ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01436110
Conditions: Asthma
Sponsor: GlaxoSmithKline
Start date: 2011-09-01; Completion date: 2012-09-01
Enrollment: 351 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A randomised, double-blind, double-dummy, placebo controlled multi-centre study to evaluate the efficacy and safety of fluticasone furoate inhalation powder and fluticasone propionate inhalation powder in the treatment of asthma in adults and adolescents not currently treated with inhaled corticosteroids

Detailed description:
This will be a multi-centre, randomised, placebo and active controlled (with rescue medication), double-blind, double-dummy, parallel-group study. Subjects meeting all the inclusion criteria and none of the exclusion criteria during Visit 1 (Screening Visit) will enter a two week Run-in Period. Subjects failing screening will not be eligible for re-screening. During the run-in and double-blind treatment periods subjects will maintain an electronic daily diary to record morning and evening peak expiratory flow (PEF), asthma symptom scores and rescue albuterol/salbutamol use. At Visit 2 (end of run-in/Randomisation Visit), subjects meeting the eligibility criteria will be randomised receive treatment with either fluticasone furoate 50 mcg once daily, fluticasone propionate 100 mcg twice daily or placebo. In addition all subjects will be supplied with albuterol/salbutamol inhalation aerosol to use as required to treat symptoms. Subjects will attend 6 on-treatment visits at Visits 3, 4, 5, 6, 7 and 8 (Weeks 2, 4, 8, 12, 18 and 24 respectively). Subjects will receive treatment for 24 weeks. A follow-up contact will be performed 1-week after completing study medication (Visit 9). Subjects will participate in the study for up to a maximum of 27 weeks (including screening, treatment and follow-up contact).

Arms: arm 1: Once daily inhalation powder via Novel Dry Powder Inhaler arm 2: Twice daily inhalation powder via DISKUS/ ACCUHALER arm 3: Inhalation Powder via Novel Dry Powder Inhaler and DISKUS/ ACCUHALER
Interventions: intervention 1: Fluticasone furoate 50mcg intervention 2: Fluticasone propionate 100mcg intervention 3: Placebo
Intervention descriptions: intervention 1: Once daily inhalation powder via Novel Dry Powder Inhaler intervention 2: Twice daily inhalation powder via DISKUS/ACCUHALER intervention 3: Inhalation powder via Novel Dry Powder Inhaler and DISKUS?ACCUHALER

Protocol documents:
Clinical trial NCT01451645
Conditions: Intercritical Gout
Keywords: Gout
Sponsor: Regeneron Pharmaceuticals
Start date: 2011-10-01; Completion date: 2012-09-01
Enrollment: 82 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if once-daily treatment with colchicine, compared to placebo, is effective in preventing gout flares in patients who are initiating therapy with allopurinol.

Detailed description:

Arms: arm 1: daily placebo dosing for 16 weeks with background allopurinol therapy arm 2: daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
Interventions: intervention 1: Colchicine (Colcrys®) intervention 2: placebo intervention 3: allopurinol
Intervention descriptions: intervention 1: daily 0.6 mg colchicine dosing for 16 weeks intervention 2: daily placebo dosing for 16 weeks intervention 3: background therapy

Protocol documents:
Clinical trial NCT01451762
Conditions: Surgery Pain
Keywords: pain anesthesia surgery postoperative
Sponsor: Northwestern University
Start date: 2011-09-01; Completion date: 2012-09-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Pain after ambulatory surgery remains an unsolved problem in The United States and Europe. It is associated with delayed hospital discharge and it can result to an increased opioid consumption with adverse side effects. The concept of multimodal analgesic technique was introduced more than 15 years ago and several techniques have been studied over the years including non steroidal antiinflammatory drugs (NSAIDs), acetaminophen, gabapentoids, ketamine, local and regional anesthetic techniques. Histamine can have effects on polymodal nociceptors and C-fibers, producing pain which is further increased by neurogenically mediated release of substance P from afferent pain fibers. Several non-selective or H1 -selective histamine receptors antagonists have been demonstrated in animal models and clinical pain. Chia et al demonstrated that preoperative promethazine had opioid sparing properties without adverse sedative effects in patients undergoing abdominal hysterectomy.

Diphenhydramine is an anti-histamine drug who has been found to be effective in reducing postoperative nausea and vomiting after ambulatory surgery but its effects on postoperative pain and other important outcomes after ambulatory surgery such as time to meet discharge criteria have not being studied.

The MQOR 40 is a validated instrument that was specifically design to evaluate patient recovery after anesthesia and surgery. This instrument can be particularly valid to examine interventions which affect different spheres of patient recovery as is the case of diphenhydramine. The objective of this study is to determine a dose response effect of preoperative diphenhydramine on postoperative quality of recovery after ambulatory surgery. The use of preoperative diphenhydramine can improve patient's quality of recovery, decrease postoperative pain, opioid consumption and opioid related side effects after ambulatory surgery.

The research question: Does a preoperative dose of diphenhydramine improve postoperative quality of recovery after ambulatory surgery? The hypothesis of this study is that preoperative diphenhydramine will improve postoperative pain, Postoperative nausea and vomiting (PONV), sleep which will translate in a better overall quality of recovery.

Detailed description:

Arms: arm 1: .9 normal saline IV arm 2: 25 mg diphenhydramine IV administered before surgery arm 3: 50 mg diphenhydramine IV administered before surgery
Interventions: intervention 1: .9 normal saline intervention 2: 25 mg diphenhydramine IV intervention 3: 50 mg diphenhydramine IV
Intervention descriptions: intervention 1: .9 normal saline administered before surgery. intervention 2: 25 mg diphenhydramine IV administered before surgery intervention 3: 50 mg diphenhydramine administered IV before surgery

Protocol documents:
Clinical trial NCT01452919
Conditions: Schizophrenia
Keywords: schizophrenia, LY2140023, pomaglumetad methionil
Sponsor: Denovo Biopharma LLC
Start date: 2011-11-01; Completion date: 2012-09-01
Enrollment: 123 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether or not people with schizophrenia who take LY2140023 become physically dependent on it, and experience a series of symptoms such as craving to have the drug when they stop using it.

This trial consists of two phases: An open-label phase consisting of up to 4 weeks and a double-blind phase consisting of up to 3 weeks.

Detailed description:
This was a short-term, multicenter, placebo-controlled, randomized withdrawal study comparing LY2140023 with placebo in the treatment of outpatients with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR \[APA 2000\]) schizophrenia. Patients were male or female outpatients, 18 to 65 years of age (inclusive) at study entry, with a diagnosis of schizophrenia as defined in the DSM-IV-TR

The primary objective of this study was to assess whether LY2140023, when administered in an acute-treatment trial with flexible doses (40 mg or 80 mg) BID, was associated with physical dependence, as measured by the occurrence of withdrawal symptoms during a randomized withdrawal phase in patients diagnosed with schizophrenia. Assessment was to be based on a comparison of randomized LY2140023-treated patients with those on placebo, as measured by the maximum of the 3-day moving average of the patient's total score on the Discontinuation Symptom Checklist-Modified Rickels (DSCMR).

Arms: arm 1: Open label phase: 40 milligram (mg) LY2140023 administered orally; given twice daily for up to 4 weeks. At the discretion of the investigator, dose may be adjusted one time to 80 mg. 80 mg dose may be adjusted back to 40 mg one time. Current dose level at randomization will remain constant through the double blind phase.

Double blind phase: 40 mg or 80 mg LY2140023 administered orally; given twice daily for up to 3 weeks. arm 2: Open label phase: 40 mg LY2140023 administered orally; given twice daily for up to 4 weeks. At the discretion of the investigator, dose may be adjusted one time to 80 mg. 80 mg dose may be adjusted back to 40 mg one time.

Double blind phase: placebo administered orally; given twice daily for up to 3 weeks.
Interventions: intervention 1: LY2140023 intervention 2: Placebo
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally

Protocol documents:
Clinical trial NCT01501162
Conditions: Alcoholic Liver Disease
Keywords: hepatitis, alcohol
Sponsor: Chuncheon Sacred Heart Hospital
Start date: 2010-10-01; Completion date: 2012-09-01
Enrollment: 130 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Background/Aims:

The investigators explored the therapeutic effects of probiotics in patients with AH.

Methods:

Between September 2010 and April 2012, the investigators conducted a 7-day, double-controlled, randomized, prospective clinical trial comparing the efficacy of probiotics in improving liver enzymes, LPS, pro-inflammatory cytokines. AH was defined as an aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \> 2 and elevated AST (ALT) level with an alcohol consumption history within 48 hours. Patients were randomized to receive 7 days of probiotics (1500 mg/day) or placebo. The levels of liver enzymes, modified Discriminant Function (mDF), LPS, and pro-inflammatory cytokines were checked at baseline and again after therapy.

Detailed description:
Background/Aims: Alcoholic hepatitis (AH) is one of the leading causes of liver diseases. Gut-derived microbial lipopolysaccharide (LPS) has been known as a central role in the pathogenesis of AH. Some animal studies suggested an emerging role of probiotics in restoration of the bowel flora and improving liver enzymes. We explored the therapeutic effects of probiotics in patients with AH.

Methods: Between September 2010 and April 2012, we conducted a 7-day, double-controlled, randomized, prospective clinical trial comparing the efficacy of probiotics in improving liver enzymes, LPS, pro-inflammatory cytokines. AH was defined as an aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \> 2 and elevated AST (ALT) level with an alcohol consumption history within 48 hours. Patients were randomized to receive 7 days of probiotics (1500 mg/day) or placebo. The levels of liver enzymes, modified Discriminant Function (mDF), LPS, and pro-inflammatory cytokines were checked at baseline and again after therapy.

Arms: arm 1: We explored the therapeutic effects of probiotics in patients with alcoholic hepatitis arm 2: We explored the therapeutic effects of probiotics in patients with alcoholic hepatitis
Interventions: intervention 1: hepatitis, alcohol, probiotics intervention 2: alcohol, hepatitis, Placebo
Intervention descriptions: intervention 1: 7 days of probiotics (1500 mg/day) intervention 2: Placebos of the same shape and size were manufactured at Pharmaceutical Corporation.

Protocol documents:
Clinical trial NCT01512849
Conditions: Type 2 Diabetes Mellitus
Keywords: TA-7284 JNJ-28431754 Canagliflozin Renal Impairment Sodium Glucose Co-transporter2 (SGLT2) inhibitor
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2012-01-01; Completion date: 2012-09-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate the PK/PD and safety of TA-7284 in patients with type 2 diabetes mellitus who have moderate renal impairment.

Detailed description:
This is an open-label, randomized, 2-way crossover study to evaluate the PK/PD and safety of TA-7284 in patients with type 2 diabetes mellitus who have moderate renal impairment relative to patients with type 2 diabetes mellitus who have normal renal function. The patients will receive both TA-7284-Low and TA-7284-High orally alone in either Period 1 or 2.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: TA-7284 Low intervention 2: TA-7284 High
Intervention descriptions: intervention 1: Low intervention 2: High

Protocol documents:
Clinical trial NCT01513317
Conditions: Myelodysplastic Syndrome
Keywords: Myelodysplastic Syndrome MDS Blood and lymphatic diseases Siltuximab Anemic
Sponsor: Janssen Research & Development, LLC
Start date: 2011-11-01; Completion date: 2012-09-01
Enrollment: 76 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy of siltuximab, demonstrated by a reduction in red blood cell (RBC), transfusions to treat the anemia of Myelodysplastic Syndrome (MDS).

Detailed description:
The study treatments will be administered double-blind for 12 weeks, meaning that the patient and study personnel will not know the identity of the treatment. Approximately 75 patients will be randomized (patients are assigned to a treatment by a chance) in a 2:1 ratio to receive siltuximab plus best supportive care (BSC) (Group A) or placebo plus BSC (Group B). BSC includes RBC transfusion, antimicrobials, white blood cell (WBC) growth factors, and platelet transfusions. Patients who complete 12 weeks of treatment may qualify to receive siltuximab as open-label (identity of treatment will be known) treatment. Treatment may continue until death, unacceptable toxicity, withdrawal of consent, or the clinical cutoff (defined as 24 weeks after the last patient is randomized), whichever occurs first. The study will end approximately 36 weeks after the last patient is randomized. Patient safety will be monitored. Siltuximab and matching placebo will be supplied as a sterile, lyophilized formulation for reconstitution and intravenous (IV) infusion. Group A: siltuximab (15 mg/kg) administered as a 1-hour infusion every 4 weeks + BSC, or Group B: placebo administered as a 1-hour infusion every 4 weeks + BSC.

Arms: arm 1: 15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC) arm 2: Placebo administered as a 1-hour infusion every 4 weeks + BSC
Interventions: intervention 1: Siltuximab intervention 2: Placebo intervention 3: Best supportive care (BSC)
Intervention descriptions: intervention 1: 15 mg/kg administered as a 1-hour intravenous infusion every 4 weeks intervention 2: Administered as a 1-hour intravenous infusion every 4 weeks intervention 3: Best supportive care according to local standards and guidelines

Protocol documents:
Clinical trial NCT01517295
Conditions: Chronic Pain
Keywords: Pharmacokinetics Hydromorphone Hydrocodone APAP
Sponsor: NEMA Research, Inc.
Start date: 2012-02-01; Completion date: 2012-09-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Objective is to evaluate the pharmacokinetics profile of hydrocodone's metabolite hydromorphone in patients who are taking hydrocodone on a routine basis for more than 3 months for chronic pain and correlate hydromorphone levels to their hydrocodone usage.

Detailed description:
Hydrocodone combinations are the most commonly prescribed pain medications in the United States. All the current available Hydrocodone formulations are short acting and have Acetaminophen/Ibuprofen in them. Chronic pain patients who take pain medications for extended time are overloaded with Acetaminophen and there is a very serious concern about liver failure from excessive concurrent alcohol use. Also all the current hydrocodone combinations available in the U.S. are short acting and provide pain relief for 3-6 hrs.

Hydromorphone is a metabolite of Hydrocodone and plays a significant role in providing pain relief in these patients. Although there are no long acting or extended release hydrocodone formulations that are FDA approve at this time, there is once a day extended release Hydromorphone (ER) approved by FDA and is currently marketed under the name Exalgo ®. PK study of chronic hydrocodone/acetaminophen usage is important to determine equivalent potency with hydromorphone ER, so that clinicians can use a simple conversion formula to switch to hydromorphone ER.

Although medical professionals use the Opiate conversion formula on a regular basis for Opioid rotation, there are no published studies showing the pharmacokinetic data in patients taking hydrocodone for chronic pain.

Our goal is to use this PK data to guide clinicians with this data in using extended release hydromorphone for chronic pain management to provide predictable pain relief and minimize the acetaminophen usage.

Arms: arm 1: Blood will be drawn at 0, 1, 3, and 5 hours after taking one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 3. arm 2: Blood will be drawn at 0, 2, 4, and 6 hours after one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 4.
Interventions: intervention 1: Hydrocodone
Intervention descriptions: intervention 1: Dose: Standard prescribed dose Frequency: Once Duration: Once

Protocol documents:
Clinical trial NCT01530243
Conditions: Disorder of Urinary Stent
Sponsor: Urmia University of Medical Sciences
Start date: 2012-01-01; Completion date: 2012-09-01
Enrollment: 104 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the investigators study is to evaluate whether alpha-blockers such as terazosin and anti-cholinergics such as tolterodine can be relieve the DJ-stent related symptoms.

Detailed description:
Ureteral stent (US) has been as essential tool in the urologist's surgeries and is useful instruments that its indications increase due to new stent technologies and improvement of patient's comfort.

US associated with discomfort complications that include lower urinary tract symptoms (LUTS) as frequency, urgency, dysuria, incomplete emptying, flanks and suprapubic's pain, incontinence, hematuria, movement of stent, infection and encrustation of stent. US related symptoms are as same as LUTS due to benign prostate hyperplasia and overactive bladder which relieve with alpha-blockers and anticholinergic. The purpose of our study is to investigate the effect of terazosin and tolterodine lonely and together in comparison of placebo on US related symptoms.

The investigators study will be done prospectively. The patients who underwent indwelling Double-j stent distributed into four groups: 1)receive placebo 2)receive terazosin 2mg twice 3)receive tolterodine 2mg daily 4) receive terazosin 2mg twice and tolterodine 2mg daily. All of the patients receive prophylactic antibiotic and on demand analgesic. After entrance to study, they fulfill the International Prostatic Symptoms Score (IPSS) and Visual Analog Scale (VAS) on the before indwelling US, two weeks after indwelling US and US removal time, then the investigators will evaluate the drug's effect on US related symptoms.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Placebo intervention 2: Terazosine intervention 3: Tolterodine intervention 4: Tolterodine + Terazosin
Intervention descriptions: intervention 1: same as tolterodine and terazosin dose intervention 2: 2 mg BID intervention 3: 2 mg daily intervention 4: 2mg daily and 2mg BID

Protocol documents:
Clinical trial NCT01545583
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2012-04-01; Completion date: 2012-09-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the safety and tolerability of LY3016859 administered as single doses, and to determine how long LY3016859 remains in the body

Detailed description:

Arms: arm 1: Placebo administered once intravenously arm 2: 0.1 mg LY3016859 administered once intravenously arm 3: 1 mg LY3016859 administered once intravenously arm 4: 10 mg LY3016859 administered once intravenously arm 5: 50 mg LY3016859 administered once intravenously arm 6: 250 mg LY3016859 administered once intravenously arm 7: 750 mg LY3016859 administered once intravenously arm 8: Placebo administered once subcutaneously arm 9: 50 mg LY3016859 administered once subcutaneously
Interventions: intervention 1: LY3016859 intravenous intervention 2: Placebo intravenous intervention 3: LY3016859 subcutaneous intervention 4: Placebo subcutaneous
Intervention descriptions: intervention 1: Administered intravenously intervention 2: Administered intravenously intervention 3: Administered subcutaneously intervention 4: Administered subcutaneously

Protocol documents:
Clinical trial NCT01551693
Conditions: Melanoma
Keywords: Stage III Stage IV Unresectable Metastatic
Sponsor: Dana-Farber Cancer Institute
Start date: 2011-09-01; Completion date: 2012-09-01
Enrollment: 3 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
STA9090 is a drug which inactivates or blocks the work of a protein called Heat Shock Protein 90 or HSP90. HSP90 is a protein that helps some molecules inside your cells to have the right shape. By stopping HSP90's activity, those molecules never get to have the right structure of be functional and they are destroyed. The investigators believe that if they stop the activity of HSP90, the rapidly dividing cells that are in your tumor(s) may slow down. In this research study the investigators are looking to see how well STA9090 works in stopping the spread of your melanoma.

Detailed description:
OBJECTIVES:

Primary

* To determine the proportion of patients alive, free of disease progression, and still taking STA-9090 at 6 months by BRAF mutant or wild type (WT) status.

Secondary

* To assess best overall response rate and six month response rate by BRAF status
* To evaluate the rates of one-year overall survival and progression-free survival by BRAF status
* To determine safety and tolerability of STA-9090 by BRAF status

Exploratory

* To compare the rates of response and of six-month PFS between BRAF status cohorts
* To explore, using peripheral blood mononuclear cells, the relationship between change in expression of hsp90 client proteins (e.g., BRAF, CRAF, AKT, CDK4, KIT) with response to therapy and progression free survival by BRAF status
* To explore the relationship in biopsied melanoma metastases between changes in expression of hsp90 client proteins (e.g., BRAF, CRAF, AKT, CDK4, KIT) with response to therapy and progression-free survival
* To explore response rate and 6 month progression free survival, in subset of patients with melanoma expressing a mutation in KIT

Arms: arm 1: Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A - BRAF mutant disease or Cohort B - BRAF wild type. Cohort A patients received STA-9090 200 mg/m2 once weekly (d1, 8, 15 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal. arm 2: Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A - BRAF mutant disease or Cohort B - BRAF wild type. Cohort B patients received STA-9090 150 mg/m2 twice weekly (d1, 4, 8, 11, 15, 18 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
Interventions: intervention 1: STA-9090
Intervention descriptions: intervention 1: None

Protocol documents: