ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00908037
Conditions: Purpura, Thrombocytopaenic, Idiopathic
Keywords: idiopathic thrombocytopenic purpura thrombocytopenia pharmacodynamics ITP eltrombopag pharmacokinetics chronic ITP pediatrics
Sponsor: GlaxoSmithKline
Start date: 2009-09-30; Completion date: 2014-02-01
Enrollment: 82 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Phase II, multi-center, 3 part, staggered cohort, open-label and double blind, randomized, placebo controlled study involving 3 age-determined cohorts (Cohort 1: between 12 and 17 years old; Cohort 2: between 6 and 11 years old; Cohort 3: between 1 and 5 years old). Daily dosing with eltrombopag will begin with 5 patients in the oldest age cohort in an open label fashion, and a review of safety, pharmacokinetic and platelet count data will be performed regularly. If no safety concerns are identified after 12 weeks, 18 additional patients will be randomised to placebo or eltrombopag (2:1 randomisation). After 7 weeks of randomized treatment, all patients will receive eltrombopag in an open label fashion. The total duration of treatment with eltrombopag will be 24 weeks. If at the time of the aforementioned 12 week review of the first 5 patients no safety issues are identified, dosing will begin in the next lower age cohort with an initial group of 5 patients. The same procedure will be followed in terms of safety review and subsequent enrolment and randomisation of the additional patients. Initiation of the younger age cohort will take place once data from the previous has been evaluated. Doses will be adjusted according to platelet counts and tolerability. The study will include a review of the safety data by a Data Safety Monitoring Board.

Detailed description:

Arms: arm 1: eltrombopag arm 2: placebo
Interventions: intervention 1: eltrombopag intervention 2: Placebo
Intervention descriptions: intervention 1: thrombopoietin receptor agonist intervention 2: placebo for comparison

Protocol documents:
Clinical trial NCT00995930
Conditions: Diabetes Mellitus, Type 2 Atherosclerosis Prediabetic State
Keywords: Atherosclerosis, Type 2 Diabetes Mellitus, T2DM, Cardiovascular Diseases, ACZ885, impaired glucose tolerance, IGT, Canakinumab
Sponsor: Novartis Pharmaceuticals
Start date: 2009-12-01; Completion date: 2014-02-01
Enrollment: 189 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the effect of ACZ885 on vascular function in patients with documented atherosclerotic disease and T2DM or IGT.

Detailed description:

Arms: arm 1: subcutaneous (SQ) monthly arm 2: 150 mg SQ monthly
Interventions: intervention 1: ACZ885 intervention 2: Placebo
Intervention descriptions: intervention 1: ACZ885 150 mg was administered subcutaneously once a month for 12 months. intervention 2: Matching placebo to ACZ885 was administered subcutaneously once a month for 12 months.

Protocol documents:
Clinical trial NCT01038856
Conditions: Polycythemia Vera
Sponsor: University of Oklahoma
Start date: 2009-12-01; Completion date: 2014-02-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to determine the overall response rate to erlotinib in patients with polycythemia vera (PV). Response rate will be assessed by improvement in the complete blood count, ultrasound of the spleen, and JAK2 molecular status. It is purposed in this study to explore a possible molecular targeting of the driving mechanism of PV.

Detailed description:
This is a phase II open-label study. Patients will be screened for MPN diagnoses and patients with Polycythemia vera proven to have JAK2V617F mutation will be given the option to enroll. Consenting patients will take erlotinib daily for 16 weeks. Blood work and pharmacokinetics will be drawn for serum level monitoring. Doses will be administered according to side effects or held. First assessment will be at day 15 wth subsequent assessments at 28 day intervals. Non-responders will be taken off the study and managed according to standard of care. Patients who do respond will continue taking the therapy for a total of 12 months. Observation will be for a total of 12 months after finishing treatment. In addition to the clinical aspect of this study, there will be correlative studies where molecular response will be checked and its correlation with clinical response.

Arms: arm 1: Patients with MPN diagnoses and polycythemia vera who also have a confirmed JAK2V617F mutation
Interventions: intervention 1: Erlotinib
Intervention descriptions: intervention 1: Erlotinib supplied as tablets; oral dose of erlotinib of 150 mg daily to be continued for 16 weeks. Responders will continue for up to 12 months, non-responders will cease taking erlotinib

Protocol documents:
Clinical trial NCT01063036
Conditions: Chronic Hepatitis B
Sponsor: Bristol-Myers Squibb
Start date: 2010-05-01; Completion date: 2014-02-01
Enrollment: 144 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to show that the combination of entecavir and tenofovir, is effective and well tolerated in chronic hepatitis B patients who have failed previous treatment.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Entecavir intervention 2: Tenofovir
Intervention descriptions: intervention 1: Tablets, Oral, 1 mg, once daily, 96 weeks intervention 2: Tablets, Oral, 300 mg, once daily, 96 weeks

Protocol documents:
Clinical trial NCT01083602
Conditions: Relapsed and Bortezomib Refractory Multiple Myeloma Refractory Multiple Myeloma Multiple Myeloma in Relapse
Keywords: Multiple Myeloma Relapsed Multiple Myeloma Refractory Multiple Myeloma
Sponsor: Novartis Pharmaceuticals
Start date: 2010-06-01; Completion date: 2014-02-01
Enrollment: 55 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is designed to assess the effectiveness of the combination of Panobinostat plus Bortezomib and Dexamethasone in patients with relapsed and bortezomib refractory Multiple Myeloma.

Detailed description:
This is a phase II, two stage, single arm, open label, multi-center study of oral PAN in combination with BTZ/Dex in patients with relapsed and refractory multiple myeloma, who are bortezomib-refractory and have received at least 2 prior lines of therapy. Patients must have been exposed to an iMID (lenalidomide or thalidomide) and progressed on or within 60 days of their last BTZ-containing line of therapy.

Arms: arm 1: panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma
Interventions: intervention 1: panobinostat intervention 2: bortezomib intervention 3: dexamethasone
Intervention descriptions: intervention 1: PAN 20 mg PO given TIW, weeks 1\&2 of each 3-week cycle;• BTZ 1.3 mg/m2 IV push given BIW weeks 1\&2 of each 3 week cycle (days 1,4,8 and 11);• Dex 20 mg PO given QIW, weeks 1\&2 of each 3-week cycle (days 1,2,4,5,8,9,11 and 12) intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01095757
Conditions: Myeloma Lymphoma
Keywords: Myeloma Lymphoma Stem cell transplantation
Sponsor: Emory University
Start date: 2010-03-01; Completion date: 2014-02-01
Enrollment: 45 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to test whether the addition of the drug plerixafor to treatment with chemotherapy and G-CSF can better activate your bone marrow stem cells to improve the chances of transplant. The study will look for the activation of a certain type of blood cell, called CD34+ cells in patients who receive plerixafor, chemotherapy and G-CSF. The investigators will follow the number of patients that achieve the target numbers of CD34+ cells. The number of patients achieving the target level of CD34+ cells, and the total number of CD34+ cells, will be compared to the numbers in previous studies testing just chemotherapy and G-CSF, without plerixafor.

The investigators will also test the safety of the combination of plerixafor with chemotherapy and G-CSF and look at the success of the transplantation after 12 months.

Detailed description:

Arms: arm 1: Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.
Interventions: intervention 1: Plerixafor
Intervention descriptions: intervention 1: 240 µg/kg subcutaneous injection on the day that the absolute neutrophil count (ANC) is \> 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached.

Protocol documents:
Clinical trial NCT01121575
Conditions: Non Small Cell Lung Cancer
Keywords: Phase 1 acquired resistance to erlotinib or gefitinib cMET inhibitor EGFR inhibitor panHER inhibitor combination trial Crizotinib
Sponsor: Pfizer
Start date: 2010-08-01; Completion date: 2014-02-01
Enrollment: 70 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Lung cancer tumors become resistant to the first generation epidermal growth factor receptor (EGFR) inhibitors erlotinib or gefitinib by changing and increasing the activity of two cell signaling pathways: the cMET pathway and the EGFR pathway. Both resistance mechanisms can occur at the same time, in the same patient and even in the same tumor. This study combines a second generation EGFR inhibitor and a cMET inhibitor to block both these pathways in order to overcome resistance and treat this disease.

Detailed description:

Arms: arm 1: PF-02341066 AND PF-00299804: Patients will be treated with combined cMET inhibitor (PF-02341066) and panHER inhibitor (PF-00299804). arm 2: PF-00299804 FOLLOWED BY COMBINED PF-02341066 AND PF-00299804: Patients will be treated with single agent panHER inhibitor (PF-00299804) until disease progression and then with the maximum tolerated combined dose of cMET inhibitor (PF-02341066) and panHER inhibitor (PF-00299804).
Interventions: intervention 1: PF-02341066 intervention 2: PF-00299804 intervention 3: PF-02341066 intervention 4: PF-00299804
Intervention descriptions: intervention 1: Arm 1: The starting dose will be 200 mg by mouth, twice a day of PF 02341066 in tablet form The dose of each drug in the combination \[PF-02341066 and PF-00299804\] will be escalated or de-escalated until the maximum tolerated combined dose is reached. Patients will then be treated with the maximum tolerated combined dose. intervention 2: Arm 1: The starting dose will be 30 mg by mouth once a day of PF-0029804 in tablet form. The dose of each drug in the combination \[PF-02341066 and PF-00299804\] will be escalated or de-escalated until the maximum tolerated combined dose is reached. Patients will then be treated with the maximum tolerated combined dose. intervention 3: Arm 2: With progressive disease the maximum tolerated combined dose of PF-02341066 (given by mouth twice a day in tablet form) and PF-00299804 (given by mouth once a day in tablet form). intervention 4: Arm 2: The dose of 45 mg by mouth once a day of PF-00299804 in tablet form until progressive disease and then the maximum tolerated combined dose of PF-02341066 (given by mouth twice a day in tablet form) and PF-00299804 (given by mouth once a day in tablet form).

Protocol documents:
Clinical trial NCT01134731
Conditions: Major Depressive Disorder Suicidal Ideation
Keywords: depression suicidality Major Depressive Disorder, current episode, with suicidality
Sponsor: University of Alabama at Birmingham
Start date: 2010-05-01; Completion date: 2014-02-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study aims to use a combined clinical and translational approach to identify an efficient pharmacotherapy for the acute management of suicidality and the epigenetic regulation associated with the treatment.The primary objective is a clinical trial to compare the efficacy of paliperidone versus lithium and placebo as adjunctive therapy to the standard of care antidepressants in the acute management of suicidality in depressed subjects.

Specific Aims 1 and 2 are described in detail below. Analysis for Specific Aim 2 is still underway.

Detailed description:
Specific Aim 1: The atypical antipsychotic, paliperidone, when initiated simultaneously with an antidepressant, is superior to lithium plus antidepressant in the early intervention of suicidality in patients with Major Depressive Disorder (MDD). The goal of this aim is to examine the clinical efficacy of paliperidone in reducing suicidality, with a focus on early intervention. The hypothesis is based on our recently completed pilot study in which we found that the atypical antipsychotic, risperidone, had a rapid onset of action to reduce suicidality in patients with MDD. In view of a shortage in acute pharmacological management of suicidality, this study will provide an important new treatment option for the life threatening psychiatric condition.

Specific Aim 2: Both paliperidone and lithium regulate epigenetics by stabilizing DNA methylation, which is correlated with inhibition of glycogen synthase kinase-3 (GSK3) activity and improved clinical symptoms. This exploratory aim is developed based on the recent findings that DNA methylation is involved in regulation of mood, behavior, and cognition, and the enzyme of this epigenetic mechanism - DNA methyltransferase-1 (DNMT1) is regulated by the therapeutic target Glycogen synthase kinase 3 (GSK3). We will measure the expression of DNMTs and DNA methylation of global DNA, Brain-derived neurotrophic factor (BDNF), and Tropomyosin receptor kinase B (TrkB) in peripheral blood before and after study drug treatment, and analyze their correlation with GSK3 activity and clinical symptoms in response to treatment. Outcomes from this study will provide important new information in future development of more effective treatment options for suicidality targeting epigenetic regulation.

Arms: arm 1: dose escalation , levels 1-5 daily dosing ranged from 1-5mg arm 2: dose escalation, level 1-5 daily dosing 300-1500mg arm 3: 1-5 placebo capsules
Interventions: intervention 1: paliperidone intervention 2: lithium intervention 3: Placebo
Intervention descriptions: intervention 1: 1-5 mg daily (QD) intervention 2: 300-1500mg QD intervention 3: 1-5 placebo capsules

Protocol documents:
Clinical trial NCT01165450
Conditions: Persistent Corneal Epithelial Defects
Keywords: persistent epithelial defect cornea
Sponsor: University of California, San Francisco
Start date: 2011-11-01; Completion date: 2014-02-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of Nexagon® in subjects with persistent corneal epithelial defects (PED) resulting from corneal epithelial debridement during diabetic vitrectomy surgery, HSV keratitis, HZV keratitis, corneal burns, post-PRK, or post-corneal transplant surgery.

Detailed description:
The purpose of this prospective, randomized, double-masked, vehicle-controlled, dose-escalation study is to evaluate the efficacy and safety of Nexagon® in subjects with persistent corneal epithelial defects (PED) resulting from corneal epithelial debridement during diabetic vitrectomy surgery, HSV keratitis, HZV keratitis, corneal burns, post-PRK, or post-corneal transplant surgery. In general, traditional therapy of PED consists of aggressive lubrication with preservative-free artificial tears and ointments, the use of bandage soft contact lenses, pressure patching, punctal plugging, and the surgical closure of the eyelids. Unfortunately, the success rates with these conventional treatment modalities are varied, and overall, disappointingly low. As such, much research is currently being directed at finding better treatments for PED. Nexagon® is a novel therapeutic agent that has been shown to be effective in treating skin lesions, and it has been shown in animal studies and in preliminary human studies to be safe and efficacious in treating PED.

Arms: arm 1: There will be 3 groups of patients with persistent epithelial defects, treated in a dose-escalation fashion from 1µg to 3µg to 10 µg. Each group will consist of 18 patients randomized to Nexagon and 6 patients randomized to placebo only. arm 2: There will be 3 groups of patients with persistent epithelial defects, treated in a dose-escalation fashion from 1µg to 3µg to 10 µg. Each group will consist of 18 patients randomized to Nexagon and 6 patients randomized to placebo only.
Interventions: intervention 1: Nexagon intervention 2: Vehicle only
Intervention descriptions: intervention 1: There will be 3 groups of patients with persistent epithelial defects, treated in a dose-escalation fashion from 1µg to 3µg to 10 µg. Each group will consist of 18 patients randomized to Nexagon and 6 patients randomized to placebo only. intervention 2: There will be 3 groups of patients with persistent epithelial defects, treated in a dose-escalation fashion from 1µg to 3µg to 10 µg. Each group will consist of 18 patients randomized to Nexagon and 6 patients randomized to placebo only.

Protocol documents:
Clinical trial NCT01169649
Conditions: PANCREAS Neuroendocrine
Keywords: MK-2206 Neuroendocrine Tumors 10-067
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2010-07-01; Completion date: 2014-02-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to test a new drug called MK-2206. This study is a phase II study. In cancer studies, a phase II study is to find out what effects, good and/or bad, a new treatment has against a certain type of cancer.

MK-2206 is an oral medication known as a targeted therapy. By attaching to the target, we hope that MK-2206 may stop the cancer cells from further growth and dividing. This study will help find out if MK-2206 is a helpful drug when taken in patients with neuroendocrine tumor.

Detailed description:

Arms: arm 1: This is an open label phase II study of MK-2206 administered to patients with metastatic neuroendocrine tumors.
Interventions: intervention 1: MK-2206
Intervention descriptions: intervention 1: MK-2206 will be given orally 200 mg qw as given in the prior Ph1 clinical trial that demonstrated safety, tolerability and adequate PK/PD values at this dose. Follow-up imaging scans will be performed every 12 weeks to evaluate response. Patients must take MK-2206 orally at least 2 hours before or 2 hours after food or a meal.

Protocol documents:
Clinical trial NCT01194973
Conditions: Atypical Hemolytic-Uremic Syndrome
Keywords: Atypical Hemolytic-Uremic Syndrome
Sponsor: Alexion Pharmaceuticals, Inc.
Start date: 2010-07-01; Completion date: 2014-02-01
Enrollment: 44 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The record Primary purpose is to assess the efficacy of eculizumab in adult patients with Atypical Hemolytic- Uremic Syndrome (aHUS) to control Thrombotic Microangiopathy (TMA) as characterized by thrombocytopenia, hemolysis and renal impairment.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Eculizumab
Intervention descriptions: intervention 1: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.

Protocol documents:
Clinical trial NCT01206296
Conditions: Pancreatic Adenocarcinoma
Keywords: Adjuvant Intraperitoneal Gemcitabine Pancreas Adenocarcinoma
Sponsor: Medstar Health Research Institute
Start date: 2010-08-01; Completion date: 2014-02-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase II study evaluating the use of intraperitoneal gemcitabine given intraoperatively and as adjuvant therapy for patients with resectable pancreas cancer.

The primary objective of this study is to evaluate the overall safety of intraperitoneal gemcitabine given intraoperatively and postoperatively for adjuvant treatment of resectable pancreatic adenocarcinoma.

The secondary objectives are to evaluate the efficacy of this treatment regimen as reflected in overall survival at 2-years, to study the patterns of disease recurrence following this treatment, to study the pharmacology of intraperitoneal gemcitabine and to study changes in peritoneal cytology with pancreatic cancer resection.

Detailed description:

Arms: arm 1: Intraperitoneal Gemcitabine
Interventions: intervention 1: Intraperitoneal Gemcitabine
Intervention descriptions: intervention 1: Standard pancreatic resection followed by heated intraoperative intraperitoneal gemcitabine 1000 mg/m2

Adjuvant intraperitoneal gemcitabine treatments (days 1, 8 and 15 of each 4-week cycle) for 6 cycles

Protocol documents:
Clinical trial NCT01234675
Conditions: Sleep Disorders Fibromyalgia Sleep
Keywords: Fibromyalgia Sleep disorders Forest Laboratories Milnacipran
Sponsor: Mansoor Ahmed M.D.
Start date: 2010-11-01; Completion date: 2014-02-01
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Fibromyalgia is a condition of chronic widespread pain, sleep disturbance and fatigue. Most of the patients with fibromyalgia complain of either non-restorative sleep or complaints of disturbed sleep due to pain. The study aimed at examining the effects of milnacipran on sleep disturbance in patients with fibromyalgia. The study is a randomized, double-blind, placebo controlled, two way crossover polysomnography (PSG) study to explore the effects of milnacipran on sleep disturbance. Patients received either milnacipran 50 mg twice a day (BID) or matching placebo.

Detailed description:
The sleep disturbance in fibromyalgia is characterized as non-restorative in nature, and is defined as a feeling of light sleep, independent of duration, and as non-refreshing. As such, these patients wake up in the morning and complain of stiffness and overall aching of the body.

It is well known that reciprocal relationship exists between sleep and pain, with sleep disturbances being an important contributor to morbidity in fibromyalgia. Milnacipran, a selective serotonin norepinephrine receptor inhibitor (SNRI), was approved by the Food and Drug Administration (FDA) for the management of fibromyalgia. Although milnacipran has extensively been studied in fibromyalgia patients, but there is no objective measure, i.e., the use of overnight polysomnography, to determine its effects on sleep.

The study was undertaken to evaluate the effects of milnacipran on PSG determined measures of sleep in patients with fibromyalgia. The study also evaluated the impact of milnacipran on subjective measures of sleep and fibromyalgia symptoms.

Arms: arm 1: Drug: milnacipran 7-day dose escalation, 28- day treatment with milnacipran 50 mg and 7-day taper period before or after crossover to placebo arm 2: Drug: placebo 45-day placebo treatment before or after crossover to milnacipran
Interventions: intervention 1: Milnacipran intervention 2: Placebo
Intervention descriptions: intervention 1: 50 mg twice daily intervention 2: 50 mg twice daily

Protocol documents: