ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02122471
Conditions: Chronic Idiopathic Constipation
Keywords: CIC Constipation Chronic Constipation Synergy Plecanatide
Sponsor: Bausch Health Americas, Inc.
Start date: 2014-04-01; Completion date: 2015-07-01
Enrollment: 1410 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 national, 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. 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: Matching placebo tablets QD for 12 weeks arm 3: Plecanatide tablets 6.0 mg QD for 12 weeks
Interventions: intervention 1: Plecanatide intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02132637
Conditions: Type 2 Diabetes Mellitus
Sponsor: Eli Lilly and Company
Start date: 2014-05-01; Completion date: 2015-07-01
Enrollment: 68 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary purpose of this study is to compare the effect of a double dose of a study drug known as insulin peglispro to a double dose of insulin glargine in participants who have type 2 diabetes. Participants will be treated with study insulin daily, in two 4-week study periods. Each participant will receive insulin peglispro during one treatment period and insulin glargine during the other treatment period.

Detailed description:

Arms: arm 1: Standard dose of insulin peglispro administered subcutaneously (SQ) once daily for 4 weeks in one of two study periods. Double dose of insulin peglispro administered once, SQ on day 3 of the inpatient stay. arm 2: Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in one of two study periods. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay.
Interventions: intervention 1: Insulin Peglispro intervention 2: Insulin Glargine
Intervention descriptions: intervention 1: Administered SQ intervention 2: Administered SQ

Protocol documents:
Clinical trial NCT02143648
Conditions: Uremic Pruritus Pruritus
Keywords: uremic pruritus itch chronic itch nalbuphine
Sponsor: Trevi Therapeutics
Start date: 2014-06-01; Completion date: 2015-07-01
Enrollment: 373 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objectives of the study 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 hemodialysis patients with moderate to severe uremic pruritus and to evaluate the safety and tolerability in the study population.

Detailed description:

Arms: arm 1: nalbuphine HCl ER tablets 60 mg BID arm 2: nalbuphine HCl ER tablets 120 mg BID arm 3: Placebo tablets BID
Interventions: intervention 1: nalbuphine HCl ER tablets 60 mg BID intervention 2: nalbuphine HCl ER tablets 120mg BID intervention 3: Placebo tablets BID
Intervention descriptions: intervention 1: nalbuphine HCl ER tablets 60 mg BID administered for 6 weeks intervention 2: nalbuphine HCl ER tablets 120mg BID administered for 6 weeks intervention 3: Placebo tablets BID administered for 8 weeks

Protocol documents:
Clinical trial NCT02147587
Conditions: Rheumatoid Arthritis
Sponsor: Pfizer
Start date: 2014-06-01; Completion date: 2015-07-01
Enrollment: 112 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate immune response following administration of zoster vaccine in subjects with rheumatoid arthritis who are receiving background methotrexate and initiate 5 mg twice daily of tofacitinib or placebo for tofacitinib 2 to 3 weeks following vaccination.

Detailed description:

Arms: arm 1: Zoster vaccine will be administered to subjects on background methotrexate; treatment with 5 mg tofacitinib twice daily will begin 2 to 3 weeks following vaccination and continue for 12 weeks. arm 2: Zoster vaccine will be administered to subjects on background methotrexate; treatment with placebo twice daily will begin 2 to 3 weeks following vaccination and continue for 12 weeks.
Interventions: intervention 1: Tofacitinib intervention 2: Placebo
Intervention descriptions: intervention 1: 5 mg twice daily of tofacitinib with background methotrexate for 12 weeks intervention 2: Placebo tablets twice daily with background methotrexate for 12 weeks

Protocol documents:
Clinical trial NCT02155010
Conditions: Blood Pressure Anxiety
Keywords: Dexmedetomidine Spinal anesthesia
Sponsor: Inje University
Start date: 2014-03-01; Completion date: 2015-07-01
Enrollment: 74 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Patients were randomized into two groups, A group and B group. A group and B group patients are injected intravenous dexmedetomidine after intrathecal injection (IT) of heavy bupivacaine and injected intravenous dexmedetomidine before IT of heavy bupivacaine, respectively.

The investigators will compare of hemodynamics and patient's comfortability between two groups.

Detailed description:
A and B group patients will intravenous inject dexmedetomidine 1mcg/kg for 10 minute loading infusion and 0.2mcg/kg/hr for continuous infusion. A group receive intravenous dexmedetomidine after procedure, and B group receive intravenous dexmedetomidine before procedure. Both group patients will hydrate 6 ml/kg crystalloid solution and will evaluated patient's anxiety and comfortability perioperative period. Vital signs will record 5 minutes interval at operating room and post-anesthetic care units.

Arms: arm 1: IV dexmedetomidine infusion before intrathecal injection of heavy bupivacaine arm 2: IV dexmedetomidine infusion after intrathecal injection of heavy bupivacaine
Interventions: intervention 1: Dexmedetomidine intervention 2: Dexmedetomidine with heavy bupivacaine
Intervention descriptions: intervention 1: Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine intervention 2: Dexmedetomidine infusion after IT of heavy bupivacaine

Protocol documents:
Clinical trial NCT02157948
Conditions: Postmenopausal Osteoporosis
Keywords: postmenopausal osteoporosis osteoporosis postmenopausal denosumab women
Sponsor: Amgen
Start date: 2014-05-01; Completion date: 2015-07-01
Enrollment: 394 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the effect of denosumab produced by two different manufacturing processes on bone mineral density at the lumbar spine in postmenopausal women with osteoporosis.

Detailed description:

Arms: arm 1: Participants received 60 mg denosumab manufactured using the current CP2 process subcutaneously once every 6 months for 1 year. arm 2: Participants received 60 mg denosumab manufactured using the new CP4 process subcutaneously once every 6 months for 1 year.
Interventions: intervention 1: Denosumab (CP2) intervention 2: Denosumab (CP4)
Intervention descriptions: intervention 1: Denosumab produced by a process referred to as CP2, administered subcutaneously from a prefilled syringe. intervention 2: Denosumab produced by a process referred to as CP4, administered subcutaneously from a prefilled syringe.

Protocol documents:
Clinical trial NCT02159950
Conditions: Hormone-Resistant Prostate Cancer Metastatic Prostate Carcinoma Recurrent Prostate Carcinoma Stage IV Prostate Cancer
Sponsor: Roswell Park Cancer Institute
Start date: 2015-01-01; Completion date: 2015-07-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase II trial studies how well sipuleucel-T with or without tasquinimod works in treating patients with hormone-resistant prostate cancer that has spread to other parts of the body. Vaccines made from a person's tumor cells and white blood cells may help the body build an effective immune response to kill tumor cells. Tasquinimod may stop the growth of prostate cancer by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether sipuleucel-T is more effective with or without tasquinimod in treating prostate cancer.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine whether tasquinimod augments immune response to sipuleucel-T.

SECONDARY OBJECTIVES:

I. To assess the safety and tolerability of the combination of sipuleucel-T and tasquinimod in patients with castration-resistant metastatic prostate cancer.

II. To obtain preliminary evidence of the clinical benefit of the combination of sipuleucel-T and tasquinimod; to include changes in prostate specific antigen (PSA) over time, and duration of progression-free survival/overall survival.

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

ARM I: Patients receive sipuleucel-T intravenously (IV) over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive tasquinimod orally (PO) once daily (QD) beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.

After completion of study treatment, patients are followed up every 3 months for up to 3 years.

Arms: arm 1: Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. arm 2: Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.
Interventions: intervention 1: Laboratory Biomarker Analysis intervention 2: Sipuleucel-T intervention 3: Tasquinimod
Intervention descriptions: intervention 1: Correlative studies intervention 2: Given IV intervention 3: Given PO

Protocol documents:
Clinical trial NCT02163837
Conditions: Hepatic Encephalopathy
Keywords: sleep quality physical activity daytime sleepiness actigraphy quality of life
Sponsor: Centre Hospitalier Universitaire Saint Pierre
Start date: 2014-03-01; Completion date: 2015-07-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Hepatic encephalopathy is responsible for sleep disturbances and daytime sleepiness. The purpose of our study is to assess sleep quality, quantity, sleep schemes and physical activity in patients suffering from HE, before and after a 2 weeks treatment with rifaximine, which is currently given to lower blood ammoniac levels.

Detailed description:
Hepatic encephalopathy (HE) is a complex neuropsychiatric syndrome related to chronic/acute hepatic failure. Sleep architecture is disturbed in this syndrome, and patients complain mainly of excessive daytime sleepiness and sleep disturbances. Hypothesis to explain these symptoms is, among others, disturbed melatonin metabolism. Few studies have been conducted in order to study sleep disorders during HE, and effect of treatment is unknown. Recently, rifaximine, an oral broad spectrum antibiotic, have been proved to decrease ammoniac production in patients with HE. The purpose of our study is to assess sleep quality, quantity, sleep schemes and physical activity in patients suffering from HE, before and after a 2 weeks treatment with rifaximine.

Arms: arm 1: None
Interventions: intervention 1: rifaximine
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02189122
Conditions: Healthy
Sponsor: Vanderbilt University
Start date: 2014-07-01; Completion date: 2015-07-01
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators will compare the effects of rapid release aspirin and NHP-544C on the prostacyclin response to intravenous bradykinin.

Detailed description:

Arms: arm 1: Group 1 will be randomized to the order in which they receive rapid-release aspirin (ASA), 81 mg), ASA 162.5 mg, and identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period. arm 2: Group 2 will be randomized to the order in which they receive NHP-544C 81 mg, NPH-544C 162.5 mg and identical-appearing placebo for five days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.
Interventions: intervention 1: Bradykinin intervention 2: Aspirin 81 mg intervention 3: Aspirin 162 mg intervention 4: NHP544-C 81 mg intervention 5: NHP544C 162 mg intervention 6: Placebo
Intervention descriptions: intervention 1: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes. intervention 2: Subjects will take Aspirin 81 mg per day for five days. intervention 3: Subjects will take aspirin 162 mg per day for 5 days. intervention 4: Subjects will take NHP544C 81 mg per day for five days. intervention 5: Subjects will take NHP544C 162 mg once a day for five days. intervention 6: Subjects will take matching placebo for five days.

Protocol documents:
Clinical trial NCT02189252
Conditions: Severe Hypertriglyceridemia
Sponsor: AstraZeneca
Start date: 2014-10-01; Completion date: 2015-07-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a randomized, open-label crossover study. The primary objective of this study is to compare the relative bioavailability of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), docosapentaenoic acid (DPA), and the ethyl esters of EPA and DHA in plasma from a single 2 g or 4 g dose of Epanova® or 4 g Lovaza®.

Detailed description:

Arms: arm 1: Crossover Sequence arm 2: Crossover Sequence arm 3: Crossover Sequence arm 4: Crossover Sequence
Interventions: intervention 1: Epanova intervention 2: Lovaza
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02189668
Conditions: Appendicitis
Keywords: Appendicitis Non-operative Children Appendicolith fecalith Pediatrics
Sponsor: Peter Minneci
Start date: 2014-07-01; Completion date: 2015-07-01
Enrollment: 14 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine if non-operative management with antibiotics alone is a feasible treatment alternative for pediatric patients with uncomplicated acute appendicitis with an appendicolith identified on imaging.

Detailed description:
This study is a prospective randomized clinical trial comparing non-operative management with antibiotics to urgent appendectomy in children (ages 7-17yrs) with acute appendicitis with the presence of an appendicolith. Enrolled participants were followed up to 1 year post-discharge to observe the rates of appendicitis recurrence as well as identify the number of patients with complicated appendicitis as determined by pathologic examination.

Arms: arm 1: Non-operative management with antibiotics only Zosyn (Piperacillin/Tazobactam) and then Augmentin unless penicillin allergic Cipro/Flagyl if penicillin allergic arm 2: Usual care with urgent appendectomy
Interventions: intervention 1: Antibiotics only (Zosyn then Augmentin)
Intervention descriptions: intervention 1: Intravenous and oral antibiotics without surgery Piperacillin/Tazobactam and then Augmentin Cipro/Flagyl if Penicillin allergic

Protocol documents:
Clinical trial NCT02197455
Conditions: Alopecia Areata (AA) Alopecia Totalis (AT) Alopecia Universalis (AU)
Sponsor: Yale University
Start date: 2014-07-01; Completion date: 2015-07-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to investigate the ability of tofacitinib citrate, a Janus kinase inhibitor, to generate hair regrowth in patients with moderate to severe alopecia areata and its variants.

Detailed description:
This study is an open-label pilot study. Participants will be treated with oral tofacitinib for a maximum of 5 months. Participants will be evaluated at 3 months after completion of therapy to evaluate for durability of response, late response and/or late adverse effects.

Arms: arm 1: 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.
Interventions: intervention 1: Tofacitinib Administration
Intervention descriptions: intervention 1: 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.

Protocol documents:
Clinical trial NCT02201056
Conditions: Healthy Volunteers
Keywords: Drug Therapy
Sponsor: Takeda
Start date: 2014-07-01; Completion date: 2015-07-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to characterize the safety and tolerability profile of TAK-935 in healthy participants when administered as a single dose of oral solution at escalating dose levels.

Detailed description:
The drug being tested in this study is TAK-935. TAK-935 is being tested to find a safe and well-tolerated dose and to assess how TAK-935 is processed by the body. This study will look at side effects and lab results in people who take TAK-935 and is designed as a randomized dose-rising study.

The study will consist of 6 Cohorts with 8 participants in each Cohort. In each Cohort, 6 participants will receive a single dose of TAK-935 and 2 participants will receive placebo after a 10-hour fast. The starting dose will be 15 mg followed by planned doses of 50, 200, 600, 900 and not to exceed 1350 mg in subsequent cohorts.

This single-center trial will be conducted in the United States. The overall time to participate in this study is up to 51 days. Participants will make 2 visits to the clinic, including one 7-day period of confinement to the clinic. All participants will be contacted by telephone 14 days after the dose of study drug for a follow-up assessment.

Arms: arm 1: TAK-935 15 mg solution, orally, once, on Day 1. arm 2: TAK-935 50 mg solution, orally, once, on Day 1. arm 3: TAK-935 200 mg solution, orally, once, on Day 1. arm 4: TAK-935 600 mg solution, orally, once, on Day 1. arm 5: TAK-935 900 mg solution, orally, once, on Day 1. arm 6: TAK-935 1350 mg solution, orally, once, on Day 1. arm 7: TAK-935 placebo-matching solution, orally, once, on Day 1.
Interventions: intervention 1: TAK-935 intervention 2: Placebo
Intervention descriptions: intervention 1: TAK-935 oral solution intervention 2: TAK-935 placebo-matching oral solution

Protocol documents:
Clinical trial NCT02220920
Conditions: Type 2 Diabetes Mellitus
Keywords: insulin resistance
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2014-08-01; Completion date: 2015-07-01
Enrollment: 146 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of Canagliflozin (TA-7284) in combination with Insulin in patients with type 2 Diabetes for 16 weeks administration.

Detailed description:
This is a randomized, 2-arm, parallel group, double blind study to evaluate the efficacy and safety of Canagliflozin (TA-7284) in Japanese patients with type 2 diabetes mellitus, who are receiving treatment with insulin therapy on diet and exercise and have inadequate glycemic control. The patients will receive either TA-7284 100mg or Placebo orally for 16 weeks.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Canagliflozin (TA-7284) intervention 2: Placebo intervention 3: Insulin
Intervention descriptions: intervention 1: The patients will receive Canagliflozin orally for 16 weeks intervention 2: The patients will receive Placebo orally for 16 weeks intervention 3: None

Protocol documents:
Clinical trial NCT02226198
Conditions: Homozygous Familial Hypercholesterolemia (HoFH)
Keywords: LDL-C HoFH Hyperlipidemia
Sponsor: AstraZeneca
Start date: 2014-11-01; Completion date: 2015-07-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of the study is to establish the efficacy, safety and tolerability of rosuvastatin in children and adolescents with homozygous familial hypercholesterolemia.

Detailed description:
This is a randomized, double-blind, placebo-controlled, multi-center, cross-over study of the efficacy, safety and tolerability rosuvastatin in children and adolescents (aged 6 to \<18 years) with homozygous familial hypercholesterolemia (HoFH). The study is designed to assess the efficacy of rosuvastatin 20 mg compared to placebo on lipids, lipoproteins and apolipoproteins in pediatric patients with HoFH. The outcome measures to be assessed include low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), total cholesterol (TC), triglycerides, non-HDL-C, LDL-C/HDL-C, TC/HDL-C, non-HDL-C/HDL-C, apolipoprotein B (ApoB), apolipoprotein A 1 (ApoA-1) and ApoB/ApoA-1 following 6 weeks of treatment with rosuvastatin 20 mg or placebo. Pharmacokinetic data of the trough plasma exposure of rosuvastatin will also be assessed in these pediatric patients with HoFH.

Arms: arm 1: 6-week treatment period, and after crossover finished a 12-week efficacy maintenance phase for all patients arm 2: 6 weeks treatment during crossover
Interventions: intervention 1: Rosuvastatin 20mg intervention 2: Placebo
Intervention descriptions: intervention 1: Active drug will be taken taken orally, QD, either in the morning or in the evening intervention 2: Will be taken taken orally, QD, either in the morning or in the evening

Protocol documents:
Clinical trial NCT02245672
Conditions: Asthma
Keywords: Asthma fluticasone salmeterol CRC749 Diskus Advair FEV1 MGR001
Sponsor: Mylan Pharma UK Ltd.
Start date: 2014-10-01; Completion date: 2015-07-01
Enrollment: 1128 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether MGR001 is equivalent to Advair Diskus when administered by inhalation in adult asthma patients

Detailed description:

Arms: arm 1: MGR001 administered two times per day by inhalation throughout the study arm 2: Advair Diskus administered two times per day by inhalation throughout the study arm 3: Placebo for Advair Diskus and MGR001 administered two times per day by inhalation throughout the study
Interventions: intervention 1: MGR001 (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate) intervention 2: Advair (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate) intervention 3: Placebo
Intervention descriptions: intervention 1: Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the CRC749 inhaler device intervention 2: Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the Diskus inhaler device intervention 3: Placebo administered via the CRC749 and Diskus devices

Protocol documents: