ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01106014
Conditions: Pulmonary Arterial Hypertension
Keywords: pulmonary arterial hypertension PAH
Sponsor: Actelion
Start date: 2009-12-01; Completion date: 2014-10-01
Enrollment: 1156 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The AC-065A302 (GRIPHON) study is an event-driven Phase 3 study to demonstrate the effect of selexipag on time to first morbidity or mortality event in patients with pulmonary arterial hypertension.

Detailed description:

Arms: arm 1: Selexipag is up-titrated from Day 1 to Week 12 to each patient's maximum tolerated dose in the range of 200-1600 µg twice a day (b.i.d.) in 200 µg steps starting with one 200 µg oral tablet on Day 1. From Day 2 onwards, a b.i.d. dose regimen with an interval of approximately 12 hours is followed. If this dose (selexipag 200 μg b.i.d.) is well-tolerated, selexipag is up-titrated with weekly increments of 200 µg. Up-titration is followed by a stable maintenance treatment period from Week 12 onwards, up to Week 26, at the maximum tolerated dose arm 2: Matching placebo is administered orally with a dosing interval of approximately12 h. A (mock) up-titration scheme is followed
Interventions: intervention 1: Selexipag intervention 2: Placebo
Intervention descriptions: intervention 1: Selexipag 200 µg tablets intervention 2: Placebo tablets matching selexipag

Protocol documents:
Clinical trial NCT01125800
Conditions: Medulloblastoma Rhabdomyosarcoma Neuroblastoma Hepatoblastoma Glioma Astrocytoma
Keywords: Recurrent, refractory, medulloblastoma, rhabdomyosarcoma, neuroblastoma, hepatoblastoma, astrocytoma, children, pediatric, hedgehog pathway inhibitor, adult
Sponsor: Novartis Pharmaceuticals
Start date: 2011-02-01; Completion date: 2014-10-01
Enrollment: 76 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Phase I dose-escalation study to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of LDE225 given orally on a daily dosing schedule in children with recurrent or refractory medulloblastoma, or other tumors potentially dependent on Hedgehog signaling pathway.

Phase II study is to assess preliminary efficacy in both adult and pediatric patients with recurrent or refractory MB.

Detailed description:

Arms: arm 1: Pediatric dose. arm 2: Pediatric dose. arm 3: Pediatric dose. arm 4: Pediatric dose. arm 5: Adult dose
Interventions: intervention 1: LDE225
Intervention descriptions: intervention 1: LDE225/sonidegib capsules were supplied to the Investigators at dose strengths of 50 mg, 100 mg, 200 mg, and 250 mg.

Protocol documents:
Clinical trial NCT01174173
Conditions: Angina Pulmonary Arterial Hypertension
Keywords: Angina Right Ventricular Ischemia Pulmonary Arterial Hypertension Pulmonary Hypertension
Sponsor: Northwestern University
Start date: 2010-06-01; Completion date: 2014-10-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to determine if the medication, ranolazine (study drug), can help improve blood flow to your heart, increase your exercise capacity and improve your quality of life (QOL). For this study, you will be asked to perform several tests in order to determine if your heart function, exercise capacity, chest pain and QOL have improved after 3 months of treatment with ranolazine. Ranolazine is approved by the U.S. Food and Drug Administration (FDA) for the treatment of angina.

Detailed description:
This study is looking to enroll patients with pulmonary hypertension (PH). PH is abnormally high blood pressure in the arteries of the lungs. It makes the right side of the heart need to work harder than normal and is usually caused by a narrowing of the small arteries of the lung. This narrowing makes it harder for the right side of the heart to circulate the blood to the lungs. Over time, the right side of the heart may become enlarged and symptoms (such as angina \[chest pain\] shortness of breath, fatigue, edema) begin to appear.

Ranolazine is a safe, well-tolerated, and FDA-approved medication for the treatment of chronic stable angina. Ranolazine may potentially improve blood flow to the right ventricle (RV), thereby relieving angina while simultaneously improving RV performance and contractility. This latter effect may increase stroke volume and cardiac output which could translate into benefits in exercise capacity and improved quality of life.

The purpose of this single center, non-randomized, prospective pilot study is to investigate the effects of 3 months treatment with ranolazine on pulmonary artery hemodynamics, exercise capacity and quality of life in patients with PAH and symptoms of angina or angina equivalent.

Arms: arm 1: 1000 mg PO BID
Interventions: intervention 1: Ranolazine
Intervention descriptions: intervention 1: ranolazine 1000 mg PO BID for 3 months

Protocol documents:
Clinical trial NCT01205828
Conditions: Hepatocellular Carcinoma
Keywords: liver cancer hepatocellular temozolomide veliparib
Sponsor: Georgetown University
Start date: 2010-08-01; Completion date: 2014-10-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is for people with liver cancer (also called hepatocellular carcinoma, or HCC in abbreviation).

The purpose of this study is to test the efficacy (effectiveness) of a new combination of drugs, ABT-888 and temozolomide for patients with liver cancer. Temozolomide acts by damaging deoxyribonucleic acid (DNA) in rapidly dividing cells, in other words, cancer cells. ABT-888 inhibits an enzyme called "PARP" which helps to fix damaged DNA. By inhibiting this enzyme, ABT-888 prevents cancer cells from repairing the damage caused by the temozolomide and will hopefully increase the killing of cancer cells, and decrease the tumors in the body.

ABT-888 is an investigational or experimental anti-cancer agent that has not yet been approved by the Food and Drug Administration (FDA) for use in liver cancer.

This study will help find out what effects (good and bad) the combination of drugs, temozolomide and ABT-888, has on liver cancer.

This research is being done because it is not known if ABT-888 will increase the effectiveness of temozolomide in liver cancer.

Detailed description:
Patients with hepatocellular carcinoma seen at Lombardi Cancer Center were evaluated for the eligibility of this study.

The Georgetown Lombardi Comprehensive Cancer Center was responsible for the data and safety monitoring of this trial. As this study is an investigator initiated study Phase II study utilizing a non-FDA approved drug for which the PI held the IND it was considered a high risk study which had real-time monitoring by the PI and study team and quarterly reviews by the LCCC Data and Safety Monitoring Committee (DSMC).

Arms: arm 1: Temozolomide 150 mg/m2/day PO Days 1-5 every 28 days ABT-888 40 mg BID PO Days 1-7 every 28 days
Interventions: intervention 1: Temozolomide intervention 2: ABT-888
Intervention descriptions: intervention 1: Temozolomide 150 mg/m2/day PO Days 1-5 every 28 days intervention 2: ABT-888 40 mg BID PO Days 1-7 every 28 days

Protocol documents:
Clinical trial NCT01221441
Conditions: Osteoarthritis, Knee
Keywords: Cartilage Knee Osteoarthritis
Sponsor: Kolon TissueGene, Inc.
Start date: 2011-05-01; Completion date: 2014-10-01
Enrollment: 102 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to see if we can safely regenerate cartilage without invasive surgery using a biologic product called TissueGene-C.

Detailed description:
Protocol TGC09201 is a multi-center, double-blind, placebo-controlled, randomized study. A total of one hundred (100) adults with grade 3 chronic degenerative joint disease (DJD) of the knee joint (as determined by radiographic examination) will be enrolled into the study. TissueGene-C will be administered intra-articularly once via x-ray guidance. TissueGene-C will be administered at a dose of 3 x 10e7 cells. Patients receiving control treatment will receive a single normal saline injection.

The objectives of this study are to:

1. Evaluate the efficacy of TissueGene-C with regard to knee functionality and symptoms of knee osteoarthritis including pain.
2. Evaluate the safety of administration of a single intra-articular dose of TissueGene-C as evidenced by observation of the injection site for irritation or other abnormalities, the incidence and severity of adverse events, and the changes in physical examination findings and laboratory tests, including immune analyses.
3. Evaluate the incidence and dose of analgesia and/or anti-inflammatory medication.
4. Evaluate the regeneration of hyaline cartilage as determined by 3T magnetic resonance imaging (MRI).
5. Evaluate distribution of hChonJb#7 cells out of the injection site.
6. Evaluate the efficacy of TissueGene-C by evaluating the need for total knee arthroplasty after treatment

Arms: arm 1: TissueGene-C at 3 x 10e7 cells per injection (intraarticular) arm 2: Normal Saline injection
Interventions: intervention 1: TissueGene-C intervention 2: Normal Saline
Intervention descriptions: intervention 1: Single intraarticular injection at 3 x 10e7 cells intervention 2: Single intraarticular injection of normal saline as a placebo control

Protocol documents:
Clinical trial NCT01252940
Conditions: HIV-1 Infection
Keywords: HIV-1 HIV Treatment Experienced
Sponsor: Gilead Sciences
Start date: 2010-11-01; Completion date: 2014-10-01
Enrollment: 482 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this randomized, open-label, multicenter, active-controlled Phase 3b study is to evaluate the noninferiority of the emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) single-tablet regimen (STR; also referred to as fixed-dose regimen or fixed-dose tablet) relative to regimens consisting of a ritonavir-boosted protease inhibitor (PI+RTV) and two nucleoside reverse transcriptase inhibitors (NRTIs) in virologically suppressed, HIV-1 infected subjects. The FTC/RPV/TDF STR could offer an attractive treatment option to patients who wish to simplify dosing by reducing pill burden or to improve the tolerability of their treatment.

Participants will be randomized into 2 groups, the FTC/RPV/TDF STR group, in which participants will switch treatment regimens at the start of the study, and the Stay on Baseline Regimen (SBR)/Delayed Switch group, in which participants will remain on their baseline regimen during the first 24 weeks of the study (designed to provide an initial active control), and may switch to the FTC/RPV/TDF STR at the Week 24 visit.

After the 48-week study analysis period, participants may continue to receive the FTC/RPV/TDF STR per protocol before switching to a commercially available source.

Detailed description:

Arms: arm 1: Participants will switch from their existing treatment regimen to the emtricitabine (FTC)/rilpivirine (RPV)/tenofovir disoproxil fumarate (TDF) single-tablet regimen (STR) at the beginning of the study. arm 2: Participants will stay on baseline regimen (SBR; their existing treatment regimen of PI+RTV plus 2 NRTIs) at the beginning of the study through Week 24, and may switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
Interventions: intervention 1: FTC/RPV/TDF intervention 2: PI intervention 3: RTV intervention 4: NRTIs
Intervention descriptions: intervention 1: Emtricitabine (FTC) 200 mg/rilpivirine (RPV) 25 mg/tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg single-tablet regimen (STR) administered orally with a meal once daily (QD) intervention 2: Protease inhibitors (PIs) included amprenavir, atazanavir, darunavir, fosamprenavir, Kaletra (lopinavir/ritonavir, coformulated), ritonavir, and saquinavir. PIs were administered according to prescribing information. intervention 3: Ritonavir (RTV) was administered according to prescribing information. intervention 4: NRTIs included abacavir, emtricitabine, Combivir (lamivudine/zidovudine, coformulated), Epzicom (abacavir/lamivudine, coformulated), lamivudine, stavudine, tenofovir DF, Truvada® (emtricitabine/tenofovir DF, coformulated), and zidovudine. NRTIs were administered according to prescribing information.

Protocol documents:
Clinical trial NCT01258738
Conditions: Spondylitis, Ankylosing
Keywords: Early ankylosing spondylitis (SpA) study; efficacy and safety and health out comes
Sponsor: Pfizer
Start date: 2011-02-01; Completion date: 2014-10-01
Enrollment: 225 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a two part study. During period one there will be a comparison of Etanercept (ETN) against a placebo with both arms maintaining the background anti inflammatory drug prescribed by their Physician. The hypothesis is that Etanercept will be superior to the placebo arm as determined by the proportion of subjects achieving Assessments in Ankylosing Spondylitis (ASAS)40 improvement at 12 weeks. This will be followed by 92 weeks extension where everyone in the trial receives Etanercept (ETN) and a background non steroidal anti inflammatory drug(NSAID).

Detailed description:

Arms: arm 1: In Period 1 : Subjects will receive via a prefilled syringe an active dose equivalent to 1.0ml of Etanercept solution once weekly SC once weekly. Additionally they will continue to take the background non steroidal anti inflammatory drug(NSAID) in the tolerated dose agreed upon by the attending Physician. arm 2: In Period 1: Subjects will receive in a prefilled syringe with a PLACEBO dose equivalent to 1.0 ml of placebo solution once weekly SC Additionally they will continue to take the background non steroidal anti inflammatory drug(NSAID) in the tolerated dose agreed upon by the attending Physician.
Interventions: intervention 1: etanercept intervention 2: Background NSAID intervention 3: PLACEBO intervention 4: Background NSAID
Intervention descriptions: intervention 1: In Period 1, subjects will receive in a prefilled syringe with 1.0 ml (test article Etanercept (SC) once weekly . Additionally they will continue to take the background non steroidal anti inflammatory drug(NSAID) in the tolerated dose agreed upon by the attending Physician. intervention 2: Subject will continue to take a concomitant background non steroidal anti inflammatory drug(NSAID)as prescribed by their attending physician. The name and dose of this NSAID is the decision of the attending physician. intervention 3: In Period 1 will receive a prefilled syringe of Placebo for Etanercept Additionally they will continue to take the background non steroidal anti inflammatory drug(NSAID) in the tolerated dose agreed upon by the attending Physician. intervention 4: Subject will continue to take a concomitant background non steroidal anti inflammatory drug(NSAID)as prescribed by attending physician (dose drug selection as tolerated and agreed upon by the attending Physician).

Protocol documents:
Clinical trial NCT01262820
Conditions: Lung Cancer
Keywords: Pazopanib Non Squamous Non Small Cell Lung Cancer After Progress on first line therapy Using Bevacizumab
Sponsor: UNC Lineberger Comprehensive Cancer Center
Start date: 2010-12-01; Completion date: 2014-10-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open label Phase II Trial that using the investigational anti-cancer agent, Pazopanib to see whether non-squamous non-small cell lung cancer will respond to its use by decreasing the size of the tumor or stopping its growth.

Detailed description:
This multi-centered phase II trial will examine pazopanib stage IIIB/IV non-squamous NSCLC patients who have progressed on first-line therapy containing bevacizumab. Treatment should continue until disease progression, unacceptable toxicity, study withdrawal, or death. Patients who progress will be treated at the discretion of their physician. all patients who initiate treatment will be evaluated for disease control rate, which is the primary endpoint of this study.

The primary objective is to estimate the disease control rate of pazopanib alone in patients with stage IIIB/IV non-squamous NSCLC who progressed while on bevacizumab. Disease control rate id defined as complete (CR) + partial response (PR) + stable disease (SD) lasting greater than or equal to 12 weeks as defined by RECIST.

Secondary Objectives To estimate the combined response rate (CR + PR) of pazopanib according to RECIST To estimate the progression free survival (defined as time of enrollment until disease progression or death) and overall survival (defined as time of enrollment until death) of patients treated with pazopanib.

To evaluate the safety and tolerability of pazopanib using the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.0 To explore potential correlations between blood biomarkers and clinical response.

Pazopanib is dosed continuously throughout the study. Cycle lengths are identified as 21 days for purposes of the calendar.

The treatment dosage and administration for participating subjects will be, Pazopanib, 800 mg by mouth daily during a 21 day cycle until disease progression.

Arms: arm 1: Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study
Interventions: intervention 1: Pazopanib
Intervention descriptions: intervention 1: Pazopanib, 800 mg by mouth daily each 21 day cycle

Protocol documents:
Clinical trial NCT01270659
Conditions: Pain
Keywords: Fentanyl buccal tablet
Sponsor: University of Oklahoma
Start date: 2011-05-01; Completion date: 2014-10-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to evaluate fentanyl buccal tablet (FBT) for analgesia in comparison to standard analgesia, to determine if the FBT allows for faster achievement of "significant analgesia"

Detailed description:
The subjects/patients will be asked if they would desire a low dose or high dose pain medication regimen. The low dose (low-FBT) group will receive FBT at a dose of 100 mcg, as well as an oral (pill) placebo preparation. The low dose (low-control) group will receive an "inactive comparator" (lansoprazole rapidly-dissolving buccal 15mg, " FBT placebo") and a dose of 5/325 Percocet tablet (oxycodone/acetaminophen 5/325). The high dose (high-FBT) group will receive 200 mcg FBT plus 2 placebo tablets. The high dose (high-control) group will receive the "FBT placebo" and a dose of 2, 5/325 Percocet tablets.

Arms: arm 1: Subject will receive FBT and placebo at a low dose arm 2: Subject will receive the high dose regimen of FBT and a high dose placebo arm 3: Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl "placebo" arm 4: Subject will receive the higher dose of the active comparator, #2 oxycodone/APAP 5/325mg, and lansoprazole solutab for the fentanyl "placebo"
Interventions: intervention 1: Fentanyl intervention 2: Fentanyl intervention 3: Oxycodone/acetaminophen intervention 4: oxycodone/acetaminophen
Intervention descriptions: intervention 1: Fentanyl buccal tablet 100 mcg once intervention 2: Fentanyl buccal tablet 200 mcg once intervention 3: Oxycodone/acetaminophen 5/325 mg once intervention 4: Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time

Protocol documents:
Clinical trial NCT01275196
Conditions: Chronic Myeloid Leukemia
Keywords: Newly diagnosed, Ph+ chronic myeloid leukemia, CML-CP
Sponsor: Novartis Pharmaceuticals
Start date: 2011-04-01; Completion date: 2014-10-01
Enrollment: 267 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will compare the efficacy and safety of Nilotinib versus Imatinib in newly diagnosed Chinese patients with CML-CP.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Nilotinib intervention 2: Imatinib
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01297491
Conditions: Non-small Cell Lung Cancer
Keywords: NSCLC PI3K
Sponsor: Novartis Pharmaceuticals
Start date: 2011-05-01; Completion date: 2014-10-01
Enrollment: 63 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this two-stage phase II study is to assess the efficacy of BKM120, as measured by determining the progression free survival (PFS), in patients with pretreated metastatic Non-small Cell Lung Cancer (NSCLC) that exhibits PI3K pathway activation. BKM120 will be investigated in two groups of NSCLC patients according to the histology of the cancer: squamous and non-squamous.

Detailed description:

Arms: arm 1: Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease. arm 2: Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
Interventions: intervention 1: BKM120
Intervention descriptions: intervention 1: Buparlisib was supplied as 10mg or 50mg capsules. It was administered on a continuous once daily dosing schedule at a dose of 100 mg. The patient was dosed on a flat scale of mg/day and not adjusted to body weight or body surface area.

Protocol documents:
Clinical trial NCT01304147
Conditions: Major Depressive Disorder
Keywords: ketamine depression treatment resistance intranasal, antidepressant glutamate NMDA receptor
Sponsor: James Murrough
Start date: 2011-10-01; Completion date: 2014-10-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of the current study is to investigate the safety and efficacy of a single dose of intranasal (IN) ketamine in treatment-resistant depression (TRD).

Detailed description:

Arms: arm 1: Subjects randomized to this arm will receive the active study medication, intranasal ketamine. arm 2: Subjects randomized to this arm will receive intranasal saline.
Interventions: intervention 1: Ketamine intervention 2: placebo
Intervention descriptions: intervention 1: A single dose of intranasal ketamine up to 50 mg intervention 2: Single dose of saline intranasal

Protocol documents:
Clinical trial NCT01325701
Conditions: Diffuse Large Cell B-lymphoma
Keywords: PCI-32765 Lymphoma, B-Cell Bruton's Tyrosine Kinase Non Hodgkin's Lymphoma Germinal Center B-Cell Activated B-Cell
Sponsor: Pharmacyclics LLC.
Start date: 2011-05-01; Completion date: 2014-10-01
Enrollment: 78 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the efficacy of ibrutinib (PCI-32765) in relapsed/refractory de novo activated B-cell (ABC) and germinal-cell B-Cell (GCB) Diffuse Large B-cell Lymphoma (DLBCL).

Detailed description:
The primary objectives of this study were to evaluate the efficacy of ibrutinib administered at 560 mg once per day in relapsed or refractory de novo ABC and GCB DLBCL, and to evaluate the efficacy of ibrutinib administered at 840 mg once per day in relapsed or refractory de novo ABC DLBCL.

The secondary objective was to evaluate the safety and tolerability of a fixed daily oral dosing regimen of ibrutinib in relapsed/refractory de novo DLBCL.

Arms: arm 1: Treatment Group 1: Subjects received 560 mg of ibrutinib once daily, on a continuous basis. arm 2: Treatment Group 2: Subjects received 840 mg of ibrutinib once daily, on a continuous basis.
Interventions: intervention 1: ibrutinib
Intervention descriptions: intervention 1: ibrutinib is an inhibitor of BTK

Protocol documents: