ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01925274
Conditions: Metastatic Colorectal Cancer
Keywords: metastatic colorectal cancer colorectal cancer KRAS colon cancer mCRC CRC PF-05212384 KRAS wild type colorectal cancer irinotecan cetuximab NRAS
Sponsor: Pfizer
Start date: 2013-11-15; Completion date: 2016-04-06
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate whether the combination of PF-05212384 plus Irinotecan improves progression free survival in patients with KRAS and NRAS wild type metastatic colorectal cancer when compared with the combination of cetuximab plus Irinotecan. A Japanese Lead in Cohort will assess the safety of the combination of PF-05212384 + irinotecan in patients enrolled at Japanese sites.

Detailed description:

Arms: arm 1: PF-05212384 plus Irinotecan arm 2: Cetuximab plus Irinotecan
Interventions: intervention 1: PF-05212384 intervention 2: irinotecan intervention 3: Cetuximab intervention 4: Irinotecan
Intervention descriptions: intervention 1: 30 minute IV infusion of PF-05212384 on days 2, 9, 16 and 23 of each cycle. Intra-patient dose escalation will commence with 110mg and will increase depending on tolerability. intervention 2: 90 minutes IV infusion of irinotecan 180mg/m\^2 on days 1 and 15 of each cycle intervention 3: 120 minute IV infusion of cetuximab 400mg/m\^2 on cycle 1 day 1; 60 minute IV infusion of cetuximab on days 8, 15, and 22 of each cycle, and on day 1 of each cycle after cycle 1 intervention 4: 90 minutes IV infusion of Irinotecan 180mg/m\^2 on days 1 and 15 of each cycle

Protocol documents:
Clinical trial NCT02188784
Conditions: Chronic Heart Failure
Sponsor: Adrian Hernandez
Start date: 2014-09-03; Completion date: 2016-04-06
Enrollment: 225 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if oral iron (Fe) polysaccharide is superior to oral placebo in improving functional capacity as measured by change in peak VO2 (oxygen uptake) by CPET (Cardiopulmonary Exercise Testing) , of a broad population of patients with HFrEF (Heart Failure with Reduced Ejection Fraction) and Fe deficiency at 16 weeks.

Hypothesis: In a broad population of HFrEF patients with Fe deficiency, compared to oral placebo, therapy with oral Fe polysaccharide will be associated with improvement in functional capacity at 16 weeks as assessed by CPET.

Detailed description:
Therapeutic options to further improve functional capacity and symptoms in HF beyond neurohormonal antagonism are limited. Studies have demonstrated impaired oxidative capacity of skeletal muscle among HF patients, which may contribute to symptoms of breathlessness and persistent fatigue.

In addition to its role in erythropoiesis, iron (Fe) plays a critical role in skeletal muscle's oxygen (O2)-storage capacity (myoglobin) and systemic aerobic energy production. As Fe deficiency is common in patients with symptomatic HF, repletion of iron stores may improve submaximal exercise capacity among these patients beyond the effects on erythropoiesis.

While intravenous Fe repletion in HF patients with mild Fe-deficiency (i.e. Ferritin \<100 or Ferritin 100-299 with transferrin saturation \<20%) with or without anemia global well-being and functional status, oral Fe repletion has not been studied. Furthermore, the efficacy of oral Fe to replete iron stores in a similar population and its impact on functional capacity, measured objectively by peak VO2, remains unknown.

Arms: arm 1: oral Fe polysaccharide 150mg twice daily for 16 weeks arm 2: Oral placebo twice a day for 16 weeks
Interventions: intervention 1: Polysaccharide Iron Complex 150 mg intervention 2: Placebo (for Polysaccharide Iron Complex)
Intervention descriptions: intervention 1: Oral Iron intervention 2: Sugar capsule designed to mimic Polysaccharide Iron Complex.

Protocol documents:
Clinical trial NCT02404168
Conditions: Epilepsy
Sponsor: University of Maryland, Baltimore
Start date: 2015-07-07; Completion date: 2016-04-06
Enrollment: 4 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The prior BEEP study involved patients being switched between brand and generic in a very structured manner. Other secondary comparisons were also made (i.e. any differences in adverse effects and seizure control). Some subjects were more disparate than other, in terms of generic being similar to brand. In this follow up study, BEEP subjects that showed disparate results will be tested again to assess reproducibility of disparate results.

Detailed description:
This is an double-blind, multiple-dose, full replicate design, pharmacokinetic study of lamotrigine in "enriched" patients with epilepsy who previously participated in HP-00048923. LAMICTAL 100mg tablets and the most commonly used generic lamotrigine 100mg tablet (from Teva) will be compared pharmacokinetically.

Arms: arm 1: lamotrigine tablet Lamictal arm 2: lamotrigine tablet Teva arm 3: lamotrigine tablet Lamictal arm 4: lamotrigine tablet Teva
Interventions: intervention 1: lamotrigine (brand Lamictal) intervention 2: lamotrigine (generic Teva)
Intervention descriptions: intervention 1: an anti-epileptic drug (brand) intervention 2: an anti-epileptic drug (brand)

Protocol documents:
Clinical trial NCT01193244
Conditions: Prostate Cancer
Sponsor: Millennium Pharmaceuticals, Inc.
Start date: 2010-10-01; Completion date: 2016-04-07
Enrollment: 1560 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel (TAK-700) plus prednisone compared with placebo plus prednisone in the treatment of men with progressive, chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC)

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Orteronel intervention 2: Placebo intervention 3: Prednisone
Intervention descriptions: intervention 1: Orteronel will be administered orally twice a day continuously throughout the study. Patients will also receive concomitant gonadotropin-releasing hormone (GnRH) analogue therapy unless they have previously undergone orchiectomy and have a testosterone concentration of \<50 ng/dL. intervention 2: Placebo will be administered orally twice a day continuously throughout the study. Additionally, all patients will receive concomitant gonadotropin-releasing hormone (GnRH) analogue therapy unless they have previously undergone orchiectomy and a testosterone concentration of \<50 ng/dL. intervention 3: Prednisone will be administered orally twice a day continuously throughout the study. Patients will also receive concomitant gonadotropin-releasing hormone (GnRH) analogue therapy unless they have previously undergone orchiectomy and have a testosterone concentration of \<50 ng/dL.

Protocol documents:
Clinical trial NCT01506947
Conditions: Moderate to Severe Secondary Hyperparathyroidism Stage 5 Chronic Kidney Diseases
Keywords: Hemodialysis Chronic kidney disease Secondary hyperparathyroidism,
Sponsor: AbbVie (prior sponsor, Abbott)
Start date: 2012-05-10; Completion date: 2016-04-07
Enrollment: 65 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the effect of PTH lowering on erythropoietin consumption in calcitriol-resistant patients with stage 5 chronic kidney disease.

Detailed description:

Arms: arm 1: Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.

Participants may have also received routine darbepoetin alfa to treat anemia.
Interventions: intervention 1: Paricalcitol intervention 2: Darbepoetin alfa
Intervention descriptions: intervention 1: Paricalcitol was administered by intravenous bolus. The initial dose was calculated according to the following formula:

\[Paricalcitol (µg) = iPTH (pg/mL) / 80\]. Subsequent doses were determined based on iPTH, calcium and phosphorus levels. intervention 2: Routine darbepoetin alfa use was allowed when transferrin saturation (TSAT) was ≥ 20% and ferritin ≥ 200 μg/L, and hemoglobin level \< 11.5 g/dL. The initial dose was 0.25 to 0.75 µg/kg/week, and the maintenance dose was 0.13 to 0.35 µg/kg/week. Target hemoglobin level was between 10 to 11.5 g/dL.

Protocol documents:
Clinical trial NCT02637037
Conditions: Bioequivalence Fixed Dose Combination Tablets Healthy Male and Female Subjects
Keywords: dapagliflozin/metformin XR 5/500 mg dapagliflozin/metformin XR10/1000 mg bioequivalence fixed dose combination tablets pharmacokinetic type 2 Diabetes Mellitus (T2DM) safety
Sponsor: AstraZeneca
Start date: 2015-12-21; Completion date: 2016-04-07
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a bioequivalence study to compare 2 fixed-dose combination tablets of dapagliflozin/metformin XR manufactured at 2 different plants in healthy subjects under fasting and fed conditions

Detailed description:
This is a Phase 1, 2-part, open-label, randomized, 4-period, 4-treatment, crossover study in healthy subjects (males and females of non-childbearing potential)

Arms: arm 1: Under fed conditions, subjects will receive single doses of dapagliflozin/metformin XR test drug (Mount Vernon) 5/500 mg dose arm 2: Under fed conditions, subjects will receive single doses of dapagliflozin/metformin XR reference drug (Humacao) 5/500 mg dose arm 3: Under fasted conditions, subjects will receive single doses of dapagliflozin/metformin XR test drug (Mount Vernon) 5/500 mg dose arm 4: Under fasted conditions, subjects will receive single doses of dapagliflozin/metformin XR reference drug (Humacao) 5/500 mg dose arm 5: Under fed conditions, subjects will receive single doses of dapagliflozin/metformin XR test drug (Mount Vernon) 10/1000 mg dose arm 6: Under fed conditions, subjects will receive single doses of dapagliflozin/metformin XR reference drug (Humacao) 10/1000 mg dose arm 7: Under fasted conditions, subjects will receive single doses of dapagliflozin/metformin XR test drug (Mount Vernon) 10/1000 mg dose arm 8: Under fasted conditions, subjects will receive single doses of dapagliflozin/metformin XR reference drug (Humacao) 10/1000 mg dose
Interventions: intervention 1: dapagliflozin/metformin XR 5/500 mg test drug (Mount Vernon) intervention 2: dapagliflozin/metformin XR 5/500 mg reference drug (Humacao) intervention 3: dapagliflozin/metformin XR 10/1000 mg test drug (Mount Vernon) intervention 4: dapagliflozin/metformin XR 10/1000 mg reference drug (Humacao)
Intervention descriptions: intervention 1: single fixed-combination dose tablets intervention 2: single fixed-dose combination tablets intervention 3: single fixed-dose combination tablets intervention 4: single fixed-dose combination tablets

Protocol documents:
Clinical trial NCT01238588
Conditions: Dialysis Cardiovascular Disease Atherosclerosis Inflammation Hyperphosphatemia
Sponsor: Brigham and Women's Hospital
Start date: 2011-06-10; Completion date: 2016-04-08
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The hypothesis is that switching calcium based phosphate binders to sevelamer carbonate will be associated with less inflammation including less atherosclerotic plaque inflammation (inflammation of the vessel walls).

Detailed description:

Arms: arm 1: Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela.
Interventions: intervention 1: Sevelamer Carbonate (Renvela)
Intervention descriptions: intervention 1: Patients' will be given doses of Renvela equivalent to their prior dose of calcium based phosphate binders and the dose will be titrated as necessary to achieve phosphate levels recommended by KDOQI guidelines.

Protocol documents:
Clinical trial NCT02287025
Conditions: Physician Education
Sponsor: Bayer
Start date: 2014-11-11; Completion date: 2016-04-08
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Randomized trial to evaluate impact of healthcare provider( clinician and nursing staff) support and education on treatment discontinuation rates in the absence of progression in patients with metastatic colorectal cancer treated with regorafenib. Intensified education and support will be provided through an application for iPad which has automatic links to grading, dose reduction and side effect management ,as well as, references for additional articles.

Detailed description:

Arms: arm 1: Investigators were supported with enhanced drug-specific information via an iPad application (SMART). arm 2: Investigators were supported with standard prescribing information.
Interventions: intervention 1: Regorafenib (Stivarga, BAY73-4506) intervention 2: iPAD application intervention 3: Bayer specialist
Intervention descriptions: intervention 1: Dose(s) 160 mg tablet (4 tablets per day at 40 mg) daily for 3 weeks on / 1 week off intervention 2: Investigators were supported with enhanced drug-specific information via an iPad application (SMART). intervention 3: The treating investigator will have access to the prescribing information and have ability to consult a Bayer specialist, should questions arise.

Protocol documents:
Clinical trial NCT02381288
Conditions: Low Testosterone
Keywords: Drug therapy
Sponsor: Takeda
Start date: 2015-09-10; Completion date: 2016-04-08
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effects on serum testosterone (ST) after 6 weeks of subcutaneous (SC) administration of different doses and dosing frequencies of TAK-448 to middle-aged and older men with low ST levels.

Detailed description:
The drug tested in this study is called TAK-448. TAK-448 was tested to define a dose and dose frequency which results in a clinically relevant improvement in ST in middle-aged and older men with low ST levels. This study looked at ST levels in men who took TAK-448.

The study enrolled 17 participants. Participants were randomly assigned (by chance, like flipping a coin) to one of the following treatment groups-which remained undisclosed to the participants and study doctor during the study (unless there is an urgent medical need):

* TAK-448 0.1 µg
* TAK-448 0.3 µg
* TAK-448 1.0 µg
* Placebo (dummy inactive injection) - this was a injection that looks like the study drug but has no active ingredient All participants received subcutaneous injection either once daily on Days 1 through 42, or twice weekly on Days 1 through 39 or once weekly on Days 1 through 36.

This single-center trial was conducted in the United States. The overall time to participate in this study is up to 56 days. Participants made daily visits to the clinic for 8 weeks, and were contacted by telephone 14 days after last dose of study drug for a follow-up assessment.

Arms: arm 1: TAK-448 0.1 mcg, injection, subcutaneously, once daily on Days 1 through 42. arm 2: TAK-448 0.3 mcg, injection, subcutaneously, twice-weekly on Days 1 through 39. arm 3: TAK-448 1.0 mcg, injection, subcutaneously, once-weekly on Days 1 through 36. arm 4: TAK-448 placebo matching injection, subcutaneously, either once daily on Days 1 through 42, or twice weekly on Days 1 through 39 or once weekly on Days 1 through 36.
Interventions: intervention 1: TAK-448 intervention 2: TAK-448 Placebo
Intervention descriptions: intervention 1: TAK-448 solution for subcutaneous injection intervention 2: TAK-448 placebo-matching solution for subcutaneous injection

Protocol documents:
Clinical trial NCT01594216
Conditions: Estrogen-receptor Positive Invasive Metastatic Breast Cancer
Keywords: Postmenopausal female
Sponsor: Abramson Cancer Center at Penn Medicine
Start date: 2012-04-01; Completion date: 2016-04-09
Enrollment: 25 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase II investigator-Initiated trial of the Investigational Drug, Ruxolitinib, in combination with Exemestane in patients with estrogen-receptor positive advanced breast cancer. The objective of this study is to determine the preliminary safety and efficacy of the combination of exemestane and Ruxolitinib (INCB018424).

Detailed description:
In vitro mechanisms link IL-6 to poor outcome in breast cancer via activated JAK/STAT tumor signaling, leading to an aggressive tumor phenotype, and our preliminary data support these mechanisms in women with ER+ disease. Our overarching hypotheses are that (1) IL-6 mediates upregulation of JAK/STAT signaling pathways that leads to poor prognosis in women with ER-positive disease, (2) blockade of JAK/STAT signaling, via JAK inhibition, in patients with activating IL-6 polymorphisms and/or upregulation of STAT3 tumor signaling will enhance the response to endocrine therapy, and (3) patients likely to respond to JAK inhibition can be identified by germline genotyping for IL-6 variants, and effectiveness of the targeted therapy will be measurable through tumor assessment of activated STAT signaling through upregulation of phospho- STAT3 and expression of STAT3 target genes.

We now propose a trial to determine whether addition of the JAK inhibitor, Ruxolitinib (INCB018424), enhances the activity of exemestane alone in women with ER-positive breast cancer who have relapsed after non-steroidal aromatase inhibitor and carry a germline polymorphism in IL-6, and to determine if tumor activation of STAT3 can identify patients most likely to respond to the combination.

Arms: arm 1: Ruxolitinib at 25 mg orally, twice daily and Exemestane, 25 mg orally once daily arm 2: Ruxolitinib at 15 mg orally, twice daily and Exemestane, 25 mg orally once daily
Interventions: intervention 1: Ruxolitinib intervention 2: Exemestane
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01075412
Conditions: Uterine Cervical Neoplasms
Keywords: Positron-Emission Tomography Radiotherapy, Intensity-Modulated
Sponsor: University of Iowa
Start date: 2009-09-01; Completion date: 2016-04-11
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Our primary hypothesis is that \[18F\]FLT PET can identify active bone marrow in addition to metabolically active tumor.

This trial will use FLT-PET imaging to define areas of active bone marrow in the pelvis. The radiation plan is then designed to spare that area, in hopes of keeping the bone marrow active during therapy. Bone marrow and tumor activity will be monitored using a sequence of FLT PET scans during the course of chemotherapy and radiation therapy.

Detailed description:
Subjects will undergo a total of up to 5 FLT PET scans.

Subjects are randomized between two groups to reduce radiation exposure from the FLT PET scans. If bone marrow activity is not identified in one scan, further scans are cancelled until the 1-month follow up scan. This is not a randomization to compare therapeutic efficacy between two study arms. Data will be pooled for analysis as pre-specified in the study's statistical plan.

Group 1 has FLT PET scans pretreatment, after 5 radiation treatments, after 10 radiation treatments, after 15 radiation treatments, and then 1 month after completing radiation therapy.

Group 2 has FLT PET scans pretreatment, after 5 radiation treatments, after 10 radiation treatments, after 20 radiation treatments, and then 1 month after completing radiation therapy.

Arms: arm 1: Receives fourth \[F18\]Fluorothymidine (FLT) PET scan after 20 fractions of radiation therapy. arm 2: Receives fourth \[F18\]Fluorothymidine (FLT) PET scan after 15 fractions of radiation therapy.
Interventions: intervention 1: [F18]Fluorothymidine
Intervention descriptions: intervention 1: FLT PET scan 5 mCi (+/- 10%)

Protocol documents:
Clinical trial NCT00346216
Conditions: Arthritis, Rheumatoid
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2006-10-04; Completion date: 2016-04-12
Enrollment: 24081 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To answer the question of overall benefit: risk of celecoxib when compared to two most commonly prescribe traditional (non-selective) nonsteroidal anti-inflammatory drugs (NSAIDs) in the treatment of arthritis pain. For this purpose, patients with osteoarthritis or rheumatoid arthritis with or at risk of developing cardiovascular disease will be recruited. The cardiovascular, gastrointestinal and renal safety and symptomatic benefit in each treatment group will be assessed accordingly.

Detailed description:

Arms: arm 1: subject receives celecoxib and dummy (placebo) ibuprofen and naproxen arm 2: subject receives ibuprofen and dummy (placebo) celecoxib and naproxen arm 3: subject receives naproxen and dummy (placebo) celecoxib and ibuprofen
Interventions: intervention 1: celecoxib intervention 2: Ibuprofen intervention 3: Naproxen
Intervention descriptions: intervention 1: 100 to 200 mg twice daily, taken by mouth intervention 2: ibuprofen 600 mg to 800 mg three times daily, taken by mouth intervention 3: naproxen 375mg to 500 mg twice daily, taken by mouth

Protocol documents:
Clinical trial NCT02049450
Conditions: Thalassemia Major
Keywords: thalassemia thalassemia major spleen enlargement INC424 ruxolitinib
Sponsor: Novartis Pharmaceuticals
Start date: 2014-05-28; Completion date: 2016-04-12
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Patients with severe thalassemia (thalassemia major) present with severe anemia that required life-long transfusion therapy, spleen enlargement that led to increased transfusion requirement, and other serious complications as early death, growth retardation, bone deformations and iron overload due to blood transfusions. Splenectomy can significantly reduce transfusion requirement in thalassemia patients, but it is associated with an increased risk of serious complications such as sepsis and thrombosis. Preliminary preclinical and clinical data suggested that JAK2 inhibition, by reducing spleen size, could improve hemoglobin levels, thereby eliminating the need for splenectomy and reducing transfusion requirement and related iron overload.

Detailed description:

Arms: arm 1: Regularly transfused adult patients with thalassemia and spleen enlargement.
Interventions: intervention 1: ruxolitinib
Intervention descriptions: intervention 1: Ruxolitinib was taken at a starting dose of 10 mg twice daily with dose adjustments within the range of 5 to 25 mg twice daily.

Protocol documents: