ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01269801
Conditions: Wrinkles
Keywords: BOTOX JUVEDERM Prospective Open Label Randomized Crossover Study
Sponsor: AboutSkin Dermatology and DermSurgery, PC
Start date: 2011-01-01; Completion date: 2012-02-01
Enrollment: 156 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to see how well Juvederm Ultra XC or Juvederm Ultra Plus XC, and BOTOX Cosmetic, work compared to each other and when used together for the cosmetic treatment of age-associated wrinkles and folds of the face.

Detailed description:
1. Compounds:

   1. BOTOX Cosmetic (onabotulinumtoxinA) for Injection
   2. JUVEDERM Ultra XC and JUVEDERM Ultra Plus XC Injectable Gel
2. The objectives of this study are:

   1. To assess physician assessment of efficacy and incremental benefit following BOTOX Cosmetic and Juvederm for the treatment of moderate to severe facial wrinkles and folds;
   2. To assess patient perceptions of treatment outcomes and incremental benefit following BOTOX Cosmetic and Juvederm for the treatment of moderate to severe facial wrinkles and folds.
3. Investigator and study sites:

   1. multicenter study
   2. 5 Sites: 2 in US, 2 in Canada, 1 in EU

Arms: arm 1: onabotulinumtoxinA for injection arm 2: JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel
Interventions: intervention 1: onabotulinumtoxinA intervention 2: JUVÉDERM
Intervention descriptions: intervention 1: * Group 1 will initially receive BOTOX® Cosmetic or VISTABEL® injections to the affected facial regions;
* Group 2 will initially receive JUVÉDERM® Ultra XC or JUVÉDERM® Ultra 2 (for moderate facial lines or folds) or JUVÉDERM® Ultra Plus XC or JUVÉDERM® Ultra 3 (for severe facial lines or folds) injections to the affected facial regions.

At 4 weeks,Group 1 patients who initially received BOTOX® Cosmetic or VISTABEL® treatment will be crossed over and receive JUVÉDERM® treatment, and Group 2 patients who initially received JUVÉDERM® treatment will be crossed over to receive BOTOX® Cosmetic or VISTABEL® treatment. intervention 2: Group 1 will initially receive BOTOX® Cosmetic or VISTABEL® injections to the affected facial regions;

• Group 2 will initially receive JUVÉDERM® Ultra XC or JUVÉDERM® Ultra 2 (for moderate facial lines or folds) or JUVÉDERM® Ultra Plus XC or JUVÉDERM® Ultra 3 (for severe facial lines or folds) injections to the affected facial regions.

At 4 weeks,Group 1 patients who initially received BOTOX® Cosmetic or VISTABEL® treatment will be crossed over and receive JUVÉDERM® treatment, and Group 2 patients who initially received JUVÉDERM® treatment will be crossed over to receive BOTOX® Cosmetic or VISTABEL® treatment.

Protocol documents:
Clinical trial NCT01294644
Conditions: Moderate or Severe Submental Fullness
Sponsor: Kythera Biopharmaceuticals
Start date: 2011-01-01; Completion date: 2012-02-01
Enrollment: 360 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).

Detailed description:

Arms: arm 1: Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. arm 2: Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. arm 3: Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
Interventions: intervention 1: Deoxycholic acid injection intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: Phosphate buffered saline placebo for injection

Protocol documents:
Clinical trial NCT01296568
Conditions: Advanced Cancer
Keywords: metastatic solid tumors Malignant/M-Neoplasm Pancreas NOS Absorption Distribution Metabolism Excretion Mass balance Metabolic profile Radiolabeled study
Sponsor: Eli Lilly and Company
Start date: 2011-02-01; Completion date: 2012-02-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label study being conducted to determine the metabolism and physiological disposition of radiolabeled LY2603618 after a single dose in patients with advanced and/or metastatic solid tumors.

After a minimum 7-day washout period following the carbon-14-labeled LY2603618 (\[\^14C\]LY2603618) dose, patients will be allowed to continue to receive continued access to LY2603618 in combination with pemetrexed or gemcitabine as outpatients.

Detailed description:

Arms: arm 1: Single 250 milligram (mg) intravenous dose of LY2603618 containing carbon-14-labeled LY2603618 (\[\^14C\]LY2603618).

After the completion of a minimum 7-day washout period, participants may receive additional doses of LY2603618 in combination as follows:

* Gemcitabine 1000 milligrams per square meter (mg/m\^2) on Days 1, 8, and 15 with 230 mg LY2603618 being administered on Days 2, 9 and 16 of a 28-day cycle OR
* Pemetrexed 500 mg/m\^2 on Day 1 and 275 mg LY2603618 on Day 2 of a 21-day cycle

Participants will be allowed to continue to receive the combination therapy until fulfilling one of the criteria for discontinuation, such as unacceptable toxicity or disease progression.
Interventions: intervention 1: LY2603618 intervention 2: Pemetrexed intervention 3: Gemcitabine
Intervention descriptions: intervention 1: Administered intravenously intervention 2: Administered intravenously intervention 3: Administered intravenously

Protocol documents:
Clinical trial NCT01313767
Conditions: Spasticity
Keywords: spasticity upperlimb Botulinum toxin
Sponsor: Medy-Tox
Start date: 2011-03-01; Completion date: 2012-02-01
Enrollment: 196 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a randomized, double blind, multi-center, active drug controlled, phase III clinical trial to compare the efficacy and safety of MEDITOXIN® versus BOTOX® in treatment of post stroke upper limb(wrist, finger, thumb) spasticity

Approximately 196 subjects(1:1 group ratio)will be enrolled. Subjects will receive a single treatment of intramuscular Investigational product up to 360U. The subjects will be observed every 4 weeks until 12 weeks post injection. Outcome measures include Modified Ashworth Scale (MAS), Disability Assessment Scale (DAS), Global Assessment Scale(patient or caregiver/investigator) and Carer burden scale. The primary efficacy endpoint is the change from baseline at week 4 for wrist flexor muscle tone as measured on the Modified Ashworth Scale. Safety parameters will also be measured including adverse events, vital signs and clinical laboratory tests (haematology, serum chemistry and urinanalysis).

Detailed description:
Each completed subject will attend 4\~5 clinic visits. The maximum study duration is 15 weeks. Only one upper limb (eligible inclusion/exclusion criteria) will be injected and evaluated in the study. Maximun injection dose is 360U.

Arms: arm 1: Botulinum toxin type A arm 2: Botulinum Toxin type A
Interventions: intervention 1: Botulinum toxin type A intervention 2: Botulinum Toxin type A
Intervention descriptions: intervention 1: Botulinum toxin type A intervention 2: Botulinum Toxin type A

Protocol documents:
Clinical trial NCT01337609
Conditions: Major Depressive Disorder Irritable Bowel Syndrome
Keywords: Depression Irritable Bowel Syndrome Probiotic Bacillus Coagulans
Sponsor: Massachusetts General Hospital
Start date: 2011-06-01; Completion date: 2012-02-01
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine the safety and effectiveness of a nutritional supplement, the probiotic bacteria GanedenBC30. Probiotics are live microorganisms which when taken in large enough amounts are supposed to provide a health benefit. The investigators would like to see whether this supplement can be used as a treatment for Irritable Bowel Syndrome (IBS) and Major Depressive Disorder (MDD). Participants in the study will have both IBS and MDD. In order to find out if GanedenBC30 is effective in treating IBS and MDD, the investigators will compare it to a placebo. About 32 people will take part in this research study. About half of these 32 people will take part at Charles River Medical Associates and half will take part at Burlington Medical Associates. Participants will be recruited from among patients already being seen at Charles River Medical Associates or Burlington Medical Associates for their primary care. The study will last for two months, during which time participants will make eight study visits and will take either Ganeden BC30 or placebo. The investigators hypothesize that subjects treated with the probiotic will have significantly better outcomes with regard to depression and IBS symptoms compared to those who receive placebo.

Detailed description:

Arms: arm 1: Arm 1 will take GanedenBC30 (Bacillus coagulans GBI-30, 6086, 1 capsule/day) for 60 days. arm 2: Arm 2 will take placebo (sugar pill) for 60 days. arm 3: Arm 3 will take placebo (sugar pill) for 30 days, followed by Ganeden BC30 for 30 days.
Interventions: intervention 1: Ganeden BC30 intervention 2: Placebo (sugar pill) intervention 3: Ganeden BC30, Placebo (sugar pill)
Intervention descriptions: intervention 1: 2 billion CFU per capsule; One pill daily for 60 days intervention 2: 1 pill daily for 60 days intervention 3: Ganeden BC30 (2 billion CFU per capsule), One capsule daily for 30 days Sugar Pill (placebo), One capsule daily for 30 days

Protocol documents:
Clinical trial NCT01340053
Conditions: Constipation Predominant Irritable Bowel Syndrome
Sponsor: Ardelyx
Start date: 2011-05-01; Completion date: 2012-02-01
Enrollment: 186 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-center, Phase 2, randomized, double-blind, placebo controlled study of RDX5791 in subjects with IBS-C. Patients who are 18 to 75 years old, meeting the definition of IBS-C as defined by the Rome III Criteria for the Diagnosis of IBS will undergo a battery of screening procedures to determine eligibility for the trial.

The study will consist of a 2-week treatment-free screening period, a 4-week blinded treatment period, and a 2-week treatment-free follow-up period.

Detailed description:

Arms: arm 1: Capsule that is identical in size and color to other treatments arm 2: 10 mg capsule of tenapanor arm 3: 30 mg capsule of tenapanor arm 4: 100 mg capsule of tenapanor
Interventions: intervention 1: RDX5791
Intervention descriptions: intervention 1: Capsule, QD

Protocol documents:
Clinical trial NCT01348139
Conditions: Asthma
Keywords: Asthma patients lung function
Sponsor: AstraZeneca
Start date: 2011-05-01; Completion date: 2012-02-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamics of single doses of three different dry powder inhalation formulations of AZD3199 administered via Single Inhalation Device (SID) compared to AZD3199 administered via Turbuhaler™ Inhaler and compared to placebo in patients with persistent asthma.

Detailed description:

Arms: arm 1: AZD3199 800 µg inhaled via single inhaler device (SID), single dose arm 2: AZD3199 880 µg inhaled via SID, single dose arm 3: AZD3199 1400 µg inhaled via SID, single dose arm 4: AZD3199 300 µg inhaled via Turbuhaler inhaler, single dose arm 5: AZD3199 1200 µg inhaled via Turbuhaler inhaler, single dose arm 6: Placebo inhaled via Turbuhaler inhaler and SID, single dose
Interventions: intervention 1: AZD3199 intervention 2: AZD3199 intervention 3: AZD3199 Placebo
Intervention descriptions: intervention 1: Inhaled via single inhaler device (SID) intervention 2: Inhaled via Turbuhaler inhaler intervention 3: Inhaled via Turbuhaler inhaler and SID

Protocol documents:
Clinical trial NCT01359150
Conditions: Rheumatoid Arthritis
Sponsor: Pfizer
Start date: 2011-09-01; Completion date: 2012-02-01
Enrollment: 223 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Randomized, Double Blind, Placebo Controlled Phase 2 Study To assess the Immune Response Following Administration of Influenza and Pneumococcal Vaccines to Subjects with Rheumatoid Arthritis receiving CP-690,550 with and Without background Methotrexate

Detailed description:

Arms: arm 1: CP-690,550 will be administered for 4 weeks, vaccines will be administered at week 4. CP-690,550 will then continue for another 5 weeks at which point the immune response will be evaluated. arm 2: Placebo will be administered for 4 weeks, vaccines will be administered at week 4. Placebo will then continue for another 5 weeks at which point the immune response will be evaluated.
Interventions: intervention 1: CP-690,550 intervention 2: placebo
Intervention descriptions: intervention 1: Treatment Group 1: 10 mg BID CP-690,550 (100 subjects). Strata 1: 10 mg BID CP-690,550 on background methotrexate (50 subjects); Strata 2: 10 mg BID CP-690,550 monotherapy (50 subjects). intervention 2: Placebo CP-690,550 (100 subjects). Strata 1: Placebo CP-690,550 on background methotrexate (50 subjects); Strata 2: Placebo CP-690,550 monotherapy (50 subjects). Influenza and pneumococcal vaccines will be administered to all subjects

Protocol documents:
Clinical trial NCT01361308
Conditions: Postmenopausal Symptoms
Keywords: Menopause Vasomotor Symptoms Hot Flashes Perimenopause Climacteric Symptoms Mesafem Low-Dose Mesylate salt of Paroxetine (LDMP)
Sponsor: Noven Therapeutics
Start date: 2011-05-01; Completion date: 2012-02-01
Enrollment: 614 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the safety \& efficacy of Brisdelle (paroxetine mesylate) Capsules 7.5 mg for treatment of vasomotor symptoms (VMS) associated with menopause.

Detailed description:
This is 12-week, multicenter, double-blind, randomized, placebo-controlled study of Brisdelle (paroxetine mesylate) Capsules 7.5 mg and placebo capsules in subjects with moderate to severe postmenopausal VMS, defined as follows:

* Moderate VMS: Sensation of heat with sweating, able to continue activity
* Severe VMS: Sensation of heat with sweating, causing cessation of activity

The study is comprised of a screening period, a run-in period, a baseline visit, and a double-blind treatment period.

Arms: arm 1: Brisdelle (paroxetine mesylate) arm 2: Placebo Capsules
Interventions: intervention 1: Brisdelle (paroxetine mesylate) intervention 2: Placebo capsules
Intervention descriptions: intervention 1: Subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo in a 1:1 ratio, administered once daily at bedtime beginning on Day 1 and continuing up to Day 84 intervention 2: Subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo in a 1:1 ratio, administered once daily at bedtime beginning on Day 1 and continuing up to Day 84

Protocol documents:
Clinical trial NCT01368536
Conditions: Hypertension Stage 2 Hypertension Diabetes
Keywords: High blood pressure diabetes
Sponsor: Novartis Pharmaceuticals
Start date: 2011-05-01; Completion date: 2012-02-01
Enrollment: 975 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a study to assess the safety and efficacy of Valturna and amlodipine or Valturna and chlorthalidone when compared to Valturna alone in patients with stage 2 hypertension and diabetes mellitus 2.

Detailed description:

Arms: arm 1: At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks. arm 2: At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks. arm 3: At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
Interventions: intervention 1: Valturna intervention 2: Amlodipine intervention 3: Chlorthalidone intervention 4: Placebo of Valturna Tablet intervention 5: Placebo Capsule
Intervention descriptions: intervention 1: Valturna (aliskiren 150 mg/valsartan 160 mg) tablet intervention 2: Amlodipine 5 mg and 10 mg capsule intervention 3: Chlorthalidone 15 mg and 25 mg capsule intervention 4: Matching placebo of valturna tablet intervention 5: Matching placebo of Amlodipine capsule OR Matching placebo of chlorthalidone capsule

Protocol documents:
Clinical trial NCT01376089
Conditions: Patient Comfort and Safety
Keywords: Safety
Sponsor: GE Healthcare
Start date: 2011-05-01; Completion date: 2012-02-01
Enrollment: 304 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate and compare overall patient comfort profile between the Iso-osmolar contrast media (IOCM), iodixanol 320 mg I/mL, and a Low-osmolar contrast media (LOCM), iopamidol 370 mg I/mL in patients undergoing Contrast-Enhanced Computed Tomographic (CECT) imaging of the abdomen/pelvis.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Iodixanol intervention 2: Iopamidol
Intervention descriptions: intervention 1: Iodixanol 320 mg I/mL as a single iv. administration. intervention 2: Comparator agent iopamidol (Isovue) 370 mg I/mL as a single iv. administration.

Protocol documents:
Clinical trial NCT01378520
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: breathlessness resistive load breathing beta-endorphins
Sponsor: Dartmouth-Hitchcock Medical Center
Start date: 2011-06-01; Completion date: 2012-02-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Beta-endorphins, which are naturally occurring narcotic substances, have been shown to alter the perception of breathlessness. Oral ketoconazole, an antifungal antibiotic, increases blood levels of beta-endorphins. The study hypothesis is that oral ketoconazole will reduce ratings of breathlessness induced by resistive breathing loads.

Detailed description:
Beta-endorphins are naturally occurring narcotic substances (like morphine) that are released by the brain under stressful conditions, such as exercise and when breathing through a resistive load (a tube containing fine wire mesh). In one study of 8 patients with coronary artery disease, ketoconazole, an oral medication used to treat fungal infections, was administered (1,200 mg at 12 midnight and 600 mg at 6 am) and increased blood levels of beta-endorphins five fold. In a recent study performed at Dartmouth-Hitchcock Medical Center, we found that ketoconazole increased blood levels of beta-endorphins in all eight patients with chronic obstructive pulmonary disease (COPD). Mean values increased by 2.5 times at four hours compared with baseline values (p = 0.0078). Based on this significant response, we propose to study the effect of ketoconazole on patients' perception of breathlessness induced by resistive breathing loads in a randomized clinical trial. The hypothesis of the study is that ketoconazole will reduce ratings of breathlessness as mediated by the increased levels of beta-endorphins.

Arms: arm 1: 600 mg ketoconazole arm 2: inert powder in capsule
Interventions: intervention 1: ketoconazole intervention 2: inert powder
Intervention descriptions: intervention 1: 600 mg capsule oral once intervention 2: oral once

Protocol documents:
Clinical trial NCT01393600
Conditions: Tardive Dyskinesia
Sponsor: Neurocrine Biosciences
Start date: 2011-08-01; Completion date: 2012-02-01
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate the efficacy, safety, and tolerability of two doses (12.5 and 50 mg) of NBI-98854 administered once daily (q.d.) for the treatment of tardive dyskinesia in subjects with schizophrenia or schizoaffective disorder.

Detailed description:

Arms: arm 1: During the Cross-Over Study, subjects will be randomly assigned to receive one of the following treatment sequences:

Sequence 1: Placebo once daily dose for Days 1-14 and 12.5 mg NBI-98854 once daily dose for Days 15-28.

Sequence 2: 12.5 mg NBI-98854 once daily dose for Days 1-14 and placebo once daily dose for Days 15-28. arm 2: During the Cross-Over Study, subjects will be randomly assigned to receive one of the following treatment sequences:

Sequence 3: Placebo once daily dose for Days 1-14 and 50 mg NBI-98854 once daily dose for Days 15-28.

Sequence 4: 50 mg NBI-98854 once daily dose for Days 1-14 and placebo once daily dose for Days 15-28.
Interventions: intervention 1: NBI-98854 intervention 2: NBI-98854 intervention 3: Placebo
Intervention descriptions: intervention 1: 12.5 mg powder in bottle once daily for 14 days intervention 2: 50 mg powder in bottle once daily for 14 days intervention 3: Solution containing no active substance

Protocol documents:
Clinical trial NCT01396161
Conditions: Diabetes Mellitus, Type 2
Keywords: Phase 1 Multiple Doses Safety Pharmacokinetics Pharmacodynamics Healthy Volunteers Type 2 Diabetic Patients
Sponsor: Pfizer
Start date: 2011-07-01; Completion date: 2012-02-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: 

Brief summary:
The primary purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of PF-05175157 in healthy volunteers and patients with type 2 diabetes mellitus.

Detailed description:

Arms: arm 1: None arm 2: Planned dose might be modified based on emerging safety and PK data. arm 3: Planned dose might be modified based on emerging safety and PK data. arm 4: Planned dose might be modified based on emerging safety and PK data. arm 5: Dose will be determined based on results obtained from Arms 1 to 4.
Interventions: intervention 1: PF-05175157 or Placebo intervention 2: PF-05175157 or Placebo intervention 3: PF-05175157 or Placebo intervention 4: PF-05175157 or Placebo intervention 5: PF-05175157 or Placebo
Intervention descriptions: intervention 1: One oral dose of PF-05175157 or placebo is administered as a powder-in-capsule once daily for 14 days immediately before breakfast, in healthy volunteers. intervention 2: One oral dose of PF-05175157 or placebo is administered as a powder-in-capsule once daily for 14 days immediately before breakfast, in healthy volunteers. intervention 3: One oral dose of PF-05175157 or placebo is administered as a powder-in-capsule once daily for 14 days immediately before breakfast, in healthy volunteers. intervention 4: One oral dose of PF-05175157 or placebo is administered as a powder-in-capsule twice daily for 14 days, immediately before breakfast and dinner, in healthy volunteers. intervention 5: One oral dose of PF-05175157 or placebo is administered as a powder-in-capsule once (or twice) daily for 14 days, immediately before breakfast (and dinner), in patients with type 2 diabetes.

Protocol documents: