ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00751036
Conditions: Gastrointestinal Stromal Tumors
Keywords: GIST
Sponsor: Novartis Pharmaceuticals
Start date: 2009-06-01; Completion date: 2012-08-01
Enrollment: 94 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will investigate the comparative efficacy and safety of two oral inhibitors of Kit and PDGFR: nilotinib 400 mg bid, a novel agent, and imatinib 400 mg bid, an approved agent with an established efficacy.

Detailed description:
This is an international, randomized, open-label, double-arm, phase III trial that will be conducted in centers in Latin America, Asia, Europe and Canada. The study will be sponsored by Novartis Pharmaceuticals Corporation. Patient enrollment will be competitive and will have a duration of up to 30 months. An interim analysis is planned to occur when approximately 60% of the PFS events occurs. A total of 150 patients per arm will be enrolled in the study. Eligible patients will have advanced/metastatic, inoperable GIST of any anatomical location or recurrent GIST while on or post imatinib adjuvant therapy, with documented disease progression on therapy with imatinib 400 mg q.d.

Arms: arm 1: Patients who were assigned to this treatment group received 400 mg. nilotinib bid. arm 2: Patients who were assigned to this treatment group received 400 mg. imatinib bid.
Interventions: intervention 1: Nilotinib intervention 2: Imatinib
Intervention descriptions: intervention 1: Nilotinib hard gel capsules were supplied to the Investigators at dose strengths of 200 mg. Nilotinib is a novel agent, which has been approved for the treatment of chronic phase and accelerated phase Philadelphia-chromosome-positive CML in adult patients resistant to or intolerant to prior therapy that included imatinib. intervention 2: Imatinib tablets were supplied at 100 mg and/or 400 mg dose strength. Imatinib is an approved agent for GIST. Efficacy of imatinib at a dose of 400 mg bid has been established in the setting of disease progression after the use of the conventional dose (400 mg qd).

Protocol documents:
Clinical trial NCT00779142
Conditions: Diabetic Macular Edema
Keywords: resistant diabetic macular edema
Sponsor: Wake Forest University
Start date: 2011-09-01; Completion date: 2012-08-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
It is well known that blindness is one of the most feared disabilities expressed by patients in the United States. Estimates of the economic impact of visual disability in the current population exceed 30 million US dollars in this country alone. The reasons for this figure are many; however age related macular degeneration (ARMD), diabetic retinopathy, glaucoma and uveitis are responsible for the majority of permanent visual disability and hence the costs in both quality of life and placing an economic burden on society. Research that may help reverse various abnormal biological responses that lead to or worsen clinical manifestations of diabetic retinopathy would be valuable.

Detailed description:
The most common reason for decreased vision in diabetic retinopathy is macular edema. Current approaches to macular edema include FDA approved interventions such as laser and better underlying control of the disease and co morbid conditions. 'Off label' interventions include intravitreal triamcinolone and bevacizumab, both of which have been demonstrated to be efficacious; at least in the short term (weeks) but carry significant risks. Surgical approaches are still controversial and have not shown long term benefits. Unfortunately, there are subsets of patients resistant to any of the above therapies. Intravitreal therapies utilizing methotrexate 400 ug (MTX) have been used for other ophthalmologic conditions associated with inflammation driven macular edema. bevacizumab an anti VEGF agent has been utilized in diseases other than macular degeneration with a favorable effect. It is known that certain similar inflammatory mediators play a role in diabetic macular edema. It would be logical to evaluate the efficacy of MTX an anti inflammatory anti metabolite at low concentrations in diabetic patients with macular edema who have failed conventional FDA approved and well studied off label therapies that involve laser and/or intravitreal drugs.

Arms: arm 1: Methotrexate intravenous 25mg/ml: Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose to subjects with diabetic macular edema resistant to conventional therapies.
Interventions: intervention 1: Methotrexate intravenous 25mg/ml
Intervention descriptions: intervention 1: Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample.

Protocol documents:
Clinical trial NCT00782626
Conditions: Glioma Low-grade Glioma Astrocytoma
Keywords: RAD001
Sponsor: Dana-Farber Cancer Institute
Start date: 2009-06-01; Completion date: 2012-08-01
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to learn if the study drug RAD001 can shrink or slow the growth of low-grade gliomas. Additionally, the safety of RAD001 will be studied. RAD001 is a drug that may act directly on tumor cells by inhibiting tumor cell growth and proliferation.

Detailed description:
OBJECTIVES:

Primary

* To determine the response of children with chemotherapy-refractory or progressive low-grade gliomas to everolimus. Secondary
* To evaluate pharmacogenetic polymorphisms of cytochrome P450 3A4 \& 3A5 alleles and P-glycoprotein/MDR for their influence on the metabolism of everolimus in this patient population.
* To evaluate the role of Apolipoprotein E genotypes as predictors for development of hyperlipidemia during therapy with everolimus.
* To assess preliminary correlations of response with changes in pharmacodynamic parameters including p70s6 kinase activity in peripheral blood mononuclear cells.
* To describe the toxicity of everolimus when administered to this patient population.
* To characterize the pharmacokinetic profile of everolimus when administered to this patient population.

STATISTICAL DESIGN:

This study used a one-stage design to evaluate response to everolimus. If at least 3 responders are observed in 20 evaluable patients, then everolimus will be considered promising. If the true response rate is 5% (null hypothesis), the chance of concluding the treatment is active is 0.08 (Type I error). If the true response rate is 25% (alternative hypothesis), the chance of concluding the treatment is active is 0.91 (power).

Arms: arm 1: Patients rcvd oral everolimus 5.0 mg/m2/day for a 28-day treatment course up to a total of 12 courses (48 weeks) if a patient had stable disease except if toxicity was unacceptable. Two dose reductions were permitted (3.0 5.0 mg/m2/day and 2.0 mg/m2/day).
Interventions: intervention 1: everolimus
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00806286
Conditions: Metastatic Non-small Cell Lung Cancer
Sponsor: Daiichi Sankyo
Start date: 2008-12-01; Completion date: 2012-08-01
Enrollment: 111 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study has a safety and a Phase 2 portion. In the safety portion of the study, subjects with metastatic non-small cell lung cancer will be treated with study drug (CS-7017) in combination with carboplatin and paclitaxel to evaluate safety. In the Phase 2 portion of the study, subjects will receive study drug (CS-7017) or placebo in combination with carboplatin and paclitaxel to evaluate effectiveness and safety. The study will find out if adding CS-7017 to carboplatin and paclitaxel will be safe and improve progression free survival in subjects with metastatic non-small cell lung cancer.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: CS7017 tablets intervention 2: Paclitaxel intervention 3: Carboplatin intervention 4: Placebo Tablets
Intervention descriptions: intervention 1: CS7017 tablets, strength 0.25 mg, two tablets, two times daily for twenty-five to thirty months intervention 2: Intravenous (IV), 200 mg/m\^2, once every three weeks for up to 18 weeks intervention 3: IV, area under the curve (AUC) of 6, once every three weeks for up to 18 weeks intervention 4: Placebo tablets matching CS-7017 tablets

Protocol documents:
Clinical trial NCT00806442
Conditions: Bronchial Asthma
Keywords: Asthma Fatty acids Leukotrienes Diet
Sponsor: Brigham and Women's Hospital
Start date: 2008-12-01; Completion date: 2012-08-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The aim of this trial is to determine the efficacy of a combination of two botanicals oils, borage seed oil and echium seed oil, as a potential treatment for bronchial asthma.

Detailed description:
Leukotrienes are important in the pathogenesis of inflammation, and leukotriene modifying drugs are now an established treatment for bronchial asthma and rhinitis. Drugs that inhibit the biosynthesis of leukotrienes are likely to be more effective than the currently available drugs that antagonize a single leukotriene receptor. Dietary supplementation with gamma linolenic acid (GLA) in borage seed oil provides effective inhibition of leukotriene generation but also increases circulating free arachidonic acid (AA), which has pro-inflammatory potential. The n-3 fatty acid, eicosapentaenoic acid (EPA), prevented the conversion of GLA to AA. However, EPA is extracted from fish oil, is not well-tolerated due to its taste, and at higher doses appeared to blunt the inhibition of leukotriene biosynthesis by GLA. Stearidonic acid (SDA) is a precursor of EPA that is extracted from Echium plantagineum; it is converted to EPA in humans and it does not have the organoleptic properties of EPA.

We recently completed a dose-ranging study in which we determined the dose of SDA that is sufficient to inhibit the rise in circulating levels of arachidonic acid while maintaining effective inhibition of leukotriene generation.

The goal of the present study is to test the efficacy of dietary supplementation with GLA and SDA (provided in borage seed oil and echium seed oil) in treating bronchial asthma.

Arms: arm 1: Borage/Echium plant seed oils: 2 g/day of borage seed oil and 7 g/day of echium seed oil to provide 1.6 g/day of GLA and 0.9 g/day of SDA. arm 2: Placebo comparator: 9 g/day corn oil
Interventions: intervention 1: Borage Seed Oil and Echium Seed Oil intervention 2: Corn Oil
Intervention descriptions: intervention 1: 2 g/day of borage seed oil and 7 g/day of echium seed oil to provide 1.6 g/day of GLA and 0.9 g/day of SDA. intervention 2: 9 g/day of corn oil

Protocol documents:
Clinical trial NCT00821327
Conditions: Urothelial Cancer
Sponsor: US Oncology Research
Start date: 2008-08-01; Completion date: 2012-08-01
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this nonrandomized Phase II study is to evaluate the objective response rate (ORR, CR+PR) in patients with advanced/metastatic UC treated with the combination of gemcitabine, cisplatin, and sunitinib.

Detailed description:
Given the strong preclinical rationale for targeting angiogenesis in urothelial carcinoma (UC), the evidence supporting co-targeting of VEGFR2 and PDGF, the safety and efficacy of single-agent sunitinib in patients with UC, and preclinical evidence of synergy with the combination of sunitinib and cisplatin, the evaluation of sunitinib in combination with gemcitabine plus cisplatin in previously untreated patients with metastatic UC is warranted.

Arms: arm 1: Gemcitabine, Cisplatin, Sunitinib
Interventions: intervention 1: Gemcitabine, Cisplatin, Sunitinib
Intervention descriptions: intervention 1: Patients will receive gemcitabine 800 mg/m2 IV (Days 1 and 8), cisplatin 60 mg/m2 IV (Day 1), and sunitinib 37.5 mg PO daily (Days 1-14) of each 21-day cycle.

2\. One cycle of treatment is defined as 21 days (3 weeks). Restaging studies will be performed after every 3 cycles of therapy.

3\. Successive cycles will be initiated every 3 weeks, and will be continued through 6 cycles unless a patient shows evidence of disease progression or intolerable toxicity.

Protocol documents:
Clinical trial NCT00824824
Conditions: Glaucoma
Keywords: Retinal Vascular Autoregulation
Sponsor: Massachusetts Eye and Ear Infirmary
Start date: 2009-01-01; Completion date: 2012-08-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
We have completed a study in which we examined the response of the retinal circulation to changes in posture from sitting to lying down in patients with primary open angle glaucoma (POAG). This alteration in position produces changes in the local blood pressure at the entrance to the retinal vasculature. In a healthy retina, the vasculature adapts by dilating and constricting in order to maintain a steady blood flow rate. In an eye with POAG, this often does not occur. As a result, there are large fluctuations in blood flow which may produce the retinal neuronal damage associated with glaucoma.

The purpose of this study is to demonstrate that topical anti-glaucoma treatments with agents that have vasoactive as well as IOP-lowering effects can have a beneficial effect on maintaining a steady retinal blood flow rate even when there are changes in local blood pressure.

Detailed description:

Arms: arm 1: Patients using timolol were switched to brimonidine tartrate / timolol maleate 0.2%/05% 1 get BID OU for six weeks. arm 2: Patients using timolol were switched ti dorzolamide hydrochloride / timolol 0.5% 2%/0.5% bid OU for six weeks
Interventions: intervention 1: Dorzolamide 2%-timolol 0.5% intervention 2: Brimonidine 0.2%-0.5% timolol 0.5
Intervention descriptions: intervention 1: BID OU for 6 weeks intervention 2: BID OU for 6 weeks

Protocol documents:
Clinical trial NCT00825344
Conditions: Inguinal Hernia Postoperative Pain
Keywords: postoperative pain inguinal hernia chronic postsurgical pain cytokine preemptive analgesia patients with inguinal hernia scheduled for surgery
Sponsor: Johns Hopkins University
Start date: 2009-01-01; Completion date: 2012-08-01
Enrollment: 77 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Inguinal hernia repair is one of the most frequently performed operations in young men. Persistent pain after inguinal surgery represents a significant cause of disability, occurring in between 15%-35% of cases. In a majority of these patients, their groin pain persisted after a previous hernia repair. The main type of chronic postsurgical pain is neuropathic, caused by injured nerves. One of the principal components in the pathophysiology of postsurgical pain is cytokines, specifically tumor necrosis factor (TNF). In animal studies, injecting TNF inhibitors before nerve injury can reduce pain behaviors and neuropathology. Finding a way to reduce the incidence of postsurgical pain after hernia repair could enhance function, and reduce the need for opioids and other analgesics. The investigators intend to conduct the first randomized, controlled study evaluating whether preemptive administration of a tumor necrosis inhibitor can reduce postoperative pain and opioid consumption after hernia repair. This is important because the degree and intensity of postsurgical pain is a major predictor for the development of chronic postsurgical pain.

Detailed description:
76 patients with an inguinal hernia scheduled for surgical repair will be randomized in a 1:1 ratio to receive either subcutaneous etanercept or saline before skin incision. The study will be double-blind (i.e. neither the surgeon, anesthesiologist, nor the person administering the injection will know which group they were assigned to). Group I will receive 50 mg of subcutaneous etanercept mixed in 1 ml sterile water 90-120" before skin incision. Group II will receive 1 ml of sterile water 90-120" before skin incision. The anesthesia and surgical procedures will be standardized. For the next 24 hours, patients will keep a q4 hour pain diary recording their average pain on a 0-10 numerical rating scale. They will also record the number of Percocet tablets they took. All patients will be seen 1 month after their surgery, where their average pain score, work status, and analgesic intake (if any) will be recorded. Patients will then be followed with a telephone follow-up 3, 6 and 12-months post-procedure, where the same variables will be recorded.

Arms: arm 1: Etanercept 50 mg preoperatively arm 2: Subcutaneous saline preoperatively
Interventions: intervention 1: Etanercept intervention 2: Saline
Intervention descriptions: intervention 1: 50 mg subcutaenous preoperatively intervention 2: Given subcutaneously preoperatively

Protocol documents:
Clinical trial NCT00851591
Conditions: Lactation
Keywords: fenugreek galactogogue breastmilk Trigonella foenum-graecum Bird's Foot Greek Clover Greek Hay Hu Lu Ba Trigonella
Sponsor: Texas Tech University Health Sciences Center
Start date: 2008-09-01; Completion date: 2012-08-01
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Each year, approximately 3 million mothers in the USA alone leave the hospital breastfeeding an infant. However, a large number discontinue breastfeeding, because milk synthesis is poor or simply stops. Termed "Insufficient Milk Syndrome," this condition probably accounts for approximately 5-10% of the total population of breastfeeding mothers and includes many mothers with premature infants, mothers with polycystic ovary syndrome, and a myriad of other unknown causes. The mother's inability to breastfeed causes enormous feelings of inadequacy, grief, depression, and other problems, not to mention increased health risks to the infant.

The most popular herbal remedy used around the world for increasing milk synthesis is fenugreek. Fenugreek (Trigonella foenum graecum) is a seed product from the legume family that is commonly sold, since the dried, ripe seed and extracts are used as an artificial flavor for maple syrup. When used orally in amounts commonly found in foods, it has been granted Generally Recognized as Safe (GRAS) status in the USA by the FDA. Although it is used by millions of women around the world to increase their milk supply, we have only one small case report which suggested it might actually increase the milk supply.

In this one study, the authors found an approximate 40% increase in milk production, although the study was not blinded, nor did they use a control population. For these reasons, we still do not know with certainty if fenugreek works as a galactagogue.

This study is designed to accurately determine if seven days of fenugreek will stimulate milk production in a selected group of subjects with poor milk supply. We hypothesize that the women enrolled in the test group will have increased milk production at the end of the 8-day study.

Detailed description:
This study is designed to accurately determine if seven days of fenugreek will stimulate milk production in a selected group of subjects with poor milk supply. We hypothesize that the women enrolled in the test group will have increased milk production at the end of the 8-day study.

Arms: arm 1: receive fenugreek arm 2: receive placebo
Interventions: intervention 1: fenugreek intervention 2: Placebo (Psyllium)
Intervention descriptions: intervention 1: 3 capsules 3 times per day with a full glass of water each dose for 7 days intervention 2: 3 capsules 3 times a day with a full glass of water each dose for 7 days

Protocol documents:
Clinical trial NCT00872898
Conditions: Autism
Keywords: autism memantine pediatric Forest Laboratories Autism in pediatric patients
Sponsor: Forest Laboratories
Start date: 2009-04-01; Completion date: 2012-08-01
Enrollment: 124 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the safety and efficacy of memantine extended release, as well as its extent of absorption in pediatric patients with autism.

Detailed description:
This is a multicenter, two-part study in pediatric (ages 6 to 18 years) patients diagnosed with autism.

Patients participating in Part One will receive a single open-label dose of memantine. Blood samples for pharmacokinetic analysis will be collected.

Part Two is a randomized, double-blind, placebo-controlled 12-week efficacy and safety study evaluating change in all core domains (social interactions, communication, and restricted interests and repetitive behaviors) of autism.

In the Forest autism trials conducted in children ages 6-12, dosing with an extended release formulation of memantine was weight-based. These weight based dose limits were selected to ensure exposure in terms of area under the curve (AUC) was less than the predefined limit of 2100 ng∙h/mL that represented a 10-fold lower exposure than observed at the NOAEL (No observed adverse effect level) of 15 mg/kg/day in juvenile rats.

The weight-based dose limits in these studies were as follows:

* Group A: ≥ 60 kg; max 15 mg/day
* Group B: 40-59 kg; max 9 mg/day
* Group C: 20-39 kg; max 6 mg/day
* Group D: \< 20 kg; max 3 mg/day

Arms: arm 1: Once daily oral administration of memantine for 12 weeks. arm 2: Once daily oral administration of placebo for 12 weeks.
Interventions: intervention 1: Memantine - Extended Release (ER) intervention 2: Placebo
Intervention descriptions: intervention 1: Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally. intervention 2: Placebo capsules, once daily, oral administration.

Protocol documents:
Clinical trial NCT00873015
Conditions: Subarachnoid Hemorrhage
Keywords: Cerebral aneurysm Subarachnoid hemorrhage Nitrite
Sponsor: Hope Pharmaceuticals
Start date: 2010-04-01; Completion date: 2012-08-01
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to examine the safety of a 14 day infusion of sodium nitrite, and to study the pharmacokinetics of nitrite, during a 14 day infusion in patients with ruptured cerebral aneurysms.

Detailed description:
Intravenous sodium nitrite has been shown to prevent and to reverse cerebral vasospasm in a primate model of subarachnoid hemorrhage (SAH). This was a Phase IIA dose escalation study of sodium nitrite to determine its safety in patients with aneurysmal SAH and to establish its pharmacokinetics during a 14 day infusion.

Sodium nitrite was delivered intravenously for 14 days in 18 patients with SAH from a ruptured cerebral aneurysm using a dose escalation scheme in three cohorts of 6 patients each (3 nitrite, 3 saline), with a maximum dose of 64 nmol/min/kg. Sodium nitrite blood levels were frequently sampled and measured using mass spectroscopy and blood methemoglobin levels were continuously monitored using a pulse oximeter.

Arms: arm 1: Continuous intravenous infusion of Sodium Nitrite arm 2: Continuous intravenous infusion of saline
Interventions: intervention 1: Sodium nitrite intervention 2: Saline
Intervention descriptions: intervention 1: 14 day continuous infusion of one of 3 escalating doses of sodium nitrite: 32 nmol/min/kg, 48 nmol/min/kg, or 64 nmol/min/kg intervention 2: 14 day continuous infusion of a vehicle control infusion

Protocol documents: