ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00846586
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: chronic obstructive pulmonary disease COPD indacaterol tiotropium bronchodilation
Sponsor: Novartis Pharmaceuticals
Start date: 2009-03-01; Completion date: 2010-03-01
Enrollment: 1134 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study assessed the efficacy and safety of indacaterol (150 µg once daily \[od\]) when combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients with chronic obstructive pulmonary disease (COPD)

Detailed description:

Arms: arm 1: Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). 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 inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). 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 150 μg intervention 2: Tiotropium 18 μg intervention 3: Placebo to indacaterol
Intervention descriptions: intervention 1: Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device. intervention 2: Tiotropium was supplied in powder filled capsules together the manufacture's proprietary inhalation device (HandiHaler®). intervention 3: Placebo to indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.

Protocol documents:
Clinical trial NCT00857766
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Chronic Obstructive Pulmonary Disease arterial stiffness Computed Tomography pulse wave velocity Pulse wave analysis
Sponsor: GlaxoSmithKline
Start date: 2009-03-01; Completion date: 2010-03-01
Enrollment: 249 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate in patients with Chronic Obstructive Pulmonary Disease (COPD) if Advair DISKUS™ 250/50mcg BID modifies arterial stiffness which is a measure associated with risk of heart disease.

Detailed description:
This is a multicenter, randomized, double-blind, placebo controlled study to evaluate the effect of Fluticasone Propionate/Salmeterol DISKUS 250/50mcg (FSC) BID on arterial stiffness in COPD subjects. Following a 1 to 14 day run-in period, approximately 250 subjects will be randomly assigned to double-blind treatment for 12 weeks. After the 12 week treatment period, subjects in both treatment arms will receive open label Tiotropium bromide Handihaler18mcg (Tio)QD for 4 weeks in addition to their continued study drug (either FSC250/50 or placebo). The primary measure of efficacy is Pulse Wave Velocity (PWV) at Endpoint. Secondary efficacy measures include Augmentation Index (AIx), Biomarkers of cardiovascular disease, measures of lung function. (e.g. FEV1). Safety will be assessed through the collection of adverse events and COPD exacerbations. Exploratory endpoints include the effect of Tiotropium on PWV and AIx when added to placebo or FSC. Treatment groups will be stratified based on current smoking status. There will be a total of 6 study visits (screening, randomization, and after 4, 8, 12 and 16 weeks of treatment). A follow-up phone contact for collection of adverse event and pregnancy information (if applicable) will be conducted approximately 14 days following the last study visit.

Arms: arm 1: Subjects receive blinded Fluticasone Propionate/Salmeterol. At 4 months subjects will receive open label SPIRIVA HANDIHALER arm 2: Subjects will receive placebo ADVAIR DISKUS. At 4 months subjects will receive open label SPIRIVA HANDIHALER
Interventions: intervention 1: ADVAIR DISKUS™ 250/50mcg intervention 2: Placebo
Intervention descriptions: intervention 1: ADVAIR DISKUS™ 250/50mcg is indicated for the twice-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. ADVAIR DISKUS™ 250/50mcg is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations. intervention 2: COPD subjects-Placebo DISKUS

Protocol documents:
Clinical trial NCT00857818
Conditions: Schizophrenia Schizoaffective Disorder Bipolar I Disorder Metabolic Syndrome
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2009-04-01; Completion date: 2010-03-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to determine whether patients with schizophrenia, schizoaffective disorder, or bipolar I disorder who also have metabolic syndrome have a larger decrease in fasting non-high density lipoprotein (non-HDL) cholesterol levels with aripiprazole than with their current atypical antipsychotic treatment (olanzapine, risperidone, or quetiapine).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Aripiprazole intervention 2: Oanzapine, risperidone, or quetiapine
Intervention descriptions: intervention 1: Aripiprazole administered orally as tablets, 5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days within a range of 10 to 30 mg daily, for 16 weeks intervention 2: Oanzapine, risperidone, or quetiapine administered orally as tablets at prior dosage for 16 weeks

Protocol documents:
Clinical trial NCT00858637
Conditions: Chronic Kidney Disease
Keywords: Chronic Kidney Disease Dialysis Dyslipidemia Bile acid sequestrant
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2009-03-01; Completion date: 2010-03-01
Enrollment: 260 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to demonstrate the superiority of MCI-196 over placebo and non-inferiority with simvastatin in reducing serum low-density lipoprotein (LDL)-cholesterol in subjects with chronic kidney disease Stage V on dialysis. This study incorporates a Washout Period and two treatment periods - an active comparison phase and a placebo-controlled withdrawal phase.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: MCI-196 intervention 2: Placebo of Simvastatin intervention 3: Simvastatin intervention 4: Placebo of MCI-196
Intervention descriptions: intervention 1: Tablets of 3 g to 12 g/day (3 times a day) with dose escalation design during 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdrawal Phase (Week 16 to Week 20) intervention 2: Tablets once a day, for 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdrawal Phase (Week 16 to Week 20) intervention 3: Tablets of 10 mg to 40 mg/day (once a day) with dose escalation design during 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdrawal Phase (Week 16 to Week 20) intervention 4: Tablets 3 times a day for 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdrawal Phase (Week 16 to Week 20)

Protocol documents:
Clinical trial NCT00869414
Conditions: Type 1 Diabetes Hypoglycemia
Keywords: hypoglycemia type 1 diabetes split dosing insulin glargine continuous glucose monitoring
Sponsor: Johns Hopkins University
Start date: 2009-07-01; Completion date: 2010-03-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This research is a prospective, randomized, cross-over study that is being done to compare the effect of morning only, evening only and twice daily insulin glargine (Lantus®) on hypoglycemia (blood glucose level \<70 mg/dL) as measured by continuous glucose monitoring (CGM) in patients with type 1 diabetes.

Detailed description:
Over the course of the 6 week study, patients will take insulin glargine in each of 3 different times: only in the morning, only at night, and half in the morning, half at night. After 2 weeks taking the insulin in one regimen, patients will be switched to another regimen. Through the whole study, patients will be injecting themselves twice daily, and neither the patient nor the treating doctor will know which vials contain the insulin and which have only saline (placebo). The vials will be labeled MORNING or EVENING. Patients will continue to take their mealtime, short acting insulin doses.

Additionally, patients will wear a continuous glucose monitor (CGM) which will be masked. Before the study, patients will be taught about how to use the CGM, and keep it taped to their abdomen. The site that the CGM inserts into their abdomen will need to be changed every 5 days. We will know if a patients' blood sugar goes low even if the patient did not feel the low. Patients will still have to self-monitor their blood sugar levels at-least four times in five days, to calibrate the CGM.

Arms: arm 1: Morning only administration of insulin glargine arm 2: Evening only administration of insulin glargine arm 3: Split dose administration of insulin glargine, half dose in morning, half dose in evening
Interventions: intervention 1: Evening only administration of insulin glargine intervention 2: Morning only administration of insulin glargine intervention 3: split dose insulin glargine
Intervention descriptions: intervention 1: Evening only administration of insulin glargine, with normal saline injection administered in the morning. intervention 2: Morning only administration of insulin glargine, with normal saline injection administered at night. intervention 3: split dose of insulin glargine, half administered in the morning, half administered in evening

Protocol documents:
Clinical trial NCT00870584
Conditions: Persistent Allergic Asthma
Keywords: Asthma; asthma management; asthma impairment ; Xolair ; omalizumab
Sponsor: Novartis Pharmaceuticals
Start date: 2009-03-01; Completion date: 2010-03-01
Enrollment: 271 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the effect of omalizumab on markers of impairment in patients with inadequately controlled persistent allergic asthma on Step 4 or above therapy as defined in the 2007 National Heart, Lung, and Blood Institute (NHBLI) Guidelines

Detailed description:

Arms: arm 1: The determined dose (at least 0.016 mg/kg/IgE (IU/mL) was administered subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used. arm 2: Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.
Interventions: intervention 1: Omalizumab intervention 2: Placebo
Intervention descriptions: intervention 1: Omalizumab was supplied as a lyophilized, sterile powder in a single-use, 5 mL vial. The vial was designed to deliver 150 mg (1.2 mL) of omalizumab for subcutaneous (s.c.) administration after reconstitution with 1.4 mL sterile water for injection. Doses of more than 150 mg were divided among multiple injection sites to limit injections to not more than 150 mg per site. intervention 2: Placebo was supplied as a lyophilized, sterile powder in a single-use, 5 mL vial. The vial was designed to deliver 150 mg (1.2 mL) of placebo for subcutaneous (s.c.) administration after reconstitution with 1.4 mL sterile water for injection. Doses of more than 150 mg were divided among multiple injection sites to limit injections to not more than 150 mg per site.

Protocol documents:
Clinical trial NCT00871871
Conditions: Hypertension
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-03-01; Completion date: 2010-03-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will measure and compare changes in insulin production and sensitivity using the hyperglycemic clamp technique in obese patients with impaired glucose tolerance and hypertension treated with placebo, isosorbide mononitrate (ISMN) or hydrochlorothiazide (HCTZ).

Detailed description:

Arms: arm 1: Placebo in Period 1 followed by HCTZ in Period 2 arm 2: HCTZ in Period 1, followed by placebo in Period 2 arm 3: Placebo in Period 1, followed by ISMN in Period 2 arm 4: ISMN in Period 1, followed by placebo in Period 2
Interventions: intervention 1: Hydrochlorothiazide (HCTZ) intervention 2: Comparator: Placebo to HCTZ intervention 3: Isosorbide mononitrate (ISMN) intervention 4: Comparator: Placebo to ISMN
Intervention descriptions: intervention 1: HCTZ 50 mg (two 25 mg capsules) once daily for 4 weeks per treatment period. intervention 2: Placebo to HCTZ two 0 mg capsules once daily for 4 weeks per treatment period intervention 3: ISMN 60 mg extended release capsule once daily for 4 weeks per treatment period intervention 4: Placebo to ISMN 0 mg capsule once daily for 4 weeks per treatment period

Protocol documents:
Clinical trial NCT00885664
Conditions: HIV Infections
Keywords: HIV immune reconstitution treatment naive
Sponsor: University of Cincinnati
Start date: 2005-10-01; Completion date: 2010-03-01
Enrollment: 60 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purposes of this study are:

1. To understand whether the use of HIV therapy in persons with more advanced HIV disease results in greater side effects.
2. To determine whether these side effects can be related to greater activation of the immune system.

Detailed description:
1. To compare the incidence and severity of self-reported symptoms in persons with CD4 counts \<100 cells/mm3 versus those with CD4 counts ≥ 100 cells/mm3 who are initiating antiretroviral therapy.
2. To determine the relationship between self-reported symptoms and levels of T cells, HIV RNA, activation marker cytokines including TNF-α, IFN-γ, IL-2, IL-4, IL-6, IL-10 and other cytokines as measured before and after the initiation of antiretroviral therapy.
3. To determine the relationship between antiretroviral drug trough levels (estimated drug concentrations) and the incidence and severity of self-reported symptoms in persons initiating antiretroviral therapy.
4. To determine the relationship between adverse events and immunological status as evidenced by lymphocyte counts and activation marker cytokine levels.
5. To determine the relationship between clinical events and immunological status as evidenced by lymphocyte counts and activation marker cytokine levels.

Arms: arm 1: All participants were treated but at baseline by design were divided based upon their CD4 count at baseline measurement. Group with CD4\<100 cells/cu mm arm 2: All participants were treated but at baseline by design were divided based upon their CD4 count at baseline measurement. Group with CD4\>/=100 cells/cu mm
Interventions: intervention 1: Truvada (tenofovir/emtricitabine) intervention 2: Kaletra (lopinavir/ritonavir)
Intervention descriptions: intervention 1: Tenofovir/emtricitabine fixed dose combination once daily intervention 2: Lopinavir/ritonavir 400/100 mg twice daily

Protocol documents:
Clinical trial NCT00895947
Conditions: Upper Respiratory Tract Infections
Keywords: Prophylaxis Treatment Symptoms Winter Colds and Flu
Sponsor: Ainos, Inc. (f/k/a Amarillo Biosciences Inc.
Start date: 2009-04-01; Completion date: 2010-03-01
Enrollment: 200 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the study is to see if lozenges containing a low dose of interferon-alpha can prevent and/or reduce the severity of colds and flu. Starting about 1 month before the expected start of the winter colds and flu season in Perth, Australia, healthy volunteers will allow a lozenge containing interferon, or a lozenge containing no medicine (a placebo), to dissolve in their mouth once a day for 16 weeks. Blood tests at the start and end of treatment will determine whether interferon was able to prevent infections with cold/flu viruses. Once a week, volunteers will complete a survey about their cold/flu symptoms, medications taken, days of work missed, etc. to see if interferon was able to make their winter colds and flu less severe.

Detailed description:

Arms: arm 1: 150 international units of interferon-alpha arm 2: placebo lozenges
Interventions: intervention 1: interferon-alpha intervention 2: placebo
Intervention descriptions: intervention 1: a lozenge for oral dissolution containing 150 international units of human interferon-alpha taken once daily for 16 weeks intervention 2: placebo lozenges for oral dissolution taken once daily for 16 weeks

Protocol documents:
Clinical trial NCT00902226
Conditions: Social Anxiety Disorder
Keywords: Social Anxiety Disorder SAD Antidepressant Anxiolytic
Sponsor: H. Lundbeck A/S
Start date: 2009-03-01; Completion date: 2010-03-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the effect of escitalopram after 12 weeks of treatment in patients with Social Anxiety Disorder (SAD), to evaluate proportion of patients who respond to escitalopram during the treatment period, and to evaluate safety of escitalopram.

Detailed description:
The study will be performed in Russia, as an open-label, uncontrolled, one arm trial. The patients will receive escitalopram for 12 weeks. Start and maintenance dosages as well as dose titration will be left to the investigators' decision (5 to 20 mg/day), in accordance with the national Summary of Products Characteristics (SPC).

Arms: arm 1: None
Interventions: intervention 1: Escitalopram
Intervention descriptions: intervention 1: Flexible-dosed (5 to 20 mg Oral Tablets Daily)

Protocol documents:
Clinical trial NCT00902564
Conditions: Generalized Anxiety Disorder
Keywords: Generalized Anxiety Disorder GAD Antidepressant Anxiolytic
Sponsor: H. Lundbeck A/S
Start date: 2009-03-01; Completion date: 2010-03-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the effect of escitalopram after 8 weeks of treatment in patients with Generalized Anxiety Disorder (GAD), to evaluate proportion of patients who respond to escitalopram during the treatment period, and to evaluate safety of escitalopram.

Detailed description:
The study will be performed in Russia, as an open-label, uncontrolled, one arm trial. The patients will receive escitalopram for 8 weeks. Start and maintenance dosages as well as dose titration will be left to the investigators' decision (5 to 20 mg/day), in accordance with the national Summary of Products Characteristics (SPC).

Arms: arm 1: None
Interventions: intervention 1: Escitalopram
Intervention descriptions: intervention 1: Flexible-dosed (5 to 20 mg Oral Tablets Daily)

Protocol documents:
Clinical trial NCT00904748
Conditions: Erectile Dysfunction
Keywords: Sildenafil Bio-equivalence
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2010-01-01; Completion date: 2010-03-01
Enrollment: 47 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to perform a relative bioavailability study between two formulations of sildenafil citrate.

Detailed description:
Bio-equivalence between two formulations of sildenafil citrate

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: sildenafil citrate 100 mg CT intervention 2: sildenafil citrate 100 mg CT intervention 3: Viagra®
Intervention descriptions: intervention 1: sildenafil citrate 100 mg CT, single dose without water intervention 2: sildenafil citrate 100 mg CT, single dose with water intervention 3: sildenafil citrate 100 mg film-coated tablet (Viagra®), single dose

Protocol documents:
Clinical trial NCT00920686
Conditions: Migraine With Aura
Keywords: Migraine aura
Sponsor: NeurAxon Inc.
Start date: 2009-06-01; Completion date: 2010-03-01
Enrollment: 239 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
NXN-188 Dihydrochloride is being developed as an immediate release oral product for the treatment of acute migraine. This study is being conducted to evaluate NXN-188 in subjects with a migraine history of aura.

Detailed description:
This was a multicenter, double-blind, parallel group, active and placebo-controlled, three arm study of a single oral dose of NXN-188 for the treatment of acute migraine headache with aura.

After study eligibility was confirmed, subjects were randomized to NXN-188 600 mg, sumatriptan 100 mg, or placebo in a 1:1:1 ratio. Subjects left the clinic to self-administer the treatment at home at the onset of moderate to severe headache in a suitable dosing environment.

Treatment was not to exceed 42 days from Randomization. If the subject did not have a headache within 42 days of randomization (s)he did not take the study medication and returned it to the site. If the subject experienced a qualifying headache (s)he recorded the symptoms in a diary, dosed with the study drug, and called the IVRS to record assessments all adverse events and to report dosing. If the study drug provided insufficient relief 2 hours post dosing (s)he was permitted to use non-triptan rescue medication recommended by the investigator.

Arms: arm 1: NXN-188, 600 mg, PRN arm 2: Sumatriptan, 100 mg, PRN arm 3: matching, PRN
Interventions: intervention 1: NXN-188 intervention 2: placebo intervention 3: sumatriptan succinate
Intervention descriptions: intervention 1: NXN-188 hard gelatin capsules, 600 mg administered as three 200 mg capsules intervention 2: administered as 3 placebo hard gelatin capsules intervention 3: administered in a hard gelatin capsule with 2 capsules of placebo

Protocol documents:
Clinical trial NCT00929708
Conditions: COPD
Keywords: COPD Efficacy Safety Inhalation
Sponsor: AstraZeneca
Start date: 2009-06-01; Completion date: 2010-03-01
Enrollment: 329 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the efficacy, safety and tolerability of 4 weeks treatment with AZD3199 in moderate to severe COPD.

Detailed description:

Arms: arm 1: AZD3199 low dose arm 2: AZD3199 intermediate dose arm 3: AZD3199 high dose arm 4: Formoterol 2x4.5 microgram bid arm 5: Placebo
Interventions: intervention 1: AZD3199 intervention 2: formoterol intervention 3: Placebo
Intervention descriptions: intervention 1: Dry powder for inhalation, o.d., 4 weeks intervention 2: Dry powder for inhalation, b.i.d., 4 weeks intervention 3: Dry powder for inhalation, b.i.d., 4 weeks

Protocol documents: