ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01167192
Conditions: Breast Neoplasms
Sponsor: Washington University School of Medicine
Start date: 2011-02-01; Completion date: 2016-09-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether platinum-based chemotherapy (either cisplatin or carboplatin), when given with radiation therapy prior to surgery, is effective in improving response to treatment in triple negative breast cancer patients. This treatment is being studied in this type of breast cancer because it does not respond well to commonly used treatments such as tamoxifen or herceptin.

Detailed description:

Arms: arm 1: Cisplatin 75 mg/m\^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.

Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.

Recommended mastectomy

Recommended adjuvant chemotherapy

-doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m2 for 14 days for 4 cycles)
Interventions: intervention 1: Cisplatin intervention 2: Carboplatin intervention 3: Radiation therapy intervention 4: Mastectomy (recommended but not mandatory)
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01228903
Conditions: Kidney Disease
Keywords: uric acid kidney disease endothelial dysfunction
Sponsor: University of Colorado, Denver
Start date: 2010-10-01; Completion date: 2016-09-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will test the hypothesis that uric acid impairs the function of vessels in patients with kidney disease

Detailed description:
The purpose of the study is to understand the effect of lowering serum uric acid levels on vascular function in individuals with chronic kidney disease by comparing the effects of:

1\) Allopurinol therapy and 2) Placebo.

Patients will receive: 3 month study drug (either allopurinol or placebo), with assessment of serum uric acid levels and vascular function.

Arms: arm 1: Patients who are randomized to this group will received placebo tablets. Placebo tables do not contain an active ingredient. This group will be used as a baseline group to compare the effects of lowering uric acid on vascular function. arm 2: Patients who are randomized to this group will receive allopurinol tablets. Allopurinol is a medicine that lowers uric acid levels. The effects of lowering uric acid on vascular function outcomes will be assessed and compared to the control group.
Interventions: intervention 1: Allopurinol intervention 2: Placebo
Intervention descriptions: intervention 1: Xanthine oxidase inhibitor- effective at lowering uric acid levels. intervention 2: Placebo tablets with no active ingredient

Protocol documents:
Clinical trial NCT01248416
Conditions: Idiopathic Short Stature
Keywords: Aromatase Growth Letrozole Anastrozole GH Children Puberty
Sponsor: Nemours Children's Clinic
Start date: 2010-11-01; Completion date: 2016-09-01
Enrollment: 76 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
When treating very short children in puberty we are time-limited, as sex hormones cause the growth plates to fuse and growth to end. Growth Hormone (GH), plus drugs that stop puberty, increase height potential, but leave children sexually infantile at a critical time in development. Human and animal data show that estrogen, in females and males, is a principal regulator of the fusion of the growth plate in puberty. Using aromatase inhibitors (AIs), which block testosterone to estrogen conversion, in boys with different growth disorders, we have shown that AIs may have beneficial effects enhancing height potential in growth-retarded males, without affecting their puberty. However, no direct comparison of the effect of AIs alone vs. conventional GH treatment has been done to date. This study will assess the effect of AIs alone, GH alone and combination treatment in enhancing height potential in adolescent boys with idiopathic short stature.

Detailed description:

Arms: arm 1: Anastrozole 1mg or Letrozole 2.5mg daily orally for 2 to 3 years arm 2: Somatropin 0.3mg/kg/week divided daily subcutaneously for 2 to 3 years arm 3: Anastrozole 1mg or Letrozole 2.5mg orally daily for 2 to 3 years and Somatropin 0.3mg/kg/week divided daily subcutaneously for 2 to 3 years
Interventions: intervention 1: Aromatase Inhibitor intervention 2: Growth Hormone intervention 3: Aromatase Inhibitor and Growth Hormone
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01394523
Conditions: Umbilical Hernia
Sponsor: Nationwide Children's Hospital
Start date: 2011-08-01; Completion date: 2016-09-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The literature has clearly demonstrated that the effective treatment of postoperative pain in infants and children is challenging. In an effort to improve postoperative analgesia while limiting opioid-related adverse effects, there continues to be an increased use of regional anesthetic techniques in infants and children. Although the pediatric caudal remains the most commonly used pediatric regional anesthetic technique, it has been demonstrated that effective analgesia can be provided with the use of peripheral nerve blockade even in the pediatric-aged patient. The purpose of this study is to prospectively compare post-operative pain relief in pediatric patients undergoing umbilical hernia repair who have received either a caudal block or bilateral rectus sheath blocks for analgesia

Detailed description:

Arms: arm 1: The caudal epidural block will be delivered with 1.5ml/kg of 0.25% Bupivacaine up to a maximum of 30 mL. arm 2: The rectus sheath block will be performed with 0.1ml/kg of 0.25% Bupivacaine on each side at the T9-T10 distribution under ultrasound guidance. arm 3: The surgeon will inject either 0.5% Bupivicaine 0.5ml/kg or 0.25% Bupivicaine 1ml/kg at the surgeon's discretion.
Interventions: intervention 1: Bupivacaine
Intervention descriptions: intervention 1: 0.25% or 0.5%

Protocol documents:
Clinical trial NCT01470196
Conditions: Waldenstrom's Macroglobulinemia
Keywords: WM untreated symptomatic
Sponsor: Dana-Farber Cancer Institute
Start date: 2011-10-01; Completion date: 2016-09-01
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Carfilzomib is a drug that has shown anti-tumor activity by inhibiting the proteasome within the cell, which is responsible for degrading or breaking down a wide variety of proteins. Carfilzomib has not been approved by the FDA.

Rituximab and dexamethasone are often used to treat Waldenstrom's Macroglobulinemia (WM), alone or in combination with other drugs. Combinations with rituximab, dexamethasone and proteasome inhibitors, like carfilzomib, show high levels of activity in WM patients.

In this research study, the investigators are testing the safety and efficacy of Carfilzomib when used along with Rituximab and Dexamethasone as a possible treatment for Waldenstrom's Macroglobulinemia.

Detailed description:
If you take part in this research study, you will receive Carfilzomib and dexamethasone as an infusion on Days 1, 2, 8, and 9 for Cycles 1-6. You will then have a Rituximab infusion on Days 2 and 9. Each cycles lasts 21 days. After completing Cycle 6 and if you are eligible, there will be a 2 month break before the maintenance phase is started. During this break, you will have a study visit with a physical exam, blood tests, and a bone marrow biopsy. If you continue to the maintenance phase, you will receive Carfilzomib and Dexamethasone on Days 1 and 2 and Rituximab on Day 2 of Cycles 1-8. Each cycle will continue to last 21 days, but will take place every 2 months. Infusions will last between 2-6 hours.

During all cycles you will have a physical exam and you will be asked questions about your general health and specific questions about any problems that you might be having and any medications you may be taking. Blood tests will also be done at each Cycle visit, and you will complete a questionnaire. Bone marrow and CT scan will only be repeated at physician discretion when appropriate and in order to ensure your response to treatment.

Arms: arm 1: Carfilzomib, dexamethasone, rituximab
Interventions: intervention 1: Dexamethasone intervention 2: Carfilzomib intervention 3: Rituximab
Intervention descriptions: intervention 1: 20 mg IV on Days 1, 2, 8, 9, of 21 day cycle for cycles 1-6 20 mg IV on Days 1, 2 of 21 day cycles q 2 months for cycles 1-8 intervention 2: 20 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycle 1 36 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycles 2-6 36 mg/m2 IV on Days 1, 2 of 21 day cycles q 2 months for Cycles 1-8 intervention 3: 375 mg/m2 IV on Days 2, 9 of 21 day cycles for Cycles 1-6 375 mg/m2 IV on Day 2 of 21 day cycles q 2 months for Cycles 1-8

Protocol documents:
Clinical trial NCT01476449
Conditions: Diabetic Retinopathy Macular Edema
Keywords: Diabetic Macular Edema Diabetic Retinal Swelling DIabetic Eye Disease
Sponsor: Retina Vitreous Associates of Florida
Start date: 2011-11-01; Completion date: 2016-09-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to see whether treating diabetic retinal swelling with ranibizumab injections into the eye monthly is better than treating diabetic retinal swelling with ranibizumab injections into the eye less frequently.

Detailed description:
This is a prospective randomized study comparing two groups of patients with diabetic macular edema. One group will receive injections of ranibizumab monthly and the other group will have the option to receive injections of ranibizumab less frequently. That is eligible to receive the injections less frequently will have fewer injections given if the patients in that group are doing well.

Arms: arm 1: Patients randomized to the Monthly Ranibizumab arm of the study will be administered intravitreal injections each month for their diabetic macular edema for the duration of the study. arm 2: Patients randomized to this arm of the study will receive intravitreal injections of ranibizumab until their maculae are anatomically "dry," at which point the evaluation and injection interval will be extended.
Interventions: intervention 1: Ranibizumab intervention 2: Ranibizumab
Intervention descriptions: intervention 1: Pars plana injection of ranibizumab 0.5mg into the vitreous cavity. intervention 2: Pars plana injection of ranibizumab 0.5mg into the vitreous cavity.

Protocol documents:
Clinical trial NCT01561755
Conditions: HIV-associated Myelopathy
Keywords: HIV associated myelopathy
Sponsor: David M. Simpson
Start date: 2012-02-01; Completion date: 2016-09-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether Intravenous Immunoglobulin (IVIG) is an effective treatment for HIV associated myelopathy.

Detailed description:
The purpose of this study is to determine whether or not intravenous immunoglobulin (lVlg), brand name Privigen, is effective in treating a disorder called HIV-associated myelopathy (HIVM). This drug is currently not approved by the Food and Drug Administration (FDA) for treating this disorder.

HIVM is a spinal cord disease that occurs at any stage of HIV infection. It is not known what causes this condition, but symptoms can include weakness in the lower body and problems with frequent urination or problems with bowel function, trouble walking or performing sexually.

Arms: arm 1: Intravenous Immunoglobulin - 2gr/kg over 2 days of Privigen® arm 2: Saline 2gr/kg over 2 days of saline
Interventions: intervention 1: Intravenous Immunoglobulin intervention 2: Placebo
Intervention descriptions: intervention 1: Intravenous Immunoglobulin - 2gr/kg over 2 days of Privigen® intervention 2: Placebo - 2gr/kg over 2 days of saline

Protocol documents:
Clinical trial NCT01589185
Conditions: Pneumonia Due to Staphylococcus Aureus
Keywords: Pneumonia Monoclonal antibody Staphylococcus aureus
Sponsor: Aridis Pharmaceuticals, Inc.
Start date: 2012-05-01; Completion date: 2016-09-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objectives of this study are to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical outcome of patients who have severe pneumonia caused by Staphylococcus aureus (S. aureus) after a single intravenous administration of KBSA301 in addition of standard of care antibiotic treatment.

Detailed description:
S. aureus is a leading cause of bloodstream, skin, soft tissue, and lower respiratory tract infections worldwide. The frequencies of both nosocomial and community-acquired S. aureus infections have increased steadily over the years and the treatment of these infections has become more challenging due to the emergence of multi-drug resistant strains (e.g. methicillin-resistant Staphylococcus aureus).

S. aureus has several virulence factors that contribute to the pathogenesis of the infection. Amongst them, alpha-toxin that is involved in the pathogenesis of pneumonia, as it leads to apoptosis and cell lysis, in particular lymphocytes, macrophages, alveolar epithelial cells, pulmonary endothelium, and thrombocytes.

In spite of preventive measures for S. aureus infections and current medical treatment (mostly antibiotic therapy, alone or in combination), there is a clear unmet medical need in the clinic for additional treatment options. Passive immunotherapy with monoclonal antibodies may improve treatment options for severe and life-threatening infections like those caused by S. aureus.

Arms: arm 1: 1 mg/kg KBSA301 arm 2: 3 mg/kg KBSA301 arm 3: 10 mg/kg KBSA301 arm 4: 20 mg/kg KBSA301 arm 5: KBSA301-placebo
Interventions: intervention 1: KBSA301 intervention 2: Placebo
Intervention descriptions: intervention 1: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4. intervention 2: Placebo administered as a single intravenous infusion

Protocol documents:
Clinical trial NCT01684423
Conditions: Venous Thrombosis
Sponsor: Bayer
Start date: 2013-02-19; Completion date: 2016-09-01
Enrollment: 64 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to find out whether rivaroxaban is safe to use in children and how long it stays in the body. There will also be a check for bleeding and worsening of blood clots.

Detailed description:

Arms: arm 1: Subjects aged from 12 - \<18 years were administered with age and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR (immediate-release) tablet once daily (OD) under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kilogram (kg) received a dose (equivalent to 20 milligram \[mg\] in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg. arm 2: Subjects aged from 12 - \<18 years received comparator as per standard of care. The dosage given was to be adjusted based on the individual body weight (low molecular weight heparin, fondaparinux) or international normalized ratio (INR) adjusted (vitamin K antagonist). arm 3: Subjects aged from 6 - \<12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kg received a dose (equivalent to 20 mg in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg. arm 4: Subjects aged from 6 - \<12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily (BID). Subjects with a body weight of 9 to less than 50 kg received a total daily dose (equivalent to 20 mg in adults) ranging from 6.4 to 15 mg and subjects with a body weight of greater than or equal to 50 kg received a total daily dose of 20 mg. arm 5: Subjects aged from 6 - \<12 years received comparator as per standard of care. The dosage given was to be adjusted based on the individual body weight (low molecular weight heparin, fondaparinux) or INR-adjusted (vitamin K antagonist).
Interventions: intervention 1: Rivaroxaban (Xarelto, BAY59-7939) intervention 2: Active comparator intervention 3: Rivaroxaban (BAY59-7939) suspension
Intervention descriptions: intervention 1: Subjects were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days. intervention 2: Subjects received comparator as per standard of care. The dosage given was to be adjusted based on the individual body weight (low molecular weight heparin, fondaparinux) or international normalized ratio (INR) adjusted (vitamin K antagonist). intervention 3: Subjects aged were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily.

Protocol documents:
Clinical trial NCT01705587
Conditions: Osteoporosis Atypical Femoral Fracture
Keywords: osteoporosis atypical femoral fractures prior bisphosphonate treatment postmenopausal women bone loss
Sponsor: Susan L. Greenspan
Start date: 2012-12-01; Completion date: 2016-09-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This open label comparison study examines the hypothesis that teriparatide given immediately following repair of an atypical subtrochanteric or diaphyseal femoral shaft fracture will enhance healing and improve bone mineral density compared to delayed treatment (after six months) with teriparatide or no treatment with teriparatide (patients who refuse therapy or for whom teriparatide is contraindicated). Patients with up-front teriparatide in addition will have greater quality of life measures and less pain compared to those with delayed or no therapy.

Detailed description:
Up to 24 postmenopausal women with osteoporosis who have been on bisphosphonate therapy for one year or more at any point prior to fracture and have sustained an atypical subtrochanteric or diaphyseal fracture will be enrolled. Subjects randomized to the two intervention arms will self-administer a daily SQ injection of the study medication for 12 months. The primary objective is to demonstrate greater radiologic evidence of healing at 10 weeks in patients on immediate teriparatide compared to those on delayed teriparatide who receive therapy six months after fracture. Secondary end points include (1) radiologic healing at 2, 6, 24, and 46 weeks; (2) increased bone density at 6 and 12 months as assessed by dual x-ray absorptiometry (DXA) at the spine, contralateral hip, and femoral neck; (3) quality of life improvements at 10 weeks and 6 months as assessed by quality of life questionnaire and pain score; and (4) differences in biochemical markers of bone turnover in patient with upfront therapy compared to patients with delayed therapy and patients who refuse therapy or for whom teriparatide is contraindicated.

Arms: arm 1: Open label teriparatide given immediately following surgical repair of fracture arm 2: Open label teriparatide given six months following surgical repair of fracture
Interventions: intervention 1: teriparatide
Intervention descriptions: intervention 1: 20 microgram once-daily subcutaneous injection

Protocol documents:
Clinical trial NCT01719367
Conditions: Atrial Fibrillation
Keywords: Baseline (pre-atenolol) Post-atenolol
Sponsor: Vanderbilt University Medical Center
Start date: 2013-01-01; Completion date: 2016-09-01
Enrollment: 38 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Atrial fibrillation (AF), the most common sustained heart rhythm disorder, is becoming increasingly prevalent in the Western world. The number of people with AF in the United States is projected to roughly double by the year 2050, to an estimated 6-12 million. For many patients with AF, rate control with atrioventricular (AV) node blockers is a widely accepted therapeutic strategy. These agents control heart rate, thus preventing symptoms and systolic heart failure associated with tachycardia due to a rapid ventricular response to AF. Beta-blockers are widely accepted as first line agents for rate control in AF, especially when patients have concomitant hypertension (HTN), coronary artery disease, cardiomyopathies, or heart failure (HF). As a class, beta-blockers are among the most commonly prescribed cardiovascular medications.

Among patients with AF treated with beta-blockers, the heart rate (HR) response varies substantially. Sometimes, adequate rate control can be achieved by titration of the beta-blocker dose; but frequently, additional AV nodal blockers and/or digoxin are necessary. In some cases, adequate rate control cannot be achieved even with the simultaneous use of multiple AV nodal blockers, necessitating mechanical ablation of the AV node and permanent pacemaker implantation.

Patient-specific variables that influence the response to beta-blockers include comorbid conditions, weight, age, and level of physical activity. Ethnic differences in the response to beta-blockers for the treatment of HTN and HF are well-described. However, the contribution of genetic variants to beta-blocker efficacy in AF is unknown. We propose to study whether the ADRB1 Gly389Asp SNP reduces response to beta-blockade in subjects with permanent AF.

Detailed description:

Arms: arm 1: Patients will undergo a standardized, graded exercise protocol before and after receiving a dose of oral atenolol.
Interventions: intervention 1: Atenolol
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01731912
Conditions: Prostate Adenocarcinoma Stage IIA Prostate Cancer Stage IIB Prostate Cancer Stage III Prostate Cancer Stage IV Prostate Cancer
Sponsor: University of Washington
Start date: 2013-05-01; Completion date: 2016-09-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This pilot clinical trial studies how well degarelix acetate before and during radiation therapy works in treating patients with prostate cancer. Androgens can cause the growth of prostate cancer cells. Drugs, such as degarelix acetate, may lessen the amount of androgens made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving degarelix acetate together with radiation therapy may work better in treating prostate cancer.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate the effect of neoadjuvant degarelix (degarelix acetate) on prostate dihydrotestosterone (DHT) and testosterone levels.

SECONDARY OBJECTIVES:

I. To determine the effect of degarelix acetate on androgen-regulated gene expression and apoptosis as assessed by immunohistochemistry, complementary deoxyribonucleic acid (cDNA) microarray analysis and reverse transcriptase (RT)-polymerase chain reaction (PCR).

II. To determine the effect of degarelix acetate on follicle stimulating hormone (FSH) and FSH receptor expression in prostate cancer and surrounding microenvironment.

OUTLINE:

Patients receive degarelix acetate subcutaneously (SC) on day 1. Treatment repeats every 4 weeks for up to 6 courses. Beginning at week 15, patients also undergo standard external beam radiation therapy (EBRT) for 8.5 weeks.

Arms: arm 1: Patients receive degarelix acetate SC on day 1. Treatment repeats every 4 weeks for up to 6 courses. Beginning at week 15, patients also undergo standard EBRT for 8.5 weeks.
Interventions: intervention 1: Degarelix intervention 2: External Beam Radiation Therapy intervention 3: Laboratory Biomarker Analysis
Intervention descriptions: intervention 1: Given SC intervention 2: Undergo standard EBRT intervention 3: Correlative studies

Protocol documents: