ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01294397
Conditions: Postmenopausal Osteopenia Rheumatoid Arthritis Osteoporosis
Keywords: Amgen Phase 1 Postmenopausal Osteopenia Rheumatoid Bone Mineral Density Arthritis Pharmacokinetics Osteoporosis
Sponsor: Amgen
Start date: 2011-03-01; Completion date: 2016-01-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of the study was to characterize the effects of a single dose of denosumab on the pharmacokinetics (PK) of etanercept in postmenopausal women with low bone mineral density (BMD) and rheumatoid arthritis based on area under the serum concentration-time curve (AUC) and maximum observed serum concentration (Cmax).

Detailed description:

Arms: arm 1: Participants received etanercept 50 mg subcutaneously once weekly for 25 weeks. On study day 8, participants were administered a single 60 mg subcutaneous injection of denosumab.
Interventions: intervention 1: Etanercept intervention 2: Denosumab
Intervention descriptions: intervention 1: Administered by subcutaneous injection once a week intervention 2: Administered by subcutaneous injection

Protocol documents:
Clinical trial NCT01301001
Conditions: Vulvodynia
Keywords: Vulvodynia
Sponsor: University of Tennessee
Start date: 2012-08-01; Completion date: 2016-01-01
Enrollment: 230 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The Specific aims of this project are to (1) test the prediction that pain from tampon insertion (primary outcome measure) is lower in PVD patients when treated with gabapentin compared to when treated with placebo. Secondary outcome measures include intercourse pain and 24-hour pain and (2)perform a mechanism-based analysis of gabapentin effectiveness, and to gain insight into the underlying pathophysiology of subtypes of PVD that may lead to more specific treatment options.

Detailed description:
This is a 18-week, randomized, double-blind, placebo-controlled, two-treatment, two-period crossover design, where 120 women between 18 of age and older who report insertional dyspareunia, pain with tampon insertion, and tenderness localized to the vulvar vestibule will be enrolled in the study. Electronically entered daily diaries will be used to determine if pain is lower in PVD subjects when treated with gabapentin (up to 3600 mg/d) compared to when treated with placebo. Biological measurements will include assessment of allodynia and hyperalgesia from capsaicin administration, muscle tension using a vaginal pressure algometer, number of tender points by clinical examination, and changes in blood pressure, pulse and heart rate variability. . The Long-range goals of this project are to explicate the underlying pathophysiologic mechanisms of PVD, and to use this knowledge to create evidence-based differential diagnoses of subtypes of PVD and to individualize treatments for each subtype. The immediate goal is to conduct a multicenter, randomized controlled trial (RCT) of gabapentin treatment for PVD, and which will also provide critical data on a new PVD-testing and response paradigm, as well as on characteristics that may define subtypes of PVD. Gabapentin, an anticonvulsant with analgesic, anxiolytic, and antispasmotic effects, was selected because of its efficacy in treating other neuropathic pain conditions.

Arms: arm 1: Placebo capsule daily in first intervention period and Gabapentin capsule 3000 mg daily in in second intervention (after washout period) arm 2: Gabapentin capsule 3000 mg daily in first intervention period and Placebo capsule in second intervention (after washout period)
Interventions: intervention 1: Placebo oral capsule intervention 2: Gabapentin
Intervention descriptions: intervention 1: Placebo 2 capsules am and 3 capsules pm intervention 2: Gabapentin 1200 mg am and 1800 mg pm

Protocol documents:
Clinical trial NCT01357655
Conditions: Leukemia
Keywords: Myelogenous Chronic BCR-ABL Positive
Sponsor: Bristol-Myers Squibb
Start date: 2011-09-01; Completion date: 2016-01-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to compare response rates in newly diagnosed Chronic Phase (CP) CML subjects treated with dasatinib plus BMS-833923 versus dasatinib alone.

Detailed description:
1. Design:

   Study Design and Duration as current described are no longer applicable since enrollment was prematurely concluded due to a decision by the sponsor. Subjects currently enrolled in the trial will continue to receive dasatinib alone at a starting dose of 100 mg QD for:
   1. a maximum of 5 years after entry into the study
   2. until progression by Investigators determination/judgment
   3. intolerance to Dasatinib
   4. the study is terminated due to safety concerns or
   5. other administrative reasons as communicated by the sponsor
2. Research Hypothesis :

The research hypothesis and primary objective of this study as originally designed are no longer applicable as subjects enrolment has been terminated due to administrative reasons by the sponsor. The objective of the altered design of this study is to describe the safety profile and tolerability of dasatinib

Arms: arm 1: None arm 2: Dasatinib for 1 year followed by dasatinib plus BMS-833923 for 2 years followed by dasatinib alone for approximately 2 years; depending on response
Interventions: intervention 1: Dasatinib intervention 2: BMS-833923
Intervention descriptions: intervention 1: Tablets, Oral, 100 mg, Once daily, approximately 5 years depending on response intervention 2: Capsules, Oral, dose to be determined, Once daily, approximately 2 years depending on response

Protocol documents:
Clinical trial NCT01361178
Conditions: Infections After Lung Transplant
Sponsor: University of Pittsburgh
Start date: 2011-01-01; Completion date: 2016-01-01
Enrollment: 133 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Immunosuppressive therapies have led to remarkable improvements in survival in lung transplantation (LT) patients. However, one important adverse effect of these therapies has been the increasing emergence of hypogammaglobulinemia (HGG) which has been previously seen mostly in patients with primary immunodeficiency (PID).

The goal of treatment of HGG in PID has been to maintain the trough IgG level above 500 mg/dl which might provide better protection against infections than do lower IgG serum concentrations. Although IgG therapy is of substantial benefit, the doses and trough levels of IgG that are optimal are not yet clearly established. The impact of high versus low IgG dosing on the frequency and severity of infections and rejection has not been studied before in LT patients with HGG. The specific aims for this study are to compare the incidence of infections in lung transplant recipients receiving higher versus lower dose of SQ IgG and to compare the incidence of infections in lung transplant recipients with mild hypogammaglobulinemia versus normal IgG levels. This study will be a single center study of all lung transplant recipients, age 18 years or older, at the University of Pittsburgh Medical Center (UPMC), with a randomized treatment arm and an observational arm.

The hypotheses for the research study are:

* Therapy with IV or SQ IgG is of substantial benefit in reducing the number of infections in lung transplant recipients with severe hypogammaglobulinemia (IgG \< 500)
* A higher dose of SQ IgG, with subsequent higher trough IgG levels, may have a higher impact on the frequency and severity of infections and rejection episodes, compared to a lower dose of SQ IgG, with subsequent lower IgG trough levels
* Lung transplant recipients with mild hypogammaglobulinemia ( IgG= 500-750) have a higher incidence of infections compared to patients with normal IgG levels

Detailed description:

Arms: arm 1: Patients participating in the observational arm of the study who do not need to receive IgG replacement. arm 2: Patients participating in the observational arm of the study who are randomized to receive a dosage of SQ IVIG due to low IgG level.
Interventions: intervention 1: SQ IVIG
Intervention descriptions: intervention 1: Group 1 will receive SQ IgG at the lower end of the dosing range at 100 mg/kg/week and group 2 will receive SQ IgG at the higher end of the dosing range at 200 mg/kg/week

Protocol documents:
Clinical trial NCT01363297
Conditions: Acute Lymphocytic Leukemia
Keywords: Relapsed/Refractory Acute Lymphocytic Leukemia (ALL)
Sponsor: Pfizer
Start date: 2011-08-01; Completion date: 2016-01-01
Enrollment: 72 participants; Allocation: ; Intervention model: 

Brief summary:
The Phase 1 portion of this study will assess the safety, tolerability and efficacy at increasing dose levels of inotuzumab ozogamicin in subjects with CD22-positive relapsed or refractory adult acute lymphocytic leukemia (ALL) in order to select the recommended phase 2 dose (RP2D) and schedule. The Phase 2 portion of the study will evaluate the efficacy of inotuzumab ozogamicin as measured by hematologic remission rate (CR + CRi) in patients in second or later salvage status.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Inotuzumab Ozogamicin
Intervention descriptions: intervention 1: Part 1: Administered intravenously as 2 - 3 weekly doses over a 28-day cycle for a maximum of 6 cycles. Total dose per cycle 0.8 mg/m\^2 to 2.0 mg/m\^2.

Part 2 Expansion and Part 3 Phase 2: Administered intravenously as 3 weekly doses over a 28-day cycle for a maximum of 6 cycles. Total initial dose per cycle 1.8 mg/m\^2.

Protocol documents:
Clinical trial NCT01449370
Conditions: Metastatic Solid Tumors
Keywords: INK1117 PIK3CA KINASE TUMOR CANCER Locally advanced or metastatic solid tumors not eligible for standard of care therapy
Sponsor: Millennium Pharmaceuticals, Inc.
Start date: 2011-10-01; Completion date: 2016-01-01
Enrollment: 125 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the maximum tolerated dose (MTD) and/or optimal biologic dose(OBD), safety and tolerability, dose-limiting toxicity (DLT) of TAK-117 when administered orally in subjects with advanced solid malignancies.

Detailed description:

Arms: arm 1: TAK-117 administered once a day orally arm 2: TAK-117 administered orally intermittently, once every other day (Monday, Wednesday, and Friday) each week arm 3: TAK-117 administered orally intermittently, once a day for 3 consecutive days (Monday, Tuesday, and Wednesday) each week
Interventions: intervention 1: TAK-117
Intervention descriptions: intervention 1: oral administration of TAK-117, daily and intermittent schedules.

Protocol documents:
Clinical trial NCT01449721
Conditions: Sepsis Severe Sepsis
Keywords: Sepsis Multiple organ failure Resuscitation
Sponsor: Christiana Care Health Services
Start date: 2011-09-01; Completion date: 2016-01-01
Enrollment: 142 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the ability of an empiric resuscitation strategy compared to standard care to decrease the incidence of organ failure in normotensive sepsis patients.

Detailed description:
Sepsis is a challenging and elusive entity with a high mortality rate. As a syndrome, clinicians are challenged to distinguish individuals with systemic infection warranting further interventions from lower severity patients. Sepsis is now recognized as a time-sensitive emergency, as patients stand the best chance for survival when effective therapeutic interventions are delivered as early as possible.

Recent data has shown that in-hospital disease progression from sepsis to septic shock is associated with a higher risk of morbidity and mortality than those with shock on initial presentation. Yet, even when identified and treated with early aggressive interventions, the development of septic shock is still associated with a mortality rate of 25-40%.

Although the presence of sustained arterial hypotension or serum lactate elevation (\>4.0 mmol/L) are the currently recommended threshold to define the presence of overt shock and the need for aggressive resuscitation, the investigators have shown that, in patients with systemic infection, a moderate lactate elevation (2.0-3.9 mmol/L) is a common occurrence and an important warning sign for the increased risk of disease progression and death. Sepsis with an elevated lactate between 2.0-3.9, referred to as the "PRE-SHOCK" state, identifies this population of patients at-risk for poor outcome. Current guidelines for sepsis management do not recommend any specific resuscitation measures or therapies for this at-risk population. This study marks the first in a series of investigations addressing the PRE-SHOCK population to further define the adverse events within this cohort and to investigate novel interventions to improve outcomes.

The investigators hypothesize that an early quantitative resuscitation strategy using a protocol-directed IV fluid resuscitation will result in a significant reduction in the development of worsening organ failure (including shock) and mortality compared to standard care.

Arms: arm 1: Standard medical care by the primary treatment team. arm 2: Protocolized empiric resuscitation delivering weight-based intravenous fluid resuscitation targeting lactate normalization
Interventions: intervention 1: Intravenous fluid
Intervention descriptions: intervention 1: 0.9% Sodium chloride intravenous fluid

Protocol documents:
Clinical trial NCT01462318
Conditions: Relapsing-Remitting Multiple Sclerosis
Keywords: Pre-filled syringe Pharmacokinetic Daclizumab High Yield Process immunogenicity
Sponsor: Biogen
Start date: 2011-11-01; Completion date: 2016-01-01
Enrollment: 133 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of the study is to assess the immunogenicity of Daclizumab High Yield Process (DAC HYP) 150 mg administered every 4 weeks by subcutaneous (SC) injection using the pre-filled syringe (PFS) in participants with relapsing-remitting multiple sclerosis (RRMS). The secondary objectives of this study are to characterize the pharmacokinetics (PK) of DAC HYP following single and multiple doses of DAC HYP administered by the PFS in a subset of participants with RRMS and to evaluate the effect of DAC HYP on the PK of probe drugs for cytochrome P450 (CYP) isoenzymes (CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A).

Detailed description:
Following a screening period, participants will receive DAC HYP over a 24-week treatment period (6 monthly injections) and then enter a 20-week washout period for assessment of immunogenicity, PK, pharmacodynamics, safety, and tolerability. The 20-week washout is necessary to ensure measurement of anti-DAC HYP binding antibodies (ADAbs) and neutralizing antibodies (NAbs) in the absence of drug interference. After washout, the participants may resume monthly treatment with DAC HYP 150 mg for an additional 3 years. All participants will be followed for 6 months after their last dose for safety monitoring. Additionally, two sub-studies will be performed: (1) an intensive serial PK sampling performed over the first and last dosing interval following DAC HYP doses administered at week 0 and at week 20, and (2) a therapeutic protein-drug interaction (TP-DI) sub-study, during which a probe drug cocktail will be administered at weeks 43 and 53 followed by serial probe-drug PK sampling up to 96 hours after probe-drug administration. A maximum of 20 participants will be enrolled in the TP-DI sub-study.

Arms: arm 1: DAC HYP 150 mg by a subcutaneous (SC) injection using the pre-filled syringe (PFS) every 4 weeks for 24 weeks followed by a 20-week washout period. After completion of the washout period, participants may resume monthly DAC HYP 150 mg using the PFS for up to 3 additional years.

Participants in the TP-DI sub-study will receive probe-drug cocktail administration at Weeks 43 and 53. The probe-drug cocktail consists of oral midazolam 5 mg, caffeine 200 mg, S-warfarin 10 mg, vitamin K 10 mg, omeprazole 40 mg, and dextromethorphan 30 mg. The oral vitamin K is used to counteract warfarin's anticoagula nt effect prophylactically.
Interventions: intervention 1: Midazolam intervention 2: Caffeine intervention 3: S-warfarin intervention 4: Vitamin K intervention 5: Omeprazole intervention 6: Dextromethorphan intervention 7: BIIB019 (Daclizumab)
Intervention descriptions: intervention 1: 5 mg intervention 2: 200 mg intervention 3: 10 mg intervention 4: 10 mg intervention 5: 40 mg intervention 6: 30 mg intervention 7: 150 mg in 1 ml PFS

Protocol documents:
Clinical trial NCT01470248
Conditions: Lung Cancer Cancer of Lung Pulmonary Cancer Pulmonary Neoplasms Carcinoma, Small Cell
Keywords: Lung Cancer Carcinoma, small cell Trisenox Arsenic trioxide phase II trial
Sponsor: Emory University
Start date: 2011-08-01; Completion date: 2016-01-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to study the effect of an anticancer drug, Arsenic Trioxide, in patients with small cell lung cancer who have failed at least one standard chemotherapy regimen as well as patients who are unable to tolerate the standard treatment for their cancer. The investigators seek to establish the safety of and efficacy of Arsenic Trioxide in this patient group. The study will include up to 36 participants with small cell lung cancer.

The investigators want to find out what effects, good or bad, that the study drug has on your cancer. This study will also look at specific biomarkers in your blood and in the tumor tissue which may help the investigators to determine if the levels of these biomarkers are related to tumor response to treatment.

Arsenic Trioxide, also known by the brand name, Trisenox, is a chemotherapy drug approved by the Food and Drug Administration (FDA) for the treatment of a specific type of blood cancer called Acute Promyelocytic Leukemia. It works in part by making cancer cells become more mature thereby stopping them from growing in number and more likely to die off.

Detailed description:

Arms: arm 1: This is a single arm study. All patients will be treated with the investigational agent, Arsenic Trioxide, according to the dose and schedule indicated in the protocol.
Interventions: intervention 1: Arsenic Trioxide
Intervention descriptions: intervention 1: Drug will be given as a loading dose of 0.32mg/kg/day for 4 days in Week 1, followed by 0.25mg/kg/day twice per week for 5 weeks, followed by 2 weeks of rest, at which time response assessment will be performed. Patients will be restaged prior to the beginning of a new cycle, every 2 months on average. Maximum of 6 cycles of therapy will be administered in the absence of tumor progression or excessive side effects

Protocol documents:
Clinical trial NCT01472432
Conditions: Chronic Foot Ulcers
Keywords: type 2 diabetes healing foot ulcers vildagliptin
Sponsor: University of Campania Luigi Vanvitelli
Start date: 2011-05-01; Completion date: 2016-01-01
Enrollment: 106 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A randomized versus placebo trial designed to evaluate the clinical and humoral effects of 4 months of vildagliptin on healing of chronic ulcers in type 2 diabetes.

Detailed description:
The chronic foot ulcer is a leading cause of hospital admissions for people with diabetes in the developed world and is a major morbidity associated with diabetes, often leading to pain, suffering, and a poor quality of life for patients. Chronic diabetic foot ulcers are estimated to occur in 15% of all patients with diabetes and precede 84% of all diabetes-related lower-leg amputations.The pathophysiology of chronic diabetic ulcers is complex and still incompletely understood, the most important predisposing factors being diabetic neuropathy and vasculopathy. Both micro and macroangiopathy strongly contribute to development and delayed healing of diabetic wounds, through an impaired tissue feeding and response to ischemia. HIF-1α and VEGF, as well as the NO production from iNOS, may contribute to limitation of hypoxic injury by promoting angiogenesis and wound healing. Experimental and pathological studies suggest that suggest that he incretin hormone glucagon-like peptide-1 (GLP-1) may improves VEGF generation, and promote pancreatic islet viability through the up-regulation of HIF1α.

Therefore, aim of this study is to evaluate the effect of the augmentation of GLP-1, by inhibitors of the dipeptidyl peptidase IV (DPP-4), such as vildagliptin, on HIF-1α, VEGF and iNOS in diabetic chronic ulcers.

Arms: arm 1: In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. All patients had diabetes and at least one full-thickness wound below the ankle for \>3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice. arm 2: The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months
Interventions: intervention 1: Placebo intervention 2: vildagliptin
Intervention descriptions: intervention 1: Placebo is added to the standard good medical practice. Plus Metformin and/or Sulfonylurea intervention 2: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice.Plus Metformin and/or Sulfonylurea

Protocol documents:
Clinical trial NCT01488019
Conditions: COPD
Sponsor: Dey
Start date: 2012-03-01; Completion date: 2016-01-01
Enrollment: 1071 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a multi-center, randomized, placebo-controlled study to evaluate the long-term safety of Perforomist® inhalation therapy in subjects with Chronic Obstructive Pulmonary Disease (COPD). Individual participation is approximately 54 weeks, including 52 weeks of double-blind treatment.

Detailed description:
None provided.

Arms: arm 1: Active arm 2: Placebo
Interventions: intervention 1: Perforomist-Placebo intervention 2: Perforomist, nebulization, COPD
Intervention descriptions: intervention 1: Placebo vehicle, 2mL, twice daily for 52 weeks intervention 2: Perforomist, 20 mcg/2 mL, twice daily for 52 weeks

Protocol documents: