ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01428219
Conditions: Prostate Cancer Metastatic
Keywords: Prostate Cancer Metastatic
Sponsor: University of Michigan Rogel Cancer Center
Start date: 2012-02-01; Completion date: 2015-09-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to look at the effects of cabozantinib on castrate-resistant prostate cancer metastatic (cancer that has spread to other parts of the body) to the bone and to learn about any side effects caused by taking cabozantinib.

Detailed description:
A significant proportion of patients with prostate cancer develop metastatic disease, which most commonly affects the skeleton. Bone metastases are the cause of significant morbidity and mortality in these patients, and require long-term management. Study participants in this research study will have a diagnosis of castration-resistant prostate cancer metastatic to bone.

Cabozantinib is not approved by the United States Food and Drug Administration (FDA) to treat people for castration-resistant prostate cancer metastatic to bone or for any other type of cancer. Giving cabozantinib to human cancer patients is experimental. Cabozantinib is currently being given to patients on other studies. Cabozantinib is known to have anti-tumor effects and to reduce bone metastases based on early clinical studies in prostate cancer and other cancers. The drug is known to have side effects. The most common side effects were fatigue, diarrhea, anorexia, rash, and palmar-plantar erythrodysesthesia (PPE) syndrome. To date, it is not known if cabozantinib is safe and/or effective.

Arms: arm 1: Cabozantinib is available in capsule form. The dose is 60 mg daily by mouth. Subjects with disease progression at 6 weeks who do not have significant toxicities may remain on therapy for an additional six weeks until a progression is confirmed. Further study drug administration beyond 12 weeks will be at the discretion of the investigator provided that the subject does not have disease progression, does not have unacceptable side effects, does not withdraw from study, or does not have a medical condition or illness that renders the subject unacceptable to receive further study drug.
Interventions: intervention 1: Cabozantinib
Intervention descriptions: intervention 1: Cabozantinib is available in capsule form. The dose is 60 mg daily by mouth. Subjects with disease progression at 6 weeks who do not have significant toxicities may remain on therapy for an additional six weeks until a progression is confirmed. Further study drug administration beyond 12 weeks will be at the discretion of the investigator provided that the subject does not have disease progression, does not have unacceptable side effects, does not withdraw from study, or does not have a medical condition or illness that renders the subject unacceptable to receive further study drug.

Protocol documents:
Clinical trial NCT01429272
Conditions: Bipolar Disorder Depression
Keywords: Bipolar Disorder Minocycline
Sponsor: Laureate Institute for Brain Research, Inc.
Start date: 2011-09-01; Completion date: 2015-09-01
Enrollment: 99 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether minocycline and aspirin are effective in the treatment of depression in individuals with bipolar disorder.

Detailed description:
Abstract:

New medication classes are needed to improve treatment effectiveness in the depressed phase of bipolar disorder (BD). Extant evidence suggests that BD is not only characterized by reduced monoaminergic signaling, but also by neural changes such as dendritic remodeling, demyelination, and glial and neuronal cell loss. These changes have been hypothesized to result from chronic inflammation, based partly on convergent evidence that proinflammatory cytokines are elevated in depressed patients with BD. The principal aims of the proposed research is to evaluate the antidepressant efficacy in bipolar depression of minocycline, a drug with neuroprotective and immune-modulating properties, and of aspirin, at doses expected to selectively inhibit cyclooxygenase 1 (COX-1), within the context of a randomized, double-blind, placebo-controlled, parallel-group clinical trial following a 2 x 2 design.

Specific Aims Specific Aim 1: To evaluate the efficacy of augmentation therapy with minocycline and/or aspirin for bipolar depression.

The investigators will test the hypothesis that compared with placebo, participants receiving minocycline and/ or aspirin will show a greater treatment response rate (defined as a \>50% increase on the MADRS for the final two consecutive visits).

Specific Aim 2: To investigate the relationship between the response to minocycline, aspirin and markers of inflammation (serum concentrations of IL-6 and CRP).

The investigators will test the hypotheses that: a) minocycline treatment will reduce inflammation to a greater extent than placebo; b) during minocycline treatment the change in inflammatory cytokine expression will correlate with the change in depression ratings; c) the baseline elevation of inflammatory markers will predict greater antidepressant response to minocycline.

Arms: arm 1: Placebo for minocycline \& placebo for aspirin arm 2: Minocycline 100mg PO BID for 6 weeks \& Aspirin 81 mg PO BID for 6 weeks
Interventions: intervention 1: Minocycline intervention 2: Aspirin intervention 3: placebo
Intervention descriptions: intervention 1: 100 mg po bid for 6 weeks intervention 2: 81 mg po bid for 6 weeks intervention 3: placebo for minocycline and/or aspirin

Protocol documents:
Clinical trial NCT01470001
Conditions: Post-micturition Incontinence Incontinence
Sponsor: University of Wisconsin, Madison
Start date: 2011-11-01; Completion date: 2015-09-01
Enrollment: 118 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a double-blind, randomized, controlled, parallel design (n=140) study with the purpose of measuring the efficacy of Solifenacin 5mg in the treatment of women with Post Void Dribbling.

Detailed description:
This investigation will have a double-blind, randomized, and controlled, parallel design with the % reduction in post void dribbling episodes (events) as the primary endpoint.

Secondary endpoints will include:

1. The % of patients with at least a 50% reduction in post void dribbling episodes.
2. Patient's perspective of the impact of their disease, which will be captured using the Pelvic Floor Distress Inventory, and another questionnaire that asks about urinary symptoms and quality of life.

We will compare Solifenacin 5 mg to placebo. 140 subjects will be enrolled, with 70 subjects in each arm. The treatment group will receive 5mg of Solifenacin daily for 12 weeks. Astellas Pharma will be supplying both drug and placebo, they will be prepackaged and numbered. The Pharmaceutical Research Center will randomly assign subjects into the treatment vs. placebo group blinding both the subjects and investigators

Arms: arm 1: patients in this arm will receive drug arm 2: patients is this arm will receive placebo
Interventions: intervention 1: solifenacin
Intervention descriptions: intervention 1: patient will receive solifenacin 5mg daily or placebo daily

Protocol documents:
Clinical trial NCT01480232
Conditions: Nicotine Dependence Smoking Cessation
Sponsor: A. Eden Evins
Start date: 2011-12-01; Completion date: 2015-09-01
Enrollment: 345 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to evaluate the initial evidence for efficacy of the investigational medicine, EVP-6124, to improve smoking cessation outcomes with and without a standard taper of nicotine replacement therapy (NRT) in healthy nicotine dependent smokers

Detailed description:

Arms: arm 1: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days) arm 2: One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days) arm 3: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days) arm 4: One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)
Interventions: intervention 1: EVP-6124 intervention 2: Placebo Capsule intervention 3: NicoDerm Patch (Active) intervention 4: NRT Patch (Placebo) intervention 5: Brief Supportive and Behavioral Treatment
Intervention descriptions: intervention 1: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) intervention 2: One placebo capsule ingested orally daily for 12 weeks (84 days) intervention 3: One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6). intervention 4: One NRT patch (Placebo) daily for first 6 weeks (42 days). intervention 5: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association.

Protocol documents:
Clinical trial NCT01480843
Conditions: Diabetes
Keywords: simplification glargine elderly
Sponsor: Joslin Diabetes Center
Start date: 2011-06-01; Completion date: 2015-09-01
Enrollment: 65 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to find out if simplifying your diabetes treatment by decreasing number of insulin injections, with the help of a long acting insulin called glargine, can decrease the episodes of low blood glucose.

Detailed description:
As patients with diabetes age, adverse social and medical problems may arise. Because of these problems patients, even those managing their diabetes for many years, find it difficult to continue with complicated insulin schedules. This may lead to errors in treatment and poor glucose control. Simplification of treatment has been found to the decrease risk of low blood glucose, a very dangerous condition at this age. In a previous study, the investigators found that simplifying treatment did not cause the blood sugars to rise out of control. In this study, the investigators plan to simplify insulin treatment and monitor for low glucose episodes with help of a continuous glucose monitor and A1C (measure of average glucose control over 3 months). The investigators will simplify the treatment by adding glucose lowering medications that you can take by mouth, in addition to the injection of long acting insulin called glargine.

Arms: arm 1: We plan to add long acting insulin glargine with/without oral medications to the regimen in all patients.
Interventions: intervention 1: Glargine
Intervention descriptions: intervention 1: Use of glargine with/without other glucose lowering agent to simplify insulin regimen in older adults

Protocol documents:
Clinical trial NCT01504867
Conditions: Acute Respiratory Distress Syndrome
Keywords: Acute Respiratory Distress Syndrome Acute Lung Injury ARDS ALI aspirin prevention
Sponsor: Mayo Clinic
Start date: 2012-01-01; Completion date: 2015-09-01
Enrollment: 400 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary hypothesis was that early aspirin administration will decrease the rate of developing acute lung injury during the first 7 days after presentation to the hospital.

Detailed description:
Acute respiratory distress syndrome (ARDS) remains a life-threatening critical care syndrome characterized by alveolar-capillary membrane injury and hypoxemic respiratory failure. The median time to onset of ARDS is 2 days after hospital presentation. Therefore, the period between hospital presentation and the development of ARDS presents a brief window of opportunity for ARDS prevention.

This was a multicenter, double-blind, placebo-controlled, parallel-group, Phase 2b, randomized clinical trial. Development of ARDS was defined by Berlin criteria (modified to require invasive mechanical ventilation) within 7 days of hospital admission. The first dose of study drug or placebo was administered within 24 hours after presentation to the hospital. Important co-interventions were standardized across sites using a web-based tool, Checklist for Lung Injury Prevention. Study participants were screened daily for receipt of mechanical ventilation and determination of the partial pressure of arterial oxygen (PaO2) or oxygen saturation to fraction of inspired oxygen ratio (SpO2:FIO2). If the participant's SpO2:FIO2 ratio was consistently below 315, hypoxemia was confirmed with measurement of arterial blood gas. Chest radiographs for all intubated patients with a SpO2:FIO2 of 300 or less were independently reviewed by both site investigator and a member of the trial's executive committee. Study participants who died or were discharged from the hospital before day 7 without meeting criteria for ARDS were adjudicated as not having ARDS.

Arms: arm 1: This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7. arm 2: This group received matching lactose powder filled capsules on days 1-7.
Interventions: intervention 1: Aspirin intervention 2: Lactose powder
Intervention descriptions: intervention 1: 325mg loading dose once on study day 1, followed by 81mg dose once daily on study days 2-7. Administered by mouth or down nasal gastric tube. intervention 2: Matching lactose powder filled capsules will be administered on days 1-7.

Protocol documents:
Clinical trial NCT01516957
Conditions: Psoriatic Arthritis
Keywords: Psoriatic Arthritis IL-17 AMG 827 AMG827 Musculoskeletal Disease Spondylarthropathy
Sponsor: Bausch Health Americas, Inc.
Start date: 2011-10-01; Completion date: 2015-09-01
Enrollment: 168 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will examine the safety and effectiveness of AMG 827 for the treatment of psoriatic arthritis

Detailed description:
The study will examine the safety and effectiveness of AMG 827 for the treatment of psoriatic arthritis. Patients will randomly receive either AMG 827 or placebo (a look-a-like liquid that does not have any drug in it) and neither the doctor nor the patient will know what treatment is being given.

Arms: arm 1: 140 mg AMG 827 arm 2: Placebo arm 3: 280 mg AMG 827 arm 4: AMG 827 SC 210 mg
Interventions: intervention 1: AMG 827 140 intervention 2: Placebo intervention 3: AMG 827 280 intervention 4: AMG 827 210
Intervention descriptions: intervention 1: 140 mg AMG 827 SC (subcutaneous) intervention 2: Placebo SC (subcutaneous) intervention 3: 280 mg AMG 827 SC (subcutaneous) intervention 4: 210 mg AMG 827 SC (subcutaneous)

Protocol documents:
Clinical trial NCT01529268
Conditions: Nonalcoholic Fatty Liver Disease (NAFLD)
Keywords: Nonalcoholic Fatty Liver Disease (NAFLD) Cysteamine bitartrate delayed release Children
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date: 2012-06-01; Completion date: 2015-09-01
Enrollment: 169 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
CyNCh is a multi-center, placebo-controlled clinical trial of children ages 8 to 17 years with biopsy-confirmed moderate to severe nonalcoholic fatty liver disease (NAFLD). The primary objective is to evaluate whether 52 weeks of treatment with cysteamine bitartrate delayed-release capsules will result in improvement in liver disease severity.

Detailed description:

Arms: arm 1: Active DR cysteamine bitartrate capsule arm 2: Placebo DR cysteamine bitartrate capsule
Interventions: intervention 1: DR cysteamine bitartrate capsule intervention 2: DR cysteamine bitartrate placebo
Intervention descriptions: intervention 1: * 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline
* 750 mg/day (five 75 mg capsules twice daily) for patients \>65 - 80 kg at baseline
* 900 mg/day (six 75 mg capsules twice daily) for patients \>80 kg at baseline intervention 2: * 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline
* 750 mg/day (five 75 mg capsules twice daily) for patients \>65 - 80 kg at baseline
* 900 mg/day (six 75 mg capsules twice daily) for patients \>80 kg at baseline

Protocol documents:
Clinical trial NCT01545336
Conditions: Pulmonary Arterial Hypertension
Sponsor: University of Pennsylvania
Start date: 2012-10-01; Completion date: 2015-09-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this clinical trial is to study the safety and efficacy of anastrozole in adults diagnosed with pulmonary arterial hypertension (PAH). The study will evaluate how well the drug is tolerated. The study will also evaluate if anastrozole effects estradiol (E2) hormone levels, a sex hormone, and improves the function of the lower right chamber of the heart (right ventricle).

Detailed description:

Arms: arm 1: 1 mg tablet by mouth once daily for 3 months arm 2: Placebo tablet by mouth once daily for 3 months
Interventions: intervention 1: Anastrozole intervention 2: Placebo
Intervention descriptions: intervention 1: 1 mg tablet to be taken 1 time daily intervention 2: 1 mg tablet to be taken 1 time daily

Protocol documents:
Clinical trial NCT01557946
Conditions: MDD Citalopram Major Depressive Disorder
Sponsor: Mclean Hospital
Start date: 2012-03-01; Completion date: 2015-09-01
Enrollment: 32 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Primarily, this study seeks to evaluate whether citalopram treatment is associated with an increase in the Glutamine (Gln)/Glutamate (Glu) ratio in the anterior cingulate cortex (ACC) from baseline to day 3 of treatment. Additionally, this study would like to examine whether citalopram treatment is associated with an increase in the Gln/Glu ratio in the ACC from baseline to day 7 of treatment. In order to more fully examine baseline neurochemical and functional abnormalities in participants with MDD, we also seek to scan a group of age- and sex-matched non-depressed comparison individuals in order to perform between-group analyses of baseline neuroimaging measures.

Detailed description:
Little is known about the acute effects of standard antidepressant treatments on brain glutamate and gamma-amino-butyric acid (GABA) levels, and their association with clinical response. In the current study, we used proton magnetic resonance spectroscopy (1H-MRS) to examine longitudinally the effects of citalopram on the glutamine/glutamate ratio and GABA levels in the pregenual anterior cingulate cortex (pgACC) - a region that has been repeatedly implicated in antidepressant response - of individuals with major depressive disorder (MDD). We acquired 1H-MRS scans at baseline and at days 3, 7, and 42 of citalopram treatment in nineteen unmedicated individuals with MDD. Ten age- and sex-matched non-depressed comparison individuals were scanned once and did not receive citalopram. The association between baseline metabolites and the change in metabolites from baseline to each time point and change in Montgomery-Åsberg Depression Rating Scale (MADRS) score from baseline to day 42 was assessed by longitudinal regression analysis, adjusting for age, sex, and baseline MADRS, using generalized estimating equations.

Arms: arm 1: Participants with major depressive disorder received citalopram 20-40 mg daily for 6 weeks. MRI scans were acquired at baseline and days 3, 7, and 42. arm 2: Healthy volunteer participants did not receive citalopram and performed one MRI scan.
Interventions: intervention 1: citalopram
Intervention descriptions: intervention 1: citalopram 20-40 mg daily

Protocol documents:
Clinical trial NCT01566409
Conditions: Constipation
Keywords: Constipation Maintenance treatment Ultrasound of rectum
Sponsor: Line Modin
Start date: 2013-09-01; Completion date: 2015-09-01
Enrollment: 115 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Constipation is a common problem among children. The majority of children suffering from constipation have no underlying disease. Although constipation has no basis in underlying disease, it often leads to a reduced quality of life of children who are on par with or worse than for children suffering from serious diseases such as cardiovascular and rheumatic diseases.

Despite the high frequency of constipation among children, little is known about the causes and treatment of constipation.

Treatment consists of symptomatic treatment with various laxatives. Movicol and Movicol junior has proven very effective and are therefore widely used in children as disimpaction and maintenance treatment. There is currently no research to prove the need for and length of maintenance treatment with laxative medications in children.

The purpose is to examining the effectiveness of maintenance treatment with Movicol. Additional til study will examine how the anal diameter change during a course of treatment and the degree to which it can be used as an indicator of treatment efficacy.

The study will test the following:

• What is the effect of maintenance treatment with PEG compared to placebo?

The results from this study are expected to form the basis for an evidence-based approach to the use of maintenance therapy and the use of ultrasound of the rectum in children with constipation.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Polyethylene glycol 3350 intervention 2: Placebo
Intervention descriptions: intervention 1: Powder for solution. Each sachet contains 13.125 g of macrogol 3350. Disimpaction dosage consists of 1,5 g/kg, maintenance treatment are adjusted according til the Bristol stool chart. The drug can be taken at anytime of the day and can also be divided. Treatment duration up to ½ year. intervention 2: Placebo will be manufactured and packaged as a powder to make it identical to the bags with the PEG 3350. The powder will comprise of a non-active substance, like a mild rehydration solution, which is a composition consisting of salt and sugar.

Protocol documents:
Clinical trial NCT01581970
Conditions: Head and Neck Cancer Head and Neck Squamous Cell Carcinoma
Keywords: head and neck cancer metastatic squamous cell cancer
Sponsor: Masonic Cancer Center, University of Minnesota
Start date: 2012-06-01; Completion date: 2015-09-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a feasibility study to assess the effectiveness of cetuximab when administered with low dose oral cyclophosphamide. Patients with metastatic squamous cell cancer of head and neck who have progressed on first line chemotherapy other than a cetuximab containing regimen will be treated with standard of care weekly cetuximab and twice daily low dose oral cyclophosphamide for 12 weeks.

Detailed description:
In this study, patients with head and neck squamous cell carcinoma (HNSCC) will be given low-dose cyclophosphamide in combination with standard of care cetuximab. Tumor biopsies will be collected before and six weeks after treatment for measurement of tumor infiltration by effector cells, including CD8+ T cells, natural killer (NK) cells, and monocytes. In addition, the proportion of Regulatory T Cells (Tregs) to effector cells will be measured in peripheral blood at the same time points.

Arms: arm 1: Safety population as defined by all patients receiving at least one treatment with cyclophosphamide on Day 1.
Interventions: intervention 1: Cyclophosphamide intervention 2: Cetuximab
Intervention descriptions: intervention 1: Patients will be given oral cyclophosphamide 50 mg twice daily to be self-administered starting the first day of therapy with weekly cetuximab for 12 weeks or until disease progression. intervention 2: The initial dose of cetuximab 400 mg/m\^2 is administered over 120 minutes followed by weekly infusions of cetuximab 250 mg/m\^2 intravenously (IV) over 60 minutes.

Protocol documents: