ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00986973
Conditions: Phenylketonuria
Keywords: PKU BH4 KUVAN PET scan Neurodevelopment
Sponsor: Children's Hospital of Philadelphia
Start date: 2010-03-01; Completion date: 2011-09-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The aim of this pilot study is to determine if there are any changes in brain glucose metabolism in the gray matter of patients with Phenylketonuria (PKU) and whether administration of Sapropterin (KUVAN) therapy can improve such deficits.

Detailed description:
Phenylketonuria (PKU) is an autosomal recessive disorder resulting from a deficiency of phenylalanine hydroxylase, which converts phenylalanine to tyrosine. Phenylalanine hydroxylase is one of the three aromatic amino acid hydroxylases that utilizes tetrahydrobiopterin (BH4) as cofactor. The published reports indicate that there is altered energy metabolism in the brain of patients with PKU. Phenylalanine and its metabolites appear to impair several aspects of brain energetics including: (1) Inhibition of glucose uptake; (2) diminished glycosylation of cytoskeletal proteins; (3) Inhibition of pyruvate kinase; and (4) reduced flux through the glycolysis. Studies in vivo with magnetic resonance spectroscopy have demonstrated phenylalanine-responsive abnormalities in cerebral energy metabolism.

Positron Emission Tomography (PET) scanning with fluorodeoxyglucose (FDG-PET) is a non-invasive method that measures regional glucose metabolic rate with high resolution and absolute quantitation. To date this technology has been used only for single case reports or the investigation of white matter abnormalities in small numbers of patients with PKU.

The aim of this pilot study is to determine if there are any changes in brain glucose metabolism in the gray matter of patients with PKU and whether Sapropterin (KUVAN) can improve such deficits. This study will also elucidate the relationship between hyperphenylalaninemia, phenylalanine intake in diet, altered brain glucose handling and the neurocognitive profile of the patients with PKU before and after KUVAN therapy.

Arms: arm 1: All subjects will receive Sapropterin (KUVAN) therapy at a dose of 20/mk/kg/day for four months.
Interventions: intervention 1: Sapropterin
Intervention descriptions: intervention 1: All subjects will receive 20 mg/kg/day Sapropterin (KUVAN) for four months. Subjects will be examined with fluorodeoxyglucose positron emission tomography (FDG-PET) brain imaging, physical and neurological exam, blood tests for phenylalanine (Phe) and tyrosine levels, and neuropsychological testing before and 4 months after KUVAN therapy. Subjects Phe and tyrosine levels will be monitored weekly during the study and subjects will keep 3-day diet records to allow for calculation of Phe intake.

Protocol documents:
Clinical trial NCT00993824
Conditions: Type 2 Diabetes
Sponsor: HealthPartners Institute
Start date: 2009-09-01; Completion date: 2011-09-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to obtain continuous glucose monitoring (CGM) data from individuals taking Welchol compared to placebo. The CGM data will determine the effect on glucose control of adding Welchol to an anti-diabetic medication regimen.

Detailed description:
To understand the effect of the addition of colesevelam HCl to oral agent therapy in individuals with type 2 diabetes on glycemic control by utilizing a novel technology, continuous glucose monitoring with ambulatory glucose profile analysis. To date there are no studies of this compound that have employed continuous glucose monitoring (CGM) with ambulatory glucose profile (AGP) analysis to obtain data that will detail the diurnal glucose patterns associated with this therapy. We plan to employ CGM at critical points throughout the study. AGP analysis will enable rapid assessment of the clinical status of the subject. Using statistically stable estimates of hourly values represented by five percentile curves AGP depicts glucose exposure, variability and stability. Previously, we have used AGP analysis to characterize glucose perturbations in individuals ranging from normal glucose tolerance to overt type 2 diabetes.

Arms: arm 1: 3.75 grams of colesevelam HCl (Welchol) at evening meal for 12 weeks, and then crossover to placebo at evening meal for 12 weeks. arm 2: Placebo taken for 12 weeks at evening meal, and then crossover to 3.75 grams of colesevelam HCl taken at evening meal fro 12 weeks.
Interventions: intervention 1: colesevelam HCl intervention 2: placebo
Intervention descriptions: intervention 1: 3.75 grams of colesevelam HCl (6 tablets) intervention 2: None

Protocol documents:
Clinical trial NCT01000649
Conditions: Septic Shock
Keywords: V1a agonist
Sponsor: Ferring Pharmaceuticals
Start date: 2009-11-01; Completion date: 2011-09-01
Enrollment: 53 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial was to examine the safety and tolerability, pharmacokinetics of FE 202158 and to assess whether it can stabilize blood pressure and reduce vascular (blood vessel) leakage. FE 202158 had previously been tested in healthy volunteers.

Detailed description:
This was a multi-centre, double-blind, randomized, placebo-controlled, parallel group trial investigating the safety, tolerability, pharmacokinetics, and pharmacodynamics of FE 202158 (using three ascending doses) in patients with vasodilatory hypotension in early septic shock, when given as continuous infusion for up to 7 days.

The trial comprised of three treatment arms where FE 202158 was administered in 1.25 ng, 2.5 ng and 3.75 ng dose, respectively. A placebo arm was also included in the trial where patients received isotonic saline.

Efficacy of FE 202158 was determined by evaluating its ability to maintain mean arterial pressure (MAP) \>60 mmHg and its modulating effect on inflammatory markers. Effects of FE 202158 on other variables like vital signs, morbidity, mortality and pulmonary function were also determined.

Arms: arm 1: Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use. arm 2: Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use. arm 3: Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 3.75 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use. arm 4: Patients in the arm received an intravenous infusion for up to 7 days of placebo.
Interventions: intervention 1: FE 202158 1.25 intervention 2: FE 202158 2.5 intervention 3: FE 202158 3.75 intervention 4: Placebo
Intervention descriptions: intervention 1: FE 202158 at dose 1.25 ng/kg/min infused. intervention 2: FE 202158 at dose 2.5 ng/kg/min infused. intervention 3: FE 202158 at dose 3.75 ng/kg/min infused. intervention 4: Isotonic saline infused.

Protocol documents:
Clinical trial NCT01011556
Conditions: Osteoporosis
Keywords: Age Related Osteoporosis Senile Osteoporosis
Sponsor: Eli Lilly and Company
Start date: 2009-11-01; Completion date: 2011-09-01
Enrollment: 233 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to help answer the following research questions:

1. How teriparatide given using a skin patch (transferred through the skin using the ViaDerm Teriparatide System) compares to teriparatide injected under the skin with a needle (pen injector) affects your bone density (how solid or porous your bones are).
2. The safety of the teriparatide skin patch and any side effects that might be associated with it.

Detailed description:
Teriparatide 20 micrograms (mcg) per day is currently only available as a subcutaneous (SQ) injection and many patients with severe osteoporosis for whom anabolic therapy with teriparatide is appropriate are either unwilling or physically unable to self-inject. The purpose of this Phase 2 study is to identify a transdermal dose or doses that will be comparable to the teriparatide 20 mcg SQ dose from a pharmacodynamic (PD) and safety standpoint for use in future Phase 3 studies.

Arms: arm 1: Received 20 micrograms (mcg) subcutaneously once daily in an unblinded manner. arm 2: Received 30 micrograms (mcg) teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level. arm 3: Received 50 micrograms (mcg) teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level. arm 4: Received 80 micrograms (mcg) teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
Interventions: intervention 1: Subcutaneous Teriparatide intervention 2: Transdermal Teriparatide
Intervention descriptions: intervention 1: Administered subcutaneously once daily for 12 months intervention 2: Administered transdermally, applied once daily for 6 hours over 12 months

Protocol documents:
Clinical trial NCT01033942
Conditions: HIV
Keywords: Pre-exposure prophylaxis HIV Prevention Truvada Many Men, Many Voices Emtricitabine Tenofovir disoproxil fumarate Young men who have sex with men HIV Seronegativity
Sponsor: University of North Carolina, Chapel Hill
Start date: 2009-08-01; Completion date: 2011-09-01
Enrollment: 68 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an exploratory mixed-methods research study that compares an efficacious behavioral HIV-prevention intervention (3MV) alone to the behavioral HIV-prevention intervention combined with a biomedical intervention (PrEP). After completing the 3MV behavioral intervention, participants will be randomly assigned to one of three study arms: 1) daily FTC/TDF as PrEP, 2) placebo pill control, or 3) "no pill" control. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks. Youth who decline to participate will be asked to complete a brief survey about their opinions on PrEP. Qualitative interviews will be completed with six study participants and the study coordinators at the end of the trial to explore further the issues of trial acceptability and feasibility. Finally, focus groups will be conducted to explore feasibility and acceptability issues with YMSM who meet all eligibility requirements of the study except for not being age 18 or older, but are at least 16 years of age.

Detailed description:

Arms: arm 1: Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention arm 2: Blinded administration of placebo pill; HIV behavioral intervention arm 3: Subjects receive HIV behavioral intervention but no pill.
Interventions: intervention 1: coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP intervention 2: Placebo intervention 3: Many Men, Many Voices (3MV)
Intervention descriptions: intervention 1: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks. intervention 2: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks. intervention 3: Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Protocol documents:
Clinical trial NCT01034397
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2010-03-01; Completion date: 2011-09-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized, double-blind, placebo-controlled study will use Magnetic Resonance Imaging (MRI) to assess the efficacy of tocilizumab plus non-biological DMARD in patients with moderate to severe rheumatoid arthritis who have had an inadequate response to non-biological DMARDS. Patients will be randomized to receive either intravenous tocilizumab at 8mg/kg (minimal dose 480mg, maximum dose 800mg) or placebo every 4 weeks, in addition to their stable dose of non-biological DMARD. Anticipated time on study treatment is 24 weeks, and target sample size is \<100.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: tocilizumab [RoActemra/Actemra] intervention 2: placebo intervention 3: non-biological DMARDs
Intervention descriptions: intervention 1: 8mg/kg (minimal dose 480mg, maximum dose 800mg) iv infusion every 4 weeks for 24 weeks intervention 2: iv every 4 weeks for 24 weeks intervention 3: stable dose at investigator's prescription

Protocol documents:
Clinical trial NCT01052012
Conditions: Postoperative Pain Abdominal Surgery
Keywords: Postoperative pain Post-operative pain Opioid Laparoscopic surgery Bupivacaine Local anesthetic
Sponsor: Durect
Start date: 2009-12-01; Completion date: 2011-09-01
Enrollment: 331 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a research study testing SABER-Bupivacaine (an experimental pain-relieving medication). SABER-Bupivacaine is designed to continuously deliver bupivacaine, a common local anesthetic, for a few days in order to treat local post-surgical pain.

The purpose of this study is to investigate safety (side effects) associated with the use of SABER-Bupivacaine and how well it works in reducing pain and opioid-related side effects following various kinds of abdominal surgeries.

Detailed description:

Arms: arm 1: SABER-Bupivacaine arm 2: Bupivacaine HCl arm 3: SABER-Placebo
Interventions: intervention 1: SABER-Bupivacaine intervention 2: Bupivacaine HCl intervention 3: SABER-Placebo
Intervention descriptions: intervention 1: Injectable Extended Release Solution; SABER-Bupivacaine /Once intervention 2: Injectable Solution; Bupivacaine HCl /Once intervention 3: Injectable Solution; SABER-Placebo/Once

Protocol documents:
Clinical trial NCT01059682
Conditions: Cardiovascular Disease
Sponsor: Hoffmann-La Roche
Start date: 2010-01-01; Completion date: 2011-09-01
Enrollment: 936 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This multicenter, double-blind, randomized, placebo-controlled study will evaluate the effect of dalcetrapib 600 mg on artherosclerotic disease progression, lipid profile and biomarker profile and long-term safety profile of dalcetrapib in patients with coronary artery disease. Atherosclerotic disease progression will be measured 1. Coronary Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography 2. Carotid B-Mode Ultrasound Intima Medial Thickness (IMT) and total plaque volume in subjects undergoing coronary angiography who have coronary artery disease (CAD). Patients will be randomized to receive dalcetrapib 600 mg orally once a day or placebo. The anticipated time on study treatment will be 24 months. The target sample size is 800-1000 patients.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Dalcetrapib intervention 2: Placebo
Intervention descriptions: intervention 1: Dalcetrapib 600 mg orally once daily intervention 2: Placebo orally once daily

Protocol documents:
Clinical trial NCT01080300
Conditions: Hot Flashes
Keywords: Hot Flushes Vasomotor Symptoms Menopausal Hot Flashes
Sponsor: Depomed
Start date: 2010-08-01; Completion date: 2011-09-01
Enrollment: 600 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Depomed's Gabapentin Extended Release is an investigational, extended release formulation of Gabapentin that is being studied for the treatment of Hot Flashes/Hot Flushes in postmenopausal women

Detailed description:
The primary study objective is to assess the efficacy of G-ER dosed at 1800mg daily (600mg AM, 1200mg PM), compared to placebo in reducing the average daily frequency and severity score of moderate to severe hot flashes in postmenopausal women at weeks 4 \& 12 of the efficacy treatment period, compared with baseline.

Arms: arm 1: Active treatment arm 2: Placebo
Interventions: intervention 1: Gabapentin Extended Release intervention 2: Placebo
Intervention descriptions: intervention 1: Gabapentin ER 1800mg daily intervention 2: Sugar pill

Protocol documents:
Clinical trial NCT01084551
Conditions: Idiopathic Restless Legs Syndrome
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2010-02-01; Completion date: 2011-09-01
Enrollment: 284 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the clinical efficacy and safety of SPM962 in patients with restless legs syndrome (RLS) with once-daily repeated doses of 4.5mg and 6.75mg during a 13-week dose-titration and maintenance period. This is a multi-center, randomized, placebo-controlled, double-blind, 3-armed parallel group comparison study.

Efficacy will be determined by investigating the superiority of SPM962 to placebo in terms of the primary efficacy variable, change in International Restless Legs Syndrome Rating Scale (IRLS) total score from baseline to the end of the dose-maintenance period.

Detailed description:

Arms: arm 1: started at 2.25 mg/day to 4.5 mg/day for 13 weeks arm 2: started at 2.25 mg/day to 6.75 mg/day for 13 weeks arm 3: for 13 weeks
Interventions: intervention 1: SPM 962 intervention 2: SPM 962 intervention 3: Placebo of SPM 962
Intervention descriptions: intervention 1: once a daily transdermal administration started at 2.25 mg/day to 4.5 mg/day for 13 weeks intervention 2: once a daily transdermal administration started at 2.25 mg/day to 6.75 mg/day for 13 weeks intervention 3: once a daily transdermal administration for 13 weeks

Protocol documents:
Clinical trial NCT01087814
Conditions: HIV HIV Infections
Keywords: efavirenz Sustiva pharmacokinetics
Sponsor: University of Minnesota
Start date: 2010-02-01; Completion date: 2011-09-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
We are studying if putting a gel capsule over a standard HIV drug changes the ability of the body to absorb the drug. This is important because we want to be able to study new HIV drugs against the most common drugs used today and the most common is Sustiva, which is also called efavirenz. We will give you Sustiva every day for 5 days and draw blood to see how much is absorbed. Then we will give you Sustiva that has a gel capsule over it for 5 days and we will draw blood to see how much is absorbed.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Efavirenz intervention 2: Over-encapsulated efavirenz
Intervention descriptions: intervention 1: Subject will take efavirenz for 5 days. intervention 2: Subject will take efavirenz that has been over-encapsulated with a gel capsule for 5 days.

Protocol documents:
Clinical trial NCT01105533
Conditions: Neoplasm
Keywords: VGEF inhibitor Anti angiogenesis Advanced Solid Tumors
Sponsor: Pfizer
Start date: 2006-05-01; Completion date: 2011-09-01
Enrollment: 46 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will test a new cancer medication to determine if this medication will block blood supply to a tumor and decrease growth of a tumor. This study will also define the safety profile and define the safest dose of this new medication for people who have cancer.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None arm 8: None arm 9: None arm 10: None
Interventions: intervention 1: PF-00337210 intervention 2: PF-00337210 intervention 3: PF-00337210 intervention 4: PF-00337210 intervention 5: PF-00337210 intervention 6: PF-00337210 intervention 7: PF-00337210 intervention 8: PF-00337210 intervention 9: PF-00337210 intervention 10: PF-00337210
Intervention descriptions: intervention 1: 0.67mg Capsule Once Daily (Accelerated Dose Escalation) Continuous intervention 2: 1mg Capsule Once Daily (Dose Escalation) Continuous intervention 3: 2mg Capsule Once Daily (Dose Escalation) Continuous intervention 4: 4mg Capsule Once Daily (Dose Escalation) Continuous intervention 5: 6mg Capsule Once Daily (Dose Escalation) Continuous intervention 6: 9mg Capsule Once Daily (Dose Escalation) Continuous intervention 7: 8mg Capsule Once Daily (Dose Escalation) Continuous intervention 8: 4mg Capsule Twice Daily (Dose Escalation) Continuous intervention 9: 6mg Capsule Twice Daily (Dose Escalation) Continuous intervention 10: 6mg Capsule Twice Daily (Dose Expansion) Continuous

Protocol documents:
Clinical trial NCT01127503
Conditions: Velo-cardio-facial Syndrome Psychosis
Keywords: Patients with velocardiofacial syndrome and psychosis
Sponsor: Bausch Health Americas, Inc.
Start date: 2010-06-01; Completion date: 2011-09-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an exploratory clinical investigation. The objectives of this study are to evaluate the safety, steady-state pharmacokinetics, and efficacy of metyrosine (Demser®) for the treatment of psychosis in patients with velocardiofacial syndrome (VCFS).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Metyrosine intervention 2: Placebo
Intervention descriptions: intervention 1: Metyrosine (250 mg capsules) were to be used at all dose levels (administered as multiples of that dosing unit). The starting dose was 250 mg/day of metyrosine. Dose escalation was to be carried out weekly for 8 weeks (up to a maximum of 8 capsules/day \[2000 mg/day if metyrosine\]) with dosage increments of 1 capsule/day per week. Weekly dose escalation was to stop based upon the investigator's assessment of safety, but not efficacy (i.e., dose escalation was to be forced to the maximum of 8 capsules/day assuming acceptable safety and tolerability). intervention 2: Placebo capsules were identically matched to Metyrosine.

Protocol documents:
Clinical trial NCT01128894
Conditions: Diabetes Mellitus, Type 2
Keywords: GSK716155 liraglutide albiglutide open-label
Sponsor: GlaxoSmithKline
Start date: 2010-05-01; Completion date: 2011-09-01
Enrollment: 841 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This open-label study examines the efficacy and safety of albiglutide as compared with liraglutide in subjects with type 2 diabetes.

Detailed description:
This randomized, open-label, multicenter, 2 parallel-group study evaluates the efficacy and safety of a weekly subcutaneously injected dose of albiglutide as compared with liraglutide. Subjects with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen of metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetics will be recruited into the study.

Arms: arm 1: weekly albiglutide subcutaneous injection arm 2: liraglutide daily subcutaneous injection, starting at 0.6mg, then up-titrating to 1.2mg then 1.8mg in accordance with prescribing information.
Interventions: intervention 1: albiglutide intervention 2: liraglutide
Intervention descriptions: intervention 1: albiglutide weekly subcutaneous injection intervention 2: liraglutide daily subcutaneous injection, starting at 0.6mg, then up-titrating to 1.2mg then 1.8mg in accordance with prescribing information.

Protocol documents: