ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00866775
Conditions: Epilepsy With Simple or Complex Partial Onset Seizures
Keywords: Seizure Epilepsy Anticonvulsant Historical Control Monotherapy
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2009-04-01; Completion date: 2013-05-01
Enrollment: 193 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an 18-week, double-blind, multicenter study with gradual conversion from previous antiepileptic therapy to eslicarbazepine acetate monotherapy in subjects with partial epilepsy.

Detailed description:
This is an 18-week, double-blind, randomized, historical control, multicenter study with gradual conversion to monotherapy in subjects with partial onset seizures who are not well controlled by current AEDs. The 18 week double-blind treatment period consists of a 2-week period for titration of study drug, 6-week period for taper or conversion off AEDs, and a 10-week monotherapy period. Subjects not entering an optional open-label extension study will enter a 1-week period to taper off study drug followed by an end of study visit (week 19). This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Arms: arm 1: Subjects randomized to 1600 mg QD of eslicarbazepine acetate will titrate from 600 mg QD (Day 0) to 1200 mg QD (Week 1) to 1600 mg QD (Weeks 2-18)

Subjects may continue in an open-label extension study with a starting dose of 1600 mg QD, or taper off study drug at the completion of this study The treatment period for subjects entering the open label extension study is up to 9 study visits over 18 weeks. The treatment period for subjects not entering the open-label extension study is up to 10 study visits over 19 weeks. arm 2: Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg QD (Day 0) to 800 mg QD (week 1) to 1200 mg QD (weeks 2-18)

Subjects may continue in an open-label extension study with a starting dose of 1600 mg QD, or taper off study drug at the completion of this study The treatment period for subjects entering the open label extension study is up to 9 study visits over 18 weeks. The treatment period for subjects not entering the open-label extension study is up to 10 study visits over 19 weeks.
Interventions: intervention 1: Eslicarbazepine acetate intervention 2: Eslicarbazepine acetate
Intervention descriptions: intervention 1: 1600 mg QD intervention 2: 1200 mg QD

Protocol documents:
Clinical trial NCT00903396
Conditions: Anal Cancer Carcinoma of the Appendix Colorectal Cancer Extrahepatic Bile Duct Cancer Gallbladder Cancer Gastric Cancer Gastrointestinal Carcinoid Tumor Liver Cancer Nausea and Vomiting Pancreatic Cancer Primary Peritoneal Cavity Cancer Small Intestine Cancer
Keywords: nausea and vomiting gastrointestinal carcinoid tumor anal cancer carcinoma of the appendix colon cancer rectal cancer extrahepatic bile duct cancer gallbladder cancer gastric cancer liver and intrahepatic biliary tract cancer pancreatic cancer small intestine cancer primary peritoneal cavity cancer
Sponsor: Alliance for Clinical Trials in Oncology
Start date: 2009-09-01; Completion date: 2013-05-01
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Palonosetron hydrochloride may prevent nausea and vomiting caused by radiation therapy. It is not yet known whether palonosetron hydrochloride is more effective than a placebo in preventing nausea and vomiting.

PURPOSE: This randomized phase II trial is studying the side effects of palonosetron hydrochloride and to see how well it works in preventing nausea and vomiting caused by radiation therapy in patients with primary abdominal cancer.

Detailed description:
OBJECTIVES:

* Evaluate the rate of complete responses, defined as no vomiting and no nausea, in patients with primary gastrointestinal and/or retroperitoneal sarcomas treated with two different dosing schedules of palonosetron hydrochloride during abdominal radiotherapy as part of their cancer treatment.
* Determine the tolerability of palonosetron hydrochloride vs placebo in these patients.
* Validate patient diaries for assessing nausea and vomiting by comparing with alternative methods for measuring nausea and vomiting in order to determine the optimal approach for future studies.

OUTLINE: Patients are stratified according to planned radiotherapy duration (\< 5 weeks vs ≥ 5 weeks), planned concurrent fluorouracil ( yes vs no), and gender. Patients are randomized to 1 of 4 treatment arms.

* Arm I: Patients receive palonosetron hydrochloride IV on day 1.
* Arm II: Patients receive palonosetron hydrochloride IV on days 1 and 4.
* Arm III: Patients receive placebo IV on day 1.
* Arm IV: Patients receive placebo IV on days 1 and 4. In all arms, courses repeat weekly during radiotherapy in the absence of disease progression or unacceptable toxicity.

Patients complete nausea and vomiting questionnaires and diaries at baseline and daily during radiotherapy. Patients also complete symptom experience diaries weekly during radiotherapy.

Arms: arm 1: Patients receive palonosetron hydrochloride IV on day 1. arm 2: Patients receive palonosetron hydrochloride IV on days 1 and 4. arm 3: Patients receive placebo IV on day 1. arm 4: Patients receive placebo IV on days 1 and 4.
Interventions: intervention 1: palonosetron hydrochloride intervention 2: placebo
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV

Protocol documents:
Clinical trial NCT00938860
Conditions: Hepatitis C Liver Transplantation
Keywords: Hepatitis C liver transplantation anti-viral therapy
Sponsor: Novartis Pharmaceuticals
Start date: 2009-09-01; Completion date: 2013-05-01
Enrollment: 92 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the rates of Sustained Virological Response following anti-viral therapy with Peg-Interferon plus Ribavirin in patients that have been liver transplanted with recurrent Hepatitis C and treated with Neoral or tacrolimus.

Detailed description:

Arms: arm 1: Neoral capsules bid, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges arm 2: Tacrolimus capsules bid, doses were adjusted as necessary to achieve and maintain recommended C0 target ranges.
Interventions: intervention 1: cyclosporin (Neoral) intervention 2: tacrolimus (Prograf)
Intervention descriptions: intervention 1: Neoral capsules bid, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges intervention 2: Tacrolimus capsules bid, doses were adjusted as necessary to achieve and maintain recommended C0 target ranges.

Protocol documents:
Clinical trial NCT00940589
Conditions: Alzheimer's Disease Sleep Disorder
Keywords: Alzheimer's Disease Acetylcholinesterase inhibitor cognitive function Circadin Sleep disturbances
Sponsor: Neurim Pharmaceuticals Ltd.
Start date: 2009-09-01; Completion date: 2013-05-01
Enrollment: 73 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this exploratory randomized, placebo controlled study is to evaluate the efficacy of Circadin® 2mg in patients with mild to moderate Alzheimer Disease (AD) treated with the acetylcholinesterase (AChE) inhibitor. The effects of add-on Circadin® 2mg vs. placebo on the decline in cognitive skills and global functioning, as well as on daytime somnolence and will be assessed.

Detailed description:

Arms: arm 1: Drug arm 2: drug
Interventions: intervention 1: Circadin intervention 2: Placebo
Intervention descriptions: intervention 1: Prolonged Release melatonin (Circadin) 2mg tablets intervention 2: Matched placebo tablets, with identical features to the Circadin tablets

Protocol documents:
Clinical trial NCT00953199
Conditions: Pancreatitis
Keywords: endoscopic retrograde cholangiopancreatography ERCP pancreatitis lidocaine post-ERCP pancreatitis
Sponsor: Abraham Mathew MD
Start date: 2010-03-01; Completion date: 2013-05-01
Enrollment: 506 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if lidocaine is effective in reducing the incidence of post-ERCP pancreatitis.

Detailed description:
Post endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis is a common cause of morbidity for which there is no known pharmacologic prophylaxis. Post-ERCP pancreatitis is thought to be caused by several factors, including intraductal pressure, multiple duct injections with contrast, and neural arc reflexes. Lidocaine is a safe, inexpensive class IV antiarrhythmic that has topical anesthetic effects, inhibits trypsin activity, and may potentially prevent post-ERCP pancreatitis by injection directly into the pancreatic duct at the time of ERCP. Lidocaine has been shown to inhibit phospholipase A2, a key pancreatic enzyme, interrupt local arc reflexes to stop neuronal transmission, and to dampen GI tract mucosal reflexes to prevent high ductal pressure.

The key objective of this study is to determine if injection of lidocaine is beneficial in preventing post-ERCP pancreatitis. Subjects will be randomized to study group or control group in an equal ratio. The physicians performing the ERCP will be unaware of the treatment group to which patients have been assigned. Study arm will receive contrast agent Diatrizoate 60% (5 ml) diluted with lidocaine 2% (5 ml) during ERCP. Control arm will receive contrast agent Diatrizoate 60% (5 ml) diluted with normal saline 0.9% (5 ml) during ERCP. Diatrizoate diluted with normal saline is the standard of care. Patients will be contacted 1 day and 1 week post-ERCP to assess for symptoms of pancreatitis.

Arms: arm 1: Study subjects receive a 1:1 combination of 5 ml Diatrizoate 60% and 5 ml Lidocaine Hydrochloride 2% arm 2: The control arm receives a 1:1 combination of 5 ml Diatrizoate and 5ml saline.
Interventions: intervention 1: Lidocaine Hydrochloride intervention 2: Normal Saline
Intervention descriptions: intervention 1: 1:1 combination of contrast dye Diatrizoate 60% (5 ml) diluted with lidocaine 2% (5 ml) used at ERCP. Lidocaine will only be used once, and thus a maximum dose of 100 mg will be employed. If the patient requires more contrast agent, this will be used without the addition of lidocaine. intervention 2: 1:1 combination of contrast dye Diatrizoate 60% (5 ml) diluted with normal saline 0.9% (5 ml) used at ERCP (standard of care).

Protocol documents:
Clinical trial NCT00953706
Conditions: Cystic Fibrosis
Keywords: Fibrosis Pancreatic Diseases Digestive System Diseases Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Pathologic Processes
Sponsor: Vertex Pharmaceuticals Incorporated
Start date: 2009-09-01; Completion date: 2013-05-01
Enrollment: 140 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to evaluate the safety and efficacy of ivacaftor in participants with cystic fibrosis (CF) who were aged 12 years or older and were homozygous for the F508del-CF transmembrane conductance regulator (CFTR) mutation. Ivacaftor is a potent and selective CFTR potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR protein. Potentiators are pharmacological agents that increase the chloride ion transport properties of the channel in the presence of cyclic adenosine monophosphate (AMP)-dependent protein kinase A (PKA) activation.

Detailed description:
This study investigated the effects of ivacaftor in participants with cystic fibrosis (CF) \>=12 years of age with a forced expiratory volume in 1 second (FEV1) \>=40 percent (%) predicted. This study was conducted in 2 parts.

* Part A of this study was a randomized, double-blind, placebo-controlled, parallel-group evaluation of participants with CF who were aged 12 years or older and were homozygous for the F508del-CFTR mutation.
* Part B of this study was an open-label extension of Part A, enrolling participants who completed Part A and met pre-specified endpoint criteria, and explored the safety and efficacy of ivacaftor over long-term treatment in participants with CF aged 12 years or older who were homozygous for the F508del-CFTR mutation.

Arms: arm 1: Placebo matched to ivacaftor tablet orally every 12 hours (q12h) for 16 weeks during Part A (double-blind treatment period), followed by ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period). arm 2: Ivacaftor 150 milligram (mg) tablet orally q12h for 16 weeks during Part A (double-blind treatment period), followed by ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
Interventions: intervention 1: Ivacaftor intervention 2: Placebo
Intervention descriptions: intervention 1: Tablet intervention 2: Tablet

Protocol documents:
Clinical trial NCT00960297
Conditions: Non-Small Cell Lung Cancer
Keywords: Non-Small Cell Lung Cancer NSCLC Preoperative chemotherapy Bevacizumab Avastin
Sponsor: SCRI Development Innovations, LLC
Start date: 2009-08-01; Completion date: 2013-05-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The rationale for this multicenter, phase II trial is to examine the impact of carboplatin/paclitaxel with bevacizumab in the preoperative treatment of patients with stage IB (\> 4.0 cm), II, and select stage III NSCLC. If this novel regimen proves to be safe and active in this setting, this would provide rationale for further investigation in a larger, prospective, randomized setting.

Detailed description:
Adjuvant chemotherapy for patients with completely resected stage II and select stage III NSCLC is considered standard therapy. At least three large, prospective randomized trials have proven the benefit of adjuvant chemotherapy in improving survival in these patients (with a magnitude of benefit ranging from 4-12%). However, in patients who are not considered to be candidates for up-front complete resection, preoperative therapy may be indicated. Many of these patients will subsequently be eligible for resection (bimodality therapy). The rationale for this multicenter, Phase II trial is to examine the impact of carboplatin/paclitaxel with bevacizumab in the preoperative treatment of patients with stage IB (\>4.0 cm), II, and select stage III NSCLC. This trial will be conducted by the Sarah Cannon Research Institute Oncology Research Consortium. If this novel regimen proves to be safe and active in this setting, this would provide rationale for further investigation in a larger, prospective, randomized setting.

Arms: arm 1: Preoperative chemotherapy and bevacizumab
Interventions: intervention 1: Carboplatin intervention 2: Paclitaxel intervention 3: Bevacizumab
Intervention descriptions: intervention 1: Carboplatin: AUC=6, given IV on Days 1, 22, 43, and 64 intervention 2: Paclitaxel: 200 mg/m2, given IV on Days 1, 22, 43, and 64 intervention 3: Bevacizumab: 15 mg/kg, given IV on Days 1, 22, and 43 (Note: bevacizumab will not be dosed on Day 64 prior to surgery)

Protocol documents:
Clinical trial NCT00982995
Conditions: Nausea Vomiting Terminally Ill
Sponsor: University of Michigan Rogel Cancer Center
Start date: 2010-11-01; Completion date: 2013-05-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to determine the complete response (no vomiting and no need for other medications to treat nausea) in terminally ill patients suffering from nausea and/or vomiting, who are treated with palonosetron. Another objective is to determine the partial response (relief of nausea and vomiting to the extent that the patient wishes to continue treatment with palonosetron) after being treated with palonosetron. Palonosetron is currently approved by the FDA to prevent nausea and vomiting associated with chemotherapy. The investigators are testing this medication to see if it can help to relieve nausea and vomiting not associated with chemotherapy.

Detailed description:

Arms: arm 1: Palonosetron 0.25 mg I.V. bolus
Interventions: intervention 1: Palonosetron
Intervention descriptions: intervention 1: Palonosetron 0.25 mg as an I.V. bolus. After Palonosetron treatment, no other nausea medication will be given for 2 hours. At that point, if no relief from nausea or vomiting has occured then other anti-nausea medications may be prescribed, and patient will be taken off study. If relief from nausea and vomiting as a result of the Palonosetron occurs, patient will not receive any more anti-nausea medication unless nausea recurs. If it does recur and patient wishes to be retreated with Palonosetron. This may be repeated for a total of 3 doses, as long as it is providing relief.

Protocol documents:
Clinical trial NCT00995371
Conditions: Lumbar Spinal Stenosis
Keywords: Spinal Stenosis Lumbar Spinal Stenosis Laminotomy Laminectomy Spine Surgery
Sponsor: Coastal Orthopedics & Sports Medicine
Start date: 2009-08-01; Completion date: 2013-05-01
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a single-center, randomized, prospective, double-blind clinical study to assess the clinical application and outcomes with MILD® devices versus epidural steroid injection in patients with symptomatic moderate to severe central canal spinal stenosis.

Detailed description:

Arms: arm 1: Patients in the Vertos mild® treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use. arm 2: Patients in the Epidural Steroid Injection (ESI) group will have ESI performed by appropriately trained physicians in accordance with product labeling and indications for use.
Interventions: intervention 1: MILD® (Minimally Invasive Lumbar Decompression) intervention 2: Epidural Steroid Injection
Intervention descriptions: intervention 1: Image guided minimally-invasive lumbar decompression performed with arthroscopic devices. intervention 2: An Epidural Steroid Injection is injected into the space around the spinal cord and nerve roots called epidural space.

Protocol documents:
Clinical trial NCT01011816
Conditions: Back Pain Chronic Low Back Pain Internal Disc Disruption Degenerative Disc Disease
Keywords: intervertebral disk
Sponsor: Spinal Restoration, Inc.
Start date: 2010-03-01; Completion date: 2013-05-01
Enrollment: 220 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this investigation is to establish the safety and efficacy of the Biostat System when used for treatment of chronic low back (lumbar) pain due to symptomatic internal disc disruptions (IDD) by comparing safety and efficacy outcome measures between one group receiving BIOSTAT BIOLOGX® Fibrin Sealant through the Biostat® Delivery Device and another group receiving a preservative-free normal saline control delivered with the Biostat Delivery Device.

Detailed description:
The Biostat System is a combination product combining a resorbable biologic product with a delivery device system used to prepare and insert the biologic material into a lumbar intervertebral disc.

Symptomatic IDD is defined as a painful disruption of the internal architecture of a lumbar intervertebral disc, which appears as fissures, cracks or tears within the internal structures of the disc. Pain arising from a lumbar disc may not only be perceived as pain located in the low back (axial pain) but also as somatic referred pain involving the posterior hips, buttocks, lateral hips, groin, or posterior thighs.

The diagnosis of symptomatic IDD cannot currently be made on the basis of imaging studies, physical examination, or symptoms alone, and is best established with meticulously conducted disc provocation studies (provocation discography) that include pressure manometry and identification of an adjacent normal disc.

This treatment and study are not designed for patients exhibiting other potential sources of chronic low back pain such as more advanced degenerative disc disease with significant loss of disc height (\>33%), spinal stenosis, or spondylolisthesis (see Eligibility Criteria).

Arms: arm 1: One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc arm 2: One injection of up to 4 mL of saline solution into a single lumbar intervertebral disc
Interventions: intervention 1: BIOSTAT BIOLOGX intervention 2: Saline
Intervention descriptions: intervention 1: One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device intervention 2: One injection of up to 4 mL of saline using the Biostat Delivery Device

Protocol documents:
Clinical trial NCT01038752
Conditions: Non-small Cell Lung Cancer
Keywords: NSCLC suramin lung cancer chemotherapy
Sponsor: Optimum Therapeutics, LLC
Start date: 2010-08-01; Completion date: 2013-05-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the benefit of adding suramin at a non-cytotoxic dose to carboplatin and docetaxel regimen in the treatment of chemo-naïve patients with non-small cell lung cancer.

Detailed description:
The primary objective is to determine the progression free survival for patients with stage III B with malignant pleural effusion or Stage IV NSCLC treated with docetaxel and carboplatin with or without suramin.

The secondary objectives are to compare median overall survival rate, compare overall response rate of patients in both arms, assess toxicity of suramin with docetaxel and carboplatin, determine whether pre-treatment bFGF levels correlate with survival, to determine whether survival benefit from suramin is associated with M phase entry in peripheral blood lymphocytes, and to determine whether adding suramin to docetaxel and carboplatin produces greater survival benefits in African-American patients.

Arms: arm 1: This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin. arm 2: This group will receive placebo with docetaxel and carboplatin.
Interventions: intervention 1: Suramin Drug:Docetaxel Drug: Carboplatin intervention 2: Placebo Drug: Docetaxel Drug: Carboplatin
Intervention descriptions: intervention 1: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour). intervention 2: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour).

Protocol documents:
Clinical trial NCT01078168
Conditions: Alzheimer Disease
Keywords: Alzheimer's Disease
Sponsor: K. Lieb
Start date: 2010-03-01; Completion date: 2013-05-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The trials investigates the changes of cerebral spinal fluid (CSF) soluble alpha-secretase cleaved APP (APPsα) levels under oral therapy with acitretin 30mg daily in patients with mild to moderate Alzheimer's disease (AD).The present study aims to demonstrate an enhancement of the α-secretase activity by acitretin as measured by increased CSF APPSα levels in human AD. Second, the safety and tolerability of acitretin in AD patients should be proven.

Detailed description:

Arms: arm 1: oral, 30 mg per day, day 1-28 arm 2: oral, day 1-28
Interventions: intervention 1: Acitretin intervention 2: Placebo
Intervention descriptions: intervention 1: 30mg per day from Day 1 to Day 28 intervention 2: Placebo

Protocol documents: