ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01114828
Conditions: Cirrhosis
Keywords: Cirrhosis ascites Tolvaptan OPC-41061
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2010-02-01; Completion date: 2011-12-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
OPC-41061 at 3.75 mg/day or 7.5 mg/day will be orally administered once daily for 7 days to cirrhosis patients with ascites despite having received treatment with conventional diuretics and pharmacodynamics, pharmacokinetics, efficacy, and safety will be investigated.

Detailed description:

Arms: arm 1: Once-daily oral administration of OPC-41061 arm 2: Once-daily oral administration of OPC-41061
Interventions: intervention 1: OPC-41061 intervention 2: OPC-41061
Intervention descriptions: intervention 1: Once-daily oral administration of OPC-41061 at 3.75 mg after breakfast for 7 days intervention 2: Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days

Protocol documents:
Clinical trial NCT01118728
Conditions: Ankylosing Spondylitis
Sponsor: Sanofi
Start date: 2010-06-01; Completion date: 2011-12-01
Enrollment: 223 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Primary Objective:

* To assess the long term safety of Sarilumab (SAR153191/REGN88) in participants with ankylosing spondylitis (AS)

Secondary Objective:

* To assess the long term efficacy of Sarilumab (SAR153191/REGN88) in participants with AS

Detailed description:
The maximum study duration per participant was to be 267 weeks (approximately 5 years) broken down as follows:

* screening up to a maximum of 1 week;
* treatment up to a maximum of 260 weeks;
* follow-up of 6 weeks after treatment discontinuation.

Arms: arm 1: Sarilumab 150 mg subcutaneous (SC) injection every week (or every other week in case of safety issue) for 260 weeks, or until commercially available, or until discontinuation of the project, whichever came first.
Interventions: intervention 1: Sarilumab
Intervention descriptions: intervention 1: Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Protocol documents:
Clinical trial NCT01120717
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: QVA149 COPD combination bronchodilator
Sponsor: Novartis Pharmaceuticals
Start date: 2010-04-01; Completion date: 2011-12-01
Enrollment: 339 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is designed to provide long-term safety data for QVA149 in patients with moderate to severe chronic obstructive pulmonary disease (COPD).

Detailed description:

Arms: arm 1: 110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI) arm 2: Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
Interventions: intervention 1: QVA149 intervention 2: Placebo
Intervention descriptions: intervention 1: capsules for inhalation, delivered by an SDDPI intervention 2: capsules for inhalation, delivered by an SDDPI

Protocol documents:
Clinical trial NCT01128049
Conditions: Aqueous Deficient Dry Eye Meibomium Gland Dysfunction
Keywords: Aqueous deficient dry eye (ADDE) Meibomium Gland Dysfunction (MGD) Normal/Control (Non Dry Eye)
Sponsor: University of Rochester
Start date: 2010-06-01; Completion date: 2011-12-01
Enrollment: 15 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Compare the objective tear film dynamic measurements in three different populations (MGD \[Meibomium Gland Dysfunction\], ADDE \[Aqueous Deficient Dry Eye\] and normal/control \[non-dry eye\]) and the subjective experience before and after instilling a single drop of saline in each eye.

Currently available office-based tests for dry eye do not reliably correlate with patients' subjective symptoms. This study is interested in assessing how individuals with these two different ocular surface diseases compare with the normal population when measured objectively using two different instruments.

Detailed description:
There will be one study day with a single visit that will consist of taking two sets of measurements. Baseline measurements are taken in both eyes using a wavefront sensor to measure visual quality followed by saline instillation. Five minutes after drops, visual quality is again measured to evaluate changes in tear dynamics.

Arms: arm 1: Non-Dry Eye patient population (intervention remains the same across all arms) arm 2: Meibomium Gland Dysfunction population(intervention remains the same across all arms) arm 3: Aqueous Deficient Dry Eye population(intervention remains the same across all arms)
Interventions: intervention 1: Subjective Questionnaire intervention 2: Measurement with wavefront sensor (right eye, then left eye) intervention 3: Instill Saline Drop
Intervention descriptions: intervention 1: The team will use a one page questionnaire to obtain subjective input before the first set of measurements and after instilling the Saline drop. intervention 2: The wavefront instrument measures the eye's ability to create a sharp image by briefly shining a laser light from the wavefront sensor into the eye and measuring the light that bounces back through the cornea. For these measurements, subjects will sit on a chair and be instructed to place their chin in a chin rest and lean their forehead against a forehead rest. The subject will be instructed to hold his/her head steady, look in a certain direction, blink or not blink. We will obtain the measurements over a short period of up to approximately 45 seconds. We will start recording data asking the subject to either blink naturally or to hold his/her eye open for a few (up to 10) seconds, and repeat the blink and hold sequence usually for up to four times. intervention 3: One drop will be instilled in both eyes and patient will wait 5 minutes prior to repeating the questionnaire and wavefront sensor. A single drop is approximately 30 µL and will be placed into the inferior cul-de-sac while the patient looks up.

Protocol documents:
Clinical trial NCT01131507
Conditions: Cystic Fibrosis Exocrine Pancreatic Insufficiency
Keywords: Exocrine Pancreatic Insufficiency Infants with CF
Sponsor: Forest Laboratories
Start date: 2010-07-01; Completion date: 2011-12-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A study to evaluate long term safety and effect on ability to thrive of EUR-1008 (APT-1008) 3,000 lipase units (Zenpep® \[pancrelipase\] delayed release capsules) in infants with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF).

Detailed description:
This is a multi-center, open-label, safety extension of Aptalis (formerly Eurand) study PR-011 (NCT01100606) in pediatric participants with EPI due to CF. The study will be carried out in participants who completed the PR-011 study.

The study is comprised of 5 visits: an enrollment visit, treatment visit 1 (3 months), treatment visit 2 (6 months), treatment visit 3 (9 months) and treatment visit 4 (12 months). Once determined eligible for participation, participants will be enrolled into the study.

Arms: arm 1: None
Interventions: intervention 1: EUR-1008 (APT-1008)
Intervention descriptions: intervention 1: EUR-1008 (APT-1008) (Zenpep® \[pancrelipase\] 3,000 lipase units delayed release capsules) from open capsules mixed with a small amount of apple juice or apple sauce will be administered orally starting at the same dose as administered at the end of study PR-011 (NCT01100606), with dose increments of 3,000 lipase units. The dose will be adjusted based on participants' age and body weight. Total dose will not exceed 10,000 lipase units per kilogram (kg) of body weight per day unless clinically indicated. Total duration of study treatment will be up to 12 months.

Protocol documents:
Clinical trial NCT01134107
Conditions: Diabetes Mellitus, Type 1
Sponsor: Eli Lilly and Company
Start date: 2010-11-01; Completion date: 2011-12-01
Enrollment: 133 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Patients will continue to use their current insulin pump for this study. Patients will receive insulin lispro and insulin aspart during this study. One medication will be taken for 12 weeks and then the other medication for 12 weeks. Neither the patient nor the study doctor will know which medication is being taken at any time. The order in which the two medications are taken will be determined by chance.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Insulin Lispro 6 Day (6D) intervention 2: Insulin Aspart 6 Day (6D)
Intervention descriptions: intervention 1: Administered by infusion pump for 12 week treatment period intervention 2: Administered by infusion pump for 12 week treatment period

Protocol documents:
Clinical trial NCT01136655
Conditions: Asthma
Keywords: asthmatic children Symbicort Foradil
Sponsor: AstraZeneca
Start date: 2010-09-01; Completion date: 2011-12-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This purpose of the study is to investigate the bronchodilating effects of 3 different dosages of formoterol given in combination with budesonide as Symbicort pMDI.

Detailed description:
A Phase 2, randomized, blinded, 5-period cross-over, placebo and active controlled, multicenter, dose-finding study comparing single doses of formoterol 2.25 µg, 4.5 µg, and 9 µg delivered via Symbicort pMDI and Foradil® 12 µg evaluating the relative bronchodilating effects and safety in children.

Arms: arm 1: 2.25 μg formoterol (as 80/2.25 μg Symbicort pMDI × 1 inhalation) + 40 μg budesonide HFA pMDI × 2 inhalations arm 2: placebo HFA pMDI × 1 inhalation + 4.5 μg formoterol (as 80/2.25 μg Symbicort pMDI × 2 inhalations) arm 3: placebo HFA pMDI × 1 inhalation + 9 μg formoterol (as 80/4.5 μg Symbicort pMDI × 2 inhalations) arm 4: placebo HFA pMDI × 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations arm 5: Foradil Aerolizer 12 μg × 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations
Interventions: intervention 1: 80/2.25 μg Symbicort pMDI intervention 2: 80/4.5 μg Symbicort pMDI intervention 3: Foradil Aerolizer 12 μg intervention 4: 40 μg budesonide HFA pMDI intervention 5: placebo HFA pMDI
Intervention descriptions: intervention 1: inhalation intervention 2: inhalation intervention 3: inhalation intervention 4: inhalation intervention 5: inhalation

Protocol documents:
Clinical trial NCT01138111
Conditions: Alzheimer Disease Amyloid Beta-Protein
Keywords: Florbetaben Amyloid beta-protein MCI Alzheimer's disease
Sponsor: Life Molecular Imaging SA
Start date: 2008-06-01; Completion date: 2011-12-01
Enrollment: 45 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The aim of the study is to investigate whether Florbetaben (BAY94-9172)positron emission tomography (PET) is able to distinguish between subjects with mild cognitive impairment (MCI) progressing to Alzheimer's disease (AD) from those with MCI not progressing to AD.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Florbetaben (BAY94-9172)
Intervention descriptions: intervention 1: single 300 megabecquerel (MBq) intravenous injection 2 mL to 10 mL, at baseline, at 12 and 24 months

Protocol documents:
Clinical trial NCT01143766
Conditions: Conscious Sedation
Keywords: Sedation Gabapentin ERCP Endoscopy
Sponsor: Indiana University
Start date: 2010-04-01; Completion date: 2011-12-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The standard approach to sedation in endoscopic retrograde cholangiopancreatography (ERCP) involves the use of benzodiazepines and opiates to achieve a moderate depth of sedation. There is data to suggest supplementing this regimen with gabapentin may lead to reduced pain, higher patient satisfaction and lower opiate requirements. The investigators are conducting a clinical trial to study this hypothesis.

Detailed description:

Arms: arm 1: Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care. arm 2: Patients will receive gabapentin 900mg PO x 1 dose, one hour prior to the procedure. At the time of ERCP, patients will be sedated in a standard fashion.
Interventions: intervention 1: Gabapentin intervention 2: Standard sedation regimen
Intervention descriptions: intervention 1: gabapentin 900mg PO x 1 dose, 1 hour prior to the procedure intervention 2: Combination opiate and benzodiazepine will be administered to achieve moderate sedation. This is the standard of care.

Protocol documents:
Clinical trial NCT01149863
Conditions: Autologous Transplantation
Keywords: Autologous Transplantation
Sponsor: Emory University
Start date: 2010-06-01; Completion date: 2011-12-01
Enrollment: 34 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Typically, the collection of blood cells for autologous stem cell transplant is done after the drugs granulocyte colony-stimulating factor (G-CSF) and plerixafor have been given to activate the bone marrow stem cells to produce a certain type of blood cell, called CD34+ cells. Currently, plerixafor is given in the evening, about 11 hours before apheresis (removal of blood) begins the following morning. The purpose of this study is to test whether plerixafor can instead be given 17 hours before apheresis. This timing would be more convenient since plerixafor would be given during normal clinic hours, and so patients would be within a clinic environment if any side effects develop.

The study will look for the activation of CD34+ cells in patients who receive plerixafor 17 hours before apheresis. We will follow the number of patients that achieve the target numbers of CD34+ cells, and the total number of CD34+ cells collected. These will be compared to the numbers in previous studies giving plerixafor 11 hours before apheresis.

We will also assess the safety of giving plerixafor 17 hours before apheresis.

Detailed description:

Arms: arm 1: Dosing of plerixafor will occur at 3PM (1500 hours).
Interventions: intervention 1: Plerixafor
Intervention descriptions: intervention 1: Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses.

Protocol documents:
Clinical trial NCT01149876
Conditions: Hyperpigmentation
Sponsor: Massachusetts General Hospital
Start date: 2010-06-01; Completion date: 2011-12-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether a topical Nu Skin product with or without a galvanic spa device improves brown spots on the face. The Nu Skin product will be compared to an over the counter moisturizer and tretinoin cream.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Nu Skin Product intervention 2: Cosmetic instrument intervention 3: Tretinoin cream 0.05 intervention 4: CeraVe moisturizer
Intervention descriptions: intervention 1: Thin layer of Nu Skin product applied to face. intervention 2: Cosmetic instrument with topical Nu Skin product. Thin layer of Nu Skin product applied to face followed by galvanic, used for 3 minutes. intervention 3: Thin layer of tretinoin applied to face. intervention 4: Thin layer of CeraVe applied to face.

Protocol documents:
Clinical trial NCT01169779
Conditions: Type 2 Diabetes Mellitus
Sponsor: Sanofi
Start date: 2010-07-01; Completion date: 2011-12-01
Enrollment: 391 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010) in comparison to placebo, as an add-on treatment to metformin with or without sulfonylurea, over a period of 24 weeks of treatment.

The primary objective is to assess the effects on glycemic control of lixisenatide (AVE0010) in comparison to placebo as an add-on treatment to metformin with or without sulfonylurea in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24.

The secondary objectives are to assess the effects of lixisenatide over 24 weeks on percentage of patients reaching HbA1c less than (\< ) 7 percent (%) or HbA1c less than or equal to (\<=) 6.5%, fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (PPG) and glucose excursion during standardized meal test, body weight; to evaluate safety, tolerability, pharmacokinetic (PK) and anti-lixisenatide antibody development.

Detailed description:
The study duration for each patient is 27 weeks +/- 10 days (up to 2 weeks screening + 1 week run-in + 24 weeks double-blind treatment + 3 days follow-up).

Arms: arm 1: 1-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) for 2 weeks, followed by 20 mcg QD up to Week 24. arm 2: 1-step initiation regimen of volume matching placebo: 10 mcg QD for 2 weeks, followed by 20 mcg QD up to Week 24.
Interventions: intervention 1: Lixisenatide (AVE0010) intervention 2: Placebo intervention 3: Pen auto-injector intervention 4: Metformin intervention 5: Sulfonylurea
Intervention descriptions: intervention 1: Self administered by subcutaneous injections once daily within the hour preceding breakfast. intervention 2: Self administered by subcutaneous injections once daily within the hour preceding breakfast. intervention 3: None intervention 4: Metformin to be continued at stable dose (at least 1.0 gram per day and not more than 1.5 gram per day) up to Week 24. intervention 5: Sulfonylurea if given at screening, to be continued up to Week 24. In patients with a screening HbA1c \<8% the dose is decreased by 25% to 50% at randomization and then increased up to the screening dose between Week 4 and 12 as per fasting self-monitored plasma glucose (SMPG) values. In patients with a screening HbA1c \>=8%, the dose is not to be changed at randomization. In any case, after Week 12, sulfonylurea is to be continued at a stable dose.

Protocol documents:
Clinical trial NCT01170390
Conditions: Body Weight Contraceptive Usage
Keywords: Obesity Body weight Oral contraception Efficacy
Sponsor: Oregon Health and Science University
Start date: 2009-09-01; Completion date: 2011-12-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main hypothesis for this study is that increased Body Mass Index (BMI) alters oral contraceptive metabolism in a manner which results in decreased effectiveness in obese women.

Detailed description:
This study is being conducted to understand how effective oral hormonal birth control (the pill) is for women with high body mass index ("BMI" - the ratio of your height and weight BMI"). Previous studies of birth control traditionally do not include women above a certain BMI number, so safety and efficacy is not clearly understood in this population, yet the pill is still widely used in women with high BMI.

Reproductive-aged, ovulatory women of obese (BMI \>30 kg/m2), will be placed on oral contraceptives for 2 months, then randomized into two intervention arms for an additional 2 months. At several key time points, synthetic steroid pharmacokinetics, gonadotropins (LH, FSH) and ovarian hormone levels (estradiol, progesterone), ovarian follicular activity by ultrasound monitoring, and cervical mucus testing will be monitored.

Arms: arm 1: A low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). arm 2: A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles arm 3: A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
Interventions: intervention 1: All participants (Aviane) intervention 2: Portia intervention 3: Aviane
Intervention descriptions: intervention 1: 20 mcg EE/0.1 mg LNG cyclically intervention 2: 30 mcg EE/0.15 mg LNG cyclically intervention 3: 20 mcg EE/0.1 mg LNG continuously dosed

Protocol documents:
Clinical trial NCT01190306
Conditions: Keratoconus
Sponsor: Topcon Medical Systems, Inc.
Start date: 2010-08-01; Completion date: 2011-12-01
Enrollment: 127 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to test the safety, tolerability, and effectiveness of corneal collagen cross-linking (CXL), when used to treat keratoconus.

Detailed description:

Arms: arm 1: Eyes randomized to the CXL treatment group with be treated with riboflavin and UV light. arm 2: Eyes in the control group will be treated with riboflavin only.
Interventions: intervention 1: The VEGA UV-A Illumination System intervention 2: Riboflavin
Intervention descriptions: intervention 1: This is a portable electronic device designed to deliver a dose of UV-A light to the treatment area intervention 2: Riboflavin is a solution that will be delivered to the treatment area

Protocol documents:
Clinical trial NCT01190436
Conditions: Hypertension
Keywords: Hypertension Diabetes Mellitus Bisoprolol
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2009-12-01; Completion date: 2011-12-01
Enrollment: 125 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The aim of this 12-week, multicenter, interventional, prospective, open-label and single-arm study is to evaluate the safety and efficacy of 5 milligram per day (mg/day) and 10 mg/day bisoprolol in Filipino hypertensive subjects with diabetes as monotherapy or as an add-on therapy.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Bisoprolol
Intervention descriptions: intervention 1: Bisoprolol will be administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure would be greater than or equal to 130/80 mmHg after 2 weeks, then dose will be adjusted to 10 mg once daily. Total duration of study treatment will be 12 weeks.

Protocol documents:
Clinical trial NCT01191320
Conditions: Type 2 Diabetes Mellitus Secondary Hypogonadism
Keywords: Adult onset hypogonadotropic hypogonadism
Sponsor: Repros Therapeutics Inc.
Start date: 2010-10-01; Completion date: 2011-12-01
Enrollment: 102 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effect the investigative drug has on glycemic control in men with type 2 diabetes mellitus (T2DM) and secondary hypogonadism

Detailed description:
A phase IIB, multi-center, randomized, parallel, placebo- and active-controlled trial in adult male subjects with secondary hypogonadism who have been treated with OHAs but are not in glycemic control. All subjects currently treated with exogenous testosterone will discontinue at screening for at least 21 days and remain off testosterone for the course of the study. One hundred twenty to 150 subjects will be randomly assigned to one of three treatment groups according to a 1:1:1 ratio. Subjects will receive one of two dose strengths of Androxal or placebo in addition to their usual dose of mono- or combination OHAs for three months. Following an initial screening period, subjects will return monthly for 3 months and 1 month later for a follow-up visit.

Arms: arm 1: Placebo arm 2: 12.5 mg/day arm 3: 25 mg/day
Interventions: intervention 1: Placebo intervention 2: Androxal
Intervention descriptions: intervention 1: Placebo capsule 1x daily for 3 months intervention 2: Capsules 12.5 mg or 25 mg 1x daily for 3 months

Protocol documents: