ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01612546
Conditions: Adenocarcinoma of the Esophagus Adenocarcinoma of the Gastroesophageal Junction Diffuse Adenocarcinoma of the Stomach Intestinal Adenocarcinoma of the Stomach Mixed Adenocarcinoma of the Stomach Recurrent Esophageal Cancer Recurrent Gastric Cancer Squamous Cell Carcinoma of the Esophagus Stage IIIB Esophageal Cancer Stage IIIB Gastric Cancer Stage IIIC Esophageal Cancer Stage IIIC Gastric Cancer Stage IV Esophageal Cancer Stage IV Gastric Cancer
Sponsor: City of Hope Medical Center
Start date: 2012-11-01; Completion date: 2015-01-15
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This pilot clinical trial studies cyclodextrin-based nanopharmaceutical CRLX101 in treating patients with advanced or metastatic stomach, gastroesophageal, or esophageal cancer that has progressed through at least one prior regimen of chemotherapy and cannot be removed by surgery. CRLX101 delivers the cytotoxic topoisomerase-1 inhibitor camptothecin into tumor cells and is hypothesized to interrupt the growth of tumor cells.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate pre- and post-treatment biopsies to assess CRLX101 (cyclodextrin-based polymer-camptothecin CRLX101) nanoparticle and 20(S)-Camptothecin (CPT) uptake in tumor and normal tissue.

SECONDARY OBJECTIVES:

I. To evaluate the safety and toxicity of CRLX101 in this patient population.

II. To examine the antitumor efficacy of CRLX101 in advanced gastric/gastroesophageal junction (GEJ)/esophageal squamous or adenocarcinoma including clinical benefit rate (complete response \[CR\] + partial response \[PR\] + stable disease \[SD\]) at 4 months and overall survival.

OUTLINE:

Patients receive cyclodextrin-based polymer-camptothecin CRLX101 intravenously (IV) over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients achieving stable disease or better, may receive treatment for an additional 6 months.

After completion of study treatment, patients are followed up monthly.

Arms: arm 1: Patients receive cyclodextrin-based polymer-camptothecin CRLX101 IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the completion of 6 courses, patients achieving stable disease or better may receive treatment for an additional 6 months.
Interventions: intervention 1: cyclodextrin-based polymer-camptothecin CRLX101 intervention 2: Laboratory biomarker analysis intervention 3: Pharmacological studies
Intervention descriptions: intervention 1: Given IV intervention 2: Correlative studies intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT01980056
Conditions: Myelodysplastic Syndrome
Keywords: INT-2 or high-risk MDS
Sponsor: Weill Medical College of Cornell University
Start date: 2013-10-25; Completion date: 2015-01-19
Enrollment: 10 participants; Allocation: ; Intervention model: SEQUENTIAL

Brief summary:
Study WCMC IST/VOS/MDS evaluates the safety and tolerability of escalating doses of vosaroxin in adult patients with pathologically confirmed Myelodysplastic Syndrome, or MDS, (\< 20% blasts in bone marrow, peripheral blood, or both) by World Health Organization (WHO) classification with an intermediate 2 (INT-2) or high-risk score (ie, ≥ 1.5) as assessed by the International Scoring System (IPSS) after failure of hypomethylating agent-based therapy. Based on 3 completed studies and xenograft models, Vosaroxin is hypothesized to be safe and will effective in this patient population.

Detailed description:
This is a phase 1-2, dose escalation study of the safety and clinical activity of vosaroxin in subjects with INT-2 or high risk MDS who have failed prior hypomethylating agent based therapy. The study will utilize a standard 3+3 design to estimate the MTD \[maximum tolerated dose\] for vosaroxin administered to subjects with MDS. MTD will be defined as the highest dose level at which no more than 33% of the subjects observed at a given dose level experience a DLT \[dose limiting toxicity\]. Subjects will be assessed for safety and DLT in the first cycle of vosaroxin. Subjects will be enrolled into the study in cohorts of 3. Three eligible subjects will be enrolled in sequential cohorts at increasing dose levels until at least 1 DLT is observed during the first cycle of vosaroxin therapy. Subjects who receive both doses of vosaroxin will be evaluated for the MTD, DLTs, and safety profile during the first cycle of therapy. Once the MTD has been determined, an expanded evaluation of safety and hematologic response or improvement rate at this dose level will be conducted in additional subjects so that the total number of subjects exposed to this dose level is up to 15 subjects, inclusive of those treated at this dose level in the dose-escalation phase. The exposure of additional subjects at the MTD will provide a better estimate of the toxicity rate. Subjects with a documented response of Complete Response, Partial Response, or hematologic improvement at the end of Cycle 2 may continue to receive vosaroxin for additional cycles at the discretion of the treating investigator and after discussion with the medical staff at Sunesis Pharmaceuticals. There will be a 30-day follow-up period following the termination of study drug treatment.

Arms: arm 1: All patients will receive vosaroxin according to the dose cohort in which they are enrolled.
Interventions: intervention 1: Vosaroxin
Intervention descriptions: intervention 1: Dose level 1: Vosaroxin 50 mg\^m2 IV on Days 1 and 4 of 28 day cycle Dose level 2: Vosaroxin 72 mg\^m2 IV on Days 1 and 4 of 28 day cycle Dose level 3: Vosaroxin 50 mg\^m2 IV on Days 1, 4, 8 and 11 of 28 day cycle

Protocol documents:
Clinical trial NCT02115347
Conditions: Type 2 Diabetes Mellitus Hepatic Impairment
Sponsor: Merck Sharp & Dohme LLC
Start date: 2014-09-19; Completion date: 2015-01-19
Enrollment: 16 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study to assess the pharmacokinetics and safety of ertugliflozin (MK-8835, PF-04971729) in participants with hepatic impairment versus healthy participants. In Part 1 of the study, participants with moderate hepatic impairment (Child-Pugh score 7-9) and matched healthy participants will be enrolled; depending on results in Part 1, Part 2 may be conducted and will enroll participants with mild hepatic impairment (Child-Pugh score 5-6).

Detailed description:

Arms: arm 1: Participants receive a single 15 mg oral dose (tablet) of ertugliflozin arm 2: Participants receive a single 15 mg oral dose (tablet) of ertugliflozin arm 3: Participants receive a single 15 mg oral dose (tablet) of ertugliflozin
Interventions: intervention 1: Ertugliflozin 15 mg
Intervention descriptions: intervention 1: Tablet

Protocol documents:
Clinical trial NCT01965158
Conditions: Opioid-induced Constipation
Keywords: Opioid-induced Constipation
Sponsor: Shionogi
Start date: 2013-08-29; Completion date: 2015-01-22
Enrollment: 547 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of naldemedine in the treatment of opioid-induced constipation (OIC) in adults with non-malignant chronic pain who are not using laxatives.

Detailed description:

Arms: arm 1: Participants received 0.2 mg naldemedine orally once daily for 12 weeks. arm 2: Participants received matching placebo orally once daily for 12 weeks.
Interventions: intervention 1: Naldemedine intervention 2: Placebo
Intervention descriptions: intervention 1: Naldemedine 0.2 mg tablet taken orally once a day intervention 2: Placebo tablet taken orally once a day

Protocol documents:
Clinical trial NCT01657799
Conditions: Brain Metastases From Non-small Cell Lung Cancer
Sponsor: AbbVie (prior sponsor, Abbott)
Start date: 2012-10-19; Completion date: 2015-01-22
Enrollment: 307 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the efficacy and safety of veliparib and whole brain radiation therapy in adults with brain metastases from non-small cell lung cancer (NSCLC).

Detailed description:

Arms: arm 1: Participants received veliparib 200 mg twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays. arm 2: Participants received veliparib 50 mg twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays. arm 3: Participants received placebo twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays.
Interventions: intervention 1: Veliparib intervention 2: Placebo intervention 3: Whole brain radiation therapy
Intervention descriptions: intervention 1: Veliparib capsules for oral administration intervention 2: Placebo to veliparib capsules for oral administration intervention 3: 30.0 grays (Gy) of WBRT given in 10 daily fractions of 3.0 Gy each, excluding weekends and holidays

Protocol documents:
Clinical trial NCT01753076
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Amyotrophic lateral sclerosis efficacy ozanezumab safety
Sponsor: GlaxoSmithKline
Start date: 2012-12-20; Completion date: 2015-01-22
Enrollment: 304 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 48-week, randomised, multi-centre, double-blind, placebo-controlled, parallel group investigation of the efficacy and safety of intravenous (IV) ozanezumab (GSK1223249) compared to placebo in subjects with Amyotrophic Lateral Sclerosis (ALS). Following a screening period of up to four weeks, eligible subjects will be randomised (1:1) to receive IV placebo or 15 milligram (mg)/ kilogram (kg) IV ozanezumab every 2 weeks for a period of 48 weeks with a follow-up visit around 14 weeks after the last infusion. A total of approximately 294 eligible subjects will be randomised from approximately 37 centers worldwide. The primary objective is to assess the effect of ozanezumab on the physical function and survival of ALS subjects over a treatment period of 48 weeks. Function will be measured using the ALS Functional Rating Scale - Revised (ALSFRS-R). Secondary objectives include the evaluation of other clinical outcomes associated with ALS (respiratory function, muscle strength, progression free survival and overall survival) in support of the primary objective. Quality of life, safety, tolerability, immunogenicity and pharmacokinetics (ozanezumab and riluzole) will also be assessed.

Detailed description:

Arms: arm 1: Administered by IV route. Treatment period - 48 Weeks arm 2: Normal saline by IV route. Treatment period - 48 weeks
Interventions: intervention 1: Ozanezumab intervention 2: Placebo
Intervention descriptions: intervention 1: Ozanezumab injection solution intervention 2: Normal saline (0.9% sodium chloride) infusion

Protocol documents:
Clinical trial NCT01819129
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2013-09-09; Completion date: 2015-01-22
Enrollment: 881 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Asia, Europe and North America. The aim of the trial is to compare FIAsp (faster-acting insulin aspart) to insulin aspart, both in combination with insulin glargine and metformin in adults with type 2 diabetes.

Detailed description:

Arms: arm 1: Meal time faster-acting insulin aspart is given in combination with once daily insulin glargine and metformin in a basal-bolus regimen. Insulin glargine and metformin treatment are open labelled background medication. arm 2: Meal time insulin aspart is given in combination with once daily insulin glargine and metformin in a basal-bolus regimen. Insulin glargine and metformin treatment are open labelled background medication.
Interventions: intervention 1: Faster-acting insulin aspart intervention 2: Insulin aspart intervention 3: Insulin glargine
Intervention descriptions: intervention 1: Mealtime FIAsp administered subcutaneously (s.c., under the skin). Dose individually adjusted. intervention 2: Mealtime insulin aspart administered subcutaneously (s.c., under the skin). Dose individually adjusted. intervention 3: Administered s.c. once daily at subjects' pre-trial dose. Subjects will continue their metformin treatment without changing the frequency or dose throughout the trial.

Protocol documents:
Clinical trial NCT01821677
Conditions: Diabetic Macular Edema
Keywords: macular edema diabetic
Sponsor: Ampio Pharmaceuticals. Inc.
Start date: 2013-02-26; Completion date: 2015-01-23
Enrollment: 354 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy of ultra low dose danazol (Optina™) for the treatment of diabetic macular edema.

Detailed description:
A Randomized, Placebo-Controlled, Parallel, Double-Masked Study to Evaluate the Efficacy and Safety of Two Doses of Oral Optina™ in Adult Patients With Diabetic Macular Edema.

The primary trial objective is to evaluate the efficacy of two oral BMI-related doses (0.5 mg per body mass index (BMI), 1.0 mg per BMI per day) of Optina™ in improving visual acuity (VA) compared to placebo.

The secondary objectives are to evaluate the efficacy of two oral BMI-related doses of Optina™ on change in central macular thickness (CMT) and VA responder status compared to placebo, and to assess the safety and tolerability of two oral BMI-related doses of Optina™ compared to placebo.

Arms: arm 1: Capsules, 0.5 mg/BMI Danazol with dose determined by subject's BMI at baseline, 2 capsules (5 mg, 7.5 mg, or 10 mg) twice daily, for 12 weeks. arm 2: Capsules, 1.0 mg/BMI Danazol with dose determined by subject's BMI at baseline, 2 capsules (5 mg, 7.5 mg, or 10 mg) twice daily, for 12 weeks. arm 3: Gelatin capsules, identical in appearance to the active capsules, filled with pharmaceutical grade lactose and magnesium stearate.
Interventions: intervention 1: Danazol Capsules intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01606800
Conditions: Hepatitis C, Chronic
Sponsor: Merck Sharp & Dohme LLC
Start date: 2013-01-01; Completion date: 2015-01-26
Enrollment: 45 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy of a short course of therapy (24 weeks) versus standard 48 week treatment in previously untreated adult participants with chronic hepatitis C (CHC) genotype 4 infection who achieve rapid virologic response (RVR), defined as HCV ribonucleic acid (RNA) negativity after 4 weeks of treatment.

Detailed description:
Participants who achieved RVR after 4 weeks of PEG-INF alfa-2b plus RBV treatment were randomized to receive either 20 or 44 weeks of continued therapy, for a total of 24 or 48 weeks total of PEG-INF plus RBV therapy.

Arms: arm 1: Participants achieving RVR at 4 weeks of treatment will receive 44 additional weeks of Peg-IFN Alfa-2b + RBV. arm 2: Participants achieving RVR at 4 weeks of treatment will receive 20 additional weeks of Peg-IFN Alfa-2b + RBV.
Interventions: intervention 1: PEG-IFN alfa-2b intervention 2: ribavirin
Intervention descriptions: intervention 1: Pegylated interferon alfa-2b administered subcutaneously 1.5 mcg/kg/week intervention 2: Ribavirin 200 mg capsules administered orally daily based on weight

Protocol documents:
Clinical trial NCT01682759
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes
Sponsor: Merck Sharp & Dohme LLC
Start date: 2012-09-10; Completion date: 2015-01-26
Enrollment: 751 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial will assess the safety and efficacy of omarigliptin (MK-3102) compared with the sulfonylurea, glimepiride, in Type 2 diabetes mellitus participants with inadequate glycemic control on metformin monotherapy. The primay hypothesis of the study is that after 54 weeks, the mean change from baseline in hemoglobin A1C (A1C) in participants treated with omarigliptin is non-inferior compared with that in participants treated with glimepiride.

Detailed description:

Arms: arm 1: Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks. arm 2: Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
Interventions: intervention 1: Omarigliptin intervention 2: Placebo to Omarigliptin intervention 3: Glimepiride intervention 4: Glimepiride Placebo intervention 5: Metformin intervention 6: Insulin Glargine
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: Glimepiride (1 mg and/or 2 mg tablets). During the 54-week double-blind treatment period, glimepiride can be up-titrated, as appropriate, to a maximum total daily dose of 6 mg/day. Throughout the trial, down-titration of glimepiride may also occur based upon the participant's glucose measurements and clinical symptoms of hypoglycemia. intervention 4: None intervention 5: Participants will continue on their stable dose (\>=1500 mg/day) of open-label metformin throughout the trial. intervention 6: Insulin glargine can be used for rescue therapy, if glycemic control is not maintained. Insulin therapy should be initiated as per local country insulin glargine label.

Protocol documents:
Clinical trial NCT01777282
Conditions: Diabetes Mellitus
Keywords: albiglutide Japanese glucagon-like peptide-1 GSK716155
Sponsor: GlaxoSmithKline
Start date: 2013-02-23; Completion date: 2015-01-27
Enrollment: 374 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to examine the long term safety and efficacy of weekly subcutaneously injected albiglutide in combination with a single oral antidiabetic drug for 52 weeks in Japanese subjects with type 2 diabetes mellitus.

Detailed description:
This study is designed to examine the long term safety and efficacy of weekly subcutaneously injected albiglutide in combination with a single oral antidiabetic drug for 52 weeks in Japanese subjects with type 2 diabetes mellitus. Subjects with a historical diagnosis of type 2 diabetes mellitus who are inadequately controlled on a single oral antidiabetic agent will be recruited into the study. Subjects will continue on their single antidiabetic agent and once weekly albiglutide will be added.

Arms: arm 1: Albiglutide in combination with background sulfonylurea arm 2: Albiglutide in combination with background biguanide arm 3: Albiglutide in combination with background glinide arm 4: Albiglutide in combination with background thiazolidinedione arm 5: Albiglutide in combination with background alpha-glucosidase inhibitor
Interventions: intervention 1: Albiglutide intervention 2: Sulfonylurea intervention 3: Biguanide intervention 4: Glinide intervention 5: Thiazolidinedione intervention 6: Alpha-glucosidase inhibitor
Intervention descriptions: intervention 1: Albiglutide is a fixed-dose, fully disposable pen injector system for delivery of albiglutide from a prefilled dual chamber glass cartridge that is an integral part of the pen. It is intended for single use by the subject. It is designed for manual reconstitution of the dose, priming, and insertion of the pen needle, and manual injection by the subject. The subject will inject albiglutide 30 mg weekly for 52 weeks (with optional uptitration to 50 mg weekly) subcutaneously into the abdomen, alternating between left and right sides. The pen is designed to work with standard pen needles. intervention 2: Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed. intervention 3: Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed. intervention 4: Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed. intervention 5: Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed. intervention 6: Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.

Protocol documents:
Clinical trial NCT01939366
Conditions: Chronic Pain Diabetic Neuropathies Diabetes Mellitus
Keywords: Painful Diabetic Peripheral Neuropathy
Sponsor: Tris Pharma, Inc.
Start date: 2013-09-27; Completion date: 2015-01-28
Enrollment: 699 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to evaluate if cebranopadol is safe and can decrease pain in patients when compared to placebo (a tablet that does not contain active product) and when compared to a marketed product containing pregabalin (Lyrica®). Furthermore, this trial will be undertaken to find out if the patient's general health and well-being improves under trial treatment.

The concentrations of cebranopadol in the blood will be investigated to get a better understanding of how it is absorbed from the gut, distributed and broken down in the body, and eliminated from the body.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: Cebranopadol 100 µg intervention 2: Cebranopadol 300 µg intervention 3: Cebranopadol 600 µg intervention 4: Pregabalin intervention 5: Matching Placebo
Intervention descriptions: intervention 1: Participants randomized to 100 μg cebranopadol will start with 100 μg per day and will remain on 100 µg per day. intervention 2: Participants randomized to 300 μg cebranopadol will start with 100 μg per day and increase to 300 µg per day on day 4 and will remain on 300 µg per day. intervention 3: Participants randomized to 600 μg cebranopadol will start with 200 μg per day and increase to 400 µg per day on day 4 and to 600 µg on day 7, thereafter they will remain on 600 µg per day. intervention 4: Stepwise titration from 75 mg twice a day to 300 mg twice a day over 2 weeks. intervention 5: Placebo will be matched to pregabalin and cebranopadol.

Protocol documents: