ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT03114995
Conditions: Non-ST Elevation Myocardial Infarction
Keywords: Tirofiban Resistance to antiplatelet agents
Sponsor: Seoul National University Bundang Hospital
Start date: 2012-02-01; Completion date: 2015-10-01
Enrollment: 140 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Investigators aimed to test the beneficial effect of tirofiban, a GPIIb/IIIa antagonist, for Non-ST-Elevation Acute Coronary Syndrome Patients who has high resistance to clopidogrel.

Detailed description:
Some patients have a poor response to dual antiplatelet therapy (DAPT), and it can result in a poor prognosis after percutaneous coronary intervention (PCI). Devices like Ultegra Rapid Platelet Function Analyzer (VerifyNow®) enable us to quantify platelet reactivity quickly in the catheter laboratory. This means that the poor responders to DAPT can be identified, and the patients' outcomes can be improved by providing additional antiplatelet agents. Tirofiban, a GP IIb/IIIa inhibitor, is a potent antiplatelet agent which is recommended for Non-ST-Elevation acute coronary syndrome (NSTE-ACS) with high risk at presentation. However, its role is not clear for patients stabilized with standard medical treatment but with a poor responsiveness to DAPT.

In this study, Investigators administered tirofiban on top of DAPT to patients with NSTE-ACS undergoing PCI who have a high platelet reactivity (HPR) identified by VerifyNow.

To the best of our knowledge, there are few studies conducted with tirofiban for tailored antiplatelet therapy. Moreover, this is the first randomized study with NSTE-ACS patients for tailored use of tirofiban under the guidance of platelet reactivity.

Arms: arm 1: Patients with high platelet reactivity unit (230 or higher) Tirofiban administered dose: 0.4 μg/kg/min continuous infusion for 30 min and then 0.10 μg/kg/min continuous infusion for 12 h arm 2: Patients with high platelet reactivity unit (230 or higher) Tirofiban was not administered arm 3: Patients with low platelet reactivity unit (less than 230) Tirofiban was not administered
Interventions: intervention 1: Tirofiban
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT03640559
Conditions: Adhesion
Keywords: Adhesion Safety
Sponsor: Pharmasyntez
Start date: 2015-05-19; Completion date: 2015-10-04
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The performed study of safety and tolerability of Seroguard, solution (JSC Pharmasyntez, Russia) in patients, undergoing planned laparoscopic cholecystectomy, demonstrated that patients from the both groups had the similar safety profile

Detailed description:
The present study was conducted as multicenter, randomized, double-blind, parallel group clinical study. After successful completion of screening procedures, patient underwent a planned laparoscopy. Randomization of patients into groups was performed on the day of surgery using envelops. The test drug or the placebo were used at the completion stage of surgery. Monitoring of patient on inpatient basis was performed for 6 days after completion of surgery. Discharge of patient from the hospital with no contraindications was possible on Day 7 of the study. In this case the follow-up of patient was performed on outpatient basis. Follow-up was performed for 4 weeks before Day 28 of the study. Study procedures aimed at evaluation of safety and tolerability of using the test drug or the placebo were identical in main and control groups.

Arms: arm 1: the group were having the administration of Placebo (saline 2.4 mL/kg IP) arm 2: the group were having the administration of Seroguard 0.41 g/L solution, 2.4 mL/kg IP
Interventions: intervention 1: Seroguard intervention 2: Placebos
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02155335
Conditions: Ulcerative Colitis
Sponsor: Merck Sharp & Dohme LLC
Start date: 2014-07-01; Completion date: 2015-10-05
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is designed to determine whether ulcerative colitis participants prefer delivery of golimumab via a prefilled syringe or the Smartject™ device.

Detailed description:

Arms: arm 1: Golimumab 50 mg supplied in a prefilled syringe administered 2 times (once by the treating physician and then by the participant under the supervision of the treating physician). Participant is then administered Golimumab 50 mg supplied in the Smartject 2 times, first by the physician and then by the participant. Participants receive a total of 200 mg of golimumbab). arm 2: Golimumab 50 mg supplied in a Smartject administered 2 times (once by the treating physician and then by the participant under the supervision of the treating physician). Participant is then administered Golimumab 50 mg supplied a prefilled syringe 2 times, first by the physician and then by the participant. Participants receive a total of 200 mg of golimumbab.
Interventions: intervention 1: Prefilled Syringe delivery of Golimumab intervention 2: Smartject Device delivery of Golimumab
Intervention descriptions: intervention 1: Golimumab 50 mg solution for subcutaneous injection using prefilled syringe intervention 2: Golimumab 50 mg solution for subcutaneous injection using Smartject Device.

Protocol documents:
Clinical trial NCT02284516
Conditions: Dry Eye Disease
Sponsor: Shire
Start date: 2014-11-06; Completion date: 2015-10-05
Enrollment: 711 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluate the efficacy and safety of Lifitegrast in subjects with dry eye disease and a recent history of artificial tear use.

Detailed description:

Arms: arm 1: Lifitegrast Ophthalmic Solution 5%, BID for 84 days arm 2: Placebo to match active treatment, BID for 84 days
Interventions: intervention 1: Lifitegrast intervention 2: Placebo
Intervention descriptions: intervention 1: Lifitegrast Ophthalmic Solution 5%, BID for 84 days intervention 2: Placebo to match active treatment, BID for 84 days

Protocol documents:
Clinical trial NCT02358369
Conditions: Primary Open-Angle Glaucoma Ocular Hypertension
Sponsor: ForSight Vision5, Inc.
Start date: 2015-01-19; Completion date: 2015-10-07
Enrollment: 156 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The Bimatoprost Ocular Insert is intended to provide sustained delivery of bimatoprost to the ocular surface to lower the intraocular pressure (IOP) in patients with Open-Angle Glaucoma or Ocular Hypertension.

This study evaluated the safety and efficacy of two different doses of the Bimatoprost Ocular Insert, compared to an active control arm with timolol ophthalmic solution (0.5%).

Detailed description:

Arms: arm 1: Washout + Placebo Ocular Insert in each eye for 4 to 6 weeks, followed by 13 mg Bimatoprost Ocular Insert in each eye (OU) for 12 weeks. Note: participants also self-administered placebo ophthalmic eye drops to each eye twice a day (BID) for the first 6 weeks. After 12 weeks, 13 mg Bimatoprost Ocular Insert in each eye for an additional 12 weeks. arm 2: Washout + Placebo Ocular Insert in each eye for 4 to 6 weeks, followed by 2.2 mg Bimatoprost Ocular Insert in each eye for 12 weeks. Note: participants also self-administered placebo ophthalmic eye drops in each eye twice a day for the first 6 weeks. After 12 weeks, 13 mg Bimatoprost Ocular Insert in each eye for an additional 12 weeks. arm 3: Washout + Placebo Ocular Insert in each eye for 4 to 6 weeks, followed by 0.5% timolol ophthalmic solution in each eye for 6 weeks. Note: participants simultaneously wore placebo ocular inserts for 12 weeks.

After 12 weeks, 13 mg Bimatoprost Ocular Insert in each eye for an additional 12 weeks.
Interventions: intervention 1: Bimatoprost intervention 2: Timolol 0.5% intervention 3: Placebo Ocular Insert intervention 4: Placebo Eye Drops
Intervention descriptions: intervention 1: Bimatoprost sustained release Ocular Insert intervention 2: BID drops OU, 0.5% ophthalmic solution intervention 3: Placebo ocular insert OU. intervention 4: Placebo eye drops BID OU.

Protocol documents:
Clinical trial NCT00422799
Conditions: Waldenstrom's Macroglobulinemia
Keywords: relapsed Waldenstrom's macroglobulinemia refractory Waldenstrom's macroglobulinemia Velcade WM
Sponsor: Dana-Farber Cancer Institute
Start date: 2006-08-30; Completion date: 2015-10-09
Enrollment: 63 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
In this study, we are trying to find out if the combination of these two drugs is effective in treating Waldenstrom's macroglobulinemia (WM). The combination of these two drugs has not been studied for patients with relapsed or refractory macroglobulinemia. The U.S. Food and Drug Administration (FDA) has approved bortezomib for the treatment of multiple myeloma, a cancer that is closely related to Waldenstrom's macroglobulinemia.

Detailed description:
* Participants will receive 6 cycles of the study treatment with bortezomib and rituximab. Each cycle is 28 days long (4 weeks).
* Participants will receive Rituximab intravenously once a week for the first and fourth cycles only. Participants will receive bortezomib once a week for three weeks on and one week off every cycle, for a total of 6 cycles.
* During the rituximab infusion, the participants blood pressure and pulse will be monitored frequently. The rate of infusion may be decreased depending upon the side effects that are experienced.
* Blood samples will be collected before the first dose and on follow up with every cycle. Blood counts will also be performed every week.
* Routine physical exams will be performed at each evaluation. A PET/CAT scan of the chest, abdomen and pelvis at the end of treatment. This scan is required to assess the response of the participants disease.
* In order to learn more on how bortezomib and rituximab affect WM, a bone marrow biopsy will be performed.
* We anticipate that participants will complete the active therapy over a period of 6 cycles provided that they are benefiting from therapy and have not had any serious side effects. The participant will be followed every three months for 2 years for office visits and laboratory tests.

Arms: arm 1: bortezomib and rituximab
Interventions: intervention 1: Bortezomib intervention 2: Rituximab
Intervention descriptions: intervention 1: Once weekly for 3 weeks intervention 2: Intravenously once a week for the first and fourth weeks of a cycle

Protocol documents:
Clinical trial NCT01276509
Conditions: Crohn's Disease
Keywords: Crohn's disease Safety Efficacy Pharmacokinetics Pharmacodynamics Crohn's Disease Activity Index (CDAI)
Sponsor: Shire
Start date: 2011-04-06; Completion date: 2015-10-09
Enrollment: 265 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Adults with Crohn's disease that is clinically active despite conventional treatment will be eligible for this study. Patients may receive one of three doses of PF-00547659 (experimental drug) or placebo (inactive drug). Disease activity will be measured every two weeks.

Detailed description:

Arms: arm 1: Placebo delivered SC, 3 doses separated by 4 weeks. arm 2: Drug dose level 1 delivered SC, 3 doses separated by 4 weeks. arm 3: Drug dose level 2 delievered SC, 3 doses separated by 4 weeks. arm 4: Drug dose level 3 delivered SC, 3 doses separated by 4 weeks.
Interventions: intervention 1: PF-00547659 SC injection intervention 2: PF-00547659 SC injection intervention 3: PF-00547659 SC injection intervention 4: PF-00547659 SC injection
Intervention descriptions: intervention 1: Placebo delivered SC, 3 doses separated by 4 weeks intervention 2: Drug dose level 1 delivered SC, 3 doses separated by 4 weeks intervention 3: Drug dose level 2 delivered SC, 3 doses separated by 4 weeks intervention 4: Drug dose level 3 delivered SC, 3 doses separated by 4 weeks

Protocol documents:
Clinical trial NCT02473367
Conditions: HIV Infection
Sponsor: Merck Sharp & Dohme LLC
Start date: 2015-06-23; Completion date: 2015-10-09
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
In order to define the safe windows for co-dosing of metal-cation antacids with once daily administered raltegravir, this study will evaluate the effect of both calcium carbonate and magnesium/aluminum hydroxide antacids on the pharmacokinetics of raltegravir, due to dosage of 1200 mg raltegravir in HIV-infected participants already taking 400 mg raltegravir twice daily as part of their HIV treatment regimen.

Detailed description:

Arms: arm 1: Starting five days prior to Period 1 participants will be treated with 1200 mg raltegravir, once daily for five days. In Period 1 participants will be treated with 1200 raltegravir alone; this is followed by Period 2 where participants will be treated with 1200 mg raltegravir and TUMS concomitantly; this is followed by Period 3 where participants will be treated with 1200 mg raltegravir and 12 hours later with Leader Antacid; followed by Period 4 where participants will be treated with 1200 mg raltegravir and 12 hours later with TUMS. The wait between Periods is 2-7 days.
Interventions: intervention 1: Raltegravir 1200 mg intervention 2: TUMS intervention 3: Leader Antacid
Intervention descriptions: intervention 1: Two tablets of 600 mg raltegravir administered orally, once daily, over 5 days of Pre-treatment, and once at the start of Periods 1-4. intervention 2: Three tablets of TUMS Ultra Strength (US) 1000, taken orally, concomitantly with raltegravir in Period 2, and 12 hours after raltegravir in Period 4 intervention 3: 20 mL Leader Antacid Maximum Strength (MS) taken orally 12 hours after raltegravir, in Period 3

Protocol documents:
Clinical trial NCT01806740
Conditions: Hepatocellular Carcinoma
Keywords: DCE-MRI Sorafenib response
Sponsor: Guerbet
Start date: 2013-05-09; Completion date: 2015-10-12
Enrollment: 37 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The main objective is to evaluate the value of dynamic contrast-enhanced Magnetic Resonance Imaging (DCE-MRI) in prediction of response of patients with hepatocellular carcinoma (HCC) to treatment with Sorafenib assessed by mRECIST.

Detailed description:
One of the secondary objectives was to evaluate the correlation between DCE-MRI perfusion parameters at baseline and:

* Overall Survival (OS)
* Progression-Free Survival (PFS)
* Time to Progression (TTP)

Three DCE-MRI examinations were done during the study:

* at the enrolment and initiation of the sorafenib treatment
* one week after initiation of the sorafenib treatment
* two weeks after initiation of the sorafenib treatment

DCE-MRI perfusion parameters were assessed by a centralized radiologist at baseline (corresponding to the day of enrolment and initiation of Sorafenib treatment), week 1 and week 2.

According to mRECIST criteria, HCC lesions were evaluated on computed tomography images by two on-site radiologists at the time of enrolment and 8 weeks later (2 months). OS, PFS and TTP were calculated from survival and tumor progression data recorded one year after initiation of the sorafenib treatment.

Arms: arm 1: there is one single arm of patients (no comparative arm)
Interventions: intervention 1: Gadoterate meglumine
Intervention descriptions: intervention 1: Gadoterate meglumine was administered at a dose of 0.1 mmol/kg (0.2 mL/kg) using a power injector, in an intravenous bolus at a rate of 3 mL/sec.

Protocol documents:
Clinical trial NCT01930188
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2013-12-02; Completion date: 2015-10-12
Enrollment: 1231 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Africa, Asia, Europe and South America. The aim of the trial is to evaluate efficacy and safety of semaglutide once-weekly versus sitagliptin once-daily as add-on to metformin and/or TZD (thiazolidinedione) in subjects with type 2 diabetes.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: semaglutide intervention 2: sitagliptin intervention 3: placebo intervention 4: placebo
Intervention descriptions: intervention 1: For subcutaneous injection (s.c., under the skin) once weekly. Will follow a fixed dose escalation regimen. The trial drug will be added on to the subject's stable pre-trial medication. intervention 2: Tablets for oral administration once daily. The trial drug will be added on to the subject's stable pre-trial medication. intervention 3: Tablets for oral administration once daily. The trial drug will be added on to the subject's stable pre-trial medication. intervention 4: For subcutaneous injection (s.c., under the skin) once weekly. Will follow a fixed dose escalation regimen. The trial drug will be added on to the subject's stable pre-trial medication.

Protocol documents:
Clinical trial NCT01607892
Conditions: Hematological Malignancies
Keywords: Selinexor KPT-330 Multiple Myeloma non-Hodgkin Lymphoma Chronic Lymphocytic Leukemia Waldenström's macroglobulinemia Peripheral T-Cell Lymphoma Cutaneous T-Cell Lymphoma Chronic Myelocytic Leukemia Acute Lymphoblastic Leukemia
Sponsor: Karyopharm Therapeutics Inc
Start date: 2012-07-23; Completion date: 2015-10-13
Enrollment: 286 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to find out more information relating to the highest dose of KCP-330 that can be given safely and side effects it may cause, to examine how the body affects KCP-330 concentrations in the blood (pharmacokinetics or PK), to examine the effects of KCP-330 on the body (pharmacodynamics or PDn) and to obtain information on its effectiveness in treating cancer.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: KPT-330
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01323530
Conditions: Metastatic Breast Cancer
Keywords: metastatic breast cancer
Sponsor: Eisai Limited
Start date: 2010-01-26; Completion date: 2015-10-13
Enrollment: 76 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
This is a Phase 1b/2, multi-center, open-label, dose escalation (in 2 different dosing schedules \[1 and 2\]) and dose-confirmation study of eribulin administered in combination with capecitabine.

Detailed description:

Arms: arm 1: Participants with advanced and/or metastatic tumors will receive eribulin mesylate as a 2 to 5 min Intravenous (IV) bolus or infusion in two different schedules (Schedule 1 \[1.2, 1.6, 2.0 mg/m2\], given on Day 1 only, and Schedule 2 \[0.7, 1.1, 1.7 mg/m\^2\], given on Days 1 and 8) and oral capecitabine 1000 mg/m2 bid on Days 1-14 (21-day cycles) in both schedules. If maximum tolerated dose (MTD) is not observed at dose level 3 the dose of capecitabine might be escalated to 1250 mg/m\^2 bid on Days 1-14 (21-day cycles) depending on the Dose limiting toxicities (DLTs) observed and/or pharmacokinetic (PK) data when available. Based on the data and safety monitoring board review of dose escalation phase data (DLTs that will be observed in first cycle), Dose-Confirmation Phase (Phase 2) will may get initiated. arm 2: Participants with advanced and/or metastatic tumors will receive Eribulin mesylate at the MTD for the selected schedule of dose escalation phase based on safety/PK data.
Interventions: intervention 1: Eribulin mesylate intervention 2: Capecitabine
Intervention descriptions: intervention 1: Intravenous (IV) bolus or infusion. intervention 2: Oral film-coated tablets.

Protocol documents:
Clinical trial NCT01981187
Conditions: Solid Tumor Hematologic Malignancies
Sponsor: Pfizer
Start date: 2014-01-14; Completion date: 2015-10-13
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this signal seeking study is to determine whether treatment with LGX818 demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic malignancies to warrant further study

Detailed description:

Arms: arm 1: LGX818 will be dosed on a flat scale of 300 mg (e.g., 3 x 100 mg capsules) once daily on a continuous dosing cycle. A complete treatment cycle is defined as 28 days. There will be no breaks between dosing cycles.
Interventions: intervention 1: LGX818
Intervention descriptions: intervention 1: LGX818 will be dosed on a flat scale of 300 mg (e.g., 3 x 100 mg capsules) once daily on a continuous dosing cycle. A complete treatment cycle is defined as 28 days. There will be no breaks between dosing cycles.

Protocol documents:
Clinical trial NCT02496221
Conditions: Diabetes Mellitus, Type 2
Keywords: Cholecystokinin ultrasonography Albiglutide Gallbladder ejection fraction
Sponsor: GlaxoSmithKline
Start date: 2015-06-11; Completion date: 2015-10-13
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Albiglutide, a novel analogue of glucagon-like peptide-1 (GLP-1), has been developed and approved for the treatment of type 2 diabetes mellitus. The primary objective of this study is to assess if a single dose of albiglutide can affect cholecystokinin-induced gallbladder emptying. To make this assessment, each study participant will receive a dose of albiglutide and a dose of placebo followed by cholecystokinin (CCK) infusion and ultrasound measurement of the gallbladder.

The study will be comprised of two periods and 20 subjects. The screening visit will occur within 42 days of the start of Treatment Period 1. The Treatment Periods will be separated by a washout period of a minimum of 42 days. Subjects will return for a follow-up visit after 28 days following the last dose of albiglutide or placebo. The total duration of a subject's participation from Screening to Follow-up will be approximately 17.5 weeks.

This study is a post marketing commitment to the United States Food and Drug Administration (USFDA).

Detailed description:

Arms: arm 1: In treatment period 1, subjects will receive Albiglutide 50 mg or Placebo subcutaneously (SC) after fasting overnight for at least 10 hours according to randomization schedule on Day 1. Subject will also receive CCK (Kinevac) infusion intravenously for a period of 50 minutes after fasting overnight for at least 10 hours on Day 4. After washout period of a minimum of 42 days in treatment period 2, subjects will receive same treatment according to randomization schedule in a cross-over fashion
Interventions: intervention 1: Albiglutide 50 mg intervention 2: Placebo intervention 3: CCK (Kinevac)
Intervention descriptions: intervention 1: Albiglutide 50 mg pen is a single-use fixed dose, fully disposable pen injector system for SC delivery in the abdomen containing 67 mg lyophilized albiglutide and 0.65 mL diluents designed to deliver a dose of 50 mg in a volume of 0.5 mL after reconstitution intervention 2: Placebo is a single-use fixed dose, fully disposable pen injector system for SC delivery of 0.5 mL injector volume in the abdomen intervention 3: CCK (Kinevac) will be infused intravenously. Kinevac is supplied in vials containing 5 microgram (mcg)/vial. Infusion prepared aseptically by adding 5 mL of Sterile Water for Injection United States Pharmacopeia (USP) to the vial to create a solution of 1 mcg/mL. Infuse 0.003 mcg/kg dose in 100 mL of Sodium Chloride Injection USP, 0.9%

Protocol documents: