ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00628134
Conditions: Cystic Fibrosis
Keywords: cystic fibrosis surfactant aerosol inhaled drug inhaled antibiotic
Sponsor: University of Pittsburgh
Start date: 2008-03-01; Completion date: 2009-08-01
Enrollment: 8 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Inhaled medications are often used to treat lung diseases such as cystic fibrosis. We are performing this study to determine whether inhaled medications dissolved in surfactant-based solutions will distribute more evenly throughout the lungs when compared to standard saline-based solutions. We think that inhaling medication that is in a surfactant-based liquid will result in more medication reaching partially blocked parts of the lung. This study will use a special nuclear medicine test called an aerosol deposition scan to compare how a drug spreads in the lung using a surfactant-based aerosol compared to a saline-based aerosol.

Detailed description:
Cystic fibrosis (CF) is an inherited chronic disease that affects the lungs and digestive system of about 30,000 children and adults in the United States (70,000 worldwide). The lungs of a person with cystic fibrosis often contain thick sticky mucus that can clog the lungs and lead to life-threatening lung infections. A major milestone in the treatment of CF was the development of an inhaled form of an antibiotic drug called tobramycin. For an inhaled antibiotic to work it must be delivered to all infected parts of the lung. Many studies have shown that blockages in the lungs, like those found in CF patients, can prevent inhaled medicines from reaching all parts of the lungs.

Usually aerosolized medications are dissolved in saline or water. Most of these medications could be dissolved in surfactant solutions and aerosolized. Soaps are common examples of surfactants. Surfactants may have the ability to spread medication over the inside surface of the lungs similar to the way dish soap spreads over water. We think that inhaling medication that is in a surfactant-based liquid will result in more medication reaching partially blocked parts of the lung. We further believe that the normal movements of the lung associated with breathing will further spread surfactant-based aerosol medications, and contribute to even more even drug distribution over longer periods of time.

A surfactant-based inhaled antibiotic would have the potential to reach more sites of infection in the lung, possibly getting rid of infection all together. This study will use a special test called an aerosol deposition scan to compare how a drug spreads in the lung using a surfactant-based aerosol compared to a saline-based aerosol. The study includes one screening and two testing visits.

Arms: arm 1: Subjects inhaled calfactant then isotonic saline arm 2: Subjects inhaled isotonic saline then calfactant
Interventions: intervention 1: calfactant intervention 2: isotonic saline
Intervention descriptions: intervention 1: single inhaled dose by nebulizer intervention 2: single inhaled dose by nebulizer

Protocol documents:
Clinical trial NCT00634504
Conditions: Osteosarcoma Leukemia Lymphoma
Keywords: high dose methotrexate Voraxaze leucovorin delayed elimination methotrexate toxicity rescue renal insufficiency
Sponsor: BTG International Inc.
Start date: 2008-05-01; Completion date: 2009-08-01
Enrollment: 20 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate whether the administration of Voraxaze reduces exposure to leucovorin and its active metabolite to below the level achieved in patients who have not received Voraxaze.

Detailed description:

Arms: arm 1: High-dose methotrexate, leucovorin, and Voraxaze arm 2: High-dose methotrexate and leucovorin without Voraxaze (glucarpidase)
Interventions: intervention 1: glucarpidase, high-dose methotrexate, leucovorin intervention 2: high-dose methotrexate, leucovorin
Intervention descriptions: intervention 1: single intravenous dose intervention 2: standard of care, leucovorin every 6 hours

Protocol documents:
Clinical trial NCT00643851
Conditions: Type 2 Diabetes
Sponsor: AstraZeneca
Start date: 2008-06-01; Completion date: 2009-08-01
Enrollment: 994 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this clinical research study is to learn if initiating treatment with BMS-51248 (Dapagliflozin) in combination with metformin XR can improve diabetes control in patients with Type 2 Diabetes who do not receive any pharmacological treatment for diabetes, when compared to initial treatment with monotherapy dapagliflozin or metformin XR. The safety of this treatment will also be studied

Detailed description:

Arms: arm 1: Dapagliflozin (5 mg) + Metformin XR (up to 2000 mg) arm 2: Dapagliflozin (5 mg) arm 3: Metformin XR (500 mg up to 2000 mg)
Interventions: intervention 1: Dapagliflozin intervention 2: Metformin XR
Intervention descriptions: intervention 1: Tablets, Oral, Once daily, 24 weeks intervention 2: Tablets, Oral, Once daily, 24 weeks

Protocol documents:
Clinical trial NCT00644592
Conditions: Healthy
Keywords: Healthy Volunteers
Sponsor: University of Florida
Start date: 2008-03-01; Completion date: 2009-08-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a research study of how a cholesterol medication known as fenofibrate works differently in people with different genetic backgrounds. "Genetics" refers to certain things that are passed to a person by their parents, such as eye color or hair color. Genetic differences lead to people having different eye and hair color. There are also genetic differences in a protein called liver X receptor-alpha (LXRA), which may be important in predicting the response to fenofibrate.

Detailed description:
This is a double blind crossover study of fenofibrate vs. placebo in healthy volunteers. The null hypothesis is that over a four week period, fenofibrate (160mg/day orally) is equivalent to placebo in terms of relative changes in cytokines ENA-78 and MCP-1 over a four week periods, separated by a four week washout. ENA-78 is a marker of inflammation. See http://en.wikipedia.org/wiki/CXCL5 for more details.

Arms: arm 1: 4 weeks of drug at 160 mg orally per day, 4 week washout, then 4 weeks of placebo arm 2: 4 weeks of placebo then 4 week washout then 4 weeks of Fenofibrate at 160 mg/day orally.
Interventions: intervention 1: Fenofibrate capsule daily for 4 weeks intervention 2: Fenofibrate
Intervention descriptions: intervention 1: Placebo capsule daily for 4 weeks intervention 2: 160 mg/day orally for 4 weeks

Protocol documents:
Clinical trial NCT00658684
Conditions: Overactive Bladder
Sponsor: Pfizer
Start date: 2008-02-01; Completion date: 2009-08-01
Enrollment: 153 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To assess the long term safety, tolerability and efficacy of fesoterodine in patients with OAB.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: fesoterodine fumarate
Intervention descriptions: intervention 1: 4 mg tablets OD for 4 weeks, then either 4 mg or 8 mg tablets OD for 48 weeks

Protocol documents:
Clinical trial NCT00665444
Conditions: Bipolar Disorder Metabolic Syndrome
Keywords: bipolar disorder sedation overweight Abilify medication
Sponsor: University of Pittsburgh
Start date: 2008-04-01; Completion date: 2009-08-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The proposed study is a non-randomized, open label trial that will examine the potential to reduce metabolic risk factors in patients with bipolar I disorder and improve psychiatric and functional outcomes. To accomplish our objective, we plan to conduct a 5-month intervention of 50 obese or overweight adults diagnosed with bipolar disorder. The study will be divided in three steps: Screening, Baseline Period (cross taper to aripiprazole, up to 2 months in duration), Months 1-3 (continued aripiprazole treatment). Subjects will be assessed and meet with their study psychiatrist at least bi-monthly throughout their participation, more frequently when clinically necessary (e.g. during medication tapering or if manic/depressive symptoms emerge). Brief clinical assessments will be conducted at each visit. More thorough assessments will be conducted at Baseline, Week 2, and Month 3.

Detailed description:

Arms: arm 1: Aripiprazole
Interventions: intervention 1: Aripiprazole
Intervention descriptions: intervention 1: All subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be changed unless medically necessary. If a subject is taking an antipsychotic in addition to divalproex, aripiprazole will replace the antipsychotic.

Protocol documents:
Clinical trial NCT00666965
Conditions: Idiopathic Restless Legs Syndrome
Keywords: SPM 962 rotigotine Idiopathic Restless Legs Syndrome RLS
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2008-06-01; Completion date: 2009-08-01
Enrollment: 230 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to investigate efficacy and safety of SPM 962 in Japanese RLS patients in a multi-center, placebo-controlled double-blind parrallel group comparative study following once-daily multiple transdermal doses of SPM 962 within a range of 2.25 to 6.75 mg/day. Recommended maintainance dose range is also to be investigated.

Detailed description:

Arms: arm 1: inactive placebo arm 2: 2.25 mg first week: 2.25 mg 1 sheet plus placebo 1 sheet 2nd to 6th week :2.25mg 1 sheet plus placebo 2 sheets arm 3: 4.5 mg/body first week : 2.25 mg 2 sheets 2nd to 6th week : 2.25 mg 2 sheets pus placebo 1 sheet arm 4: 6.75 mg/body first week : 2.25 mg 2 sheets 2nd to 6th week : 2.25 mg 3sheets
Interventions: intervention 1: SPM 962
Intervention descriptions: intervention 1: transdermal application, 1 time per day, 0-6.75 mg/body, titration, 6weeks

Protocol documents:
Clinical trial NCT00669955
Conditions: Helicobacter Infections
Keywords: H. Pylori Quadruple therapy Eradication rate Multinational trial Resistance to antibiotics Subjects with confirmed Helicobacter Pylori infection
Sponsor: Forest Laboratories
Start date: 2008-06-01; Completion date: 2009-08-01
Enrollment: 440 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study aims at evaluating efficacy and safety of quadruple therapy (bismuth, metronidazole, tetracycline and omeprazole: OBMT) vs triple therapy (amoxicillin, clarithromycin and omeprazole: OAC) in H. Pylori eradication. It is hypothesized that quadruple therapy will be comparable in efficacy to triple therapy. Subjects with confirmed H. pylori positive status will be randomized to one of the treatments described above. At week 6 and 10 follow-up visits, a urea breath test (UBT) will be performed to confirm eradication.

Detailed description:
The study will include three phases: screening, treatment and follow-up. Screening: this phase will last a maximum of 30 days and subjects eligibility will be evaluated after informed consent signature. Endoscopy and Urea Breath test will be performed in addition to the baseline routine evaluations.

Treatment: Subjects assigned to OAC will be treated for 7 days. Those assigned to Pylera will be treated for 10 days. A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 8 and 14.

Follow-up: includes two visits. approximately one and two months post-treatment. Eradication of H. Pylori will be confirmed through UBT, and resistance will be evaluated in case of treatment failure. These subjects will undergo an endoscopy.

Arms: arm 1: Triple therapy, given for 7 days at a dose of omeprazole 20 mg twice daily, amoxicillin 500 mg 2 capsules twice daily, and clarithromycin 500 mg 1 tablet twice daily arm 2: OBMT (Pylera), consisting of a 3 in 1 capsule, made of bismuth subcitrate potassium 120 mg, metronidazole 125 mg, and tetracycline 125 mg, administered as 3 capsules 4 times daily. Omeprazole 20 mg is administered twice daily.
Interventions: intervention 1: Omeprazole, amoxicillin, clarithromycin intervention 2: Pylera (Bismuth subcitrate potassium, metronidazole, tetracycline) given in combination with omeprazole
Intervention descriptions: intervention 1: Triple therapy given for 7 days at a dose of omeprazole 20 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID intervention 2: Pylera is a three in one capsule containing bismuth subcitrate potassium 120 mg, metronidazole 125 mg and tetracycline 125 mg given as 3 capsules QID, with omeprazole 20 mg BID.

Protocol documents:
Clinical trial NCT00670306
Conditions: Benign Prostatic Hypertrophy
Keywords: Cetrorelix BPH
Sponsor: AEterna Zentaris
Start date: 2008-03-01; Completion date: 2009-08-01
Enrollment: 528 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Benign Prostatic Hyperplasia (BPH) is the most common hyperplastic disease occuring in human males over the age of 50 which increases in prevalence with age and 40% of males reported moderate or severe urinary symptoms of prostatism by the age of 50 to 80. The purpose of this study is to collect safety and efficacy data for this dosage regimen of cetrorelix pamoate.

For this study, study medication (Cetrorelix pamoate) is administered by injection in the buttocks (Intramuscular).

Detailed description:

Arms: arm 1: Drug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26.
Interventions: intervention 1: Cetrorelix Pamoate
Intervention descriptions: intervention 1: Cetrorelix Pamoate IM, 52 mg week 0, 26 mg week 2,

Protocol documents:
Clinical trial NCT00677534
Conditions: End-Stage Renal Disease
Keywords: Endstage renal disease Vitamin D Monocyte function
Sponsor: University of Kansas
Start date: 2008-05-01; Completion date: 2009-08-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this study is to evaluate the role of nutritional Vitamin D deficiency as a potential contributor to the morbidity witnessed in patients with end-stage renal disease

Detailed description:
The goals of this study are to elucidate the function of extrarenal 1 alpha-hydroxylase activity in the setting of renal failure and to evaluate the role of nutritional vitamin D deficiency as a potential contributor to monocyte-associated inflammatory pathways in patients with end-stage renal disease (ESRD). This study will consist of patients on chronic maintenance hemodialysis three times per week who have been identified to have nutritional vitamin D deficiency. After consent for study enrollment, patients will undergo a 4 week washout period of all active vitamin D supplementation. After washout is complete, an blood sample will be obtained for baseline 25(OH)D levels and monocyte isolation for analysis by flow cytometry. Patients will then be started on cholecalciferol 50,000 IU twice weekly for 8 weeks. 25-vitamin D levels will be monitored midway through the treatment phase of the study and dosing adjusted as further described in detail within the protocol section. An additional blood sample will be drawn post-therapy for repeat 25(OH)D levels and monocyte isolation for flow cytometry analysis.

Arms: arm 1: Cholecalciferol (Vitamin D)
Interventions: intervention 1: Cholecalciferol
Intervention descriptions: intervention 1: 50,000 Units PO Twice weekly for 8 weeks

Protocol documents:
Clinical trial NCT00680043
Conditions: Anemia Chronic Renal Failure Chronic Kidney Disease
Keywords: anemia chronic kidney disease CKD chronic renal failure CRF erythropoietin EPO erythropoiesis stimulating agent ESA Hematide™ hemoglobin Hb Hgb Omontys peginesatide red blood cell red blood cell production
Sponsor: Affymax
Start date: 2008-06-01; Completion date: 2009-08-01
Enrollment: 114 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of peginesatide for the treatment of anemia in participants with chronic kidney disease who are on dialysis and are not taking any treatment to increase their red blood cell production.

Detailed description:
Anemia associated with chronic kidney disease is due to several factors, primarily the inability of the diseased kidneys to produce adequate amounts of endogenous erythropoietin. Ancillary factors include the shortened lifespan of red blood cells, iron and other nutritional deficiencies, infection, and inflammation. The presence and severity of anemia are related to the duration and extent of kidney failure. Anemia is associated with increased mortality, increased likelihood of hospitalization, reduced cognitive function, and increased left ventricular hypertrophy and heart failure.

Erythropoiesis stimulating agents (ESAs) have been established as a treatment for anemia in chronic renal failure subjects, and have improved the management of anemia over alternatives such as transfusion. Peginesatide is a parenteral formulation developed for the treatment of anemia in patients with chronic kidney disease. Peginesatide binds to and activates the human erythropoietin receptor and stimulates erythropoiesis in human red cell precursors in a manner similar to other known erythropoiesis-stimulating agents.

Eligible participants were randomized in equal proportions to two peginesatide treatment regimens, in which participants received peginesatide once every 4 weeks, and one control, epoetin alfa, treatment regimen, in which participants received epoetin alfa three times per week. Total commitment time of this study was a 4 week screening period followed by a minimum of 7 months of treatment.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: peginesatide intervention 2: peginesatide intervention 3: Epoetin Alfa
Intervention descriptions: intervention 1: Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL). intervention 2: Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL. intervention 3: Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.

Protocol documents:
Clinical trial NCT00683917
Conditions: Uterine Fibroids
Keywords: Uterine fibroids Fibroids
Sponsor: Repros Therapeutics Inc.
Start date: 2008-05-01; Completion date: 2009-08-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
PK of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.

Detailed description:
The primary objective is to evaluate the pharmacokinetics (PK) of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.

Arms: arm 1: Proellex 25 mg arm 2: Proellex 50 mg arm 3: Lupron Depot
Interventions: intervention 1: Proellex 25 mg intervention 2: Proellex 50 mg intervention 3: Lupron Depot
Intervention descriptions: intervention 1: Proellex 25 mg, 1 capsule daily for 4 months intervention 2: Proellex 50 mg, 2 capsules daily for 4 months intervention 3: Lupron 3.75 mg monthly intramuscular injections for 4 months

Protocol documents:
Clinical trial NCT00686712
Conditions: Type 2 Diabetes Mellitus
Keywords: Glargine Type 2 diabetes Basal insulin
Sponsor: Charles Drew University of Medicine and Science
Start date: 2003-02-01; Completion date: 2009-08-01
Enrollment: 108 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the efficacy and safety of once-nightly insulin glargine versus a single morning injection of glargine or once-nightly NPH insulin in ethnic minority type 2 diabetic patients inadequately controlled on combination oral agents.

Detailed description:
Insulin glargine has a longer action than compared to NPH insulin, but whether this results in improved control when used as a once-nightly or morning basal insulin injection in type 2 diabetic patients who are inadequately controlled on combination oral agents has been controversial. Inner city ethnic minority patients with diabetes are a particularly challenging population of diabetic patients to treat. This study investigates whether insulin glargine may be a more effective or safer first-line basal insulin than NPH in this population.

Arms: arm 1: Insulin glargine injected subcutaneously once daily at bedtime arm 2: Insulin glargine injected subcutaneously once daily in the morning arm 3: NPH insulin injected subcutaneously once daily at bedtime
Interventions: intervention 1: 1- Insulin glargine QHS intervention 2: 2 - Insulin glargine QAM intervention 3: 3 - NPH insulin QHS
Intervention descriptions: intervention 1: Insulin glargine at bedtime (dose titrated to maintain 50% of fasting glucose readings \<120 mg/dL) intervention 2: Insulin glargine in AM (dose titrated to maintain 50% of pre-supper glucose readings \<120 mg/dL) intervention 3: NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses \<120 mg/dL)

Protocol documents:
Clinical trial NCT00687453
Conditions: Type 2 Diabetes Mellitus
Keywords: Glargine Type 2 diabetes Basal insulin
Sponsor: Charles Drew University of Medicine and Science
Start date: 2003-02-01; Completion date: 2009-08-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the efficacy and safety of once-nightly insulin glargine versus twice-daily NPH insulin in ethnic minority type 2 diabetic patients inadequately treated with once-nightly NPH insulin alone.

Detailed description:
Insulin glargine has a longer action than compared to NPH insulin, but whether this results in improved control when compared to twice-daily NPH insulin is not known when used in low-income ethnic minority patients. This study investigates whether insulin glargine may be more or less effective and safe than twice-daily NPH insulin in this population.

Arms: arm 1: Insulin glargine injected at bedtime arm 2: NPH insulin injected twice-daily, before breakfast and at bedtime
Interventions: intervention 1: Insulin glargine at bedtime instead of NPH intervention 2: NPH twice-daily
Intervention descriptions: intervention 1: Insulin glargine at bedtime substituting for NPH insulin at bedtime intervention 2: Addition of morning NPH to bedtime NPH

Protocol documents: