ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01721486
Conditions: Tonsillitis Airway Obstruction Difficulty Swallowing
Keywords: tonsillitis recurrent tonsillitis obstructed air passages swallowing difficulties
Sponsor: Kaveh Aslani, MD
Start date: 2012-09-01; Completion date: 2015-01-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare IV acetaminophen to oral acetaminophen for pain control in children undergoing tonsillectomy with or without adenoidectomy.

Detailed description:
Tonsillectomy with or without adenoidectomy is a common surgical procedure in children and adolescents. Usually performed for recurrent tonsillitis or symptoms of airway obstruction, the procedure can result in significant post-operative pain. Common analgesic techniques include the use of oral acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen by mouth (PO) or ketorolac intravenous (IV), and narcotics. Acetaminophen has been shown to be effective in reducing pain and post-operative opioid requirements. Its administration can be oral, rectal, or intravenous. NSAIDs, though effective for pain control, have been shown to increase bleeding risk and disrupt hemostasis. Narcotics are effective for pain control but increase the risk of nausea and vomiting. They also have the potential to cause respiratory depression.

IV acetaminophen (OFIRMEV) is indicated for management of mild to moderate pain, and as an adjunct to opioids for severe pain. Several studies have examined the efficacy of IV acetaminophen vs placebo and/or active controls (meperidine, rectal acetaminophen (PR), tramadol). IV acetaminophen has been shown to be superior to placebo for pain control. Though there is data regarding peak plasma and Cerebral Spinal Fluid (CSF) concentration of acetaminophen when given by different routes (PO vs IV vs PR), there is no data comparing the efficacy of oral vs IV administration for pain control post-tonsillectomy in children.

Arms: arm 1: IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion. arm 2: PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.
Interventions: intervention 1: IV acetaminophen intervention 2: PO acetaminophen
Intervention descriptions: intervention 1: IV acetaminophen 15 mg/kg (up to 1000 mg) over 15 minute infusion after IV placement in OR . intervention 2: PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30minutes) prior to induction of anesthesia in the pre-operative area.

Protocol documents:
Clinical trial NCT01723228
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease Cognition Rasagiline
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2012-11-01; Completion date: 2015-01-01
Enrollment: 170 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 24-week, multicenter, randomized, double-blind, placebo-controlled, add-on, parallel-group study to evaluate the effect of rasagiline on cognitive function in adults with mild cognitive impairment (MCI) in Parkinson's disease (PD-MCI).

Detailed description:

Arms: arm 1: Rasagiline 1 mg oral tablets once daily for 24 weeks arm 2: Placebo oral tablets once daily for 24 weeks
Interventions: intervention 1: Rasagiline intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01728324
Conditions: Hepatitis C, Chronic
Sponsor: Boehringer Ingelheim
Start date: 2012-11-01; Completion date: 2015-01-01
Enrollment: 496 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the study is to confirm efficacy and safety of treatment with 600 mg of BID BI 207127 in combination with 120 mg QD FDV and RBV for 16 or 24 weeks in target chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.

Detailed description:

Arms: arm 1: BI 207127 in combination with FDV and RBV for 24 weeks (randomised) arm 2: BI 207127-placebo, FDV-placebo and RBV-placebo for 8 weeks followed by BI 207127 in combination with FDV and RBV for 16 weeks (randomised) arm 3: BI 207127 in combination with FDV and RBV for 24 weeks (allocated to patients with compensated cirrhosis)
Interventions: intervention 1: BI 207127-placebo: 8-week treatment intervention 2: Ribavirin: 24-week treatment intervention 3: BI 207127: 24-week treatment intervention 4: Faldaprevir: 24-week treatment intervention 5: Faldaprevir: 24-week treatment intervention 6: Ribavirin-placebo: 8-week treatment intervention 7: BI 207127: 24-week treatment intervention 8: Faldaprevir-placebo: 8-week treatment intervention 9: Faldaprevir: 16-week treatment intervention 10: Ribavirin: 16-week treatment intervention 11: RBV: 24-week treatment intervention 12: BI 207127: 16-week treatment
Intervention descriptions: intervention 1: 8 weeks of placebo treatment intervention 2: 24 weeks of active treatment intervention 3: 24 weeks of active treatment intervention 4: 24 weeks of active treatment intervention 5: 24 weeks of active treatment intervention 6: 8 weeks of placebo treatment intervention 7: 24 weeks of active treatment intervention 8: 8 weeks of placebo treatment intervention 9: 16 weeks of active treatment intervention 10: 16 weeks of active treatment intervention 11: 24 weeks of active treatment intervention 12: 16 weeks of active treatment

Protocol documents:
Clinical trial NCT01732796
Conditions: Hepatitis C, Chronic
Sponsor: Boehringer Ingelheim
Start date: 2012-12-01; Completion date: 2015-01-01
Enrollment: 470 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the study is to confirm efficacy of treatment for 16 and 24 weeks in chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.

Detailed description:

Arms: arm 1: 24 weeks of BI 207127 and BI 201335 in combination with Ribavirin arm 2: 16 weeks of BI 207127 and QD BI 201335 RBV, followed by additional 8 weeks of placebo BI 207127+ placebo BI 201335 in combination with placebo RBV arm 3: 24 weeks of BI 207127and BI 201335 in combination with RBV
Interventions: intervention 1: Ribavirin (RBV) intervention 2: BI 201335 (Faldaprevir) intervention 3: Ribavirin (RBV) intervention 4: BI 207127 intervention 5: BI 201335 (Faldaprevir) intervention 6: Ribavirin (RBV) intervention 7: BI 207127 intervention 8: Faldaprevir (BI 201335) intervention 9: BI 207127
Intervention descriptions: intervention 1: 24 weeks of active RBV intervention 2: 16 weeks of BI 201335 followed by 8 weeks placebo to BI 201335 intervention 3: 24 weeks of active RBV intervention 4: 24 weeks of BI 207127 intervention 5: 24 weeks of BI 201335 intervention 6: 16 weeks of Ribavirin followed by 8 weeks of placebo to Ribavirin intervention 7: 16 weeks BI 207127 followed by 8 weeks placebo to BI 207127 intervention 8: 24 weeks of 201335 intervention 9: 24 weeks of BI 207127

Protocol documents:
Clinical trial NCT01753310
Conditions: Cervical Dystonia
Sponsor: Ipsen
Start date: 2013-01-01; Completion date: 2015-01-01
Enrollment: 134 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the protocol is to evaluate the efficacy and safety of Dysport® using 2 mL dilution compared with placebo for the treatment of Cervical Dystonia.

Detailed description:

Arms: arm 1: Dysport® (intramuscular injection), between 250 and 500 units (U)/vial using 2mL dilution, 1 cycle only arm 2: Placebo, up to 2mL
Interventions: intervention 1: Botulinum toxin type A intervention 2: Placebo
Intervention descriptions: intervention 1: Intramuscular injection, between 250 and 500 units (U)/vial using 2mL dilution, 1 cycle only intervention 2: Up to 2mL

Protocol documents:
Clinical trial NCT01755416
Conditions: Type 1 Diabetes
Keywords: Type 1 diabetes closed loop artificial pancreas insulin victoza liraglutide
Sponsor: Albert Einstein College of Medicine
Start date: 2013-01-01; Completion date: 2015-01-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Hypothesis: In type 1 diabetes mellitus, in the setting of a closed loop glucose control system: adjunctive therapy with Liraglutide will afford better post-prandial glycemic excursions than insulin mono-therapy.

Specific Aim: To determine if post-prandial glucose excursions are lowered with the addition of Liraglutide compared to insulin mono-therapy.

Study Design: This is a randomized open labeled crossover design trial comparing adjuvant Liraglutide and insulin Vs. insulin mono-therapy using the ePID closed-loop system for insulin delivery.

Detailed description:
After the screening visit, subjects will be randomized to come for two overnight visits. Study A- the subjects will be on the closed loop device with Novolog rapid acting insulin. In Study B- in addition to insulin the subjects will take a one time sub cutaneous injection of 1.2 mg of Victoza before dinner on Day 1. Both visits will last for approximately 30 hours and the subjects will be managed by the closed loop device for approximately 25 hours.

Arms: arm 1: subject will be on the closed loop device with enlite sensors for about 27 hours. They will not be on any study medication and will be on insulin alone. arm 2: Subject will be on the closed loop device with enlite sensors for about 27 hours. In addition to being on insulin, they would take a single injection of 1.2 mg of Liraglutide subcutaneously before dinner, on Day 1.
Interventions: intervention 1: Closed loop with sensor and Insulin intervention 2: Closed loop with sensor, Insulin and Liraglutide
Intervention descriptions: intervention 1: Subject will be on the closed loop device with enlite sensors for about 27 hours. They will not be on any study medication and will be on insulin alone. intervention 2: In this study visit the subject will be on the closed loop device with enlite sensors for about 27 hours. In addition to being on insulin, they would take a single injection of 1.2 mg of Liraglutide subcutaneously before dinner on Day 1.

Protocol documents:
Clinical trial NCT01756560
Conditions: Duration of Pain Relief
Keywords: anterior cruciate ligament block duration
Sponsor: University of Chicago
Start date: 2013-01-01; Completion date: 2015-01-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Anterior cruciate ligament reapair is a painful procedure. Single shot femoral and sciatic nerve block only last 12-16 hrs. Since dexamethasone prolongs brachial plexus block, using it in lower extremity blocks will prolong the analgesia to provide better outpatient pain relief after surgery at home.

Detailed description:

Arms: arm 1: in this group, plain bupivacaine will be used to block femoral and sciatic nerve arm 2: Bupivacaine mixed with dexamethasone will be used to block femoral and sciatic nerve
Interventions: intervention 1: dexamethsone intervention 2: Bupivacaine
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01756573
Conditions: Duration of Pain Relief
Keywords: block duration analgesia
Sponsor: University of Chicago
Start date: 2013-01-01; Completion date: 2015-01-01
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Effect of dexamethasone on prolonging upper extremity block is well known. But it not known if the effect comes from its local effect on the nerves or from its general analgesic effect. In this study we will compare the systemic effect to its local effect to find out if there is a difference or not.

Detailed description:

Arms: arm 1: Control arm 2: Dexamethasone will be mixed with bupivacaine arm 3: Dexamethasone will be given intravenously
Interventions: intervention 1: Dexamthsone intervention 2: Bupivacaine
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01801930
Conditions: Colorectal Cancer
Keywords: OCV-C02 Colorectal Cancer Antigen specific cancer immunotherapeutic
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2013-03-01; Completion date: 2015-01-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the safety and tolerability of OCV-C02 in Patients With Advanced or Relapsed Colorectal Cancer Who Are Refractory or Intolerant to Standard Chemotherapy

Detailed description:
The incidence of dose limiting toxicity (DLT) will be evaluated in cohorts of six patients by starting OCV-C02 administration at dose level 1 (OCV-103 and OCV-104 at 0.3 mg each), increasing the dose to dose level 2 (at 1 mg each), level 3 (at 3 mg each), and then up to dose level 4 (at 6 mg each). Once-weekly administration will be repeated four times in each treatment cycle, and the incidence of DLT from Day 1 to Day 29 will be evaluated.

At the end of Cycle 1, patients who wish to continue OCV-C02 treatment and have provided their written consent will be permitted to continue participation in the trial using the same dosing schedule for each subsequent cycle as that for Cycle 1.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: OCV-103 and OCV-104 intervention 2: OCV-103 and OCV-104 intervention 3: OCV-103 and OCV-104 intervention 4: OCV-103 and OCV-104
Intervention descriptions: intervention 1: 0.3 mg of each intervention 2: 1 mg of each intervention 3: 3 mg of each intervention 4: 6 mg of each

Protocol documents:
Clinical trial NCT01806896
Conditions: Huntington's Disease
Sponsor: Pfizer
Start date: 2013-09-01; Completion date: 2015-01-01
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the Safety, Tolerability and Brain Function of 2 doses of PF-0254920 in Subjects with Early Huntington's Disease.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: PF-02545920 intervention 2: Placebo intervention 3: PF-02545920 intervention 4: Placebo
Intervention descriptions: intervention 1: * Dose will be titrated up every 2 days by 5mg increments: 5mg Days 1-2, 10mg days 3-4, 15mg days 5-6, and reach 20 mg from Days 7 to Day28.
* Orally, approx. Q12H (range 10-14 hours), administered at least one hour prior to, or two hours after meals.
* Treatment for 28 days. intervention 2: \- Orally, approx. Q12H (range 10-14 hours), administered at least one hour prior to, or two hours after meals.

Dosing for 28 days. intervention 3: * 5mg dose
* Orally, approx. Q12H (range 10-14 hours), administered at least one hour prior to, or two hours after meals.
* Dosing for 28 days. intervention 4: * Orally, approx. Q12H (range 10-14 hours), administered at least one hour prior to, or two hours after meals.
* Dosing for 28 days.

Protocol documents:
Clinical trial NCT01822548
Conditions: Type 2 Diabetes
Keywords: EPC diabetes DPP IV inhibitors
Sponsor: Azienda Ospedaliero-Universitaria di Parma
Start date: 2010-10-01; Completion date: 2015-01-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effect of Dipeptidyl peptidase (DPP) -IV inhibitor Vildagliptin vs. Glibenclamide on circulating endothelial progenitor cells (EPCs) number in type 2 diabetes patients in metformin failure. Subjects will be followed for 12 months after randomization.

Detailed description:
Diabetic patients show a higher cardiovascular risk compared with non-diabetic patients. It is therefore crucial that blood glucose lowering drugs reveal a favorable cardiovascular risk profile independently of metabolic control.

EPCs are a subset of circulating mononuclear cells derived from the bone marrow. EPCs play a fundamental role in the formation of new blood vessels (neo-endothelization) and repairing of existing blood vessels (re-endothelization) in order to maintain endothelial homeostasis and integrity. Endothelial damage and tissue ischemia, through the release of growth factors and cytokines, represent a strong stimulus for the mobilization of EPCs from the bone marrow. Reduced EPC number has been related to the presence of traditional risk factors for cardiovascular disease and to the development of atherosclerosis and has been shown to predict cardiovascular (CV)risk. Type 2 diabetes is known to be associated with an increased CV risk and a reduced EPC number. Recent data suggest that DPP-IV inhibitors might be involved in the mechanisms promoting bone-marrow EPC mobilization. This putative ancillary effect of DPP-IV might have a favorable impact on type 2 diabetes, a condition characterized by an increased CV risk.

This is a randomized, open-label, active-treatment-controlled, two parallel arm (2:1), intervention trial comparing DPP-IV inhibitor Vildagliptin (100 mg daily) with Glibenclamide (maximum daily dose of 10 mg). Treatment allocation and titration regimens are not blinded.

Primary end-point:Absolute change in the EPC number at visit: V0 (randomization), V2 (month 4), V3 (month 8) and V4 (month 12).

Secondary end-point: Absolute change in HbA1C compared to baseline.

Arms: arm 1: Vildagliptin 100 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration arm 2: Glibenclamide maximum dose of 10 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration
Interventions: intervention 1: Vildagliptin intervention 2: Glibenclamide intervention 3: Metformin
Intervention descriptions: intervention 1: 100 mg daily intervention 2: 2.5 mg (total daily), progressively increased up to a maximum dose of 5 mg x 2/ day. intervention 3: concomitant therapy with metformin is present in each arm (MAX dose: 2500 mg/die)

Protocol documents:
Clinical trial NCT01842594
Conditions: Sarcoma
Keywords: Sarcoma, Hydroxychloroquine, Sirolimus, PET
Sponsor: Shin Kong Wu Ho-Su Memorial Hospital
Start date: 2012-08-01; Completion date: 2015-01-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Determine the objective response rate in sarcoma patients treated with hydroxychloroquine and sirolimus.

Detailed description:
This study evaluates the daily morning single dose of hydroxychloroquine /sirolimus combined therapy in sarcoma patients. Study arm were treated with hydroxychloroquine 400 mg /sirolimus 2mg gd for 8-wk therapy. Patients will be discontinued from the study after 8-wk observation period.

Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study.

TREATMENT PLAN:

1. Both hydroxychloroquine 200 mg/tab and sirolimus 1 mg/tab are pills each are taken 2 tablet orally every day. Treatment will be divided into time periods called cycles. Each treatment cycle is 28 days. The exception to this 28 day cycle is when participants start taking the pills for the first time. When the hydroxychloroquine and sirolimus begins, the first cycle of 28 days begins.
2. There are several tests and procedures that will be performed at specific time periods during protocol treatment. These include: blood work, performance status assessment, questions about medical history and medications, tumor assessment with PET/CT or MRI and, eye exams.
3. Dose modification criteria:

Participants may continue to receive study treatment as long as they experienced grade 1 or 2 side effects. The treatment drug will be 50% reduction of dose in any grade 3 toxicity; and discontinued of treatment (off-study) in any grade 4 toxicity or disease progression during treatment.

Arms: arm 1: Both hydroxychloroquine 200 mg/tab and sirolimus 1 mg/tab are pills each are taken 2 tablet orally once daily(QD) for 2 cycles . Each treatment cycle is 28 days.
Interventions: intervention 1: Sirolimus and hydroxychloroquine
Intervention descriptions: intervention 1: Both hydroxychloroquine 200 mg/tab and sirolimus 1 mg/tab are pills each are taken 2 tablet orally QD for 2 cycles .

Each treatment cycle is 28 days.

Protocol documents:
Clinical trial NCT01849692
Conditions: Exudative Age-Related Macular Degeneration
Keywords: Exudative Age-Related Macular Degeneration Wet AMD Choroidal neovascularization (CNV) Vascular endothelial growth factor (VEGF)
Sponsor: Alcon Research
Start date: 2013-06-01; Completion date: 2015-01-01
Enrollment: 107 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to demonstrate a treatment effect of ESBA1008 applied as a microvolume injection or infusion on retinal function and morphology in subjects with exudative age-related macular degeneration (AMD).

Detailed description:
This 4-cohort study was conducted in 2 stages. Stage 1 consisted out of 2 Cohorts. In each cohort subjects were randomized 10:3 to either receive ESBA1008 (Cohort 1 : 2 injections, Cohort 2 : 1 infusion and 1 injection) or 2 Lucentis injections. Stage 2 was conducted similarly with a different dosing level for ESBA1008 (Cohort 3 and 4). Subjects had follow-up visits at Day 7 and Day 14. All cohorts receiving ESBA1008 on Day 0 also received ESBA1008 6mg/50 μL via injection on Day 28. After the Day 28 visit (all cohorts), subjects returned for follow up visits at Day 42 and Day 56.

Arms: arm 1: Cohort 1: One intravitreal injection on Day 0, followed by one intravitreal (IVT) injection of ESBA1008 6 mg/50 μL on Day 28 arm 2: Cohort 2: One intravitreal infusion on Day 0, followed by one intravitreal injection of ESBA1008 6 mg/50 μL on Day 28 arm 3: Cohort 3: One intravitreal injection on Day 0, followed by one intravitreal injection of ESBA1008 6 mg/50 μL on Day 28 arm 4: Cohort 4: One intravitreal infusion on Day 0, followed by one intravitreal injection of ESBA1008 6 mg/50 μL on Day 28 arm 5: Cohorts 1-4: One intravitreal injection on Day 0, followed by another intravitreal injection on Day 28
Interventions: intervention 1: ESBA1008 solution intervention 2: Ranibizumab
Intervention descriptions: intervention 1: Intravitreal injection or infusion intervention 2: Intravitreal injection

Protocol documents:
Clinical trial NCT01851174
Conditions: Pancreatic Carcinoma Non-resectable Stage IV Pancreatic Cancer
Sponsor: Western Regional Medical Center
Start date: 2013-02-01; Completion date: 2015-01-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To determine whether the occurrence of adverse events can be decreased by moving to a bi-weekly schedule of gemcitabine plus nab-Pacitaxel for the treatment of unresectable/metastatic pancreatic cancer.

Detailed description:
This study will help determine whether the occurrence of adverse events can be decreased by moving to a bi-weekly, opposed to a weekly, dosing schedule of gemcitabine plus nab-Pacitaxel for the treatment of unresectable/metastatic pancreatic cancer.

Arms: arm 1: Gemcitabine (1,000 mg/m\^2) administered intravenously on days 1 and 15, every 28 days

nab-Paclitaxel (125 mg/m\^2) administered intravenously on days 1 and 15, every 28 days
Interventions: intervention 1: Gemcitabine intervention 2: nab-Paclitaxel
Intervention descriptions: intervention 1: Patients will receive Gemcitabine (1,000 mg/m\^2) IV over 30 minutes after nab-paclitaxel infusion intervention 2: Patients will receive nab-Paclitaxel (125 mg/m\^2) IV over 30 minutes before Gemcitabine infusion

Protocol documents: