ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01145482
Conditions: Memory Disorders
Keywords: Memory Disorders Alzheimer's Disease
Sponsor: University of Texas at Austin
Start date: 2010-07-01; Completion date: 2014-04-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The study described in the present application will test the hypothesis that insulin mediated facilitation of memory in Alzheimer's disease (AD) is achieved through enhanced glutamatergic neurotransmission due to improvements in cerebral glucose metabolism. The effect of a single dose of intranasal insulin on memory and cerebral glutamate concentrations in adults with mild AD or amnestic mild cognitive impairment (aMCI), the presumed prodromal phase of AD will be studied. Successful completion of this study may set the stage for a larger-scale treatment trial of intranasal insulin for adults with memory disorders. However, the use of insulin in this manner at this point in time is purely experimental.

Detailed description:
The specific aims of this project will be accomplished through a cross sectional repeated measures design in which 15 participants with mild AD or amnestic MCI will undergo assessments of brain structure and function 15 minutes after a single dose of insulin (20 IU) or placebo. Insulin and placebo conditions will be counterbalanced across participants.

Intranasal insulin or placebo administration: Saline and insulin (NovoLog) will be ordered though the UT Student Health Services Pharmacy (Sharon Roberson, Chief Pharmacist) and stored at 4°C, according to standard pharmacy protocols. Three ml doses of saline or insulin will be packaged in nasal spray bottles (e.g., Spectrum Pharmacy Products bottles 969-17404P and actuators 551-24362P) designed to deliver 100μL dose with each spray. A total volume of 200μL will be delivered during each administration (one 100μL dose in each nostril).

Arms: arm 1: 20 IU of insulin was administered once daily on two occasions in either the first intervention period or second intervention period using a nasal spray bottle arm 2: 200 micro liters of saline was administered once daily on two separate occasions in either the first intervention period or second intervention period using a nasal spray bottle
Interventions: intervention 1: Insulin intervention 2: Saline
Intervention descriptions: intervention 1: 20 IU of insulin was administered once daily on two occasions in either the first intervention period or second intervention period using a nasal spray bottle intervention 2: 200 micro liters of saline was administered once daily on two separate occasions in either the first intervention period or second intervention period using a nasal spray bottle

Protocol documents:
Clinical trial NCT01183065
Conditions: Head and Neck Cancer
Keywords: Pralatrexate Vitamin B12 Folic Acid 10-112
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2010-08-01; Completion date: 2014-04-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to find out if the experimental drug pralatrexate with the vitamins folic acid and vitamin B12 might be an effective treatment for head and neck cancer. The reason we are doing this study is because another drug called methotrexate has been used for a long time to treat head and neck cancer patients. Pralatrexate was designed by scientists to be a new drug that works better than methotrexate. Laboratory studies have shown that pralatrexate works better than methotrexate at killing cancer cells.

Pralatrexate has already been studied in patients with other types of cancers, such as lymphoma and lung cancer. The results from those studies were promising. Pralatrexate was recently approved by the Food and Drug Administration (FDA) as a new treatment for a cancer called peripheral T cell lymphoma.

Detailed description:

Arms: arm 1: This will be an open-label, single arm, Simon optimal two-stage design phase II study.
Interventions: intervention 1: Pralatrexate With Vitamin B12 and Folic Acid
Intervention descriptions: intervention 1: Patients will be treated with 30 mg/m2 of pralatrexate intravenously once weekly for 3 weeks in a 4 week cycle with vitamin supplementation. Patients will take 1.0-1.25 mg oral folic acid on a daily basis. Folic acid should be initiated during the 10-day period preceding the first dose of pralatrexate and dosing will be continued during the full course of therapy and for 30 days after the last dose of pralatrexate. Patients will also receive a vitamin B12 (1 mg) intramuscular injection no more than 10 weeks prior to the first dose of pralatrexate and every 8-10 weeks thereafter. Subsequent vitamin B12 injections may be given the same day as treatment with pralatrexate.

Protocol documents:
Clinical trial NCT01190813
Conditions: Amblyopia
Keywords: amblyopia, levodopa
Sponsor: Jaeb Center for Health Research
Start date: 2010-09-01; Completion date: 2014-04-01
Enrollment: 139 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of oral levodopa and patching versus oral placebo and patching as treatment for residual amblyopia in children 7 to \<13 years old with visual acuity of 20/50 to 20/400 in the amblyopic eye.

Detailed description:
Amblyopia is the most common cause of monocular visual impairment in both children and young and middle-aged adults. Both patching and atropine are accepted treatment modalities for the management of moderate amblyopia in children. Despite best efforts with conventional amblyopia treatment, many older children and teenagers with amblyopia fail to achieve normal visual acuity in the amblyopic eye. In a previous PEDIG study where children 7 to 12 years old were treated with atropine and patching, only 36% of the children with moderate amblyopia and only 23% of the children with severe amblyopia achieved 20/40 or better acuity.

Many clinicians have recognized that conventional therapies with patching and atropine have not been universally successful and have sought alternatives. PEDIG has discussed for several years the problem of residual amblyopia and how the remaining visual acuity deficit could be reduced. A number of research groups have evaluated the short term use of oral levodopa-carbidopa as an adjunct to patching therapy for older children.

Arms: arm 1: Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid arm 2: Oral placebo tid
Interventions: intervention 1: Levodopa/Carbidopa intervention 2: Placebo intervention 3: Patching
Intervention descriptions: intervention 1: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid intervention 2: Oral placebo tid intervention 3: Two hours of daily patching

Protocol documents:
Clinical trial NCT01228149
Conditions: Glaucoma
Keywords: glaucoma trabeculectomy intraocular pressure
Sponsor: Katrin Lorenz
Start date: 2010-08-01; Completion date: 2014-04-01
Enrollment: 62 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The most common cause of post-trabeculectomy filtration failure is postoperative scarring. Long-term preoperative treatment with local antiglaucoma agents containing preservatives has an increased risk of post-operative scarring of the filtration bleb. Therefore many surgeons prepare their patients for planned trabeculectomy by discontinuing local antiglaucoma drugs, controlling IOP with oral acetazolamide, and treating the eye with local steroids.

Preservative-free COSOPT-S® eye drops b.i.d now provide a possibility to reduce IOP preoperatively with the aim of avoiding postoperative excessive scarring and the known adverse effects of oral acetazolamide while achieving comparable IOP reduction and long-term outcomes.

This study will investigate comparability (non-inferiority) of medical benefits of two different IOP lowering pharmaceutical interventions prior to trabeculectomy comparing COSOPT-S® bid to oral acetazolamide plus dexamethasone.

Detailed description:
The most common cause of post-trabeculectomy filtration failure is postoperative scarring. Long-term preoperative treatment with local antiglaucoma agents containing preservatives has an increased risk of post-operative scarring of the filtration bleb. Therefore many surgeons prepare their patients for planned trabeculectomy by discontinuing local antiglaucoma drugs, controlling IOP with oral acetazolamide, and treating the eye with local steroids.

Preservative-free COSOPT-S® eye drops b.i.d now provide a possibility to reduce IOP preoperatively with the aim of avoiding postoperative excessive scarring and the known adverse effects of oral acetazolamide while achieving comparable IOP reduction and long-term outcomes.

This study will investigate comparability (non-inferiority) of medical benefits of two different IOP lowering pharmaceutical interventions prior to trabeculectomy comparing COSOPT-S® bid to oral acetazolamide plus dexamethasone.

Arms: arm 1: Patients receive Diamox (oral acetazolamide) starting 28 days Prior to trabeculectomy. 7 days preoperatively DexaEDO (dexamethasone) eyedrops without preservatives are applied additionally. Patient will undergo trabeculectomy. arm 2: Patients receive Cosopt S (dorzolamide/timolol) eye drops starting 28 days before trabeculectomy.
Interventions: intervention 1: Trabeculectomy with preoperative Diamox/DexaEDO treatment intervention 2: Trabeculectomy with preoperative Cosopt S treatment
Intervention descriptions: intervention 1: Filtrating glaucoma surgery, preoperative treatment with Diamox (acetazolamide) 28 day prior surgery. DexaEDO (dexamethasone) 7 days prior surgery intervention 2: Filtrating glaucoma surgery, preoperative treatment with Cosopt S (dorzolamide/timolol) 28 day prior surgery.

Protocol documents:
Clinical trial NCT01232296
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma HCC Liver cancer Child Pugh A HCC Stage C
Sponsor: Novartis Pharmaceuticals
Start date: 2011-07-01; Completion date: 2014-04-01
Enrollment: 162 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this open-label, randomized, phase II study is to compare the safety and efficacy of dovitinib versus sorafenib as first-line treatment in adult patients with advanced Hepatocellular Carcinoma (HCC). This trial will be opened in countries of the Asia-Pacific region.

Detailed description:

Arms: arm 1: capsule arm 2: tablet
Interventions: intervention 1: dovitinib intervention 2: sorafenib
Intervention descriptions: intervention 1: 500 mg p.o. o.d. 5 days on/2 days off intervention 2: 400 mg p.o. b.i.d.

Protocol documents:
Clinical trial NCT01234922
Conditions: Hypertension Unspecified Adult Solid Tumor, Protocol Specific
Sponsor: Wake Forest University Health Sciences
Start date: 2011-02-01; Completion date: 2014-04-01
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Benazepril hydrochloride, lisinopril, ramipril, and losartan potassium may help lower blood pressure.

PURPOSE: This phase II trial is studying how well benazepril hydrochloride, lisinopril, ramipril, or losartan potassium works in treating hypertension in patients with solid tumors.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine which drug has the greatest effect on Ang-(1-7) levels in cancer patients with hypertension.

SECONDARY OBJECTIVES:

I. To determine the effect of these drugs on levels of Ang II, VEGF, PlGF, and ACE in the same patients.

OUTLINE: Patients are randomized to 1 of 4 treatment arms.

* ARM I: Patients receive oral benazepril hydrochloride once daily on days 1-7.
* ARM II: Patients receive oral lisinopril once daily on days 1-7.
* ARM III: Patients receive oral ramipril twice daily on days 1-7.
* ARM IV: Patients receive oral losartan potassium once daily on days 1-7. In all arms, treatment continues in the absence of unacceptable toxicity.

Arms: arm 1: Patients receive oral benazepril hydrochloride once daily on days 1-7. arm 2: Patients receive oral lisinopril once daily on days 1-7. arm 3: Patients receive oral ramipril twice daily on days 1-7. arm 4: Patients receive oral losartan potassium once daily on days 1-7.
Interventions: intervention 1: lisinopril intervention 2: losartan potassium intervention 3: laboratory biomarker analysis intervention 4: benazepril hydrochloride intervention 5: ramipril
Intervention descriptions: intervention 1: Given orally intervention 2: Given orally intervention 3: Correlative studies intervention 4: Given orally intervention 5: Given orally

Protocol documents:
Clinical trial NCT01253447
Conditions: Adult Acute Megakaryoblastic Leukemia (M7) Adult Acute Minimally Differentiated Myeloid Leukemia (M0) Adult Acute Monoblastic Leukemia (M5a) Adult Acute Monocytic Leukemia (M5b) Adult Acute Myeloblastic Leukemia With Maturation (M2) Adult Acute Myeloblastic Leukemia Without Maturation (M1) Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Del(5q) Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) Adult Acute Myelomonocytic Leukemia (M4) Adult Erythroleukemia (M6a) Adult Pure Erythroid Leukemia (M6b) Recurrent Adult Acute Myeloid Leukemia
Sponsor: National Cancer Institute (NCI)
Start date: 2010-10-01; Completion date: 2014-04-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well AKT inhibitor MK-2206 works in treating patients with relapsed or refractory acute myeloid leukemia (AML). AKT inhibitor MK-2206 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. Determine the proportion of patients achieving Morphologic Complete Response (CR), Morphologic CR with incomplete count recovery (CRp) or Partial Response (PR) as best response within 3 cycles of therapy with MK-2206.

SECONDARY OBJECTIVES:

I. Describe the disease-free survival of patients that achieve CR/CRp.

II. Determine the toxicity profile of single-agent MK-2206 in this patient population.

III. To determine the biologic effects of MK-2206 on leukemia cells.

OUTLINE:

Patients receive AKT inhibitor MK-2206 orally (PO) once weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically.

Arms: arm 1: Akt inhibitor MK2206 200 mg orally once a week for each 28 day treatment cycle
Interventions: intervention 1: Akt inhibitor MK2206 intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: 200 mg orally (PO) once weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT01260467
Conditions: Glioblastoma
Keywords: recurrent
Sponsor: University of Rochester
Start date: 2010-11-01; Completion date: 2014-04-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if a medication called memantine is effective in treating glioblastoma. Memantine targets a specific receptor, called a glutamate receptor, which is thought to be involved in the growth of brain tumors. It has previously been studied for other types of conditions, such as Alzheimer's disease, but it has not yet been evaluated in the treatment of brain tumors. The investigators will also be determining how common it is for patients with brain tumors to have side effects to memantine. Memantine will be taken by mouth twice a day.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: memantine
Intervention descriptions: intervention 1: 10 milligrams orally twice a day

Protocol documents:
Clinical trial NCT01285323
Conditions: Eosinophilic Asthma
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2011-03-01; Completion date: 2014-04-01
Enrollment: 464 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to determine whether reslizumab is more effective than placebo in reducing the number of clinical asthma exacerbations (CAEs) in patients with eosinophilic asthma.

Detailed description:

Arms: arm 1: Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses. arm 2: Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
Interventions: intervention 1: Reslizumab intervention 2: Placebo
Intervention descriptions: intervention 1: Patients were administered intravenously over 15 to 30 minutes reslizumab at a dosage of 3.0 mg/kg at baseline and once every 4 weeks relative to baseline over 48 weeks for a total of 13 doses. intervention 2: Matching placebo (acetate sucrose buffer), administered intravenously (iv) once every 4 weeks for a total of 13 doses.

Protocol documents:
Clinical trial NCT01294163
Conditions: Coronary Artery Disease General Anesthetic Drug Allergy Coronary Artery Bypass Graft Surgery
Keywords: Xenon Sevoflurane Propofol Total intravenous anaesthesia Anaesthesia Coronary artery disease Coronary artery bypass graft
Sponsor: Air Liquide Santé International
Start date: 2011-04-01; Completion date: 2014-04-01
Enrollment: 509 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Xenon is a gaseous anaesthetic agent registered in several European countries. It has been administered safely during cardiac surgery in pilot studies. In animal studies, xenon decreases the size of experimental myocardial infarction.

This 3-arm study will compare xenon, sevoflurane and a propofol-based total intravenous anaesthesia for maintenance of anaesthesia during coronary artery bypass graft surgery conducted with extra-corporeal circulation. Xenon and sevoflurane will be administered before and after extracorporeal circulation. Propofol will be administered during extracorporeal circulation in the three groups of patients.

The study will compare the postoperative myocardial damage observed 24 hours after surgery from blood levels of troponin I, a largely accepted biomarker of myocardial necrosis. The main hypothesis is that the myocardial damage observed after xenon administration will not be superior to the damage observed after sevoflurane administration (non-inferiority). The second hypothesis is that the myocardial damage observed after xenon administration will be inferior to the damage observed after total intravenous anaesthesia.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Xenon intervention 2: Sevoflurane intervention 3: Propofol
Intervention descriptions: intervention 1: Inhaled xenon, maximal inspired concentration of 65%. intervention 2: Inhaled sevoflurane, maximal inspired concentration of 1.8%. intervention 3: Hourly dose of 2-4 mg/kg

Protocol documents:
Clinical trial NCT01298193
Conditions: Breast Cancer
Keywords: Early-stage breast cancer patients
Sponsor: Spanish Breast Cancer Research Group
Start date: 2011-05-01; Completion date: 2014-04-01
Enrollment: 212 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a prospective, multicenter, open label, non-comparative trial in Spain.

The primary objective of this study is to determine the complete response, defined as no vomiting and no use of rescue treatment, in women with early-stage breast cancer treated with one cycle of Docetaxel-Cyclophosphamide and active therapy for the prevention of CINV (Chemotherapy-induced nausea and vomiting) day 1, 5-hydroxytryptamine 3 (5-HT3) antagonist plus 3 days of dexamethasone. A second step (efficacy phase) is designed to examine the efficacy and tolerability of aprepitant in the second cycle among patients who failed to the previous CINV prevention treatment.

The study will focus on early-stage chemonaive breast cancer patients receiving docetaxel-cyclophosphamide and a 5-HT3 antagonist plus dexamethasone for the CINV prevention. The CINV incidence in those patients will be evaluated on the first cycle. All refractory patients, will be asked to participate in the second phase, where aprepitant on days 1, 2 and 3 will be added to their antiemetic regimen.

Assuming a drop out of 5%, 212 patients will be included in the study. It is anticipated that around 48 patients will enter the efficacy phase.

The duration of the study, from first patient visit to last patient visit will be approximately 21 months.

Detailed description:
Sample size We want to obtain an estimation of the percent of the patients that we assume won't have a response to the treatment against vomiting. Reviewing bibliography, we think that the percent is approximately 25%.

We are going to obtain an estimation of this percent with an accuracy of +/- 6%, with a bilateral confidence level of 95% bilateral. Whit all this premises it would be needed 201 patients.

Assuming a drop out of 5%, 212 patients will be included in the study.

A maximum of 212 patients will be included in the trial. It is anticipated that around 48 patients will enter the efficacy phase.

APPROXIMATE DURATION OF THE STUDY. Inclusion period: 18 months approximately. Estimated follow-up: December 2012 Estimated date of end of study: June 2013

Arms: arm 1: Observational phase (first cycle):

Day 0 (Dexamethasone 8mg) Day 1 (5-HT3 antagonist, Ondansetron: 8 mg x2, Granisetron: 1mg x2,Tropisetron: 5 mg, Dexamethasone 24 mg) + Chemotherapy (Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 ).

Days 2 and 3 (Dexamethasone 16 mg).

If not complete response:

Efficacy phase (second cycle):

Day 0 (Dexamethasone 8mg) Day 1 (Aprepitant: 125 mg,5-HT3 antagonist, Ondansetron: 8 mg x2, Granisetron: 1mg x2, Tropisetron: 5 mg, Dexamethasone 12 mg)+ Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 .

Days 2 and 3 (Aprepitant: 1 capsule of 80 mg daily, Dexamethasone 8 mg).
Interventions: intervention 1: Aprepitant
Intervention descriptions: intervention 1: Efficacy phase (second cycle)

Protocol documents:
Clinical trial NCT01313039
Conditions: Breast Cancer
Keywords: Breast Cancer ER-negative Allred Score
Sponsor: University of Miami
Start date: 2011-02-01; Completion date: 2014-04-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
If AZD6244 is able to increase ER expression in ER-negative/low cancers then it may be possible to effectively use hormonal therapy in these patients resulting in improved outcomes. The investigators propose a single-arm Simon two-step study to examine whether treatment with AZD6244 will result in increased ER expression in ER-negative/low primary breast tumors.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: AZ6244
Intervention descriptions: intervention 1: AZD6244 75 mg (3 x 25mg capsules) orally twice per day on Days 1 - 15

Protocol documents:
Clinical trial NCT01316042
Conditions: Premature Pubarche
Keywords: Puberty Hormones
Sponsor: Milton S. Hershey Medical Center
Start date: 2011-05-01; Completion date: 2014-04-01
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to determine the safety and efficacy of metformin in lowering serum DHEAS levels in girls with premature pubarche and secondary, to observe changes in hormones associated with pubertal development including gonadotropins, sex steroids, insulin, adipocytokines, and growth factors.

Detailed description:

Arms: arm 1: 2 pills per day for 12 months arm 2: 2 212.5mg pill/day for 12 months
Interventions: intervention 1: sugar pill intervention 2: Metformin, glucophage
Intervention descriptions: intervention 1: 2 pills per day for 12 months intervention 2: 2 212.5mg pills/day for 12 months

Protocol documents: