ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01951768
Conditions: Diabetic Foot Ulcer
Sponsor: University Hospital, Geneva
Start date: 2013-09-01; Completion date: 2016-06-01
Enrollment: 88 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether Garamycin Sponge (Gentamicin-Collagen sponge) in combination with antibiotics is safe and effective in treating moderate and severe diabetic foot infections.

Detailed description:
Infected skin ulcers with diabetes can be very debilitating because they are difficult to heal. Diabetic ulcers are responsible for frequent health care visits, and are a major predictor of amputation. Diabetic ulcers can be caused by a patient's inability to sense pain or warmth as well as peripheral vascular disease, which causes diminished blood flow to the foot. Early aggressive treatment is necessary to treat infection and ultimately prevent the need for amputation.

Gentamicin is an antibiotic that is effective in treating certain kinds of infection. Collagen is a protein that is found in all mammals. The gentamicin sponge being used in this study is commercially available in Switzerland as Garamycin® Sponge. The Garamycin Sponge is a thin flat sponge made out of collagen that comes from bovine tendons and containing gentamicin. When applied to an open ulcer, the collagen breaks down and the gentamicin is released into the ulcer, but very little is absorbed into the blood stream. The high levels of gentamicin in the open infected ulcer may help treat the infection.

All subjects will be given the necessary supplies and taught how to take care their foot ulcer. All subjects will also receive oral an antibiotic. Additionally, subjects who are randomly assigned to receive the gentamicin-collagen sponge will place a gentamicin-collagen sponge on their ulcer during daily wound care.

Arms: arm 1: Garamycin Sponge (Gentamicin-Collagen sponge) applied daily plus systemic antibiotic and standard ulcer care arm 2: Systemic antibiotic therapy and standard ulcer care
Interventions: intervention 1: Garamycin Sponge (Gentamicin-Collagen sponge) intervention 2: Systemic Antibiotic
Intervention descriptions: intervention 1: Gentamicin Collagen Sponge: 5 × 5 cm in size containing Type I bovine collagen and 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base) intervention 2: Antibiotics options per protocol:

Levofloxacin PO 750 mg q.24h or 500 mg q.12h Levofloxacin IV 750 mg q.24h or 500 mg q.12h Amoxicillin/clavulanate PO 500/125 mg q.12h. or q.8h Amoxicillin/clavulanate IV 1000/200 mg q.12h or q.8h Clindamycin PO 300 mg or 450 mg q.6h Clindamycin IV 600 mg q.8h or q.6h Linezolid PO 600 mg q.12h Linezolid IV 600 mg q.12h Metronidazole PO 400 mg or 500 mg q.8h or 500 mg q.6h Metronidazole IV 500 mg q.8h or q.6h Aztreonam IV 1 g or 2 g q.12h or q.8h Piperacillin/tazobactam IV 3000/375 mg q.6h or 4000/500 mg q.8h

Protocol documents:
Clinical trial NCT01968226
Conditions: Carotid Artery Disease Carotid Stenosis
Keywords: carotid artery disease carotid stenosis carotid endarterectomy RDG-K5 PET imaging
Sponsor: The Cleveland Clinic
Start date: 2013-11-01; Completion date: 2016-06-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to investigate the ability of the compound\[F-18\]RGD-K5, when used as a tracer during PET (positron emission tomography) imaging, to detect regions of unstable atherosclerotic plaque in the carotid artery of subjects being considered for carotid endarterectomy (CEA),and to confirm this ability through histological studies of samples of carotid artery plaques that will be collected during the planned carotid surgery.

Detailed description:
Patients will be chosen for the study based on presence of carotid artery stenosis ascertained by CTA and carotid artery ultrasound. Patients will receive and intravenous injection of the radiolabeled PET tracer,\[F-18\]RGD-K5, and will undergo PET imaging of their carotid arteries bilaterally. PET images will be analyzed to determine the standard uptake value (SUV) of \[F-18\]RGD-K5 uptake by the carotid artery plaque and this will be compared to the SUV of the background (blood pool in the aorta). This will be expressed as a target to background ratio (TBR). Investigators expect to find a significant uptake of \[F-18\]RGD-K5 by carotid artery palque and investigators therefore expect to find a TBR that is significantly \>1. Investigators also expect to find that plaque from patients who show a TBR \>1 will also be enriched for histologic markers for inflammation and angiogenesis.

Arms: arm 1: This is an observational study of a group of individuals who all have carotid artery stenosis. The observation will be the measurement of \[F-18\]RGD-K5 uptake by the carotid artery plaque after intravenous administration of this radiolabeled tracer using PET imaging.
Interventions: intervention 1: [F-18] RDG-K5
Intervention descriptions: intervention 1: Up to fifteen (15) subjects with carotid stenosis \>50% who are undergoing planned carotid endarterectomy will be imaged under PET with \[F-18\] RDG-K5

Protocol documents:
Clinical trial NCT01968694
Conditions: Endometriosis
Keywords: endometriosis chronic pain intravenous lidocaine
Sponsor: Brigham and Women's Hospital
Start date: 2010-12-01; Completion date: 2016-06-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
We are doing this research study to find out if intravenous (in your vein, "IV") lidocaine can lessen pain from endometriosis. The U.S. Food and Drug Administration (FDA) has approved intravenous lidocaine to treat irregular heart beats, but the FDA has not approved intravenous lidocaine to treat pain from endometriosis. Intravenous lidocaine has been used for more than 25 years to treat different acute and chronic pain conditions but has not yet been studied for endometriosis pain.

This is a cross-over trial over two months where one month you will receive the active medication (lidocaine) and one month you will receive the active placebo (diphenhydramine, commonly known as benadryl). We will compare the effect on pain from endometriosis of lidocaine to active placebo.

Detailed description:

Arms: arm 1: IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes arm 2: IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes
Interventions: intervention 1: IV Lidocaine intervention 2: IV diphenhydramine
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01970241
Conditions: Diabetes Mellitus
Keywords: corticosteroid diabetes insulin
Sponsor: Hennepin Healthcare Research Institute
Start date: 2014-07-01; Completion date: 2016-06-01
Enrollment: 85 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Despite a significant problem with out-of-control glucose levels in patients with diabetes receiving corticosteroids for a variety of illnesses, there are no published protocols addressing how to adequately treat corticosteroid-induced hyperglycemia. Investigators propose to test a protocol using scheduled dosing of NPH (Neutral protamine Hagedorn) insulin for inpatients with diabetes receiving corticosteroids. NPH insulin action is ideally timed to counteract corticosteroid-induced hyperglycemia, and the dose is added to the patient's usual insulin regimen and timed to correspond to the corticosteroid dosing regimen. Investigators will prospectively enroll eligible consented patients with diabetes who are receiving corticosteroids as part of their treatment in a large county hospital, will randomize them to intervention or control groups, and will monitor their glucose levels during their inpatient stay. The protocol will demonstrate improved control of glucose levels with minimal risk of hypoglycemia, and will provide a practical and readily implementable protocol using NPH insulin as therapy for corticosteroid-induced diabetes.

Detailed description:
As above.

Arms: arm 1: Receive NPH with each corticosteroid dose during the study duration (2-5 days).

Low dose corticosteroids High dose corticosteroids Eating and 6a-8p 0.15 units NPH/kg 0.3 units NPH/kg NPO(nothing by mouth) or 8p-6a 0.1 units NPH/kg 0.2 units NPH/kg arm 2: Receive usual care with background insulin and correction factor for duration of study (2-5 days)
Interventions: intervention 1: NPH intervention 2: Correction Factor
Intervention descriptions: intervention 1: NPH given per study table based on steroid dose and patient weight in kg. intervention 2: Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.

Protocol documents:
Clinical trial NCT01971593
Conditions: Tetralogy of Fallot Transposition of the Great Vessels With an Arterial Switch Single Ventricle With a Fontan Palliation
Sponsor: Washington University School of Medicine
Start date: 2013-08-01; Completion date: 2016-06-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Hypothesis:

By blocking aldosterone signaling in patients with Tetralogy of Fallot, Transposition of the great vessels with a prior atrial switch, and single ventricle "Fontan" patients, incident heart failure will be delayed, symptoms of heart failure ameliorated, and risk of arrhythmias decreased through decreases in myocardial fibrosis.

Half of enrolled patients will complete an SF-36 quality of life questionnaire, perform a 6 minute walk, and have blood drawn for biomarker analysis at enrollment, again after 3 months without therapy, after 6 months on therapy, then finally after 12 months of eplerenone therapy. Half of enrolled patients will have the 3 month drug free period at the end of 12 months on therapy. Patients will be randomly assigned to drug free period up front versus at the conclusion of the trial period. Eplerenone will be started at a dose of 25mg and titrated up to 50mg at 4 weeks if tolerated. Blood will be drawn for basic metabolic panel analysis at enrollment, 3 months, 4 months to allow for dose titration, and at 6 and 12 months for monitoring.

Detailed description:

Arms: arm 1: Patients will be given eplerenone 50mg for 12 months after an initial 3 month drug free period arm 2: Patients will be given eplerenone 50mg for 12 months, followed by a 3 month drug free period
Interventions: intervention 1: Eplerenone
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01986933
Conditions: Atopic Dermatitis
Sponsor: Chugai Pharmaceutical
Start date: 2013-11-01; Completion date: 2016-06-01
Enrollment: 264 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the safety, tolerability and efficacy of CIM331, compared to placebo, in atopic dermatitis patients who are inadequately controlled by or intolerant to topical therapy

Detailed description:

Arms: arm 1: Part A: nemolizumab (CIM331) Part B: nemolizumab (CIM331) arm 2: Part A: nemolizumab (CIM331) Part B: nemolizumab (CIM331) arm 3: Part A: nemolizumab (CIM331) Part B: nemolizumab (CIM331) arm 4: Part A: nemolizumab (CIM331) Part B: nemolizumab (CIM331) arm 5: Part A: Placebo Part B: nemolizumab (CIM331)
Interventions: intervention 1: nemolizumab (CIM331) intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01997463
Conditions: Childhood Asthma
Sponsor: University of Arizona
Start date: 2014-08-01; Completion date: 2016-06-01
Enrollment: 442 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators hypothesize that school-based, direct supervision of daily controller therapy will result in more effective asthma control, as assessed by the Asthma Control Questionnaire than usual care. Additionally, as the result of enhanced asthma control and resulting decrease in health care utilization, school-based, direct supervision of daily controller therapy will result in lower cost per quality-adjusted life year (QALY) gained than usual care.

Detailed description:
This research is being done to test if children with asthma will have fewer asthma symptoms if they are monitored at school to make sure they take their inhaled steroid medication (ICS) every day and take the medication the right way. All of the children with asthma in the school will be asked to participate. In the first year in one-half of the schools, children and school staff will participate in a standardized asthma education program presented by the American Lung Association (ALA). Children will have daily monitoring of their inhaled asthma medication. The other half of schools will continue with the usual treatment of children with asthma. In the second year of the study, all schools and children will have the asthma education program and monitoring. Parents will be queried quarterly for information about their child's asthma.

Arms: arm 1: Regular Asthma Therapy arm 2: Supervised asthma therapy in schools
Interventions: intervention 1: Supervised asthma therapy in schools
Intervention descriptions: intervention 1: Therapy observed daily in school. Asthma education by American Lung Association

Protocol documents:
Clinical trial NCT02048904
Conditions: Type 2 Diabetes Microalbuminuria
Keywords: microalbuminuria type 2 diabetes
Sponsor: University of Missouri-Columbia
Start date: 2014-01-01; Completion date: 2016-06-01
Enrollment: 142 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The people being asked to participate in this study have type 2 diabetes and abnormal levels of protein in their urine. This indicates that they are starting to develop diabetic kidney disease. The standard treatment for this is the use of one of two blood pressure medicines, either an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB). However, these medicines are not always completely effective in stopping/reversing the kidney disease. Some studies have previously suggested that another type of medicine, called sitagliptin, normal used to treat diabetes may also help prevent diabetic kidney disease from getting worse.

This study is being performed to test the effectiveness of sitagliptin as compared to a placebo, along with a stable dose of an ACE inhibitor or ARB, to determine whether or not it will reduce protein levels in their urine. Protein levels in the urine are a marker of the severity of kidney disease.

Detailed description:
The people being asked to participate in this study have type 2 diabetes and abnormal levels of protein in their urine. This indicates that they are starting to develop diabetic kidney disease. The standard treatment for this is the use of one of two blood pressure medicines, either an ACE inhibitor or ARB. However, these medicines are not always completely effective in stopping/reversing the kidney disease. Some studies have previously suggested that another type of medicine, called sitagliptin, normal used to treat diabetes may also help prevent diabetic kidney disease from getting worse.

Arms: arm 1: 100 mg/day for 3 months arm 2: 1 pill/day for 3 months
Interventions: intervention 1: Sitagliptin intervention 2: Placebo
Intervention descriptions: intervention 1: Sitagliptin 100 mg/day for 3 months intervention 2: Placebo 1 pill/day for 3 months

Protocol documents:
Clinical trial NCT02058966
Conditions: Methamphetamine Dependence
Keywords: Entacapone COMT val158met Methamphetamine
Sponsor: Oregon Health and Science University
Start date: 2014-06-01; Completion date: 2016-06-01
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Addiction to methamphetamine is a serious health problem. There are no medications that a doctor can give someone to help them stop using methamphetamine. Entacapone (Comtan©) is a medication that could help people addicted to methamphetamine.

This study will see how entacapone works in healthy people who are given methamphetamine. We think that the study drug will be well tolerated, and that it will prevent some of the effects of methamphetamine that make it so addictive. We also want to see how differences in people's genes may cause differences in the ways the study drug and methamphetamine work for them.

The study has six total visits. The first visit is for screening. Tests and procedures will make sure it is safe for subjects to participate.

The second visit is a familiarization day. Subjects will receive methamphetamine, but no entacapone. This is done to make sure they can tolerate the drug and recognize its effects before being given a second drug on the same day. Subjects will take surveys and computer tests to see how the medications change mood, thinking, and liking the drug.

The final four visits are the actual study days. Subjects will be randomly assigned (like the flip of a coin) to the different ways to get either 1) study medication or placebo (placebo contains no active study medication) and then 2) methamphetamine or placebo. Subjects will be in all four groups during the study, which means that each day a subject will get a different group.

Detailed description:

Arms: arm 1: Subjects will receive placebo, then one hour later, placebo arm 2: Subjects will receive placebo, then one hour later, methamphetamine arm 3: Subjects will receive entacapone, then one hour later, placebo arm 4: Subjects will receive entacapone, then one hour later, methamphetamine
Interventions: intervention 1: Entacapone intervention 2: Methamphetamine intervention 3: Placebo
Intervention descriptions: intervention 1: Entacapone 200 mg oral dose intervention 2: Methamphetamine 20 mg oral dose intervention 3: capsules compounded to be of similar appearance to the active drugs

Protocol documents:
Clinical trial NCT02060526
Conditions: Sanfilippo Syndrome
Keywords: sulfoglucosamine sulfohydrolase (SGSH) recombinant human heparan N-sulfatase (rhHNS) Hunter's Syndrome Shire HGT Lysosomal Storage Disease (LSD) Sanfilippo Syndrome Type A (Sanfilippo A) enzyme replacement therapy (ERT)
Sponsor: Shire
Start date: 2014-02-26; Completion date: 2016-06-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Sanfilippo syndrome Type A, or Mucopolysaccharidosis (MPS) IIIA, is a rare lysosomal storage disease caused by deficiency of the enzyme heparan N-sulfatase (sulfamidase). In the absence of this enzyme, there is an accumulation of the glycosaminoglycan, heparan sulfate, resulting in progressive neurodegeneration. Symptoms are usually first noted in the 1st or 2nd year of life, although definitive diagnosis is often delayed, with an average age of diagnosis of 4.5 years. The disease is characterized by developmental delays initially, followed by neurological developmental arrest, then regression. These developmental deficits are typically associated with severe behavioral disturbances. Patients have a significantly reduced lifespan, with few surviving beyond the 2nd or 3rd decade.

The purpose of this study is to evaluate the safety and efficacy of recombinant human heparan-N-sulfatase (rhHNS) in pediatric patients with Early Stage Mucopolysaccharidosis Type III A Disease.

Detailed description:
No effective, disease-modifying therapies are currently approved as treatments for this devastating and disabling disease.

Shire Human Genetic Therapies (Shire HGT) is developing an enzyme replacement therapy (ERT) recombinant human heparan-N-sulfatase (rhHNS) for patients with MPS IIIA. rhHNS is being administered into the cerebrospinal fluid (CSF) via an surgically implanted intrathecal drug delivery device (IDDD), because when administered intravenously (IV) it does not cross the blood brain barrier (BBB).

This study will evaluate the effect of 48 weeks of rhHNS treatment on the clinical course of MPS IIIA, using cognitive function as the primary outcome measure. The trial will evaluate 2 dosing regimens of rhHNS administered via an IDDD in comparison with a no treatment control group. Patients will be randomized 1:1:1 to either of the treatment groups or the no treatment group. Treatment will be administered in an open-label manner. The safety and tolerability profile of rhHNS will continue to be evaluated in this study.

Arms: arm 1: rhHNS 45 mg administered intrathecally Q2W (once every 2 weeks ie, every 14 days), for 48 weeks via the surgically implanted IDDD (or LP) arm 2: rhHNS 45 mg administered intrathecally Q4W (once every 4 weeks ie, every 28 days), for 48 weeks via the surgically implanted IDDD (or LP) arm 3: The comparator group will receive no treatment with rhHNS.
Interventions: intervention 1: Recombinant human heparan N-sulfatase [rhHNS]
Intervention descriptions: intervention 1: Recombinant human heparan N-sulfatase \[rhHNS\]

Protocol documents:
Clinical trial NCT02062879
Conditions: Acute Pain Multiple Trauma Fractures
Keywords: pain trauma
Sponsor: University of Cincinnati
Start date: 2014-04-01; Completion date: 2016-06-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare ketamine and hydromorphone as alternative patient-controlled interventions for trauma-related pain. Patients receiving ketamine PCA are expected to require less total and breakthrough opioid and to have similar or improved objective pain scores. Patients receiving ketamine are also expected to have shorter duration of supplemental oxygen requirement, fewer episodes of oxygen desaturation, improved pulmonary toilet, lower use of antiemetics, and shorter times to first bowel movement. Ketamine is further expected to be associated with decreased intensive care unit and hospital lengths of stay, faster time to maximum allowable ambulation, decreased opioid dosage at discharge, and lower report of chronic pain syndromes.

Detailed description:

Arms: arm 1: Ketamine 90mg/30 mL PCA (3 mg/mL) arm 2: Hydromorphone 6mg/30 mL PCA (0.2 mg/mL)
Interventions: intervention 1: Ketamine intervention 2: Hydromorphone
Intervention descriptions: intervention 1: Ketamine administered as patient-controlled analgesia. intervention 2: Hydromorphone administered as patient-controlled analgesia.

Protocol documents:
Clinical trial NCT02112370
Conditions: Thyroid Neoplasm Goiter
Keywords: Ropivacaine Epinephrine Endoscopy Robotics Thyroidectomy
Sponsor: Seoul National University Hospital
Start date: 2014-05-01; Completion date: 2016-06-01
Enrollment: 148 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the pain relief and the hemodynamic stability of ropivacaine with epinephrine in BABA endoscopic and robotic thyroidectomy.

Detailed description:
Diluted ropivacaine with epinephrine is injected into the subcutaneous space to relieve pain and reduce bleeding during procedures. The synergistic effect of ropivacaine with epinephrine can contribute to patients' welfare, such as relieving pain and structuring the hemodynamic stability.

Arms: arm 1: 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection. arm 2: 1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.
Interventions: intervention 1: Ropivacaine with epinephrine injection intervention 2: Placebo
Intervention descriptions: intervention 1: 1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection for the experiment group. intervention 2: 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection for the placebo group.

Protocol documents: