ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00510653
Conditions: Ovarian Cancer
Keywords: Ovarian Cancer Primary Peritoneal Cancer Fallopian Tube Cancer Recurrent Platinum-Resistant Taxane-Resistant Epithelial Ovarian Cancer Imatinib Mesylate Gleevec STI571 Protein tyrosine kinase inhibitor
Sponsor: M.D. Anderson Cancer Center
Start date: 2002-03-01; Completion date: 2012-02-01
Enrollment: 73 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Primary Objectives:

1. To determine the efficacy of Gleevec in patients with recurrent platinum-resistant, taxane-resistant epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer whose tumor expresses either c-KIT, platelet-derived growth factor receptor (PDGRF), or ABL.
2. To determine the nature and degree of toxicity of Gleevec in this cohort of patients.

Detailed description:
Imatinib Mesylate is a new medication that blocks several proteins important in the development of cancer. Before going on study, potential participants will have their tumor tested for c-KIT, PDGFR, and ABL for positivity. Those participants who have at least one positive biomarker will be eligible for treatment.

Before treatment starts, participants will have a complete checkup, blood tests, chest x-ray, and heart function test. Women able to have children must have a negative blood pregnancy test. A blood sample (3 teaspoons) will be taken once a week during treatment and at the end of treatment. A complete exam will also be done at the end of treatment. Tumors will be measured by computed tomography (CT) scan every 6 weeks while one study and at the end of treatment.

Participants in this study will take Imatinib Mesylate by mouth in a single dose on a daily basis. Participants will be treated for 6 weeks, which is one cycle of therapy. After 6 weeks, participants will be evaluated for side effects and tumor response. The dose may be decreased for the next cycle if participants side effects. Participants will be removed from the study if the tumor gets worse. Participants may remain on the study as long as the tumor has not gotten worse and there are no intolerable side effects.

This is an investigational study. Imatinib Mesylate has been approved for chronic myelogenous leukemia patients. However this is an investigational study of Imatinib Mesylate in patients with ovarian, tubal, or peritoneal cancer. Participants may responsible for the cost of all or part of this drug. At least 24 and as many as 74 patients will take part in this study. All will be enrolled at M. D. Anderson.

Arms: arm 1: 600 mg/day orally for 6 Weeks
Interventions: intervention 1: Imatinib Mesylate
Intervention descriptions: intervention 1: 600 mg by mouth daily for 6 Weeks

Protocol documents:
Clinical trial NCT00535262
Conditions: Bipolar Depression
Keywords: Bipolar depression
Sponsor: New York State Psychiatric Institute
Start date: 2007-03-01; Completion date: 2012-02-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This pilot study will evaluate the efficacy of the monoamine oxidase inhibitor (MAOI)EmSam, a selegiline transdermal system (STS), in bipolar depression.

Detailed description:
Most current treatments for bipolar depression have been shown to be of modest effectiveness. There is some literature which suggests that Monoamine Oxidase Inhibitors (MAOIs) have greater efficacy than tricyclic antidepressants, and that they are effective for treatment-resistant depression of all types, both unipolar and bipolar. The MAOI selegiline has demonstrated antidepressant efficacy. EmSam, a selegiline transdermal system, provides central nervous system but not intestinal/liver MAO inhibition without clinically significant increases in sensitivity to dietary tyramine. This transdermal system appears to be associated with fewer side effects and increased safety relative to oral MAOI's. This pilot study will evaluate the efficacy of EmSam in bipolar depression.

Arms: arm 1: EmSam will be administered in open-label fashion for 8-weeks during phase I of the study during which symptoms of depression will be assessed weekly. Those whose depression responds after 8-weeks will be entered into an 8-month open-label continuation phase during which they will be maintained on EmSam and be assessed on a monthly basis.
Interventions: intervention 1: EmSam
Intervention descriptions: intervention 1: Selegiline Transdermal System (STS); monoamine oxidase inhibitor patch

Protocol documents:
Clinical trial NCT00568698
Conditions: Muscular Atrophy, Spinal
Sponsor: Stanford University
Start date: 2004-01-01; Completion date: 2012-02-01
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The objectives of this trial are: to establish a safety profile for use of Hydroxyurea in children with Type I Spinal Muscular Atrophy; to identify reliable outcome measures for HU treatment in Type I SMA; and to detect the clinical efficacy of HU treatment in children with Type I SMA.

Detailed description:
SMA is a neuromuscular disorder characterized by degeneration of spinal cord motor neurons and muscular atrophy. SMA is classified into three clinical subtypes according to the severity and age of onset (Types I, II and III). Type I SMA (also called severe, infantile or acute SMA, or Werdnig-Hoffman disease) is the most severe phenotype. The onset of symptoms is within the first 6 months of life, and weakness of intercostal muscles and lack of airway protection lead to respiratory insufficiency and aspiration pneumonia, often resulting in early infant death.

In our laboratory, our preliminary results indicate that HU treatment significantly increases both SMN mRNA expression and intact SMN protein levels in vitro. These data confirm previous observations that in vitro treatments of SMA lymphocytes with hydroxyurea resulted in augmentation of the SMN2 gene expression in a dose and time related manner. Based on these exciting pre-clinical data, coupled with the well-documented side-effect profile of HU in children, we are conducting a pilot clinical trial using HU in children with Type I SMA. This clinical trial study is intended to establish the safety profile in children with Type I SMA; to identify reliable outcome measures; and to detect the possible clinical efficacy of HU treatment in children with Type I SMA.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Hydroxyurea intervention 2: Placebo to match hydroxyurea
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00604214
Conditions: Sepsis
Keywords: Sepsis Septic shock
Sponsor: Eli Lilly and Company
Start date: 2008-03-01; Completion date: 2012-02-01
Enrollment: 1696 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this placebo-controlled study is to determine if drotrecogin alfa (activated) treatment provides significant mortality reduction improvement in patients with septic shock compared with placebo treatment in patients receiving the current standard of care for septic shock. This study will also assess the effectiveness of drotrecogin alfa (activated) in reducing 28-day mortality in patients with septic shock and concomitant severe protein C deficiency.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Drotrecogin alfa (activated) intervention 2: Placebo
Intervention descriptions: intervention 1: 24 microgram/kilogram/hour, intravenous, 96 hours (hr) intervention 2: 0.9% sodium chloride, intravenous, 96 hours

Protocol documents:
Clinical trial NCT00631163
Conditions: Chronic Anemia Transfusional Hemosiderosis
Keywords: Iron Overload, Chelation, MDS, Chronic Anemia, Deferasirox, Transfusional hemosiderosis,
Sponsor: Novartis Pharmaceuticals
Start date: 2007-10-01; Completion date: 2012-02-01
Enrollment: 102 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The overall purpose of this trial is to further evaluate the efficacy and safety of deferasirox, dosed initially according to the transfusional iron intake, in patients with transfusion dependant anemia related to disorders other than β-thalassemia and sickle cell disease.

During the study, the dose will be adjusted based on serum Ferritin.The overall purpose of the extension is to allow further treatment of patients who have already completed the core study, and to enable collection of long term efficacy and safety data. Patients will continue to receive Deferasirox at the dose they received at the end of the core study.

Detailed description:

Arms: arm 1: Participants received initial dose of 20 milligrams per kilogram (mg/kg) Deferasirox tablets was administered orally once daily (OD) based on the Participants body weight. The dose of Deferasirox was adjusted to either 10 mg/kg or 30 mg/kg based on the volumes of blood transfusions being administered.
Interventions: intervention 1: Deferasirox (ICL670)
Intervention descriptions: intervention 1: The recommended initial daily dose of Deferasirox is 20 mg/kg body weight.

Protocol documents:
Clinical trial NCT00631696
Conditions: Healthy
Keywords: Healthy males Human volunteers pregabalin or placebo sperm quality and quantity
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2008-02-01; Completion date: 2012-02-01
Enrollment: 222 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being performed as a Phase IV FDA commitment study and is being powered adequately to assess changes in sperm concentration, FSH and testosterone in healthy male subjects treated with pregabalin as compared to placebo, in addition to confirming lack of effects on sperm motility.

Detailed description:
This is a Phase 4 FDA commitment study. The purpose of the study is to evaluate the effects of pregabalin as compared to placebo on sperm concentration in healthy male subjects

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Pregabalin intervention 2: Placebo
Intervention descriptions: intervention 1: pregabalin 600 mg given twice a day intervention 2: Placebo

Protocol documents:
Clinical trial NCT00643604
Conditions: Hypertension, Pulmonary
Keywords: Pulmonary arterial hypertension treatment satisfaction rapid switch remodulin Quality of life
Sponsor: United Therapeutics
Start date: 2008-03-01; Completion date: 2012-02-01
Enrollment: 7 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this 8-week study is to compare the effects of switching from therapy with epoprostenol or Flolan to IV Remodulin. This study will also assess the effect that changing to Remodulin will have on patient satisfaction with their treatment and impact on quality of life.

Detailed description:
Pulmonary arterial hypertension (PAH), which is defined as an elevation in pulmonary arterial pressure and pulmonary vascular resistance, is a severe hemodynamic abnormality common to a variety of diseases and syndromes. Elevation in pulmonary arterial pressure causes an increase in right ventricular afterload, impairing right ventricular function and ultimately leading to inactivity and death. The goal of PAH treatment is to lengthen survival time, to ameliorate symptoms of PAH and to improve health related quality of life (HRQOL).

Remodulin® (treprostinil sodium), a stable analogue of prostacyclin, possesses potent pulmonary and systemic vasodilatory and platelet anti-aggregatory actions in vitro and in vivo. Recently, Remodulin received FDA approval for intravenous therapy based upon bioequivalence of the IV and SC routes of administration. Remodulin is more chemically stable than epoprostenol and may offer potential safety and convenience advantages compared to intravenous epoprostenol that may impact Health Related Quality of Life (HRQOL) and/or patient satisfaction. Unlike epoprostenol, Remodulin does not need to be mixed daily and is stable at room temperature eliminating the need for ice packs. Furthermore, since Remodulin remains in the body longer than epoprostenol (4 hrs instead of less than 5 minutes) there is less risk of cardiovascular collapse from a sudden interruption of infusion, such as a line clog. In an open-label study in Europe, patients who were using a type of portable medication pump called the CADD Legacy pump were rapidly switched from Flolan to Remodulin with no serious side effects. This study will examine effects of switching from therapy with epoprostenol or Flolan to IV Remodulin and compare changes in HRQOL and treatment satisfaction before and after rapid switch from epoprostenol to Remodulin in patients with pulmonary hypertension using the CADD legacy pump.

Arms: arm 1: all subjects had switched from IV epoprostenol to IV treprostinil sodium
Interventions: intervention 1: treprostinil sodium
Intervention descriptions: intervention 1: rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium

Protocol documents:
Clinical trial NCT00652366
Conditions: Pancreatic Cancer
Sponsor: Hoffmann-La Roche
Start date: 2008-05-01; Completion date: 2012-02-01
Enrollment: 467 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the efficacy and safety of escalating versus standard doses to rash of Tarceva, in combination with gemcitabine, in patients with metastatic pancreatic cancer. During a 4 week run-in period, all patients will receive Tarceva 100mg/day po plus gemcitabine 1000mg/m2 iv on days 1, 8,15 and 22. After 4 weeks, patients who have not developed rash, or only develop grade 1 rash, will be randomized to one of 2 groups. Group 1 will receive a starting dose of Tarceva 150mg po daily, increased in steps of 50mg every 2 weeks up to a maximum of 250mg/day po, until development of grade 2 rash or other dose-limiting toxicity. Group 2 will continue to receive Tarceva 100mg/day po. All patients will continue to receive gemcitabine 1000mg/m2 iv on days 1, 8 and 15 of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: Participants received erlotinib, 100 milligrams (mg), orally (PO), once daily until disease progression or unacceptable toxicity. Participants also received gemcitabine, 1000 mg per (/) square meter (m\^2), intravenously (IV), on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression or unacceptable toxicity. arm 2: Participants received erlotinib, beginning at 150 mg/day, PO, once daily, and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal. Participants also received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression or unacceptable toxicity.
Interventions: intervention 1: Erlotinib, escalating dose intervention 2: Erlotinib, standard dose intervention 3: Gemcitabine
Intervention descriptions: intervention 1: 100mg, PO, once daily, escalating to a maximum of 250mg, PO, once daily intervention 2: 100mg, PO, once daily intervention 3: 1000 mg/m2, IV, on days 1,8 and 15 of each 4 week cycle

Protocol documents:
Clinical trial NCT00675597
Conditions: Lung Cancer
Keywords: Bevacizumab (Avastin) Taxotere (Docetaxel) Vinorelbine Tartrate (Navelbine) 07-178
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2008-05-01; Completion date: 2012-02-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether a combination of the drugs docetaxel (Taxotere ® ), plus vinorelbine (Navelbine ® ), will result in fewer side effects than cisplatin chemotherapy, thereby improving delivery of chemotherapy in patients.

Another purpose of this study is to determine whether a third drug, bevacizumab (Avastin®), may be delivered safely with docetaxel plus vinorelbine in patients who are eligible to receive bevacizumab.

Detailed description:

Arms: arm 1: Docetaxel (Taxotere), Vinorelbine, and Bevacizumab, as Adjuvant Chemotherapy for Patients with Resected Stage I-III Non-small Cell Lung Cancer
Interventions: intervention 1: Bevacizumab (Avastin), Taxotere (Docetaxel), Vinorelbine Tartrate (Navelbine)
Intervention descriptions: intervention 1: Patients will be treated as follows: vinorelbine (45 mg/m2) + docetaxel (45 mg/m2) intravenously on day 1, followed by pegylated filgrastim 6mg subcutaneously on day 2, delivered every 2 weeks for 8 doses total. Patients who have already received one cycle of cisplatin-based adjuvant chemotherapy need only complete 3 cycles of vinorelbine+docetaxel for a total of 4 cycles of adjuvant chemotherapy. Patients who require post-operative radiation therapy (PORT) will begin PORT after completion of vinorelbine + docetaxel.

Protocol documents:
Clinical trial NCT00688324
Conditions: Schizophrenia Schizoaffective Disorder
Keywords: schizophrenia schizoaffective disorder glutamate NMDA receptor magnetic resonance spectroscopy acamprosate
Sponsor: University of Maryland, Baltimore
Start date: 2008-06-01; Completion date: 2012-02-01
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
NMDA receptors are brain receptors that are stimulated by glutamate. Poorly functioning NMDA receptors are thought to be involved in the pathology of schizophrenia. This hypothesis is based on the observation that PCP, which blocks the NMDA receptor, produces symptoms and cognitive impairments similar to schizophrenia. Efforts to enhance the function of the NMDA receptor with glycine and D-cycloserine have met with limited success. An alternative approach would be to use the drug acamprosate.

Acamprosate, FDA-approved for maintenance of sobriety after detoxification from alcohol, seems to act through modulation of the NMDA receptor. In the lab, acamprosate has been noted to act as an antagonist when the NMDA receptors are maximally stimulated but as an agonist when NMDA receptor stimulation is minimal. This "smart drug" action makes acamprosate appealing for use in schizophrenia. If acamprosate works as a smart drug in patients, then we would predict that it would enhance the function of NMDA receptors in schizophrenia and improve cognition and the symptoms of the illness. Additionally, acamprosate seems to modulate the NMDA receptor in novel ways distinct from glycine and D-cycloserine.

We will also see if the response to acamprosate differs based on whether participants do or do not have a past history of alcohol use disorders.

Detailed description:
We propose to measure the response of symptoms and cognition in people schizophrenia given acamprosate or placebo. We hypothesize that symptoms and cognition will improve following two weeks of acamprosate. We will also use proton magnetic resonance spectroscopy (MRS) to examine the effect of acamprosate on glutamate \& glutamine (Glu\&Gln) brain levels in people with schizophrenia. We hypothesize that Glu\&Gln concentrations in people with chronic schizophrenia will increase following two weeks of treatment with acamprosate.

The proposed study will consist of 50 individuals with chronic schizophrenia/schizoaffective disorder, 18-55 years old, from in/outpatient programs at the Maryland Psychiatric Research Center (MPRC). The dose of acamprosate will follow manufacturer recommendations with two 333mg tablets given three times per day. MRS will be acquired from areas involved in schizophrenia \[dorsolateral-prefrontal cortex (DLPFC) and anterior cingulate cortex (ACC)\] at baseline and week two. Symptom ratings and cognitive testing will occur at baseline and be repeated at week two.

Arms: arm 1: All subjects will have baseline measures, receive acamprosate for 2 weeks, then have measures repeated.
Interventions: intervention 1: Acamprosate
Intervention descriptions: intervention 1: Acamprosate 333mg, ii tablets PO tid x 2 weeks

Protocol documents:
Clinical trial NCT00690898
Conditions: Acromegaly
Sponsor: Ipsen
Start date: 2008-05-01; Completion date: 2012-02-01
Enrollment: 108 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Acromegaly is a chronic disease caused by excessive secretion of growth hormone (GH) and mainly due to benign tumour localized in the pituitary gland.

The disease develops insidiously, causing a gradual progression of symptoms; consequently most patients are diagnosed in their fourth decade of life.

Administration of somatostatin analogues such as lanreotide have been shown to result in normalisation or the decrease of GH and insulin growth factor (IGF-1) levels and improvement of clinical symptoms in acromegalic patients. The purpose of this study is to evaluate whether lanreotide is also effective on tumour volume reduction (tumour shrinkage) and the benefits of this potential tumour shrinkage on disease symptoms and patient's quality of life.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Lanreotide autogel 120 mg
Intervention descriptions: intervention 1: 12 months

Protocol documents:
Clinical trial NCT00695019
Conditions: Hepatitis C, Chronic
Keywords: Prevention of Relapse HCV genotype 1b Recurrence
Sponsor: Ainos, Inc. (f/k/a Amarillo Biosciences Inc.
Start date: 2009-06-01; Completion date: 2012-02-01
Enrollment: 169 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether lozenges of interferon-alpha that are dissolved in the mouth can prevent relapse in patients with hepatitis C virus infection who had a complete virologic response after receiving a combination of injected interferon-alpha and oral ribavirin.

Detailed description:

Arms: arm 1: 500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day arm 2: 500 IU interferon-alpha lozenge taken 3 times per day arm 3: placebo lozenges taken 3 times per day
Interventions: intervention 1: interferon-alpha lozenges intervention 2: placebo lozenges
Intervention descriptions: intervention 1: 500 IU lozenges of natural human interferon-alpha for oral dissolution given once or three times per day for 24 weeks intervention 2: 200 mg matching placebo lozenges

Protocol documents: