ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00822926
Conditions: Pain
Sponsor: Stanford University
Start date: 2009-01-01; Completion date: 2013-12-01
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Superficial injection of Botulinum toxin has been advocated for cosmetic purposes but has also been reported to be helpful for some pain conditions. The investigators have observed prolonged profound analgesia following subcutaneous superficial injection of Botulinum Toxin Type A (BTA) in patients with certain types of neuropathic pain. the investigators propose to study if addition of BTA extends pain relief compared to placebo when injected subcutaneously into areas of cutaneous allodynia (the property that a normally non-noxious stimulus is perceived as painful).

Detailed description:
Patients with post-herpetic neuralgia, complex regional pain syndrome, and post-surgical neuromatous pain patients have marked cutaneous allodynia. Touching their skin with normally non-painful stimuli results in pain. Injected local anesthetics are often effective in providing temporary relief. In the course of clinical practice the investigators have observed that a number of patients with cutaneous allodynia have had marked persistent benefit from subcutaneous injection of Botulinum toxin Type A.

Rather than killing targeted neurons, Botulinum toxin type A inhibits release of acetylcholine from cholinergic nerve terminals in a prolonged but ultimately reversible manner. Neuropathic pain and its hallmark allodynia are classically difficult to treat. Standard treatment with tricyclic antidepressants, anti-epileptic drugs, opiates and spinal cord stimulation is frequently disappointing leaving patients with refractory pain. Surgical or percutaneous ablation of involved nerves has fallen out of favor among many due to disappointing results.

A pilot study is needed to assess the efficacy of superficially injected Botulinum Toxin type A for treatment of cutaneous allodynia and spontaneous pain among patients with neuropathic pain.

Arms: arm 1: Injection 1: Saline- Subcutaneous injection of saline into scar tissue Injection 2: Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue arm 2: Injection 1: Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue Injection 2: Saline- Subcutaneous injection of saline into scar tissue
Interventions: intervention 1: Botulinum Toxin Type A intervention 2: Saline
Intervention descriptions: intervention 1: Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue intervention 2: Subcutaneous injection of saline into scar tissue

Protocol documents:
Clinical trial NCT00824538
Conditions: Breast Cancer
Keywords: stage IA breast cancer stage IB breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer
Sponsor: University of California, San Francisco
Start date: 2009-02-01; Completion date: 2013-12-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with stage I, stage II, or stage III breast cancer who have tumor cells in the bone marrow.

Detailed description:
OBJECTIVES:

Primary

* To determine the effect of sunitinib malate on occult tumor cells (OTC) in the bone marrow of patients with high-risk stage I-III breast cancer.

Secondary

* To evaluate the number of patients who are able to tolerate this drug for 6 months and complete the study.
* To evaluate the toxicities of this drug in these patients.
* To evaluate the effects of this drug on OTC in peripheral blood.
* To evaluate correlative markers, including endothelial cells, soluble cKIT, and VEGF.
* To evaluate relapse-free and overall survival of patients treated with this drug.

OUTLINE: Patients receive oral sunitinib malate once daily for 6 months in the absence of disease progression or unacceptable toxicity.

Patients undergo bone marrow aspiration and peripheral blood sample collection at baseline and at 6 and 12 months. Bone marrow aspirate samples are analyzed by IHC and flow cytometry. Peripheral blood samples are analyzed for circulating tumor cells.

After completion of study treatment, patients are followed at 1 and 6 months.

Arms: arm 1: Study to evaluate the effect of sunitinib (37.5 mg/day orally for 6 months) on occult tumor cells in the bone marrow of patients with high risk early stage breast cancer
Interventions: intervention 1: sunitinib malate intervention 2: flow cytometry intervention 3: immunohistochemistry staining method intervention 4: laboratory biomarker analysis
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00838513
Conditions: Atypical Hemolytic Uremic Syndrome
Keywords: aHUS
Sponsor: Alexion Pharmaceuticals, Inc.
Start date: 2009-07-01; Completion date: 2013-12-01
Enrollment: 15 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether eculizumab is safe and effective in the treatment of adult patients with plasma therapy-sensitive Atypical Hemolytic-Uremic Syndrome (aHUS).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: eculizumab
Intervention descriptions: intervention 1: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.

Protocol documents:
Clinical trial NCT00844428
Conditions: Atypical Hemolytic Uremic Syndrome
Sponsor: Alexion Pharmaceuticals, Inc.
Start date: 2009-07-01; Completion date: 2013-12-01
Enrollment: 5 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether eculizumab is safe and effective in the treatment of adolescent patients with plasma therapy-sensitive Atypical Hemolytic-Uremic Syndrome (aHUS).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: eculizumab
Intervention descriptions: intervention 1: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.

Protocol documents:
Clinical trial NCT00855010
Conditions: Obesity Type 2 Diabetes
Keywords: Pioglitazone prediabetes diabetes obesity Pancreatic fat
Sponsor: University of Texas Southwestern Medical Center
Start date: 2009-02-01; Completion date: 2013-12-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Randomized, double blind, placebo controlled trial evaluating the effect of pioglitazone on pancreatic fat content and bone turnover markers.

Detailed description:

Arms: arm 1: pioglitazone tablet 45 mg once daily arm 2: placebo pill once daily (look-alike pill which contains no active ingredients)
Interventions: intervention 1: pioglitazone intervention 2: placebo
Intervention descriptions: intervention 1: pioglitazone 45 mg daily intervention 2: one daily

Protocol documents:
Clinical trial NCT00887458
Conditions: Prostate Cancer
Keywords: metastatic prostate cancer castration resistant prostate cancer rising PSA
Sponsor: Johns Hopkins University
Start date: 2009-07-01; Completion date: 2013-12-01
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This research is being done to test an investigational drug, called itraconazole, in the treatment of prostate cancer. Itraconazole is approved by the Food and Drug Administration (FDA) for the treatment of various fungal infections such as fingernail/toenail infections and other more serious fungal infections. The word "investigational" means that itraconazole is not approved for use in people with cancer. However, the FDA is allowing the use of itraconazole in this research study. Itraconazole has been shown to have activity against cancer (including prostate cancer) in the laboratory, but has not been tested against cancer in humans.

The purpose of this study is to find out:

* If itraconazole is safe when given at two different doses
* How itraconazole affects prostate specific antigen (PSA): a blood test that measures substances released by prostate cancer
* Whether itraconazole can delay further prostate cancer growth and spread
* How itraconazole affects other markers of prostate cancer

Detailed description:
Itraconazole is an oral, generic, and commercially available antifungal drug with a long safety record when used at doses ranging from 200 to 600 mg daily.

Itraconazole has been shown in cellular and animal models to be a potent angiogenesis inhibitor as well as a Hedgehog pathway antagonist; both pathways are considered important in prostate cancer. Itraconazole has not previously been tested as an antineoplastic agent, but given its well-established safety profile, the gap between further preclinical studies and human clinical trials can be narrowed to accelerate development of this agent as a putative anticancer drug. The investigators hypothesize that itraconazole will prevent PSA progression in a significant proportion of men with metastatic CRPC and that it will have an acceptable safety profile at both doses. Itraconazole may ultimately delay the need for chemotherapy in these men.

Arms: arm 1: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose) arm 2: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)
Interventions: intervention 1: Itraconazole 200 mg intervention 2: Itraconazole 300mg
Intervention descriptions: intervention 1: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose) intervention 2: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)

Protocol documents:
Clinical trial NCT00896337
Conditions: Iliac Artery Stenosis
Keywords: iliac artery stenosis claudication atherosclerotic iliac disease peripheral vascular disease
Sponsor: Boston Scientific Corporation
Start date: 2009-05-01; Completion date: 2013-12-01
Enrollment: 125 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The ORION study is being conducted to determine whether the Epic™ Nitinol Stent for primary stenting of iliac atherosclerotic lesions shows acceptable performance at 9 months.

Detailed description:
ORION is a prospective, single arm, non-randomized, multicenter study. A subject could receive a maximum of 2 study stents for up to 2 target lesions. A maximum of 1 non-target lesion in 1 non-target vessel could be treated with a commercially approved treatment during the index procedure.

Arms: arm 1: All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with iliac artery stenting with the Epic™ Nitinol Stent System.
Interventions: intervention 1: Epic™ Nitinol Stent System intervention 2: Anti-platelet therapy intervention 3: Anti-coagulation therapy
Intervention descriptions: intervention 1: The Epic™ Nitinol Stent System is comprised of two components: the implantable nitinol endoprosthesis and the stent delivery system. intervention 2: Investigators must prescribe concomitant anti-platelet medication consistent with current clinical practice. Anti-platelet therapy should be administered preprocedure and continued throughout participation in the trial. intervention 3: Anti-coagulation therapy must be administered during the procedure consistent with current clinical practice.

Protocol documents:
Clinical trial NCT00924807
Conditions: Prostate Cancer
Keywords: Prostate Cancer Combined Androgen Blockade Radiotherapy Sorafenib
Sponsor: Beth Israel Medical Center
Start date: 2008-09-01; Completion date: 2013-12-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety of a new drug- sorafenib, which is to be administered at the same time as standard treatment, which includes hormonal therapy and external beam radiotherapy.

Detailed description:
Leuprolide acetate (a luteinizing hormone releasing hormone (LHRH) agonist) and Bicalutamide (an anti-androgen) are hormonal agents which are commonly used to reduce testosterone blood level for prostate cancer treatment. Intensity modulated external beam radiotherapy is a standard treatment for localized prostate cancer. Previous studies have shown that combining hormonal therapy and radiation is more effective than radiation alone. Unfortunately, significant percentages (50-75%) of patients still relapse. Sorafenib reduces the growth of cancer cells and has proven effective in the treatment of solid tumors including kidney and liver cancer. This drug is approved by the FDA for treatment kidney and liver cancer. The study investigators believe that adding sorafenib to standard treatment, comprising hormonal therapy and radiation, might be more effective then standard hormonal therapy.

Arms: arm 1: Everyone will receive Leuprolide acetate, Bicalutamide,Sorafenib and radiotherapy.
Interventions: intervention 1: Leuprolide acetate, Bicalutamide, Sorafenib
Intervention descriptions: intervention 1: Leuprolide acetate - depot, Bicalutamide 50 mg, Sorafenib 400mg

Protocol documents:
Clinical trial NCT00924898
Conditions: Acute HIV Infection HIV Infections
Keywords: Acute HIV HIV Acute Infections Acute Infection
Sponsor: University of North Carolina, Chapel Hill
Start date: 2005-01-01; Completion date: 2013-12-01
Enrollment: 92 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a pilot study of treatment of acute HIV infection with a once daily regimen of Emtricitabine, Tenofovir and Efavirenz. The primary objectives of this study are:

1. To determine the safety and tolerability, and the virologic and immunologic efficacy of FTC, TDF, and efavirenz given once daily to patients with acute HIV infection.
2. To assess the impact of once daily therapy combined with a standardized adherence program on treatment adherence, virologic suppression, and rate of viral load decline in blood and infectious fluids (semen, cervico-vaginal secretions).
3. To define the prevalence of genotypic and phenotypic resistance to antiretroviral agents among persons diagnosed with acute HIV infection in the Southeastern United States.

Detailed description:
Hypothesis: Once daily ART with fixed dose combination FTC/TDF/EFV will reduce viral replication to \<200 copies RNA/ml plasma in blood and other body compartments in patients with acute HIV infection, reducing infectivity. The treatment regimen will be well tolerated during treatment follow-up. A coordinated program of counseling and support will facilitate adherence and promote successful therapy. Prevalence of transmitted drug resistant HIV-1 will be assessed.

Study Design: Dual-center, prospective, single-arm pilot study of FTC/TDF/EFV in patients with acute HIV infection. Study sites will be members of the Duke-UNC Acute HIV Infection Study Consortium. Patients will be followed intensively for 96 weeks.

Arms: arm 1: Single arm, open label study in which all participants received the same study treatment with efavirenz, emtricitabine, and tenofovir DF
Interventions: intervention 1: efavirenz, emtricitabine, and tenofovir
Intervention descriptions: intervention 1: Once daily ART with emtricitabine, tenofovir DF and efavirenz

Protocol documents:
Clinical trial NCT00940901
Conditions: Sickle Cell Disease Priapism
Keywords: priapism sickle cell disease sildenafil phosphodiesterase type 5 inhibitor
Sponsor: Johns Hopkins University
Start date: 2008-06-01; Completion date: 2013-12-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This research is being done to evaluate if the phosphodiesterase type 5 (PDE5) inhibitor sildenafil has an effect on the frequency of recurrent priapism and the quality of life of males with sickle cell disease (SCD).

Detailed description:
The proposed research is designed to investigate the utility of continuous, long-term PDE 5 inhibitor therapy as an intervention for recurrent ischemic priapism, a disorder of non-willful, excessive penile erection, in patients with SCD. Although precise prevalence figures are not available, priapism in SCD is highly prevalent and thought to afflict approximately 40% of males, based on available literature. Additionally, the disorder exacts devastating consequences, including erectile tissue necrosis, erectile dysfunction, and psychological distress. Management of this disorder remains challenging because the mechanisms underlying priapism are incompletely understood.

Arms: arm 1: Participants assigned to this arm were given sildenafil 50 mg tablet daily for 16 weeks. arm 2: Participants assigned to this arm were given a placebo pill for the first 8 weeks, and then Sildenafil 50 mg for weeks 9-16.
Interventions: intervention 1: sildenafil intervention 2: placebo
Intervention descriptions: intervention 1: sildenafil 50 mg tablet daily for first 8 weeks (phase 1), and then sildenafil 50 mg tablet daily for final 8 weeks (phase 2) intervention 2: placebo 50 mg tablets daily for first 8 weeks (phase 1), and then sildenafil 50mg tablet daily for final 8 weeks (phase 2)

Protocol documents:
Clinical trial NCT00961532
Conditions: Intracerebral Hemorrhage
Keywords: intracerebral hemorrhage platelets
Sponsor: Northwestern University
Start date: 2010-12-01; Completion date: 2013-12-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The investigators intend to show that DDAVP improves platelet activity from baseline to 60 minutes after treatment start.

Detailed description:

Arms: arm 1: DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes
Interventions: intervention 1: DDAVP injection (desmopressin acetate)
Intervention descriptions: intervention 1: 0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes

Protocol documents:
Clinical trial NCT01003210
Conditions: Otitis Media
Keywords: otitis media children homeopathy
Sponsor: University of Washington
Start date: 2009-10-01; Completion date: 2013-12-01
Enrollment: 210 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if a commercially available homeopathic ear drop preparation is effective in reducing symptoms in children 6 months - 11 years old with acute otitis media in whom the health care provider has recommended that antibiotics not be immediately administered. A total of 150 study patients with otitis media will be randomized to receive homeopathic ear drops, or no ear drops, in addition to receiving standard care. It is postulated that children using the ear drops will have more rapid resolution of symptoms and need fewer antibiotics than those randomized to not receive the ear drops.

Detailed description:

Arms: arm 1: Commercially available homeopathic ear drops arm 2: standard therapy for otitis media, no ear drops
Interventions: intervention 1: Hyland's earache drops
Intervention descriptions: intervention 1: 3-4 drops in affected ear 3 times a day as needed for up to 5 days

Protocol documents:
Clinical trial NCT01004250
Conditions: Non-Small Cell Lung Cancer
Sponsor: Eli Lilly and Company
Start date: 2009-10-01; Completion date: 2013-12-01
Enrollment: 109 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Participants with advanced non-small cell lung cancer (NSCLC) will receive a first-line treatment of Pemetrexed, Cisplatin and Bevacizumab as induction therapy followed by a maintenance treatment of Pemetrexed and Bevacizumab. Treatment will continue until disease progression or unacceptable toxicity occurs. The primary objective of this study is to measure how long this treatment could prevent the disease progression.

Detailed description:
The study will have 3 periods: a baseline period; a study treatment period, including both induction and maintenance treatment; and a follow-up period. Approximately 110 participants will be enrolled into the study, with the aim of having 100 evaluable participants. Eligible participants will first receive 4 cycles of induction chemotherapy with pemetrexed-cisplatin-bevacizumab. Participants who achieve a response or do not progress after completion of induction chemotherapy and have an adequate performance status will receive maintenance therapy with pemetrexed-bevacizumab. Treatment will continue until disease progression or unacceptable toxicity occurs. When treatment is discontinued, the participants health status will be monitored till death, loss to follow-up or data cut-off date.

Participants who continue to receive benefit from treatment at the time of data cut-off may receive continued access to pemetrexed and bevacizumab until disease progression, unacceptable toxicity, or any other reason at investigator or participants decision.

Arms: arm 1: None
Interventions: intervention 1: Pemetrexed intervention 2: Cisplatin intervention 3: Bevacizumab
Intervention descriptions: intervention 1: 500 milligram per square meter (mg/m²) given intravenously on Day 1 of each 21-day cycle for four cycles of Induction Therapy, and continued in Maintenance Therapy until progression or unacceptable toxicity. intervention 2: 75 mg/m² given intravenously on Day 1 of 21-day cycle for a maximum of 4 cycles intervention 3: 7.5 milligram per kilogram (mg/kg) given intravenously on Day 1 of 21-day cycle for four cycles of Induction Therapy, and continued in Maintenance Therapy until progression or unacceptable toxicity

Protocol documents: