ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02086968
Conditions: Iron Deficiency Anemia Secondary to IBD or Gastric Bypass
Sponsor: American Regent, Inc.
Start date: 2014-01-01; Completion date: 2017-10-01
Enrollment: 198 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the treatment response of Injectafer vs. oral iron to baseline hepcidin levels to determine if any of these select IBD or Gastric Bypass patients may demonstrate to be inappropriate for oral iron therapy.

Detailed description:
The primary objective of this study is to evaluate the treatment response of Injectafer vs. oral iron in patients with varying hepcidin levels correlating the treatment response/hepcidin levels to more common laboratory parameters such as ferritin and CRP (C-Reactive Protein) levels and possibly determine if any of these select IBD or Gastric Bypass patients may demonstrate to be inappropriate for oral iron therapy.

Arms: arm 1: 2 doses of Injectafer, at 15 mg/kg for a maximum single dose of 750 mg given on Days 0 and 7 for a total of up to 1500 mg arm 2: Oral Ferrous Sulfate at 325 mg (1 tablet) three times a day for 28 days
Interventions: intervention 1: Injectafer intervention 2: Ferrous Sulfate tablets
Intervention descriptions: intervention 1: 2 doses of Injectafer, at 15mg/kg for a maximum single dose of 750mg given on days 0 and 7 for a total of up to 1500mg intervention 2: 325mg (1 tablet) three times a day for 28 days

Protocol documents:
Clinical trial NCT02093520
Conditions: Spinal Stenosis, Lumbar Region, With Neurogenic Claudication
Keywords: Lumbar Spinal Stenosis Spinal Stenosis Neurogenic Claudication
Sponsor: Vertos Medical, Inc.
Start date: 2014-05-01; Completion date: 2017-10-01
Enrollment: 302 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study Objective: To compare patient outcomes following treatment with either the MILD procedure or epidural steroid injections (ESIs) in patients with painful lumbar spinal stenosis exhibiting neurogenic claudication and having verified ligamentum flavum hypertrophy as a contributing factor.

Detailed description:

Arms: arm 1: The MILD procedure is an image-guided minimally-invasive lumbar decompression arm 2: An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine.
Interventions: intervention 1: MILD Procedure intervention 2: Epidural Steroid Injection
Intervention descriptions: intervention 1: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue. intervention 2: Injection of epidural steroids into the lumbar spine

Protocol documents:
Clinical trial NCT02104752
Conditions: Schizophrenia Cognition Psychosis
Keywords: Curcumin Turmeric Schizophrenia Cognition Psychosis
Sponsor: VA Greater Los Angeles Healthcare System
Start date: 2014-07-01; Completion date: 2017-10-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators propose to test whether curcumin nanoparticles will improve behavioral measures and biomarkers of cognition and neuroplasticity in patients with schizophrenia who are already receiving a stable dose of antipsychotic.

Detailed description:
The investigators will use a formulation of curcumin with high bioavailability that possesses a pharmacokinetic profile expected to exert biological effects. Specifically, 36 subjects will be enrolled in the double-blind randomized controlled trial. They will be randomized to curcumin or placebo for 8 weeks. At baseline, and 4 and 8 weeks, subjects will receive assessments of neurocognition (e.g., processing speed, attention and vigilance, working memory, learning, reasoning and problem solving), social cognition, EEG biomarkers (e.g., visual cortical plasticity and mismatch negativity), a serum marker of neurogenesis (BDNF levels), and clinical symptoms (positive and negative symptoms). At weeks 2 and 6 subjects will return for additional safety (e.g., vitals, side effects, akathisia) and medication adherence assessments. Improvement on the primary outcome measure (MATRICS Consensus Cognitive Battery), as well as secondary outcome measures, will be compared between participants randomized to placebo versus curcumin. The results of this study will establish whether curcumin is a viable adjunctive agent for future larger clinical trials.

Arms: arm 1: Curcumin capsules (Theracurmin formulation of curcumin nanoparticles). Subjects randomized to curcumin will receive 360 mg/day (divided into twice daily oral doses). arm 2: Matched placebo, 2 capsules twice daily.
Interventions: intervention 1: Curcumin intervention 2: Placebo
Intervention descriptions: intervention 1: 360 mg/day (divided into twice daily oral doses) intervention 2: Inactive, matched placebo ("Sugar Pill")

Protocol documents:
Clinical trial NCT02561806
Conditions: Plaque Psoriasis
Sponsor: Eli Lilly and Company
Start date: 2015-10-01; Completion date: 2017-10-01
Enrollment: 302 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to evaluate the efficacy of the study drug ixekizumab compared to ustekinumab in participants with moderate-to-severe-plaque psoriasis.

Detailed description:

Arms: arm 1: 45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants \>100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections will be used for blinding. arm 2: 160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52.Placebo for ustekinumab injections will be used for blinding.
Interventions: intervention 1: Ixekizumab intervention 2: Ustekinumab intervention 3: Placebo
Intervention descriptions: intervention 1: Administered SC intervention 2: Administered SC intervention 3: Administered SC

Protocol documents:
Clinical trial NCT01980628
Conditions: Marginal Zone Lymphoma B-cell Lymphoma
Keywords: MZL NHL SMZL NMZL MALT
Sponsor: Pharmacyclics LLC.
Start date: 2013-12-01; Completion date: 2017-10-02
Enrollment: 63 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Phase 2, open-label, non-randomized, monotherapy study to evaluate the safety and efficacy of ibrutinib in subject with relapsed/refractory Marginal Zone Lymphoma (MZL).

Detailed description:
Ibrutinib is a first-in-class, potent, orally administered covalent inhibitor of Bruton's tyrosine kinase (BTK). Inhibition of BTK blocks downstream B-cell receptor (BCR) signaling pathways and thus prevents B-cell proliferation. In vitro, ibrutinib inhibits purified BTK and selected members of the kinase family with 10-fold specificity compared with non-BTK kinases. Phase 1 and 2 studies of ibrutinib in B-cell malignancies demonstrate modest toxicity and significant single agent activity in a variety of B-cell malignancies, including NHL.

Arms: arm 1: ibrutinib capsules: 560 mg once daily
Interventions: intervention 1: ibrutinib
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01827267
Conditions: HER2-mutant Non-Small Cell Lung Cancer
Keywords: Lung cancer Puma neratinib HKI-272 PB-272 Nerlynx
Sponsor: Puma Biotechnology, Inc.
Start date: 2013-07-01; Completion date: 2017-10-06
Enrollment: 62 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 2, therapeutic-exploratory, adaptive design, open-label, multicenter, multinational study evaluating neratinib monotherapy and neratinib plus temsirolimus combination therapy in patients with non-small cell lung cancer (NSCLC) who have documented somatic HER2 mutations.

Detailed description:
This is a Phase 2, therapeutic-exploratory, adaptive design, open-label, multicenter, multinational study evaluating neratinib monotherapy and neratinib plus temsirolimus combination therapy in patients with NSCLC and documented somatic HER2 mutations. Patients randomized at study entry into 1 of 2 treatment arms:

* Arm A: neratinib 240 mg orally once daily
* Arm B: neratinib 240 mg orally once daily plus temsirolimus 8 mg once weekly by intravenous (IV) infusion

In the case of disease progression, patients initially assigned to neratinib monotherapy arm given option to add temsirolimus 8 mg IV once weekly.

Patients on combination therapy given option to dose-escalate temsirolimus to 15 mg/week at the end of first cycle of treatment, if well tolerated and at the physician's discretion. If neratinib 240 mg/day plus temsirolimus 15 mg/week dose not well tolerated, patient subsequently dose reduced back to neratinib 240 mg/day plus temsirolimus 8 mg/week.

Dosing continuous on nominal 3-week cycles until evidence of progressive disease, unacceptable toxicity, or patient withdrawal of consent.

Disease measured radiographically at baseline and every 6 weeks until disease progression or withdrawal from the study.

Arms: arm 1: 240 mg once daily with food, continuously in 21 day cycles arm 2: 240 mg neratinib plus 8 mg temsirolimus IV with optional dose escalation to 15 mg temsirolimus
Interventions: intervention 1: neratinib intervention 2: temsirolimus
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00826020
Conditions: Parenteral Nutrition Associated Liver Disease PNALD Cholestasis
Keywords: PN parenteral nutrition fat emulsions omega-6 fatty acid liver disease fatty acid deficiency
Sponsor: University of Nebraska
Start date: 2009-05-01; Completion date: 2017-10-06
Enrollment: 72 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if established parenteral nutrition (PN) associated liver disease can be reversed or its progression halted by using a parenteral fat emulsion prepared from fish oil as measured by normalization of serum levels of hepatic enzymes and bilirubin.

Detailed description:
The primary objective of this study is to evaluate the need for and time to small bowel transplantation or liver transplantation. This will be calculated as both the age at time of primary transplant as well as the length of time from initial evaluation to transplant.Secondary objectives are to determine if there are improvements in clinical measures associated with established parenteral nutrition- associated liver disease (PNALD). These will be determined by measurement of total and direct bilirubin levels, platelet count, serum albumin, and changes in both length and weight growth curves.

Arms: arm 1: This study will be a prospective, non-randomized, open-label study of Omegaven™ for provision of parenteral lipid calories. The study cohort, receiving the parenteral nutrition (PN) lipid at 1g/kg/day, will be compared to historical controls at University of Nebraska Medical Center (UNMC) where parenteral lipid calories were provided exclusively through soybean-based formulations. The study is planned to enroll 100 patients. The Intestinal Rehabilitation Program at UNMC sees between 20 and 30 new pediatric patients per year, with almost all being PN-dependent and over 75% presenting with a bilirubin ≥ 2mg/dL. Based on these calculations, we estimate 4-5 years to enroll 100 patients.
Interventions: intervention 1: Omegaven™
Intervention descriptions: intervention 1: 10% Omegaven™, 50 or 100 mL bottle; 1gram/kg/day and is infused over 12-24 hours.

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT03231969
Conditions: Allergic Conjunctivitis
Sponsor: Faes Farma, S.A.
Start date: 2017-07-20; Completion date: 2017-10-11
Enrollment: 121 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy of Bilastine Ophthalmic Solution (0.2%,0.4%,0.6%) compared to vehicle for the treatment of the signs and symptoms of allergic conjunctivitis

Detailed description:

Arms: arm 1: Bilastine Ophthalmic solution 0.2%

1 drop in each eye at 3 separate times during a 25 day period. arm 2: Bilastine Ophthalmic solution 0.4%

1 drop in each eye at 3 separate times during a 25 day period. arm 3: Bilastine Ophthalmic solution 0.6%

1 drop in each eye at 3 separate times during a 25 day period. arm 4: Vehicle of Bilastine Ophthalmic Solution

1 drop in each eye at 3 separate times during a 25 day period.
Interventions: intervention 1: Bilastine 0.2% intervention 2: Bilastine 0.4% intervention 3: Bilastine 0.6% intervention 4: Bilastine 0%
Intervention descriptions: intervention 1: 1 drop in each eye at 3 separate times during a 25 day period. intervention 2: 1 drop in each eye at 3 separate times during a 25 day period. intervention 3: 1 drop in each eye at 3 separate times during a 25 day period. intervention 4: 1 drop in each eye at 3 separate times during a 25 day period.

Protocol documents:
Prot_SAP_001.pdf:
Clinical trial NCT02242045
Conditions: Chronic Lymphocytic Leukemia Indolent Non-Hodgkin Lymphoma Follicular Lymphoma Small Lymphocytic Lymphoma Lymphoplasmacytic Lymphoma (With or Without Waldenstrom Macroglobulinemia) Marginal Zone Lymphoma
Sponsor: Gilead Sciences
Start date: 2014-10-01; Completion date: 2017-10-17
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to evaluate the 28-day safety and tolerability, and to determine the pharmacokinetics (PK) of idelalisib in Japanese participants with relapsed or refractory indolent B-cell non-Hodgkin lymphomas (iNHL) or chronic lymphocytic leukemia (CLL).

Detailed description:

Arms: arm 1: Participants with iNHL or CLL will receive idelalisib until the earliest of the following: unacceptable toxicity, substantial noncompliance, disease progression, pregnancy, initiation of another anticancer or experimental therapy, investigator discretion, or idelalisib discontinuation.
Interventions: intervention 1: Idelalisib
Intervention descriptions: intervention 1: 150 mg tablet(s) administered orally twice daily

Protocol documents:
Clinical trial NCT01328249
Conditions: HER2-normal
Keywords: Breast Cancer HER2-normal Stage I to III invasive breast cancer
Sponsor: Eisai Inc.
Start date: 2011-03-03; Completion date: 2017-10-19
Enrollment: 81 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the feasibility of dose-dense doxorubicin and cyclophosphamide followed by eribulin mesylate for adjuvant treatment of early stage breast cancer.

Detailed description:
This is a multicenter, single-arm Phase II trial to assess the feasibility of dose-dense adjuvant chemotherapy in subjects with early stage (I-III), HER-2 normal breast cancer. A total of 80 adult subjects will be enrolled in order to have 73 subjects who start the eribulin portion of the adjuvant study regimen. After completion of 4 cycles of AC, each subject will begin 4 cycles of eribulin mesylate 1.4 mg/m2 intravenously over 2 to 5 minutes on Days 1 and 8 of every 21 day cycle.

Arms: arm 1: None
Interventions: intervention 1: eribulin mesylate
Intervention descriptions: intervention 1: Dose dense doxorubicin and cyclophosphamide for 4 cycles during the first 8 weeks followed by eribulin mesylate 1.4mg/m2 for 4 cycles during the next 12 weeks.

Protocol documents:
Clinical trial NCT01195883
Conditions: Postoperative Complications
Keywords: IV fluid recovery goal directed fluid replacement improved patient recovery
Sponsor: The Cleveland Clinic
Start date: 2010-11-01; Completion date: 2017-10-20
Enrollment: 1102 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A trial in which patients having open abdominal surgery are randomized to receive either crystalloids or colloids intraoperatively, guided by esophageal Doppler. The investigators test the primary hypothesis that goal-directed colloid administration during elective abdominal surgery decreases a composite of postoperative complications within 30 days of surgery.

Detailed description:
Patients will be given 5-7 ml/kg of crystalloid (lactated Ringer's) in the immediate preoperative period, which will be followed by 4 ml/kg/h crystalloid for maintenance normalized to ideal body weight \[Men: Ideal Body Weight (in kilograms) = 52 kg + 1.9 kg for every 2.5 cm over 150 cm; Women: Ideal Body Weight (in kilograms) = 49 kg + 1.7 kg for every 2.5 cm over 150 cm\].

They will then be randomly assigned to additional volume replacement, guided by esophageal Doppler, to either lactated Ringer's solution of Voluven starch.

Arms: arm 1: Lactated Ringers solution will be used for fluid replacement. arm 2: Low-molecular weight colloid HES 130/0.4 (Voluven) will be used for fluid replacement
Interventions: intervention 1: Crystalloid intervention 2: Colloid
Intervention descriptions: intervention 1: For goal directed volume management we use corrected aortic flow time (FTc) and stroke volume derived from esophageal Doppler as in previous studies. In case of hypovolemia, detected by esophageal Doppler monitoring (CardioQ, Deltex Medical Group PLC, Chichester, UK) according to a previously published algorithm, an additional fluid bolus of 250 ml of LR will be given over a period of 5 minutes. intervention 2: For goal directed volume management we use corrected aortic flow time (FTc) and stroke volume derived from esophageal Doppler as in previous studies. In case of hypovolemia, detected by esophageal Doppler monitoring (CardioQ, Deltex Medical Group PLC, Chichester, UK) according to a previously published algorithm, an additional fluid bolus of 250 ml of Hydroxyethylstarch 6% 130/0.4 (Voluven®Fresenius-Kabi, Bad Homburg, Germany) will be given over a period of 5 minutes.

Protocol documents:
Clinical trial NCT00876395
Conditions: Breast Cancer
Keywords: Breast Cancer HER2+ mTOR everolimus RAD001 first line metastatic locally advanced Trastuzumab Paclitaxel First Line Therapy HER2 Positive Metastatic Breast Cancer
Sponsor: Novartis Pharmaceuticals
Start date: 2009-09-10; Completion date: 2017-10-23
Enrollment: 719 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this Phase III study was to confirm the value of adding everolimus to weekly paclitaxel and trastuzumab as treatment of HER2-overexpressing metastatic breast cancer.

Detailed description:

Arms: arm 1: Everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22 arm 2: Placebo of everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22
Interventions: intervention 1: Everolimus intervention 2: Placebo intervention 3: Trastuzumab intervention 4: Paclitaxel
Intervention descriptions: intervention 1: Everolimus was administered in a continuous oral daily dosing of 10 mg (two 5-mg tablets). intervention 2: Everolimus placebo was administered in a continuous oral daily dosing of 10 mg (two 5-mg tablets). intervention 3: Trastuzumab, 2 mg/kg weekly was used intravenously. intervention 4: Paclitaxel, 80 mg/m2 weekly was used intravenously.

Protocol documents:
Clinical trial NCT01949844
Conditions: Coronary Artery Disease CAD
Keywords: MRI Magnetic Resonance Imaging myocardial perfusion myocardial perfusion imaging Novel MRI Techniques
Sponsor: Daniel S. Berman
Start date: 2014-05-16; Completion date: 2017-10-23
Enrollment: 44 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a pilot study in a patient population with suspected coronary artery disease (CAD) as defined by the presence of a prior abnormal nuclear (PET/SPECT) myocardial perfusion scan. In this study design, PET/SPECT will serve as the comparative standard for presence of myocardial ischemia. We intend to determine the accuracy of an improved magnetic resonance imaging (MRI) technique for detection of myocardial ischemia in subjects with suspected CAD.

This is not a study to specifically evaluate the efficacy or safety of the drugs but rather the diagnostic performance of the improved cardiac MRI procedure.

Detailed description:
A total of two imaging protocols will be used as "protocol options" in this study (only one of the protocols will be used for each enrolled subject): (1) "Two-day protocol," which involves MRI of subjects who have had a recent abnormal PET/SPECT study and includes an optional second-day visit; (2) "One-day protocol," which involves the subjects undergoing stress myocardial perfusion SPECT and MRI in the same day.

Two blinded readers will interpret MR and SPECT/PET studies by consensus to assess the presence of perfusion deficits at stress and rest.

Arms: arm 1: This pilot study has a single arm/group of subjects with suspected CAD based on the following inclusion criteria:

1. Prior nuclear myocardial perfusion scan (PET/SPECT) with a visual interpretation of definitely abnormal, or prior myocardial infarction; or,
2. Clinically stable individuals with suspected coronary artery disease on the basis of coronary angiography.

The study protocol involved only a myocardial perfusion MRI procedure for detection of ischemia (perfusion deficits) using an improved protocol with the administration of a vasodilator drug (Regadenoson/Lexiscan®) and gadolinium-based MRI contrast agent (Optimark®; dose: 0.2 mmol/kg). Lexiscan® was used off-label as a vasodilator drug during the MRI scan (0.4 mg/5mL) supplied by the manufacturer, Astellas Pharma U.S.
Interventions: intervention 1: regadenoson intervention 2: Optimark® intervention 3: Myocardial perfusion MRI
Intervention descriptions: intervention 1: Lexiscan® is being used off-label. The FDA Issued IND # is 119898. For the cardiac MRI, Lexiscan® will be used at the same dosage and administration as prescribed in the package insert - 5 mL (0.4 mg regadenoson) as packaged and supplied by the manufacturer, Astellas Pharma U.S., in single-use pre-filled syringes administered by rapid intravenous injection, followed immediately by saline flush. intervention 2: For the cardiac MR, the contrast agent, Optimark® is administered as a bolus peripheral intravenous injection at a dose of 0.2 mL/kg (0.1 mmol/kg) and at a rate of 1 to 2 mL/sec delivered by manual injection. intervention 3: None

Protocol documents:
Clinical trial NCT02276612
Conditions: HIV
Sponsor: Gilead Sciences
Start date: 2014-12-03; Completion date: 2017-10-23
Enrollment: 60 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to evaluate the safety and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) in HIV-infected virologically suppressed adolescents 12 to \< 18 years of age.

Detailed description:

Arms: arm 1: Treatment-experienced participants will receive open-label E/C/F/TAF for up to 48 weeks.

After completion of 48 weeks of treatment, all eligible participants will be given the option to participate in an open-label extension phase to receive E/C/F/TAF until a) the participant turns 18 years old and E/C/F/TAF is commercially available for use in adults in the country the participant is enrolled, or b) E/C/F/TAF becomes commercially available for use in the participant's current age group in the country the participant is enrolled, or c) E/C/F/TAF becomes accessible to participants through an access program, or d) Gilead Sciences elects to terminate development of E/C/F/TAF in the applicable country.
Interventions: intervention 1: E/C/F/TAF
Intervention descriptions: intervention 1: 150/150/200/10 mg fixed-dose combination (FDC) tablet administered orally once daily with food

Protocol documents: