ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01826214
Conditions: Acute Leukemias
Keywords: acute myeloid leukemia AML acute lymphoblastic leukemia ALL leukemia acute LDE225 adult patients relapsed/refractory
Sponsor: Novartis Pharmaceuticals
Start date: 2013-05-01; Completion date: 2015-05-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will evaluate the efficacy, safety and tolerability of two dosing schedules of LDE225 in patients with relapsed/refractory acute leukemia or elderly patients with untreated acute leukemia.

Detailed description:

Arms: arm 1: Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and then after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study. arm 2: Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
Interventions: intervention 1: LDE225
Intervention descriptions: intervention 1: LDE225 will be supplied as 200 mg capsules by Novartis. Patients will receive study treatment on an outpatient basis. LDE225 will be dispensed every two weeks for the first four weeks and at the start of every four weeks thereafter, as needed.

Protocol documents:
Clinical trial NCT01853072
Conditions: Non-Proliferative Diabetic Retinopathy Cataract
Keywords: Diabetes Type I Diabetes Type II non-proliferative diabetic retinopathy macular edema Cataract
Sponsor: Alcon Research
Start date: 2013-06-01; Completion date: 2015-05-01
Enrollment: 881 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to demonstrate superiority of Nepafenac Ophthalmic Suspension, 0.3% dosed once daily relative to Nepafenac Vehicle based upon clinical outcomes among diabetic subjects following cataract surgery.

Detailed description:

Arms: arm 1: With prednisolone acetate standard of care, Nepafenac Ophthalmic Suspension, 0.3%, 1 drop instilled in the operative eye 1 day prior to surgery, continuing on the day of surgery, and for 90 days following surgery. An additional 1 drop will be administered 30 to 120 minutes prior to surgery. arm 2: With prednisolone acetate standard of care, Nepafenac vehicle, 1 drop instilled in the operative eye 1 day prior to surgery, continuing on the day of surgery, and for 90 days following surgery. An additional 1 drop will be administered 30 to 120 minutes prior to surgery.
Interventions: intervention 1: Nepafenac Ophthalmic Suspension, 0.3% intervention 2: Nepafenac vehicle intervention 3: Prednisolone acetate
Intervention descriptions: intervention 1: Test intervention intervention 2: Inactive ingredients used as placebo comparator intervention 3: 1 drop instilled in the operative eye 4 times daily beginning post-operatively on the day of surgery for the first 2 weeks, followed by 2 times daily for the next 2 weeks

Protocol documents:
Clinical trial NCT01868542
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2013-06-01; Completion date: 2015-05-01
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Asia. The aim of the trial is to compare the glycaemic control of Levemir® (insulin detemir) administered once daily according to two titration algorithms after 20 weeks in subjects with type 2 diabetes inadequately controlled on metformin treatment with or without other anti-diabetic drugs (OADs).

Detailed description:

Arms: arm 1: A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values, the following insulin detemir dose adjustments were done : \>6.1 mmol/L (\>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, \< 4.4 mmol/L (\<80 mg/dL) -3U insulin detemir. arm 2: A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial. During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : \>10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, \<3.1 mmol/L (\<56 mg/dL) -4U insulin detemir.
Interventions: intervention 1: insulin detemir
Intervention descriptions: intervention 1: Insulin detemir was administered once daily to the subjects. The dose was titrated based on the previous breakfast SMPG values.

Protocol documents:
Clinical trial NCT01868633
Conditions: Postoperative Pain
Keywords: Cesarean delivery Analgesia Pain Dexamethasone intrathecal morphine spinal anesthesia
Sponsor: University of Iowa
Start date: 2013-03-01; Completion date: 2015-05-01
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the effectiveness intravenous (IV) dexamethasone when used as part of a multimodal regimen to manage post cesarean delivery pain.

We hypothesize that a single dose of IV dexamethasone administered, as part of a multimodal analgesia after spinal anesthesia will significantly reduce post cesarean delivery opioid consumption and pain

Detailed description:
After the subjects consent to participate in the study they will be transferred to the operating room for their scheduled cesarean delivery. They will have their routine spinal anesthesia with the dosages of drugs used standardized, and a standardized regimen to manage hypotension. After delivery of the baby the subjects will be administered either the study drug or placebo depending on the randomization. The subjects will then be prescribed a standard post-operative analgesia regimen. The subjects will then be interviewed at 12,24 and 48 hours post cesarean delivery. During the interview the subjects will be asked to rate their pain, nausea and vomiting and pruritus. They will also be asked to rate their quality of recovery from the surgery using Quality of Recovery-40 questionnaire. The subjects will be contacted 6 months after the study to rate their pain using a Short-Form McGill Pain Questionnaire

Arms: arm 1: intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively arm 2: intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively
Interventions: intervention 1: Dexamethasone intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01870843
Conditions: Depressive Disorder, Major
Keywords: Depressive Disorder, Major Depressive Disorder Depression Anxiety Escitalopram Quality of life Social functionality
Sponsor: Xian-Janssen Pharmaceutical Ltd.
Start date: 2014-03-01; Completion date: 2015-05-01
Enrollment: 261 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the impact of escitalopram on quality of life and social functionality in patients with major depressive disorder with anxiety symptom.

Detailed description:
This is an open-label (all people know the identity of the intervention), multi-center, prospective (a study in which the participants are identified and then followed forward in time for the outcome of the study), single-arm (all participants receiving one intervention) study. Approximately 260 participants will be enrolled in this study. This study consists of two phases: screening phase and treatment phase. In the treatment phase, participants will receive escitalopram for 8 weeks: escitalopram 10 mg per day for 1 week and then the dose of escitalopram will be flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment. Safety evaluations will include assessment of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination which will be monitored throughout the study. The total study duration will be approximately 2 years.

Arms: arm 1: Participants will receive escitalopram 10 mg per day for 1 week and then the dose of escitalopram will be flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
Interventions: intervention 1: Escitalopram
Intervention descriptions: intervention 1: Escitalopram will be administered as oral tablets 10 mg per day and then the dose of escitalopram will be flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.

Protocol documents:
Clinical trial NCT01872611
Conditions: Non-Proliferative Diabetic Retinopathy Cataract
Keywords: Diabetes Type I Diabetes Type II Non-proliferative diabetic retinopathy Macular edema Cataract
Sponsor: Alcon Research
Start date: 2013-06-01; Completion date: 2015-05-01
Enrollment: 819 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to demonstrate superiority of Nepafenac Ophthalmic Suspension, 0.3% dosed once daily relative to Nepafenac Vehicle based upon clinical outcomes among diabetic participants following cataract surgery.

Detailed description:

Arms: arm 1: With prednisolone acetate standard of care, Nepafenac Ophthalmic Suspension, 0.3%, 1 drop instilled in the operative eye 1 day prior to surgery, continuing on the day of surgery, and for 90 days following surgery. An additional 1 drop will be administered 30 to 120 minutes prior to surgery. arm 2: With prednisolone acetate standard of care, Nepafenac vehicle, 1 drop instilled in the operative eye 1 day prior to surgery, continuing on the day of surgery, and for 90 days following surgery. An additional 1 drop will be administered 30 to 120 minutes prior to surgery.
Interventions: intervention 1: Nepafenac Ophthalmic Suspension, 0.3% intervention 2: Vehicle intervention 3: Prednisolone acetate
Intervention descriptions: intervention 1: None intervention 2: Inactive ingredients used as placebo comparator intervention 3: 1 drop instilled in the operative eye 4 times daily beginning post-operatively on the day of surgery for the first 2 weeks, followed by 2 times daily for the next 2 weeks

Protocol documents:
Clinical trial NCT01880424
Conditions: Irritable Bowel Syndrome With Constipation (IBS-C)
Sponsor: AstraZeneca
Start date: 2013-07-01; Completion date: 2015-05-01
Enrollment: 1722 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This clinical trial is an international, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial comparing one dose of linaclotide to placebo. Approximately 800 patients with a diagnosis of IBS-C (modified Rome III criteria) will be randomized at up to 60 trial centers in China, Australia, and New Zealand.

The trial will consist of up to 21 days of screening, 14 to 21 days of pre-treatment, 12 weeks of double-blind treatment, and 2 weeks of follow-up. At the end of the Pre-treatment Period, patients meeting the entry criteria for this trial will be randomized to one of two double-blind treatment groups: 290 ug linaclotide, or placebo (1:1).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Placebo intervention 2: Linaclotide
Intervention descriptions: intervention 1: matching Placebo Capsules, Oral, once daily intervention 2: Linaclotide 290 ug Capsules, Oral, once daily

Protocol documents:
Clinical trial NCT01895543
Conditions: Chronic Idiopathic Constipation
Sponsor: Ferring Pharmaceuticals
Start date: 2013-09-01; Completion date: 2015-05-01
Enrollment: 411 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Safety and Tolerability Extension Trial for Patients with Chronic Idiopathic Constipation (CIC)

Detailed description:
This was a Phase 3 multicenter, open-label, safety and tolerability extension trial of 10 mg elobixibat daily, with possibility for dose adjustment to 5 mg daily, for 52-week Treatment Period in patients with CIC. A dose adjustment to 5 mg/day was allowed for the remainder of the trial if a patient reported unacceptable treatment-related diarrhoea that occurred within the first four weeks of treatment.

The trial enrolled patients from two lead-in, double-blind efficacy trials (trial codes NCT01827592 and NCT01833065).

Arms: arm 1: Elobixibat 10 mg
Interventions: intervention 1: Elobixibat 10 mg
Intervention descriptions: intervention 1: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily.

Protocol documents:
Clinical trial NCT01908972
Conditions: Hemangioma
Keywords: Hemangioma Propranolol prednisolone steroid
Sponsor: Seoul National University Hospital
Start date: 2013-06-01; Completion date: 2015-05-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety and efficiency of Propranolol as an initial treatment for pediatric hemangioma.

Detailed description:
* Randomized (A group : propranolol, B group : prednisolone)
* A group : 3 days admission and medication for 16 weeks
* B group : medication for 16 weeks without admission
* Hemangioma volume comparison by using MRI
* other measurement and drug adverse reaction monitoring

Arms: arm 1: Patients who will receive prednisolone medication (2 mg/kg/day ) for 16 weeks arm 2: Patients who will receive propranolol medication 2 mg/kg/day for 16 weeks
Interventions: intervention 1: Prednisolone intervention 2: Propranolol
Intervention descriptions: intervention 1: 2mg/kg/day for 16weeks intervention 2: 2mg/kg/day for 16weeks

Protocol documents:
Clinical trial NCT01925950
Conditions: Chronic Gastrointestinal Graft vs Host Disease
Keywords: BDP orBec GVHD beclomethasone dipropionate bone marrow transplant hematopoietic cell transplant HCT stem cell transplant marrow transplant SCT beclomethasone 17,21-dipropionate
Sponsor: Soligenix
Start date: 2013-12-01; Completion date: 2015-05-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Use of an oral topically-active glucocorticoid with limited side effects may control the gastrointestinal inflammatory process of GVHD and minimize glucocorticoid exposure.

Detailed description:

Arms: arm 1: Control arm 2: Investigational drug
Interventions: intervention 1: orBec intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01928381
Conditions: Diabetic Neuropathy, Painful; Diabetic Neuropathies
Sponsor: AstraZeneca
Start date: 2013-11-01; Completion date: 2015-05-01
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 2-part study. In Part 1 of the study, subjects will undergo a pain reporting training program in which a painful stimulus will be applied to the subject's hand, and the subjects will be asked to report how painful the stimulus is. Over the course of the pain training sessions, feedback will be provided to the subject about how accurately they are reporting their degree of pain, relative to the amount of pressure stimulus applied to evoke pain. Those subjects who have adequate pain reporting ability will be asked to continue into Part 2 of the study in which 3 different blinded study drugs will be administered to each subject, in a crossover design to compare whether or not the study drugs improve pain associated with diabetic neuropathy.

Detailed description:
This is a multi-center, randomized, two-part study in adults (ages 18-75 years) with Painful Diabetic Neuropathy (PDN).

In Part 1 of the study, eligible subjects will enter a 4-week Pain Training Period. During the Pain Training Period, subjects will receive three weekly in-clinic training sessions using repeated rating of experimental pressure pain stimuli. Subjects will receive feedback during this training and will be evaluated on their pain-reporting ability during each in-clinic session. Subjects with acceptable pain-reporting ability at the conclusion of the Pain Training Period will be eligible to enter Part 2 of the study. Subjects with unacceptable pain-reporting ability at the conclusion of the Pain Training Period will be discontinued from the study.

Part 2 of the study will consist of three consecutive double-blind crossover periods. Each crossover period will include 31 days of double-blind treatment. A follow-up visit will occur 14 ± 7 days after the last dose of study medication.

One of three treatments (placebo, pregabalin, or pregabalin + AZD5213) will be administered during each crossover treatment period, as determined by a randomly assigned treatment sequence.

Approximately 65 subjects will be screened in Part 1 of the study, in order to randomize up to approximately 32 subjects in Part 2 of the study.

Arms: arm 1: Capsules to match pregabalin and AZD5213 arm 2: AZD5213 in combination with pregabalin arm 3: pregabalin capsules
Interventions: intervention 1: AZD5213 + pregabalin intervention 2: Placebo intervention 3: pregabalin capsules
Intervention descriptions: intervention 1: Double blind Investigational drug AZD5213 (capsules) given in combination with pregabalin (capsules) intervention 2: Double blind placebo capsules to match AZD5213 and pregabalin intervention 3: Double blind pregabalin capsules to match AZD5213 and placebo

Protocol documents:
Clinical trial NCT01932112
Conditions: Atrial Fibrillation Persistent Common Pulmonary Vein
Keywords: Pulmonary Vein Isolation Adenosin effect Atrial fibrillation ablation
Sponsor: Yong Seog Oh
Start date: 2012-11-01; Completion date: 2015-05-01
Enrollment: 378 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The investigators studied the effects of adenosine on the reconnection rate after successful pulmonary veins isolation by radiofrequency catheter ablation in patients with drug-resistant atrial fibrillation

Detailed description:
Pulmonary vein isolation has emerged as an effective therapy for paroxysmal atrial fibrillation. However, atrial fibrillation recurs in up to 50% of patients, generally because of recovery of pulmonary vein conduction.

Adenosine given during the initial procedure may reveal dormant pulmonary vein conduction, thereby identifying the need for additional ablation, leading to improved outcomes.

Arms: arm 1: single arm study
Interventions: intervention 1: Adenosine arm
Intervention descriptions: intervention 1: After pulmonary vein isolation,20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.

Protocol documents:
Clinical trial NCT01936844
Conditions: Heart Failure
Sponsor: Virginia Commonwealth University
Start date: 2014-02-01; Completion date: 2015-05-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Anakinra ADHF is a double-blind randomized clinical trial of anakinra, recombinant human interleukin-1 receptor blocker, or placebo in patients with acute decompensated heart failure with the aim to quench the acute inflammatory response, as measured by the area-under-the-curve for C reactive protein over 14 days.

Detailed description:

Arms: arm 1: Anakinra 100 mg twice daily for the first 3 days followed by 100 mg daily for days 4-14 arm 2: Placebo injections twice daily for the first 3 days then once daily for days 4-14.
Interventions: intervention 1: Anakinra (high dose) intervention 2: Anakinra (standard dose) intervention 3: Placebo intervention 4: Placebo
Intervention descriptions: intervention 1: Anakinra 100 mg daily twice daily for days 1, 2, and 3 intervention 2: Anakinra 100 mg daily for days 4-14 intervention 3: Placebo twice daily for days 1, 2, and 3 intervention 4: Placebo daily for days 4-14

Protocol documents:
Clinical trial NCT01971580
Conditions: Single Ventricle Fontan Palliation
Sponsor: Washington University School of Medicine
Start date: 2012-08-01; Completion date: 2015-05-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Hypothesis:

Patients with a Fontan type palliation are limited by preload, or the rate at which blood returns to the heart after passively traversing the pulmonary capillary bed. By decreasing pulmonary vascular resistance using an endothelin receptor antagonist, both ventricular filling pressures and volumes will increase with a simultaneous decrease in systemic impedance to flow and decrease in central venous pressures, leading to an improved capacity to increase cardiac output, and thereby an improvement in patient functional status.

Patients who are candidates for the study will be randomized to a double-blind single crossover study. Therapy with either ambrisentan or placebo will be continued for 12 weeks, with a 2 week washout period between treatment periods. Subjects will be subjected to a VO2 max test to evaluate exercise capacity at enrolment, and on the last day of each treatment period. As a component of the VO2 max testing the patient's VE, VCO2, VE/VCO2 slope, ventilatory anaerobic threshold (VAT), peak work, efficiency, and other physiologic parameters as typically obtained from cardiopulmonary testing will be assessed. In addition, each patient will be asked to complete an SF-36 quality of life questionnaire at enrollment, and on the last day of each study period.

Detailed description:

Arms: arm 1: These patients will be randomized to have ambrisentan during the first study period, and placebo during the second study period. arm 2: These patients will be randomized to have placebo during the first study period, and ambrisentan during the second study period.
Interventions: intervention 1: Ambrisentan
Intervention descriptions: intervention 1: None

Protocol documents: