ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01205529
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation ST elevation Genotype
Sponsor: Vanderbilt University Medical Center
Start date: 2010-11-01; Completion date: 2015-06-01
Enrollment: 161 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to look for a similarity in people's genes that may help understand which people could benefit from certain drugs for the treatment of atrial fibrillation (AF).

Detailed description:
Current drug therapies to suppress AF are incompletely and unpredictably effective and carry significant (albeit generally small) risks of serious adverse effects, including drug-induced long QT syndrome (diLQTS), other forms of proarrhythmia, increased mortality through uncertain mechanisms, and extracardiac toxicity. Identification of clinical and genetic subtypes of AF will permit stratification of therapeutic approaches and thereby facilitate the practice of personalized medicine. Furthermore, limited success of drug therapy and increase in drug toxicity in AF is probably because the arrhythmia represents a final common pathway of multiple initiating mechanisms, including some that are genetically-defined.

Identifying specific intermediate phenotypes ("endophenotypes") associated with defined clinical courses in AF represents a potential method to systematically subtype patients by underlying mechanism and represents a much-needed clinical advance. Clinical endophenotypes that have been studied include atrial fibrillatory rate, prolonged signal-averaged P-wave duration, and biomarker profiles. The endophenotype we will study here is right precordial ST segment elevation, seen not only in Brugada syndrome (BrS) (where it is unmasked by sodium channel blocking drugs) but also commonly in early-onset ('lone') AF and in patients with AF-associated rare variants in genes encoding the cardiac sodium channel α- or β-subunits. Taken together these data suggest the hypothesis to be tested in this study, that variants in multiple genes can culminate in a similar AF-prone substrate by reducing sodium current that can be identified by screening for baseline or manifest right precordial ST segment elevation endophenotype after sodium channel block with intravenous procainamide.

Arms: arm 1: Those patients with ST segment or J Point elevation on electrocardiogram. Can be on initial screening electrocardiogram or on electrocardiograms during procainamide infusion. These subjects will harbor cardiac sodium channel gene variants.
Interventions: intervention 1: Procainamide
Intervention descriptions: intervention 1: One time intravenous infusion of Procainamide administered over 30 minutes. Dosage is calculated as 10mg/kg based on subject's ideal body weight.

Protocol documents:
Clinical trial NCT01217606
Conditions: Glaucoma, Open-Angle Ocular Hypertension
Sponsor: Allergan
Start date: 2011-01-01; Completion date: 2015-06-01
Enrollment: 185 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of Triple Combination Therapy compared with Fixed Combination brimonidine tartrate/timolol ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension.

Detailed description:

Arms: arm 1: Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for up to 12 months. arm 2: Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for up to 12 months.
Interventions: intervention 1: bimatoprost/brimonidine tartrate/timolol ophthalmic solution (Triple Combination Therapy) intervention 2: Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution
Intervention descriptions: intervention 1: One drop of Triple Combination Therapy administered to each eye, twice daily for up to 12 months. intervention 2: One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for up to 12 months.

Protocol documents:
Clinical trial NCT01261793
Conditions: Systemic Lupus Erythematosus
Keywords: Lupus Monoclonal antibody B-Cell immunotherapy Epratuzumab
Sponsor: UCB Pharma
Start date: 2010-12-01; Completion date: 2015-06-01
Enrollment: 791 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with Systemic Lupus Erythematosus (SLE).

Detailed description:

Arms: arm 1: Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles arm 2: 600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12 week treatment cycles arm 3: 1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks over four 12-week treatment cycles
Interventions: intervention 1: Placebo intervention 2: Epratuzumab intervention 3: Epratuzumab
Intervention descriptions: intervention 1: Placebo infusions delivered weekly for 4 weeks over four 12-week treatment cycles intervention 2: 600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12- week treatment cycles intervention 3: 1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles

Protocol documents:
Clinical trial NCT01342549
Conditions: Alcohol Dependence
Keywords: Alcohol Use Disorders Traumatic Brain Injury Mood and Anxiety Disorders
Sponsor: VA Office of Research and Development
Start date: 2011-09-01; Completion date: 2015-06-01
Enrollment: 62 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to understand the effectiveness of valproate (a common mood stabilizer) to further reduce alcohol misuse when given in addition to attending an alcohol rehabilitation program as well as the treatment of mood disorders or PTSD. The main goal of this project is to understand if people receiving valproate will have a better recovery than people receiving the standard treatment for alcohol dependence: naltrexone.

Detailed description:
Veterans are vulnerable to develop complex forms of addictive disorders characterized by the presence of traumatic brain injury and psychiatric conditions such as post-traumatic stress disorder and mood disturbances. Alcohol use disorders are frequently observed among veterans and exert a detrimental effect on community reintegration after deployment. Attending to this veteran health problem, the VA is devoting extraordinary efforts to develop adequate treatment strategies. In this study we will evaluate treatment outcomes and identify specific factors that influence alcohol use disorders treatment response in a VA Intensive Outpatient Program offering rehabilitation treatment to the growing number of veterans with alcohol use disorders. Cooperation between researchers and clinical staff will allow optimizing treatment strategies that enhance the recovery of veterans with alcohol use disorders.

Arms: arm 1: sodium valproate arm 2: naltrexone
Interventions: intervention 1: Valproate intervention 2: Naltrexone
Intervention descriptions: intervention 1: 250mg per day 30 minutes after a meal. Dosages will be increase as tolerated to a maximum recommended dosage of 60 mg per kg per day. Usual dosage is between 1250mg to 2000mg per day intervention 2: 25mg per day, taken by mouth for 7 days, then 50mg per day

Protocol documents:
Clinical trial NCT01371110
Conditions: Obsessive Compulsive Disorder
Keywords: OCD Obsessive-Compulsive Disorder ketamine treatment
Sponsor: Wayne Goodman MD
Start date: 2012-06-01; Completion date: 2015-06-01
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Obsessive-Compulsive Disorder (OCD) is a chronic and disabling anxiety disorder and a leading cause of worldwide disability that presents a significant public health problem. Treatment options are limited and many OCD patients fail to respond completely or quickly to standard treatments, including pharmacotherapy and psychotherapy. At this time, patients who fail to respond to treatment with serotonergic drugs, augmenting antipsychotic agents, and behavioral therapy, have few additional treatment options aside from deep brain stimulation. Therefore, despite advances in current pharmacological and behavioral treatments, and the utility of serotonergic drugs, it is likely that other neurotransmitter systems are involved and that targeting these systems may increase treatment efficacy. Despite little evidence for serotonergic dysfunction in OCD, there is significant evidence that glutamatergic dysregulation may contribute to the development and progression of the disorder. Also, preliminary studies suggest that glutamatergic modulators (i.e. riluzole and d-cycloserine), particularly agents acting at the NMDA receptor (i.e. memantine), may be useful in OCD. The NMDA antagonist, ketamine, has demonstrated rapid effects when delivered as a single intravenous (IV) dose in depressed patients. Therefore, the objective of the current study is to investigate the safety and efficacy of a single dose of IV ketamine in treatment-resistant OCD.

Detailed description:
This study will test the safety and efficacy of a single intravenous (IV) dose of the N-methyl-D-aspartate (NMDA) glutamate receptor antagonist, ketamine, in treatment-resistant OCD.

Arms: arm 1: Study participants will receive a one-time intravenous infusion of 0.5 mg/kg racemic ketamine hydrochloride arm 2: Study participants will receive a one-time intravenous infusion of 0.045 mg/kg midazolam
Interventions: intervention 1: Ketamine intervention 2: Midazolam
Intervention descriptions: intervention 1: Ketamine hydrochloride is a nonbarbiturate anesthetic. It is formulated as a slight acid (pH 3.5 to 5.5) sterile solution for intravenous or intramuscular injection in concentrations containing the equivalent of either 50 or 100mg ketamine base per milliliter. intervention 2: Midazolam is a short-acting benzodiazepine central nervous (CNS) depressant.

Protocol documents:
Clinical trial NCT01379521
Conditions: Hepatocellular Carcinoma
Keywords: Localised unresectable chemoembolization
Sponsor: Novartis Pharmaceuticals
Start date: 2011-06-01; Completion date: 2015-06-01
Enrollment: 65 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the role of everolimus in combination with local Transcatheter Arterial Chemoembolization (TACE) procedure in patients with localized unresectable Hepatocellular Carcinoma (HCC).

Detailed description:

Arms: arm 1: everolimus 7.5mg/day by mouth + transcatheter arterial chemoembolization (TACE) arm 2: Placebo by mouth + transcatheter arterial chemoembolization (TACE)
Interventions: intervention 1: everolimus intervention 2: everolimus placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01400477
Conditions: Schizophrenia Schizoaffective Disorder
Keywords: Drug Trial Smoking Smoking Cessation Cognition Mental Focus
Sponsor: University of Colorado, Denver
Start date: 2011-07-01; Completion date: 2015-06-01
Enrollment: 97 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators hypothesize that sustained-release DMXB-A-SR (3-2,4 dimethoxybenzylidene anabaseine sustained release) will provide clinical improvement in cognition in patients with schizophrenia who are smokers and who are non-smokers. The study drug may also maintain abstinence from cigarette smoking and improve other symptoms in patients with schizophrenia.

Detailed description:
Patients with schizophrenia will be screened then enrolled for one week placebo trial in addition to their existing antipsychotic medication. If pill compliance is greater than 80%, then they will receive baseline clinical, cognitive, and brain imaging and all clinical laboratory examinations and a physical examination, vital signs, and cardiogram. Then patients will receive in a randomized double blind trial either DMXB-A-SR (3-2,4 dimethoxybenzylidene anabaseine sustained release) or placebo comparator in addition to their existing antipsychotic medication. After one month patients will receive repeat clinical, cognitive, and brain imaging testing and all clinical laboratory examinations and a physical examination, vital signs, and cardiogram.

Arms: arm 1: Study Drug: 3-2, 4 dimethoxybenzylidene anabaseine sustained release (DMXB-A-SR), 3-2, 4 dimethoxybenzylidene anabaseine sustained release (GTS-21) arm 2: Inert capsule to resemble active drug.
Interventions: intervention 1: DMXB-A-SR intervention 2: Placebo
Intervention descriptions: intervention 1: Experimental Study Drug: 3-2, 4 dimethoxybenzylidene anabaseine sustained release (DMXB-A-SR) intervention 2: Placebo Comparator

Protocol documents:
Clinical trial NCT01402063
Conditions: Glioblastoma Multiforme
Keywords: Brain Tumors Glioblastoma Multiforme GBM
Sponsor: Brown University
Start date: 2011-09-01; Completion date: 2015-06-01
Enrollment: 63 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To obtain preliminary data in a randomized phase II study whether PPX/RT improves progression-free survival as compared to temozolomide/RT for patients with GBM without MGMT methylation.

Detailed description:
To evaluate the toxicities of PPX/RT To evaluate neuro-cognitive functional assessments of patients with GBM receiving PPX/RT To obtain preliminary data in a randomized phase II study whether PPX/RT improves overall survival as compared to temozolomide /RT for patients with GBM without MGMT methylation to facilitate planning a phase III study.

Arms: arm 1: Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments

\+ intravenous PPX every week x 6 weeks for a total of 6 treatments arm 2: Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments

\+ Daily oral temozolomide(TMZ) (7 days) x 6 wks for a total of 42 days
Interventions: intervention 1: PPX (CT2103) intervention 2: Temozolomide
Intervention descriptions: intervention 1: XRT: 60 Gy at 2 Gy/fraction x 30 fractions PPX: 50 mg/m2/week x 6 weeks during radiation Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum. intervention 2: XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide, 75 mg/m2/day, 7 days per week, from the first to the last day of radiotherapy Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum

Protocol documents:
Clinical trial NCT01421667
Conditions: Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoma, T-Cell
Keywords: Lymphoma, Large B-Cell, Diffuse Antigens, CD30 Antibody-Drug Conjugate Antibodies, Monoclonal Lymphoma, Non-Hodgkin Monomethyl auristatin E Drug Therapy Immunotherapy Hematologic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, T-Cell
Sponsor: Seagen Inc.
Start date: 2011-08-01; Completion date: 2015-06-01
Enrollment: 176 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an open-label, multicenter, phase 2 clinical trial to evaluate the efficacy and safety of brentuximab vedotin as a single agent in patients with CD30-positive non-Hodgkin lymphoma (NHL) (Part A). The study will also evaluate the safety and efficacy of brentuximab vedotin in combination with rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) (Part B) as well as further evaluate correlation of CD30 expression and response in DLBCL (Part C).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: brentuximab vedotin intervention 2: rituximab
Intervention descriptions: intervention 1: 1.8 mg/kg every 3 weeks by IV infusion intervention 2: 375 mg/m2 every 3 weeks by IV infusion

Protocol documents:
Clinical trial NCT01447706
Conditions: Epithelial Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer
Keywords: Ovarian Cancer Platinum-resistant Platinum-refractory Fallopian tube cancer Peritoneal Cancer Paclitaxel ErbB3 Phase II locally advanced/metastatic or recurrent
Sponsor: Merrimack Pharmaceuticals
Start date: 2011-10-01; Completion date: 2015-06-01
Enrollment: 223 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine whether the combination of MM-121 plus paclitaxel is more effective than paclitaxel alone

Detailed description:
This is a multicenter, open-label, randomized, Phase II study of MM-121 in patients with platinum resistant or refractory recurrent/advanced ovarian cancers. Up to 210 patients will be randomized (2:1) to receive MM-121 plus paclitaxel or paclitaxel alone.

Arms: arm 1: Standard dosing paclitaxel: 80 mg/m2 QW intravenously) arm 2: administered intravenously at 40 mg/kg loading dose on Cycle 1, Week 1 followed by 20 mg/kg QW for all subsequent doses
Interventions: intervention 1: MM-121 intervention 2: Paclitaxel
Intervention descriptions: intervention 1: MM-121 (SAR256212) (IV) intervention 2: Standard dosing Paclitaxel (IV)

Protocol documents:
Clinical trial NCT01451164
Conditions: Schizophrenia
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2011-10-01; Completion date: 2015-06-01
Enrollment: 459 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate the efficacy and safety of OPC-34712 in comparison with placebo in patients with schizophrenia.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: OPC-34712 intervention 2: OPC-34712 intervention 3: OPC-34712 intervention 4: Placebo
Intervention descriptions: intervention 1: orally administered once daily intervention 2: orally administered once daily intervention 3: orally administered once daily intervention 4: orally administered once daily

Protocol documents:
Clinical trial NCT01458639
Conditions: Pulmonary Embolism
Keywords: Pulmonary embolism PE
Sponsor: Cyclomedica Australia PTY Limited
Start date: 2012-08-01; Completion date: 2015-06-01
Enrollment: 18 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Phase 3 within-subject trial of Technegas V/Q SPECT and Tc-99m macro-aggregated albumin (MAA) imaging compared to Xenon-133 V/Q planar and Tc-99m macroaggregate of albumin (MAA) imaging for the diagnosis of Pulmonary Embolism (PE).

Detailed description:
This is a Phase 3 within-subject trial of Technegas Ventilation SPECT and Tc-99m MAA perfusion imaging compared to xenon (Xe-133) Ventilation Planar and Tc-99m MAA perfusion imaging for the diagnosis of PE. Diagnosis of PE provided by review of the subjects' documented clinical information after 30 days of follow-up. Primary assessments of efficacy will be based on an independent blind reads of the Technegas V/Q SPECT images by three different readers and the independent blind reads of Xe 133 V/Q planar images by three different readers.

Arms: arm 1: Technegas V SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles; approximately 1.1 milliCuries of Technegas, compared with the results of Xenon-133 ventilation scan arm 2: Xenon-133 ventilation Planar imaging compared with the results of the Technegas scan.
Interventions: intervention 1: Technegas V SPECT imaging intervention 2: Xenon-133 Ventilation Planar imaging
Intervention descriptions: intervention 1: Technegas V SPECT imaging and Technetium 99m MAA Perfusion imaging for the diagnosis pf pulmonary embolism. intervention 2: Xenon-133 Ventilation Planar imaging and Technetium 99m MAA Perfusion imaging for the diagnosis pf pulmonary embolism.

Protocol documents:
Clinical trial NCT01458951
Conditions: Ulcerative Colitis
Keywords: Tofacitinib CP-690 550 Moderate to severe ulcerative colitis phase 3 clinical trial Mayo score
Sponsor: Pfizer
Start date: 2012-06-01; Completion date: 2015-06-01
Enrollment: 547 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to evaluate the efficacy and safety of tofacitinib (CP-690,550) in patients with moderate to severe ulcerative colitis who have failed or be intolerant to one of following treatments for ulcerative colitis: oral steroids, azathiopurine/6-mercaptopurine, or anti-TNF-alpha therapy.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: tofacitinib intervention 2: Placebo
Intervention descriptions: intervention 1: 10 mg oral BID intervention 2: Placebo oral BID

Protocol documents:
Clinical trial NCT01491035
Conditions: Depressive Disorder Anxiety Disorder
Keywords: Children Adolescents Pharmacokinetic Pharmacodynamic
Sponsor: H. Lundbeck A/S
Start date: 2012-04-01; Completion date: 2015-06-01
Enrollment: 48 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The objective of the study is to evaluate the pharmacokinetics of vortioxetine and its metabolites in connection with multiple oral dosing in child and adolescent patients with a DSM-IV-TR diagnosis of Depressive or Anxiety Disorder

Detailed description:
The study will be conducted in the US and in Europe and will include paediatric patients diagnosed with depressive or anxiety disorders of two age populations; children aged 7-11 years and adolescents of the age 12-17 years. It is an open study to allow pharmacokinetic (PK) sampling of all patients and four dose levels will be tested. Following lower initial doses for 2 to 6 days, the patients will be treated once daily at the assigned dose levels for 14 days, and it is expected that patients may benefit from treatment during this period. As the treatment duration is not sufficient according to treatment guidelines, if judged or indicated by the investigator, the patients are offered to continue in an extension treatment of up to six months to allow possibility for therapeutic satisfaction.

Preferably, the cohorts will be dosed in the following order: AC1, AC2, CC1, AC3, CC2, AC4, CC3, and CC4. An external data safety monitoring board (DSMB) will be established to evaluate safety, tolerability and preliminary PK data from the dosed cohort(s) prior to any dosing of subsequent cohort (s). The dose regimen may be adjusted based on the recommendation of the DSMB. Adolescents will be exposed to a certain dose of vortioxetine before children receive the same dose.

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
Interventions: intervention 1: Vortioxetine intervention 2: Vortioxetine intervention 3: Vortioxetine intervention 4: Vortioxetine
Intervention descriptions: intervention 1: 5 mg tablets for 14 days; orally; once daily intervention 2: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily intervention 3: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily intervention 4: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily

Protocol documents: