ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01537900
Conditions: Hepatitis C
Sponsor: Merck Sharp & Dohme LLC
Start date: 2013-10-01; Completion date: 2014-07-31
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this study was to compare hepatic pharmacokinetics (PK) derived from liver tissue to plasma PK after administration of grazoprevir (MK-5172) to participants with chronic hepatitis C virus (HCV) infection. Participants will be randomized to one of four different liver ultrasound-guided Fine Needle Aspirate (FNA) schedules (at 4-, 8-, 24-, or 72-hours after the Day 7 dose).

Detailed description:

Arms: arm 1: Participants received GZR 100 mg once daily (q.d.) for 7 days. Liver FNA was performed on Day 7.
Interventions: intervention 1: Grazoprevir
Intervention descriptions: intervention 1: GZR 100 mg tablet by mouth q.d. for 7 days.

Protocol documents:
Clinical trial NCT01713036
Conditions: Locally Advanced or Metastatic Solid Tumors
Keywords: Mass balance, bioavailability, cancer, 14C
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2012-11-30; Completion date: 2014-07-31
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase 1, open-label, single centered trial to evaluate the mass balance, bioavailability and metabolism of pimasertib in cancer subjects with locally advanced or metastatic solid tumors.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Pimasertib
Intervention descriptions: intervention 1: Part A: Subjects will receive unlabeled pimasertib capsules orally at a single dose of 60 milligram (mg) on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kilobecquerel (kBq) \[14C\] pimasertib will be administered as a bolus injection. On Days 3-21 (except Day 8), subjects will receive unlabeled pimasertib capsules orally at a dose of 60 mg twice daily (BID). In the morning of Day 8, subjects will receive 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 megabecquerel (MBq) (70 microcuries \[mcgCi\]) of \[14C\] pimasertib orally. In the evening of Day 8, subjects will receive the evening dose of 60 mg pimasertib as unlabeled pimasertib capsules orally. Part B : Subjects will be administered with 60 mg BID unlabeled pimasertib as oral capsules continuously in cycles of 21 days until progression of the disease, unacceptable toxicity, withdrawal of consent by the subject, loss to follow-up or death.

Protocol documents:
Clinical trial NCT01138657
Conditions: Uveitis
Keywords: inflammation of uvea
Sponsor: AbbVie (prior sponsor, Abbott)
Start date: 2010-08-01; Completion date: 2014-08-01
Enrollment: 239 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study comparing the safety and efficacy of adalimumab compared with placebo in patients with active uveitis.

Detailed description:

Arms: arm 1: Participants received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15. arm 2: Participants received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
Interventions: intervention 1: Adalimumab intervention 2: Prednisone intervention 3: Placebo
Intervention descriptions: intervention 1: Administered subcutaneously as an 80 mg loading dose (2 syringes) at Baseline followed by a 40 mg dose eow starting at Week 1. intervention 2: Administered orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper schedule in which all participants continuing in the study were to discontinue prednisone no later than Week 15. intervention 3: Administered by subcutaneous injection

Protocol documents:
Clinical trial NCT00100230
Conditions: Retinitis Pigmentosa X-linked Genetic Diseases
Keywords: retina electroretinography clinical trial docosahexaenoic acid omega-3 fatty acid x-linked inheritance
Sponsor: Retina Foundation of the Southwest
Start date: 2004-09-01; Completion date: 2014-08-01
Enrollment: 78 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Purpose:

Retinitis pigmentosa (RP) is characterized by progressive loss of visual function due to specific genetic mutations. This trial is focused on patients with one of the most severe forms of the disease, X-linked inherited RP (XLRP). This disease is characterized by early onset (typically loss of night vision as a child) followed by loss of peripheral vision as a teenager and young adult. There is no male-to-male transmission of the disease in the family.

There is no cure for RP and treatment options are limited. Two clinical trials have not found a benefit from nutritional supplementation with the long-chain polyunsaturated fatty acid, docosahexaenoic acid (DHA), at low daily doses although there is evidence that it slows disease progression in certain instances. In this clinical trial, we propose that a high dose nutritional DHA supplement will slow the loss of visual function and preserve usable vision in patients with XLRP.

This study is a 4-year placebo-controlled randomized clinical trial meaning that patients have a 50-50 chance of receiving placebo or experimental treatment. A total of 66 patients will be enrolled; 33 will receive placebo and 33 will receive the treatment. Entry criteria include diagnosis of XLRP by an ophthalmologist, age 7 to 32 years, male, sufficient visual function such that disease progression can be followed for the entire duration of the trial, and a willingness to visit the testing site (Dallas, TX) once a year.

Annual visual function testing includes ETDRS visual acuity, full-field and multifocal electroretinography (ERG), static peripheral visual fields, and fundus photography. Cone ERG function is the primary outcome measure.

Funding Source - FDA, Foundation Fighting Blindness, DSM Nutritionals

Detailed description:
Location \& Contact Information:

Retina Foundation of the Southwest, 9600 N. Central Expressway, Suite 200, Dallas, TX 75231 Contact: Dr. D. Hoffman (dhoffman@retinafoundation.org) or Dr. D. Birch (dbirch@retinafoundation.org).

Arms: arm 1: Oral Docosahexaenoic acid, dosage based on body weight arm 2: corn/soy oil placebo; oil not containing DHA...dosage based on body weight
Interventions: intervention 1: docosahexaenoic acid OR corn/soy oil placebo
Intervention descriptions: intervention 1: daily intake of DHA based on body weight or corn/soy oil placebo(oil not containing DHA; 4 year trial

Protocol documents:
Clinical trial NCT00308139
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes exenatide long acting release LAR Amylin Lilly
Sponsor: AstraZeneca
Start date: 2006-04-01; Completion date: 2014-08-01
Enrollment: 303 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Randomized, Open-Label, Multicenter, Comparator-Controlled Study to Examine the Effects of Exenatide Long-Acting Release (LAR) on Glucose Control (HbA1c) and Safety in Subjects with Type 2 Diabetes Mellitus Managed with Diet Modification and Exercise and/or Oral Antidiabetic Medications.

Detailed description:
This trial is designed to examine the effect of exenatide once weekly compared to exenatide twice daily on glucose control and safety in subjects for at least 30 weeks. The study is also designed to examine glucose control during the transition from exenatide twice daily for 30 weeks to exenatide once weekly. Long-term safety and efficacy will be monitored during the open-ended assessment periods. This study will be conducted in approximately 300 subjects with type 2 diabetes treated with diet modification and exercise alone or in combination with a stable regimen of metformin, SU, thiazolidinedione (TZD), a combination of metformin and SU, a combination of metformin and TZD, or a combination of SU and TZD.

Arms: arm 1: Subcutaneous injection (SC), once a week of long acting release (LAR) exenatide. arm 2: subcutaneous injection (SC), twice a day for the first 30 weeks, followed by exenatide LAR SC injection weekly for the remainder of the study.

Sub-study: Exenatide 2 mg subcutaneous injection, Administered Using the Exenatide Once Weekly Single-Dose Tray , once a week for 11 visits, switch to Exenatide 2 mg subcutaneous injection, Administered Using the Dual chamber pen device. Exenatide 2mg SC injection administered using the Dual chamber pen device.
Interventions: intervention 1: exenatide, long acting release intervention 2: exenatide
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00324259
Conditions: Breast Neoplasms
Sponsor: Washington University School of Medicine
Start date: 2004-08-01; Completion date: 2014-08-01
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study aims to examine whether estradiol is an appropriate for future Phase 3 studies as second or third line endocrine treatment. In addition the protocol explores several approaches to enhance the safety of estrogen therapy, including the establishment of the efficacy of a lower dose than that currently recommended and through the early identification of non-responders to avoid drug exposure in patients who are unlikely to benefit to estrogen treatment.

Detailed description:
The purpose of this study is to compare the effects of two doses (6 mg and 30 mg) of Estradiol, a type of estrogen. This and other forms of estrogen used at doses much higher than those used for postmenopausal hormone replacement therapy have been shown to cause tumor growth stabilization or shrinkage in patients with breast cancer.

Arms: arm 1: 6 mg of estradiol daily (2 mg tid). arm 2: 30 mg of estradiol. (10 mg tid)
Interventions: intervention 1: Estradiol
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00387647
Conditions: Leukemia
Keywords: myeloid acute monocytic
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Start date: 2006-08-01; Completion date: 2014-08-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to find out if patients older than 60, with acute myeloid leukemia, who are in complete remission following initial chemotherapy, will live longer and have a lower rate of leukemia relapse when treated with azacitidine.

Detailed description:
Patient activity will encompass approximately 48 months: an approximate 24 month enrollment period, followed by 6 to 12 months of patient treatment. Patients will be followed for 1 year following completion of study drug treatment. During follow-up, bone marrow biopsies to confirm disease status should be obtained if peripheral blood blasts are present or if there is development of unexpected blood abnormalities to warrant suspicion of relapse, or at a minimum of every 6 months.

Arms: arm 1: Azacitidine 50 mg/m\^2 subcutaneously daily for 5 days (Monday through Friday) on days 1 through 5, every 28 days for 6-12 cycles.
Interventions: intervention 1: Azacitidine
Intervention descriptions: intervention 1: Azacitidine given subcutaneously as outlined in treatment arm.

Protocol documents:
Clinical trial NCT00391092
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2006-09-01; Completion date: 2014-08-01
Enrollment: 424 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study will compare the efficacy and safety of Avastin plus Herceptin/docetaxel, versus Herceptin/docetaxel alone, in patients with HER2 positive locally recurrent or metastatic breast cancer who have not received prior chemotherapy for their metastatic disease. Patients will be randomized 1:1 to receive either Avastin (15mg/kg iv q3weeks) + Herceptin (8mg/kg iv loading dose and 6mg/kg iv q3weeks maintenance) + docetaxel (100mg/m2 iv q3weeks) or Herceptin + docetaxel alone. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: bevacizumab [Avastin] intervention 2: Docetaxel intervention 3: Herceptin
Intervention descriptions: intervention 1: 15mg/kg iv every 3 weeks intervention 2: 100mg/m2 iv every 3 weeks intervention 3: 8mg/kg iv loading dose, followed by 6mg/kg iv every 3 weeks

Protocol documents:
Clinical trial NCT00416494
Conditions: Colorectal Cancer
Keywords: adenocarcinoma of the colon recurrent colon cancer stage IV colon cancer adenocarcinoma of the rectum recurrent rectal cancer stage IV rectal cancer
Sponsor: Herbert Hurwitz, MD
Start date: 2003-09-01; Completion date: 2014-08-01
Enrollment: 50 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as capecitabine, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving capecitabine and oxaliplatin together with bevacizumab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine together with bevacizumab works in treating patients with metastatic or recurrent colorectal cancer.

Detailed description:
OBJECTIVES:

Primary

* Evaluate the response rate in patients with previously untreated metastatic colorectal cancer treated with capecitabine, oxaliplatin, and bevacizumab.

Secondary

* Assess time to progression (TTP), disease-free survival (DFS), and overall survival (OS) in patients treated with this regimen.
* Assess the safety and tolerability of bevacizumab, oxaliplatin, and capecitabine in patients with previously untreated metastatic colorectal cancer.

Exploratory

* Evaluate the effect of this regimen on the biomarkers of angiogenesis.
* Assess the effect of this regimen on wound angiogenesis.

OUTLINE: Patients receive oral capecitabine twice daily on days 1-5 and 8-12, oxaliplatin IV over 2 hours on day 1, and bevacizumab IV over 1-1½ hours on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: bevacizumab intervention 2: oxaliplatin intervention 3: Capecitabine intervention 4: Capecitabine
Intervention descriptions: intervention 1: 10 mg/kg intravenously over 30-90 minutes on day 1 intervention 2: 85 mg/m2 intravenously over 2 hours on day 1. intervention 3: Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort intervention 4: Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort

Protocol documents:
Clinical trial NCT00540644
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma Revlimid
Sponsor: Attaya Suvannasankha
Start date: 2007-10-01; Completion date: 2014-08-01
Enrollment: 70 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study to explore the combination of Revlimid®, oral cyclophosphamide and prednisone (RCP) in patients with newly diagnosed multiple myeloma.

Detailed description:
This is a phase II single institution trial in patients with newly diagnosed multiple myeloma. Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D..

Arms: arm 1: Lenalidomide orally on Days 1-21 followed by 7 days rest, repeated every 28 days.

Cyclophosphamide twice daily, orally on Days 1-21 followed by 7 days rest, repeated every 28 days.

Prednisone every other day orally.
Interventions: intervention 1: lenalidomide (Revlimid®) intervention 2: Cyclophosphamide intervention 3: Prednisone
Intervention descriptions: intervention 1: 25 mg p.o. daily on days 1-21 of each 28 day cycle intervention 2: 50 mg p.o. BID daily on days 1-21 of each 28 day cycle intervention 3: 50 mg p.o. Q.O.D.

Protocol documents:
Clinical trial NCT00574834
Conditions: Metabolic Syndrome
Sponsor: University of Maryland, Baltimore
Start date: 2007-03-01; Completion date: 2014-08-01
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will be focused on determining the integrated in-vivo mechanisms responsible for Ramipril's effects on delaying type 2 diabetes and restoring normal (blood sugar levels) glycemia in patients with impaired glucose tolerance.

Hypothesis - Ramipril effects will delay the onset of type 2 diabetes and restore normal glycemia in patients with impaired glucose tolerance.

Detailed description:
Several studies have demonstrated that therapeutic agents used to reduce glucose levels and/or weight can delay the onset of type 2 diabetes. Intriguingly, angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARB) also result in reduction in the onset of type 2 DM. The most striking effect was found with Ramipril in the HOPE study. The onset of new type 2 DM was reduced by 34% (p\<0.001) as compared to placebo. Furthermore, the results of the DREAM trial demonstrate that Ramipril at a dose of 15 mg can significantly reverse impaired glucose tolerance. However, the mechanisms underlying Ramipril effects to delay type 2 diabetes are not known.

The proposal will be focused on determining the integrated in-vivo mechanisms responsible for Ramipril's effects on delaying type 2 DM and restoring normal glycemia in patients with impaired glucose tolerance.

The specific aims of the project are:

* to determine the effect of Ramipril on insulin resistance at the level of the liver and peripheral tissues,
* to determine the effect of Ramipril on endothelial function,
* to determine the effects of Ramipril on insulin secretion, and
* to determine the effects of Ramipril on substrate flux, lipolysis and inflammatory cytokines.

Arms: arm 1: Patients randomized to 6 months treatment of Ramipril. arm 2: PAtients randomized to 6 months treatment of HCTZ. arm 3: Patients randomized to 6 months treatment of Ramipril+HCTZ.
Interventions: intervention 1: Ramipril intervention 2: HCTZ-hydrochlorothiazide intervention 3: Ramipril+HCTZ
Intervention descriptions: intervention 1: Ramipril 20 mg once daily for 6 months intervention 2: HCTZ 25 mg once daily for 6 months intervention 3: Ramipril 20 mg and HCTZ 25 mg, both once daily for 6 months

Protocol documents:
Clinical trial NCT00577382
Conditions: Mucosal Lentiginous Melanoma Acral Lentiginous Malignant Melanoma
Keywords: Sutent malignant melanoma
Sponsor: Dana-Farber Cancer Institute
Start date: 2007-08-01; Completion date: 2014-08-01
Enrollment: 52 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate how effective Sunitinib works in treating acral lentiginous and mucosal melanoma which has spread beyond the local region. Suninitib is a protein-tyrosine kinase inhibitor and acts as a c-kit inhibitor drug. It is believed to work by blocking signals on certain cancer cells which allow the malignant cells to multiply and spread due to a change in the genetic make up of the cancer cell.

Detailed description:
OBJECTIVES:

Primary

* To determine the proportion of participants with metastatic mucosal or acral/lentiginous melanoma who are alive and without disease progression at two months after beginning treatment with sunitinib.
* To determine the best overall response rate.

Secondary

* To determine the time to progression and overall survival.
* To correlate c-kit mutational status with response to therapy.
* To evaluate the use of FDG-PET scanning in determining early biologic response to therapy.
* To assess amplification of c-kit status through quantitative PCR and/or FISH and other related molecular pathway targets.

Arms: arm 1: Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year.

Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.
Interventions: intervention 1: Sunitinib
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00597558
Conditions: Food Hypersensitivity
Keywords: Egg allergy
Sponsor: University of North Carolina, Chapel Hill
Start date: 2003-02-01; Completion date: 2014-08-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if children with egg allergy can be desensitized to egg protein and if this desensitization can help them outgrow their egg allergy at an earlier time than normal. Our hypothesis is that children with egg allergy can be orally desensitized to egg protein and that this desensitization will help them outgrow their egg allergy at an earlier time than normal.

Detailed description:
Egg allergy in children under 5 years of age is extremely common. Egg, along with milk and peanuts, cause 80% of the food allergy reactions in children in the United States. Children have allergic reactions to egg ranging from mild urticaria to systemic anaphylaxis. The current therapy for children with egg allergy is to place the child on an egg-free diet until the allergy is outgrown. Because egg protein is a part of a significant number of processed foods it is difficult to totally avoid all egg proteins. Accidental ingestions leading to reactions to egg can occur with a bite of a cookie (\~70 mg of egg protein) or a bite of a cake (\~55 mg of egg protein). Children typically do not outgrow their egg allergy for several years. Therefore it would be helpful if a specific form of therapy would make children outgrow their allergic reactions to egg sooner. Egg protein is given to children in this study in small increasing amounts to desensitize them to the egg protein with the goal of helping them to outgrow their allergy.

Arms: arm 1: Subjects, who are egg allergic, are given egg white protein for desensitization with the hypothesis they will develop tolerance.
Interventions: intervention 1: Egg white protein
Intervention descriptions: intervention 1: Egg white protein powder

Protocol documents: