ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01533948
Conditions: Extraocular Extension Melanoma Metastatic Intraocular Melanoma Recurrent Intraocular Melanoma Recurrent Melanoma Stage IIIA Intraocular Melanoma Stage IIIA Melanoma Stage IIIB Intraocular Melanoma Stage IIIB Melanoma Stage IIIC Intraocular Melanoma Stage IIIC Melanoma Stage IV Intraocular Melanoma Stage IV Melanoma
Sponsor: Roswell Park Cancer Institute
Start date: 2012-01-01; Completion date: 2015-07-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well axitinib works in treating patients with melanoma that has spread to other places in the body or cannot be removed by surgery. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the overall response rate (ORR) to axitinib in advanced melanoma. This will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.

SECONDARY OBJECTIVES:

I. Evaluate toxicity of axitinib as a single agent. II. Determine progression-free survival and overall survival. III. Explore the utility of 3'-deoxy-3'-\[18F\] fluorothymidine-labeled positron emission tomography (FLT-PET) as a predictive marker for response and compare to standard radiographic imaging.

TERTIARY OBJECTIVES:

I. Examine the prognostic and predictive significance of circulating melanoma tumor cells.

II. To examine whether functionally relevant polymorphisms in axitinib-related genes (vascular endothelial growth factor receptor \[VEGFR\] 1, VEGFR2 and VEGFR3) correlate with efficacy and toxicity of axitinib in advanced melanoma.

OUTLINE:

Patients receive axitinib orally (PO) twice daily (BID). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days.

Arms: arm 1: Patients receive axitinib PO BID. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: axitinib intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given PO intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT01548417
Conditions: Alcoholism
Keywords: Alcohol Relapse
Sponsor: The Scripps Research Institute
Start date: 2012-03-01; Completion date: 2015-07-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary hypotheses under test are that alcohol dependent subjects treated with mifepristone will report decreased craving for alcohol following alcohol exposure in the laboratory and report significantly less drinking under naturalistic conditions, than those treated with placebo.

Detailed description:

Arms: arm 1: 600 mg daily taken orally for one week arm 2: placebo pill daily taken orally for one week
Interventions: intervention 1: Korlym (mifepristone) intervention 2: Sugar Pill
Intervention descriptions: intervention 1: 600 mg/day, oral pill, 7 days intervention 2: 600 mg/day, oral pill, 7 days

Protocol documents:
Clinical trial NCT01550744
Conditions: Psoriasis
Keywords: Psoriasis Ustekinumab STELARA Skin disease Monoclonal
Sponsor: Janssen Biotech, Inc.
Start date: 2012-03-01; Completion date: 2015-07-01
Enrollment: 478 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to assess the effect of extending maintenance dosing intervals beyond 12 weeks on the clinical efficacy and safety of ustekinumab in subjects with moderate-to-severe plaque psoriasis.

Detailed description:
In this study, a proportion of subjects will receive study agent at its recommended dose and interval (45mg for subjects less than or equal to 100kg, or 90mg for subjects greater than 100kg; every 12 weeks after 2 starter doses at Weeks 0 and 4). The majority of subjects will have the opportunity to receive study agent less frequently during the randomization period depending on the subject's response. The study consists of a 4-week screening period; a 28-week open-label run-in period; a double-blind treatment period from Week 28 to Week 104; a 12 week post-treatment period; and a 20-week safety follow-up. Participants will be randomized for the double blind period into one of two study groups. Group 1 participants will receive an injection of the study medication at a 12 week dosing interval. Group 2 participants will undergo a placebo withdrawal and may receive study agents at an extended interval greater than 12 weeks. During the double-blind treatment period, subjects in Groups 1 and 2 will receive placebo as necessary to maintain the blind.

Arms: arm 1: Active ustekinumab study agent q12 weeks with sham/placebo as necessary to maintain blind arm 2: Subjects will undergo placebo withdrawal and will receive active study agent up to q24w intervals with sham/placebo injections to maintain the blind.
Interventions: intervention 1: Ustekinumab 45 mg intervention 2: Ustekinumab 90 mg intervention 3: Placebo
Intervention descriptions: intervention 1: Form = Injection, route = subcutaneous intervention 2: Form = Injection, route = subcutaneous intervention 3: Form = Injection, route = subcutaneous

Protocol documents:
Clinical trial NCT01557569
Conditions: Methamphetamine Dependence
Keywords: methamphetamine addiction relapse atomoxetine
Sponsor: University of Arkansas
Start date: 2012-04-01; Completion date: 2015-07-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the ability of atomoxetine compared to placebo to increase time to relapse in methamphetamine dependent volunteers. Our hypothesis is that atomoxetine will increase time before (if) the participant relapses.

Detailed description:
During the study participants will spend the initial 2-weeks of the study at an inpatient facility. This will help participants initiate withdrawal. During the following 8-weeks the participant will come in for 3-4 visits each week. Three of these visits will be with the research assistants and one visit will be with a therapist in order to work with the participant using a cognitive behavioral therapy approach. Therapy visits are typically scheduled on a day that the participant is coming for clinic anyways so the number of visits per week is typically 3. During the 10-week period the investigators will collect various measures, including vitals, cognitive assessments, mood assessments, urine drug screens, weekly use reports of methamphetamine, and any reports of symptoms or side effects. This will tell the investigators if atomoxetine is safe and if a participant lapsed or relapsed.

Arms: arm 1: Group receiving atomoxetine arm 2: Group will receive placebo instead of atomoxetine
Interventions: intervention 1: Atomoxetine intervention 2: placebo
Intervention descriptions: intervention 1: During the first 2 weeks and three days the dose of atomoxetine will be titrated up starting with 20 mg/day for first 3 days, 36 mg/day for next 4 days, 50 mg/day for next 3 days, and finally 80 mg/day until the final day of the study (week 10, day 7) intervention 2: participants in this group will receive 1 dose of placebo daily for the entire 10-weeks.

Protocol documents:
Clinical trial NCT01574703
Conditions: Smoking Cessation
Keywords: smoking cessation psychiatric disease cardiovascular events
Sponsor: Pfizer
Start date: 2012-05-01; Completion date: 2015-07-01
Enrollment: 4595 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Non-treatment extension to study A3051123, aimed at collecting data on cardiovascular safety for all participants in the A3051123 trial for an additional 28 weeks, allowing for a total of 52 weeks of cardiovascular safety data collection.

Detailed description:
This study is an extension protocol for study A3051123. No treatment is provided during this study. This study is to monitor for cardiovascular events 28 weeks after completion of A3051123. This study is an extension protocol for study A3051123. No treatment is provided during this study. This study is to monitor for cardiovascular events 28 weeks after completion of A3051123.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: placebo intervention 2: varenicline tartrate intervention 3: bupropion hydrochloride intervention 4: Nicotine Replacement Therapy Patch
Intervention descriptions: intervention 1: All dosing to have taken place per study A3051123 intervention 2: All dosing to have taken place per study A3051123 intervention 3: All dosing to have taken place per study A3051123 intervention 4: All dosing to have taken place per study A3051123

Protocol documents:
Clinical trial NCT01575054
Conditions: Muscle Spasticity
Sponsor: Allergan
Start date: 2012-05-01; Completion date: 2015-07-01
Enrollment: 468 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of BOTOX® in the treatment of adult post-stroke lower limb spasticity.

Detailed description:

Arms: arm 1: Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period. arm 2: Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
Interventions: intervention 1: botulinum toxin Type A intervention 2: Normal Saline
Intervention descriptions: intervention 1: Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period. intervention 2: Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles.

Protocol documents:
Clinical trial NCT01578486
Conditions: Schizophrenia Schizoaffective Disorder
Keywords: Schizophrenia Cognition Metabolism Antipsychotics Psychopathology
Sponsor: University of Massachusetts, Worcester
Start date: 2011-06-01; Completion date: 2015-07-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a 12-week, open-label trial of salsalate 3 g/day as an adjunctive treatment in 15 schizophrenia subjects to examine salsalate's effect on psychopathology, cognitive functioning, and metabolic parameters.

Potential subjects will be identified by their clinicians at the Freedom Trail Clinic, or Massachusetts General Hospital. A total of 15 subjects will be enrolled.

Detailed description:
The specific aims include:

Primary aims:

1. Examine the efficacy of salsalate (3g/day) in improving positive and negative symptoms as measured by the Positive and Negative Syndrome Scale (PANSS) and the Scale for Assessment of Negative Symptoms (SANS).
2. Examine the efficacy of salsalate in improving cognition as measured by the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) composite score.

Secondary aims:

1\. Examine salsalate's effects on inflammatory markers such as high sensitivity C-reactive protein (hs-CRP), TNF-α and IL-6.

Arms: arm 1: open-label trial of salsalate 3g/day
Interventions: intervention 1: salsalate
Intervention descriptions: intervention 1: open-label trial of salsalate 3g/day for 12 weeks.

Protocol documents:
Clinical trial NCT01585584
Conditions: Hepatitis C
Keywords: Boceprevir Hepatitis C Genotype 3
Sponsor: University of Calgary
Start date: 2012-05-01; Completion date: 2015-07-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to test the potential antiviral efficacy of triple-combination therapy with Peginterferon α-2b + ribavirin + boceprevir (PRB) in patients with HCV genotype 3 who previously failed Peginterferon α + ribavirin (non-responders or relapsers).

Detailed description:
i) Obtain preliminary information on the association between important baseline and on-treatment factors and SVR in this patient population. Variables to be examined may include gender, age, advanced fibrosis or cirrhosis (F3 or F4 estimated by Fibroscan), baseline viral load, RVR, wk 8 viral load, end-of-treatment viral response.

ii) Evaluate adverse events. iii) Evaluate viral resistance.

Arms: arm 1: None
Interventions: intervention 1: Boceprevir
Intervention descriptions: intervention 1: All patients will receive a 4-week lead-in with Peginterferon and Ribavirin therapy, followed by 24 weeks of Pegetron 1.5microg/kg + weight-based ribavirin + boceprevir 800mg tid. HCV RNA (Cobas TaqMan) will be measured at baseline and at treatment weeks 4, 6,8,12,16,20,24 and 28, and post-treatment weeks 12 and 24 (to obtain SVR-12 and SVR-24 results).

Protocol documents:
Clinical trial NCT01588236
Conditions: Primary Dysmenorrhea
Sponsor: Jiangsu Kanion Pharmaceutical Co., Ltd
Start date: 2012-05-01; Completion date: 2015-07-01
Enrollment: 280 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to further assess the efficacy, safety and dose-response of KYG0395 in the treatment of primary dysmenorrhea.

Detailed description:
Compare the effect and safety of the investigational drug and placebo on dysmenorrhea in adult otherwise healthy women.

Arms: arm 1: Patients received high dose KYG0395 capsule (tid) arm 2: Patients received lower dose KYG0395 capsule (bid) arm 3: Patients received placebo (tid)
Interventions: intervention 1: high dose KYG0395 intervention 2: lower dose KYG0395 intervention 3: Placebo
Intervention descriptions: intervention 1: 3 KYG0395 capsules tid (morning, midday, and evening) intervention 2: 3 KYG0395 capsules 2 times a day (bid) (morning and evening) plus 3 capsules of placebo (midday) intervention 3: 3 capsules of placebo tid (morning, midday, and evening)

Protocol documents:
Clinical trial NCT01588418
Conditions: Impaired Glucose Tolerance (IGT) Diabetes
Keywords: Impaired glucose tolerance (IGT) Diabetes
Sponsor: The University of Texas Health Science Center at San Antonio
Start date: 2010-07-01; Completion date: 2015-07-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This research study will examine brain glucose metabolism after an overnight fast to determine the effect of exenatide on brain glucose metabolism and lipid metabolism.

Detailed description:
This study will elucidate if exenatide has an effect on brain glucose metabolism. This will be accomplished by measuring the rate of glucose binding in various brain regions by Positron Emission Tomography (PET) after glucose load with exenatide injection and compare it with placebo injection measured in the same subject. The changes will be compared with peripheral and hepatic glucose metabolism and lipolysis.

Arms: arm 1: Exenatide 5mcg was injected subcutaneously 30 min before Oral Glucose Tolerance Test (OGTT)-PET study. The same subject was studied again a few weeks later with the same protocol with Placebo injection. arm 2: Placebo was injected subcutaneously 30 min before OGTT-PET study. The same subject was studied again a few weeks later with the same protocol with injection of Exenatide 5mcg .
Interventions: intervention 1: Exenatide intervention 2: Placebo
Intervention descriptions: intervention 1: Exenatide (5mcg) was administered in random order 30 min before OGTT-PET study, crossover study intervention 2: Placebo was administered in random order 30 min before OGTT-PET study in the same subject

Protocol documents:
Clinical trial NCT01589237
Conditions: Familial Chylomicronemia Syndrome (FCS) (HLP Type I)
Keywords: Familial Chylomicronemia Syndrome (FCS) (HLP type I) LCQ908
Sponsor: Novartis Pharmaceuticals
Start date: 2013-02-01; Completion date: 2015-07-01
Enrollment: 38 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study was to determine long-term safety and tolerability, and continued efficacy in lowering triglycerides of LCQ908 in subjects with Familial Chylomicronemia Syndrome (FCS) (HLP type I).

Detailed description:
This study was an 52 weeks open label extension starting at the lowest treatment dose used in CLCQ908B2302/NCT01514461 (i.e., 10 mg) with optional up-titrations, to evaluate the overall long-term safety and tolerability of LCQ908 in patients with Familial Chylomicronemia Syndrome, who either discontinued from the CLCQ908B2302/NCT01514461 study (due to tolerability issues) or completed the CLCQ908B2302/NCT01514461 study after 52 weeks. In addition, patients who had previously completed study CLCQ908A2212/NCT01146522 were eligible to participate.

Following Protocol amendment 2, the original 52 week duration of this study (CLCQ908B2305) became Part A of LCQ908B2305 and a 78 week extension became Part B. However, following Protocol amendment 3, Part B was ended at the same time as the last patient of Part A completed 52 weeks. The reason for termination of Part B was the findings from the December 2014 interim analysis which suggested that the size of benefit that was anticipated from continued participation of patients in the 18 month extension trial (Part B) no longer supported trial extension beyond Part A.

Arms: arm 1: Patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose will be allowed. One down titration allowed from the highest dose attained.
Interventions: intervention 1: LCQ908
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01600326
Conditions: Tendinosis Tendinitis
Sponsor: University of Michigan
Start date: 2010-07-01; Completion date: 2015-07-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effectiveness of various treatment soft tendinosis also known as tendinitis.

Detailed description:
Currently there are three treatments that are considered standard of care; rest, tenotomy and tenotomy with injections of platelet-rich plasma (PRP). Tenotomy is performed by passing a needle through the abnormal tendon repeatedly until the needle has passed through all areas of the abnormal tendon with softening of the tendon. Tenotomy with PRP injections is performed in the same manner but includes an injection of platelet-rich plasma (PRP) into the tendon. This study will evaluate the effectiveness of tenotomy versus PRP treatment.

Arms: arm 1: Subject enrolled in this arm will receive treatment for tendinitis and pain evaluation of pain pre and post treatment. arm 2: Treatment is Ultrasound guided platelet rich plasma injection.
Interventions: intervention 1: Tenotomy (no injection) intervention 2: Ultrasound guided platelet rich plasma injection
Intervention descriptions: intervention 1: Subjects randomized to this group will fill out a pre-treatment pain survey and have a blood draw They will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti-inflammatory medications for 2 weeks before the study. Two weeks after enrollment subjects see their referring physician to begin physical therapy. intervention 2: Subjects will fill out a pre-treatment pain survey, then will undergo ultrasound and have blood drawn from their arm.

The blood sample will be separated into blood cells and plasma. The plasma portion of the blood (liquid minus the cells) will be injected into the tendon under sterile conditions. Ultrasound will help guide the injection. This is called "Ultrasound guided platelet rich plasma injection."

Subjects will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti inflammatory medications for 2 weeks before the study and 2 weeks after the study.

Subjects will see their referring physician two weeks after treatment to begin physical therapy.

Protocol documents:
Clinical trial NCT01613014
Conditions: Alcohol Dependence Alcohol Abuse Alcohol Use Disorders Alcoholism
Keywords: Alcohol Alcohol Dependence Alcohol Abuse Alcohol Use Disorders Alcoholism
Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Start date: 2013-02-01; Completion date: 2015-07-01
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary efficacy endpoint examines the hypothesis that ABT-436 will decrease the weekly percentage of heavy drinking days during Study Weeks 2 through 12 (Days 8-84) as compared to placebo. A "heavy drinking day" is 4 or more drinks per drinking day for women and 5 or more drinks per drinking day for men.

Detailed description:
Adrenocorticotropic hormone (ACTH) release from the pituitary gland via V1B stimulation is central to the hypothalamus-pituitary-adrenal (HPA) axis stress response (Carrasco \& Van de Kar-2003, Herman \& Cullinan-1997, Sapolsky et al-2000; Tsigos \& Chrousos-2002). Chronic dysregulation of the HPA axis is common in major depressive disorder, anxiety disorders, and substance abuse disorders characterized by elevated AVP, increased responsiveness to AVP, as well as either increased or decreased overall HPA axis activity or responsiveness (Dinan \& Scott-2005). HPA axis normalization via pituitary V1B antagonism is a mechanism for potential ABT-436 efficacy in these disorders (Schüle et al-2009). Limbic V1B antagonism in the brain may also contribute to efficacy (Roper et al-2011).

Alcohol dependence, or alcoholism, is characterized by a chronic relapsing course, in which alcohol-associated cues and stress are known relapse triggers (Brownell et al-1986, Heilig \& Egli-2006, Sinha \& Li-2007). Recent research suggests that neural systems mediating behavioral stress responses may offer useful targets for pharmacotherapy of alcoholism. In animal models, excessive alcohol consumption that results from a history of alcohol dependence is accompanied by increased behavioral sensitivity to stress (Heilig \& Koob-2007). Preclinical studies have shown that V1B antagonists can attenuate reinstatement of heroin and alcohol self-administration, and block dependence-induced exaggeration of alcohol intake, in rats. V1B antagonists have also been shown to block stress-induced reinstatement of drug and alcohol seeking in ethanol dependent rats (Zhou-2011). For these reasons the NIAAA Clinical Investigations Group (NCIG) proposes to test ABT-436 in a Phase 2, proof of concept trial for the treatment of alcohol dependence.

Arms: arm 1: Matched Placebo sugar pill - target dose 2 pills BID arm 2: ABT-436 Target dose of 400 mg BID
Interventions: intervention 1: ABT-436 intervention 2: Matched Placebo - Sugar Pill
Intervention descriptions: intervention 1: Target dose - 400mg BID intervention 2: Target Dose - 2 pills BID

Protocol documents: