ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00905021
Conditions: Metastatic Breast Cancer
Keywords: Breast Cancer Metastatic Hormone Receptor Positive
Sponsor: Baylor Breast Care Center
Start date: 2010-03-01; Completion date: 2012-02-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The investigators want to find out if the treatments used in this study are helpful to patients that are diagnosed with hormone receptor positive metastatic breast cancer. The investigators want to also look at any side effects that could happen while patients are on the study treatments. The investigators want to see if there are any changes that could show us if your cancer is responding to the study treatments.

Detailed description:
The study design is a phase II design. Eligible patients will undergo staging work up and start treatment. Every 28-day period (4 weeks) will count as a cycle. Medical evaluations will be performed every 4 weeks and staging work up will be repeated every 12 weeks.

The primary objective of the study is to assess progression free survival (PFS) of treatment with exemestane and sunitinib in post¬menopausal subjects with hormone receptor positive (ER-positive and/or PR-positive) unresectable locally advanced or metastatic breast cancer subjects who have progressed on prior hormonal treatment.

In addition we want to:

1. Obtain assessments of overall response rate (ORR), clinical benefit rate (CBR), and overall survival (OS).
2. Determine the safety and tolerability of the combination regimen.
3. Study molecular changes in tissue biopsies, circulating tumor cells (CTCs), and circulating endothelial cells (CECs), and explore associations with treatment response and resistance.

1\. Blood samples will be drawn for enumeration and profiling of circulating tumor cells and circulating endothelial cells at study entry (prior to starting study medications), four weeks after starting study medications, twelve weeks after starting study medications and at disease progression. These samples will be strongly encouraged but the patients may decline any or all of them without impacting their eligibility or continuation on the study.

2\. If the patient participating on the study has an easily accessible breast mass or metastatic lesion (e.g. lymphadenopathy, skin metastasis, chest wall metastasis), a core needle or punch biopsy will be obtained at study entry (prior to starting study medications), four weeks after starting study medications, and at disease progression. These biopsies will be strongly encouraged but the patients may decline any or all of them without impacting their eligibility or continuation on the study.

Arms: arm 1: All patients enrolled on the study will receive treatment as follows:

1. Exemestane 25 mg by mouth every day.
2. Sunitinib 37.5 mg by mouth every day.
Interventions: intervention 1: Exemestane intervention 2: Sutent
Intervention descriptions: intervention 1: Exemestane 25 mg by mouth every day. intervention 2: Sunitinib 37.5 mg by mouth every day.

Protocol documents:
Clinical trial NCT00909545
Conditions: Parkinson Disease
Keywords: Early Parkinson disease
Sponsor: Northwestern University
Start date: 2009-07-01; Completion date: 2012-02-01
Enrollment: 99 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to establish a dosage of isradipine CR that is tolerable and demonstrates preliminary efficacy for utilization in future pivotal efficacy studies.

Detailed description:
There is solid scientific rational and preclinical data supporting a clinical trial of isradipine CR as a potential disease modifying agent in early PD. Human pharmacokinetic data demonstrate that it is feasible to achieve the serum concentrations in humans that were neuroprotective in preclinical models with the FDA approved dosage range. Pilot data demonstrate acceptable tolerability of isradipine CR in the PD population. Tolerability is inversely proportional to the dosage dependent. Considering that tolerability of isradipine CR is inversely proportional to the dosage exposure, it is essential to proceed with the dose selection tolerability study in preparation for the future efficacy trials.

The tolerability, defined as the ability to complete the study, of three dosages of isradipine CR relative to placebo in subjects with early Parkinson's disease will be examined first. The dosage that is tolerable and demonstrates preliminary efficacy will be evaluated further in the future pivotal efficacy studies.

Arms: arm 1: Isradipine CR 5mg/day arm 2: Isradipine CR 10mg/day arm 3: Isradipine CR 20mg/day arm 4: Placebo
Interventions: intervention 1: Isradipine CR 5mg intervention 2: Isradipine CR 10mg intervention 3: Isradipine CR 20mg intervention 4: Placebo
Intervention descriptions: intervention 1: 5mg dose: 1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily intervention 2: 10mg dose: 2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily intervention 3: 20mg dose: 4 Dynacirc CR 5mg tablets once daily intervention 4: 4 Placebo to Match (PTM) tablets once daily

Protocol documents:
Clinical trial NCT00914849
Conditions: Hematologic Neoplasms
Sponsor: Washington University School of Medicine
Start date: 2009-08-01; Completion date: 2012-02-01
Enrollment: 68 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To reduce the number of donors treated with IV AMD3100 who require a second collection to obtain the minimum cells necessary for allogeneic stem cell transplant.

Detailed description:
* To reduce the number of donors treated with intravenous (IV) AMD3100 who require a second collection to obtain the minimum CD34/kg (2 X 106) necessary for allogeneic stem cell transplantation when compared to our historic group who received 240ug SC AMD3100 from 33% (8 in 24) to 11% (3 in 27).
* To estimate with 95% confidence intervals the proportion of human leukocyte antigen (HLA)-identical sibling donors who experience grade 3-4 infusional toxicity and the proportion from whom ≥ 2.0 x 10e6 CD34+ cells/kg recipient weight are safely mobilized following one or two intravenous infusions.
* To determine the kinetics of stem cell and lymphocyte mobilization using IV AMD3100 and to determine if peripheral blood stem cell products collected after mobilization with IV AMD3100 can be used safely for hematopoietic cell transplantation in HLA-matched recipients as measured by neutrophil engraftment by day +21.
* To determine the pharmacokinetics and pharmacodynamics of IV AMD3100 on stem cell and T-cell phenotyping and on immune reconstitution after transplantation.
* To determine the rate of acute graft-versus-host disease (GVHD) and chronic GVHD in patients who receive IV AMD3100 mobilized peripheral blood stem cells.

Arms: arm 1: * Day 1

  * AMD3100 320 ug/kg IV
  * Leukopheresis
* Day 2 (if peripheral blood stem cell (PBSC) collected is not sufficient)

  * AMD3100 320 ug/kg IV
  * Leukopheresis arm 2: Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM

Day 0 = Stem Cell Transplant
Interventions: intervention 1: AMD3100 intervention 2: Leukopheresis intervention 3: Stem cell transplant
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00928772
Conditions: Anxiety
Keywords: Cranial Electro Stimulation First Eye Cataract Surgery Preoperative sedation Perioperative sedation
Sponsor: University of Oklahoma
Start date: 2009-07-01; Completion date: 2012-02-01
Enrollment: 115 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Cranial electro stimulation (CES) provides safe, adequate, side-effect free sedation without excessive drowsiness in preoperative settings.

Detailed description:
CES Alpha-Stim is a non-invasive device which has been in place and has been approved for patients to reduce anxiety by the FDA. This study involves the use of CES Alpha-Stim device applied to the patient 30 minutes before and through-out cataract surgery procedure and then to measure the level of anxiety and discomfort by using a visual analog scale (VAS). We propose that by applying the device the patients will be able to have markedly less level of anxiety and discomfort before and during the surgery and will ultimately avoid the traditional use of sedative or analgesic drugs being used for these kinds of surgery.

Arms: arm 1: One hour Alpha-Stim intervention with sham midazolam arm 2: Sham Alpha-Stim intervention with real midazolam administration arm 3: No Alpha-Stim and only topical anesthetics
Interventions: intervention 1: CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM intervention 2: MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY intervention 3: NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED
Intervention descriptions: intervention 1: APPLYING OF ELECTRODES ON THE EAR LOBES AND TEMPLES WHICH ARE SENDING AN ACTIVE MICROCURRENT THROUGH THE MIDBRAIN PRODUCING SEDATION WITHOUT PHARMACOLOGICAL AGENTS AND GIVING NORMAL SALINE AS A SHAM DRUG SEDATION intervention 2: CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION intervention 3: NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM.

Protocol documents:
Clinical trial NCT00960869
Conditions: Gastric Ulcer
Keywords: PA32540 is proposed for the secondary prevention of cardio- and cerebrovascular events in patients at risk for developing aspirin-associated gastric ulcers.
Sponsor: POZEN
Start date: 2009-10-01; Completion date: 2012-02-01
Enrollment: 519 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary: To demonstrate that PA32540 causes fewer gastric ulcers in subjects at risk for developing aspirin-associated gastric ulcers compared to enteric coated (EC) aspirin 325 mg.

Detailed description:

Arms: arm 1: PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD) arm 2: EC-Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
Interventions: intervention 1: PA32540 intervention 2: EC-Aspirin 325 mg
Intervention descriptions: intervention 1: PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole intervention 2: The comparator aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole)

Protocol documents:
Clinical trial NCT00962871
Conditions: Hepatitis B, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2009-08-01; Completion date: 2012-02-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This open-label, randomized, parallel-arm study will assess the early immunologic response in treatment-naïve Asian male patients with chronic hepatitis B after initiation of treatment with Pegasys or tenofovir or Pegasys plus tenofovir. Patients will be randomized to one of 4 cohorts to receive either Pegasys (360mcg subcutaneously weekly) or tenofovir (300mg orally daily) or both or no treatment for 2 weeks. After 2 weeks on study treatment, patients may opt to receive standard of care treatment with Pegasys. Target sample size is \<50.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: peginterferon alfa-2a [Pegasys] intervention 2: tenofovir
Intervention descriptions: intervention 1: 360 micrograms sc/week for 2 weeks intervention 2: 300mg po daily for 2 weeks

Protocol documents:
Clinical trial NCT00969761
Conditions: Neoplasms
Sponsor: Boehringer Ingelheim
Start date: 2009-08-01; Completion date: 2012-02-01
Enrollment: 61 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this trial is to identify the maximum tolerated dose (MTD) of BI 6727 therapy in terms of drug-related adverse events when combined with a platinum therapy (cisplatin or carboplatin).

Secondary objectives are the collection of overall safety and antitumour efficacy data and the determination of the pharmacokinetic profile of BI 6727 combination treatment with cisplatin and carboplatin.

Detailed description:

Arms: arm 1: patient to receive 3-weekly infusion escalating dose of BI 6727 combined to cisplatin arm 2: patient to receive 3-weekly infusion escalating dose of BI 6727 combined to carboplatin
Interventions: intervention 1: BI-6727 intervention 2: BI 6727
Intervention descriptions: intervention 1: Low to high dose (administered every 3 weeks). Depending on the toxicities observed, intermediary dose levels may be added intervention 2: low to high dose

Protocol documents:
Clinical trial NCT01017250
Conditions: Malignant Glioma
Keywords: Recurrent
Sponsor: Duke University
Start date: 2009-12-01; Completion date: 2012-02-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the central nervous system (CNS) toxicity in patients with recurrent malignant gliomas treated with concurrent Avastin and stereotactic radiosurgery (SRS).

Detailed description:
In this pilot study, 15 human subjects with recurrent, unifocal malignant gliomas up to 5-cm in maximum dimension no longer responding to conventional chemotherapy but able to tolerate further chemotherapy will be enrolled. The primary endpoint of this study will be the proportion of patients who experience CNS toxicity, with secondary endpoints progression-free survival, overall survival, steroid dosage, development of radionecrosis, quality of life, objective radiographic response and performance status.

Arms: arm 1: Avastin and Radiosurgery
Interventions: intervention 1: Stereotactic Radiosurgery (SRS) intervention 2: Bevacizumab
Intervention descriptions: intervention 1: Tumor Volume \< 2.0cm receives 24 Gy in 1 fraction Tumor Volume 2.0-2.9cm receives 18 Gy in 1 faction Tumor Volume 3.0-4.9cm receives 25 Gy in 5Gy/fraction intervention 2: Bevacizumab (Avastin) 10 mg/kg given the day before SRS and 2 weeks after SRS

Protocol documents:
Clinical trial NCT01044498
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2009-12-01; Completion date: 2012-02-01
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This open-label, randomized, cross-over study evaluated the effect of tocilizumab (TCZ) on the pharmacokinetics and pharmacodynamics of a common oral contraceptive (OC) in female patients with active rheumatoid arthritis (RA) and in healthy female volunteers of child bearing age. The RA patients received OC in combination with TCZ, whereas the healthy volunteers received OC only. The RA patients received OC in 3 cycles of 21 days each; TCZ 8 mg/kg was administered once as an intravenous infusion on the first day of Cycle 2. The healthy volunteers received OC for only one 21-day cycle.

Detailed description:

Arms: arm 1: Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously. arm 2: Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle.
Interventions: intervention 1: Tocilizumab intervention 2: Ortho-Novum® 1/35
Intervention descriptions: intervention 1: Tocilizumab 8 mg/kg was administered in a single 1-hour infusion on Day 1 of Cycle 2. intervention 2: Each Ortho-Novum® 1/35 tablet contained 1 mg of norethindrone and 0.035 mg of ethinyl estradiol.

Protocol documents:
Clinical trial NCT01050530
Conditions: Cirrhosis
Keywords: Cirrhosis ascites Tolvaptan OPC-41061
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2009-12-01; Completion date: 2012-02-01
Enrollment: 162 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
OPC-41061 at 7.5 mg/day or placebo will be orally administered once daily for 7 days to cirrhosis patients with ascites despite having received treatment with conventional diuretics and the change in body weight from baseline at the time of the final administration will be compared between the two groups.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: OPC-41061 intervention 2: Placebo
Intervention descriptions: intervention 1: Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days intervention 2: Once-daily oral administration of placebo after breakfast for 7 days

Protocol documents:
Clinical trial NCT01063153
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD Adults Electroencephalography (EEG) Concerta
Sponsor: Massachusetts General Hospital
Start date: 2009-09-01; Completion date: 2012-02-01
Enrollment: 71 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to study a device called an electroencephalograph (EEG) in the diagnosis of treatment of attention deficit hyperactivity disorder (ADHD) in adults. People with ADHD have symptoms such as difficulty sustaining attention, organizing, and managing impulsivity. They can have trouble in school, at work, and at home. Subjects with ADHD who participate in this study will be given a once daily stimulant medication called osmotic release methylphenidate (Concerta) for 6 weeks, and have EEG testing done before and after the treatment period. Subjects will perform a computer based cognitive task during EEG testing. The U.S. Food and Drug Administration has approved osmotic release methylphenidate (Concerta) for the treatment of ADHD in adults and children. Similar procedures, without medication, will be performed with a sample of healthy adults without ADHD.

Detailed description:

Arms: arm 1: Open-Label Concerta (Osmotic Release Methylphenidate) arm 2: Healthy subjects without ADHD will be assessed using EEG.
Interventions: intervention 1: Osmotic Release Methylphenidate
Intervention descriptions: intervention 1: During a 6 week treatment period, adult subjects with ADHD are prescribed, in an open label fashion, once daily doses of osmotic release methylphenidate to a maximum daily dose of 144 mg. Efficacy and tolerability assessments are completed, in addition to EEG and cognitive testing. Healthy adults without ADHD will not receive medication.

Protocol documents:
Clinical trial NCT01066364
Conditions: Nonalcoholic Steatohepatitis
Keywords: NASH NAFLD Steatohepatitis Nonalcoholic Fatty Liver Disease
Sponsor: University of California, San Diego
Start date: 2010-02-01; Completion date: 2012-02-01
Enrollment: 59 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to see if the drug colesevelam is a potential treatment for Nonalcoholic Steatohepatitis(NASH).

Detailed description:
We plan to investigate the role of colesevelam, a bile-acid binding resin, in patients with NASH residing in the United States and assess liver fat changes during therapy using MRI of the liver. It can be hypothesized that colesevelam would lead to a greater improvement in insulin sensitivity and lipid profile compared with placebo and may lead to greater improvement in liver fat by MRI as compared to placebo.

In this pilot study, we propose to randomize approximately 55 patients (1:1 ratio) to either colesevelam or placebo and treat them for 24-weeks to evaluate changes in baseline insulin sensitivity, serum biochemistry (ALT and AST), and liver fat by MRI during therapy. Liver histologic changes would also be examined as an exploratory outcome for future studies.

Arms: arm 1: Six tablets per day (identical to colesevelam) arm 2: 3.75 grams per day
Interventions: intervention 1: Colesevelam Hcl
Intervention descriptions: intervention 1: 3.75 gm/day (six 675 mg tablets)

Protocol documents:
Clinical trial NCT01108094
Conditions: Basal Cell Carcinoma (BCC) Skin Cancer
Sponsor: Stanford University
Start date: 2010-04-01; Completion date: 2012-02-01
Enrollment: 29 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Basal cell carcinomas (BCCs) are the most common human cancer in the US and affect over 1 million people. There is no effective drug to prevent basal cell carcinomas of the skin.

We hope to learn if an oral anti-fungal drug, itraconazole, might inhibit a marker of proliferation and a biomarker (tumor signaling pathway) of BCC development.

Itraconazole is an FDA-approved drug for the treatment of fungal infections of the skin, and has been used for the past 25 years with relatively few side effects. It has been shown in mice to reduce a BCC biomarker and to reduce growth of BCCs.

Thus, it may reduce BCC growth in humans.

Detailed description:
Participants with at least one BCC tumor measuring 4 mm or greater in diameter will be enrolled onto 1 of 2 treatment cohorts to receive oral itraconazole.

* Cohort A - 400 mg itraconazole (as 200 mg twice daily for 30 days), stratified by:

  * Cohort A1 - Participants are vismodegib-naive.
  * Cohort A2 - Participants had received prior vismodegib treatment.
* Cohort B - 200 mg itraconazole (as 100 mg twice daily, for up to 4 months). The objective of this cohort is to assess the anti-cancer efficacy of lower-dose extended treatment.
* Control Group - Tumors from untreated participants.

Arms: arm 1: Oral itraconazole 400 mg as 200 mg twice daily, for 1 month, stratified by prior vismodegib history arm 2: Oral itraconazole 200 mg as 100 mg twice daily, for up to 3 months arm 3: Patients otherwise eligible but unwilling to take itraconazole were enrolled onto the control arm of the study and received no treatment
Interventions: intervention 1: Itraconazole
Intervention descriptions: intervention 1: * Cohort A: oral itraconazole 400 mg as 200 mg twice daily; for 1 month
* Cohort B: oral itraconazole 200 mg as 100 mg twice daily; for up to 3 months

Protocol documents:
Clinical trial NCT01133639
Conditions: Bunion
Sponsor: Beth Israel Deaconess Medical Center
Start date: 2010-05-01; Completion date: 2012-02-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This will be a randomized double-blind placebo-controlled clinical trial that will accept all eligible consecutive patients undergoing elective Kalish bunionectomies. Patients will be randomized into either receiving ketorolac (30 mg IV dose intra-operatively followed by 10 mg orally every 8 hours for five days) plus standard of care or placebo plus standard of care. The purpose of this study is to evaluate the effects of ketorolac plus standard of care on post-operative pain control and radiographic osseous healing. Patients will be assessed for pain via a validated pain questionnaire and for delayed unions via a radiographic scoring system shown to have both high inter- and intra-observer reliability by a blinded board certified radiologist. Additional outcomes of bunionectomy procedures will also be evaluated including adverse events and time to regular shoe gear and activities.

Detailed description:

Arms: arm 1: Placebo plus standard of care arm 2: 30 mg IV dose intra-operatively followed by 10 mg orally every 8 hours for five days plus standard of care
Interventions: intervention 1: Ketorolac intervention 2: Placebo
Intervention descriptions: intervention 1: 30 mg IV dose intra-operatively followed by 10 mg orally every 8 hours for five days plus standard of care intervention 2: Placebo plus standard of care

Protocol documents:
Prot_SAP_001.pdf: