ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00702962
Conditions: Small Cell Lung Cancer
Keywords: lung cancer small cell lung cancer
Sponsor: Milton S. Hershey Medical Center
Start date: 2008-09-01; Completion date: 2012-07-01
Enrollment: 8 participants; Allocation: ; Intervention model: SEQUENTIAL

Brief summary:
The Phase I portion of the study is to assess the maximum tolerated dose of vorinostat when combined with carboplatin plus etoposide. The Phase II portion is to determine progression-free survival among patients with extensive disease small cell lung cancer receiving carboplatin plus etoposide with vorinostat.

Detailed description:
Vorinostat inhibits growth and induces apoptosis in various human carcinoma cells. Furthermore, it affects the expression of various genes that are necessary for proliferation of cancer cells. Vorinostat also appears to block angiogenic signaling. Pre-treating four human cancer cell lines (including a brain tumor line) with vorinostat increased the killing efficiency of etoposide, ellipticine, doxorubicin, or cisplatin, but not of the topoisomerase I inhibitor camptothecin 13. Topoisomerase II is a ubiquitous nuclear enzyme that is involved in DNA replication, transcription, chromosome segregation, and apoptosis. It is the target for several anti-cancer drugs including etoposide. Treatment with HDAC inhibitors induces expression of topoisomerase II in cancer cells and enhances the sensitivity to etoposide 14.

Early phase clinical trials have demonstrated single agent anti-cancer activity with vorinostat. In our study, combination of vorinostat with carboplatin and paclitaxel, demonstrated promising anticancer activity against NSCLC, including histological subsets of patients whose tumors demonstrated neuroendocrine differentiation 8. For all these reasons, vorinostat is a rational choice to combine with the regimen of carboplatin and etoposide for evaluation in patients with SCLC-ED.

Arms: arm 1: Vorinostat 200 mg PO QD D1-14; Administer with Carbo 6 (AUC) D3; Etoposide 100 mg/m2 D1,2,3 "Vorinostat", "Carboplatin", "Etoposide"
Interventions: intervention 1: Vorinostat, Carboplatin, Etoposide
Intervention descriptions: intervention 1: Study originally a Phase I standard dose escalation of the study medication Vorinostat with sequential cohorts of 3-6 participants entered to 3 dose levels (200mg, 300mg, 400mg). Dose escalation stopped after participant 1 on dose level 2 due to recently published research identifying an appropriate dosing regimen. A set dose was then to be administered to all subsequent participants. This regimen (a "cycle") consisted of Vorinostat on Day 1 through Day 4, Carboplatin AUC 6 on Day 3, and Etoposide 100 mg/m2 on Day 3 through Day 5. Treatment cycles were repeated every 21 days (3 weeks) for 4 cycles total.

Protocol documents:
Clinical trial NCT00721110
Conditions: Abdominal Hysterectomy (& Wertheim)
Keywords: pain control nausea surgery recovery
Sponsor: The Cleveland Clinic
Start date: 2008-07-01; Completion date: 2012-07-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
This study is being done to determine if combined infusions of lidocaine and ketamine is better than a lidocaine or ketamine infusion alone, or to placebo in improving recovery after abdominal hysterectomy. Participants will be randomized into one of four groups. Evaluations will be done through walking tests, pain and fatigue questionnaires and blood tests.

Detailed description:
Subjects undergoing abdominal hysterectomy surgery are randomized into one of four groups: Intravenous Lidocaine, Intravenous Ketamine, Intravenous Lidocaine and Ketamine or Placebo. Subjects will perform a six-minute walk test prior to surgery and on the second day postoperatively. After surgery and on days 1 and 2 after surgery, subjects will rate their pain. On day 1 postoperatively, subjects will rate their fatigue. On postoperative days 1 and 2 incisional pain will be analysed using von Frey filaments. Two hours after surgery, 10 ml of venous blood will be sampled for cytokine analysis. Telephone follow up will take place 6 and 12 months postoperatively to access pain and quality of life.

Arms: arm 1: Intravenous Lidocaine Group - Lidocaine is administered intravenously throughout surgery and during the 24 hours following surgery arm 2: A lidocaine placebo is administered intravenously throughout surgery and during the 24 hours after surgery. arm 3: Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery arm 4: both ketamine and Lidocaine are administered intravenously throughout surgery and during the 24 hours after surgery.
Interventions: intervention 1: Lidocaine intervention 2: Placebo intervention 3: Ketamine intervention 4: Ketamine + Lidocaine
Intervention descriptions: intervention 1: Upon general anesthesia induction, lidocaine (1.5 mg/kg) will be given. Lidocaine infusion of 2 mg/kg/hour, to a maximum of 200 mg/hour during The lidocaine infusion will be reduced to 1.3 mg/kg/hour, to a maximum of 133 mg/hour, at skin closure and discontinued 24 hours postoperatively. intervention 2: Placebo boluses and infusions will be substituted intervention 3: Ketamine (0.25 mg/kg) will be given followed by an infusion of ketamine (0.25 mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively. intervention 4: both Ketamine and Lidocaine will be given

Protocol documents:
Clinical trial NCT00726986
Conditions: Lung Cancer
Keywords: extensive stage small cell lung cancer
Sponsor: Afshin Dowlati, MD
Start date: 2008-07-01; Completion date: 2012-07-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with combination chemotherapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving sorafenib together with cisplatin and etoposide works in treating patients with extensive-stage small cell lung cancer.

Detailed description:
OBJECTIVES:

* To evaluate the 1-year progression-free survival of patients with extensive-stage small cell lung cancer treated with sorafenib tosylate in combination with cisplatin and etoposide.
* To evaluate the 1-year overall survival and response rate in these patients.
* To evaluate the safety of these drugs in these patients.

OUTLINE: This is a multicenter study.

Patients receive cisplatin IV over 30-60 minutes on day 1 and etoposide IV over 60 minutes on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral sorafenib tosylate twice daily beginning on day 1 of course 1 and continuing for up to 1 year in the absence of disease progression or unacceptable toxicity.

Arms: arm 1: None
Interventions: intervention 1: cisplatin intervention 2: etoposide intervention 3: sorafenib tosylate
Intervention descriptions: intervention 1: Cisplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. intervention 2: Etoposide IV over 60 minutes on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. intervention 3: Oral sorafenib tosylate twice daily beginning on day 1 of course 1 and continuing for up to 1 year in the absence of disease progression or unacceptable toxicity.

Protocol documents:
Clinical trial NCT00735826
Conditions: Aerodigestive Tract Cancer Lung Cancer Esophageal Cancer Head and Neck Cancer
Keywords: resectable stage I-III NSCLC vorinostat esophagus head and neck proof of principle
Sponsor: Dartmouth-Hitchcock Medical Center
Start date: 2009-03-01; Completion date: 2012-07-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary aim is to study the effects of vorinostat on cyclin E, cyclin D1 and Ki-67 expression in aerodigestive tract tumors (lung, esophagus, and head and neck). Secondary aims are: To evaluate the concentration of vorinostat in tumor tissue and to correlate tumor tissue distribution with the plasma level in these patients; to perform exploratory analyses of the effects of vorinostat on the induction of apoptosis or necrosis in treated as compared to untreated tumors and on expression of p21, p27, EGFR and phospho-EGFR in aerodigestive tract tumors.

Detailed description:

Arms: arm 1: Vorinostat will be administered orally once daily in an open-labeled unblinded manner to all subjects enrolled in the study. Subjects will received 400 mg once daily on a continuous daily basis for 7 to 10 days prior to surgical resection.
Interventions: intervention 1: Vorinostat
Intervention descriptions: intervention 1: Vorinostat will be administered orally once daily in an open-labeled, unblinded manner to all subjects enrolled in the study. Subjects will receive vorinostat 400 mg once daily on a continuous daily basis for 7 to 10 days prior to surgical resection. Vorinostat should be taken with food within 0 to 30 minutes of a meal if possible. Patients should take the medication at approximately the same time each day on an ongoing basis. Missed doses will not be made up.

Protocol documents:
Clinical trial NCT00763750
Conditions: Brain Tumor
Keywords: glioblastoma multiforme or anaplastic glioma
Sponsor: howard safran
Start date: 2008-10-01; Completion date: 2012-07-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the antitumor activity of PPX in combination with temozolomide and radiation for patients with newly diagnosed brain tumors.

Detailed description:
To evaluate the safety/tolerability and potential antitumor activity of PPX in combination with temozolomide and radiation for patients with newly diagnosed brain tumors.

Arms: arm 1: XRT 60Gy at 2 GY/fractions x 30 fractions TMZ 75mg/m2/day PPX 40mg/m2/week x 6 weeks Days 1,8,15,22,22,29,36
Interventions: intervention 1: PPX +TMZ+XRT
Intervention descriptions: intervention 1: PPX 50 mg/m2/week x 6 weeks (Days #1, 8, 15, 22, 29, 36) XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide 75 mg/m2/day: Day #1 of XRT until completion (including weekends and holidays)

Protocol documents:
Clinical trial NCT00770679
Conditions: Diabetes
Sponsor: Johns Hopkins University
Start date: 2008-06-01; Completion date: 2012-07-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Cholesterol-lowering drugs called statins improve the functioning of the endothelium, and help prevent heart disease. The investigators are testing whether statins improve endothelial function more in the arteries that have worse endothelium to begin with. One of the functions of the endothelium is to help control how blood vessels dilate (expand) or contract (narrow) in different situations. This affects how blood flows through those vessels. Magnetic resonance imaging (MRI) can be used to evaluate endothelial function in the arms and legs noninvasively.

Detailed description:
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Arms: arm 1: 80 mg atorvastatin daily for 3 weeks
Interventions: intervention 1: lipitor
Intervention descriptions: intervention 1: 80 mg everyday (QD) for 3 weeks

Protocol documents:
Clinical trial NCT00789750
Conditions: Type 2 Diabetes Mellitus
Sponsor: Daiichi Sankyo
Start date: 2009-04-01; Completion date: 2012-07-01
Enrollment: 562 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The current study investigates colesevelam as add-on therapy to pioglitazone to improve glycemic control in subjects with type 2 diabetes mellitus not adequately controlled with pioglitazone monotherapy or pioglitazone in combination with either metformin or a sulfonylurea. The study will evaluate if colesevelam add-on to pioglitazone therapy for type 2 diabetes mellitus will be safe, well tolerated, and efficacious.

Detailed description:

Arms: arm 1: Participants receive six colesevelam tablets (3.8 grams/day) in addition to pioglitazone-based therapy (30 mg or 45 mg) arm 2: Participants receive six placebo tablets in addition to pioglitazone-based therapy (30 mg or 45 mg)
Interventions: intervention 1: Colesevelam intervention 2: Placebo intervention 3: Pioglitazone
Intervention descriptions: intervention 1: Colesevelam 625 mg tablets intervention 2: Placebo tablets appearing to be colesevelam intervention 3: 30 mg or 45 mg pioglitazone therapy

Protocol documents:
Clinical trial NCT00790738
Conditions: Depression Bipolar Disorder
Keywords: bipolar disorder depression treatment randomized controlled trial
Sponsor: Northwell Health
Start date: 2008-07-01; Completion date: 2012-07-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluates the efficacy of the thyroid hormone T3 for depression in patients with bipolar disorder. In this study patients will be randomized to receive T3 or placebo.

Detailed description:
Bipolar affective disorder is a debilitating illness, and is characterized by depression episodes that dominates the longitudinal course and are most difficult to treat. Controlled trials with monotherapy mood stabilizers such as lithium and valproate show little to no efficacy and antidepressants may offer no additional efficacy. Recently there has been a growing interest in the use of quetiapine in bipolar depression. However, a successful treatment may take up to 8 weeks, and full remission is achieved in only 50% of patients. Thyroid hormone augmentation strategies have been used in unipolar depression with good results, but there is a paucity of its efficacy in bipolar depression (BD). To our knowledge there are no controlled studies regarding the efficacy of thyroid augmentation in BD. The present study proposes to evaluate the efficacy of T3 as an augmentation to treatment as usual in the treatment of BD. We plan to enroll patients with bipolar disorder I or II who are currently presenting with depressive symptoms. Patients will be randomized to 2 groups - liothyronine or placebo Results will provide information on the possible role of thyroid hormone augmentation in the treatment of patients with bipolar depression, and may contribute to alleviate the burden of this disabling condition.

Arms: arm 1: liothyronine (T3) arm 2: placebo
Interventions: intervention 1: Liothyronine (T3) intervention 2: placebo
Intervention descriptions: intervention 1: liothyronine (T3) up to 50 micrograms a day intervention 2: placebo

Protocol documents:
Clinical trial NCT00810368
Conditions: Persian Gulf Syndrome
Keywords: Carnosine antioxidant Persian Gulf War Gulf War Syndrome GWI Gulf War Illness Exercise Chronic Fatigue Fibromyalgia Veterans Irritable Bowel Syndrome Migraine headaches Neuropathy Multiple Chemical Sensitivity
Sponsor: Georgetown University
Start date: 2008-08-01; Completion date: 2012-07-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to perform a randomized double-blind, placebo-controlled, 12 week study of the effects of carnosine on cognitive, psychometric, autonomic, and muscle strength outcomes in 100 GWI subjects.

Detailed description:
Background: Homocarnosine (beta-alanine - gamma-aminobutyric acid) is one of the most abundant dipeptides in the brain. It has important antioxidant properties. Both beta-alanine and GABA are neurotransmitters, suggesting that cleavage of this dipeptide by carnosine dipeptidase 1 (CNDP1) may have important regulatory functions in vivo.

Drug: Homocarnosine is not available. Carnosine (beta-alanine - histidine) is an over-the-counter dietary supplement that shares the antioxidant properties. We proposed that oral carnosine would be absorbed from the gut, cross the blood brain barrier, reduce presumed brain oxidant stress that participated in illness pathology, and improve subject health.

Hypothesis: Carnosine supplementation for 12 weeks by mouth in Gulf War Illness subjects would improve cognitive and other outcomes compared to placebo treatment.

Subjects: Gulf War Illness subjects met 1996 Fukuda criteria for Chronic Multisymptom Illness.

Design: Pilot study. Double blind randomized placebo controlled with comparisons between Week 0 (Baseline, pre-randomization) and Week 12 (end of study) Outcomes: This pilot study included included cognitive testing, magnetic resonance imaging during the 2-back working memory task, self-report of psychometric and other subjective symptoms, tenderness testing by dolormetry, and pain threshold to assess reproducibility in the placebo-treated subjects, and potential treatment effects in the active study drug subjects. The study and each of the outcomes at weeks 0 and 12 are described in detail in the final published paper and in its extensive supplementary on-line materials (Baraniuk JN et al. Glob J Health Sci. 2013 5:69-81. PMID:23618477 PMCID:PMC4209301).

An improvement on accuracy on the 2-back working memory task between 0 and 12 weeks was the primary outcome.

Other evaluations were secondary outcomes.

Arms: arm 1: Carnosine treatment group arm 2: Placebo control group
Interventions: intervention 1: Carnosine intervention 2: Placebo
Intervention descriptions: intervention 1: 500mg Carnosine x2 daily intervention 2: Microcrystalline cellulose placebo tablets x2 daily

Protocol documents:
Clinical trial NCT00814346
Conditions: Alzheimer's Disease Cognitive Impairment
Keywords: Mild Alzheimer's disease (AD) patients Memory complaint patients with cognitive impairment (MC) Memory complaint patients cognitively normal (CNE)
Sponsor: Ipsen
Start date: 2008-10-01; Completion date: 2012-07-01
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the study is to evaluate the effect of EGb761®, in comparison to placebo, on cerebral glucose metabolism, in three groups of elderly patients: newly diagnosed mild Alzheimer's disease (AD), memory complaint patients with cognitive impairment (MC) and memory complaint patients cognitively normal (CNE). The first phase includes four weeks treatment with EGb761® for all groups, with change in brain glucose metabolism at month 1 using 18 FDG-PET, as primary endpoint which will be followed by an open 17 months follow-up (FU) period with EGb761® treatment in MC and CNE patients.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: EGb761® intervention 2: Placebo
Intervention descriptions: intervention 1: Four weeks for AD patients, 18 months for MC and CNE patients intervention 2: Placebo 1 tablet BID

Protocol documents:
Clinical trial NCT00821951
Conditions: Non-Small Cell Lung Cancer (NSCLC)
Sponsor: Yale University
Start date: 2009-05-01; Completion date: 2012-07-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a dose escalation study that will assess the safety of Vorinostat, a Histone Deacetylase (HDAC) inhibitor, in combination with palliative radiotherapy in patients with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC). Vorinostat has been approved for use in patients with cutaneous T-cell lymphomas, but several pre-clinical studies suggest activity in lung cancer cell lines. Several HDAC inhibitors,including Vorinostat, may enhance the effect of radiotherapy, and this study will seek to confirm this.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Vorinostat intervention 2: Radiotherapy
Intervention descriptions: intervention 1: 200 mg, 300 mg, 400 mg, once per RT fraction intervention 2: Standard fractionation of 3.0 Gy per day over 2 weeks, to a total dose of 30 Gy, will be utilized for all patients. All patients will be treated one time per day, 5 days per week unless interruption is clinically indicated.

Protocol documents:
Clinical trial NCT00845728
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Indacaterol Tiotropium COPD
Sponsor: Novartis Pharmaceuticals
Start date: 2009-03-01; Completion date: 2012-07-01
Enrollment: 3439 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study compares indacaterol with tiotropium in terms of bronchodilation over 52 weeks

Detailed description:

Arms: arm 1: Indacaterol 150 µg o.d. delivered via single-dose dry powder inhaler (SDDPI) arm 2: Tiotropium 18 µg o.d. delivered via the handihaler®
Interventions: intervention 1: Indacaterol 150 µg intervention 2: Tiotropium
Intervention descriptions: intervention 1: Indacaterol 150 µg o.d. delivered via SDDPI intervention 2: Tiotropium 18 µg o.d. delivered via handihaler®

Protocol documents:
Clinical trial NCT00864721
Conditions: Non Small Cell Lung Cancer
Keywords: Untreated NSCLC in patients > 70
Sponsor: US Oncology Research
Start date: 2009-02-01; Completion date: 2012-07-01
Enrollment: 63 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to find out what effects (good and bad) sunitinib has on patients and their NSCLC.

Detailed description:
In this trial, the activity and tolerability of sunitinib malate (Sutent) will be examined in previously untreated elderly patients (\>70 years old) felt not to be candidates for standard cytotoxic chemotherapy.

Arms: arm 1: Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle.
Interventions: intervention 1: Sutent
Intervention descriptions: intervention 1: Sunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle.

Protocol documents:
Clinical trial NCT00871780
Conditions: Relapsing Remitting Multiple Sclerosis (RRMS)
Keywords: TYSABRI naive Relapsing-remitting multiple sclerosis (RRMS)
Sponsor: Biogen
Start date: 2009-08-01; Completion date: 2012-07-01
Enrollment: 224 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of the study is to evaluate the evolution of walking capacity as measured by the timed 100-meter walk test (T100T), timed 25-foot walk test (T25FW), maximum walking distance (MWD), and Expanded Disability Status Scale (EDSS) during the first year of therapy with natalizumab. The secondary objectives of this study are as follows:

* To evaluate the correlation between the MWD and EDSS and both walking tests, the T100T and the T25FW at Baseline, at Week 24 and at Week 48 of therapy.
* To determine how well each of the walking tests, T100T or T25FW, predicts walking limitations in all participants and in the subgroups of participants stratified by baseline EDSS.

Detailed description:

Arms: arm 1: natalizumab 300 mg IV every 4 weeks for 48 weeks
Interventions: intervention 1: BG00002 (natalizumab)
Intervention descriptions: intervention 1: None

Protocol documents: