ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00998049
Conditions: Multiple Myeloma Refractory Multiple Myeloma Stage I Multiple Myeloma Stage II Multiple Myeloma Stage III Multiple Myeloma
Sponsor: Mayo Clinic
Start date: 2009-12-01; Completion date: 2015-04-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Rationale: Giving colony-stimulating factors, such as G-CSF and plerixafor helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored. Purpose: This phase II trial is studying how well plerixafor works in patients with multiple myeloma previously treated with lenalidomide and planning to undergo autologous stem cell transplant.

Detailed description:
Primary Objective: I. To determine the proportion of patients reaching a stem cell yield of 3 million CD34 cells/kg by second day of apheresis with intravenously administered AMD3100 among patients receiving primary therapy for myeloma with lenalidomide. Secondary Objectives: I. Safety and tolerability of intravenously administered AMD3100. II. Rate of failure to mobilize. Outline: Patients receive plerixafor IV on days 5-8 and filgrastim subcutaneously on days 1-8 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.

Arms: arm 1: Plerixafor 160mg/kg/dose by IV on days 5-8

Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8.
Interventions: intervention 1: plerixafor intervention 2: filgrastim
Intervention descriptions: intervention 1: Plerixafor 160mg/kg/dose by IV on days 5-8 intervention 2: Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8.

Protocol documents:
Clinical trial NCT01003106
Conditions: Retinal Vein Occlusion
Keywords: RVO BRVO CRVO Vein occlusion
Sponsor: Peter A Campochiaro, MD
Start date: 2009-11-01; Completion date: 2015-04-01
Enrollment: 81 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary Objective of this study is to evaluate the safety and tolerability of intraocular injections of 0.5mg or 2.0mg of ranibizumab in patients with macular edema due to retinal vein occlusion.

Detailed description:
The secondary objectives are to assess the efficacy of 0.5mg versus 2.0mg of monthly ranibizumab injections in patients with macular edema due to retinal vein occlusion between baseline and month 6. At week 24, patients will be re-randomized to receive pro re nata (prn) ranibizumab+laser photocoagulation versus ranibizumab alone and the efficacy of both treatment options will be compared. Treatment efficacy will be assessed by comparing changes in best corrected visual acuity (BCVA) and central subfiled thickness (CST) between the treatment groups.

Arms: arm 1: Branch retinal vein occlusion patients randomized to this group will receive 0.5mg of ranibizumab alone as per protocol without laser photocoagulation. arm 2: Branch retinal vein occlusion patients randomized to this group will receive 0.5mg/2.0mg of ranibizumab as per protocol, and additional laser photocoagulation if required. arm 3: Branch retinal vein occlusion patients randomized to this group will receive 2.0mg of ranibizumab alone as per protocol without laser photocoagulation. arm 4: Branch retinal vein occlusion patients randomized to this group will receive 0.5mg/2.0mg of ranibizumab as per protocol, without additional laser photocoagulation. arm 5: Central retinal vein occlusion patients randomized to this group will receive 0.5mg of ranibizumab alone as per protocol without laser photocoagulation arm 6: Central retinal vein occlusion patients randomized to this group will receive 0.5mg/2.0mg of ranibizumab as per protocol, and additional laser photocoagulation if required. arm 7: Central retinal vein occlusion patients randomized to this group will receive 2.0mg of ranibizumab alone as per protocol without laser photocoagulation. arm 8: Central retinal vein occlusion patients randomized to this group will receive 0.5mg/2.0mg of ranibizumab as per protocol, without additional laser photocoagulation.
Interventions: intervention 1: Ranibizumab 0.5mg (monthly) intervention 2: Ranibizumab 2.0mg (monthly) intervention 3: Pro re nata (prn) ranibizumab intervention 4: Pro re nata (prn) Laser photocoagulation
Intervention descriptions: intervention 1: Branch retinal vein occlusion- Intravitreal injection of 0.5mg ranibizumab alone intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01058655
Conditions: Gastrointestinal Cancer
Keywords: Colorectal Cancer
Sponsor: Dana-Farber Cancer Institute
Start date: 2010-02-01; Completion date: 2015-04-01
Enrollment: 56 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Research has shown that anti-angiogenic agents can be effective therapies to treat cancer. Anti-angiogenic agents target the blood vessels required for tumors to grow. Vascular endothelial growth factor (VEGF) is one of the cell pathways used for this blood vessel growth. When the investigators interfere with the VEGF pathway, the investigators inhibit this blood vessel growth which is required by tumors. One of the study drugs being used, tivozanib (AV-951), selectively interferes with the VEGF pathway. The second study drug being used, everolimus (RAD001) interferes with the mTOR pathway. The mTOR pathway is another pathway involved in blood vessel and tumor cell growth. By combining these two drugs the investigators hope to slow or reverse tumor cell growth in patients whose tumors have become resistant to other therapies for their disease.

Detailed description:
Primary Objective

Phase I

* To determine the safety, tolerability, and maximally tolerated dose (MTD) of everolimus and tivozanib administered in combination to patients with advanced gastrointestinal tumors.

Phase II

* At the MTD, to assess progression-free survival associated with everolimus and tivozanib in patients with refractory, metastatic colorectal cancer.

Secondary Objectives

Phase II

* To assess tumor response rate.
* To assess overall survival.

Arms: arm 1: Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent. arm 2: Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent. arm 3: Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent. arm 4: Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
Interventions: intervention 1: Everolimus intervention 2: Tivozanib
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01105702
Conditions: Brain Cancer
Keywords: brain tumor brain cancer glioma
Sponsor: NYU Langone Health
Start date: 2010-05-01; Completion date: 2015-04-01
Enrollment: 28 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This pilot phase II trial studies how well giving temozolomide, bevacizumab, lithium carbonate, and radiation therapy works in treating patients with newly diagnosed high grade glioma.

Detailed description:
Treatment of high grade glioma (HGG) with anti-angiogenic therapy results in clinical improvement and prolonged progression-free survival (PFS). However, mant patients experience diffuse recurrence and treatment failure. This is a phase II trial testing the feasibility of adding lithium carbonate, previously shown to have anti-invasive properties in HGG, to bevacizumab and chemoradiation following surgical resection of HGG.

Arms: arm 1: Cycle 1(One 42-day cycle)

* Temozolomide 75 mg/m\^2 orally (42 consecutive days), beginning the night prior to the first radiation treatment
* Radiation within 3-5 weeks of surgery
* Bevacizumab 10mg/kg, IV, starting 29 (+3) days post surgery and every 2 weeks

Treatment Cycles 2-7 (28 days per cycle)

* Temozolomide at a dose of 150 mg/m\^2 on Days 1-7
* Bevacizumab 10 mg/kg on Day 8 and Day 22
* Initiate Lithium carbonate treatment at 300 mg, orally, twice a day; dose increased every 7 days up to 600mg, orally, twice a day, to a serum lithium level of 0.8-1.2 mEq/L.
Interventions: intervention 1: Temozolomide intervention 2: Bevacizumab intervention 3: Lithium Carbonate intervention 4: Radiation
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01107730
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation Cardiac valve repair Aneurysm repair CABG On-pump Cardiac surgery Vitamin C
Sponsor: Attikon Hospital
Start date: 2010-04-01; Completion date: 2015-04-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether vitamin C is effective in the prophylaxis of post-operative atrial fibrillation in on-pump cardiac surgery

Detailed description:
Atrial fibrillation (AF) is the single most common post-operative complication after on-pump cardiac surgery, ranging from roughly 25% in CABG procedures, up to 65% in valve replacement procedures. The presence of AF in cardiac surgery patients doubles the morbidity amongst these patients, as well as raising the mortality rates. VitC is an electron donor for a number of enzymatic systems, reducing potentially harmful free radicals. In post-procedural AF, there is increased peroxynitrite concentration, which is a target for vitamin C. A randomized, double blind study will be conducted in order to establish the efficiency of vitamin C as prophylaxis for postoperative AF.

Arms: arm 1: L-Carnitine intravenously (2 gr/day \[1grX2\] for 2 days prior to surgery, and postoperatively for 4 days arm 2: VitC intravenously (2g/day \[500mgX4\] for 2 days prior to surgery, and postoperatively for 4 days arm 3: None
Interventions: intervention 1: Vitamin C intervention 2: L-Carnitine intervention 3: Placebo
Intervention descriptions: intervention 1: VitC intravenously (2g/day \[500mgX4\] for 2 days prior to surgery, and postoperatively for 4 days intervention 2: L-Carnitine intravenously (2 gr/day \[1grX2\] for 2 days prior to surgery, and postoperatively for 4 days intervention 3: Placebo

Protocol documents:
Clinical trial NCT01108445
Conditions: Advanced Non-clear Cell Renal Cell Carcinoma
Keywords: cancer kidney cancer sutent everolimus renal cancer papillary renal cell chromophobe renal cell papillary chromophobe
Sponsor: Duke University
Start date: 2010-09-01; Completion date: 2015-04-01
Enrollment: 131 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the anti-tumor activity of everolimus and sunitinib in subjects with metastatic renal cell carcinoma (mRCC) with non-clear cell pathology.

Detailed description:
This will be an international (USA, Canada, and UK) open-label, outpatient, multicenter, randomized study of treatment with RAD001 (everolimus (Afinitor®) or sunitinib (Sutent®) in subjects with mRCC and non-clear cell histology. Special emphasis is placed on papillary and chromophobe histologies while sarcomatoid clear cell variants, medullary, and collecting duct carcinomas will be excluded (see eligibility). Subjects may continue receiving study drugs until disease progression, unacceptable toxicities, or withdrawal of consent, for a maximum of 24 months. Continuation of study assigned treatment will be allowed beyond 24 months at the discretion of the sponsor. Stratification variables will include histology (papillary vs. chromophobe) and Motzer risk criteria (0, 1-2, and 3). Tumor progression will be assessed locally and by independent review, in strict accordance with Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria measured every 12 weeks. At the time of progression, subjects will be taken off study other than simple administrative mortality follow-up. Primary pathologic samples and plasma/urine angiokine levels at baseline and over time will be collected and stored centrally for biomarker analysis.

Arms: arm 1: Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle. arm 2: Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
Interventions: intervention 1: Everolimus intervention 2: Sunitinib
Intervention descriptions: intervention 1: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle. intervention 2: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.

Protocol documents:
Clinical trial NCT01116921
Conditions: Respiratory Distress Syndrome
Keywords: laryngeal mask airway surfactant respiratory distress syndrome neonate
Sponsor: University of Minnesota
Start date: 2011-02-01; Completion date: 2015-04-01
Enrollment: 103 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this research is to compare the need for intubation and mechanical ventilation in the first seven days of life for infants with respiratory distress syndrome (RDS) on nasal continuous positive airway pressure (nCPAP) who receive surfactant via a Laryngeal Mask Airway (LMA) with those who are maintained on nCPAP and do not receive surfactant.

Detailed description:
Secondary outcomes were total number of hours on mechanical ventilation, CPAP and supplemental oxygen during the first 7 days of life and for the entire hospitalization. Other secondary outcomes were number of surfactant doses, incidence of pulmonary air leak, survival until discharge, chronic lung disease (defined as need for oxygen at 36 weeks PMA), oxygen requirement at discharge, severe intraventricular hemorrhage (Grade 3/4), and periventricular leukomalacia.

Arms: arm 1: Infants in the Control Group were maintained continuously on nasal CPAP 6 cm H2O with no surfactant administered. arm 2: Once proper placement of the LMA was achieved, surfactant (Curosurf®, 2.5 ml/kg, Chiesi USA, Inc., Cary, NC) was administered. The LMA cuff was then deflated, LMA removed and the infant placed back on nasal CPAP 6 cm H2O.
Interventions: intervention 1: Nasal continuous positive airway pressure (nCPAP) intervention 2: Laryngeal Mask Airway (LMA) to deliver surfactant intervention 3: Surfactants, Pulmonary
Intervention descriptions: intervention 1: nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU. intervention 2: Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA) intervention 3: Curosurf®, Chiesi USA, Inc., Cary, NC

Protocol documents:
Clinical trial NCT01189370
Conditions: Renal Cell Cancer
Keywords: carcinoma, renal cell kidney cancer
Sponsor: University of Kansas Medical Center
Start date: 2008-06-01; Completion date: 2015-04-01
Enrollment: 25 participants; Allocation: ; Intervention model: SEQUENTIAL

Brief summary:
The purpose of this study is to determine whether an increase in the dose of sorafenib when given over five instead of 7 days/week, will result in an improvement of the response rate (degree of shrinkage of your cancer) and an improvement in the length of time that sorafenib will control your cancer, without causing a significant increase in side effects.

Detailed description:
In 2006, an estimated 38,890 people in the United States were diagnosed with kidney cancer and greater than 12,000 died from the disease. Kidney cancer that has spread to other parts of the body is one of the most treatment-resistant diseases. Standard of care treatment usually involves chemotherapy. Results from chemotherapy have been disappointing. Therefore, there is a need to develop additional safe and effective therapies to treat advanced kidney cancer.

Sorafenib (Nexavar®) has been approved by the FDA for the treatment of advanced kidney cancer. Sorafenib works by interfering with a type of protein in your body that determines how your kidney cells work and grow. Sorafenib at standard doses for 400mg(two pills) twice/day, given seven days/week, may slow progression of the disease for an average of three months but it is not expected to be curative. Preliminary studies have suggested higher doses of sorafenib may increase the chance that the tumor will shrink.

Arms: arm 1: All patients will receive a starting dose of sorafenib 400 mg by mouth twice daily. At four weeks, all patients who have not experienced Grade 3 or 4 toxicity will undergo dose escalation using a treatment schedule of days 1-5 days of each week. Doses will continue to be escalated every 4 weeks depending on tolerability and tumor response.
Interventions: intervention 1: sorafenib
Intervention descriptions: intervention 1: Dose Level:

1. 400mg twice daily, continuous.
2. 600mg twice daily, days 1-5 of each week.
3. 800mg twice daily, days 1-5 of each week.

Protocol documents:
Clinical trial NCT01201265
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2011-02-01; Completion date: 2015-04-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This multicenter study will assess the efficacy and safety of bevacizumab in combination with gemcitabine and cisplatin as first line treatment in participants with triple negative metastatic breast cancer. Participants will receive bevacizumab at a dose of 15 mg/kg intravenously (iv) every 3 weeks, plus gemcitabine (1000 mg/m2 iv) and carboplatin (iv to an area under curve \[AUC\]=2) on Days 1 and 8 of each 3-week cycle. Anticipated time on study treatment is until disease progression.

Detailed description:

Arms: arm 1: Participants received a combination therapy of bevacizumab with gemcitabine plus carboplatin.
Interventions: intervention 1: Bevacizumab intervention 2: Carboplatin intervention 3: Gemcitabine
Intervention descriptions: intervention 1: 15 mg/kg iv every 3 weeks intervention 2: to an AUC = 2, on days 1 and 8 of each 3-week cycle intervention 3: 1000 mg/m2 iv on days 1 and 8 of each 3-week cycle

Protocol documents:
Clinical trial NCT01205503
Conditions: Breast Cancer Non-Hodgkin's Lymphoma
Keywords: chemobrain Oxidative Stress Mesna
Sponsor: Mara Chambers
Start date: 2010-09-01; Completion date: 2015-04-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine whether the drug mesna is able to block a series of chemical changes that occur in the blood of patients who receive the chemotherapy medicine doxorubicin. The researchers believe these blood chemical changes may the cause of "cloudy thinking" or "chemobrain" that are reported by some patients receiving chemotherapy.

Detailed description:
Patients with lymphoma and breast cancer receiving chemotherapy regimens that include anthracycline drugs, such as doxorubicin, are at risk for developing cognitive and cardiac impairment. This potential cognitive impairment is refered to as "chemobrain" by some patients. We have demonstrated in mice that the drug mesna, which is used to prevent other complications of other chemotherapy drugs, prevents certain types of doxorubicin-induced damage of blood proteins. Blocking doxorubicin's damage of these blood proteins has blunted or prevented the subsequent markers of neurologic and cardiac injury in mice. This clinical trial will determine if mesna prevents doxorubicin-induced damage of blood proteins in cancer patients, and may establish if blood protein injury is the first step in anthracycline-induced cognitive and cardiac dysfunction and if using the drug mesna can blunt or prevent these changes in blood markers of injury for patients with cancer.

Arms: arm 1: Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) with following Cyclophosphamide 6 hours post doxorubicin during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion with following Cyclophosphamide 6 hours post doxorubicin during 2nd cycle arm 2: Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion with following Cyclophosphamide 6 hours post doxorubicin during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) with following Cyclophosphamide 6 hours post doxorubicin during 2nd cycle
Interventions: intervention 1: Mesna intervention 2: Saline intervention 3: Doxorubicin intervention 4: Cyclophosphamide
Intervention descriptions: intervention 1: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes intervention 2: Saline (used as a placebo) infused over the same time as mesna intervention intervention 3: 60mg/m2 given IV over 15 minutes after receiving mesna or saline. Can allow for premedications of Ondansetron 8 mg orally, dexamethasone 12 mg orally, Aprepitant 125 mg orally. intervention 4: 600 mg/m2 IV over 30 minutes. Start 6 hours after doxorubicin started.

Protocol documents: