ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01059643
Conditions: Ovarian Cancer Non Small Cell Lung Cancer Prostate Cancer Colorectal Cancer Gastric Cancer Esophageal Cancer Cancer of Head and Neck
Sponsor: Eli Lilly and Company
Start date: 2011-04-01; Completion date: 2012-12-01
Enrollment: 103 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to estimate the rate of response for patients with ovarian, non-small cell lung, prostate, colorectal, gastroesophageal, and head and neck cancers who are administered LY2523355.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: LY2523355 intervention 2: pegfilgrastim
Intervention descriptions: intervention 1: Dose determined by participant body surface area: 5 milligrams/square meter(mg/m²) or 6 mg/m², administered intravenously as a 1-hour infusion on Days 1, 2 and 3 of a 21 day cycle; for up to 2 cycles (4 cycles for prostate cancer patients). Additional cycles administered based on patient response assessment. intervention 2: 6 milligrams (mg), administered subcutaneously approximately 24 hours after third dose of LY2523355 on Day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer patients). Additional cycles of LY2523355 administered based on patient response assessment.

Protocol documents:
Clinical trial NCT01090102
Conditions: HIV Infections Sexually Transmitted Diseases Immune System Diseases Lentivirus Infections Acquired Immunodeficiency Syndrome
Sponsor: University of California, San Francisco
Start date: 2010-06-01; Completion date: 2012-12-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of this study is to determine whether 12 weeks of mesalamine therapy added to a standard HIV treatment decreases systemic immune activation and inflammation in HIV-infected patients, possibly resulting in better recovery of the immune system. The study hypothesis is that decreasing inflammation directly in the gut may decrease both of these potential causes of chronic inflammation, potentially resulting in an immunologic benefit.

Detailed description:
While most HIV-infected patients can now achieve nearly complete viral suppression on currently available HIV medications, they still have at least a 10-year shorter life expectancy than the general population and are at higher risk for diseases associated with accelerated aging including cardiovascular disease and non-AIDS-defining cancers. Persistent inflammation and immune activation are believed to drive this increased risk. Despite suppression of viral replication in peripheral blood by effective HIV medications, HIV may continue to be expressed at low levels by T cells in the lining of the gut and may also result in translocation of bacterial products across the lining of the gut, driving persistent inflammation. We believe that decreasing inflammation directly in the gut may decrease both of these potential causes of chronic inflammation, potentially resulting in an immunologic benefit. Mesalamine is an oral anti-inflammatory drug used to treat patients with inflammatory bowel disease, acts locally on the gut tissue to decrease inflammation, and is associated with very few side effects. If mesalamine therapy reduces immune activation and inflammation in our study, it would prompt larger studies to see if mesalamine decreases clinical outcomes like cardiovascular disease, cancer, and mortality in this setting.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Mesalamine (5-aminosalicylic acid, Apriso) intervention 2: Placebo
Intervention descriptions: intervention 1: Four mesalamine capsules once daily (1.5 gram/day) for the first 12 weeks, PO(by mouth).

Four placebo capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth). intervention 2: Four placebo capsules once daily (1.5g/d) for the first 12 weeks, PO (by mouth).

Four mesalamine capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).

Protocol documents:
Clinical trial NCT01096342
Conditions: Refractory Multiple Myeloma
Sponsor: National Cancer Institute (NCI)
Start date: 2009-07-01; Completion date: 2012-12-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well giving dinaciclib works in treating patients with relapsed or refractory multiple myeloma. Dinaciclib may stop the growth of cancer cells by clocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate the efficacy (overall response rate) of single agent SCH 727965 in patients with relapsed or refractory multiple myeloma.

SECONDARY OBJECTIVES:

I. To evaluate the toxicities associated with use of single agent SCH 727965 in patients with relapsed or refractory multiple myeloma.

II. To evaluate the response duration and progression free survival among patients with relapsed or refractory multiple myeloma undergoing treatment with single agent SCH 727965.

III. To study the effect of SCH 727965 on myeloma cell proliferation, apoptotic rates and to assess the ability of the drug to inhibit drug targets (cyclin dependent kinases, cdk in the myeloma cell.

OUTLINE: This is a multicenter, dose-escalation study.

Patients receive dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Blood and bone marrow samples are collected periodically for correlative studies. (US sites only)

After completion of study treatment, patients are followed up for up to 3 years.

Arms: arm 1: Patients receive dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: dinaciclib intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given IV intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT01102972
Conditions: Infection, Human Immunodeficiency Virus
Keywords: HIV-1 HIV
Sponsor: ViiV Healthcare
Start date: 2010-04-01; Completion date: 2012-12-01
Enrollment: 297 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to compare the efficacy and safety of simplifying therapy from a regimen of atazanavir (ATV) + ritonavir (RTV) + tenofovir/emtricitabine (TDF/FTC) to a regimen of ATV + abacavir sulfate/lamivudine (ABC/3TC) without RTV in virologically suppressed, HIV-1 infected, HLA-B\*5701 negative subjects for 48 weeks.

Detailed description:
A prospective, randomized, multicenter, open-label study to compare the efficacy and safety of simplifying from a regimen of atazanavir (ATV) + ritonavir (RTV) + tenofovir/emtricitabine (TDF/FTC) to ATV + abacavir sulfate/lamivudine (ABC/3TC) without RTV for 48 weeks in virologically suppressed, HIV-1 infected, HLA-B\*5701 negative subjects.

ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.

Arms: arm 1: Subjects will change to ATV 400mg administered as two 200mg capsules orally, once daily and to the fixed-dose combination tablet of ABC 600mg/3TC 300mg (EPZICOM) administered as one tablet orally, once daily for 48 weeks. The subject's pre-study RTV will be discontinued. arm 2: Subjects will continue their pre-study therapy, un-modified, of ATV 300mg administered as one capsule orally, once daily plus RTV 100mg administered orally, once daily plus fixed dose combination tablet tenofovir 300mg/emtricitabine 200mg administered as one tablet orally, once daily for 48 weeks.
Interventions: intervention 1: Reyataz + Norvir + Truvada intervention 2: Reyataz + Epzicom
Intervention descriptions: intervention 1: atazanavir 300mg + ritonavir 100mg + tenofovir 300mg/emtricitabine 200mg intervention 2: atazanavir 400mg + abacavir 600mg/lamivudine 300mg

Protocol documents:
Clinical trial NCT01106950
Conditions: Leukemia, Myelogenous, Acute
Keywords: acute myelogenous leukemia primary acute myelogenous leukemia secondary acute myelogenous leukemia relapsed acute myelogenous leukemia
Sponsor: Masonic Cancer Center, University of Minnesota
Start date: 2010-07-01; Completion date: 2012-12-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase II therapeutic study of related donor HLA-haploidentical NK-cell based therapy after a high dose of fludarabine/cyclophosphamide with denileukin diftitox preparative regimen for the treatment of poor prognosis acute myelogenous leukemia (AML).

Detailed description:
Patients achieving a complete remission and neutrophil recovery (ANC \> 500) for at least 4 weeks will be considered for allogeneic transplant to prolong remission (independent of this study).

All patients, including those who go on to transplant, will be followed to determine disease free survival, treatment related mortality, and time to relapse.

Arms: arm 1: Patients are treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
Interventions: intervention 1: Natural Killer Cells intervention 2: Fludarabine intervention 3: Cyclophosphamide intervention 4: Denileukin diftitox intervention 5: Donor lymphapheresis intervention 6: IL-2
Intervention descriptions: intervention 1: Given by infusion on Day 0. The product is T cell-depleted (CD3-) and B cell-depleted (CD19). Target dose for infusion is \< or = 8 x 10\^7 nucleated cells/kilogram. intervention 2: Administered as a 1 hour intravenous infusion once a day for 5 doses beginning on day -6. intervention 3: Administered as a 2 hour intravenous infusion with high volume fluid flush and mesna per institutional guidelines on day -5 and -4 one hour after fludarabine infusion. (Day -4 administration may be omitted if patient has had a transplant in the previous 4 months.) intervention 4: 12 ug/kg/day will be administered on day -1 and day -2 intravenously. intervention 5: Day -1 before planned NK cell infusion, the donor will undergo lymphapheresis (Removal of lymphocytes from donated blood, with the remainder of the blood retransfused into the donor). intervention 6: Administered after NK cell infusion, 10 million units every other day for a total of 6 doses. (Patients weighing less than 45 kilograms will receive a dose of 5 million units/m\^2 every other day for 6 doses).

Protocol documents:
Clinical trial NCT01131884
Conditions: Spinal Cord Injury Osteoporosis
Keywords: ASIA A or ASIA B Spinal Cord Injury
Sponsor: University of Rochester
Start date: 2010-06-01; Completion date: 2012-12-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study is designed to evaluate the efficacy of oral fosamax in prevention on osteoporosis in acute spinal cord injury. Efficacy will be measured by a duel energy X-Ray absorptiometry (DEXA) scan every 6 months. Patients will complete 3 visits, screening, 6 months, 12 months and be required to take oral fosamax versus placebo weekly.

Detailed description:
The project was funded on August 13, 2009 and was awarded to one of our trainees, Dr. Matthew Abraham, a PGY3 in our program and our IRB approval was obtained with much time and effort on February 24, 2010. We followed the protocol and so far we recruited just one patient on September 19, 2011 who completed the study but we encountered with many unexpected obstacles to recruit any more patients to the study. The main obstacle was that the spine surgeons' refusal to start the study drug for months after surgery for fear of complications with wound healing. Secondly, the few appropriate and eligible patients we tried to recruit declined to participate.

We were unable to recruit any more patients to this study and hence the study was closed.

The one patient that was recruited completed the study. Since it is only one subject in the study, no conclusions can be drawn.

Arms: arm 1: Fosamax at 70 mgs q weekly by mouth for the duration of the study. arm 2: Double blind study using Fosamax versus placebo. Placebo is an inactive drug.
Interventions: intervention 1: Fosamax intervention 2: Placebo
Intervention descriptions: intervention 1: 70mg of Bisphosphonate therapy (Fosamax) will be taken weekly for a year intervention 2: Placebo is an inactive pill that will look similar to the active drug. You will not know whether you are receiving active drug or placebo.

Protocol documents:
Clinical trial NCT01138969
Conditions: Peptic Ulcer
Keywords: proton pump inhibitor peptic ulcer clopidogrel prevention
Sponsor: Kaohsiung Veterans General Hospital.
Start date: 2008-08-01; Completion date: 2012-12-01
Enrollment: 165 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Proton Pump Inhibitors (PPI) can prevent the recurrence of peptic ulcer in clopidogrel users.

Detailed description:
The aim of the prospective, randomized study is to investigate the efficacy of PPI in prevention of ulcer recurrence for clopidogrel users. We plan to enroll 300 clopidogrel users without baseline gastroduodenal ulcer at initial endoscopy. The patients will be randomly assigned to receive either (1) esomeprazole (20 mg qd) plus clopidogrel or (2) clopidogrel treatment alone for 6 months. The ulcer recurrence rate between the treatment groups will be compared.

Arms: arm 1: esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months arm 2: clopidogrel 75 mg qd for 6 months
Interventions: intervention 1: esomeprazole
Intervention descriptions: intervention 1: esomeprazole 20 mg qd for 6 months

Protocol documents:
Clinical trial NCT01141049
Conditions: Alcohol Dependence
Keywords: Alcohol Withdrawal Reducing Alcohol Consumption Promoting abstinence in alcohol-dependent patients Gabapentin
Sponsor: New York State Psychiatric Institute
Start date: 2010-08-01; Completion date: 2012-12-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Hypotheses:

1\. Gabapentin will significantly reduce alcohol consumption and promote abstinence as compared to placebo. The primary outcome measure will be the number of the heavy drinking days (defined as any day where the number of standard drinks was at least 5 for men and at least 4 for women) per week as measured by the timeline follow-back method.

Secondary Hypotheses:

1\. Gabapentin will be superior to placebo in reducing alcohol use as measured by percent days abstinent.

Detailed description:
In an 8-week randomized double-blind placebo-controlled outpatient pilot trial the efficacy of gabapentin in the treatment of alcohol dependence will be studied in 60 patients. Participants will be randomly assigned to treatment under double-blind conditions with either 1) a fixed dosing schedule of gabapentin or 2) placebo. All participants will receive weekly supportive behavioral treatment that promotes abstinence from alcohol and other substances, encourages mutual-support meeting attendance, and facilitates compliance with study medication. The primary outcome measures will be: the reduction of heavy drinking days per week as measured by the timeline follow-back method.

Participants will be alcohol-dependent men and nonpregnant women who report drinking a minimum of 5 standard drinks for men or 4 standard drinks for women at least 4 days per week over the past 28 days. The daily minimum drinking requirements are consistent with the commonly accepted definition of "binge drinking." A minimum requirement of having a heavy drinking episode 4 days a week would select for a population of individuals who are drinking excessively more days than not. A minimum threshold of weekly alcohol use is set to prevent a "floor effect" (i.e. participants with minimal alcohol use at baseline would be unable to demonstrate significant improvement.)

Arms: arm 1: Gabapentin will be titrated over a 7-day period to the dose target or the maximum tolerated dose. The maximum dose will be 1200mg TID. Participants must be able to tolerate and comply with at least 400 mg daily. arm 2: Placebo capsules will be administered TID.
Interventions: intervention 1: Gabapentin intervention 2: Placebo
Intervention descriptions: intervention 1: During week 1 the dosage will be increased 3 times. Days 1 and 2, participants will receive 400 mg of Gabapentin three times daily. During days 3 and 4 the dosage will be increased to 800 mg three times daily. On day 5 through 7, participants will receive a dose of 1200 mg three times daily, which will continue from week 2 through 8. During week 9 patients will be tapered off for the duration of the week. intervention 2: Placebo, TID

Protocol documents:
Clinical trial NCT01147627
Conditions: Diabetes Mellitus, Type 2 Newly Diagnosed
Keywords: diabetes mellitus, type 2 newly diagnosed exenatide premixed insulin analog thiazolidinedione β-cell function glycemic control
Sponsor: Sun Yat-sen University
Start date: 2010-08-01; Completion date: 2012-12-01
Enrollment: 416 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate and evaluate the effects of different interventions (1. exenatide, 2. insulin, 3. thiazolidinedione) on glycemic control and β-cell function in newly diagnosed drug-naïve type 2 diabetic patients.

Detailed description:
One of the fundamental defects in type 2 diabetes mellitus is declining β-cell function. Exenatide targets multiple metabolic disturbances in type 2 diabetes and exerts direct effects on β-cell, which indicates that it may not only contribute to the glucose control but also delay disease progression. There are trials demonstrated efficacy, safety and tolerability of exenatide. However, no study has compared the effects of exenatide with other hypoglycemic therapies with β cell protective function in newly diagnosed and drug-naïve type 2 diabetic patients. This current study is thus designed to evaluate the effects of exenatide, insulin and pioglitazone on glycemic control and β-cell function in newly diagnosed drug-naïve type 2 diabetic patients.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: exenatide injection intervention 2: Mixed Protamine Zinc Recombinant Human Insulin Lispro 25R intervention 3: Pioglitazone
Intervention descriptions: intervention 1: Patients in exenatide group will be treated with exenatide (Byetta®, Eli Lilly and Company) 5 µg BID for the first 4 weeks and then 10 µg BID thereafter. intervention 2: Patients in insulin group will be treated with premixed insulin analog (Humalog Mix 25, Eli Lilly and Company). The initial insulin doses are 0.4 IU/kg per day(50% before breakfast and 50% before dinner). Insulin doses are titrated following a forced schedule according to blood glucose before breakfast and dinner. intervention 3: Patients in thiazolidinedione group will be treated with Pioglitazone 30mg daily as single dose. The dose will be increased to 45mg daily after 4 weeks.

Protocol documents:
Clinical trial NCT01149616
Conditions: Post Operative Pain Nausea
Sponsor: Beth Israel Deaconess Medical Center
Start date: 2009-12-01; Completion date: 2012-12-01
Enrollment: 82 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine the opiate sparing effects of intravenously administered dexamethasone in outpatient knee surgery. Dexamethasone is a glucocorticoid with well known antiemetic effects. However, the analgesic effects of dexamethasone have not been adequately researched. Following surgery, patients are typically discharged home with PO opiates to manage post-operative pain. The investigators believe that by using VAS (Visual Analog Scale) for Pain the investigators can show that a single dose of dexamethasone can reduce pain scales and opiate consumption post-operatively, on Post Operative Day (POD 1) when compared to placebo.

Detailed description:
Findings of Modest improvement in pain scores and postoperative nausea at 24 hours with Dexamethasone

Arms: arm 1: Dexamethasone 8mg iv x 1 arm 2: placebo
Interventions: intervention 1: Dexamethasone 8mg iv x1 intervention 2: placebo
Intervention descriptions: intervention 1: Dexamethasone 8mg iv x1 intervention 2: 2 ml normal saline IV x1

Protocol documents:
Clinical trial NCT01153425
Conditions: Osteoporosis, Osteopenia
Keywords: Osteoporosis Osteopenia Fracture Risk teriparatide or Forteo zoledronic acid or Reclast
Sponsor: University of Pennsylvania
Start date: 2008-07-01; Completion date: 2012-12-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to apply a novel advanced magnetic resonance imaging methodology to evaluate the response to drug intervention involving two treatment arms of postmenopausal participants with osteoporosis, randomized into either a teriparatide (Forteo™) or zoledronic acid (Reclast™) group.

Detailed description:
The overall design is to determine and compare the effect of teriparatide and of zoledronic acid on trabecular architecture by magnetic resonance imaging of the midshaft tibia. Post-menopausal women, aged 60 or older with osteoporosis and/or at increased risk of fracture, will be randomized to receive either teriparatide or zoledronic acid. Trabecular microarchitecture, biomechanical parameters and bone mineral density will be examined at 0 and 12 months at 3T MRI.

Arms: arm 1: 20 µg of Teriparatide will be self-injected subcutaneously once a day for 12 months and an MRI at 3T ('Virtual Bone Biopsy') will be performed at 0 and 12 months. arm 2: 5 mg of zoledronic Acid will be administered intravenously at baseline and 12 months and an MRI at 3T ('Virtual Bone Biopsy) will be performed at 0 and 12 months.
Interventions: intervention 1: Virtual Bone Biopsy intervention 2: Teriparatide intervention 3: Zoledronic Acid
Intervention descriptions: intervention 1: MRI technology allowing generation of 3D images with considerably smaller voxel size than previous technology through the use of novel pulse sequences and advanced interpolation techniques. intervention 2: Participants are clinically indicated for treatment. intervention 3: Participants are clinically indicated for treatment.

Protocol documents: