ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00853047
Conditions: Carcinoid Syndrome
Sponsor: Lexicon Pharmaceuticals
Start date: 2009-03-01; Completion date: 2014-06-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and tolerability of telotristat etiprate (LX1606) versus a placebo control in participants with symptomatic carcinoid syndrome not managed by stable-dose long-acting octreotide therapy. Following determination of the maximally tolerated or effective dose, cohort expansion will occur to confirm effect on symptoms and safety profile.

Detailed description:

Arms: arm 1: Telotristat etiprate capsules,150 mg orally 3 times daily for 28 days in the double-blind treatment period (core phase) in combination with stable-dose octreotide long-acting release (LAR) depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period. arm 2: Telotristat etiprate capsules, 250 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period. arm 3: Telotristat etiprate capsules, 350 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period. arm 4: Telotristat etiprate capsules, 500 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with a stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period. arm 5: Placebo-matching telotristat etiprate capsules, orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to receive telotristat etiprate in the optional open-label extension period. arm 6: Telotristat etiprate at assigned dose level for 8 weeks in combination with stable-dose octreotide LAR depot therapy given once per month in the open-label extension period. Upon completion of the 8-week period, participants could enter an additional extension period of 172 weeks, receiving telotristat etiprate at the assigned dose or maximum tolerated dose (500 mg 3 times daily).
Interventions: intervention 1: Telotristat etiprate intervention 2: Octreotide LAR Depot intervention 3: Placebo
Intervention descriptions: intervention 1: Telotristat etiprate capsules; orally 3 times daily. intervention 2: A stable-dose octreotide LAR depot therapy; administered subcutaneously once per month. intervention 3: Placebo-matching telotristat etiprate capsules; orally 3 times daily.

Protocol documents:
Clinical trial NCT00917735
Conditions: Breast Cancer
Keywords: Green tea Breast cancer Prevention COMT genotype EGCG (Epigallocatechin gallate) Mammographic density Reproductive hormones IGF axis proteins Oxidative stress
Sponsor: University of Minnesota
Start date: 2009-07-01; Completion date: 2014-06-01
Enrollment: 1075 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Green tea extract contains ingredients (catechins) that may lower the risk of breast cancer.

PURPOSE: This phase II trial is studying how well green tea extract works in preventing breast cancer compared to a placebo in postmenopausal women with high breast density.

The investigators have hypothesized that green tea consumption reduces breast cancer risk, and this effect is seen primarily in women who have the low-activity COMT genotype. The investigators will test this by evaluating the effects of green tea extract on breast cancer biomarkers including mammographic density, plasma insulin-like growth factor 1 (IGF-1), IGF binding protein 3 (IGFBP-3), estrone, estradiol, androstenedione, sex hormone binding globulin (SHBG), urinary estrogen metabolites and plasma F2-isoprostanes.

Detailed description:
OBJECTIVES:

1. Primary:

   1.1 To determine the effects of green tea extract consumption (containing 800 mg EGCG per day) for 12 months on the following recognized biomarkers of breast cancer risk:
   1. Mammographic density
   2. Circulating concentrations of insulin-like growth factor 1 (IGF-1) and IGF binding protein 3 (IGFBP-3)
   3. Circulating concentrations of reproductive hormones (estrone, estradiol, androstenedione) and sex hormone binding globulin (SHBG)

   1.2 To determine the effects of COMT genotype on the green tea extract effects described above.
2. Secondary:

2.1 To determine the effects of green tea extract consumption (containing 800 mg EGCG per day) for 12 months on the following hypothesized biomarkers of breast cancer risk:

1. Urinary estrogen metabolites (estrone, estradiol, and their 2-hydroxy, 4-hydroxy, 2-methoxy, and 4-methoxy metabolites, estriol, and 16- hydroxyestrone)
2. Circulating concentrations of F-2 isoprostanes, a recognized biomarker of systemic oxidative stress

2.2 To determine the effects of COMT genotype on the green tea extract effects described above.

2.3 To determine the effects of COMT genotype on catechin metabolism and excretion, as measured by circulating and urinary concentrations.

Arms: arm 1: Green tea extract capsules containing 80.7 % total catechins (51.7 % EGCG) arm 2: Placebo capsules containing 50% maltodextrin, 49.5 % cellulose, and 0.5 % magnesium stearate
Interventions: intervention 1: Green tea extract supplement intervention 2: Placebo
Intervention descriptions: intervention 1: Two green tea extract capsules twice daily after breakfast and dinner for one year intervention 2: Two placebo capsules twice daily after breakfast and dinner for one year

Protocol documents:
Clinical trial NCT00929240
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2009-07-01; Completion date: 2014-06-01
Enrollment: 287 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized study will compare maintenance therapy with Avastin (bevacizumab) + Xeloda (capecitabine) versus Avastin alone, in patients with HER2-negative metastatic breast cancer who have not progressed during first-line therapy with docetaxel + Avastin. Eligible patients will receive up to 6 x 3 week cycles of treatment with Avastin (15 mg/mg IV on Day 1 of each cycle) + docetaxel (75-100 mg/m2 IV on Day 1 of each cycle). Those patients who do not progress will be randomized to 3 week cycles of either a) Avastin (15 mg/kg IV on Day 1 of each cycle) + Xeloda (1000 mg/m2 po bid on Days 1-14 of each cycle) or b) Avastin alone. Study treatment will continue until disease progression, unacceptable toxicity, patient request for withdrawal or end of study, 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: capecitabine [Xeloda]
Intervention descriptions: intervention 1: 15 mg/kg iv on day 1 of each 3 week cycle (maintenance phase) intervention 2: 1000 mg/m2 po bid on days 1-14 of each 3 week cycle (maintenance phase)

Protocol documents:
Clinical trial NCT00976404
Conditions: HIV Infection
Keywords: HIV-1 infection Treatment intensification Immunomodulation HIV-rAd5 vaccine
Sponsor: Robert L. Murphy
Start date: 2009-11-01; Completion date: 2014-06-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to discover a new approach in which human immunodeficiency virus (HIV) can be eradicated from an infected individual by intensified antiretroviral treatment coupled with immunomodulation. The hypothesis is that eradication is possible only if very potent antiretroviral drugs are delivered in conjunction with an immunomodulatory agent that simultaneously attack the viral reservoirs.

Detailed description:
The objective of this study is to measure the impact of immunomodulation plus treatment intensification on the HIV reservoir in HIV-infected patients who have viral suppression on combination antiretroviral therapy. Treatment regimens first will be intensified by the addition of raltegravir and maraviroc for 8 week followed by immunomodulation with the NIH HIV-rAd5 vaccine plus DNA prime-boost for 24 weeks. The primary endpoint is measurement of change in peripheral cellular HIV DNA. A decrease of 0.5 log is considered significant. A secondary endpoints include change in HIV DNA in the rectal mucosa, immunologic changes in the peripheral blood and safety.

Arms: arm 1: ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks) arm 2: ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32)
Interventions: intervention 1: DNA + HIV-rAd5 vaccine intervention 2: ART intensification (raltegravir) intervention 3: ART intensification (maraviroc)
Intervention descriptions: intervention 1: 4 mg subcutaneous injection at weeks 8 (DNA prime), 12 (DNA prime), 16 (DNA prime), and 32 (HIV-rAd5) intervention 2: raltegravir 400 mg PO BID for 56 weeks intervention 3: maraviroc 150, 300, or 600 mg PO BID (depending on PK interactions with other medications) for 56 weeks

Protocol documents:
Clinical trial NCT00987415
Conditions: Heart Failure Elevated Serum Uric Acid
Sponsor: Duke University
Start date: 2010-05-01; Completion date: 2014-06-01
Enrollment: 253 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether allopurinol is effective in relieving symptoms of patients with heart failure and high blood uric acid levels.

Detailed description:

Arms: arm 1: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks. arm 2: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
Interventions: intervention 1: allopurinol intervention 2: sugar pill
Intervention descriptions: intervention 1: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks. intervention 2: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.

Protocol documents:
Clinical trial NCT01027598
Conditions: Non Small Cell Lung Cancer
Keywords: Lung Cancer Previously Treated Advanced Non Small Cell Lung Cancer Erlotinib Pazopanib
Sponsor: SCRI Development Innovations, LLC
Start date: 2010-01-01; Completion date: 2014-06-01
Enrollment: 202 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This randomized, placebo-controlled, Phase II trial will compare the combination of erlotinib with pazopanib (providing concurrent EGFR and VEGFR inhibition) with erlotinib alone in the second- or third-line treatment of patients with advanced NSCLC. This study will be conducted though the Sarah Cannon Research Consortium, a community-based clinical trial network.

Detailed description:
Erlotinib is the current treatment standard for second- or third-line therapy of advanced NSCLC. Since angiogenesis inhibitors have also shown activity in NSCLC, the simultaneous inhibition of the EGFR and VEGF pathway may improve the efficacy of therapy. In a recently reported Phase III trial (Hainsworth et al. 2008), the combination of bevacizumab and erlotinib improved the Progression- Free-Survival (PFS) vs. erlotinib alone when given as second-line therapy in NSCLC (3.4 months vs. 1.7 months, respectively; HR 0.63). Pazopanib also inhibits the angiogenesis pathway, and may have advantages over bevacizumab including: (1) inhibition of other potentially important targets, including PDGFR; and (2) more convenient oral administration.

Arms: arm 1: Erlotinib: 150 mg orally daily

Pazopanib: 600 mg orally daily arm 2: Erlotinib: 150 mg orally daily

Placebo: orally daily
Interventions: intervention 1: Pazopanib intervention 2: Erlotinib
Intervention descriptions: intervention 1: Pazopanib: 600 mg orally daily intervention 2: Erlotinib: 150 mg orally daily

Protocol documents:
Clinical trial NCT01029002
Conditions: Chronic Renal Insufficiency Proteinuria
Keywords: Vitamin D CKD proteinuria
Sponsor: Albert Einstein College of Medicine
Start date: 2009-10-01; Completion date: 2014-06-01
Enrollment: 74 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A randomized clinical trial to determine if vitamin D repletion in CKD (Chronic Kidney Disease) patients with low vitamin D levels will decrease proteinuria, a marker of kidney damage.

Detailed description:
This RCT will enroll 74 subjects, men and women over age of 18, with stage 3-4 CKD from various causes including diabetes and hypertension. Patients will be recruited from the Montefiore Medical Center Nephrology clinics and the Montefiore Medical Center internal medicine clinics and other interested individuals.

Informed consent will be obtained on all subjects. All subjects with meet with one of the investigators who will verbally explain to them the purpose of the study and the alternatives.

Blood and urine tests will be collected to assess for proteinuria, vitamin D levels, serum creatinine, calcium and phosphorus, as well as a urine albumin, calcium and creatinine. These tests will be used for experimental purposes only and will be collected at each study visit over the span of 6 months.

There will be two arms, an arm randomized to 50000IU of ergocalciferol once weekly and a placebo arm for 3 months. For an additional 3 months, all patients will be repleted with Vitamin D via open-label extension, based on their levels after 3 months.

Secondary outcomes include ambulatory blood pressure monitoring, hemoglobin A1c, HOMA-IR.

Arms: arm 1: Patients randomized to this arm will receive 50,000 IU of ergocalciferol in one unmarked pill once weekly. arm 2: Patients randomized to this arm will receive a placebo pill once weekly.
Interventions: intervention 1: Vitamin D intervention 2: Placebo
Intervention descriptions: intervention 1: Vitamin D, ergocalciferol, 50000 IU, weekly for 12 weeks, with open label extension for another 3 months intervention 2: Patients randomized to this arm will receive one placebo pill once weekly.

Protocol documents:
Clinical trial NCT01089647
Conditions: Obstructive Sleep Apnea
Keywords: OSA Medical treatment
Sponsor: Romaker & Associates
Start date: 2010-09-01; Completion date: 2014-06-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In children with mild apnea combined therapy with an inhaled nasal steroid and a medication that decreased nasal congestion (montelukast) was shown to be effective. We are testing to see if this combination works in adults with mild apnea as well.

Detailed description:
40 adults with mild OSA (\< 5 apneas/hypopneas per hour of sleep) will receive either a combination of two medicines that decrease nasal congestion-montelukast and nasal budesonide-or a placebo pill and nasal spray. After 3 months of therapy, a repeat sleep study will be done to determine the differences, if any, in the frequency of sleep disordered breathing in the two groups.

Arms: arm 1: treatment arm arm 2: sugar pill, salt water nasal spray
Interventions: intervention 1: budesonide and montelukast intervention 2: Placebo
Intervention descriptions: intervention 1: budesonide aqua nasal spray 1 spray each nostril bid for 12 weeks Montelukast pill 10 mg po daily for 12 weeks intervention 2: sugar pill po daily for 12 weeks salt water nasal spray 1 spray each nostril bid for 12 weeks

Protocol documents:
Clinical trial NCT01102413
Conditions: Iron Deficiency Anemia Chronic Kidney Disease
Sponsor: Pharmacosmos A/S
Start date: 2010-04-01; Completion date: 2014-06-01
Enrollment: 351 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is designed to determine the effects of an investigational drug Monofer in subjects with non-dialysis dependent chronic kidney disease (NDD-CKD) subjects and with iron deficiency anaemia (IDA).

Detailed description:

Arms: arm 1: Injections or infusions arm 2: Oral intake
Interventions: intervention 1: Monofer intervention 2: Iron Sulphate
Intervention descriptions: intervention 1: Infusion or injections intervention 2: Oral intake

Protocol documents:
Clinical trial NCT01121406
Conditions: Ovarian Neoplasms
Sponsor: Boehringer Ingelheim
Start date: 2010-04-01; Completion date: 2014-06-01
Enrollment: 110 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an international, randomized phase II trial. The aim is to assess the efficacy and the safety of BI 6727 Versus investigator's best choice single agent cytotoxic in recurrent third and fourth lines platinum resistant/refractory ovarian cancer.

100 patients will be randomised at the study entry to receive either BI 6727 (Arm A: 50 patients) or non-platinum single agent cytotoxic (Arm B: 50 patients) Treatment will be continued until disease progression or unacceptable toxicity. Primary endpoint: disease control rate at week 24 according to Response Evaluation Criteria In Solid Tumours version 1.1.

Secondary endpoints: efficacy (progression free survival, overall survival, biological tumour response, biological progression free survival assessed by serum CA 125 according to Gynecologic Cancer Intergroup criteria, safety according to the NCI CTCAE v.3, disease symptoms control assessed by the EORTC QLQ-C30, QLQ-OV28 and individual symptoms questionnaires, pharmacokinetics of BI 6727.

Others endpoints: biomarkers and pharmacogenetics analysis (optional)

Detailed description:

Arms: arm 1: Patients receive BI 6727 infusion every 3 weeks arm 2: At the investigator discretion, patient will receive one of the following cytotoxics: topotecan, paclitaxel, gemcitabine or liposomal doxorubicin
Interventions: intervention 1: Paclitaxel intervention 2: Gemcitabine intervention 3: Topotecan intervention 4: Pegylated liposomal doxorubicin (PLD) intervention 5: BI 6727
Intervention descriptions: intervention 1: Patients receive paclitaxel in a 4 week schedule intervention 2: Patients receive gemcitabine in a 3 week schedule intervention 3: Patients receive topotecan in 3 or 4 week schedule intervention 4: Patients receive PLD in a 4 week schedule intervention 5: Patients receive BI 6727 infusion every 3 weeks

Protocol documents:
Clinical trial NCT01130337
Conditions: Gastric Cancer
Sponsor: Hoffmann-La Roche
Start date: 2010-07-01; Completion date: 2014-06-01
Enrollment: 36 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the disease free survival rate of a combination of capecitabine \[Xeloda\] and oxaliplatin (XELOX) with trastuzumab \[Herceptin\] in patients with resectable gastric cancer. The combination of Xeloda (orally, 1000 mg/m2 on day 1-14 of every cycle) and Herceptin (intravenously, 8 mg/kg loading dose, then 6 mg/kg on days 1-14 of every cycle) will be administered for three cycles prior to surgery to resect the tumor. If complete resection, R0 or microscopic residual tumor R1 is achieved, patients will continue with three cycles of XELOX and Herceptin and then for completion of 12 months treatment with Herceptin alone. Oxaliplatin will be administered intravenously at a dose of 130 mg/m2 on day 1 in every cycle. The anticipated time on study drug will be 12 months.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Capecitabine [Xeloda] intervention 2: Oxaliplatin intervention 3: Trastuzumab [Herceptin]
Intervention descriptions: intervention 1: 1.000 mg/m2 orally every 12 hours from day 1 to day 14 of every cycle for 6 cycles intervention 2: 130 mg/m2 intravenous infusion day 1 of every cycle intervention 3: First dose 8 mg/kg, subsequent cycles 6 mg/kg, intravenously, day of every cycle for 15 cycles

Protocol documents:
Clinical trial NCT01131065
Conditions: Hepatitis B Liver Transplantation
Keywords: Hepatitis B HBV Orthotopic liver transplantation Liver transplantation Recurrence Reinfection Protective titers HBsAb Hepatitis B virus immune globulin Niuliva
Sponsor: Instituto Grifols, S.A.
Start date: 2010-07-01; Completion date: 2014-06-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The aim of this clinical trial is to evaluate the efficacy, safety, and tolerability of Niuliva (Hepatitis B virus immune globulin) in the prophylaxis of hepatitis B virus (HBV) reinfection in patients submitted to liver transplantation due to HBV-induced liver disease by reaching and maintaining certain hepatitis B antibody (HBsAg) levels considered as protective during the first six and twelve months post-transplantation.

Detailed description:

Arms: arm 1: Treatment group (newly liver transplanted subjects due to HBV induced liver disease)
Interventions: intervention 1: Hepatitis B immune globulin
Intervention descriptions: intervention 1: Daily doses of 10,000 IU of intravenous hepatitis B immune globulin during the first week post-transplantation (anhepatic phase + days 1-7), followed by weekly and monthly doses of 5,000 IU during weeks 2,3, and 4 and months 2,3,4,5,6,7,8,9,10,11 and 12, respectively.

Protocol documents:
Clinical trial NCT01182337
Conditions: Early Lumbar Disc Degeneration
Sponsor: DePuy Spine
Start date: 2010-06-01; Completion date: 2014-06-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study to show the safety, tolerability and preliminary effectiveness of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration

Detailed description:

Arms: arm 1: The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc. In vitro experiments have shown that rhGDF-5 can stimulate gene expression and synthesis of the extracellular matrix proteins type II collagen and aggrecan. In vivo experiments in rabbit models of disc degeneration have shown that intradiscal injections of rhGDF-5 can stimulate an increase in disc height and hydration. arm 2: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
Interventions: intervention 1: Intradiscal rhGDF-5 intervention 2: Vehicle control
Intervention descriptions: intervention 1: The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc. In vitro experiments have shown that rhGDF-5 can stimulate gene expression and synthesis of the extracellular matrix proteins type II collagen and aggrecan. In vivo experiments in rabbit models of disc degeneration have shown that intradiscal injections of rhGDF-5 can stimulate an increase in disc height and hydration. intervention 2: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection

Protocol documents: