ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00570687
Conditions: Diabetes Mellitus, Type 2
Keywords: Inhaled Insulin
Sponsor: Mannkind Corporation
Start date: 2007-09-01; Completion date: 2009-01-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The original protocol was a randomized, open-label, 3-way cross-over study with 9 scheduled visits. The visits comprised an initial screening visit, 3 treatment visits for the meal challenge followed by a 2-6-week blood-loss recovery period, an interim safety visit, 3 sequential visits for the glucose clamp, and a final close-out visit.

Protocol Amendment 1 was a randomized, open-label, 2-way cross-over study with 7 visits for each completed subject. The visits comprise an initial screening visit, 2 treatment visits for the meal challenge followed by a 2-6-week blood-loss recovery period, an interim safety visit, 2 sequential visits for the glucose clamp, and a final close-out visit.

For both the original protocol and Protocol Amendment 1, subjects were hospitalized in the clinical unit for all procedures.

Detailed description:
The original protocol was a randomized, open-label, 3-way cross-over study with 9 scheduled visits. The visits comprised an initial screening visit, 3 treatment visits for the meal challenge followed by a 2-6-week blood-loss recovery period, an interim safety visit, 3 sequential visits for the glucose clamp, and a final close-out visit.

After review of the meal challenge data from the Original Protocol design, it became apparent that the TI Inhalation Powder, insulin lispro, and Exubera doses were not well matched, and resulted in significantly higher insulin exposure following insulin lispro than the two inhaled treatments. All meal challenge visits were completed for the 18 subjects enrolled. However, the glucose clamp visits were discontinued since it was discovered that a direct comparison between the treatments was not possible.

The protocol was amended (Amendment 1) to ensure that the insulin exposures between TI Inhalation Powder and insulin lispro were more suited (increased the TI Inhalation Powder doses and decreased the insulin lispro dose). An Exubera arm was not included in Amendment 1 due to the market removal of this product.

Protocol Amendment 1 was a randomized, open-label, 2-way cross-over study with 7 visits for each completed subject. The visits comprise an initial screening visit, 2 treatment visits for the meal challenge followed by a 2-6-week blood-loss recovery period, an interim safety visit, 2 sequential visits for the glucose clamp, and a final close-out visit.

For both the original protocol and Protocol Amendment 1, subjects were hospitalized in the clinical unit for all procedures.

Arms: arm 1: Technosphere Insulin
Interventions: intervention 1: Technosphere Insulin
Intervention descriptions: intervention 1: Inhalation 15U/30U

Protocol documents:
Clinical trial NCT00598702
Conditions: Pain Fever
Sponsor: Mallinckrodt
Start date: 2008-01-01; Completion date: 2009-01-01
Enrollment: 100 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Intravenous acetaminophen (IVAPAP) is safe in repeated dose, multi-day clinical use when administered at a daily dose of 40 to 75 mg/kg body weight

Detailed description:
To assess the safety of intravenous acetaminophen (IV APAP) when used over one or more days for the treatment of acute pain or fever in pediatric (neonates, infants, children and adolescents) inpatients who are unable to take anything by mouth (NPO), require or would benefit from IV treatment, or are willing and able to stay on IVAPAP therapy for 1 to 7 days.

Arms: arm 1: 40 to 75 mg/kg/day every 4 to 6 hours
Interventions: intervention 1: IV Acetaminophen
Intervention descriptions: intervention 1: Target is 1 to 7 days of therapy with intravenous (IV) Acetaminophen (IV APAP) at a dose of 40 to 75 mg/kg body weight/day administered as an IV infusion (or by syringe pump) over 15 minutes and given every 4 to 6 hours as a scheduled dose

Protocol documents:
Clinical trial NCT00604786
Conditions: Allergic Rhinitis
Keywords: Basophils Mast Cells IgE IgE receptors omalizumab
Sponsor: Johns Hopkins University
Start date: 2007-07-01; Completion date: 2009-01-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This research is being done to study the effects of the drug omalizumab (Xolair) in people with cat allergies. The investigators will use omalizumab to study changes in the cells in the nose, skin and blood that cause allergies. The investigators predict that cells in the blood will be effected before cells in the nose or skin.

Detailed description:
Omalizumab is a monoclonal antibody directed against Immunoglobulin E (IgE) and is FDA-approved for use in allergic asthma, though its clinical role is not precisely defined. It binds IgE on the same site of the Fc domain as the high affinity IgE receptor (FcεRI), and therefore, blocks the interaction between IgE and mast cells or basophils. It, therefore, may be used as a mechanistic tool in the study of IgE. As IgE levels are reduced with omalizumab, FcεRI expression on human basophils is reduced. This reduction of basophil receptors and allergen induced activation is pronounced within 7 days of the initial administration and is reversible once omalizumab administration is discontinued. The omalizumab-induced reductions in mast cell FcεRI expression and function is unchanged at day 7 and significantly reduced by day 70. These changes were based upon intravenously administered omalizumab at a dose of 0.03 mg/kg/IU IgE/mL in a total of three subjects. We propose to exploit the kinetics of faster omalizumab effects on circulating basophils relative to tissue mast cells to elucidate the role of the basophil versus mast cell activation in nasal airway allergen challenge, which has not been studied to date.

Arms: arm 1: This active are will receive treatment with omalizumab subcutaneously at the dose currently FDA-approved for the treatment of allergic asthma. There is a weight and IgE based dosing table in the and subjects receive therapy by subcutaneous injection every 2 or 4 weeks. The lower range of dosing is 150 mg q 4weeks ( one injection) with the upper range 375 mg every 2 weeks ( three injections).

The dosing is based on IgE levels and IGE and is given by subcutaneous injection every 2 to 4 weeks arm 2: This placebo arm will receive identical treatment with placebo injections subcutaneously at the dose currently FDA-approved for the treatment of allergic asthma. There is a weight and IgE based dosing table in the and subjects receive therapy by subcutaneous injection every 2 or 4 weeks. The lower range of dosing is 150 mg q 4weeks ( one injection) with the upper range 375 mg every 2 weeks ( three injections).

The dosing is based on IgE levels and IGE and is given by subcutaneous injection every 2 to 4 weeks.
Interventions: intervention 1: omalizumab intervention 2: placebo
Intervention descriptions: intervention 1: Dosing is based on IgE level and weight given every 2 or 4 weeks intervention 2: Dosing is based on IgE level and weight given every 2 or 4 weeks

Protocol documents:
Clinical trial NCT00605202
Conditions: Hypokalemia
Sponsor: University of Oulu
Start date: 2008-02-01; Completion date: 2009-01-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This clinical trial is designed to study the effect of the combination of licorice and hydrochlorothiazide on plasma potassium levels in volunteers. In one arm, 10 healthy volunteers will be given 32 grams of licorice a day together with a 25 mg dose of daily hydrochlorothiazide for 14 days. This combination is compared with 32 grams of licorice a day for 14 days given in the other arm. The study is a randomized, open-label cross-over trial. There is at least a 3-week wash-out between the arms. The hypothesis is that the combination of licorice and hydrochlorothiazide will cause hypokalemia. The main outcome measure is the change in the plasma level of potassium between the arms.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Hydrochlorothiazide intervention 2: Licorice
Intervention descriptions: intervention 1: Hydrochlorothiazide 25 mg a day for 14 days. intervention 2: Licorice candy 32 grams a day for 14 days.

Protocol documents:
Clinical trial NCT00607477
Conditions: Treatment Induced Hypertension
Sponsor: University of Chicago
Start date: 2008-01-01; Completion date: 2009-01-01
Enrollment: 2 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to describe the length of time and extent of blood pressure response to minoxidil and hydralazine among cancer patients with difficult-to-treat vascular endothelial growth factor (VEGF) inhibitor treatment induced hypertension.

Detailed description:

Arms: arm 1: Minoxidil arm 2: Hydralazine
Interventions: intervention 1: Minoxidil intervention 2: Hydralazine
Intervention descriptions: intervention 1: 2.5 mg taken twice daily for 1 week, followed by 5 mg taken twice daily for the next week, followed by 10 mg twice daily for the next week intervention 2: 25 mg taken twice daily for 1 week, followed by 50 mg taken twice daily for the next week, followed by 100 mg twice daily for the next week

Protocol documents:
Clinical trial NCT00608543
Conditions: Major Depressive Disorder
Keywords: cognitive function psychosocial function augmentation treatment refractory depression
Sponsor: University of Texas Southwestern Medical Center
Start date: 2005-10-01; Completion date: 2009-01-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Our target population will have been adequately treated with one of three selective serotonin reuptake inhibitors (SSRIs; escitalopram, citalopram, or sertraline) for at least 8-12 weeks and continue to experience symptoms of depression that have prompted them to seek additional treatment. Escitalopram, citalopram, and sertraline were selected for use in this study because they are among the most commonly selected SSRIs and they are associated with a reduced likelihood of drug-drug interactions with aripiprazole. After completion of the screening process, eligible participants will be augmented with aripiprazole (5, 10, or 15 mg) for 6 weeks. Participants will continue SSRI treatment with their prescribing physician, in conjunction with study participation. Symptom severity will be assessed on a weekly basis, and cognitive and psychosocial function will be assessed at pre- and post-augmentation. We hypothesize that aripiprazole augmentation will be associated with reductions in symptom severity, and with improved performance on measures of psychosocial and cognitive function.

Detailed description:

Arms: arm 1: This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment.
Interventions: intervention 1: Aripiprazole
Intervention descriptions: intervention 1: varied dose (5, 10, 15 mg qd) for 6 wks

Protocol documents:
Clinical trial NCT00608868
Conditions: Non Small Cell Lung Carcinoma
Keywords: Carcinoma Non Small Cell Lung EGFR mutation Gefitinib
Sponsor: AstraZeneca
Start date: 2007-01-01; Completion date: 2009-01-01
Enrollment: 156 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate ORR (Objective Response Rate) of gefitinib as a second-line therapy for NSCLC patients based on RECIST (Response Evaluation Criteria in Solid Tumors Group) and check up ORR difference by EGFR mutation, gender, smoking history, and type of tumor.

Detailed description:

Interventions: intervention 1: Gefitinib
Intervention descriptions: intervention 1: Gefitinib tablet 250mg once daily orally

Protocol documents:
Clinical trial NCT00620022
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: indacaterol chronic obstructive pulmonary disease exercise endurance moderate to severe chronic obstructive pulmonary disease COPD
Sponsor: Novartis
Start date: 2008-04-01; Completion date: 2009-01-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study compared the effect of indacaterol (300 μg once daily \[od\]) on exercise endurance with that of placebo in patients with moderate to severe chronic obstructive pulmonary disease.

Detailed description:

Arms: arm 1: Patients first received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. After a 3-week washout period, patients received placebo delivered od via a SDDPI in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. arm 2: Patients first received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. After a 3-week washout period, patients received indacaterol 300 μg delivered od via a SDDPI in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Interventions: intervention 1: Indacaterol 300 μg intervention 2: Placebo
Intervention descriptions: intervention 1: Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device. intervention 2: Placebo was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.

Protocol documents:
Clinical trial NCT00622713
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease cholinesterase inhibitor rivastigmine
Sponsor: Novartis
Start date: 2008-01-01; Completion date: 2009-01-01
Enrollment: 228 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is designed to confirm the efficacy, the tolerability, the patient compliance and the caregiver satisfaction with rivastigmine target patch size 10 cm\^2 in patients with probable Alzheimer's Disease (Mini-Mental State Examination 10-26) in the community setting

Detailed description:

Interventions: intervention 1: Rivastigmine transdermal patch
Intervention descriptions: intervention 1: The study treatment was delivered as a patch sizes 5 and 10 cm\^2 containing respectively 9 and 18 mg of rivastigmine. During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm\^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm\^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm\^2.

Protocol documents:
Clinical trial NCT00624559
Conditions: Hypertension
Keywords: Salt sensitivity of Blood Pressure
Sponsor: University of Delaware
Start date: 2008-02-01; Completion date: 2009-01-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine if the drug Celebrex changes the way the kidney gets rid of salt and maintains blood pressure.

Detailed description:
There have been many studies done with analgesics such as acetaminophen and non-steroidal anti-inflammatory drugs; however it is not understood how blood pressure changes while using Celebrex. The study hypothesis is that Celebrex will increase salt sensitivity of blood pressure.

Arms: arm 1: Subject completes a normal sodium diet (3 days), a low salt diet (7 days), followed by a high salt diet (7 days) while taking a celebrex pill (100 mg twice a day for 17 day trial), randomized for trial order (drug versus placebo) and sodium diet order (low versus high sodium). arm 2: Subject completes a normal sodium diet (3 days), a high salt diet (7 days), followed by a low salt diet (7 days) while taking a celebrex pill (100 mg twice a day for 17 day trial), randomized for trial order (drug versus placebo) and sodium diet order (low versus high sodium). arm 3: Subject completes a normal sodium diet (3 days), a low salt diet (7 days), followed by a high salt diet (7 days) while taking a placebo pill (twice a day for 17 day trial), randomized for trial order (drug versus placebo) and sodium diet order (low versus high sodium). arm 4: Subject completes a normal sodium diet (3 days), a high salt diet (7 days), followed by a low salt diet (7 days) while taking a placebo pill (twice a day for 17 day trial), randomized for trial order (drug versus placebo) and sodium diet order (low versus high sodium).
Interventions: intervention 1: celecoxib (Celebrex) intervention 2: Placebo
Intervention descriptions: intervention 1: Celecoxib (Celebrex) was administered at 100 mg, twice per day for each day of sodium diet intervention 2: Placebo pill taken twice per day on each day of the diet

Protocol documents:
Clinical trial NCT00624832
Conditions: Asthma
Keywords: Asthma allergen challenge bronchoprovocation Methacholine challenge serum Immunoglobulin E Nitric Oxide skin prick test
Sponsor: Novartis
Start date: 2008-02-01; Completion date: 2009-01-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was intended to demonstrate that patients with standard and high immunoglobulin E (IgE) levels can be protected from allergen induced broncho-constriction by Xolair

Detailed description:

Arms: arm 1: Patients with screening Immunoglobulin E (IgE) levels = 30-300 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight. arm 2: Patients with screening Immunoglobulin E (IgE) levels = 700- 2000 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight. arm 3: Patients with screening Immunoglobulin E (IgE) levels = 301- 699 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight. arm 4: By subcutaneous injection of a solution with a concentration of 125 mg/mL placebo in a supine position: Patients in Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL) group received doses of 150 mg to 375 mg of placebo every 2 or 4 weeks for 12 or 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL) group received doses of 450 mg, 525 mg, or 600 mg of placebo every 2 weeks for 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL) group received doses of 225 mg to 375 mg of placebo every 2 weeks for 6 weeks.
Interventions: intervention 1: Xolair intervention 2: Placebo
Intervention descriptions: intervention 1: Xolair (Omalizumab) dose: 2 x 450 mg, 2 x 525 mg or 2 x 600 mg; subcutaneous injection; intervention 2: Matching placebo of Xolair (omalizumab), by subcutaneous injection of a solution with a concentration of 125 mg/mL in a supine position.

Protocol documents:
Clinical trial NCT00627445
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2008-02-01; Completion date: 2009-01-01
Enrollment: 441 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Asia. The trial aims to investigate if the blood glucose control of biphasic insulin aspart 50 is at least as effective as treatment with biphasic insulin aspart 30 both in combination with metformin.

Detailed description:

Arms: arm 1: Biphasic insulin aspart 50 administered before breakfast and lunch + biphasic insulin aspart 30 at dinner combined with metformin arm 2: Biphasic insulin aspart 30 administered before breakfast and dinner combined with metformin
Interventions: intervention 1: biphasic insulin aspart 30 intervention 2: metformin intervention 3: biphasic insulin aspart 50
Intervention descriptions: intervention 1: Treat-to-target dose titration scheme (dose adjusted individually), s.c. (under the skin) injection before dinner intervention 2: Tablets, 500 - 2000 mg, once, twice or three times daily intervention 3: Treat-to-target dose titration scheme (dose adjusted individually), s.c. (under the skin) injection before breakfast and lunch

Protocol documents:
Clinical trial NCT00628212
Conditions: Type 2 Diabetes
Keywords: insulin resistance
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2008-01-01; Completion date: 2009-01-01
Enrollment: 324 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety and to determine the appropriate dose for phase 3 confirmatory trial, of MP-513 (Teneligliptin) in patients with type 2 Diabetes based on the change of HbA1c and adverse events after 12 weeks administration once daily in multi-center, randomized, double-blind, placebo-controlled, parallel assignment manner.

Detailed description:

Arms: arm 1: Teneligliptin 10 mg, orally, once daily arm 2: Teneligliptin 20 mg, orally, once daily arm 3: Teneligliptin 40 mg, orally, once daily arm 4: Teneligliptin placebo-matching tablets, orally, once daily
Interventions: intervention 1: Teneligliptin 10mg intervention 2: Teneligliptin 20 mg intervention 3: Teneligliptin 40 mg intervention 4: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00630825
Conditions: Diabetes Mellitus Type 2
Sponsor: Eli Lilly and Company
Start date: 2008-04-01; Completion date: 2009-01-01
Enrollment: 262 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To study once weekly injections of LY2189265 compared to placebo on blood glucose by measuring glycosylated hemoglobin (HbA1c) change from baseline after 16 weeks in overweight Type 2 Diabetes Mellitus participants.

Detailed description:

Arms: arm 1: LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks arm 2: LY2189265: 1.0 mg, subcutaneous (SC) injection, once weekly (QW) for 16 weeks arm 3: LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks arm 4: Placebo: subcutaneous (SC) injection, once weekly (QW) for 16 weeks
Interventions: intervention 1: LY2189265 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: