ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01736358
Conditions: Postoperative Pain Management Urolithiasis
Keywords: Sprix Intranasal ketoralac Ketoralac Urolithiasis Kidney stone Uretal stone Ureteroscopic removal of stones URS Pain management Pain
Sponsor: Montefiore Medical Center
Start date: 2012-10-01; Completion date: 2014-06-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Despite an overall reduction in the perioperative complication rate, post operative pain management after ureteroscopic removal of stones (URS) remains a major factor delaying discharge of patients. The investigators hypothesize that perioperative usage of intranasal ketorolac will provide a reduction in post operative opioid requirements, better post operative pain control, higher anesthesia satisfaction and faster recovery.

Detailed description:
The prevalence and incidence of urolithiasis, or kidney stone disease, are increasing in the general population. Life-time incidence of urolithiasis is estimated to be between 5%- 12%. The treatment of kidney stones depends on stone type and size, symptom severity, and the presence of obstruction.

URS is a common ambulatory procedure as improved technological advances and increased clinical utilization have helped decrease postoperative complications. Despite an overall reduction in the perioperative complication rate, post operative pain management after URS remains a major factor delaying discharge of patients.

Post operative pain after URS is usually treated with opioids and non steroidal anti inflammatory drugs. Intranasal ketorolac (SprixTM) is an FDA approved pain formulation for short term management (5 days) of moderate to moderately severe pain that requires analgesia at the opioid level. The efficacy of intranasal ketorolac formulation was demonstrated in placebo-controlled studies in patients following major surgeries.

The primary objective of the study is to evaluate the role perioperative usage of single-dose of intranasal ketorolac on immediate post operative opioid requirements. Secondary objectives of the study are to (a) evaluate the post operative pain score 30 minutes after surgery, 1 hour after surgery, and 2 hours after surgery, (b) find the incidence of immediate (until discharge) and 24hrs post operative side effects in the target population, (c) find the level of anesthesia satisfaction in the target population, (d) find the time to discharge in the target population, (e) compare the two groups post anesthesia discharge score.

Arms: arm 1: A single dose of Sprix (31.5 mg) will be administered to patients 20 minutes before the end of surgery. 15.75 mg of Sprix will be sprayed in each nostril. arm 2: A single dose of placebo will be administered 20 minutes before the end of surgery. 15.75 mg of the placebo will be sprayed in each nostril.
Interventions: intervention 1: Intranasal Ketoralac intervention 2: Placebo
Intervention descriptions: intervention 1: 15.75 mg of Sprix in each nostril 20 minutes before end of surgery intervention 2: 15.75 mg of placebo will be administered in each nostril 20 minutes before the end of surgery

Protocol documents:
Clinical trial NCT01745367
Conditions: Triple Negative Breast Cancer
Keywords: Tivozanib hydrochloride triple negative breast cancer paclitaxel pharmacokinetics biomarkers metastatic breast cancer mBC TNBC
Sponsor: AVEO Pharmaceuticals, Inc.
Start date: 2012-11-01; Completion date: 2014-06-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase 2 multicenter, double-blind, randomized, placebo-controlled, two-arm study for subjects with locally recurrent or metastatic triple negative breast cancer.

Detailed description:
This is a phase 2 multicenter, double-blind, randomized, placebo-controlled, two-arm study for subjects with locally recurrent or metastatic triple negative breast cancer.

Patients will be randomized 2:1 to either tivozanib hydrochloride and weekly paclitaxel or placebo and weekly paclitaxel.

Subjects will be stratified based on Eastern Cooperative Oncology Group (ECOG) performance score (0 vs 1) and line of treatment (first vs second).

All subjects will be evaluated for progression free survival and overall survival as well as safety and tolerability. Biomarker and pharmacokinetic (PK) analysis are also included in study. This study will determine whether tivozanib hydrocholoride combined with weekly paclitaxel improves clinical outcomes in patients with triple negative breast cancer.

Arms: arm 1: Placebo orally once daily on a 3 weeks on/1 week off schedule with 90 mg/m2 of paclitaxel administered intravenously 3 weeks on (Day 1, Day 8 and Day 15)/1 week off (4 weeks = 1 Cycle). arm 2: 1.5 mg tivozanib hydrochloride orally once daily on a 3 weeks on/1 week off schedule with 90 mg/m2 of paclitaxel administered intravenously 3 weeks on (Day 1, Day 8 and Day 15)/1 week off (4 weeks = 1 Cycle).
Interventions: intervention 1: Tivozanib Hydrochloride intervention 2: paclitaxel intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01748162
Conditions: Croup
Keywords: croup recurrent croup barky cough
Sponsor: University of Michigan
Start date: 2012-09-01; Completion date: 2014-06-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Presently children who experience recurring croup symptoms receive a variety of treatments. This is because it is not clear which treatments may be best. Some children are given inhaled steroids (similar to what children with asthma use). Others are carefully watched and cautioned to avoid potential triggers (certain foods, environmental allergens, etc), and should episodes of croup recur they are treated with a short course of oral steroids. The purpose of this study is to compare two safe and clinically appropriate methods for treating recurrent croup, daily inhaled steroids versus observation with oral steroids on an as needed basis, to see if either is useful in preventing future episodes of croup.

Detailed description:

Arms: arm 1: Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months. arm 2: Patient and clinician observation with short term oral prednisolone as needed. Offered at 1mg/kg (body weight) daily dosing for symptomatic treatment on as needed basis for three days, but may be modified per managing physician's discretion.
Interventions: intervention 1: Fluticasone intervention 2: Prednisolone IF needed
Intervention descriptions: intervention 1: Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months. intervention 2: None

Protocol documents:
Clinical trial NCT01751087
Conditions: Abortion, Induced
Keywords: abortion, induced
Sponsor: Planned Parenthood League of Massachusetts
Start date: 2013-01-01; Completion date: 2014-06-01
Enrollment: 300 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to compare three different ways of opening a woman's cervix before her second-trimester surgical abortion.

* Osmotic dilators: small rods that, when inserted into the cervix, gently expand to open the cervix
* Osmotic dilators plus mifepristone, a medicine that is swallowed
* Osmotic dilators plus misoprostol, a medicine that is placed between the cheek and gum

Hypotheses:

* adding buccal misoprostol 3 hours preoperatively will significantly improve dilation compared to laminaria alone, making procedures faster, easier and safer.
* adding oral mifepristone at the time of laminaria placement will confer a similar benefit.
* the efficacy of adjunctive misoprostol and mifepristone will be influenced by gestational age, with women later in gestation having increased efficacy from these agents.
* significantly more patients who receive adjunctive misoprostol or mifepristone will have adequate initial dilation, fewer will require manual dilation or additional cervical preparation and there will be fewer complications in these arms, although complication rates will be low and we will only be able to detect relatively large differences.
* patients will prefer to have the procedure done as quickly as possible with as little discomfort as possible, that cervical ripening with adjunctive misoprostol will be associated with more cramping than osmotic dilators alone and that mifepristone will be well tolerated and may not cause more cramping or other side effects than osmotic dilators alone.

Detailed description:

Arms: arm 1: Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2. arm 2: Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2. arm 3: Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.
Interventions: intervention 1: Mifepristone intervention 2: misoprostol intervention 3: Osmotic dilators intervention 4: placebo intervention 5: placebo
Intervention descriptions: intervention 1: oral mifepristone 200 mg on Day 1. intervention 2: buccal misoprostol 400 mcg on Day 2 intervention 3: osmotic dilators on Day 1 intervention 4: placebo for mifepristone, on day 1 intervention 5: placebo for misoprostol, on day 2

Protocol documents:
Clinical trial NCT01753856
Conditions: Osteoporosis
Sponsor: Eli Lilly and Company
Start date: 2013-01-01; Completion date: 2014-06-01
Enrollment: 69 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine how teriparatide or denosumab affects the bone of postmenopausal women with osteoporosis after 3 months of treatment, as determined by a bone biopsy sample taken from the iliac crest (upper part of the pelvis).

Detailed description:

Arms: arm 1: 20 micrograms (µg) teriparatide administered subcutaneously (SC) once every day for 6 months.

Demeclocycline (DEM): Beginning 18 days prior to randomization: Days 1, 2, 3 and 16, 17, 18: 150 milligrams (mg) DEM will be taken orally every 6 hours; Days 4 to15: DEM will not be administered.

Tetracycline (TET): Beginning 22 days prior to the biopsy procedure: Days 1, 2, 3 and 16, 17, 18: 250 mg TET will be taken orally every 6 hours; Days 4 through 15: TET will not be administered.

Calcium: Approximately 1000 milligrams per day (mg/day) administered orally.

Vitamin D: Approximately 800 to 1200 International Units per day (IU/day) administered orally. arm 2: 60 mg denosumab administered SC once in 6 months.

DEM: Beginning 18 days prior to randomization: Days 1, 2, 3 and 16, 17, 18: 150 mg DEM will be taken orally every 6 hours; Days 4 to 15: DEM will not be administered.

TET: Beginning 22 days prior to the biopsy procedure: Days 1, 2, 3 and 16, 17, 18: 250 mg TET will be taken orally every 6 hours; Days 4 through 15: TET will not be administered.

Calcium: Approximately 1000 mg/day administered orally.

Vitamin D: Approximately 800 to 1200 IU/day administered orally.
Interventions: intervention 1: Teriparatide intervention 2: Denosumab intervention 3: Demeclocycline intervention 4: Tetracycline intervention 5: Calcium Supplement intervention 6: Vitamin D
Intervention descriptions: intervention 1: Administered SC intervention 2: Administered SC intervention 3: Administered orally intervention 4: Administered orally intervention 5: Administered orally intervention 6: Administered orally

Protocol documents:
Clinical trial NCT01764607
Conditions: Squamous Cell Skin Carcinoma
Keywords: Squamous Renal Transplant
Sponsor: University of Florida
Start date: 2013-04-01; Completion date: 2014-06-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Solid organ transplant recipients (SOTR) have a 3-5x increased occurrence of cancer in contrast to the general population with basal and squamous cell skin cancer. The use of immunosuppressant or anti-rejection drugs that are needed after SOTR is known to increase the risk of developing certain kinds of cancer. The purpose of this study is to find out how well Sirolimus (also known as Rapamune) works at treating squamous cell carcinoma in renal transplant patients.

Detailed description:
This is a Phase II randomized study to evaluate the effectiveness of Sirolimus in treating and preventing squamous cell skin cancer carcinoma using a Simon's 2-stage design. As part of the study, after the biopsy results of the skin cancer show squamous cell carcinoma and consent had been obtain, the participant will begin taking Sirolimus. The calcineurin inhibitor (tacrolimus or cyclosporine) will be discontinued once the transplant doctors find that the participants Sirolimus is therapeutic by checking blood tests once a week x 3 weeks. Approximately 5 weeks after starting Sirolimus, the squamous cell skin cancer will be removed by a surgeon. Participant next follow up visit for the study is scheduled one year post-operatively. .The study will look at your squamous cell skin cancer under the microscope to see if sirolimus had any effect at treating your squamous cell skin cancer.

Arms: arm 1: Patients will receive sirolimus 5 weeks prior to removal of squamous cell skin carcinoma. After the 5 weeks of treatment, nephrology will determine/manage each patient's immunosuppressant therapy.
Interventions: intervention 1: Sirolimus
Intervention descriptions: intervention 1: Patients randomized to this arm of the study will receive sirolimus from the time of randomization at least until 5 weeks or the removal of the skin tumor. Nephrology will determine/manage the immunosuppressant therapy.

Protocol documents:
Clinical trial NCT01765270
Conditions: Type 2 Diabetes Mellitus Cardiovascular Disease
Keywords: Diabetes Diabetes Mellitus Type 2 Diabetes Cardiovascular Disease Coronary Artery Bypass Surgery
Sponsor: Duke University
Start date: 2013-03-01; Completion date: 2014-06-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Individuals with type 2 diabetes mellitus (T2DM) are at increased risk for cardiovascular events (for example, heart attack) and the risk is related to one's overall control of blood glucose levels. In this study the investigators will measure the effects of saxagliptin, compared to placebo, before, during, and after coronary artery bypass graft (CABG) surgery. The investigators will use samples of the patients' blood and tissue to measure and evaluate indicators of the body's response to the treatment. This study is being done to evaluate the effect of saxagliptin on biomarkers of the heart to help us understand whether reducing or controlling a person's blood glucose levels during and after CABG surgery will produce better clinical outcomes (for example, better heart health).

Detailed description:
This study is a randomized, double-blind, placebo-controlled clinical trial to evaluate the effect of saxagliptin on cardiac biomarkers of myocardial necrosis, cardiac function, inflammation, and apoptosis in subjects with Type 2 diabetes mellitus (T2DM) undergoing CABG surgery (on pump, via a median sternotomy approach) as an integrated measure of the potential mechanistic effects of saxagliptin on prevention of cardiovascular (CV) outcomes. Approximately 74 subjects will be randomized and complete the study.

Arms: arm 1: Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery. arm 2: Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
Interventions: intervention 1: Saxagliptin intervention 2: Placebo
Intervention descriptions: intervention 1: one 5-mg saxagliptin tablet daily intervention 2: 5mg placebo tablet daily

Protocol documents:
Clinical trial NCT01765569
Conditions: Malignant Melanoma, Neoplasms
Sponsor: Hoffmann-La Roche
Start date: 2013-07-01; Completion date: 2014-06-01
Enrollment: 29 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This open-label, multi-center, three-period, one sequence study will investigate the effect of vemurafenib on the pharmacokinetics of digoxin in patients with unresectable BRAFV600-mutation positive metastatic melanoma or other malignant tumor type that harbors a V600-activating mutation of BRAF without acceptable standard treatment options. Patients will receive multiple doses of vemurafenib in Periods B and C and a single dose of digoxin in Periods A and C. Eligible patients will have the option to continue treatment with vemurafenib as part of an extension study (NCT01739764). The anticipated time on study treatment is approximately 36 days.

Detailed description:

Arms: arm 1: Single oral dose of digoxin 0.25 mg tablet on Day 1 in Period A, followed by vemurafenib 960 mg tablet orally BID from Day 8 to Day 28 in Period B, and then single oral dose of digoxin 0.25 mg on Day 29, and vemurafenib 960 mg orally BID from Day 29 to Day 35 in Period C.
Interventions: intervention 1: Digoxin intervention 2: Vemurafenib
Intervention descriptions: intervention 1: Participants received single oral dose of digoxin 0.25 mg tablet on Day 1 and Day 29. intervention 2: Participants received vemurafenib 960 mg tablet orally BID from Day 8 to Day 35.

Protocol documents:
Clinical trial NCT01791725
Conditions: Down Syndrome
Sponsor: OPKO Health, Inc.
Start date: 2013-09-01; Completion date: 2014-06-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a prospective, randomized, double-blind, placebo-controlled, parallel-group, three-arm, multicenter study of the safety and PK of ELND005 administered orally for 4 weeks. This study will enroll Down Syndrome patients 18 to 45 years of age (inclusive) without dementia.

Detailed description:

Arms: arm 1: ELND005 250 mg BID arm 2: ELND005 250 mg QD arm 3: Placebo BID
Interventions: intervention 1: ELND005 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01811186
Conditions: Chronic Pain
Keywords: moderate to severe non-malignant chronic pain
Sponsor: Mundipharma Korea Ltd
Start date: 2012-12-01; Completion date: 2014-06-01
Enrollment: 261 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Objectives:

1. Objective of main interest

   \- To assess the drop-out rate caused by adverse event\* after 6 weeks treatment
2. Further objectives

   * To assess the drop-out rate caused by adverse event\* after 1 week treatment
   * To assess the pain reduction rate after 6 weeks treatment from baseline
   * To assess the Euroquol (EQ-5D) quality of life
   * To assess physician's overall satisfaction
   * To assess subject's overall satisfaction
   * To assess safety

Detailed description:
Study Design (Methodology):

This will be a single center, open-label, randomised, phase IV, exploratory interventional study to compare the efficacy and tolerability of current titration patterns and slow titration pattern with Targin® (Oxycodone/Naloxone) in the treatment of moderate to severe non-malignant chronic pain patients who are dissatisfied with their current analgesic medication World Health Organisation (WHO) step II analgesics).

Upon providing written informed consent, subject will be screened in the study and assessment will be performed at that time such as safety laboratory assessments, physical examination, vital sign, medical history taking, 24 hours pain intensity score. If the patient is eligible in inclusion/exclusion criteria at the time of visit 1, the patient will be randomized in a 1:1 ratio to allocate in Group A or Group B. Re-screening, study drug dose interruption is not allowed.

Arms: arm 1: Start oxycodone/naloxone 10/5mg b.i.d. titration-\>20/10mg b.i.d.-\>30/15mg b.i.d-\>40/20mg b.i.d. arm 2: Start oxycodone/naloxone 5/2.5mg b.i.d titration-\> 10/5mg b.i.d.-\>20/10mg b.i.d.-\>30/15mg b.i.d-\>40/20mg b.i.d.
Interventions: intervention 1: Oxycodone/naloxone
Intervention descriptions: intervention 1: Oxycodone/naloxone titration

Protocol documents:
Clinical trial NCT01815008
Conditions: Platelet Aggregation Platelet Transcriptome Coronary Artery Disease
Keywords: Platelet aggregation Clopidogrel Platelet transcriptome
Sponsor: Johns Hopkins University
Start date: 2012-10-01; Completion date: 2014-06-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This clinical trial is examining the role of genetic polymorphism on the effect of clopidogrel (with or without aspirin) on platelet response in persons at high-risk for myocardial infarction or stroke due to family history of early-onset coronary artery disease.

Detailed description:
The main goal of this study is to explore the impact of the PEAR1 genetic variant (rs12041331) on responsiveness to clopidogrel. The investigators will further assess the role of other genetic variants in determining the response to single or dual anti-platelet therapy. Apparently healthy subjects (N= 2108) from high-risk families are being (a) identified from a proband with early-onset CAD and (b) genotyped on the Illumina 1 million platform, with imputation to 2.5 million single nucleotide polymorphisms. The investigators plan to characterize the variance in platelet aggregation to multiple agonists (ADP, collagen, and arachidonic acid) after 1-week therapy with clopidogrel in a high-risk subset of GeneSTAR subjects (N=100). The investigators further plan to determine the extent to which variants identified in the PEAR1 gene modify platelet responsiveness to inhibition by clopidogrel in this high-risk subset. In addition, the investigators aim is to determine the extent to which variants in other recently discovered genes, by themselves, and in combination with PEAR1, modify platelet responsiveness to clopidogrel alone and with aspirin in this high-risk subset. Lastly, the investigators also want to determine what changes in platelet mRNA are produced by aspirin alone and by aspirin with clopidogrel.

Arms: arm 1: Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily
Interventions: intervention 1: Clopidogrel intervention 2: Aspirin
Intervention descriptions: intervention 1: Clopidogrel 75 mg daily intervention 2: Aspirin 81 mg daily

Protocol documents:
Clinical trial NCT01821378
Conditions: Schizophrenia
Keywords: Schizophrenia Lurasidone Latuda
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2013-05-01; Completion date: 2014-06-01
Enrollment: 412 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to evaluate the efficacy of lurasidone 20 mg/day in subjects with an acute exacerbation of schizophrenia.

Detailed description:
The primary purpose of this study is to evaluate the efficacy of lurasidone 20 mg/day in subjects with an acute exacerbation of schizophrenia. This study will also evaluate the efficacy and safety of lurasidone 80 mg/day and160 mg/day versus placebo in subjects who are early non-responders (operationally defined per protocol) to lurasidone 80 mg/day.

Arms: arm 1: Lurasidone 20 mg once daily arm 2: Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2 arm 3: Placebo Comparator 20 or 80 mg once daily
Interventions: intervention 1: Lurasidone intervention 2: Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2 intervention 3: Placebo
Intervention descriptions: intervention 1: Lurasidone 20 mg once daily intervention 2: Lurasidone 80 mg once daily intervention 3: Once Daily

Protocol documents: