ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00789256
Conditions: Acute Myelogenous Leukemia Myelodysplastic Syndromes
Keywords: Acute Myelogenous Leukemia AML Myelodysplastic Syndromes MDS Melphalan Bortezomib Velcade
Sponsor: Dartmouth-Hitchcock Medical Center
Start date: 2004-09-01; Completion date: 2008-12-01
Enrollment: 26 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the response rate of the combination of bortezomib and melphalan in patients with Acute Myelogenous Leukemia (AML) or high-risk Myelodysplastic Syndromes (MDS).

Detailed description:
In patients who develop acute myelogenous leukemia (AML) or a high-risk myelodysplastic syndrome (MDS), the current standard treatment involves multidrug induction chemotherapy utilizing an anthracycline or anthraquinone with cytarabine. While chemotherapy has proven effective at inducing remission in up to 90% of patients, elderly patients fair far worse. In patients over the age of sixty, the disease is not only less responsive to therapy, but an increased number of comorbid conditions makes induction therapy a more dangerous endeavor. Because of this, many patients are not offered standard induction chemotherapy and there is a dearth of viable alternatives for treatment of these otherwise fatal diseases.

Low dose melphalan has previously been shown to be an effective palliative treatment for patients diagnosed with AML and high-risk MDS. It was found to have an overall response rate of 40% in AML patients (30% complete remission and 10% partial remission) and a 57% overall response in high-risk MDS patients (33% complete remission, 5% partial remission, and 19% minor responses). This therapy, while not curative, is one of the few options for patients unable to tolerate more intensive treatment regimens, but desiring a potentially effective palliative regimen.

Bortezomib (VELCADE®) is an intravenously administered reversible, selective inhibitor of the 26S proteosome. Although all of the mechanisms by which this novel drug acts as an antineoplastic agent are not fully understood, in vivo and in vitro studies indicate they ultimately result in the inhibition of the gene expression necessary for cell growth and survival pathways, apoptotic pathways, and cellular adhesion, migration, and angiogenesis mechanisms.

Preclinical and clinical evaluation of the combination of melphalan and bortezomib has demonstrated impressive synergy in refractory multiple myeloma cell lines and patients with myeloma. This study aims to determine if these findings hold true in AML and MDS patients.

Arms: arm 1: All patients will receive the following regimen: 1) Melphalan 2 mg orally, once daily. 2) Bortezomib 1.0 mg/M2 IV on days 1, 4, 8, 11.
Interventions: intervention 1: Melphalan intervention 2: Bortezomib intervention 3: Melphalan and bortezomib
Intervention descriptions: intervention 1: Melphalan: 2mg orally, once daily intervention 2: Bortezomib: 1.0mg/M2 IV on days 1, 4, 8, 11 intervention 3: None

Protocol documents:
Clinical trial NCT00794144
Conditions: Allergic Rhinitis
Keywords: Allergic Rhinitis Pediatric PATANASE
Sponsor: Alcon Research
Start date: 2008-10-01; Completion date: 2008-12-01
Enrollment: 132 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to assess the safety of the study drug, Patanase (Olopatadine Hydrochloride Nasal Spray 0.6%) compared to placebo (inactive substance) in children ages 2 to less than 6 who have a history of nasal allergies, and to assess the pharmcokinetics (study of the action of a drug in the body) in these children

Detailed description:

Arms: arm 1: Olopatadine Hydrochloride Nasal Spray 0.6% arm 2: Olopatadine Hydrochloride Nasal Spray Vehicle
Interventions: intervention 1: Olopatadine Hydrochloride Nasal Spray 0.6% intervention 2: Olopatadine Hydrochloride Nasal Spray Vehicle
Intervention descriptions: intervention 1: one spray in each nostril twice daily for 2 weeks intervention 2: one spray in each nostril twice daily for 2 weeks

Protocol documents:
Clinical trial NCT00803283
Conditions: Cancer Pain
Keywords: Pain Hydromorphone hydrochloride OROS Morphine
Sponsor: Johnson & Johnson Taiwan Ltd
Start date: 2008-11-01; Completion date: 2008-12-01
Enrollment: 2 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effectiveness and safety of Osmotic Release Oral System (OROS) hydromorohone Hydrochloride (HCl) compared with morphine sustain release (SR) in participants with chronic (lasting a long time) malignant (cancerous) cancer pain.

Detailed description:
This is an open-label (all people know the identity of the intervention), multi-center (when more than 1 hospital or medical school team work on a medical research study), active-controlled, randomized (the study drug is assigned by chance) study to evaluate safety and efficacy of OROS extended-release (ER) hydromorhone HCl compared to twice daily morphine SR, in Taiwan participants with cancer pain. The study consists of 3 phases: Screening phase (14 days before administration of study drug), Dose titration phase (3 to 14 days) and Dose maintenance phase (14 days). This study will include 8 visits (Visit 1 \[Day 1\], Visit 2 \[Day 1-13 telephonic\], Visit 3 \[Day 14\], Visit 4 \[Day 15 to Day 21 telephonic\], Visit 5 \[Day 22\], Visit 6 \[Day 23 to 27 telephonic\] and Visit 7 \[Day 28\]). In dose titration phase, participants will be randomly assigned to 1 of the 2 treatments, OROS hydromorphone or morphine SR and dose of study medication will be adjusted every 48 hours at Investigator's discretion according to participant's analgesic (drug used to control pain) requirements. Morphine HCl will be used as rescue medication (maintained at 3 doses per day or less) for breakthrough pain. Participants primarily will be evaluated for equivalence of efficacy using the "worst pain" item of the brief pain inventory (BPI). Participants' safety will be monitored throughout the study duration.

Arms: arm 1: Participants will receive hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS will be continued as per Investigator's discretion for next 14 days of maintenance phase. arm 2: Participants will receive morphine SR 8 mg every 24 hours, for 3 to14 days of titration phase. Morphine SR will be continued as per Investigator's discretion for next 14 days of maintenance phase.
Interventions: intervention 1: Hydromprphone Hydrochloride (HCl) OROS intervention 2: Morphine Sustain Release (SR)
Intervention descriptions: intervention 1: Participants will receive hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS will be continued as per Investigator's discretion for next 14 days of maintenance phase. intervention 2: Participants will receive morphine SR 8 mg every24 hours, for 3 to14 days of titration phase. Morphine SR will be continued as per Investigator's discretion for next 14 days of maintenance phase.

Protocol documents:
Clinical trial NCT00804648
Conditions: Glaucoma, Open Angle Ocular Hypertension
Sponsor: Vistakon Pharmaceuticals
Start date: 2008-11-01; Completion date: 2008-12-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study compares patient symptoms and anterior segment safety in patients treated with timolol hemihydrate, generic timolol gel forming solution or timolol maleate.

Detailed description:

Arms: arm 1: Period one - Timolol hemihydrate 0.5% Period two - Timolol maleate 0.5% Period three - Timolol maleate gel forming solution 0.5% arm 2: Period one - Timolol maleate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol hemihydrate 0.5% arm 3: Period one - Timolol maleate gel forming solution 0.5% Period two - Timolol hemihydrate 0.5% Period three - Timolol maleate 0.5% arm 4: Period one - Timolol hemihydrate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol maleate 0.5% arm 5: Period 1 - Timolol maleate 0.5% Period 2 - Timolol hemihydrate 0.5% Period 3 - Timolol maleate gel forming solution 0.5% arm 6: Period 1 - Timolol maleate gel forming solution 0.5% Period 2 - Timolol maleate 0.5% Period 3 - Timolol hemihydrate 0.5%
Interventions: intervention 1: Timolol Maleate in Sorbate intervention 2: Timolol hemihydrate intervention 3: Timolol maleate gel forming solution
Intervention descriptions: intervention 1: 0.5% intervention 2: 0.5% intervention 3: 0.5%

Protocol documents:
Clinical trial NCT00808769
Conditions: Normal Healthy Subject Population
Sponsor: Procter and Gamble
Start date: 2008-11-01; Completion date: 2008-12-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to compare Prilosec OTC® and Zegerid® in their effects on gastric acid suppression.

Detailed description:

Arms: arm 1: Zegerid® arm 2: Prilosec OTC®
Interventions: intervention 1: Zegerid® intervention 2: Prilosec OTC®
Intervention descriptions: intervention 1: capsule(20 mg omeprazole/sodium bicarbonate), single dose intervention 2: Omeprazole-magnesium 20.6 mg, tablet, single dose

Protocol documents:
Clinical trial NCT00827632
Conditions: Ovarian Suppression
Keywords: Ovarian Suppression Oral Contraceptives Obese and Normal BMI
Sponsor: Columbia University
Start date: 2006-07-01; Completion date: 2008-12-01
Enrollment: 226 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study proposes a double blind randomized clinical trial to include normal weight and obese women who have normal ovulatory function at baseline; the investigators will randomize women to 2 widely used OCs and evaluate ovarian follicle development and circulating progesterone to assess ovarian suppression during OC use.

Detailed description:
There is a large gap between lowest expected failure rates of about 1.5% and typical use failure rates of about 7% per year. This gap may be due to incorrect use or to decreased oral contraceptive (OC) effectiveness in population subgroups. Recent reports suggest greater OC failure among heavier women, particularly those using the lowest doses. The prevalence of obesity in the US population has recently increased to about 23% in women aged 20-29, peak years for OC use. OC physiology and effectiveness have not been evaluated in obese women.

Arms: arm 1: Participants with a BMI of 19-24.9 kg/m\^2 arm 2: Participants with a BMI of 30-39.9 kg/m\^2
Interventions: intervention 1: Low dose formulation intervention 2: High dose formulation
Intervention descriptions: intervention 1: Participants are randomized to either Portia (levonorgestrel/ethinyl estradiol tablets, United States Pharmacopeia (USP)0.15 mg/0.03 mg or Lessina (levonorgestrel/ethinyl estradiol tablets, USP 0.1 mg/0.02 mg) for 3 months use.

Dose formula contains 20 ug of ethinyl estradiol (EE) and 100 ug of levonorgestrel (LN) per tablet. intervention 2: Participants are randomized to either Portia (levonorgestrel/ethinyl estradiol tablets, United States Pharmacopeia (USP)0.15 mg/0.03 mg or Lessina (levonorgestrel/ethinyl estradiol tablets, USP 0.1 mg/0.02 mg) for 3 months use.

Dose formula contains 30 ug of ethinyl estradiol (EE) and 150 ug of levonorgestrel (LN) per tablet.

Protocol documents:
Clinical trial NCT00881894
Conditions: Healthy
Keywords: Rotigotine Neupro® Transdermal Patch
Sponsor: UCB Pharma
Start date: 2008-10-01; Completion date: 2008-12-01
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The major aim of this study is to investigate and compare the drug amount delivered to the body after sequential application of 2 rotigotine transdermal patches from 2 different manufacturing processes.

Detailed description:

Arms: arm 1: Two single applications of rotigotine patches from two different manufacturing processes in the order A-B separated by a washout phase of at least 5 days arm 2: Two single applications of rotigotine patches from two different manufacturing processes in the order B-A separated by a washout phase of at least 5 days
Interventions: intervention 1: Rotigotine transdermal patch
Intervention descriptions: intervention 1: Rotigotine 4.5mg/10cm\^2 patch applied for 24 hours

Protocol documents:
Clinical trial NCT00893516
Conditions: T-cell Lymphoma
Keywords: non cutaneous peripheral t-cell lymphoma with nodal involvement
Sponsor: Emergent BioSolutions
Start date: 2007-05-01; Completion date: 2008-12-01
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluation of CD4 in combination with CHO chemotherapy in subjects with nodal involvement of non cutaneous Tcell lymphoma.

Detailed description:

Arms: arm 1: CHOP chemo therapy + CD4 therapy arm 2: CHOP chemotherapy
Interventions: intervention 1: CHOP + CD4 intervention 2: CHOP
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00939562
Conditions: Bacterial Infection
Keywords: Bioequivalence
Sponsor: Pfizer
Start date: 2008-11-01; Completion date: 2008-12-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this protocol is to study if two different tablet formulations of doxycycline are bioequivalent to each other.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: doxycycline monohydrate tablet intervention 2: doxycycline carragenate tablet
Intervention descriptions: intervention 1: Tablet, 100 mg, Single dose intervention 2: Tablet, 100 mg, Single dose

Protocol documents:
Clinical trial NCT00953329
Conditions: Chronic Plaque Psoriasis
Sponsor: John Murray
Start date: 2008-02-01; Completion date: 2008-12-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Study Status:

Duke University Health System Institutional Review Board has received notification of study termination; final IRB closure date is 12/12/2008. Study enrollment is now closed.

Enrollment Update:

Only one subject was entered into this study out of an expected enrollment of 15 patients in this single site clinical trial. With no recruitment interest, the financial sponsor and Sponsor-PI chose to close the clinical trial.

Detailed description:
This is an open-label study using alefacept in the treatment of patients with chronic plaque psoriasis who have not responded to treatment with an anti-TNF agent. Patients not responding to Enbrel® 50 mg weekly with a 75% reduction of Psoriasis Area and Severity Index (PASI) Score or a Physician Global Assessment (PGA) score of 'almost clear' or 'clear', will be treated with 15 mg alefacept intramuscularly (IM) once weekly for up to 20 weeks. Patients who have 'cleared' or 'almost cleared' at the end of 12 weeks of treatment with alefacept will have completed the 'standard treatment' phase of the study. Study subjects who have not responded to treatment during the initial 12 weeks will continue with alefacept therapy for an additional 8 weekly doses or until the subject has reached a PGA of 'almost clear' or 'clear'. Alefacept is FDA approved for this indication for 12 weeks of treatment and this clinical trial is extending the treatment window for up to 8 additional weeks. Because of this increased exposure to alefacept, all subjects will be carefully monitored while on treatment and followed post-treatment at 3, 4, 6, 9 and 12 months after the last dose of alefacept is given.

Purpose:

This open-label study will determine the safety and efficacy of Amevive® 15 mg IM weekly in subjects with chronic plaque psoriasis who have not sufficiently responded to etanercept, an anti-TNF agent. The plan also is to determine the length of response time to point of relapse and to determine the length of time before retreatment with alefacept is necessary.

Patient Population:

This study is for adult men and women, ages 18 to 80, with chronic plaque psoriasis. At the time of enrollment, the subject must have received 50 mg per week of Enbrel without achieving a response of 'almost clear' or 'clear' according to PGA or has not responded with a 75% reduction of PASI Score.

Arms: arm 1: Alefacept will be given to subjects with plaque psoriasis who have failed treatment with Fnbrel.
Interventions: intervention 1: alefacept
Intervention descriptions: intervention 1: Alefacept 15 mg IM once a week were to be administered for 12 weeks, which is the FDA approved dosage, duration, and frequency. This study allowed an additional 8 doses if subject did not achieve a 'clear' response with the original 12 weeks of treatment. Each enrolled subject must have failed a response to anti-TNF therapy prior to entering this study.

Protocol documents:
Clinical trial NCT00957528
Conditions: Hypogonadism
Keywords: Low Normal Testosterone Male Aging
Sponsor: The University of Texas Medical Branch, Galveston
Start date: 2006-01-01; Completion date: 2008-12-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether testosterone (male hormone) therapy is effective if administered in a cyclic fashion (periodic dosing) compared to continuous dosing in men aged 60 to 85 years. Effectiveness will be determined based on improvements in body composition, muscle metabolism, muscle strength, and bone metabolism.

Detailed description:
Men and women undergo a progressive reduction in lean muscle mass (sarcopenia) with advancing age regardless of their level of physical activity. A 12-yr longitudinal study in healthy sedentary older men showed a correlation between loss of muscle cross-sectional area and muscle strength of the thigh, quadriceps, and flexor muscles. Once weakened, older individuals are prone to falls that prevent independent living and diminish the quality of life. There is a need to develop therapies to counteract losses in skeletal muscle strength with aging. Studies show that exercise and testosterone administration increase skeletal muscle mass and strength in older men. However, the increase in muscle strength by testosterone in older men has not been consistent in all studies. Androgens increase muscle mass by either increasing muscle protein synthesis or inhibiting muscle protein breakdown. This proposal will investigate the hypothesis that cyclic testosterone administration (monthly on/off cycles) will preferentially increase muscle protein synthesis and result in a consistent and greater improvement in muscle strength than continuous testosterone administration.

Arms: arm 1: Weekly placebo treatment for a duration of 5 months. arm 2: A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months. arm 3: Weekly testosterone treatment for a duration of 5 months
Interventions: intervention 1: Testosterone intervention 2: Placebo
Intervention descriptions: intervention 1: Weekly im injections of 100 mg testosterone enanthate. intervention 2: Weekly IM injections of sesame oil.

Protocol documents:
Clinical trial NCT00974051
Conditions: Type 1 Diabetes
Keywords: Children Exercise Hypoglycemia
Sponsor: University of Colorado, Denver
Start date: 2008-03-01; Completion date: 2008-12-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The investigators hypothesize that the use of an oral dose of Terbutaline or a 20% basal reduction will be able to prevent nocturnal hypoglycemia after an afternoon exercise session. This is a randomized three period cross-over study including treatment with Terbutaline, a 20% basal reduction for six hours, or no treatment (control).

Detailed description:
In this study, a minimum of 16 youth with type 1 diabetes will be recruited. All subjects must have been diagnosed with type 1 diabetes for at least one year and on an insulin pump for at least one month. Subjects are between the ages of 10 and 17 years, inclusive, have an HbA1c less than 10.0% and normal thyroid function. Subjects can not have had a severe hypoglycemic episode in the last three months, any other illness or treatment that may affect the wearing of a continuous glucose monitor or the completion of the study as determined by the investigator. Subjects may not use drugs containing pseudoephedrine within 48 hours of the study visits.

This study consists of three overnight visits at the Clinical Translational Research Center. Meals eaten during the study will be consistent for each of the three visits.

Subjects will participate in a standardized afternoon exercise session on a treadmill as has been done in previous Diabetes Research in Children Network studies. Exercise will begin at 4pm and must be completed by 6pm. Dinner will be eaten at the end of the exercise.

At 9pm, treatment will be given as determined by the randomization group the subject is assigned to. The treatment includes either an oral dose of 2.5mg Terbutaline, a 20% basal reduction for six hours or no treatment as the control. Blood glucose levels will be measured every 30 minutes until 6am.

Arms: arm 1: Subjects complete the same exercise routine, however no treatment is given at 9:00pm. arm 2: Subjects complete same exercise routine. At 9:00pm, an oral dose of 2.5 mg of Terbutaline is administered. arm 3: All subjects complete the same exercise session. At 9:00pm, subject's basal rate is decreased by 20% for six hours.
Interventions: intervention 1: Terbutaline intervention 2: 20% basal insulin reduction intervention 3: Control
Intervention descriptions: intervention 1: Oral (2.5mg) one time administration at 9:00pm intervention 2: Basal insulin rate is reduced by 20% the normal (home dose) for six hours. intervention 3: No treatment is given for the study. This arm is for comparison with the two intervention arms.

Protocol documents:
Clinical trial NCT00981409
Conditions: Embolism, Pulmonary
Keywords: Fondaparinux sodium contrast-enhanced MDCT Deep Vein Thrombosis Pulmonary thromboembolism
Sponsor: GlaxoSmithKline
Start date: 2007-07-01; Completion date: 2008-12-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to evaluate the efficacy (as measured by the rate of recurrent symptomatic Venous Thromboembolism \[VTE\] (i.e., Pulmonary thromboembolism \[PE\] and Deep Vein Thrombosis \[DVT\])) and safety of GSK576428 as the initial treatment in subjects with acute PE in an open-label design.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Fondaparinux sodium intervention 2: unfractionated heparin (UFH)
Intervention descriptions: intervention 1: The dose of Fondaparinux will be determined based on a subject's body weight (\<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; \>100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection. intervention 2: UFH therapy will be started on Day 1 while adjusting activated partial thromboplastin time (aPTT) to maintain aPTT 1.5 to 2.5 times control.

Protocol documents: