ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00873119
Conditions: Carcinoma of Unknown Primary
Keywords: Belinostat PXD101 Carboplatin Paclitaxel CUP Carcinoma of unknown primary Occult primary
Sponsor: Valerio Therapeutics
Start date: 2009-02-01; Completion date: 2012-12-01
Enrollment: 89 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess efficacy and safety of belinostat in combination with carboplatin and paclitaxel in patients with previously untreated carcinoma of unknown primary.

Detailed description:
This is an open-label, multinational, multicenter, randomized, comparative efficacy and safety study in previously untreated patients with carcinoma of unknown primary. Patients meeting inclusion and exclusion criteria will be randomized to treatment in Arm A (BelCaP) or Arm B (CaP).

Arms: arm 1: Group A: belinostat 1000 mg/m² administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat 2000 mg administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel 175 mg/m² administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3. arm 2: Group B: paclitaxel 175 mg/m² administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
Interventions: intervention 1: belinostat, carboplatin, paclitaxel intervention 2: carboplatin, paclitaxel
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00883675
Conditions: Non-small Cell Lung Cancer
Keywords: Lung cancer Adjuvant therapy
Sponsor: Michael Mann
Start date: 2009-05-01; Completion date: 2012-12-01
Enrollment: 133 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether it is safe to treat lung cancer patients who have undergone an attempt at curative resection with the combination of docetaxel and carboplatin.

Detailed description:
Patients with stage Ib - IIIa NSCLC participated in an open-label, single arm study to assess the safety and tolerability of docetaxel (75 mg/kg) and carboplatin (AUC 5.5) administered for 3 cycles after resection for curative intent. The primary endpoint of the study was safety, as reflected by a febrile neutropenia rate of \<10%. Other endpoints assessed protocol compliance and the impact of minimally invasive surgical technique.

Arms: arm 1: Docetaxel: 75 mg/m2 over 1 hour every 3 weeks for 3 doses Carboplatin Area Under the Curve 5.5 over 0.5 to 1 hour every 3 weeks for 3 doses
Interventions: intervention 1: Docetaxel-Carboplatin
Intervention descriptions: intervention 1: Docetaxel: 75 mg/m2 over 1 hour every 3 weeks for 3 doses Carboplatin AUC 5.5 over 0.5 to 1 hour every 3 weeks for 3 doses

Protocol documents:
Clinical trial NCT00892697
Conditions: Hepatitis C
Keywords: hepatitis C FNA intrahepatic
Sponsor: Weill Medical College of Cornell University
Start date: 2009-05-01; Completion date: 2012-12-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the decline of virus in the blood and liver in patients treated with telaprevir, pegylated interferon and ribavirin.

Fine Needle Aspiration (FNA) procedure will be used to repeatedly sample the liver to enhance the understanding of how the virus decays in the liver in response to treatment with anti-viral compounds and the measurement of the concentration of the drugs in the liver. FNA is an alternative procedure to core needle biopsy in its ability to repeatedly sample the liver with significantly reduced morbidity.

Detailed description:

Arms: arm 1: 15 subjects will receive Telaprevir in combination with pegylated interferon alfa-2a and ribavirin
Interventions: intervention 1: Telaprevir intervention 2: Peginterferon alfa-2a intervention 3: Ribavirin
Intervention descriptions: intervention 1: Fifteen subjects will receive the same treatment: 12 weeks of telaprevir (750 mg q8h) with Peg-IFN- alfa-2a (Pegasys(R)) (180 mcg SQ qwk) and RBV (1200 mg per day if \>75 kg or 1000mg per day if \< 75 kg). intervention 2: Fifteen subjects will receive the same treatment: 12 weeks of telaprevir (750 mg q8h) with Peg-IFN- alfa-2a (Pegasys(R)) (180 mcg SQ qwk) and RBV (1200 mg per day if \>75 kg or 1000mg per day if \< 75 kg). intervention 3: Fifteen subjects will receive the same treatment: 12 weeks of telaprevir (750 mg q8h) with Peg-IFN- alfa-2a (Pegasys(R)) (180 mcg SQ qwk) and RBV (1200 mg per day if \>75 kg or 1000mg per day if \< 75 kg).

Protocol documents:
Clinical trial NCT00908375
Conditions: Neuropathy; Radicular, Lumbar, Lumbosacral Failed Back Surgery Syndrome Spinal Stenosis Herniated Disc
Keywords: Pregabalin Radicular pain Failed back surgery Of greater than 3 months duration
Sponsor: Northwestern University
Start date: 2009-05-01; Completion date: 2012-12-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate whether pregabalin is effective in reducing the pain in patients who present with radicular pain due to a herniated disc, spinal stenosis or failed back surgery syndrome.

Detailed description:
Although the efficacy of pregabalin has been demonstrated in several pain states and it is approved by the FDA for use in post herpetic neuralgia, diabetic neuropathy and fibromyalgia there are few studies of its efficacy in patients with radicular pain from herniated disc, spinal stenosis or failed back surgery syndrome. This study was conducted to evaluate the efficacy of pregabalin in these pain states.

Arms: arm 1: A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks. arm 2: One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks.
Interventions: intervention 1: Pregabalin intervention 2: Sugar Pill
Intervention descriptions: intervention 1: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks. intervention 2: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks.

Protocol documents:
Clinical trial NCT00913458
Conditions: Active Rheumatoid Arthritis Arthritis, Rheumatoid Rheumatoid Arthritis
Sponsor: Pfizer
Start date: 2009-09-01; Completion date: 2012-12-01
Enrollment: 306 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study to evaluate whether there is sustained remission and productivity in subjects with early rheumatoid arthritis started on etanercept plus methotrexate treatment.

Detailed description:

Arms: arm 1: etanercept + methotrexate; etanercept + methotrexate
Interventions: intervention 1: etanercept
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00939510
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate hormone-resistant prostate cancer recurrent prostate cancer stage IV prostate cancer
Sponsor: Robert Dreicer MD
Start date: 2005-07-01; Completion date: 2012-12-01
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Lenalidomide may stop the growth of prostate cancer by blocking blood flow to the tumor. GM-CSF may stimulate the immune system in different ways and stop tumor cells from growing. Giving lenalidomide together with GM-CSF may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of lenalidomide when given together with GM-CSF and to see how well it works in treating patients with prostate cancer.

Detailed description:
OBJECTIVES:

* Establish the safety of a predetermined target dose or, if the target dose is not tolerable, find the maximum tolerated dose of lenalidomide when administered in combination with sargramostim in patients with androgen-independent prostate cancer.
* Evaluate the preliminary efficacy of this regimen to ascertain whether additional study of lenalidomide is warranted in patients with androgen-independent prostate cancer.
* Evaluate the safety of this regimen in these patients.
* Describe the effects of this regimen on serum cytokines (e.g., TNF-α, bFGF, sIL2R, IL-8, and IL-12) and on serum VEGF levels.
* Assess the co-stimulatory effects of this regimen on CD4+, CD8+, CD83, and CD86 cells.

OUTLINE: This is a phase I, dose-escalation study of lenalidomide followed by a phase II study.

Patients receive oral lenalidomide on days 1-21 and sargramostim subcutaneously on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Blood samples are collected periodically for correlative biomarker and immunological laboratory studies.

After completion of study therapy, patients are followed up at 30 days and then every 3 months thereafter.

Arms: arm 1: None
Interventions: intervention 1: sargramostim intervention 2: lenalidomide intervention 3: laboratory biomarker analysis
Intervention descriptions: intervention 1: All patients will receive GM-CSF at a dose of 250 mcg subcutaneously on Mondays, Wednesdays and Fridays every week. No dose escalation or de-escalations will be made to GM-CSF. intervention 2: Lenalidomide will be administered at 25 mg/day orally on days 1-21 of a 28-day cycle. Initially 6 patients will be entered at the 25 mg/day level. If 0 or 1 patients have a dose limiting toxicity, then the 25 mg lenalidomide + GM-CSF 250 mcg subcutaneously on Mondays, Wednesdays and Fridays every week will be accepted as the phase II dose. intervention 3: Prior to the initiation of each cycle of therapy for the first 3 cycles, and at discontinuation from study blood will be collected for assessments of a prostate cancer specific immune response.

Protocol documents:
Clinical trial NCT00950352
Conditions: Methamphetamine Dependence
Keywords: methamphetamine Citicoline CDP-Choline Neuroimaging MRI Brain MRS DTI
Sponsor: Perry Renshaw
Start date: 2010-01-01; Completion date: 2012-12-01
Enrollment: 104 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine if citicoline (a nutritional supplement) is effective in helping people reduce their dependence on methamphetamine. The investigators will use neuroimaging to look at the structure and chemical make up of the brain at the start of the study and after 8-9 weeks of treatment of citicoline or placebo.

Detailed description:
This is a prospective, randomized, double-blind, placebo-controlled study, in which we will systematically evaluate the therapeutic effects of citicoline, which may both increase dopamine and normalize cognitive and structural deficits in the brains of methamphetamine dependent subjects. Methamphetamine dependent subjects will undergo baseline and repeat cognitive assessments after 8-9 weeks of placebo or oral citicoline as a nutritional supplement. We will also evaluate the chemical and structural changes in brain regions identified by magnetic resonance spectroscopy (MRS), diffusion tension imaging (DTI) and cortical thickness, which in turn are expected to recover after 8-9 weeks of citicoline treatment. Specific brain regions of interest include the prefrontal cortices, temporal cortex, and the caudate/putamen all of which are known to be involved in the pathophysiology of methamphetamine dependence.

Arms: arm 1: In a double-blind randomization design, subjects with methamphetamine dependence will be treated with citicoline or placebo for 8-9 weeks. arm 2: In a double-blind randomization design, subjects with methamphetamine dependence will be treated with citicoline or placebo for 8-9 weeks.
Interventions: intervention 1: Citicoline intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects will be given 1g citicoline twice daily for a total of 8-9 weeks. intervention 2: Subjects will be given 1 capsule of placebo twice daily for 8-9 weeks. They will be taking the same quantity as the citicoline group.

Protocol documents:
Clinical trial NCT00951899
Conditions: Type 2 Diabetes
Keywords: Incretins colesevelam hepatobiliary circulation
Sponsor: Mayo Clinic
Start date: 2009-08-01; Completion date: 2012-12-01
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of this study was to determine the metabolic mechanism for a certain type medication's ability to lower blood sugar after a meal in Type 2 Diabetics, in order to develop a better understanding of it's potential role in the treatment of obesity.

Detailed description:
Welchol (colesevelam hydrochloride) is a bile acid sequestrant (BAS) recently approved by the FDA for glucose lowering in patients with type 2 diabetes mellitus. Four randomized, controlled clinical studies in subjects with type 2 diabetes have demonstrated significant treatment difference in HbA1c (-0.5%). Study durations ranged from 12-26 weeks of therapy. In diabetes clinical studies, a therapeutic response to colesevelam hydrochloride, as reflected by reduction in A1c was initially noted following 4-6 weeks of treatment and reached maximal or near-maximal effect after 12-18 weeks of treatment. Reductions in both fasting plasma glucose and postprandial concentrations have been demonstrated. Simple measures of insulin secretion and action have suggested that this is due to improved insulin action rather than improved insulin secretion. The mechanism by which bile acids interact with the key pathways regulating glucose concentrations is largely unknown. The investigators propose a randomized, double-blind, placebo controlled trial with a parallel-group design where subjects are randomized to receive colesevelam or matching placebo for a 12 week treatment period. A labeled mixed meal before and after treatment will be used to measure intestinal transit, postprandial and fasting glucose fluxes, insulin secretion and action as well as enteroendocrine secretion.

Arms: arm 1: Treatment with colesevelam hydrochloride in addition to Metformin and Diet arm 2: Treatment with placebo in addition to Metformin and Diet
Interventions: intervention 1: Colesevelam intervention 2: Placebo intervention 3: Diet intervention 4: Metformin
Intervention descriptions: intervention 1: Colesevelam hydrochloride; three 625mg tablets taken orally twice per day before breakfast and before the evening meal over a 12-week treatment period. intervention 2: Three placebo tablets matching the active drug colesevelam in appearance, taken orally twice per day before breakfast and before the evening meal over a 12-week treatment period. intervention 3: Subjects were instructed to follow a weight maintenance diet (\~55% carbohydrate, 30% fat and 15% protein) for the 12 week study period. intervention 4: Subjects continued to take their pre-study therapeutic doses of metformin (Metformin 500mg tablets taken by mouth twice daily for a total daily dose of 1000 to 2000 mg) through the 12 week study period.

Protocol documents:
Clinical trial NCT00962949
Conditions: Postural Orthostatic Tachycardia Syndrome (POTS)
Keywords: POTS Orthostatic intolerance
Sponsor: Vanderbilt University Medical Center
Start date: 2009-04-01; Completion date: 2012-12-01
Enrollment: 28 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the role of the renin-angiotensin-aldosterone in the pathophysiology of postural tachycardia syndrome, and to provide an insight about the disease process in this disorder.

Detailed description:

Arms: arm 1: Healthy controls arm 2: Patients with Postural Tachycardia Syndrome
Interventions: intervention 1: Angiotensin II
Intervention descriptions: intervention 1: Angiotensin II infusion for 1 hour

Protocol documents:
Clinical trial NCT00978822
Conditions: Subarachnoid Hemorrhage Hypertension
Keywords: Subarachnoid hemorrhage Hypertension brain Aneurysm intracerebral hemorrhage antihypertensive calcium channel blockers infusion neurocritical care
Sponsor: Henry Ford Health System
Start date: 2009-06-01; Completion date: 2012-12-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is designed to assess how rapidly and how safely Clevidipine can be used to control high Blood Pressure in patients with subarachnoid hemorrhage which is a type of brain bleed that happens because of a weak balloon like structure in one of the brain vessels. Control of blood pressure is of high value in preventing this balloon that ruptured and bled from rebleeding. The ultimate cure would be to shut down the aneurysm by a surgical procedure. Clevidipine is a drug that can lower blood pressure and it is given through the vein as a continuous infusion. It is a very short acting drug which is important in controlling labile blood pressure condition with rapid changes between up and down. This trial will test for its rapid actions and check for any side effects and possibly any other potential benefit.

Detailed description:
This is a single center, single-arm, non-blinded dose titration efficacy and safety trial evaluating the ability of clevidipine, a vascular-selective L-type calcium channel antagonist, to rapidly control acute hypertension in patients with aneurysmal subarachnoid hemorrhage. At screening a clinical and neurological examination will be carried out. For the purposes of this study, acute hypertension will be defined as a range of SBP to be controlled within immediately prior to initiation of study drug. Approximately 20 patients with acute A SAH will be enrolled. Infusion of study drug will be initiated as soon ass the patient arrives in the ER and diagnosis is made and consent is obtained. All eligible patients will be enrolled to receive clevidipine in an open label manner.

Clevidipine will be infused at an initial rate of 2.0 mg/h for the first 90 seconds. Thereafter, titration to higher infusion rates can be attempted as needed q90 seconds to obtain the target SBP range.

Titration to effect is to proceed by doubling the dose every 90 seconds, up to a maximum of 32.0 mg/h, until the desired effect (SBP within the target range) is attained. Clevidipine infusion may continue for up to a maximum of 48 hours. Blood pressure and ICP recording will be recorded q 5 minutes. Assessment of safety will be performed throughout the treatment period and until 6 hours after termination of study drug.

Arms: arm 1: None
Interventions: intervention 1: Clevidipine butyrate injectable emulsion
Intervention descriptions: intervention 1: Clevidipine butyrate injectable emulsion infusion starting at 2 mg/hour and titrating up for effect till 32 mg/h for up to 24 hours starting in the emergency department and continued in the critical care units.

Protocol documents:
Clinical trial NCT00980018
Conditions: Chronic Myelogenous Leukemia
Keywords: CML Leukemia Tasigna nilotinib AMN107 CML-CP Chronic Phase
Sponsor: Novartis Pharmaceuticals
Start date: 2009-12-01; Completion date: 2012-12-01
Enrollment: 52 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this exploratory study will be to examine changes in chronic low grade chronic adverse events, measured by Common Terminology Criteria for Adverse Events (CTCAE) grading, when patients are switched from imatinib to nilotinib therapy.

Detailed description:

Arms: arm 1: Participants received two 150 \[a total of 300 mg at each dosing\] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules \[a total of 400 mg at each dosing\] for patients enrolled prior to Protocol Amendment 1).
Interventions: intervention 1: Nilotinib
Intervention descriptions: intervention 1: Participants received two 150 \[a total of 300 mg at each dosing\] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules \[a total of 400 mg at each dosing\] for patients enrolled prior to Protocol Amendment 1).

Protocol documents:
Clinical trial NCT00986427
Conditions: Brittle Nails
Sponsor: Julian M. Mackay-Wiggan
Start date: 2009-07-01; Completion date: 2012-12-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This purpose of this study is to assess the safety and effectiveness of Restasis® ophthalmic emulsion versus emulsion alone( Refresh Dry Eye therapy) both for the treatment of brittle nails and for the enhancement of normal nail growth and texture. The investigators think that daily application of Restasis® to nails and nail beds in patients with brittle nails will enhance nail growth and improve nail texture in both affected and unaffected nails.

Detailed description:
This is a single center, investigator-blinded (investigator masked), head to head comparison of Restasis® and its vehicle, Refresh® Dry Eye Therapy in 24 patients. Three target fingernails will be identified in each subject. Two of the target nails will be the two nails that have the most severe signs of brittle nail syndrome. The third target nail will be a normal nail or, in the absence of a normal nail, the patient's second-healthiest appearing nail. The patients most normal-appearing nail will be untreated so that growth in the treated nails can be compared to growth in an untreated normal nail, this will be the fourth target nail. Study medication will be applied to target nails (the subjects may also apply to all nails if they wish, except one nail which will be untreated in order to determine the subject's baseline rate of fingernail growth) for 24 weeks. The target nails will be assessed at each visit, every four weeks. There will be a 12-week follow up period after treatment is completed.

This 36 week study will be conducted at one center. Adult male and female patients meeting the inclusion and exclusion criteria will be screened for eligibility. The principal investigator or his/her designee will obtain informed consent from all patients before any protocol specific procedures are performed.

Arms: arm 1: Subjects will apply Restasis® to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period. arm 2: Subjects will apply Refresh® Dry Eye therapy to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
Interventions: intervention 1: Restasis (cyclosporine ophthalmic emulsion) 0.05% intervention 2: Refresh® Dry Eye therapy
Intervention descriptions: intervention 1: cyclosporine ophthalmic emulsion 0.05% intervention 2: Emulsion contains glycerin 1% and polysorbate 80

Protocol documents: