ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01163032
Conditions: Non-24-Hour Sleep-Wake Disorder
Keywords: Blindness Eye Diseases Nap Disorders Circadian Rhythm Disorders Sleep disorders Circadian Rhythm Sleep Disorders Dyssomnias Nervous System Diseases
Sponsor: Vanda Pharmaceuticals
Start date: 2010-08-01; Completion date: 2012-11-01
Enrollment: 136 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of a six month double-mask treatment of tasimelteon or placebo in male and female subjects with Non-24-Hour Sleep-Wake Disorder

Detailed description:
Non-24-Hour Sleep-Wake Disorder (N24HSWD) occurs when individuals, primarily those without light perception, are unable to synchronize their endogenous circadian pacemaker to the 24-hour light-dark cycle, and the timing of their circadian rhythm instead reflects the intrinsic period of their endogenous circadian pacemaker. As a result, the circadian rhythm of sleep-wake propensity in these individuals moves gradually later and later each day if there circadian period is \> 24 hours and earlier and earlier if \< 24 hours. These individuals will be able to sleep well at night when their sleep-wake propensity rhythm is approximately aligned with the 24-hour light-dark and social cycle. However, after a short time, the endogenous sleep-wake propensity rhythm and the 24-hour light-dark cycle will move out of synchrony with each other, and they may have difficulty falling asleep until well into the night. In addition to problems sleeping at the desired time, the subjects experience daytime sleepiness and daytime napping.

This will be a multicenter, randomized, double-masked, placebo-controlled, parallel study. The study has two phases: the pre-randomization phase followed by either the randomization phase or the open-label extension (OLE). The pre-randomization phase comprises a screening visit where subject's initial eligibility will be evaluated, a circadian period (τ) estimation segment, and a variable-length in-phase transition segment in which subjects will wait to start treatment until their circadian phase is aligned with their target bedtime. Subjects that meet all entry criteria for the study will enter the randomization phase. During the randomization phase, subjects will be asked to take either 20 mg tasimelteon or placebo approximately 1 hour prior to their target bedtime for 26 weeks in a double-masked fashion. Subjects who have a τ greater than 24.0 and meet all entry criteria but that are ineligible for the randomization phase due to their τ estimate may be given the opportunity to participate in the OLE phase. During the OLE phase, subjects will take open-label 20mg tasimelteon for 26 weeks.

Arms: arm 1: 20 mg tasimelteon capsules, PO daily for 6 months arm 2: Placebo capsules, PO daily for 6 months
Interventions: intervention 1: tasimelteon intervention 2: Placebo
Intervention descriptions: intervention 1: 20 mg tasimelteon capsules, PO daily for 6 months intervention 2: Placebo capsules, PO daily for 6 months

Protocol documents:
Clinical trial NCT01166958
Conditions: Osteoporosis
Sponsor: University of Wisconsin, Madison
Start date: 2010-09-01; Completion date: 2012-11-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Current osteoporosis therapies produce a prompt increase in bone mass, followed by only modest or no further subsequent gains. This limitation, known as the "remodeling transient," reflects the "coupling" of bone resorption with formation such that interventions impacting either of these processes lead to compensatory changes of the other. For example, medications which increase bone formation promptly also stimulate bone resorption. Thus, given the need to dramatically increase bone mass in patients with osteoporosis, it is necessary to "uncouple" formation and resorption. The investigators believe this to be possible using currently existing FDA-approved therapeutic agents, by using a novel, sequential approach.

This pilot project will obtain preliminary data essential to support future work. In this study, the investigators will begin to explore the use of sequential anabolic treatment with teriparatide followed by antiresorptive therapy with raloxifene. The investigators propose that such sequential treatment will allow opening of the "anabolic window," the brief period of time following initiation of teriparatide therapy in which bone formation exceeds resorption.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Teriparatide intervention 2: Raloxifene
Intervention descriptions: intervention 1: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day. intervention 2: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature.

Protocol documents:
Clinical trial NCT01169675
Conditions: Neoplasms
Sponsor: Boehringer Ingelheim
Start date: 2010-07-01; Completion date: 2012-11-01
Enrollment: 53 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This Phase I study will investigate the safety of BIBW 2992 in combination with standard dose pemetrexed (500mg/m2) given on a 21 day cycle in patients with advanced solid cancers. BIBW 2992 will be given on two different dose schedules; dosing on days 1-21 and dosing on days 1 to 6 of a 21 day cycle.

The use of epidermal growth factor receptor tyrosine kinase inhibitors (EGFR TKIs), including BIBW 2992 have demonstrated efficacy in solid tumors including non-small cell lung cancer (NSCLC). In addition, pemetrexed has demonstrated efficacy and has been approved as single agent chemotherapy in second-line NSCLC patients with adenocarcinoma. The data obtained from this trial shall allow for a conclusion as to whether BIBW 2992 may be safely administered in advanced cancer patients in combination therapy with pemetrexed.

Detailed description:

Arms: arm 1: patient receives low dose tablet BIBW 2992 po daily plus pemetrexed 500mg/m\^2 on day 1 of 21 day cycle arm 2: patient receives medium dose BIBW 2992 po daily plus pemetrexed 500mg/m\^2 on day 1 of 21 day cycle arm 3: patient receives high dose BIBW 2992 po daily plus pemetrexed 500mg/m\^2 on day 1 of 21 day cycle arm 4: patient receives low dose BIBW 2992 po daily on days 1-6 plus pemetrexed 500mg/m\^2 on day 1 of 21 day cycle arm 5: patient receives medium BIBW 2992 po daily on days 1-6 plus pemetrexed 500mg/m\^2 on day 1 of 21 day cycle arm 6: patient receives high dose BIBW 2992 po daily on days 1-6 plus pemetrexed 500mg/m\^2 on day 1 of 21 day cycle
Interventions: intervention 1: BIBW 2992 low dose intervention 2: BIBW 2992 high dose intervention 3: pemetrexed intervention 4: pemetrexed intervention 5: BIBW 2992 high dose 6 day intervention 6: pemetrexed intervention 7: pemetrexed intervention 8: pemetrexed intervention 9: pemetrexed intervention 10: BIBW 2992 low dose 6 day intervention 11: BIBW 2992 medium dose 6 day intervention 12: BIBW 2992 medium dose
Intervention descriptions: intervention 1: patient receives low dose BIBW 2992 po daily on day 1 of 21 day cycle intervention 2: patient receives high dose BIBW 2992 po daily on day 1 of 21 day cycle intervention 3: given intravenously on day 1 of a 21 day cycle intervention 4: given intravenously on day 1 of a 21 day cycle intervention 5: patient receives high dose BIBW 2992 po daily on days 1-6 on 1 of 21 day cycle intervention 6: given intravenously on day 1 of a 21 day cycle intervention 7: given intravenously on day 1 of a 21 day cycle intervention 8: given intravenously on day 1 of a 21 day cycle intervention 9: given intravenously on day 1 of a 21 day cycle intervention 10: patient receives low dose BIBW 2992 po daily on days 1-6 on day 1 of 21 day cycle intervention 11: patient receives medium dose BIBW 2992 po daily on day1 to 6 of a 21 day cycle intervention 12: patient receives medium dose BIBW 2992 po daily on day 1 of 21 day cycle

Protocol documents:
Clinical trial NCT01172808
Conditions: Asthma
Sponsor: Boehringer Ingelheim
Start date: 2010-08-01; Completion date: 2012-11-01
Enrollment: 1071 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this trial is to evaluate the efficacy and safety of 2.5 and 5 mcg tiotropium over a 24-week treatment period as compared to placebo and salmeterol (50 mcg twice daily). Tiotropium inhalation solution delivered by the Respimat® inhaler will be examined on top of maintenance treatment with inhaled corticosteroid controller medication in patients with moderate persistent asthma. Efficacy and safety will be assessed by measuring effects on lung function, effects on asthma exacerbations, effects on quality of life, effects on asthma control, effects on health care resource utilisation, and number of adverse events.

Detailed description:

Arms: arm 1: Once daily, delivered with Respimat® inhaler (+ inhalation of placebo HFA MDI twice daily) arm 2: Once daily, delivered with Respimat® inhaler (+ inhalation of placebo HFA MDI twice daily) arm 3: Twice daily, delivered with HFA MDI (+ inhalation of placebo Respimat® inhaler once daily) arm 4: Once daily, delivered with Respimat® inhaler + twice daily delivered with HFA MDI
Interventions: intervention 1: Placebo intervention 2: tiotropium Respimat® low dose intervention 3: Placebo intervention 4: Placebo intervention 5: tiotropium Respimat® high dose intervention 6: 50 mcg salmeterol HFA MDI intervention 7: Placebo intervention 8: Placebo
Intervention descriptions: intervention 1: Placebo that represents comparator intervention 2: IMP intervention 3: Placebo that represents comparator intervention 4: Placebo that represents comparator intervention 5: IMP intervention 6: Active comparator intervention 7: Placebo that represents BI drug intervention 8: Placebo that represents BI drug

Protocol documents:
Clinical trial NCT01172821
Conditions: Asthma
Sponsor: Boehringer Ingelheim
Start date: 2010-08-01; Completion date: 2012-11-01
Enrollment: 1032 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this trial is to evaluate the efficacy and safety of 2.5 and 5 mcg tiotropium over a 24-week treatment period as compared to placebo and salmeterol (50 mcg twice daily). Tiotropium inhalation solution delivered by the Respimat® inhaler will be examined on top of maintenance treatment with inhaled corticosteroid controller medication in patients with moderate persistent asthma. Efficacy and safety will be assessed by measuring effects on lung function, effects on asthma exacerbations, effects on quality of life, effects on asthma control, effects on health care resource utilisation, and number of adverse events.

Detailed description:

Arms: arm 1: Once daily, delivered with Respimat® inhaler (+ inhalation of placebo HFA MDI twice daily) arm 2: Once daily, delivered with Respimat® inhaler (+ inhalation of placebo HFA MDI twice daily) arm 3: Twice daily, delivered with HFA MDI (+ inhalation of placebo Respimat® inhaler once daily) arm 4: Once daily, delivered with Respimat® inhaler + twice daily delivered with HFA MDI
Interventions: intervention 1: placebo intervention 2: placebo intervention 3: placebo intervention 4: tiotropium Respimat® low dose intervention 5: placebo intervention 6: tiotropium Respimat® high dose intervention 7: 50 mcg salmeterol HFA MDI intervention 8: placebo
Intervention descriptions: intervention 1: Placebo that represents BI drug intervention 2: Placebo that represents comparator intervention 3: Placebo that represents comparator intervention 4: IMP intervention 5: Placebo that represents BI drug intervention 6: IMP intervention 7: Active comparator intervention 8: Placebo that represents comparator

Protocol documents:
Clinical trial NCT01173471
Conditions: Raised Intraocular Pressure
Keywords: Raised intraocular pressure
Sponsor: AstraZeneca
Start date: 2010-12-01; Completion date: 2012-11-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy of systemically administered AZD4017, compared with placebo, over a 28-day period in patients with raised intra-ocular pressure (IOP).

Detailed description:

Arms: arm 1: Europe: 200 mg AZD4017 arm 2: Europe: placebo arm 3: USA: 800 mg AZD4017 arm 4: USA: placebo
Interventions: intervention 1: AZD4017 intervention 2: Placebo intervention 3: AZD4017 intervention 4: Placebo
Intervention descriptions: intervention 1: tablet, oral, one tablet once daily, 28 days intervention 2: matching placebo tablet, oral, one tablet once daily, 28 days intervention 3: tablet, oral 2 tablets twice daily, 28 days intervention 4: matching placebo tablets, oral, 2 tablets twice daily, 28 days

Protocol documents:
Clinical trial NCT01174004
Conditions: Parkinson's Disease Psychosis
Sponsor: ACADIA Pharmaceuticals Inc.
Start date: 2010-07-01; Completion date: 2012-11-01
Enrollment: 199 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of 40 mg pimavanserin compared to placebo in patients with Parkinson's disease psychosis (PDP).

Detailed description:

Arms: arm 1: pimavanserin tartrate, 40 mg, tablet, once daily by mouth for 6 weeks arm 2: placebo, tablet, once daily by mouth for 6 weeks
Interventions: intervention 1: pimavanserin tartrate intervention 2: placebo
Intervention descriptions: intervention 1: pimavanserin tartrate, 40 mg, tablet, once daily by mouth for 6 weeks intervention 2: placebo, tablet, once daily by mouth for 6 weeks

Protocol documents:
Clinical trial NCT01175811
Conditions: Diabetes Mellitus, Type 2
Keywords: Metabolic Diseases Diabetes Mellitus, Type 2 Glargine Diabetes Mellitus Insulin LISPRO Insulin
Sponsor: Eli Lilly and Company
Start date: 2011-02-01; Completion date: 2012-11-01
Enrollment: 402 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to compare the effects on overall glycaemic control of two insulin intensification therapies.

Detailed description:

Arms: arm 1: Twice daily (before breakfast and lunch) insulin lispro mix 50 (50% insulin lispro, 50% insulin lispro protamine suspension \[LM50\]) and once daily (before dinner) insulin lispro mix 25 (25% insulin lispro, 75% insulin lispro protamine suspension \[LM25\]) arm 2: Once daily (bedtime) insulin glargine and three pre-meal insulin lispro
Interventions: intervention 1: Insulin Lispro Premix intervention 2: Insulin Glargine intervention 3: Insulin Lispro
Intervention descriptions: intervention 1: Participant dependent dose, administered subcutaneously for 24 weeks intervention 2: Participant dependent dose, administered subcutaneously for 24 weeks intervention 3: Participant dependent dose, administered subcutaneously for 24 weeks

Protocol documents:
Clinical trial NCT01177956
Conditions: Squamous Cell Carcinoma of the Head and Neck
Keywords: Recurrent and/or metastatic squamous cell carcinoma of the head and neck 1st-line Cetuximab Chemotherapy EMR 62241 -055 Merck KGaA Recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN)
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2009-12-01; Completion date: 2012-11-01
Enrollment: 73 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this trial is to assess the antitumor activity and safety profile of cetuximab when given in combination with cisplatin + 5-Fluorouracil (5-FU) for the first-line treatment of recurrent and/or metastatic Squamous Cell Carcinoma in Head and Neck (SCCHN) in Asian subjects.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Cetuximab intervention 2: Cisplatin intervention 3: 5-Fluorouracil
Intervention descriptions: intervention 1: The initial dose of cetuximab will be 400 milligram per square meter (mg/m\^2) as an intravenous (IV) infusion over 120 minutes. Subsequent weekly doses will be 250 mg/m\^2 as an IV infusion over 60 minutes.

Chemotherapy will be continued for up to a maximum of six 3-week cycles in the absence of progressive disease (PD) or unacceptable toxicity. All subjects will receive cetuximab treatment until the occurrence of PD or unacceptable toxicity to cetuximab. intervention 2: Subjects will receive 75 mg/m\^2 cisplatin as an IV infusion over 60 minutes on day 1 of each 3-week treatment cycle. intervention 3: Subjects will receive 750 mg/m\^2 per day 5-FU as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle.

Protocol documents:
Clinical trial NCT01180660
Conditions: Pain Obesity
Keywords: Gastric Surgery Pain Recovery Laparoscopic Surgery
Sponsor: Northwestern University
Start date: 2010-06-01; Completion date: 2012-11-01
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Can Intraoperative systemic lidocaine decrease postoperative opioid consumption and improve quality of recovery after laparoscopic gastric bypass surgery? The hypotheses:does the use of intraoperative systemic lidocaine decrease postoperative opioid consumption and improve quality of recovery after laparoscopic gastric bypass surgery.

This study has the potential to confirm an opioid sparing strategy for morbid obese patients undergoing laparoscopic gastric bypass surgery. The high incidence of obstructive sleep apnea and the increased risk of postoperative hypoxemia make the development of opioid sparing techniques in this patient population warranted.

Detailed description:

Arms: arm 1: Lidocaine infusion arm 2: Placebo Normal Saline Infusion
Interventions: intervention 1: Lidocaine Infusion intervention 2: Normal Saline
Intervention descriptions: intervention 1: 1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period intervention 2: Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period

Protocol documents:
Clinical trial NCT01241760
Conditions: Genotype 1 Chronic Hepatitis C Treatment Naive
Keywords: Genotype 1 chronic hepatitis C VX-950-C211 VX-950 IL28B Telaprevir Hepatitis C BID Q8h SOC
Sponsor: Janssen Infectious Diseases BVBA
Start date: 2010-12-01; Completion date: 2012-11-01
Enrollment: 744 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effectiveness of telaprevir administered twice daily versus every 8 hours in combination with Peg-IFN-alfa-2a and ribavirin in treatment-naïve participants with chronic HCV genotype 1 infection.

Detailed description:
This is a randomized (study drug assigned by chance), open-label (all persons know the study drug assignment) multicenter study to evaluate the effectiveness of telaprevir administered orally as 1125 milligram (mg) twice daily versus 750mg every 8 hours in combination with Peg-IFN-alfa-2a, administered via intramuscular injection once a week, and ribavirin, administered as an oral tablet twice a day, in treatment-naïve study participants with chronic hepatitis C virus (HCV) genotype 1 infection.

Telaprevir will be given orally (by mouth) from Day 1 through Week 12 as 3 tablets (1125mg) twice daily or 2 tablets (750mg) every 8 hours. Peg-IFN-alfa-2a will be administered once a week as an injection under the skin (180 microgram/week) from Day 1 through Week 24 or 48 (based on the patient's treatment response on week 4). Ribavirin is administered orally (by mouth) twice daily from Day 1 through Week 24 or 48 (based on the participant's treatment response on week 4) as 1,000-1,200 mg per day. After the end of treatment (Week 24, Week 48, or at early discontinuation of all study drugs), participants with undetectable HCV RNA at end of treatment will be required to attend follow-up visits until Week 72 safety/tolerability assessments will be performed throughout the treatment period and during the follow-up period.

Arms: arm 1: Telaprevir (T) 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (P) and ribavirin (R) arm 2: Telaprevir (T) 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (P) and ribavirin (R)
Interventions: intervention 1: Ribavirin intervention 2: Telaprevir intervention 3: Pegylated interferon alfa-2a intervention 4: Telaprevir
Intervention descriptions: intervention 1: Ribavirin (RBV) 1000-1200 milligram (mg) per day (weight dependent) twice daily regimen oral tablets for 24 or 48 weeks depending on the patient's treatment response at week 4 intervention 2: 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks intervention 3: 180 microgram (µg) per week, subcutaneous injection, for 24 or 48 weeks Pegylated interferon alfa-2a 180 microgram (µg) per week subcutaneous injection for 24 or 48 weeks depending on the patient's treatment response at week 4 intervention 4: 750 mg (2 oral tablets) every 8 hours for 12 weeks

Protocol documents:
Clinical trial NCT01244061
Conditions: Smoking Cessation
Sponsor: Pfizer
Start date: 2010-12-01; Completion date: 2012-11-01
Enrollment: 498 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to compare the effectiveness and safety of the re-treatment of smokers with varenicline with placebo for smoking cessation during the last 4 weeks of a 12 week course of treatment. The study will also assess whether smokers remain abstinent at Week 24 (12 weeks after the end of treatment) and Week 52 (40 weeks after the end of treatment).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Varenicline intervention 2: Placebo
Intervention descriptions: intervention 1: Varenicline 1mg twice daily intervention 2: Matched placebo twice daily

Protocol documents:
Clinical trial NCT01256177
Conditions: Bipolar Depression
Keywords: Bipolar Depression Mental disease,
Sponsor: AstraZeneca
Start date: 2010-12-01; Completion date: 2012-11-01
Enrollment: 361 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the superior efficacy of quetiapine extended release(XR) mono-therapy, administered once daily compared to placebo, in the treatment of depressive symptoms in patients with Bipolar I and Bipolar II Disorder

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Quetiapine Fumarate (SEROQUEL) Extended Release intervention 2: Placebo
Intervention descriptions: intervention 1: Quetiapine fumarate extended release(XR) will be administered orally, once daily in the evening. The initial dose will be 50 mg. This dose will be adjusted on Day 2 to 100 mg, on Day 3 to 200 mg, and on Day 4 to 300 mg and after. intervention 2: Placebo matching quetiapine extended release(XR) 50 mg, 200 mg, and 300 mg tablets will be orally administered once daily, in the evening. The initial dose will be 50 mg. This dose will be adjusted on Day 2 to 100 mg, on Day 3 to 200 mg, and on Day 4 to 300 mg and after.

Protocol documents: