ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00375973
Conditions: Fatigue Syndrome, Chronic
Keywords: Fatigue Fatigue syndrome, chronic Chronic fatigue syndrome CFS Fibromyalgia
Sponsor: University of Cincinnati
Start date: 2006-09-01; Completion date: 2014-03-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety and efficacy of duloxetine compared with placebo for reducing fatigue in patients diagnosed with Chronic Fatigue Syndrome (CFS).

Detailed description:
Chronic fatigue syndrome (CFS) is characterized by severe disabling fatigue of at least six months duration that cannot be fully explained by an identifiable medical condition . Pain symptoms are also a part of the diagnostic criteria for CFS, and include muscle pain, multi-joint pain, and headaches. The prevalence of CFS ranges from 0.007 to 2.8 % in the general adult population and 0.006 to 3.0% in primary care practice (2). Although most who receive a CFS diagnosis are 30-40 years of age, Caucasian, and female, CFS affects both women and men, adults and children, and all racial and socioeconomic classes.

Patients with CFS have 2-4 times the rate of depression and anxiety compared with the general population. CFS is also commonly comorbid with fibromyalgia, a disorder characterized by chronic widespread pain, tenderness, fatigue, sleep and mood disturbances. In some samples, 70% of patients with fibromyalgia also meet criteria for CFS. CFS and fibromyalgia are characterized by greater similarities than differences and may share pathophysiologic features. Like fibromyalgia, CFS is associated with chronic pain, sleep and mood disturbances. Because fibromyalgia responds to treatment with antidepressants, particularly the dual serotonin and norepinephrine reuptake inhibitors, including duloxetine, antidepressant trials in CFS are clearly needed.

Arms: arm 1: Duloxetine po 60-120 mg/day for 12 weeks arm 2: Placebo comparator to Duloxetine
Interventions: intervention 1: Duloxetine intervention 2: Placebo
Intervention descriptions: intervention 1: Duloxetine po 60-120 mg/day for 12 weeks intervention 2: Sugar pill dose comparable to duloxetine

Protocol documents:
Clinical trial NCT00410904
Conditions: Recurrent Non-small Cell Lung Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2006-10-01; Completion date: 2014-03-01
Enrollment: 60 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well giving AZD2171 together with pemetrexed disodium works in treating patients with relapsed non-small cell lung cancer. AZD2171 and pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. AZD2171 may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving AZD2171 together with pemetrexed disodium may kill more tumor cells.

Detailed description:
PRIMARY OBJECTIVES:

I. Evaluate the response rate in patients with relapsed non-small cell lung cancer treated with AZD2171 and pemetrexed disodium.

SECONDARY OBJECTIVES:

I. Assess the progression-free and overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to prior bevacizumab treatment (yes vs no).

Patients receive oral AZD2171 once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks\* in the absence of disease progression or unacceptable toxicity.

\[Note: \* The first course is 4 weeks in duration; all subsequent courses are 3 weeks in duration.\]

After completion of study treatment, patients are followed at 4 weeks and then periodically thereafter.

Arms: arm 1: Patients receive oral AZD2171 once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: cediranib maleate intervention 2: pemetrexed disodium
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00426556
Conditions: Metastatic Breast Cancer
Keywords: Breast cancer Cancer of the breast Human mammary carcinoma HER-2 Metastatic everolimus trastuzumab paclitaxel
Sponsor: Novartis Pharmaceuticals
Start date: 2007-07-01; Completion date: 2014-03-01
Enrollment: 88 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Phase I: will look at different dose levels and regimens of everolimus combined with weekly trastuzumab and paclitaxel therapy in patients with HER-2 overexpressing metastatic breast cancer.

Phase II: will assess the efficacy and safety of the 10mg daily dose of everolimus combined with weekly trastuzumab and paclitaxel therapy in patients with HER-2 overexpressing metastatic breast cancer.

Detailed description:

Arms: arm 1: Daily dosing schedule of EPT = Paclitaxel \& Trastuzumab verolimus 5mg plus Paclitaxel plus Trastuzumab. arm 2: Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel \& Trastuzumab arm 3: Weekly dosing schedule of Everolimus 30mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel \& Trastuzumab. arm 4: Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel \& Trastuzumab
Interventions: intervention 1: Everolimus intervention 2: Trastuzumab intervention 3: Paclitaxel
Intervention descriptions: intervention 1: Everolimus (RAD001) was supplied as tablets in 3 different dosage strengths, 2.5, 5, and 10 mg. The drug was packaged in blisters containing 10 tablets per blister. Blisters and packaging labels were compliant with local regulations and were printed in local language. intervention 2: Commercially-available trastuzumab was used in this study. A 4 mg/kg loading dose was administered, intra-venous (IV), over 90 minutes on Day 1 (if patient was not already receiving trastuzumab); this was followed by weekly trastuzumab 2 mg/kg IV administered over 30 minutes. For patients who continued to receive trastuzumab and everolimus after completion/discontinuation of chemotherapy in the core treatment phase, trastuzumab may have been administered once every 3 weeks at a dose of 6 mg/kg. PT = Paclitaxel \& Trastuzumab intervention 3: Commercially-available paclitaxel was used in this study. Paclitaxel infusion was administered on Days 1, 8, and 15 of each 28-day cycle, after administration of trastuzumab. Paclitaxel (80 mg/m2) was administered as a 60-minute continuous IV infusion after standard premedication. Patients received paclitaxel for 6 cycles. At the investigator's discretion, treatment with paclitaxel could continue beyond 6 cycles.

Protocol documents:
Clinical trial NCT00458848
Conditions: Leukemia
Keywords: B-cell adult acute lymphoblastic leukemia T-cell adult acute lymphoblastic leukemia untreated adult acute lymphoblastic leukemia L1 adult acute lymphoblastic leukemia L2 adult acute lymphoblastic leukemia TdT positive adult acute lymphoblastic leukemia
Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Start date: 2004-10-01; Completion date: 2014-03-01
Enrollment: 470 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. When the healthy stem cells are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving combination chemotherapy together with imatinib mesylate and peripheral stem cell transplant may be an effective treatment for acute lymphoblastic leukemia.

Nevertheless, in the last few years GIMEMA has pubblished a paper in which 100% of Ph+ ALL patients reach HCR only with Imatinib, without any chemiotherapy. Thus, this treatment will be implemented in patients pertaining to this category.

Detailed description:

Interventions: intervention 1: asparaginase intervention 2: daunorubicin hydrochloride intervention 3: etoposide intervention 4: idarubicin intervention 5: imatinib mesylate intervention 6: mercaptopurine intervention 7: methotrexate intervention 8: methylprednisolone intervention 9: mitoxantrone hydrochloride intervention 10: prednisone intervention 11: vincristine sulfate intervention 12: allogeneic hematopoietic stem cell transplantation intervention 13: autologous hematopoietic stem cell transplantation intervention 14: peripheral blood stem cell transplantation intervention 15: radiation therapy
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None intervention 8: None intervention 9: None intervention 10: None intervention 11: None intervention 12: None intervention 13: None intervention 14: None intervention 15: None

Protocol documents:
Clinical trial NCT00528775
Conditions: Lung Cancer
Keywords: adenocarcinoma of the lung large cell lung cancer squamous cell lung cancer recurrent non-small cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer
Sponsor: Roswell Park Cancer Institute
Start date: 2007-08-01; Completion date: 2014-03-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. This may be an effective treatment for advanced non-small cell lung cancer that blocks the air passages.

PURPOSE: This phase II trial is studying how well photodynamic therapy using HPPH works in treating patients with advanced non-small cell lung cancer that blocks the air passages.

Detailed description:
OBJECTIVES:

Primary

* To determine the efficacy of photodynamic therapy (PDT) using HPPH in patients with advanced obstructing endobronchial non-small cell lung cancer.

Secondary

* To determine palliation of symptoms in patients treated with this regimen.
* To determine the amount of HPPH taken up by the obstructing endobronchial tumors in these patients.
* To determine the extent of STAT3 cross-links, which are molecular markers of immediate PDT reaction, in the obstructing tumors of these patients before and after PDT treatment.
* To determine inflammation and apoptosis in the obstructing bronchial tumors of these patients before and after PDT treatment.

OUTLINE: Patients receive HPPH IV over 1 hour on day 1. On day 3, patients undergo photodynamic therapy (PDT) comprising laser light delivered by flexible, fiberoptic fibers passed through the biopsy channel of an endoscope. Patients undergo endoscopic debridement on day 5. If viable tumor is found outside of the initial treatment area, patients may receive another dose of laser light without additional HPPH.

Patients may undergo tumor biopsies periodically during study for optional biomarker/correlative studies. Tumor tissue samples are analyzed for STAT3 cross-links by western blotting; apoptosis and inflammation biomarkers by immunohistochemistry, TUNEL, and other immunological laboratory methods; and tumor concentrations of HPPH by fluorescence emission spectroscopy.

After completion of study treatment, patients are followed at 4-6 weeks and then periodically thereafter.

Arms: arm 1: Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.
Interventions: intervention 1: HPPH intervention 2: endoscopic procedure
Intervention descriptions: intervention 1: 4 mg/m2 IV intervention 2: Treatment with 150 joules from laser

Protocol documents:
Clinical trial NCT00552071
Conditions: Acromegaly
Keywords: Acromegaly Octreotide LAR Ultrasound guidance
Sponsor: Cedars-Sinai Medical Center
Start date: 2007-07-01; Completion date: 2014-03-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Approximately half of patients with acromegaly do not respond to treatment with somatostatin receptor ligands such as octreotide LAR. This may be due to inadequate drug delivery if the standard of care regular injection is inaccurately delivered in the intramuscular (IM) compartment. Ultrasound guidance of IM injections may improve accuracy of placement of IM injections and increase drug levels, thereby improving efficacy of octreotide LAR for the treatment of acromegaly. The purpose of this study is to determine whether octreotide LAR drug levels differ if given by ultrasound-guided IM injection or by regular IM injection in patients with acromegaly.

Detailed description:

Arms: arm 1: Subjects received octreotide LAR 30 mg injection via ultrasound-guided IM gluteal injection every 28 days for 3 months. arm 2: Subjects received octreotide LAR 30 mg injection via regular IM gluteal injections every 28 days for 3 months
Interventions: intervention 1: Octreotide LAR 30 MG Injection
Intervention descriptions: intervention 1: Stable dose of 30 mg octreotide LAR, or a dose determined by historical dosing, delivered every 28 days for 3 months.

Protocol documents:
Clinical trial NCT00553696
Conditions: Stomach Neoplasms
Keywords: chemotherapy combination
Sponsor: Pfizer
Start date: 2007-11-01; Completion date: 2014-03-01
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To assess the maximal tolerated dose (MTD) and overall safety of sunitinib when administered in combination with S-1 and Cisplatin in patients with advanced/metastatic gastric cancer.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Cisplatin intervention 2: S-1 intervention 3: Sunitinib
Intervention descriptions: intervention 1: Cisplatin 60 mg/m2 on day 1 of each 28 day cycle intervention 2: S-1 80 mg/m2 on days 1-21 of each 28 day cycle intervention 3: Sunitinib 25 mg, 37.5 mg and 50 mg daily S-1 80 mg/m2 on days 1-21 of each 28 day cycle Cisplatin 60 mg/m2 on day 1 of each 28 day cycle

Protocol documents:
Clinical trial NCT00633399
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder Major Depression Depression Geodon Ziprasidone SSRI Augmentation Treatment Resistant Depression
Sponsor: Massachusetts General Hospital
Start date: 2008-07-01; Completion date: 2014-03-01
Enrollment: 458 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to see if adding the study drug, ziprasidone, to an antidepressant medication helps improve symptoms of Major Depressive Disorder (MDD). We are studying the drug's effectiveness in treating depression, as well as its safety when it is added to another drug.

Hypothesis A: There will be a difference in the percentage of responders in the two treatment conditions during phase 2; response rates will be higher for the ziprasidone group.

Detailed description:
The proposed study involves three phases. The first phase is an 8-week, open-label trial of an SSRI for MDD. Patients who do not experience sufficient symptom improvement following this open-label trial will be enrolled in a 6-week, double-blind, placebo controlled trial of ziprasidone augmentation (second phase). Ziprasidone and placebo-remitters will then enter a 12-month, double-blind extension phase (third phase). We estimate that approximately 400 patients will enter phase 1 of the study so that a minimum of 180 subjects will enter double-blind treatment (phase 2) over 5 years. Each treatment arm during phase 2 will have 90 subjects.

Hypothesis B1: During phase 2, there will be a difference between the two groups in the percentage of responders (50% or greater reduction in symptom severity) with regards to anxious symptoms of MDD as measured by the 14-item Hamilton Anxiety Rating Scale (HAM-A); response rates will be higher for the ziprasidone group.

Hypothesis B2: During phase 2, there will be a difference between the two groups in the percentage of responders (50% or greater reduction in symptom severity) with regards to painful symptoms of MDD, as measured by the overall visual analogue pain (VAS-pain) scale scores; response rates will be higher for the ziprasidone group.

Hypothesis C: The time to relapse during phase 3 will be shorter among adjunctive placebo- than ziprasidone-remitters.

Arms: arm 1: Patients in group 1 will receive Ziprasidone for the full 8 weeks of Phase 2. If they are in remission following phase two, and decide to enter phase three, they will continue on Ziprasidone for 12 months. arm 2: Patients in group 2 will receive Placebo for the full 8 weeks of Phase 2. If they are in remission following phase two, and decide to enter phase three, they will continue on Placebo for 12 months.
Interventions: intervention 1: Ziprasidone intervention 2: Placebo
Intervention descriptions: intervention 1: 20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient. intervention 2: 0mg Placebo per day (1-4 tablets per day). "Dose increases" and "dose decreases" may occur, but patient will remain at 0mg placebo.

Protocol documents:
Clinical trial NCT00703508
Conditions: Polycystic Ovary Syndrome
Keywords: PCOS
Sponsor: Virginia Commonwealth University
Start date: 2008-07-01; Completion date: 2014-03-01
Enrollment: 55 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
1. The polycystic ovary syndrome is the major cause of infertility in the United States. Metformin has been shown to increase frequency of ovulations in PCOS, and is used in clinical practice to treat infertility, but some women with PCOS do not respond to metformin treatment.
2. Knowing that a specific gene predicts the effect of metformin on ovulation would facilitate more efficient and effective treatment of infertility in PCOS.

Detailed description:
The polycystic ovary syndrome (PCOS) affects approximately 6-10% of women of childbearing age, i.e., 3.5-5.5 million women in the United States. PCOS is the most common endocrine disturbance of young women and the major cause (75%) of anovulatory infertility in the United States. We hypothesize that women with the polycystic ovary syndrome (PCOS) who have the G/G genotype of single nucleotide polymorphism (SNP)\_ rs8111699 in STK11 will exhibit a significantly greater response to metformin, in terms of ovulation, compared with women with either the C/G or C/C genotype. Specifically, we anticipate the frequency of ovulation (defined by number of ovulations/9 months/subject) to be at least 2-fold higher in women with the G/G STK11 genotype compared with women with either the C/G or C/C genotype.

To test this hypothesis, we will obtain DNA for STK11 genotyping in 36 women with PCOS who are treated with metformin and carefully monitored for ovulation for 9 months. STK11 genotype status will be determined, and the ovulation rates in the G/G, G/C and C/C genotype groups will be compared with one another. Our goal is to identify the genes that predict or modify response to commonly prescribed medications that will allow physicians to better choose among existing therapies and individualize treatment. While metformin has been shown to increase ovulatory frequency in PCOS and is widely used in clinical practice to treat infertility, a substantial number of women either do not respond or are slow to respond to metformin treatment.

Knowing that a specific STK11 genotype predicts the effect of metformin on ovulation would facilitate more efficient and effective treatment of infertility in PCOS.

Arms: arm 1: Metformin tablet, 500 mg/tablet, 2 tablets every twelve hours, 9 months duration
Interventions: intervention 1: Metformin 500 mg tablet
Intervention descriptions: intervention 1: Metformin 500 mg tablets; two tablets every 12 hours for 9 months

Protocol documents:
Clinical trial NCT00710762
Conditions: Ovarian Neoplasms
Sponsor: Boehringer Ingelheim
Start date: 2006-03-01; Completion date: 2014-03-01
Enrollment: 89 participants; Allocation: ; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to estimate the Progression Free Survival Rates (PFS) of patients with relapsed ovarian cancer after 9 months of continuous treatment with either BIBF 1120 or matching placebo.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: BIBF1120 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00753935
Conditions: Coronary Artery Disease
Keywords: aspirin aspirin resistance aspirin nonresponse cyclooxygenase thromboxane oxidative stress
Sponsor: Vanderbilt University
Start date: 2006-06-01; Completion date: 2014-03-01
Enrollment: 92 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate possible mechanisms of aspirin resistance at a molecular level in aspirin-treated patients with coronary artery disease. We hypothesize that certain patient characteristics associate with aspirin resistance. In addition, we will compare the effects of enteric-coated aspirin and chewable aspirin.

Detailed description:
Aspirin is commonly used for its antithrombotic effects in patients at risk for cardiovascular events. Its primary mechanism of action is the irreversible acetylation of platelet cyclooxygenase-1, thereby inhibiting platelet production of thromboxane A2, a potent vasoconstrictor and activator of platelets. Thromboxane A2, the major product of cyclooxygenase cytochrome oxidase (COX-1) in platelets, induces platelet aggregation. Thromboxane B2 is an inactive metabolite/product of thromboxane A2. This primary outcome measures the extent of inhibition of platelet COX-1 by measuring the amount of the metabolite thromboxane B2 in serum.

Previous studies have demonstrated that many patients have recurrent events despite treatment with aspirin, which has been termed "aspirin resistance" or "aspirin nonresponse." This study addresses some of the possible mechanisms for aspirin nonresponse; specifically, we will test the hypothesis that aspirin nonresponse results from states that produce high peroxide concentrations ("oxidative stress") in platelets. In addition, we will evaluate the effect of enteric coating on the pharmacologic efficacy of aspirin in patients with coronary artery disease.

Arms: arm 1: patients received enteric-coated aspirin 81 mg qd for 2 weeks arm 2: Patients received chewable aspirin 81 mg qd for 2 weeks
Interventions: intervention 1: enteric-coated aspirin intervention 2: Chewable aspirin
Intervention descriptions: intervention 1: enteric-coated aspirin 81mg daily for 2 weeks intervention 2: chewable aspirin 81mg daily for 2 weeks

Protocol documents: