ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00844597
Conditions: Duchenne Muscular Dystrophy
Sponsor: Sarepta Therapeutics, Inc.
Start date: 2009-01-01; Completion date: 2010-12-01
Enrollment: 19 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The specific aim of this Phase I/II study is to assess the safety of intravenous administered Morpholino oligomer directed against exon 51 (AVI-4658 PMO).

Detailed description:
Primary outcome is safety, tolerability and dose selection for future studies.

Arms: arm 1: Subjects in this group will receive a 0.5 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period arm 2: Subjects in this group will receive a 1.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period arm 3: Subjects in this group will receive a 2.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period arm 4: Subjects in this group will receive a 4.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period arm 5: Subjects in this group will receive a 10.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period arm 6: Subjects in this group will receive a 20.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
Interventions: intervention 1: AVI-4658 for Injection
Intervention descriptions: intervention 1: AVI-4658 for Injection, is packaged as 100 mg/mL in phosphate buffered saline with 1 mL per vial. Study dosages will be infused over a 1 hour period with Normal saline in 6 dose cohorts.

Protocol documents:
Clinical trial NCT00853996
Conditions: Breast Cancer
Sponsor: University of Kansas Medical Center
Start date: 2009-02-01; Completion date: 2010-12-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well acolbifene works in preventing cancer in premenopausal women at high risk of breast cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of acolbifene may stop cancer from growing or coming back.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the effect of six months of acolbifene 20 mg/day on Ki-67 in high risk premenopausal women with baseline hyperplasia +/- atypia and Ki-67 positivity of \>= 2%..

SECONDARY OBJECTIVES:

I. To determine the effect of six months of acolbifene 20 mg/day on mammographic breast density in high risk premenopausal women.

II. To determine the effect of six months of acolbifene 20 mg/day on serum levels of follicular phase bioavailable estradiol, and luteal phase progesterone, testosterone, and fasting IGF-1/IGFBP-3.

III. To determine the effect of six months of acolbifene 20 mg/day on epithelial cell cytomorphology and molecular markers such as ER, PgR, and pS2.

IV. To determine the effect of six months of acolbifene on markers of cardiovascular risk (C-reactive protein, functional AntiThrombin III, and fasting lipid profile) and bone turnover markers associated with bone mineral density gain or loss (serum osteocalcin and N-telopeptide crosslinks).

V. To assess any increase in reported hot flashes, menstrual cycle irregularities, pelvic pain, musculoskeletal complaints, and fatigue from baseline.

OUTLINE:

Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.

Patients undergo symptom assessment (hot flashes, menstrual abnormalities, pelvic pain, muscle and joint pain, and fatigue) at baseline, 6-8 weeks, monthly for 6 months, and then at 2 weeks after completion of study treatment.

Patients undergo random periareolar fine needle aspiration between days 1-10 of menstrual cycle at baseline and at 6 months. Patients also undergo blood sample collection between days 1-10 and days 20-24 of menstrual cycle at baseline and at 6 months. Samples taken between days 1-10 of menstrual cycle are analyzed for Ki-67 expression, cytomorphology, molecular markers (estrogen receptor, progesterone receptor, and pS2 expression), and bioavailable estradiol levels. Samples taken between days 20-24 of menstrual cycle are analyzed for progesterone, testosterone, IGF-1, IGFBP-3, lipid profile, bone-turnover markers (osteocalcin and N-telopeptide crosslinks), C-reactive protein, and functional antithrombin III.

After completion of study treatment, patients are followed at 2 weeks.

Arms: arm 1: Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.
Interventions: intervention 1: acolbifene hydrochloride
Intervention descriptions: intervention 1: Given orally

Protocol documents:
Clinical trial NCT00857896
Conditions: Overactive Bladder Neurogenic Detrusor Overactivity
Keywords: Study of fesoterodine in pediatric overactive bladder patients
Sponsor: Pfizer
Start date: 2009-03-01; Completion date: 2010-12-01
Enrollment: 21 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to evaluate the pharmacokinetics, safety, and tolerability of fesoterodine following administration to pediatric patients, aged 8-17 years, with overactive bladder.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Fesoterodine
Intervention descriptions: intervention 1: 4 mg once daily for Weeks 1-4 and 8 mg once daily for Weeks 5-8

Protocol documents:
Clinical trial NCT00860158
Conditions: Prostate Cancer
Sponsor: Noah Hahn, M.D.
Start date: 2009-03-01; Completion date: 2010-12-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This trial will investigate the activity of dasatinib plus LHRH analogue therapy in high-risk localized prostate cancer.

Detailed description:
OUTLINE: This is a multi-center study.

* Dasatinib -100 mg administered once daily per oral route for 28 consecutive days.
* Leuprolide acetate - 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).

The 28 days of dasatinib and leuprolide injection (plus the time required to recover from toxicity if encountered) is defined as a cycle. Patients will be treated for up to a maximum of 3 cycles of dasatinib and leuprolide acetate.

Radical Prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery.

Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Hematopoietic:

* Hemoglobin (Hgb) ≥ 8.0 g/dL
* Platelets ≥ 100 K/mm3
* Absolute neutrophil count (ANC) ≥ 1.0 K/mm3

Hepatic:

* Total bilirubin \< 2.0 X Upper Limit Normal (ULN)
* Aspartate aminotransferase (AST) \< 2.5 X ULN
* Alanine aminotransferase (ALT) \< 2.5 X ULN

Renal:

* Calculated creatinine clearance of ≥ 60 cc/min using the Cockcroft-Gault formula

Cardiovascular:

* No uncontrolled angina, congestive heart failure or myocardial infarction within 6 months prior to registration for protocol therapy.

Arms: arm 1: Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy
Interventions: intervention 1: Dasatinib intervention 2: Leuprolide Acetate (LHRH Analogue) intervention 3: Radical Prostatectomy
Intervention descriptions: intervention 1: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days intervention 2: Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days). intervention 3: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose.

Protocol documents:
Clinical trial NCT00860405
Conditions: Cardiac Surgery Cardiopulmonary Bypass
Sponsor: Fresenius Kabi
Start date: 2009-03-01; Completion date: 2010-12-01
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the clinical efficacy and safety of Voluven® and Human Albumin during elective open-heart surgery in pediatric patients.

Detailed description:
In the past, human albumin has been widely accepted as the therapeutic "gold standard" in paediatric volume replacement therapy because of the physiological hypoproteinemia in newborns and infants. In adult patients, artificial colloids such as hydroxyethyl starch have replaced human albumin as first choice in many settings. This study will compare the clinical efficacy and safety of HES 130/0.4 (6%) in normal saline vs. HSA 50g/L in volume replacement therapy during elective open-heart surgery in paediatric patients. The hypothesis of this study is to demonstrate that HES 130/0.4 (6%) and HSA 50g/L are equivalent regarding efficacy and provide comparable safety during elective open-heart surgery in paediatric patients 2 to 12 years of age.

Arms: arm 1: Investigational drug: HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion) arm 2: Control drug: Human serum albumin (HSA 50g/L)
Interventions: intervention 1: HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion), Human serum albumin (HSA 50g/L) intervention 2: Human serum albumin (HSA 50g/L)
Intervention descriptions: intervention 1: Study medication will be given as part of the priming of the ECC and for plasma volume replacement after start of ECC up to the maximum dosage of 50 mL/kg body weight/day. intervention 2: Human serum albumin (HSA 50g/L)

Protocol documents:
Clinical trial NCT00869518
Conditions: Staphylococcus Aureus HIV Infections
Keywords: Staphylococcus aureus colonization eradication HIV rifabutin
Sponsor: University of California, San Francisco
Start date: 2009-07-01; Completion date: 2010-12-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
DESIGN: This single center, double-blinded, randomized phase II study is being conducted to assess the efficacy of a rifabutin based regimen to eliminate S. aureus colonization in HIV infected individuals. Individuals must have HIV infection and a skin and skin structure infection (SSSI) in the prior 6 months to be eligible for screening. Prior to enrollment, subjects will be cultured for evidence of S. aureus colonization. Individuals who are culture positive at ≥ one body site will be eligible for enrollment. Subjects who meet inclusion and exclusion criteria and consent to participate in the study will be randomized to seven days of rifabutin plus trimethoprim-sulfamethoxazole (TMP-SMX) or TMP-SMX alone. Following completion of treatment subjects will be screened seven days, 30 days, and 60 days post-treatment for colonization at multiple body-sites. Subjects will also be actively followed for evidence of SSSI.

SUBJECT PARTICIPATION DURATION: 12 weeks

SAMPLE SIZE: 88 total subjects

POPULATION: 200 HIV infected individuals who receive care at San Francisco General Hospital HIV clinic (Ward 86) with a history of SSSI in the prior 6 months will be screened for S. aureus colonization.

DESCRIPTION OF AGENT OR INTERVENTION: This is a double-blind trial comparing rifabutin plus TMP-SMX versus placebo plus TMP-SMX. Placebo will be administered at a dose of 300 mg p.o. daily or an equivalent dose depending on co-administration of other drugs that may adjust the serum level of rifabutin. TMP-SMX will be administered at a dose of trimethoprim 160 mg and sulfamethoxazole 800 mg p.o. twice daily or adjusted per CrCl. Study drug will be provided by the study and administered for 7 days.

Detailed description:

Arms: arm 1: Subjects will be assigned to 7 days of treatment with rifabutin plus trimethoprim-sulfamethoxazole arm 2: Subjects will be assigned to 7 days of treatment with placebo plus trimethoprim-sulfamethoxazole
Interventions: intervention 1: rifabutin plus trimethoprim sulfamethoxazole intervention 2: placebo plus trimethoprim-sulfamethoxazole
Intervention descriptions: intervention 1: rifabutin 300 mg PO daily or equivalent depending on concomitant medications plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days intervention 2: placebo plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days

Protocol documents:
Clinical trial NCT00869960
Conditions: Healthy
Keywords: Healthy Volunteers
Sponsor: University of Alabama at Birmingham
Start date: 2009-03-01; Completion date: 2010-12-01
Enrollment: 24 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Data suggest that women taking drugs to treat human immunodeficiency virus (HIV) have higher amounts of drugs in their body compared with men taking the same dose of anti-HIV drugs. The reason for this higher drug exposure has not been determined. The primary purpose of this study is to examine whether the pharmacokinetics (factors that determine the amount of drug in the body) of anti-HIV drugs change during different phases of the menstrual cycle in women and ultimately result in higher amounts of drug in the body compared with men. In other words, we plan to examine whether changes in sex hormones throughout the menstrual cycle affect the amount of anti-HIV drugs in women. The antiretroviral drugs atazanavir, ritonavir, tenofovir and emtricitabine will be studied. This study will be conducted in healthy women since HIV may change the pharmacokinetics of anti-HIV drugs.

Detailed description:

Arms: arm 1: Healthy volunteers received two doses of Tenofovir, Emtricitabine, Atazanavir and Ritonavir administered twice (on day 6 - 10 and day 20 - 25 after day of Follicular phase); with pharmacokinetic measurements at 6 - 10 days after menses and then again at day 20 - 25 after menses.
Interventions: intervention 1: tenofovir intervention 2: emtricitabine intervention 3: atazanavir intervention 4: ritonavir
Intervention descriptions: intervention 1: tenofovir 300 mg one dose on 2 separate visits: within 5 days after Day 1 of Follicular phase and then within a 4 day window of the leutal phase (day 14 of the menstrual cycle) intervention 2: emtricitabine 200 mg on 2 separate visits: within 5 days after Day 1 of Follicular phase and then within a 4 day window of the leutal phase (day 14 of the menstrual cycle). intervention 3: atazanavir 300mg one dose on 2 separate visits: within 5 days after Day 1 of Follicular phase and then within a 4 day window of the leutal phase (day 14 of the menstrual cycle). intervention 4: ritonavir 100 mg one dose on 2 separate visits: within 5 days after Day 1 of Follicular phase and then within a 4 day window of the leutal phase (day 14 of the menstrual cycle).

Protocol documents:
Clinical trial NCT00884793
Conditions: HIV Infections
Keywords: HIV persistence reservoirs residual replication gut gut-associated lymphoid tissue treatment experienced
Sponsor: University of California, San Francisco
Start date: 2008-09-01; Completion date: 2010-12-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The "PLUS" study is a pilot study to measure the effect of therapy intensification (with raltegravir and optional second agent) on HIV levels in the gut and blood in patients on antiretroviral therapy (ART) with viral load \< 50 copies/mL (herein referred to as "suppressed"). We hypothesize that there is ongoing replication in the gut despite suppressive ART and that this replication can be inhibited by the addition of one or two new antiretroviral drugs whose activity affects a distinct part of the viral life cycle. All study participants will have upper and lower endoscopy at baseline (before intensification) and after intensification. These endoscopies will be used to obtain gut tissue and single cells (for CD4+ cells) .

Detailed description:
The "PLUS" study is a prospective, longitudinal pilot study to measure the effect of therapy intensification (with raltegravir and possible addition of a study PI or NNRTI-Non-Nucleoside Reverse Transcriptase Inhibitor) on HIV-1 DNA/RNA levels in the gut-associated lymphoid tissue (GALT) and blood in patients on ART with viral load (VL) \< 50 copies/mL (herein referred to as "suppressed"). We hypothesize that there is ongoing replication in the GALT despite suppressive ART and that this replication can be inhibited by the addition of one or two new antiretroviral drugs whose activity affects a distinct part of the viral life cycle. All study participants will have a colonoscopy and esophagogastroduodenoscopy (EGD) at baseline (before intensification) and a second colonoscopy with EGD 12 weeks after intensification. These endoscopies will be used to obtain GALT mononuclear cells (for CD4+ lymphocytes) as well as tissue for in situ hybridization and immunohistochemical studies.

Arms: arm 1: Intensification with raltegravir 400mg PO BID +/- a study PI or NNRTI
Interventions: intervention 1: raltegravir intervention 2: Study NNRTI intervention 3: Study PI
Intervention descriptions: intervention 1: The baseline ART regimen will be intensified with raltegravir 400mg orally (PO) twice daily (BID) (all participants) +/- a study NNRTI or protease inhibitor (PI) (at the option of the participant and the study clinical team). intervention 2: Subjects who are not already on an NNRTI and who are suitable candidates will have the option of adding a study NNRTI (either efavirenz or etravirine). intervention 3: Subjects who are not on a PI and who are suitable candidates will have the option of adding a study PI. PIs used as study drugs will include atazanavir (+/- ritonavir), fosamprenavir (+/-ritonavir), lopinavir/ritonavir, and darunavir/ritonavir.

Protocol documents:
Clinical trial NCT00887341
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2009-05-01; Completion date: 2010-12-01
Enrollment: 76 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study will compare the incidence of tocilizumab-related infusion reactions, using 2 different infusion times, in patients with moderate to severe rheumatoid arthritis who have shown an inadequate response to DMARDs (Disease Modifying Anti Rheumatic Drugs) or anti-TNFs.Patients will be randomized to one of 2 groups, to receive tocilizumab 8mg/kg iv every 4 weeks either a)over a 1h infusion time for all administrations or b) a 1h infusion time for the first administration, followed by a 31 minute infusion time for subsequent administrations (unless drug-related infusion reactions occur).The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: tocilizumab [RoActemra/Actemra] intervention 2: tocilizumab [RoActemra/Actemra]
Intervention descriptions: intervention 1: 8mg/kg iv every 4 weeks for 6 infusions; first infusion 1h duration, subsequent infusions 31 minutes duration intervention 2: 8mg/kg iv every 4 weeks for 6 infusions; each infusion 1h duration

Protocol documents:
Clinical trial NCT00895193
Conditions: Hypercholesterolemia Flushing
Keywords: Niacin Hypercholesterolemia Flushing
Sponsor: Patrick Moriarty, MD, FACP, FACC
Start date: 2009-01-01; Completion date: 2010-12-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Niacin (Vitamin B3) is known to effectively and safely treat hypercholesterolemia. However, use of niacin is limited due to incidents of flushing which limits its acceptability. Some information suggests that applesauce can reduce the incidence and severity of flushing. The apple pectin in particular is thought to be the ingredient that affects this reaction. To determine if the apple pectin does affect flushing from niacin, the investigators will study the affects of isolated apple pectin in pill form. The investigators plan on recruiting 100 patients, and giving them 1000 mg of Niacin to induce flushing. Patients will be divided into 4 treatment groups and receive either pectin, aspirin, a combination of both, or placebo. Incidents and severity of flushing will be monitored for up to 6 hours post Niacin ingestion.

Detailed description:

Arms: arm 1: Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin. arm 2: Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin. arm 3: Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin. arm 4: Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Interventions: intervention 1: Apple pectin intervention 2: Aspirin 325 mg intervention 3: Placebo
Intervention descriptions: intervention 1: Apple pectin 2000mg intervention 2: Aspirin 325 mg intervention 3: Placebo

Protocol documents:
Clinical trial NCT00919113
Conditions: Interstitial Cystitis Painful Bladder Syndrome
Keywords: Bladder Pain GAG replacement therapy IC/PBS
Sponsor: Watson Pharmaceuticals
Start date: 2009-07-01; Completion date: 2010-12-01
Enrollment: 98 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A new device for interstitial cystitis is compared to inactive control to determine if it is safe and effective. The study lasts approximately 7 weeks with a 19-week follow-up period.

Detailed description:
Multi-center, randomized, double-blind, parallel, 8 weekly instillations over a 7-week period with post-treatment follow-up for an additional 19 weeks for a total study length of 26 weeks.

Arms: arm 1: 20 mL Uracyst (2% sodium chondroitin sulfate) per instillation; 8 instillations over a 7-week period arm 2: 20 mL inactive control buffer (phosphate-buffered saline); 8 instillations over a 7-week period
Interventions: intervention 1: 2% sodium chondroitin sulfate intervention 2: Placebo
Intervention descriptions: intervention 1: Weekly 20 mL Intravesical instillation intervention 2: The identical buffer used in Uracyst for the same administration

Protocol documents:
Clinical trial NCT00922636
Conditions: Attention Deficit Hyperactivity Disorder
Sponsor: Eli Lilly and Company
Start date: 2009-06-01; Completion date: 2010-12-01
Enrollment: 340 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of your child's participation in this study is to determine whether LY2216684 can help pediatric patients with attention-deficit/hyperactivity disorder (ADHD); and assess the safety of LY2216684 and any side effects that might be associated with it.

Detailed description:

Arms: arm 1: Extended-release methylphenidate 18 milligrams per day (mg/day) to 54 mg/day, based on weight, given once daily (QD) and orally (po) as a capsule for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the taper phase. arm 2: None arm 3: Taken in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the taper phase. arm 4: Taken in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the taper phase. arm 5: Taken in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the taper phase.
Interventions: intervention 1: LY2216684 intervention 2: Methylphenidate intervention 3: Placebo (tablet) intervention 4: Placebo (capsule)
Intervention descriptions: intervention 1: Taken in tablet form QD po. intervention 2: Extended-release methylphenidate 18 mg/day to 54 mg/day, based on weight, QD po as a capsule for the 8-week double-blind treatment phase. intervention 3: Placebo given as a tablet for LY2216684 blind QD po for the 8-week double-blind treatment phase, followed by 2 weeks in the taper phase. intervention 4: Placebo given as a capsule for methylphenidate blind QD po for the 8-week double-blind treatment phase followed by 2 weeks in the taper phase.

Protocol documents: