ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01344538
Conditions: Colorectal Cancer
Keywords: ginger Zingiber officinale Cancer Risk Reductive Eicosanoids Colorectal Cancer Inflammation
Sponsor: University of Michigan
Start date: 2007-04-01; Completion date: 2012-12-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if ginger root extract when taken daily for 28 days is able to decrease levels of inflammatory chemicals called eicosanoids in the gut tissue of people who are at normal risk and those at increased of developing colorectal cancer compared to people taking placebo.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ginger Root Extract (Pure Encapsulations) intervention 2: Placebo Capsule
Intervention descriptions: intervention 1: 2.0 g per day (10:1 extract) intervention 2: 2.0 g per day

Protocol documents:
Clinical trial NCT01358968
Conditions: Cancer
Sponsor: Eli Lilly and Company
Start date: 2011-06-01; Completion date: 2012-12-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the effect LY2603618 on a protein \[enzyme cytochrome P (CYP) 2D6\] which is involved in the metabolic pathway of Desipramine in participants with cancer. This is a drug interaction study so the treatment of the disease will not be the main purpose of the study.

The study involves two single doses of 50 milligrams (mg), 1 tablet by mouth, on Day 1 of Period 1 and 2. In Period 1 Desipramine will be administered alone. In Period 2 Desipramine will be administered in combination with LY2603618. LY2603618 will be administered as a 275mg intravenous (IV) infusion over 1 hour (hr).

Desipramine will be administered at the end of the LY2603618 infusion. Information about any side effects that may occur will also be collected.

Detailed description:

Arms: arm 1: Single 50 milligrams (mg) oral dose of desipramine on day 1 of study period 1. Single 275 mg intravenous infusion over one hour of LY2603618 followed by single 50 mg oral dose of desipramine on day 1 of study period 2. Participants may then receive additional doses of LY2603618 in combination as follows: 1000 milligrams per square meter (mg/m²) intravenous administration over 30 minutes of gemcitabine on days 1, 8 and 15 and 230 mg intravenous dose of LY2603618 on days 2, 9 and 16 of 28-day cycles OR 500 mg/m² intravenous administration over 10 minutes of pemetrexed on day 1 and 275 mg intravenous dose of LY2603618 on day 2 of 21-day cycles.

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: Desipramine intervention 3: Pemetrexed intervention 4: Gemcitabine
Intervention descriptions: intervention 1: Administered intravenously as a 1-hour infusion. intervention 2: Administered orally intervention 3: Administered intravenously as a 10-minute infusion. intervention 4: Administered intravenously as a 30-minute infusion.

Protocol documents:
Clinical trial NCT01383954
Conditions: Knee Osteoarthritis
Keywords: Knee osteoarthritis
Sponsor: Brigham and Women's Hospital
Start date: 2011-06-01; Completion date: 2012-12-01
Enrollment: 52 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this proposed study is to conduct a trial with knee osteoarthritis (OA) patients using the diclofenac gel.

Detailed description:
The purpose of this proposed study is to conduct a trial with knee OA patients using the diclofenac gel. The effectiveness of diclofenac gel in managing breakthrough pain or the neuropathic components of pain (e.g., the burning, soft tissue joint sensitivity, or allodynic components) in knee OA is unknown. It is likely that patients will use the gel in a as needed (prn) fashion, on top of other analgesics prescribed for their pain. The neuropathic components of a generally nociceptive or inflammatory condition, such as knee OA, are underappreciated, and typically not tracked in OA analgesic studies. Yet, evidence across a variety of chronic painful conditions suggests that these components are quite disabling. The results of this study would show whether diclofenac gel as a prn medication is beneficial to patients suffering from knee OA pain.

Arms: arm 1: Diclofenac gel 4 grams (g) applied topically 4 times daily (QID) to the affected knee(s) for up to 4 weeks. Participants took a maximum dosage of 32 g/day.
Interventions: intervention 1: Diclofenac Gel
Intervention descriptions: intervention 1: Diclofenac gel 4 grams (g) applied topically 4 times daily (QID) to the affected knee(s) for up to 4 weeks. Participants took a maximum dosage of 32 g/day.

Protocol documents:
Clinical trial NCT01387737
Conditions: Type 2 Diabetes Mellitus
Keywords: TA-7284 JNJ-28431754 Canagliflozin Sodium Glucose Co-Transporter (SGLT2 inhibitor)
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2011-05-01; Completion date: 2012-12-01
Enrollment: 1299 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of TA-7284 as monotherapy or combination therapy with other oral anti-hyperglycaemic agent in Japanese patients with Type 2 diabetes mellitus on 52 weeks oral administration.

Detailed description:
This is a randomized, 2-arm, parallel group, open-label study to evaluate the safety and efficacy of TA-7284 in Japanese patients with Type 2 diabetes mellitus, who are not optimally controlled on diet and exercise or with oral anti-hyperglycaemic agent. The patients will receive either TA-7284-Low or TA-7284-High orally alone or in combination with oral anit-hyperglycaemic agent for 52 weeks.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: TA-7284-Low intervention 2: TA-7284-High
Intervention descriptions: intervention 1: TA-7284-Low intervention 2: TA-7284-High

Protocol documents:
Clinical trial NCT01393119
Conditions: Prostate Cancer
Sponsor: GTx
Start date: 2011-08-01; Completion date: 2012-12-01
Enrollment: 77 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the appropriate loading and maintenance dose of GTx-758 to reach and maintain castration for the duration of the study.

Detailed description:
The original purpose of the study was to determine the appropriate loading and maintenance dose of GTx-758 to reach and maintain castration for the duration of the study. The primary endpoint was used to assess the loading dose, while the secondary endpoint was intended to be used to assess maintenance. Due to the study being terminated early, as requested by FDA, the secondary assessment of maintenance was unable to be assessed. Hence, all summaries provided are for subjects in the two loading dose groups of 1000 mg BID and 1500mg BID only and not broken out by the maintenance dose.

Arms: arm 1: 1000mg Loading Dose GTx-758 BID and Maintenance Dose 1000mg arm 2: 1000mg Loading Dose GTx-758 BID and Maintenance Dose 2000mg arm 3: 1500 mg Loading Dose GTx-758 BID and Maintenance Dose 1000mg arm 4: 1500 mg Loading Dose GTx-758 BID and Maintenance Dose 2000mg
Interventions: intervention 1: GTx-758
Intervention descriptions: intervention 1: 3-fluoro-N-( 4-fluorophenyl)-4-hydroxy-N-( 4-hydroxyphenyl) benzamide; a nonsteroidal selective estrogen receptor (ER) a agonist

Protocol documents:
Clinical trial NCT01393132
Conditions: Dry Eye Sjogren's Syndrome Graft vs. Host Disease
Keywords: Dry Eye Sjogren's Syndrome Graft vs. Host Disease Rheumatoid arthritis Systemic lupus erythematosus Scleroderma
Sponsor: Michigan Cornea Consultants, PC
Start date: 2011-03-01; Completion date: 2012-12-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Severe dry eye is a debilitating ocular disease resulting in loss of vision, reduced day-to-day function and significant discomfort. Tear substitutes are an important part of the treatment of all patients, however, even with aggressive us, the corneal(ocular)surface often remains very irregular due to poor surface healing.

The agent being evaluated in this study, Thymosin Beta 4, promotes healing of the corneal surface and has been studied in patients with recalcitrant corneal ulcers and erosions with significant success (Arch Ophthalmol. 2010;128(5):636-638., Ann of the NY Acad of Sci, May, 2010).

The study hypothesis is that Thymosin Beta 4, in its role as a modulator of corneal surface healing, may be able to promote healing of the corneal surface allowing for more conventional modalities to take over and maintain a smooth and regular ocular surface. The investigators hope to be able to demonstrate an improvement in visual acuity, surface healing and a reduction in dry-eye related symptoms.

Detailed description:
See above

Arms: arm 1: It is a preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into each eye, six times daily for 28 days arm 2: It is composed of the same excipients as RGN-259 but does not contain Tβ4 for direct instillation into each eye, six times daily for 28 days.
Interventions: intervention 1: Thymosin Beta 4 eye drops intervention 2: Vehicle Control
Intervention descriptions: intervention 1: Patients will be randomized and will receive the same eye drops the Thymosin Beta 4. intervention 2: Patients will be randomized and will receive the same eye drops without the Thymosin Beta 4.

Protocol documents:
Clinical trial NCT01397461
Conditions: Impetigo
Sponsor: Ferrer Internacional S.A.
Start date: 2012-03-01; Completion date: 2012-12-01
Enrollment: 465 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is multicenter, randomised, placebo controlled, parallel, blinded (double-blind for ozenoxacin versus placebo comparison and investigator blinded for retapamulin versus placebo comparison), superiority clinical study comparing ozenoxacin cream versus placebo and retapamulin ointment vs placebo, in patients with a clinical diagnosis of non-bullous or bullous impetigo.

Detailed description:

Arms: arm 1: 1% cream arm 2: cream arm 3: 1% ointment
Interventions: intervention 1: ozenoxacin placebo intervention 2: retapamulin 1% ointment intervention 3: ozenoxacin 1% cream
Intervention descriptions: intervention 1: cream intervention 2: ointment intervention 3: 1% cream

Protocol documents:
Clinical trial NCT01398280
Conditions: Rosacea
Keywords: Rosacea Dermatology UCSD Skin disease
Sponsor: University of California, San Diego
Start date: 2011-07-01; Completion date: 2012-12-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effect of topical aminocaproic acid on the immune system by assessing the levels of antimicrobial peptides in the skin of patients with rosacea. It is hypothesized that aminocaproic acid applied topically will alter the body's immune system in patients with rosacea by inhibiting activation of antimicrobial peptides.

Detailed description:

Arms: arm 1: Subjects will treat their facial skin twice daily for up to 12 weeks with 5-6 visits and 2 telephone visits. Investigator and subject will be blinded. Tape strip samples will be collected from facial skin at each visit to assess Kallikrein 5 (KLK5) activity. arm 2: Subjects will apply vehicle twice daily for up to 12 weeks with 5-6 visits and 2 telephone visits. Investigator and subject will be blinded. Tape strip samples will be collected from facial skin at each visit to assess Kallikrein 5 (KLK5) activity.
Interventions: intervention 1: Topical aminocaproic acid (ACA) mixed with Vanicream intervention 2: Vehicle cream
Intervention descriptions: intervention 1: 25% Aminocaproic acid cream twice daily for up to 12 weeks. intervention 2: Vehicle cream moisturizer twice daily for up to 12 weeks

Protocol documents:
Clinical trial NCT01400113
Conditions: Agitation
Keywords: Acute Agitation schizophrenia bipolar psychosis panss-ec
Sponsor: Unity Health Toronto
Start date: 2012-04-01; Completion date: 2012-12-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Our proposal is to administer asenapine to patients who are clinically agitated and in need of immediate intervention. At present there are no controlled studies that we know of that explores the use of asenapine for this purpose. Establishing the utility of asenapine for this common clinical problem will support its use as an additional treatment option in acutely agitated patients.

Detailed description:
A psychiatrist (blinded) will assess the patient for agitation and their capacity to consent. Patients will be informed about the study and asked to complete informed consent prior to being included in the study. Patients who decline will not be included. A nurse (blinded) will administer either 10mg asenapine or placebo sublingually in a randomized fashion. Efficacy in reducing acute agitation will be evaluated using the PANSS-EC. A trained rater (blinded) will rate patients at baseline and at 15, 30, 60, 90 and 120 minutes (or endpoint) after medication administration. Efficacy in reducing acute agitation will also be evaluated using the Clinical Global Impression Scale (CGI). A trained rater (blinded) will rate patients at baseline CGI-Severity and CGI-Change at 60 and 120 minutes (or endpoint) after medication administration. The need for additional medications, interventions or physical restraints will be recorded and constitute the endpoint for that patient. Demographics, diagnoses, blood alcohol level, urine toxicology, and urine pregnancy will be collected.

Arms: arm 1: This group received 10mg asenapine sl x 1 dose arm 2: This group received placebo sl x 1 dose
Interventions: intervention 1: Asenapine intervention 2: Placebo
Intervention descriptions: intervention 1: Asenapine Sublingual Tablet 10mg, single-dose intervention 2: Placebo Sublingual Tablet, single-dose

Protocol documents:
Clinical trial NCT01400815
Conditions: Smoking Cessation
Keywords: smoking smoking cessation quitting smoking
Sponsor: 22nd Century Limited, LLC
Start date: 2011-07-01; Completion date: 2012-12-01
Enrollment: 234 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A randomized, active controlled clinical trial in which a total of 216 healthy smokers will be enrolled and followed over approximately 19 weeks.

The trial will evaluate the efficacy and safety of using X-22 as a smoking cessation aid.

Healthy smokers who plan to quit smoking will be screened for eligibility. Subjects will be randomized in a 1:1 ratio to 1 of the 2 treatment arms:

* Group 1: X-22 Cigarettes (very low nicotine)
* Group 2: Active Control Cigarettes The randomization will be stratified by gender. Efficacy will be assessed by analysis of cigarette consumption using self-report diaries and measurement of exhaled carbon monoxide (CO) and cotinine concentrations.

Safety will be assessed by evaluation of adverse events, physical examinations, clinical laboratory tests, and measurement of heart rate, blood pressure, and body weight at each study visit.

Detailed description:

Arms: arm 1: The X-22 Smoking Cessation Product is a tobacco-based (botanical) medical product consisting of very low nicotine (VLN) cigarettes. arm 2: The Active Control cigarette is identical to the X-22 cigarette except for the tobacco, which has a nicotine content similar to that of a conventional "light" cigarette.
Interventions: intervention 1: X-22 Smoking Cessation Product intervention 2: Active Control Cigarettes
Intervention descriptions: intervention 1: The X-22 Smoking Cessation Product is a tobacco-based (botanical) medical product consisting of very low nicotine (VLN) cigarettes.

Subjects will be allowed to smoke as much as desired throughout the 6-week treatment period. intervention 2: The Active Control cigarette is identical to the X-22 cigarette except for the tobacco, which has a nicotine content similar to that of a conventional "light" cigarette.

Subjects will be allowed to smoke as much as desired throughout the 6-week treatment period.

Protocol documents:
Clinical trial NCT01401257
Conditions: Charcot-Marie-Tooth Disease Hereditary Neuropathy With Liability to Pressure Palsies Genetic Disorders
Keywords: PXT3003 Charcot-Marie-Tooth Disease Hereditary Motor and Sensory Neuropathies
Sponsor: Pharnext S.C.A.
Start date: 2010-12-01; Completion date: 2012-12-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The present trial is a randomized, placebo-controlled study evaluating 3 different doses of PXT3003 in patients with CMT1A disease.

Detailed description:
In addition to the safety and tolerability of the treatment, clinical, electrophysiological and biological endpoints (PMP22 mRNA, skin biopsy histology and plasma biomarkers) will be assessed. Standard laboratory tests and drug plasma concentrations will also be measured. Because of the slow progression of the disease and the nature of the observed symptoms, a minimum duration of 12 months of treatment is required in order to observe a potential improvement in any of the efficacy parameters.

Arms: arm 1: Oral Liquid formulation, 1/100, bid, 12 months arm 2: Oral Liquid formulation, 1/50, bid, 12 months arm 3: Oral Liquid formulation, 1/10, bid, 12 months arm 4: Oral Liquid formulation, bid, 12 months
Interventions: intervention 1: PXT3003 Low dose intervention 2: PXT3003 Intermediate Dose intervention 3: PXT3003 High Dose intervention 4: Placebo
Intervention descriptions: intervention 1: Liquid,5 ml, twice a day, 12-month treatment intervention 2: Liquid,5 ml, twice a day, 12-month treatment intervention 3: Liquid,5 ml, twice a day, 12-month treatment intervention 4: Liquid,5 ml, twice a day, 12-month treatment

Protocol documents:
Clinical trial NCT01409239
Conditions: Type 2 Diabetes Inpatient
Keywords: hospital diabetes glycemic variability autonomic tone
Sponsor: Kathleen Dungan
Start date: 2011-07-01; Completion date: 2012-12-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Glycemic variability has been associated with mortality in hospitalized patients with hyperglycemia. However, it is unknown how modulation of glycemic variability would impact outcomes. One possibility is that glycemic variability could impact autonomic tone. In particular, heart rate variability (HRV) measurement is a sensitive marker for measuring autonomic tone, and aberrations in HRV have been associated with mortality. The current randomized pilot study will compare the effects of continuous intravenous (IV) insulin and subcutaneous basal bolus insulin on glycemic variability and autonomic tone in hospitalized non-critically ill patients with diabetes. Non-critically ill patients who are hyperglycemic or are requiring at least 20 units of insulin per day will be included. Patients with conditions that preclude accurate HRV readings (such as atrial fibrillation or paced rhythms) will be excluded. Patients randomized to intravenous insulin will receive the therapy for 24 hours according to our standard hospital guideline. Patients randomized to subcutaneous (SQ) insulin will receive basal bolus therapy using insulin analogues. All therapies will begin between 8 and 10 AM. Patients will undergo repeated heart rate variability recordings during the 24 hour period. Blood draws will be collected at baseline and at 24 hours for measurement of catecholamines, insulin, and c-peptide. Glycemic variability will be measured using a continuous subcutaneous glucose monitor and reported as coefficient of variation. The primary outcome measure is low frequency-to-high frequency power spectrum ratio of heart rate variability.

1. Glycemic variability is associated with unfavorable changes in autonomic tone, as assessed by low frequency (LF)/high frequency (HF) HRV ratio, independent of changes in overall glycemia.
2. Short-term increases in glycemic variability, followed by more prolonged glycemic stability are observed in generalized hospitalized patients treated with intravenous insulin compared to standardized basal bolus therapy. LF/HF HRV differs among subjects receiving intravenous compared to subcutaneous insulin.
3. Glycemic variability differs among subjects receiving intravenous compared to subcutaneous insulin

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Intravenous insulin intervention 2: Subcutaneous Insulin
Intervention descriptions: intervention 1: 24 hr IV insulin administered according to hospital guideline intervention 2: basal bolus insulin using carb counting technique and insulin analogues

Protocol documents:
Clinical trial NCT01415518
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Severe chronic obstructive pulmonary disease (COPD) patients
Sponsor: AstraZeneca
Start date: 2011-09-01; Completion date: 2012-12-01
Enrollment: 581 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Efficacy and tolerability study in severe chronic obstructive pulmonary disease (COPD) patients.

Detailed description:
Efficacy and tolerability study of Symbicort Turbuhaler (160/4.5µg/inhalation,2inhalations twice daily) added to Atrovent (20µg/inhalation, 2 inhalations 4 times daily) + theophylline SR(0.1g/tablet, 1 tablet p.o. twice daily) compared with Atrovent + theophylline SR in severe COPD patients.

Arms: arm 1: budesonide/formoterol (Symbicort Turbuhaler 160/4.5µg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 µg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily) arm 2: ipratropium (AtroventTM 20 µg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
Interventions: intervention 1: Drug: Budesonide/formoterol (Symbicort Turbuhaler intervention 2: Drug: ipratropium (AtroventTM) intervention 3: theophylline SR
Intervention descriptions: intervention 1: budesonide/formoterol (Symbicort Turbuhaler 160/4.5µg/inhalation, 2 inhalations twice daily) intervention 2: ipratropium (AtroventTM 20 µg/inhalation, 2 inhalations four times daily) intervention 3: theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)

Protocol documents:
Clinical trial NCT01420861
Conditions: Prostate Cancer
Keywords: castrate resistant
Sponsor: GTx
Start date: 2011-09-01; Completion date: 2012-12-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the effect of GTx-758 on Serum Prostate-specific antigen (PSA) levels in men with castrate resistant prostate cancer who are maintained on androgen deprivation therapy (Serum PSA response and Serum PSA progression)

Detailed description:

Arms: arm 1: subjects will receive daily doses of 1000 mg GTx-758
Interventions: intervention 1: GTx-758
Intervention descriptions: intervention 1: two GTx 758 tablets per day

Protocol documents: