ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00635817
Conditions: Puberty, Precocious
Keywords: CPP central precocious puberty pediatrics suppression of luteinizing hormone Lupron leuprolide acetate depot formulation GnRHa GnRH agonist GnRH analog luteinizing hormone
Sponsor: Abbott
Start date: 2008-06-01; Completion date: 2010-06-01
Enrollment: 84 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if 11.25 and 30 mg formulations of leuprolide are effective in treating children with Central Precocious Puberty (CPP).

Detailed description:
Study Design:

A total of 80 children with confirmed CPP were planned to be enrolled and randomized in a 1:1 ratio to receive 2 injections of either leuprolide acetate 11.25 mg or 30 mg depot formulation, each injection administered 3 mo apart (6 mo of treatment):

This study includes a 4-week Screening Period, two 3-mo treatment cycles, and a posttreatment follow-up period (12 weeks following the Mo 6 visit). Study visits will occur at Screening, Day 1, Week 2 (only for subjects participating in the pharmacokinetic subset), Mo 1, 2, 3, Mo 6/Early Termination, and 12 weeks later, for the Posttreatment Follow-up Visit.

This study was conducted at 18 sites in the United States and 4 sites in Puerto Rico.

Arms: arm 1: There are 2 arms that received leuprolide acetate 11.25 mg. Subjects who are treatment naive to leuprolide acetate are designated to be in Arm A and subjects who have previously been treated with leuprolide acetate are designated to be in Arm B. arm 2: There are 2 arms that received leuprolide acetate 30 mg. Subjects who are treatment naive to leuprolide acetate are designated to be in Arm C and subjects who have previously been treated with leuprolide acetate are designated to be in Arm D.
Interventions: intervention 1: Leuprolide acetate 11.25 mg intervention 2: Leuprolide acetate 30 mg
Intervention descriptions: intervention 1: Two intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 mo apart. intervention 2: Two intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 mo apart.

Protocol documents:
Clinical trial NCT00637247
Conditions: Pancreatic Neoplasms
Keywords: pancreatic cancer metastatic chemotherapy naive
Sponsor: AmpliMed Corporation
Start date: 2008-04-01; Completion date: 2010-06-01
Enrollment: 142 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if imexon in combination with gemcitabine could improve overall survival as compared to gemcitabine alone in subjects with pancreatic cancer that has spread to other organs such as the liver or lungs. The study will also look at the safety of the combination as compared to gemcitabine alone. Participants in the study will be randomly assigned to either treatment and neither the participant or their doctors will know which treatment they will be receiving.

Detailed description:

Arms: arm 1: imexon + gemcitabine arm 2: Placebo in combination with gemcitabine
Interventions: intervention 1: imexon in combination with gemcitabine intervention 2: imexon placebo + gemcitabine
Intervention descriptions: intervention 1: 875 mg/m\^2 imexon IV + 1000 mg/m\^2 gemcitabine IV intervention 2: imexon placebo IV + 1000 mg/m\^2 gemcitabine IV

Protocol documents:
Clinical trial NCT00655486
Conditions: Partial Epilepsies Partial Onset Seizures
Keywords: Epilepsy seizures antiepileptic Lacosamide Vimpat safety adjunctive
Sponsor: UCB BIOSCIENCES, Inc.
Start date: 2008-04-01; Completion date: 2010-06-01
Enrollment: 97 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to allow eligible subjects from the parent study, SP925 \[NCT00655551\] to continue lacosamide and to obtain additional long-term safety data

Detailed description:
A multicenter, open-label extension study to assess the long-term safety and tolerability of lacosamide as adjunctive therapy in subjects with partial-onset seizures who were previously enrolled in the SP925 study \[NCT00655551\] (intravenous lacosamide loading dose followed by approximately 1 week of oral lacosamide maintenance).

Arms: arm 1: Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)
Interventions: intervention 1: lacosamide
Intervention descriptions: intervention 1: Subjects' dose of lacosamide may be increased or decreased as needed to maintain a subject's effective and tolerable dose during the study. Tablets are 50 mg or 100 mg each; Dose is 100 mg/day up to 800 mg/day administered twice daily throughout the study (up to 2 years).

Protocol documents:
Clinical trial NCT00661830
Conditions: Adenocarcinoma
Keywords: advanced metastatic biliary tract
Sponsor: PD Dr Markus Möhler
Start date: 2008-05-01; Completion date: 2010-06-01
Enrollment: 103 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial will be conducted to evaluate the efficacy, safety and tolerability of a combination of gemcitabine plus sorafenib in comparison of gemcitabine plus placebo as a first-line palliative therapy in chemo-naive advanced or metastatic CCC. There is strong scientific rationale for exploring the role of sorafenib in combination with gemcitabine in advanced CCC.

Sorafenib is a novel signal transduction inhibitor that prevents tumor cell proliferation and angiogenesis through blockade of the Raf/MEK/ERK pathway at the level of Raf kinase and the receptor tyrosine kinases VEGF-R2, R3 and PDGFR-β.

Mutations in these signaling pathways display by far the most common genetic alterations in CCC and overexpression correlates to poor prognosis. Furthermore, there is no evidence of a consistent or meaningful pharmacokinetic interaction between sorafenib and gemcitabine, suggesting that sorafenib can safely be combined with gemcitabine.

Clinical results of a combination of sorafenib and gemcitabine in a phase I study in pancreatic cancer suggested a therapeutic effect, and the safety and efficacy results together with the knowledge of the molecular pathology of CCC provide a rationale for a randomized, placebo-controlled phase II trial consisting of gemcitabine plus sorafenib in advanced CCC.

Detailed description:

Arms: arm 1: Gemcitabine + Sorafenib arm 2: Gemcitabine + Placebo
Interventions: intervention 1: Gemcitabine intervention 2: Placebo intervention 3: Sorafenib
Intervention descriptions: intervention 1: Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15. intervention 2: Placebo intervention 3: Sorafenib 400 mg bid orally continuously

Protocol documents:
Clinical trial NCT00672438
Conditions: Pain
Sponsor: Martin Angst
Start date: 2008-05-01; Completion date: 2010-06-01
Enrollment: 242 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Proposed twin study will test to what degree inter-individual differences in pain sensitivity and amount of pain relief in response to opioid therapy are inherited or alternatively, are due to environmental factors. This knowledge is important to guide future studies trying to explain such inter-individual differences. For example, finding that differences are largely due to environmental factors would discourage genomic studies and emphasize epidemiological studies.

Detailed description:
The principal hypothesis to be evaluated is that the degree of analgesia provided by opioids in humans displays substantial familial aggregation, and is, in fact, heritable. These studies will use a classical twin paradigm to determine the role of genetics and the environment in influencing analgesia and a range of other opioid effects.

Specific Aims: (1) Determine the degree to which opioid analgesic responses show familial aggregation and make preliminary estimates of heritability using both a heat and cold pressor pain model, and (2) determine the degree to which non-analgesic opioid responses show familial aggregation and make preliminary estimates of heritability. Side effects such as sedation, nausea, respiratory depression, and pruritus, as well as the positive affective response, a measure of abuse potential, will be monitored. Monozygotic (MZ) and dizygotic (DZ) twin pairs (125 total pairs) will be tested under controlled pain laboratory conditions for their responses to opioid infusion using the complementary pain models while monitoring side effects and additional psychometric indices of mood, sleep, and abuse potential. The selected models provide unique mechanistic information because they involve different peripheral and/or central pain pathways. DNA samples will be collected for zygosity testing and banked for future studies.

Arms: arm 1: Subjects will receive an intravenous infusion of normal saline. arm 2: Subjects will receive an intravenous infusion of alfentanil.
Interventions: intervention 1: Alfentanil intervention 2: Saline placebo infusion
Intervention descriptions: intervention 1: Target controlled intravenous infusion of alfentanil at a plasma concentration of 100ng/ml intervention 2: Intravenous infusion of normal saline

Protocol documents:
Clinical trial NCT00676195
Conditions: Autistic Disorder
Keywords: N-Acetyl Cysteine
Sponsor: Stanford University
Start date: 2008-06-01; Completion date: 2010-06-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to test the tolerability and efficacy of N-Acetyl Cysteine (NAC) in children with Autism.

Detailed description:
N-Acetyl Cysteine (NAC) is a compound that increases the levels of Glutathione, the body's main antioxidant. Glutathione is a compound in the blood that is part of a natural defense system (the antioxidant system). Anti-oxidants protect the body from damage caused by internal toxins called free radicals. It is possible that children with Autism tend to have lower levels of glutathione, an important compound in our bodies that helps combat the effects of toxic free radicals. We hope that by studying the antioxidant system in more detail, we will increase our understanding of the reasons why people develop Autism so that we can design better ways to treat individuals with this condition. This study is meant to test the safety tolerability of N-Acetyl Cysteine and its effectiveness in the treatment of behavioral difficulties in children with autism. It will also examine the possible benefit of this agent in improving the core deficits in autism such as social deficits.

Arms: arm 1: Dosage of orally administered N-Acetyl Cysteine is as follows:

Days 1-30: 900 mg, once per day Days 31-60: 900 mg, twice per day Days 61-90: 900 mg, three times per day
Interventions: intervention 1: N-Acetyl Cysteine
Intervention descriptions: intervention 1: Dosage of orally administered N-Acetyl Cysteine is as follows:

Days 1-30: 900 mg, once per day Days 31-60: 900 mg, twice per day Days 61-90: 900 mg, three times per day

Protocol documents:
Clinical trial NCT00683878
Conditions: Type 2 Diabetes
Sponsor: AstraZeneca
Start date: 2008-07-01; Completion date: 2010-06-01
Enrollment: 972 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in subjects with Type 2 Diabetes who are not well controlled on TZD alone. The safety of this treatment will also be studied

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Dapagliflozin intervention 2: Dapagliflozin intervention 3: Placebo matching Dapagliflozin intervention 4: Thiazolidinedione (Pioglitazone)
Intervention descriptions: intervention 1: Tablets, Oral, 5.0 mg, once daily, up to 48 weeks intervention 2: Tablets, Oral, 10.0 mg, once daily, up to 48 weeks intervention 3: Tablets, Oral, 0 mg, once daily, up to 48 weeks intervention 4: Tablets, ≥ 30 mg, Once daily, up to 48 weeks

Protocol documents:
Clinical trial NCT00709098
Conditions: Pulmonary Arterial Hypertension
Keywords: pulmonary arterial hypertension inhaled treatment inhalation solution iloprost Ventavis
Sponsor: Actelion
Start date: 2008-09-01; Completion date: 2010-06-01
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Patients with symptomatic idiopathic (IPAH) or familial (FPAH) pulmonary arterial hypertension in New York Heart Association (NYHA) class II to IV , naive to PAH treatment or currently being treated with a stable dose of either bosentan or sildenafil and who complete PROWESS 15 will be enrolled in the PROWESS 15 Extension study. This is a double-blind (12 week), randomized study to compare the safety and tolerability of inhaled iloprost power disc-15 and power disc-6 in patients with symptomatic pulmonary arterial hypertension (PAH). After completion of the double blind period, patients will be entered in the open label period using iloprost power disc-15.

Detailed description:

Arms: arm 1: iloprost power 15 arm 2: iloprost power 15
Interventions: intervention 1: iloprost intervention 2: iloprost
Intervention descriptions: intervention 1: Iloprost 5 mcg delivered by I-neb(R) adaptive aerosol delivery (AAD)(R) System power disc-6 administered 6 to 9 times per day for 12 weeks. If patient enters open label follow-up period, iloprost 5 mcg delivered by I-neb(R)AAD(R) System power disc-15 administered 6 to 9 times per day until the end of study. intervention 2: Iloprost 5 mcg delivered by I-neb(R)AAD(R) System power disc-15 administered 6 to 9 times per day for 12 weeks. If patient enters open label follow-up period, iloprost 5 mcg delivered by I-neb(R)AAD(R) System power disc-15 administered 6 to 9 times per day until the end of study.

Protocol documents:
Clinical trial NCT00711477
Conditions: Obesity
Keywords: obesity overweight magnetic resonance imaging naltrexone bupropion
Sponsor: Orexigen Therapeutics, Inc
Start date: 2008-09-01; Completion date: 2010-06-01
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to assess the effect of naltrexone SR/bupropion SR (NB) on brain function in response to food cues using functional magnetic resonance imaging in overweight or obese subjects.

Detailed description:

Arms: arm 1: Naltrexone SR 32 mg/bupropion SR 360 mg/day arm 2: Placebo tablets
Interventions: intervention 1: Naltrexone SR 32 mg/bupropion SR 360 mg/day intervention 2: Placebo intervention 3: fMRI scan
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: fMRI to assess the effects of the drug/placebo on areas of the brain

Protocol documents:
Clinical trial NCT00716807
Conditions: Temporomandibular Joint Dysfunction Syndrome Burning Mouth Syndrome
Keywords: BMS TMD
Sponsor: University of California, San Francisco
Start date: 2008-01-01; Completion date: 2010-06-01
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Patients with chronic masticatory muscle pain (i.e., pain greater than three months) or patients with burning mouth syndrome participate in this study. The aim of the study is to compare the pain killing effectiveness of nalbuphine, a narcotic pain killer, administered with either placebo or naloxone, a drug used to treat opiate overdose. A second goal is to determine if there are sex differences in these two drug regimens. Drugs will be administered with single-use intranasal spray devices. All participants will receive two sprays (one spray per nostril). One of the two sprays will be nalbuphine (5 mg). The other spray will be naloxone in half the participants and placebo in the other half.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: nalbuphine plus naloxone intervention 2: nalbuphine plus placebo intervention 3: nalbuphine plus naloxone intervention 4: nalbuphine plus placebo
Intervention descriptions: intervention 1: Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only). intervention 2: Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only). intervention 3: Patient group: burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only). intervention 4: Patient group: Burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).

Protocol documents:
Clinical trial NCT00723190
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: CLONICEL Attention Deficit Hyperactivity Disorder clonidine HCl sustained release
Sponsor: Shionogi
Start date: 2008-01-01; Completion date: 2010-06-01
Enrollment: 303 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this 12-month, multi-center, open-label study is to evaluate the safety of CLONICEL (clonidine HCl sustained release) when administered chronically under regular clinical conditions either as monotherapy or in combination with stimulant therapy to children and adolescents with attention deficit hyperactivity disorder (ADHD).

Detailed description:

Arms: arm 1: CLONICEL (Clonidine HCl sustained release)
Interventions: intervention 1: CLONICEL (Clonidine HCl sustained release)
Intervention descriptions: intervention 1: 0.1 mg for 1 week; the dose may be escalated to 0.2 mg/day at week 2, 0.3 mg/day at week 3, and 0.4 mg/day at week 4

Protocol documents:
Clinical trial NCT00734500
Conditions: Invasive Fungal Infections
Sponsor: Michael Cohen-Wolkowiez
Start date: 2008-01-01; Completion date: 2010-06-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a prospective, open-label, single center, pharmacokinetic study of anidulafungin in infants and toddlers less than 24 months of age with suspected serious infection. There will be up to 24 subjects enrolled; each will receive anidulafungin. Patients will receive anidulafungin 3 mg/kg loading dose on day 1 of study and will receive 1.5 mg/kg every 24 hours on study days 2-5.Plasma pharmacokinetics will be evaluated using a limited sampling scheme. We hypothesize that the PK parameters of anidulafungin will not differ from those observed in older children and adults.

Detailed description:

Arms: arm 1: Treatment
Interventions: intervention 1: Anidulafungin
Intervention descriptions: intervention 1: Intravenous form. Loading Dose: 3 mg/kg/dose. Maintenance dose: 1.5 mg/kg/dose. Treatment duration: 5 days total.

Protocol documents:
Clinical trial NCT00740831
Conditions: Uterine Myomas
Keywords: Uterine Myomas
Sponsor: PregLem SA
Start date: 2008-08-01; Completion date: 2010-06-01
Enrollment: 301 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial will assess the efficacy and safety of PGL4001 versus GnRH agonist, over a 3-month period for the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding due to uterine myoma.

Detailed description:

Arms: arm 1: Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection) arm 2: Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection) arm 3: PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)
Interventions: intervention 1: PGL4001 intervention 2: leuprorelin
Intervention descriptions: intervention 1: tablets intervention 2: solution for injection

Protocol documents:
Clinical trial NCT00742872
Conditions: Constipation-Predominant Irritable Bowel Syndrome
Keywords: Mosapride Irritable Bowel Syndrome Constipation
Sponsor: American University of Beirut Medical Center
Start date: 2008-09-01; Completion date: 2010-06-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether Mosapride, an agent which acts on serotonin receptors in the gastrointestinal tract, is effective in the treatment of constipation-predominant irritable bowel syndrome (C-IBS).

Detailed description:

Arms: arm 1: Mosapride arm 2: Placebo
Interventions: intervention 1: Mosapride Citrate intervention 2: Placebo
Intervention descriptions: intervention 1: One 5 mg tablet taken orally three times per day (15 min before meals) for 8 weeks. intervention 2: One tablet (identical in shape and form to the actual drug) taken orally three times per day (15 min before meals) for 8 weeks.

Protocol documents:
Clinical trial NCT00750698
Conditions: Non Small Cell Lung Cancer
Keywords: lung cancer non small cell lung cancer
Sponsor: Syndax Pharmaceuticals
Start date: 2008-08-01; Completion date: 2010-06-01
Enrollment: 8 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the tumor responses to SNDX-275 (entinostat) in combination with continued erlotinib in participants with non-small Cell Lung Carcinoma (NSCLC) who are progressing on erlotinib.

Detailed description:

Arms: arm 1: Participants self-administered entinostat in combination with continued erlotinib self-administration.

"Erlotinib-responsive" participants are those who progressed following either a complete or partial response to erlotinib or a period of stable disease lasting at least 3 months. arm 2: Participants self-administered entinostat in combination with continued erlotinib self-administration.

"Erlotinib-nonresponsive" participants are those who either progressed immediately during treatment with erlotinib (after at least 1 full cycle of erlotinib treatment) or had an objective response or period of stable disease lasting less than 3 months.
Interventions: intervention 1: Entinostat intervention 2: Erlotinib
Intervention descriptions: intervention 1: Entinostat (10 milligrams \[mg\] fixed dose orally \[PO\] every 2 weeks \[Q2W\]) on Days 1 and 15 of a 28-day cycle for up to 6 cycles intervention 2: Erlotinib (150 mg PO QD) for up to six (6) 28-day cycles

Protocol documents: