ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01754987
Conditions: Metastatic Hepatocellular Carcinoma Advanced Liver Cancer
Keywords: Vitamins Malignant Tumor, Tumour Integrative Medicine Complementary Medicine Alternative Medicine Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Micronutrients Growth Substances Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Radiation-Sensitizing Agents Liver Cancer
Sponsor: Thomas Jefferson University
Start date: 2012-09-01; Completion date: 2016-01-01
Enrollment: 5 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This protocol is a phase I/II, study of ascorbic acid (AA) infusions combined with treatment with sorafenib versus treatment with sorafenib alone in subjects with metastatic hepatocellular carcinoma. The phase I aspect will assess the safety and efficacy of the concurrent treatments and the phase II aspect will utilize CT (computer-tomography) scans to assess overall tumor response rate and evaluate disease progression

Detailed description:
Intravenous Ascorbic Acid (Vitamin C) is a widely used alternative cancer treatment. This trial will study an intravenous Vitamin C treatment for persons with liver cancer that has spread, who are also receiving Sorafenib (a standard cancer drug), to see whether the combination of Vitamin C and Sorafenib is safe and well tolerated. Phase I will involve 6 persons who will receive the Vitamin C for 8 weeks to more specifically assess the safety of getting Vitamin C in combination with Sorafenib. Phase II will be randomized to receive either Vitamin C plus Sorafenib or Sorafenib alone for 16 weeks. If Vitamin C has a beneficial effect on tumour cells, patients may experience a regression of tumor or tumor markers. Additional benefits include scans at no charge to the patient.

Arms: arm 1: Drug: Vitamin C Other Names: Ascorbic Acid, Ascorbate

Dosage:

Vitamin C : 100 grams (infusion) Phase I: 3x a week for 8 weeks Phase II: 3x a week for 16 weeks Sorafenib: taken daily (oral) arm 2: Sorafenib: taken daily (oral)
Interventions: intervention 1: Ascorbic Acid + Sorafenib intervention 2: Sorafenib
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01769170
Conditions: CMV
Keywords: CMV Hematopoietic Stem Cell Transplant Recipients Prevention
Sponsor: Chimerix
Start date: 2013-08-01; Completion date: 2016-01-01
Enrollment: 452 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized, double-blind, placebo-controlled, parallel group, multicenter study compared the effectiveness of oral brincidofovir (BCV) to placebo for the prevention of cytomegalovirus (CMV) infection in stem cell transplant patients who were CMV seropositive but negative for CMV viremia before starting treatment with BCV.

Detailed description:
This was a randomized, double-blind, placebo-controlled, parallel group multicenter study of oral brincidofovir (BCV) in approximately 450 cytomegalovirus (CMV)-seropositive subjects who had undergone allogeneic hematopoietic stem cell transplantation (HCT). The study consisted of a screening evaluation and a treatment phase of 10 to 14 weeks. Dosing with the study drug (BCV or placebo) was initiated as soon as individual subjects could ingest tablets after transplant but no later than Day 28 post-transplant, and was continued through Week 14. All randomized subjects remained on study and followed the same scheduled study treatment. Study assessments were performed weekly from randomization through completion of the first post-treatment follow-up assessment at Week 15, and every 3 weeks thereafter through Week 24.

Arms: arm 1: Matching placebo administered orally twice weekly arm 2: 100 mg brincidofovir administered orally twice weekly
Interventions: intervention 1: Brincidofovir intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01774591
Conditions: Hypertension
Keywords: Post Menopause Female Obese
Sponsor: University of Chicago
Start date: 2013-01-01; Completion date: 2016-01-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the research is to evaluate the effect of azilsartan medoximil on blood pressure and urinary aldosterone levels in postmenopausal females.

Detailed description:
The study is a randomized, placebo-controlled trial of post-menopausal females with stage 1 hypertension. The goal is to randomize 40 post-menopausal females with stage 1 hypertension and assess whether azilsartan reduces urinary aldosterone levels. We will compare subjects having azilsartan medoximil (treatment group) with placebo group. Additionally, a small sub-study comparing pre-menopausal and post-menopausal female aldosterone levels was performed as well as the presence of aldosterone production in fat cell cultures of a subset of 3 patients in the randomized trial.

Arms: arm 1: Subjects randomized to azilsartan medoximil arm will take 80 mg of azilsartan medoximil tablets by mouth each day. arm 2: Subjects randomized to the placebo arm will take 80 mg of placebo tablets by mouth each day
Interventions: intervention 1: Azilsartan medoximil intervention 2: Placebo
Intervention descriptions: intervention 1: All subjects were randomized to 80mg azilsartan medoxomil (azilsartan) daily or placebo and followed for six months. intervention 2: All subjects were randomized to 80mg azilsartan medoxomil (azilsartan) daily or placebo and followed for six months.

Protocol documents:
Clinical trial NCT01801189
Conditions: Post-operative Pain
Sponsor: Legacy Health System
Start date: 2013-02-01; Completion date: 2016-01-01
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Randomized clinical trial to evaluate whether a single pre-operative dose of Pregabalin will alleviate post-operative pain and decrease post-operative analgesic requirements in morbidly obese patients undergoing laparoscopic gastric bypass surgery.

Detailed description:
Pregabalin is a popular adjunct for relieving neuropathic pain in diabetics. There have been multiple studies evaluating its use in pre and post-operative pain control in various surgeries. Post-operative pain control is a challenging problem in bariatric patients due to the high doses of narcotic required, related to the high body mass, and the danger of concomitant respiratory depression. In the obese patient, the goal of postoperative pain management is provision of comfort, early mobilization and improved respiratory function, without causing inadequate pain control, respiratory compromise or increased nausea.

Methods: A Randomized Controlled Trial, whereby patients undergoing Laparoscopic Roux-en-Y gastric bypass will be administered a single pre-operative dose of Pregabalin or a placebo. We plan to follow their immediate post-operative course in the hospital, with regard to the following primary endpoints:

* Post-operative analgesic requirements
* Post-operative pain scale (rated 0-10)
* Episodes of vomiting
* Post-operative antiemetic requirement
* Length of stay

Arms: arm 1: Single, 300 mg pre-operative oral dose of Pregabalin. arm 2: Single, placebo pre-operative dose.
Interventions: intervention 1: Pregabalin intervention 2: Placebo (for Pregabalin)
Intervention descriptions: intervention 1: One 300 mg oral dose of Pregabalin given before surgery. intervention 2: One oral dose of placebo given before surgery.

Protocol documents:
Clinical trial NCT01844726
Conditions: Psychiatric Illness Healthy
Keywords: healthy individuals schizophrenia schizoaffective disorder learning memory cognitive enhancement fMRI
Sponsor: Northwestern University
Start date: 2013-05-01; Completion date: 2016-01-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The present study proposes to evaluate the potential cognitive enhancing effects of GLYX-13, an NMDAR partial agonist, among a group of healthy adults and those with psychiatric illness on a series of functional magnetic resonance imaging (fMRI) learning and memory tasks.

Detailed description:
In a single blind randomized parallel group design, we will evaluate the whether a single dose of GLYX-13 vs. placebo increases cognitive performance on tasks of learning, declarative memory, and working memory, and associated task-related increases in blood oxygen level-dependent (BOLD) activation in hippocampus and dorsolateral prefrontal cortex, respectively. Positive findings will provide biomarker evidence for GLYX-13 effects on neural systems underlying these cognitive processes.

Arms: arm 1: Single IV infusion of GLYX-13, 5mg/kg, arm 2: Single IV administration of placebo
Interventions: intervention 1: GLYX-13 intervention 2: Placebo
Intervention descriptions: intervention 1: Single injection (5 mg/kg) of GLYX-13, an NMDAR partial agonist intervention 2: Single injection of placebo (saline)

Protocol documents:
Clinical trial NCT01861717
Conditions: Acromegaly
Keywords: excess growth hormone excess GH gigantism pituitary tumor pituitary adenoma growth hormone tumor GH secreting adenoma Somatuline lanreotide
Sponsor: Saint John's Cancer Institute
Start date: 2013-05-01; Completion date: 2016-01-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
If someone is diagnosed with a pituitary tumor that causes acromegaly (too much growth hormone) the treatment is to have it surgically removed. This study has two phases.

The first phase provides medical treatment with a drug that will be provided for 3 months before surgery to see if complications of surgery are reduced and to see whether or not remission improves following surgery if you have this medical treatment. The drug administered is approved by the FDA for long-term treatment of acromegaly. It is not routinely administered before surgery, and is therefore experimental as used in this way. All other procedures performed during this research are standard of care with the exception of the 3 questionnaires to be completed at each visit.

The second phase of this study is from 3 months until 12 months after surgery and is only for people who do not go into remission after the operation. This phase assesses the possible remission of acromegaly after resuming the drug treatment for an additional 3 to 9 months. The drug will be prescribed by your physician as part of your regular medical care and will not be included as part of the study. All other procedures performed during this research are standard of care with the exception of the 3 questionnaires to be completed at each visit.

The study lasts approximately 16 months - 3 month before surgery and 12 months after surgery.

Detailed description:

Arms: arm 1: Somatuline Depot SC 90mg deep subcutaneous injection every 4 weeks for 3 doses before surgery. The dose will be 60 mg for patients with mild liver or kidney dysfunction.
Interventions: intervention 1: lanreotide
Intervention descriptions: intervention 1: Somatuline Depot 90 mg deep subcutaneous injection every 4 weeks X 3 doses

Protocol documents:
Clinical trial NCT01878526
Conditions: Gastroesophageal Reflux Disease Systemic Sclerosis Scleroderma
Keywords: gastroesophageal reflux disease heart burn regurgitation systemic sclerosis scleroderma proton pump inhibitor alginic acid omeprazole prokinetic
Sponsor: Khon Kaen University
Start date: 2013-06-01; Completion date: 2016-01-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators purposes are to define the prevalence of omeprazole resistance gastroesophageal reflux disease (GERD) in systemic sclerosis (SSc), to compare the efficacy of omeprazole in combination with algycon versus omeprazole in combination with domperidone on the severity of reflux symptoms in omeprazole resistant GERD in SSc, and to compare the efficacy of omeprazole in combination with algycon versus omeprazole in combination with domperidone on the frequency of symptoms in omeprazole- resistant GERD in SSc.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Alginic acid intervention 2: placebo (for domperidone) intervention 3: Domperidone intervention 4: placebo (of alginic acid)
Intervention descriptions: intervention 1: Algycon 1 tab chew tid after meal intervention 2: placebo (for domperidone) 1 tab oral tid before meal intervention 3: domperidone (10 mg) 1 tab oral tid before meal intervention 4: placebo (for alginic acid) 1 tab chew tid after meal

Protocol documents:
Clinical trial NCT01907815
Conditions: Recurrent Adult Acute Myeloid Leukemia Untreated Adult Acute Myeloid Leukemia
Sponsor: National Cancer Institute (NCI)
Start date: 2013-10-01; Completion date: 2016-01-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well trametinib and protein kinase B (Akt) inhibitor GSK2141795 work in treating patients with acute myeloid leukemia. Trametinib and Akt inhibitor GSK2141795 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the proportion of patients achieving complete remission (CR) or CR with incomplete recovery of platelets (CRp) as best response within 4 cycles of therapy of trametinib in combination with GSK2141795 (Akt inhibitor GSK2141795) in acute myeloid leukemia (AML) patients with rat sarcoma (RAS) mutations.

SECONDARY OBJECTIVES:

I. To determine the disease-free survival of patients achieving CR/CRp. II. To determine the duration of response of patients achieving CR/CRp. III. To determine the toxicity profile of trametinib in combination with GSK2141795 in this patient population.

IV. To determine the biologic effects of trametinib in combination with GSK2141795 on leukemia cells.

OUTLINE:

Patients receive trametinib orally (PO) once daily (QD) and Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 12 weeks.

Arms: arm 1: Trametinib orally once daily (PO QD) and Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Akt Inhibitor GSK2141795 intervention 2: Laboratory Biomarker Analysis intervention 3: Trametinib
Intervention descriptions: intervention 1: Given PO intervention 2: Correlative studies intervention 3: Given PO

Protocol documents:
Clinical trial NCT01912495
Conditions: Hepatitis C Human Immunodeficiency Virus
Sponsor: Erasmus Medical Center
Start date: 2013-08-01; Completion date: 2016-01-01
Enrollment: 65 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Prospective open label proof of concept feasibility interventional clinical trial in which 60 acute HCV genotype 1 patients co-infected with HIV will receive 12 weeks of boceprevir in addition to Standard Of Care Peginterferon + Ribavirin if they show a Rapid Viral Responds at week 4.

The primary hypothesis of this study is that the subset of patients with a Rapid Viral Responds after 4 weeks of triple therapy with boceprevir, peginterferon alpha-2b (P) and ribavirin (RVR4) can be successfully treated with a shorter 12-week triple therapy regimen.

Detailed description:

Arms: arm 1: All patients were intended to be treated in the 12 week peginterferon, ribavirin and boceprevir arm.
Interventions: intervention 1: Boceprevir
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01930890
Conditions: Lupus Nephritis
Sponsor: Biogen
Start date: 2013-11-01; Completion date: 2016-01-01
Enrollment: 87 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB023 in participants with lupus nephritis (LN).

Detailed description:
This is an extension study for all participants who completed study 211LE201 (NCT01499355) through Week 52 and did not discontinue BIIB023 or placebo. Eligible participants from Study 211LE201 will be followed for up to 108 weeks.

Participants who received BIIB023 low dose or high dose in 211LE201 will continue to receive the same dosing in this study (211LE202; NCT01930890) in addition to background therapy. Participants who received placebo in 211LE201 are randomized to receive either BIIB023 low dose or high dose in addition to background therapy.

Arms: arm 1: Participants will receive BIIB023 3 mg/kg IV every 4 weeks through Week 100 plus background therapy including oral steroids (prednisone or equivalent) and mycophenolate mofetil (MMF). arm 2: Participants will receive BIIB023 20 mg/kg IV every 4 weeks through Week 100 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
Interventions: intervention 1: BIIB023 intervention 2: mycophenolate mofetil intervention 3: oral corticosteroids
Intervention descriptions: intervention 1: None intervention 2: titrated to a target daily dose of 2 g (1 g twice daily) intervention 3: oral corticosteroids (prednisone or equivalent) at a target prednisone dose of 10 mg/day

Protocol documents:
Clinical trial NCT01963845
Conditions: Non-alcoholic Fatty Liver Disease
Sponsor: University of California, San Diego
Start date: 2014-01-01; Completion date: 2016-01-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Nonalcoholic fatty liver disease (NAFLD) represents a spectrum of diseases ranging from simple steatosis to nonalcoholic steatohepatitis (NASH), the progressive form of liver disease that can lead to cirrhosis and liver-related mortality in persons who drink little or no alcohol. NAFLD is defined as the presence of hepatic steatosis with no evidence of hepatocellular injury in the form of ballooning of the hepatocytes. NASH is defined as the presence of hepatic steatosis and inflammation with hepatocyte injury (ballooning) with or without fibrosis. NASH is benign in many affected individuals but can cause progressive liver injury and, indeed, may be the major cause of cryptogenic cirrhosis1. Currently, there is no FDA approved treatment for NAFLD. Weight loss and exercise are the recommended but often difficult maintain these lifestyle changes in the long term and therefore therapeutic agents have been investigated. In this study, we propose to treat 50 patients with NAFLD and diabetes with either sitagliptin or placebo for 24 weeks. After an initial evaluation for insulin sensitivity and MRI liver fat distribution, patients will receive either 100 mg/day of sitagliptin or placebo. Patients will be monitored at regular intervals for symptoms of liver disease, side effects of sitagliptin and serum biochemical and metabolic indices. At the end of 24-weeks, patients will have a repeat medical evaluation, liver MRI and an optional liver biopsy. Pre and post treatment MRI-derived liver fat content and insulin sensitivity will be compared. The primary end point of successful therapy will be improvement in hepatic steatosis measured by MRI. Secondary end points will be improvement in insulin sensitivity and liver biochemistry.

Detailed description:
Primary objectives:

1\. To examine the efficacy of sitagliptin 100 mg orally daily versus placebo in improving hepatic steatosis assessed by magnetic resonance imaging in patients with NAFLD.

Secondary objectives:

1. To examine the efficacy of sitagliptin in improving serum AST in patients with NAFLD.
2. To examine the efficacy of sitagliptin in improving serum ALT in patients with NAFLD.
3. To examine the efficacy of sitagliptin in improving serum LDL in patients with NAFLD.
4. To examine the efficacy of sitagliptin in the improvement of insulin sensitivity in patients with NAFLD.

Arms: arm 1: Placebo arm 2: Sitagliptin 100 mg
Interventions: intervention 1: Sitagliptin intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01984684
Conditions: Skin and Subcutaneous Tissue Bacterial Infections Skin Structures and Soft Tissue Infections
Keywords: Bacterial skin infection infection skin delafloxacin vancomycin aztreonam methicillin-resistant Staphylococcus aureus (MRSA) bacteria bacterial infection Anti-Infective Agents
Sponsor: Melinta Therapeutics, Inc.
Start date: 2014-05-01; Completion date: 2016-01-01
Enrollment: 850 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effects of Delafloxacin versus Vancomycin plus Aztreonam in the treatment of patients with acute bacterial skin and soft tissue infections.

Detailed description:
The purpose of this study is to determine if delafloxacin, an investigational drug, is safe and effective in the treatment of skin and nearby tissue infections compared with a combination of other antibiotics, vancomycin and aztreonam.

Arms: arm 1: Delafloxacin 300 mg IV Q12H for 6 doses, then Delafloxacin 450 mg oral tablet Q12H for a minimum of 10 up to a maximum of 28 doses total arm 2: Vancomycin 15 mg/kg IV plus two grams Aztreonam every 12 hours for a minimum of 10 up to a maximum of 28 doses total (Aztreonam was discontinued as soon as possible if a gram-negative organism was not identified in baseline cultures)
Interventions: intervention 1: delafloxacin intervention 2: vancomycin intervention 3: aztreonam
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02000596
Conditions: Metastatic Breast Cancer
Keywords: HER2 overexpressed Metastatic Breast Cancer Elderly
Sponsor: University of Maryland, Baltimore
Start date: 2014-01-01; Completion date: 2016-01-01
Enrollment: 2 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase II study that combines Trastuzumab with Pertuzumab to see how it works in women age greater than 60 who have been diagnosed with HER2/neu overexpressed locally advanced and/or metastatic breast carcinoma.

Detailed description:
Currently available standard therapies for HER2 overexpressed metastatic breast cancers (MBC) include treatments with chemotherapy or hormonal therapy, alone or in combination with medications that target HER2 gene, such as Trastuzumab or Pertuzumab. This study will examine the effect of treating HER2 overexpressed MBC with the combination of Trastuzumab plus Pertuzumab, without hormonal or chemotherapy, as a first line treatment. If patients progress on this treatment, they will receive hormonal or chemotherapy in addition to the Trastuzumab plus Pertuzumab treatment. The objective is to see how the overall response rate for this treatment compares to other first line treatments in the same patient population.

Arms: arm 1: Trastuzumab plus Pertuzumab as first line treatment for HER2 overexpressed Metastatic Breast Cancer (without hormonal therapy or chemotherapy) arm 2: Hormonal Therapy with Anastrozole and Fulvestrant in addition Trastuzumab plus Pertuzumab for women who progressed on T+P alone, and who are ER/PR + arm 3: Chemotherapy with Eribulin in addition to Trastuzumab plus Pertuzumab for women who progressed on T+P alone and who are ER/PR -
Interventions: intervention 1: Trastuzumab plus Pertuzumab intervention 2: Hormonal Therapy with Anastrozole and Fulvestrant intervention 3: Chemotherapy with Eribulin
Intervention descriptions: intervention 1: None intervention 2: Anastrozole 1mg by mouth daily FULVESTRANT 500mg i.m. D1, D15, D28 then every 28-30 days intervention 3: None

Protocol documents: