ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01100528
Conditions: Ciliary Body and Choroid Melanoma, Medium/Large Size Ciliary Body and Choroid Melanoma, Small Size Iris Melanoma Recurrent Intraocular Melanoma
Sponsor: Case Comprehensive Cancer Center
Start date: 2009-11-11; Completion date: 2017-12-14
Enrollment: 38 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as dacarbazine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Recombinant interferon alfa-2b may interfere with the growth of tumor cells. Giving interferon alfa-2b together with dacarbazine may be an effective treatment for primary uveal melanoma.

PURPOSE: This phase II trial is studying how well giving dacarbazine together with recombinant interferon alfa-2b works in treating patients with primary uveal melanoma with genetic imbalance.

Detailed description:
PRIMARY OBJECTIVES:

I. Assess disease-free survival (DFS) with sequential dacarbazine and interferon-alfa-2b as an adjuvant to primary therapy for patients with uveal melanoma with genetic imbalance.

SECONDARY OBJECTIVES:

I. Evaluate side effects and assess safety in the patient population.

II. Examine the relationship between the levels of plasma biomarkers of immune function and tumor invasion and the clinical outcome.

OUTLINE: Patients receive dacarbazine IV on days 1 and 29. Beginning 4 weeks after the second dose of dacarbazine, patients receive recombinant interferon alfa-2b subcutaneously 3 times a week for 24 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 6 months.

Arms: arm 1: Patients receive dacarbazine IV on days 1 and 29. Beginning 4 weeks after the second dose of dacarbazine, patients receive recombinant interferon alfa-2b subcutaneously 3 times a week for 24 weeks in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: recombinant interferon alfa-2b intervention 2: dacarbazine intervention 3: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given subcutaneously (SC) 3 times a week for 24 weeks intervention 2: Given IV on days 1 and 29 intervention 3: Correlative studies obtained prior to therapy, every 8 weeks while on therapy, and then every 6 months during follow-up

Protocol documents:
Clinical trial NCT01720264
Conditions: Acute Myeloid Leukemia Acute Lymphoid Leukemia Hematopoetic Myelodysplasia Leukemia, Myelogenous, Chronic Lymphoma, Non-Hodgkin
Sponsor: Sherif S. Farag
Start date: 2012-11-02; Completion date: 2017-12-15
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The main purpose of this trial is to assess the efficacy and safety of sitagliptin in enhancing engraftment following umbilical cord blood transplantation (recovery of blood counts after transplant).

Detailed description:
Umbilical cord blood (UCB) is more commonly used for transplantation in children but is being used in adults more often. However, because adults are larger than children, the relatively smaller stem cell dose in UCB is major limitation for transplantation in adults and engraftment can be delayed. This study is trying to find out if the drug sitagliptin can be used to increase and speed up engraftment in adults receiving UCB transplantation.

Arms: arm 1: Sitagliptin q 12 hours PO starting on Day -1 then given every 12 hours (total 10 doses) on Day 0, Day +1, +2 and Day +3.
Interventions: intervention 1: Sitagliptin
Intervention descriptions: intervention 1: Sitagliptin q 12 hours PO starting on Day -1 then given every 12 hours (total 10 doses) on Day 0, Day +1, +2 and Day +3.

Protocol documents:
Clinical trial NCT02660580
Conditions: Psoriasis Plaque Type Psoriasis Moderate to Severe Plaque Psoriasis
Keywords: Adalimumab MSB11022 Psoriasis Phase III
Sponsor: Fresenius Kabi SwissBioSim GmbH
Start date: 2016-02-16; Completion date: 2017-12-18
Enrollment: 443 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to compare the efficacy, safety and immunogenicity of MSB11022 and Humira® in adult subjects with moderate to severe chronic plaque type psoriasis.

Detailed description:

Arms: arm 1: Participants received MSB11022 subcutaneously at an initial dose of 80 milligram (mg) on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period. arm 2: Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period. arm 3: Participants who had achieved PASI 50 and received MSB11022 during Core Treatment Period continued to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period. arm 4: Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period and continued to receive EU-Humira subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 after re-randomization in extended treatment period. arm 5: Participants who had achieved PASI 50 and received EU-Humira in Core Treatment Period were re-randomized to receive MSB11022 subcutaneously at dose of 40 mg every other week starting at Week 16 up to and including Week 50 in extended treatment period.
Interventions: intervention 1: MSB11022 intervention 2: Humira®
Intervention descriptions: intervention 1: Participants received MSB11022 drug subcutaneously MSB11022 (Core Treatment Period), MSB11022 (Extended Treatment Period) and EU-Humira/MSB11022 arm. intervention 2: Participants received EU-Humira subcutaneously in EU-Humira, EU-Humira/EU-Humira and EU-Humira/MSB11022 arm.

Protocol documents:
Clinical trial NCT01482962
Conditions: Relapsed Peripheral T-Cell Lymphoma Refractory Peripheral T-Cell Lymphoma
Keywords: Drug Therapy
Sponsor: Millennium Pharmaceuticals, Inc.
Start date: 2012-06-11; Completion date: 2017-12-18
Enrollment: 271 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase 3, randomized, 2-arm, open-label, international trial evaluating alisertib compared with single-agent treatment, as selected by the investigator from the offered options of pralatrexate or gemcitabine or romidepsin, in participants with relapsed or refractory peripheral T-cell lymphoma (PTCL). Note: romidepsin was not used as a single-agent comparator outside the United States of America (USA) as supply was not available.

Detailed description:
The drug being tested in this study was Alisertib. Alisertib was tested to treat people who have relapsed/refractory peripheral T-cell lymphoma (PTCL).

This study evaluated alisertib for the improvement in overall response rate (ORR) compared with single-agent treatment, as selected by the investigator from the offered options of pralatrexate, romidepsin (US only), or gemcitabine, in participants with relapsed or refractory PTCL.

The study enrolled 271 patients. Participants were randomized (1:1) to one of 2 treatment arms:

* Alisertib
* Investigator's choice (Pralatrexate, Romidepsin, or Gemcitabine)

This multi-center trial was conducted worldwide. The overall time to participate in this study was approximately 5 years. Participants made multiple visits to the clinic, and then were contacted by telephone up to 42-months after the last participant was randomized, or until death, for follow-up assessment.

Arms: arm 1: Alisertib 50 mg, enteric-coated tablet formulation, orally, twice daily for 7 consecutive days (Cycle Days 1-7) in a 21-day cycle (Up to 148 Weeks). arm 2: Pralatrexate 30 mg/m\^2, intravenous (IV) push over 3 to 5 minutes, once weekly, for 6 weeks in 7-week cycles with concurrent vitamin B12 and folic acid supplementation. Cycles were repeated every 7-weeks provided the participant continued to benefit from and tolerate the therapy (Up to 115 Weeks), or Gemcitabine 1,000 mg/m\^2 over 30 minutes, intravenously, on Days 1, 8, and 15 of a 28-day cycle until the absence of disease progression or unacceptable toxicity (Up to 32 Weeks), or Romidepsin 14 mg/m\^2, intravenously over a 4-hour period, on Days 1, 8, and 15 of a 28-cycle. Cycles were repeated every 28 days provided the patient continued to benefit from and tolerate the therapy (Up to 30 Weeks).
Interventions: intervention 1: Alisertib intervention 2: Pralatrexate intervention 3: Gemcitabine intervention 4: Romidepsin
Intervention descriptions: intervention 1: Alisertib enteric coated tablets intervention 2: Pralatrexate IV infusion intervention 3: Gemcitabine IV infusion intervention 4: Romidepsin IV infusion

Protocol documents:
Clinical trial NCT01846416
Conditions: Non-Small Cell Lung Cancer
Sponsor: Genentech, Inc.
Start date: 2013-05-30; Completion date: 2017-12-18
Enrollment: 138 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This multicenter, single-arm study will evaluate the efficacy and safety of atezolizumab (MPDL3280A) in participants with PD-L1-positive locally advanced or metastatic NSCLC. Participants will receive an intravenous (IV) dose of 1200 milligrams (mg) atezolizumab (MPDL3280A) on Day 1 of 21-day cycles until disease progression.

Eligible participants will be categorized in to three groups as follows:

1. Participants with no prior chemotherapy for advanced disease;
2. Participants who progress during or following a prior-platinum based chemotherapy regimen for advanced disease (2L+participants);
3. Participants who are 2L+ and previously treated for brain metastases.

Detailed description:

Arms: arm 1: Participants with no prior chemotherapy for advanced NSCLC disease will receive atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression. arm 2: Participants who progress during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies will receive atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator. arm 3: Participants with previously treated brain metastases and who progress during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, will receive atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
Interventions: intervention 1: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody
Intervention descriptions: intervention 1: Atezolizumab 1200 mg IV on Day 1 of each 21-day cycle until disease progression.

Protocol documents:
Clinical trial NCT03172481
Conditions: ADHD
Sponsor: Purdue Pharma, Canada
Start date: 2017-05-01; Completion date: 2017-12-19
Enrollment: 156 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, parallel group, placebo-controlled, dose optimized, phase 3 study to evaluate the safety and efficacy of PRC-063 in the treatment of ADHD in pediatric subjects between 6 to 12 years of age.

Detailed description:

Arms: arm 1: PRC-063 25, 35, 45, 55, 70 or 85 mg arm 2: None
Interventions: intervention 1: PRC-063 oral capsules intervention 2: Placebo oral capsules
Intervention descriptions: intervention 1: Daily dose intervention 2: Daily dose

Protocol documents:
Prot_SAP_000.pdf: 
















Summary statistics will be provided for safety endpoints.
Clinical trial NCT00721409
Conditions: Breast Cancer
Keywords: hormone-receptor positive advanced breast cancer
Sponsor: Pfizer
Start date: 2008-09-15; Completion date: 2017-12-20
Enrollment: 177 participants; Allocation: RANDOMIZED; Intervention model: 

Brief summary:
The study is aimed to confirm that letrozole + PD 0332991 is safe and tolerable and to assess the effect of the combination on advanced breast cancer

Detailed description:

Arms: arm 1: letrozole + PD 0332991 arm 2: letrozole
Interventions: intervention 1: PD 0332991 intervention 2: letrozole intervention 3: letrozole
Intervention descriptions: intervention 1: 125 mg/d capsules orally for 3 out of 4 weeks in repeated cycles intervention 2: 2.5 mg/d tablets orally on a continuous regimen intervention 3: 2.5 mg/d tablets orally on a continuous regimen

Protocol documents:
Clinical trial NCT02305238
Conditions: Wet Macular Degeneration
Keywords: Eylea, Aflibercept Treat and Extend regimen Age-related macular degeneration
Sponsor: Bayer
Start date: 2014-12-19; Completion date: 2017-12-20
Enrollment: 288 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the efficacy of intravitreal (IVT) administration of aflibercept with two different approaches of Treat and Extend dosing regimens in Japanese subjects with neovascular (wet) Age-related Macular Degeneration (wAMD) .

To assess the safety of IVT administration of aflibercept with two different approaches of Treat and Extend dosing regimen in Japanese subjects with wAMD for up to 2 years.

Detailed description:

Arms: arm 1: Participants received Aflibercept IVT injection at Week 0, Week 4, Week 8 and Week 16 followed by the variable treatment intervals with the criteria of Treat and Extend regimen. In the case the study eye of a participant met the criteria, the length of treatment interval was to be extended or shortened by 2 weeks from the last interval, respectively. Minimum/Maximum treatment interval is 8 weeks and 16 weeks during Week 16 to 96. arm 2: Participants received Aflibercept IVT injection at Week 0, Week 4, Week 8 and Week 16 followed by the variable treatment intervals. In the case the study eye of a participant met the criteria of the shortening, the length of the treatment interval was to be shortened by 2 weeks. But when the last treatment interval for a participant was extended by 4 weeks from the second last interval, the treatment interval was shortened by 4 weeks. In the case the study eye of a participant met the criteria of the extension, the length of the treatment interval was to be extended by 4 weeks. But when a participant had a history of receiving treatment with interval shortened by 4 weeks during this study, the length of the extension was 2 weeks. Minimum/Maximum treatment interval is 8 weeks and 16 weeks during Week 16 to 96.
Interventions: intervention 1: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Intervention descriptions: intervention 1: Aflibercept 2mg is intravitreally injected.

Protocol documents:
Clinical trial NCT02506868
Conditions: Chronic Kidney Disease End Stage Renal Failure on Dialysis Anemia
Keywords: darbepoetin alfa
Sponsor: Biocad
Start date: 2015-08-08; Completion date: 2017-12-21
Enrollment: 196 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to prove equivalence of efficacy and safety of BCD-066 and Aranesp® in treatment of anemia in end-stage chronic kidney disease patients on dialysis.

Detailed description:
In this study CKD patients on dialysis previously treated by short-acting epoetins will switch to one of darbepoetin alfa products - BCD-066 (experimental arm) or Aranesp (active comparator) to maintain previously achieved target level of hemoglobin (100-120 g/l).

Patients will be treated for 52 weeks. IV iron supplementation will be provided to maintain serum ferritin level above 500 µg/l according to KDIGO Anemia Guidelines (2012).

Arms: arm 1: Patients in this arm will receive weekly subcutaneous injections of BCD-066 (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 52 weeks arm 2: Patients in this arm will receive weekly subcutaneous injections of Aranesp (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 52 weeks
Interventions: intervention 1: Darbepoetin alfa
Intervention descriptions: intervention 1: Weekly sc administration of darbepoetin alfa

Protocol documents:
Clinical trial NCT02285634
Conditions: Epistaxis Blood Pressure
Sponsor: Mayo Clinic
Start date: 2014-11-01; Completion date: 2017-12-22
Enrollment: 68 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Nosebleeds (epistaxis) are a frequent cause of emergency department visits, reportedly inciting 1 in 200 visits. They are most common in those less than ten and older than seventy, often occurring in the winter months secondary to dry indoor heating. Epistaxis is associated with elevated blood pressures, but it is controversial whether hypertension is actual a contributing cause.

In non-life-threatening epistaxis, the first step in management is commonly the application of a topical vasoconstrictive medication. In many cases this will lead to cessation of the bleeding or facilitate the exam in those that continue to bleed. Frequently used medications include phenylephrine, oxymetazoline, and lidocaine with epinephrine.

Classic teaching has been to avoid the use of these medications in patients with elevated blood pressures due to concerns of inducing hypertensive crisis. Strict avoidance of topical vasoconstrictors in this patient group with epistaxis severely limits the treatment options for a many patients given the association between the two conditions.

Though universally taught, the actual effect of these agents on blood pressure remains unquantified. Studies investigating the prevention of nose bleeding during nasotracheal intubations suggest that the effect might be minor with little variation between agents.

Clinical question:

What is the effect of commonly used intranasal vasoconstrictors on blood pressure in volunteers without a history of hypertension.

Detailed description:

Arms: arm 1: Oxymetazoline 0.05% arm 2: Phenylephrine 0.25% arm 3: Lidocaine 1% plus epinephrine 1:100,000 arm 4: Bacteriostatic 0.9% NaCL
Interventions: intervention 1: Oxymetazoline 0.05% intervention 2: Phenylephrine 0.25% intervention 3: Lidocaine 1% plus epinephrine 1:100,000 intervention 4: Bacteriostatic 0.9% NaCL
Intervention descriptions: intervention 1: sterile gauze soaked in 5 milliliters (mL) of Oxymetazoline 0.05% into one nostril and placement of a nasal clamp. The nasal clamp and medication will be removed after 15 minutes. intervention 2: sterile gauze soaked in 5 milliliters (mL) of Phenylephrine 0.25% into one nostril and placement of a nasal clamp. The nasal clamp and medication will be removed after 15 minutes. intervention 3: sterile gauze soaked in 5 milliliters (mL) of Lidocaine 1% plus epinephrine 1:100,000 into one nostril and placement of a nasal clamp. The nasal clamp and medication will be removed after 15 minutes. intervention 4: sterile gauze soaked in 5 milliliters (mL) of Bacteriostatic 0.9% NaCL into one nostril and placement of a nasal clamp. The nasal clamp and medication will be removed after 15 minutes.

Protocol documents:
Clinical trial NCT01097057
Conditions: Non-Hodgkin Lymphoma
Sponsor: Fred Hutchinson Cancer Center
Start date: 2010-11-09; Completion date: 2017-12-26
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well giving rituximab; ifosfamide, carboplatin, and etoposide (ICE) combination chemotherapy; and filgrastim (G-CSF) together with plerixafor works in treating patients with non-Hodgkin lymphoma undergoing mobilization of autologous peripheral blood stem cells. Giving chemotherapy (ICE) with monoclonal antibodies, such as rituximab, stops the growth of cancer cells by stopping them from dividing or by killing them and helps get better autologous stem cell product. 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 for future autologous transplant.

Detailed description:
OBJECTIVES:

I. Evaluate the efficacy of combining RICE (rituximab-ifosfamide-carboplatin-etoposide regimen \[R-ICE regimen\]), G-CSF, and plerixafor to collect autologous peripheral blood stem cell (PBSC) for non-Hodgkin's lymphoma (NHL) patients by: the number of days of apheresis required to reach \>= 5 x 10\^6 cluster of differentiation (CD)34 cells/kg and by the total number of CD34 cells/kg collected in a maximum of 4 days if \>= 5 x 10\^6 CD34 cells/kg is not obtained.

OUTLINE:

Patients receive rituximab intravenously (IV) on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive filgrastim subcutaneously (SC) once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.

After completion of study treatment, patients are followed up at 30 days and then periodically for up to 12 months.

Arms: arm 1: Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.
Interventions: intervention 1: Carboplatin intervention 2: Etoposide intervention 3: Filgrastim intervention 4: Ifosfamide intervention 5: Leukapheresis intervention 6: Plerixafor intervention 7: Rituximab
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: Given SC intervention 4: Given IV intervention 5: Given through catheter intervention 6: Given SC intervention 7: Given IV

Protocol documents:
Clinical trial NCT02229396
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus Exenatide Dapagliflozin Diabetes medication Treatment efficacy Placebo Metabolism Cardiovascular metabolic
Sponsor: AstraZeneca
Start date: 2014-09-04; Completion date: 2017-12-28
Enrollment: 695 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study D5553C0003 is a 28-week, randomized, double-blind, active-controlled, multicenter, Phase 3 efficacy and safety study with 24-week and 52-week extension phases of simultaneous administration of exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg once daily (QD) compared to EQW 2 mg alone and dapagliflozin 10 mg QD alone in patients with Type 2 diabetes who have inadequate glycemic control on metformin.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Exantide with Dapagliflozin intervention 2: Exentide intervention 3: Dapagliflozin
Intervention descriptions: intervention 1: 2 mg weekly suspension injection and 10 mg Dapagliflozin intervention 2: 2 mg intervention 3: 10 mg once daily Dapagliflozin

Protocol documents: