ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01501110
Conditions: Acute Myocardial Infarction Euthyroid Sick Syndrome Ischemic Heart Disease
Keywords: Euthyroid Sick Syndrome low T3 syndrome deiodases oxidative stress ischemic heart disease
Sponsor: Federal University of Rio Grande do Sul
Start date: 2011-11-01; Completion date: 2013-11-01
Enrollment: 83 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The propose of this study is to determine whether N-acetylcysteine is effective in reversing the changes in thyroid hormones seen in critical illness, known as the low T3 syndrome.

Detailed description:
The low T3 syndrome or nonthyroidal illness is characterized by low levels of T3, normal or high normal levels of rT3, low or normal levels of T4 and inappropriately normal or low levels of TSH. These changes affect up to 75% of patients and have prognostic implications.

Interleukin-6 (IL6) seems to have a causative role in the pathogenesis of nonthyroidal illness. There is evidence that the reduction in serum T3 was inversely associated with serum IL-6, while the rT3 have a positive association. The mechanism of action of cytokines on the metabolism of thyroid hormones has not been determined and the potential role of cytokines on the deiodases has been the focus of research.

In a cell culture model study, IL-6 was able to suppress the conversion of T4 to T3 by deiodases type 1 and 2 and stimulate the inactivation of T3 by deiodase type 3, a situation similar to nonthyroidal illness. The use of N-acetylcysteine prevented this alterations, been consistent with the hypothesis that IL6 inhibits the function of the deiodases by increasing the oxygen reactive species and by consuming gluthathione or some gluthathione dependent cofactor.

Considering the absence of human studies evaluating the use of N-acetylcysteine in nonthyroidal illness, the aim of this study is to investigate whether NAC has in vivo effect on changes of thyroid hormones.

Arms: arm 1: intra-venous infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours. arm 2: No intervention
Interventions: intervention 1: N-acetylcysteine
Intervention descriptions: intervention 1: in infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours

Protocol documents:
Clinical trial NCT01508702
Conditions: Gout
Keywords: Gout
Sponsor: Ardea Biosciences, Inc.
Start date: 2012-01-01; Completion date: 2013-11-01
Enrollment: 214 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the serum uric acid lowering effects and safety of lesinurad compared to placebo in patients who are intolerant or have a contraindication to allopurinol or febuxostat.

Detailed description:
Allopurinol is the standard of care for the treatment of gout. In practice, approximately 20% of patients report side effects with allopurinol and 5% discontinue allopurinol due to side effects. Allopurinol can cause gastrointestinal intolerance, such as nausea and diarrhea, which appears to be dosedependent. Rash develops in about 2% of patients treated with allopurinol, and in about 20% of patients treated with allopurinol and ampicillin or amoxicillin. Allopurinol hypersensitivity syndrome remains a major concern among physicians. Mortality has been estimated to be up to nearly one quarter of AHS cases, with multiorgan system disease including hepatocellular changes and renal failure being a serious concern. Allopurinol is also relatively contraindicated for use in combination with 6-mercaptopurine and azathioprine, for which 1/4 to 1/3 lower doses must be given in order to avoid hematologic toxicity. Febuxostat, in clinical trials, has shown a similar AE profile to allopurinol. Liver function abnormalities, nausea, arthralgia and rash were the most commonly reported AEs. In postmarketing experience, Stevens Johnson Syndrome and hypersensitivity rashes have been reported (febuxostat prescribing information). Withdrawals due to AEs were similar in frequency to allopurinol as well. Relative contraindications in combination with 6-mercaptopurine and azathioprine are similar to allopurinol as well. Lesinurad may be an important therapeutic option for patients who either cannot tolerate or who have a contraindication to the use of allopurinol or febuxostat.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: lesinurad intervention 2: Placebo
Intervention descriptions: intervention 1: Tablets, 400 mg QD intervention 2: Tablets, Placebo QD

Protocol documents:
Clinical trial NCT01533922
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2012-03-01; Completion date: 2013-11-01
Enrollment: 295 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of this trial is to investigate the effect of 6 weeks treatment with tiotropium + olodaterol fixed dose combination inhalation solution on lung hyperinflation and exercise tolerance in patients with COPD

Detailed description:

Arms: arm 1: patient will receive tiotropium 5 mcg + olodaterol 5 mcg in a fixed dose combination once daily arm 2: patient will receive tiotropium 2.5 mcg + olodaterol 5 mcg in a fixed dose combination once daily arm 3: patient will receive tiotropium 5 mcg once daily arm 4: patient will receive olodaterol 5 mcg once daily arm 5: None
Interventions: intervention 1: Placebo intervention 2: Tiotropium intervention 3: Olodaterol intervention 4: tiotropium + olodaterol intervention 5: Tiotropium + Olodaterol intervention 6: Respimat
Intervention descriptions: intervention 1: placebo matching tiotropium + olodaterol FDC intervention 2: Tiotropium 5 mcg once daily intervention 3: Olodaterol 5 mcg once daily intervention 4: tiotropium + olodaterol 5 mcg once daily intervention 5: Tiotropium 2.5 mcg + Olodaterol 5 mcg once daily intervention 6: Respimat inhaler

Protocol documents:
Clinical trial NCT01539317
Conditions: Vulvodynia Dyspareunia Breast Cancer Menopause
Keywords: Vulvodynia Dyspareunia Breast Cancer Menopause Vaginal dryness Painful intercourse
Sponsor: OHSU Knight Cancer Institute
Start date: 2011-12-01; Completion date: 2013-11-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this protocol is to determine whether pain with sexual intercourse can be reduced in menopausal, breast cancer survivors and to evaluate the effectiveness of a non-hormonal therapy (Lidocaine Liquid) vs. a placebo liquid in reducing pain.

The investigators hypothesize that the pain arises in the vulvar vestibule. The investigators predict that the localized use of lidocaine will be more efficacious than use of placebo liquid.

Detailed description:
For this study there will be three visits over a 3 month period. Subjects will undergo a gynecological exam at the screening visit to determine the severity of pain associated with uncomfortable intercourse. A touch test using Q-tips will be used during screening exam so subjects can report pain during application of both study drug and placebo. Subjects will also report pain during tampon test. A sample of vaginal cells and liquid will be obtained at screening visit so that PI can rule out possible infection, disease, or disorders. PI will also show subject the area of the vestibule in a mirror so that subject can apply study drug at home properly. Subjects will fill out 4 questionnaires about medical and health history, cancer history, pain, and distress and sexual activity. Subject will be given a supply of either study drug or placebo to take home. The first visit will last approximately 2 hours.

Subjects will return for a second visit after 4 weeks and a third visit after 8 weeks for diary review, questionnaires, and examination. The second and third visit examinations will be repeats of the examination done at the first visit, but there will be no comparison with placebo, the PI will use only study drug during the touch test. The second and third visits will last approximately 1 hour.

Subjects will fill out questionnaires throughout study participation. Topics include; medical and health history, cancer history, pain, distress and sexual activity. Subjects will also fill out a diary that charts tampon test completed from home, sexual activity performed, pain levels and study drug application days.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Topical liquid lidocaine intervention 2: Topical saline
Intervention descriptions: intervention 1: active intervention drug numbs the hypersensitive mucosa of the vulvar vestibule intervention 2: saline applied to the vestibule mucosa will not reverse the local tenderness

Protocol documents:
Clinical trial NCT01539590
Conditions: Myocardial Infarction
Keywords: hepatocyte growth factor mimetic hepatocyte growth factor(HGF) Myocardial Infarction Acute ST Segment Elevation Myocardial Infarction (STEMI) Percutaneous Coronary Intervention (PCI)
Sponsor: Angion Biomedica Corp
Start date: 2012-07-01; Completion date: 2013-11-01
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will evaluate the effect of BB3 to preserve myocardial (heart) tissue and function following myocardial infarction (heart attack).

Detailed description:
Percutaneous coronary intervention (PCI) has become the mainstay for treatment of ST-segment elevation myocardial infarction (STEMI). Whereas early recanalization undoubtedly salvages myocardial tissue, reperfusion following prolonged ischemia can also exacerbate injury. Infarct size needs to be limited, and the conditions favoring adaptive ventricular healing and remodeling optimized because in patients with acute myocardial infarction (AMI) who do not die of out-of-hospital arrhythmias, long-term prognosis is dependent on the amount of myocardium that is lost, and the outcome of ventricular remodeling. Angion Biomedical Corp. has identified BB3, a small molecule mimetic of hepatocyte growth factor/scatter factor (HGF/SF) whose activity is expected to preserve tissue viability and attenuate dysfunction in the setting of organ injury while obviating the logistical difficulties associated with gene or protein therapy. HGF/SF is a naturally occurring cell survival factor that holds significant therapeutic potential. BB3 has been shown to possess HGF/SF activities, including protection against heart injury following myocardial infarction. This study is designed to evaluate clinical efficacy of BB3 in patients presenting with acute ST segment elevation myocardial infarction (A-STEMI) who undergo PCI.

Arms: arm 1: Daily intravenous administration of 2 mg/kg BB3 for four (4) days arm 2: Daily intravenous administration for four (4) days
Interventions: intervention 1: BB3 intervention 2: Normal saline
Intervention descriptions: intervention 1: Daily intravenous administration of 2 mg/kg BB3 for four (4) days intervention 2: Daily intravenous administration for four (4) days. The volume of normal saline will vary by estimated weight.

Protocol documents:
Clinical trial NCT01549041
Conditions: Schizophrenia
Keywords: schizophrenia asenapine Once daily twice daily
Sponsor: Duke University
Start date: 2012-04-01; Completion date: 2013-11-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators propose to explore: 1. the acceptance by patients of once versus twice daily dosing with asenapine, 2. the acceptance by staff of once versus twice daily dosing with asenapine, and 3. the changes in psychopathology associated with these two dosing strategies, in 30 patients with schizophrenia or schizoaffective disorder.

The investigators hypothesize that patient and staff acceptance will be better with once daily dosing and that improvements in psychopathology will be similar across once daily and twice daily dosing

Detailed description:
The investigators will randomly assign 30 patients newly admitted to Central Regional Hospital (CRH) for a psychotic exacerbation of schizophrenia or schizo-affective disorder to 14 days of treatment with either asenapine 5 mg BID or asenapine 10 mg QHS.

The investigators will assess patient and staff acceptance on day 14. The investigators will assess staff acceptance on day 14. The investigators will assess changes in psychopathology (Brief Psychiatric Rating Scale) from baseline to day 14.

The investigators propose to achieve the following specific aims:

1. To compare the patient acceptance of once daily versus twice daily asenapine; The investigators hypothesize that patient acceptance will be better for asenapine 10 mg QHS than for asenapine 5 mg BID at day 14
2. To compare the staff (medication nurses) acceptance of once daily versus twice daily asenapine; the investigators hypothesize that staff acceptance will be better for asenapine 10 mg QHS than for asenapine 5 mg BID at day 14
3. To compare the changes in psychopathology with once daily versus twice daily asenapine; the investigators hypothesize that changes in psychopathology from baseline to day 14 will be similar for the two dosing strategies

Arms: arm 1: Patients will receive their entire daily dose of asenapine as a single dose in the evening arm 2: Patients will receive asenapine 5 mg daily in the morning and 5 mg daily in the evening
Interventions: intervention 1: Asenapine 10 mg daily in the evening intervention 2: Asenapine 5 mg twice daily
Intervention descriptions: intervention 1: The total daily dose of Asenapine will be given once daily in the evening intervention 2: Asenapine will be given in two doses, 5 mg in the morning and 5 mg in the evening, daily

Protocol documents:
Clinical trial NCT01558492
Conditions: Prostate Cancer
Keywords: Metastatic Castrate Resistant Prostate Cancer CRPC
Sponsor: Weill Medical College of Cornell University
Start date: 2011-03-01; Completion date: 2013-11-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to look at the clinical benefit of carboplatin and paclitaxel and correlate response to study treatment with biologic parameters (i.e. lab studies of blood, urine, or tissue). It is hoped that this will allow researchers to gain insight into the underlying biology of prostate tumor progression and perhaps predict which patients may benefit from this chemotherapy regimen.

Detailed description:
Docetaxel/prednisone is the standard of care in patients with metastatic, castrate-resistant prostate cancer (CRPC) but duration of response is limited, with median time to prostate-specific antigen (PSA) progression of 6-8 months. There is currently no standard second-line therapy for patients who have progressed after receiving docetaxel. Carboplatin and paclitaxel have demonstrated activity, but prospective clinical trials evaluating this regimen are limited. In addition, correlative studies investigating why some patients respond are lacking.

Arms: arm 1: Carboplatin and Paclitaxel
Interventions: intervention 1: Carboplatin intervention 2: Paclitaxel
Intervention descriptions: intervention 1: AUC = 5 intravenously (IV) on day 1 of a 28 day cycle intervention 2: 80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle

Protocol documents:
Clinical trial NCT01566162
Conditions: Schizophrenia
Keywords: Lurasidone Latuda Schizophrenia
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2012-04-01; Completion date: 2013-11-01
Enrollment: 191 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a 12-week, multi-center, open-label extension study designed to evaluate the longer-term safety, tolerability and effectiveness of lurasidone for the treatment of subjects with schizophrenia.

Detailed description:
This is a 12-week, multi-center, open-label extension study designed to evaluate the longer-term safety, tolerability and effectiveness of lurasidone for the treatment of subjects with schizophrenia who have participated in Study D1050238, a double-blind, placebo-controlled, randomized withdrawal study of lurasidone for the maintenance treatment of subjects with schizophrenia. Subjects who have completed the 28-week double-blind phase or who have experienced a protocol-defined relapse event during the double-blind phase of study D1050238 will have the option to participate in this study. In addition, if/when the study is discontinued by the sponsor, all subjects participating in the open-label phase and the double-blind phase of study D1050238 will have the option to participate in this extension study

Arms: arm 1: Lurasidone 40 - 80mg flexible dose
Interventions: intervention 1: Lurasidone
Intervention descriptions: intervention 1: Lurasidone 40-80 mg taken orally taken once daily

Protocol documents:
Clinical trial NCT01568073
Conditions: Parkinson's Disease
Keywords: Parkinson PD Wearing-off Levodopa/DDCI
Sponsor: Bial - Portela C S.A.
Start date: 2011-03-01; Completion date: 2013-11-01
Enrollment: 600 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study aims to demonstrate the efficacy and safety of BIA 9-1067, compared with entacapone or placebo, when administered with the existing treatment of L-DOPA plus a Dopa Decarboxylase Inhibitor (DDCI), in patients with Parkinson's Disease (PD) and end-of-dose motor fluctuations.

Detailed description:
Efficacy and safety of BIA 9-1067 in idiopathic Parkinson's disease patients with "wearing-off" phenomenon treated with levodopa plus a dopa decarboxylase inhibitor (DDCI): a double-blind, randomised, placebo- and active-controlled, parallel-group, multicentre clinical study.

Arms: arm 1: OPC, Opicapone arm 2: Comtan®; Active comparator arm 3: PLC, Placebo
Interventions: intervention 1: BIA 9-1067 intervention 2: Entacapone intervention 3: Placebo intervention 4: Levodopa intervention 5: Carbidopa intervention 6: Benserazide
Intervention descriptions: intervention 1: 5, 25 and 50 mg of BIA 9-1067 (once-daily) intervention 2: 200 mg entacapone (concomitantly with each L-dopa/DDCI dose) intervention 3: 200 mg intervention 4: None intervention 5: DOPA decarboxylase inhibitor intervention 6: DOPA decarboxylase inhibitor

Protocol documents:
Clinical trial NCT01614743
Conditions: Rosacea
Keywords: Rosacea
Sponsor: DeNova Research
Start date: 2012-06-01; Completion date: 2013-11-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a double-blinded, randomized placebo controlled pilot study comparing the efficacy and safety of incobotulinumtoxinA versus saline injections to the cheek region in patients with rosacea.

The pilot study will enroll and treat a total of 10 subjects who present with rosacea of the cheek area. Upon study entry, subjects will be randomized to receive treatment with incobotulinumtoxinA or bacteriostatic saline to the cheek area. Study treatment will be prepared by an unblinded designee and both Physician Investigator (PI) and subject will remain blinded for the duration of the study. At the 16 week visit, control subjects will enter the rescue arm portion of the study and all study subjects will receive treatment with incobotulinumtoxinA to the cheek areas.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: IncobotulinumtoxinA intervention 2: Bacteriostatic saline
Intervention descriptions: intervention 1: Experimental injection given at baseline and Week 16 intervention 2: Placebo at baseline, incobotulinumtoxinA at 16 weeks

Protocol documents:
Clinical trial NCT01624259
Conditions: Type 2 Diabetes
Sponsor: Eli Lilly and Company
Start date: 2012-06-01; Completion date: 2013-11-01
Enrollment: 599 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to assess the benefits and risks of once-weekly dulaglutide compared to once-daily liraglutide in participants with type 2 diabetes who have inadequate glycemic control on metformin.

Detailed description:

Arms: arm 1: LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 26 weeks

Metformin: at least 1500 mg/day, oral, for 26 weeks arm 2: Liraglutide 0.6 mg, SC, once daily for 7 days, then titrated up to Liraglutide 1.2 mg, SC, once daily for 7 days, then titrated up to Liraglutide 1.8 mg, SC, once daily for 24 weeks

Metformin: at least 1500 mg/day, oral, for 26 weeks
Interventions: intervention 1: LY2189265 intervention 2: Liraglutide intervention 3: Metformin
Intervention descriptions: intervention 1: Administered SC intervention 2: Administered SC intervention 3: None

Protocol documents:
Clinical trial NCT01628692
Conditions: Hepatitis C Virus
Sponsor: Bristol-Myers Squibb
Start date: 2012-07-01; Completion date: 2013-11-01
Enrollment: 230 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the safety and efficacy of daclatasvir and simeprevir with and without ribavirin for genotype 1 chronic hepatitis C virus infection in patients who are treatment-naive or null responders to previous pegylated interferon/ribavirin therapy.

Detailed description:

Arms: arm 1: Participants with hepatitis C virus genotype 1b received daclatasvir, 30 mg, once daily with or without food + simeprevir, 150 mg, once daily with a meal for 12 weeks arm 2: Participants with hepatitis C virus genotype 1b received daclatasvir, 30 mg, once daily with or without food + simeprivir, 150 mg, once daily with a meal + ribavirin, twice daily with food (patients weighing \<75 kg received a total ribavirin dose of 1000 mg per day; those weighing \>=75 kg received 1200 mg per day) for 12 weeks. arm 3: Participants with hepatitis C virus genotype 1a received daclatasvir, 30 mg, once daily with or without food + simeprevir, 150 mg, once daily with a meal + ribavirin, twice daily with food (patients weighing \<75 kg received a total ribavirin dose of 1000 mg per day; those weighing \>=75 kg received 1200 mg per day) for 12 weeks. arm 4: Participants with hepatitis C virus genotype 1a received daclatasvir, 30 mg, once daily with or without food + simeprivir, 150 mg, once daily with a meal + ribavirin, twice daily with food (patients weighing \<75 kg received a total ribavirin dose of 1000 mg per day; those weighing \>=75 kg received 1200 mg per day.
Interventions: intervention 1: Daclatasvir intervention 2: Simeprevir intervention 3: Ribavirin
Intervention descriptions: intervention 1: Tablets, oral, 30 mg, once daily intervention 2: Capsule, oral, 150 mg, once daily intervention 3: Tablets, oral, 500-600 mg, twice daily

Protocol documents:
Clinical trial NCT01653262
Conditions: Epilepsy
Keywords: Brivaracetam Levetiracetam Epilepsy Nonpsychotic behavior
Sponsor: UCB Pharma SA
Start date: 2012-07-01; Completion date: 2013-11-01
Enrollment: 29 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Trial N01395 is to evaluate the reduction of nonpsychotic behavioral side effects in subjects with Epilepsy who switched to BRV 200 mg/day after discontinuing LEV due to such side effects; as well as the efficacy, safety and tolerability of BRV. No statistical hypothesis testing will be performed.

Detailed description:

Arms: arm 1: The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.

Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.

At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks.
Interventions: intervention 1: Brivaracetam
Intervention descriptions: intervention 1: None

Protocol documents: