ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00957268
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes mellitus Non-insulin dependent diabetes mellitus Drug therapy Pediatrics
Sponsor: Takeda
Start date: 2009-09-01; Completion date: 2013-11-01
Enrollment: 46 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the pharmacokinetic and safety profile of alogliptin in children, adolescents, and adults with type 2 diabetes mellitus.

Detailed description:
Alogliptin is a selective, orally available inhibitor of dipeptidyl peptidase-4 being developed by Takeda Global Research \& Development as a treatment for type 2 diabetes mellitus. Inhibition of dipeptidyl peptidase-4 (DPP-4) prolongs the action of 2 important incretin hormones, glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP). These hormones are responsible for increasing insulin synthesis, regulating β-cell proliferation, inhibiting gastric emptying, and inhibiting glucagon secretion.

To date, alogliptin has not been studied in participants less than 18 years of age. As with adults, there is growing evidence of an increase in the prevalence of type 2 diabetes mellitus in children and adolescents.

This study is designed to determine the pharmacokinetic, pharmacodynamic, and safety profiles of alogliptin in children and adolescents with type 2 diabetes mellitus. These profiles will be compared with those of similarly matched adult participants with type 2 diabetes mellitus. Pharmacokinetic, pharmacodynamics, and safety endpoints will be analyzed.

Arms: arm 1: Alogliptin 12.5 mg, tablets, orally, 1 dose only. arm 2: Alogliptin 25 mg, tablets, orally, 1 dose only. arm 3: Alogliptin 12.5 mg, tablets, orally, 1 dose only. arm 4: Alogliptin 25 mg, tablets, orally, 1 dose only. arm 5: Alogliptin 25 mg, tablets, orally, 1 dose only.
Interventions: intervention 1: Alogliptin
Intervention descriptions: intervention 1: Alogliptin tablets

Protocol documents:
Clinical trial NCT00958074
Conditions: Cutaneous T-cell Lymphoma Stage I Cutaneous T-cell Lymphoma Stage II Cutaneous T-cell Lymphoma Stage III Cutaneous T-cell Lymphoma Stage IV
Sponsor: University of Washington
Start date: 2009-07-01; Completion date: 2013-11-01
Enrollment: 11 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This phase II trial studies the side effects and how well vorinostat works in treating patients with primary cutaneous T-cell lymphoma. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the objective response rate to treatment with dose-adjusted Vorinostat schedule in subjects with cutaneous T-cell lymphoma (CTCL) who did not receive prior systematic therapy or have been treated with single agent targretin (bexarotene).

SECONDARY OBJECTIVES:

I. To determine the safety and tolerability of dose-adjusted Vorinostat schedule when administered to patients with primary cutaneous T-cell lymphoma who did not receive prior systematic therapy or have been treated with single agent targretin.

II. To determine the time to objective response in subjects with CTCL treated with dose-adjusted schedule of Vorinostat as primary therapy.

III To determine the duration of objective response in subjects with CTCL.

IV. To determine the time to loss of objective response.

V. To determine the objective response rate of extracutaneous manifestations of CTCL (lymph node enlargement, Sezary cells in peripheral blood).

VI. To compare the efficacy, toxicity and tolerability of dose-adjusted schedule to currently recommended flat dose of Vorinostat in subjects with CTCL.

OUTLINE: Patients are assigned to 1 of 2 treatment arms according to age (\< 65 vs \>= 65 years old).

COHORT I (\>= 65 years old): Patients receive 200 mg vorinostat orally (PO) once daily (QD) on days 1-28. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

COHORT II (\< 65 years old): Patients receive 400 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for at least 30 days.

Arms: arm 1: 200 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity. arm 2: 400 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.
Interventions: intervention 1: vorinostat intervention 2: flow cytometry intervention 3: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given PO intervention 2: correlative study intervention 3: correlative study

Protocol documents:
Clinical trial NCT00975975
Conditions: Acute Myelogenous Leukemia Acute Lymphocytic Leukemia Chronic Myelogenous Leukemia Chronic Lymphocytic Leukemia Myelodysplasia Non-Hodgkin's Lymphoma Hodgkin's Disease Multiple Myeloma Myelofibrosis Anemia, Aplastic Hemoglobinuria, Paroxysmal
Keywords: Paroxysmal nocturnal hemoglobinuria severe aplastic anemia Mantle cell
Sponsor: Indiana University School of Medicine
Start date: 2009-09-01; Completion date: 2013-11-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to compare the effects (good and bad) of the medication basiliximab in combination with cyclosporine (investigational therapy) for the prevention of a complication of bone marrow transplantation known as graft-versus-host disease (GVHD). GVHD is a complication in which the cells of the transplanted bone marrow react against organs and tissues.

Detailed description:
This study is for patients with a blood condition or myelodysplasia (bone marrow disease) which has either not responded to treatment or is not treatable by conventional/routine medical treatments. Bone marrow transplantation is a medical treatment that involves giving high doses of chemotherapy followed by the transplantation of the blood-forming and immune cells from a relative or from a "matched" unrelated person through the National Marrow Donor Program, in an attempt to cure disease in the recipient (the person receiving the donated cells). Nonmyeloablative (bone-marrow preservation) bone marrow transplantation is a relatively new technique in which lower than usual doses of chemotherapy are given before transplantation, in hopes of reducing adverse side effects of the chemotherapy in transplant patients. Nonmyeloablative bone marrow transplantation has several advantages which doctors have determined are beneficial for this condition.

This research is being done because the complication of graft-versus-host disease can be bad for a person and there is no completely safe and effective way to prevent this complication. We know that cyclosporine helps but would like to know if the addition of basiliximab, given with cyclosporine, will decrease the incidence and/or severity of graft-versus-host disease after a transplant known as nonmyeloablative or "mini" transplant.

Arms: arm 1: Basiliximab will be given by IV on Day +7 post transplant for recipients of matched unrelated cells. Basiliximab will be given by IV on Day +9 post transplant for recipients of matched related cells.
Interventions: intervention 1: Basiliximab
Intervention descriptions: intervention 1: Basiliximab given 1 time on Day +7 or Day +9.

Protocol documents:
Clinical trial NCT00982319
Conditions: Breast Cancer
Keywords: Broccoli Sprout Extract Breast Cancer
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Start date: 2009-04-01; Completion date: 2013-11-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research is to examine the effect of a broccoli sprout preparation on specific factors in breast tissue that are related to breast cancer risk and to assess whether sulforaphane a key component of broccoli sprouts increases the levels of protective enzymes in breast tissue. In addition, the investigators will also examine how acceptable the broccoli sprouts preparation is to the study participants.

Detailed description:
A double-blind randomized Phase II chemoprevention trial of BSE versus placebo will be conducted in up to 35 women diagnosed with DCIS on core biopsy prior to their definitive surgery (study diagram below). The primary study endpoint will be a decrease in the mean proliferative rate measured by Ki67%.

Women diagnosed with DCIS on core or incisional/excisional biopsy scheduled for definitive surgery at Johns Hopkins Hospital will be recruited for this study. Participants will be placed on a cruciferous free diet for the 14 days prior to their surgical date and drink a randomized intervention beverage (mango juice with or without broccoli sprout extract). Additionally participants will provide 2 blood and 2 urine sample collections, report medication use and adverse events using prepared forms and complete a daily diet check list during the 14 day intervention. On the day of definitive breast surgery, 1-2 grams of breast tissue (including normal adjacent breast tissue) will be collected during surgery.

Arms: arm 1: Patients will be randomized to 14 day intervention of broccoli sprout extract and mango juice consisting of a dose of 100 µmols of sulforaphane dissolved in 150 mL mango juice once a day. arm 2: Patients will be randomized to 14 day intervention of 150 mL mango juice without broccoli sprout extract extract once a day.
Interventions: intervention 1: Broccoli sprout extract intervention 2: Mango juice
Intervention descriptions: intervention 1: 100 µmols of sulforaphane (dissolvable) intervention 2: 150 mL of mango juice

Protocol documents:
Clinical trial NCT00995488
Conditions: Urothelial Cancer Bladder Cancer
Keywords: Urothelial Cancer ABI-007 Bladder Cancer front-line
Sponsor: University of Michigan Rogel Cancer Center
Start date: 2009-10-01; Completion date: 2013-11-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the safety and efficacy of the combination of ABI-007, carboplatin and gemcitabine in the treatment of patients with advanced bladder cancer.

Study participants will have been diagnosed with advanced bladder cancer. Cisplatin based chemotherapy in this setting has activity but is not curative. Furthermore, patients with this disease have comorbidities that limit the use of cisplatin based therapy. Combination paclitaxel, carboplatin and gemcitabine is active and well tolerated in this patient population.

Paclitaxel is formulated with ethanol and a Cremophor EL (polyoxyethylated castor oil) which contribute to the side effects associated with paclitaxel. ABI-007 (brand name Abraxane™) is a form of paclitaxel that does not contain these additives and may deliver more drug to tumor cells. ABI-007 is approved by the United States Food and Drug Administration (FDA) in the treatment of metastatic (advanced) breast cancer based on superior anticancer effect, and is being evaluated in other cancers in research studies.

Detailed description:
On the basis of the known single agent activity of paclitaxel in urothelial cancer, the activity of combination therapy with paclitaxel, carboplatin, and gemcitabine in advanced urothelial cancer coupled with the results from studies in breast cancer demonstrating improved clinical efficacy of ABI-007 over paclitaxel with a more favorable toxicity profile, we propose this phase II trial evaluating the efficacy and safety of the combination of ABI-007, carboplatin, and gemcitabine in patients with advanced urothelial cancer.

Carboplatin and gemcitabine dosing and schedule is based on our previous trial of paclitaxel, carboplatin, and gemcitabine which showed acceptable toxicity.

Due to the extent of hematologic toxicities expected with this combination and reported with weekly schedules of ABI-007 based combinations as well as our experience on UMCC protocol 2007.061 which originally utilized a weekly ABI-007 with gemcitabine and carboplatin, we do not feel continuous weekly dosing will be feasible. Therefore this trial is designed with ABI-007 on a D1 only schedule every 21 days. The starting dose of ABI-007 will be 220 mg/m2, because of the risk of significant bone marrow suppression, with the option of a dose escalation in patients who tolerate therapy well after the first cycle to 260 mg/m2 every 21 days.

Arms: arm 1: ABI-007 combined with Carboplatin, and Gemcitabine
Interventions: intervention 1: ABI-007 (Abraxane®)
Intervention descriptions: intervention 1: ABI-007 is a novel albumin-bound paclitaxel combining a protein with a chemotherapeutic agent in the particle form.

Protocol documents:
Clinical trial NCT01016847
Conditions: Asthma
Sponsor: Duke University
Start date: 2010-01-01; Completion date: 2013-11-01
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Obesity is associated with increased airway inflammation and asthma severity that results in suboptimal control of asthma despite therapy with high dose inhaled corticosteroids (ICS). The investigators suggested that the addition of Singular (montelukast)\[LTRA\] to moderate doses of inhaled corticosteroids will improve asthma control. This cross over study will be treat subjects with moderate dose ICS/LTRA for 12 weeks and high dose ICS with placebo for 12 weeks.

Detailed description:
Subjects will enter the 2-week run-in period after meeting eligibility criteria at the screening visit (visit 1). During run-in subjects will have all usual asthma medications discontinued and will be placed on inhaled corticosteroids at moderate doses and leukotriene receptor antagonists will be withdrawn (LTRA wash-out). Subjects will be monitored to rule out any acute infection or symptoms consistent with an exacerbation. The run-in period will be used to assess subject compliance and understanding of study related procedures. Following the run-in, to be eligible for the randomization subjects must have an ACQ score \>1.25 on the Juniper Asthma Control Questionnaire.

Arms: arm 1: Montelukast (LTRA) administered with moderate dose of inhaled steroid arm 2: High dose of inhaled steroid administered with sugar pill
Interventions: intervention 1: Montelukast intervention 2: Sugar pill
Intervention descriptions: intervention 1: 10 mg Q day intervention 2: Sugar pill that looks like Montelukast that will be given Q day

Protocol documents:
Clinical trial NCT01056341
Conditions: Infantile Hemangioma
Keywords: Infantile Hemangioma Propranolol
Sponsor: Pierre Fabre Dermatology
Start date: 2010-01-01; Completion date: 2013-11-01
Enrollment: 512 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
There is an unsatisfied medical need for a first-line treatment of proliferating IHs with a good benefit/risk profile. Based on the recent findings of encouraging results obtained with propranolol in a series of infants with severe Infantile Hemangioma (IH), propranolol is expected to be of significant benefit in the management of the condition. The present study has been designed to confirm efficacy of propranolol in severe IH by demonstrating superiority over placebo and to document the safety profile of propranolol in this indication.

Detailed description:
Primary objective The primary objective of this study is to identify the appropriate dose and duration of propranolol treatment and demonstrate its superiority over placebo based on the complete/nearly complete resolution of target IH at W24.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Propranolol intervention 2: Placebo
Intervention descriptions: intervention 1: Propranolol (1 or 3 mg/kg/day for 3 or 6 months) intervention 2: Treatment with placebo for 6 months

Protocol documents:
Clinical trial NCT01103063
Conditions: Intermittent Preventive Treatment In Pregnancy (IPTp)
Keywords: P. falciparum malaria IPTp
Sponsor: Pfizer
Start date: 2010-10-01; Completion date: 2013-11-01
Enrollment: 2891 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to establish superiority of AZCQ over SP in protective efficacy for IPTp as measured by the proportion of subjects with sub-optimal pregnancy outcome.

Detailed description:
After interim analysis of efficacy data by an External Data Monitoring Committee, this study was terminated. Investigators were notified on 22 Aug 2013. There were no safety concerns that led to this termination.

Arms: arm 1: Azithromycin/chloroquine arm 2: sulfadoxine-pyrimethamine (Fansidar)
Interventions: intervention 1: Azithromycin plus chloroquine intervention 2: sulfadoxine-pyrimethamine
Intervention descriptions: intervention 1: combination tablet of 250mg azithromycin/155 chloroquine, Once daily PO for three days per treatment. There are total 3 treatments at 4-8 weeks intervals. The first treatment course will be administered during the second trimester (14-26 weeks of gestation as confirmed by ultrasound). The last treatment course should be given to subjects prior to or during 36 weeks of gestation. intervention 2: Fansidar tablet (500 mg sulfadoxine /25 mg pyrimethamine), once daily, PO, single dose per treatment. There are total 3 treatments at 4-8 weeks intervals. The first treatment course will be administered during the second trimester (14-26 weeks of gestation as confirmed by ultrasound). The last treatment course should be given to subjects prior to or during 36 weeks of gestation.

Protocol documents:
Clinical trial NCT01121562
Conditions: Pancreatic Neuroendocrine Tumors
Keywords: Neuroendocrine tumors
Sponsor: Pfizer
Start date: 2010-07-01; Completion date: 2013-11-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to evaluate the effect of Sunitinib on the clinical benefit response rate.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Sunitinib
Intervention descriptions: intervention 1: Sunitinib capsule will be given orally at continuous daily dosing with a dose of 37.5 mg in the morning (regardless fasting or non-fasting, One cycle will be 28days)

Protocol documents:
Clinical trial NCT01164579
Conditions: Rheumatoid Arthritis
Keywords: Early Rheumatoid Arthritis Joint Structure Magnetic Resonance Imaging Janus Kinase (JAK) Inhibitor Tasocitinib Tofacitinib
Sponsor: Pfizer
Start date: 2010-10-01; Completion date: 2013-11-01
Enrollment: 109 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluation of efficacy and safety of tofacitinib (CP-690,550) for the treatment of early rheumatoid arthritis in adult patients with moderate to severe disease who are methotrexate naïve. The efficacy will be evaluated by exploring the effects on joint structure assessed by magnetic resonance imaging, x-rays and by standard clinical assessment.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Tasocitinib plus Methotrexate intervention 2: Tofacitinib plus placebo methotrexate intervention 3: Placebo tofacitinib plus Methotrexate
Intervention descriptions: intervention 1: Tofacitinib (CP 690,550) 10 mg BID, tablets + methotrexate (MTX) 10 mg/wk to 20 mg/wk, titrated over 2 months intervention 2: Tofacitinib (CP-90,550) 10 mg BID, tablets. Placebo to match methotrexate (MTX) capsules titrated as in Treatment Arm 1. intervention 3: Methotrexate (MTX) 10 mg/wk to 20 mg/wk, capsules, titrated over 2 months. Placebo in tablets to match tofacitinib

Protocol documents:
Clinical trial NCT01169467
Conditions: Endotracheal Intubation Continuous IV Sedation ICP Monitoring
Sponsor: Duke University
Start date: 2009-10-01; Completion date: 2013-11-01
Enrollment: 89 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the effects of using dexmedetomidine (Precedex) in addition to the current standard-of-care for sedation.

Detailed description:
Primarily, this study seeks to explore whether there is a difference in mean arterial pressure (MAP) variability, incidence of intracranial hypertension, intracranial pressure (ICP) variability, cerebral perfusion pressure (CPP) and Cerebrovascular pressure reactivity index (PRx) in two groups of subjects.

Patients must be submitted to the ICU and be endotracheally intubated and receiving mechanical ventilation with continuous IV sedation for less than 24 hours after recruitment into the study.

Arms: arm 1: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment. arm 2: Subjects who are treated with the standard of care sedation regiment only.
Interventions: intervention 1: Standard-of-Care plus Dexmedetomidine intervention 2: Standard-of-Care
Intervention descriptions: intervention 1: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment intervention 2: Subjects who are treated with the standard of care sedation regiment only.

Protocol documents: