ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01169558
Conditions: Colorectal Cancer
Sponsor: Hoffmann-La Roche
Start date: 2006-05-01; Completion date: 2009-07-01
Enrollment: 168 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This expanded access study will assess the safety and efficacy of intravenous bevacizumab (5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks) in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum. The anticipated time on study treatment is 3-12 months.

Detailed description:

Arms: arm 1: Bevacizumab will be administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
Interventions: intervention 1: Bevacizumab intervention 2: Fluoropyrimidine-based Chemotherapy
Intervention descriptions: intervention 1: 5 mg/kg bevacizumab administered intravenously every 2 weeks or 7.5 mg/kg bevacizumab administered intravenously every 3 weeks according to the standard chemotherapy regimen. intervention 2: Fluoropyrimidine-based chemotherapy administered according to standard of care.

Protocol documents:
Clinical trial NCT02169440
Conditions: Parkinson's Disease (PD)
Keywords: Parkinson's disease (PD) BIA 9-1067 Opicapone
Sponsor: Bial - Portela C S.A.
Start date: 2009-06-01; Completion date: 2009-07-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to investigate CYP2C9 inhibition by BIA 9-1067 through the assessment of its effect on the pharmacokinetics of S-warfarin, a substrate of CYP2C9.

Detailed description:
Single-centre, open-label, randomised, two-way crossover study in healthy young male and female volunteers. The study was to consist of 2 treatment periods separated by a washout period of 14 days or more. In one period, subjects were to receive a single-dose of 25 mg BIA 9-1067 with a single-dose of racemic 25 mg warfarin. In the other period, a 25 mg warfarin single-dose was to be administered alone.

Arms: arm 1: Period 1: BIA 9-1067 + warfarin Period 2: warfarin arm 2: Period 1: warfarin Period 2: BIA 9-1067 + warfarin
Interventions: intervention 1: BIA 9-1067 intervention 2: Warfarin
Intervention descriptions: intervention 1: BIA 9-1067 25 mg intervention 2: Warfarin 25 mg

Protocol documents:
Clinical trial NCT02170532
Conditions: Asthma
Keywords: asthma
Sponsor: Duke University
Start date: 2007-07-01; Completion date: 2009-07-01
Enrollment: 10 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Dr. MacIntyre and his colleagues are studying inhaled medications in asthma. There are two new medications that have been approved by the United States Food and Drug Administration (FDA): levalbuterol and formoterol. Both of these drugs are similar to standard asthma bronchodilator drugs but offer theoretical advantages in terms of fewer side effects. There are also newer devices to deliver these medications into the lungs: breath actuated nebulizers (BANs) and non-static chambers (Aerochamber-max) that can be used with metered dose inhalers (MDIs or "puffers"). The purpose of this study is to deliver these new medications using several different devices and measuring lung function, heart rate, and sensations of breathlessness.

Detailed description:
Patients will be studied on five separate mornings. The duration of the study and frequency of the visits will be solely dependant on the subject availability. Each subject will receive all 5 treatments in the same order.

Arms: arm 1: 0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer arm 2: 0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer arm 3: levalbuterol metered dose inhaler 2 puffs arm 4: levalbuterol MDI + aerochamber max without pause 2 puffs arm 5: levalbuterol MDI + aerochamber max with 2 second pause 2 puffs
Interventions: intervention 1: levalbuterol intervention 2: saline intervention 3: levalbuterol MDI intervention 4: breath actuated nebulizer intervention 5: aerochamber max intervention 6: ipratroprium
Intervention descriptions: intervention 1: 0.5 ml. levalbuterol intervention 2: 0.5ml saline intervention 3: None intervention 4: None intervention 5: None intervention 6: None

Protocol documents:
Clinical trial NCT02951312
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Emphysema Chronic bronchitis COPD Chronic Obstructive Pulmonary Disease
Sponsor: Sunovion Respiratory Development Inc.
Start date: 2009-05-01; Completion date: 2009-07-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study assessed the safety and ability of several doses of an orally inhaled medicine \[ie, Glycopyrrolate Inhalation Solution = GIS\] to improve airflow in the lungs when delivered with an electronic eFlow nebulizer system in patients with Chronic Obstructive Pulmonary Disease (COPD). The study was conducted in 12 patients in 2 parts. Part 1 was designed to find the once-a- day GIS dose that produced the highest improvement in lung airflow. Part 2 tested the GIS dose with the highest improvement in lung airflow and a placebo (ie, no drug) delivered by a general purpose nebulizer. The airflow improvements of the same GIS dose were compared between the two nebulizer systems to determine what effect the device had on GIS delivery.

Detailed description:
In Part I, 12 subjects were randomly allocated to one of 2 cohorts, running in parallel. The 6 cohort 1 subjects received 25 mg and then 200 mg during their treatment periods 1 and 2, respectively. The 6 cohort 2 subjects received 75mg, 500mg, and 1000 mg during their treatment periods 1, 2, and 3, respectively. During Part II of the study, the same 12 subjects from Part I were randomized to receive either 200 mg jet or placebo in a 1:1 ratio.

Arms: arm 1: Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily arm 2: Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily arm 3: Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily arm 4: Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily arm 5: Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily arm 6: Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily arm 7: Placebo 0.5 mL via jet nebulizer, once daily
Interventions: intervention 1: Glycopyrrolate Inhalation Solution 25mg intervention 2: Glycopyrrolate Inhalation Solution 75mg intervention 3: Glycopyrrolate Inhalation Solution 200mg intervention 4: Glycopyrrolate Inhalation Solution 200mg Jet intervention 5: Glycopyrrolate Inhalation Solution 500mg intervention 6: Glycopyrrolate Inhalation Solution1000mg intervention 7: Placebo
Intervention descriptions: intervention 1: 25 μg oral inhalation via eFlow Nebulizer, once daily intervention 2: 75 μg oral inhalation via eFlow Nebulizer, once daily intervention 3: 200 μg oral inhalation via eFlow Nebulizer, once daily intervention 4: 200 μg oral inhalation via inhalation via jet nebulizer, once daily intervention 5: 500 μg oral inhalation via eFlow nebulizer, once daily intervention 6: 1000 μg oral inhalation via eFlow nebulizer, once daily intervention 7: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily

Protocol documents:
Clinical trial NCT00758524
Conditions: Essential Hypertension
Keywords: Essential hypertension Phase 2 study Antihypertensive agent
Sponsor: Novartis Pharmaceuticals
Start date: 2008-09-11; Completion date: 2009-07-02
Enrollment: 628 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was a proof-of-efficacy, dose finding study of LCI699 in participants with mild-to-moderate uncomplicated essential hypertension in order to assess the blood pressure (BP) lowering effect, safety and tolerability of LCI699 as compared to placebo and eplerenone.

Detailed description:

Arms: arm 1: Participants received LCI699 0.25 mg capsules, orally, once daily (QD), with or without food for up to 8 weeks. arm 2: Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks. arm 3: Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks. arm 4: Participants received LCI699 0.5 mg capsules, orally, twice daily (BID), with or without food for up to 8 weeks. arm 5: Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks. arm 6: Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks. arm 7: Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9). arm 8: Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9). arm 9: Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9). arm 10: Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9). arm 11: Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9). arm 12: Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9). arm 13: Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9). arm 14: Participants received LCI699 matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9). arm 15: Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9). arm 16: Participants received eplerenone matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9). arm 17: Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 1 week (Week 8 to Week 9).
Interventions: intervention 1: LCI699 intervention 2: Eplerenone intervention 3: LCI699-matching Placebo intervention 4: Eplerenone-matching Placebo
Intervention descriptions: intervention 1: LCI699 oral capsules intervention 2: Eplerenone oral capsules intervention 3: LCI699-matching placebo oral capsules intervention 4: Eplerenone-matching placebo oral capsules

Protocol documents:
Clinical trial NCT00901576
Conditions: Healthy
Keywords: Healthy volunteers
Sponsor: Shire
Start date: 2009-05-18; Completion date: 2009-07-06
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a drug-drug interaction study; the purpose of this study is to examine the pharmacokinetics (levels of drug in the blood) of SPD503 (guanfacine hydrochloride) and Concerta (methylphenidate HCl) when given alone, and in combination.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: SPD503 intervention 2: Concerta intervention 3: SPD503 + Concerta
Intervention descriptions: intervention 1: SPD503 (guanfacine hydrochloride) extended-release 4 mg orally administered tablets intervention 2: CONCERTA (methylphenidate HCl) extended-release 36 mg orally administered tablets. intervention 3: SPD503 4 mg + CONCERTA 36 mg orally administered tablets (taken together).

Protocol documents:
Clinical trial NCT00258960
Conditions: Breast Cancer
Keywords: HER2 positive breast cancer Metastatic breast cancer
Sponsor: Spanish Breast Cancer Research Group
Start date: 2006-02-15; Completion date: 2009-07-14
Enrollment: 49 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Eligible patients must receive Caelyx plus Cyclophosphamide plus Herceptin for 6 cycles that will be administered every 4 weeks.

Detailed description:
Sample size calculation will be done by means of Simon's method in 2 stages for phase II studies and will be based on the principal aim of the study (evaluation of the rate of objective response).

The hypothesis brings over of the efficiency of the treatment it will be accepted if a rate of objective response of at least 55 % is obtained, rejecting the efficiency of the treatment when the rate of response targets be lower than 35 %. In this case, considering an alpha error of 0.05 and 80 % power, 14 patients will be included in the first stage; the study would continue if more than 5 objective responses were found. The total number of patients to including in the study would be 44. The results will be significant if they find at least 20 objective responses.

Assuming a drop-out rate of 10 %, the total number of patients needed is 49 patients.

Arms: arm 1: Caelyx (Liposomal Doxorubicin) 50 mg/m2 every 4 weeks for 6 cycles, Cyclophosphamide 600 mg/m2 every 4 weeks for 6 cycles, Trastuzumab weekly for 24 weeks, at dose of 2mg/kg (day 1 loading dose of 4mg/kg)
Interventions: intervention 1: Liposomal Doxorubicin intervention 2: Cyclophosphamide intervention 3: Trastuzumab
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00812929
Conditions: Asthma
Keywords: Asthma, Exercise Induced Asthma, Exercise Induced Bronchospasm
Sponsor: GlaxoSmithKline
Start date: 2008-12-01; Completion date: 2009-07-15
Enrollment: 47 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is intended to determine the dose response and duration of action of GSK2190915 in mild asthmatic adult subjects who experience exercise-induced bronchoconstriction.

Detailed description:
This study is intended to determine the dose response and duration of action of GSK2190915 in mild asthmatic adult subjects who experience exercise-induced bronchoconstriction. Subjects will be invited to complete a screening visit, during which time exercise induced bronchoconstriction must be demonstrated, defined as a decrease between 20-40% in FEV1 compared to baseline immediately following exercise challenge. Eligible subjects will complete a randomized, double-blind, five-way crossover study. Subjects will be randomized to a single dose of either 10 mg, 50 mg, 100 mg, 200 mg GSK2190915, or placebo during each treatment period. Each treatment period will last 2 days and will include various assessments following exercise challenge at 2, 9.5, and 24 hours post dose. A minimum 7 day washout between treatment periods will be required. Regardless if a subject completes or prematurely withdraws from the study, a follow up visit will be completed 7-21 days following last dose.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: Placebo intervention 2: GSK2190915
Intervention descriptions: intervention 1: The current study will include a placebo arm to allow for a valid evaluation of adverse events attributable to GSK2190915 versus those independent of GSK2190915. intervention 2: This study will assess FEV1 at various intervals following exercise challenge in subjects who have been administered a single dose of 10 mg, 50 mg, 100 mg, or 200 mg GSK2190915, compared to a placebo control.

Protocol documents:
Clinical trial NCT03643575
Conditions: Healthy Subjects
Sponsor: Reckitt Benckiser Inc.
Start date: 2009-06-30; Completion date: 2009-07-16
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Characterize the relative pharmacokinetics (PK) of 3 marketed products containing guaifenesin

Detailed description:

Arms: arm 1: Vicks Cough immediate-release (IR) syrup 15 mL (containing 200 mg guaifenesin) every 4 hours x 3 doses with 240 mL of water after an overnight fast arm 2: Robitussin Extra Strength Chest Congestion 5 ml (containing 200 mg guaifenesin) every 4 hours x 3 doses with 240 mL of water after an overnight fast arm 3: Organ-I- NR 200 mg guaifenesin tablet every 4 hours x 3 doses with 240 mL of water after an overnight fast
Interventions: intervention 1: Vicks Cough Syrup for Chesty Coughs intervention 2: Robitussin Extra Strength Chest Congestion intervention 3: Organ-I- NR tablet
Intervention descriptions: intervention 1: Vicks Cough Syrup for Chesty Coughs 15 mL (containing 200 mg guaifenesin) IR syrup with 240 mL of water intervention 2: Robitussin Extra Strength Chest Congestion 5 mL (containing 200 mg guaifenesin) IR syrup with 240 mL of water intervention 3: Organ-I- NR tablet (containing 200 mg guaifenesin) with 240 mL of water

Protocol documents:
Clinical trial NCT00882557
Conditions: End-stage Renal Disease Renal Failure Chronic Requiring Hemodialysis
Keywords: End-stage renal disease hemodialysis chronic renal failure
Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Start date: 2009-04-29; Completion date: 2009-07-17
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine whether daptomycin at a higher dose given during the last 30 minutes of a dialysis session is equal to a lower dose of daptomycin given after a dialysis session.

Detailed description:

Arms: arm 1: 9 mg/kg of daptomycin administered during the last 30 minutes of a hemodialysis session. arm 2: Post dialysis dosing
Interventions: intervention 1: daptomycin intervention 2: daptomycin
Intervention descriptions: intervention 1: intradialytic: 9 mg/kg during the last 30 minutes of dialysis intervention 2: 6 mg/kg administered after a hemodialysis session

Protocol documents:
Clinical trial NCT02242305
Conditions: Abdominal Pain
Sponsor: Boehringer Ingelheim
Start date: 2008-11-01; Completion date: 2009-07-20
Enrollment: 302 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In contrast with Hyoscine Butylbromide Capsule 10mg, Study is to evaluate the efficacy and safety of Hyoscine Butylbromide tablets 10 mg (20mg, 3 times daily, orally) over a period of 3 days for the treatment of occasional or recurrent episodes of self-reported gastric or intestinal spasm-like pain or discomfort

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Hyoscine Butylbromide - Tablet intervention 2: Hyoscine Butylbromide - Capsule intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00888238
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-05-12; Completion date: 2009-07-21
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will evaluate the effect of a single dose of sitagliptin on glucose dependent insulin secretion using a meal tolerance test (MTT) during a hyperglycemic clamp (HCG) procedure.

Detailed description:

Arms: arm 1: Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods arm 2: Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods arm 3: Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods
Interventions: intervention 1: sitagliptin intervention 2: Comparator: Placebo
Intervention descriptions: intervention 1: Single oral dose of sitagliptin 100 mg (2 x 50 mg) tablets followed by the hyperglycemic clamp procedure and meal tolerance test. intervention 2: Single oral dose of 2 tablets placebo to sitagliptin followed by the hyperglycemic clamp procedure and meal tolerance test.

Protocol documents:
Clinical trial NCT00662792
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2008-04-15; Completion date: 2009-07-22
Enrollment: 147 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of this trial is to establish superiority of the once-daily Tiotropium plus Salmeterol Inhalation Powder in daytime lung function response and non-inferiority in night-time lung function response over the comparator treatments inhaled in their established dose regimens when administered for 6-week periods to patients with chronic obstructive pulmonary disease (COPD). The main secondary objective is to evaluate the safety of the Tiotropium plus Salmeterol Inhalation Powder versus the comparator treatments.

Detailed description:

Arms: arm 1: 7.5 µg/ 25 µg Tiotropium/Salmeterol (T+S\_PE)/ 18 µg Tiotropium (Tio18GEL) / 50 µg Salmeterol MDPI (Salm50DPI) / 18 µg Tiotropium (T18GEL) plus 50 µg Salmeterol MDPI (S\_DPI) BID arm 2: 18 µg Tiotropium (Tio18GEL) / 18 µg Tiotropium (T18GEL) + 50 µg Salmeterol MDPI (S\_DPI) BID / 7.5 µg/ 25 µg Tiotropium/Salmeterol (T+S\_PE) / 50 µg Salmeterol MDPI (Salm50DPI) arm 3: 50 µg Salmeterol MDPI (Salm50DPI) / 7.5 µg/ 25 µg Tiotropium/Salmeterol (T+S\_PE) / 18 µg Tiotropium (T18GEL) + 50 µg Salmeterol MDPI (S\_DPI) BID / 18 µg Tiotropium (Tio18GEL) arm 4: 18 µg Tiotropium (T18GEL) + 50 µg Salmeterol MDPI (S\_DPI) BID / 50 µg Salmeterol MDPI (Salm50DPI) / 18 µg Tiotropium (Tio18GEL) / 7.5 µg/ 25 µg Tiotropium/Salmeterol (T+S\_PE)
Interventions: intervention 1: Tiotropium (Tio18GEL) intervention 2: Salmeterol MDPI (Salm50DPI) intervention 3: Tiotropium (T18GEL) + Salmeterol MDPI (S_DPI) intervention 4: Tiotropium/Salmeterol (T+S_PE)
Intervention descriptions: intervention 1: 18 µg Tiotropium (Tio18GEL) inhalation powder intervention 2: 50 µg Salmeterol MDPI (Salm50DPI) twice daily (BID) intervention 3: 18 µg Tiotropium (T18GEL) inhalation powder plus 50 µg Salmeterol MDPI (S\_DPI) twice daily (BID) intervention 4: Fixed-dose combination of 7.5 µg/ 25 µg Tiotropium/Salmeterol (T+S\_PE) inhalation powder

Protocol documents:
Clinical trial NCT00678561
Conditions: Psoriasis
Keywords: chronic plaque psoriasis topical treatment
Sponsor: Pfizer
Start date: 2008-10-13; Completion date: 2009-07-24
Enrollment: 81 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study will test effectiveness of an experimental drug applied once or twice daily to two psoriasis plaques. Requires 1 clinic visit each week for 5 weeks.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None arm 8: None
Interventions: intervention 1: CP-690,550 intervention 2: CP-690,550 intervention 3: CP-690,550 intervention 4: CP-690,550 intervention 5: CP-690,550 intervention 6: CP-690,550 intervention 7: Placebo Vehicle intervention 8: Placebo Vehicle
Intervention descriptions: intervention 1: Topical treatment once daily for 28 days intervention 2: Topical treatment once daily for 28 days intervention 3: Topical treatment once daily for 28 days intervention 4: Topical treatment twice daily for 28 days intervention 5: Topical treatment twice daily for 28 days intervention 6: Topical treatment twice daily for 28 days intervention 7: Topical treatment once daily for 28 days intervention 8: Topical treatment twice daily for 28 days

Protocol documents: