150 mg tablet administered orally twice daily intervention 2: Administered intravenously at a starting dose of 90 mg/m\^2 for up to 6 cycles. Dosing will be based on mg/m\^2 of body surface area. intervention 3: Single-use vials administered intravenously weekly starting at 375 mg/m\^2 on Day 1 (Week 0) and 500 mg/m\^2 thereafter for a total of 6 infusions intervention 4: Placebo to match idelalisib administered orally twice daily

Protocol documents: