ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01925183
Conditions: Hepatitis C, Chronic HIV
Keywords: Boceprevir HIV/HCV-coinfection HIV/HCV coinfection HIV/HCV Response-guided therapy
Sponsor: Markus Peck-Radosavljevic
Start date: 2013-08-01; Completion date: 2015-06-01
Enrollment: 6 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Response-guided triple-therapy with boceprevir (BOC) in combination with pegylated interferon (PEGIFN) and ribavirin (RBV) is the current standard of care for HIV-negative patients infected with hepatitis C genotype (HCV-GT) 1. In contrast, in HIV-positive patients, a fixed treatment duration of 48 weeks is used.

The aim of this study is to assess efficacy and safety of response-guided triple-therapy with BOC in combination with PEGIFN and RBV in HIV-positive patients. Thus, treatment duration will be individualized based on HCV-RNA negativity at treatment week 8 (W8). All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at W8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks, while patients with detectable HCV-RNA at W8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks.

Detailed description:

Arms: arm 1: All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at treatment week 8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks. arm 2: All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with detectable HCV-RNA at treatment week 8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks
Interventions: intervention 1: Pegylated interferon alpha-2a intervention 2: Ribavirin intervention 3: Boceprevir
Intervention descriptions: intervention 1: 180mcg once weekly; subcutaneous injection intervention 2: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients \<75kg; orally intervention 3: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally

Protocol documents:
Clinical trial NCT01937364
Conditions: Alcoholism Alcohol Withdrawal
Sponsor: Essentia Health
Start date: 2013-11-01; Completion date: 2015-06-01
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is determine if the medication baclofen can prevent the symptoms of Alcohol Withdrawal Syndrome (AWS) in hospitalized patients who may be at risk for AWS. This medication is most often used for patients who have spasticity of their muscles due to a neuromuscular disease. In several European studies, and in an earlier study at Essentia Health (NCT00597701), baclofen has been found to have a significant effect on the severity of symptoms of AWS.

Detailed description:

Arms: arm 1: Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours. arm 2: Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
Interventions: intervention 1: Baclofen intervention 2: Placebo
Intervention descriptions: intervention 1: Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours. intervention 2: Identical appearing placebo every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.

Protocol documents:
Clinical trial NCT01937598
Conditions: Type 2 Diabetes
Keywords: Incretin, DPP-4 inhibitor
Sponsor: Michael A. Nauck
Start date: 2013-08-01; Completion date: 2015-06-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Objectives: To quantify differences in control of glycemia (primary objective) and the secretion of endogenous incretin hormones (secondary objective) comparing sitagliptin or placebo added to pre-existing therapy with liraglutide and metformin

Detailed description:
This is a double blind, controlled, cross-over comparison of adding sitagliptin (or placebo) to pre-existing metformin+liraglutide therapy. Patients with type 2 diabetes mellitus (T2DM) on pre-existing treatment with metformin (≥ 1500 mg/d) monotherapy or metformin plus liraglutide (1.2 mg/d) will be studied. Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week). At the end of this 2 weeks therapy, a mixed meal challenge will take place, with the assessment of glucose and hormone responses (insulin, C-peptide, glucagon, GLP-1 \[glucagon-like peptide-1\], GIP (gastric inhibitory peptide) and gastric emptying as measured by 13C (carbon 13)-octanoate breath tests. Prior to the meal tests, liraglutide will be administered at a dose of 1.2 mg per injection, which is the recommended dose for treatment. Sitagliptin will be used at a dose of 100 mg, which is recommended for clinical use.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Placebo intervention 2: Mixed meal test intervention 3: Liraglutide intervention 4: Sitagliptin
Intervention descriptions: intervention 1: Patients administered a single dose of placebo during a mixed meal challenge. intervention 2: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored intervention 3: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study. intervention 4: Patients administered a single dose of Sitagliptin during a mixed meal challenge.

Protocol documents:
Clinical trial NCT01950247
Conditions: Iron Deficiency Anemia (IDA)
Sponsor: American Regent, Inc.
Start date: 2013-08-15; Completion date: 2015-06-01
Enrollment: 1025 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main objective of this study is to compare the safety, effect on quality of life, and resource utilization of Injectafer vs. intravenous (IV) iron standard of care (SOC) for the treatment of iron deficiency anemia (IDA) in an infusion center setting. The study will also assess the ability of baseline serum hepcidin levels to predict if subjects will have a clinically meaningful hemoglobin response to oral iron therapy or to IV iron therapy.

Detailed description:
The main objective of this study is to compare the safety, effect on quality of life, and resource utilization of Injectafer vs. intravenous (IV) iron standard of care (SOC) for the treatment of iron deficiency anemia (IDA) in an infusion center setting. The study will also assess the ability of baseline serum hepcidin levels to predict if subjects will have a clinically meaningful hemoglobin response to oral iron therapy for 28 days or to IV iron therapy.

Arms: arm 1: 2 doses at 15 mg/kg for a maximum single dose of 750 mg given 7 days apart for a total of up to 1500 mg. arm 2: At a dose and administration regimen as determined by the study site investigator
Interventions: intervention 1: Injectafer intervention 2: SOC
Intervention descriptions: intervention 1: 2 doses at 15 mg/kg for a maximum single dose of 750 mg given 7 days apart for a total of up to 1500 mg. intervention 2: None

Protocol documents:
Clinical trial NCT01950364
Conditions: Hodgkin Lymphoma Anaplastic Large-cell Lymphoma
Keywords: Lymphoma Hodgkin Anaplastic Large-cell Relapsed Refractory Antigens, CD30 Antibody-Drug Conjugate Antibodies, Monoclonal Lymphoma, Non-Hodgkin Lymphoma, Large-Cell, Anaplastic Monomethyl auristatin E Drug Therapy Immunotherapy Hematologic Diseases
Sponsor: Millennium Pharmaceuticals, Inc.
Start date: 2013-11-01; Completion date: 2015-06-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an open-label trial to estimate the concentrations of brentuximab vedotin in relapsed/refractory Hodgkin lymphoma (HL) or relapsed/refractory systemic anaplastic large cell lymphoma (sALCL) participants treated with either brentuximab vedotin or brentuximab vedotin + rifampicin.

Detailed description:

Arms: arm 1: Brentuximab vedotin will be administered every 3 weeks at a dose of 1.8 mg/kg. arm 2: Brentuximab vedotin will be administered every 3 weeks at a dose of 1.8 mg/kg beginning on Cycle 1, Day 1; daily rifampicin (600 mg PO) will be administered during Cycles 0 through 3 only, beginning on Cycle 0, Day 1 (7 days before the Cycle 1, Day 1 dose of brentuximab vedotin) and continuing through Cycle 3, Day 21.
Interventions: intervention 1: brentuximab vedotin intervention 2: Brentuximab vedotin and rifampicin
Intervention descriptions: intervention 1: Brentuximab vedotin will be administered every 3 weeks at a dose of 1.8 mg/kg. intervention 2: Brentuximab vedotin will be administered every 3 weeks at a dose of 1.8 mg/kg beginning on Cycle 1, Day 1; daily rifampicin (600 mg PO) will be administered during Cycles 0 through 3 only, beginning on Cycle 0, Day 1 (7 days before the Cycle 1, Day 1 dose of brentuximab vedotin) and continuing through Cycle 3, Day 21.

Protocol documents:
Clinical trial NCT01951963
Conditions: Pain
Keywords: pain management ketamine morphine pediatrics emergency medicine
Sponsor: HealthPartners Institute
Start date: 2012-12-01; Completion date: 2015-06-01
Enrollment: 77 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The proposed trial is a prospective, double blinded, randomized control trial with the primary aim of determining whether a single, sub-dissociative dose of ketamine will decrease the total narcotic requirements of pediatric patients requiring intravenous analgesia in an urban emergency department (ED) compared to a group of patients who receive morphine alone for pain management. Patients are randomized to receive either a single bolus of ketamine (0.3 mg/kg) or a single bolus of morphine (0.05mg/kg). All subsequent pain management will be accomplished using morphine. Patient, family member, and research staff pain scores will be recorded, until 3 hours post study medication administration. Family members are contacted via telephone 24 hours post-ED discharge, and again at 7 days post-hospital discharge, for evaluation via Post Hospitalization Behavior Questionnaire. Narcotic equivalents will be calculated for up to 3 hours post study medication administration and compared between the ketamine and morphine groups.

Detailed description:

Arms: arm 1: Ketamine, single dose, 0.3 mg/kg, IV arm 2: Morphine, single dose, 0.05 mg/kg, IV
Interventions: intervention 1: Ketamine intervention 2: Morphine
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01968460
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease, Rasagiline, Pramipexole
Sponsor: Pharma Two B Ltd.
Start date: 2013-12-01; Completion date: 2015-06-01
Enrollment: 149 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate an oral fixed-dose, once daily product that combines pramipexole and rasagiline for the treatment of early Parkinson's disease.

Animal studies support the therapeutic advantage of combining low doses of rasagiline and pramipexole and suggest further improvement when both are administered in a sustained fashion. Both rasagiline and pramipexole are well known marketed drugs for Parkinson's disease with a good safety profile. combining the drugs in low doses and controlled release may provide better symptom management than the existing drugs alone or together.

Detailed description:

Arms: arm 1: Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily. arm 2: Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily arm 3: Placebo once daily for 12 weeks.
Interventions: intervention 1: P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg), intervention 2: Placebo intervention 3: P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg),
Intervention descriptions: intervention 1: Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily intervention 2: placebo intervention 3: Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily

Protocol documents:
Clinical trial NCT01982240
Conditions: Chronic Idiopathic Constipation
Keywords: CIC Constipation Chronic Constipation Synergy Plecanatide
Sponsor: Bausch Health Americas, Inc.
Start date: 2013-11-01; Completion date: 2015-06-01
Enrollment: 1394 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to confirm that the investigational medication, plecanatide, is safe and effective in treating chronic idiopathic constipation.

Detailed description:
This is a randomized, 12-week, double-blind, placebo-controlled, study in approximately 1350 adult male and female patients with CIC comparing 2 doses of plecanatide to placebo. The study will be conducted at approximately 180 clinical study sites in the United States (US) and Canada. The primary objective of the study is to evaluate the efficacy and safety of 3.0 and 6.0 mg of plecanatide administered once daily (QD) for 12 weeks in a population of patients with CIC. The study population will include only patients without other causes of constipation or other chronic conditions that could interfere with study assessments. Patients may not take laxatives (with the exception of the study-provided rescue medication, bisacodyl 5mg tablets), or a number of prohibited drugs that are known to cause constipation or diarrhea, during study participation.

There are 6 scheduled study visits, including the screening and follow-up visits. The planned duration of participation in this study will be 112 days and up to 155 days, with washout and all visit windows considered.

Arms: arm 1: Plecanatide tablets 3.0 mg QD for 12 weeks arm 2: Plecanatide tablets 6.0 mg QD for 12 weeks arm 3: Matching placebo tablets QD for 12 weeks arm 4: Rescue medication
Interventions: intervention 1: Plecanatide intervention 2: Placebo intervention 3: Bisacodyl
Intervention descriptions: intervention 1: Plecanatide tablets QD for 12 weeks intervention 2: Matching placebo tablets QD for 12 weeks intervention 3: Rescue medication

Protocol documents:
Clinical trial NCT01982812
Conditions: Seizure Epilepsy Cerebral Malaria
Sponsor: University of Rochester
Start date: 2014-01-01; Completion date: 2015-06-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Pediatric cerebral malaria (CM) affects more than 3 million children each year killing \~20% and leaving one third of survivors with long term neurologic and psychiatric sequelae. Seizures occur commonly with CM and are associated with an increased risk of death and neuropsychiatric disabilities. In this Malawi-based, safety and feasibility study of enteral levetiracetam in pediatric CM, the investigators will lay the groundwork for future efficacy studies aimed at improving seizure control and ultimately decreasing the neurologic morbidity of pediatric CM.

Detailed description:
Cerebral malaria (CM) affects \~3 million children each year, primarily in sub-Saharan Africa. Antimalarial medications can rapidly clear P. falciparum parasites, but mortality rates remain high (12-25%). Survivors do not escape unscathed--\~30% experience neurologic sequelae including epilepsy, behavioral disorders and gross neurologic deficits. Acute seizures occur commonly in CM and are associated with higher neurologic morbidity and mortality. Seizure management in malaria endemic regions is challenging because the available antiepileptic drugs (AED) induce respiratory suppression and assisted ventilation is unavailable. More optimal seizure control may improve neurologic outcomes in pediatric CM survivors, especially if the medication used is affordable and can be delivered safely and easily in resource limited settings. The investigators conducted a dose- escalation study detailed elsewhere (NCT01660672) to determine the optimal dose for use in this safety and feasibility study of enteral levetiracetam (LVT) for seizure control in children with CM and seizures admitted to Queen Elizabeth Central Hospital in Blantyre, Malawi. Enteral LVT given via nasogastric tube (NGT) rather than an intravenous (IV) formulation will be used since LVT has excellent enteral bioavailability and IV formations are not affordable in most malaria-endemic regions. LVT 40mg/kg followed by 30mg per kg Q12 hourly. Children admitted with cerebral malaria and seizures will be randomized to LVT vs. standard of care with phenobarbital as needed comparing seizure control, safety, and neurological outcomes.

Arms: arm 1: Oral Levetiracetam administered by NG tube. arm 2: Standard AED regimen
Interventions: intervention 1: Oral Levetiracetam intervention 2: Standard AED
Intervention descriptions: intervention 1: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days intervention 2: Active comparitor, Standard AED

Protocol documents:
Clinical trial NCT01993849
Conditions: Onychophagia
Keywords: Anxiety Impulse control Depression ADHD Fingernail Biting N-Acetylcysteine NAC
Sponsor: Kevin Gray, MD
Start date: 2013-10-01; Completion date: 2015-06-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To conduct a pilot randomized placebo-controlled feasibility trial of N-acetylcysteine (NAC) in onychophagia, preliminarily assessing the tolerability and effects of this pharmacotherapy on young adults who bite their fingernails. It is proposed that NAC will help decrease fingernail biting.

Detailed description:
This is a proof-of-concept pilot placebo-controlled trial of N-acetylcysteine (NAC) in young people who bite fingernails. The primary interest is in assessing the feasibility of conducting this line of research, while preliminarily exploring potential effects on nail biting, as measured by nail length.

Arms: arm 1: Oral N-acetylcysteine 1200 mg twice daily dosing for 8 weeks arm 2: Oral placebo (matched in appearance to active treatment) twice daily dosing for 8 weeks
Interventions: intervention 1: N-Acetylcysteine (NAC) intervention 2: Placebo
Intervention descriptions: intervention 1: This is the medication N-acetylcysteine (NAC) intervention 2: Placebo, designed to match in appearance to NAC

Protocol documents:
Clinical trial NCT02005029
Conditions: Parkinson's Disease Levodopa
Keywords: Parkinson's Disease Levodopa motor fluctuations gastroparesis
Sponsor: Virginia Commonwealth University
Start date: 2013-04-01; Completion date: 2015-06-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Gastroparesis (slow stomach emptying) is a common feature of Parkinson's Disease. Levodopa (Sinemet), a common medication for Parkinson's Disease, can make gastroparesis worse. Gastroparesis effects how the levodopa is absorbed and used by the body. This study will explore the possibility of using Erythromycin, a drug commonly used (off label) for gastroparesis, along with levodopa to determine if there is improved levodopa absorption and motor function.

Detailed description:
Participants will be required to make four visits for evaluation. Visit 1 is a screening visit, participants will receive the study drug or a placebo during visits 2 and 3, and visit 4 is a follow up visit. Participants will provide blood and urine samples during the visits. Participants will also be required to complete questionnaires and a series of motor tests.

Arms: arm 1: One time IV dose of placebo arm 2: One time IV dose of 100 mg Erythromycin
Interventions: intervention 1: Erythromycin intervention 2: placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02009878
Conditions: Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)
Keywords: SIADH
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2013-11-01; Completion date: 2015-06-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study to evaluate how the body handles and metabolizes (PK) the various doses of the drug Tolvaptan, and what the effect (PD) of the various doses of Tolvaptan are on the content of "salt" in blood and urine

Detailed description:

Arms: arm 1: tolvaptan 3.75 mg arm 2: tolvaptan 7.5 mg arm 3: tolvaptan 15 mg
Interventions: intervention 1: tolvaptan
Intervention descriptions: intervention 1: Subjects will receive a single dose of 3.75, 7.5 or 15 mg of tolvaptan on study Day 1

Protocol documents:
Clinical trial NCT02011516
Conditions: Marijuana Dependence
Keywords: Marijuana Addiction fMRI Baclofen Treatment
Sponsor: University of Pennsylvania
Start date: 2013-12-01; Completion date: 2015-06-01
Enrollment: 47 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Studies show that certain reminders of drug use such as the sight of someone using marijuana, pictures of blunts, particular moments throughout the day, prompt marijuana users to smoke marijuana. We are measuring the brain and behavioral responses of marijuana dependent individuals to these reminders (cues) We will examine brain responses during cue exposure and determine whether these responses are associated with treatment outcome.

We are testing the hypothesis that the medication baclofen reduces brain responses during marijuana cue exposure and/or craving in marijuana dependent individuals. Baclofen is FDA-approved for other uses, but not for the treatment of marijuana dependence. Functional magnetic resonance imaging (fMRI) will be used to measure the brain's response to marijuana cues. fMRI is a painless technique that takes special pictures of the brain (or other parts of your body). It does not involve radiation or injections.

Eligible participants will have a 50% chance of receiving placebo (sugar pill) and a 50% chance of receiving baclofen. Neither the participant nor study personnel will know whether participants are receiving baclofen or placebo. Participants will also receive twice weekly psychosocial treatment with a certified clinician. Twelve weeks of treatment will be followed by a 12 week follow up.

Detailed description:

Arms: arm 1: twice weekly appointments with a certified clinician arm 2: 20 mg. q.i.d. twice weekly appointments with a certified clinician
Interventions: intervention 1: Baclofen intervention 2: Psychosocial intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02015520
Conditions: Rheumatoid Arthritis
Sponsor: CSL Behring
Start date: 2012-06-01; Completion date: 2015-06-01
Enrollment: 143 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to identify an appropriate dose of study medication.

Detailed description:

Arms: arm 1: Clazakizumab Dose # A injection by subcutaneous for 12 weeks + background Methotrexate arm 2: Clazakizumab Dose # B injection by subcutaneous for 12 weeks + background Methotrexate arm 3: Clazakizumab Dose # C injection by subcutaneous for 12 weeks + background Methotrexate arm 4: Clazakizumab Dose # D injection by subcutaneous for 12 weeks + background Methotrexate
Interventions: intervention 1: Clazakizumab intervention 2: Placebo (Matching with Clazakizumab)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: