ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01202721
Conditions: Cardiac Disease
Keywords: Congenital Aortic Valve Bicuspid Aortopathy bicuspid aortic valve aortopathy
Sponsor: Hamilton Health Sciences Corporation
Start date: 2011-06-01; Completion date: 2016-11-01
Enrollment: 85 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether long-term treatment with a beta-blocker (BB) such as atenolol and/or an angiotensin receptor blocker (ARB) such as telmisartan, given to adult patients with bicuspid aortic valve (BAV) disease (aortopathy) reduces the widening (dilatation) of the aorta from its baseline size.

Detailed description:
Bicuspid aortic valve (BAV) is the most common congenital heart disease lesion with an estimated 280 000 to 560 000 people affected in the Canada. Dilatation of the ascending aorta is a common feature in patients with BAV and is a result of inherent vascular abnormalities with superimposed effects of age and acquired cardiovascular risk factors. Severe aortic dilatation (\> 50mm) leads to aortic dissection and premature death.

Histopathological studies of the aortas in patients with BAVs report similar findings to that of patients with Marfan syndrome. Beta Blocker (BB) therapy and more recently, Angiotensin Receptor Blocker (ARB) therapy, have been shown to decrease to rate of aortic dilatation and be of benefit to patients with Marfan syndrome. There is no such data however in patients with BAV and aortopathy.

Within the context of a randomized clinical trial, the investigators proposed to test the hypothesis that BB or ARB will reduce the rate of progressive aortic dilatation in adults with BAVs and ascending aortopathy as compared to placebo.

Design: Multicentre, randomized, double-blind, placebo-controlled, trial of adult patients with bicuspid aortic valve aortopathy. Patients who are eligible to take either study medication will be randomly allocated to participate in either the BB (atenolol) vs. placebo arm, or the ARB (telmisartan) vs. placebo arm. Patients who are ineligible for the BB arm will be assigned to the ARB vs. placebo arm and patients who are ineligible for the ARB arm will be assigned to the BB vs. placebo arm. Within each arm, all participants will be randomized to take either placebo or active medication. The atenolol arm will be up-titrated to100mg/day and the telmisartan arm will be up-titrated to 80 mg/day, or to the maximum tolerated dose.

Arms: arm 1: Atenolol or matching placebo 25 mg up-titrated to 100 mg. arm 2: Telmisartan or matching placebo 40 mg up-titrated to 80mg
Interventions: intervention 1: Atenolol intervention 2: Telmisartan
Intervention descriptions: intervention 1: Atenolol or matching placebo 25 mg up-titrated to 100 mg intervention 2: Telmisartan or matching placebo 40 mg up-titrated to 80mg.

Protocol documents:
Clinical trial NCT01409993
Conditions: Impaired Glucose Tolerance
Keywords: BMI greater than 25 Elevated fasting blood sugar (100-125mg/dL)
Sponsor: Vanderbilt University
Start date: 2011-08-01; Completion date: 2016-11-01
Enrollment: 78 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effect of chronic PDE5 inhibitor therapy on glucose metabolism in persons with prediabetes.

Detailed description:

Arms: arm 1: sildenafil 25 mg p.o. tid arm 2: matching placebo p.o. tid arm 3: sildenafil 25 mg p.o. tid arm 4: matching placebo p.o. tid
Interventions: intervention 1: Sildenafil intervention 2: Placebo intervention 3: Hyperglycemic clamp intervention 4: Euglycemic clamp
Intervention descriptions: intervention 1: Sildenafil 25 mg by mouth three times a day for three months intervention 2: Matching placebo three times a day for three months intervention 3: Subjects with prediabetes will have a baseline hyperglycemic clamp (Aim 1) and then receive sildenafil or placebo for 3 months. Another hyperglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test. intervention 4: Subjects with prediabetes will have a baseline euglycemic clamp (Aim 2) and then receive sildenafil or placebo for 3 months. Another euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test.

Protocol documents:
Clinical trial NCT01412957
Conditions: Metastatic Colorectal Cancer
Keywords: Best Supportive Care Panitumumab Chemorefractory Wild-type KRAS Overall Survival Phase 3
Sponsor: Amgen
Start date: 2011-11-01; Completion date: 2016-11-01
Enrollment: 377 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the benefit of panitumumab in addition to best supportive care compared to best supportive care alone in patients with chemorefractory wild-type KRAS (Kirsten rat sarcoma viral oncogene homolog) metastatic colorectal cancer.

Detailed description:

Arms: arm 1: Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus BSC until disease progression, withdrawal of consent, death, or intolerance of study drug. arm 2: Participants received best supportive care until disease progression, withdrawal of consent, or death.
Interventions: intervention 1: Best Supportive Care (BSC) intervention 2: Panitumumab
Intervention descriptions: intervention 1: BSC was defined as the best palliative care available as judged appropriate by the investigator and according to institutional guidelines and could include antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any other symptomatic therapy as clinically indicated. intervention 2: Administered intravenously

Protocol documents:
Clinical trial NCT01423604
Conditions: Pancreatic Cancer
Keywords: Metastatic pancreatic cancer
Sponsor: Incyte Corporation
Start date: 2011-07-01; Completion date: 2016-11-01
Enrollment: 136 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to determine whether ruxolitinib added to capecitabine is effective in improving the overall survival of patients with metastatic pancreatic cancer.

Detailed description:
The study consisted of an open-label, safety run-in period that was composed of 1 patient cohort with 9 patients/cohort. This phase of the study determined the safety of the capecitabine/ruxolitinib combination in this patient population.

A randomized, double-blind study with two treatment arms was conducted once the safety run-in results from the first part of the study showed that the capecitabine/ruxolitinib combination was safe and additional patients could be treated. All patients have received capecitabine therapy in addition to the ruxolitinib or placebo (Study Drug).

Treatment for all patients consisted of repeating 21-day cycles. Capecitabine was self-administered for the first 14 days of each cycle, and the Study Drug was self-administered during the entire 21-day cycle. Treatment cycles continued as long as the regimen was tolerated and the patient did not meet any of the discontinuation criteria. In the event of disease progression, capecitabine therapy was discontinued but the Study Drug could continue to be administered. Subjects who discontinued treatment with the Study Drug continued to be followed to obtain information regarding subsequent treatment regimens and survival.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Capecitabine intervention 2: Ruxolitinib intervention 3: Placebo
Intervention descriptions: intervention 1: Capecitabine starting dose - 2000 mg/m\^2 (1000 mg/m\^2 twice a day (BID)) (NOTE: Frequency of administration may be adjusted during the study.) intervention 2: Ruxolitinib starting dose - 15 mg BID (NOTE: Starting dose of randomized study drug may be 10 mg BID based on results from safety run-in study. Dose of ruxolitinib may be increased during randomized study.) intervention 3: Placebo matching ruxolitinib

Protocol documents:
Clinical trial NCT01459614
Conditions: Pancreatic Cancer
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Start date: 2011-11-01; Completion date: 2016-11-01
Enrollment: 44 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Primary Objectives

To assess the efficacy of the combination of gemcitabine, taxotere, and xeloda (GTX) with cisplatin in subjects with metastatic pancreatic cancer based on the progression-free survival (PFS) rate at 6 month.

Secondary Objectives

* To assess safety and characterize toxicities of the combination of GTX with cisplatin in subjects with metastatic pancreatic cancer.
* To estimate disease control rate (DCR), PFS, and overall survival (OS).
* To estimate a PFS rate of an expansion cohort testing an alternative schedule.

Study Design

This study is a single arm phase II study to assess the efficacy of GTX with cisplatin in subjects with metastatic pancreatic cancer. Approximately 38 evaluable subjects will be enrolled, 28 in the initial cohort and 10 in the expansion cohort

The study will have a safety run-in phase consisting of 6 subjects. To ensure that the combination is safe, the first six subjects will be treated at DL1 and observed for limiting toxicity for the first 2 cycles before continuation with further accrual. After the safety run-in, the study will be continuously monitored for adverse events.

The primary endpoint will be the PFS rate at 6 month, which is defined as the proportion of subjects alive, free of disease progression at 6 months. The treatment regimen would be considered of insufficient activity for further study in this population if PFS rate at 6 months is 50% or less, and the minimum required level of efficacy that would warrant further study with the proposed regimen is a 75% PFS rate at 6 months. The study design includes interim monitoring for futility using a predictive probability approach. We will stop the study early if given the information at the interim analysis, it is unlikely that the PFS rate at 6 months will be greater than 50% if the study continues to the end.

Detailed description:

Arms: arm 1: Each cycle is 21 days (2 weeks Tx + 1 week off). Xeloda given days 1-14, Gemcitabine, Taxotere, and Cisplatin given days 4 and 11.

For expansion cohort, each cycle is 28 days (2 weeks of Tx + 2 weeks off)
Interventions: intervention 1: Gemcitabine intervention 2: Taxotere intervention 3: Xeloda intervention 4: Cisplatin
Intervention descriptions: intervention 1: IV on Days 4 and 11 intervention 2: IV on Days 4 and 11 intervention 3: orally, twice a day Days 1-14 intervention 4: IV Days 4 and 11

Protocol documents:
Clinical trial NCT01527682
Conditions: Childhood Glaucoma
Keywords: Intraocular pressure Latanoprost Dorzolamide
Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Start date: 2009-07-01; Completion date: 2016-11-01
Enrollment: 37 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Objectives:

The study will assess the ocular hypotensive effect of latanoprost and dorzolamide in a selected sample of patients affected by primary Pediatric Glaucoma (PG), refractory to surgical procedures. Safety will be assessed, too.In the first version of the protocol 96 eyes were forecasted to complete the enrolment. The protocol was then amended and now to complete the study 68 eyes should be included. This number of eyes could be achieved by recruiting from 34 to 68 patients due to not in all patients both eyes should be eligible for the study.

Detailed description:
Study design:

Single arm, prospective, experimental study. Due to ethical reasons and in order to adhere as much as possible to current clinical practice, the presence of a control arm is not planned. Due to the non-comparative nature of the study, no blinding of treatment is planned.

Arms: arm 1: According to intraocular (IOP) assessment, the eye will receive Latanoprost, Dorzolamide or both.
Interventions: intervention 1: Latanoprost, Dorzolamide
Intervention descriptions: intervention 1: * Latanoprost 0.005% ophthalmic solution given once a day at nighttime (9.00 PM)
* Dorzolamide 2% ophthalmic solution given three times a day as a monotherapy, two times a day if in combination with latanoprost

Protocol documents:
Clinical trial NCT01580410
Conditions: Carcinoma of the Appendix Primary Peritoneal Cavity Cancer
Sponsor: Wake Forest University Health Sciences
Start date: 2009-05-01; Completion date: 2016-11-01
Enrollment: 136 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase II trial is studying the side effects and how well giving oxaliplatin or mitomycin C directly into the abdomen after surgery works in treating patients with tumors of the appendix. Drugs used in chemotherapy, such as oxaliplatin and mitomycin C, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Heating a chemotherapy solution and infusing it directly into the abdomen may kill more tumor cells. Giving these treatments after surgery may kill any tumor cells that remain after surgery.

Detailed description:
PRIMARY OBJECTIVES:

I. To compare the toxicity profiles within 4 weeks of surgery of oxaliplatin and mitomycin C delivered via Hyperthermic Intraperitoneal Chemotherapy in patients with peritoneal surface malignancies from primary appendiceal tumors.

SECONDARY OBJECTIVES:

I. To compare the time to progression in patients treated with oxaliplatin vs. mitomycin C delivered via Hyperthermic Intraperitoneal Chemotherapy for surface malignancies from primary appendiceal tumors.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients undergo surgical cytoreduction and receive mitomycin C by hyperthermic intraperitoneal chemotherapy (HIPEC).

Arm II: Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC.

After completion of study treatment, patients are followed up at 6, 12, 18, 24, 30, and 36 months.

Arms: arm 1: Patients undergo surgical cytoreduction and receive mitomycin C by HIPEC. arm 2: Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC.
Interventions: intervention 1: mitomycin C intervention 2: oxaliplatin intervention 3: therapeutic conventional surgery intervention 4: quality-of-life assessment intervention 5: hyperthermic intraperitoneal chemotherapy
Intervention descriptions: intervention 1: Given by HIPEC intervention 2: Given by HIPEC intervention 3: Undergo surgery intervention 4: Ancillary studies intervention 5: Undergo HIPEC

Protocol documents:
Clinical trial NCT01614210
Conditions: Newly Diagnosed Hormone Positive Clinical Stage 1 or 2 Breast Cancer
Sponsor: University of Utah
Start date: 2012-08-01; Completion date: 2016-11-01
Enrollment: 52 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to see if tumors respond to endocrine therapy by taking a total of 21 doses of Tamoxifen before and after surgery. Tamoxifen is currently approved by the FDA (Food and Drug Administration) for use in the treatment of hormone positive breast cancer.

Detailed description:
Patients who are eligible (newly diagnosed hormone positive clinical stage 1 or 2 breast cancer) will be approached about the study. If they sign informed consent a prescription for 21 doses of Tamoxifen will be provided. The patient's surgery will be scheduled at a time convenient for the patient and the surgeon. Once the surgery has been scheduled, a medication calendar will be completed that allows the patient to take tamoxifen for 7 days preoperatively with the 7th dose of tamoxifen to coincide with the day before surgery. The patient will continue to take tamoxifen for 2 weeks (14 days) after surgery. Patients will then proceed along normal treatment guidelines. For those needing chemotherapy or radiation therapy, we recommend the long term endocrine therapy start at the conclusion of chemo and/or radiation treatments. For those not going on to any additional therapy, the prescription for endocrine therapy will be written at the initial post-operative visit.

Unstained slides from the formalin-fixed, paraffin-embedded tissue blocks from the patient's breast tissue from which the original diagnosis of breast cancer was made by H\&E will be stained for Ki67. After endocrine therapy and subsequent resection, carcinoma will be confirmed by the participating pathologist on H\&E, and Ki67 will be performed on unstained slides from a representative tissue block containing invasive carcinoma. The pathologist will circle a designated area of tumor on the H\&E slide and both the H\&E and immunostained (Ki67) slides will be scanned in a digital imaging device (Aperio XT Scanscope), which quantitatively analyzes the tumor designated by the pathologist with image analysis algorithms. The algorithm accurately detects regions of interest and distinguishes cells and sub-cellular objects within these target regions. It determines morphology and expression profiles per individual cell or cell compartment. For Ki67 analysis, a nuclear Immunohistochemistry (IHC) algorithm will be used.

Arms: arm 1: All patients enrolled in the study.
Interventions: intervention 1: Tamoxifen intervention 2: Breast cancer surgery
Intervention descriptions: intervention 1: All patients will take tamoxifen 20 mg po daily for 7 days prior to surgery and for 14 days after surgery. intervention 2: Breast cancer surgery

Protocol documents:
Clinical trial NCT01640808
Conditions: Hepatic Neoplasm Malignant Recurrent
Sponsor: Kowa Company, Ltd.
Start date: 2012-04-01; Completion date: 2016-11-01
Enrollment: 616 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to verify the superiority of NIK-333 (Peretinoin) to placebo in inhibiting the recurrence of HCV-positive HCC in patients showing complete cure of the disease, with the recurrence-free survival as the primary endpoint, in a multi-center, randomized, double-blind, placebo-controlled, parallel-group comparison study.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: NIK-333(peretinoin) intervention 2: Placebo
Intervention descriptions: intervention 1: 600mg (8 x 75mg capsules) orally, twice a day intervention 2: Placebo (8 x Placebo capsules) orally, twice a day

Protocol documents:
Clinical trial NCT01716104
Conditions: Benign Prostatic Hyperplasia
Sponsor: Materia Medica Holding
Start date: 2012-11-01; Completion date: 2016-11-01
Enrollment: 260 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is:

* To assess safety of Afalaza drug within 12 months in patients with symptoms of benign prostatic hyperplasia (BPH) and risk of progression.
* To assess efficacy of Afalaza drug within 12 months in patients with symptoms of benign prostatic hyperplasia and risk of progression.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Afalaza intervention 2: Placebo
Intervention descriptions: intervention 1: Safety and Efficacy intervention 2: Safety and Efficacy

Protocol documents:
Clinical trial NCT01730846
Conditions: Smoking
Keywords: smoking lapse behavior smoking cessation doxazosin medication effect on smoking lapse behavior medication effect on smoking cessation stress
Sponsor: Yale University
Start date: 2013-02-01; Completion date: 2016-11-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine whether doxazosin will attenuate the ability of stress to precipitate smoking lapse behavior in treatment seeking daily smokers. Participants will participate in a smoking cessation attempt after the laboratory sessions.

Detailed description:

Arms: arm 1: doxazosin 4mg/day arm 2: placebo control arm 3: doxazosin 8mg/day
Interventions: intervention 1: Doxazosin 4mg/day intervention 2: Placebo intervention 3: Doxazosin 8mg/day
Intervention descriptions: intervention 1: 4 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study. intervention 2: Placebo intervention 3: 8 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study.

Protocol documents:
Clinical trial NCT01772719
Conditions: Multiple Myeloma
Keywords: refractory multiple myeloma
Sponsor: University of Louisville
Start date: 2012-08-01; Completion date: 2016-11-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to examine the effect of simvastatin and zoledronic acid on M-protein and/or free light chains when added to conventional chemotherapy for the treatment of multiple myeloma patients.

Detailed description:
We hypothesize that the addition of simvastatin and zoledronic acid to bortezomib, thalidomide, melphalan or dexamethasone based regimens will decrease drug resistance when treating refractory multiple myeloma. We hypothesize that the addition of simvastatin and zoledronic acid will not increase the chemotherapy toxicity significantly and will be tolerable for patients. We believe simvastatin and zoledronic acid have antitumor properties and will contribute to reversal of resistance. Treatment will be significantly enhanced when these agents are combined

Arms: arm 1: Study Arm
Interventions: intervention 1: Simvastatin and zoledronic acid
Intervention descriptions: intervention 1: 1. Simvastatin 80 mg PO daily starting two days before starting chemotherapy and stopping two days after chemotherapy.
2. Zoledronic acid 4 mg IV over 15 minutes on day 1 and then monthly.

Protocol documents:
Clinical trial NCT01777568
Conditions: 30% Oxygen Concentration During Colorectal Surgery 80% Oxygen Concentration During Colorectal Surgery
Sponsor: The Cleveland Clinic
Start date: 2012-11-01; Completion date: 2016-11-01
Enrollment: 5749 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Our primary objective is to develop a clinical pathway for care of patients having colorectal surgery at the Clinic. In particular, the investigators would like to determine what intraoperative concentration of oxygen is optimal in our patients.

Detailed description:
The investigators therefore propose to test the primary hypothesis that supplemental oxygen (80% versus 30%) reduces the risk of a composite of surgical sites infection and potentially oxygen-related wound complications. Secondarily, the investigators will assess the incremental cost benefit of 80% versus 30% oxygen. As a safety measure, enough oxygen will always be given to maintain oxygen saturation (as determined by pulse oximetry) ≥95%.

Arms: arm 1: Inspired oxygen will be maintained at 30%. arm 2: Inspired oxygen will be maintained at 80%.
Interventions: intervention 1: 30% oxygen intervention 2: 80% oxygen
Intervention descriptions: intervention 1: Inspired oxygen will be maintained at 30%. intervention 2: Inspired oxygen will be maintained at 30%.

Protocol documents: