ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01129206
Conditions: Adenocarcinoma of the Esophagus Adenocarcinomas of the Gastroesophageal Junction Recurrent Esophageal Cancer Squamous Cell Carcinoma of the Esophagus Stage IV Esophageal Cancer
Keywords: Gastroesophageal Cancer Gastroesophageal Carcinoma Adenocarcinoma
Sponsor: Ohio State University Comprehensive Cancer Center
Start date: 2010-07-01; Completion date: 2012-09-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Pralatrexate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving pralatrexate together with docetaxel may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving pralatrexate together with docetaxel works in treating patients with stage IV esophageal or gastroesophageal cancer who have failed platinum-based therapy.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate overall response rate CR \& PR(Complete Response + Partial Response)as assessed by RECIST (Response Evaluation Criteria in Solid Tumors v 1.1) of the combination of pralatrexate and docetaxel in patients with advanced esophageal and gastroesophageal carcinomas.

SECONDARY OBJECTIVES:

I. Evaluation of progression free survival and overall survival. II. Correlation of FDG(fludeoxyglucose)PET(positron emission tomography)response defined as a 35% reduction in SUV(standard uptake value)during the early course of chemotherapy to progression free and overall survival in addition to radiographic response as measured by RECIST v 1.1 criteria on CT imaging.

OUTLINE:

Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Arms: arm 1: Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: pralatrexate intervention 2: docetaxel intervention 3: fludeoxyglucose F 18 intervention 4: positron emission tomography
Intervention descriptions: intervention 1: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2. intervention 2: Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days. intervention 3: Correlative studies intervention 4: Correlative studies

Protocol documents:
Clinical trial NCT01146808
Conditions: Hepatitis B Liver Transplantation
Keywords: Vaccination Immunocompromised Host Antiviral Agents Drug Resistance, Viral Resource Allocation
Sponsor: Columbia University
Start date: 2006-03-01; Completion date: 2012-09-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose of this study is to evaluate the efficacy of adefovir (ADV) in preventing de novo Hepatitis B in patients who receive Hepatitis B core antibody (HBcAb) positive grafts but who are not Hepatitis B Surface antigen (HBsAg) positive prior to transplant (Hepatitis B naive patients). The second objective is to evaluate the efficacy of accelerated vaccination with Hepatitis B in inducing innate immunity, thereby obviating the need for life-long antiviral therapy.

Detailed description:
The investigators will conduct a prospective, open-label study of Hepatitis B naive patients who received HBcAb + livers and adefovir prophylaxis post-transplant. At one year to 18 months following transplantation, all study patients will then be vaccinated with standard Hepatitis B vaccine at double dose on a monthly basis for three months, at which point they will be tested for Hepatitis B surface antibody (HBsAb). Any study patients that have developed a sufficient antibody response (HBsAb \>500 IU) will be given the option to discontinue anti-viral treatment in a monitored setting.

Arms: arm 1: Adefovir dipivoxil and hepatitis B vaccination: All subjects will receive adefovir 10mg po daily, or adjusted for renal function and an option for Hepatitis B vaccination, double dose.
Interventions: intervention 1: Adefovir dipivoxil and hepatitis B vaccination
Intervention descriptions: intervention 1: Adefovir 10mg po daily, or adjusted for renal function and option for Hepatitis B vaccination, double dose

Protocol documents:
Clinical trial NCT01160484
Conditions: Multiple Myeloma
Keywords: multiple myeloma refractory relapsed bortezomib doxil
Sponsor: Oncotherapeutics
Start date: 2009-09-01; Completion date: 2012-09-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase II, multicenter, open label, nonrandomized study to evaluate the efficacy and safety of lenalidomide at a dose of 10 mg/dose in combination with bortezomib at 1.0 mg/m2/dose, pegylated liposomal doxorubicin (PLD) at 4.0 mg/m2/dose, and intravenous (IV) dexamethasone at 40 mg/dose in adult patients with relapsed/refractory multiple myeloma (MM). The study consists of a screening period, followed by up to eight 28 day open label treatment cycles, a final assessment to occur 28 days after the end of the last treatment cycle, and a follow-up period.

Detailed description:
Studies have shown that combinations of PLD and bortezomib have striking synergy in preclinical studies and impressive response rates (73 \& 89%) in early clinical trials for MM patients with relapsed/refractory disease as well as first-line therapy. In addition, the efficacy of PLD with bortezomib in anthracycline-insensitive patients has been greater than single-agent bortezomib when comparing across studies. The immunomodulatory drugs, thalidomide and lenalidomide, target the tumor cell microenvironment, are antiangiogenic, have an immune activation effect and also exert a direct cytotoxic effect on myeloma cells. A phase 1 clinical study by our group also demonstrated that low dose PLD, administered at a more frequent dosing schedule, in combination with bortezomib, and dexamethasone (DVD regimen) is well tolerated and associated with high response rates and durable responses. In this phase II prospective trial, we will evaluate this regimen and show that this change enhances the DVD-R regimen's safety and efficacy for patients with relapsed/refractory MM.

Arms: arm 1: Dose schematic of Dexamethasone + Bortezomib + Pegylated Liposomal Doxorubicin + Lenalidomide (DVD-R) Therapy:

Dexamethasone\*- 40 mg IV Bortezomib\*\*- 1.0 mg/m2 IV Push Pegylated Liposomal Doxorubicin\*- 4.0 mg/m2 IV Lenalidomide\*\*\*- 10 mg PO

Per 28 Day Cycle

* Intravenous infusion (IV) Days 1, 4, 8 and 11 \*\* Intravenous push (IVP) Days 1, 4, 8 and 11 \*\*\* Per Orem (PO) Days 1-14
Interventions: intervention 1: DVD-R
Intervention descriptions: intervention 1: 40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.

Protocol documents:
Clinical trial NCT01185301
Conditions: Early Rheumatoid Arthritis
Keywords: Arthritis Erosion Humira Adalimumab Injection Rheumatoid Methotrexate
Sponsor: AbbVie (prior sponsor, Abbott)
Start date: 2010-10-01; Completion date: 2012-09-01
Enrollment: 395 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effects of different doses of methotrexate (MTX) when taken with adalimumab in subjects with early rheumatoid arthritis (RA).

Detailed description:

Arms: arm 1: 2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks arm 2: 5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks arm 3: 10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks arm 4: MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
Interventions: intervention 1: adalimumab intervention 2: methotrexate
Intervention descriptions: intervention 1: Pre-filled syringe every other week intervention 2: weekly oral capsule dosing

Protocol documents:
Clinical trial NCT01213199
Conditions: Acne Scars
Sponsor: Galderma R&D
Start date: 2011-03-01; Completion date: 2012-09-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the efficacy and safety of Adapalene Gel 0.3% in the treatment of atrophic acne scars.

Detailed description:

Arms: arm 1: Differin® 0.3% Gel

Adapalene 0.3%

Topical to the face, once daily application in the evening for the first four weeks and twice daily application in the morning and in the evening for the following 20 weeks.
Interventions: intervention 1: Adapalene
Intervention descriptions: intervention 1: Adapalene Gel 0.3%

Protocol documents:
Clinical trial NCT01215435
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2011-03-01; Completion date: 2012-09-01
Enrollment: 245 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Asia. The aim of this trial is to compare the glycaemic control when subjects initiate a biphasic insulin aspart 30 treatment followed by an intensified treatment if treatment target of HbA1c below 7% is not reached by OAD (oral anti-diabetic drugs) alone.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: biphasic insulin aspart 30 intervention 2: biphasic insulin aspart 30
Intervention descriptions: intervention 1: Administered subcutaneously (under the skin) once daily, before breakfast. The trial has 3 treatment phases for both treatment arms intervention 2: Administered subcutaneously (under the skin) once daily, before dinner. The trial has 3 treatment phases for both treatment arms

Protocol documents:
Clinical trial NCT01217112
Conditions: Dyslipidemias Diabetes Mellitus, Type 2
Keywords: Dyslipidemias Diabetes Liver Fat Body Fat
Sponsor: Jazz Pharmaceuticals
Start date: 2010-10-01; Completion date: 2012-09-01
Enrollment: 62 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 15-19 week study is being conducted by GW Pharma Ltd as a pilot study in order to determine the efficacy and safety of two cannabinoids: GWP42004 and GWP42003 alone, or in combination in patients with Type 2 diabetes. This is the first study to determine whether the study medications have a positive benefit for subjects on their cholesterol levels, body weight, liver fat content and other metabolic parameters compared with a placebo medication.

Detailed description:
In this study there was a 1-5 week baseline period followed by a 13 week treatment period, and a one week follow-up. Eligible subjects entered the study at a screening visit (Visit 1) before returning for randomisation (Visit 2, Day 1). At the discretion of the investigator (based on individual subjects), Visit 1 could be split into two separate visits (Visits 1A and B) to allow a 21-day washout period of prohibited medications prior to blood sampling for eligibility. Further outpatient study visits (for assessment purposes) took place at the study site at the end of Week 4 of treatment (Visit 3, Day 29), and at the overall end of treatment at Week 13 (Visit 5, Day 92). A telephone assessment was also performed at Day 57 (Visit 4) and at Week 14 (Visit 6, Day 99) for safety follow-up purposes.

During the 13 week randomised treatment phase, subjects received blinded, oral doses of their allocated randomised treatment twice daily. Treatment was self-administered on an outpatient basis, once in the morning and once in the evening for 13 weeks. Subjects were instructed to time study medication to 30 minutes before breakfast and evening meals.

Physical and metabolic parameters were assessed before, during and after treatment to evaluate clinical response. Diabetic and dyslipidaemic medication usage (where applicable), and appetite 0-10 NRS data were collected daily during the treatment period, using the study diary.

Arms: arm 1: Contains GWP42004 5 mg and placebo (excipients only) arm 2: Contains 5 mg each of GWP42003 and GWP42004 arm 3: Contains 100 mg GWP42003 and 5 mg GWP42004 arm 4: Contains excipients only arm 5: Contains 100 mg GWP42003 and placebo (excipients only)
Interventions: intervention 1: GWP42003 intervention 2: GWP42003 intervention 3: GWP42004 intervention 4: Placebo
Intervention descriptions: intervention 1: 100 mg capsules, PO, BD, 91 days intervention 2: 5 mg capsules, PO, BD, 91 days intervention 3: 5 mg capsules, PO, BD, 91 days intervention 4: 0 mg capsules, QDS, PO, 91 days

Protocol documents:
Clinical trial NCT01221272
Conditions: Myocardial Perfusion Imaging Myocardial Ischemia
Keywords: SPECT MPI
Sponsor: Gilead Sciences
Start date: 2010-09-01; Completion date: 2012-09-01
Enrollment: 81 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study enrolled participants with documented exercise-induced myocardial ischemia in order to evaluate whether ranolazine, when taken prior to exercise, can improve blood flow to the heart (myocardial perfusion), as assessed by exercise-induced myocardial perfusion defect size (PDS) and total perfusion deficit (TPD), using gated single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI).

This was a 2-period crossover study. The last dose of each period must have been taken 3-4 hours prior to conduct of the exercise SPECT MPI. After the research exercise SPECT MPI was performed at the end of Period 1, participants discontinued the treatment they were randomized to for that period and began the other treatment in Period 2.

Detailed description:

Arms: arm 1: Participants received ranolazine from Day 1 through Day 15 (± 2 days) of Period 1, followed by an exercise SPECT MPI study, then received placebo to match ranolazine from Day 1 through Day 15 (± 2 days) of Period 2, followed by an exercise SPECT MPI study. arm 2: Participants received placebo to match ranolazine from Day 1 through Day 15 (± 2 days) of Period 1, followed by an exercise SPECT MPI study, then received ranolazine from Day 1 through Day 15 (± 2 days) of Period 2, followed by an exercise SPECT MPI study.
Interventions: intervention 1: Ranolazine intervention 2: Placebo to match ranolazine intervention 3: SPECT MPI intervention 4: Exercise
Intervention descriptions: intervention 1: * One 500 mg tablet in the evening on Day 1 of the period
* One 500 mg tablet, twice daily on Days 2-3 of the period
* Two 500 mg tablets (1000 mg total), twice daily from Day 4 to the end of the period (Day 15 ± 2 days) intervention 2: Placebo to match ranolazine administered in the same form and frequency as the active drug. intervention 3: Gated single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) to confirm the presence of reversible exercise-induced left ventricular perfusion defect size (PDS) performed within 12 weeks prior to baseline or at the baseline visit, and at the end-of-period 1 and end-of-period 2 visits. intervention 4: Treadmill stress test

Protocol documents:
Clinical trial NCT01235715
Conditions: Osteoarthritis
Keywords: osteoarthritis total knee replacement
Sponsor: Hospital for Special Surgery, New York
Start date: 2010-09-01; Completion date: 2012-09-01
Enrollment: 200 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Application of "Evicel" hemostatic matrix during operation for unilateral total knee replacement surgery (TKA) will result in decreased bleeding and postoperative drain output, a reduction in transfusion requirements, and less reduction of hemoglobin.

Detailed description:
No additional data desired

Arms: arm 1: Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent. arm 2: Patients will receive standard treatment for bleeding as practiced at the Hospital for Special Surgery.
Interventions: intervention 1: Evicel fibrin sealant
Intervention descriptions: intervention 1: Used for hemostasis to control bleeding. It has been shown to stop bleeding in 2 minutes or less. It is a combination of a biologic activated component containing human fibrinogen and topical thrombin functioning on wet, actively bleeding tissue.

Protocol documents:
Clinical trial NCT01255722
Conditions: Coronary Artery Disease
Keywords: iodinated contrast media, coronary artery disease
Sponsor: Guerbet
Start date: 2010-11-01; Completion date: 2012-09-01
Enrollment: 468 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to demonstrate the (statistical) non-inferiority of iobitridol (Xenetix® 350) when compared to contrast agents with higher iodine concentrations, iopromide (Ultravist® 370) and iomeprol (Iomeron® 400) in terms of coronary CT scan evaluability (quality and interpretability of images).

Detailed description:
Patients suspected of coronary artery disease were submitted to coronary CT angiography using either iobitridol or contrast agents with higher iodine concentrations (iopromide or iomeprol). Independent off-site readers evaluated image quality regarding the ability to identify coronary artery stenosis (score 0- non evaluable to 4- excellent quality). The study was aimed at showing the non-inferiority of iobitridol in its ability to provide evaluable CT scans for the identification of coronary stenosis.

Arms: arm 1: Patients were IV injected with a single dose of iobitridol before a coronary CT angiography arm 2: Patients were IV injected with a single dose of iopromide before a coronary CT angiography arm 3: Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
Interventions: intervention 1: iobitridol intervention 2: iopromide intervention 3: iomeprol
Intervention descriptions: intervention 1: single IV injection intervention 2: Single IV injection intervention 3: Single IV injection

Protocol documents:
Clinical trial NCT01257204
Conditions: Hepatitis C Virus
Sponsor: Bristol-Myers Squibb
Start date: 2010-12-01; Completion date: 2012-09-01
Enrollment: 196 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To identify a shorter duration of antiviral therapy (12 or 16 weeks) for the combination of daclatasvir with pegylated interferon alfa-2a and ribavirin.

Detailed description:

Arms: arm 1: Placebo + Pegylated interferon alfa-2a + Ribavirin arm 2: Daclatasvir + Pegylated interferon alfa-2a + Ribavirin arm 3: Daclatasvir + Pegylated interferon alfa-2a + Ribavirin
Interventions: intervention 1: Placebo intervention 2: Daclatasvir intervention 3: Pegylated interferon alfa-2a intervention 4: Ribavirin
Intervention descriptions: intervention 1: Tablets, oral, 0 mg, once daily, for 24 weeks intervention 2: Tablets, oral, 60 mg, once daily, for 12, 16, or 24 weeks intervention 3: Solution for injection, subcutaneous injection, 180 µg/0.5 mL, once weekly, for 12, 16, or 24 weeks intervention 4: Tablets, oral, 800 mg, twice daily, for 12, 16, or 24 weeks

Protocol documents:
Clinical trial NCT01258049
Conditions: Plasmodium Falciparum Malaria
Keywords: Plasmodium infections Remittent fever Artemether Artemesinins Quinine Malaria Protozoan infections sublingual drug delivery Parasitic disease Antiprotozoan agents
Sponsor: Proto Pharma Ltd
Start date: 2010-12-01; Completion date: 2012-09-01
Enrollment: 151 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to demonstrate that ArTiMist (sublingual artemether spray) is better than intravenous quinine in reducing parasite counts by \>= 90% within 24 hours after the start of treatment in children with severe malaria, or uncomplicated malaria with gastrointestinal complications

Detailed description:
Malaria causes significant morbidity and mortality in children in developing countries, despite the availability of highly effective antimalarial therapy. One of the key contributing factors is the delay in the initiation of treatment.

ArTiMist is a sublingual formulation of the established antimalarial treatment, artemether. In previous studies good bioavailability has been demonstrated. In an exploratory study (ART003) ArTiMist demonstrated a non statistically significant improvement of 26% (when compared to intravenous quinine) in the numbers of patients experiencing a parasite reduction of \>= 90% within 24 hours of the initiation of treatment.

This Phase 3 study is being conducted to establish whether treatment with ArTiMist in children with severe falciparum malaria or uncomplicated falciparum malaria with gastrointestinal complications is at least 20% superior in providing parasitological success (defined as \>= 90% reduction in parasite count at 24 hours after start of treatment) when compared to intravenous quinine.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Artemether Sublingual Spray intervention 2: Quinine
Intervention descriptions: intervention 1: Artemether sublingual spray administered at 3 mg/kg (milligrams per kilogram) at specified timepoints intervention 2: Quinine administered intravenously, 20 mg/kg loading dose followed by 10 mg/kg every eight hours

Protocol documents:
Clinical trial NCT01261780
Conditions: Neuropathy, Paraneoplastic
Keywords: neuropathy,paraneoplastic paraneoplastic peripheral neuropathy pain hyperalgesia
Sponsor: University of Wisconsin, Madison
Start date: 2011-04-01; Completion date: 2012-09-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Painful chemotherapy induced peripheral neuropathy (CIPN) is a common complication of cancer therapy with few treatment options. CIPN is a complex side effect that varies between individuals and can be difficult to describe, difficult to treat and can significantly effect quality of life for patients.

The purpose of this study is to determine if patients with painful CIPN will have a decrease in pain scores after treatment with the MC-5A device.

Detailed description:

Arms: arm 1: Sham therapy device to area of painful chemotherapy induced peripheral neuropathy (CIPN) for 45 minutes daily x 10 days arm 2: MC-5A therapy to the area of painful CIPN for 45 minutes daily for a total of 10 days.
Interventions: intervention 1: MC-5A intervention 2: Sham device
Intervention descriptions: intervention 1: 45 minutes daily x 10 treatments (given over the course of 2 weeks) intervention 2: Sham therapy daily x 45 minutes for 10 treatments (given over course of 2 weeks)

Protocol documents: