ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01802320
Conditions: Colon Mucinous Adenocarcinoma Colon Signet Ring Cell Adenocarcinoma Rectal Mucinous Adenocarcinoma Rectal Signet Ring Cell Adenocarcinoma Recurrent Colon Carcinoma Recurrent Rectal Carcinoma Stage IIIA Colon Cancer Stage IIIA Rectal Cancer Stage IIIB Colon Cancer Stage IIIB Rectal Cancer Stage IIIC Colon Cancer Stage IIIC Rectal Cancer Stage IVA Colon Cancer Stage IVA Rectal Cancer Stage IVB Colon Cancer Stage IVB Rectal Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2013-03-01; Completion date: 2015-08-05
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well v-akt murine thymoma viral oncogene homolog 1 (Akt) inhibitor MK2206 works in treating patients with previously treated colon or rectal cancer that has spread from the primary site to other places in the body or nearby tissue or lymph nodes and cannot be removed by surgery. Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the response rate to MK-2206 (Akt inhibitor MK2206), defined as complete response (CR) + partial response (PR).

SECONDARY OBJECTIVES:

I. To determine response rate to MK-2206 in patients with phosphatase and tensin homolog (PTEN) loss or phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PIK3CA) mutation in a pretreatment biopsy from a metastatic site.

II. To determine progression-free survival (PFS) and overall survival (OS). III. To determine the time to treatment failure (TTF), and duration of tumor response (DR).

IV. To determine the safety profile and tolerability of this regimen in this patient population.

V. To determine effect of PTEN, v-raf murine sarcoma viral oncogene homolog B1 (BRAF), PIK3CA, and AKT mutations and semi-quantitative grading of PTEN expression on clinical response.

OUTLINE:

Patients receive Akt inhibitor MK2206 orally (PO) on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months.

Arms: arm 1: Akt inhibitor MK2206 orally (PO) on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Akt Inhibitor MK2206 intervention 2: Laboratory Biomarker Analysis intervention 3: Pharmacological Study
Intervention descriptions: intervention 1: Given PO intervention 2: Correlative studies intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT00261846
Conditions: Chronic Myeloid Leukemia
Keywords: Leukemia tyrosine kinase inhibitor philadelphia chromosome Myeloid Philadelphia Positive
Sponsor: Pfizer
Start date: 2006-01-18; Completion date: 2015-08-06
Enrollment: 571 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, continuous daily dosing, two-part safety and efficacy study of SKI-606 (bosutinib) in Philadelphia chromosome positive leukemias (Ph+). Part 1 is a dose-escalation study in chronic phase Chronic Myelogenous Leukemia (CML) subjects to establish the maximum tolerated dose (MTD) in this subject population. Part 2 has begun after the completion of Part 1 and after a dose has been established for the compound in chronic phase subjects. Part 2 is a study of the the efficacy of 500mg daily oral SKI-606 (bosutinib) in patients with all phases of Ph+ CML and Ph+ Acute Lymphocytic Leukemia (ALL). The protocol will test the hypotheses that oral daily dosing of bosutinib at 500 mg will attain (1) Major Cytogenetic Response (MCyR) in chronic phase CML patients and (2) Overall Hematological Response (OHR) in advanced leukemia patients. Each phase of the disease will be evaluated as a separate cohort.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Bosutinib
Intervention descriptions: intervention 1: Part 1, starting dose 400 mg oral, daily dosing in the dose-escalation component.

Part 2, 500 mg oral, continuous, daily dosing.

Protocol documents:
Clinical trial NCT01637272
Conditions: Dumping Syndrome
Keywords: Dumping syndrome SOM230 pasireotide LAR
Sponsor: Novartis Pharmaceuticals
Start date: 2013-01-08; Completion date: 2015-08-07
Enrollment: 43 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
multi-center, phase II study evaluating efficacy, safety and pharmacokinetics of pasireotide in patients with dumping syndrome

Detailed description:
43 adult patients with dumping syndrome received pasireotide s.c. during the dose escalation phase (3 months dose could be increased based on the presence of hypoglycemia during OGTT). After completing Month 3, patients were switched to pasireotide LAR for 3 months (up to Month 6). The core phase of the study was completed at the end of Month 6. Patients were allowed to enter the 6 month extension phase if they experienced benefit with pasireotide LAR treatment.

Arms: arm 1: Subjects with dumping syndrome treated with pasireotide
Interventions: intervention 1: SOM230
Intervention descriptions: intervention 1: Pasireotide (SOM230) sc injection was provided as solution for injection in individual 1-point-cut 1 mL ampule, containing nominally 200 μg of pasireotide (as free base). Doses: 50, 100, 150 and 200 μg. Pasireotide im LAR depot injection was provided as micro particles powder in vials containing nominally 10, 20, 40 \& 60 mg of pasireotide (as free base) \& solvent for suspension for injection in ampules for the reconstitution of the LAR micro particles. Doses: 10, 20, 30, 40 or 60 mg

Protocol documents:
Clinical trial NCT02392494
Conditions: Hepatitis C
Sponsor: Merck Sharp & Dohme LLC
Start date: 2015-04-28; Completion date: 2015-08-10
Enrollment: 9 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The purpose of this study is to evaluate the safety and pharmacokinetics of MK-1075, and to determine the ability of MK-1075 to reduce HCV viral load, following administration of a single dose in HCV-infected participants.

Detailed description:
Per protocol, panels may be omitted if the objectives of the study are met in preceding panels.

Arms: arm 1: HCV-infected participants receive a single 100 mg dose of MK-1075. arm 2: HCV-infected participants receive a single 200 mg dose of MK-1075. arm 3: HCV-infected participants receive a single 400 mg dose of MK-1075. arm 4: HCV-infected participants receive a single 800 mg dose of MK-1075.
Interventions: intervention 1: MK-1075
Intervention descriptions: intervention 1: MK-1075 supplied as 10 mg or 100 mg tablets for oral administration.

Protocol documents:
Clinical trial NCT02216071
Conditions: Acute Otitis Externa
Sponsor: Exela Pharma Sciences, LLC.
Start date: 2014-07-20; Completion date: 2015-08-11
Enrollment: 499 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to demonstrate the clinical therapeutic non-inferiority of EXL CDOS to commercially available Ciprofloxacin 0.3% and Dexamethasone 0.1% Sterile Otic Suspension (Ciprodex®, Alcon) in the treatment of acute otitis externa (AOE) when administered twice daily for 7 days.

Detailed description:
This was a Phase 3, multicenter, randomized, double-blind, active-controlled, parallel-group study in adults and children (age 6 months and older) with a diagnosis of AOE with a 2-day screening period followed by a 2-week participation period. Subjects were administered study drug, EXL CDOS or RLD, 4 drops in the affected ear(s) BID for 7 days. The primary endpoint, the proportion of subjects with a clinical AOE score of 0, was measured at the TOC Visit on Day 15.

Arms: arm 1: Ciprodex®, Otic Suspension, Twice daily for 7 days arm 2: EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension, Otic Suspension, Twice daily for 7 days
Interventions: intervention 1: Ciprodex® intervention 2: EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension
Intervention descriptions: intervention 1: Treatment of acute otitis externa (AOE) when administered twice daily for 7 days intervention 2: Treatment of acute otitis externa (AOE) when administered twice daily for 7 days

Protocol documents:
Clinical trial NCT00946153
Conditions: Hepatocellular Carcinoma
Keywords: Carcinoma Hepatocellular
Sponsor: Eisai Co., Ltd.
Start date: 2009-07-24; Completion date: 2015-08-13
Enrollment: 66 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine maximum tolerated dose (MTD), efficacy, safety and tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor effect of E7080 when is administered continually once daily in participants with advanced hepatocellular carcinoma.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Lenvatinib
Intervention descriptions: intervention 1: In the Dose-Escalation Component of the study, lenvatinib will be administered as continuous once-daily oral dosing. Dose-escalation will occur based on safety information obtained during Cycle 1. The recommended dose for the Expansion Component of the study will use the MTD in Cycle 1.

Protocol documents:
Clinical trial NCT02438683
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2015-05-04; Completion date: 2015-08-13
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This trial will be conducted to further evaluate, in a controlled setting, potential cardiac effects of an anticipated therapeutic and supra-therapeutic dose of BI 409306 under resting and exercise conditions. Since the drug is being developed in part for a disease with an expectedly high number of elderly (AD), the characterization of cardiac safety of BI 409306 is considered to be important for the development of this compound.

This trial will be conducted to further evaluate, in a controlled setting, potential cardiac effects of an anticipated therapeutic and supra-therapeutic dose of BI 409306 under resting and exercise conditions.

Since the drug is being developed in part for a disease with an expectedly high number of elderly (AD), the characterization of cardiac safety of BI 409306 is considered to be important for the development of this compound.

Detailed description:

Arms: arm 1: Participants received matching Placebo oral dose with 240 mL of water after a standardized light breakfast on Day 1 and Day 3 under resting/exercise conditions. arm 2: Participants received BI 409306 50 mg oral dose with 240 mL of water after a standardized light breakfast on Day 1 and Day 3 under resting/exercise conditions. arm 3: Participants received BI 409306 200 mg oral dose with 240 mL of water after a standardized light breakfast on Day 1 and Day 3 under resting/exercise conditions.
Interventions: intervention 1: BI 409306 intervention 2: BI 409306 intervention 3: Placebo
Intervention descriptions: intervention 1: high dose, single dose, oral administration intervention 2: low dose, single dose, oral administration intervention 3: single dose, oral administration

Protocol documents:
Clinical trial NCT02025179
Conditions: Spinal Cord Injury Bone Loss Osteoporosis
Keywords: Teriparatide Osteoporosis Spinal Cord Injury Bone Diseases Metabolic Bone Diseases Musculoskeletal Diseases Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Nervous System Wounds and Injuries Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Vibration
Sponsor: Northwestern University
Start date: 2013-01-01; Completion date: 2015-08-14
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if a second year of exposure to teriparatide in both subjects that received a year of teriparatide or teriparatide-placebo will result in a greater increase in bone mass density (BMD) compared to that seen in a single year's treatment.

This study will also investigate 1) if a second year of teriparatide therapy will increase bone strength in people with chronic spinal cord injury (SCI) who previously received a year of teriparatide or teriparatide-placebo, 2) the number of participants with adverse events from teriparatide, and 3) the effects of teriparatide on serum markers of bone metabolism.

Detailed description:
This extension study will only enroll individuals who have completed one year of treatment in the parent protocol "Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury (NCT01225055)". This study will allow those individuals who received Teriparatide (20ug/day) and vibration (10 min/day) during the parent study to be treated for a second year and will allow those individuals who received teriparatide-placebo to have the opportunity to have a full year of teriparatide therapy. This study will determine if two years of exposure to teriparatide will result in a greater increase in Bone Mass Density (BMD) than that seen after a single year's treatment. Subjects will be evaluated at 6 and 12 months after initiating treatment with measurement of bone density as well as bone markers of formation and resorption.

Arms: arm 1: Experimental: Teriparatide and vibration

Drug: Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months

Device: Vibration 10 min/day for 12 months
Interventions: intervention 1: Teriparatide intervention 2: Vibration
Intervention descriptions: intervention 1: Teriparatide 20 ug daily Sub-Q over 12 months intervention 2: Vibration 10 min/day for 12 months

Protocol documents:
Clinical trial NCT02277106
Conditions: Essential Tremor
Sponsor: Sage Therapeutics
Start date: 2014-09-23; Completion date: 2015-08-14
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Stage 1 is a double-blind, proof-of-concept study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of SAGE-547 Injection in male and female participants with essential tremor in the upper limb.

Stage 2 is an open-label arm designed to evaluate the safety, tolerability, PK, and effectiveness of SAGE-547 Injection at a higher dose than in Stage 1. Participants who completed Stage 1 were invited to participate in Stage 2.

Detailed description:

Arms: arm 1: Participants received a 12-hour intravenous (IV) infusion of SAGE 547, at ascending doses of 29, 58, and 86 micrograms per kilogram of body weight per hour (μg/kg/h), 4 hours each, on Day 1 of Stage 1 \[Treatment Period 1 (TP 1)\]. After a washout period of approximately 7 days, participants received a 12-hour IV infusion of SAGE-547 matching-placebo, on Day 10 of Stage 1 \[Treatment Period 2 (TP 2)\]. arm 2: Participants received a 12-hour IV infusion of SAGE-547 matching-placebo on Day 1 of Stage 1 (TP 1). After a washout period of approximately 7 days, participants received a 12-hour IV infusion of SAGE 547 at ascending doses of 29, 58, and 86 μg/kg/h, 4 hours each, on Day 10 of Stage 1 (TP 2). arm 3: Participants who completed Stage 1 were invited to receive a 10-hour IV infusion of SAGE 547, at ascending doses of 90 μg/kg/h for 1 hour, 120 μg/kg/h for 1 hour, and 150 μg/kg/h for 8 hours on Day 1 of Stage 2.
Interventions: intervention 1: SAGE-547 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01519414
Conditions: Hormone-Resistant Prostate Cancer Prostate Adenocarcinoma Recurrent Prostate Carcinoma Stage IV Prostate Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2012-01-11; Completion date: 2015-08-18
Enrollment: 78 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This randomized phase II trial studies how well tivantinib works compared to placebo in treating patients with metastatic prostate cancer. Tivantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine progression-free survival (PFS) in men with minimally symptomatic or asymptomatic metastatic, castrate-resistant, chemotherapy-naïve prostate cancer treated with ARQ 197 (tivantinib).

SECONDARY OBJECTIVES:

I. To determine the prostate-specific antigen (PSA) response rate at 12 weeks in men with metastatic, castrate-resistant, chemotherapy-naïve prostate cancer treated with ARQ 197.

II. To determine the radiographic response rate at 12 weeks based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria on computed tomography (CT) scans and stability of bone lesions on bone scan in castrate-resistant, chemotherapy-naïve prostate cancer treated with ARQ 197.

III. To determine the proportion of patients who are progression-free at 12 weeks.

IV. To assess safety and tolerability in patients treated with ARQ 197 using the National Institute of Cancer (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grading of toxicities.

TERTIARY OBJECTIVES:

I. Evaluate markers of bone turnover. (Exploratory)

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

Arm I: Patients receive tivantinib orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Arm II: Patients receive placebo PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I.

After completion of study treatment, patients are followed up every 3 months for 6 months.

Arms: arm 1: Patients receive tivantinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. arm 2: Patients receive placebo PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I.
Interventions: intervention 1: Laboratory Biomarker Analysis intervention 2: Placebo intervention 3: Tivantinib
Intervention descriptions: intervention 1: Optional correlative studies intervention 2: Given PO intervention 3: Given PO

Protocol documents:
Clinical trial NCT00384176
Conditions: Colorectal Cancer
Keywords: Metastatic Colorectal Cancer RECENTIN
Sponsor: AstraZeneca
Start date: 2006-08-30; Completion date: 2015-08-19
Enrollment: 1814 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to see if Cediranib in combination with FOLFOX is effective in treating metastatic colorectal cancer and to see how it compares with Avastin (Bevacizumab) in combination with FOLFOX.

Detailed description:

Arms: arm 1: Bevacizumab + FOLFOX arm 2: Cediranib + FOLFOX
Interventions: intervention 1: Cediranib intervention 2: Bevacizumab intervention 3: 5-fluorouracil ( in FOLFOX) intervention 4: Leucovorin (in FOLFOX) intervention 5: Oxaliplatin (in FOLFOX)
Intervention descriptions: intervention 1: oral tablet once daily intervention 2: intravenous infusion intervention 3: intravenous infusion intervention 4: intravenous infusion intervention 5: intravenous infusion

Protocol documents:
Clinical trial NCT02504775
Conditions: Pain
Sponsor: GlaxoSmithKline
Start date: 2015-08-01; Completion date: 2015-08-19
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This will be a monocentric, single blinded, randomized, single-dose, two-periods, two-sequence, crossover bioequivalence study of two oral formulations in healthy participants under fasting conditions.

Detailed description:

Arms: arm 1: Participants will first receive one tablet \[500 milligram (mg) of paracetamol\] of Tylenol® Caplets, orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h fasting. After a washout period of 72 h, they then will receive one tablet (500 mg of paracetamol) of Mejoral® 500 tablets, orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h fasting. arm 2: Participants will first receive one tablet (500 mg of paracetamol) of Mejoral® 500 tablets, orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h fasting. After a washout period of 72 h, they then will receive one tablet (500 mg of paracetamol) of Tylenol® Caplets, orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h fasting.
Interventions: intervention 1: Mejoral® 500 Tablets intervention 2: Tylenol® Caplets
Intervention descriptions: intervention 1: 500 mg tablet of paracetamol intervention 2: 500 mg tablet of paracetamol

Protocol documents:
Clinical trial NCT01649427
Conditions: Pharmacokinetics Study in de Novo Kidney Transplantation
Keywords: Pharmacokinetics Study Tacroliums GFR kidney transplant rejection allograft rejection xenograft rejection host vs graft disease renal transplant
Sponsor: Novartis Pharmaceuticals
Start date: 2012-10-17; Completion date: 2015-08-20
Enrollment: 73 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to investigate if Tacrolimus Hexal® has similar pharmacokinetic properties compared to Prograf® in de novo renal transplant patients and whether the comparable exposure resulted in similar renal function.

Detailed description:
In Phase II of this study there was a high patient drop-out rate and an associated long recruitment timespan. Eighty-one patients were recruited to Phase I and only 45 of the required 54 patients were available for PK analysis. To complete Phase II, 245 (in addition to 81) patients were to be required to achieve calculated sample size. Therefore the protocol was amended to stop recruitment and analyze Phase I patient data of CERL080ADE27 (PK-Phase I). Patients that were still ongoing were scheduled for an end of study (EOS) visit. During this visit patients were informed by the investigator about the end of study and advised about further treatment course.

Arms: arm 1: Control therapy: one capsule containing 0.5 mg, 1mg or 5mg Prograf®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect® arm 2: Investigational therapy: one capsule containing 0.5mg, 1mg or 5mg Tacrolimus Hexal®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect®
Interventions: intervention 1: Prograf intervention 2: Tacrolimus Hexal
Intervention descriptions: intervention 1: Prograf® capsules were supplied as capsules of 0.5 mg, 1 mg and 1.5 mg dose strengths. intervention 2: Tacrolimus Hexal® capsules were supplied to the investigators at dose strengths of 0.5 mg,

1 mg and 1.5 mg.

Protocol documents: