ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01350947
Conditions: Chronic Myelomonocytic Leukemia
Keywords: Chronic Myelomonocytic Leukemia CMML
Sponsor: University of Utah
Start date: 2011-04-01; Completion date: 2014-09-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is:

Response to treatment will be evaluated according to the revised International Working Group (IWG) categories natural history, hematologic improvement and cytogenetic response1;2. The primary objective is:

To determine the rate of complete hematologic response and hematologic improvement (according to IWG 2006 criteria) in CMML patients treated with 5-azacitidine.

Detailed description:
In this study, eligible patients with a confirmed diagnosis of CMML will be treated with 5-azacitidine to determine the rates of complete hematologic response, hematologic improvement, complete and partial cytogenetic response, and overall and progression free survival.

To develop biomarkers associated with response and gain insights into the mechanisms that determine response, gene expression profiling, genome-wide SNP array analysis, microRNA analysis, and DNA methylation analysis will be performed prior to therapy and at defined time points during the study. Phosphoproteomics profiling may be included in the analysis.

Arms: arm 1: All participants enrolled.
Interventions: intervention 1: 5-Azacitidine
Intervention descriptions: intervention 1: Administered on Days 1-7 of each Cycle.

Subcutaneous administration:

To provide a homogeneous suspension, the contents of the syringe must be re-suspended by inverting the syringe 2-3 times and vigorously rolling the syringe between the palms for 30 seconds immediately prior to administration.

The 5-azacitidine suspension is administered subcutaneously.

Intravenous Administration:

5-Azacitidine solution is administered intravenously. Administer the total dose over a period of 10-40 minutes.

Protocol documents:
Clinical trial NCT01353209
Conditions: Lymphangioleiomyomatosis
Keywords: Lymphangiomyomatosis Postmenopausal
Sponsor: University of Cincinnati
Start date: 2011-05-01; Completion date: 2014-09-01
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The hypothesis in this study is that estrogen suppression by an aromatase inhibitor in postmenopausal women with lymphangioleiomyomatosis (LAM) will prevent or delay progression of lung disease and result in a decrease in the rate of decline in FEV1

Detailed description:
Lymphangioleiomyomatosis, or LAM, is an uncommon, progressive, cystic lung disease that predominantly affects young women. Pulmonary parenchymal changes consistent with LAM are found in about one third of women with tuberous sclerosis complex (TSC), an autosomal dominant tumor suppressor syndrome. LAM also occurs in a sporadic form that is not associated with germline mutations in TSC genes. Recent evidence that recurrent LAM after lung transplantation results from seeding of the graft from a remote source and suggests a metastatic mechanism for the disease.

Since LAM occurs almost exclusively in women, and is exacerbated by pregnancy, menses and hormonal therapies suggest that estrogen suppression might be expected to prevent or delay progression of disease.

In postmenopausal women, estrogens are mainly derived from the action of the aromatase enzyme, which converts adrenal androgens (primarily androstenedione and testosterone) to estrone and estradiol. The suppression of estrogen biosynthesis in peripheral tissues can therefore be achieved by specifically inhibiting the aromatase enzyme. Letrozole is a nonsteroidal aromatase inhibitor (inhibitor of estrogen synthesis) that has been shown to be effective in other neoplasms that affect women, such as breast cancer.

Arms: arm 1: Patients are placed on letrozole, 1 tablet (2.5 mg) daily for one year arm 2: Patients are placed on placebo, 1 tablet daily for one year
Interventions: intervention 1: Letrozole intervention 2: Placebo
Intervention descriptions: intervention 1: 2.5 mg daily for twelve months intervention 2: placebo given daily for twelve months

Protocol documents:
Clinical trial NCT01368276
Conditions: Melanoma
Keywords: Melanoma Stage IIIb, IIIc and IV Disease oncolytic OncoVex OncoVEX^GM-CSF
Sponsor: BioVex Limited
Start date: 2010-10-01; Completion date: 2014-09-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to learn about the safety and the risks of using talimogene laherparepvec in patients who already received treatment with talimogene laherparepvec in study 005/05 (NCT00769704), and to see if extended treatment with talimogene laherparepvec can destroy melanoma tumors.

Detailed description:

Arms: arm 1: Granulocyte macrophage colony-stimulating factor (GM-CSF) was administered at a dose of 125 μg/m²/day subcutaneously for 14 consecutive days followed by 14 days of rest, in 28-day treatment cycles for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met. arm 2: Talimogene laherparepvec was administered at a concentration of 10⁸ plaque forming units (PFU)/mL injected into 1 or more skin or subcutaneous tumors on Days 1 and 15 of each 28-day cycle for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
Interventions: intervention 1: Talimogene Laherparepvec intervention 2: Granulocyte Macrophage Colony-Stimulating Factor (GM-CSF)
Intervention descriptions: intervention 1: Up to 4 mL of 10⁸ pfu/mL/per intratumoral injection intervention 2: 125 µg/m² subcutaneous injection

Protocol documents:
Clinical trial NCT01408030
Conditions: Telangiectasia, Hereditary Hemorrhagic Epistaxis
Keywords: epistaxis HHT bevacizumab tranexamic acid nosebleed estrogen
Sponsor: James Gossage
Start date: 2011-08-01; Completion date: 2014-09-01
Enrollment: 123 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the NOSE Study is to carefully examine the efficacy and safety of 3 nasal sprays (bevacizumab, estriol, and tranexamic acid), compared to placebo, for the treatment of HHT related nosebleeds.

Detailed description:
140 patients with moderate to severe epistaxis secondary to HHT will be randomized to receive one of four intranasal sprays for a period of 12 weeks and then followed for an additional 12 weeks off therapy. Enrollment will occur over a period of 18-36 months. The primary endpoint will be the frequency of epistaxis. Secondary endpoints will include duration of epistaxis, the Hoag Epistaxis Severity Score (ESS), a quality of life survey, satisfaction with treatment, hemoglobin and ferritin levels, transfusion requirements, and treatment failure. The sprays will be: saline spray (Placebo); estriol 0.1% in methylcellulose suspension (EST); tranexamic acid 10% in saline (TA), and bevacizumab 1% in saline (BEV). All sprays will be applied to the nasal mucosa by an identical spray bottle at a dose of 0.1 ml per nostril twice daily (total dose of 0.4 ml daily). Thus, the delivered doses will be: EST, 0.4 mg/day; TA, 40 mg/day; BEV, 4 mg/day.

Arms: arm 1: sterile saline arm 2: bevacizumab 1% arm 3: Estriol 0.1% arm 4: tranexamic acid 10%
Interventions: intervention 1: Sterile saline intervention 2: Bevacizumab intervention 3: Estriol intervention 4: Tranexamic Acid
Intervention descriptions: intervention 1: 0.9%, 0.1 ml spray in each nostril bid intervention 2: 1% solution in saline, 0.1 ml spray in each nostril bid intervention 3: 0.1% suspension in methylcellulose, 0.1 ml spray in each nostril bid intervention 4: 10% solution in saline, 0.1 ml spray in each nostril bid

Protocol documents:
Clinical trial NCT01422187
Conditions: Gaucher Disease
Keywords: enzyme replacement therapy
Sponsor: Pfizer
Start date: 2011-08-01; Completion date: 2014-09-01
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-center trial to further extend the assessment of the safety and efficacy of taliglucerase alfa in adult subjects (≥18 years old) with Gaucher disease who have enrolled in Protocol PB-06-003. Subjects will continue to receive an intravenous (IV) infusion of taliglucerase alfa every two weeks. The duration of treatment will be a maximum of 21 months or until taliglucerase alfa is commercially available to the subject at the discretion of the Sponsor.

Detailed description:

Arms: arm 1: Subjects randomized to receive 30 units/kg arm 2: Subjects randomized to 60 units/kg
Interventions: intervention 1: Taliglucerase alfa
Intervention descriptions: intervention 1: Taliglucerase infusion every two weeks for 21 months

Protocol documents:
Clinical trial NCT01430455
Conditions: Bipolar Disorder I or II
Keywords: Major Depressive Episode Depression NOS Bipolar Disorder Bipolar Disorder I Bipolar Disorder II Bipolar Depression Major Depression
Sponsor: New York State Psychiatric Institute
Start date: 2011-11-01; Completion date: 2014-09-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study seeks to investigate whether tranylcypromine (Parnate®) might be an effective treatment of bipolar depression. New treatments are needed, as there is little evidence that standard antidepressants are effective in treating this condition, and the two antipsychotic medications that have indications for bipolar depression can cause substantial side effects. This study will focus specifically on currently depressed outpatients having a bipolar history for whom at least one standard antidepressant medication was ineffective. Patients will be treated openly with tranylcypromine for 8-10 months, depending on treatment response.

Detailed description:

Arms: arm 1: Active, open-label tranylcypromine treatment
Interventions: intervention 1: Tranylcypromine
Intervention descriptions: intervention 1: Tranylcypromine, between 10 mg/day and 120 mg/day throughout 16 week study

Protocol documents:
Clinical trial NCT01433354
Conditions: Fragile X Syndrome
Keywords: Fragile X Syndrome Martin-Bell Syndrome Genetic Diseases X-Linked Escalante's syndrome
Sponsor: Novartis Pharmaceuticals
Start date: 2011-11-01; Completion date: 2014-09-01
Enrollment: 119 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to generate long-term safety, tolerability and efficacy data for AFQ056 in eligible adolescent patients with FXS who have participated in the CAFQ056B2214 study, the PK study CAFQ056B2131, or another study of AFQ056 which included FXS patients below 18 years of age provided the patient is at least 12 years of age at the time of entry into the current study.

Detailed description:

Arms: arm 1: All patients will initiate treatment with AFQ056 at a starting dose of 25 mg b.i.d. The dose will be titrated from 25 mg b.i.d to 50 mg b.i.d., 75 mg b.i.d. and 100 mg b.i.d. at weekly intervals. Dose adjustments (up- and down-titrations) will be permitted as needed to manage any tolerability issues and to ensure that patients reach their highest tolerated dose, not to exceed 100 mg b.i.d.
Interventions: intervention 1: AFQ056
Intervention descriptions: intervention 1: The investigational drug, AFQ056, will be provided as hard gelatin capsules. Two different oral dosage strengths,25mg and 100 mg, identical in appearance, will be used.

Protocol documents:
Clinical trial NCT01444092
Conditions: Crohn's Disease
Sponsor: Padagis LLC
Start date: 2011-11-01; Completion date: 2014-09-01
Enrollment: 123 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A Safety Study using Entocort EC for children with mild to moderate Crohn's Disease

Detailed description:
A Multicenter, Open label, Non-comparative Study to Evaluate the Safety of Entocort EC for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive

Arms: arm 1: Study Medication
Interventions: intervention 1: Entocort
Intervention descriptions: intervention 1: Entocort capsules, oral

Protocol documents:
Clinical trial NCT01471574
Conditions: Hepatitis C, Genotype 1
Sponsor: Bristol-Myers Squibb
Start date: 2011-12-01; Completion date: 2014-09-01
Enrollment: 549 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this open label study is to evaluate the safety and efficacy of daclatasvir plus pegylated interferon-alfa 2a and ribavirin in untreated hepatitis C virus in patients coinfected with HIV

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Daclatasvir intervention 2: Ribavirin intervention 3: PEG-Interferon alfa 2a
Intervention descriptions: intervention 1: Tablets; oral; 30, 60, or 90 mg; once daily; up to 24 weeks intervention 2: Tablets; oral; for patients weighing \<75 kg, the total dose is 1000 mg per day (2 200-mg tablets in the morning and 3 200-mg tablets in the evening); for patients weighing \>75 kg, the total dose is 1200 mg per day (3 200-mg tablets in morning and 3 200-mg tablets in evening); twice daily with food; 24 or 48 weeks depending on response intervention 3: Syringe, subcutaneous injection, 180 μg, once weekly, 24 or 48 weeks depending on response

Protocol documents:
Clinical trial NCT01480297
Conditions: Peripheral Neuropathy Type 1 Diabetes
Keywords: Pain Neuropathy Diabetes type 1
Sponsor: University of Michigan
Start date: 2011-11-01; Completion date: 2014-09-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This 12 week study will examine the effects of daily Salsalate treatment on markers of neuropathic pain and intra-epidermal nerve fiber density. the study is being done in people with type 1 diabetes with signs and symptoms of peripheral neuropathy.

Detailed description:
This project will be used to establish preliminary data for a planned NIH-sponsored multicenter study of the effects of salsalate on diabetic neuropathy (DN) in people with type 1 diabetes. Diabetic peripheral neuropathy (DN) ultimately affects one-half of the patients with type 1 diabetes (T1DM) and is a major cause of disability, high mortality, and poor quality of life. Although intensive glucose control has proven efficacy in delaying or preventing DN in T1DM and type 2 diabetes (T2DM), most people with diabetes do not reach and maintain glycemic levels needed to achieve these benefits. In addition, many patients with diabetes still develop diabetic complications, including DN, despite good glucose control. For DN, no disease modifying treatment other than glycemic control is available. Therefore, it is essential to identify new drug targets and to treat DN as early as possible in its course.

The investigators planned, multi-center study will be the first to determine the effect of an anti-inflammatory agent, salsalate, on DN development and progression, and on DN pain in type 1 diabetes. This proof-of-concept pilot study will measure the effects of short term (12 week) treatment with Salsalate on novel and on established measures of peripheral neuropathy. Ultimately, this may permit measurement of treatment effects over a shorter period of time than by using established measures such as nerve conduction studies. Salsalate, a prodrug form of salicylate, is used to treat osteoarthritis and other rheumatologic conditions. It is highly effective in modulating the IKKβ/NF-κB pathway, with a large margin of safety, and has a glucose lowering effect in patients with type 2 diabetes. The IKKβ/NF-κB pathway is unique in that it is implicated in both the pathogenesis of nerve fiber loss as well as pain in DN. The proposed study design employs a quantifiable early measure of DN, IENFD of the thigh, allowing for accurate assessment of actual nerve fiber density over time.

In the pilot study, biomarkers of pain found in IENF's as well as IENFD will be measured pre and post 3 months of treatment with Salsalate, 3 grams daily.

Arms: arm 1: All subjects will take Salsalate, 3 grams daily (as 3 divided doses of 1 gram with breakfast, lunch and dinner).
Interventions: intervention 1: Salsalate
Intervention descriptions: intervention 1: Salsalate 3 grams daily (1 gram TID with meals)

Protocol documents:
Clinical trial NCT01482169
Conditions: Coronary Artery Disease
Keywords: Left heart catheterization Fractional flow reserve Adenoscan® Regadenoson
Sponsor: Ochsner Health System
Start date: 2012-03-01; Completion date: 2014-09-01
Enrollment: 48 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to demonstrate that intravenous regadenoson is equivalent to intravenous Adenoscan® for the physiological assessment of intermediate coronary lesions.

Detailed description:
This is a prospective open label, single center pilot trial that will evaluate regadenoson compared to Adenoscan® to be given IV in the assessment of Fractional Flow Reserve. Forty eight subjects will be enrolled and get Adenoscan® administered via IV followed by Regadenoson IV.

Arms: arm 1: Subjects will have the FFR Measurement with IV Adenoscan® arm 2: Subjects will have the FFR Measurement with IV Regadenoson
Interventions: intervention 1: FFR Measurement with IV Adenoscan® then with Regadenoson
Intervention descriptions: intervention 1: Testing will be completed during a Left Heart Catheterization (LHC). The first 48 eligible patients enrolled will receive an initial infusion of IV Adenoscan® through a peripheral vein at 140 mcg/kg/min. FFR measurements will be obtained utilizing a coronary pressure guide wire once peak hyperemia has been achieved. It takes about 84 seconds to reach peak hyperemia with Adenoscan®. Subsequently, these subjects will receive a dose of regadenoson at 0.4 mg through the same peripheral access site. FFR measurements will be obtained once peak hyperemia is achieved, which takes less than 30 seconds with regadenoson. Patients who react to either medication will be supported conservatively under close scrutiny.

Protocol documents:
Clinical trial NCT01490918
Conditions: Type 2 Diabetes Mellitus
Keywords: Acarbose ACADEMIC
Sponsor: The Catholic University of Korea
Start date: 2012-04-01; Completion date: 2014-09-01
Enrollment: 165 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary objective To evaluate the efficacy of Acarbose add-on therapy on glucose control in subjects with type 2 diabetes inadequately controlled with Metformin and Sitagliptin combination therapy.

The effect of acarbose, an alpha glucosidase inhibitor as a third-line therapeutic medication in subject who are inadequately controlled with metformin and DPP4 inhibitor will be evaluated with multicenter, randomized, 24-week, double blinded, placebo-controlled study in Korea.

Detailed description:
Eligible subjects will be assigned among 3 groups randomly at a ration of 2:2:1 to the following groups and primary efficacy variable analyzed at week 16.

group 1 : acarbose placebo + metformin + sitagliptin (with switching placebo to acarbose qt week 16) group 2 : acarbose + metformin + sitagliptin group 3 : acarbose + metformin placebo + sitagliptin (with switching placebo to metformin at week 16)

After 16 week of treatment, all subjects in 3 groups will be treated as triple combination of acarbose + metformin + sitagliptin, and diabetes related variables be collected and analyzed.

1. Primary Endpoint Changes in HbA1c (hemoglobin A1c) at 16 week from baseline between group1 vs grou2
2. Secondary Endpoints (1) Changes of HbA1c at 24 week between 3 groups (2) Changed of post-prandial blood glucose at 2 hour (ppg2h) at 16, 24 week

for exploratory purpose, following data will be collected and analyzed

1. continuous glucose monitoring system (CGMS) data among selected subjects in 3 groups
2. mixed meal tolerance test in only available institution. (glucose, insulin, GLP-1, GIP, glucagon ) among selected subjects in group 1 and group 2
3. oxidative stress markers (8-OHdG, nitrotyrosin, CML)
4. self monitoring of blood glucose

Arms: arm 1: The Acarbose placebo should be changed into real Acarbose from the 16th week. arm 2: Metformin, Sitagliptin, Acarbose group arm 3: The Metformin placebo should be changed into real Metformin from the 16th week.
Interventions: intervention 1: Acarbose intervention 2: Placebo acarbose intervention 3: placebo metformin
Intervention descriptions: intervention 1: Acarbose 50mg b.i.d at first, at the 2nd week 50mg t.i.d and the 4th week, 100mg tid. intervention 2: acarbose placebo intervention 3: metformin placebo

Protocol documents:
Clinical trial NCT01491802
Conditions: COPD
Keywords: COPD Combination therapy Anticholinergic Beta2-agonist Exercise Dyspnea Respiratory mechanics
Sponsor: Queen's University
Start date: 2012-01-01; Completion date: 2014-09-01
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Preliminary information from our laboratory indicated that even patients with milder chronic obstructive pulmonary disease (COPD) can have significant physiological derangements which become more pronounced during exercise, leading to intolerable dyspnea at lower levels of ventilation than in health. This study will explore pathophysiological mechanisms of dyspnea and activity limitation in GOLD stage II COPD and will determine if there is a sound physiological rationale for the use of dual long-acting beta2-agonist (LABA)/long-acting muscarinic antagonist (LAMA) therapy (GSK573719/ GW642444 Inhalation Powder) versus LAMA alone (GSK573719) as treatment for dyspnea and exercise intolerance in this subpopulation. Objectives of this study are to determine if: 1) neuromechanical uncoupling of the respiratory system contributes to exertional dyspnea in milder COPD, and 2) treatment with LABA/LAMA improves dyspnea and exercise endurance compared with LAMA by improving neuromechanical coupling. The investigators hypothesize that: 1) dyspnea is related to excessive dynamic lung hyperinflation, tidal volume restriction and increased ratio of central respiratory neural drive to tidal volume displacement, a measure of neuromechanical uncoupling of the respiratory system, and 2) LABA/LAMA will improve dyspnea and exercise endurance, which will be explained by partial reversal of the above mechanical abnormalities. The investigators will conduct a randomized, double-blind crossover study and compare the effects of once-daily LABA/LAMA over 4-weeks with LAMA on dyspnea, exercise endurance and ventilatory mechanics in GOLD stage II COPD.

Detailed description:

Arms: arm 1: Participants will first receive an inhaled long-acting muscarinic antagonist (LAMA) once daily for 4 weeks. After a 2 week washout period, they will then receive the fixed-dose combination product \[LAMA plus long-acting beta2-agonist (LABA)\] once daily for 4 weeks. arm 2: Participants will first receive a long-acting muscarinic antagonist (LAMA) plus long-acting beta2-agonist (LABA) combination product once daily for 4 weeks. After a 2 week washout period, they will then receive the LAMA single product once daily for 4 weeks.
Interventions: intervention 1: LAMA/LABA intervention 2: LAMA
Intervention descriptions: intervention 1: GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy will be taken once daily for 4 weeks. intervention 2: GSK573719 (125mcg) inhalation powder is a long-acting muscarinic antagonist that will be taken once daily for 4 weeks

Protocol documents: