ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01194453
Conditions: Non-small Cell Lung Cancer Efficacy
Sponsor: Sun Yat-sen University
Start date: 2009-11-01; Completion date: 2012-08-01
Enrollment: 288 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A phase III trial has demonstrated that in advanced non-small cell lung cancer (NSCLC) cisplatin/ pemetrexed provides similar efficacy with better tolerability and more convenient administration than cisplatin/gemcitabine. Moreover,this trial showed survival differences based on histologic type. The investigators want to research some biomarkers that can predict clinical outcomes.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: cisplatin, dexamethasone,vitamin B12, folic acid intervention 2: cisplatin, gemcitabine
Intervention descriptions: intervention 1: Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment intervention 2: cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8

Protocol documents:
Clinical trial NCT01200862
Conditions: Obese Hypogonadotropic Hypogonadism
Keywords: Obese obesity hypogonadism hypogonadotropic hyperestrogenemic testosterone hypogonadal
Sponsor: Mereo BioPharma
Start date: 2010-08-01; Completion date: 2012-08-01
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed as a 2-part study, with Part 1 being open-label to best determine the appropriate dose levels to use in Part 2, which has a randomized, double-blind, placebo controlled design. The study aims to assess the safety and tolerability of BGS649, and determine whether or not BGS649 is able to normalize testosterone levels and improve insulin sensitivity in obese, hypogonadotropic hypogonadal (OHH) men

Detailed description:

Arms: arm 1: BGS649 1mg and 0.1mg in hard gelatin capsules. In part 1 there was individualised dosing to titrate the subject's testosterone into the normal range. If the dose was lower than 0.1mg then specific instructions for dilution of an oral solution of BGS649 were provided. arm 2: Matching placebo to BGS649 (0.3 and 0.1mg). 0.3mg placebo capsule given on Day 1 and 0.1mg placebo capsule on other treatment visits (week 1 to 11). arm 3: 0.3 or 0.1mg hard gelatin capsules of BGS649 given orally. 0.3mg on Day 1 and 0.1 on all other treatment visits (week 1 to 11).
Interventions: intervention 1: Investigational new drug company code: BGS649 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01206439
Conditions: Hypertension
Sponsor: Jack Rubinstein
Start date: 2010-09-01; Completion date: 2012-08-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if Nebivolol has any effect on heart function determined by changes in echocardiographic data or exercise tolerance.

Detailed description:
Subjects will be given either 5 or 10 mg daily of oral Nebivolol for blood pressure control. They will undergo stress echocardiography at baseline, day 14, 90 and 180.

Arms: arm 1: Subject will receive either 5 or 10 mg of oral nebivolol daily. Dose will be determined by control of blood pressure.
Interventions: intervention 1: nebivolol
Intervention descriptions: intervention 1: nebivolol 5 or 10 mg oral, daily

Protocol documents:
Clinical trial NCT01215357
Conditions: Pathological Gambling
Keywords: Pathological Gambling ecopipam Dopamine
Sponsor: Emalex Biosciences Inc.
Start date: 2010-10-01; Completion date: 2012-08-01
Enrollment: 34 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
This study is designed to test the hypothesis that ecopipam is able to reduce urges to gamble in patients diagnosed with Pathological Gambling.

Detailed description:
The purpose of this study is to determine if ecopipam is able to stop urges to gamble in patients diagnosed with Pathological Gambling. Nerves communicate with each other by releasing chemicals called "neurotransmitters". One of these neurotransmitters in the brain is called "dopamine". After dopamine is released by the nerve it "talks" to other nerves by interacting with receptors that are unique to that neurotransmitter. Ecopipam is a drug that selectively blocks one family of dopamine receptors. Some scientists believe that the urge to gamble is related to having too much dopamine in the brain. By blocking the receptors that dopamine uses, ecopipam may be able to relieve the urge to gamble.

Arms: arm 1: Ecopipam is a selective antagonist of one the classes of dopamine receptor. arm 2: Placebo given first week of the study.
Interventions: intervention 1: Ecopipam
Intervention descriptions: intervention 1: 50mg tablets

Protocol documents:
Clinical trial NCT01216943
Conditions: Glaucoma Ocular Hypertension
Sponsor: Allergan
Start date: 2010-11-01; Completion date: 2012-08-01
Enrollment: 126 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will investigate the safety and efficacy of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) in patients with glaucoma or ocular hypertension who have elevated intraocular pressure (IOP) on brimonidine/timolol ophthalmic solution.

Detailed description:

Arms: arm 1: One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.
Interventions: intervention 1: bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution
Intervention descriptions: intervention 1: One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.

Protocol documents:
Clinical trial NCT01217840
Conditions: Obesity
Keywords: Adolescents, Vitamin D
Sponsor: Stanford University
Start date: 2010-09-01; Completion date: 2012-08-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Large studies of children show that over half of the children in the United States of America do not have enough vitamin D stored in their bodies. In children who are overweight or obese, the percentage of children who do not have enough vitamin D is even higher.

Vitamin D is essential for the body to maintain normal calcium levels and strong bones. Recent research shows that through the actions of inflammatory markers, levels in the blood that measure inflammation in the body, vitamin D plays many other important roles in the body like helping to regulate the immune system, blood sugar levels, blood pressure, and body fat.

The purpose of this study is to determine the effect of vitamin D supplementation on inflammatory markers in obese and overweight adolescents. As a secondary goal, we would like to evaluate cardiometabolic risk factors and the correlation between body mass index, vitamin D stores and inflammatory cytokines.

In an observed, randomized controlled trial over 6 months we will provide observed vitamin D supplementation or placebo to healthy obese and overweight adolescents and measure changes in inflammatory markers, lipids, blood pressure, and mean blood sugars. We hypothesize that administration of vitamin D to these patients will improve their inflammatory profile and cardiometabolic risk factors (blood glucose, blood pressure, and lipid profile).

Detailed description:
Supplementation with vitamin D at 150,000 IU every 3 months failed to increase serum 25-hydroxy vitamin D (25OHD) or alter inflammatory markers and lipids in overweight and obese youth. Further studies are needed to establish the dose of vitamin D required to increase 25OHD and determine potential effects on metabolic risk factors in obese teens.

During the course of the study, blood pressure removed from the prespecified outcome measures.

Arms: arm 1: Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments.

Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks arm 2: Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital's clinical trial pharmacist and were administered by study staff blinded to group assignments. Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks
Interventions: intervention 1: Drisdol (Ergocalciferol) Vitamin D2 intervention 2: Placebo
Intervention descriptions: intervention 1: Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks. intervention 2: Placebo pill - 3 pills every 12 weeks for total of 24 weeks

Protocol documents:
Clinical trial NCT01217944
Conditions: Pathological Myopia
Keywords: Pathologic myopia PM choroidal neovascularization CNV ranibizumab verteporfin PDT
Sponsor: Novartis Pharmaceuticals
Start date: 2010-10-01; Completion date: 2012-08-01
Enrollment: 277 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to evaluate the efficacy and safety of two different dosing regimens of 0.5 mg ranibizumab given as intravitreal injection in comparison to verteporfin PDT in patients with visual impairment due to choroidal neovascularization (CNV) secondary to pathologic myopia (PM).

Detailed description:

Arms: arm 1: Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria arm 2: Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity arm 3: Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
Interventions: intervention 1: Ranibizumab intervention 2: Verteporfin PDT intervention 3: Sham Ranibizumab intervention 4: Sham verteporfin PDT
Intervention descriptions: intervention 1: 0.5 mg ranibizumab intravitreal injection intervention 2: Verteporfin (6 mg/m2) intravenous infusion intervention 3: Empty vial to mimic the intravitreal injection intervention 4: Sham vPDT intravenous infusion of dextrose 5% solution followed by light application (PDT).

Protocol documents:
Clinical trial NCT01219738
Conditions: Asthma
Keywords: Asthma, airway blood flow, budesonide, glucocorticosteroid.
Sponsor: University of Miami
Start date: 2008-07-01; Completion date: 2012-08-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Glucocorticosteroids recently have been shown to have non-genomic actions that are plasma membrane-mediated and do not require gene transcription and translation. One of these non-genomic effects is the inhibition of adrenergic agonist transport into airway vascular smooth muscle cells with an increase of adrenergic agonist concentrations at adrenergic receptor sites and enhance the physiological effects of endogenous adrenergic agonists (e.g. locally released norepinephrine from noradrenergic neurons) or exogenous adrenergic agonists (e.g. inhaled beta-adrenergic agonists).

Detailed description:
Inhaled glucocorticosteroids typically are not recommended for the treatment of acute asthma attacks. This practice is based on the fact that glucocorticosteroids by themselves do not cause rapid bronchodilation. However, the acute inhibition of adrenergic agonist disposal by the non-genomic action of glucocorticosteroids could lead to bronchial vasoconstriction by locally released norepinephrine thereby decongesting the airway wall, and potentiate the bronchodilator effect of a concomitantly administered beta-adrenergic agonist through the same mechanism. The purpose of this study is to assess the vasoconstrictive effects of single and repetitive high-dose budesonide inhalations in moderate to severe asthmatics who use inhaled glucocorticosteroids regularly. As a secondary endpoint, airway inflammation and airway function will also be measured with the expectation that acute improvements in airflow might be detectable as a result of airway decongestion, notably in subjects with moderately severe asthma who have lower baseline lung function.

Arms: arm 1: asthmatic subject received different doses of inhaled budesonide in random other arm 2: asthmatic subject received different doses of inhaled budesonide in random other arm 3: asthmatic subject received different doses of inhaled budesonide in random other arm 4: asthmatic subject received inhaled placebo arm 5: asthmatic subject received 720ug of inhaled budesonide 4 times separated by 30 minutes.
Interventions: intervention 1: Budesonide 360ug intervention 2: Budesonide 720ug intervention 3: Budesonide 1440ug intervention 4: Budesonide720ug 4 times intervention 5: Placebo
Intervention descriptions: intervention 1: A single inhaled dose of 360ug budesonide from a DPI. intervention 2: A single inhaled dose of 720ug budesonide from a DPI. intervention 3: A single dose of 1440ug of the budesonide from DPI. intervention 4: 720ug of budesonide will be inhaled by the subjects 4 times, separated by 30 minutes. intervention 5: A single inhaled dose of placebo from a DPI.

Protocol documents:
Clinical trial NCT01222871
Conditions: Nasal Polyps
Keywords: Treatment
Sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc.
Start date: 2010-07-01; Completion date: 2012-08-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to compare the effectiveness of intranasal Triamcinolone delivered through a bio-absorbable nasal dressing verses oral steroids and a saline soaked dressing, in the treatment and prevention of early nasal polyposis.

Detailed description:
nasopore, a bio-absorbable nasal dressing, may offer an alternative route of sustained steroid drug delivery. The use of topical targeted intranasal steroids may prevent the routine adverse effects of oral steroids while maintaining the same therapeutic / clinical efficacy.

Arms: arm 1: Triamcinolone soaked nasopore dressing arm 2: Saline soaked sponge
Interventions: intervention 1: Triamcinolone intervention 2: Saline soaked sponge
Intervention descriptions: intervention 1: Triamcinolone soaked nasopore dressing intervention 2: saline soaked sponge

Protocol documents:
Clinical trial NCT01225146
Conditions: Ischemia Retinal Vein Occlusion Pathologic Processes Retinal Diseases Eye Diseases
Keywords: Ischemic Central Retinal Vein Occlusion Ranibizumab Lucentis CRVO ISCRVO
Sponsor: David M. Brown, M.D.
Start date: 2010-10-01; Completion date: 2012-08-01
Enrollment: 8 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The RAVE 2 trial is a phase I, open label, 12-month trial of intravitreal ranibizumab 2.0 mg in patients with ischemic CRVO who have been either previously treated with ranibizumab or treatment naïve.

Detailed description:
The most devastating complication of ischemic CRVO is the development of anterior segment neovascularization and the resulting morbidity from neovascular glaucoma. This complication appears to be directly correlated with intraocular VEGF levels. Currently there is no proven treatment to decrease the formation of rubeosis. Current management of the disease consists of pan-retinal photocoagulation once significant anterior segment neovascularization becomes manifest. This treatment destroys peripheral retina (with peripheral retinal field) and presumably works by eventually lowering ocular VEGF levels which causes secondary regression of rubeosis.

As ranibizumab blocks VEGF, this treatment when delivered intraocularly may prevent neo-vascular glaucoma while preserving peripheral visual fields in this patient population.

A higher dose of ranibizumab may allow for both a longer duration of treatment effect and potentially more efficacy leading to better outcomes for patients that are somewhat treatment resistant and need continual therapy. Nonclinical and early clinical data indicate that higher doses of ranibizumab up to and including 2.0 mg are safe and tolerated by patients.

Arms: arm 1: Previously treated with 6 or more intravitreal ranibizumab with persistent edema followed in RAVE 1 (FVF3348s).

Cohort 1 patients will receive 1 dose of ranibizumab 2.0 mg, followed by PRN based on pre-defined retreatment criteria arm 2: Treatment naïve. Cohort 2 patients will receive 6 doses of ranibizumab 2.0 mg, followed by PRN based on pre-defined re-treatment criteria.
Interventions: intervention 1: ranibizumab
Intervention descriptions: intervention 1: Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution.

Protocol documents:
Clinical trial NCT01226420
Conditions: Chronic Graft-versus-host Disease
Keywords: GVHD Alefacept Amevive
Sponsor: Dana-Farber Cancer Institute
Start date: 2010-10-01; Completion date: 2012-08-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Alefacept is a drug tht may reduce the number of T cells in circulation. This drug has been used in the treatment of psoriasis, which is a skin disorder also caused by T cells, like chronic GVHD. Information from studies in psoriasis and in other patients with GVHD suggests that this drug may help to treat chronic GVHD. Chronic GVHD is a medical condition that can develop after allogeneic stem cell transplantation. It occurs when the donor immune cells (the "graft") attack and damage organs and tissue (the "host"). It is thought that T cells, a subtype of immune cells, are responsible for the tissue damage in chronic GVHD. In this research study we are looking to see how well Alefacept works in treating chronic GVHD that has not resolved after therapy with corticosteroids.

Detailed description:
* During the first week of treatment, participants will receive 2 doses of Alefacept intravenously (Day 1 and Day 4). During weeks 2-12, Alefacept will be given subcutaneously once weekly.
* On weeks 1, 2 and every other week through Week 12 of study treatment, participants will have a physical exam, blood tests, and be asked general health and specific questions about any problems they may be having.
* Every other week, participants will be asked to complete a questionnaire about their physical symptoms, activity level and emotional well being.

Arms: arm 1: Alefacept iv
Interventions: intervention 1: Alefacept
Intervention descriptions: intervention 1: Given intravenously Days 1 and 4 of Week 1, then subcutaneously once weekly for Weeks 2-12

Protocol documents:
Clinical trial NCT01251978
Conditions: Choroidal Melanoma
Keywords: Choroidal melanoma Ranibizumab Transpupillary Thermotherapy CSTIP Indocyanine Green
Sponsor: New England Retina Associates
Start date: 2010-07-01; Completion date: 2012-08-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Ranibizumab has proven to be of benefit to improve the perfusion in the retina of patients with Choroidal Melanoma. The investigators consider that higher doses of Ranibizumab can help reduce the number of laser treatments that might be needed to control the tumor.

Detailed description:

Arms: arm 1: 6 patients will receive 3 injections of Ranibizumab (2 mg) a month apart. arm 2: 6 patients will receive 0.5 mg of Ranibizumab every two weeks per 3 months.
Interventions: intervention 1: Ranibizumab 2 mg intervention 2: 0.5 mg Ranibizumab
Intervention descriptions: intervention 1: intravitreal injections of ranibizumab once a month, times 3. intervention 2: 6 intravitreal injections of 0.5 mg Ranibizumab every 2 weeks x 3 months.

Protocol documents:
Clinical trial NCT01262677
Conditions: Partial Seizures Epilepsies, Partial
Keywords: Partial epilepsy partial seizures epilepsy seizures adjunctive therapy intervention controlled-release placebo-controlled seizure
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2011-02-17; Completion date: 2012-08-01
Enrollment: 325 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Approximately 30% percent of subjects with partial seizures are refractory to treatment with single or combination antiepileptic drugs. The present study will compare the efficacy of two different dosages of pregabalin CR dosed once daily as compared to placebo, when used as adjunctive therapy in subjects requiring adjunctive therapy for partial onset epilepsy, using a randomized, parallel group design.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: pregabalin intervention 2: pregabalin intervention 3: pregabalin intervention 4: pregabalin intervention 5: pregabalin intervention 6: pregabalin intervention 7: placebo
Intervention descriptions: intervention 1: Controlled Release Tablets, 82.5 mg, once per day (QD) for 3 days intervention 2: Controlled Release Tablets, 165 mg, once per day (QD) for 11 days intervention 3: Controlled Release Tablets, 330 mg, once per day (QD) for the remainder of the double-blind treatment phase (max is 12 weeks) intervention 4: Controlled Release Tablets, 165 mg, once per day (QD) for 7 days intervention 5: Controlled Release Tablets, 82.5 mg, once per day (QD) for 3 days intervention 6: Controlled Release Tablets, 165 mg, once per day (QD) for the remainder of the up-titration and double-blind treatment and taper phases (max 14.5 weeks) intervention 7: matched to the active drug

Protocol documents:
Clinical trial NCT01270256
Conditions: Perennial Allergic Rhinitis
Keywords: allergy
Sponsor: University of Chicago
Start date: 2011-01-01; Completion date: 2012-08-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to see if a nasal steroid drug delivered to the nose with the NasoNeb™ inhaler improves the symptoms of people with perennial allergic rhinitis (year round allergy symptoms).

Detailed description:

Arms: arm 1: Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily arm 2: Placebo delivered intranasally via NasoNeb nebulizer once daily
Interventions: intervention 1: Budesonide intervention 2: Placebo
Intervention descriptions: intervention 1: Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily intervention 2: Placebo delivered intranasally via NasoNeb nebulizer once daily

Protocol documents:
Clinical trial NCT01272921
Conditions: The Duration of Motor Block May Vary Between 12-36 Hrs
Sponsor: Northwestern University
Start date: 2010-11-01; Completion date: 2012-08-01
Enrollment: 142 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The duration of motor block for infragluteal parabiceps sciatic nerve block following total knee replacement may vary between 12-36 hrs depending on the amount of local anesthetic given.

Detailed description:

Arms: arm 1: Varying does to determine duration of analgesia following a sciatic nerve block arm 2: Varying does to determine duration of analgesia following a sciatic nerve block
Interventions: intervention 1: Bupivacaine intervention 2: Ropivacaine
Intervention descriptions: intervention 1: Varying doses to determine the duration of analgesia intervention 2: Varying doses to determine the duration of analgesia

Protocol documents: