ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01340664
Conditions: Diabetes Mellitus, Type 2
Keywords: Canagliflozin Placebo Metformin Hemoglobin A1c Type 2 diabetes mellitus
Sponsor: Janssen Research & Development, LLC
Start date: 2011-07-01; Completion date: 2012-04-01
Enrollment: 279 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in patients with type 2 diabetes mellitus who are receiving treatment with metformin monotherapy (ie, treatment with a single drug) and have inadequate glycemic (blood sugar) control.

Detailed description:
This is a randomized (study drug assigned by chance), double-blind (neither the patient nor the study doctor will know the identity of assigned study drug), placebo-controlled, parallel-group,3-arm (3 treatment groups) multicenter study to determine the efficacy, safety, and tolerability of canagliflozin compared to placebo (a capsule that is identical in appearance to canagliflozin but does not contain active drug) in patients with type 2 diabetes mellitus (T2DM) who are not achieving an adequate response from current antihyperglycemic therapy with metformin to control their diabetes. Canagliflozin (a Sodium-Glucose Cotransporter 2 inhibitor) is currently under development to lower blood sugar levels in patients with T2DM. Patients will take single-blind placebo capsules orally (by mouth) for 2 weeks before randomization. Patients will be randomly assigned canagliflozin or matching placebo, orally, twice daily, with 1 capsule taken with the morning meal and 1 capsule taken with the evening meal (2 capsules per day) and concurrent with metformin, if applicable, for up to 18 weeks. The dosing time of metformin should remain the same throughout the study.

Arms: arm 1: Each patient will receive 50 mg canagliflozin twice daily for 18 weeks. arm 2: Each patient will receive 150 mg canagliflozin twice daily for 18 weeks arm 3: Each patient will receive matching placebo twice daily for 18 weeks
Interventions: intervention 1: Canagliflozin 50 mg intervention 2: Placebo intervention 3: Canagliflozin 150 mg intervention 4: Metformin
Intervention descriptions: intervention 1: One canagliflozin 50-mg capsule taken orally twice daily with a meal for 18 weeks intervention 2: 1 placebo capsule taken orally twice daily with a meal for 18 weeks intervention 3: 1 canagliflozin 150-mg capsule taken orally twice daily with a meal for 18 weeks intervention 4: The patient's stable daily dose of Metformin background therapy should be continued throughout the study.

Protocol documents:
Clinical trial NCT01341782
Conditions: Secondary Hyperparathyroidism Hemodialysis
Keywords: Secondary hyperparathyroidism Paricalcitol Hemodialysis Maxacalcitol
Sponsor: AbbVie (prior sponsor, Abbott)
Start date: 2011-05-01; Completion date: 2012-04-01
Enrollment: 255 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a comparison of the efficacy and safety of paricalcitol injection with maxacalcitol injection in adult Japanese chronic kidney disease patients receiving hemodialysis with secondary hyperparathyroidism. The main objective of this study is to demonstrate the efficacy of paricalcitol injection in reducing levels of parathyroid hormone without clinically significant hypercalcemia, compared to maxacalcitol injection.

Detailed description:

Arms: arm 1: Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg. arm 2: Participants received maxacalcitol at an initial dose of 5 µg (iPTH \< 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.
Interventions: intervention 1: paricalcitol intervention 2: maxacalcitol intervention 3: paricalcitol placebo intervention 4: maxacalcitol placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01361568
Conditions: Postoperative Pain
Keywords: pain acute pain visceral pain kappa agonist opioid analgesics peripheral nervous system agents physiological effects of drugs surgery hysterectomy post-operative post-operative complications
Sponsor: Cara Therapeutics, Inc.
Start date: 2011-07-01; Completion date: 2012-04-01
Enrollment: 203 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to determine if CR845 is effective in treating the pain associated with a laparoscopic hysterectomy.

Detailed description:
Currently, the most widely used drugs to treat pain after surgery are opiates, such as morphine. Morphine works mainly by activating one of several types of opiate receptors that control some of our pain sensation - the so-called mu opiate receptors. These receptors are located in many areas of the brain and also outside of the brain. By activating these receptors, morphine provides significant pain relief, but also causes side effects that limit its use. Some of these side effects include: respiratory depression or arrest (slowed or stopped breathing), sedation (a state of calmness or extreme relaxation), euphoria (an exaggerated feeling of physical and mental well-being), constipation, nausea, vomiting, and drug addiction.

In order to avoid the side effects of morphine and other mu opiates, the present experimental drug CR845 was designed to work at a different type of opiate receptor - called kappa - that can also provide pain relief, by acting on sensory nerves outside the brain. CR845 was designed to penetrate the brain much less than other opiate drugs, which should result in pain relief similar to that of morphine, but with fewer side effects. Because CR845 activates kappa receptors instead of mu receptors, the side effects are different than with a morphine-type drug. In particular, kappa opiates, such as CR845, do not cause respiratory depression or arrest, euphoria, constipation, drug tolerance, physical drug dependence or drug addiction. For these reasons, CR845 may present a distinct advantage over other opiates that are currently used for pain relief and post-operative pain in particular.

Arms: arm 1: Peripheral kappa opioid receptor agonist arm 2: Matched Placebo
Interventions: intervention 1: CR845 intervention 2: Placebo intervention 3: CR845 intervention 4: Placebo
Intervention descriptions: intervention 1: Single i.v. dose (0.04 mg/kg) administered preoperatively intervention 2: Single i.v. dose administered preoperatively intervention 3: Single i.v. dose (0.04 mg/kg) administered postoperatively for pain intervention 4: Single i.v. dose administered postoperatively for pain

Protocol documents:
Clinical trial NCT01365507
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2011-06-01; Completion date: 2012-04-01
Enrollment: 276 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Asia and North America. The aim of this trial is to compare the efficacy and safety of insulin degludec/insulin aspart (IDegAsp) once daily in insulin-naïve subjects with type 2 diabetes mellitus when using two different titration algorithms (dose individually adjusted) as add-on to subject's ongoing treatment with metformin.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: insulin degludec/insulin aspart
Intervention descriptions: intervention 1: Insulin degludec/insulin aspart injected subcutaneously (under the skin) once daily. Dose individually adjusted.

Protocol documents:
Clinical trial NCT01370590
Conditions: Hypercholesterolemia
Sponsor: Organon and Co
Start date: 2011-09-01; Completion date: 2012-04-01
Enrollment: 406 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine whether ezetimibe/atorvastatin 10 mg/20 mg combination tablet is equivalent to the coadministration of ezetimibe 10 mg and atorvastatin 20 mg in lowering low-density-lipoprotein-cholesterol (LDL-C) after 6 weeks of treatment.

Detailed description:

Arms: arm 1: Medication will be administered in a double dummy fashion as 3 tablets orally on a daily basis, including 10 mg ezetimibe, 20 mg atorvastatin, and placebo to ezetimibe/atorvastatin. arm 2: Medication will be administered in a double dummy fashion as 3 tablets orally on a daily basis, including ezetimibe/atorvastatin 10 mg/20 mg, placebo to ezetimibe, and placebo to atorvastatin.
Interventions: intervention 1: Atorvastatin intervention 2: Ezetimibe intervention 3: Ezetimibe/atorvastatin intervention 4: Placebo to atorvastatin intervention 5: Placebo to ezetimibe intervention 6: Placebo to ezetimibe/atorvastatin
Intervention descriptions: intervention 1: 20 mg tablet administered orally once daily intervention 2: 10 mg tablet administered orally once daily intervention 3: Ezetimibe/atorvastatin 10 mg/20 mg combination tablet administered orally once daily intervention 4: Administered orally once daily intervention 5: Administered orally once daily intervention 6: Administered orally once daily

Protocol documents:
Clinical trial NCT01382446
Conditions: Ventilator Associated Pneumonia
Keywords: Trauma Mechanical Ventilation Ventilator Associated Pneumonia Oral Care
Sponsor: St. Joseph's Hospital and Medical Center, Phoenix
Start date: 2010-07-01; Completion date: 2012-04-01
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Examine the use of 0.12% Chlorhexidine Gluconate as an adjunct to current oral care protocol for trauma patients on ventilator support to decrease the incidence of Ventilator Associated Pneumonia and oral bacterial load.

Detailed description:
To see a significant decrease in the bacterial load in the oral mucosa and subsequently, a decrease in the pathogenesis of Ventilator Associated Pneumonia through the use of an oral rinse containing 0.12% Chlorhexidine Gluconate as part of an oral care protocol. Current oral care protocol includes the use of 1.5% H2O2-coated swabs every four hours, toothbrushing with toothpaste every 12 hours, and use of continuous subglottic suction apparatus.

Arms: arm 1: Current oral care protocol includes the use of 1.5% H2O2-coated swabs every four hours, toothbrushing with toothpaste every 12 hours, and use of continuous subglottic suction apparatus. arm 2: This study will compare our current oral care practice with the use of Chlorhexidine Gluconate 0.12% (Peridex, 3M Corporation) Twice daily in addition to regularly scheduled oral care as a means to decrease the incidence of VAP utilizing evidence-based strategies.
Interventions: intervention 1: Chlorhexidine gluconate intervention 2: Toothpaste
Intervention descriptions: intervention 1: 0.12% Chlorhexidine Gluconate 15ml Twice Daily, administered via toothbrushing and swabbing teeth, tongue, gingiva, and oral mucosa. intervention 2: Brushing the teeth, tongue, gingiva, and oral mucosa twice daily with toothbrush and toothpaste.

Protocol documents:
Clinical trial NCT01383447
Conditions: Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia Recurrent Adult Acute Lymphoblastic Leukemia
Sponsor: National Cancer Institute (NCI)
Start date: 2010-10-01; Completion date: 2012-04-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase I/II trial is studying the side effects and best dose of entinostat when given together with imatinib mesylate and to see how well it works in treating patients with relapsed or refractory Philadelphia chromosome-positive acute lymphoblastic leukemia. Entinostat and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose (MTD) of entinostat when given in combination with imatinib (matinib mesylate).

SECONDARY OBJECTIVES:

I. To estimate the rate of complete response (CR) for patients greater ≥ 18 years of age with relapsed/refractory Ph+ ALL treated with a combination of entinostat and imatinib.

II. To estimate the 1 year progression free survival (PFS) for patients greater ≥ 18 years of age with relapsed/refractory Ph+ ALL treated with a combination of entinostat and imatinib III. To describe the comparative pharmacokinetics (PK) and pharmacodynamics (PD) of entinostat when administered alone vs. in combination with imatinib.

IV. To assess the predictive value of levels of flow cytometric minimal residual disease (MRD) on duration of progression free survival for the study population.

OUTLINE: This is a phase I, dose-escalation study of entinostat followed by a phase II study.

Patients receive entinostat orally (PO) daily on days 1, 8, 15, and 22 and imatinib mesylate PO twice daily on days 1-28 (days 4-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days.

Arms: arm 1: Patients receive entinostat PO daily on days 1, 8, 15, and 22 and imatinib mesylate PO twice daily on days 1-28 (days 4-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: entinostat intervention 2: imatinib mesylate intervention 3: laboratory biomarker analysis intervention 4: pharmacological study intervention 5: western blotting intervention 6: immunohistochemistry staining method intervention 7: flow cytometry intervention 8: polymerase chain reaction intervention 9: high performance liquid chromatography intervention 10: mass spectrometry
Intervention descriptions: intervention 1: Given PO intervention 2: Given PO intervention 3: Correlative studies intervention 4: Correlative studies intervention 5: Correlative studies intervention 6: Correlative studies intervention 7: Correlative studies intervention 8: Correlative studies intervention 9: Correlative studies intervention 10: Correlative studies

Protocol documents:
Clinical trial NCT01395901
Conditions: Postoperative Nausea and Vomiting
Keywords: Prevention of Postoperative Nausea and Vomiting Palonosetron Ondansetron Pediatric
Sponsor: Helsinn Healthcare SA
Start date: 2011-06-01; Completion date: 2012-04-01
Enrollment: 670 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the efficacy of a single palonosetron IV dose compared to a single ondansetron IV dose in the prevention of postoperative nausea and vomiting through 24 hours after surgery in children aged from neonates up to less than 17 years undergoing elective surgical procedures requiring general intravenous anesthesia. The secondary objective is to evaluate the safety and tolerability of IV palonosetron in pediatric patients.

Detailed description:

Arms: arm 1: Intervention: Drug: Palonosetron arm 2: Intervention: Drug: Comparator: Ondansetron
Interventions: intervention 1: Palonosetron intervention 2: Ondansetron intervention 3: Placebo to Ondansetron intervention 4: Placebo to Palonosetron
Intervention descriptions: intervention 1: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg) intervention 2: Single dose Ondansetron IV:

* 0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for \>40 kg;
* 13 years to less than 17 years dose: 4 mg intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01400932
Conditions: Acne Vulgaris
Keywords: inflammatory lesion Benzoyl peroxide (BPO) once daily acne vulgaris vehicle gel clindamycin (CLDM) 1%-BPO 3% gel non-inflammatory lesion
Sponsor: GlaxoSmithKline
Start date: 2011-07-01; Completion date: 2012-04-01
Enrollment: 360 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter, randomized, double-blinded, vehicle-controlled, parallel-group study in Japanese subjects with acne vulgaris to demonstrate the efficacy of GI148512 (benzoyl peroxide \[BPO\] 3% gel) when applied once daily for 12 weeks. This study will also evaluate the safety of GI148512 when applied topically once daily for 12 weeks.

Detailed description:
Main inclusion criteria will be 12 to 45 years of age, who have an Investigator Static Global Assessment (ISGA) score of 2 or greater at baseline visit, and have both 17 to 60 facial inflammatory lesions (papules plus pustules) and 20 to 150 facial non-inflammatory lesions (open and closed comedones), including nasal lesions. The primary objective is to demonstrate the superiority of GI148512 to vehicle gel in total lesion counts. The secondary objectives are to demonstrate the superiority of GI148512 to vehicle gel in inflammatory lesion counts, and to evaluate the efficacy of GI148512 compared with vehicle gel at each visit. A total of 360 subjects will be enrolled and randomly assigned to one of the groups.

Arms: arm 1: Subjects will apply in a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin). Also, the dose regimen will be once daily in the evening/bedtime. Comparison of 2 arms (GI148512 vs vehicle) arm 2: Subjects will apply in a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin). Also, the dose regimen will be once daily in the evening/bedtime.
Interventions: intervention 1: GI148512 intervention 2: vehicle gel
Intervention descriptions: intervention 1: GI148512, Topical gel in 1 g containing benzoyl peroxide 30 mg intervention 2: Matching vehicle gel of GI148512, not containing active ingredient (benzoyl peroxide)

Protocol documents:
Clinical trial NCT01408888
Conditions: Diabetes Mellitus, Type 2
Sponsor: Eli Lilly and Company
Start date: 2011-08-01; Completion date: 2012-04-01
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to study the effect of LY2189265 on how the body absorbs and processes a Type 2 Diabetes Mellitus (T2DM) drug (sitagliptin) and how sitagliptin affects LY2189265 when they are taken together.

The duration of participation in this study is expected to be approximately 61 days. The study requires 2 clinic confinements (one of 2 nights and one of 19 nights duration).

The study involves 3 injections, subcutaneous, of 1.5 milligrams (mg) LY2189265 and 18 daily doses of 100 mg sitagliptin tablets administered orally.

Detailed description:

Arms: arm 1: A single 1.5-milligram (mg) dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). arm 2: 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). There was a washout of at least 21 days before crossing over and receiving a single 1.5 mg dose of LY2189265 administered subcutaneously (Treatment 1).
Interventions: intervention 1: LY2189265 intervention 2: Sitagliptin
Intervention descriptions: intervention 1: Administered subcutaneously intervention 2: Administered orally

Protocol documents:
Clinical trial NCT01415531
Conditions: Hypertension
Keywords: Stage 1 Stage 2 Hypertension
Sponsor: Forest Laboratories
Start date: 2011-08-01; Completion date: 2012-04-01
Enrollment: 641 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy, safety, and tolerability of 8 weeks of therapy with nebivolol in comparison to placebo in younger patients 18 - 54 years of age with stage 1 or stage 2 essential hypertension.

Detailed description:

Arms: arm 1: Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration arm 2: Dose-matched placebo
Interventions: intervention 1: Nebivolol intervention 2: Placebo
Intervention descriptions: intervention 1: Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration intervention 2: Dose-match placebo

Protocol documents:
Clinical trial NCT01422434
Conditions: Psoriasis
Keywords: A national multi-centre prospective randomised double-blind active-controlled 3-arm parallel group 4 week study
Sponsor: LEO Pharma
Start date: 2011-07-01; Completion date: 2012-04-01
Enrollment: 676 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy of LEO 90105 ointment applied once daily with Dovonex® ointment applied twice daily and with Rinderon®-DP ointment applied once daily in Japanese subjects with psoriasis vulgaris.

Detailed description:
LEO 90105 ointment contains both calcipotriol and betamethasone dipropionate. It has been approved for the treatment of psoriasis in more than 60 centres, including most European countries, the US, China, Korea and Taiwan. This trial will investigate its safety and efficacy in the treatment of Japanese subjects with psoriasis.

Arms: arm 1: LEO 90105 ointment applied once daily for 4 weeks. arm 2: Applied twice daily for 4 weeks. arm 3: Applied once daily for 4 weeks
Interventions: intervention 1: LEO 90105 = calcipotriol + betamethasone dipropionate intervention 2: Dovonex® = calcipotriol intervention 3: Rinderon® - DP = betamethasone dipropionate
Intervention descriptions: intervention 1: Applied once daily for 4 weeks. intervention 2: Applied twice daily for 4 weeks. intervention 3: Applied once daily for 4 weeks.

Protocol documents:
Clinical trial NCT01426854
Conditions: Cataract
Keywords: Cataract Surgery Anti-ocular Inflammation Anti-ocular Pain
Sponsor: Alcon Research
Start date: 2011-07-01; Completion date: 2012-04-01
Enrollment: 260 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to demonstrate that Nepafenac Ophthalmic Suspension, 0.1% is superior to Nepafenac Vehicle (placebo) for the prevention and treatment of ocular inflammation and pain associated with cataract surgery in Chinese subjects.

Detailed description:

Arms: arm 1: Nepafenac Ophthalmic Suspension, 0.1%, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery. arm 2: Nepafenac Vehicle, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
Interventions: intervention 1: Nepafenac Ophthalmic Suspension, 0.1% intervention 2: Nepafenac Vehicle Ophthalmic Solution
Intervention descriptions: intervention 1: Topical ocular administration intervention 2: Inactive ingredients used as placebo; topical ocular administration

Protocol documents: