ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02134951
Conditions: Healthy Controls
Sponsor: New York State Psychiatric Institute
Start date: 2014-05-01; Completion date: 2015-11-01
Enrollment: 65 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the relative feasibility of 2 potential functional measures of target engagement (Glx MRS, BOLD fMRI) to systematically assess mGluR 2/3 in drug development for psychotic spectrum disorders.

Detailed description:
This is a pilot study of healthy subject to assess the feasibility of Glx MRS and BOLD fMRI to measure ketamine induced changes in glutamatergic indices. The investigators will randomize 18 subjects at each site. Subjects will be randomized to ketamine or placebo in a 2:1 ratio and receive two drug challenges separated by at least two weeks. Ketamine challenge is used to induce a "glutamate surge" within prefrontal brain regions that can be detected using neurochemical and functional imaging techniques. Each subject will receive MRS and BOLD fMRI during each challenge day. The goal of the pilot study is to assess the feasibility of both the proposed ketamine challenge paradigm and of the proposed imaging-based biomarkers. Specific indices to be used in assessing feasibility will include effect size, cross-site and cross-subject reliability, safety, and subject tolerability as similar studies will be performed independently at Yale and UC Davis. Second this information will be used to select and refine final study parameters for a subsequent full proof-of-clinical mechanism (POCM) study investigating the effect of Pomaglumetad on ketamine-induced MRS and fMRI effects.

Arms: arm 1: IV infusion of ketamine 0.23mg/kg bolus over 1 minutes followed by 0.58 mg/kg/hr over 30 minutes then 0.29mg/kg/hr over 64 minutes arm 2: Placebo group will receive normal saline
Interventions: intervention 1: Ketamine intervention 2: Normal saline
Intervention descriptions: intervention 1: intravenous infusion of saline solution with ketamine intervention 2: Normal saline will be used for placebo in this group

Protocol documents:
Clinical trial NCT02135432
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive pulmonary disease, Ivacaftor
Sponsor: University of Alabama at Birmingham
Start date: 2015-05-01; Completion date: 2015-11-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The study is a randomized, double-blind, placebo-controlled, multiple-dose, pilot study of orally-administered ivacaftor in subjects with chronic obstructive pulmonary disease. Subjects will be administered the study drug ivacaftor 150 mg (or placebo) twice daily (BID).

Detailed description:

Arms: arm 1: twice a day administration of Ivacaftor: 150mg arm 2: matching placebo
Interventions: intervention 1: Ivacaftor intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02152007
Conditions: Pachyonychia Congenita
Keywords: pachyonychia congenita
Sponsor: TransDerm, Inc.
Start date: 2014-01-01; Completion date: 2015-11-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
A study to evaluate safety and efficacy of topical sirolimus to treat plantar keratoderma in adults with PC. Subjects may receive either placebo or treatment with at least 1 foot receiving topical sirolimus at some time. For certain phases of the study treatment assignment to the right and left foot will be randomized in a double blind fashion. Blood levels will test systemic absorption of sirolimus. Other safety and efficacy measures will be taken through the 39-week study duration. Funding Source - FDA OOPD

Detailed description:

Arms: arm 1: This is a split-body design. Subjects will self-administer 1% topical sirolimus cream or placebo cream (no drug, vehicle control) on the plantar surface of each foot. At least one foot will be treated with topical sirolimus at some time during the study. Application will be one time daily for a total of 26 weeks. There will be an additional follow-up visit 3 months after the last application of study drug. The total duration of the study is 39 weeks.
Interventions: intervention 1: 1% sirolimus cream (TD201 1%)
Intervention descriptions: intervention 1: 1% sirolimus cream (TD201 1%)

Protocol documents:
Clinical trial NCT02157298
Conditions: Type 2 Diabetes Mellitus
Keywords: Japanese patients with type 2 diabetes with inadequate glycemic control on insulin
Sponsor: AstraZeneca
Start date: 2014-06-01; Completion date: 2015-11-01
Enrollment: 266 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Japanese male and female patients with Type 2 Diabetes and aged ≥ 20 years old, with inadequate glycemic control on insulin defined as Haemoglobin A1c ≥ 7.2% and \< 11% will be enrolled into the wash-out phase or directly into the lead-in phase depending on whether the patient has been receiving an Oral antidiabetic drug (including Glucagon-Like Peptide-1 agonists and excluding Thiazolidinedions) other than a Dipeptidyl Peptidase-4 inhibitor as part of the baseline treatment. Additional treatment with a concomitant Dipeptidyl Peptidase-4 inhibitor is allowed. And around 180 eligible patients in total will be randomized into the study with a 2:1 randomization scheme (i.e.120 patients into the dapagliflozin treatment group and 60 patients into the placebo treatment group. All subjects who completed a 16 weeks double-blind treatment period will shift to a 36 weeks open extension treatment period.

Detailed description:

Arms: arm 1: dapagliflozin tablet 5mg arm 2: dapagliflozin tablet 5mg placebo
Interventions: intervention 1: Dapagliflozin 5 mg intervention 2: Placebo tablet
Intervention descriptions: intervention 1: Dapagliflozin, a blood glucose lowering drug. Oral dose intervention 2: Placebo tablet. Oral dose

Protocol documents:
Clinical trial NCT02160899
Conditions: Elevated Lipoprotein(a)
Keywords: High Lipoprotein(a)
Sponsor: Ionis Pharmaceuticals, Inc.
Start date: 2014-06-01; Completion date: 2015-11-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ISIS-APO(a)Rx given to participants with high lipoprotein(a) for 12 weeks.

Detailed description:
Lipoprotein(a) \[Lp(a)\] is a genetic variant of low-density lipoprotein (LDL) in which the apolipoprotein B (apoB) -100 component of LDL is linked by a disulfide bond to apolipoprotein(a) \[apo(a)\], the distinct protein component of Lp(a) that is mainly responsible for its signature structural and functional properties. Lp(a) is now recognized as an important genetic risk factor for coronary artery disease, stroke and aortic stenosis.

The purpose of this study is to determine if ISIS-APO(a)Rx can reduce the production of apolipoprotein(a), or apo(a). This study will enroll 50 participants with Lipoprotein(a) ≥50 and \<175 mg/dL and 10 participants with Lipoprotein(a) ≥175 mg/dL.

Arms: arm 1: Participants will receive placebo (normal saline) subcutaneously on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. arm 2: Participants will receive ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated. arm 3: Participants will receive ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated. arm 4: Participants will receive placebo (normal saline) subcutaneously on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. arm 5: Participants will receive ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated. arm 6: Participants will receive ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
Interventions: intervention 1: ISIS-APO(a)Rx intervention 2: Placebo
Intervention descriptions: intervention 1: ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated. intervention 2: Normal saline as Placebo, subcutaneously on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.

Protocol documents:
Clinical trial NCT02196688
Conditions: Colorectal Cancer
Keywords: Colorectal cancer Fruquintinib 013
Sponsor: Hutchison Medipharma Limited
Start date: 2014-04-01; Completion date: 2015-11-01
Enrollment: 71 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Fruquintinib administered at 5mg once daily in 4 weeks treatment cycle (three weeks on and one week off) was well tolerated and demonstrated encouraging preliminary clinical antitumor activity in patients with advanced Colorectal Cancer (CRC) in Phase Ib study.

This study is aimed to evaluate the efficacy and safety of Fruquintinib in the treatment of patients with metastatic CRC who have progressed after metastatic CRC second line or above standard chemotherapy.

Detailed description:
This is a randomized, double-blind, placebo-controlled, multicenter Phase II clinical trial to compare the efficacy and safety of Fruquintinib plus Best Supportive Care (BSC) versus placebo plus BSC in patients with metastatic colorectal cancer who have progressed after second-line or above standard chemotherapy.

After checking eligibility criteria, subjects will be randomized into Fruquintinib plus BSC group (treatment group) or placebo plus BSC group (control group) in a ration of 2:1.

Primary Efficacy Endpoint:

Progression free survival (PFS) (According to RECIST Version 1.1).

Secondary Efficacy Endpoints:

Objective Response Rate (ORR), Disease Control Rate (DCR), Overall Survival (OS).

Safety and tolerance will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI common terminology criteria for adverse events (CTC AE) Version 4.0.

Arms: arm 1: treatment arm- subjects will receive Fruquintinib 5mg orally, once daily (QD), plus BSC for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria. arm 2: control arm- subjects will receive Fruquintinib placebo 5mg orally, once daily (QD), plus BSC for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria.
Interventions: intervention 1: fruquintinib intervention 2: placebo
Intervention descriptions: intervention 1: fruquintinib is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off intervention 2: Placebo is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off

Protocol documents:
Clinical trial NCT02201901
Conditions: Hepatitis C Virus Infection
Keywords: Sofosbuvir Velpatasvir SOF/VEL GS-5816 Hepatitis C HCV Cirrhosis CPT-B
Sponsor: Gilead Sciences
Start date: 2014-07-01; Completion date: 2015-11-01
Enrollment: 268 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) with and without ribavirin (RBV) for 12 weeks and SOF/VEL FDC for 24 weeks in adults with chronic hepatitis C virus (HCV) infection and Child-Pugh-Turcotte (CPT) class B cirrhosis.

Detailed description:

Arms: arm 1: Participants will receive SOF/VEL FDC for 12 weeks. arm 2: Participants will receive SOF/VEL FDC plus RBV for 12 weeks. arm 3: Participants will receive SOF/VEL FDC for 24 weeks.
Interventions: intervention 1: SOF/VEL intervention 2: RBV
Intervention descriptions: intervention 1: 400/100 mg tablets administered orally once daily intervention 2: Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Protocol documents:
Clinical trial NCT02227108
Conditions: B-Cell Pediatric ALL
Keywords: pediatric cancer,pediatric acute lymphoblastic leukemia, lymphoblastic lymphoma, B-cell leukemia, ALL, moxetumomab pasudotox, CD22
Sponsor: MedImmune LLC
Start date: 2014-08-01; Completion date: 2015-11-01
Enrollment: 37 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to evaluate the efficacy of moxetumomab pasudotox in pediatric participants with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL) or B-cell lymphoblastic lymphoma.

Detailed description:
This is a global, multicenter, open-label, single-arm Phase 2 study to evaluate the efficacy and safety of moxetumomab pasudotox monotherapy in pediatric participants with relapsed or refractory B-cell ALL or B-cell lymphoblastic lymphoma. Participants will be enrolled at sites in North America, Europe, and Australia. This is an approximate 35 month study.

Arms: arm 1: Participants received 6 doses of moxetumomab pasudotox 40 microgram per kilogram (mcg/kg) intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
Interventions: intervention 1: Moxetumomab Pasudotox
Intervention descriptions: intervention 1: Participants received 6 doses of moxetumomab pasudotox 40 microgram per kilogram (mcg/kg) intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.

Protocol documents:
Clinical trial NCT02260648
Conditions: Hypercholesterolemia
Sponsor: Eli Lilly and Company
Start date: 2015-01-01; Completion date: 2015-11-01
Enrollment: 149 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to evaluate the efficacy and safety of the study drug known as evacetrapib when administered in combination with atorvastatin for 12 weeks in Japanese participants with primary hypercholesterolemia.

Detailed description:

Arms: arm 1: 130 milligrams (mg) evacetrapib and 10 mg atorvastatin administered PO once a day for 12 weeks. arm 2: 10 mg ezetimibe and 10 mg atorvastatin administered PO once a day for 12 weeks as a reference arm. arm 3: Placebo and 10 mg atorvastatin administered PO once a day for 12 weeks.
Interventions: intervention 1: Evacetrapib intervention 2: Ezetimibe intervention 3: Atorvastatin intervention 4: Placebo
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally intervention 3: Administered orally intervention 4: Administered orally

Protocol documents:
Clinical trial NCT02274792
Conditions: Plaque Psoriasis
Sponsor: Amgen
Start date: 2015-01-01; Completion date: 2015-11-01
Enrollment: 132 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to learn more about the immune response to etanercept produced using a modified process in patients with plaque psoriasis.

Detailed description:
This is a multicenter, open-label, single-arm phase 4 study in patients with plaque psoriasis who are etanercept-naïve and who are not receiving methotrexate therapy. The study will consist of a screening period of up to 30 days, a 24-week treatment period and a 30-day follow-up period for safety. Etanercept dosing will follow the recommended label dosing for patients with plaque psoriasis.

Arms: arm 1: Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
Interventions: intervention 1: Etanercept
Intervention descriptions: intervention 1: Etanercept produced using the serum free process (SFP)2 was supplied in a single-use 1 mL prefilled syringe for subcutaneous injection.

Protocol documents:
Clinical trial NCT02278614
Conditions: Open Angle Glaucoma Ocular Hypertension
Sponsor: Laboratoires Thea
Start date: 2014-12-01; Completion date: 2015-11-01
Enrollment: 242 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the study is to assess the efficacy and safety of T2347 (Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops) versus Xalacom® in ocular hypertensive or glaucomatous patients initially treated, stabilised by Xalacom® or generics (fixed combination Latanoprost 0.005% + Timolol 0.5% preserved eye drops).

Detailed description:
Phase III, international, multicentre, randomised, investigator masked, 3 month duration, 2 parallel groups, 2 X 97 evaluable patients

Arms: arm 1: T2347: fixed combination Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops arm 2: Xalacom®: Latanoprost 0.005% + Timolol 0.5% preserved eye drops
Interventions: intervention 1: T2347 intervention 2: Xalacom
Intervention descriptions: intervention 1: T2347 eye drop solution is presented in SDU. It is supplied in 0.20 ml single use polyethylene containers. intervention 2: Xalacom® 0.01% eye drop solution is supplied in 2.5 ml multidose container.

Protocol documents:
Clinical trial NCT02306759
Conditions: Pain
Keywords: analgesia ketamine pain
Sponsor: The Brooklyn Hospital Center
Start date: 2015-01-01; Completion date: 2015-11-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the study is to compare the safety \& efficacy of low dose ketamine and morphine versus morphine alone for acute generalized pain in the Emergency Department (ED). The investigators are also interested to investigate whether low-dose ketamine is a safe and effective alternative option to opioids for the acute treatment of pain in the Emergency Department.

The agents that are available in the department includes acetaminophen, non-steroidal anti-inflammatory (NSAIDS) and opioids. In most cases, acetaminophen and NSAIDS are not adequate to manage acute pain crisis. There is also heightening concerns for increased opioid use or abuse by patients. Since the HCAPHS survey includes various questions which inquires about patient perception of pain management in the department, the investigators are interested in investigating the safety and efficacy of low-dose ketamine to as an alternative method to opioids for the acute management of pain. There has been limited, mostly observational pilot studies, published in the literature. Limited data in the literature have reported the incidence of nausea and vomiting ranged from 3-13%. All published literature administered low-dose ketamine as an intravenous push. To the best of our knowledge our study would be the first study to administer low-dose ketamine as a short bolus infusion to mitigate the incidence of nausea and vomiting. The investigators believe our study would provide important scientific data to fill the theoretical gap that low-dose ketamine at 0.3mg/kg/dose may be a safe and effective agent for acute pain management in an ED that is located in the center of a densely populated urban area.

Detailed description:
The aim of the study is to compare the safety \& efficacy of low dose ketamine and morphine versus morphine alone for acute generalized pain in the Emergency Department (ED). The is a randomized double blind placebo controlled trial to investigate the effects of low dose ketamine and morphine versus placebo and morphine for the management of acute pain in the ED.

Arms: arm 1: Ketamine 0.3mg/kg intravenous piggyback (IVPB) in 50ml NS over 15 minutes Morphine 0.1mg/kg intravenous push (IVP) PRN at designated intervals arm 2: Normal saline 50ml intravenous piggyback (IVPB) over 15 minutes Morphine 0.1mg/kg intravenous push (IVP) PRN at designated intervals
Interventions: intervention 1: Ketamine intervention 2: Placebo
Intervention descriptions: intervention 1: Ketamine 0.3mg/kg in 50ml normal saline, administered over 15 minutes intervention 2: Normal saline 50ml, administered over 15 minutes

Protocol documents:
Clinical trial NCT02317705
Conditions: Ovarian Cancer
Sponsor: On Target Laboratories, LLC
Start date: 2014-12-01; Completion date: 2015-11-01
Enrollment: 48 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is being done to:

* test the safety of OTL38
* see if OTL38 helps light up the cancer when viewed with the special camera system
* test the safety of the special camera system for use along with OTL38 during surgery

Detailed description:

Arms: arm 1: All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging.
Interventions: intervention 1: OTL38 intervention 2: Near infrared camera imaging system intervention 3: Laparotomy
Intervention descriptions: intervention 1: None intervention 2: Near infrared camera imaging system intervention 3: primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery

Protocol documents:
Clinical trial NCT02322788
Conditions: Asthma
Keywords: Inhalation, Pharmacodynamic, Patients,
Sponsor: AstraZeneca
Start date: 2015-03-01; Completion date: 2015-11-01
Enrollment: 95 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
A randomised, double-blind, double-dummy, multi-site, phase III, single dose, 4-way cross-over pharmacodynamic study evaluating the efficacy of Bricanyl Turbuhaler M3 compared to Bricanyl Turbuhaler M2 by studying the protective effect on methacholine induced bronchoconstriction in patients with stable, mild to moderate asthma

Detailed description:
The study will include female and male patients, between 18 and 65 years old, with stable, mild to moderate asthma who are on short acting β2-agonist (SABA) alone, on low dose inhaled corticosteroid (ICS) (200-400 µg budesonide or corresponding) or on a combination of low dose ICS and long acting β2-agonists (LABA). Approximately 60 patients will be randomised in order to have 49 completed.

The primary objective is to demonstrate therapeutic equivalence between Bricanyl Turbuhaler M3 and Bricanyl Turbuhaler M2 using bronchoprotective effect. Outcome measure: PC20 (Methacholine provocative concentration causing a 20% drop in FEV1). The safety objective is to compare safety of Bricanyl Turbuhaler M2 and Bricanyl Turbuhaler M3. Outcome measure Adverse Events/Serious.

Study period Q1 2015 - Q1 2016.

Arms: arm 1: Terbutaline sulphate powder for inhalation, 0.5 mg terbutaline per inhalation arm 2: Terbutaline sulphate powder for inhalation, 0.4 mg terbutaline per inhalation arm 3: Placebo powder for inhalation arm 4: Placebo powder for inhalation
Interventions: intervention 1: Terbutaline sulphate intervention 2: Terbutaline sulphate intervention 3: Placebo for terbutaline sulphate intervention 4: Placebo for terbutaline sulphate
Intervention descriptions: intervention 1: Bricanyl Turbuhaler M2 intervention 2: Bricanyl Turbuhaler M3 intervention 3: Placebo Turbuhaler M2 intervention 4: Placebo Turbuhaler M3

Protocol documents: