ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01466764
Conditions: Pain Inflammation
Keywords: biomarkers
Sponsor: Stanford University
Start date: 2011-10-01; Completion date: 2013-06-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators hypothesize that perioperative administration of anakinra will reduce incisional pain by lowering the concentration of inflammatory mediators in surgical wounds. This knowledge is important because it suggests a new, previously unexplored pharmacological target for the control of postoperative incisional pain.

Detailed description:
This study will test whether administration of anakinra, an IL-1 receptor antagonist, will decrease pain and improve wound healing in patients undergoing vascular or orthopedic surgical procedures. The investigators will administer two doses of Anakinra via an injection under the skin, one dose one hour before surgery and a second dose on the first postoperative day (24 hours after surgery). The investigators will remove fluid from the surgical incisions using a small plastic catheter placed under skin during surgery and measure the amounts of pain- causing inflammatory mediators. The investigators will also measure the amount of pain the participant is experiencing using questions about pain intensity and by gently touching the incision to determine sensitivity of the incision site.

Arms: arm 1: Two subcutaneous injections of anakinra (IL-1ra) were given, the first one hour prior to surgery and the second 24 hours after surgery. arm 2: Two subcutaneous injections of normal saline (same volume as the anakinra group injection) were given, the first one hour prior to surgery and the second 24 hours after surgery.
Interventions: intervention 1: Anakinra intervention 2: Normal Saline
Intervention descriptions: intervention 1: An injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery. intervention 2: An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery.

Protocol documents:
Clinical trial NCT01479530
Conditions: Parkinson's Disease
Keywords: Rasagiline Azilect Parkinson´s Disease Motor fluctuations
Sponsor: H. Lundbeck A/S
Start date: 2011-12-01; Completion date: 2013-06-01
Enrollment: 321 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The rationale for conducting this study is to evaluate the efficacy, tolerability, and safety of rasagiline compared to placebo in levodopa-treated Parkinson's Disease (PD) Chinese patients with motor fluctuations. Azilect® (Rasagiline) is indicated for the treatment of idiopathic PD as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Placebo intervention 2: Azilect®
Intervention descriptions: intervention 1: Once daily; tablet; orally; 16 weeks intervention 2: 1 mg daily; tablet; orally; 16 weeks

Protocol documents:
Clinical trial NCT01482884
Conditions: Ulcerative Colitis
Keywords: tralokinumab inflammatory bowel disease moderate to severe ulcerative colitis
Sponsor: AstraZeneca
Start date: 2012-03-01; Completion date: 2013-06-01
Enrollment: 147 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is designed to evaluate the clinical efficacy and safety of tralokinumab as compared to placebo. Investigational product will be administered as subcutaneous injection. All patients will continue background therapy for ulcerative colitis as per local standards of care in addition to investigational product.

Detailed description:
A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis

Arms: arm 1: tralokinumab (CAT-354) sc injection arm 2: placebo sc injection
Interventions: intervention 1: tralokinumab intervention 2: placebo
Intervention descriptions: intervention 1: 2 sc injections of every 2 weeks for 12 weeks. intervention 2: 2 sc injections of every 2 weeks for 12 weeks.

Protocol documents:
Clinical trial NCT01496352
Conditions: Surgical Site Infection
Keywords: Surgical site infection Colorectal surgery
Sponsor: Dr. Reddy's Laboratories Limited
Start date: 2012-02-01; Completion date: 2013-06-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, placebo controlled, safety, tolerability, and pharmacokinetic dose escalation Phase II study of DFA-02 in patients undergoing colorectal surgery to evaluate the safety, tolerability and pharmacokinetics of DFA-02.

Detailed description:
Despite antibiotic prophylaxis and improvements in surgical techniques, surgical site infections (SSI) still occur. DFA-02 is a novel bioresorbable modified release gel containing both gentamicin and vancomycin to be applied during surgical incision closure for the prevention of surgical site infections (SSIs) in patients undergoing colorectal surgery.

Arms: arm 1: Progressive cohorts of 10 subjects (8 active, 2 placebo) receiving 10, 20 , 30 or 40 mL of DFA-02 or matching placebo. arm 2: None
Interventions: intervention 1: DFA-02 intervention 2: Placebo
Intervention descriptions: intervention 1: Modified release product containing gentamicin and vancomycin for application at the conclusion of surgery after closure of the fascia and prior to skin closure intervention 2: DFA-02 placebo

Protocol documents:
Clinical trial NCT01500083
Conditions: Indolent Non-Hodgkin's Lymphoma Chronic Lymphocytic Leukemia
Keywords: iNHL CLL
Sponsor: Lundbeck Canada Inc.
Start date: 2012-03-01; Completion date: 2013-06-01
Enrollment: 90 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the current study is to evaluate additional safety data of bendamustine in up to 100 patients with Indolent Non-Hodgkin's Lymphoma (iNHL) relapsing from a rituximab regimen or Chronic Lymphocytic Leukemia (CLL). Patients will receive up to 6 or 8 cycles of bendamustine treatment using the dosing regimens of TREANDA® (bendamustine) approved in several countries, which have been shown to be reasonably well tolerated. The study protocol includes safety monitoring (i.e., adverse events, concomitant medications, supportive care, clinical safety laboratory tests, and clinical disease status monitoring).

It is an interventional, multicentre, prospective, open-label expanded access study, which in addition allows investigators in Canada, and their patients, access to bendamustine while it is pending Canadian marketing approval.

Although the treatment options available for patients with iNHL or CLL do induce substantial responses, there is no curative treatment. One potential drug candidate for the treatment of CLL and iNHL is bendamustine.

Bendamustine has been widely used in Germany for more than 30 years and is marketed in the United States for treatment of CLL and for treatment of iNHL that has progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen. In October 2010, the European Medicines Agency formally approved bendamustine in a number of Member States of the European Union for the treatment of patients with iNHL, CLL, and multiple myeloma. The drug's safety profile in these patient populations has been extensively characterized and no unexpected safety concerns are anticipated.

Detailed description:

Arms: arm 1: Patients with CLL will receive bendamustine at a dose of 100 mg/m2 on Days 1 and 2 in treatment cycles of 28 days for up to six cycles. arm 2: Patients with iNHL will receive bendamustine at a dose of 120 mg/m2 on Days 1 and 2 in treatment cycles of 21 or 28 days for up to eight cycles.
Interventions: intervention 1: Bendamustine at a dose of 100 mg/m2 intervention 2: Bendamustine at a dose of 120 mg/m2
Intervention descriptions: intervention 1: Bendamustine will be administered intravenously over 30 minutes. intervention 2: Bendamustine will be administered intravenous (i.v.) over 60 minutes.

Protocol documents:
Clinical trial NCT01504412
Conditions: Pain Diabetic Peripheral Neuropathy
Keywords: Pain Diabetic Peripheral Neuropathy
Sponsor: Daiichi Sankyo Co., Ltd.
Start date: 2012-01-01; Completion date: 2013-06-01
Enrollment: 450 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the effectiveness and safety of DS-5565, compared to placebo, in subjects with pain associated with diabetic peripheral neuropathy.

Detailed description:

Arms: arm 1: DS-5565 10mg/day, administered in 2 doses. Treatment period: 1 week titration and 6 weeks of fixed dose. arm 2: DS-5565 20mg/day, administered in 2 doses. Treatment period: 1 week titration and 6 weeks of fixed dose. arm 3: DS-5565 30mg/day, administered in 2 doses. Treatment period: 1 week titration and 6 weeks of fixed dose. arm 4: DS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day. arm 5: Pregabalin capsules 300mg/day administered in 2 doses
Interventions: intervention 1: DS-5565 intervention 2: DS-5565 intervention 3: DS-5565 intervention 4: Placebo intervention 5: Pregabalin capsules
Intervention descriptions: intervention 1: Oral tablets administered twice daily intervention 2: Oral tablets administered twice daily intervention 3: Oral tablets administered twice daily intervention 4: DS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day intervention 5: Pregabalin oral capsules 150 mg administered twice a day

Protocol documents:
Clinical trial NCT01505881
Conditions: Thromboembolism Heart Valve Prosthesis
Sponsor: Boehringer Ingelheim
Start date: 2011-12-01; Completion date: 2013-06-01
Enrollment: 158 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To collect additional data relating to safety and indicators of efficacy for patients who have participated in the 1160.113 study.

Detailed description:

Arms: arm 1: Patient dose determined by dose allocated in 1160.113 and CrCl levels arm 2: warfarin doses to maintain INR levels
Interventions: intervention 1: dabigatran etexilate low dose intervention 2: warfarin 5mg intervention 3: dabigatran etexilate intermediate dose intervention 4: warfarin 1mg intervention 5: dabigatran etexilate high dose intervention 6: warfarin 3mg
Intervention descriptions: intervention 1: active treatment (low) intervention 2: comparator warfarin intervention 3: active treatment (medium) intervention 4: comparator warfarin intervention 5: active treatment (high) intervention 6: comparator warfarin

Protocol documents:
Clinical trial NCT01519700
Conditions: Chemotherapy Associated Neutropenia Breast Cancer
Keywords: Filgrastim G-CSF, neutropenia supportive care breast cancer
Sponsor: Sandoz
Start date: 2011-12-01; Completion date: 2013-06-01
Enrollment: 218 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will assess the efficacy of EP2006 compared to Filgrastim with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.

Detailed description:

Arms: arm 1: Eligible patients will be teated with EP2006 arm 2: Eligible patients will be teated with Filgrastim
Interventions: intervention 1: EP2006 intervention 2: Filgrastim
Intervention descriptions: intervention 1: Eligible patients will be teated with EP2006 intervention 2: Eligible patients will be teated with Filgrastim

Protocol documents:
Clinical trial NCT01525225
Conditions: Type 2 Diabetes Mellitus
Sponsor: AstraZeneca
Start date: 2012-09-01; Completion date: 2013-06-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the pharmacokinetics of Saxagliptin, 5-hydroxy Saxagliptin, and Metformin in pediatric subjects with Type 2 diabetes mellitus (T2DM) following oral administration of Saxagliptin and Metformin XR fixed dose combination tablet and co-administration of Saxagliptin and Glucophage® (Metformin) IR tablets

Detailed description:
The primary purpose is to assess the pharmacokinetics of Saxagliptin, 5-hydroxy Saxagliptin, and Metformin in pediatric subjects aged 10 to 17 years with T2DM following oral administration of Saxagliptin and Metformin XR fixed dose combination tablet and co-administration of Saxagliptin and Glucophage® (Metformin) IR tablets

Arms: arm 1: None
Interventions: intervention 1: Metformin immediate release (IR) intervention 2: Saxagliptin intervention 3: Metformin IR intervention 4: Saxagliptin/Metformin XR FDC intervention 5: Metformin XR
Intervention descriptions: intervention 1: Tablet, Oral, 1000 mg, twice daily, 1 day intervention 2: Tablet, Oral, 5 mg, single-dose, 1 day intervention 3: Tablet, Oral, 1000 mg, twice daily, 5 days intervention 4: Tablet, Oral, 2.5 mg Saxagliptin/1000 mg Metformin extended release (XR), Single-dose of 2 tablets. Fixed dose combination (FDC). intervention 5: Tablet, Oral, 500 mg, Single-dose of 4 tablets

Protocol documents:
Clinical trial NCT01534182
Conditions: Relapsing Remitting Multiple Sclerosis
Keywords: Relapsing Remitting Multiple Sclerosis (RRMS) Fingolimod Disease Modifying Therapy (DMT) TSQM-9
Sponsor: Novartis Pharmaceuticals
Start date: 2012-01-01; Completion date: 2013-06-01
Enrollment: 298 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient Outcomes, Safety and Tolerability of (fingolimod) 0.5 mg/day in Patients with Relapsing Remitting Multiple Sclerosis who are candidates for MS therapy change from Previous Disease Modifying Therapy.

Detailed description:

Arms: arm 1: Participants received 0.5 mg orally once a day. arm 2: Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week or glatiramer acetate (GA), 20 mg subcutaneously once a day.
Interventions: intervention 1: Fingolimod intervention 2: Interferon beta - 1a (IFN) intervention 3: Glatiramer acetate (GA)
Intervention descriptions: intervention 1: 0.5 mg orally once a day intervention 2: 44 mcg subcutaneously three times a week intervention 3: 20 mg subcutaneously once a day

Protocol documents:
Clinical trial NCT01535014
Conditions: Obesity
Sponsor: Materia Medica Holding
Start date: 2011-12-12; Completion date: 2013-06-01
Enrollment: 493 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is:

* To assess safety of Dietressa in the dose of 6 tablets daily within 24 weeks in treatment of obese patients.
* To assess clinical efficacy of Dietressa in the dose of 6 tablets daily within 24 weeks of therapy in reducing body weight in obese patients.
* To compare clinical efficacy of two dosage patterns for Dietressa (1 tablet 6 times daily and 2 tablets 3 times daily) within 24 weeks in treatment of obese patients.

Detailed description:
In general, patients will be observed during 24 weeks of trial.

Arms: arm 1: Patients with Body Mass Index 30.0-34.9 (kg/m2) without previous anti-obesity treatment received Dietressa (2 tablets 3 times daily) for 24 weeks. arm 2: Patients with Body Mass Index 30.0-34.9 (kg/m2) without previous anti-obesity treatment received Dietressa (1 tablet 6 times daily) for 24 weeks. arm 3: Patients with Body Mass Index 30.0-34.9 (kg/m2) without previous anti-obesity treatment received Placebo (2 tablets 3 times daily) for 24 weeks. arm 4: Patients with Body Mass Index 30.0-34.9 (kg/m2) without previous anti-obesity treatment received Placebo (1 tablet 6 times daily) for 24 weeks.
Interventions: intervention 1: Dietressa intervention 2: Placebo
Intervention descriptions: intervention 1: Comparison of different dosages (frequency) of drug intervention 2: Placebo either (2 tablets 3 times daily) or

(1 tablet 6 times daily)

Protocol documents:
Clinical trial NCT01542502
Conditions: Heart Failure
Keywords: Heart failure with preserved ejection fraction Diastolic heart failure Aerobic exercise performance
Sponsor: Virginia Commonwealth University
Start date: 2012-02-01; Completion date: 2013-06-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This will be a randomized, double-blind, crossover pilot study to measure the safety and feasibility of Interleukin-1 (IL-1) blockade with Anakinra in patients with stable heart failure with preserved ejection fraction.

Detailed description:

Arms: arm 1: Treatment with daily subcutaneous injections of Anakinra 100 mg arm 2: Treatment with daily subcutaneous injection of placebo
Interventions: intervention 1: Anakinra intervention 2: Placebo
Intervention descriptions: intervention 1: Anakinra 100 mg daily subcutaneous injection intervention 2: Placebo daily subcutaneous injection

Protocol documents:
Clinical trial NCT01546922
Conditions: Adrenal Insufficiency
Keywords: Hydrocortisone Cognition Adrenal insufficiency Quality of Life Common Somatic Complaints Cardiovascular/Metabolic Profile Somatosensation
Sponsor: University Medical Center Groningen
Start date: 2012-02-01; Completion date: 2013-06-01
Enrollment: 63 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The aim of this study is to investigate whether a physiologically low hydrocortisone (HC) dose is better for cognition as compared to a physiologically high HC dose. In addition, quality of life, metabolic profile and somatosensation will be described in relation to HC dose.

Detailed description:
* Rationale: A wide variety in hydrocortisone (HC) substitution dose-regimens are considered physiological for patients with adrenal insufficiency. However, it is likely that cognition is negatively influenced by higher cortisol exposure to the brain. No studies have been performed to assess the effects of treatment regimens with a low physiological HC substitution dose on cognition in comparison to a high physiological HC substitution dose. These treatment regimens should take body weight and multiple dosing into account. In addition, substitution doses should be monitored by clinical evaluation and biochemical analysis for adverse effects associated with over- or under-replacement.
* Intervention: Patients with secondary adrenal insufficiency will be randomized in two groups to receive either a low dose HC (0.2-0.3 mg/kg body weight) for 10 weeks followed by 10 weeks of high dose HC (0.4-0.6 mg/kg body weight) or vice versa. At baseline and after both treatment periods, patients will be tested.

Arms: arm 1: First low dose of hydrocortisone = 0.2-0.3 mg/kg body weight for 10 weeks followed by a high dose of hydrocortisone = 0.4-0.6 mg/kg body weight arm 2: First a high dose of hydrocortisone = 0.4-0.6 mg/kg body weight for 10 weeks followed by a low dose of hydrocortisone = 0.2-0.3 mg/kg body weight
Interventions: intervention 1: Hydrocortisone
Intervention descriptions: intervention 1: Patients receive either a low dose HC (0.2-0.3 mg/kg body weight) for 10 weeks followed by 10 weeks of high dose HC (0.4-0.6 mg/kg body weight) or vice versa.

Protocol documents:
Clinical trial NCT01548404
Conditions: Atopic Dermatitis
Sponsor: Regeneron Pharmaceuticals
Start date: 2012-04-01; Completion date: 2013-06-01
Enrollment: 109 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective was to assess the clinical efficacy of repeated subcutaneous (SC) doses of Dupilumab in adult participants with moderate-to-severe atopic dermatitis (AD).

Detailed description:

Arms: arm 1: Placebo (for Dupilumab) once weekly for 12 weeks by subcutaneous (SC) injection. arm 2: Dupilumab 300 mg once weekly for 12 weeks by SC injection.
Interventions: intervention 1: Placebo intervention 2: Dupilumab
Intervention descriptions: intervention 1: Subcutaneous injection altered between back of arms, abdomen and upper thighs. intervention 2: Subcutaneous injection altered between back of arms, abdomen and upper thighs.

Protocol documents:
Clinical trial NCT01549873
Conditions: Idiopathic Scoliosis
Sponsor: Nationwide Children's Hospital
Start date: 2012-01-01; Completion date: 2013-06-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
When patients have spinal surgery, electrodes are placed on the body to measure motor evoked potentials (MEP) and somatosensory evoked potentials (SSEP). Many hospitals only use IV anesthesia because they feel that measuring MEP and SSEP is easier using IV anesthesia. At this hospital the investigators typically use inhaled anesthesia and are able to successfully measure MEP and SSEP. This is a study to find out if one method of anesthesia is better than the other for measuring MEP and SSEP.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: propofol intervention 2: Desflurane
Intervention descriptions: intervention 1: Propofol adjusted to maintain the bispectral index at 40-60. intervention 2: Desflurane adjusted to maintain the bispectral index at 40-60.

Protocol documents:
Clinical trial NCT01555931
Conditions: Postpartum Contraception
Sponsor: University of North Carolina, Chapel Hill
Start date: 2012-03-01; Completion date: 2013-06-01
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This will be a randomized clinical trial of 190 women aged 18-45 who plan to breastfeed their infant for at least 6 months and desire to use the LNG-IUS as their primary contraceptive method postpartum. The investigators will compare the frequency of breastfeeding among women receiving the levonorgestrel-releasing intrauterine system (LNG-IUS) immediately after vaginal delivery compared to 4-8 weeks later. The investigators hypothesize there will be no difference in breastfeeding prevalence between the two groups.

Detailed description:

Arms: arm 1: Placement within 48 hours of delivery arm 2: Placement 4-8 weeks after delivery
Interventions: intervention 1: Levonorgestrel-releasing intrauterine system
Intervention descriptions: intervention 1: Placement within 48 hours of delivery

Protocol documents: