ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01710332
Conditions: Central Serous Chorioretinopathy
Keywords: Persistent Central Serous Chorioretinopathy Regeneron CSR CSCR
Sponsor: Wills Eye
Start date: 2012-10-01; Completion date: 2013-06-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A preliminary study to determine the safety and efficacy of intravitreal aflibercept injection in patients with persistent central serous chorioretinopathy.

Detailed description:
Intravitreal Aflibercept Injection for Persistent Central Serous Chorioretinopathy: A Prospective Pilot Study

Arms: arm 1: 2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times). arm 2: 2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times).
Interventions: intervention 1: Intravitreal Aflibercept Injection
Intervention descriptions: intervention 1: GROUP A - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total).

GROUP B - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total).

Protocol documents:
Clinical trial NCT01712334
Conditions: Cystic Fibrosis
Sponsor: Genentech, Inc.
Start date: 2012-12-01; Completion date: 2013-06-01
Enrollment: 99 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This phase IV, multicenter, randomized, open-label, two-period crossover study will evaluate the comparable efficacy and safety of Pulmozyme (dornase alfa) delivered by the eRapid nebulizer system in patients with cystic fibrosis. Patients who have been receiving Pulmozyme once daily chronically for at least 6 months will continue to receive Pulmozyme once daily for a run-in period of 2 weeks using the Pari LC Plus nebulizer. Patients will then be randomized to receive in a crossover design Pulmozyme once daily for two treatment periods of 2 weeks each using either the Pari LC Plus or the eRapid nebulizer. Anticipated time on study treatment is 6 weeks.

Detailed description:

Arms: arm 1: Dornase alfa (Pulmozyme®) inhaled once daily by the Pari eRapid nebulizer for 2 weeks. arm 2: Dornase alfa (Pulmozyme®) inhaled once daily by the Pari LC Plus jet nebulizer for 2 weeks.
Interventions: intervention 1: dornase alfa [Pulmozyme®] intervention 2: dornase alfa [Pulmozyme®]
Intervention descriptions: intervention 1: Inhaled once daily by Pari eRapid nebulizer. intervention 2: Inhaled once daily by Pari LC Plus jet nebulizer.

Protocol documents:
Clinical trial NCT01716052
Conditions: Pain
Keywords: Mammogram Ibuprofen Pain management
Sponsor: Kenneth A. Kist,
Start date: 2012-07-01; Completion date: 2013-06-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine in a randomized trial whether it is possible to decrease the discomfort of mammography by using the analgesic ibuprofen, or by using a scripted, supportive text informing patients about mammography.

Detailed description:
This study is designed to evaluate two methods of reducing pain and discomfort caused by mammography, one of the barriers to the procedure.

Arms: arm 1: Pfizer 200 mg caplets (Advil) arm 2: Lactulose
Interventions: intervention 1: placebo intervention 2: Ibuprofen
Intervention descriptions: intervention 1: Lactulose intervention 2: None

Protocol documents:
Clinical trial NCT01734772
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2012-11-01; Completion date: 2013-06-01
Enrollment: 48 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To investigate the pharmacokinetic and pharmacodynamic interaction of dabigatran and ticagrelor under steady state conditions; to investigate the effect of staggered administration of ticagrelor loading dose on dabigatran exposure (in Part II)

Detailed description:

Arms: arm 1: multiple doses of dabigatran (alone) arm 2: concomitant administration of dabigatran and ticagrelor arm 3: staggered administration of ticagrelor and dabigatran
Interventions: intervention 1: dabigatran etexilate intervention 2: dabigatran etexilate intervention 3: ticagrelor intervention 4: ticagrelor intervention 5: ticagrelor intervention 6: dabigatran etexilate
Intervention descriptions: intervention 1: multiple doses of dabigatran intervention 2: medium dose dabigatran intervention 3: loading dose of ticagrelor intervention 4: multiple doses of ticagrelor intervention 5: loading dose of ticagrelor intervention 6: single dose of dabigatran

Protocol documents:
Clinical trial NCT01735201
Conditions: Rosacea Erythema
Sponsor: Allergan
Start date: 2012-12-01; Completion date: 2013-06-01
Enrollment: 357 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of 3 doses of AGN-199201 once and twice daily compared to vehicle for the treatment of moderate to severe facial erythema associated with rosacea.

Detailed description:

Arms: arm 1: AGN-199201 Dose A applied once daily to the face for 28 days. arm 2: AGN-199201 Dose B applied once daily to the face for 28 days. arm 3: AGN-199201 Dose C applied once daily to the face for 28 days. arm 4: AGN-199201 Vehicle applied once daily to the face for 28 days. arm 5: AGN-199201 Dose A applied twice daily to the face for 28 days. arm 6: AGN-199201 Dose B applied twice daily to the face for 28 days. arm 7: AGN-199201 Dose C applied twice daily to the face for 28 days. arm 8: AGN-199201 Vehicle applied twice daily to the face for 28 days.
Interventions: intervention 1: AGN-199201 Dose A intervention 2: AGN-199201 Dose B intervention 3: AGN-199201 Dose C intervention 4: AGN-199201 Vehicle
Intervention descriptions: intervention 1: AGN-199201 Dose A applied once or twice daily to the face for 28 days. intervention 2: AGN-199201 Dose B applied once or twice daily to the face for 28 days. intervention 3: AGN-199201 Dose C applied once or twice daily to the face for 28 days. intervention 4: AGN-199201 Vehicle applied once or twice daily to the face for 28 days.

Protocol documents:
Clinical trial NCT01766024
Conditions: Healthy
Keywords: interferon beta-1a pharmacokinetics pharmacodynamics volunteers
Sponsor: Biocad
Start date: 2013-02-01; Completion date: 2013-06-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a randomized double-blind crossover study of pharmacokinetics, pharmacodynamics and tolerability of BCD-033 (interferon beta-1a manufactured by CJSC BIOCAD, Russia) and Rebif® (Merck Serono S.p.A.., Italy) in healthy volunteers. The purpose of the study is to demonstrate the non-inferiority of pharmacokinetics, pharmacodynamics and tolerability parameters after single subcutaneous injection. Each dtug will be administered to each volunteer at a dose of 44 µg as a single subcutaneous injection with an interval of at least 14 days.

Detailed description:
Each dtug (BCD-033 and Rebif) will be administered to each volunteer at a dose of 44 µg as a single subcutaneous injection with an interval of at least 14 days.

Arms: arm 1: Volunteers in this group initially will receive a single sc injection of the study drug BCD-033 (interferon beta-1a) at a dose of 44 µg (on Day 1) and then, after at least 14 days, a single sc injection of the reference drug Rebif® (interferon beta-1a) at a dose of 44 µg. arm 2: Volunteers in this group initially will receive a single sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg (on Day 1) and then, after at least 14 days, a single sc injection of the study drug BCD-033 (interferon beta-1a) at a dose of 44 µg.
Interventions: intervention 1: Interferon beta-1a
Intervention descriptions: intervention 1: Each volunteer will receive 1 subcutaneous (sc) injection of the study drug BCD-033 (interferon beta-1a) and 1 sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg with an interval of at least 14 days.

Protocol documents:
Clinical trial NCT01771991
Conditions: Radiation Induced Fibrosis to the Head and Neck
Keywords: fibrosis radiation neck cancer Sodermix
Sponsor: Sanford Health
Start date: 2012-08-01; Completion date: 2013-06-01
Enrollment: 74 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if topical superoxide dismutase is an effective treatment of radiation related neck fibrosis, and to determine the quality of life impact from radiation related fibrosis in the head and neck cancer patients at Sanford Health.

Detailed description:
The primary goal of this study is to evaluate the effect of topical Superoxide Dismutase (SOD) on the radiation induced fibrosis in head and neck cancer patients. A prospective, blinded, two group control design will be used with pretest and post test quality of life as well as objective fibrosis assessment. Patients will be randomized to alternatively receive topical SOD or placebo as instructed on twice daily use for 3 months. Pre and post treatment quality of life surveys and objective assessment will determine if the topical SOD improves neck fibrosis/function and global quality of life.

This study will increase clinical trial awareness and participation while potentially improving the long term functional outcomes of head and neck cancer patients.

Arms: arm 1: Patients with measurable radiation induced fibrosis of the neck. Patients will be randomized to applying Topical Sodermix Dismutase in the form of Sodermix(SOD) to the area of neck skin fibrosis twice a day for 12 weeks. arm 2: Cetaphil cream
Interventions: intervention 1: Topical Sodermix Dismutase in the form of Sodermix (SOD) intervention 2: Placebo
Intervention descriptions: intervention 1: Topical Sodermix Dismutase in the form of Sodermix (SOD) will be applied twice daily, of half dollar application for 12 weeks to fibrosed area. intervention 2: Placebo or cetaphil cream will be applied twice daily, of half dollar size for 12 weeks to fibrosed area.

Protocol documents:
Clinical trial NCT01774305
Conditions: Coughing
Sponsor: Yonsei University
Start date: 2012-12-01; Completion date: 2013-06-01
Enrollment: 141 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Coughing during emergence from general anaesthesia may lead to dangerous effects including laryngospasm, detrimental haemodynamic changes. Post-thyroidectomy bleeding occurs in 1-4% of patients, and severe coughing may cause bleeding. Dexmedetomidine, a potent α adrenoreceptor agonist, is theoretically appropriate for reducing airway and haemodynamic reflexes during emergence from anaesthesia.

In this study, we investigated whether intravenous single-dose dexmedetomidine at the end of surgery reduces coughing during extubation after thyroidectomy.

Detailed description:

Arms: arm 1: We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing. arm 2: We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.
Interventions: intervention 1: Dexmedetomidine intervention 2: Saline
Intervention descriptions: intervention 1: We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously) at time of muscle layer closing. intervention 2: We administrate the normal saline (single bolus, 0.25ml/kg) intravenously at time of muscle layer closing.

Protocol documents:
Clinical trial NCT01778010
Conditions: Cocaine Dependence
Keywords: cocaine modafinil self-administration DRD4
Sponsor: New York State Psychiatric Institute
Start date: 2009-03-01; Completion date: 2013-06-01
Enrollment: 8 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Modafinil has been reported to reduce cocaine use in a clinical sample of infrequent users (2 days/week), but the effects of modafinil on cocaine self-administration in the laboratory have not been studied. The present study investigated the effects of modafinil maintenance on cocaine self-administration by frequent users (4 days/week) under controlled laboratory conditions. During this 48-day double-blind, crossover design study, the effects of modafinil maintenance (0, 200, and 400mg/day) on response to smoked cocaine (0, 12, 25, and 50 mg) were examined in nontreatment seeking cocaine-dependent individuals (n = 8).

Detailed description:

Arms: arm 1: Participants were maintained on modafinil (0 mg/day) for 15 days, and underwent a dose response of cocaine. arm 2: Participants were maintained on modafinil (200 mg/day) for 15 days, and underwent a dose response of cocaine. arm 3: Participants were maintained on modafinil (400 mg/day) for 15 days, and underwent a dose response of cocaine.
Interventions: intervention 1: Modafinil 0 mg intervention 2: Modafinil 200 mg intervention 3: Modafinil 400 mg intervention 4: Cocaine 0 mg intervention 5: Cocaine 12 mg intervention 6: Cocaine 25 mg intervention 7: Cocaine 50 mg
Intervention descriptions: intervention 1: Modafinil (0 mg/day) intervention 2: Modafinil (200 mg/day) intervention 3: Modafinil (400 mg/day) intervention 4: Cocaine (0 mg/day) intervention 5: Cocaine (12 mg/day) intervention 6: Cocaine (25 mg/day) intervention 7: Cocaine (50 mg/day)

Protocol documents:
Clinical trial NCT01790516
Conditions: Head and Neck Squamous Cell Cancer
Keywords: Head and neck cancer genetic testing cisplatin erbitux radiation therapy
Sponsor: Georgetown University
Start date: 2012-05-01; Completion date: 2013-06-01
Enrollment: 2 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is for patients with newly diagnosed head and neck cancer that cannot be removed by surgery.

The purpose of this study is to determine the feasibility of using genetic variations in patients to select the right drug to treat head and neck cancer. Cisplatin and cetuximab (Erbitux)are both approved by the FDA to treat head and neck cancer in combination with radiation therapy. In this study the investigators will test whether genetic differences between patients can be used to pick which of these two drugs a patient should receive. All patients will have a blood sample drawn that will be tested for genetic differences. If patients have genetic differences that correlate with a better outcome from cisplatin they will receive cisplatin with radiation. If patients have genetic differences that do not correlate with a better outcome from cisplatin they will receive cetuximab with their radiation therapy.

Detailed description:
Treatment-naive patients with locally advanced, non-metastatic (Stage III to IVB) squamous cell carcinoma of the head and neck who are candidates for concurrent chemoradiotherapy as primary therapy with curative intent will be enrolled. Patients will be genotyped for germline variations at four SNP loci in three genes involved in DNA nucleotide excision repair (ERCC1, ERCC2, and XRCC1). Patients with 3 to 8 variants will receive cisplatin (Arm A). Patients with 2 or fewer variants will receive cetuximab (Arm B).

The hypothesis of the study is that prospectively testing patients for variations in DNA repair enzymes to determine whether to use cisplatin or cetuximab in locally advanced head and neck squamous cell cancer is feasible.

Arms: arm 1: Cisplatin arm 2: cetuximab
Interventions: intervention 1: Cisplatin intervention 2: cetuximab intervention 3: Radiation
Intervention descriptions: intervention 1: Cisplatin 100 mg/m2 during weeks 1,4, and 7 of radiation therapy intervention 2: Cetuximab beginning at a dose of 400 mg/m2 the week before radiation commences and then 250 mg/m2 weekly during weeks 1 and 7 of radiation. intervention 3: daily radiation for 7 weeks

Protocol documents:
Clinical trial NCT01791972
Conditions: Exercise-Induced Bronchoconstriction (EIB)
Keywords: Exercise-Induced Bronchoconstriction (EIB) Spiromax® Albuterol sulfate
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2013-03-01; Completion date: 2013-06-01
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of this study is to evaluate the efficacy of a single dose (2 inhalations, 180 mcg total) of Albuterol SPIROMAX (90 mcg per inhalation) versus placebo in patients with EIB.

Detailed description:
This study is a single-dose, randomized, double-blind, placebo-controlled, 2-treatment, 2-sequence, 2-way crossover, multicenter study in patients with a documented history of EIB, with or without underlying asthma. Each patient will participate in the study for approximately 5 weeks. Each patient will complete 2 screening visits (SV1 and SV2), 2 treatment visits (TV1 and TV2), and a follow-up telephone call (FV).

Arms: arm 1: Albuterol Spiromax, 180 mcg (2 inhalations of 90 mcg/inhalation), single dose on Day 1. Placebo Spiromax (2 inhalations), single dose on approximately Day 7. arm 2: Placebo Spiromax, (2 inhalations), single dose on Day 1. Albuterol Spiromax 180 mcg (2 inhalations of 90 mcg/inhalation), single dose on approximately Day 7.
Interventions: intervention 1: Albuterol Spiromax intervention 2: Placebo Spiromax
Intervention descriptions: intervention 1: Albuterol Spiromax is an inhalation-driven, multi-dose dry powder inhaler (DPI) containing a blend of albuterol sulfate with alpha-lactose monohydrate. Each actuation represents a dose of 90 mcg of albuterol sulfate. Participants received one dose of two inhalations (180 mcg). intervention 2: Placebo Spiromax is an inhalation-driven, multi-dose dry powder inhaler (DPI) delivering placebo to match the experimental drug. Participants received one dose of two inhalations.

Protocol documents:
Clinical trial NCT01795716
Conditions: Chronic Myeloid Leukemia
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Start date: 2012-09-01; Completion date: 2013-06-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
1. purpose: To conduct the relative bioavailability study of a single dose and multiple doses of imatinib mesylate capsule (Jiangsu Chia-Tai Tianqing Pharmacy Co. Ltd.) versus Glivec (Novartis Pharma Stein AG).
2. Experimental Design： Two-period crossover design
3. Test drug: imatinib mesylate capsule Reference drug: Glivec
4. Sample size：20

Detailed description:
To conduct the relative bioavailability study of a single dose and multiple doses of imatinib mesylate capsule(Jiangsu Chia-Tai Tianqing Pharmacy Co. Ltd.) versus Glivec (Novartis Pharma Stein AG) and compare the bioequivalence and pharmacokinetics of the two products in 20 patients with chronic myeloid leukemia.

Arms: arm 1: Single and multiple oral mesylate imatinib capsule 400mg qd arm 2: Single and multiple oral Glivec 400mg qd
Interventions: intervention 1: mesylate imatinib capsule intervention 2: Glivec
Intervention descriptions: intervention 1: Single and multiple oral mesylate imatinib capsule 400mg qd intervention 2: Single and multiple oral Glivec 400mg qd

Protocol documents:
Clinical trial NCT01805687
Conditions: Asthma
Sponsor: Cornerstone Therapeutics Inc.
Start date: 2013-03-01; Completion date: 2013-06-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Study to evaluate the bronchodilator effects of Zyflo CR in patients with chronic stable asthma.

Detailed description:

Arms: arm 1: Oral, 1200 mg (2 x 600 mg tablets)
Interventions: intervention 1: Zileuton extended release
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01810432
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2013-03-01; Completion date: 2013-06-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to measure how much of the drug gets into the blood stream and how long it takes the body to get rid of it when given to healthy participants. Information about any side effects that may occur will also be collected.

The study has 2 periods. In each period, participants will take the study drug for 10 days, either with or without a meal. There is a minimum 14-day washout between each period.

This study is approximately 50 days, not including screening. Screening is required within 28 days prior to the start of the study.

Detailed description:

Arms: arm 1: 130 milligram (mg) oral dose of evacetrapib once daily in a fasted state for 10 days. arm 2: 130 mg oral dose of evacetrapib once daily following a high-fat breakfast for 10 days.
Interventions: intervention 1: Evacetrapib intervention 2: High-fat Meal
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally, at breakfast.

Protocol documents:
Clinical trial NCT01818700
Conditions: Spinal Disorder
Sponsor: Mundipharma Korea Ltd
Start date: 2012-09-01; Completion date: 2013-06-01
Enrollment: 245 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the pain reduction rate after 8 weeks treatment of NORSPAN® from baseline.

And secondary purpose are: pain reduction rate after 4 weeks treatment from baseline(week 0) the EQ-5D, the pain and sleep questionnaire, physician's overall satisfaction subject's overall satisfaction, and safety

Detailed description:
Upon providing written informed consent, subject will be screened in the study and assessment will be performed at that time such as safety laboratory assessments, physical examination, vital sign, medical history taking, 24 hours pain intensity score, EQ-5D, pain and sleep questionnaire, physician's overall satisfaction and subject's overall satisfaction.

If patient is eligible in inclusion/exclusion criteria at the time of visit 1, the patient will receive treatment with NORSPAN®.

Treatment with NORSPAN® will be started from 5 μg/h (1 patch a week) for 2 weeks, and proper titration (up-titration) will be allowed at visit 2(wk 2) and at visit 3(wk 4) according to the investigator's decision.

Arms: arm 1: This trial is single arm with Norspan patch. Treatment with NORSPAN Ò will be started from 5 μg/h (1 patch a week) for 2 weeks, and proper titration (up-titration) will be allowed at visit 2(wk 2) and at visit 3(wk 4) according to the investigator's decision. The up-titration will be considered by investigator's judgement as follows; (1) if the rescue medication was used more than 2 times per day, on average or (2) based on the daily average NRS(Numeric Rating Scale), if the NRS was changed to worsen since the previous visit, (3) Investigator's judgement by considering any titration needed situation (e.g. dose, frequency of rescue medication).
Interventions: intervention 1: Buprenorphine
Intervention descriptions: intervention 1: 8weeks treatment with Norspan®(Buprenorphine)

Protocol documents:
Clinical trial NCT01825876
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2013-04-01; Completion date: 2013-06-01
Enrollment: 17 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
All study participants will receive both warfarin and a study drug called evacetrapib. The main purpose of this study is to look at how much warfarin gets into the blood stream and how long it takes the body to get rid of warfarin when given both with and without evacetrapib. Another purpose is to evaluate the effectiveness of warfarin therapy to prevent blood clots when given with evacetrapib by measuring the time it takes for blood to clot and comparing it to an average of the international normalized ratio (INR). INR measures the time it takes for blood to clot and compares it to an average.

The study will last approximately 5 weeks, not including screening.

Detailed description:

Arms: arm 1: 15 milligrams (mg) warfarin administered as a single oral dose arm 2: 130 mg evacetrapib administered once daily (QD), orally, for 16 days with 15 mg warfarin co-administered once orally on Day 10
Interventions: intervention 1: Evacetrapib intervention 2: Warfarin
Intervention descriptions: intervention 1: Oral administration intervention 2: Oral administration

Protocol documents: