ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01439568
Conditions: Extensive Stage Small Cell Lung Carcinoma
Keywords: Cancer Lung Metastasis
Sponsor: Eli Lilly and Company
Start date: 2011-09-01; Completion date: 2016-08-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to compare the progression free survival of LY2510924 + carboplatin + etoposide therapy versus carboplatin + etoposide therapy in participants with extensive-stage disease small cell lung cancer (SCLC)

Detailed description:

Arms: arm 1: LY2510924: 20 milligram (mg) administered once daily as a subcutaneous(SC) injection on days 1 to 7 of the 21 day cycle; repeat every 21 days for 6 cycles. Carboplatin: 5 milligram/millimeter/per minute (mg/mL/min) area under the curve (AUC) administered intravenously on day 1 of the 21 day cycle; repeat every 21 days for 6 cycles.

Etoposide: 100 milligram square meter (mg/m\^2) administered intravenously on days 1 to 3 of the 21 day cycle; repeat every 21 days for 6 cycles. arm 2: Carboplatin: 5 mg/mL/min area under the curve administered intravenously on day 1 of the 21 day cycle; repeat every 21 days for 6 cycles.

Etoposide: 100 milligram square meter (mg/m\^2) administered on days 1 to 3 of the 21 day cycle; repeat every 21 days for 6 cycles.
Interventions: intervention 1: LY2510924 intervention 2: Carboplatin intervention 3: Etoposide
Intervention descriptions: intervention 1: Administered subcutaneous injection intervention 2: Administered intravenously intervention 3: Administered intravenously

Protocol documents:
Clinical trial NCT01452412
Conditions: Chronic Kidney Disease Metabolic Acidosis
Keywords: Alkali Sodium bicarbonate Kidney disease Acidosis
Sponsor: Albert Einstein College of Medicine
Start date: 2011-10-01; Completion date: 2016-08-01
Enrollment: 149 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Kidney disease is a common medical condition. Individuals with kidney disease develop a build-up of acid in their blood. This acid can affect their muscles, bones, glucose metabolism and kidneys. The investigators will test alkali treatment, to treat acid build-up, in a randomized placebo-controlled clinical trial to evaluate effects on muscles, bones, glucose metabolism and kidney.

Detailed description:

Arms: arm 1: 0.4 mEq/kg/day ideal body weight to be taken once a day arm 2: placebo dosage/frequency equivalent to sodium bicarbonate
Interventions: intervention 1: Sodium bicarbonate intervention 2: Placebo
Intervention descriptions: intervention 1: 0.4 mEq/kg/day ideal body weight to be taken once a day intervention 2: To be taken on the same schedule as the active arm

Protocol documents:
Clinical trial NCT01488318
Conditions: Squamous Cell Carcinoma Of The Head And Neck
Keywords: Cetuximab Dasatinib Squamous Cell Head and Neck After Cetuximab Containing Chemoradiotherapy Recurrent Metastatic
Sponsor: Julie E. Bauman, MD, MPH
Start date: 2011-09-01; Completion date: 2016-08-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a single-arm, non-masked, open-label, Phase II study of cetuximab + dasatinib in recurrent Squamous Cell Carcinoma of The Head and Neck (SCCHN) that has recurred after cetuximab-containing therapy (please see attached schema).

The primary endpoint 12-week PFS.

Detailed description:
Patients must have recurrent SCCHN and may have received any number of prior palliative systemic therapies for recurrent disease (without cetuximab or othr EGFR inhibitor). One prior curative regimen (induction, primary or postoperative chemoradiotherapy) should have been given AND all patients should have been exposed to cetuximab as part of prior potentially curative treatment.Those who have received a prior Src kinase inhibitor or EGFR inhibitor other than cetuximab are not eligible.

Patients will be tested for serum IL-6. If IL-6 is detectable, the patient will be ineligible. If IL-6 is not detected, the patient will be eligible for the study. Subjects more than 2 weeks post last dose of Cetuximab will receive an initial loading dose 400 mg/m2 on cycle 1, day 1. Subjects who have received Cetuximab within 2 weeks of starting study will start Cycle 1 with dose of 250 mg/m2. Dasatinib will start 3 days after initial cetuximab study dose on cycle 1 (i.e cycle 1, day 4), and continue without interruption.

Arms: arm 1: Cetuximab on a standard weekly schedule (see Section 6.2). Group 1 (subjects more than 2 weeks post last dose of Cetuximab): Loading dose of 400 mg/m2 on cycle 1, day 1 then 250 mg/m2 IV weekly.

Group 2 (subjects last Cetuximab treatment within 2 weeks): Cycle 1 will start at a dose of 250 mg/m2 Dasatinib 150 mg once daily without interruption. On the FIRST cycle (1 cycle is 3 weeks) dasatinib will start 3 days after the cetuximab loading dose (i.e. cycle 1, day 4) to avoid headache as shown on the previous phase I trial.

Treatment will continue until progression.
Interventions: intervention 1: Cetuximab intervention 2: Dasatinib
Intervention descriptions: intervention 1: Cetuximab 250 mg/m2 IV weekly after loading dose 400 mg/m2 on cycle 1, day 1 intervention 2: Dasatinib 150 mg po

Protocol documents:
Clinical trial NCT01512797
Conditions: Type 2 Diabetes Mellitus
Keywords: Januvia Sitagliptin Diabetes Gastric-Bypass
Sponsor: Blandine Laferrere
Start date: 2012-07-01; Completion date: 2016-08-01
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess whether Januvia (sitagliptin phosphate 100mg) is safe and effective for the treatment of Type 2 Diabetes in patients who have had Gastric Bypass.

Detailed description:
Januvia (sitagliptin phosphate 100mg) is an FDA approved medication for the treatment of Type 2 Diabetes. Sitagliptin works by inhibiting the Dipeptidyl peptidase-4 enzyme, resulting in increased active glucagon-like peptide-1 (GLP-1) levels. GLP-1 is an incretin which increases post-prandial insulin secretion. Because Gastric Bypass has also been shown to increase GLP-1 levels, this study seeks to determine the additional effect of DDP-4 inhibition on glucose control in patients who have elevated incretin levels post Gastric Bypass. The study will also assess if Januvia (Sitagliptin phosphate) is safe and well tolerated in patients after Gastric Bypass.

Recruitment and data collection for this study was started at St. Luke's Hospital in New York, NY and later moved to Columbia University Medical Center in New York, NY.

Arms: arm 1: 100 mg/day sitagliptin phosphate (Januvia) PO once a day for 4-5 weeks arm 2: 1 Placebo pill / day PO once a day for 4-5 weeks
Interventions: intervention 1: Sitagliptin phosphate intervention 2: Placebo
Intervention descriptions: intervention 1: 100 mg/day orally intervention 2: 1 Placebo Pill per day

Protocol documents:
Clinical trial NCT01523496
Conditions: HIV Infections
Keywords: HIV Vitamin D Deficiency
Sponsor: University Hospitals Cleveland Medical Center
Start date: 2011-12-01; Completion date: 2016-08-01
Enrollment: 190 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the correct dose of Vitamin D to give to prevent HIV related complications.

Detailed description:
The purpose of the this study was to compare control dose of vitamin D (low dose of 600 IU/d) to supplementation dose (medium dose of 2000 IU/d or higher doses of vitamin D of 4000 IU/d) on HIV-related comorbidities including immune activation, inflammation, cardiovascular diseases, and metabolic complications in HIV-infected youth.

Arms: arm 1: All will be HIV+ and receiving randomized dose of vitamin D control dose (low dose) or supplementation dose (vitamin D medium dose or vitamin D high dose) arm 2: HIV negative controls will be receiving randomized Vitamin D doses: control vitamin D dose (low dose) or vitamin D supplementation dose (vitamin D medium dose or vitamin D high dose)
Interventions: intervention 1: Vitamin D control dose intervention 2: Vitamin D supplementation-
Intervention descriptions: intervention 1: 18,000 IU per month intervention 2: 60,000 IU per month(medium dose) or 120,000 IU/month(high dose)

Protocol documents:
Clinical trial NCT01558661
Conditions: Adenoid Cystic Carcinoma
Keywords: axitinib (AG-013736) recurrent metastatic 12-004
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2012-03-01; Completion date: 2016-08-01
Enrollment: 33 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to find out what effects, good and/or bad, a new treatment called axitinib has on the patient and adenoid cystic carcinoma. This type of cancer study is called a phase II study.

Axitinib is an oral medication that can interfere with cancer cell growth and reduce the growth of blood vessels around tumors. This study will help find out if axitinib is a useful drug for treating patients with adenoid cystic carcinomas. Axitinib is an experimental drug that has not yet been approved by the Food and Drug Administration for use in adenoid cystic carcinoma.

Detailed description:

Arms: arm 1: This is a single-arm phase II study evaluating the clinical efficacy of axitinib in the treatment of patients with progressive, recurrent/metastatic adenoid cystic carcinoma (ACC).
Interventions: intervention 1: AG-013736 (AXITINIB)
Intervention descriptions: intervention 1: All eligible patients will receive a starting axitinib dose of 5 mg twice daily (BID) taken orally in 4-week (28-day) cycles. Patients who tolerate axitinib with no adverse events related to study drug above CTCAE v. 4.0 Grade 2 for a consecutive 2-week period may have their dose increased by one dose level according to the discretion of the treating physician (NOT allowed for patients with blood pressure (BP) \> 150/90 mm Hg or who are receiving antihypertensive medication). This dose escalation is not mandatory. RECIST v1.1 tumor assessments will be made at baseline (CT or MRI) and then approximately every 2 cycles (or every 8 weeks (+/- 1 week)). After 10 months, imaging will be done every 3 cycles (or every 12 weeks (+/- 1 week)). Patients may remain on study until progression of disease or unacceptable toxicity.

Protocol documents:
Clinical trial NCT01590758
Conditions: Diabetic Foot Infection
Keywords: Diabetic Foot Ulcer Infection
Sponsor: Dipexium Pharmaceuticals, Inc.
Start date: 2014-06-01; Completion date: 2016-08-01
Enrollment: 189 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to establish the clinical superiority and the safety of topical pexiganan cream 0.8% plus standard local wound care, as compared to placebo cream plus standard local wound care, in the treatment of mildly infected diabetic foot ulcers.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Topical pexiganan cream 0.8% intervention 2: Topical placebo cream intervention 3: Standard wound care
Intervention descriptions: intervention 1: 14 days of treatment intervention 2: 14 days of treatment intervention 3: 14 days of treatment

Protocol documents:
Clinical trial NCT01662492
Conditions: Migraine Disorders
Sponsor: Allergan
Start date: 2012-10-01; Completion date: 2016-08-01
Enrollment: 125 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy and safety of Botulinum Toxin Type A versus placebo (normal saline) as headache prophylaxis in adolescents (children 12 to 17) with chronic migraine.

Detailed description:

Arms: arm 1: Botulinum toxin type A Dose 1 intramuscular injections into specified muscles. arm 2: Botulinum toxin type A Dose 2 intramuscular injections into specified muscles. arm 3: Placebo (Normal Saline) intramuscular injections into specified muscles.
Interventions: intervention 1: Botulinum toxin type A Dose 1 intervention 2: Botulinum toxin type A Dose 2 intervention 3: Placebo (Normal Saline)
Intervention descriptions: intervention 1: Botulinum toxin type A Dose 1 intramuscular injections into specified muscles. intervention 2: Botulinum toxin type A Dose 2 intramuscular injections into specified muscles. intervention 3: Placebo (Normal Saline) intramuscular injections into specified muscles.

Protocol documents:
Clinical trial NCT01668147
Conditions: Drug Effects
Keywords: PET Imaging Efavirenz Ritonavir [11C] desmethyl-loperamide Healthy volunteers
Sponsor: Washington University School of Medicine
Start date: 2012-08-01; Completion date: 2016-08-01
Enrollment: 13 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
To determine the effects of ritonavir and efavirenz on the activity of P-glycoprotein in human brain.

Detailed description:
Sequential crossover using tracer 11C-desmethylloperamide, a substrate for brain P-glycoprotein, and positron emission tomography (PET), administered after nothing (control), oral ritonavir (3d), and oral efavirenz (14d) with washout in between

Arms: arm 1: Session 1: Control (no pretreatment) - IV 10-14 mCi of \[11C\] desmethyl-loperamide (dLop) with PET/CT imaging arm 2: Session 2: Pretreatment with oral ritonavir for 3 days followed by IV 10-14 mCi of \[11C\]dLop with PET/CT imaging arm 3: Session 3: Pretreatment with oral efavirenz for 14 days followed by IV 10-14 mCi of \[11C\]dLop with PET/CT imaging
Interventions: intervention 1: [11C] desmethyl-loperamide intervention 2: Control - no pretreatment intervention 3: Oral ritonavir intervention 4: Oral efavirenz
Intervention descriptions: intervention 1: IV administration of 10-14 mCi of \[11C\] desmethyl-loperamide with PET/CT imaging intervention 2: Session 1: IV administration of 10-14 mCi \[11C\] desmethyl-loperamide (dLop) with PET/CT imaging and brain MRI intervention 3: Session 2: Pretreatment with oral ritonavir for 3 days followed by IV administration of 10-14 mCi \[11C\]dLop with PET/CT imaging and brain MRI intervention 4: Session 3: Pretreatment with oral efavirenz for 14 days followed by IV administration of 10-14 mCi \[11C\]dLop with PET/CT imaging and brain MRI

Protocol documents:
Clinical trial NCT01696032
Conditions: Ovarian Cancer
Keywords: Ovarian Cancer
Sponsor: Astex Pharmaceuticals, Inc.
Start date: 2012-09-01; Completion date: 2016-08-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A 2-part, Phase 2 controlled, open-label, randomized study in participants with platinum-resistant recurrent ovarian cancer. In Part 1, participants received SGI-110 and carboplatin. The optimum dose of SGI-110 (guadecitabine) was identified in Part 1 based on safety and efficacy. In Part 2, participants were randomized to receive the dose identified in Part 1 plus carboplatin or one of four treatment of choice at the discretion of the investigator. The treatment of choice consisted of topotecan, pegylated liposomal doxorubicin, paclitaxel or gemcitabine.

Detailed description:

Arms: arm 1: Stage 1 was a safety lead-in stage with a dose escalation design. Participants were evaluated with the combination of SGI-110 (guadecitabine) plus carboplatin (G+C), given as 28-day treatment cycles: guadecitabine administered subcutaneous (SC) daily on Days 1-5, at a starting dose of 45 mg/m2/day in Cohort 1, followed by carboplatin intravenous (IV) based on a targeted dose of area under the curve (AUC) 5 on Day 8. After dose limiting toxicities were noted, guadecitabine dose was reduced to 30 mg/m2/day for subsequent cycles for 4 participants. Cohort 2 received 30 mg/m2/day guadecitabine and carboplatin IV AUC 4. arm 2: Stage 2 was an open-label, randomized, controlled trial. Eligible participants were randomly assigned in a 1:1 ratio to receive either (1) G+C combination treatment in 28-day cycles at 30 mg/m2 SC once daily on Days 1-5 and carboplatin IV AUC 4 on Day 8, or (2) treatment of choice (TC) of topotecan, pegylated liposomal doxorubicin (PLD), paclitaxel, or gemcitabine based on recommended dosing in 28-day cycles; participants initially randomized to TC were able to cross over to receive 30 mg/m2 G+C due to disease progression.
Interventions: intervention 1: SGI-110 intervention 2: Treatment of Choice (topotecan, pegylated liposomal doxorubicin, paclitaxel, or gemcitabine) intervention 3: Carboplatin
Intervention descriptions: intervention 1: None intervention 2: Investigator chose to treat with either topotecan, pegylated liposomal doxorubicin, paclitaxel, or gemcitabine intervention 3: None

Protocol documents:
Clinical trial NCT01696461
Conditions: Related Donors Donating Peripheral Blood Stem Cells (PBSC) to a Family Member Acute Myelogenous Leukemia Acute Lymphoblastic Leukemia Myelodysplastic Syndrome Chronic Myelogenous Leukemia Non-Hodgkin's Lymphoma Hodgkin's Disease Chronic Lymphocytic Leukemia
Sponsor: Center for International Blood and Marrow Transplant Research
Start date: 2013-05-01; Completion date: 2016-08-01
Enrollment: 127 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase II, open-label, two strata, multicenter, prospective study of plerixafor-mobilized HLA-identical sibling allografts in recipients with hematological malignancies. This study will establish the safety and efficacy of subcutaneous plerixafor for this purpose.

Detailed description:
The primary objective is to determine the proportion of donors whose cells can be successfully mobilized and collected with a sufficient CD34+ cell dose using plerixafor as the mobilizing agent, using an intention-to-treat analysis. Donor mobilization following plerixafor will be considered successful if ≥ 2.0x10e6 CD34+ cells/kg recipient weight are collected in no more than two leukapheresis collections.

All donors receiving plerixafor will be included in the analysis of the primary objective based on the intention-to-treat principle.Recipients will be classified into one of the two strata, myeloablative or reduced intensity, according to his/her conditioning regimen. The target enrollment is 64 donor/recipient pairs, 32 pairs per stratum.

Arms: arm 1: Collection of sufficient CD34+ cells using plerixafor as the mobilizing agent.

Eligible donors determined according to institutional standards

* 18-65 years of age
* 6/6 HLA-matched sibling
* Fulfill individual Transplant Center criteria to serve as a mobilized blood cell donor
* Serum creatinine \<1.5 x institution upper limit of normal (ULN) or estimated creatinine clearance (CLCR) \>50 mL/min

Treatment Description:

* Receive subcutaneous plerixafor at 240 μg/kg and commence leukapheresis approximately 4 hours later.
* Leukapheresis will be performed up to two consecutive days. The target CD34+ cell dose is \> 4.0 x 106/kg with a minimum of \> 2.0 x 106/kg. arm 2: Patients undergoing conditioning under a myeloablative regimen

Myeloablative (one of four general regimens):

Busulfan (\> 9 mg/kg po or iv total) with fludarabine Busulfan (\> 9 mg/kg po or iv total) with cyclophosphamide Total body irradiation (\> 1000 cGy) plus etoposide Total body irradiation (\> 500 cGy) plus cyclophosphamide arm 3: Patients undergoing conditioning using a reduced intensity conditioning regimen.

Reduced Intensity (one of three general regimens):

Busulfan (\< 9 mg/kg po or iv total) plus fludarabine Melphalan (100-140 mg/m2 iv total) plus fludarabine Fludarabine plus cyclophosphamide (\> 2000 mg/m2 total)
Interventions: intervention 1: Plerixafor
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01709409
Conditions: Respiratory Distress Syndrome
Keywords: Prematurity
Sponsor: Ottawa Hospital Research Institute
Start date: 2013-03-01; Completion date: 2016-08-01
Enrollment: 88 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to see if a medication called Curosurf can reduce the length of time that small premature babies with Respiratory Distress Syndrome (immature lungs) or RDS, stay on the ventilator, as compared to the standard medication called BLES. Curosurf is a medication that is already used in other countries around the world but not yet in Canada.

Babies born under 32 weeks of gestation frequently need respiratory support after birth, including being placed on a breathing machine or respirator. The most common reason is Respiratory Distress Syndrome (RDS) whereby immature lungs don't produce enough surfactant, a soapy like substance that helps the air sacs open and close. Our current standard treatment is a surfactant called BLES. Curosurf contains more active ingredient per volume therefore the amount is smaller. The investigators hypothesize that babies who receive Curosurf will be able to be removed from the ventilator sooner.

Babies in this study will have a 50/50 chance of receiving either Curosurf or BLES and the investigators will monitor their progress during their Neonatal Intensive Care Unit admission.

The study is taking place in Canada. The goal is to enroll 88 babies. There are no extra tests (blood tests or X-Rays) or return visits to the hospital for the purposes of this study.

Detailed description:

Arms: arm 1: Surfactant(Curosurf in this arm) is given for treatment of RDS after the diagnosis has been made by the Neonatologist. The treatment dose for Curosurf® is 2.5 ml/kg (200mg/kg) for the first dose and 1.25 ml/kg (100mg/kg) for repeat doses, given by endotracheal method. There is a maximum of 3 doses in the study. arm 2: Surfactant(BLES in this arm) is given for treatment of RDS after the diagnosis has been made by the Neonatologist. For BLES the recommended dose is 5 ml/kg. given by endotracheal method. There is a maximum of 3 doses in the study.
Interventions: intervention 1: Curosurf-Group1 intervention 2: BLES-group 2
Intervention descriptions: intervention 1: Maximum of 3 doses are administered to infants diagnosed with RDS. intervention 2: Maximum of 3 doses are administered to infants with RDS

Protocol documents: