ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01283152
Conditions: Hepatic Encephalopathy Cirrhosis Portosystemic Encephalopathy PSE
Keywords: Hepatic Encephalopathy HE Cirrhosis PSE Portosystemic Encephalopathy Hepatic coma AMS Altered mental status Complications of cirrhosis Chronic liver disease
Sponsor: University of Texas Southwestern Medical Center
Start date: 2011-01-01; Completion date: 2012-06-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being done to find out if the laxative polyethylene glycol (also known as GoLYTELY® or Miralax®) can treat your hepatic encephalopathy (confusion due to your liver disease and/or cirrhosis) better and/or more safely than lactulose (another laxative). In this study, the investigators will evaluate if polyethylene glycol (GoLYTELY®) is more effective than lactulose on neurocognition (memory and thinking skills) and determine if it decreases the hospital stay.

Detailed description:

Arms: arm 1: None arm 2: Per standard of care
Interventions: intervention 1: Polyethylene glycol 3350-electrolyte solution (GoLYTELY®) intervention 2: Lactulose
Intervention descriptions: intervention 1: If randomized to this arm, subjects will receive a 1 time dose of 1 gallon intervention 2: If randomized to this arm, subjects will receive 10-30 grams per standard of care

Protocol documents:
Clinical trial NCT01292473
Conditions: Chronic Idiopathic Urticaria
Sponsor: Genentech, Inc.
Start date: 2011-03-01; Completion date: 2012-06-01
Enrollment: 323 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult patients aged 12-75 who have been diagnosed with refractory CIU and who remain symptomatic despite standard-dosed H1 antihistamine treatment.

Detailed description:
The trial incorporated a Type I error control plan, as follows:

The testing of the primary endpoint was conducted in the following hierarchical order. A p-value that is less than 0.05 can only be claimed statistically significant if statistical significance has been claimed at the previous stage.

* Stage 1: Omalizumab 300-mg group vs. placebo
* Stage 2: Omalizumab 150-mg group vs. placebo
* Stage 3: Omalizumab 75-mg group vs. placebo

A hierarchical analysis of the secondary endpoints was performed for each dose found to be significant in the primary endpoint. A p-value that is less than 0.05 can only be claimed statistically significant if statistical significance has been claimed at the previous stage.

* Stage 1: Change from baseline in Urticaria Activity Score (UAS7) at Week 12
* Stage 2: Change from baseline in the weekly number of hives score at Week 12
* Stage 3: Time to weekly itch severity score Minimally Important Difference (MID) response at Week 12
* Stage 4: Proportion of patients with UAS7 ≤ 6 at Week 12
* Stage 5: Proportion of weekly itch severity score MID Responders at Week 12
* Stage 6: Change from baseline in weekly size of the largest hive score at Week 12
* Stage 7: Change from baseline in overall Dermatology Life Quality Index (DLQI) score at Week 12
* Stage 8: Proportion of angioedema-free days from Week 4 to Week 12

Arms: arm 1: Placebo subcutaneously (sc) every 4 weeks arm 2: Omalizumab 75 mg sc every 4 weeks arm 3: Omalizumab 150 mg sc every 4 weeks arm 4: Omalizumab 300 mg sc every 4 weeks.
Interventions: intervention 1: Placebo intervention 2: Omalizumab
Intervention descriptions: intervention 1: Placebo was supplied lyophilized in vials. intervention 2: Omalizumab was supplied lyophilized in vials.

Protocol documents:
Clinical trial NCT01297920
Conditions: Open-Angle Glaucoma Ocular Hypertension
Keywords: Open-Angle Glaucoma Ocular Hypertension Brinzolamide Brimonidine Intraocular pressure
Sponsor: Alcon Research
Start date: 2011-03-01; Completion date: 2012-06-01
Enrollment: 1062 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to evaluate the safety and efficacy of a new ophthalmic suspension (Brinz/Brim) in lowering intraocular pressure (IOP) relative to its individual active components in subjects with open-angle glaucoma and/or ocular hypertension.

Detailed description:
This study consisted of 7 visits conducted during 2 sequential phases: the screening/eligibility phase, which included a screening visit and 2 eligibility visits, and the treatment phase, which included 4 on-therapy visits conducted at Week 2, Week 6, Month 3, and Month 6. A washout period based on previous ocular medication preceded Eligibility Visit 1. Subjects who met all inclusion/exclusion criteria at both eligibility visits were randomized to 1 of 3 study drug groups. The study was designed to evaluate the efficacy and safety of Brinzolamide/Brimonidine over a 3-month period, with an additional 3 months of study drug exposure intended to provide further safety data.

Arms: arm 1: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 3 times a day for 3 months arm 2: Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each eye 3 times a day for 3 months arm 3: Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each eye 3 times a day for 3 months
Interventions: intervention 1: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension intervention 2: Brinzolamide ophthalmic suspension, 1% intervention 3: Brimonidine tartrate ophthalmic solution, 0.2%
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01330108
Conditions: Pulmonary Arterial Hypertension
Keywords: Pulmonary Arterial Hypertension PAH WHO Group 1
Sponsor: University of Alabama at Birmingham
Start date: 2011-05-01; Completion date: 2012-06-01
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to assess the safety and tolerance of changing patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension.

Detailed description:
The therapy of pulmonary arterial hypertension (PAH) has been revolutionized with the development and subsequent instruction of oral endothelin receptor antagonists (ERA). The first approved ERA, bosentan (Tracleer, Actelion, Inc.) is an effective drug widely used throughout the world in the therapy of PAH. Newer ERA's, with purported advantages over the first approved drug have since been tested and subsequently been approved for the therapy of PAH in the USA and other countries including ambrisentan (Letairis, Gilead Sciences, Inc.). However, there is little data available on the efficacy, safety and tolerability of the elective change from oral bosentan to oral ambrisentan in PAH.

Arms: arm 1: patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension.
Interventions: intervention 1: ambrisentan
Intervention descriptions: intervention 1: ambrisentan 2.5mg, 5mg, \& 10mg. Daily dosage.

Protocol documents:
Clinical trial NCT01342211
Conditions: Hypercholesterolemia Dyslipidemia
Keywords: PF-04950615 RN316
Sponsor: Pfizer
Start date: 2011-07-01; Completion date: 2012-06-01
Enrollment: 93 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate the effect of PF-04950615, a new investigational lipid lowering agent, on LDL-C and other lipids.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: Placebo intervention 2: Statin intervention 3: PF-04950615 (RN316) intervention 4: Statin intervention 5: PF-04950615 (RN316) intervention 6: Statin intervention 7: PF-04950615 (RN316) intervention 8: Satin intervention 9: PF-04950615 (RN316) intervention 10: Statin
Intervention descriptions: intervention 1: Intravenous placebo monthly during treatment phase. intervention 2: Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET. intervention 3: Intravenous 10mg/mL based on weight monthly during treatment phase. intervention 4: Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET. intervention 5: Intravenous 10mg/mL based on weight monthly during treatment phase. intervention 6: Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET. intervention 7: Intravenous 10mg/mL based on weight monthly during treatment phase. intervention 8: Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET. intervention 9: Intravenous 10mg/mL based on weight monthly during treatment phase. intervention 10: Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET.

Protocol documents:
Clinical trial NCT01343823
Conditions: ACE Inhibitor Induced Angioedema
Sponsor: Shire
Start date: 2011-06-01; Completion date: 2012-06-01
Enrollment: 79 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A double-blind, randomized, controlled trial comparing the safety and effectiveness of conventional therapy with ecallantide to conventional therapy with placebo.

Detailed description:

Arms: arm 1: Administered as one 3 mL SC injection containing 10 mg ecallantide and one 3 mL SC injection of matching placebo. arm 2: Administered as two SC 3 mL injections arm 3: Administered as two 3 mL SC injections, each containing 30 mg ecallantide arm 4: Administered as one 3 mL SC injection containing 30 mg ecallantide and one 3 mL SC injection of matching placebo.
Interventions: intervention 1: ecallantide 60 mg intervention 2: ecallantide 30 mg intervention 3: ecallantide 10 mg intervention 4: placebo intervention 5: placebo match for 30 mg ecallantide arm intervention 6: placebo match for 10 mg ecallantide arm
Intervention descriptions: intervention 1: Administered as two 3 mL SC injections, each containing 30 mg ecallantide intervention 2: Administered as one 3 mL SC injection containing 30 mg ecallantide intervention 3: Administered as one 3 mL SC injection containing 10 mg ecallantide. intervention 4: Administered as two SC 3 mL injections intervention 5: One 3 mL SC injection of matching placebo given to subjects randomized to the 30 mg ecallantide arm. intervention 6: One 3 mL SC injection of matching placebo given to subjects randomized to the 10 mg ecallantide arm.

Protocol documents:
Clinical trial NCT01350141
Conditions: Hypercholesterolemia Dyslipidemia
Keywords: Hypercholesterolemia dyslipidemia high cholesterol LDL antibody PCSK9 PF-04950615 RN316
Sponsor: Pfizer
Start date: 2011-06-01; Completion date: 2012-06-01
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
PF-04950615 is a new investigational hypercholesterolemic agent that is being tested in this study to evaluate if it can lower LDL cholesterol.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Placebo intervention 2: PF-04950615 (RN316) intervention 3: PF-04950615 (RN316)
Intervention descriptions: intervention 1: An infusion lasting approximately 60 minutes intervention 2: An infusion lasting approximately 60 minutes intervention 3: An infusion lasting approximately 60 minutes

Protocol documents:
Clinical trial NCT01359254
Conditions: Hematological Disease
Sponsor: University of Chicago
Start date: 2010-04-01; Completion date: 2012-06-01
Enrollment: 1 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to assess the rate of engraftment with combined haploidentical-cord blood transplantation in patients with pre-existing donor specific antibodies and in those with active disease.

Detailed description:
Primary Objective

\- To assess the rate of engraftment with combined haploidentical-cord blood transplantation in patients with pre-existing donor specific anti-HLA antibodies and in those with active disease

Secondary Objectives

* To determine the long term fate of the haplo transplant and the cord blood transplant in this setting.
* To describe the incidence and severity of acute and chronic GVHD.

Arms: arm 1: Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG) arm 2: Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).
Interventions: intervention 1: Melphalan intervention 2: Fludarabine intervention 3: Antithymocyte Globulin (ATG) intervention 4: Busulfan intervention 5: Total Body Irradiation (TBI)
Intervention descriptions: intervention 1: Melphalan is given daily for 2 days, overlapping with the completion of fludarabine. intervention 2: Fludarabine is given through the vein daily for 5 days. intervention 3: ATG is given every other day for 4 days. intervention 4: Busulfan is given daily for 4 days. intervention 5: TBI is given twice on the last day.

Protocol documents:
Clinical trial NCT01362998
Conditions: Pain
Keywords: fentanyl, morphine, duramorph, Cesarean section, epidural
Sponsor: Goodman, Evan, M.D.
Start date: 2011-01-01; Completion date: 2012-06-01
Enrollment: 2 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
For post-Cesarean analgesia, the investigators will compare the efficacy of single-shot epidural preservative free morphine with a continuous epidural fentanyl infusion. The investigators will be comparing the patient's pain level and satisfaction with the two techniques, as well as the side effects that the patients experience, such as itching, nausea, back pain and respiratory depression.

Detailed description:
Included in the study will be all healthy (ASA I or II) woman having elective Cesarean sections who are candidates for regional anesthesia. Exclusion criteria include morbid obesity (BMI \> 40), age less that 18 years, history of sleep apnea, and abuse of or intolerance to opioid analgesics.

All patients will also receive 100 micrograms of fentanyl once epidurally during the Cesarean section, and they will receive ibuprofen every six hours for the first 24 hours after the Cesarean section. The patients will be visited twice a day postoperatively for two days. The epidural morphine will be expected to last only approximately 20 hours, while the fentanyl infusion will be kept in place for two days after the procedure. Additional analgesics, such as intravenous morphine or PO oxycodone and tylenol, will be available for breakthrough pain.

Arms: arm 1: This group will receive 3mg of preservative free morphine epidurally during the procedure. arm 2: This group will receive an epidural infusion of fentanyl (60 micrograms per hour), which will be started during the Cesarean section and which will continue for the next two days.
Interventions: intervention 1: Preservative free morphine intervention 2: Fentanyl
Intervention descriptions: intervention 1: 3mg given epidurally during the Cesarean section. intervention 2: An infusion of epidural fentanyl started during the Cesarean section. It will be given on a patient controlled analgesia basis, with a basal rate of 60 micrograms, a demand dose of 16 micrograms, and a lockout of 15 mins.

Protocol documents:
Clinical trial NCT01363700
Conditions: Allergic Conjunctivitis
Sponsor: Santen Pharmaceutical Co., Ltd.
Start date: ; Completion date: 2012-06-01
Enrollment: 87 participants; Allocation: ; Intervention model: 

Brief summary:
The purpose of the study is to demonstrate safety and efficacy of DE-114 ophthalmic solution compared to its Placebo and Olopatadine hydrochloride 0.1% ophthalmic solution in patients with allergic conjunctivitis.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: DE-114 ophthalmic solution intervention 2: Placebo ophthalmic solution intervention 3: Olopatadine Hydrochloride 0.1% Ophthalmic Solution
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01363986
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2011-09-01; Completion date: 2012-06-01
Enrollment: 3 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This single-arm, multicenter, open-label study will evaluate the efficacy and safety of Herceptin (trastuzumab) in combination with whole brain radiotherapy on brain metastases in patients with HER-2 positive breast cancer. The patients will receive Herceptin 4 mg/kg (loading dose) followed by 2 mg/kg for a maximum of 18 weekly cycles. The anticipated time on study treatment is 18 weeks.

Detailed description:

Arms: arm 1: Participants received an initial loading dose of 4 milligrams per kilogram (mg/kg) trastuzumab intravenous (i.v.), followed by weekly doses of 2 mg/kg i.v. for up to 18 weeks.
Interventions: intervention 1: trastuzumab [Herceptin]
Intervention descriptions: intervention 1: Initial loading dose of 4 mg/kg i.v. infusion, followed by weekly doses of 2 mg/kg for up to 18 weeks.

Protocol documents:
Clinical trial NCT01388816
Conditions: Type II Hyperlipidemia
Keywords: Randomized Double-Blind Placebo Controlled Parallel Arm Type II Hyperlipidemia Cholesteryl Ester Transferase Protein Inhibitor CETP Inhibitor
Sponsor: Dr. Reddy's Laboratories Limited
Start date: 2011-07-01; Completion date: 2012-06-01
Enrollment: 176 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if a new drug, DRL-17822, is safe and effective in elevating high density lipoprotein cholesterol (HDL-C) and reducing low density lipoprotein cholesterol (LDL-C) in people with abnormal cholesterol levels that may put them at risk for heart disease.

Detailed description:
Cardiovascular disease is a leading cause of death worldwide. Among cardiovascular disorders, coronary heart disease (CHD) caused by atherosclerosis is the most common cause of morbidity and mortality. Prevention, stabilization and regression of atherosclerotic plaques may have a major impact on reducing the risk of acute coronary events.

LDL-C lowering agents, primarily the statins, are the current mainstay in the pharmacologic management of dyslipidemia. However even with stain use, residual CHD risk from dyslipidemia remains. Epidemiologic and observational studies have shown that HDL-C is also a strong independent predictor of CHD, suggesting that raising HDL-C levels might afford clinical benefit in the reduction of cardiovascular risk.

Presently only niacin is approved by the FDA for HDL-C elevation and can raise HDL-C levels by 20-30%. However its use can be limited by a high incidence of flushing and, less commonly, by elevation of blood glucose and potential hepatic toxicity.

Cholesteryl ester transfer protein (CETP) inhibitors are being explored for their ability to elevate HDL-C. A small molecule CETP inhibitor, torcetrapib, has been demonstrated to elevate HDL-C by 60-100%. However, a large clinical trial (ILLUMINATE) where it increased HDL-C by a mean of 72% compared to baseline was halted as it failed to show benefit. Post-hoc analysis of this study implicated an off-target increase in blood pressure as potentially counteracting any anti-atherosclerotic benefits. Post-hoc subgroup analysis showed that patients in the highest HDL-C quartile had a 57% reduction in the risk of cardiovascular events.

Increased blood pressure appears to be specifically related to torcetrapib as two other small molecule CETP inhibitors, anacetrapib and dalcetrapib, have not shown this in clinical trials and have been well tolerated. DRL-17822 has also not shown elevation of blood pressure in either animals or in normal volunteers.

This study will investigate the efficacy and tolerability of DRL-17822 as dyslipidemia monotherapy in patients with Type II hyperlipidemia.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: DRL-17822 or placebo
Intervention descriptions: intervention 1: DRL-17822 50, 150 or 300 mg or matching placebo once daily after breakfast

Protocol documents:
Clinical trial NCT01394926
Conditions: Carotid Artery Disease
Keywords: CE-U/S - Contrast-Enhanced U/S U/S - Ultrasound Assess effectiveness
Sponsor: GE Healthcare
Start date: 2011-06-01; Completion date: 2012-06-01
Enrollment: 21 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to find the optimal dose from 3 different dose levels - 0.15 mL, 0.5 mL and 1.5 mL of Optison in assessing the presence of disease of the carotid arteries when comparing pre-contrast to post-contrast ultrasound (U/S) by dose group.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Optison
Intervention descriptions: intervention 1: Optison is a sterile non-pyrogenic suspension of perflutren for IV administration.

Protocol documents:
Clinical trial NCT01396239
Conditions: Duchenne Muscular Dystrophy
Keywords: DMD
Sponsor: Sarepta Therapeutics, Inc.
Start date: 2011-07-01; Completion date: 2012-06-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of AVI-4658 (eteplirsen) in both 50.0 mg/kg and 30.0 mg/kg doses administered over 24 weeks in subjects diagnosed with Duchenne muscular dystrophy (DMD).

Detailed description:
For details regarding the roll-over extension study 4658-us-202, please refer to NCT01540409.

Arms: arm 1: 1. 50 mg/kg eteplirsen for 28 weeks
2. 30 mg/kg eteplirsen for 28 weeks arm 2: 3a. Placebo 50 mg/kg phosphate buffered saline solution identical in appearance to eteplirsen for 24 weeks followed by 50 mg/kg of eteplirsen for 4 weeks.

3b. Placebo 30 mg/kg phosphate buffered saline solution identical in appearance to eteplirsen for 24 weeks followed by 30 mg/kg of eteplirsen for 4 weeks.
Interventions: intervention 1: AVI-4658 (Eteplirsen) intervention 2: Placebo
Intervention descriptions: intervention 1: Treatment group 1 (n=4): 50.0 mg/kg eteplirsen once weekly x 24 weeks via a 60-minute i.v. infusion Treatment group 2 (n=4): 30.0 mg/kg eteplirsen once weekly x 24 weeks via a 60-minute i.v. infusion Treatment group 3 (n=4): matching placebo once weekly x 24 weeks via a 60-minute i.v. infusion; treatment group 3a will match two placebo subjects to 50.0 mg/kg eteplirsen; treatment group 3b will match two placebo subjects to 30.0 mg/kg eteplirsen intervention 2: sterile, isotonic, clear, colorless phosphate buffered saline solution of eteplirsen at a concentration of 100 mg/mL in single-use vials containing a nominal volume of 1.0 mL without preservatives.

Protocol documents: