ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01096810
Conditions: Multiple Myeloma
Keywords: Asymptomatic
Sponsor: Jagannath, Sundar, M.D.
Start date: 2008-09-01; Completion date: 2014-03-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Purpose:

The purpose of this study is to see if TBL 12, which is a blend of Sea Cucumber, Sea Sponge, Shark Fin, and Sea Urchin (animals that live in the Pacific Ocean) as well as Sargassum (a plant that lives in the Pacific Ocean), will have effects against asymptomatic multiple myeloma and to see what the side effects are.

Eligibility:

Several criteria must be met to be eligible for this study, including but not limited to the following:

* a diagnosis of asymptomatic multiple myeloma
* adequate cardiac, liver and kidney function
* age 18 and older

Detailed description:
Multiple myeloma is a cancer that evolves from a state known as Monoclonal Gammopathy of Undetermined Significance (MGUS), defined by parameters of M spike and bone marrow. After evolution to myeloma, patients may be asymptomatic, that is, without any endorgan disease of hypercalcemia, renal insufficiency, anemia or bone lesions. In asymptomatic myeloma (ASxM), there is no standard therapy. Thalidomide has been tried in patients with ASxM but with significant toxicity. The patients with ASxM are evaluable in terms of paraprotein measurements. TBL12 sea cucumber extract has been shown to have a number of antitumor properties preclinically, including antiangiogenesis and direct tumor cytotoxicity. TBL12 has been used by a number of patients as a food supplement without any toxicity detected. We thus propose to determine the clinical activity of this agent in patients with ASxM. Patients will be given TBL12 at the dose of 2 units of 20 mL each twice per day daily for one year and the effects on the paraprotein noted. Clinical effects seen will be correlated with any in vitro changes in angiogenesis in patient bone marrow samples. The results of this trial may form the basis for the use of this nontoxic agent in patients with the prodrome of or with other early cancers.

Arms: arm 1: TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression
Interventions: intervention 1: TBL 12
Intervention descriptions: intervention 1: TBL 12 will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression.

Protocol documents:
Clinical trial NCT01114516
Conditions: Cervical Insufficiency
Keywords: cervical insufficiency
Sponsor: Northwestern University
Start date: 2010-03-01; Completion date: 2014-03-01
Enrollment: 53 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Though cervical insufficiency is a common cause of second trimester pregnancy loss, the placement of an emergent cerclage in these patients is thought to improve perinatal outcomes. It is unknown whether the use of tocolytics and antibiotics prolongs pregnancies complicated by need for emergent cerclage.

The objective is to determine whether administration of peri-operative antibiotics and indomethacin to patients receiving emergent cerclages for cervical insufficiency increases latency period to delivery compared with patients receiving emergent cerclage alone.

Detailed description:

Arms: arm 1: emergent cerclage with no peri-operative antibiotics or indomethacin arm 2: perioperative antibiotics and indomethacin
Interventions: intervention 1: Indomethacin and antibiotics (cefazolin or clindamycin)
Intervention descriptions: intervention 1: q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin

Protocol documents:
Clinical trial NCT01126099
Conditions: Alzheimer's Disease
Keywords: double-blind treatment prazosin Disruptive behaviors in Alzheimer's Disease
Sponsor: Seattle Institute for Biomedical and Clinical Research
Start date: 2010-03-01; Completion date: 2014-03-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study of outpatient participants with Alzheimer's disease or a related dementia who have difficult behaviors that are upsetting for them or their caregivers. Prazosin is a medication that is commonly used to treat people with high blood pressure. Research with prazosin has shown that it may be effective in treating behavioral problems by reducing excess adrenalin effects in the brain.

Detailed description:
This is a 24 week study with 14 visits to the research clinic. Approximately 6 of these visits may be done by phone. Additional phone checks are scheduled at the beginning of each 12 week part of the study. Participants will have a 50:50 chance of being on prazosin or placebo in the first 12 weeks of the study. For the second 12 weeks, all participants will take prazosin.

Study visits include a physical and neurological exam; memory testing; interviews with the caregiver about behaviors; and vital signs.

Arms: arm 1: In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin. arm 2: In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.
Interventions: intervention 1: Prazosin intervention 2: Placebo
Intervention descriptions: intervention 1: 4 mg capsules twice daily for 12 weeks intervention 2: Placebo capsules twice daily for 12 weeks

Protocol documents:
Clinical trial NCT01158924
Conditions: Early Lumbar Disc Degeneration
Sponsor: DePuy Spine
Start date: 2010-03-01; Completion date: 2014-03-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Study to show the safety, tolerability and preliminary effectiveness of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration.

Detailed description:

Arms: arm 1: The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc. In vitro experiments have shown that rhGDF-5 can stimulate gene expression and synthesis of the extracellular matrix proteins type II collagen and aggrecan. In vivo experiments in rabbit models of disc degeneration have shown that intradiscal injections of rhGDF-5 can stimulate an increase in disc height and hydration.
Interventions: intervention 1: Intradiscal rhGDF-5
Intervention descriptions: intervention 1: The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc. In vitro experiments have shown that rhGDF-5 can stimulate gene expression and synthesis of the extracellular matrix proteins type II collagen and aggrecan. In vivo experiments in rabbit models of disc degeneration have shown that intradiscal injections of rhGDF-5 can stimulate an increase in disc height and hydration.

Protocol documents:
Clinical trial NCT01169532
Conditions: Lymphoma Unspecified Adult Solid Tumor, Protocol Specific
Sponsor: Fox Chase Cancer Center
Start date: 2010-10-01; Completion date: 2014-03-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase I trial is studying the side effects and best dose of giving ridaforolimus and vorinostat together in treating patients with advanced solid tumors or lymphoma. Giving ridaforolimus in combination with vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine which dose combinations of Ridaforolimus and Vorinostat are safe and tolerable.

II. To define the maximum tolerated dose. III. To characterize dose limiting toxicities.

SECONDARY OBJECTIVES:

I. To describe the activity of this combination amongst all enrolled patients in terms of response rate, progression free survival and overall survival.

II. To describe the activity of this combination in the subset of patients with RCC in terms of response rate, progression free survival and overall survival.

III. To describe the pharmacodynamic effects of these agents in combination.

OUTLINE: This is a dose escalation study.

Patients receive ridaforolimus orally (PO) once daily on days 1-5 and vorinostat PO twice daily on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

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

Arms: arm 1: Patients receive ridaforolimus PO once daily on days 1-5 and vorinostat PO twice daily on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: ridaforolimus intervention 2: vorinostat intervention 3: biopsy intervention 4: pharmacological study intervention 5: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given PO intervention 2: Given PO intervention 3: Optional correlative studies intervention 4: Correlative studies intervention 5: Correlative studies

Protocol documents:
Clinical trial NCT01169701
Conditions: Renal Transplant
Keywords: Renal transplant, everolimus, cardiovascular profile, CNI-free immunosuppression, left ventricular hypertrophy, biopsy proved acute rejection (BPAR)
Sponsor: Novartis Pharmaceuticals
Start date: 2010-08-01; Completion date: 2014-03-01
Enrollment: 71 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the study is to compare the cardiovascular profile of an everolimus and mycophenolic acid immunosuppressive regimen with a calcineurin inhibitor and mycophenolic acid regimen in maintenance renal transplant patients

Detailed description:

Arms: arm 1: Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml). arm 2: Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
Interventions: intervention 1: Everolimus intervention 2: Tacrolimus intervention 3: Mycophenolic acid (MPA)
Intervention descriptions: intervention 1: Everolimus was supplied in boxes with 60 tablets. Available tablets: 1.0 mg, 0.5 mg and 0.25 mg. intervention 2: Tacrolimus was administrated as Prograf® or Advagraf®, but could not be changed during study. intervention 3: Myfortic® (MFS) was given as 720-1440 mg/day or 360-1440 mg/day. Cell-Cept® (MMF) was given as 1000-2000 mg/day or 500-2000 mg/day.

Protocol documents:
Clinical trial NCT01188499
Conditions: Cancer
Sponsor: TetraLogic Pharmaceuticals
Start date: 2010-10-01; Completion date: 2014-03-01
Enrollment: 176 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a dose escalation safety study of birinapant (TL32711) in combination with chemotherapy in subjects with advanced or metastatic solid tumors.

Detailed description:
The purpose of this study is to determine the safety and maximum tolerated dose of birinapant (TL32711) as a 30 minute intravenous infusion once a week, for 2 consecutive weeks, when combined with standard regimens of chemotherapy in subjects with advanced or metastatic solid tumors. Additionally the study will assess anti-tumor activity, pharmacokinetics, and exploratory biomarkers as a measurement of pharmacodynamic effects.

Arms: arm 1: Carboplatin (AUC 6/Paclitaxel (175 mg/m2/IV) once every 3 (q3) weeks + birinapant (TL32711) once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle). arm 2: Irinotecan (350 mg/m2/IV) once every 3 (q3) weeks + birinapant (TL32711) once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle). arm 3: Docetaxel (75 mg/m2/IV) once every 3 (q3) weeks + birinapant (TL32711) once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle). arm 4: Gemcitabine (1000 mg/m2/IV) once weekly (7 days +/- 2 days) for 3 consecutive weeks followed by 1 week off + birinapant (TL32711) once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 week off for each cycle (4 weeks per cycle). arm 5: Liposomal doxorubicin (40 mg/m2/IV) every 4 weeks + birinapant (TL32711) once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 weeks off for each cycle (4 weeks per cycle).
Interventions: intervention 1: Birinapant
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01197417
Conditions: Sickle Cell Disease
Keywords: Sickle Cell Disease Magnesium Sulfate Pediatric
Sponsor: Medical College of Wisconsin
Start date: 2010-12-01; Completion date: 2014-03-01
Enrollment: 208 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety and efficacy of intravenous magnesium in shortening the duration of a pain crisis and to determine the health-related quality of life and short term outcomes of children treated with intravenous magnesium during an acute pain crisis.

Detailed description:
It is well known that children with sickle cell disease are at risk for acute pain crises. The usual treatment for these pain crises, intravenous fluids and pain medicines such as morphine, has changed little over the past three decades. In a pilot study, the addition of intravenous magnesium to standard therapy decreased length of stay; however, this study was not randomized, not blinded, not placebo-controlled, and not adequately powered to assess safety.

We will conduct a multi-center, randomized, double-blind, placebo controlled trial of about 208 children, ages 4-21 years. Patients will be randomized to receive intravenous magnesium sulfate or placebo every 8 hours for a total of 6 doses, or until discharge. Patients will return for a routine clinic visit up to 3 months after discharge for a baseline assessment. Patients will also complete health-related quality of life measures at 4 timepoints throughout the study.

Arms: arm 1: Intravenous Magnesium Sulfate arm 2: Normal Saline placebo
Interventions: intervention 1: Intravenous Magnesium Sulfate intervention 2: Normal Saline Placebo
Intervention descriptions: intervention 1: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses intervention 2: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses

Protocol documents:
Clinical trial NCT01203787
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma HCC Liver Cancer
Sponsor: University of Florida
Start date: 2010-12-01; Completion date: 2014-03-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Open-label study to evaluate the safety and tolerability of Sorafenib dose ramp-up (starting at a lower dose and then gradually increasing the dose) versus standard Sorafenib dosing in subjects with unresectable and/or metastatic hepatocellular carcinoma.

Detailed description:
This is an open-label study that investigates the impact of a dose ramp-up strategy for sorafenib in patients with HCC. Clinical trial and post-marketing data suggest that sorafenib dose reductions and discontinuations due to adverse events are common and limit the drug's effectiveness. It is our hypothesis that a dose escalation strategy for sorafenib will improve the tolerability and allow a greater percentage of patients to remain on drug. The primary end-point of the study is the total accumulated and median daily dose of sorafenib delivered at month 2 and 4.

Arms: arm 1: Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24 arm 2: 200 mg daily from Day 0-Day 13 200 mg twice daily from Day 14-Day 20 600 mg daily from Day 21-Day 27 400 mg twice daily beginning Day 28 until end of treatment or Week 24
Interventions: intervention 1: Sorafenib Standard Dosing Regimen intervention 2: Sorafenib Ramp-Up Regimen
Intervention descriptions: intervention 1: Sorafenib 400 mg twice daily until wk 24 or end of treatment intervention 2: 200 mg daily, Day 0-Day 13 200 mg twice daily, Day 14-Day 20 600 mg daily, Day 21-Day 27 400 mg twice daily, Day 28 until end of treatment400 mg twice daily

Protocol documents:
Clinical trial NCT01226719
Conditions: Colorectal Cancer
Keywords: liver-only metastatic KRAS wild-type colorectal cancer Panitumumab Oxaliplatin Irinotecan Leucovorin 5-Fluorouracil
Sponsor: SCRI Development Innovations, LLC
Start date: 2010-12-01; Completion date: 2014-03-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
In this Phase II study the investigators plan to determine the overall response rate (ORR) of the combination of FOLFOXIRI plus panitumumab as first-line treatment of patients with liver-only metastatic KRAS wild-type colorectal cancer.

Detailed description:
Further data has emerged showing a consistent lack of efficacy using EGFR inhibitor panitumumab in combination with chemotherapy in the treatment of patients with KRAS mutant colorectal cancer. For patients with liver-only metastatic colorectal cancer, improvement in response rates with newer chemotherapy regimens has led to a larger percentage of patients eligible for surgical resection. Treatment with FOLFOXIRI improves response rates when compared to FOLFIRI. Similarly, the addition of an EGFR inhibitor improves the response rate of FOLFIRI in patients with wild-type KRAS. In this trial, we will attempt to maximize the response rate and the surgical resection rate by using FOLFOXIRI and panitumumab.

Arms: arm 1: All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:

* Panitumumab
* Oxaliplatin
* Irinotecan
* Leucovorin
* 5-Fluorouracil
Interventions: intervention 1: Panitumumab intervention 2: Oxaliplatin intervention 3: Irinotecan intervention 4: Leucovorin intervention 5: 5-Fluorouracil
Intervention descriptions: intervention 1: 6 mg/kg, 60-90 minute IV infusion every 2 weeks intervention 2: 85 mg/m2, 2-hour IV infusion every 2 weeks intervention 3: 125 mg/m2, 1-hour IV infusion every 2 weeks intervention 4: 200 mg/m2, 2-hour IV infusion every 2 weeks intervention 5: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks

Protocol documents:
Clinical trial NCT01229111
Conditions: Adult Primary Cholangiocellular Carcinoma Advanced Adult Primary Liver Cancer Cholangiocarcinoma of the Extrahepatic Bile Duct Cholangiocarcinoma of the Gallbladder Localized Unresectable Adult Primary Liver Cancer Periampullary Adenocarcinoma Recurrent Adult Primary Liver Cancer Recurrent Extrahepatic Bile Duct Cancer Recurrent Gallbladder Cancer Unresectable Extrahepatic Bile Duct Cancer Unresectable Gallbladder Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2010-10-01; Completion date: 2014-03-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well giving cediranib maleate together with combination chemotherapy works in treating patients with advanced biliary cancers. Cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cediranib maleate together with combination chemotherapy may kill more tumor cells.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the response rate to AZD2171 (cediranib maleate) and modified folinic acid-fluorouracil-oxaliplatin-6 regimen (FOLFOX 6) in subjects with advanced biliary cancers.

SECONDARY OBJECTIVES:

I. To determine overall assessment of toxicity of AZD2171 and modified FOLFOX6. II. To determine the progression-free survival of subjects with advanced biliary cancers treated with AZD2171 and modified FOLFOX6.

III. To determine overall survival of subjects with advanced biliary cancers treated with AZD2171 and modified FOLFOX6.

OUTLINE:

Patients receive cediranib maleate orally (PO) once daily (QD) on days 1-14 and modified FOLFOX6 comprising oxaliplatin intravenously (IV) over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Arms: arm 1: Patients receive cediranib maleate PO QD on days 1-14 and modified FOLFOX6 comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1.
Interventions: intervention 1: cediranib maleate intervention 2: oxaliplatin intervention 3: leucovorin calcium intervention 4: fluorouracil
Intervention descriptions: intervention 1: Given PO intervention 2: Given IV intervention 3: Given IV intervention 4: Given IV

Protocol documents: