ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02132884
Conditions: Malignant Pericardial Effusion Malignant Pleural Effusion Recurrent Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer
Sponsor: Fox Chase Cancer Center
Start date: 2015-03-01; Completion date: 2016-08-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized clinical trial studies how well genetic sequencing-informed targeted therapy works in treating patients with stage IIIB-IV non-small cell lung cancer. Targeted therapy is a type of treatment that uses drugs or other substances to identify and attack specific types of tumor cells that may have less harm to normal cells. Genetic sequencing may help identify these specific types of tumor cells in patients with non-small cell lung cancer.

Detailed description:
PRIMARY OBJECTIVES:

I. The three month progression free survival (PFS) of patients treated with targeted agents in the second line setting based on the tumor molecular signature as defined by CancerCode will be 40% vs 20% with standard cytotoxic chemotherapy.

SECONDARY OBJECTIVES:

I. Response rate (RR). II. Overall survival (OS). III. Proportion of Arm-B patients whose second line therapy is changed as a result of physician access to CancerCode-50 results.

IV. Concordance of variants identified when sequencing is performed on samples from the same patient collected at baseline and follow-up time points.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM A: Patients receive standard of care therapy based on the discretion of the treating physician.

ARM B: Patients undergo collection of tissue and blood samples for analysis via sequencing. Upon disease progression following front-line treatment, patients receive specific targeted therapy based on the mutational status obtained during sequencing.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 1 year, and then annually thereafter.

Arms: arm 1: Patients receive standard of care treatment based on the discretion of the treating physician. arm 2: Patients undergo collection of tissue and blood samples for analysis via sequencing. Upon disease progression following front-line treatment, patients receive specific targeted therapy based on the mutational status obtained during sequencing.
Interventions: intervention 1: cytology specimen collection procedure intervention 2: therapeutic procedure intervention 3: targeted therapy intervention 4: laboratory biomarker analysis
Intervention descriptions: intervention 1: Undergo collection of tissue and blood samples intervention 2: Receive standard of care treatment intervention 3: Receive specific targeted therapy intervention 4: Correlative studies

Protocol documents:
Clinical trial NCT02160535
Conditions: Chronic Post Traumatic Headache
Keywords: Mild Traumatic Brain Injury Concussion Post Concussive Headache
Sponsor: University of Washington
Start date: 2014-05-01; Completion date: 2016-08-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will provide evidence on whether the use of an FDA-approved drug therapy for the treatment of chronic migraine (OnabotulinumtoxinA) shows similar efficacy for treatment of chronic headaches caused by traumatic injury to the brain (TBI) from a direct hit to the head, or a fall, or a motor vehicle accident, or some other traumatic event.

Detailed description:
Headaches caused by trauma are called post-traumatic headaches (PTH). The Center for Disease Control estimates that between 1.4 and 1.8 million civilians in the US sustain a traumatic brain injury (TBI) each year. The objectives of the study will be evaluated in a civilian population which has sustained a mild Traumatic Brain Injury (mTBI). Research has found that the total cost due to headache in the US workforce is $20 billion per year, most of which is in the form of reduce productivity while at work. For patients with TBI who are already struggling with cognitive and health challenges in an effort to be productive, it seems reasonable to suspect that chronic PTH may slow rehabilitation efforts and successful re-entry into the work force and societal responsibility. Results from this study have the potential to contribute to recommendations for treatment of chronic PTH.

Arms: arm 1: OnabotulinumtoxinA
Interventions: intervention 1: OnabotulinumtoxinA
Intervention descriptions: intervention 1: 155 units of OnabotulinumtoxinA administered intramuscularly. Injections are divided across seven injection specific head/neck muscle areas every 12 weeks to prevent chronic migraine post traumatic headache

Protocol documents:
Clinical trial NCT02174419
Conditions: Prurigo Nodularis Nodularis Prurigo Prurigo Pruritus
Keywords: Itch Chronic Itch nalbuphine
Sponsor: Trevi Therapeutics
Start date: 2015-03-01; Completion date: 2016-08-01
Enrollment: 62 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objectives of the study are to evaluate the effects of two doses of nalbuphine HCl ER tablets on the change from baseline in the worst itch Numerical Rating Scale (NRS) in patients with prurigo nodularis and to evaluate the safety and tolerability in the study population.

Detailed description:

Arms: arm 1: nalbuphine HCl ER tablets 90 mg BID arm 2: nalbuphine HCl ER tablets 180 mg BID arm 3: Placebo tablets BID
Interventions: intervention 1: nalbuphine HCl ER tablets 90 mg BID intervention 2: nalbuphine HCl ER tablets 180 mg BID intervention 3: Placebo tablets BID
Intervention descriptions: intervention 1: nalbuphine HCl ER tablets 90 mg BID administered for 8 weeks intervention 2: nalbuphine HCl ER tablets 180 mg BID administered for 8 weeks intervention 3: Placebo tablets BID administered for 10 weeks

Protocol documents:
Clinical trial NCT02177786
Conditions: Diabetic Kidney Disease
Keywords: Diabetic Kidney Disease Gilead
Sponsor: Gilead Sciences
Start date: 2014-06-01; Completion date: 2016-08-01
Enrollment: 334 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to determine the effect of selonsertib (formerly GS-4997) on estimated glomerular filtration rate (eGFR) decline in participants with diabetic kidney disease (DKD). Participants will be randomized with a 1:1:1:1 allocation to receive 1 of 3 doses of selonsertib (2 mg, 6 mg, or 18 mg) or matching placebo.

Detailed description:

Arms: arm 1: Participants will receive selonsertib 2 mg for 48 weeks. arm 2: Participants will receive selonsertib 6 mg for 48 weeks. arm 3: Participants will receive selonsertib 18 mg for 48 weeks. arm 4: Participants will receive placebo to match selonsertib for 48 weeks.
Interventions: intervention 1: Selonsertib intervention 2: Placebo to match selonsertib
Intervention descriptions: intervention 1: Tablets administered orally once daily intervention 2: Tablets administered orally once daily

Protocol documents:
Clinical trial NCT02191033
Conditions: Cigarette Smoking
Keywords: cigarette smoking tobacco use cessation products
Sponsor: Yale University
Start date: 2015-01-01; Completion date: 2016-08-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a randomized-controlled clinical trial which evaluates the efficacy of physician brief advice, nicotine replacement therapy and a 6-week course of text messaging in promoting cigarette smoking in smokers enrolled in college.

The primary hypothesis is that smokers receiving physician brief advice, nicotine replacement therapy, and text messaging will have higher quit rates that smokers receiving physician brief advice and nicotine replacement therapy alone.

Detailed description:

Arms: arm 1: Smoking counseling, nicotine patch, text messaging arm 2: Smoking counseling, nicotine patch
Interventions: intervention 1: Smoking counseling intervention 2: Text messaging intervention 3: Nicotine patch
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02204410
Conditions: Attention Deficit Hyperactivity Disorder Deficient Emotional Self-Regulation
Keywords: ADHD Attention Deficit Hyperactivity Disorder DESR Deficient Emotional Self-Regulation Emotional Dysregulation Omega-3 Fatty Acids Fish Oil
Sponsor: Massachusetts General Hospital
Start date: 2014-07-01; Completion date: 2016-08-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is a 12-week open-label trial to assess the effectiveness of Omega-3 fatty acids for deficient emotional self-regulation (DESR) as a supplement to Attention Deficit/Hyperactivity Disorder (ADHD) treatment in children and adolescents with Attention Deficit/Hyperactivity Disorder. Subjects will be between the ages of 6-17 and will currently be on medication for their Attention Deficit/Hyperactivity Disorder but still experience DESR traits.

Detailed description:

Arms: arm 1: Participants will receive open-label treatment with Omega-3 Fatty Acids. All participants must also be treated with a stable dose of a traditional ADHD medication at the time of enrollment.
Interventions: intervention 1: Omega-3 Fatty Acid intervention 2: ADHD Medication
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02239380
Conditions: Status Epilepticus
Keywords: Lorazepam Status Epilepticus
Sponsor: Pfizer
Start date: 2014-11-01; Completion date: 2016-08-01
Enrollment: 26 participants; Allocation: ; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the efficacy, safety and pharmacokinetics of Lorazepam on Japanese patients with Status Epilepticus or Repetitive Status Eplilepticus.

Detailed description:

Arms: arm 1: Lorazepam intravenous formulation
Interventions: intervention 1: Lorazepam
Intervention descriptions: intervention 1: intravenous administration. Dosage for adult subjects (16 years aged and over): 4 mg Dosage for pediatric subjects (3 months to \< 16 years): 0.05 mg/kg (but not exceeding 4 mg) Frequency: Intravenous administration of lorazepam. Subjects whose seizure does not stop or recurs within 10 minutes after the initial dose may receive the same amount of lorazepam injection no earlier than 10 minutes following the initial dose.

Also, subjects whose seizure stops within 10 minutes after the initial dose, but recurs thereafter (within 12 hours) may receive the same amount of lorazepam injection; a total of 2 doses will be permitted in this study.

Protocol documents:
Clinical trial NCT02244606
Conditions: Mycoses Candidiasis, Invasive Candidemia
Keywords: Invasive Candidiasis Invasive Candida infections Candidemia SCY-078 Micafungin Fluconazole Echinocandin
Sponsor: Scynexis, Inc.
Start date: 2014-09-01; Completion date: 2016-08-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the safety, pharmacokinetics, and efficacy of oral SCY-078 vs. standard-of-care following initial intravenous echinocandin therapy in the treatment of invasive candidiasis.

Detailed description:
Patients will receive initial intravenous (IV) echinocandin therapy. Patients who are eligible for randomization will receive SCY-078 500-mg orally, SCY-078 750-mg orally, or standard-of-care.

Arms: arm 1: A single loading dose of SCY-078 1000-mg orally on the first day, followed by SCY-078 500-mg orally once-daily on subsequent days. arm 2: A single loading dose of SCY-078 1250-mg orally on the first day, followed by SCY-078 750-mg orally once-daily on subsequent days. arm 3: Oral fluconazole 400 mg daily (with a loading dose of 800 mg on the first day) or IV micafungin 100 mg daily.
Interventions: intervention 1: SCY-078 intervention 2: Fluconazole intervention 3: Micafungin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02247401
Conditions: HCV Hepatitis C Infection Genotype 4
Keywords: Genotype 4 non-responder treatment experienced HCV naive relapser hepatitis infection compensated cirrhosis hepatitis c Cirrhosis Egypt null responder partial responder
Sponsor: AbbVie
Start date: 2014-11-04; Completion date: 2016-08-01
Enrollment: 160 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluates the efficacy and safety of ABT-450/r/ABT-267 with RBV in treatment-naive and treatment-experienced HCV GT4 subjects without or with compensated cirrhosis.

Detailed description:
Non-cirrhotic subjects were directly enrolled into Arm A. Cirrhotic subjects were randomized to either Arm B (12 weeks of treatment) or Arm C (24 weeks of treatment).

Arms: arm 1: ABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 direct acting antiviral agent \[DAA\]) plus Ribavirin (RBV) for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants without cirrhosis. arm 2: ABT-450/r/ABT-267 plus RBV for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis. arm 3: ABT-450/r/ABT-267 plus RBV for 24 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
Interventions: intervention 1: 2 DAA intervention 2: RBV
Intervention descriptions: intervention 1: ABT-450/r/ABT-267 tablets intervention 2: Ribavirin tablets

Protocol documents:
Clinical trial NCT02273050
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus, Dipeptidyl-Peptidase 4 Inhibitors, Saxagliptin, Metformin, Endocrine System Diseases
Sponsor: AstraZeneca
Start date: 2014-12-01; Completion date: 2016-08-01
Enrollment: 1136 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination with Metformin IR as Initial Therapy Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Subjects with Type 2 Diabetes who have Inadequate Glycaemic Control

Detailed description:
Allocation: Randomized Endpoint Classification: Efficacy/Safety study Intervention Model: Parallel Assignment Masking: Double Blind Primary Purpose: Treatment

Arms: arm 1: Saxagliptin 5 mg once daily and metformin 500 mg once daily, then titrate. Acarbose will be used as rescue medication as needed. arm 2: Saxagliptin 5 mg once daily and Placebo 500 mg once daily, then titrate. Acarbose will be used as rescue medication as needed. arm 3: Placebo 5 mg once daily and metformin 500 mg once daily, then titrate. Acarbose will be used as rescue medication as needed.
Interventions: intervention 1: Saxagliptin 5 mg intervention 2: Placebo 5 mg for Saxagliptin intervention 3: Placebo 500 mg for metformin (with titration) intervention 4: Metformin 500 mg with titration
Intervention descriptions: intervention 1: Tablet, Oral, 5 mg, Once daily in the morning intervention 2: Tablet, Oral, 5 mg, Once daily in the morning intervention 3: Tablet, 500 mg, Once daily in the evening the first two weeks and thereafter according to titration. intervention 4: Tablet, 500 mg, Once daily in the evening the first two weeks and thereafter according to titration.

Protocol documents:
Clinical trial NCT02285010
Conditions: Post Operative Pain
Keywords: pregabalin postoperative pain abdominal hysterectomy
Sponsor: Mahidol University
Start date: 2014-11-01; Completion date: 2016-08-01
Enrollment: 125 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study aims to compare the effect of pre-operative oral pregabalin on post operative morphine consumption after abdominal hysterectomy with/without salpingo-oophorectomy.

Detailed description:
The participants are randomized into two groups by computer randomization. The patient undergo spinal anesthesia with 0.5% Heavy bupivacaine with morphine 0.2 mg. IV PCA morphine is initiate in the post-anesthetic care unit. We compare post operative morphine consumption in the first 24 hours, time to first analgesia, adverse event, and patient satisfaction.

Arms: arm 1: Placebo in capsule is prescribed to the patient 60 min prior to the surgery. arm 2: Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery.
Interventions: intervention 1: placebo intervention 2: Pregabalin
Intervention descriptions: intervention 1: Placebo in capsule is prescribed to the patient 60 min prior to the surgery. Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed. intervention 2: Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery.

Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed.

Protocol documents:
Clinical trial NCT02335125
Conditions: Posttraumatic Stress Disorder Depression Alcohol-Related Disorders Suicidal Ideation Substance-Related Disorders Mild Cognitive Impairment Quality of Life
Sponsor: University of Washington
Start date: 2015-02-01; Completion date: 2016-08-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of this pilot study is to develop and implement a larger scale, multi-site stepped collaborative care trial that targets injured patients with presentations of posttraumatic stress disorder (PTSD) and related comorbidities.

Detailed description:

Arms: arm 1: The intervention aims to prevent the development of chronic PTSD and depressive symptoms, alcohol use problems, and enduring physical disability in survivors of both TBI and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, medication, and psychotherapy elements. arm 2: Only standard care practices will be administered to this arm.
Interventions: intervention 1: Motivational Interviewing intervention 2: Cognitive Behavioral Therapy Elements intervention 3: Psychotropic Drugs intervention 4: Care Management
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT02336178
Conditions: HEMOPHILIA B
Sponsor: Pfizer
Start date: 2015-01-01; Completion date: 2016-08-01
Enrollment: 70 participants; Allocation: ; Intervention model: 

Brief summary:
The purpose of this post-approval study is to evaluate the safety and efficacy of Benefix in subjects with hemophilia B in usual care settings in China.

Detailed description:
The purpose of this post-approval study is to provide supplementary information relating to the use of BeneFIX in Chinese subjects with hemophilia B, especially on the safety and efficacy in different populations of Chinese hemophilia B patients, in particular in pediatric patients \<6 years of age, pediatric patients ≥6 to ≤12 years of age, Previously Untreated Patients (PUPs) , subjects receiving prophylaxis treatment after enrollment in the study, and severe patients (FIX activity \<1%).

Arms: arm 1: This is a single arm study. Subjects will be treated with Benefix by the investigator according to usual care in China and in accord with the China BeneFIX Package Insert.
Interventions: intervention 1: Benefix
Intervention descriptions: intervention 1: Subjects will be treated by the investigator according to usual care in China and in accord with the China BeneFIX Package Insert.

The treatment duration is approximately 6 months (±7 days) or approximately 50 Exposure Days (EDs) (±5 EDs) (see protocol definition on EDs) whichever occurs first.

Protocol documents:
Clinical trial NCT02356107
Conditions: Major Depressive Disorder
Sponsor: Perry Renshaw
Start date: 2015-04-01; Completion date: 2016-08-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The investigators hypothesize that the administration of two widely available, naturally occurring dietary supplements, 5 hydroxytryptophan and creatine monohydrate, will reduce the severity of depression in individuals exposed to chronic hypoxia by living at altitude. The purpose of this study is to determine if 8 weeks of dietary augmentation with oral 5 g creatine daily and 100 mg 5-HTP twice daily reduces hypoxia-related depressive symptoms measured by the 17-item Hamilton Depression Rating Scale (HAM-D) in women with SSRI or SNRI-resistant depression.

Detailed description:
Serotonin and creatine are processed separately in the brain, and deficits in these brain biochemicals lead to distinct clinical problems. Therefore, investigators believe that treatment with a combination therapy, which could correct both deficits, would have a synergistic effect in the treatment of hypoxia-related depression and possibly other forms of treatment-resistant depression. Thus, investigators propose to investigate antidepressant efficacy of dietary 5-hydroxytryptophan (5-HTP) and creatine, as a means to restore the brain neurotransmitter and metabolic imbalances linked to chronic hypoxia caused by high altitude residence.

Arms: arm 1: None
Interventions: intervention 1: 5-hydroxytryptophan and Creatine monohydrate
Intervention descriptions: intervention 1: None

Protocol documents: