ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00967226
Conditions: Hemangioma of Infancy
Keywords: hemangioma
Sponsor: Nancy Bauman
Start date: 2009-07-01; Completion date: 2014-12-01
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Hemangiomas are relatively common lesions in infants. Most go away spontaneously after one year of life and do not need treatment. Others require treatment because they cause significant symptoms such as pain, or difficulty with breathing, eating or ambulating. Steroids have classically been used to treat hemangiomas and help to shrink them in 1/3 - 2/3 of patients. Unfortunately, steroids have many side effects in babies so physicians have sought other ways to treat them. Recently, the use of propranolol, a heart medication, was serendipitously found to reduce the size of hemangiomas. It appears to have many fewer side effects than steroids but it is not yet known if it works as well as steroids. This study seeks to compare the effect and the side effects of propranolol versus steroids for treating hemangiomas that cause symptoms in infants.

Detailed description:
Infants with symptomatic hemangiomas will be enrolled. Magnetic resonance imaging will be completed before starting medication if the extent of the hemangioma is not evident on clinical examination alone. Infants will be randomized to receive either propranolol or steroids for 4-6 months. Hemangioma response will be measured and compared monthly as will tolerability of the medications. Additionally, urine specimens will be collected at each visit to determine if markers are present that can predict response to therapy.

Additionally, any hemangiomas that are excised will be examined for genetic markers to aid in predicting response to therapy.

Arms: arm 1: Assessing efficacy and tolerability of propranolol in management of symptomatic hemangiomas arm 2: Assessing efficacy and tolerability of prednisolone in management of symptomatic hemangiomas and comparing to propranolol.
Interventions: intervention 1: propranolol intervention 2: Prednisolone
Intervention descriptions: intervention 1: propranolol 0.5 mg/kg orally, 4 per day - 4-6 months intervention 2: 1.0 mg/kg orally, 2 per day 4-6 months

Protocol documents:
Clinical trial NCT00982488
Conditions: Leukemia
Sponsor: Bristol-Myers Squibb
Start date: 2007-10-01; Completion date: 2014-12-01
Enrollment: 238 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study assesses the long-term safety and tolerability of dasatinib administered to patients with chronic myelogenous leukemia or Philadelphia chromosome positive acute lymphoblastic leukemia and experienced clinical benefit from treatment with dasatinib or imatinib in previous protocols.

Detailed description:

Arms: arm 1: Participants with chronic phase disease continued on the previous study dose of dasatinib, ranging from 50 mg once daily (QD) to 120 mg twice daily (BID). arm 2: Participants with chronic phase disease received 400 mg of imatinib twice BID. arm 3: Participants with advanced phase disease, accelerated phase (AP), continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. arm 4: Participants with advanced phase disease, myeloid blast cell (MBP), continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. arm 5: Participants with advanced phase disease, Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID.
Interventions: intervention 1: Dasatinib intervention 2: Imatinib
Intervention descriptions: intervention 1: Dasatinib was supplied as 20- and 50-mg tablets. intervention 2: Imatinib was supplied as 100- and 400-mg tablets.

Protocol documents:
Clinical trial NCT01020474
Conditions: Fibromyalgia
Keywords: juvenile primary fibromyalgia syndrome pediatric fibromyalgia pregabalin and Lyrica
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2010-05-01; Completion date: 2014-12-01
Enrollment: 107 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare pregabalin with placebo over a 15 week period in adolescents with fibromyalgia aged 12-17 years to evaluate the safety and efficacy of pregabalin.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: placebo intervention 2: pregabalin (Lyrica)
Intervention descriptions: intervention 1: matching placebo capsules twice daily. intervention 2: 75-450mg/day pregabalin dose optimised at start of study

Protocol documents:
Clinical trial NCT01020487
Conditions: Chronic Kidney Disease Stage 3 and 4
Keywords: Reduction of parathyroid hormone levels in pediatric patients with Chronic Kidney Disease Stage 3 and 4
Sponsor: AbbVie (prior sponsor, Abbott)
Start date: 2010-02-01; Completion date: 2014-12-01
Enrollment: 47 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Part 1: To determine the safety, tolerability, and pharmacokinetics of a single dose of 3 μg paricalcitol capsules in children ages 10 to 16 years with moderate to severe chronic kidney disease (CKD Stages 3 and 4).

Part 2: To determine the safety and efficacy of paricalcitol capsules as compared to placebo in decreasing serum intact parathyroid hormone (iPTH) in children ages 10 to 16 years with moderate to severe chronic kidney disease with an initial 12 weeks of double-blinded study drug followed by a minimum of 12 weeks of open-label active drug.

Detailed description:
The study consists of two parts. Part 1 is an open-label single-dose, non-fasting, multicenter study to evaluate the pharmacokinetics (PK) of paricalcitol capsules in 12 children ages 10 to 16 years with CKD Stages 3 and 4. Part 2 of this study will be conducted as a 12 week randomized double-blind, placebo-controlled study, followed by 12 weeks open-label treatment. Participants active or enrolled under amendment 5 will enter a follow-up period and have study visits every 4 weeks until the final participant reaches Week 24.

Arms: arm 1: Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1. arm 2: Participants received placebo capsules three times a week (TIW) for 12 weeks during the double-blind treatment phase. From Weeks 12 to 24 participants received open-label paricalcitol at an initial dose of 1 µg three times a week. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) target levels. arm 3: Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
Interventions: intervention 1: Paricalcitol intervention 2: Placebo
Intervention descriptions: intervention 1: Paricalcitol capsules taken with water. intervention 2: Placebo capsules taken with water

Protocol documents:
Clinical trial NCT01028222
Conditions: Melanoma
Keywords: Melanoma AMN107 c-Kit c-Kit mutated metastatic and/or inoperable melanoma
Sponsor: Novartis Pharmaceuticals
Start date: 2010-06-01; Completion date: 2014-12-01
Enrollment: 55 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether nilotinib is efficacious in the treatment of metastatic and/or inoperable melanoma harboring a c-Kit mutation.

Detailed description:
This trial began as a multi-center, randomized, Phase III, controlled trial for nilotinib vs (DTIC) dacarbazine to assess the efficacy and safety of nilotinib (400 mg bid) in patients with c-Kit mutated metastatic and/or inoperable melanoma. The study was open to patients with mucosal or acral melanoma.

Due to substantial difficulties identifying and recruiting eligible patients, the trial design was altered from a randomized, two-arm, Phase III study to a single-arm, Simon two-stage Phase II study with protocol Amendment 2 (27-Jul-2011). While the original protocol required the recruitment of 120 patients, this amendment required the study to recruit only 41 patients (patients randomized to nilotinib prior to Amendment 2 were to be counted in this total, but those randomized to dacarbazine ( DTIC ) DTIC were not). Patients randomized to DTIC were allowed to cross-over to nilotinib, either immediately or at the time of progression.

Arms: arm 1: 400 mg twice daily arm 2: 850 mg/m2 IV every 3 weeks
Interventions: intervention 1: Nilotinib intervention 2: DTIC
Intervention descriptions: intervention 1: Nilotinib was provided as 200 mg hard gelatin capsules for oral use. intervention 2: DTIC was supplied locally as sterile powder for i.v. infusion.

Protocol documents:
Clinical trial NCT01031381
Conditions: Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Carcinoma
Keywords: Recurrent ovarian fallopian tube primary peritoneal cancer Recurrent ovarian, fallopian tube, primary peritoneal cancer
Sponsor: University of Pittsburgh
Start date: 2010-09-01; Completion date: 2014-12-01
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will investigate the efficacy as well as the safety of RAD001 in combination with bevacizumab for recurrent ovarian, peritoneal, and fallopian tube cancer. RAD001 will be taken orally once daily and bevacizumab will be administered once every 14 days. The study will be conducted over a period of about 3 to 4 years.

Detailed description:
In this trial, approximately 50 patients will receive the study drug, RAD001 in combination with bevacizumab (Avastin)chemotherapy. RAD001 will be taken orally once daily and bevacizumab will be administered intravenously once every 14 days. In addition to study treatment, a few blood samples and a sample of the patients tumor from a previous surgery if available will be collected for research.

Arms: arm 1: Patients will receive RAD001 by mouth everyday and Bevacizumab IV every 14 days until clinical progression.
Interventions: intervention 1: RAD001 intervention 2: bevacizumab
Intervention descriptions: intervention 1: RAD001 10mg is taken orally (by mouth) once daily on a continuous basis. RAD001 is provided in tablet form and should be taken with a big glass of water on an empty stomach or after a low-fat meal. intervention 2: bevacizumab will be administered intravenously (IV) once every 14 days.

Protocol documents:
Clinical trial NCT01058941
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease fish oil lipoic acid
Sponsor: Oregon Health and Science University
Start date: 2010-09-01; Completion date: 2014-12-01
Enrollment: 67 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to see if taking lipoic acid plus omega-3 fatty acids (omega-3s) can slow the Alzheimer's disease (AD) process. To see if the treatment can slow the AD process, the investigators looked at changes in memory and changes in a person's daily activities over 18 months.

Detailed description:
Current pharmacological agents for AD have had no impact on disease prevalence and have had limited effects on improving the clinical course of AD. The exponential rise in the prevalence, incidence, and cost of care for AD make finding therapeutic agents that can either prevent AD or delay disease progression an urgent health care need. Since inflammation, lipid dysregulation, and insulin resistance have each been associated with AD pathology, the combination of lipoic acid plus fish oil has the potential to maximize therapeutic benefit by acting on all three mechanisms associated with disease pathology.

Arms: arm 1: Three 1-gram fish oil capsules per day (2 capsules in the morning and 1 capsule in the evening) plus two lipoic acid (LA) capsules per day in the morning. Total daily dose of study drug: 675 mg DHA, 975 mg EPA, 600 mg LA. arm 2: Three placebo oil capsules per day (2 capsules in the morning and 1 capsule in the evening) plus two placebo LA capsules per day in the morning.
Interventions: intervention 1: Lipoic acid and fish oil concentrate intervention 2: Placebo
Intervention descriptions: intervention 1: Lipoic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months intervention 2: Placebo LA and placebo oil capsules for 18 months

Protocol documents:
Clinical trial NCT01144455
Conditions: Pancreatic Adenocarcinoma
Keywords: Locally Advanced Unresectable Pancreatic Adenocarcinoma Metastatic Pancreatic Adenocarcinoma Locally Advanced Unresectable or Metastatic Pancreatic Adenocarcinoma
Sponsor: ImmunoGenesis
Start date: 2010-06-01; Completion date: 2014-12-01
Enrollment: 214 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether Gemcitabine versus Gemcitabine and TH-302 are effective in the treatment of subjects with first-line metastatic pancreatic adenocarcinoma.

Detailed description:
A hypoxic microenvironment is a characteristic of many solid tumors including pancreatic cancer. The presence of hypoxia in solid tumors is associated with a more malignant phenotype and resistance to chemotherapy. The hypoxia-activated prodrug, TH-302, is designed to selectively physiologically target the hypoxic microenvironment. There is an absence of therapeutic options for subjects with metastatic pancreatic cancer. Gemcitabine provides clinical benefit as a single agent, but median survival is about 6 months. Combining gemcitabine with TH-302 may enable the targeting of both the normoxic and hypoxic regions of pancreatic cancer.

Arms: arm 1: Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle arm 2: TH-302: 240 mg/m2 administered IV over 30 minutes Day 1, 8, and 15 of each 28-day cycle

Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle arm 3: TH-302: 340 mg/m2 of TH-302 be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.

Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle
Interventions: intervention 1: Gemzar (Gemcitabine) intervention 2: TH-302 intervention 3: TH-302
Intervention descriptions: intervention 1: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle. intervention 2: 240 mg/m2 of TH-302 will be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle. intervention 3: 340 mg/m2 of TH-302 will be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.

Protocol documents:
Clinical trial NCT01159054
Conditions: Dialysis Cardiovascular Disease Atherosclerosis Inflammation
Sponsor: Brigham and Women's Hospital
Start date: 2010-07-01; Completion date: 2014-12-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Patients with kidney failure on hemodialysis have an extremely high rate of cardiovascular disease including atherosclerotic cardiovascular disease. This, at least in part, is due to the chronic inflammatory status usually seen in these patients. Here we try to see if treatment with extended release nicotinic acid (Niaspan) can reduce their overall inflammatory burden (in general) and the atherosclerotic plaque inflammation (in particular).

Detailed description:

Arms: arm 1: Blood sample and scan results to be compared before and after intervention in each subject.
Interventions: intervention 1: Extended Release Nicotinic Acid (Niaspan)
Intervention descriptions: intervention 1: Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks.

Protocol documents:
Clinical trial NCT01166724
Conditions: Kidney Transplant
Keywords: Kidney transplant
Sponsor: The Cleveland Clinic
Start date: 2010-07-01; Completion date: 2014-12-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators hypothesize that Tacrolimus (Tac) withdrawal from a Tac, MMF and steroid based triple therapy regimen leads to long term improved/stabilized graft function (glomerular filtration rate, GFR) primarily as a consequence of halting CNI-induced fibrogenetic processes that mediate loss of functioning renal tissue. The investigators further hypothesize that the underlying fibrotic mechanism is mediated by pathophysiologic processes that promote epithelial to mesenchymal transition (EMT) (mediated by TGF- ƒÒ) and that early therapeutic intervention may reverse this process (mediated by BMP-7)4.

To address these hypotheses the investigators propose the following clinical and mechanistic aims:

The investigators will test the hypothesis that switching from Tac to SRL in a Tac based triple therapy regimen with MMF and steroids in living and or deceased donor renal transplant recipients leads to improvement in allograft structure and function at 2 years post-transplantation.

The investigators will test this hypothesis in an open label controlled trial where stable renal allograft recipients on Tac, MMF, prednisone maintenance immunosuppression will undergo renal biopsy at 3-4 months post-transplantation and will be randomized to either a) Remain on Tac, MMF and prednisone (CNI-maintenance) or b) switch the Tac to SRL and continue MMF and prednisone. The investigators will then compare biopsy derived measures of allograft fibrosis (CADI, Sirius Red, Banff Chronicity Index) and GFR in the two groups

Detailed description:
We will test this hypothesis in an open label controlled trial where stable renal allograft recipients on Tac, MMF, prednisone maintenance immunosuppression will undergo renal biopsy at 3-4 months post-transplantation and will be randomized to either a) Remain on Tac, MMF and prednisone (CNI-maintenance) or b) switch the Tac to SRL and continue MMF and prednisone. We will then compare biopsy derived measures of allograft fibrosis (CADI, Sirius Red, Banff Chronicity Index) and GFR in the two groups

Arms: arm 1: patients will be switched from Tacrolimus to Sirolimus arm 2: Patient will stay on Tacrolimus
Interventions: intervention 1: Sirolimus intervention 2: Tacrolimus
Intervention descriptions: intervention 1: Tacrolimus to Sirolimus intervention 2: dosage per trough level

Protocol documents:
Clinical trial NCT01169103
Conditions: Obesity
Keywords: Obesity Adolescent Insulin resistance Growth hormone Visceral fat Adolescent obesity
Sponsor: Massachusetts General Hospital
Start date: 2010-03-01; Completion date: 2014-12-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Teenagers and adults who are overweight or obese have an increase in fat in the abdomen, which increases their risk for diabetes and heart disease. Reducing abdominal fat is important to reduce risk for diabetes and for heart disease. Overweight teenagers also have low levels of growth hormone compared to normal weight teenagers, and teenagers with the lowest growth hormone levels also have the greatest abdominal fat. In children who are unable to make growth hormone for other reasons, giving back growth hormone leads to a decrease in abdominal fat. We are studying whether giving growth hormone in small doses to overweight teenagers can change body composition. We hypothesize that growth hormone will cause abdominal fat to decrease and reduce the risk markers for diabetes and heart disease.

Detailed description:

Arms: arm 1: Forty subjects will be randomized to receive either recombinant human growth hormone or placebo. arm 2: Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.
Interventions: intervention 1: recombinant human growth hormone (rhGH) intervention 2: Placebo
Intervention descriptions: intervention 1: Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks. intervention 2: Placebo will be administered by daily subcutaneous injections. Sham increases will be used.

Protocol documents:
Clinical trial NCT01174264
Conditions: Malignant Neoplasm
Sponsor: National Cancer Institute (NCI)
Start date: 2009-10-01; Completion date: 2014-12-01
Enrollment: 63 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized clinical trial studies the effect of food on the pharmacokinetics of vismodegib. Studying the effects of meals on the absorption of vismodegib may help doctors prescribe correct doses and label the drug accurately.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate the effect of prandial states on the pharmacokinetic parameters of GDC-0449 (vismodegib).

II. To evaluate the effect of fat content of meals on the pharmacokinetic parameters of GDC-0449.

SECONDARY OBJECTIVES:

I. To evaluate the effect of prandial states and fat content of meals on the safety profile of GDC-0449.

II. To describe any anticancer activities of GDC-0449.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

ARM I: Patients receive a single dose of vismodegib orally (PO) on an empty stomach. Beginning 7 days later, patients receive vismodegib PO on an empty stomach daily on days 1-28.

ARM II: Patients receive a single dose of vismodegib PO after eating a high fat meal. Beginning 7 days later, patients receive vismodegib PO on an empty stomach daily on days 1-28.

ARM III: Patients receive a single dose of vismodegib PO after eating a low fat meal. Beginning 7 days later, patients receive vismodegib PO after eating a meal daily on days 1-28.

In all arms, treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.

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

Arms: arm 1: Patients receive a single dose of vismodegib PO on an empty stomach. Beginning 7 days later, patients receive vismodegib PO on an empty stomach daily on days 1-28. arm 2: Patients receive a single dose of vismodegib PO after eating a high fat meal. Beginning 7 days later, patients receive vismodegib PO on an empty stomach daily on days 1-28. arm 3: Patients receive a single dose of vismodegib PO after eating a low fat meal. Beginning 7 days later, patients receive vismodegib PO after eating a meal daily on days 1-28.
Interventions: intervention 1: Pharmacological Study intervention 2: Vismodegib
Intervention descriptions: intervention 1: Correlative studies intervention 2: Given PO

Protocol documents: