ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00814138
Conditions: Myasthenia Gravis
Keywords: myasthenia gravis
Sponsor: University of Kansas Medical Center
Start date: 2009-04-01; Completion date: 2014-01-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Myasthenia gravis is a rare neuromuscular disorder characterized by weakness and fatigability of ocular, bulbar, and extremity musculature. The specific aim of this study is to determine if oral methotrexate is an effective therapy for myasthenia gravis (MG) patients who are prednisone dependent. Patients will be randomized to receive either methotrexate or placebo and those who are entered onto this trial will have symptoms and signs of the disease while on prednisone therapy. The hypothesis is that adding methotrexate therapy in these patients will improve the MG manifestations so that the prednisone dose can be reduced and clinical measures of MG severity will improve.

Funding Source - FDA OOPD

Detailed description:

Arms: arm 1: Methotrexate arm 2: Placebo
Interventions: intervention 1: Methotrexate intervention 2: Placebo
Intervention descriptions: intervention 1: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study intervention 2: Weekly

Protocol documents:
Clinical trial NCT00879333
Conditions: Advanced Gastric Cancer
Keywords: Gastric cancer, advanced gastric cancer, stomach neoplasm, stomach disease, adenocarcinoma of stomach, GI neoplasm
Sponsor: Novartis Pharmaceuticals
Start date: 2009-07-01; Completion date: 2014-01-01
Enrollment: 656 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to assess the safety and efficacy of RAD001 monotherapy in patients with advanced gastric cancer which has progressed after one or two lines of prior chemotherapy.

Detailed description:

Arms: arm 1: All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments. arm 2: All patients were randomized to receive placebo + BSC. All patients orally took two 5 mg tablets of matching placebo once daily. Therefore, all patients in the placebo receive matching tablets of total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
Interventions: intervention 1: Everolimus intervention 2: Everolimus placebo intervention 3: Best Supportive Care (BSC)
Intervention descriptions: intervention 1: Everolimus was formulated as tablets of 5 mg strength. In both treatment arms, the study drug was given by continuous oral daily dosing of 10 mg (2 tablets x 5 mg) each morning. intervention 2: Placebo was formulated to be indistinguishable from the everolimus tablets, also formulated as tablets of 5 mg strength. In both treatment arms, the study drug was given by continuous oral daily dosing of 10 mg (2 tablets x 5 mg) each morning. intervention 3: Best supportive care is defined as care in accordance with the local practice of an individual institution or center, specifically excluding anti-cancer treatments.

Protocol documents:
Clinical trial NCT00929734
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Inflammation Atherosclerosis Hydroxymethylglutaryl-coenzyme A Reductase Inhibitors
Sponsor: University Hospital, Akershus
Start date: 2010-03-01; Completion date: 2014-01-01
Enrollment: 99 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate whether rosuvastatin improves measures of endothelial function, decreases measures of inflammation, and improves pulmonary function in patients with stable chronic obstructive pulmonary disease.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Rosuvastatin intervention 2: Placebo
Intervention descriptions: intervention 1: 10mg tablets, once daily in three months intervention 2: 1 tablet, once daily in three months

Protocol documents:
Clinical trial NCT00957229
Conditions: Basal Cell Nevus Syndrome Gorlin Syndrome
Sponsor: UCSF Benioff Children's Hospital Oakland
Start date: 2009-08-01; Completion date: 2014-01-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to reduce the number of new surgically eligible BCCs by 50% appearing during month 3-18 of medication ingestion.

Detailed description:
This is a Phase II, 18 month, double blind, randomized placebo-controlled, two arm multicenter clinical study design. During the 18-month treatment period, the safety and chemopreventive efficacy of 150 mg/day GDC-0449 versus placebo will be assessed, and include evaluations of the skin at monthly intervals for the first three months and then every 3 months for the next 15 months. Removal of new surgically eligible BCCs (SEBs) will be done by primary skin care physicians (PSCPs) or at Study Centers. A Data Safety Monitoring Board (DSMB) will review unblinded results for an interim analysis when 20 subjects have completed 12 months of drug. This review will focus on adverse events and efficacy results. Subjects will be monitored for the development of new SEBs after they discontinue study treatment. At the end of the 18 months, given that the observed adverse events are minimal, patients on placebo will be offered the opportunity to take GDC-0449 for 18 months in an open label continuation, followed by six months observation, and patients on GDC449 will be monitored for the next 24 months for assessment of the duration of benefit after stopping the drug.

Arms: arm 1: placebo pill by mouth once daily arm 2: vismodegib 150MG by mouth once daily
Interventions: intervention 1: GDC-0449
Intervention descriptions: intervention 1: capsule, 150 mg, one pill daily, 18 months

Protocol documents:
Clinical trial NCT00959647
Conditions: Ovarian Cancer Basal Cell Carcinoma Metastatic Colorectal Cancer
Keywords: Hedgehog pathway inhibitor
Sponsor: Genentech, Inc.
Start date: 2009-09-01; Completion date: 2014-01-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This was a multicenter, open-label extension study. Patients who received vismodegib (GDC-0449) in a Genentech-sponsored study and who had completed the parent study or who continued to receive vismodegib at the time the parent study closed were eligible for continued treatment in this protocol.

Detailed description:

Arms: arm 1: Participants received 150 mg vismodegib orally once a day until disease progression, intolerable toxicity, or withdrawal from the study. If a participant had been receiving combination chemotherapy and/or biotherapy (FOLFOX, FOLFIRI, bevacizumab) in a parent study, the same combination chemotherapy and/or biotherapy as specified in the parent study could be continued in this study at the discretion of the investigator.
Interventions: intervention 1: Vismodegib intervention 2: FOLFOX intervention 3: FOLFIRI intervention 4: Bevacizumab
Intervention descriptions: intervention 1: Vismodegib was supplied in capsules. intervention 2: FOLFOX (folinic acid \[FOL, leucovorin\], fluorouracil \[F, 5-FU\], and oxaliplatin \[OX\]) was supplied as solutions for intravenous administration. intervention 3: FOLFIRI (folinic acid \[FOL, leucovorin\], fluorouracil \[F, 5-FU\], and irinotecan \[IRI\]) was supplied as solutions for intravenous administration. intervention 4: Bevacizumab was supplied as a solution for intravenous administration.

Protocol documents:
Clinical trial NCT00965185
Conditions: Cardiovascular Disease HIV Atherosclerosis Inflammation Statins, HMG-CoA HIV Infections
Keywords: Cardiovascular Disease HIV Atherosclerosis Inflammation Statins treatment experienced
Sponsor: Massachusetts General Hospital
Start date: 2009-09-01; Completion date: 2014-01-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In HIV patients, statin therapy will attenuate plaque inflammation, thus, making plaques less vulnerable, will deter plaque progression, and improve endothelial function. In addition to known cholesterol-lowering and C-reactive protein lowering effects, immunomodulatory effects of statins will lead to a shift from pro-inflammatory monocyte and T cell subsets to less atherogenic subpopulations.

Detailed description:

Arms: arm 1: 20 mg PO QD for the first 3 months, followed by 40 mg PO QD for the final 9 months. arm 2: None
Interventions: intervention 1: atorvastatin intervention 2: Placebo
Intervention descriptions: intervention 1: 20 mg PO QD for the first 3 months, followed by 40 mg PO QD for the final 9 months. intervention 2: Placebo

Protocol documents:
Clinical trial NCT00965731
Conditions: Non-Small Cell Lung Cancer
Keywords: Lung Neoplasms Crizotinib
Sponsor: Pfizer
Start date: 2010-01-01; Completion date: 2014-01-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 1/2 study comparing the safety and anti-tumor activity of erlotinib alone versus erlotinib in combination with PF-02341066 in patients with advanced non-small cell lung cancer.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Erlotinib intervention 2: Erlotinib intervention 3: PF-02341066
Intervention descriptions: intervention 1: Erlotinib, 150 mg, QD will be administered orally on a continuous schedule (Phase 2 only) intervention 2: For Phase 1 - escalating doses of erlotinib will be administered orally on a continuous schedule. The planned doses to be evaluated are 100 and 150 mg QD. The dose determined in Phase 1 will be used in Phase 2 intervention 3: For Phase 1 - escalating doses of PF-02341066 will be administered orally on a continuous schedule. The planned doses to be evaluated are 200 and 250 mg BID. The dose determined in Phase 1 will be used in Phase 2

Protocol documents:
Clinical trial NCT01021956
Conditions: Macular Degeneration Choroidal Neovascularization
Keywords: Macular Degeneration Age Related Macular Degeneration Choroidal Neovascularization AMD CNV WST11 Stakel Photodynamic therapy Vascular Targeted Photodynamic therapy VTP
Sponsor: Steba Biotech S.A.
Start date: 2010-06-01; Completion date: 2014-01-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objectives of this study are to evaluate the safety(first objective) and efficacy(second objective)of an experimental drug product,Stakel®, in the treatment of neovascular Age related Macular Degeneration (AMD). The drug product is activated in patients by exposure to light at a specific wavelength ("Vascular Targeted Photodynamic therapy", "VTP"). The exploratory objective is to assess whether it is possible to delay or reduce the requirement for anti Vascular Endothelium Growth Factor (anti VEGF) intravitreal therapy in the first 12 weeks after VTP.

All subjects will have a 52 weeks safety follow up telephone call (Not for Adverse Events (AEs) collection).

Detailed description:
The primary objective of this Phase IIa clinical study is to evaluate the safety of treatment with Stakel®-mediated VTP in subjects with neovascular AMD. The secondary objective of this Phase IIa clinical study is to explore the effect of treatment with Stakel®-mediated VTP in subjects with neovascular AMD. The exploratory objective is to assess whether it is possible to delay or reduce the requirement for anti Vascular Endothelium Growth Factor (anti VEGF) intravitreal therapy in the first 12 weeks after VTP.

All subjects will have a 52 weeks safety follow up telephone call. (Not for AEs collection).

Arms: arm 1: Single doses of 2.5 mg/kg of STAKEL® in combination with transpupilar illumination of the macula at escalating doses from 12.5 to 75 Joules/cm².
Interventions: intervention 1: STAKEL
Intervention descriptions: intervention 1: Open-label,safety and exploratory efficacy study in subjects with active CNV followed for 12 weeks.During first stage(dose escalating stage) subjects assigned to group 1 to 4 will receive a single treatment of VTP at one of three light levels and one of two Drug Light Interval (DLI).Second stage(dose confirmation)will be only initiated at a dose level in which an effect has been seen at week 1 and there is a maximum of one Dose Limiting Toxicity (DLT) out of three subject at week 5.

Protocol documents:
Clinical trial NCT01026909
Conditions: Legg-Calve Perthes Disease
Sponsor: Seattle Children's Hospital
Start date: 2009-03-01; Completion date: 2014-01-01
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Legg-Calve-Perthes disease (LCP) represents the loss of blood flow to the head of the femur, resulting in significant hip pain and potential long term disability. This study represents a single center, randomized, prospective, controlled study comparing the treatment of LCP with an intraarticular corticosteroid (triamcinolone hexacetonide) injection with traditional nonoperative treatment.

Detailed description:
Legg-Calve-Perthes disease (LCP) represents the loss of blood flow to the head of the femur, resulting in significant hip pain and potential long term disability. The cause of LCP is still unknown, but tends to occur predominantly in boys from ages 4-12. For the majority of those affected, observation and symptomatic treatment with oral antiinflammatories, such as ibuprofen, is indicated. This study represents a single center, randomized, prospective, controlled study comparing the treatment of LCP with an intraarticular corticosteroid (triamcinolone hexacetonide) injection with traditional nonoperative treatment. The investigators will test for improved outcomes by measuring functional outcomes (PODCI and ASKp questionnaires, StepWatch activity monitor), hip range of motion and visual-analog pain scales. The investigators hypothesize that injections of corticosteroids (potent, injectable antiinflammatories) will result in improved overall function through decreased pain and increased hip range of motion in this patient population.Additional biological research will be performed. There is no human information on the inflammatory response that occurs in the hip joint of children with Perthes disease, and there are no true animal models of Perthes disease. To better understand the pathobiology of Perthes disease, the collection of joint fluid from both hips may provide insight into the treatment of a disease for which we currently have no explanation of cause, and consequently no therapies

Arms: arm 1: Patients in this arm receive one single dose of Triamcinolone hexacetonide injectable suspension (Aristopan), USP, 20mg/mL Parenteral. They will aso be enrolled in physical therapy. arm 2: Patients will be enrolled in physical therapy
Interventions: intervention 1: Aristospan 20mg
Intervention descriptions: intervention 1: Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose.

Protocol documents:
Clinical trial NCT01028053
Conditions: Mild Cognitive Impairment Alzheimer's Disease
Keywords: Mild Cognitive Impairment Positron Emission Tomography National Institute of Neurological and Communicative Disorders and Stroke Alzheimer's Disease and Related Disorders Association Assess Prognostic Usefulness of Flutemetamol Injection for Identifying Subjects who will Convert to Clinically Probable Alzheimer's Disease
Sponsor: GE Healthcare
Start date: 2009-12-01; Completion date: 2014-01-01
Enrollment: 365 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will investigate the efficacy of the Flutemetamol (18F) Injection PET tracer in identifying abnormal (18F) flutemetamol uptake patterns which predict the conversion from aMCI to a b-amyloid associated clinically probable Alzheimer's disease.

Detailed description:

Arms: arm 1: Flutemetamol (18F) Injection
Interventions: intervention 1: Flutemetamol (18F) Injection
Intervention descriptions: intervention 1: All subjects will receive an i.v. dose of (18F) flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of (18F) flutemetamol will be 185 MBq.

Protocol documents:
Clinical trial NCT01043874
Conditions: Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase
Keywords: Chronic phase Chronic myelogenous leukemia CML Philadelphia chromosome positive Ph+ Nilotinib CML-CP Suboptimal molecular response
Sponsor: Novartis Pharmaceuticals
Start date: 2009-12-01; Completion date: 2014-01-01
Enrollment: 45 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the major molecular response (MMR) rate at 12 months of nilotinib treatment on study in patients with Philadelphia Chromosome Positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP) who have a suboptimal molecular response to imatinib at 18 months or later.

Detailed description:

Arms: arm 1: 400 mg BID
Interventions: intervention 1: Nilotinib
Intervention descriptions: intervention 1: 400 mg BID

Protocol documents:
Clinical trial NCT01061671
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Chronic Obstructive Pulmonary Disease COPD Exacerbation Lung function Cardiovascular Smoking Statins Simvastatin
Sponsor: University of Minnesota
Start date: 2010-03-01; Completion date: 2014-01-01
Enrollment: 885 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine the effect of daily administration of 40 mgms simvastatin taken for at least 12 months (range 12-36 months) on the frequency of exacerbations of chronic obstructive lung disease (COPD) in patients with moderate to severe COPD who are prone to exacerbations and do not have other indications for statin treatment.

Detailed description:
COPD exacerbation is a common complication that significantly contributes to the high morbidity, mortality and costs associated with COPD. COPD exacerbations are associated with heightened lung inflammation that may have systemic implications (e.g., peripheral muscle weakness, cognitive impairment, depression, stroke, acute coronary syndrome, and atherosclerosis). Statins are potent agents that significantly reduce vascular events in patients with increased risks due to prior cardiac or cerebral vascular events and elevated lipid profiles. Statins have pleiotropic effects that extend well beyond their lipid lowering effects and may be potent anti-inflammatory agents. Retrospective data conducted in COPD patients indicate that statin use is associated with markedly decreased rates of COPD hospitalization and stabilization of lung function. Decreases in mortality in COPD due to complications of flu-like illnesses and deaths due to cardiovascular events have also been reported. Inflammatory biomarkers (C-reactive protein and interleukin- 6) are reported to be elevated in moderate to severe COPD patients who are prone to exacerbations. Inflammatory biomarkers (C-reactive protein and interleukin- 6) are reported to be reduced by statin therapy in patients with hyperlipidemia and cardiovascular diseases. Treatments that can effectively lessen the prevalence and severity of COPD exacerbations are desperately needed

Arms: arm 1: 40 mgms of simvastatin daily arm 2: Matched placebo pill daily
Interventions: intervention 1: simvastatin intervention 2: Placebo
Intervention descriptions: intervention 1: 40 mgms of simvastatin daily intervention 2: Matched placebo pill daily

Protocol documents:
Clinical trial NCT01086475
Conditions: Autistic Disorder Asperger's Disorder Pervasive Developmental Disorder NOS
Keywords: Autism Spectrum Disorder D-cycloserine Social Skills Training
Sponsor: Indiana University
Start date: 2010-03-01; Completion date: 2014-01-01
Enrollment: 68 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effectiveness of D-cycloserine for improving social impairment in child with pervasive developmental disorders (PDD).

Detailed description:
This study will evaluate the efficacy of D-Cycloserine given 30 minutes prior to each of 10 weekly Social Skills Training Sessions for the treatment of social impairment in children (ages 5-11 years) with PDD during a randomized placebo-controlled trial. This will examine our central hypothesis that D-cycloserine will enhance learning of social skills in children with PDD's.

Arms: arm 1: Subjects randomized to D-cycloserine will be administered 50 mg 30 minutes prior to each of ten Social Skills Training Sessions arm 2: Subjects randomized to placebo arm will receive placebo pill 30 minutes prior to each of ten Social Skills Training Sessions
Interventions: intervention 1: D-cycloserine intervention 2: Placebo
Intervention descriptions: intervention 1: 50 mg dose administered 30 minutes prior to each of the ten Social Skill Training Sessions intervention 2: Placebo pill administered 30 minutes prior to each of the ten Social Skill Training Sessions

Protocol documents:
Clinical trial NCT01090427
Conditions: Psoriasis
Keywords: Ustekinumab Injection CNTO 1275 Stelara Pediatric psoriasis Adolescents
Sponsor: Janssen Research & Development, LLC
Start date: 2010-05-01; Completion date: 2014-01-01
Enrollment: 110 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study of the safety and efficacy of ustekinumab (CNTO 1275) in adolescent patients with moderate to severe psoriasis.

Detailed description:
This is a randomized (drug assigned by chance), double-blind (a medical research study in which neither the researchers nor the participants know what treatment the participant is receiving), placebo-controlled, parallel (a medical research study comparing the response in two or more groups of participants receiving different treatments), multicenter of ustekinumab in adolescent participants with moderate to severe psoriasis. The total duration of study will be 60 weeks. The study will consists of 2 parts; a Screening period and a Treatment period. In treatment period participants will receive either ustekinumab half standard dosage, ustekinumab standard dosage or Placebo. Participants receiving ustekinumab half standard dosage and ustekinumab standard dosage at Week 0, will receive placebo at Week 12 and participants receiving placebo at Week 0 will be randomly assigned to either ustekinumab half standard dosage or ustekinumab standard dosage Weeks 12, 16, 28, and 40. Primarily efficacy will be evaluated by physician's global assessment (PGA) score of cleared or minimal disease. Participants' safety will be monitored throughout the study.

Arms: arm 1: Participants will receive ustekinumab at half the standard dosage at Weeks 0, 4, 16, 28, and 40. In addition, all participants will receive a single SC dose of placebo at Week 12. arm 2: Participants will receive ustekinumab at the standard dosage at Weeks 0, 4, 16, 28, and 40. In addition, all participants will receive a single SC dose of placebo at Week 12. arm 3: Participants will receive matching placebo at Week 0 and 4, followed by ustekinumab at half-standard or standard dosage at Weeks 12, 16, 28, and 40.
Interventions: intervention 1: Ustekinumab - Half-Standard Dosage intervention 2: Ustekinumab - Standard Dosage intervention 3: Placebo
Intervention descriptions: intervention 1: Ustekinumab 0.375 mg/kg, 22.5 mg, or 45 mg based on body weight, administered subcutaneously (under the skin) at Weeks 0, 4, 16, 28, and 40. intervention 2: Ustekinumab 0.75 mg/kg, 45 mg, or 90 mg based on body weight administered subcutaneously at Weeks 0, 4, 16, 28, and 40. intervention 3: Placebo administered subcutaneously at Weeks 0 and 4 or at Week 12.

Protocol documents: