ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02297412
Conditions: Acute Pain Breast Carcinoma Peripheral Neuropathy
Sponsor: Academic and Community Cancer Research United
Start date: 2014-11-01; Completion date: 2016-07-08
Enrollment: 47 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized pilot trial studies how well minocycline hydrochloride works in reducing chemotherapy-induced peripheral neuropathy and acute pain in patients with breast cancer undergoing treatment with paclitaxel. Drugs used in chemotherapy, such as paclitaxel, may cause damage to nerves that result in aches, pains, and tingling or numbness of fingers and toes. Minocycline hydrochloride may help lessen nerve damage from paclitaxel and improve the quality of life in breast cancer patients.

Detailed description:
PRIMARY OBJECTIVES:

I. To estimate whether minocycline hydrochloride (minocycline) can alleviate paclitaxel-induced peripheral neuropathy.

II. To estimate whether minocycline can alleviate paclitaxel acute pain syndrome (P-APS).

III. To examine the possible relative toxicities related to minocycline therapy in this study situation.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive minocycline hydrochloride orally (PO) twice daily (BID) on days 1-7. Treatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive a placebo PO BID on days 1-7. Treatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of the study, patients are followed up every month for 6 months.

Arms: arm 1: Patients receive minocycline hydrochloride PO BID on days 1-7. Treatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. arm 2: Patients receive a placebo PO BID on days 1-7. Treatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Minocycline Hydrochloride intervention 2: Placebo intervention 3: Quality-of-Life Assessment intervention 4: Questionnaire Administration
Intervention descriptions: intervention 1: Given PO intervention 2: Given PO intervention 3: Ancillary studies intervention 4: Ancillary studies

Protocol documents:
Clinical trial NCT01968551
Conditions: HIV-1 HIV Infections Acquired Immunodeficiency Syndrome
Keywords: HIV-1 HIV Treatment-Experienced
Sponsor: Gilead Sciences
Start date: 2013-09-03; Completion date: 2016-07-09
Enrollment: 158 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed dose combination (FDC) plus darunavir (DRV) relative to current antiretroviral regimens (ARV) in virologically suppressed, HIV-1 positive participants with HIV-1 RNA \<50 copies/mL at Week 24.

This study consists of 48 weeks of open-label phase followed by an optional Extension Phase in which all the participants will receive E/C/F/TAF+DRV.

Detailed description:

Arms: arm 1: Participants will receive E/C/F/TAF FDC + DRV once daily with food for 48 weeks.

Based on safety and efficacy data from Cohort 1 at Week 4, the participants will be randomized into Cohort 2. The participants in Cohort 1 will continue receiving E/C/F/TAF FDC + DRV through 48 weeks. arm 2: Participants will be randomized to receive E/C/F/TAF FDC+DRV once daily with food for 48 weeks. arm 3: Participants will be randomized to continue on their baseline DRV-containing ARV regimen for 48 weeks.
Interventions: intervention 1: E/C/F/TAF intervention 2: DRV intervention 3: Baseline DRV- containing ARV regimen
Intervention descriptions: intervention 1: 150/150/200/10 mg FDC tablet administered orally once daily intervention 2: 800 mg tablet administered orally once daily intervention 3: Participants will take their baseline DRV- containing ARV regimen as prescribed.

Protocol documents:
Clinical trial NCT02577107
Conditions: Age-related Macular Degeneration
Keywords: Age-related macular degeneration, ranibizumab, conbercept, plasma VEGF PK
Sponsor: Novartis Pharmaceuticals
Start date: 2016-01-13; Completion date: 2016-07-09
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
An exploratory single site, open label, randomized, controlled study evaluated plasma vascular endothelial growth factor levels after intravitreal injection of ranibizumab (Lucentis) and conbercept (Langmu) for neovascular age-related macular degeneration

Detailed description:
This prospective, randomized, open label study enrolled patients with neovascular AMD who were naïve to anti-VEGF therapy or have not received intravitreal anti-VEGF therapy for the previous 3 months. Patients were randomized in two treatment arms for 3 months:

* Study arm 1: Three monthly injections of 0.5mg Ranibizumab
* Study arm 2: Three monthly injections of 0.5mg Conbercept Blood sample (plasma/serum) was collected at baseline (pre-dose), 3h post-injections and days 1, 3, 7 and 28, following doses 1 and 3 for PK and systemic VEGF analysis. The lab staff was blinded for treatment allocation.

Plasma VEGF concentration was measured by a blinded laboratory using Quantikine® ELISA kits. Serum ranibizumab and conbercept concentration will be determined using validated ELISA assay.

The study was divided into 2 stages: the 1st initial feasibility stage with 6 patients per arm (12 patients in total) to verify SD for sample size justification and 2nd stage to confirm the findings with justified sample size.

Arms: arm 1: Three monthly injections of 0.5mg Ranibizumab arm 2: Three monthly injections of 0.5mg Conbercept
Interventions: intervention 1: ranibizumab intervention 2: Conbercept
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02151903
Conditions: B-cell Non-Hodgkin Lymphoma
Keywords: NHL Immunocytokine Lymphoma Non-Hodgkin B-cell IL (interleukin)
Sponsor: Alopexx Oncology, LLC
Start date: 2014-11-04; Completion date: 2016-07-11
Enrollment: 5 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an open-label extension study enrolling participants experiencing clinical benefit following 6 cycles of DI-Leu16-IL2 while enrolled in the Alopexx Oncology Dose-Escalation AO-101 study (NCT01874288). Participants will be permitted to continue to receive DI-Leu16-IL2 at the same dose, schedule, and route of administration they received during Study AO-101 (Main Study). Prior pre-treatment (for example, Rituximab) will continue as before.

Detailed description:

Arms: arm 1: Participants will receive DI-Leu16-IL2 1.0 milligrams per square meter (mg/m\^2) subcutaneously (SC) for 3 consecutive days every 3 weeks (21-day cycle). Participants will continue to receive therapy through the duration of the study as long as they will have clinical benefit and will not experience any untoward side effects. arm 2: Participants will receive DI-Leu16-IL2 2.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle). Participants will continue to receive therapy through the duration of the study as long as they will have clinical benefit and will not experience any untoward side effects.
Interventions: intervention 1: DI-Leu16-IL2
Intervention descriptions: intervention 1: DI-Leu16-IL2 will be administered per dose and schedule specified in the arm.

Protocol documents:
Clinical trial NCT02167594
Conditions: Progressive Supranuclear Palsy Corticobasal Degeneration
Sponsor: Avid Radiopharmaceuticals
Start date: 2014-08-12; Completion date: 2016-07-11
Enrollment: 29 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate flortaucipir for brain imaging of tau in subjects with progressive supranuclear palsy (PSP), corticobasal degeneration (CBD) and healthy volunteers.

Detailed description:

Arms: arm 1: Amyloid negative subjects with PSP receiving a flortaucipir PET scan at baseline and at 9 months. arm 2: Amyloid negative subjects with CBD receiving a flortaucipir PET scan at baseline and at 9 months. arm 3: Healthy volunteers receiving a flortaucipir PET scan at baseline.
Interventions: intervention 1: Flortaucipir F18 intervention 2: Brain PET scan
Intervention descriptions: intervention 1: IV injection, 370 megabecquerel (MBq) (10 mCi) intervention 2: positron emission tomography (PET) scan of the brain 75-105 minutes post-injection

Protocol documents:
Clinical trial NCT01679197
Conditions: Fatty Liver Disease, Nonalcoholic Nonalcoholic Steatohepatitis Lipodystrophy
Keywords: Nonalcoholic fatty liver disease NAFLD Nonalcoholic steatohepatitis NASH Lipodystrophy Leptin Metreleptin Hypertriglyceridemia Diabetes mellitus
Sponsor: University of Michigan
Start date: 2012-10-08; Completion date: 2016-07-13
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study involves research about an investigational medicine called metreleptin. The reason for this study is to find out how metreleptin can improve non-alcoholic steatohepatitis or nonalcoholic fatty liver disease associated with lipodystrophy, a rare disorder associated with abnormal loss of the body's fat tissue. In this study, metreleptin is considered to be investigational for the treatment of lipodystrophy. Metreleptin will be given via injections under the skin. We plan to continue therapy for a period of one year and evaluate the change in liver disease by a liver biopsy. We will also follow the metabolic parameters (e.g. blood cholesterol, liver function, insulin resistance) and body composition characteristics (e.g. the pattern of fat distribution in the body).

Detailed description:
The goal is to test the efficacy of restorative leptin therapy on the degree of hepatic steatosis and on amelioration of pathological features of NASH/NAFLD. In addition, the study will evaluate the impact of leptin therapy on total body insulin sensitivity and lipid levels as well as energy expenditure. In order to accomplish this aim, we now propose an efficacy study with recombinant human leptin therapy in patients with all forms of lipodystrophy who also have NASH/NAFLD.

1. AIM 1: To determine the efficacy of leptin in promoting amelioration of body composition, hepatic steatosis and histopathological scores in patients with all forms of lipodystrophy and NAFLD/NASH. We will conduct a 1 year, open-label study, to assess the metabolic effects of recombinant human leptin (METRELEPTIN, AztraZeneca, Wilmington, DE). The primary outcome measure will be NASH scores. We will also explore body weight, insulin sensitivity, glucose and lipid control, body composition, and free fatty acid levels.
2. AIM 2: To Investigate molecular effects of leptin therapy. In parallel to our preliminary studies, gene expression will be performed on individuals participating in Aim 1 at baseline and following 1 year of leptin. We will combine this with measures of liver metabolite levels to provide novel insights into alterations in metabolism that occur secondary to leptin therapy. We will also measure plasma metabolites at baseline and after 2 (optional), 24 and 48 weeks of therapy to assess the dynamic changes induced by leptin and correlate these changes with phenotypic measures.

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

Protocol documents:
Clinical trial NCT02064920
Conditions: Alzheimer's Disease
Sponsor: Merck Sharp & Dohme LLC
Start date: 2014-04-22; Completion date: 2016-07-13
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study aims to determine whether the Cogstate testing battery can detect improvements in cognitive function in participants with mild AD. The primary hypothesis is that for one of the Cogstate battery tests, One Card Learning (OCL), the standard deviation associated with the change from baseline in OCL measurements after 12 weeks of donepezil and placebo treatments is =\<0.1

Detailed description:

Arms: arm 1: Placebo for donepezil hydrochloride capsule administered orally once a day for 16 weeks. arm 2: During the first 4 weeks, participants received placebo for donepezil. Over the following 2 weeks, participants were treated with donepezil at 5 mg per day. Then, over the remaining 10 weeks were titrated to up to 10 mg per day donepezil based on tolerability.
Interventions: intervention 1: Placebo intervention 2: Donepezil intervention 3: Donepezil
Intervention descriptions: intervention 1: Placebo for donepezil hydrochloride capsule intervention 2: 5 mg donepezil hydrochloride capsule. intervention 3: 10 mg donepezil hydrochloride capsule.

Protocol documents:
Clinical trial NCT02351960
Conditions: Gastroesophageal Reflux Disease
Keywords: Drug therapy GERD Dexlansoprazole
Sponsor: Takeda
Start date: 2015-03-19; Completion date: 2016-07-13
Enrollment: 296 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effectiveness of symptom control in gastroesophageal reflux disease (GERD) participants following treatment with dexlansoprazole.

Detailed description:
The drug being tested in this study is called dexlansoprazole. A dual delayed release formulation of dexlansoprazole, referred to as dexlansoprazole modified release (dexlansoprazole MR) was tested to treat people who have gastroesophageal reflux disease (GERD). This study looked at the healing of the esophageal lining of the GERD participants who took dexlansoprazole MR.

The study enrolled 296 patients. Participants were assigned to two study groups based on the endoscopy screening procedures to receive treatments as follows:

* Dexlansoprazole 30 mg to participants with non-erosive reflux disease (NERD)
* Dexlansoprazole 60 mg to participants with erosive esophagitis (EE)

All participants were asked to take one capsule in the morning each day throughout the study. All participants were asked to record the presence and maximum severity of daytime and nighttime heartburn and regurgitation symptoms during screening and, if assigned to a treatment group, throughout the duration of the study using the supplied paper diary.

This multi-center trial was conducted in Asia (Hong Kong, Taiwan, South Korea). The overall time to participate in this study was up to 8 weeks. Participants would make up to 3 visits to the clinic, and would be contacted by telephone 30 days after the last dose of study drug for a follow-up assessment.

Arms: arm 1: Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks to participants with non-erosive reflux disease (NERD). arm 2: Dexlansoprazole 60 mg, capsules orally, once daily for up to 8 weeks to participants with erosive esophagitis (EE).
Interventions: intervention 1: Dexlansoprazole
Intervention descriptions: intervention 1: Dexlansoprazole capsules

Protocol documents:
Clinical trial NCT00689936
Conditions: Multiple Myeloma
Keywords: newly diagnosed multiple myeloma Lenalidomide Revlimid phase III
Sponsor: Celgene
Start date: 2008-08-21; Completion date: 2016-07-14
Enrollment: 1623 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the safety and efficacy of Lenalidomide plus low dose dexamethasone to that of the combination of melphalan, prednisone and thalidomide.

Detailed description:
CC-5013-MM020/IFM 07-01 is a Phase III, multicenter, randomized, open-label, 3-arm study that will compare the efficacy and safety of two Lenalidomide plus low-dose dexamethasone regimens given for two different durations of time (i.e., until progressive disease \[PD\] or for up to a maximum of 18 four-week cycles) to that of MPT given for a maximum of 12 six-week cycles.

Arms: arm 1: Lenalidomide plus low-dose dexamethasone given until disease progression arm 2: Lenalidomide plus low-dose dexamethasone given for 18 four-week cycles arm 3: Combination of Melphalan, Prednisone and Thalidomide given for 12 six-week cycles
Interventions: intervention 1: Lenalidomide and low-dose dexamethasone intervention 2: Lenalidomide plus low-dose dexamethasone given for 18 four-week cycles intervention 3: Melphalan, Prednisone and Thalidomide
Intervention descriptions: intervention 1: Lenalidomide - oral, 2.5mg, 5mg, 10mg, 15mg 20mg, or 25 mg capsules, given either days 1-21 of each 28 day cycles or given every other day for 21 days until documentation of PD.

Dexamethasone - oral 4mg tablets for a total dose of 20mg or 40 mg given days 1,8,15 and 22 of each 28 day cycle up to disease progression intervention 2: lenalidomide - oral, 2.5mg, 5mg, 10mg, 15mg, 20 mg or 25 mg capsules given on days 1-21 of each 28 day cycle or every other day for 21 days for 18 cycles.

Dexamethasone - oral 4mg tablets for a total dose of 20mg or 40 mg given days 1,8,15 and 22 of each 28 day cycle for 18 cycles intervention 3: Melphalan - oral, 2mg tablets dosed at either 0.25mg/kg, 0.125 mg/kg, 0.20mg/kg or 0.10mg/kg on days 1-4 of each 42 day cycle up to 12 cycles Prednisone - oral, 5mg, 10mg, 20 mg and 50 mg tablets dosed at 2mg/kg daily days 1-4 of each 42 day cycle for up to 12 cycles Thalidomide - oral, 50mg, 100mg and 200 mg capsules dosed at either 100mg or 200 mg daily on days 1-41 of each 42 day cycle for up to 12 cycles

Protocol documents:
Clinical trial NCT01630616
Conditions: Osteoporosis
Sponsor: Merck Sharp & Dohme LLC
Start date: 2013-03-12; Completion date: 2016-07-14
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of single doses of odanacatib in mature adolescents and young adults who are currently receiving glucocorticoid therapy. The primary hypotheses for the study are that a single dose of odanacatib is well tolerated in mature adolescents and following single dose administration of odanacatib 50 mg, there is no clinically important difference in AUC0-inf between mature adolescents and young adults.

Detailed description:

Arms: arm 1: Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents. arm 2: Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents. arm 3: Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents. arm 4: Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults. arm 5: Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
Interventions: intervention 1: Odanacatib intervention 2: Placebo
Intervention descriptions: intervention 1: single oral dose, tablets, 10 or 50 mg intervention 2: single oral dose, tablets

Protocol documents:
Clinical trial NCT02146430
Conditions: Pain Associated With Fibromyalgia
Keywords: pain fibromyalgia
Sponsor: Daiichi Sankyo
Start date: 2014-10-27; Completion date: 2016-07-14
Enrollment: 1293 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main objective of this trial is to compare change in weekly average daily pain score (ADPS) from baseline to Week 13 in subjects receiving either dose of DS-5565 versus placebo. Weekly ADPS is based on daily pain scores reported by the participant that best describes his or her worst pain over the previous 24 hours.

Detailed description:

Arms: arm 1: Participants take one each of placebo tablet and capsule in the morning, and one DS-5565 tablet once daily (QD) with a placebo capsule in the evening arm 2: Participants take one DS-5565 tablet and one placebo capsule, twice daily (BID) arm 3: Participants take one pregabalin capsule and one placebo tablet BID arm 4: Participants take one each of placebo tablet and capsule BID
Interventions: intervention 1: DS-5565 intervention 2: Pregabalin intervention 3: Placebo tablet intervention 4: Placebo capsule
Intervention descriptions: intervention 1: DS-5565 15 mg tablet for oral administration intervention 2: Pregabalin 150 mg capsule for oral administration intervention 3: Placebo tablet (matching DS-5565) for oral administration intervention 4: Placebo capsule (matching pregabalin) for oral administration

Protocol documents:
Clinical trial NCT02502097
Conditions: Idiopathic Pulmonary Fibrosis Cough
Sponsor: Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Start date: 2015-08-26; Completion date: 2016-07-14
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
A randomized, double-blind, placebo-controlled, crossover, dose escalation study of gefapixant (AF-219) in participants with Idiopathic Pulmonary Fibrosis (IPF) with persistent cough.

Detailed description:
Prior to Amendment 3, participants were randomized to receive either placebo twice daily (BID) for 14 days during Period 1 followed by gefapixant 50 mg BID for 10 days then gefapixant 150 mg BID for 4 days BID during Period 2; or gefapixant 50 mg BID for 10 days then gefapixant 150 mg BID for 4 days during Period 1, followed by placebo BID for 14 days during Period 2. Each period was separated by a 14 to 21-day washout period.

During Amendment 3, participants were randomized to receive either placebo BID for 14 days during Period 1 followed by gefapixant 50 mg BID for 14 days during Period 2; or gefapixant 50 mg BID for 14 days during Period 1, followed by placebo BID for 14 days during Period 2. Each period was separated by a 14 to 21-day washout period.

Arms: arm 1: Gefapixant 50 mg twice daily (BID) for 10 days, then 150 mg BID for 4 days in Period 1, followed by a 14-21 day washout period, then placebo BID for 14 days in Period 2 arm 2: Placebo BID for 14 days in Period 1, followed by a 14-21 day washout period, then gefapixant 50 mg BID for 10 days, then 150 mg for 4 days in Period 2 arm 3: Gefapixant 50 mg twice daily (BID) for 14 days in Period 1, followed by a 14-21 day washout period, then placebo BID for 14 days in Period 2 arm 4: Placebo BID for 14 days in Period 1, followed by a 14-21 day washout period, then gefapixant 50 mg BID for 14 days in Period 2
Interventions: intervention 1: Gefapixant intervention 2: Placebo
Intervention descriptions: intervention 1: Gefapixant 50 mg tablet, administered by mouth intervention 2: Matching placebo to gefapixant, tablet administered by mouth

Protocol documents: