ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00634933
Conditions: Arthritis, Rheumatoid
Keywords: active rheumatoid arthritis anti CD20
Sponsor: Pfizer
Start date: 2008-03-01; Completion date: 2012-10-01
Enrollment: 222 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy and safety of two dosing regimens of a compound known as TRU-015 in combination with methotrexate (MTX) in patients with active rheumatoid arthritis.

Detailed description:

Arms: arm 1: Consists of Arms 1a and 1b arm 2: Consists of Arms 2a and 2b arm 3: Consists of Arms 3a and 3b.
Interventions: intervention 1: TRU-015 intervention 2: Methylprednisolone intervention 3: Prednisone intervention 4: TRU-015 intervention 5: Methylprednisolone intervention 6: Prednisone intervention 7: TRU-015 intervention 8: Methylprednisolone intervention 9: Prednisone
Intervention descriptions: intervention 1: IV 800 mg TRU-015 at Baseline (both arms) and Week 24 (both arms); corresponding IV Placebo at Week 12 and Week 36 (both arms). intervention 2: IV 100 mg Methylprednisolone at Baseline (both arms), Week 12 (arm 1a) and Week 24 (both arms); corresponding IV Placebo at Week 12 (Arm 1b) and Week 36 (both arms). intervention 3: Oral 20 mg tablets Prednisone at Baseline (both arms), Week 12 (arm 1a), and Week 24 (both arms); corresponding Oral Placebo at Week 12 (Arm 1b) and Week 36 (both arms) intervention 4: IV 800 mg TRU-015 at Baseline (both arms), Week 12 (both arms), and Week 36 (both arms); corresponding IV Placebo at Week 24 (both arms). intervention 5: IV 100 mg Methylprednisolone at Baseline (both arms), Week 12 (both arms), and Week 36 (both arms); corresponding IV Placebo at Week 36 (both arms). intervention 6: Oral 20 mg tablets Prednisone at Baseline (both arms), Week 12 (arm 2a) and Week 36 (both arms); corresponding Oral Placebo at Week 12 (Arm 2b) and Week 24 (both arms). intervention 7: IV 800 mg TRU-015 at Week 24 (both arms) and Week 36 (arm 3a); corresponding IV Placebo at Baseline (both arms), Week 12 (both arms) and Week 36 (arm 3b). intervention 8: IV 100 mg Methylprednisolone at Baseline (both arms), Week 12 (arm 3a), Week 24 (both arms), and Week 36 (arm 3a); corresponding IV Placebo at Week 12 (arm 3b) and Week 36 (arm 3b). intervention 9: Oral 20 mg tablets Prednisone at Baseline (both arms), Week 12 (arm 3a), Week 24 (both arms) and Week 36 (arm 3a); corresponding Oral Placebo at Week 12 (Arm 3b) and Week 36 (arm 3b).

Protocol documents:
Clinical trial NCT00645333
Conditions: Metastatic Breast Cancer
Keywords: breast cancer Phase I clinical trial cancer stem cells agents with other mechanisms of action Notch inhibitors
Sponsor: University of Michigan Rogel Cancer Center
Start date: 2008-03-01; Completion date: 2012-10-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
New and better therapies for locally advanced and metastatic breast cancer are needed because, even if standard treatment is successful in shrinking the cancer, there is still a high chance that the cancer will recur. Recent research suggests that breast tumors have a small number of cells in them that are "breast cancer stem cells", which are very resistant to standard treatment. It is thought that the reason that many patients cannot be cured of their breast cancers is that the stem cells are unable to be killed and remain in the body after standard treatment. Laboratory research has shown that a new drug, MK-0752, can target stem cells and prevent tumor recurrences when the drug is combined with docetaxel, a chemotherapy drug commonly used to treat breast cancer.

We know that MK-0752 is safe when given by itself to people. We do not know if treatment with MK-0752 and docetaxel combined is safe or if it will kill "breast cancer stem cells" in people with breast cancer. This clinical trial is being done to determine the safety of several doses of MK-0752 in combination with docetaxel. Preliminary data about the effectiveness of MK-0752 in combination with docetaxel will be collected. Also, tumor biopsy samples will be taken from some patients who have tumors that can be easily biopsied. The samples will be used to perform research tests to help determine if the "breast cancer stem cells" are being killed by the drug combination.

Detailed description:
Purpose-Accumulating evidence supports the existence of breast cancer stem cells (BCSCs), which are characterized by their capacity to self-renew and divide indefinitely, and resistance to conventional therapies. The Notch pathway is important for stem cell renewal, and is a potential target for BCSC-directed therapy. Experimental Design-Using human breast tumorgraft studies, we evaluated the impact of gamma secretase inhibitors (GSI) on the BCSC population and the efficacy of combining GSI with docetaxel treatment. The mouse experimental therapy paralleled a concurrent clinical trial in advanced breast cancer patients, designed to determine the maximally tolerated dose of the GSI, MK-0752, administered sequentially with docetaxel, and to evaluate BCSC markers in serial tumor biopsies.

Arms: arm 1: MK-0752, Docetaxel, Pegfilgrastim in combination with escalating doses of MK-0752
Interventions: intervention 1: MK-0752, Docetaxel, Pegfilgrastim
Intervention descriptions: intervention 1: MK-0752 in escalating doses of 300, 450, 600, and 800 mg given orally on days 1-3, followed by docetaxel 80 mg/m2 day 8 and pegfilgrastim 6 mg SQ on day 9

Protocol documents:
Clinical trial NCT00684957
Conditions: Growth Hormone Deficiency
Keywords: rhGH rhIGF-1
Sponsor: Columbia University
Start date: 2008-01-01; Completion date: 2012-10-01
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to see if giving growth hormone or insulin-like growth factor-1 (IGF-1) to subjects with growth hormone deficiency effects cardiovascular risk factors differently.

Detailed description:
Insulin-like growth factor-1 (IGF-1) in some circumstances acts as the mediator of the metabolic effects of growth hormone. However, there is some evidence to suggest that growth hormone (GH) and IGF-1 act differently in some metabolic pathways. We will study the differences between GH and IGF-1 when provided as therapy for growth hormone deficiency in adults. Specifically we will be assessing if either medication impacts cardiovascular risk factors and if so do they impact risk factors differently. Ten adult males ages 18-65 who are growth hormone deficient on stable medications and with stable magnetic resonance imaging (MRI) findings (in the event of a known pituitary mass) will be recruited for the study.

Arms: arm 1: Subjects will take rhGH for eight weeks followed by a two month wash out period and then will cross over to rhIGF1 for eight weeks. arm 2: Subjects will take rhIGF1 for eight weeks followed by a two month wash out period and then will cross over to rhGH for eight weeks.
Interventions: intervention 1: Recombinant Human Growth Hormone intervention 2: Recombinant Human IGF-1
Intervention descriptions: intervention 1: 300 mcg sc qd (which may be increased to 400 mcg sc qd after 4 weeks) intervention 2: 30 µg/kg for first 4 weeks (may be increased thereafter based on IGF-1 levels)

Protocol documents:
Clinical trial NCT00718510
Conditions: Schizophrenia
Sponsor: University of Alberta
Start date: 2009-09-01; Completion date: 2012-10-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
STUDY OBJECTIVES: To determine whether the addition of L-arginine to treatment as usual (TAU) in schizophrenia further improves and enhances therapeutic efficacy (positive, negative and depressive symptoms) and effectiveness of antipsychotic treatment

STUDY POPULATION: Patients diagnosed (DSM-IV criteria) with schizophrenia or schizoaffective disorder

Total expected number of patients: 14

INVESTIGATIONAL COMPOUND: L-arginine capsules, 3 grams of L-arginine given twice a day (total daily dose of 6 grams/day)

DURATION OF ACTIVE TREATMENT: 3 weeks followed by wash-out phase of 5 days and 3 weeks of second treatment phase (cross-over design)

EVALUATION CRITERIA: Primary (efficacy) outcomes: PANSS scores. Secondary outcomes: Calgary Depression Scale for schizophrenia, CGI; AIMS, UKU-assessment of side-effects

ASSESSMENT SCHEDULE: Treatment arm 1: Baseline, weeks: 1,2,3, wash-out phase; week 4, cross-over phase: treatment phase-2; weeks 5,6,7

STATISTICAL CONSIDERATIONS: Analysis of variance of outcome measures with treatment as the between-subject factor and pre- and post-treatment scores as within- subjects factors.

DURATION OF STUDY PERIOD: Patient recruitment to be completed in 12 months, study full completion 18 months.

Detailed description:
In the current study, our goals were to examine the clinical benefits of the nitric oxide (NO) donor and main precursor of NO, L-arginine, to further improve the symptoms of schizophrenia with minimum or no additional side-effects. L-Arginine is classified as a semi-essential or conditionally essential amino acid depending on the developmental stage and health status of the individual. Glutamate N-methyl-D-aspartate (NMDA) receptors have functional connections to the NO system in the brain. Dysfunction of connectivity of the neuroregulators glutamate and NO have been implicated in mechanisms of psychosis. Therefore, any downstream effects of NMDA dysfunction in schizophrenia may be ultimately mediated by the NO system at a cellular level. As an augmenting treatment to antipsychotic therapy, we examined the ability of L-arginine to further improve residual symptoms in the illness.

Arms: arm 1: Patients with diagnosis of schizophrenia will be randomised to receive L-arginine first/placebo second 3 grams bid (cross-over design) in addition to treatment as usual. The active treatment period will be 3 weeks, with a wash-out period of 5 days and re-commencing on the alternative arm of the randomization arm 2: Patients with diagnosis of schizophrenia will be randomised to receive placebo first/L-arginine second 3 grams bid (cross-over design) in addition to treatment as usual. The active treatment period will be 3 weeks, with a wash-out period of 5 days and re-commencing on the alternative arm of the randomization
Interventions: intervention 1: L-Arginine
Intervention descriptions: intervention 1: 3 grams, twice daily, oral administration

Protocol documents:
Clinical trial NCT00735917
Conditions: Adenocarcinoma of the Pancreas Recurrent Pancreatic Cancer Stage IV Pancreatic Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2008-10-01; Completion date: 2012-10-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well saracatinib works in treating patients with previously treated metastatic pancreatic cancer. Saracatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the 6-month survival of biomarker-positive patients with previously treated metastatic pancreatic cancer receiving AZD0530 (saracatinib).

II. To determine the adverse events of this drug in these patients.

SECONDARY OBJECTIVES:

I. To evaluate the response rate in patients treated with this drug. II. To evaluate the overall survival of patients treated with this drug. III. To explore the pharmacodynamic effects of AZD0530 with optional tumor biopsies, pharmacokinetic studies, and positron emission tomography (PET) scans in a subset of patients.

OUTLINE:

Patients receive saracatinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 2 years.

Arms: arm 1: Patients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: saracatinib intervention 2: pharmacogenomic studies intervention 3: pharmacological study intervention 4: positron emission tomography intervention 5: fludeoxyglucose F 18 intervention 6: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given PO intervention 2: Optional correlative studies intervention 3: Optional correlative studies intervention 4: Optional correlative studies intervention 5: Optional correlative studies intervention 6: Optional correlative studies

Protocol documents:
Clinical trial NCT00754572
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2009-02-01; Completion date: 2012-10-01
Enrollment: 418 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This single arm, open-label study will assess the safety and efficacy with regar d to reduction of signs and symptoms of treatment with tocilizumab in combinatio n with methotrexate, in patients with moderate to severe active rheumatoid arthr itis. Patients will receive tocilizumab 8mg/kg iv, every 4 weeks and methotrexat e 10-25mg weekly. The anticipated time on study treatment is 3-12 months, and th e target sample size is \<500 individuals.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: tocilizumab [RoActemra/Actemra] intervention 2: methotrexate
Intervention descriptions: intervention 1: 8mg/kg iv, every 4 weeks intervention 2: 10-25mg oral or parenteral weekly.

Protocol documents:
Clinical trial NCT00765895
Conditions: Idiopathic Gastroparesis
Keywords: idiopathic gastroparesis
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date: 2009-01-01; Completion date: 2012-10-01
Enrollment: 130 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The principal objective of this multicenter, randomized, placebo-controlled trial is to evaluate whether treatment with nortriptyline will improve gastroparesis symptoms compared with placebo.

Detailed description:

Arms: arm 1: Nortriptyline Hydrochloride dose escalation from 10 mg to 75 mg arm 2: No treatment
Interventions: intervention 1: Nortriptyline Hydrochloride intervention 2: Placebo (for nortriptyline)
Intervention descriptions: intervention 1: Nortriptyline; 10 mg, one capsule, po qhs (by mouth at bedtime each night) x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks, f06 visit, 50 mg, two capsules, po qhs x 3 weeks, f09 visit, 75 mg, three capsules, po qhs x 6 weeks, f15 visit: taper study drug by one capsule a week, off study drug for the last week intervention 2: Placebo (for nortriptyline), 10 mg, one capsule, po qhs x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks;

Protocol documents:
Clinical trial NCT00786682
Conditions: Prostate Cancer
Keywords: stage IV prostate cancer recurrent prostate cancer
Sponsor: University of Medicine and Dentistry of New Jersey
Start date: 2008-12-01; Completion date: 2012-10-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hydroxychloroquine may help docetaxel work better and kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving docetaxel together with hydroxychloroquine works in treating patients with metastatic prostate cancer.

Detailed description:
OBJECTIVES:

Primary

* To assess the antitumor activity, in terms of tumor response rate, of docetaxel in combination with hydroxychloroquine in patients with metastatic, hormone-refractory, chemotherapy-naive prostate cancer.

Secondary

* To measure time to disease progression and overall survival.
* To determine the feasibility and safety of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral hydroxychloroquine twice daily on days 1-21 and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days (up to 6 courses with docetaxel) in the absence of disease progression or unacceptable toxicity.

Arms: arm 1: Drug: Docetaxel 75 mg/m2 intravenously every 21 days on Day 1 of the treatment cycle

Drug: hydroxychloroquine 200 mg twice daily

A cycle is defined as an interval of 21 days.
Interventions: intervention 1: docetaxel intervention 2: hydroxychloroquine
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00796991
Conditions: Advanced Melanoma
Keywords: Untreated Advanced Melanoma
Sponsor: Bristol-Myers Squibb
Start date: 2009-02-01; Completion date: 2012-10-01
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this clinical research study is to learn the pharmacokinetics of Ipilimumab when combined with Paclitaxel/Carboplatin or Dacarbazine

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Ipilimumab intervention 2: Carboplatin intervention 3: Paclitaxel intervention 4: Dacarbazine
Intervention descriptions: intervention 1: Solution, intravenous, 10mg/kg, every 3 weeks in the induction phase, up to 4 doses in the induction phase, 48 weeks intervention 2: Solution, intravenous, Area Under the Concentration Time Curve=6, every 3 weeks in the induction phase, up to 8 doses in the induction phase, 48 weeks intervention 3: Solution, intravenous, 175 mg/m2, every 3 weeks in the induction phase, up to 8 doses in the induction phase, 48 weeks intervention 4: Solution, intravenous, 850 mg/m2, every 3 weeks in the induction phase, up to 8 doses in the induction phase, 48 weeks

Protocol documents:
Clinical trial NCT00798720
Conditions: Carcinoma, Non Small Cell Lung
Keywords: non small cell lung cancer HDAC proteasome inhibitor
Sponsor: University of Wisconsin, Madison
Start date: 2008-12-01; Completion date: 2012-10-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the efficacy of vorinostat and bortezomib in the third line treatment of advanced NSCLC, as well as to assess toxicity (including neuropathy) and tolerability of this regimen.

Detailed description:
Current treatment for non-small cell lung cancer (NSCLC) remains inadequate. Vorinostat is a novel agent that inhibits the enzymatic activity of histone deacetylases (HDACs). Bortezomib is a small molecule proteasome inhibitor. Preclinical and clinical studies have shown the advantages of combining these two agents in the treatment of NSCLC

Arms: arm 1: Vorinostat 400 mg + Bortezomib 1.3 mg/m2
Interventions: intervention 1: vorinostat intervention 2: bortezomib
Intervention descriptions: intervention 1: 400 mg by mouth once daily for days 1-14 of each 21 day cycle intervention 2: 1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle

Protocol documents:
Clinical trial NCT00800202
Conditions: Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche
Start date: 2009-04-01; Completion date: 2012-10-01
Enrollment: 91 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the efficacy and safety of Avastin combined with first li ne paclitaxel-carboplatin (cohort 1) or second line Tarceva (cohort 2) in patien ts with non-squamous non-small cell lung cancer with asymptomatic untreated brai n metastasis. Two cohorts of patients will be studied; the first will receive Av astin 15mg/kg iv every 3 weeks combined with first line paclitaxel 200mg/m2 iv p lus carboplatin AUC6 iv every 3 weeks for a maximum of 6 cycles, and the second cohort will receive Avastin 15mg/kg iv every 3 weeks combined with second line T arceva 150mg/kg po.The anticipated time on study treatment is until disease prog ression, 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: carboplatin intervention 3: erlotinib [Tarceva] intervention 4: paclitaxel
Intervention descriptions: intervention 1: 15mg/kg iv every 3 weeks intervention 2: AUC6 iv every 3 weeks for 6 cycles intervention 3: 150mg/day po intervention 4: 200mg/m2 iv every 3 weeks for 6 cycles

Protocol documents:
Clinical trial NCT00838578
Conditions: Colorectal Cancer
Keywords: KRN330 Colorectal Cancer Antimetabolites Antimetabolites, Antineoplastic Digestive System Neoplasms Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Physiological Effects of Drugs Colonic Diseases Irinotecan Enzyme Inhibitors Intestinal Diseases Immunosuppressive Agents Rectal Diseases Pharmacologic Actions Intestinal Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Fluorouracil Neoplasms Gastrointestinal Neoplasms Antineoplastic Agents, Phytogenic Colorectal Neoplasms
Sponsor: Kyowa Kirin Co., Ltd.
Start date: 2009-03-01; Completion date: 2012-10-01
Enrollment: 65 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of the Phase II portion of this study is to assess the efficacy of KRN330 in combination with irinotecan after first-line or adjuvant FOLFOX (5-fluorouracil, leucovorin, and oxaliplatin)/CapOx (capecitabine and oxaliplatin) treatment failure in patients with metastatic colorectal cancer.

Detailed description:
Phase II portion is an open-label, single arm study. Based on the results of the Phase I portion, weekly KRN330 (0.5 mg/kg) and biweekly irinotecan (180 mg/m2) will be used in the Phase II portion. To be eligible for the Phase II portion, a patient will have recurred or progressed within 6 months of the last cycle of FOLFOX/CapOx +/- bevacizumab (first-line or adjuvant regimen for metastatic colorectal cancer). Patients will continue the treatment until disease progression.

Per protocol, the decision was made to terminate the study based on interim analysis results. The Response Rate in Phase II did not meet the protocol-specified RR of 15% when 0.5 mg/kg KRN330 was administered weekly in combination with irinotecan(180 mg/m2)biweekly.

Arms: arm 1: open label, single arm
Interventions: intervention 1: KRN330 intervention 2: Irinotecan
Intervention descriptions: intervention 1: KRN330 will be dosed at 0.5 mg/kg weekly until disease progression. intervention 2: Irinotecan will be dosed at 180 mg/m2 biweekly until disease progression.

Protocol documents:
Clinical trial NCT00840450
Conditions: Ovarian Cancer
Keywords: ovarian cancer recurrent Gleevec Paclitaxel Taxane mullerian
Sponsor: NYU Langone Health
Start date: 2007-04-01; Completion date: 2012-10-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is designed to determine whether the combination treatment of Paclitaxel and Gleevec on recurrent ovarian cancer patients or other cancers of mullerian origin will generate better clinical response than Paclitaxel alone.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Gleevec/Paclitaxel
Intervention descriptions: intervention 1: One treatment cycle:

Gleevec: 300 mg twice a day orally for 4 consecutive days, then off for 3 days, every 7 days for 28 days.

Paclitaxel: 80 mg/m\^2/week intravenously, 3 weeks on, one week off, every 28 days.

After 3 treatment cycles, decision made to continue or not with the combination based on tolerance and lack of progression.

Protocol documents: