ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01416155
Conditions: Relapsing-Remitting Multiple Sclerosis Multiple Sclerosis
Sponsor: Biogen
Start date: 2010-10-01; Completion date: 2014-12-01
Enrollment: 97 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of the study is to further evaluate the long-term safety and tolerability profiles of BG00002 (natalizumab) in Japanese participants with relapsing-remitting multiple sclerosis (RRMS). The secondary objective of this study is to further evaluate the long-term efficacy profile of BG00002 in Japanese participants with RRMS.

Detailed description:
This is a multicenter, long-term, open-label, extension study in participants who have successfully completed Study 101MS203 (NCT01440101).

Arms: arm 1: 300 mg intravenous (IV) infusions of natalizumab every 4 weeks until product is approved in Japan or development is discontinued in Japan, whichever comes first.
Interventions: intervention 1: natalizumab
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01428063
Conditions: Hepatitis C Virus Infection
Sponsor: Bristol-Myers Squibb
Start date: 2011-09-01; Completion date: 2014-12-01
Enrollment: 276 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to provide anti-hepatitis C virus drugs to patients who received placebo + peginterferon alfa-2a + ribavirin in prior Bristol-Myers Squibb (BMS) studies and determine whether addition of these drugs results in higher cure rates in patients who previously failed therapy. Approximately 100 genotype 1b patients who received placebo in BMS study NCT01428063 (AI447-028) will receive active drugs in this study.

Detailed description:
* Intervention Model:

  * Parallel: for all patients entering the trial
  * Cross-over: for genotype 1b patients rolling over from NCT01428063 (AI447-028) who require rescue therapy after initial treatment in this study
* Peginterferon alfa-2a
* Ribavirin
* Daclatasvir
* Asunaprevir

Arms: arm 1: Patients received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule or 200-mg tablet, by mouth twice daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks arm 2: Patients received daclatasvir, (two 30-mg tablets or one 60-mg tablet, by mouth once daily) + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (\<75 kg=1000 mg once daily; \>=75 kg=1200 mg once daily) for 24 weeks arm 3: Patients received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule, by mouth twice daily for 24 weeks
Interventions: intervention 1: Daclatasvir intervention 2: Asunaprevir intervention 3: Pegylated interferon alfa-2a intervention 4: Ribavirin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01450319
Conditions: Colorectal Neoplasms
Keywords: K-RAS FcγRII/IIIa genotypes CRC Colorectal cancer
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2011-12-01; Completion date: 2014-12-01
Enrollment: 73 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This national, multicenter, open-label phase 2 study without any control arm aims to evaluate the activity of cetuximab monotherapy in the treatment of refractory colorectal cancer in subjects with K-RAS mutated and FcγRIIa polymorphism tumors, in which there is no therapeutic alternative for treatment. Failure of the first and second line conventional therapeutic lines was documented.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Cetuximab
Intervention descriptions: intervention 1: Cetuximab will be administered intravenously at a dose of 500 milligram per square meter (mg/m\^2) every 2 weeks until disease progression, death, or consent withdrawal.

Protocol documents:
Clinical trial NCT01455519
Conditions: Low Back Pain
Keywords: Low Back Pain Back Pain Chronic back pain
Sponsor: Shirley Ryan AbilityLab
Start date: 2011-10-01; Completion date: 2014-12-01
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
You are asked to take part in this study because you have chronic, non-radicular low back pain. This study is done to investigate the pain relieving effects of the study drug Exalgo (Hydromorphone ER) for people who experience chronic non-radicular low back pain. The purpose of this research is to look at how the study drug can be used to benefit people who experience this type of pain. This is a phase IV study done to study the safety and effectiveness of the drug. At this point the drug has been approved by the Food and Drug Administration and has been studied in more than 2,000 pain patients in clinical trials, including individuals with low back pain. About 36 subjects will take part in this study.

Detailed description:
As a participant in this study, you will be asked to come to the Rehabilitation Institute of Chicago (RIC), Center for Pain Studies (446 E Ontario St. Suite 1011, Chicago, IL 60611). Your part in this study will last for 8 weeks and will involve 3 visits to the Rehabilitation Institute of Chicago and anywhere from weekly phone calls to phone calls every other day.

If you are in this study, you will be placed in one of two study groups: one group will receive the study drug and one will receive a placebo. You will be assigned a study group by chance using a process similar to the flip of a coin. This process is called randomization. Neither you nor the study staff will select the group you will be in. A placebo looks like the study drug but is an inactive substance that has no medication. Researchers use a placebo to see if the study drug works better or is safer than not taking anything. You will have a 66% chance of getting the study drug. You will receive placebo at some point during the study but you will not know whether you are receiving placebo or study drug during the entire study. However, if you have a medical emergency, the investigators can get this information.

Arms: arm 1: Subjects may receive a pill with no medicine. arm 2: Subjects received study drug: Hydromorphone ER
Interventions: intervention 1: Hydromorphone ER intervention 2: Sugar pill
Intervention descriptions: intervention 1: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used. intervention 2: Sugar pill

Protocol documents:
Clinical trial NCT01460654
Conditions: Hypogonadism Osteopenia Osteoporosis
Sponsor: Massachusetts General Hospital
Start date: 2011-10-01; Completion date: 2014-12-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate the hypothesis that the combination of testosterone replacement and alendronate will improve bone density and parameters of bone quality more than either medication alone in older men with low testosterone levels and low bone density.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Testosterone intervention 2: Alendronate intervention 3: Placebo Alendronate intervention 4: Placebo Testosterone
Intervention descriptions: intervention 1: Testosterone Gel (Fortesta) 40mg daily. intervention 2: Alendronate (Fosamax) 70mg every week. intervention 3: A placebo alendronate tablet will be taken every week by subjects in the Testosterone and Placebo Alendronate Group. intervention 4: Placebo testosterone gel will be applied daily by subjects in the Alendronate and Placebo Testosterone group.

Protocol documents:
Clinical trial NCT01461499
Conditions: Type 2 Diabetes Mellitus Hypertension
Keywords: Hypertension Albuminuria Direct renin inhibitor Angiotensin receptor blocker Type 2 diabetes
Sponsor: Shiga University
Start date: 2011-10-01; Completion date: 2014-12-01
Enrollment: 237 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the effects of a direct renin inhibitor (DRI), aliskiren, on the urinary albumin excretion in hypertensive patients with type 2 diabetes under strict blood pressure control with angiotensin receptor blocker (ARB).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Aliskiren intervention 2: any angiotensin receptor blockers
Intervention descriptions: intervention 1: The patient will start taking one a daily 150 mg/day of aliskiren. In case blood pressure doesn't reach the target (SBP/DBP \< 130/80 mmHg), higher dose of aliskiren will be given.In case the blood pressure doesn't achieve the target, another anti-hypertensive drug other than RAS inhibitors (ARB or ACE-inhibitor) or potassium-retaining diuretics will be added from the minimum effective dose. intervention 2: The patient will start taking one a standard dose of an ARB in Japan. In case blood pressure doesn't reach the target (SBP/DBP \< 130/80 mmHg), higher dose of the ARB will be given. In case the blood pressure doesn't achieve the target, another anti-hypertensive drug other than RAS inhibitors (DRI, another ARB or ACE-inhibitor) or potassium-retaining diuretics will be added from the minimum effective dose.

Protocol documents:
Clinical trial NCT01461538
Conditions: Acute Lymphoid Leukemia Acute Myeloid Leukemia Anemia, Refractory, With Excess of Blasts Solid Tumors
Keywords: Acute Lymphoid Leukemia Myelodysplastic Syndrome Acute Myeloid Leukemia Solid Tumors Anemia, Refractory, with Excess of Blasts Antibodies, Monoclonal Antibody-Drug Conjugate Antigens, CD30 Drug Therapy Hematologic Diseases Immunotherapy Monomethyl Auristatin E
Sponsor: Seagen Inc.
Start date: 2011-10-01; Completion date: 2014-12-01
Enrollment: 84 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an open-label, multicenter, phase 2 clinical trial to evaluate the antitumor activity of brentuximab vedotin as a single agent in patients with CD30-positive nonlymphomatous malignancies.

Detailed description:

Arms: arm 1: Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion arm 2: Brentuximab vedotin 2.4 mg/kg every 3 weeks by IV infusion arm 3: Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by IV infusion
Interventions: intervention 1: brentuximab vedotin intervention 2: brentuximab vedotin intervention 3: brentuximab vedotin
Intervention descriptions: intervention 1: 1.8 mg/kg every 3 weeks by intravenous (IV) infusion intervention 2: 2.4 mg/kg every 3 weeks by intravenous (IV) infusion intervention 3: 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion

Protocol documents:
Clinical trial NCT01464229
Conditions: Major Depressive Disorder
Sponsor: Maurizio Fava, MD
Start date: 2012-04-01; Completion date: 2014-12-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Iloperidone is an atypical antipsychotic drug, FDA-approved for the acute treatment of schizophrenia in adults in 2009 (Marino et al., 2010); moreover, some of its pharmacological features seem to be very promising in treating symptoms like anger and anxiety (Fava et al., 1997; Wang et al., 2010). The investigators therefore feel that an adequately sized, well powered, double-blind, placebo-controlled, randomized, cross-over study of iloperidone augmentation of SSRIs among MDD outpatients in partial remission with residual anger and irritability is warranted at this point to evaluate its efficacy, safety and tolerability on residual anger, irritability and depressive symptoms.

Main hypothesis: Adults with MDD in partial remission, who are experiencing residual symptoms of anger and irritability, assigned to treatment with iloperidone will demonstrate a significantly greater reduction in the total score of the Anger/Hostility Scale of the Symptom Questionnaire from baseline to endpoint than those assigned to placebo using the cross-over design.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Iloperidone intervention 2: Placebo
Intervention descriptions: intervention 1: Iloperidone 1-8 mg for 4 weeks intervention 2: Placebo

Protocol documents:
Clinical trial NCT01475838
Conditions: Acquired Immunodeficiency Syndrome HIV Infections
Keywords: HIV-1 HIV Treatment Experienced
Sponsor: Gilead Sciences
Start date: 2011-11-01; Completion date: 2014-12-01
Enrollment: 438 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the non-inferiority of Stribild® (elvitegravir/cobicistat/ emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) single-tablet regimen (STR) relative to regimens consisting of a protease inhibitor (PI) boosted with ritonavir (RTV) plus Truvada® (FTC/TDF) fixed-dose combination in maintaining HIV-1 RNA \< 50 copies/mL at Week 48 in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety, tolerability, and efficacy of the two regimens through 96 weeks of treatment.

Detailed description:

Arms: arm 1: Participants will switch from their baseline treatment regimen to Stribild for up to 96 weeks, and may continue to receive Stribild in the extension phase. arm 2: Participants will stay on their baseline treatment regimen antiretroviral regimen consisting of a PI boosted with RTV plus FTC/TDF for up to 96 weeks, and may switch to Stribild in the extension phase.
Interventions: intervention 1: PI intervention 2: RTV intervention 3: FTC/TDF intervention 4: Stribild
Intervention descriptions: intervention 1: PI administered according to prescribing information; allowed PIs include atazanavir (ATV), darunavir (DRV), fosamprenavir (FPV), lopinavir (LPV), or saquinavir (SQV) intervention 2: RTV administered according to prescribing information FTC/TDF administered according to prescribing information intervention 3: FTC/TDF (200/300 mg) administered according to prescribing information intervention 4: Stribild (E/C/F/TDF) (150/150/200/300 mg) STR administered orally once daily with food

Protocol documents:
Clinical trial NCT01481740
Conditions: Hypotension
Keywords: spinal induced hypotension nausea and vomiting cesarean delivery
Sponsor: IWK Health Centre
Start date: 2010-11-01; Completion date: 2014-12-01
Enrollment: 178 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Previous research regarding the use of phenylephrine has excluded obese subjects (BMI \>35). This subgroup of patients represents a large portion of the obstetric patient population locally and nationally. It is unclear whether previous research should be extrapolated to the obese patient population. This study is being done to compare the incidence of hypotension, intraoperative nausea and vomiting, and neonatal acidosis between obese patients who receive a prophylactic phenylephrine infusion versus those who receive phenylephrine boluses for the treatment of established hypotension. This study will help us determine whether using a phenylephrine infusion or a phenylephrine bolus is the best way to prevent/treat spinal induced hypotension during cesarean deliveries in obese patients.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Phenylephrine bolus intervention 2: phenylephrine infusion
Intervention descriptions: intervention 1: 10 ml of 100mcg/ml phenylephrine and placebo infusion intervention 2: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus

Protocol documents:
Clinical trial NCT01483820
Conditions: Neuroblastoma Medulloblastoma
Sponsor: Giselle Sholler
Start date: 2011-12-01; Completion date: 2014-12-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to evaluate a new investigational drug (TPI 287) for neuroblastoma and medulloblastoma. An investigational drug is one that has not yet been approved by the Food and Drug Administration. This investigational drug is called TPI 287. This study will look at the tumor's response to the study drug, TPI 287, as well as the safety and tolerability of the drug.

TPI 287 was shown to be effective in stopping tumor growth and was also shown to be safe in three different animal species. TPI 287 has been tested in humans in four clinical trials, and approximately 100 subjects with various types of cancers have received the drug, including a pediatric population in our previous Phase I trial.

Detailed description:

Arms: arm 1: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.
Interventions: intervention 1: TPI 287
Intervention descriptions: intervention 1: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.

Protocol documents:
Clinical trial NCT01489176
Conditions: Coronary Artery Disease Myocardial Perfusion Abnormalities
Keywords: Stress Echocardiography Real-Time Perfusion Imaging Regadenoson Optison
Sponsor: University of Nebraska
Start date: 2012-07-31; Completion date: 2014-12-01
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose if this study is to examine how effective Regadenoson is in detecting coronary artery disease during a stress echocardiogram when Optison is administered. Optison is a contrast agent that improves the images of the heart on the echocardiogram (echo) machine. Optison is approved by the Food and Drug Administration (FDA) to use during stress echocardiograms. Regadenoson is a commercially available rapid acting stress agent that is used to chemically increase the heart rate and is approved for nuclear imaging tests. Regadenoson is a FDA approved drug but not for the intended use in this study.

Detailed description:
Stress perfusion imaging has primarily been done with radionuclide scintigraphy or single photon emission computed tomography (SPECT) and has not reached its full clinical potential because of the poor spatial resolution of SPECT, increased expense of this procedure, patient exposure to ionizing radiation, and lack of availability. The A2A receptor agonist Regadenoson has been utilized to detect myocardial perfusion abnormalities during SPECT myocardial perfusion imaging.

A 100 patient pilot study (Regadenoson Real Time Perfusion Imaging Trial, IRB #566-08-FB) demonstrated the feasibility and accuracy of real-time perfusion echocardiography (RTPE) in detecting coronary artery disease following Regadenoson bolus injection and Definity as an ultrasound contrast agent. The aim of this study is to determine whether similar feasibility and accuracy can be achieved with Optison (a Food and Drug Administration approved ultrasound contrast agent that differs slightly in microbubble size and composition) in detecting coronary artery disease (CAD) following Regadenoson bolus injection. As with the original study, sensitivity, specificity, and accuracy of perfusion and wall motion analysis to identify a coronary stenosis \>50% in diameter by quantitative angiography will be analyzed.

Arms: arm 1: Use of Regadenoson as the chemical stress agent using Optison as a contrast agent during stress echocardiography.
Interventions: intervention 1: Regadenoson; Optison
Intervention descriptions: intervention 1: A one-time intravenous bolus of Regadenoson 400 mcg; continuous intravenous infusion of Optison of 2-4 mL/minute.

Protocol documents:
Clinical trial NCT01495702
Conditions: Acquired Immunodeficiency Syndrome HIV Infections
Keywords: HIV-1 HIV Treatment Experienced
Sponsor: Gilead Sciences
Start date: 2011-12-01; Completion date: 2014-12-01
Enrollment: 439 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the noninferiority of Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) single-tablet regimen (STR) relative to regimens consisting of a nonnucleoside reverse transcriptase inhibitor (NNRTI) plus Truvada® (FTC/TDF) in maintaining HIV-1 RNA \< 50 copies/mL at Week 48 in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety, tolerability, and efficacy of the two regimens through 96 weeks of treatment.

Detailed description:

Arms: arm 1: Participants will switch from their baseline treatment regimen to Stribild for up to 96 weeks, and may continue to receive Stribild in the extension phase. arm 2: Participants will stay on their baseline treatment regimen antiretroviral regimen consisting of an NNRTI plus FTC/TDF for up to 96 weeks, and may switch to Stribild in the extension phase.
Interventions: intervention 1: NNRTI intervention 2: FTC/TDF intervention 3: Stribild
Intervention descriptions: intervention 1: NNRTI agents administered according to prescribing information; allowed NNRTIs include efavirenz (EFV), nevirapine, or rilpivirine. intervention 2: FTC/TDF (200/300 mg) administered according to prescribing information intervention 3: Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; E/C/F/TDF) (150/150/200/300 mg) STR administered orally once daily with food

Protocol documents:
Clinical trial NCT01505608
Conditions: Neuroblastoma
Sponsor: Giselle Sholler
Start date: 2011-12-01; Completion date: 2014-12-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this research study is to evaluate a new investigational drug (TPI 287) for early relapsed neuroblastoma. An investigational drug is one that has not yet been approved by the Food and Drug Administration. This investigational drug is called TPI 287. This study will look at the tumor's response to the study drug, TPI 287, in combination with Irinotecan and Temozolomide versus the combination of Irinotecan and Temozolomide alone. This study will also evaluate the safety and tolerability of the study drug, TPI 287.

Detailed description:

Arms: arm 1: 1. Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.
2. Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.

Patients who show progression on the I+TMZ arm may crossover to the I+TMZ+TPI 287 arm at anytime during cycles 1 to 6. If there is evidence of progression after completion of the I+TMZ arm (after completion of cycle 6) then the patient will have been considered to have completed therapy and is not eligible for the crossover. arm 2: Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287

1. Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.
2. Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.
3. Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.
Interventions: intervention 1: TPI 287 intervention 2: Temozolomide intervention 3: Irinotecan
Intervention descriptions: intervention 1: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle. intervention 2: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle intervention 3: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.

Protocol documents: