ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01977794
Conditions: Hypertension
Keywords: Bisoprolol Amlodipine Fixed dose combination (FDC) Systolic Blood Pressure (SBP) Diastolic Blood Pressure (DBP)
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2014-03-01; Completion date: 2015-03-01
Enrollment: 200 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, comparative Phase 3 trial to investigate the efficacy of fixed dose combination (FDC) of bisoprolol and amlodipine in hypertensive subjects (superiority of FDC over monotherapies).

Detailed description:

Arms: arm 1: Subjects who failed monotherapy with bisoprolol 5 milligram (mg) before trial inclusion will be randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet arm 2: Subjects who failed monotherapy with amlodipine 5 mg before trial inclusion will be randomized to amlodipine failed group to receive Bisoprolol/Amlodipine FDC tablet.
Interventions: intervention 1: Bisoprolol/Amlodipine (Bisoprolol failed group) intervention 2: Bisoprolol/Amlodipine (Amlodipine failed group)
Intervention descriptions: intervention 1: Bisoprolol/Amlodipine FDC tablet will be orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If blood pressure (BP) is controlled at Week 6 (Day 43), the same dose will continue for next 6 weeks. If the BP is not controlled at Day 43, the dose will be increased to Bisoprolol/Amlodipine 5mg/10mg or 10mg/5mg for next 6 weeks. Subjects who have controlled BP at Week 12 (Day 85), will continue with the same dose for next 6 weeks. If their BP is not controlled at Day 85, dose will be increased to the next level (Bisoprolol/Amlodipine 5mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/5mg dose and Bisoprolol/Amlodipine and 10mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/10mg dose) until Week 18 (Day 127). intervention 2: Bisoprolol/Amlodipine FDC tablet will be orally administered at an initial dose of 5 milligram (mg)/5 mg once daily for 6 weeks. If BP is controlled at Week 6 (Day 43), the same dose will continue for next 6 weeks. If the BP is not controlled at Day 43, the dose will be increased to Bisoprolol/Amlodipine 5mg/10mg or 10mg/5mg for next 6 weeks. Subjects who have controlled BP at Week 12 (Day 85), will continue with the same dose for next 6 weeks. If their BP is not controlled at Day 85, dose will be increased to the next level (Bisoprolol/Amlodipine 5mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/5mg dose and Bisoprolol/Amlodipine and 10mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/10mg dose) until Week 18 (Day 127).

Protocol documents:
Clinical trial NCT00293540
Conditions: Breast Cancer
Keywords: metastatic secondary Hormone Receptor-Positive Breast Cancer
Sponsor: International Breast Cancer Research Foundation
Start date: 2006-02-01; Completion date: 2015-03-01
Enrollment: 249 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will determine if hormone receptor positive premenopausal metastatic breast cancer patients who undergo removal of the ovaries in mid-luteal versus mid-follicular phase have a longer survival.

Detailed description:
Rationale: Previous research suggests that women who have their ovaries removed as part of their treatment for breast cancer may live longer if the ovarian surgery is performed during the luteal phase (last 14 days of the menstrual cycle) rather than the follicular phase (the first 14 days of the menstrual cycle). The current study will evaluate this important research question in premenopausal women with metastatic hormone receptor-positive breast cancer who will be treated with surgery and tamoxifen.

Purpose: The purpose of this research is to find out if premenopausal women with breast cancer that has spread to other parts of the body live longer if their ovaries are removed during the second half of the menstrual cycle. This study will compare how long women live if they have their ovaries removed during the first half of their menstrual cycle (follicular phase) to how long women live if they have their ovaries removed during the second half of their menstrual cycle (luteal phase). Tamoxifen will also be given to study participants.

Treatment: Study participants will have tests performed in advance of surgery to remove their ovaries. Surgery will be performed within four weeks of these tests. The exact day will be determined by the study participant's menstrual history and by a process called randomization, which is a random decision making process to determine if each study participant will have their surgery during the first or second half of their menstrual cycle. On the day of surgery, blood will be taken immediately prior to surgery and three hours after surgery for hormone tests. After the surgery, study participants will be given tamoxifen in oral pills for daily consumption. Study participants will be asked to return to the hospital every two months for tests and distribution of additional tamoxifen tablets. Treatments will be discontinued for disease progression or unacceptable adverse effects.

Arms: arm 1: Surgical oophorectomy in history-estimated mid-luteal phase of menstrual cycle plus Tamoxifen arm 2: Surgical oophorectomy in history-estimated mid-follicular phase of menstrual cycle plus Tamoxifen
Interventions: intervention 1: oophorectomy intervention 2: Tamoxifen
Intervention descriptions: intervention 1: Excision of an ovary intervention 2: 20 mg orally every day

Protocol documents:
Clinical trial NCT00347919
Conditions: Neoplasms, Breast
Keywords: GW786034 Quality of Life GW572016 Lapatinib Pazopanib Metastatic Breast cancer Genetics FISH Advanced
Sponsor: GlaxoSmithKline
Start date: 2006-07-01; Completion date: 2015-03-01
Enrollment: 189 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being conducted to compare the efficacy and safety of pazopanib in combination with lapatinib with that of lapatinib alone in subjects with locally advanced or metastatic breast cancer whose tumors overexpress the ErbB2 protein.

Detailed description:

Arms: arm 1: 1500 mg (6 x 250 mg tablets) oral lapatinib once daily arm 2: 1000 mg (4 x 250 mg tablets) of oral lapatinib and 400 mg (4 x 100 mg tablets) of oral pazopanib taken together once daily arm 3: 1500 mg (6 x 250 mg tablets) of oral lapatinib and 800 mg (1 x 500 mg tablets plus 3 x 100 mg tablets) of oral pazopanib taken together once daily
Interventions: intervention 1: pazopanib (GW786034) 400 mg intervention 2: lapatinib (GW572016) 1500 mg intervention 3: lapatinib (GW572016) 1000 mg intervention 4: pazopanib (GW786034) 800 mg
Intervention descriptions: intervention 1: 400 mg administered orally once daily intervention 2: 1500 mg administered orally once daily. intervention 3: 1000 mg administered orally once daily intervention 4: 800 mg administered orally once daily

Protocol documents:
Clinical trial NCT00358501
Conditions: Severe Hepatic Veno-Occlusive Disease
Keywords: Defibrotide Severe veno occlusive disease Multi organ failure Stem cell transplant Liver Regimen related toxicity Day 100 survival
Sponsor: Jazz Pharmaceuticals
Start date: 2006-07-01; Completion date: 2015-03-01
Enrollment: 134 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to (1) demonstrate the efficacy and safety (toxicity) of 25 mg/kg/day of Defibrotide in patients with severe veno-occlusive disease (sVOD) and (2) evaluate serum and endothelial markers of veno-occlusive disease (VOD) through the analysis of blood samples.

Detailed description:
This is a historically-controlled, multicenter, open label Phase 3 study to determine the safety and efficacy of 25 mg/kg/day of Defibrotide (DF) for the treatment of severe VOD in hematopoietic stem cell transplantation (HSCT) patients.

In this study, the term "severe VOD" is defined as those patients who meet the Baltimore diagnostic criteria for VOD (total bilirubin \>/= 2.0 mg/dL plus two of the following: ascites, \>/=5% weight gain and hepatomegaly), who also have multi-organ failure (i.e., pulmonary and/or renal dysfunction). This represents a group of patients in whom mortality at Day+100 has been estimated to be \>80%.

Comparisons: The primary parameter is Complete Response at 100 days following stem cell transplant, utilizing historical controls as a comparator. The historical control database will be generated through a retrospective medical chart review performed at participating centers; the survival outcome of patients who would otherwise have met eligibility criteria for this trial will be compared to the survival observed in patients prospectively treated with Defibrotide. Secondary parameters include survival rate at 100 days and 6 months post stem cell transplantation (SCT), and special studies of endothelial and serum markers for VOD. This study will assess safety of the dose and schedule in this setting.

Arms: arm 1: Defibrotide treatment arm 2: Historical control group
Interventions: intervention 1: Defibrotide
Intervention descriptions: intervention 1: Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days.

Protocol documents:
Clinical trial NCT00445146
Conditions: HIV Infections
Keywords: Phase 2 Open-label Rollover Integrase Inhibitor Antiretroviral Agents Highly Active Antiretroviral Activity HAART HIV, HIV-1, AIDS virus, Human Immunodeficiency Virus Acquired Immune Deficiency Syndrome Virus treatment experienced
Sponsor: Gilead Sciences
Start date: 2007-02-01; Completion date: 2015-03-01
Enrollment: 192 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The main objective of this study is to observe the long-term safety of elvitegravir (EVG) boosted with ritonavir (RTV) in combination with other antiretroviral (ARV) agents in participants who have completed a prior EVG+RTV treatment study.

Detailed description:

Arms: arm 1: EVG 85 mg or 150 mg + RTV + ARV regimen

Participants receiving lopinavir/ritonavir (LPV/r) or atazanavir/ritonavir (ATV/r) as part of their ARV regimen will receive EVG 85 mg and all other participants will receive EVG 150 mg.

Some participants may receive EVG 300 mg during the course of protocol amendment 2.
Interventions: intervention 1: EVG intervention 2: RTV intervention 3: ARV regimen
Intervention descriptions: intervention 1: Elvitegravir (EVG) tablet administered orally once daily with food intervention 2: Ritonavir (RTV; /r) 100 mg capsule administered orally once daily with food intervention 3: The components of the ARV regimen will be selected by the investigator without input from the sponsor. The antiretroviral regimen must consist of at least 2 agents, not including the non-nucleoside reverse transcriptase inhibitors (NNRTIs) efavirenz, nevirapine, or delavirdine; the protease inhibitors saquinavir, nelfinavir, or indinavir; or investigational agents (without sponsor approval).

Protocol documents:
Clinical trial NCT00458822
Conditions: Multiple Myeloma and Plasma Cell Neoplasm
Keywords: primary systemic amyloidosis
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2007-02-01; Completion date: 2015-03-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study in patients needing treatment for AL amyloidosis is to see how well treatment with IV melphalan works and then, if some clonal plasma cells are still present about 2 to 3 months after melphalan treatment, to see how well treatment with bortezomib and dexamethasone works to reduce the rest of the clonal plasma cell disease.

Detailed description:

Arms: arm 1: All patients treated with Melphalan with Stem Cell Transplant and Adjuvant Bortezomib and Dexamethasone for Recently Diagnosed Untreated Patients with Systemic Light-Chain (AL) Amyloidosis
Interventions: intervention 1: bortezomib intervention 2: dexamethasone
Intervention descriptions: intervention 1: Given IV intervention 2: Given orally

Protocol documents:
Clinical trial NCT00465179
Conditions: Renal Cell Cancer Kidney Cancer
Keywords: Non-Clear Cell Renal Carcinoma Non-clear cell renal cell cancer Renal Cell Cancer Kidney Cancer Papillary Chromophobe Collecting duct carcinoma CDC Renal medullary carcinoma RMC Sunitinib Malate Sutent SU011248
Sponsor: M.D. Anderson Cancer Center
Start date: 2007-03-01; Completion date: 2015-03-01
Enrollment: 61 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this clinical research study is to learn the effectiveness of Sutent® (sunitinib malate, SU011248) in the treatment of patients with non-clear cell renal cell cancer. The safety of sunitinib malate will also be studied.

Detailed description:
Sunitinib malate is designed to block pathways that control important events such as the growth of blood vessels that are essential for the growth of cancer.

If you are found to be eligible to take part in this study, you will take sunitinib malate once a day (either with or without food) for 4 weeks in a row followed by 2 weeks of rest with no study drug. These 6 weeks are considered 1 cycle of study treatment.

Around Day 15 of each cycle, your vital signs will be measured and recorded, and you will have blood drawn (about 2 teaspoons) for routine testing. These evaluations can be done at your local doctor's office.

You will be required to return to clinic for a follow-up visit around Day 29 of Cycle 1.

At this visit, your medical history will be recorded, and your ability to perform daily activities will be evaluated. You will have a physical exam, including measurement of your vital signs. You will be asked about any side effects you may have experienced since your last visit. You will be asked about any medicines you may be currently taking. You will have blood drawn (about 4 teaspoons) for routine testing.

Beginning Day 1 of Cycle 3, you will return to clinic every 12 weeks (Day 1 of each cycle). You will have the same evaluations as you did at the Day 29 visit.

On Day 1 of every other cycle, you will have an ECG and a doppler echocardiogram or multigated acquisition (MUGA) scan to evaluate your heart health.

You will have follow-up imaging scans (CT and/or MRI) to track your response to treatment on Day 1 of the first 2 cycles and every 12 weeks thereafter for as long as you are receiving treatment on this study.

You will continue to receive treatment on this study, unless your disease gets worse, you develop an illness that prevents you from continuing treatment, or you experience any intolerable side effects of the study drug. You will be removed from this study if any of these circumstances occur.

This is an investigational study. Sunitinib malate has been authorized by the FDA for treatment of clear cell renal carcinoma. Its use in non-clear cell renal carcinoma is experimental. Up to 60 patients will take part in this study. All will be enrolled at MD Anderson.

Arms: arm 1: Sunitinib Malate 50 mg by mouth daily for 4 weeks, then 2 weeks off.
Interventions: intervention 1: Sunitinib Malate
Intervention descriptions: intervention 1: 50 mg by mouth daily for 4 weeks, then 2 weeks off.

Protocol documents:
Clinical trial NCT00570232
Conditions: Head and Neck Cancer
Keywords: Resectable, recurrent head and neck cancer
Sponsor: University of Alabama at Birmingham
Start date: 2007-12-01; Completion date: 2015-03-01
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether erlotinib will be effective in controlling cancer that has returned after treatment with salvage surgery and radiation. This study will also determine what effects, good and/or bad, this drug has on the participants.

Detailed description:
An investigator-initiated Phase II clinical trial of the safety and tolerability of erlotinib as an adjuvant therapy after definitive therapy via salvage surgery in head and neck cancer patients.

Arms: arm 1: All patients will be prescribed erlotinib 150mg daily
Interventions: intervention 1: Erlotinib
Intervention descriptions: intervention 1: 150 mg per day by mouth for 12 months

Protocol documents:
Clinical trial NCT00674973
Conditions: Pancreatic Cancer
Sponsor: Hoffmann-La Roche
Start date: 2008-06-01; Completion date: 2015-03-01
Enrollment: 207 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to identify biomarkers which may predict improvement in progression free survival from treatment with Tarceva, in patients with advanced pancreatic cancer who failed one prior regimen of standard chemotherapy or who are deemed unsuitable for chemotherapy. It will also assess the efficacy and safety of Tarceva in this patient population. Patients will be randomized to receive either Tarceva 150mg/day po, or placebo po daily. Tumor tissue will be used for biomarker analysis. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until disease progression, unacceptable toxicity, withdrawal, or death. arm 2: Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression, unacceptable toxicity, withdrawal, or death.
Interventions: intervention 1: Erlotinib intervention 2: Placebo
Intervention descriptions: intervention 1: Participants received erlotinib 150 mg tablet orally once daily. intervention 2: Participants received placebo matching to erlotinib 150 mg tablet orally once daily.

Protocol documents:
Clinical trial NCT00702949
Conditions: Breast Cancer Hot Flashes
Keywords: breast cancer hot flashes
Sponsor: Alliance for Clinical Trials in Oncology
Start date: 2008-06-01; Completion date: 2015-03-01
Enrollment: 207 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Pregabalin may help relieve hot flashes in women with a history of breast cancer or those who have no history and do not wish to take estrogen therapy for fear of increased risk of breast cancer. It is not yet known what dose of pregabalin may be more effective in treating hot flashes.

PURPOSE: This is a randomized phase III trial to determine the efficacy of two doses of pregabalin, in comparison to placebo, in the prevention of hot flashes.

Detailed description:
OBJECTIVES:

* To evaluate the efficacy of 150 mg of pregabalin versus placebo on hot flash scores in women with a history of breast cancer or women who do not wish to take estrogen therapy for fear of increased risk of breast cancer.
* To evaluate the side effect profile of different doses of pregabalin in these patients.
* To evaluate the effect of 150 mg of pregabalin versus placebo on the secondary outcome of interference of activities from hot flashes in these patients.
* To evaluate the efficacy and side effect profile of 75 mg of pregabalin versus placebo in these patients.

OUTLINE: Patients are stratified according to age (18-49 years vs ≥ 50 years); selective estrogen-receptor modulator (i.e., tamoxifen or raloxifene) or aromatase inhibitor use (yes vs no); duration of hot flashes (\< 9 months vs ≥ 9 months); and frequency of hot flashes per 24-hour period (4-9 vs ≥ 10). Patients are randomized to 1 of 3 treatment arms.

* Arm I: Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
* Arm II: Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
* Arm III: Patients receive oral placebo twice daily for 6 weeks. Treatment in all arms continues in the absence of unacceptable toxicity.

Patients complete Hot Flash Diaries at baseline and once daily during treatment and the Symptom Experience Diary at baseline and once weekly during treatment. Patients also complete the Profile of Mood States and the Hot Flash Related Daily Interference Scale questionnaires at baseline and after completion of study treatment.

Arms: arm 1: Patients receive 75 mg of oral pregabalin twice daily for 6 weeks. arm 2: Patients receive 150 mg of oral pregabalin twice daily for 6 weeks. arm 3: Patients receive oral placebo twice daily for 6 weeks.
Interventions: intervention 1: pregabalin intervention 2: placebo
Intervention descriptions: intervention 1: Given orally intervention 2: Given orally

Protocol documents:
Clinical trial NCT00844883
Conditions: Hepatocellular Carcinoma Hepatoma
Keywords: primary liver cancer sorafenib Nexavar doxorubicin drug eluting beads transarterial chemoembolization
Sponsor: Yale University
Start date: 2009-02-01; Completion date: 2015-03-01
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will combine two therapies to treat patients with unresectable hepatocellular carcinoma; sorafenib, and drug eluting beads delivered intra-arterially. The purpose of the study is to establish the safety and the effectiveness of the combination therapy. The investigators hypothesize that the combination of the two therapies will not result in greater toxicities to patients than that expected for either therapy given alone.

Detailed description:

Arms: arm 1: single arm
Interventions: intervention 1: sorafenib intervention 2: LC Bead-TACE
Intervention descriptions: intervention 1: sorafenib: given 400 mg twice per day for as long as it is beneficial intervention 2: LC Beads loaded with doxorubicin

Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period

Protocol documents: