ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01536587
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: influence of bronchodilatation with salmeterol on the autonomic nervous systems in COPD patients will be measured using MSNA. Relation of COPD and sympathetic nerve activity is to be evaluated,
Sponsor: GlaxoSmithKline
Start date: 2012-07-01; Completion date: 2012-11-01
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a 4-week non-randomized, partially blinded, single-arm monocentre study in subjects with Chronic Obstructive Pulmonary Disease (COPD) Global Initiative for Chronic Obstructive Lung Disease (GOLD) class II or III with the aim to demonstrate that inhaled therapy with salmeterol reduces sympathetic activity as evaluated by microneurography. A maximum of 32 subjects is planned to be enrolled.

Detailed description:
This is a 4-week non-randomized, partially blinded, single-arm monocentre study in subjects with COPD GOLD class II or III with the aim to demonstrate that inhaled therapy with salmeterol reduces sympathetic activity as evaluated by microneurography. A maximum of 32 subjects is planned to be enrolled.

During a complex data registration period comprising the continuous recording of muscle sympathetic nerve activity (MSNA) and respiration and of various other measurements at Visit 1, placebo and 50 μg of salmeterol via Diskus™ inhaler will be administered in a sequential design. Following Visit 1, the subjects will be treated with salmeterol 50 μg twice daily via Diskus inhaler for 4 weeks. At the Final Visit (Visit 2) the data registration period of Visit 1 will be repeated with the only difference that no placebo will be administered.

Further endpoints, besides the evaluation of MSNA, include heart rate variability (HRV), spontaneous baroreflex sensitivity and lung function parameters.

Study enrolment will be stopped when valid MSNA data on the immediate effect of inhalation (manoeuvres at Visit 1) are available for 24 subjects.

Arms: arm 1: Inhalation of salmeterol 50 µg twice daily over 4 weeks
Interventions: intervention 1: Salmeterol
Intervention descriptions: intervention 1: At visit 1 the sympathetic activity will be registered using microneurographic recordings of efferent muscle sympathetic nerve activity (MSNA) in the peroneal nerve and respiration over 2 hours, after 20 minutes of recording, 1 dose of placebo will be administered and after a further recording period of 45 minutes a dose of salmeterol 50 µg will be administered which will be followed by a further period of data registration. At visit 2 following 4 weeks of inhaled treatment with salmeterol the same procedures will be performed but a placebo inhalation will not be performed.

Protocol documents:
Clinical trial NCT01536886
Conditions: Psoriasis Vulgaris
Sponsor: LEO Pharma
Start date: 2012-05-01; Completion date: 2012-11-01
Enrollment: 376 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate whether LEO 90100 and calcipotriol plus betamethasone are effective in the treatment of psoriasis vulgaris.

Detailed description:

Arms: arm 1: Aerosol foam with no active ingredient arm 2: Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) ointment arm 3: LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) arm 4: Ointment with no active ingredients
Interventions: intervention 1: LEO 90100 intervention 2: Betamethasone plus calcipotriol intervention 3: Ointment vehicle intervention 4: LEO 90100 vehicle
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01536938
Conditions: Psoriasis Vulgaris
Sponsor: LEO Pharma
Start date: 2012-05-01; Completion date: 2012-11-01
Enrollment: 303 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate whether LEO 90100, calcipotriol and betamethasone are effective in the treatment of psoriasis vulgaris.

Detailed description:

Arms: arm 1: Calcipotriol aerosol foam: calcipotriol 50 mcg/g.

Applied once daily for up to 4 weeks arm 2: Betamethasone dipropionate aerosol foam: betamethasone 0.5 mg/g (as dipropionate)

Applied once daily for up to 4 weeks arm 3: LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)

Applied once daily for up to 4 weeks
Interventions: intervention 1: LEO 90100 intervention 2: Calcipotriol intervention 3: Betamethasone
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01549977
Conditions: Angina
Keywords: Drug Therapy
Sponsor: Takeda
Start date: 2012-07-01; Completion date: 2012-11-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effect of febuxostat, once daily (QD), compared to placebo as an add on to stable anti-anginal therapy, on the total exercise time of participants with Chronic Stable Angina.

Detailed description:
This is a phase 2 multicenter, randomized, placebo-controlled double-blind study. This study is comprised of a single-blind placebo run-in qualifying phase lasting approximately 3 weeks and a double-blind treatment phase lasting 12 weeks. A safety follow-up visit is scheduled for 2 weeks after last dose of study drug.

All participants will undergo 3 visits during a 3 week, run-in phase (Days -21 to Day 1). During the run-in phase, all participants will receive single-blind placebo. Two exercise treadmill tests (ETTs) will be conducted using the modified Bruce Protocol at Day -14 and at Day -7. The results from the Day -7 ETT will be considered as Baseline.

A total of approximately 100 participants will be randomized 1:1 to receive either febuxostat 80 mg once daily (QD) or placebo QD in a double-blind treatment for 12 weeks, and 5 more visits.

All participants will complete the Seattle Angina Questionnaire (SAQ) and Euroqol 5 dimension (EQ-5D) quality-of-life measurements at Day 1, Week 6 and Week 12/Early Termination (ET) Visit. The investigator will also rate the overall severity of the participant's angina at each visit based on the Canadian Cardiovascular Society Grading of Angina (CCSGA).

This 12-week phase 2 proof-of-concept study was designed to assess the effect of febuxostat as an add-on to stable anti-anginal therapy on the total exercise time of participants with chronic stable angina and a serum urate ≥5 mg/dL. At this time, Takeda has decided to terminate the study for business reasons.

Arms: arm 1: Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks. arm 2: Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.
Interventions: intervention 1: Febuxostat intervention 2: Placebo
Intervention descriptions: intervention 1: Febuxostat tablets intervention 2: Febuxostat placebo-matching tablets

Protocol documents:
Clinical trial NCT01569841
Conditions: Diabetes Diabetes Mellitus, Type 1
Sponsor: Novo Nordisk A/S
Start date: 2012-04-01; Completion date: 2012-11-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This trial is conducted in the United States of America (USA). The aim of this trial is to compare the efficacy of insulin decludec with insulin glargine on glycaemic control using continuous glucose monitoring in patients with type 1 diabetes.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: insulin degludec intervention 2: insulin glargine
Intervention descriptions: intervention 1: Administered subcutaneously (s.c., under the skin) once daily. intervention 2: Administered subcutaneously (s.c., under the skin) once daily.

Protocol documents:
Clinical trial NCT01578785
Conditions: Relapsing-Remitting Multiple Sclerosis
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2012-03-01; Completion date: 2012-11-01
Enrollment: 178 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate the efficacy, safety and tolerability of a new formulation of glatiramer acetate administered at 20 mg/0.5 ml daily versus placebo in patients with Relapsing-Remitting Multiple Sclerosis (RRMS).

Detailed description:
Approximately 1400 participants were planned for this study, however only 178 were enrolled prior to early termination.

Arms: arm 1: Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily. arm 2: Placebo solution in prefilled syringe for subcutaneous injection once daily.
Interventions: intervention 1: Glatiramer Acetate intervention 2: Placebo
Intervention descriptions: intervention 1: Glatiramer acetate 20mg in 0.5ml for subcutaneous injection in a pre-filled syringe (PFS) is administered daily. Each PFS also contains 20mg mannitol dissolved in water for injection. intervention 2: Matching placebo injection; 20 mg mannitol dissolved in 0.5 mL water for subcutaneous injection in a PFS is administered daily.

Protocol documents:
Clinical trial NCT01581658
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2012-04-01; Completion date: 2012-11-01
Enrollment: 32 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to assess the effect of the different degrees of renal impairment on the pharmacokinetics, pharmacodynamics and safety of BI10773 following oral administration of high dose BI10773 as a single dose in Japanese patients with type 2 diabetes mellitus.

Detailed description:

Arms: arm 1: BI10773 medium dose tablet single dose group 1 arm 2: BI10773 medium dose tablet single dose group 2 arm 3: BI10773 medium dose tablet single dose group 3 arm 4: BI10773 medium dose tablet single dose group 4
Interventions: intervention 1: BI10773 intervention 2: BI10773 intervention 3: BI10773 intervention 4: BI10773
Intervention descriptions: intervention 1: BI10773 medium dose tablet single dose intervention 2: BI10773 medium dose tablet single dose intervention 3: BI10773 medium dose tablet single dose intervention 4: BI10773 medium dose tablet single dose

Protocol documents:
Clinical trial NCT01582490
Conditions: Mammoplasty Postoperative Pain
Keywords: Mammoplasty Postoperative pain Analgesia
Sponsor: Pacira Pharmaceuticals, Inc
Start date: 2012-04-01; Completion date: 2012-11-01
Enrollment: 19 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase 4, prospective, open-label, non-randomized, sequential study with two treatment groups differing only in the technique used for EXPAREL administration (instillation or infiltration).

Detailed description:
Each subject underwent bilateral augmentation mammoplasty and received the same dose of EXPAREL. This primary objective of this study was to assess the efficacy of EXPAREL when administered via infiltration versus instillation as part of bilateral augmentation mammoplasty. The secondary objectives were to further assess other efficacy measures and the safety profile of EXPAREL.

Arms: arm 1: Group 2 will receive diluted EXPAREL (i.e., the contents of one 20 mL vial, 266 mg, diluted with 20 mL of preservative-free 0.9% normal saline to a total of 40 mL) for postsurgical analgesia. Half of the resulting mixture (i.e., 20 mL) will be administered via local infiltration into each surgical site per the surgeon's normal practice at the beginning of surgery. arm 2: Group 1 will receive diluted EXPAREL (i.e., the contents of one 20 mL vial, 266 mg, diluted with 20 mL of preservative-free 0.9% normal saline to a total of 40 mL) for postsurgical analgesia. Half of the resulting mixture (i.e., 20 mL) will be instilled into each breast pocket at the beginning of surgery.
Interventions: intervention 1: Instillation - EXPAREL intervention 2: Infiltration - EXPAREL
Intervention descriptions: intervention 1: Intravenous (IV) morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed. intervention 2: IV morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed.

Protocol documents:
Clinical trial NCT01603043
Conditions: Geographic Atrophy
Keywords: Geographic Atrophy Age-Related Macular Degeneration Intravitreal injection
Sponsor: Alcon Research
Start date: 2012-06-01; Completion date: 2012-11-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to to demonstrate superiority of AL-78898A intravitreal (IVT) injections compared to sham injections by assessing mean geographic atrophy (GA) lesion size change from baseline at Month 12.

Detailed description:
Participants meeting inclusion/exclusion criteria were randomized in a 2:1 ratio to receive AL-78898A or a sham injection. The study eye was assessed before and after each injection to ensure that the injection procedure and/or study medication had not endangered the health of the eye. The Investigator determined each month whether the patient was eligible to receive the next injection. The study was terminated due to a high likelihood that continued enrollment would reach the predefined study stopping criteria based upon the number of patients with drug deposit formation, which made an assessment of efficacy futile.

Arms: arm 1: 1 intravitreal injection per month for up to 12 months arm 2: 1 mock injection per month for 12 months
Interventions: intervention 1: Al-78898A intervention 2: Sham injection
Intervention descriptions: intervention 1: 0.400 milligrams (mg) per 50 microliters (μL) administered as an intravitreal injection intervention 2: Mock injection administered as an empty hub without needle

Protocol documents:
Clinical trial NCT01622231
Conditions: Rhinitis
Sponsor: GlaxoSmithKline
Start date: 2012-06-01; Completion date: 2012-11-01
Enrollment: 61 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Safety of GW685698X (55 µg/day, q.d.) nasal spray over a period of 12 weeks in Japanese paediatric subjects ages 2 to \< 15 years with perennial allergic rhinitis will be evaluated. And secondarily, efficacy and systemic exposure of GW685698X (55 µg/day, q.d.) nasal spray over a period of 12 weeks in Japanese paediatric subjects ages 2 to \< 15 years with perennial allergic rhinitis will also be evaluated.

Detailed description:

Arms: arm 1: GW685698X 55mcg/day
Interventions: intervention 1: Fluticasone furoate
Intervention descriptions: intervention 1: 55 mcg/day, intranasal, 12 weeks

Protocol documents:
Clinical trial NCT01637922
Conditions: Hepatitis C
Sponsor: Boehringer Ingelheim
Start date: 2012-08-01; Completion date: 2012-11-01
Enrollment: 34 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Otherwise healthy subjects who are currently bein maintained on either methadone or buprenorphine/naloxone for opioid maintenance therapy who have been on a stable dose for at least 30 days will be administered BI 201335 daily to determine if a drug interaction occurs between BI 201335 and either methadone or buprenorphine/naloxone.

Detailed description:

Arms: arm 1: patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day arm 2: patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day.
Interventions: intervention 1: BI 201335 intervention 2: BI 201335
Intervention descriptions: intervention 1: BI 201335 for 9 days intervention 2: BI 201335 for 9 days

Protocol documents:
Clinical trial NCT01648764
Conditions: Malignant Solid Tumor Solid Tumor Metastatic Tumor
Sponsor: Eli Lilly and Company
Start date: 2008-09-01; Completion date: 2012-11-01
Enrollment: 73 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate two different dosing regimens of LY2334737 in participants with cancer that is advanced and/or has spread to other parts of the body. Information about side effects will be collected.

Detailed description:
This study will consist of a Dose Escalation Phase (Arms A and B) followed by a Dose Confirmation Phase.

Arms: arm 1: LY2334737 administered orally at escalating doses \[40 milligrams (mg) - 200 mg\] every other day for 21 days followed by 7 days without study drug (28 day treatment cycle). Participants may receive additional treatment cycles until discontinuation criterion is met. arm 2: LY2334737 administered orally at escalating doses (40 mg - 200 mg) every day for 7 days followed by 7 days without study drug then repeated (28 day treatment cycle). Participants may receive additional treatment cycles until discontinuation criterion is met.
Interventions: intervention 1: LY2334737
Intervention descriptions: intervention 1: Administered orally

Protocol documents:
Clinical trial NCT01662999
Conditions: Type 2 Diabetes Mellitus
Sponsor: AstraZeneca
Start date: 2012-08-01; Completion date: 2012-11-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate whether the pharmacokinetics (body concentrations/metabolism of the drug) of Saxagliptin and Dapagliflozin are affected when they are administered together

Detailed description:

Arms: arm 1: Treatment A: Saxagliptin 5mg, Tablet, Oral; Single dose Treatment B: Dapagliflozin 10mg, Tablet, Oral; single dose Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; single dose arm 2: Treatment A: Saxagliptin 5mg, Tablet, Oral, single dose; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral, single dose; Treatment B: Dapagliflozin 10mg, Tablet, Oral, single dose arm 3: Treatment B: Dapagliflozin 10mg, Tablet, Oral, single dose. Treatment A: Saxagliptin 5mg, Tablet, Oral, single dose; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral, single dose arm 4: Treatment B: Dapagliflozin 10mg, Tablet, Oral, single dose; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral, single dose; Treatment A: Saxagliptin 5mg, Tablet, Oral, single dose arm 5: Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral, single dose; Treatment A: Saxagliptin 5mg, Tablet, Oral, single dose; Treatment B: Dapagliflozin 10mg, Tablet, Oral, single dose arm 6: Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral, single dose; Treatment B: Dapagliflozin 10mg, Tablet, Oral, Once daily, single dose; Treatment A: Saxagliptin 5mg, Tablet, Oral, single dose
Interventions: intervention 1: Saxagliptin intervention 2: Dapagliflozin
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01664624
Conditions: Type 2 Diabetes
Keywords: Drug Therapy
Sponsor: AstraZeneca
Start date: 2012-07-01; Completion date: 2012-11-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the effect of roflumilast plus alogliptin on glucagon-like peptide-1 (GLP-1) and glucose levels in patients with type 2 diabetes.

Detailed description:
This is a study to evaluate the antiglycemic efficacy and safety of roflumilast + alogliptin compared to alogliptin alone and roflumilast alone; it will also include an open-label exenatide treatment arm as a control. The antiglycemic efficacy of the combination will be evaluated through the measurement of postprandial active GLP-1 level, ß cell secretion activity (via the measurement of C-peptide and insulin levels), appetite sensations (as assessed by VAS) and glycemic control as assessed by a continuous glucose monitoring system (CGMS).

Arms: arm 1: Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days. arm 2: Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days. arm 3: Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days. arm 4: Exenatide 5 μg subcutaneous injection twice a day for 11 days.
Interventions: intervention 1: Roflumilast intervention 2: Alogliptin intervention 3: Exenatide intervention 4: Placebo to roflumilast intervention 5: Placebo to alogliptin
Intervention descriptions: intervention 1: Roflumilast tablets intervention 2: Alogliptin tablets intervention 3: Exenatide solution intervention 4: Placebo-matching roflumilast tablets intervention 5: Placebo-matching alogliptin tablets

Protocol documents:
Clinical trial NCT01672788
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2012-08-01; Completion date: 2012-11-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of this trial is to establish bioequivalence of two FDC tablets and the single tablets when administered together after a high fat high caloric meal.

Detailed description:

Arms: arm 1: fixed dose combination tablet arm 2: empagliflozin tablets and metformin tablet arm 3: fixed dose combination tablet arm 4: empagliflozin tablet and metformin tablet
Interventions: intervention 1: Empagliflozin intervention 2: Empagliflozin + Metformin intervention 3: Metformin intervention 4: Metformin intervention 5: Empagliflozin + Metformin intervention 6: Empagliflozin
Intervention descriptions: intervention 1: empagliflozin tablets and metformin tablet intervention 2: fixed dose combination tablet (low) intervention 3: empagliflozin tablets and metformin tablet intervention 4: empagliflozin tablet and metformin tablet intervention 5: fixed dose combination tablet (low) intervention 6: empagliflozin tablet and metformin tablet

Protocol documents:
Clinical trial NCT01679613
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2012-09-01; Completion date: 2012-11-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of the current study is to investigate the relative bioavailability of a single dose of nintedanib low or high dose with and without coadministration of ketoconazole at steady state

Detailed description:

Arms: arm 1: single dose, oral with 240 ml water arm 2: Nintedanib single dose, Ketoconazole steady state, oral with 240 ml water arm 3: single dose, oral with 240 ml water arm 4: Nintedanib single dose, Ketoconazole steady state, oral with 240 ml water
Interventions: intervention 1: Nintedanib intervention 2: Nintedanib intervention 3: Ketoconazole intervention 4: Nintedanib intervention 5: Nintedanib intervention 6: Ketoconazole
Intervention descriptions: intervention 1: low or medium dose depending on pilot part intervention 2: low dose oral administration intervention 3: oral administration intervention 4: low dose oral administration intervention 5: low or medium dose depending on pilot part intervention 6: oral administration

Protocol documents:
Clinical trial NCT01685242
Conditions: Allergic Conjunctivitis
Sponsor: Aciex Therapeutics, Inc.
Start date: 2012-09-01; Completion date: 2012-11-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the onset and duration of action of AC-170 0.24% compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in the conjunctival allergen challenge (CAC) model.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: AC-170 0.24% intervention 2: AC-170 0%
Intervention descriptions: intervention 1: 1 drop in each eye at 2 separate times during a 14 day period intervention 2: 1 drop in each eye at 2 separate times during a 14 day period

Protocol documents: