ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00602771
Conditions: Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome Adult Acute Megakaryoblastic Leukemia (M7) Adult Acute Minimally Differentiated Myeloid Leukemia (M0) Adult Acute Monoblastic Leukemia (M5a) Adult Acute Monocytic Leukemia (M5b) Adult Acute Myeloblastic Leukemia With Maturation (M2) Adult Acute Myeloblastic Leukemia Without Maturation (M1) Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Del(5q) Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) Adult Acute Myelomonocytic Leukemia (M4) Adult Erythroleukemia (M6a) Adult Pure Erythroid Leukemia (M6b) Secondary Acute Myeloid Leukemia Untreated Adult Acute Myeloid Leukemia
Sponsor: National Cancer Institute (NCI)
Start date: 2008-01-01; Completion date: 2011-10-01
Enrollment: 84 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase II trial is studying the side effects and how well giving tipifarnib together with etoposide works in treating older patients with newly diagnosed, previously untreated acute myeloid leukemia. Tipifarnib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving tipifarnib together with etoposide may kill more cancer cells.

Detailed description:
OBJECTIVES:

I. To compare the efficacy and toxicity of two schedules of tipifarnib plus etoposide as induction therapy in older patients with newly diagnosed, previously untreated acute myeloid leukemia.

II. To study mechanisms of leukemia cell resistance to tipifarnib in combination with etoposide.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive 600 mg of oral tipifarnib twice daily on days 1-14 and 100 mg of oral etoposide once daily on days 1-3 and 8-10.

ARM II: Patients receive 400 mg of oral tipifarnib twice daily on days 1-14 and 200 mg of oral etoposide once daily on days 1-3 and 8-10. (closed to accrual as of November 2008)

Treatment in both arms repeats every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 30 days and then every 90 days thereafter.

Arms: arm 1: Patients receive 600 mg of oral tipifarnib twice daily on days 1-14 and 100 mg of oral etoposide once daily on days 1-3 and 8-10. arm 2: Patients receive 400 mg of oral tipifarnib twice daily on days 1-14 and 200 mg of oral etoposide once daily on days 1-3 and 8-10.
Interventions: intervention 1: tipifarnib intervention 2: etoposide
Intervention descriptions: intervention 1: Given orally intervention 2: Given orally

Protocol documents:
Clinical trial NCT00660387
Conditions: Advanced Parkinson's Disease
Keywords: levodopa-carbidopa Carbidopa levodopa dyskinesia Duodopa levodopa-carbidopa intestinal gel Severe Motor Fluctuations levodopa/carbidopa suspension DUOPA
Sponsor: AbbVie (prior sponsor, Abbott)
Start date: 2009-12-01; Completion date: 2011-10-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study was to demonstrate the superiority of levodopa - carbidopa intestinal gel over treatment with optimized oral levodopa/carbidopa during 12 weeks.

Detailed description:
Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387) were 2 identically designed, Phase 3, 12-week, randomized, double-blind, double-dummy, parallel-group, multicenter studies recruiting subjects from distinct sites. These studies evaluated the efficacy, safety, and tolerability of levodopa-carbidopa intestinal gel (LCIG) in the treatment of levodopa-responsive subjects with advanced PD who had persistent severe motor fluctuations, despite optimized treatment with oral levodopa-carbidopa, concomitant with other available antiparkinsonian medications. Participants were randomized to either LCIG active gel + placebo capsules or levodopa-carbidopa immediate release (IR) active capsules + placebo gel. Both treatment arms received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration, active LCIG or placebo gel. Data from these 2 studies were combined for analysis. The decision to combine the study data for analysis was made before enrollment was completed for both studies.

Arms: arm 1: Participants were randomized to LCIG (levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG. arm 2: Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Interventions: intervention 1: Levodopa carbidopa intestinal gel (LCIG) intervention 2: Placebo Gel intervention 3: Levodopa-carbidopa (LC) oral encapsulated immediate release (IR) tablets intervention 4: Placebo (PBO) oral capsules intervention 5: CADD-Legacy® 1400 ambulatory infusion pump intervention 6: PEG tube intervention 7: J-tube
Intervention descriptions: intervention 1: infusion should be kept within a range of 0.5-10 mL/hour (10-200 mg levodopa/hour) and is usually 2-6 mL/hour (40-120 mg levodopa/hour) intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: percutaneous endoscopic gastrostomy tube intervention 7: jejunal tube

Protocol documents:
Clinical trial NCT00662363
Conditions: Constipation
Keywords: constipation opioid rehabilitation post-operative orthopedic
Sponsor: Shirley Ryan AbilityLab
Start date: 2008-04-01; Completion date: 2011-10-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Patients requiring opioids for post-operative pain control following elective orthopedic procedures which has resulted in constipation symptoms, and who are in inpatient rehabilitation will be randomized to two different treatment arms: lubiprostone or senna. Baseline scores regarding constipation and a quality of life bowel questionnaire will be compared the day following 6 days of treatment intervention.

Detailed description:
The purpose of this study is to assess the efficacy of Lubiprostone (Amitiza) compared to standard care for the treatment of constipation in orthopedic patients receiving opioids for pain control during inpatient rehabilitation. Lubiprostone (Amitiza®) is a locally acting chloride channel activator that increases intestinal fluid, and thus increases intestinal motility. It has been approved for chronic constipation, but not in the setting of opioid-induced constipation. Senna is a stimulant laxative that increases propulsive peristaltic activity of the colon through local effects on the mucosa.

Subjects will be compared using from the Patient Assessment of Constipation (PAC) which has previously been found to be a valid and reliable way to measure constipation symptoms and clinical course. (Frank, Kleinman et al. 1999) as well as with other measures of bowel-related symptoms and functional outcomes.

Arms: arm 1: Lubiprostone (Amitiza) 24 µg po BID given with meals for 6 days with two tabs placebo Senna at noon arm 2: Senna 2 tabs daily for 6 days at noon and placebo Lubiprostone 1 Cap BID
Interventions: intervention 1: Lubiprostone intervention 2: Senna
Intervention descriptions: intervention 1: 24 µg po BID given with meals for 6 days intervention 2: 2 tabs daily for 6 days

Protocol documents:
Clinical trial NCT00674622
Conditions: Lateral Epicondylitis Tennis Elbow
Keywords: Lateral epicondylitis Tennis elbow Prolotherapy
Sponsor: University of Pittsburgh
Start date: 2007-09-01; Completion date: 2011-10-01
Enrollment: 67 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Lateral epicondylitis (LE), or tennis elbow, is a common and often disabling condition affecting young and middle-aged adults-most commonly manual workers and recreational athletes. It results in significant pain and disability, limiting work productivity and an individual's ability to participate in and enjoy recreational activities. Like many other chronic musculoskeletal conditions LE often shows an incomplete response to acute treatments, leading to chronic pain and disability. Prolotherapy (PrT) involves the injection of an irritant or proliferant solution into tendons, ligaments, and joints to treat chronic musculoskeletal pain. We will be conducting a 3-group randomized, blinded trial to determine the safety and efficacy of PrT injections in the treatment of chronic LE. Additionally, we will seek to determine to what extent any beneficial effect of PrT is derived from deep needle placement vs. a specific effect of the injectate. The specific aims for this study are: 1) to determine if PrT is a safe, well-tolerated, and effective treatment for individuals with chronic LE; and 2) to determine whether the deep needle placement alone is responsible for the therapeutic effect, independent of injectate. In order to accomplish these aims, we will measure indicators of pain and disability using self-rating scales, questionnaires and physical measures. Subjects will be stratified prior to randomization on two factors: 1) unilateral vs. bilateral LE; and 2) treatment with steroids within the prior 6 months. If effective, subjects receiving PrT will show greater reduction of pain and functional impairment compared with the other two groups. This research will guide future studies on prolotherapy by determining what may be the best control condition. Additionally, further studies may explore the mechanism responsible for any beneficial effect.

Detailed description:
Same

Arms: arm 1: Deep injection with 15% dextrose in lidocaine arm 2: Deep injection with saline/lidocaine arm 3: Superficial injection with saline/lidocaine
Interventions: intervention 1: Prolotherapy intervention 2: Placebo
Intervention descriptions: intervention 1: Injection of 15% dextrose with lidocaine at the lateral epicondyle intervention 2: Saline/lidocaine

Protocol documents:
Clinical trial NCT00690274
Conditions: Schizophrenia
Keywords: schizophrenia cognitive deficients cognitive enhancing antipsychotics
Sponsor: University of Texas Southwestern Medical Center
Start date: 2008-06-01; Completion date: 2011-10-01
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the cognitive enhancing effect of BF2.649 and to evaluate the effect of BF2.649 on symptom severity in persons with schizophrenia or schizoaffective disorder.

Detailed description:
We will recruit persons with schizophrenia or schizoaffective disorder who are not currently experiencing an acute exacerbation of psychotic symptoms, but still display cognitive symptoms and have consequent psychosocial dysfunction. The subjects recruited will be taking haloperidol, aripiprazole, risperidone or paliperidone. Each study subject will spend 4 weeks on a fixed dose of his or her APD with stable symptoms, during which time the baseline workup will be completed. At baseline (Week 0), each study subject will have a full symptom evaluation, side effects, and neuropsychological battery along with the full clinical laboratory and baseline safety study workup. Next, subjects, while remaining on their APD, will be randomized to BF2.649 or placebo. The dose of BF2.649 will be up to 20 mg/day. Assessment of safety parameters (vital signs, EKGs, clinical labs) and side effects (adverse events, BAS, SAS) will occur once weekly for the first 4 weeks (through study week 4) and then every other week for the next 4 weeks (to study week 8) including End of Study (week 12). An EEG will be taken at Week 1 and then at Week 8. Symptomatic outcome measures (PANSS and CGI) will be measured every two weeks during the double blind phase and at end of study. The neuropsychological battery will be done first at baseline and repeated at the end of the 8-week double blind phase. After 8 weeks of medication, the double-blinded drug will be stopped and the patient followed for a period 4 weeks with clinical and side effect measures recorded weekly with the exception of clinical laboratories, which will be recorded every other week. Each study participant will be seen weekly throughout the protocol for clinical assessment.

Finally, persons with schizophrenia display severe deficits in neuropsychological, cognitive, and social functioning. Our primary outcome measure will be to determine if BF2.649 can produce a cognitive enhancing effect and repair some of the neuropsychological deficiencies seen in this population. Therefore, blood samples will be collected from study volunteers for DNA analysis, serology testing, and white cell immortalization during and only at the baseline phase of the study (Week 0). If a therapeutic effect is seen, it will be important to be able to identify the genetic characteristics of the responders to BF2.649.

Arms: arm 1: Volunteers are given Placebo, up to 20mg per day arm 2: Volunteers are given BF2.649, up to 20mg per day
Interventions: intervention 1: BF2.649 intervention 2: Placebo
Intervention descriptions: intervention 1: up to 20mg per day intervention 2: up to 20mg per day

Protocol documents:
Clinical trial NCT00720122
Conditions: Disorder of Bone Density and Structure, Unspecified
Keywords: Bone density Bone turnover markers rhIGF-1 Bone structure Anorexia nervosa
Sponsor: Massachusetts General Hospital
Start date: 2008-07-01; Completion date: 2011-10-01
Enrollment: 28 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Adolescents and young adults with anorexia nervosa (AN) are at high risk for low bone mineral density at a time when healthy adolescents are rapidly accruing bone, with implications for peak bone mass and fracture risk in later life. They are also deficient in insulin-like growth factor 1 (IGF-1), the bone trophic factor made in the liver in response to growth hormone (GH), despite elevated levels of growth hormone. It is possible that deficiency of insulin-like growth factor 1, a hormone very important for the maintenance of skeletal integrity, may contribute to the severe osteopenia seen in anorexia nervosa. The physiologic effects of recombinant human insulin-like growth factor 1 (rhIGF-1) treatment in adolescents and young adults with anorexia nervosa have not been studied. The goal of this proposal is to investigate the effects of recombinant human insulin-like growth factor 1 on bone density and bone microarchitecture in adolescent girls and young adult women with anorexia nervosa over a 6 month period. We hypothesize that adolescent and young adult anorexia nervosa patients, being insulin-like growth factor 1 deficient, will respond to exogenously administered recombinant human insulin-like growth factor 1 with elevations in biochemical indices of bone turnover and an increase in bone density and improvement in bone structure, or maintain bone density (in contrast to the decrease in bone density expected in adolescent girls and women with anorexia nervosa who are not treated).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Recombinant human insulin like growth factor-1 (rhIGF-1)
Intervention descriptions: intervention 1: Twice daily

Protocol documents:
Clinical trial NCT00730236
Conditions: Homozygous Familial Hypercholesterolemia
Sponsor: Aegerion Pharmaceuticals, Inc.
Start date: 2007-12-01; Completion date: 2011-10-01
Enrollment: 29 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this trial is to study the effects of AEGR-733 on LDL cholesterol, other lipids as well as measures of safety over the long-term.

Detailed description:
Homozygous familial hypercholesterolemia (FH) is a serious life-threatening genetic disease. Total plasma cholesterol levels are generally over 500 mg/dl and markedly premature cardiovascular disease is the major consequence. Untreated, most patients develop atherosclerosis before age 20 and generally do not survive past age 30. The primary goal of therapy involves reducing cholesterol (specifically, LDL cholesterol) and preventing coronary artery disease. Unfortunately, patients with homozygous FH are minimally responsive or unresponsive to available drug therapy and thus there are limited treatment options. The current standard of care is LDL apheresis, a physical method of removing the plasma of LDL cholesterol which can transiently reduce cholesterol by more than 50%. However, there is rapid re-accumulation of LDL cholesterol in plasma, and therefore apheresis has to be repeated frequently (every 1-2 weeks) and requires 2 separate sites for IV access. Although anecdotally this procedure may delay the onset of atherosclerosis, it is laborious, expensive, and not readily available. Furthermore, although it is a procedure that is generally well tolerated, the fact that it needs frequent repetition and IV access can be challenging for many of these young patients. Therefore, there is a tremendous unmet medical need for new medical therapies for this orphan disease.

AEGR-733 is a novel oral therapeutic agent for hypercholesterolemia. Its mechanism involves inhibition of microsomal triglyceride transfer protein, resulting in a reduction of LDL cholesterol. Earlier studies in patients with homozygous FH reveal AEGR-733 is highly effective in lowering LDL cholesterol, yet long term safety and efficacy need to be established.

Arms: arm 1: None
Interventions: intervention 1: AEGR-733
Intervention descriptions: intervention 1: 5-80 mg daily by mouth for 1.5 yrs

Protocol documents:
Clinical trial NCT00733993
Conditions: Cocaine Dependence
Keywords: substance abuse cocaine caffeine impulsivity
Sponsor: Virginia Commonwealth University
Start date: 2008-04-01; Completion date: 2011-10-01
Enrollment: 23 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is being done to find out if medicines that affect a neurotransmitter (chemical messenger) in the brain called adenosine improve behavioral problems that are related to drug abuse. Another purpose of the study is to find out how genes related to adenosine change how people respond to these medicines. More information about how these medicines change behaviors may be helpful to come up with new treatments for drug abuse.

Detailed description:
Specific Aims:

Aim 1. To characterize the behavioral and subjective effects of acute caffeine administration in cocaine-dependent subjects, using laboratory measures of impulse control, drug discrimination (with d-amphetamine as the training dose), and subjective effects.

Hypotheses related to Aim 1:

1. Subjects will show decreases in impulsivity (delay to reward and response inhibition) after acute oral doses of caffeine compared to placebo.
2. Subjects will show some stimulant-like subjective effects following acute oral doses of caffeine, but not the euphoric effects that would predict abuse potential.

Arms: arm 1: Caffeine 150 mg arm 2: Placebo arm 3: Amphetamine arm 4: Caffeine 300 mg
Interventions: intervention 1: Caffeine 150 MG intervention 2: Placebo intervention 3: Amphetamine intervention 4: Caffeine 300 MG
Intervention descriptions: intervention 1: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion intervention 2: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion intervention 3: Across five separate testing days, subjects were administered two placebo doses, 20 mg damphetamine,150 mg caffeine, and 300 mg caffeine in counterbalanced fashion intervention 4: Across five separate testing days, subjects were administered two placebo doses, 20 mg damphetamine,150 mg caffeine, and 300 mg caffeine in counterbalanced fashion

Protocol documents:
Clinical trial NCT00735306
Conditions: Pancreatic Cancer
Keywords: Locally advanced Unresectable
Sponsor: Duke University
Start date: 2008-07-01; Completion date: 2011-10-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose of this trial is to define the maximum tolerated and/or recommended phase II dose of the combination of Avastin and Tarceva in patients undergoing radiation therapy for carcinoma of the pancreas. An additional primary objective is to describe the frequency and nature of grade III/IV and grade I/II toxicities associated with this regimen. Secondary objectives include describing 1-year disease-free survival and overall survival rates as well as to estimate clinical and pathologic complete response rates associated with this regimen.

Detailed description:
This is a phase I/II study in which up to 18 patients will be enrolled in the phase I portion and up to an additional 26 patients in the phase II portion. Patients will be treated with Tarceva (cohort specified dose), along with fixed doses of Avastin and radiation therapy.

Avastin will be given as an IV dose on days 1, 15, and 29. Tarceva will be given as a once daily by mouth. On radiation days Tarceva will be taken immediately before or after XRT.

XRT will be given to a total dose of 50.4 Gy in 28 fractions, each fraction given once daily on Monday through Friday for 5.5 weeks

Arms: arm 1: Avastin, Tarceva and Radiation Therapy
Interventions: intervention 1: Avastin intervention 2: Tarceva intervention 3: Radiation Therapy
Intervention descriptions: intervention 1: Avastin 10 mg/kg IV on days 1, 15 and 29 Begins the first day of radiation therapy intervention 2: Daily by mouth per assigned dose, for 5.5 weeks Begins the first day of radiation therapy intervention 3: Radiation to the pancreas Monday through Friday for 28 treatments

Protocol documents:
Clinical trial NCT00759395
Conditions: Anxious Major Depressive Disorder
Keywords: Anxious Major Depressive Disorder
Sponsor: AstraZeneca
Start date: 2009-01-01; Completion date: 2011-10-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will determine if a highly selective enkephalinergic receptor modulator is effective in the treatment of anxious major depressive disorder.

Detailed description:

Arms: arm 1: AZD2327 3mg BID arm 2: Placebo BID
Interventions: intervention 1: AZD2327 intervention 2: Placebo
Intervention descriptions: intervention 1: Tablet, Oral, Daily intervention 2: Tablet, Oral, Daily

Protocol documents:
Clinical trial NCT00767325
Conditions: Rheumatoid Arthritis
Sponsor: Bristol-Myers Squibb
Start date: 2008-12-01; Completion date: 2011-10-01
Enrollment: 104 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to assess early signs of response to abatacept+methotrexate in metacarpophalangeal joints in both hands using power Doppler ultrasonography in patients with active rheumatoid arthritis.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Abatacept intervention 2: Methotrexate
Intervention descriptions: intervention 1: Abatacept, 10 mg/kg, solution given intravenously on Days 1, 15, 29,57, 85, 113, 141, and 169 intervention 2: Methotrexate administered in a dose of 15 mg/week or higher for at least 3 months and at a stable dose for at least 28 days prior to baseline

Protocol documents: