ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00645788
Conditions: Cystic Fibrosis
Keywords: Ciprofloxacin cystic fibrosis sweat test pulmonary function test
Sponsor: Bayer
Start date: 2008-05-01; Completion date: 2011-01-01
Enrollment: 288 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the change in forced expiratory volume (FEV1) from baseline to Day 28-30 between Cipro Inhale-treated and placebo-treated subjects after a 4-week treatment period.

Detailed description:
Safety issues are addressed in the Adverse Events section.

Arms: arm 1: 32.50 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days arm 2: 48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days arm 3: Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days arm 4: Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
Interventions: intervention 1: Ciprofloxacin (Cipro Inhale, BAYQ3939) intervention 2: Placebo intervention 3: Ciprofloxacin (Cipro Inhale, BAYQ3939) intervention 4: Placebo
Intervention descriptions: intervention 1: 32.5 mg ciprofloxacin DPI corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation powder twice a day for 28 days intervention 2: 50 mg matching placebo powder formulation twice a day for 28 days intervention 3: 48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation powder twice a day for 28 days (Arm 3 and Arm 4 was introduced after amendment 2) intervention 4: 75 mg matching placebo powder formulation twice a day for 28 days (Arm 3 and Arm 4 was introduced after amendment 2)

Protocol documents:
Clinical trial NCT00659165
Conditions: Diabetes Mellitus
Keywords: diabetes insulin dependent diabetes diabetes mellitus detemir levemir glargine lantus insulin appetite satiety centrally acting mediators of satiety three factor eating questionnaire PYY ghrelin leptin
Sponsor: University of New Mexico
Start date: 2008-04-01; Completion date: 2011-01-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Patients with diabetes treated with insulin often gain weight, which may deter patients from adhering to insulin treatment. Detemir is one type of long acting insulin approved by the Food and Drug Administration for use in people with diabetes. It is similar to other long acting insulins (Neutral Protein Hagedorn \[NPH\], glargine) except that it has been associated with less weight gain compared to other types of insulin. The reasons for this are still unclear. One possibility is that detemir insulin acts differently than do other insulins in affecting how diabetic patients eat meals. The purpose of this study is to determine whether appetite and calories eaten during a meal are affected by the type of insulin used to treat diabetes. This is a pilot study which means we are gathering preliminary information to determine if a larger study can be done.

Detailed description:
Insulin detemir is a neutral, soluble long acting insulin analog with weight neutral properties. In limited studies, it has been shown to result in less weight gain in type 1 and type 2 diabetics compared with other long acting insulin formations. A possible mechanism for its weight neutrality is the fatty acid chain that may allow for improved central nervous system activity and effects on satiety. The primary objective of this study is to determine if patients with type 1 diabetes consume fewer calories when allowed to eat to satiety while treated with insulin detemir compared to insulin glargine. Secondary objectives are 1) subject responses on validated satiety scales and food diaries, 2) bioelectrical impedance analysis, 3) resting energy expenditure on indirect calorimetry/metabolic cart measurement, and 4) centrally acting mediators of satiety measured in the serum (Peptide YY \[PYY\], ghrelin, leptin).

Arms: arm 1: Insulin Detemir arm 2: Insulin Glargine
Interventions: intervention 1: Insulin Detemir intervention 2: Insulin Glargine
Intervention descriptions: intervention 1: Subjects will be given a dose of detemir equivalent to their current long acting insulin regimen. Study insulin will be injected subcutaneously at 8 AM and 8 PM for at least 3 weeks. intervention 2: Subjects will be given a dose of glargine equivalent to their current long acting insulin regimen. Study insulin will be injected subcutaneously at 8 AM and 8 PM for at least 3 weeks.

Protocol documents:
Clinical trial NCT00669019
Conditions: Recurrent Melanoma Stage IIA Melanoma Stage IIB Melanoma Stage IIC Melanoma Stage IV Melanoma
Sponsor: National Cancer Institute (NCI)
Start date: 2006-07-01; Completion date: 2011-01-01
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well saracatinib works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery. Saracatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

Detailed description:
PRIMARY OBJECTIVES:

I. To determine whether the Src kinase inhibitor, AZD0530 (saracatinib), has single agent clinical activity in patients with advanced melanoma.

II. To determine whether this drug will increase progression-free survival of these patients from 3 months to 4.5 months.

SECONDARY OBJECTIVES:

I. To determine whether this drug may inhibit the activation of peripheral blood T cells analyzed ex vivo.

OUTLINE:

Patients receive saracatinib orally (PO) once daily (QD) in the absence of disease progression or unacceptable toxicity.

Arms: arm 1: Patients receive saracatinib 175 mg oral once daily in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: saracatinib
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00673231
Conditions: Type 2 Diabetes
Keywords: Dapagliflozin efficacy safety add on to insulin Oral AntiDiabetic Type 2 diabetes
Sponsor: AstraZeneca
Start date: 2008-04-01; Completion date: 2011-01-01
Enrollment: 1240 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being carried out to see if Dapagliflozin in addition to insulin is effective and safe in treating patients with type 2 diabetes when compared to placebo (identical looking inactive treatment) in addition to insulin

Detailed description:

Arms: arm 1: 2.5mg arm 2: 5mg arm 3: 10mg arm 4: None
Interventions: intervention 1: Dapagliflozin intervention 2: Dapagliflozin intervention 3: Dapagliflozin intervention 4: Placebo intervention 5: Dapagliflozin intervention 6: Dapagliflozin
Intervention descriptions: intervention 1: tablet oral 2.5 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I) intervention 2: Tablet oral 5 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I) intervention 3: Tablet oral 10 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I) intervention 4: Placebo intervention 5: tablet oral 2.5 total daily dose once daily 56 weeks (= 56 week study extension period II) intervention 6: tablet oral 10 mg total daily dose once daily 56 weeks (= 56 week study extension period II)patients that have been treated with 5 mg during the 24 week randomised treatment period and extension I period will during extension II period switched to 10 mg

Protocol documents:
Clinical trial NCT00676338
Conditions: Type 2 Diabetes Mellitus
Keywords: Amylin Lilly exenatide once weekly Byetta Januvia sitagliptin thiazolidinedione
Sponsor: AstraZeneca
Start date: 2008-11-01; Completion date: 2011-01-01
Enrollment: 820 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the effects of 2.0 mg exenatide once weekly injection as monotherapy to 3 active comparators(metformin, dipeptidyl peptidase-4 inhibitor, and thiazolidinedione) in drug naive patients with type 2 diabetes treated with diet and exercise.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: exenatide once weekly intervention 2: metformin intervention 3: sitagliptin intervention 4: pioglitazone
Intervention descriptions: intervention 1: subcutaneous injection, 2mg, once weekly plus placebo oral once daily intervention 2: oral, 1000-2500mg, daily plus placebo once weekly subcutaneous injection intervention 3: oral, 100 mg, daily plus placebo once weekly subcutaneous injection intervention 4: oral, 30-45mg, daily plus placebo once weekly subcutaneous injection

Protocol documents:
Clinical trial NCT00711191
Conditions: Pancreatic Neoplasm
Keywords: pancreas cancer; cancer of the pancreas; gemcitabine; chemotherapy; monoclonal antibody; immunotherapy; CD40
Sponsor: Hoffmann-La Roche
Start date: 2008-06-01; Completion date: 2011-01-01
Enrollment: 22 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study aims to seek evidence that activation of certain cells of the immune system will be safe and well tolerated in combination with cytotoxic chemotherapy. Preliminary evidence of clinical anti-tumor activity will be sought.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: monoclonal antibody intervention 2: chemotherapy
Intervention descriptions: intervention 1: CP-870,893 intravenous administration \[IV\] on day 3 of 4-week cycles intervention 2: gemcitabine 1000 mg/m\^2 intravenous administration \[IV\] q week \[wk\]x3 of 4-week cycles

Protocol documents:
Clinical trial NCT00713830
Conditions: Diabetes Mellitus, Type 2
Keywords: hyperglycemia, GLP-1
Sponsor: Sanofi
Start date: 2008-07-01; Completion date: 2011-01-01
Enrollment: 859 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to sulfonylurea without or with metformin, over a period of 24 weeks of treatment, followed by an extension.

The primary objective is to assess the effects of lixisenatide when added to sulfonylurea with or without metformin on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24.

The secondary objectives are to assess the effects of lixisenatide on percentage of patients reaching HbA1c less than (\<) 7 percent (%); percentage of patients reaching HbA1c less than or equal to (\<=) 6.5%; body weight; fasting plasma glucose (FPG); beta-cell function assessed by homeostasis model assessment (HOMA) beta; 2-hour postprandial plasma glucose (PPG), glucagon, insulin, proinsulin, and C-peptide after a standardized meal challenge test in a sub-study in all patients in selected centers; to evaluate safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.

Detailed description:
Patients who complete the 24-week main double-blind treatment would undergo a variable double-blind extension treatment, which ends for all patients at approximately the scheduled date of Week 76 visit (Visit 25) for the last randomized patient.

Arms: arm 1: 2-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment. arm 2: 2-step initiation regimen of volume matching placebo: 10 mcg QD for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
Interventions: intervention 1: Lixisenatide (AVE0010) intervention 2: Placebo intervention 3: Pen auto-injector intervention 4: Sulfonylurea intervention 5: Metformin
Intervention descriptions: intervention 1: Self administered by subcutaneous injections once daily within the hour preceding breakfast. intervention 2: Self administered by subcutaneous injections once daily within the hour preceding breakfast. intervention 3: None intervention 4: Sulfonylurea to be continued at maximum effective dose according to local labeling up to end of treatment. intervention 5: Metformin if given to be continued at stable dose (at least 1.5 gram per day \[except at least 0.75 gram per day in Japan and 1.0 gram per day in South Korea\]) up to the end of treatment.

Protocol documents:
Clinical trial NCT00718887
Conditions: Hepatitis B, Chronic
Sponsor: Bristol-Myers Squibb
Start date: 2008-07-01; Completion date: 2011-01-01
Enrollment: 228 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Switching to Entecavir will result in superior antiviral efficacy as compared to continuing with Adefovir in patients with a suboptimal response to Adefovir

Detailed description:

Arms: arm 1: None arm 2: Control
Interventions: intervention 1: Entecavir intervention 2: Adefovir/Entecavir
Intervention descriptions: intervention 1: Tablets, Oral, 0.5 mg, once daily (QD), 52 weeks intervention 2: Tablets, Oral, 10-mg adefovir QD for 12 weeks followed by 0.5-mg entecavir QD for a maximum of 52 weeks

Protocol documents:
Clinical trial NCT00762424
Conditions: Kidney Stone
Keywords: Kidney stone Ureterolithiasis Tamsulosin Flowmax Emergency Department
Sponsor: WellSpan Health
Start date: 2007-06-01; Completion date: 2011-01-01
Enrollment: 53 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Tamsulosin (Flowmax)is approved by the FDA for the treatment for enlarged prostate. Several studies regarding the use of Tamsulosin for the treatment of lower kidney stones have been carried out in the non-Emergency Department setting. This study will compare Tamsulosin 0.4 mg with placebo in regards to rate and time of stone passing and will also look at amount of pain. The purpose of this study is to compare the usefulness of Tamsulosin versus placebo on time to stone passage and pain relief in Emergency Department patients with kidney stones.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Flowmax intervention 2: placebo
Intervention descriptions: intervention 1: 0.4 mg once a day until stone passage total = 9 tablets intervention 2: cornstarch

Protocol documents:
Clinical trial NCT00763451
Conditions: Diabetes Mellitus, Type 2
Keywords: hyperglycemia, GLP-1
Sponsor: Sanofi
Start date: 2008-09-01; Completion date: 2011-01-01
Enrollment: 484 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to metformin, over a period of 24 weeks of treatment, followed by an extension.

The primary objective is to assess the effects of lixisenatide when added to metformin on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction when it is used in two steps dose titration regimen at Week 24.

Secondary objectives are to assess the effects of lixisenatide when added to metformin on glycemic control in comparison to placebo in terms of HbA1c reduction when it is used in a one-step dose titration regimen, the percentage of patients with HbA1c less than 7 percent or less than or equal to 6.5%, body weight, fasting plasma glucose (FPG); to assess the safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.

Detailed description:
Patients who complete the 24-week main double-blind treatment would undergo a variable double-blind extension treatment, which ends for all patients at approximately the scheduled date of Week 76 visit (Visit 25) for the last randomized patients.

Arms: arm 1: 2-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment. arm 2: 1-step initiation regimen of lixisenatide: 10 mcg QD for 2 weeks, then 20 mcg QD up to the end of treatment. arm 3: 2-step initiation regimen of volume matching placebo: 10 mcg QD for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment. arm 4: 1-step initiation regimen of volume matching placebo: 10 mcg QD for 2 weeks, then 20 mcg QD up to the end of treatment.
Interventions: intervention 1: Lixisenatide (AVE0010) intervention 2: Placebo intervention 3: Pen auto-injector intervention 4: Metformin
Intervention descriptions: intervention 1: Self-administered by subcutaneous injections once daily within the hour preceding breakfast. intervention 2: Self-administered by subcutaneous injections once daily within the hour preceding breakfast. intervention 3: None intervention 4: Metformin to be continued at stable dose (at least 1.5 gram per day) up to the end of treatment.

Protocol documents:
Clinical trial NCT00768469
Conditions: Advanced Malignant Solid Tumors
Keywords: HKI-272 Paclitaxel Combination Solid Tumor
Sponsor: Puma Biotechnology, Inc.
Start date: 2008-10-01; Completion date: 2011-01-01
Enrollment: 10 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an open-label, phase 1 study of ascending multiple oral doses of HKI-272 in combination with paclitaxel.

Detailed description:

Arms: arm 1: Neratinib 160 mg + Paclitaxel 80 mg/m\^2 arm 2: Neratinib 240 mg + Paclitaxel 80 mg/m\^2
Interventions: intervention 1: Neratinib intervention 2: Paclitaxel
Intervention descriptions: intervention 1: Administered orally, continuous, once daily. intervention 2: Administered IV, on days 1, 8, 15 of 28 day cycle.

Protocol documents:
Clinical trial NCT00784238
Conditions: Schizophrenia
Keywords: Schizophrenia Paliperidone Extended-release Paliperidone R076477
Sponsor: Janssen Korea, Ltd., Korea
Start date: 2008-04-01; Completion date: 2011-01-01
Enrollment: 289 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate improvement and efficacy of paliperidone extended-release for subjective well-being and drug attitudes of participants, when switching from oral antipsychotics in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

Detailed description:
This is an open-label (all people know the identity of the intervention), multi-centric (conducted in more than one center), prospective (study following participants forward in time), and non-comparative study, in participants with schizophrenia. The study consists of following parts: Screening (that is, 14 days before study commences on Day 1); Acute Treatment phase (24 weeks); Extension phase 1 (24 weeks), which will be followed by additional Extension phase 2 (48 weeks). Total study duration per participant will be 96 weeks. Efficacy will primarily be evaluated by change from Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale score and change from Baseline in Drug Attitude Inventory scores. Participants' safety will be monitored throughout the study.

Arms: arm 1: Paliperidone Extended-Release (ER) oral tablet will be administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range will be 3 to 12 mg per day.
Interventions: intervention 1: Paliperidone
Intervention descriptions: intervention 1: Paliperidone ER oral tablet will be administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range will be 3 to 12 mg per day.

Protocol documents:
Clinical trial NCT00786916
Conditions: Pain
Keywords: pain propofol lidocaine sedation pediatric
Sponsor: Akron Children's Hospital
Start date: 2008-02-01; Completion date: 2011-01-01
Enrollment: 109 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This protocol describes a double-blind, placebo-controlled trial intended to demonstrate the effectiveness of lidocaine at reducing pain associated wiht propofol infusion for short-term deep sedation in children. Patients will be randomized to receive either placebo (saline) or one of two dosing regimens of IV lidocaine prior to initiating propofol infusion. The efficacy of the differing lidocaine doses will be compared to determine the minimum dose required to safely achieve alleviation of pain. We hypothesize that premedicating with lidocaine will significantly decrease pain experienced by pediatric patients receiving propofol for outpatient sedation.

Detailed description:

Arms: arm 1: Saline arm 2: Lidocaine 0.25 mg/kg arm 3: Lidocaine 0.5 mg/kg
Interventions: intervention 1: normal saline intervention 2: lidocaine intervention 3: lidocaine
Intervention descriptions: intervention 1: A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive saline placebo IV (Group A) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated. intervention 2: A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive lidocaine 0.25 mg/kg IV (Group B) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated. intervention 3: A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive lidocaine 0.5 mg/kg IV (Group C) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated.

Protocol documents:
Clinical trial NCT00791999
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis Certolizumab Pegol Cimzia
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2008-11-01; Completion date: 2011-01-01
Enrollment: 316 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this trial is to investigate the efficacy (American College of Rheumatology 20% : ACR20) superiority of two dose regiments of CDP870 versus placebo in combination with MTX in active RA patients who have an incomplete response to MTX. The pharmacokinetics and immunogenicity profile of CDP870 will also be investigated to assess the extrapolability of foreign data to the Japanese population.

Detailed description:

Arms: arm 1: 200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks arm 2: 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks arm 3: 400mg CDP870 given every 2 weeks arm 4: Placebo given every 2 weeks
Interventions: intervention 1: CDP870 400mg intervention 2: CDP870 200mg intervention 3: CDP870 100mg intervention 4: Placebo of CDP870
Intervention descriptions: intervention 1: 400mg CDP870 given every 2 weeks until Week22 (SC) intervention 2: 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks until Week22 (SC) intervention 3: 200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks until Week22 subcutaneously(SC) intervention 4: given every 2 weeks until Week22 (SC)

Protocol documents: