ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01493947
Conditions: Papulopustular Rosacea
Sponsor: Galderma R&D
Start date: 2012-04-01; Completion date: 2013-12-01
Enrollment: 962 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study objectives:

* To compare efficacy and safety of Ivermectin 1% cream versus metronidazole 0.75% cream in subjects with papulopustular rosacea after 16-week topical treatment.
* And to compare, for subjects initially successfully treated by 16 weeks treatment, Ivermectin 1 % cream versus metronidazole 0.75% cream during a 36-week extension period by assessing, the time of first relapse, the relapse rate, and the number of days free of treatment

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ivermectin 1% cream intervention 2: Metronidazole 0.75% cream
Intervention descriptions: intervention 1: Ivermectin 1% cream applied once daily on the face during 16-week plus 36-week extension period. intervention 2: Metronidazole 0.75% cream applied twice daily on the face during 16-week plus 36-week extension period.

Protocol documents:
Clinical trial NCT01516736
Conditions: Chemotherapy-induced Neutropenia Breast Cancer
Keywords: Pegfilgrastim G-CSF neutropenia breast cancer myelosuppressive chemotherapy
Sponsor: Sandoz
Start date: 2012-03-01; Completion date: 2013-12-01
Enrollment: 308 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will assess the efficacy of LA-EP2006 compared to Neulasta® with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.

Detailed description:
The Pegfilgrastim Randomized Oncology (Supportive Care) Trial to Evaluate Comparative Treatment (PROTECT-2) was a confirmatory efficacy and safety study designed to compare the proposed biosimilar LA-EP2006 with the reference pegfilgrastim in woman with early stage breast cancer receiving (neo)-adjuvant myelosuppressive chemotherapy. Patient received TAC (intravenous docetaxel 75mg/m\^2, doxorubicin 50 mg/m\^2, and cyclophosphamide 500mg/m\^2) on day1 of each cycle, for six or more cycles. A total of 308 patients were randomized to LA-EP2006 (n=155) or reference Neulasta® (n=153). Treatment was given subcutaneously on day 2 of each cycle. The primary end point was the duration of severe neutropenia (DSN) during Cycle 1 (defined as number of consecutive days with absolute neutrophil count \<0.5 × 10\^9 cells/L). LA-EP2006 was equivalent to the reference product in DSN (difference: -0.16 days; 95% CI \[-0.40, 0.08\]). Further, LA-EP2006 and the reference pegfilgrastim showed no clinically meaningful differences regarding efficacy and safety.

Arms: arm 1: During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application. arm 2: During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.
Interventions: intervention 1: LA-EP2006 intervention 2: Neulasta®
Intervention descriptions: intervention 1: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application. intervention 2: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle Neulasta® is injected s.c. post chemotherapy application.

Protocol documents:
Clinical trial NCT01519518
Conditions: Acute ST Elevation Myocardial Infarction
Keywords: ST elevation myocardial infarction Primary percutaneous coronary intervention Unfractionated heparin Bivalirudin primary angioplasty
Sponsor: Liverpool Heart and Chest Hospital NHS Foundation Trust
Start date: 2012-02-01; Completion date: 2013-12-01
Enrollment: 1829 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare unfractionated heparin (UFH) and bivalirudin in the performance and subsequent outcomes of Primary percutaneous coronary intervention. This will be a pragmatic trial. Interventional procedures will be performed to reflect current and evolving standards, including predominant radial access. All patients will be treated with routine oral anti-platelet therapy pre-procedure. GP IIb/IIIa inhibitors will be reserved for 'bail out' treatment only.

Detailed description:
HEAT-PPCI is a single-centre prospective, dual-arm, open-label, randomised controlled trial comparing two antithrombotic agents in patients undergoing PPCI. All patients presenting to the PPCI service at Liverpool Heart and Chest Hospital will be assessed for trial eligibility. The patients will be allocated by randomisation in equal proportions to the two treatment groups receiving UFH (70 units/kg prior to the procedure) or bivalirudin (bolus of 0.75 mg/kg prior to the start of the intervention, followed by an infusion of 1.75 mg/kg per hour for the duration of the procedure).

Pre-Specified Subgroup Analyses

* Subgroup analyses looking at the impact of access site comparing radial versus femoral route
* Assessment of the outcomes in diabetic patients receiving oral hypoglycaemic or insulin therapy versus all other patients
* Comparing the outcomes in patients \< or ≥ 75 years of age
* Type of p2y12 receptor inhibiting antiplatelet agent (Examples: clopidogrel, prasugrel, ticagrelor)
* Patients with impaired LV function versus normal LV function
* Patients managed with actual or attempted primary PCI versus no immediate PCI procedure attempted

PLATELET FUNCTION SUBSTUDY A substudy will be performed to assess indices of coagulation and platelet function studies comparing the impact of heparin or bivalirudin therapy on coagulation status at the end of the PPCI procedure. This study will be performed on all patients treated between the hours of 0800 and 1600, Monday to Friday. A single blood sample taken at the time of general blood sampling for routine clinical screening will be analysed.

Arms: arm 1: 70 units/kg body weight intravenous arm 2: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour
Interventions: intervention 1: unfractionated heparin intervention 2: Bivalirudin
Intervention descriptions: intervention 1: 70 units/kg body weight intravenous intervention 2: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour

Protocol documents:
Clinical trial NCT01577706
Conditions: AOD Effects and Consequences
Keywords: GABA glutamate glutamine spectroscopy brain imaging alprazolam dextroamphetamine placebo
Sponsor: Mclean Hospital
Start date: 2013-06-01; Completion date: 2013-12-01
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
An advanced technique for rapid magnetic resonance proton spectroscopic imaging (1H-MRSI) will be employed in a drug challenge study in healthy volunteers to spatially map and measure acute changes in the brain chemicals GABA, glutamate and glutamine after administration of a drug. Three condition will be tested in a double-blind fashion, i)depressant, ii)stimulant, iii)placebo. It is hypothesized that unique and reproducible spatial and directional metabolic response patterns will be observed, unique to each condition within the brain.

Detailed description:
Proton magnetic resonance spectroscopy (1H MRS) is a powerful tool for assessing neurochemistry non-invasively in vivo. However, the primary shortcoming in most studies is the lack of spatial coverage afforded by the typical single-voxel design. Limits on participant tolerance and financial resources restrict single-voxel studies to an examination of one or two carefully chosen voxels per scan, thus inadequately addressing the question of focal vs. global pathophysiology. A secondary shortcoming is that most studies report on either GABA or glutamate-glutamine (Glu-Gln) due to the technically demanding spectral-editing techniques that must be implemented in order to resolve and quantify those metabolites with any accuracy.

1H MRS imaging (MRSI) can partially overcome these limitations by providing a global picture of brain chemistry rather than just the focal snapshot afforded by the single-voxel design. However, the scan time necessary for collecting enough data for adequate spatial resolution and signal-to-noise, particularly if also using specialized spectral-editing techniques, is still too lengthy. We recently developed a method that combines Spectroscopic Imaging with the MEGAPRESS-based difference-editing acquisition for optimal GABA detection as well as for optimal detection of Glu and Gln. This MEGACSI sequence will permit us to obtain the maximum amount of neurochemical information in a clinically sound scan time, while using the current state-of-the-art MRS editing methods for optimal detection of GABA, Glu, and Gln.

Arms: arm 1: Alprazolam (Xanax), gel-capsule, 1mg, single-dose, 1-day arm 2: Dextroamphetamine (Dexedrine), gel-capsule, 20mg, single-dose, 1-day arm 3: Placebo gel-capsule, single-dose, 1-day
Interventions: intervention 1: Alprazolam intervention 2: Dextroamphetamine intervention 3: Placebo
Intervention descriptions: intervention 1: Alprazolam, gel-capsule, 1mg, single-dose, 1-day intervention 2: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day intervention 3: Placebo, gel-capsule, single-dose, 1-day

Protocol documents:
Clinical trial NCT01579474
Conditions: Hepatitis C
Sponsor: Boehringer Ingelheim
Start date: 2012-04-01; Completion date: 2013-12-01
Enrollment: 131 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this trial is to evaluate the safety and efficacy of BI 201335 given for 12 or 24 weeks in combination with PegIFN alfa-2b/RBV given for 24 or 48 weeks in chronic genotype 1 hepatitis C virus infected treatment-naïve and treatment-experienced Japanese patients

Detailed description:

Arms: arm 1: low dose BI 201335 NA once daily for 12 or 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-naive patients arm 2: high dose BI 201335 NA once daily for 12 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-naive patients arm 3: high dose BI 201335 NA once daily for 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients arm 4: high dose BI 201335 NA once daily for 24 weeks combined with PegIFN/RBV for 48 weeks in treatment-experienced (null responder, partial responder, breakthrough) patients
Interventions: intervention 1: BI 201335 high dose intervention 2: BI 201335 low dose intervention 3: BI 201335 high dose intervention 4: BI 201335 high dose
Intervention descriptions: intervention 1: BI 201335 high dose with PegIFN/RBV intervention 2: BI 201335 low dose with PegIFN/RBV intervention 3: BI 201335 high dose with PegIFN/RBV intervention 4: BI 201335 high dose with PegIFN/RBV

Protocol documents:
Clinical trial NCT01604408
Conditions: Muscle Weakness
Sponsor: Eli Lilly and Company
Start date: 2012-05-01; Completion date: 2013-12-01
Enrollment: 201 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
LY2495655 is an investigational drug being tested for muscle wasting.

Detailed description:

Arms: arm 1: Participants received a 315-milligram (mg) dose of LY2495655, administered subcutaneously (SC), every 4 weeks (Q4W) for 20 weeks. arm 2: Participants received a LY2495655-matching dose of placebo, administered SC, Q4W for 20 weeks.
Interventions: intervention 1: LY2495655 intervention 2: Placebo
Intervention descriptions: intervention 1: Administered SC intervention 2: Administered SC

Protocol documents:
Clinical trial NCT01607203
Conditions: Infertility
Keywords: ovarian hyper stimulation syndrome (OHSS) metaphase II oocytes (MII) good quality embryo's implantation pregnancy
Sponsor: AZ Jan Palfijn Gent
Start date: 2011-11-01; Completion date: 2013-12-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to see whether patients triggered with only human Chorion Gonadotropin (hCG) have higher number of Metaphase II oocytes (MII) and implantation rate than patients triggered with hCG combined with Gonadotropin Releasing Hormone (GnRH) agonist.

Detailed description:

Arms: arm 1: 5000 IU Pregnyl SC arm 2: 5000 IU Pregnyl SC + 0.2 mg Decapeptyl daily SC
Interventions: intervention 1: Decapeptyl Daily intervention 2: pregnyl
Intervention descriptions: intervention 1: Decapeptyl 0.2 mg SC once 1day intervention 2: 5000 IU SC

Protocol documents:
Clinical trial NCT01633944
Conditions: Low Back Pain
Keywords: CLBP Chronic Low Back Pain Chronic Pain Back Pain
Sponsor: BioDelivery Sciences International
Start date: 2012-08-01; Completion date: 2013-12-01
Enrollment: 752 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if buprenorphine hydrochloride (HCl) buccal film is effective in treating opioid-naive subjects, with moderate to severe chronic low back pain (CLBP), who require continuous around-the-clock (ATC) pain relief for an extended period of time.

Detailed description:

Arms: arm 1: Twice Daily Dosing arm 2: Twice Daily Dosing
Interventions: intervention 1: Buprenorphine intervention 2: Placebo
Intervention descriptions: intervention 1: Buprenorphine HCl Buccal Film at doses ranging from 75-600 mcg twice daily intervention 2: Matching Placebo Buccal Film twice daily

Protocol documents:
Clinical trial NCT01643408
Conditions: Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma
Keywords: Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma Erwinaze asparaginase Eusa Pharma Pharmacokinetic study NSAA
Sponsor: Jazz Pharmaceuticals
Start date: 2012-11-01; Completion date: 2013-12-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will utilize Erwinaze via intravenous administration in patients between the ages of 1 and 30 who have experienced an allergy to their frontline therapy. The study will determine the proportion of patients with 2 day nadir serum asparaginase activity levels that are \>0.1 IU/mL during the first 2 weeks of treatment with 3 times per week IV dosing.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: asparaginase Erwinia chrysanthemi
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01645111
Conditions: Neuromuscular Scoliosis
Sponsor: Nationwide Children's Hospital
Start date: 2012-06-01; Completion date: 2013-12-01
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The current study would prospectively evaluate the dosing requirements, efficacy and safety of clevidipine for controlled hypotension during spinal surgery in the pediatric population. As the investigators currently have projects underway which include those patients having scoliosis surgery for idiopathic scoliosis, this trial would include only those undergoing scoliosis surgery for neuromuscular disease.

Detailed description:
This would basically be an observational study without a significant change in our current practice. There would be no change in the standard and usual anesthetic care including premedication, anesthetic induction, intraoperative anesthetic management, and intraoperative monitoring. Our usual anesthetic routine includes:

1. Intravenous or oral premedication with midazolam
2. Inhalational or intravenous induction based on the preference of the patient
3. Facilitation of endotracheal intubation with a dose of rocuronium with placement of intraoperative monitors including an arterial cannula
4. Maintenance anesthesia to include desflurane titrated to maintain the bispectral index at 40-60, fentanyl 2-4 µg/kg followed by a remifentanil infusion to maintain the mean arterial pressure at 55-65 mmHg.
5. Tranexamic acid to limit intraoperative bleeding
6. As needed, agent to control blood pressure to maintain the MAP at 55-65 mmHg if remifentanil in doses up to 0.3 µg/kg/min are ineffective.

As needed, clevidipine will be started at 1 µg/kg/min and titrated up in 1 µg/kg/min every 1-2 minutes to achieve an MAP at 55-65mmHg. Vital signs including heart rate will be recorded every 1 minute until the target MAP is achieved and then at 15 minute increments after that.

Arms: arm 1: None
Interventions: intervention 1: Clevidipine
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01645735
Conditions: Infections
Keywords: Infections Teflaro cephalosporin Ceftaroline antibiotics pneumonia
Sponsor: Forest Laboratories
Start date: 2012-10-01; Completion date: 2013-12-01
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether ceftaroline is effective and safe for the treatment of patients with Community-acquired Bacterial Pneumonia (CABP) at risk for infection due to Methicillin-resistant Staphylococcus aureus (MRSA).

Detailed description:
A Multicenter, Multinational, Randomized, Double-blind Study to Evaluate the Efficacy and safety of Ceftaroline fosamil Versus Ceftriaxone Plus Vancomycin in Adult Subjects with Community-acquired Bacterial Pneumonia at Risk for Infection Due to Methicillin-resistant Staphylococcus aureus.

Arms: arm 1: Ceftaroline fosamil 600 mg Intravenous (IV) administration over 60 minutes, every 8 hours (q8h); dosing to be adjusted for renal function; treatment duration 5 to 14 days arm 2: Ceftriaxone 2 g IV over 30 minutes once per day (q24h) plus vancomycin 15 mg/kg IV every 12 hours (q12h) initially and then dose adjusted based on trough concentrations; treatment duration 5 to 14 days
Interventions: intervention 1: Ceftaroline fosamil intervention 2: Ceftriaxone plus vancomycin
Intervention descriptions: intervention 1: Ceftaroline fosamil 600 mg IV over 60 minutes q8h; treatment duration 5 to 14 days intervention 2: Ceftriaxone 2g IV over 30 minutes q24h plus vancomycin 15 mg/kg IV q12h initially and then dose adjusted based on trough concentrations; treatment duration 5 to 14 days

Protocol documents:
Clinical trial NCT01653418
Conditions: Multiple Myeloma
Sponsor: Washington University School of Medicine
Start date: 2012-09-01; Completion date: 2013-12-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
BEAM regimen (BCNU, etoposide, cytarabine, and melphalan) is the most commonly used conditioning regimen for relapsed/refractory lymphoma patients needing autologous stem cell transplantation. Since these components are all effective in myeloma and bortezomib has shown promising results in the transplant setting, here the investigators propose a phase II study to investigate the combination of bortezomib and BEAM as a new conditioning regimen for patients who relapse or progress after the first autologous transplantation and for whom a second autologous transplant is considered.

Detailed description:

Arms: arm 1: Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
Interventions: intervention 1: Bortezomib intervention 2: Carmustine intervention 3: Etoposide intervention 4: Cytarabine intervention 5: Melphalan intervention 6: Stem cell infusion
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None

Protocol documents:
Clinical trial NCT01667536
Conditions: Prostate Cancer
Keywords: PROSTATE CANCER HIGH-RISK PROSTATECTOMY SURGERY NEWLY DIAGNOSED
Sponsor: Molecular Insight Pharmaceuticals, Inc.
Start date: 2012-08-01; Completion date: 2013-12-01
Enrollment: 105 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This was a multicenter, multi-reader, open-label, Phase 2 study assessing the safety and performance characteristics of MIP 1404 imaging in the detection of prostate gland and pelvic lymph node cancer. Comparative performance characteristics between MIP 1404 imaging and MRI were also assessed, as judged by histopathology results.

Detailed description:
This is a single arm, open label study of approximately 100 high-risk prostate cancer patients scheduled for prostatectomy and extended pelvic lymph node dissection. Patients receive a single IV dose of 99mTc-MIP-1404 (study drug) followed by SPECT/CT scan 3-6 hours after injection. As standard of care, patients will undergo prostatectomy and extended pelvic lymph node dissection (EPLND) within three weeks of study drug dosing. 99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology.

Arms: arm 1: 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404
Interventions: intervention 1: Drug: 99mTc-MIP-1404
Intervention descriptions: intervention 1: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404

Protocol documents:
Clinical trial NCT01691508
Conditions: Asthma
Keywords: Safety Steroid Reduction Efficacy SB-240563 Eosinophils Quality of Life Mepolizumab Severe Refractory Asthma
Sponsor: GlaxoSmithKline
Start date: 2012-10-01; Completion date: 2013-12-01
Enrollment: 135 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomised, double-blind, placebo-controlled, parallel-group, multicenter study of mepolizumab in comparison with placebo in reducing Oral Corticosteroid (OCS) use in subjects with severe refractory asthma. The study consists of four phases, OCS Optimisation Phase (Week -8 to Week 0), and the double-blind treatment period divided into an Induction Phase (Week 0 to Week 4), OCS Reduction Phase (Week 5 upto Week 20) followed by Maintenance Phase (Week 20 to Week 24). During the Optimisation Phase the investigator will adjust the OCS (prednisone/prednisolone) dose according to the Optimisation titration schedule based on a review of Asthma Control Questionnaire (ACQ)-5 score and exacerbation. In the Induction Phase subjects will be randomized 1:1 (approximately 60 per arm) to receive either mepolizumab (100 mg) administered subcutaneously (SC) or placebo every 4 weeks in addition to their existing maintenance asthma therapy with the lowest dose of OCS from Optimisation Phase. The Induction Phase will allow sufficient time for those subjects randomised to the mepolizumab arm to achieve a decrease in the eosinophilic inflammation prior to the reduction in OCS. During the Reduction Phase, subjects will continue receiving 100 mg mepolizumab/placebo every 4 weeks and the OCS dose reduction will be done every 4 weeks using the reduction titration schedule based on a review of eDiary parameters recorded by the subject, the subjects' exacerbation history, and a review of the signs and symptoms of adrenal insufficiency. In the Maintenance Phase subjects will be maintained without any further OCS dose adjustment. Subjects who complete the 24 week double-blind period and meet the eligibility criteria, will be offered the opportunity to participate in an open label extension (OLE) study otherwise they will return for a Follow-up Visit 12 weeks after their last dose of double blind study treatment. At each clinic visit, adverse events, safety labs, spirometery parameters and exacerbations will be assessed. The pharmacokinetic samples will be collected in the beginning of the treatment, prior to last dose, at the end of study (exit visit) and the follow up.

Detailed description:

Arms: arm 1: Mepolizumab 100 mg subcutaneous once every 4 weeks upto Week 20 arm 2: Placebo subcutaneous once every 4 weeks upto Week 20
Interventions: intervention 1: Mepolizumab intervention 2: Placebo intervention 3: OCS (prednisone/prednisolone)
Intervention descriptions: intervention 1: Mepolizumab is a fully humanised Immunoglobulin G antibody (IgG1, kappa) with human heavy and light chain frameworks. intervention 2: Will be available as an equivalent volume of 0.9% sodium chloride. intervention 3: Oral Corticosteroid (prednisone/prednisolone)

Protocol documents: