ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02802592
Conditions: Cardiac Surgery-CABG Cardiac Valve Replacement
Sponsor: Johns Hopkins University
Start date: 2015-05-01; Completion date: 2017-02-27
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
EPOgen and Restrictive Transfusions in Patients Undergoing Cardiac Surgery (EPORT)

Detailed description:
The investigator proposes a study investigating the use of restrictive transfusion triggers and administration of single preoperative high dose shot of epoetin alfa (rhEPO) in a young (age \< 65 years of age) population undergoing cardiac surgery. The investigator believes that participants can tolerate a lower Hemoglobin (Hgb). Therefore, the control group will benefit from a restrictive transfusion trigger and experimental group will benefit from EPO providing a synergistic stimulus for erythropoiesis. This proposed study has potential to reduce overall transfusion utilization in cardiac surgery and improve standard of care.

Arms: arm 1: 1000 IU/kg Epogen in 250 ml of normal saline infused over 1 hr arm 2: 250 ml normal saline infused over 1 hr
Interventions: intervention 1: Epogen intervention 2: Normal Saline
Intervention descriptions: intervention 1: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm intervention 2: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm

Protocol documents:
Clinical trial NCT01137682
Conditions: Acromegaly
Keywords: Acromegaly hormone disorder growth hormone insulin like growth factor-1 pituitary tumor pasireotide SOM230
Sponsor: Novartis Pharmaceuticals
Start date: 2010-07-19; Completion date: 2017-02-28
Enrollment: 198 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy and safety of pasireotide LAR 40 and 60 mg versus octreotide LAR or lanreotide ATG in patients with inadequately controlled acromegaly.

Detailed description:

Arms: arm 1: Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution) arm 2: Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution) arm 3: If a patient is randomized to the open label arm the investigator will either:

* be instructed to contact a Novartis delegate to initiate shipment of either octreotide LAR 30 mg or lanreotide ATG 120 mg from a Novartis or designee depot to the site, or
* continue to dispense either octreotide LAR 30 mg or lanreotide ATG 120 mg available at the institution to the patient if permitted by local regulations.
Interventions: intervention 1: Pasireotide intervention 2: octreotide LAR 30mg intervention 3: lanreotide ATG 120mg
Intervention descriptions: intervention 1: * Double-blind pasireotide LAR 40 mg i.m. injection once every 28 ± 2 days for 24 weeks or
* Double-blind pasireotide LAR 60 mg i.m. injection once every 28 ± 2 days for 24 weeks intervention 2: In an open-label, active control arm, continue on the same treatment with octreotide LAR 30 mg every 28 ± 2 days as received for at least 6 months prior to randomization intervention 3: In an open-label, active control arm, continue on the same treatment with lanreotide ATG 120 mg every 28 ± 2 days as received for at least 6 months prior to randomization

Protocol documents:
Clinical trial NCT01721954
Conditions: Colorectal Cancer Metastatic
Keywords: colon rectum metastatic colorectal cancer liver metastases
Sponsor: Sirtex Medical
Start date: 2013-05-01; Completion date: 2017-02-28
Enrollment: 209 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a randomized, multi-center study that will compare the efficacy and safety of selective internal radiation therapy (SIRT) using SIR-Spheres microspheres plus a standard chemotherapy regimen of FOLFOX6m versus FOLFOX6m alone as first-line therapy in patients with non-resectable liver metastases from primary colorectal carcinoma.

Treatment with the biologic agent bevacizumab, if part of the standard of care at participating institutions, is allowed within this study at the discretion of the Investigator.

Detailed description:

Arms: arm 1: Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure. arm 2: Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres.
Interventions: intervention 1: FOLFOX6m intervention 2: SIR-Spheres microspheres
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02361216
Conditions: Actinic Keratosis
Sponsor: LEO Pharma
Start date: 2015-04-01; Completion date: 2017-03-01
Enrollment: 729 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the trial is to investigate efficacy and safety of ingenol mebutate gel for actinic keratosis applied to large treatment areas once daily for three consecutive days on face, scalp or chest.

Detailed description:

Arms: arm 1: Treatment once daily for 3 days arm 2: Treatment once daily for 3 days
Interventions: intervention 1: Ingenol Mebutate intervention 2: Vehicle
Intervention descriptions: intervention 1: None intervention 2: Vehicle gel

Protocol documents:
Clinical trial NCT01069510
Conditions: Congenital Heart Disease Heart Failure Endomyocardial Fibrosis
Sponsor: Oregon Health and Science University
Start date: 2010-02-01; Completion date: 2017-03-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to see if the study drug called spironolactone reduces fibrous (stiffening) in heart muscle tissue and improves heart function. Subjects from the study titled "Heart Failure in Congenital Heart Disease: the role of myocardial fibrosis" who have evidence of heart dysfunction and/or evidence of fibrosis (stiffening) in the heart muscle will be asked to take part in this study.

Detailed description:
This study will include randomizing the subject to receive the study drug or placebo. Randomization will occur during visit 1.

Visit 1 will include the following:

* Subjects will answer questions about how well they can breathe.
* An MRI. Dye called gadolinium will be injected into the subject's vein.
* They will go to the Oregon Clinical and Translational Research Institute where 2 tablespoons of blood will be drawn from an intravenous (IV) catheter (tube).
* They will do a 6 minute walk test..
* They will also have an echocardiogram, which is a test that looks at the movement of the subject's heart. A technician will place a cool jelly on their chest and use a small wand to take pictures through the skin.

Subjects' will also have visits 3-6 weeks, 3, 6, 9 months, and 12 months after randomization. Visits 2-5 will include the following:

* They will go to the Oregon Clinical and Translational Research Institute where 1/2 tablespoon of blood will be drawn.
* They will do a 6 minute walk test. During this test, they will walk back and forth in a hallway. The goal is to walk as far as possible for 6 minutes. Subjects will probably get out of breath or become exhausted. If they do, they can slow down, stop, or rest as they need to. Blood pressure will be taken before the walk.
* They will have a health review at 6 months.

Visit 6 will be identical to visit 1 and include the following:

* Subjects will answer questions about how well they can breathe.
* An MRI. Dye called gadolinium will be injected into the subject's vein.
* They will go to the Oregon Clinical and Translational Research Institute where 2 tablespoons of blood will be drawn from an intravenous (IV) catheter (tube).
* They will do a 6 minute walk test..
* They will also have an echocardiogram, which is a test that looks at the movement of the subject's heart. A technician will place a cool jelly on their chest and use a small wand to take pictures through the skin.

The investigators will compare the study drug, called spironolactone, to placebo with regard to any changes in heart stiffening and function of the heart.

Arms: arm 1: Patients will receive placebo arm 2: Spironolactone 25 mg daily
Interventions: intervention 1: Spironolactone 25mg intervention 2: Placebo
Intervention descriptions: intervention 1: Spironolactone 25 mg daily for 12 months intervention 2: Placebo daily for 12 months

Protocol documents:
Clinical trial NCT01433991
Conditions: Advanced Solid Tumors
Sponsor: Eisai Inc.
Start date: 2011-10-13; Completion date: 2017-03-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter, open-label, Phase 1b/2 study which will be conducted in two parts: a Phase 1b part comprising a dose escalation and an expansion cohort; and a Phase 2 part which will comprise two cohorts. The purpose of the Phase 1b part is to identify the maximum tolerated dose (MTD) of E7050 and E7080 (lenvatinib) in combination in participants with unresectable advanced or metastatic solid tumors. In the subsequent Phase 1b expansion cohort and Phase 2 cohorts, additional participants with recurrent glioblastoma or unresectable Stage III or Stage IV melanoma and disease progression after prior systemic treatment will be enrolled to confirm the MTD (expansion cohort) and to further explore the clinical activity of E7050 and lenvatinib.

Detailed description:

Arms: arm 1: Participants with unresectable advanced or metastatic solid tumors will receive E7050 in combination with lenvatinib to identify a Maximum Tolerated Dose. Dose escalation will begin at low doses of both E7050 and lenvatinib, and then gradually increase in future cohorts until a recommended combination dose is identified. A dose of E7050 and lenvatinib to be used in combination in Phase 2 will be recommended (RP2 dose). Participants will continue on treatment until disease progression, development of unacceptable toxicity, or withdrawal of consent. arm 2: Participants with recurrent glioblastoma (bevacizumab-naïve) will receive E7050 and lenvatinib at the RP2 dose. arm 3: Participants with recurrent glioblastoma (bevacizumab-naïve) will receive single agent lenvatinib 24 mg/day (1\*4 mg capsule + 2\*10 mg capsule) and at time of progression, E7050 add-on therapy at the RP2 dose (in combination with lenvatinib at dose of either the RP2 dose or the most recent dose of single agent lenvatinib, whichever is the lowest). arm 4: Participants with unresectable Stage III or Stage IV melanoma and disease progression after prior systemic treatment will receive E7050 and lenvatinib at the RP2 dose. arm 5: Participants with unresectable Stage III or Stage IV melanoma and disease progression after prior systemic treatment will receive single agent E7050 400 mg/day.
Interventions: intervention 1: Golvatinib intervention 2: Lenvatinib intervention 3: Lenvatinib
Intervention descriptions: intervention 1: Participants will receive E7050 50 mg and/or 100 mg tablets. E7050 will be administered orally once daily, in 28-day cycles. intervention 2: Participants will receive lenvatinib 1 mg and/or 4 mg and/or 10 mg capsules. Lenvatinib will be administered orally once daily, in 28-day cycles. intervention 3: Participants will receive lenvatinib 24 mg (1\*4 mg capsule + 2\*10 mg capsule) capsules. Lenvatinib will be administered orally once daily, in 28-day cycles.

Protocol documents:
Clinical trial NCT01663272
Conditions: Pancreatic Cancer
Keywords: oncology pancrease
Sponsor: University of Michigan Rogel Cancer Center
Start date: 2012-07-01; Completion date: 2017-03-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Gemcitabine is considered one of the standard drugs for advanced pancreatic cancer and is approved by the FDA to treat it. Cabozantinib is a new drug that has demonstrated effectiveness against pancreatic cancer in laboratory experiments, especially when given with gemcitabine. Initial studies with cabozantinib in pancreatic cancer have shown some activity against the disease. The purpose of this study is to determine the safest and highest dose of cabozantinib that can be given together with standard doses of gemcitabine in patients with pancreatic cancer. This study will determine the safety and tolerability of this two drug combination.

Detailed description:
Preclinical work at the University of Michigan has demonstrated that inhibition of c-Met with cabozantinib prevented the development of metastatic disease in an intra-cardiac injection model in NOD/SCID mice. Additionally, the combination of cabozantinib and gemcitabine demonstrated improved tumor control compared to either agent alone in a relevant orthotopic implantation mouse model.

Combining gemcitabine with the c-Met inhibitor cabozantinib in advanced pancreatic cancer is a novel strategy that takes advantage of an established cytotoxic agent with one that targets a pathway known to be important for the growth, dissemination, and resistance of this disease.

Arms: arm 1: The Study Treatment Period will consist of continued treatment during which time patients will receive cabozantinib and gemcitabine until either disease progression or the occurrence of unacceptable drug-related toxicity
Interventions: intervention 1: CABOZANTINIB intervention 2: gemcitabine
Intervention descriptions: intervention 1: Daily oral cabozantinib administered days -7 until disease progression, intolerable adverse event(s) or patient choice. intervention 2: Gemcitabine administered intravenously on days 1, 8, and 15 every 28 days.

Protocol documents:
Clinical trial NCT01848145
Conditions: Chronic Lymphocytic Leukemia
Keywords: Chronic Lymphocytic Leukemia Ofatumumab Rapid Infusion
Sponsor: SCRI Development Innovations, LLC
Start date: 2013-07-01; Completion date: 2017-03-01
Enrollment: 34 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase II, single-arm study of ofatumumab investigating the safety of an accelerated infusion schedule of ofatumumab in patients who have received at least one prior therapy for CLL. The primary endpoint is to evaluate the number of subjects able to complete infusion number 3 (2000 mg) within 15 minutes of the planned time.

Detailed description:
The purpose of this study is to develop an accelerated infusion regimen that allows ofatumumab to be delivered in a safe manner while minimizing the time required administering the treatment. We hypothesize there will be fewer infusion-related reactions using the proposed dose-dense approach the first week before accelerating the rate of infusion.

Arms: arm 1: Rapid Infusion of Ofatumumab
Interventions: intervention 1: Ofatumumab
Intervention descriptions: intervention 1: The first dose of ofatumumab administered on Day 1 will be 300 mg to minimize infusion reactions. If the initial 300 mg dose of ofatumumab is well-tolerated, without occurrence of any infusion-associated AEs of \>= grade 3, on Day 3 ofatumumab will increase to 1000 mg IV. If the Day 3 dose was well-tolerated (i.e., no infusion-associated AE \>= grade 3), on Day 8 the ofatumumab dose will escalate to 2000 mg IV. To achieve the primary endpoint for this study, 20% of the 2000 mg ofatumumab dose only will be administered over the first 30 minutes and if tolerated the remaining 80% of the dose will be infused over the remaining 1.5/hours of each treatment. Ofatumumab doses, weeks 3-8, will remain at 2000 mg IV with no further dose escalations. If the Day 8 (Week 2) dose is tolerated all subsequent doses may be infused in the same manner.

Protocol documents:
Clinical trial NCT02024724
Conditions: Typical Facial Pain Atypical Facial Pain
Sponsor: Northwestern University
Start date: 2013-11-01; Completion date: 2017-03-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Trigeminal neuralgia is a craniofacial pain syndrome that is typically characterized by unilateral severe, recurrent, electrical pain in one or more distributions of the trigeminal nerve. Current treatment strategies include oral medications as first line therapy with surgical interventions reserved for those patients who are refractory to medications or unable to tolerate medication side effects. Despite these current treatment options, many patients continue to have symptoms. Ultrasound-guided trigeminal nerve block allows for fine adjustment of the needle tip and direct observation of the medicine.

Local anesthetic and steroids have been successfully used for diagnostic and or therapeutic nerve pain with great success. Steroids can be short or long acting in duration with varying side effects. If there exists a difference in duration of action, using the longer acting drug will provide a greater period of symptom relief for the patient and may allow the patient to undergo fewer interventional procedures.

Detailed description:

Arms: arm 1: 4 mg of Dexamethasone and 4 mL of 0.25% bupivacaine arm 2: 40 mg of Triamcinolone and 4 mL of 0.25% bupivacaine
Interventions: intervention 1: Bupivacaine intervention 2: Triamcinolone intervention 3: Dexamethasone
Intervention descriptions: intervention 1: 4 mL of 0.25% bupivacaine intervention 2: 40 mg of Triamcinolone intervention 3: 4 mg of Dexamethasone

Protocol documents:
Clinical trial NCT02033876
Conditions: Type 2 Diabetes Mellitus
Sponsor: Mayo Clinic
Start date: 2013-10-01; Completion date: 2017-03-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate whether bile acids are able to increase insulin sensitivity and enhance glycemic control in T2DM patients, as well as exploring the mechanisms that enhance glycemic control. These observations will provide the preliminary data for proposing future therapeutic as well as further mechanistic studies of the role of bile acids in the control of glycemia in T2DM.

Detailed description:
Background: Intra-jejunal administration of bile acids improves insulin sensitivity.

Hypothesis: The bile acid, ursodeoxycholic acid (UDCA) in delayed (ileocolonic)-release formulation, stimulates bile acid membrane receptor (TGR-5) and farnesol X (FXR) receptors in the ileum and colon, increasing the secretion of Fibroblast growth factor 19 (FGF-19), GLP-1, oxyntomodulin (OXM), and Peptide (PYY3-36), improving insulin sensitivity and inducing weight loss.

Aim: To study the effect of an ileocolonic formulation of UDCA on insulin sensitivity, postprandial plasma glycemia and incretin levels, gastric emptying and body weight in overweight or obese type 2 diabetic subjects on monotherapy with metformin.

Study design: This is a single center, placebo-controlled, parallel group, single dose randomized controlled trial to study the effect of delayed (ileocolonic)-release UDCA 600 mg twice daily on insulin sensitivity, gastric emptying of liquids and solids (measured by scintigraphy)and weight loss in overweight or obese type 2 diabetic subjects. Participants will be receiving monotherapy with metformin. Blood samples will be collected at defined times to measure glycemia and the incretin (GLP-1, OXM, PYY3-36) fasting levels and responses to the meal.

Anticipated Results: In comparison with placebo, UDCA will increase insulin sensitivity, enhance glycemic control, increase postprandial incretins, and delay gastric emptying (GE) of liquids.

Significance: This study will prove that ileocolonic-release UDCA enhances glycemic control in T2DM patients.

Arms: arm 1: Ursodeoxycholic acid (UDCA) 600mg in delayed (ileocolonic)-release to be taken twice daily arm 2: matching placebo capsules to be taken twice daily
Interventions: intervention 1: Ursodiol
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02054130
Conditions: Asthma
Keywords: Asthma
Sponsor: MedImmune LLC
Start date: 2013-12-13; Completion date: 2017-03-01
Enrollment: 584 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to evaluate the effect of 3 dose levels of MEDI9929 (AMG 157) on asthma exacerbations in adult subjects with inadequately controlled, severe asthma.

Detailed description:

Arms: arm 1: Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. arm 2: Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. arm 3: Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. arm 4: Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
Interventions: intervention 1: Placebo intervention 2: MEDI9929 70 mg intervention 3: MEDI9929 210 mg intervention 4: MEDI9929 280 mg
Intervention descriptions: intervention 1: Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50. intervention 2: Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. intervention 3: Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50. intervention 4: Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.

Protocol documents:
Clinical trial NCT02199314
Conditions: Idiopathic Scoliosis
Keywords: intra operative neurophysiologic monitoring transcranial motor evoked potential anesthesia pulses
Sponsor: Children's Hospital Medical Center, Cincinnati
Start date: 2013-03-01; Completion date: 2017-03-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Test the hypothesis to recruit larger motor responses to transcranial stimulation.

Detailed description:
The study is designed to test the hypothesis that it is possible to recruit larger motor responses to transcranial stimulation by increasing the number of stimulating pulses under both baseline conditions and conditions of increased anesthetic suppression of the motor responses.

Arms: arm 1: Transcranial motor evoked potentials are obtained under total intravenous anesthesia (TIVA) and again after desflurane at 3%, for at least 5 minutes.at two different time points. Each subject is his/her own control
Interventions: intervention 1: Desflurane
Intervention descriptions: intervention 1: None

Protocol documents: