ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02465866
Conditions: Healthy
Keywords: Plasma concentration Time to plasma concentration Elimination rate constant Elimination half life Area under the curve
Sponsor: Charleston Laboratories, Inc
Start date: 2014-11-01; Completion date: 2015-04-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will compare the relative bioavailability of hydrocodone, acetaminophen, and promethazine in CL-108 (hydrocodone 7.5mg/ acetaminophen 325 mg/ promethazine 12.5 mg) manufactured by Charleston Laboratories, Inc. to hydrocodone in Vicoprofen (hydrocodone 7.5 mg /ibuprofen 200 mg), promethazine 12.5 mg, and acetaminophen in Ultracet (tramadol HCl 37.5 mg/acetaminophen 325 mg) under fasted and fed conditions.

Detailed description:

Arms: arm 1: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition arm 2: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition arm 3: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition arm 4: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
Interventions: intervention 1: CL-108 intervention 2: Vicoprofen intervention 3: Ultracet intervention 4: Phenergan
Intervention descriptions: intervention 1: Hydrocodone bitartrate/acetaminophen/promethazine 7.5 mg/325 mg/12.5 mg single dose by mouth intervention 2: Hydrocodone Bitartrate and Ibuprofen 7.5 mg/200 mg single dose tablet by mouth intervention 3: Tramadol HCl/acetaminophen 37.5 mg/325 mg single dose tablet by mouth intervention 4: Phenergan (Promethazine HCl, USP) 12.5 mg single dose tablet by mouth

Protocol documents:
Clinical trial NCT02470390
Conditions: Healthy
Keywords: Volunteer Pharmacokenetics (PK) (plasma and Cerebrospinal Fluid [CSF])
Sponsor: Depomed
Start date: 2014-11-01; Completion date: 2015-04-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
A partially randomized, open-label, 3-way crossover, single-center, systemic and CSF PK and bioavailability study in healthy volunteers.

Detailed description:
An Open-Label Single-Dose Crossover Study Comparing the Plasma and Cerebrospinal Fluid Pharmacokinetics and Bioavailability of Fentanyl Delivered Intranasally Versus Sublingually Versus Intravenously in Healthy Volunteers

Arms: arm 1: nasal fentanyl, 200 μg, administered as one 100 μg spray (100 μL) to each nostril; both completed within one minute.

Will be administered on either study day 1 or 3 per protocol and randomization. arm 2: sublingual fentanyl, 200 μg, administered as a single spray (100 μL) under the tongue.

Will be administered on either study day 1 or 3 per protocol and randomization. arm 3: IV fentanyl, 100 μg in 2 mL administered as an intravenous injection over 1-3 minutes.

Will be administered on study day 5 per protocol.
Interventions: intervention 1: Fentanyl
Intervention descriptions: intervention 1: Lazanda (nasal spray), Subsys (sub-lingual) and intravenous fentanyl

Protocol documents:
Clinical trial NCT02806973
Conditions: Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2
Sponsor: Eli Lilly and Company
Start date: 2015-01-01; Completion date: 2015-04-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will investigate how the body processes nasal glucagon (NG) and the effect of nasal glucagon on the body. The study is expected to last about 50 days for each participant. The study is open to adults with type 1 or type 2 diabetes and will last about 50 days.

Detailed description:

Arms: arm 1: One dose of 3 milligram (mg) NG administered in one of four study periods. arm 2: Two NG doses, 3 mg each dose, administered 15 minutes apart, in the same nostril, in one of four study periods. arm 3: Two NG doses, 3 mg each dose, administered 15 minutes apart, in opposite nostrils, in one of four study periods. arm 4: Two NG doses, 3 mg each dose, administered one immediately after the other, in opposite nostrils, in one of four study periods.
Interventions: intervention 1: Nasal Glucagon
Intervention descriptions: intervention 1: Administered intranasally.

Protocol documents:
Clinical trial NCT01127451
Conditions: Stage IIIC Melanoma Stage IV Melanoma
Keywords: Neoplasms
Sponsor: Eisai Inc.
Start date: 2010-06-22; Completion date: 2015-04-07
Enrollment: 75 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether participants with Stage IIIC and Stage IV Melanoma experience benefit when treated with Denileukin diftitox in two different dosing schedules.

Detailed description:
This is a multicenter, open-label, dose/schedule and clinical efficacy study in participants with Stage IIIC and Stage IV melanoma.

Dose-Schedules: This is a schedule, dose, and pharmacodynamic study of Denileukin diftitox in participants with Stage IIIC and Stage IV melanoma. Two arms of 40 participants each were originally planned (see below) for a total of 80 participants. Participants were randomly assigned to 1 of 2 arms: 1. 12 mcg/kg/day on Days 1 through 4 of each 21-day treatment cycle, for a total of 4 cycles (12 weeks); 2. 12 mcg/kg/day on Days 1, 8, and 15 of each 21-day treatment cycle, for a total of 4 cycles (12 weeks). Participants will be evaluated for (clinical response, safety and tolerability, and pharmacodynamic measures of ONTAK activity. An optional substudy will be conducted that will involve collection of serial tumor biopsies at study entry and Day 84 in order to assess tissue pharmacodynamic markers of ONTAK activity (Treg depletion in tumor, appearance of melanoma antigen-specific CD8+lymphocytes, and other markers of mucosal immunity and inflammatory response).

Following an amendment, participants will be enrolled in Arm 1 only (expanded to a total of 55 participants) and Arm 2 was closed. According to the original design, if two responses or less were observed among 22 participants on either arm, that arm would be discontinued.

Participants experiencing clinical benefit (immune-related stable disease \[irSD\], immune-related partial response \[irPR\], or immune-related complete response \[irCR\] per irRC) after 4 cycles of treatment, may continue their denileukin diftitox treatment for up to 8 cycles.

Arms: arm 1: Participants received Denileukin Diftitox 12 mcg/kg/day (microgram per kilogram) on Days 1 through 4 of each 21-day treatment cycle, for a total of 4 cycles (12 weeks). arm 2: Participants received Denileukin Diftitox 12 mcg/kg/day on Days 1, 8, and 15 of each 21-day treatment cycle, for a total of 4 cycles (12 weeks).

ARM 2 was closed. Participants experiencing clinical benefit (irSD, irPR, or irCR per irRC) after 4 cycles of treatment, may continue their denileukin diftitox treatment for up to 8 cycles.
Interventions: intervention 1: Denileukin diftitox
Intervention descriptions: intervention 1: Denileukin diftitox intravenous infusion over 30-60 minutes.

Protocol documents:
Clinical trial NCT01709331
Conditions: Hypogonadism Hypogonadotropic Hypogonadism
Sponsor: Organon and Co
Start date: 2013-02-11; Completion date: 2015-04-08
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess if corifollitropin alfa (MK-8962), when administered in combination with human chorionic gonadotropin (hCG), will increase testicular volume in men with HH who remain azoospermic after treatment with hCG alone.

Hypothesis: The lower limit of the 95% confidence interval for the geometric mean increase in testicular volume from Day 1 to Week 52 is greater than one.

Detailed description:

Arms: arm 1: During a 16-week pretreatment phase, participants will receive twice-weekly subcutaneous (SC) injections of hCG 1500 or 3000 international units (IU). Eligible participants will then be enrolled in the combined treatment phase in which they will receive a single dose of corifollitropin alfa 150 μg by SC injection once every 2 weeks for 52 weeks. In addition, eligible participants will continue to receive twice-weekly hCG injections on the same schedule as the pretreatment phase.
Interventions: intervention 1: Corifollitropin alfa intervention 2: hCG
Intervention descriptions: intervention 1: Corifollitropin alfa 150 μg by SC injection, once every 2 weeks for 52 weeks intervention 2: hCG 1500 or 3000 IU by SC injection twice a week; administered alone for 16 weeks (pre-treatment phase) and then in combination with corifollitropin alfa for 52 weeks (combined treatment phase)

Protocol documents:
Clinical trial NCT02009163
Conditions: Binge Eating Disorder
Sponsor: Shire
Start date: 2014-01-27; Completion date: 2015-04-08
Enrollment: 418 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate maintenance of efficacy based on time to relapse between SPD489 (50 or 70mg) and placebo, as measured by the number of binge days (defined as days during which at least 1 binge episode occurs) per week as assessed by clinical interview based on subject diary and Clinical Global Impression - Severity (CGI-S) scores for patients who responded to SPD489 by the end of the Open-label Treatment Phase.

Detailed description:

Arms: arm 1: Administer one capsule (50 or 70 mg) orally daily at approximately 7:00 AM. arm 2: Administer one capsule orally daily at approximately 7:00 AM.
Interventions: intervention 1: Lisdexamfetamine dimesylate intervention 2: Placebo
Intervention descriptions: intervention 1: SDP489 30, 50, or 70mg capsule once per day (open-label and double-blind periods) intervention 2: Placebo capsule once per day (double-blind period)

Protocol documents:
Clinical trial NCT01963728
Conditions: Diabetes Mellitus
Keywords: post-transplant diabetes mellitus renal transplant kidney transplant lung transplant heart transplant insulin
Sponsor: Inova Health Care Services
Start date: 2013-11-27; Completion date: 2015-04-09
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine if the use of insulin isophane results in improved control of blood sugars compared to the use of insulin glargine in new onset diabetes after kidney, lung, or heart transplantation (NODAT).

Detailed description:
A large percentage of organ transplant recipients develop de novo diabetes mellitus after transplantation, also called "New Onset Diabetes After Transplant" or NODAT. The cause of the diabetes appears to be commonly used anti-rejection medications, particularly calcineurin inhibitors and glucocorticoids.

Management of glucose levels in NODAT often requires insulin therapy. Standard practice is to start long-acting insulin. However, patients with NODAT often exhibit fasting morning glucose levels that are relatively low compared to pre-lunch and pre-dinner glucose levels. This seems to make NODAT patients more susceptible to fasting, or morning, hypoglycemia on long-acting insulin analogues than non-transplant patients with type II diabetes. This phenomenon of morning hypoglycemia in NODAT often limits the up-titration of basal insulin resulting in suboptimal treatment of hyperglycemia later in the day. Because of this pattern, transplant patients may respond better to morning insulin isophane (intermediate acting) than to long-acting insulin glargine preparations.

Our trial is designed to compare morning NPH insulin (isophane insulin) with conventional therapy of basal glargine insulin on both continuous blood glucose levels and hemoglobin A1c (glycosylated hemoglobin).

Arms: arm 1: daily dose will be titrated based on fasting morning glucose values arm 2: daily dose will be titrated based on fasting morning glucose values
Interventions: intervention 1: Insulin, Isophane intervention 2: insulin glargine
Intervention descriptions: intervention 1: daily dosing based on fasting morning glucose levels intervention 2: daily dose based on fasting morning glucose levels

Protocol documents:
Clinical trial NCT03335566
Conditions: Liver Lesions
Sponsor: GE Healthcare
Start date: 2014-05-11; Completion date: 2015-04-09
Enrollment: 424 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy of Sonazoid™ and SonoVue® in participants with focal liver lesions (FLLs), by comparing pre-and post-contrast ultrasound examination findings with regard to various aspects of lesion diagnosis including diagnosis as benign versus malignant, specific lesion diagnosis, confidence in diagnosis, and quality of delineation of lesion-related blood vessels (from images obtained during vascular imaging) and detection of lesion presence and quality of delineation of the whole liver (from images obtained during whole liver imaging).

Detailed description:

Arms: arm 1: Participants will receive single intravenous (I.V) bolus injection of Sonazoid™ 0.12 microliter (µL) microbubbles (MB)/kilogram (kg) body weight. arm 2: Participants will receive single I.V bolus injection of SonoVue® 2.4 milliliter (mL).
Interventions: intervention 1: Sonazoid™ intervention 2: SonoVue®
Intervention descriptions: intervention 1: Single Dose of Sonazoid™ 0.12 µL MB/kg as I.V. injection. intervention 2: Single Dose of SonoVue® 2.4 mL as I.V. injection.

Protocol documents:
Clinical trial NCT02275546
Conditions: Contraception: Optional Applicator for Insertion of Vaginal Ring
Sponsor: Organon and Co
Start date: 2014-12-11; Completion date: 2015-04-10
Enrollment: 164 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of the study is to assess the performance and safe use of the vaginal ring applicator as an optional aid for insertion of a placebo vaginal ring into the vagina in healthy women

Detailed description:

Arms: arm 1: Treatment period 1: Participants will use applicator to insert vaginal ring. Treatment period 2: Participants will manually insert vaginal ring using fingers only. arm 2: Treatment period 1: Participants will manually insert vaginal ring using fingers only. Treatment period 2: Participants will use applicator to insert vaginal ring.
Interventions: intervention 1: Placebo vaginal ring intervention 2: Single-use, non-sterile applicator
Intervention descriptions: intervention 1: Drug-free placebo vaginal ring intervention 2: Single-use, non-sterile, plastic applicator for insertion of vaginal ring.

Protocol documents:
Clinical trial NCT01895972
Conditions: Glaucoma Ocular Hypertension
Sponsor: Bausch & Lomb Incorporated
Start date: 2013-07-05; Completion date: 2015-04-14
Enrollment: 130 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study is to demonstrate the clinical safety of latanoprostene bunod 0.024% once daily (QD) over a 1-year treatment period.

Detailed description:

Arms: arm 1: Latanoprostene bunod 0.024% instilled into the eye once daily (QD) over a 1-year treatment period.
Interventions: intervention 1: Latanoprostene bunod
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02332798
Conditions: Schizophrenia
Keywords: Multiple ascending doses safety tolerability pharmacokinetics cognitive impairment associated with schizophrenia (CIAS)
Sponsor: Biogen
Start date: 2015-01-06; Completion date: 2015-04-15
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study aims to assess the safety, tolerability and pharmacokinetics of PF-04958242 in multiple ascending doses in subjects with stable schizophrenia.

Detailed description:
This study aims to assess the safety, tolerability and pharmacokinetics of PF-04958242 compared to placebo over 14 days twice a day dosing in multiple ascending doses in subjects with stable schizophrenia.

This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.

Arms: arm 1: All participants who received PF-04958242 0.25 milligram (mg) twice daily (BID) for 14 consecutive days with the last dose occurring in the morning on Day 14. arm 2: All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14. arm 3: All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
Interventions: intervention 1: PF-04958242 intervention 2: Placebo
Intervention descriptions: intervention 1: Administered as specified in the treatment arm intervention 2: Administered as specified in the treatment arm

Protocol documents:
Clinical trial NCT01691248
Conditions: Clostridium Difficile-Associated Diarrhea (CDAD)
Keywords: Clostridium difficile Clostridium difficile-Associated Diarrhea Prophylaxis Hematopoietic Stem Cell Transplantation
Sponsor: Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Start date: 2012-10-10; Completion date: 2015-04-16
Enrollment: 611 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to demonstrate the efficacy and safety of Fidaxomicin versus placebo for prophylaxis against Clostridium difficile-Associated Diarrhea (CDAD) in adult participants undergoing hematopoietic stem cell transplantation (HSCT). The primary hypothesis is that Fidaxomicin is superior to placebo in preventing CDAD in participants undergoing HSCT.

Detailed description:

Arms: arm 1: 200 mg Fidaxomicin tablet once daily for no longer than 40 days arm 2: Placebo tablet once daily for no longer than 40 days
Interventions: intervention 1: fidaxomicin intervention 2: Placebo
Intervention descriptions: intervention 1: Fidaxomicin 200 mg tablet once daily from the start (+/- 2 days) of condition (prior to transplantation) or at the time of Fluoroquinolone initiation. Study drug treatment will continue until 7 days after either neutrophil engraftment or the completion of any Fluoroquinolone antibiotic regimen (whichever occurs later).

Study drug treatment will stop at onset of CDAD or no longer than 40 days of duration, even if other antibiotics are still administered or neutrophil engraftment extends beyond 40 days. intervention 2: Placebo tablet once daily from the start (+/- 2 days) of condition (prior to transplantation) or at the time of Fluoroquinolone initiation. Treatment will continue until 7 days after either neutrophil engraftment or the completion of any Fluoroquinolone antibiotic regimen (whichever occurs later).

Treatment will stop at onset of CDAD or no longer than 40 days of duration, even if other antibiotics are still administered or neutrophil engraftment extends beyond 40 days.

Protocol documents:
Clinical trial NCT01978145
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: efficacy tolerability capsule-based inhaler quality of life safety multi-dose inhaler fluticasone propionate/salmeterol (FSC) 250/50 mcg Chronic obstructive pulmonary disease
Sponsor: GlaxoSmithKline
Start date: 2013-11-14; Completion date: 2015-04-16
Enrollment: 665 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a multi-centre, randomised, double-blind, double-dummy, two way cross-over, 12 weeks noninferiority study to evaluate the efficacy, safety, and tolerability of FSC 250/50 mcg capsule-based inhaler and a multi-dose inhaler administered BID in adults with COPD. The primary objective of this study is to establish the non-inferiority of the efficacy of the FSC 250/50 mcg capsule-based inhaler compared to the FSC 250/50 mcg multi-dose inhaler administered BID. The study consists of 6 phases: Pre-screening, Screening/Run-in (3 weeks), Treatment Period 1 (12 weeks), Washout (minimum 4 weeks), Treatment Period 2 (12 weeks) and Follow-up (1 week). The total duration of the study for each subject will be at least 32 weeks.

Detailed description:

Arms: arm 1: Placebo administered BID by multi-dose inhaler followed by FSC (250/50 mcg) administered BID by capsule-based inhaler. arm 2: FSC (250/50 mcg) administered BID by multi-dose inhaler followed by placebo administered BID by capsule-based inhaler.
Interventions: intervention 1: FSC intervention 2: Placebo
Intervention descriptions: intervention 1: Subject will be administered FSC 250 mcg/50 mcg via dry powder inhalation device -or multi-dose dry powder inhalation device BID for each treatment periods intervention 2: Subject will be administered placebo via dry powder inhalation device or multi-dose dry powder inhalation device BID for each treatment periods

Protocol documents:
Clinical trial NCT02296853
Conditions: Hepatitis B Virus
Keywords: Severe Hepatic Impairment
Sponsor: Gilead Sciences
Start date: 2014-12-22; Completion date: 2015-04-17
Enrollment: 20 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the single-dose pharmacokinetics of tenofovir alafenamide (TAF) and its metabolite tenofovir (TFV) in participants with normal hepatic function and in participants with severe hepatic impairment.

Detailed description:

Arms: arm 1: Participants with severe hepatic impairment will receive a single oral dose of TAF 25 mg on Day 1. arm 2: Participants with normal hepatic function will receive a single oral dose of TAF 25 mg on Day 1.
Interventions: intervention 1: TAF
Intervention descriptions: intervention 1: 25 mg tablet administered orally

Protocol documents:
Clinical trial NCT03603106
Conditions: Healthy Volunteers Brain Lesion
Sponsor: Guerbet
Start date: 2013-11-25; Completion date: 2015-04-17
Enrollment: 142 participants; Allocation: RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The primary objective of this study was to evaluate the safety (clinical and biological) and pharmacokinetics (plasma and urine) profile of P03277 following single administration at ascending dose levels in healthy subjects.

Detailed description:
This single-center, single ascending dose, phase I/IIa study was divided into 2 parts, involving both healthy subjects and patients with brain lesions:

* Study Part I included healthy subjects: double-blind, randomized, placebo control;
* Study Part II included patients with brain lesions: open-label.

In Part I, the following 6 dosing groups were investigated:

* Group 1: 0.025 mmol/kg
* Group 2: 0.05 mmol/kg
* Group 3: 0.075 mmol/kg
* Group 4: 0.1 mmol/kg
* Group 5: 0.2 mmol/kg
* Group 6: 0.3 mmol/kg

Healthy subjects were included and were then administered with P03277 or placebo and were to undergo MRI examination according to the randomization scheme.

In Part II, the following 4 doses groups were investigated:

* Group 7: 0.05 mmol/kg
* Group 8: 0.075 mmol/kg
* Group 9: 0.1 mmol/kg
* Group 10: 0.2 mmol/kg

Patients with brain lesions were included and were then administered with P03277 and underwent MRI examination.

Arms: arm 1: In each dose group (0.025, 0.05, 0.075, 0.1, 0.2 and 0.3 mmol/kg), 9 healthy subjects were to be included: 6 subjects received P03277 and 3 subjects received placebo in one single intravenous administration. arm 2: In each dose group (0.05, 0.075, 0.1 and 0.2 mmol/kg), all 3 patients received one single intravenous administration of P03277.
Interventions: intervention 1: P03277 intervention 2: Placebo
Intervention descriptions: intervention 1: Part I: P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.

Part II: P03277 was administered intravenously with a flow rate of 2 mL/s. intervention 2: Part I: Placebo was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.

Part II: Placebo was administered intravenously with a flow rate of 2 mL/s.

Protocol documents: