ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01510379
Conditions: Nausea and Vomiting Post-foregut Surgery
Keywords: nausea vomiting post-operative foregut surgery
Sponsor: Kyle A Perry
Start date: 2011-08-01; Completion date: 2012-08-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The effect a ReletexTM device has on postoperative nausea and vomiting when used with ondansetron after foregut surgery will be studied. A ReletexTM device is a FDA approved wristwatch-like device that painlessly stimulates a nerve in the wrist and has been shown to decrease nausea and vomiting. The investigators will randomize 100 patients who are having a fundoplication for either gastroesophageal reflux disease (GERD), paraesophageal hernia, or Heller Myotomy for achalasia into two groups. A control group will receive scheduled ondansetron for prevention and treatment of postoperative nausea and vomiting and phenergan as needed. The treatment group will wear a ReletexTM wrist band after surgery for 7 days. These patients will also get scheduled ondansetron and phenergan as needed, like the control group. The investigators will compare nausea, retching, and the amount of supplemental nausea medication used between the two groups. The patients will be provided a diary to document their nausea, retching, and medication use.

The hypothesis of this study is that use of the ReletexTM device will reduce post-operative nausea and vomiting, and will reduce post-operative use of anti-emetic medications in patients who have undergone foregut surgery.

Detailed description:

Arms: arm 1: Reletex plus scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge. arm 2: Scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge.
Interventions: intervention 1: Reletex intervention 2: IV ondansetron 4 mg q 6 hours for a total of 4 doses intervention 3: IV promethazine 25 mg q 6 hours prn intervention 4: Elixir promethazine 25 mg q 6 hours prn after discharge
Intervention descriptions: intervention 1: Neurostimulation device for prevention/treatment of post-operative nausea and vomiting, Reletex arm. intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01514734
Conditions: Glaucoma
Keywords: Primary open-angle glaucoma Ocular hypertension Pigment dispersion glaucoma
Sponsor: Alcon Research
Start date: 2012-03-01; Completion date: 2012-08-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to assess the efficacy and tolerability of changing to AZARGA® from prior COMBIGAN® pharmacotherapy in patients with open-angle glaucoma or ocular hypertension.

Detailed description:

Arms: arm 1: Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks
Interventions: intervention 1: Brinzolamide/timolol maleate fixed combination
Intervention descriptions: intervention 1: Commercially marketed topical ocular agent for the treatment of open-angle glaucoma (OAG) or ocular hypertension.

Protocol documents:
Clinical trial NCT01541397
Conditions: Hyperphenylalaninemia Phenylketonuria
Keywords: Hyperphenylalaninemia Phenylketonuria Adults Bone Mineral Density
Sponsor: The University of Texas Health Science Center, Houston
Start date: 2011-06-01; Completion date: 2012-08-01
Enrollment: 6 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Prospective study to compare the bone mineral density in adults with HPA on KUVAN™ therapy to those not on therapy. The investigators hypothesize that after one year of KUVAN™ therapy, there will be an improvement in their bone mineral density.

Detailed description:
Hyperphenylalaninemia (HPA) is a rare metabolic disorder caused by a deficiency of the enzyme phenylalanine hydroxylase (PAH) (NIH, October 16-18, 2000). Elevated plasma levels of phenylalanine (phe) cause mental retardation, microcephaly, delayed speech, seizures, eczema, and behavior abnormalities. Adequate control of the plasma levels of phe by a phe-restricted diet can prevent the developmental and behavioral problems.

The foundation of this diet is a phe-free metabolic medical product/formula made from free amino acids. Based on longitudinal studies, it has been reported that the most benefit is attained by individuals who maintain a phe-restricted diet throughout life. On December 13, 2007, KUVAN™ (sapropterin dihydrochloride) was approved by the FDA for the indication of reducing blood phe levels in patients with HPA due to BH4 responsive PKU, in conjunction with a phe restricted diet (BioMarin Pharmaceutical Inc., Investigator's Brochure March 25, 2008). Studies were performed to determine a definition of response to KUVAN™. In a phase 2 clinical trial in 2007, Burton, et. al. defined a Kuvan™ responder as having a 30% or greater improvement in blood phenylalanine levels compared to baseline after 8 days of drug therapy.

Kuvan™ has been shown to improve phenylalanine tolerance in some individuals with HPA. This drug enables these individuals to consume more protein from natural sources. However, there have been no research studies assessing the effects of KUVAN™ along with liberalization of the diet on bone mineral density.

The investigators propose a prospective study to compare the bone mineral density in adults with HPA on KUVAN™ therapy to those not on therapy. The investigators hypothesize that after one year of KUVAN™ therapy, there will be an improvement in their bone mineral density.

Arms: arm 1: Adults with hyperphenylalaninemia who have are not receiving Kuvan therapy. arm 2: Adults with hyperphenylalaninemia who are treated with Kuvan (sapropterin).
Interventions: intervention 1: Sapropterin
Intervention descriptions: intervention 1: 20 mg/kg, orally, daily, 1 year or patient chooses to discontinue therapy

Protocol documents:
Clinical trial NCT01563081
Conditions: Rhinitis
Keywords: Allergic rhinitis Pediatric Pruritus Levocetirizine
Sponsor: GlaxoSmithKline
Start date: 2012-04-01; Completion date: 2012-08-01
Enrollment: 60 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the safety of treatment with levocetirizine oral solution in pediatric patients aged form 6 months to 2 years old with allergic rhinitis or pruritus associated with the skin diseases.

Detailed description:
This is a multi-center, open-labelled study to confirm the safety as main objective, and consisting of minimum 1-week screening period and 2-week treatment period. The subjects who meet the inclusion criteria are to be placed on one of the following two regimens according to their ages at the start of treatment period: once daily administration of levocetirizine at a dose of 1.25 mg (in the morning) to infants aged between 6 months and 1 year old (younger age group), and twice daily administration of levocetirizine at a dose of 1.25 mg (in the morning, in the evening before sleep) to infants aged between 1 year and 2 years old (older age group).

Arms: arm 1: Clear solution, 0.50 mg levocetirizine dihydrochloride contains in one milliliter of the solution
Interventions: intervention 1: Levocetirizine intervention 2: Levocetirizine
Intervention descriptions: intervention 1: Clear solution, 0.50 mg levocetirizine dihydrochloride contains in one milliliter of the solution. Levocetirizine oral solution are administered once daily at a dose of 2.5 mL (1.25 mg of levocetirizine) in the morning to infants aged between 6 months and 1 year old intervention 2: Clear solution, 0.50 mg levocetirizine dihydrochloride contains in one milliliter of the solution. Levocetirizine oral solution are administered twice daily at a dose of 2.5 mL (1.25 mg of levocetirizine) in the morning and evening before sleep to infants aged between 1 year and 2 years old

Protocol documents:
Clinical trial NCT01566773
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Sponsor: Pearl Therapeutics, Inc.
Start date: 2012-03-01; Completion date: 2012-08-01
Enrollment: 140 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The overall objective of this study is to determine an optimal dose and dosing regimen of PT001 MDI for further evaluation in later stage studies.

Detailed description:
The primary objective of this study is to assess efficacy relative to placebo of GP MDI in subjects with moderate to severe chronic obstructive pulmonary disease (COPD) within the range of doses evaluated in this protocol. To this end, each dose of GP MDI will be compared to placebo with respect to the primary efficacy endpoint, FEV1 AUC0-12 relative to baseline.

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: PT001 MDI intervention 2: Tiotropium Bromide intervention 3: PT001 Placebo MDI
Intervention descriptions: intervention 1: Administered as two puffs BID for 14 days intervention 2: Taken as 1 capsule containing 18 µg of tiotropium via the Handihaler DPI intervention 3: None

Protocol documents:
Clinical trial NCT01570244
Conditions: Hepatitis C, Chronic
Sponsor: Boehringer Ingelheim
Start date: 2012-04-01; Completion date: 2012-08-01
Enrollment: 16 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will investigate possible effect of multiple oral doses of BI 201335 on the steady state pharmacokinetics of ethinylestradiol and levonogestrel

Detailed description:

Arms: arm 1: multiple doses of Microgynon arm 2: multiple doses of Microgynon + BI 201335
Interventions: intervention 1: levonorgestrel intervention 2: Ethinylestradiol intervention 3: levonorgestrel intervention 4: BI 201335 intervention 5: Ethinylestradiol
Intervention descriptions: intervention 1: multiple doses intervention 2: multiple doses intervention 3: multiple doses intervention 4: multiple doses intervention 5: multiple doses

Protocol documents:
Clinical trial NCT01578278
Conditions: Seasonal Allergic Rhinitis
Sponsor: Bausch & Lomb Incorporated
Start date: 2011-12-01; Completion date: 2012-08-01
Enrollment: 606 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a clinical study to evaluate the safety and efficacy of a bepotastine besilate-corticosteroid combination nasal spray for the treatment of seasonal allergic rhinitis (SAR) in an open exposure study with subjects who have a demonstrated history of Mountain Cedar pollen allergy. The primary study objective is to assess the reduction from baseline in averaged morning (AM) and evening (PM) values of reflective total nasal symptom scores for each of 3 nasal sprays (bepotastine besilate-fluticasone propionate combination nasal spray, bepotastine besilate nasal spray, fluticasone propionate nasal spray) compared to placebo nasal spray. For enrolled subjects, the study will involve a 7-10 day run-in screening period dosing with placebo nasal spray and then a 14-day treatment period where subjects will dose twice a day with 1 of the 4 test agent nasal sprays and record reflective and instantaneous scores for both nasal and ocular symptoms prior to each dosing.

Detailed description:

Arms: arm 1: Nasal Spray arm 2: Nasal Spray arm 3: Nasal Spray arm 4: Nasal Spray
Interventions: intervention 1: Bepotastine besilate formulation intervention 2: Fluticasone propionate intervention 3: Bepotastine besilate-fluticasone propionate intervention 4: Placebo Comparator
Intervention descriptions: intervention 1: Nasal Spray intervention 2: Nasal Spray intervention 3: Nasal Spray intervention 4: Nasal Spray

Protocol documents:
Clinical trial NCT01581684
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2012-04-01; Completion date: 2012-08-01
Enrollment: 62 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of the current study is to investigate the safety, tolerability and pharmacokinetics of BI 411034 in healthy male volunteers following oral administration of single rising doses.

The secondary objective is to explore dose proportionality of BI 411034 in CYP2C19 (Cytochrome P450) genotyped extensive metabolisers (EM).

Another objective is to compare the safety and pharmacokinetic profiles between two different groups of CYP2C19 genotyped subjects, extensive metabolisers (EM) and poor metabolisers (PM)

Detailed description:

Arms: arm 1: Solution for oral administration arm 2: Solution for oral administration arm 3: Solution for oral administration arm 4: Solution for oral administration arm 5: Solution for oral administration arm 6: Solution for oral administration arm 7: Solution for oral administration arm 8: Solution for oral administration arm 9: Solution for oral administration
Interventions: intervention 1: BI 411034 intervention 2: Placebo intervention 3: BI 411034 intervention 4: BI 411034 intervention 5: BI 411034 intervention 6: BI 411034 intervention 7: BI 411034 intervention 8: BI 411034 intervention 9: BI 411034
Intervention descriptions: intervention 1: Low dose solution for oral administration intervention 2: Solution for oral administration intervention 3: Medium dose solution for oral administration intervention 4: Low dose solution for oral administration intervention 5: High dose solution for oral administration intervention 6: High dose solution for oral administration intervention 7: Medium dose solution for oral administration intervention 8: High dose solution for oral administration intervention 9: Medium dose solution for oral administration

Protocol documents:
Clinical trial NCT01591330
Conditions: Healthy Volunteers
Sponsor: Denovo Biopharma LLC
Start date: 2012-04-01; Completion date: 2012-08-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The study will evaluate the effect of different particle size of LY2140023. The study involves 4 single doses of 80 milligrams (mg) LY2140023 taken as 1 tablet by mouth with a washout period of at least 3 days between doses. This study will last approximately 60 days not including screening. Screening is required within 30 days prior to study entry.

Detailed description:

Arms: arm 1: LY2140023: 80 mg, administered once, orally. There is a minimum 3-day washout period between dosing in one period and dosing in the next dosing period. arm 2: LY2140023: 80 mg, low particle size, administered once, orally. There is a minimum 3-day washout period between dosing in one period and dosing in the next dosing period. arm 3: LY2140023: 80 mg, medium particle size, administered once, orally. There is a minimum 3-day washout period between dosing in one period and dosing in the next dosing period. arm 4: LY2140023: 80 mg, high particle size, administered once, orally. There is a minimum 3-day washout period between dosing in one period and dosing in the next dosing period.
Interventions: intervention 1: LY2140023 Reference form intervention 2: LY2140023 Test-Low intervention 3: LY2140023 Test-Medium intervention 4: LY2140023 Test-High
Intervention descriptions: intervention 1: 80-mg tablet administered orally intervention 2: 80-mg tablet administered orally intervention 3: 80-mg tablet administered orally intervention 4: 80-mg tablet administered orally

Protocol documents:
Clinical trial NCT01591785
Conditions: Hand Eczema Foot Eczema
Keywords: Hand Foot Eczema Atopic Dermatitis
Sponsor: Gary Goldenberg
Start date: 2012-01-01; Completion date: 2012-08-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Atopic dermatitis is a chronic disease characterized by itching and eczematous lesions. In adults, eczema commonly localizes to the hands or feet. Several studies have implicated bacterial contamination, especially with Staphylococcus aureus (S. aureus), to be a factor in atopic dermatitis, as infection with this bacteria correlates with disease severity. No trial to date has investigated how to treat S. aureus infection in adults with hand or hand/foot dermatitis. Using retapamulin ointment in the nose and on the hands or hands/feet, the investigators expect to have a significant clearance rate of s. aureus infection. The investigators believe that treating the bacterial infection along with treating the condition with a topical corticosteroid will significantly decrease the severity of hand/foot dermatitis in our study population.

Detailed description:
Primary Study Objectives:

1. To evaluate the efficacy of retapamulin 1% ointment with clobetasol propionate 0.05% foam versus vehicle ointment with clobetasol propionate 0.05% foam as a treatment regimen for hand or hand/foot atopic dermatitis.
2. To evaluate the incidence of intranasal and hand/foot S aureus carriage rates in subjects with hand/foot atopic dermatitis via cultures of an anterior nare and the most severely graded target lesion of the hand/foot dermatitis.
3. To evaluate the incidence of mupirocin-resistance and methicillin-resistance in S aureus isolates in subjects with hand/foot atopic dermatitis via cultures of an anterior nare and the most severely graded target lesion of the hand/foot dermatitis.

Primary and secondary endpoints will be analyzed by appropriate statistical models by a qualified statistician. Any results of this pilot study will be treated as exploratory and hypothesis generating.

Arms: arm 1: Retapamulin 1% ointment for 5 days AND clobetasol propionate foam for 14 days arm 2: Placebo ointment for 5 days AND clobetasol propionate foam for 14 days
Interventions: intervention 1: Retapamulin 1% ointment intervention 2: Placebo
Intervention descriptions: intervention 1: Retapamulin 1% ointment for 5 days AND clobetasol propionate foam for 14 days intervention 2: Placebo ointment for 5 days AND clobetasol propionate foam for 14 days

Protocol documents:
Clinical trial NCT01611311
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2012-05-01; Completion date: 2012-08-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the current study is to investigate the safety and tolerability of BI 409306 in healthy young and elderly male and female volunteers following oral administration of repeated rising doses, given once daily over 14 days to young healthy genotyped and elderly healthy male/female volunteers.

Detailed description:

Arms: arm 1: Young healthy subjects received placebo matching film-coated tablets of BI 409306 orally after an overnight fast once daily for 14 days arm 2: Young healthy subjects received 25 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days arm 3: Young healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days arm 4: Elderly healthy subjects received placebo matching film-coated tablets of BI 409306 orally after an overnight fast once daily for 14 days arm 5: Elderly healthy subjects received 25 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days arm 6: Elderly healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
Interventions: intervention 1: BI 409306 intervention 2: Placebo
Intervention descriptions: intervention 1: Film-coated tablet intervention 2: Elderly healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days

Protocol documents:
Clinical trial NCT01618968
Conditions: Rheumatoid Arthritis (RA)
Sponsor: Antares Pharma Inc.
Start date: 2012-05-01; Completion date: 2012-08-01
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Relative Bioavailability Comparison study

Detailed description:
A Phase 2, Open-Label, Randomized, 3-Way Crossover Study to Compare the Relative Bioavailability of Oral Methotrexate and the VIBEX™ MTX Device in Adult Subjects With Rheumatoid Arthritis

Arms: arm 1: MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned. arm 2: MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned. arm 3: MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned. arm 4: MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned.
Interventions: intervention 1: MTX
Intervention descriptions: intervention 1: * Treatment A - 1 dose (4, 6, 8 or 10 tablets respectively to make up 10 mg, 15 mg, 20 mg or 25 mg MTX - per subject's dose group)
* Treatment B - SC injection using VIBEX MTX device into abdomen (VIBEX MTX device pre-filled with 10 mg, 15 mg, 20 mg or 25 mg MTX)
* Treatment C - SC injection using VIBEX MTX device into thigh (VIBEX MTX device pre-filled with 10 mg, 15 mg, 20 mg or 25 mg MTX)

Protocol documents:
Clinical trial NCT01621776
Conditions: Type 1 Diabetes
Keywords: post-prandial hyperglycemia
Sponsor: University of Florida
Start date: 2011-06-01; Completion date: 2012-08-01
Enrollment: 107 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study aims to compare the post-meal blood glucose values of two drugs in a "real-world" setting.

Detailed description:
This is a randomized, open-label trial that aims to compare the glycemic excursion following food intake following post-meal injection of Glulisine (Apidra) insulin and Lispro (Humalog) insulin in a real-world setting. Children participating in the Florida Camp for Children and Youth with Diabetes will be randomized to receive either Glulisine or Apidra to cover carbohydrates after meals. The difference in blood glucose values will be analyzed before and 2 hours after meals to see if there is a difference in post-prandial hyperglycemia between groups.

Arms: arm 1: Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. arm 2: Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. arm 3: Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.)
Interventions: intervention 1: Apidra intervention 2: Humalog intervention 3: Novolog
Intervention descriptions: intervention 1: Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. intervention 2: Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. intervention 3: Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.)

Protocol documents: