ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01369732
Conditions: Dissection of Thoracic Aorta
Sponsor: Yonsei University
Start date: 2011-05-01; Completion date: 2013-01-01
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
During thoracic aortic surgery, hypothermic cardiac arrest causes aortic ischemia and reperfusion (IR) periods, respectively. Aortic ischemia results in an ischemic insult to the lower extremities and successive reperfusion results in injury to remote organs, including kidneys. So, there has been considerable interest in the development of therapeutic strategies aimed at attenuating IR injury. One such group of agents that are attracting interest due to their potential protective effects on vascular endothelium is the erythropoietin.

However, the effect of erythropoietin on renal injury induced by aortic IR in humane has not been fully clarified. Therefore, the purpose of this study is to determine whether the prophylactic administration of erythropoietin reduce the incidence of acute kidney injury (AKI) in patients undergoing thoracic aorta surgery with hypothermic cardiac arrest. The investigators administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia. The differences between the control and study groups are observed by clinical indicators such as serum creatinine, TNF-α, NGAL.

Detailed description:

Arms: arm 1: We administrate the saline single bolus (5ml, intravenously) 30 min before the commencement of ischemia. arm 2: We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia.
Interventions: intervention 1: recombinant human erythropoietin intervention 2: saline
Intervention descriptions: intervention 1: We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia. intervention 2: We administrate the saline single bolus (5ml intravenously) 30 min before the commencement of ischemia.

Protocol documents:
Clinical trial NCT01401049
Conditions: Complication of Injection Pain
Keywords: Fospropofol Propofol Colonoscopy Lusedra
Sponsor: NYU Langone Health
Start date: 2010-08-01; Completion date: 2013-01-01
Enrollment: 116 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the incidence and intensity of possible pain on injection as well as patient satisfaction caused by propofol (a lipid based medication); Lusedra (a water based medication); and the drug combination of propofol with lidocaine (a local anesthetic commonly used with propofol injection).

Detailed description:
Propofol (2,6-diisopropylphenol) is one of the most common induction and sedative agents used today. Properties that make this agent popular include rapid onset and quick recovery. However, as its use became more widespread, side effects such as pain on injection have attracted more attention. The incidence of pain on propofol injection is as high as 70 - 90%. Numerous studies report that more than 50% of patients recall the unpleasant burning sensation during injection.

Many techniques to minimize pain on injection associated with propofol have been described; pre-administration of different medications including lidocaine, ketamine, thiopental, metoclopramide, dexamethasone, ondansetron, and remifentanil have been reported with mixed success. Some have even tried to use lidocaine with a tourniquet. Others have reported the use of distraction techniques including counting numbers aloud.

Recently, a solvent mixture of medium chain triglyceride and long chain triglyceride has been tested for prevention of pain on propofol injection. Lusedra (fospropofol disodium), the water-soluble prodrug of propofol, does not cause pain on injection as it is water based medication. Demonstrating the benefit of fospropofol over propofol in patient satisfaction will improve acceptance by anesthesia providers.

Arms: arm 1: To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control. arm 2: The purpose of this study is to compare the incidence and intensity of possible pain on injection as well as patient satisfaction caused by propofol (a lipid based medication); Lusedra (a water based medication); and the drug combination of propofol with lidocaine (a local anesthetic commonly used with propofol injection).
Interventions: intervention 1: Fospropofol intervention 2: Propofol/Lidocaine
Intervention descriptions: intervention 1: To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control. intervention 2: We plan to assess the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion).

Protocol documents:
Clinical trial NCT01410240
Conditions: Knee Replacement Surgery Osteoarthritis
Sponsor: Baxter Healthcare Corporation
Start date: 2011-09-01; Completion date: 2013-01-01
Enrollment: 137 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy and safety of FLOSEAL to standard of care for hemostasis in subjects undergoing total knee arthroplasty.

Detailed description:

Arms: arm 1: SoC: conventional hemostatic techniques such as cautery and manual compression arm 2: FLOSEAL: consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.

SoC: conventional hemostatic techniques such as cautery and manual compression
Interventions: intervention 1: Standard of Care intervention 2: FLOSEAL Hemostatic Matrix + Standard of care
Intervention descriptions: intervention 1: Conventional hemostatic techniques, such as cautery and manual compression, will be used. intervention 2: FLOSEAL will be applied topically to areas of the knee where bleeding is observed (e.g. cut bone surfaces, subcutaneous tissue, posterior joint capsule, synovial tissue, medial and lateral gutters, branches of the genicular vessels, and suprapatellar pouch) and will occur intraoperatively. Sufficient amounts of FLOSEAL will be applied quickly using the provided applicators, followed by immediate approximation with a damp gauze, lap pad or sponge for approximately 2 minutes.

\+ Standard of care: conventional hemostatic techniques, such as cautery and manual compression, will be used

Protocol documents:
Clinical trial NCT01428128
Conditions: Cancer Other Than Leukemia
Sponsor: The University of Texas Health Science Center at San Antonio
Start date: 2011-04-01; Completion date: 2013-01-01
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Many types of cancer are treated with chemotherapy drugs and/or radiation therapy. These forms of treatment, however, can also damage normal (non-cancer) cells and cause a variety of side effects. There are many side effects of chemotherapy. A few examples are: lowered red blood cell counts (anemia) which can lead to tiredness, weakness or shortness of breath; lowered white cell counts (white blood cells which help the body to fight infection); low platelet counts (platelets help blood to clot); nausea and vomiting; diarrhea; lip and mouth sores and hair loss. These side effects can range from mild to severe. P53 is a protein in the body that regulates the cell cycle. If a cell becomes damaged from chemotherapy or radiation treatment, the p53 protein becomes activated. This activation can cause the cell to die and is involved in causing side effects from chemotherapy or radiation therapy.

Arsenic trioxide is a drug that is currently approved by the FDA (Food and Drug Administration) for the treatment of acute promyelocytic leukemia (APL), which is a type of blood and bone marrow cancer. It is given by I.V (intravenous, by vein). New preclinical studies have shown that when given in smaller than normal doses before treatment with chemotherapy and/or radiation therapy, the arsenic trioxide can block the activation of p53 and protect normal tissues from treatment damage. Preclinical means that the studies have been done in a laboratory and not on humans.

This study has two purposes. The first is to find the dose range for arsenic trioxide that will block p53 activity. This dose has been determined from the first five subjects who took part in the study and received arsenic trioxide. The dose of arsenic trioxide for this study is about 1/30 of the normal dose given when arsenic trioxide is used to treat acute promyelocytic leukemia. The second is to see if the arsenic trioxide will decrease the side effects of chemotherapy. In this study, arsenic trioxide is investigational. "Investigational" means that arsenic trioxide has not yet been approved by the FDA to block p53 activity.

This study will help find out what the smallest (best) dose is that can be given and the effects, good and/or bad, this drug has on people who take it. The safety of this drug in humans has been tested in prior research studies; however, whether the side effects will still be present at this lower dose is not yet known.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Arsenic Trioxide
Intervention descriptions: intervention 1: IV; 0.005mg/kg. Infusion on Days -3, -2 and -1 of Chemo Cycles 2, 4, and 6 (if more than 4 cycles received).

Protocol documents:
Clinical trial NCT01429051
Conditions: Break Through Pain Cancer
Keywords: Break through pain BTP Cancer Intranasal Fentanyl Spray INFS cancer patients
Sponsor: Takeda
Start date: 2011-08-01; Completion date: 2013-01-01
Enrollment: 46 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The aim of this clinical trial was to demonstrate the efficacy of a 400 μg dose strength of intranasal fentanyl spray (INFS, Instanyl®) and to evaluate the safety and to establish long term tolerability of treatment with INFS doses of 50, 100, 200 and 400 μg.

Detailed description:
This is a clinical trial with 12 weeks treatment of Intranasal fentanyl (INFS) in cancer patients with breakthrough pain (BTP). It was composed of a dose titrated, placebo-controlled, double-blind, randomised, cross-over efficacy phase, combined with a titration and a tolerability phase assessing the safety and nasal tolerability of INFS. The trial is set up with a screening period and three treatment phases: a titration phase (I), an efficacy phase (II) and a tolerability phase (III). The entire trial period for each completed patient consisted of the one week screening period and 12 weeks treatment with INFS.

Arms: arm 1: All participants were step-wise titrated to an effective dose of 50, 100, 200 or 400 μg INFS in the Titration Phase (I). Participants titrated to 200 or 400 μg INFS in the Titration Phase were randomized to an 8-spray sequence in the Efficacy Phase (II); 6 BTP episodes were treated with 400 μg INFS and 2 BTP episodes with placebo in a random sequence. Participants entered the Tolerability Phase (III) either directly from the Titration Phase (with an effective dose of 50 or 100 μg) or from the Efficacy Phase (400 μg) and continued with this specific dose, unless adjustment was needed, for a total treatment time of 12 weeks.
Interventions: intervention 1: Intranasal Fentanyl Spray (INFS) intervention 2: Placebo
Intervention descriptions: intervention 1: Applied as 1 puff (= 1 dose) in one nostril, or applied as two puffs (= 2 doses, 1 in each nostril) with ten minutes apart. intervention 2: Matching intranasal placebo spray

Protocol documents:
Clinical trial NCT01433159
Conditions: Pressure Ulcers Spinal Cord Injury
Keywords: Pressure Ulcers Spinal Cord Injury Healthpoint Xenaderm 011-101
Sponsor: Healthpoint
Start date: 2011-09-01; Completion date: 2013-01-01
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The trial will compare the effects of 14 days treatment with HP011 101 versus Standard Care in subjects with Stage I or II pressure ulcers as a complication of spinal cord injury, measured as change from baseline in composite wound bed scores of the PUSH 3.0 tool.

Detailed description:

Arms: arm 1: None arm 2: Standard Care at each site other than Xenaderm Ointment or other BCT-containing products
Interventions: intervention 1: HP011-101 (Xenaderm Ointment) intervention 2: Standard Care
Intervention descriptions: intervention 1: The test article will be applied at approximately the thickness of a dime twice daily, or more often if removed incidental to cleansing for 14 days treatment with HP011 101. intervention 2: No restrictions are placed on the nature of this care, except that it conform to the typical practices in place during the prior 3 months and that the regimen does not include the use of a BCT ointment (ointments containing Balsam Peru, castor oil and trypsin).

Protocol documents:
Clinical trial NCT01451424
Conditions: Uterine Fibroids
Sponsor: Repros Therapeutics Inc.
Start date: 2012-02-01; Completion date: 2013-01-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine the safety, pharmacokinetics and efficacy of 4 doses (3, 6, 12, 24 mg) of Proellex in premenopausal women with uterine fibroids confirmed by ultrasound. Drug will be administered vaginally.

Detailed description:
This study is a phase II, 5 arm study with a 12 week active dosing period. The study will be conducted in 2 stages. In the first stage, the first 6 women to be enrolled will be treated at the 12mg dose level, and in addition to the other required study assessments will be monitored with a 24-hour PK assessment on Day 14, and daily trough assessments for the first 14 days. If, at Visit 3, the Cmax or AUC of any subject treated at 12mg exceeds the mean observed for the highest safe oral dose administered in the ZP-204 study, all subjects enrolled at the 12mg level will be discontinued, no further patients will be treated at this dose level, and the 6mg vaginal dose will be assessed in a similar fashion. In the second stage, the remaining subjects will be randomized to a dose of 3, 6, 12 or 24 mg.

For all subjects there will be a 4-6 week placebo run-in period, to establish baseline parameters (bleeding and quality of life) followed by treatment at one of three single-blind Proellex doses (3, 6 or 12 mg daily, administered vaginally in capsule form.) The primary efficacy endpoint will be bleeding assessed using the Pictorial Blood Loss Assessment Chart (PBAC) after 12 or 16 weeks of treatment. The secondary endpoints will be changes in size of uterine fibroids assessed by MRI and improvement in quality of life assessed using the Uterine Fibroid Symptom and Health-Related Quality of Life questionnaire (UFSQOL0. Safety endpoints include significant adverse events, changes in physical examination results, and/or clinical laboratory results significantly outside of normal range. For subjects enrolled in Stage 2, PK will be assessed after the first and last doses and trough levels every 2 weeks.

Arms: arm 1: Subjects receiving 12 mg Proellex administered vaginally, and completing a PK arm consisting of 1 x 24 hr PK of Proellex, 14 days of daily Proellex trough measurements, and 1 x 24 hr PK of Proellex after 14 days of daily dosing. 12 mg PK subjects will continue with the protocol as written after the first 2 week period and will be treated for a total of 16 weeks. arm 2: Subjects receiving 12 mg Proellex daily, vaginally for 12 weeks arm 3: Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks arm 4: Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks. arm 5: 24 mg vaginal Proellex daily for 16 weeks
Interventions: intervention 1: Proellex
Intervention descriptions: intervention 1: vaginal suppository, daily, for 12 weeks

Protocol documents:
Clinical trial NCT01456169
Conditions: Essential Hypertension
Keywords: High Blood Pressure Drug Therapy
Sponsor: Takeda
Start date: 2011-10-01; Completion date: 2013-01-01
Enrollment: 507 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of the fixed dose combinations of azilsartan medoxomil plus chlorthalidone (40/12.5 and 40/25 mg), once daily, in participants with grades 2 or 3 essential hypertension who do not reach target blood pressure following treatment with 40 mg azilsartan medoxomil monotherapy after 4 weeks.

Detailed description:
Eligible participants completed a 2-week single-blind run-in period (Days -42 to -29) prior to a Single-Blind Monotherapy Treatment Period (Day -28 to Day -1) where they received azilsartan medoxomil 40 mg. After the Single-Blind Monotherapy Treatment Period, those participants who achieved target blood pressure discontinued treatment and resumed standard of care management at the discretion of their treating physician, while those participants who did not achieve target blood pressure (defined as clinic systolic blood pressure ≥140 mmHg) were randomly assigned to 1 of 3 active treatment arms: azilsartan medoxomil 40 mg plus placebo, azilsartan medoxomil plus chlorthalidone 40/12.5 mg, or azilsartan medoxomil plus chlorthalidone 40/25 mg.

Arms: arm 1: Azilsartan medoxomil 40 mg and placebo to chlorthalidone combination tablets, orally, once daily for up to 8 weeks. arm 2: Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks. arm 3: Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
Interventions: intervention 1: Azilsartan medoxomil/placebo intervention 2: Azilsartan medoxomil - chlorthalidone
Intervention descriptions: intervention 1: Azilsartan medoxomil and placebo to chlorthalidone combination tablets intervention 2: Azilsartan medoxomil and chlorthalidone fixed dose combination tablets

Protocol documents:
Clinical trial NCT01462942
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD Bronchitis Chronic Emphysema
Sponsor: AstraZeneca
Start date: 2011-10-01; Completion date: 2013-01-01
Enrollment: 2443 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective is to provide data supporting the use of LAS40464 as an efficacious and safe maintenance bronchodilator treatment of patients with Chronic Obstructive Pulmonary Disease (COPD).

Detailed description:
This Phase III study seeks to confirm the long-term bronchodilator efficacy and effects on COPD related health status and other secondary parameters as well as the safety of two doses of the combination of aclidinium bromide/formoterol FDC (FDC 400/12 μg and 400/6 μg) compared with aclidinium bromide monotherapy 400 μg, formoterol monotherapy 12 μg and placebo.

Arms: arm 1: 24 week, double blind treatment period arm 2: 24 week, double blind treatment period arm 3: 24 week, double blind treatment period arm 4: 24 week, double blind treatment period arm 5: 24 week, double blind treatment period
Interventions: intervention 1: Aclidinium Bromide/Formoterol Fumarate intervention 2: Aclidinium Bromide/Formoterol Fumarate intervention 3: Aclidinium Bromide intervention 4: Placebo intervention 5: Formoterol Fumarate
Intervention descriptions: intervention 1: Inhaled Aclidinium/formoterol Fixed Dose Combination (FDC) low dose (400/6 μg), twice per day intervention 2: Inhaled Aclidinium/formoterol FDC high dose (400/12 μg), twice per day intervention 3: Inhaled Aclidinium 400 μg, twice per day intervention 4: Inhaled dose-matched placebo, twice per day intervention 5: Inhaled Formoterol 12 μg, twice per day

Protocol documents:
Clinical trial NCT01464723
Conditions: Age-Related Macular Degeneration
Sponsor: University of California, San Diego
Start date: 2008-05-01; Completion date: 2013-01-01
Enrollment: 66 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to investigate whether the efficacy of Lucentis treatment for exudative age-related macular degeneration is associated with VEGF and HTRA1 DNA polymorphisms

Detailed description:
Age-related macular degeneration (AMD) is a progressive disease that causes irreversible visual impairment and blindness in nearly 50 million people globally. Although geographic atrophy and neovascularization represent the advanced forms of AMD, neovascular AMD is the more aggressive form and accounts for almost 90% of blindness from this disease. It is characterized by choroidal neovascularization (CNV) which is the development of abnormal blood vessels underneath the retina. Randomized clinical trials (MARINA, ANCHOR) have conclusively demonstrated that continued intravitreal therapy with Lucentis (ranibizumab) in patients with subfoveal CNV from AMD leads to stabilization of vision in over 90% of patients and improvement in vision in at least a third of the patients and has led to the approval of Lucentis for the treatment of neovascular AMD (see investigator brochure). This study could provide insight as to the reasons that some patients do not experience vision stabilization with Lucentis, and could possibly help physicians to determine which patients are the best candidates for receiving Lucentis.

This is an open-label study of 100 treatment-naïve (study eye only) AMD patients treated on-label with intravitreally administered Lucentis. Consented, enrolled subjects will receive multiple open-label intravitreal injections of 0.5 mg ranibizumab administered monthly for the first 4 months, and then as needed for a total duration of 12 months. Their blood will be genotyped and sequenced for various SNPs on VEGF and HTRA1.

Arms: arm 1: Consented, enrolled subjects will receive multiple open-label intravitreally administered 0.5 mg ranibizumab administered monthly for the first 4 months, and then as needed for a total duration of 12 months.
Interventions: intervention 1: Ranibizumab
Intervention descriptions: intervention 1: Intravitreal injections of 0.5 mg ranibizumab administered monthly for the first 4 months, and then as needed for a total duration of 12 months.

Protocol documents:
Clinical trial NCT01475461
Conditions: Type 2 Diabetes Mellitus
Keywords: Phase 2 type 2 diabetes mellitus PF-04937319
Sponsor: Pfizer
Start date: 2011-11-01; Completion date: 2013-01-01
Enrollment: 345 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
B1621007 is designed to study the safety and efficacy of PF-04937319 in patients with type 2 diabetes

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None
Interventions: intervention 1: Placebo intervention 2: PF-04937319 - 3mg intervention 3: PF-04937319 - 20mg intervention 4: PF-04937319 - 50mg intervention 5: PF-04937319 - 100mg intervention 6: Sitagliptin - 100mg
Intervention descriptions: intervention 1: double-dummy placebo tablets administered once-daily for 84-days intervention 2: PF-04937319 3mg administered as tablets once-daily for 84-days intervention 3: PF-04937319 20mg administered as tablets once-daily for 84-days intervention 4: PF-04937319 50mg administered as tablets once-daily for 84-days intervention 5: PF-04937319 100mg administered as tablets once-daily for 84-days intervention 6: Sitagliptin 100mg administered as tablets once-daily for 84-days

Protocol documents: