ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02243176
Conditions: Type 2 Diabetes Mellitus
Keywords: Saxagliptin Acarbose Type 2 Diabetes Metformin
Sponsor: AstraZeneca
Start date: 2014-09-01; Completion date: 2015-09-01
Enrollment: 689 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
SMART Study - A 24-Week, Multicenter, Randomized, Parallel-group, Open-label, Active Controlled Phase IV Study to Assess the Efficacy, Safety and Tolerability of Saxagliptin Compared with Acarbose when in Combination with Metformin in Patients with Type 2 Diabetes Mellitus (T2D) Inadequately Controlled with Metformin Monotherapy

Detailed description:

Arms: arm 1: The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm. arm 2: Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
Interventions: intervention 1: Saxagliptin intervention 2: Acarbose
Intervention descriptions: intervention 1: The dose of saxaglitpin will be 5mg oral qd. intervention 2: Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose.

Protocol documents:
Clinical trial NCT02244944
Conditions: Nonalcoholic Fatty Liver Disease (NAFLD)
Keywords: nonalcoholic fatty liver disease NAFLD
Sponsor: Gregory Graf, PhD
Start date: 2014-09-01; Completion date: 2015-09-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research is to gather information on the combination Zetia® (Ezetimibe) and Urso Forte® with respect to sterol balance and their effects on biomarkers of liver function in subjects with nonalcoholic fatty liver disease (NAFLD).

Detailed description:
The study will be conducted as a prospective open label trial with pre- and post-treatment measures for all dependent variables. This trial will enroll subjects with a clinical diagnosis of nonalcoholic fatty liver disease (NAFLD) by magnetic resonance imaging (MRI), computed tomography (CT) or ultrasound, including those diagnosed with nonalcoholic steatohepatitis (NASH). Subjects will be consented, blood collected and a MRI conducted on the first visit. Patients will be advised on the proper use of the study drug and given the first three month's supply of the study drug to take home with them. For the remaining three months, study drug will be delivered by US mail along with return packaging for the prior three month's study medication in order to monitor compliance. Patients will be called routinely to encourage compliance, retention, and monitor side effects or adverse events. After six months of study drug administration, subjects will return for a follow-up visit. Blood will be drawn, an MRI will be obtained and a post-study questionnaire will be administered.

Duration of Patient Enrollment: 6 months Duration of Study: 18 months

Arms: arm 1: Ursodiol (URSO Forte) 13-15 mg per kg (250-500 mg b.i.d. or t.i.d depending on body weight) combined with Ezetimibe (Zetia) 10 mg o.p.d.
Interventions: intervention 1: EZ-Urso combination therapy
Intervention descriptions: intervention 1: Ursodiol 13-15 mg per kg per day combined with Ezetimibe (Zetia) 10 mg per day

Protocol documents:
Clinical trial NCT02246478
Conditions: Duchenne Muscular Dystrophy
Sponsor: Taiho Pharmaceutical Co., Ltd.
Start date: 2014-09-01; Completion date: 2015-09-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the safety and pharmacokinetic of TAS-205 in patients with Duchenne Muscular Dystrophy.

Detailed description:
Duchenne Muscular Dystrophy (DMD) is the most common fatal genetic disorder diagnosed in childhood, affecting approximately 1 in every 3500 lives male births. DMD patients suffer from a relentless decline in muscle strength that impairs the ability of walking and breathing, resulting in their lives with wheelchairs and loss of upper body function. The objective of this study is to evaluate the safety and pharmacokinetic of TAS-205 after single and multiple doses in DMD patients. It is also evaluated if TAS-205 affects the urinary excretion of pharmacodynamic (PD) marker in DMD patients.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: TAS-205 intervention 2: Placebo
Intervention descriptions: intervention 1: * Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals
* Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals intervention 2: * Single-dose phase: 3steps (low dose, middle dose or high dose group), 2 patients/step, single oral administration after meals
* Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 2 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals

Protocol documents:
Clinical trial NCT02248818
Conditions: Healthy Volunteers
Sponsor: AstraZeneca
Start date: 2014-11-01; Completion date: 2015-09-01
Enrollment: 258 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, placebo-controlled study of single and multiple ascending dosage levels of AZD8108 in healthy volunteers. The study includes an up to 28-day screening period, an in-house period during which AZD8108 or placebo will be administered orally as a solution, and a 4- to 10-day follow-up period after discharge.

Detailed description:
In Part 1 of the study (single ascending dose portion), approximately 32 subjects will be randomly assigned. Eight (8) subjects will be randomized in each of 4 dosage-level cohorts (AZD8108 or placebo). Within each cohort, 6 subjects will be randomized to receive AZD8108 and 2 subjects will be randomized to receive placebo. Each subject will receive only one dose of either AZD8108 or placebo on Day 1. In Part 2 of the study (multiple ascending dose portion), approximately 24 subjects will be randomly assigned. Eight (8) subjects will be randomized in each of 3 dosage-level cohorts. Within each cohort, 6 subjects will be randomized to receive AZD8108 and 2 subjects will be randomized to receive placebo. Each subject will receive twelve doses of either AZD8108 or placebo

Arms: arm 1: Subjects will participate in 1 of 7 groups and receive single or multiple doses of AZD8108 or matching placebo. In each group 6 subjects will receive AZD8108 arm 2: Subjects will participate in 1 of 7 groups and receive single or multiple doses of AZD8108 or matching placebo. In each group 2 subjects will receive matching placebo
Interventions: intervention 1: AZD8108 intervention 2: Placebo
Intervention descriptions: intervention 1: Drug: AZD8108 Single or Multiple doses administered orally as a solution. intervention 2: Placebo to match AZD8108 Single or Multiple doses of matching placebo administered orally as a solution

Protocol documents:
Clinical trial NCT02266797
Conditions: Dysphagia After Anterior Cervical Decompression and Fusion of the Spine
Sponsor: NYU Langone Health
Start date: 2013-11-01; Completion date: 2015-09-01
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, placebo-controlled study to examine the effect of local intravenous steroids following anterior cervical spine surgery on the development of dysphagia in patients.

Detailed description:
The purpose of this randomized, double-blind, placebo-controlled study is to examine the effect of local intravenous steroids following anterior cervical spine surgery on the development of dysphagia in patients. This study aims to investigate if there is a difference in the efficacy of intravenous steroids compared to a placebo of physiological saline for patients undergoing anterior cervical spine surgery. Furthermore, this study aims to investigate the correlation between radiographic measurements of soft tissue swelling and the severity of dysphagia for patients. Finally, this study aims to examine the impact of intravenous steroids on nausea and radicular pain in patients. Secondary outcome measures will include patient focused outcomes questionnaires, pain medication requirements, and fusion rates.

Arms: arm 1: Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose. arm 2: Subject will receive doses of intravenous physiological saline solution.
Interventions: intervention 1: Dexamethasone intervention 2: Saline
Intervention descriptions: intervention 1: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose. intervention 2: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose.

Protocol documents:
Clinical trial NCT02269319
Conditions: Bacterial Infections
Keywords: ABSSSI MRX-I Acute Bacterial Skin and Skin Structure Infections
Sponsor: MicuRx
Start date: 2015-02-01; Completion date: 2015-09-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether MRX-I is as safe and effective as Linezolid in the treatment of adult patients with acute bacterial skin and skin structure infections

Detailed description:

Arms: arm 1: MRX-I tablets 800 mg given twice a day for 10 days arm 2: Linezolid 600 mg given twice a day for 10 days
Interventions: intervention 1: MRX-I intervention 2: Linezolid
Intervention descriptions: intervention 1: Oral MRX-I 800mg given twice a day for 10 days intervention 2: Oral linezolid 600mg given twice a day for 10 days

Protocol documents:
Clinical trial NCT02290821
Conditions: Acute Blunt Soft Tissue Injuries/Contusions
Sponsor: Novartis
Start date: 2014-12-01; Completion date: 2015-09-01
Enrollment: 215 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the analgesic efficacy of DSG 1% compared to placebo in the reduction of the pain associated with acute blunt trauma injuries.

Detailed description:

Arms: arm 1: diclofenac sodium gel 1% arm 2: Placebo
Interventions: intervention 1: placebo intervention 2: Placebos
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02291601
Conditions: Surgery
Keywords: Preoperative surgical skin preparation
Sponsor: Medline Industries
Start date: 2014-10-01; Completion date: 2015-09-01
Enrollment: 879 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluate the effects of CHG cloth on the reduction of bacteria on the skin.

Detailed description:
Examine the antimicrobial cloth effects on normal flora bacteria of the abdomen and groin area post CHG application.

Arms: arm 1: 2% CHG, single application arm 2: Excipients on cloth arm 3: Dynahex 2% CHG
Interventions: intervention 1: Chlorhexidine Gluconate intervention 2: Vehicle intervention 3: DynaHex-2
Intervention descriptions: intervention 1: comparison with other CHG products intervention 2: Excipients of CHG product only. intervention 3: 2% CHG solution

Protocol documents:
Clinical trial NCT02291718
Conditions: Thoracic Aortic Aneurysm
Keywords: Suspected or confirmed TAA Computed tomography angiography CTA Contrast agent Radiation dose Thoracoabdominal aortic aneurysm
Sponsor: Duke University
Start date: 2014-01-01; Completion date: 2015-09-01
Enrollment: 150 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the contrast agents and imaging techniques used for thoracoabdominal aortic imaging in CT. Imaging parameters and contrast volume are changed and adjusted based on the contrast agent, since contrast agents have varying iodine concentrations. If the contrast iodine concentration is higher, it may be possible to adjust the imaging parameters and lower the overall radiation dose to the patient.

Detailed description:

Arms: arm 1: Isovue 300 75mL injected 120 kVp 250 mAs arm 2: Isovue 370 75mL injected 100 kVp 240 mAs arm 3: Isovue 370 60mL injected 100 kVp 240 mAs
Interventions: intervention 1: Isovue
Intervention descriptions: intervention 1: iodine contrast

Protocol documents:
Clinical trial NCT02294773
Conditions: Infertility
Keywords: Infertility Intrauterine insemination Luteinizing hormone surge
Sponsor: Midwest Fertility Specialists
Start date: 2013-10-01; Completion date: 2015-09-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study is to assess the impact of the timing of intrauterine insemination (IUI) in relation to the natural surge of luteinizing hormone (LH), as detected by home ovulation predictor kits, on pregnancy rates per treatment cycle. The study will take place at the offices of Midwest Fertility Specialists and include patients who have been independently recommended by their primary physician to undergo ovulation induction with clomiphene citrate (CC) or letrozole and IUI as therapy for infertility.

Detailed description:
Intrauterine insemination is a procedure that is performed in the physician's office. During the procedure the sperm from the male partner are placed directly into the female partner's uterus around the time of ovulation (release of oocyte or egg). Ovulation predictor kits, available over the counter at pharmacies, test for the presence of luteinizing hormone in the urine. When the test result is a positive, it means the hormone is present in the urine. This is a sign of ovulation. Physicians typically choose to perform intrauterine insemination either the day of a positive ovulation test or the day after a positive ovulation test. The purpose of this study is to determine if the day when intrauterine insemination is performed influences the chance of becoming pregnant.

Arms: arm 1: This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive. arm 2: This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive.
Interventions: intervention 1: Intrauterine Insemination intervention 2: Clomiphene intervention 3: Letrozole
Intervention descriptions: intervention 1: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive. intervention 2: Patient is to take clomiphene citrate during cycle days 3-7. intervention 3: Patient is to take letrozole during cycle days 3-7.

Protocol documents:
Clinical trial NCT02329743
Conditions: Inflammation Pain Cataract
Sponsor: A.T. Resolve SARL
Start date: 2014-12-01; Completion date: 2015-09-01
Enrollment: 256 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to assess the efficacy and safety of 2 concentrations of RX-10045 ophthalmic solution, 0.05% and 0.1%, compared to placebo for the treatment of ocular inflammation and pain in subjects undergoing cataract surgery.

Detailed description:

Arms: arm 1: topical eye drops arm 2: topical eye drops arm 3: topical eye drops
Interventions: intervention 1: RX-10045
Intervention descriptions: intervention 1: topical therapy

Protocol documents:
Clinical trial NCT02337062
Conditions: PONV
Sponsor: Acacia Pharma Ltd
Start date: 2015-02-01; Completion date: 2015-09-01
Enrollment: 1147 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A comparison of the efficacy of APD421 and placebo when combined with a standard anti-emetic in the prevention of PONV in patients at high risk of Post-operative Nausea and Vomiting (PONV).

Detailed description:

Arms: arm 1: Single dose of IV APD421 arm 2: Single dose of IV placebo
Interventions: intervention 1: APD421 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02355158
Conditions: Painful Diabetic Neuropathy Diabetes
Keywords: pain diabetic neuropathy pain in feet
Sponsor: BioDelivery Sciences International
Start date: 2014-06-01; Completion date: 2015-09-01
Enrollment: 197 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Study CLO-311 is a multicenter, open-label, single-arm study to assess the long-term use of Clonidine Gel in the treatment of pain associated with PDN. Subjects who have completed their 12-week participation in Study CLO-290 or Study CLO-310 are eligible to rollover into this study and receive active study drug in an open-label manner.

Detailed description:
Study CLO-311 is a multicenter, open-label, single-arm study to assess the long-term use of Clonidine Gel in the treatment of pain associated with PDN. Subjects who have completed their 12-week participation in Study CLO-290 or Study CLO-310 are eligible to rollover into this study and receive active study drug in an open-label manner. All eligible subjects will receive Clonidine Gel regardless of the blinded treatment they have received in the previous double-blind study (Clonidine Gel or Placebo Gel). Study drug will be applied topically TID to both feet for 12 months during an Open-Label Treatment Phase. Approximately 400 adult subjects with PDN are estimated to enroll in this study.

Arms: arm 1: Clonidine hydrochloride topical gel, 0.1%
Interventions: intervention 1: clonidine hydrochloride topical gel, 0.1%
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02363478
Conditions: Systemic Sclerosis
Sponsor: Laikο General Hospital, Athens
Start date: 2014-12-01; Completion date: 2015-09-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Esophagus is commonly affected in Systemic Sclerosis (SSc) and esophageal function is compromised in about 75% of patients. Previous studies have shown that buspirone, an orally available 5-HT1A (serotonin 1a receptor agonist), enhances esophageal motility in healthy volunteers. Recently, the investigators observed that a single dose of buspirone (10mg) improves lower esophageal sphincter (LES) function in patients with SSc and esophageal involvement .

Objectives: To evaluate the effect of continuous administration of buspirone on esophageal dysfunction and related symptoms in SSc using high resolution manometry (HRM).

Detailed description:
Systemic sclerosis (SSc) is a chronic autoimmune disease affecting the skin and other organs especially the gastrointestinal tract. Esophageal involvement occurs in up to 90% of SSc patients. Symptoms of esophageal disease are due to gastroesophageal reflux disease (GERD) and esophageal motor dysfunction. Thus, heartburn, regurgitation and dysphagia have been reported by 80% of SSc patients.

The gold standard method for the assessment and detection of esophageal dysmotility in SSc patients is manometry. High-resolution manometry (HRM) is the most accurate tool to assess esophageal motility using multiple closely spaced (\<2cm) pressure sensors, assessment of esophageal motility is more sensitive ,and allows a better assessment of LES and of the whole esophagus.

Buspirone, an orally available 5-HT1A receptor agonist, exerts a beneficial acute effect on esophageal motor dysfunction and LES pressure and may enhances an important role in improvement of esophageal symptoms in SSc patients. Thus, the investigators will conduct a study to evaluate the putative beneficial long-term effect of buspirone i) on esophageal motor dysfunction and ii) on esophageal symptoms in symptomatic SSc patients.

Arms: arm 1: 4-weeks buspirone administration (20mg) in patients with SSc and esophageal involvement
Interventions: intervention 1: buspirone
Intervention descriptions: intervention 1: buspirone 10 mg X2 for 4 weeks

Protocol documents:
Clinical trial NCT02404285
Conditions: Acne Vulgaris
Sponsor: Next Science TM
Start date: 2015-03-01; Completion date: 2015-09-01
Enrollment: 68 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 12 week, multi-site, double-blind, vehicle-controlled study in subjects with mild to moderate facial acne. Subjects will be randomized 1:1 to apply either topical NAG or vehicle gel daily. Subjects will be evaluated for clinical acne and quality of life outcomes at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks.

Detailed description:
Sample Size: N= 60 completed subjects Male and female subjects 12 years or older diagnosed with mild to moderate inflammatory facial acne vulgaris.

Subjects will be treated with once daily topical NAG or matching vehicle and will attend screening, randomization, 2,4,8 and 12 week visits. The following will be assessed:

1. Lesion counts with photography
2. Investigator Global Assessment
3. Acne Quality of Life Questionnaire
4. Treatment Area Assessment by Investigator

Subjects will discontinue all baseline topical acne treatments with a 2 week washout and/or all systemic acne treatments with a 3 week washout. All subjects will be provided open label Cetaphil facial cleanser and double-blind NAG or vehicle product.

Arms: arm 1: Subjects will be treated with once daily vehicle and will attend screening, randomization, 2,4,8 and 12 week visits. The following will be assessed:

1. Lesions will be counted and right, left and forward facing photographs will be taken
2. Investigator Global Assessment
3. Acne Quality of Life Questionnaire
4. Treatment Area Assessment by Investigator arm 2: Subjects will be treated with once daily NAG and will attend screening, randomization, 2,4,8 and 12 week visits. The following will be assessed:

1. Lesions will be counted and right, left and forward facing photographs will be taken
2. Investigator Global Assessment
3. Acne Quality of Life Questionnaire
4. Treatment Area Assessment by Investigator
Interventions: intervention 1: Next Science Acne Gel intervention 2: Vehicle
Intervention descriptions: intervention 1: Subjects will be instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should not be applied around the eyes or near the mucous membranes. No other acne treatments will be applied to the face during study participation. Hands should be washed following application of study gel. intervention 2: Subjects will be instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should not be applied around the eyes or near the mucous membranes. No other acne treatments will be applied to the face during study participation. Hands should be washed following application of study gel.

Protocol documents: