ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01077713
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche
Start date: 2010-02-01; Completion date: 2014-07-01
Enrollment: 86 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study will evaluate the efficacy and safety of Avastin + gemcitabine, and Avastin + gemcitabine + attenuated doses of cisplatin, as first line treatment in elderly patients with non-squamous non-small cell lung cancer. Patients will be randomised to receive either Avastin 7.5mg/kg iv on day 1 + gemcitabine 1200mg/m2 on days 1-8 of each 3 week cycle, or Avastin 7.5mg/kg iv on day 1 + cisplatin 60mg/m2 on day 1 + gemcitabine 1000mg/m2 on days 1-8 of each 3 week cycle. After 6 cycles of combination therapy, all patients will continue to receive Avastin monotherapy. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: bevacizumab [Avastin] intervention 2: cisplatin intervention 3: gemcitabine intervention 4: gemcitabine
Intervention descriptions: intervention 1: 7.5mg/kg iv on day 1 of each 3 week cycle intervention 2: 60mg/m2 on day 1 of each 3 week cycle intervention 3: 1200mg/m2 on days 1-8 of each 3 week cycle intervention 4: 1000mg/m2 on days 1-8 of each 3 week cycle

Protocol documents:
Clinical trial NCT01209195
Conditions: Locally Advanced/Metastatic or Recurrent Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer or Endometrial Cancer Locally Advanced/Metastatic Her2 Non Overexpressing Breast Cancer
Keywords: Ovarian cancer HER-2 negative breast cancer Breast cancer Fallopian tube cancer
Sponsor: Merrimack Pharmaceuticals
Start date: 2010-10-01; Completion date: 2014-07-01
Enrollment: 41 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study was a Phase 1 and pharmacologic open-labeled dose-escalation trial of MM-121 in combination with paclitaxel using a "3+3" design.

Detailed description:
Successive cohorts of three or more patients were treated at escalating doses until a maximum tolerated dose/recommended phase 1 dose was identified. Once the maximum tolerated dose was identified, an Expansion Cohort was enrolled at that dose to further characterize safety and to explore pharmacodynamic endpoints.

Arms: arm 1: Escalating doses of MM-121 given IV QW in combination with paclitaxel at standard dose of 80 mg/m2 IV QW
Interventions: intervention 1: MM-121 intervention 2: Paclitaxel
Intervention descriptions: intervention 1: increasing doses of MM-121 IV QW intervention 2: Paclitaxel - 80 mg/m2 IV QW

Protocol documents:
Clinical trial NCT01493531
Conditions: Gout
Keywords: Gout
Sponsor: Ardea Biosciences, Inc.
Start date: 2011-12-01; Completion date: 2014-07-01
Enrollment: 610 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the serum uric acid lowering effects, clinical benefits, and safety of lesinurad in combination with allopurinol to allopurinol alone in subjects with gout who have had an inadequate response to allopurinol.

Detailed description:
Allopurinol is the standard of care for the treatment of gout. Nevertheless, most patients treated with allopurinol do not achieve the recommended sUA target of \< 6.0 mg/dL and need additional therapy to achieve the target. Probenecid and benzbromarone are URAT1 inhibitors, generally recommended as second-line agents for patients who are either resistant to or intolerant of allopurinol. However, benzbromarone is not available in the US and probenecid is rarely used. Consequently, there is a clear unmet medical need for a new safe and effective therapy for gout, such as lesinurad, a potent URAT1 inhibitor, that can be used in combination with allopurinol in patients not responding adequately to allopurinol monotherapy so that very high rates of response can be achieved by nearly all gout patients, rather than a minority.The subjects selected for this study will have moderate to severe gout with an inadequate response to allopurinol

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Lesinurad intervention 2: Lesinurad intervention 3: Placebo intervention 4: Allopurinol
Intervention descriptions: intervention 1: Tablets, 200 mg QD intervention 2: Tablets, 400 mg QD intervention 3: Tablets, Placebo QD intervention 4: Tablets

Protocol documents:
Clinical trial NCT01811732
Conditions: Skin and Subcutaneous Tissue Bacterial Infections
Keywords: Bacterial skin infection skin infection infection skin delafloxacin vancomycin aztreonam MRSA bacteria bacterial infection Anti-Infective Agents Anti-Bacterial Agents
Sponsor: Melinta Therapeutics, Inc.
Start date: 2013-04-01; Completion date: 2014-07-01
Enrollment: 660 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was designed to evaluate the efficacy of delafloxacin patients with acute bacterial skin and soft tissue infections (ABSSSI).

Detailed description:
The efficacy and safety of delafloxacin, compared to that of vancomycin plus aztreonam, will be evaluated in a population of patients with acute bacterial skin and soft tissue infections (ABSSSI), including major cutaneous abscesses, wound infections, cellulitis/erysipelas, and burn-related infections.

Arms: arm 1: Delafloxacin 300 mg IV every 12 hours for a minimum of 10 and up to a maximum of 28 doses arm 2: Vancomycin 15 mg/kg IV plus two grams Aztreonam every 12 hours for a minimum of 10 and up to a maximum of 28 doses (Aztreonam was discontinued as soon as possible if a gram-negative organism was not identified in baseline cultures)
Interventions: intervention 1: Delafloxacin intervention 2: Vancomycin intervention 3: Aztreonam intervention 4: Placebo
Intervention descriptions: intervention 1: Delafloxacin intervention 2: Vancomycin intervention 3: Aztreonam intervention 4: Placebo

Protocol documents:
Clinical trial NCT00041938
Conditions: Heart Disease Stroke Ischemic Heart Disease Myocardial Infarction
Keywords: heart disease stroke ischemic heart disease myocardial infarction atrial fibrillation low ejection fraction cardiac failure aspirin Warfarin anticoagulant
Sponsor: Columbia University
Start date: 2002-10-01; Completion date: 2014-07-01
Enrollment: 2305 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine which of two treatments, Warfarin or aspirin, is better for preventing death and stroke in patients with poor heart function.

We are now transitioning into the sub-analysis part of the WARCEF patient data.

The study has recently completed data analysis for its Primary Aim. All randomized patients have completed their follow up. All study related procedure as per the protocol has been completed. We are now in the extension phase of the study to obtain more patient data to address further aims of the study. No new procedures are performed and data already in place at the sites will be collected (EKG and echocardiograms).

The aims for this study extension are:

* To assess progression of cardiac dysfunction over time among heart failure patients
* To correlate prognosis with cardiac dysfunction

Detailed description:
Warfarin has proven effective in patients with ischemic heart disease, especially in the reduction of stroke, death and re-infarction following myocardial infarction, and in the reduction of stroke in atrial fibrillation. Warfarin is the most promising unstudied intervention in patients with cardiac failure. This randomized, double-blind, multi-center study will define optimal antithrombotic therapy for patients with cardiac (heart) failure and patients with low ejection fraction (EF). EF is the proportion of left ventricular volume emptied during systole. It reliably measures left ventricular systolic function.

With the rapidly increasing numbers of elderly patients with heart failure, this study has important public health implications. The study will determine which of two commonly used treatments Warfarin, an anticoagulant, or aspirin, a drug which affects platelet function is better for preventing death and stroke in patients with low ejection fraction.

Arms: arm 1: Aspirin: 325 mg per day arm 2: Warfarin: International Normalized Ratio (INR) 2.5-3.0; target INR 2.75
Interventions: intervention 1: aspirin intervention 2: Warfarin
Intervention descriptions: intervention 1: 325 mg per day intervention 2: INR 2.5-3.0; target INR 2.75

Protocol documents:
Clinical trial NCT00451204
Conditions: Relapsing Remitting Multiple Sclerosis
Keywords: Multiple sclerosis estrogen estriol progesterone
Sponsor: University of California, Los Angeles
Start date: 2007-03-01; Completion date: 2014-07-01
Enrollment: 158 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a double-blinded, placebo controlled study of estriol pills versus placebo pills in relapsing remitting multiple sclerosis. The study treatment will be an added on to Copaxone injections in all subjects. The primary outcome measure is a reduction in relapses.

Detailed description:
Multiple sclerosis (MS) relapses are known to be significantly decreased during pregnancy. This proposal will establish whether oral treatment with estriol, the major estrogen of pregnancy, induces a decrease in relapses in relapsing remitting multiple sclerosis (RRMS) subjects when used in combination with injectable Copaxone. Previously, in a pilot study, it has been demonstrated that treatment of RRMS subjects with oral estriol for six months resulted in a significant reduction in gadolinium enhancing lesions on serial brain MRIs (Annals of Neurology, 2002; 52:421-428) and caused a favorable shift in immune responses (Journal of Immunology, 2003; 171:6267-6274). This is an add-on study aiming to extend these previous findings by treating longer and focusing on clinical outcomes. The combination of Copaxone injection plus estriol pill (8 mg per day) will be compared to Copaxone injection plus placebo pill in a double blind trial. The duration of treatment will be two years and the primary outcome measure will be relapse rate. Other outcomes will include disability measures and brain MRI outcomes. Safety measures (blood tests and gynecologic evaluations) will also be followed and correlations will be made between serum estriol levels with efficacy and safety. The overall goal of this study will be the development of a new oral treatment, estriol, for RRMS.

Arms: arm 1: Estriol Capsules (daily) plus Copaxone injections (daily). Progestin capsules given for 2 weeks every 3 months to avoid unopposed estrogens. arm 2: Placebo Capsules (daily) plus Copaxone injections (daily). A second placebo capsule given for 2 weeks every 3 months.
Interventions: intervention 1: Estriol intervention 2: Placebo intervention 3: Copaxone
Intervention descriptions: intervention 1: Estriol 8 mg capsule, once per day, duration of treatment is 2 years intervention 2: Placebo capsule, once a day, treatment duration is 2 years intervention 3: Injection, once a day, all subjects

Protocol documents:
Clinical trial NCT00463060
Conditions: Cancer
Keywords: erlotinib celecoxib radiation progression-free survival
Sponsor: Icahn School of Medicine at Mount Sinai
Start date: 2007-01-01; Completion date: 2014-07-01
Enrollment: 47 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Cancer is the second leading cause of death in the United States, with approximately 90% of deaths resulting from patients with metastatic spread. Save for notable exceptions such as testicular cancer, chemotherapy alone cannot cure patients with metastases. Some patients with limited metastatic deposits (most commonly colon cancer spread to the liver) can be cured with surgery followed by chemotherapy. Therefore, some patients with metastases should be considered for aggressive local therapy (surgery and/or radiation).

Even though chemotherapy has improved significantly, patients treated with conventional chemotherapy and/or biologically targeted therapy are not cured of their disease. For the most common types of cancer, chemotherapy alone can shrink or stabilize tumors for an average of 6 months before the tumors regrow. Both chemotherapy and biologically targeted therapy have major limitations preventing cure of these patients.

Radiation therapy is an effective modality of treating cancer. Until recently, radiation for metastases was used only to relieve symptoms resulting from local tumor growth. Technological advances, including stereotactic radiotherapy, allow for radiation to be more precisely delivered to the tumor while sparing nearby normal organs. Stereotactic radiotherapy can completely eradicate local tumors with minimal side effects. Stereotactic radiotherapy has never been combined with drug therapy. Sutent is a new F.D.A. approved cancer therapy that targets tumor blood vessels. It is effective against two types of cancer that rarely respond to chemotherapy (GI stromal tumors and kidney cancer). We propose combining biologically targeted drug therapy with physically targeted stereotactic radiotherapy. Our goal is to determine if this is a safe regimen and the best method of combining these treatments. Ultimately, our goal is to cure some patients with previously incurable metastatic cancer with this combination.

Detailed description:

Arms: arm 1: Participants treated with chemotherapy and radiotherapy
Interventions: intervention 1: sunitinib malate (Sutent) intervention 2: radiotherapy
Intervention descriptions: intervention 1: Sutent administered PO QD from days 1 to 28 Two weeks after completion of any chemotherapy, maintenance Sutent in 6 week cycles (consisting of Sutent 50 mg PO QD weeks 1-4 followed by no treatment weeks 5-6) until progression or death If no chemotherapy is planned, maintenance Sutent (as described above) will start on day 43. intervention 2: Radiation is to be delivered to each site over 10 fractions separated by at least 16 hours. Up to 5 sites may be treated

Protocol documents:
Clinical trial NCT00480857
Conditions: Prostate Cancer
Keywords: Prostate Radiation
Sponsor: University of Michigan Rogel Cancer Center
Start date: 2007-03-01; Completion date: 2014-07-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The main purpose of this study is to try to find out whether adding chemotherapy to the standard treatment for your stage of prostate cancer is more effective than the standard treatment by itself. The kind of treatment that most physicians would consider standard for this stage of prostate cancer is radiation therapy alone, possibly in combination with hormonal therapy. In this study, all patients will receive chemotherapy and radiation therapy. It is hoped that chemotherapy will be found to provide additional benefit, but chemotherapy has significant side effects. The use of chemotherapy is experimental in prostate cancer; it needs to be tested to determine if it is beneficial and to find out more about the side effects of the two different treatments. This study is to determine the effects, good and/or bad, of adding chemotherapy to radiation therapy as "salvage" treatment for recurrent prostate cancer after surgery.

Detailed description:
There is no treatment proven more effective for clinically localized prostate cancer than radical prostatectomy. Nonetheless, approximately 30,000 men annually in the U.S. develop recurrence of their prostate cancer after prostatectomy. Radiation therapy is commonly utilized as attempted salvage treatment for patients who develop a rising PSA (Prostate Specific Antigen) after prostatectomy and have no evidence of metastatic disease. This study is designed to determine whether concurrent chemotherapy, weekly docetaxel, and daily radiation therapy will result in improved disease control and survival rates over those obtained with radiotherapy alone in the treatment of men with biochemical recurrence after radical prostatectomy.

Arms: arm 1: None
Interventions: intervention 1: Docetaxel (Taxotere)
Intervention descriptions: intervention 1: Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.

Protocol documents:
Clinical trial NCT00563797
Conditions: Alcohol Dependence Depression
Keywords: treatment alcohol dependence depression mecamylamine
Sponsor: Yale University
Start date: 2007-08-01; Completion date: 2014-07-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the efficacy of mecamylamine (MEC, 10 mg/day) versus placebo in reducing depressive and alcohol symptoms in patients with depression and co-morbid alcohol dependence. The researchers hypothesize that MEC will significantly reduce depressive symptoms and decrease alcohol consumption compared to placebo in patients with depression and alcohol dependence who are on a stable dose of a selective serotonin reuptake inhibitor (SSRI).

Detailed description:
Depression with co-morbid alcohol dependence is very prevalent and it is very costly to treat. The co occurrence of the two disorders leads to greater severity and worse long-term outcome, including suicide. Although a number of treatment strategies have been implemented for depressed patients with alcohol dependence the controversy concerning best treatment options for those patients persists.

The clinical relationship between depression and alcohol dependence suggests some common mechanism underlying both disorders. It has been hypothesized that medications that block presynaptic nAChR may be effective in the treatment of alcoholism and depression. Mecamylamine (Inversine ®) is a noncompetitive, high affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Mecamylamine has never been investigated as an effective adjunct treatment for dually diagnosed patients with depression and alcohol dependence. Methods: Thirty participants with a current diagnosis of depression and alcohol dependence will be recruited for this 12-week treatment study. Fifteen participants will be randomized to mecamylamine and fifteen to placebo. Participants will be included in the study if: they meet current DSM-IV criteria for Major Depression and Alcohol Dependence and have been on a stable SSRI dose for 2 weeks. All participants will come weekly to take their medications and complete weekly assessments. Weekly assessments will consist of questioners that will assess depressive symptoms and alcohol consumption over the entire treatment period. Significance: This study is the first to evaluate the efficacy of mecamylamine as an augmenting agent for treatment of depression and alcohol dependence.

Arms: arm 1: Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks. arm 2: Placebo capsules were prepared by the pharmacy and were identical in size and color to the medication capsules.
Interventions: intervention 1: Mecamylamine intervention 2: Placebo
Intervention descriptions: intervention 1: mecamylamine 10mg/day for 12 weeks intervention 2: Placebo pill

Protocol documents:
Clinical trial NCT00673673
Conditions: Gastroesophageal Cancer Gastric Cancer
Sponsor: Yale University
Start date: 2008-05-01; Completion date: 2014-07-01
Enrollment: 39 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase II open-label study to determine the anti-tumor efficacy and tolerability of FOLFOX in combination with bevacizumab (Avastin(TM))in patients with metastatic or unresectable gastroesophageal and gastric adenocarcinoma. Our primary objective is to determine the time to progression in patients treated with FOLFOX in combination with bevacizumab.

Detailed description:

Arms: arm 1: FOLFOX in combination with bevacizumab
Interventions: intervention 1: FOLFOX intervention 2: bevacizumab
Intervention descriptions: intervention 1: Oxaliplatin 85/mg/m2 IV infused over two hours followed by Leucovorin 400 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours intervention 2: bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy

Protocol documents:
Clinical trial NCT00691301
Conditions: Cervical Cancer
Keywords: cervical squamous cell carcinoma recurrent cervical cancer stage III cervical cancer stage IVA cervical cancer stage IVB cervical cancer
Sponsor: Gynecologic Oncology Group
Start date: 2008-09-01; Completion date: 2014-07-01
Enrollment: 55 participants; Allocation: NA; Intervention model: SINGLE_GROUP

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

PURPOSE: This phase II trial is studying the side effects of giving pemetrexed together with cisplatin and to see how well it works in treating patients with advanced, persistent, or recurrent cervical cancer.

Detailed description:
OBJECTIVES:

Primary

* To estimate the antitumor activity of pemetrexed disodium and cisplatin with objective tumor response (partial and complete response) in patients with advanced, persistent, or recurrent carcinoma of the cervix.
* To determine the nature and degree of toxicity of this regimen in these patients.

Secondary

* To determine the effects of this regimen on progression-free survival and overall survival.

OUTLINE: This is a multicenter study. Patients are stratified according to prior cisplatin therapy as a radiosensitizer (yes vs no).

Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 1-4 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Arms: arm 1: Pemtrexed plus cisplatin on day 1 every 21 days
Interventions: intervention 1: cisplatin intervention 2: pemetrexed disodium
Intervention descriptions: intervention 1: Cisplatin as an IV infusion at less than 1 mg/min over less than 4 hours at a dose of intervention 2: None

Protocol documents:
Clinical trial NCT00728468
Conditions: Advanced Malignant Solid Tumors
Keywords: Phase 1 PF-00299804 Dextromethorphan CYP2D6 Inhibition Cancer Patients
Sponsor: Pfizer
Start date: 2008-09-01; Completion date: 2014-07-01
Enrollment: 16 participants; Allocation: ; Intervention model: 

Brief summary:
Research in test tubes suggests that may affect cytochrome P450 2D6 (CYP2D6), an important enzyme that is responsible for eliminating many drugs that cancer patients need to take, including dextromethorphan. The purpose of this study is to test the impact of PF-00299804 on the activity of CYP2D6, and how the human body handles dextromethorphan.

Detailed description:
To assess the effect of repeated dosing with 45 mg QD PF-00299804 on the pharmacokinetics of dextromethorphan, a CYP2D6 probe, in cancer patients with advanced malignant solid tumors.

Arms: arm 1: None
Interventions: intervention 1: PF-00299804
Intervention descriptions: intervention 1: PF-00299804: Patients take oral 45 mg PF-00299804 once daily starting on Cycle 1 Day 1 until disease progression or unacceptable toxicities occur. One cycle equals 21 days. Dextromethorphan: Patient take a single 30 mg oral dose of dextromethorphan HBr three days prior to Cycle 1 Day 1, and then on Cycle 2 Day 7.

Protocol documents: