ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01821625
Conditions: Thrombocytopenia Hepatitis C
Keywords: Thrombocytopenia Hepatitis Platelets Eltrombopag Liver Disease Antiviral Treatment
Sponsor: University of Texas Southwestern Medical Center
Start date: 2013-04-01; Completion date: 2016-04-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will provide chronic hepatitis C patients with low platelets (less than 75x10\^9/L) the opportunity to undergo treatment and possible cure of their virus. The main hepatitis C drugs will be administered as standard of care, with the addition of the study drug eltrombopag.

The investigators hypothesize that providing eltrombopag to chronic hepatitis C patients with low platelets (less than 75x10\^9/L) will permit the initiation and completion of antiviral triple therapy with boceprevir, ribavirin, and pegylated-interferon.

Detailed description:
SQUELCH-C is an investigator-initiated, single arm, non-blinded pilot study on the use of eltrombopag in combination with ribavirin, pegylated-interferon, and boceprevir, for patients who would not otherwise be treatment candidates because of low platelet counts (less than 75x10\^9/L).

Administration of the drugs ribavirin and boceprevir will be standard of care, with one exception for interferon.

The total drug treatment period for the study patient will range from 32 - 56 weeks, depending on liver disease stage and viral response. Follow-up will take place at 12 and 24 weeks post treatment to evaluate for sustained viral response. Total study participation may require 1.5 years.

Arms: arm 1: All study patients will undergo intervention in this study.

The intervention will be a lead-in with eltrombopag and antiviral triple therapy (interferon, ribavirin and boceprevir).
Interventions: intervention 1: Eltrombopag
Intervention descriptions: intervention 1: Study patients will be provided eltrombopag to raise platelet levels before anti-hepatitis C drugs are initiated, and will continue eltrombopag throughout the study.

Protocol documents:
Clinical trial NCT01855867
Conditions: Human Immunodeficiency Virus
Keywords: HIV PEP nPEP Prophylaxis Post Exposure Prophylaxis exposure to HIV HIV prevention
Sponsor: Kenneth H. Mayer, MD
Start date: 2013-05-01; Completion date: 2016-04-01
Enrollment: 100 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to see if an anti-HIV medication known as Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir DF) is safe, tolerable and acceptable when taken for 28 days, once a day after a possible, sexual, exposure to the Human Immune Deficiency Virus (HIV).

Detailed description:
Stribild is a combination of 1 integrase strand transfer inhibitor, 1 pharmacokinetic enhancer, and 2 nucleos(t)ide analog HIV-1 reverse transcriptase inhibitors, and was approved in August 2012, as a complete treatment regimen for HIV-1 infection in adults who are antiretroviral treatment-naïve. We are proposing to evaluate the safety, tolerability and acceptability of Stribild given to participants over age 18 after a possible sexual exposure to HIV-1. Enrolled participants will have experienced a moderate to high risk exposure, as outlined in the study protocol, within the last 72 hours - per 2005 Center for Disease Control and Prevention guidelines. Participants will take one Stribild tablet, by mouth, once a day for 28 days. Study staff will assess for changes in blood chemistries and clinical signs and symptoms from baseline health. Study participation is 90 days and will include HIV testing, STI screening, HIV/STI risk reduction counseling, clinical assessments, blood draws and surveys designed to gather knowledge and perception of HIV post-exposure prophylaxis (PEP) and HIV pre-exposure prophylaxis (PrEP). Conditional referrals to continued HIV/STI risk reduction counseling and testing will be made if risk remains high at study termination. In addition, participants will be connected to a medical provider if risk demonstrates a potential need for HIV pre-exposure prophylaxis.

Arms: arm 1: Single dose Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg) taken for 28 days, within 72 hours of a possible sexual exposure to HIV
Interventions: intervention 1: Single Dose Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg)
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01860040
Conditions: Non-squamous Cell Non-Metastatic Non-Small Cell Lung Cancer Squamous Cell Non-Metastatic Non-Small Cell Lung Cancer
Sponsor: Western Regional Medical Center
Start date: 2013-04-01; Completion date: 2016-04-01
Enrollment: 1 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine the rate of pathologic complete responses (pCR) at the time of definitive surgical resection of non-small cell lung cancer (NSCLC)

Detailed description:
Participants in this study will have a lung mass and are undergoing a procedure to determine if they have non-small cell lung cancer that could be removed surgically. If confirmed to have non-small cell lung cancer that can be surgically removed, he or she may be able to continue as a possible participant in this study.

The purpose of this study is to determine whether neoadjuvant chemotherapy (chemotherapy that is given before surgery) will improve the amount of time a participant is free from disease in people with non-metastatic (has not spread from the original site) non-small cell lung cancer. The chemotherapy medications that will be used in this study are cisplatin and pemetrexed or cisplatin and gemcitabine and have been shown to be effective in patients with non-small cell lung cancer.

Arms: arm 1: Cisplatin on day 1 and pemetrexed on day 1, 1 cycle = 21 days, deliver 4 neoadjuvant cycles arm 2: Cisplatin on day 1 and gemcitabine on days 1 and 8, 1 cycle = 21 days, deliver 4 neoadjuvant cycles
Interventions: intervention 1: Cisplatin intervention 2: Pemetrexed intervention 3: Gemcitabine
Intervention descriptions: intervention 1: Alkylating antineoplastic agent (Chemotherapy) intervention 2: Antimetabolite antineoplastic agent (Chemotherapy) intervention 3: Antimetabolite antineoplastic agent (Chemotherapy)

Protocol documents:
Clinical trial NCT01866917
Conditions: Pain
Keywords: Transversis Abdominis Plane Block obese robotic surgery laparoscopic surgery
Sponsor: Montefiore Medical Center
Start date: 2013-04-01; Completion date: 2016-04-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study the effect of the Transversis Abdominis Plane (TAP) block on pain after surgery for obese women undergoing laparoscopic or robotic gynecologic procedures.

Detailed description:

Arms: arm 1: Patients will receive Ropivicaine 0.5% 20cc injectate from a study labeled syringe arm 2: Patients will receive Normal saline 20cc injectate from a study labeled syringe
Interventions: intervention 1: Ropivacaine 0.5% 20cc injectate bilaterally intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01882439
Conditions: Psoriatic Arthritis
Keywords: psoriatic arthritis tofacitinib ACR20 HAQ-DI TNF inhibitor failure
Sponsor: Pfizer
Start date: 2013-08-01; Completion date: 2016-04-01
Enrollment: 395 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To examine the safety and efficacy of tofacitinib in subjects with active psoriatic arthritis who have previously had an inadequate response to at least one TNF inhibitor either due to lack of efficacy or an adverse event.

Detailed description:

Arms: arm 1: Tofacitinib 5 mg BID for 6 months arm 2: Tofacitinib 10 mg BID for 6 months arm 3: Placebo for 3 months then tofacitinib 5 mg BID for 3 months arm 4: Placebo for 3 months then tofacitinib 10 mg BID for 3 months
Interventions: intervention 1: Tofacitinib intervention 2: Tofacitinib intervention 3: Placebo intervention 4: Tofacitinib intervention 5: Placebo intervention 6: Tofacitinib
Intervention descriptions: intervention 1: tablets, 5 mg BID x 6 months intervention 2: tablets, 10 mg BID x 6 months intervention 3: tablets, to match tofacitinib 5 mg BID x 3 months intervention 4: tablets, 5 mg BID x 3 months intervention 5: tablets, to match tofacitinib 10 mg BID x 3 months intervention 6: tablets, 10 mg BID x 3 months

Protocol documents:
Clinical trial NCT01895127
Conditions: Antibody-mediated Rejection Humoral Rejection
Keywords: Kidney Transplant Renal Transplant Rejection Antibody mediated Humoral Eculizumab
Sponsor: Brigham and Women's Hospital
Start date: 2013-11-01; Completion date: 2016-04-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an open-label analysis that will compare eculizumab versus Plasmapheresis (PP) and Immunoglobulin (IVIg) for the treatment of antibody-mediated rejection (AMR) in renal transplant recipients. All patients will be evaluated from the time of AMR diagnosis for 12 months.

Detailed description:

Arms: arm 1: * Plasmapheresis (PP) x 3, at 40-60 cc/kg.
* Immunoglobulin (IVIg), to be administered after each PP arm 2: * 1200 mg first dose (Time: Screening/Week "0", after Biopsy Proven AMR)
* 900 mg weekly for 4 doses (Weeks 1, 2, 3, 4)
* 1200 mg week 5
* Week 6: If donor specific antibody \< 50% of baseline DSA then no further treatment, otherwise 1200 mg weeks 7, 9
Interventions: intervention 1: Eculizumab intervention 2: Immunoglobulin intervention 3: Plasmapheresis
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01896700
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis postural balance walking
Sponsor: Oregon Health and Science University
Start date: 2013-07-01; Completion date: 2016-04-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Methylphenidate is an amphetamine-like psychomotor stimulant drug currently approved for the treatment of attention-deficit hyperactivity disorder (ADHD), postural orthostasis tachycardia syndrome and narcolepsy. It is also often prescribed off label to people with MS to improve fatigue. It is proposed that methylphenidate may also improve imbalance and walking deficits in MS by improving concentration and central integration, one of the primary mechanisms thought to underlie imbalance and walking deficits in MS.

Detailed description:
The proposed pilot study will examine the effects of methylphenidate on imbalance and walking in 24 subjects with MS and imbalance. The subjects will be randomly assigned to receive either an escalating does of methylphenidate, 20mg, 40mg or 60mg, divided into two doses each day, or matched placebo for 2 weeks at each dose. If a subject does not tolerate dose escalation they will be instructed to discontinue use of the drug. The maximum safely tolerated dose for each subject will be noted. Changes from baseline in subject's walking speed, balance, vestibular function, cognitive function, and fatigue will be assessed at each dose.

Arms: arm 1: Intervention: An escalating dose of methylphenidate taken by mouth: 20mg for 2 weeks, 40mg for 2 weeks, 60mg for 2 weeks. All doses divided twice/day.

Other name: Ritalin arm 2: Placebo pill, bid for 6 weeks
Interventions: intervention 1: Methylphenidate intervention 2: Placebo
Intervention descriptions: intervention 1: Escalating dose of methylphenidate, 20mg, 40mg, 60mg/day, for 2 weeks each intervention 2: Escalating matched dose of placebo

Protocol documents:
Clinical trial NCT01903798
Conditions: Alcoholic Hepatitis
Sponsor: Southern California Institute for Research and Education
Start date: 2014-12-01; Completion date: 2016-04-01
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This clinical trial will test two new therapies for the treatment of alcoholic hepatitis. Patients who "respond" to the current standard of care therapy for alcoholic hepatitis(corticosteroid/prednisolone therapy) after 1 week of treatment will be randomly assigned to either continue on standard therapy, or, to begin treatment with rilonacept in combination with standard therapy. Patients who are "non-responders" to the current standard of care therapy after 1 week of treatment will be randomly assigned to standard of care or to begin treatment with mycophenolate mofetil in combination with standard therapy. Patients will be treated for a total of 4 weeks in this clinical trial. Patients will be followed for up to five months after completing therapy (6 months total).

Detailed description:
This is a prospective, randomized trial of two experimental treatments, prednisolone + mycophenolate mofetil and prednisolone + rilonacept, in comparison with standard of care, in patients with alcoholic hepatitis. Patients will start therapy with prednisolone. At Day 8 response to prednisolone will be determined using the Lille score. Patients with a Lille score ≥ 0.45 will be randomized to standard of care (continue prednisolone, stop all therapy and/or offer palliative care) or to have prednisolone continued and mycophenolate added for the next three weeks. Patients with a Lille score \<0.45 will be randomized to continue prednisolone alone (standard of care) or to have rilonacept added to their treatment regimen (experimental group) for the next three weeks. Patients will complete follow-up visits at Week 12 and Week 24.

Arms: arm 1: At Day 8, after randomization, this participants will continue prednisolone 40 mg/day (current standard of care) for 21 days. arm 2: This group will continue Prednisolone (40mg/day). Additionally, they will receive rilonacept (Arcalyst®) once a week for 21 days. After randomization at Day 8, study participants will be given 320 mg subcutaneously (two injections of 2.0 ml, 160 mg each). On Day 15 and Day 22, study participants will be given 160 mg subcutaneously (one injection of 160 mg). arm 3: Prednisolone (40 mg/day) for the first 7 days, after randomization at Day 8, they will stop all therapy. arm 4: This group will continue Prednisolone (40mg/day). Additionally, they will receive mycophenolate mofetil (CellCept®) for a total of 21 days. After randomization at Day 8, they will receive CellCept® at a dose of 1000 mg per day for the first four days followed by 2000 mg per day (two 500 mg tablets bid) for the remaining 17 days.
Interventions: intervention 1: Mycophenolate mofetil intervention 2: Prednisolone intervention 3: Rilonacept
Intervention descriptions: intervention 1: Immunosuppressive agent intervention 2: Corticosteroid intervention 3: None

Protocol documents:
Clinical trial NCT01919450
Conditions: Myocardial Blood Flow Reserve
Keywords: PET Lexiscan Regadenoson Rubidium Blood Flow Reserve Myocardial Perfusion Quantitated Myocardial Perfusion
Sponsor: Timothy M. Bateman, MD
Start date: 2013-07-01; Completion date: 2016-04-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the consistency of quantitative peak stress myocardial blood flow and myocardial blood flow reserve following a 10 second, 1 minute, 2 minute or 4 minute delay in beginning the rubidium-82 infusion post-Lexiscan (regadenoson) injection. It is anticipated that there will be no or minimal difference between the four delay times.

Detailed description:

Arms: arm 1: A 10 second delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. arm 2: A 2 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. arm 3: A 4 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. arm 4: A 1 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.
Interventions: intervention 1: Regadenoson intervention 2: Rubidium-82
Intervention descriptions: intervention 1: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. intervention 2: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.

Protocol documents:
Clinical trial NCT01920568
Conditions: Fractures, Bone
Keywords: GSK2371746 Denosumab China skeletal-related events bone metastases bridging study solid tumors
Sponsor: GlaxoSmithKline
Start date: 2013-08-01; Completion date: 2016-04-01
Enrollment: 487 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, double-dummy study designed to provide bridging data in an Asian population to Amgen's studies of denosumab in subjects with bone metastases from solid tumors. The study is designed to provide data to a large global dataset of phase-III studies including breast cancer, prostate cancer, and all solid tumors, plus multiple myeloma, to support the regulatory approval for marketing and patient access to denosumab for the prevention of SREs in Chinese subjects with bone metastases from solid tumors. The primary objective of this study is to evaluate and compare the percent change from baseline to Week 13 in the bone marker urinary amino-terminal cross-linking telopeptide of type I collagen (uNTx) corrected for urine creatinine (uNTx/uCr) in subjects treated with denosumab to those treated with zoledronic acid. The study is designed to test the superiority of denosumab over zoledronic acid.

Detailed description:

Arms: arm 1: Subjects will be administered with Denosumab 120 mg subcutaneous (SC) injection for a maximum of 13 doses and placebo IV infusion over \&gt;=15 minutes once every 4 weeks. arm 2: Subjects will be administered with Zoledronic acid 4 mg IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo SC once every 4 weeks.
Interventions: intervention 1: Denosumab 70 mg/mL intervention 2: Zoledronic acid 4 mg intervention 3: Placebo IV intervention 4: Placebo SC intervention 5: Calcium supplement intervention 6: Vitamin D supplement
Intervention descriptions: intervention 1: Denosumab will be given as a SC injection of 120 mg by administering a 1.7 mL volume in a single injection intervention 2: Zoledronic acid 4 mg (or equivalent clearance-adjusted dose in subjects with baseline creatinine clearance \<=60 ml/min) will be diluted in either 0.9% sodium chloride or 5% dextrose injection and administered IV. intervention 3: The placebo will consist of 1.7 mL 0.9% w/v sodium chloride intervention 4: The placebo will consist of either 0.9% w/v sodium chloride or 5% dextrose injection intervention 5: Subjects are strongly recommended to take daily supplements of at least 500 mg calcium from the day of consent and until completion of the Week 73 follow-up visit. intervention 6: Subjects are strongly recommended to take daily supplements of at least 400 IU of vitamin D from the day of consent and until completion of the Week 73 follow-up visit.

Protocol documents:
Clinical trial NCT01969799
Conditions: Pneumonia, Bacterial
Keywords: Gram-negative pneumonia Aerosol antibiotics Mechanical ventilation Amikacin Fosfomycin Pneumonia, Bacterial Pneumonia Bacterial Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions
Sponsor: Cardeas Pharma
Start date: 2013-12-01; Completion date: 2016-04-01
Enrollment: 143 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To demonstrate the safety and efficacy of adjunctive therapy with the Amikacin fosfomycin inhalation system (AFIS) versus aerosolized placebo to treat Gram-negative pneumonia in mechanically ventilated patients receiving IV antibiotics.

Detailed description:
The primary purpose of this study is to demonstrate the safety and efficacy of the amikacin fosfomycin inhalation system (AFIS). AFIS consists of amikacin solution and fosfomycin solution, delivered by aerosol to the lungs via the PARI Investigational eFlow Inline System (eFlow Inline System). All patients will receive a standardized course of intravenous (IV) antibiotics for a minimum of 7 days. Patients will be randomized to receive 10 days of treatment with either AFIS or placebo, in addition to the IV therapy. The primary efficacy endpoint is defined as the change from baseline in the Clinical Pulmonary Infection Score (CPIS) during the randomized course of study drug. The study was designed to enroll up to 150 patients with the desire to enroll at least 140 patients with gram negative pneumonia. The study was terminated at 143 when that goal was achieved

Arms: arm 1: 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System. arm 2: Aerosolized placebo twice daily for 10 days administered using the eFlow Inline System
Interventions: intervention 1: Amikacin fosfomycin inhalation solution intervention 2: Aerosolized placebo
Intervention descriptions: intervention 1: 300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System intervention 2: Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System

Protocol documents:
Clinical trial NCT02015481
Conditions: Oculopharyngeal Muscular Dystrophy
Keywords: Case control, safety, tolerability, efficacy.
Sponsor: Bioblast Pharma Ltd.
Start date: 2014-02-01; Completion date: 2016-04-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The Purpose of this study is to assess the Safety, Tolerability and Efficacy of Intravenous Cabaletta® in Oculopharyngeal Muscular Dystrophy (OPMD) Patients.

Detailed description:

Arms: arm 1: weekly IV of Cabaletta 30gr.
Interventions: intervention 1: Cabaletta
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02020577
Conditions: Neoplasms
Sponsor: Boehringer Ingelheim
Start date: 2013-12-01; Completion date: 2016-04-01
Enrollment: 58 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The trial is divided in two parts, Part A and Part B. Part A will involve dose-finding of dose-limiting toxicity (DLT) and MTD in patients with advanced solid tumours. Part B will involve expansion of the MTD to 3 cohorts including non-small cell lung cancer squamous histology, recurrent/ metastatic squamous cell carcinoma of head and neck and other advanced solid tumours (except sarcomas).

Detailed description:

Arms: arm 1: Patients to receive afatinib once daily plus weekly cetuximab infusion
Interventions: intervention 1: Cetuximab( erbitux®) intervention 2: Afatinib
Intervention descriptions: intervention 1: once per week intervention 2: once per day

Protocol documents: