ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01650350
Conditions: Melanoma Prostate Cancer Renal Cancer
Keywords: Melanoma Prostate Cancer Renal Cancer
Sponsor: Brown University
Start date: 2012-11-01; Completion date: 2013-10-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
will scientifically evaluate whether Low Dose Naltrexone (LDN) has activity in refractory solid tumors within the context of a phase II clinical study

Detailed description:
Three types of solid tumors will be studied in this protocol: Melanoma, castrate resistant prostate cancer and kidney cancer. Systemic chemotherapy may weaken the immune system reducing the potential for response to LDN. Therefore, patients must either have not had previous chemotherapy or patients must not have received more than 1 prior chemotherapy regimen which must have been completed at least 6 months prior to LDN. Systemic chemotherapy has at best modest activity in melanoma, CRPC and renal cancer.

* Melanoma will be evaluated since the responding patient at the Miriam Hospital had melanoma. Immunomodulatory agents such as ipilimumab have already demonstrated a survival advantage in melanoma.
* Castrate Resistant Prostate Cancer (CRPC): It is common in CRPC for patients to have rising PSA after failure of androgen deprivation. These patients may be asymptomatic or minimally symptomatic and there is reluctance to initiate treatment with systemic chemotherapy with standard docetaxel since this agent has substantial toxicity and will impair quality of life. Waiting until symptomatic disease progression in patients with CRPC and rising PSA is a commonly utilized strategy. These patients are excellent candidates for a treatment with minimal toxicity such as LDA. The immunomodulatory agent Sipuleucel also improves survival in prostate cancer suggesting that an agent such as LDN could also be helpful.
* Renal cancer will also be studied since this is a disease that has activity with immunomodulants such as IL-2 and interferon. Targeted therapies are generally used for renal cancer. Chemotherapy has minimal activity so most patients are chemotherapy-naive.

Arms: arm 1: LDN, 5 mg/day-(1 cycle = 28 days).
Interventions: intervention 1: Naltrexone
Intervention descriptions: intervention 1: 4.1 Low Dose Naltrexone (LDN) LDN, 5 mg/day, at approximately 9pm, on an empty stomach, until disease progression, unacceptable toxicity, need for initiation of narcotic analgesia, or removal from protocol treatment according to section 12.0. (1 cycle = 28 days).

LDN, 5mg/ml, will be prepared by the Lifespan hospital pharmacy for patient use for this study.

Protocol documents:
Clinical trial NCT01650805
Conditions: Chronic Myeloid Leukemia
Keywords: Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases
Sponsor: Ariad Pharmaceuticals
Start date: 2012-06-01; Completion date: 2013-10-01
Enrollment: 307 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy of ponatinib and imatinib in patients with newly diagnosed chronic myeloid leukemia (CML) in the chronic phase.

Detailed description:
This multicenter, international, phase 3 trial will test the hypothesis that ponatinib is an effective treatment for newly diagnosed CP-CML patients when compared with standard imatinib.

Patients will be randomized in a 1:1 fashion, stratified by Sokal risk score at diagnosis (low, intermediate, high), to receive once daily oral administration of either ponatinib or imatinib. Efficacy measures include molecular, cytogenetic, and hematologic response rates at various timepoints; time to, duration of, and durability of responses; and survival follow-up. Safety measures include clinical laboratory testing, adverse event monitoring, vital signs, physical exams, ECGs, and ECHOs. Other measures include two patient-reported health outcomes questionnaires (FACT-Leu and EQ-5D-5L), determination of mutation status, and, for ponatinib only, measurement of steady-state plasma concentration. Accrual is expected to take approximately 2 years, and patients will be followed for survival for up to 8 years after the last patient's first dose; therefore, patient participation may last up to 10 years.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: ponatinib intervention 2: imatinib (Gleevec/ Glivec)
Intervention descriptions: intervention 1: 45 mg tablet, taken orally once daily intervention 2: 400 mg tablet, taken orally once daily

Protocol documents:
Clinical trial NCT01654380
Conditions: Healthy Volunteers Diabetes Mellitus, Type 1
Sponsor: Eli Lilly and Company
Start date: 2012-07-01; Completion date: 2013-10-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
LY2605541 is an investigational drug being developed for the treatment of diabetes mellitus. This study is designed to understand how the body handles the investigational drug, what effect this investigational drug has on the body, and how much should be given. This study will also measure how much of the investigational drug gets into the blood stream and how long it takes the body to get rid of it. The study has 2 parts: Part A will be conducted in healthy participants. Part B will be conducted in participants with type 1 diabetes mellitus (T1DM). This study will take approximately 10-14 days spread over 6-20 weeks, not including screening. Screening will be performed within 30 days of the start of the study.

Detailed description:

Arms: arm 1: Healthy participants received 5.1 milliunits/minute (mU/min) in Period 1, 10.2 mU/min in Period 2, and 15.3 mU/min in Period 3, administered intravenously (IV) over 8 hours. All periods were separated by a minimum 6-day washout period arm 2: Healthy participants received insulin glargine (30 milliunits/meter squared/minute \[mU/m\^2/min\]) administered IV over 8 hours in Period 4. All periods were separated by a minimum 6-day washout period arm 3: Healthy participants received 15.3 mU/min in Period 1, 37.0 mU/min in Period 2, and 74.1 mU/min in Period 3, administered IV over 8 hours. All periods were separated by a minimum 6-day washout period. arm 4: Healthy participants received insulin glargine (60 mU/m\^2/min) administered IV over 8 hours in Period 4. All periods were separated by a minimum 6-day washout period. arm 5: Participants with T1DM received 15.3 mU/min in 1 of 4 study periods, administered IV up to 8 hours and received 74.1 mU/min in 1 of 4 Periods, administered IV up to 10 hours. Each dose was separated by a minimum 6-day washout period. arm 6: Participants with T1DM received 1 insulin glargine dose per study period (10 and 20 mU/m\^2/min) administered IV over 8 hours in 2 of 4 study periods. Each dose was separated by a minimum 6-day washout period.
Interventions: intervention 1: LY2605541 intervention 2: Insulin glargine
Intervention descriptions: intervention 1: LY2605541 is a solution. The concentration of LY2605541 is 100 units/milliliter (U/mL). intervention 2: Insulin glargine is a 100 U/mL solution in 10 milliliter (mL) glass vial.

Protocol documents:
Clinical trial NCT01660191
Conditions: Hypercholesterolemia
Keywords: LDL, HDL
Sponsor: University of Kansas Medical Center
Start date: 2011-12-01; Completion date: 2013-10-01
Enrollment: 134 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if Pitavastatin lowers CoQ10 less than Atorvastatin or Rosuvastatin.

Detailed description:
Statins are known effectively treat high cholesterol and heart disease. However, statins may lower endogenous levels of Coenzyme10 (CoQ10). This decrease in CoQ10 levels may be responsible for side effects such as myalgia.

Previous studies have shown that Pitavastatin may not affect CoQ10 levels as other statins do, while still lowering cholesterol.

In this study, investigators intend to compare the plasma levels of CoQ10 in patients taking 3 different FDA-approved statins, in equipotent doses.

Arms: arm 1: Pitavastatin 4mg tablet by mouth once daily for 12 weeks arm 2: Atorvastatin 20mg tablet by mouth once daily for 12 weeks arm 3: rosuvastatin 5 mg tablet by mouth once daily for 12 weeks
Interventions: intervention 1: Pitavastin 4mg intervention 2: Atorvastatin 20mg intervention 3: Rosuvastatin 5mg
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01674712
Conditions: Dyslipidemia
Keywords: Fibrates Dyslipidemia
Sponsor: Abbott
Start date: 2012-06-01; Completion date: 2013-10-01
Enrollment: 575 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a double-blind, randomized study designed to compare the efficacy and safety of two fixed combinations of fenofibrate / simvastatin 145/20 mg and fenofibrate / simvastatin 145/40 mg tablets vs. matching monotherapies in subjects with abnormal fat (lipids) in the blood and at high risk of cardiovascular disease. Fenofibrate is a treatment that lowers fat in blood. It is prescribed in patients with high levels of triglycerides (TG). The drug has been marketed in more than 80 countries since 1975. Simvastatin is also used for the treatment of patients with a high level of cholesterol. These have also been marketed worldwide for more than 20 years. It is important to treat high levels of fats in the blood because it has been shown that even mildly elevated level of lipids in the blood can lead to diseases of the blood vessels. It has been shown in several studies and in clinical practice that the combination of fenofibrate plus simvastatin can lead to improved effects on blood fats, compared to treatment with simvastatin or fenofibrate alone. The main objective of the study is to compare the efficacy of the two fixed-combinations (FC) -fenofibrate/simvastatin 145/20 mg tablet and fenofibrate/simvastatin 145/40 mg tablet in reducing TG and increasing high density lipoprotein cholesterol (HDL-C) versus simvastatin 20 mg or 40 mg, and in reducing low density lipoprotein cholesterol (LDL-C) versus fenofibrate 145 mg.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: Fixed Combination of Fenofibrate/simvastatin 145/20 mg intervention 2: Simvastatin 20 mg intervention 3: Fenofibrate 145 mg intervention 4: Fixed Combination of Fenofibrate/simvastatin 145/40 mg intervention 5: Simvastatin 40 mg
Intervention descriptions: intervention 1: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks intervention 2: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks intervention 3: Fenofibrate, tablet, 145 mg, once daily, 12 weeks intervention 4: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks intervention 5: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks

Protocol documents:
Clinical trial NCT01681576
Conditions: Salt-sensitive Hypertension
Keywords: hypertension, salt sensitivity, valsartan, LCZ696
Sponsor: Novartis Pharmaceuticals
Start date: 2012-08-01; Completion date: 2013-10-01
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will evaluate the effect of LCZ696 and valsartan on natriuresis, diuresis, and blood pressure in salt-sensitive Asian hypertensive patients.

Detailed description:

Arms: arm 1: Period 1: LCZ696 400mg QD for 4 weeks then washout followed by Period 2: Valsartan 320mg QD for 4 weeks arm 2: Period 1: Valsartan 320mg QD for 4 weeks then washout followed by Period 2: LCZ696 400mg QD for 4 weeks
Interventions: intervention 1: Valsartan intervention 2: LCZ696
Intervention descriptions: intervention 1: Valsartan 320mg tablet once daily intervention 2: LCZ696 400mg tablet once daily

Protocol documents:
Clinical trial NCT01681836
Conditions: Focus of Study of Healthy Adults
Sponsor: Gladwin, Mark, MD
Start date: 2012-10-01; Completion date: 2013-10-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This proposal hypothesizes that oral supplementation with sodium nitrite or nitrate will result in in vivo conversion of nitrate to nitrite and nitrite to nitric oxide with limited toxicity in the doses proposed in healthy adult normal volunteers. We utilize a powerful in vivo technique (pharmacokinetic testing) and are the first to design inorganic nitrate and nitrite capsules for cardiovascular disease.

Detailed description:
Preclinical and clinical research over the last decade has revealed the important vasoprotective effects of nitrates and nitrites with regards to reduction in blood pressure, vascular inflammation and endothelial dysfunction. New findings suggest an effect of nitrate and nitrite therapy in the regulation of glucose-insulin homeostasis. Development of an oral formulation of nitrate and nitrite salts is attractive, whereby nitrite would ensure rapid acting effects upon absorption, while the nitrate would continuously provide a slow formation of nitrite over a prolonged period of time via the enterosalivary circulation pathway.

For this reason, development of an oral formulation of nitrate and nitrite salts is attractive, whereby nitrite would ensure rapid acting effects upon absorption, while the nitrate would continuously provide a slow formation of nitrite over a prolonged period of time via the enterosalivary circulation pathway. This study aims to establish the pharmacokinetics, metabolism and interconversion of nitrate to nitrite and nitrite to nitric oxide in vivo in healthy adult normal volunteers.

Arms: arm 1: Oral sodium nitrate 1,000 mg once first, then washout followed by oral sodium nitrite 20 mg once arm 2: Oral sodium nitrite 20 mg once first, then washout followed by oral sodium nitrate 1,000 mg once
Interventions: intervention 1: 15Nitrogen(15N)-labeled sodium nitrite intervention 2: 15Nitrogen(15N)-labeled sodium nitrate
Intervention descriptions: intervention 1: 15Nitrogen(15N)-labeled sodium nitrite 20 mg once intervention 2: 15Nitrogen(15N)-labeled sodium nitrate 1,000 mg once

Protocol documents:
Clinical trial NCT01688037
Conditions: Tardive Dyskinesia
Sponsor: Neurocrine Biosciences
Start date: 2012-09-01; Completion date: 2013-10-01
Enrollment: 109 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy, safety, and tolerability of two doses (50 and 100 mg) of NBI-98854 administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.

Detailed description:
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy, safety, and tolerability of two doses (50 and 100 mg) of NBI-98854 administered once daily for up to 2 weeks. The study will also allow for an evaluation of the efficacy of NBI-98854 50 mg once daily for up to 6 weeks and the safety and tolerability of NBI 98854 50 mg once daily for up to 12 weeks.

The double-blind placebo-controlled treatment period the study has three arms:

* NBI-98854 50 mg once daily for 6 weeks
* NBI-98854 100 mg once daily for 2 weeks followed by 50 mg once daily for the remaining 4 weeks
* placebo

At the end of the 6-week placebo-controlled double-blind treatment period, subjects will continue in the study for an additional 6-week open-label period where all subjects who have completed the double-blind treatment period will receive NBI-98854 50 mg once daily. Two and four weeks after the last dose of study drug, follow-up assessments will be performed.

Arms: arm 1: NBI-98854 50 mg administered as two (2) 25 mg capsules by mouth, taken every morning between 7:00am - 10:00am for 6 weeks. arm 2: NBI-98854 100 mg administered as two (2) 50 mg capsules taken every morning between 7:00am - 10:00am for 2 weeks. After 2 weeks, NBI-98854 50 mg administered by two (2) 25 mg capsules by mouth, taken every morning between 7:00am - 10:00am for remaining 4 weeks. arm 3: Capsule containing no active substance, manufactured to mimic NBI-98854 25 mg and 50 mg capsules.
Interventions: intervention 1: NBI-98854 intervention 2: NBI-98854 intervention 3: Placebo
Intervention descriptions: intervention 1: 25 mg capsule intervention 2: 50 mg capsule intervention 3: None

Protocol documents:
Clinical trial NCT01689337
Conditions: Cartilage Injury of Knee
Keywords: Microfracture surgery Cartilage repair Knee surgery
Sponsor: EMD Serono
Start date: 2013-04-01; Completion date: 2013-10-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 2, double-blind, multicenter, randomized, placebo-controlled trial to evaluate the efficacy and safety of Sprifermin (AS902330) (recombinant human fibroblast growth factor-18 \[rhFGF-18\]) as an adjunct treatment to subjects following microfracture (MFx) surgery for cartilage injury of the knee.

Primary Objectives

* To evaluate the effect of Sprifermin (AS902330) intra-articular knee injections as adjunct to microfracture (MFx) surgery on the composition of the refilled cartilage in the target knee, as measured by gadolinium-enhanced magnetic resonance imaging (MRI) of cartilage (dGEMRIC) time constant 1 (T1) relaxation time at 6 months after MFx surgery
* To evaluate the safety profile of Sprifermin (AS902330) when administered intra-articular into the knee as adjunct to MFx surgery in subjects with cartilage injury of the knee

Secondary Objectives

* To further support the efficacy and safety of Sprifermin (AS902330) as an adjunct to MFx for cartilage injury repair through symptomatic outcomes and quantitative MRI measurement

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Sprifermin (AS902330) intervention 2: Sprifermin (AS902330) intervention 3: Placebo
Intervention descriptions: intervention 1: Sprifermin (AS902330) will be administered at a dose of 30 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery. intervention 2: Sprifermin (AS902330) will be administered at a dose of 100 mcg as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery. intervention 3: Placebo matched to Sprifermin (AS902330) will be administered as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.

Protocol documents:
Clinical trial NCT01691313
Conditions: Symptomatic Atrial Fibrillation Atrial Flutter
Keywords: vanoxerine atrial fibrillation atrial flutter a-fib
Sponsor: Laguna Pharmaceuticals, Inc.
Start date: 2012-11-01; Completion date: 2013-10-01
Enrollment: 104 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluate the safety and efficacy of a single oral dose of vanoxerine compared to placebo, in a dose modification manner, on the conversion of symptomatic atrial fibrillation (a-fib) or flutter of recent onset to normal sinus rhythm.

Detailed description:
Vanoxerine has important antiarrhythmic properties and may prove effective in converting AF/AFL to sinus rhythm in subjects with a history of AF. This is a prospective, randomized, double-blinded, placebo-controlled, dose-modifying study in subjects who have been in symptomatic AF or AFL for more than 3 hours and less than 7 days as dated by symptoms, who have AF/AFL documented on ECG at the time of study drug administration, and who satisfy the inclusion and exclusion criteria. The primary objectives of the trial are to evaluate the safety and efficacy of a single oral dose of vanoxerine compared to placebo following oral administration.

Arms: arm 1: vanoxerine HCl 200mg single dose (2x 100 mg oral capsule) arm 2: placebo to match vanoxerine oral capsule arm 3: vanoxerine HCl 300 mg single dose (3x 100mg oral capsules) arm 4: vanoxerine HCl 400 mg single dose (4x 100 mg oral capsules)
Interventions: intervention 1: Vanoxerine intervention 2: Placebo
Intervention descriptions: intervention 1: single oral dose intervention 2: single oral dose

Protocol documents:
Clinical trial NCT01696058
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2012-09-01; Completion date: 2013-10-01
Enrollment: 1137 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The overall objective of this study is to assess efficacy and safety of 12 weeks, once daily, orally inhaled co-administration of olodaterol 5 µg (delivered by the Respimat® Inhaler) and tiotropium (delivered by the Handihaler® as Spiriva Handihaler®), compared to tiotropium (Spiriva Handihaler®) monotherapy on lung function in patients with COPD.

Detailed description:

Arms: arm 1: 2 puffs Olodaterol from Respimat and one capsule Tiotropium by Handihaler once daily in am, co-administered arm 2: 2 puffs placebo inhalation solution from Respimat and one capsule Tiotropium by Handihaler once daily in am, co-administered
Interventions: intervention 1: Tiotropium intervention 2: Placebo matching Olodaterol intervention 3: Tiotropium intervention 4: Olodaterol
Intervention descriptions: intervention 1: marketed product intervention 2: one dose intervention 3: marketed product intervention 4: one dose

Protocol documents:
Clinical trial NCT01703741
Conditions: Adult Male Hypogonadism
Sponsor: Ferring Pharmaceuticals
Start date: 2012-12-01; Completion date: 2013-10-01
Enrollment: 145 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a multicenter extension trial in adult hypogonadal males. The purpose of this study is to evaluate the safety of testosterone gel delivered using an applicator over an extended period of time.

Detailed description:

Arms: arm 1: Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months.
Interventions: intervention 1: Testosterone Gel (FE 999093)
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01709864
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Anticholinergic Antimuscarinic Chronic Obstructive Airway Disease Chronic Obstructive Lung Disease Chronic Obstructive Pulmonary Disease COPD LAMA Lung Disease Lung Diseases, Obstructive Lung Function Muscarinic receptor antagonist Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases
Sponsor: Novartis Pharmaceuticals
Start date: 2012-11-01; Completion date: 2013-10-01
Enrollment: 440 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study serves to determine whether the treatment of patients with stable, symptomatic Chronic Obstructive Pulmonary Disease (COPD) with the investigational drug NVA237 is efficient and safe. The efficacy and safety of the drug will be tested against a placebo treatment.

The primary criterion to assess efficacy will be the difference between the serial lung function measurements of patients who have been treated for 12 weeks with NVA237 versus those that have received placebo treatment for 12 weeks. A serial lung function measurement (FEV1 testing) will be conducted and the "area under the curve" will be the measure for the ability to breathe.

Detailed description:

Arms: arm 1: NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks arm 2: Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
Interventions: intervention 1: NVA237 intervention 2: Placebo
Intervention descriptions: intervention 1: NVA237 (glycopyrronium bromide) as a powder for inhalation in single-dose capsules. intervention 2: Placebo powder for inhalation in single-dose capsules (matching those for NVA237).

Protocol documents: