ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00775463
Conditions: Systemic Sclerosis Scleroderma
Keywords: Scleroderma, Diffuse Scleroderma, Limited Scleroderma, Systemic Ulcer prostacyclin
Sponsor: United Therapeutics
Start date: 2009-05-01; Completion date: 2011-07-01
Enrollment: 148 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the effect of treprostinil diethanolamine (UT-15C) sustained release tablets(compared to placebo) on digital ulcers in patients with scleroderma. Treprostinil diethanolamine is an analog of prostacyclin. Prostacyclin is a naturally occuring substance produced by the cells of blood vessels that inhibits platelet aggregation, induces vasodilation, and suppresses smooth muscle proliferation. Improvement in blood flow in lower limbs and fingers would be anticipated to result in a reduction in ischemic pain, Raynaud's phenomenon and promote healing of digital ulcers and other ischemic wounds.

Detailed description:

Arms: arm 1: Treprostinil diethanolamine sustained release tablet initiated at 0.25 mg BID and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose. arm 2: Matching placebo sustained release tablet initiated at 0.25 mg BID and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose.
Interventions: intervention 1: treprostinil diethanolamine intervention 2: placebo
Intervention descriptions: intervention 1: oral sustained release tablet. Maximum tolerable dose not exceeding 16 mg twice daily (BID) intervention 2: None

Protocol documents:
Clinical trial NCT00776984
Conditions: Asthma
Sponsor: Boehringer Ingelheim
Start date: 2008-10-01; Completion date: 2011-07-01
Enrollment: 453 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The trial is a randomised, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of 5 µg tiotropium over a 48-week treatment period as compared to placebo. Tiotropium inhalation solution delivered by the Respimat® inhaler will be examined as add-on controller therapy on top of usual care in patients with severe persistent asthma. The primary objective of each trial is to evaluate the long term efficacy of tiotropium over placebo on top of usual care in patients with severe persistent asthma as determined by pulmonary function testing, effects on asthma exacerbations, effects on quality of life, on asthma control and health care resource utilisation. The secondary objective of each trial is to compare the long term safety of tiotropium with placebo in this patient population.

Detailed description:

Arms: arm 1: patient to receive double-blind treatment with either 5mcg/day tiotropium inhalation solution or placebo inhalation solution arm 2: patient to receive double-blind treatment with either 5mcg/day tiotropium inhalation solution or placebo inhalation solution
Interventions: intervention 1: tiotropium 5mcg/day intervention 2: placebo
Intervention descriptions: intervention 1: Intervention = Randomisation: patient to receive double-blind treatment with either 5mcg/day tiotropium inhalation solution or placebo inhalation solution intervention 2: Intervention = Randomisation: patient to receive double-blind treatment with either 5mcg/day tiotropium inhalation solution or placebo inhalation solution

Protocol documents:
Clinical trial NCT00785629
Conditions: Chronic Kidney Disease
Keywords: phosphorus secondary hyperparathyroidism vascular calcification
Sponsor: Denver Nephrologists, P.C.
Start date: 2009-02-01; Completion date: 2011-07-01
Enrollment: 148 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the ability of 3 commercially available phosphorus binders (calcium acetate, sevelamer carbonate, and lanthanum carbonate) to achieve and maintain a phosphorus level in the normal range in patients with chronic kidney disease.

Detailed description:
It is the specific aim of this pilot study to assess the feasibility of achieving and maintaining a serum P less than or equal to 3.5 mg/dL (1.13 mmol/L) in patients with eGFR \>20 and \<45 mL/min with any of the 3 commercially available P lowering agents (calcium acetate, sevelamer carbonate, or lanthanum carbonate). Results of this study will clarify the degree of separation in serum P that can be achieved with the use of P lowering agents and the current standard of care (P binder initiation when P \> 5.5 mg/dL or 1.78 mmol/L). Furthermore, this knowledge, combined with analyses of the secondary aims and outcomes of interest, will serve to facilitate the design of a properly powered, randomized, placebo controlled clinical outcomes trial that will firmly establish the necessity of achieving a specific target P in patients with CKD. The secondary aims of this pilot study are to provide insight into the optimal detection of progression of abnormalities in mineral metabolism and their relationship to vascular disease in CKD. The tertiary aim is to evaluate long term outcomes related to phosphorus normalization with respect to renal replacement therapy or death.

Arms: arm 1: 667 mg with meals arm 2: 500 mg with meals arm 3: 800 mg with meals arm 4: with meals
Interventions: intervention 1: Calcium acetate intervention 2: Lanthanum Carbonate intervention 3: Sevelamer Carbonate intervention 4: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00789698
Conditions: Chronic Schizophrenia
Keywords: Schizophrenia SM-13496 Latuda Lurasidone
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2008-12-01; Completion date: 2011-07-01
Enrollment: 240 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe as compared with quetiapine XR long term among schizophrenic outpatients with chronic schizophrenia.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Lurasidone HC1 intervention 2: Quetiapine XR
Intervention descriptions: intervention 1: Lurasidone 40-160 mg/day flexibly dosed. intervention 2: Quetiapine XR 200-800 mg/day flexibly dosed.

Protocol documents:
Clinical trial NCT00790673
Conditions: Chronic Hepatitis C
Keywords: Hepatitis C Viral hepatitis
Sponsor: Can-Fite BioPharma
Start date: 2009-07-01; Completion date: 2011-07-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial will test the hypothesis that CF102 can safely and effectively suppress viral load in patients with chronic hepatitis C and high circulating levels of virus. The trial will monitor the safety of twice-daily oral dosing with CF102 over a 16-week period; will measure changes in viral load during therapy; and will measure blood concentrations of CF102 at various time points during dosing.

Detailed description:
This is a Phase 1/2, randomized, double-blind, placebo-controlled, dose-escalation study of subjects with chronic hepatitis C genotype 1. Eligible subjects will be assigned in a 3:1 ratio (8 subjects in each cohort) to receive qd or bid treatment for 15 days with oral CF-102 or with placebo. Dose escalation will occur in 2 sequential cohorts.

The decision to continue dosing within a cohort (eg, Subcohort 1a to Subcohort 1b), or to escalate to a new dose level Cohort (eg, Subcohort 1b to Subcohort 2a) will be determined by a blinded independent review of safety data. This review will be conducted by a qualified Safety Review Committee comprising the medical monitor, the consulting toxicologist, and an independent expert clinician.

For the first 2 cohorts, subjects will return to the study center for follow-up assessments on Days 8, 15, and 22. Subjects dosed qd will receive a total of 15 doses of CF-102. Subjects dosed bid will receive a total of 29 doses. The 30th dose has been deleted to accommodate PK sampling on the morning of Day 16, 24 hours after the last dose of CF-102.

For the 3rd cohorts, subjects will return to the study center for follow-up assessments on weeks 2, 4, 8, 12, 16 and 18.

Arms: arm 1: CF102 1 mg qd arm 2: CF102 1 mg bid arm 3: CF102 1 mg bid; 16 weeks arm 4: None
Interventions: intervention 1: CF 102 intervention 2: Placebo
Intervention descriptions: intervention 1: Oral capsules intervention 2: Matching placebo capsules

Protocol documents:
Clinical trial NCT00817336
Conditions: Schizophrenia Schizoaffective Disorder
Keywords: biomarker EEG schizophrenia NMDA D-serine
Sponsor: Nathan Kline Institute for Psychiatric Research
Start date: 2009-06-01; Completion date: 2011-07-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
N-methyl-D-aspartate (NMDA)-type glutamate receptors are thought to play a pivotal role in neurocognitive dysfunction associated with schizophrenia. Further, several novel glutamate-based classes of compound are presently in development as potential novel treatments for persistent negative and cognitive symptoms. The study will assess effectiveness of a NMDA-based intervention on biomarkers related to schizophrenia as a mechanism for developing appropriate outcome batteries for future trials of novel compounds.

Detailed description:
16 in- or outpatients with DSM-IV-TR schizophrenia or schizoaffective disorder and prominent negative symptoms will be recruited for this study. This study will consist of a randomized trial of D-serine (60 mg/kg/d) vs. placebo using a crossover design with a 2-week baseline lead-in, and two 6-week intervention arms separated by a two week, placebo controlled washout period. Biomarkers will be assessed at baseline for each treatment arm, acutely (day 7) following treatment initiation, and following 6 weeks of treatment (6 biomarker sessions total). Primary biomarker outcome measures will include 1) amplitude of the mismatch negativity (MMN) waveform and 2) amplitude of the visual P1 potential. Symptomatic outcome measures will include PANSS and composite score of the MATRICS neuropsychological battery. The study will be supported from ongoing NIMH-funded Cooperative Drug Development Grant (CDDG) to the PI.

Arms: arm 1: 60 mg/kg/day arm 2: None
Interventions: intervention 1: D Serine intervention 2: Placebo
Intervention descriptions: intervention 1: 60 mg/kg/day intervention 2: oral

Protocol documents:
Clinical trial NCT00817999
Conditions: Healthy
Keywords: Platelet Aggregation Inhibition
Sponsor: Creighton University
Start date: 2008-11-01; Completion date: 2011-07-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will measure the percentage of platelet aggregation inhibition with a loading dose of clopidogrel (300 mg) using the VerifyNow Assay System in healthy volunteers who have drank 11 oz of grapefruit juice. It will also measure the percentage of platelet aggregation inhibition with a maintenance dose of clopidogrel (75 mg/day) using the VerifyNow Assay System in healthy volunteers who have drank 11 oz grapefruit juice daily.

Detailed description:
This study will examine the effect of GFJ on the loading dose (300 mg) of clopidogrel and will evaluate the effect of GFJ on the maintenance dose (75 mg/day) of clopidogrel. Subjects will be randomized to either initially receive GFJ prior to their loading dose of clopidogrel or receive GFJ prior to their second loading dose. The subjects who have been randomized to receive GFJ initially will drink two small cans (11 oz total) of regular strength GFJ in the morning, followed two hours later by a loading dose (300 mg) of clopidogrel and will then return to the clinic 6 hours after their loading dose to have their platelet inhibition measured. Subjects will have \~ 5 milliliters (1 teaspoonful) of whole blood drawn from an antecubital vein in their forearm via a 21 gauge needle attached to a blue-top plastic vacuette sodium citrate blood collection (Greiner, Monroe, NC) tube to test inhibition of platelet aggregation. After their first loading dose, a 2 week washout period will follow to allow for their platelet aggregation to return to normal. Following the washout period, the subjects will take their second loading dose of clopidogrel and again return to the clinic for platelet inhibition measurement. The same timing will be followed for the loading dose taken without prior GFJ.

During the maintenance dose phase of this study, subjects will take 75 mg/day clopidogrel for 7 days with or without GFJ. Subjects will be randomized to either GFJ during the first period or GFJ during the second period. A minimum 2 week washout period will occur between the two 7 day courses of clopidogrel. Platelet inhibition measurement will occur at the end of each 7 day period as described above.

Arms: arm 1: Participants received a 300 mg dose of clopidogrel with or without GFJ. arm 2: Participants received clopidogrel 75 mg/day for 7 days with or without GFJ
Interventions: intervention 1: Grapefruit juice intervention 2: Clopidogrel 75 mg/day intervention 3: Clopidogrel 300 mg
Intervention descriptions: intervention 1: Participants received grapefruit juice during 1 of the 2 periods. intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00820612
Conditions: Post-ERCP Pancreatitis
Sponsor: University of Michigan
Start date: 2009-01-01; Completion date: 2011-07-01
Enrollment: 602 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Pancreatitis (inflammation of the pancreas) is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP), a procedure for the diagnosis and treatment of disorders of the pancreas and bile duct.

Preliminary data has shown that non-steroidal antiinflammatory drugs, when administered rectally, can reduce the risk of pancreatitis after ERCP. This study is intended to definitively determine whether rectally administered indomethacin (a non-steroidal antiinflammatory drug)is effective at preventing pancreatitis after ERCP.

Detailed description:
This study is a multi-center, randomized, placebo-controlled, double-blinded clinical trial of rectal indomethacin in the prevention of post-ERCP pancreatitis in high risk patients.

Arms: arm 1: Indomethacin suppository arm 2: Placebo suppository
Interventions: intervention 1: Indomethacin intervention 2: Placebo suppositories
Intervention descriptions: intervention 1: 100 mg PR once at the time of ERCP intervention 2: 2 placebo suppositories at the time of ERCP

Protocol documents:
Clinical trial NCT00826111
Conditions: Depression Anxiety Insomnia
Keywords: Magnetic Resonance Spectroscopy Glutamate Glutamine GABA Lexapro Lunesta Escitalopram Eszopiclone
Sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc.
Start date: 2007-08-01; Completion date: 2011-07-01
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study examined the effects of adding the sleep aid eszopiclone to Lexapro on mood and levels of the neurotransmitters glutamate, glutamine, and GABA in women with depression, anxiety, and insomnia. Specifically, the objective was to determine the role of glutamate, glutamine, and GABA in mediating the response the to the combined treatment. The hypothesis was that levels of glutamine and glutamate will be increased in women receiving eszopiclone compared to those receiving placebo. The antidepressant effect of the medication combination and its effect on sleep status was also assessed.

Detailed description:

Arms: arm 1: Lexapro for 10 weeks together with eszopiclone. arm 2: Lexapro for 10 weeks together with placebo.
Interventions: intervention 1: Eszopiclone intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects receive 10 mg escitalopram daily for four weeks and 10 or 20 mg for an additional six weeks. Subjects also receive 3 mg eszopiclone. intervention 2: Subjects receive 10 mg of escitalopram daily for four weeks followed by 10 or 20 mg for an additional six weeks. Subjects also receive placebo for eszopiclone.

Protocol documents:
Clinical trial NCT00830362
Conditions: Cocaine Dependence
Keywords: cocaine cocaine-dependent propranolol craving beta-blockade cue exposure drug addiction memory addictive behavior
Sponsor: Medical University of South Carolina
Start date: 2009-02-01; Completion date: 2011-07-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the effects of propranolol versus placebo on responses to cocaine cues in cocaine dependent individuals.

Detailed description:
This study will employ cocaine-dependent individuals to investigate the acute effects of propranolol vs. placebo, administered immediately after a retrieval session of cocaine cue exposure, on the subjective and physiological responses occurring during a subsequent test session of cocaine cue exposure. Participants (N=52) will be randomly assigned to receive 40 mg propranolol or placebo immediately after the first of two cocaine cue exposure sessions scheduled to occur on consecutive days of an inpatient stay at MUSC's General Clinical Research Center (GCRC). The first session will serve as a retrieval session where cocaine cue exposure will putatively elicit retrieval and reconsolidation of memories about the association between the cues and cocaine administration; the second session of cocaine cue exposure will be a test session to examine the potential modulatory role of propranolol on the reconsolidated memories putatively elicited during the previous cue exposure session. It is assumed that changes in craving and physiological reactivity during the test session will reflect propranolol's effects on memory reconsolidation processes elicited by cue exposure during the retrieval session. Medications will be administered in a double-blind fashion. Craving and physiological arousal (heart rate, skin conductance, blood pressure) will be obtained at baseline and at regular intervals during and after both cue exposure sessions. Approximately 7 days following discharge from the inpatient stay at the GCRC, participants will return to the GCRC to undergo a 1-week follow-up cue exposure session that will be identical to the previous two sessions (no medications will be administered). The goal of the follow-up will be to examine if any craving and/or physiological reactivity differences identified during the test session were sustained and to assess if the groups differed in their cocaine use during the intervening 7-day period.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Propranolol intervention 2: Placebo
Intervention descriptions: intervention 1: 40 mg administered once intervention 2: administered once

Protocol documents:
Clinical trial NCT00854724
Conditions: Alcohol Abuse
Sponsor: Mclean Hospital
Start date: 2009-02-01; Completion date: 2011-07-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This research is designed to assess the impact of pretreatment with puerarin (NPI-031G), a major ingredient in the plant kudzu, on alcohol drinking. Hypothesis: Short-term treatment with this compound will reduce alcohol self-administration in a simulated natural settings laboratory.

Detailed description:
Participants will have an opportunity to drink up to 6 beers, plus water and juice, during a 90 minute afternoon drinking session in our simulated apartment room laboratory. Drinking sessions will be conducted in the afternoon after participants take puerarin or placebo for 7 days.

Arms: arm 1: None arm 2: Sugar beet filler in capsule
Interventions: intervention 1: Puerarin, Placebo
Intervention descriptions: intervention 1: 400 mg, three times a day for 7 days

Protocol documents:
Clinical trial NCT00856791
Conditions: Ovarian Cancer
Keywords: Ovarian Cancer Cisplatin Carboplatin
Sponsor: Traws Pharma, Inc.
Start date: 2009-03-01; Completion date: 2011-07-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
ON 01910.Na has undergone preclinical and clinical phase I studies showing activity in patients with progressing ovarian cancer resistant to platinum-based chemotherapies. This study will look at a larger population of patients to determine whether treatment with ON 01910.Na has an effect on progression free survival rates in patients with platinum-resistant ovarian cancer. ON 01910.Na will be given as an intravenous infusion over 2 hours on days 1, 4, 8, 11, 15, and 18 of a 28-day cycle. Patients will be treated for 6 or more cycles.

Detailed description:
This is a Phase II single arm study of ON 01910.Na to be administered as a 2-hour infusion biweekly to patients with progressive ovarian cancer resistant to platinum-based therapy.

The primary objective is to evaluate progression-free survival (PFS). The secondary objectives are to document other measures of outcome \[objective response rate (ORR), duration of response, duration of stable disease, and overall survival (OS)\], and tolerability of study drug.

Thirty-seven (37) patients with progressive ovarian cancer resistant to platinum-based therapy will be enrolled in a single arm study and treated with ON 01910.Na administered as a 2-hour infusion on Days 1, 4, 8, 11, 15 and 18 of a 28-day cycle. Patients will be treated until disease progression or withdrawal for other causes (unacceptable toxicity, patient or investigator decision) with ON 01910.Na. Toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v3.0). Progression-free survival, objective response, duration of response, and duration of stable disease will be assessed using RECIST (Response Evaluation Criteria in Solid Tumor) guidelines, as well as overall survival. Grades 3 and 4 hematologic toxicities, grade \>2 non-hematologic toxicities will be monitored. A futility analysis will be performed after 17 evaluable patients are enrolled and evaluated for overall objective response. If 3 or fewer objective response (CR and PR) are observed, the study will be closed to further accrual and deemed futile. An extension study for an additional 25 weeks with complete monitoring will be considered for patients who have not progressed by week 25.

The ON 01910.Na dose to be used in this study (2-hour infusions of 2400 or 3200 mg twice weekly for 3 weeks of a 4-week cycle) was selected based on the maximum tolerated doses and activities documented in phase 1 protocols.

Arms: arm 1: 3200 mg ON 01910.Na administered intravenously over 2 hours on days 1, 4, 8, 11, 15, and 18 of 28-day cycle
Interventions: intervention 1: ON 01910.Na
Intervention descriptions: intervention 1: None

Protocol documents: