ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02289989
Conditions: Atopic Dermatitis
Keywords: Atopic dermatitis Oregano Atopic Dermatitis Quick (ADQ) score Eczema Area and Severity Index score Reflectance confocal microscopy
Sponsor: Rutgers, The State University of New Jersey
Start date: 2014-11-01; Completion date: 2017-01-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study is designed to evaluate and compare the efficacy of 3% oregano extract ointment prepared in aqueous solution versus 1% hydrocortisone ointment, a standard treatment, in decreasing the inflammation associated with mild to moderate atopic dermatitis. We plan to recruit 40 patients on the ages comprised between 2 and 17 years old and the study duration for each of the patient is 1 month.

Detailed description:
A single-center, investigator initiated, randomized controlled, double-blind trial will be conducted to determine the effects of an oregano extract in aqueous solution versus 1% hydrocortisone in the treatment of acute-subacute pediatric atopic dermatitis (AD). We suspect that topical oregano will serve as an effective, non-steroidal AD therapy, simultaneously offering extra benefits to pediatric patients as oregano is a natural product with antimicrobial, anti-inflammatory, and antiseptic properties that lacks reports of adverse effects associated with steroids, which children have been noted to be more susceptible to.

Arms: arm 1: Intervention: hydrocortisone 1% ointment will be applied to one patient's forearm arm 2: Intervention: Oregano extract cream for mild to moderate atopic dermatitis will be applied to the other patient's forearm
Interventions: intervention 1: Oregano extract cream intervention 2: Hydrocortisone
Intervention descriptions: intervention 1: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment intervention 2: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment

Protocol documents:
Clinical trial NCT02318368
Conditions: Non-small Cell Lung Cancer
Sponsor: AVEO Pharmaceuticals, Inc.
Start date: 2014-11-01; Completion date: 2017-01-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Phase 2 multicenter, controlled, randomized, double-blind study to evaluate the efficacy and safety of ficlatuzumab versus placebo when administered with erlotinib in subjects with previously untreated metastatic EGFR-mutated NSCLC and BDX004 Positive Label.

Detailed description:
This is a Phase 2 multicenter, controlled, randomized, double-blind study to evaluate the efficacy and safety of ficlatuzumab versus placebo when administered with erlotinib in subjects with previously untreated metastatic EGFR-mutated NSCLC and BDX004 Positive Label.

Prior to screening, subjects will have tested positive for a sensitizing EGFR mutation to determine eligibility for treatment with erlotinib. During screening, subject serum samples will be tested using the investigational companion diagnostic (BDX004) test. Only those subjects who have a BDX004 Positive Label will be enrolled. Subject randomization will be stratified by EGFR mutation type and smoking status (ever versus never smokers). Subjects will be designated as never smokers if they have smoked less than 100 cigarettes in their lifetime. Radiographic tumor assessment, to include CT or MRI of chest and abdomen, will be performed every 4 weeks for the first 8 cycles, and every 8 weeks thereafter, using the same imaging modality per subject. Safety assessments will be performed on an ongoing basis.

Arms: arm 1: 150 mg Erlotinib orally once daily starting on Day 1 of Cycle 1 with 20 mg/kg Ficlatuzumab administered intravenously once every 2 weeks on Day 1 and Day 15 of each 28 day cycle. arm 2: 150 mg Erlotinib orally once daily starting on Day 1 of Cycle 1 with Placebo administered intravenously once every 2 weeks on Day 1 and Day 15 of each 28 day cycle.
Interventions: intervention 1: Ficlatuzumab intervention 2: Erlotinib intervention 3: placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02359110
Conditions: Postoperative Pain
Keywords: laparoscopy postoperative pain gynecology gabapentin
Sponsor: Milton S. Hershey Medical Center
Start date: 2015-06-01; Completion date: 2017-01-01
Enrollment: 112 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to prospectively determine the influence of immediate pre-operative gabapentin administration on acute postoperative pain. The investigators hypothesize that immediate post-operative pain will be improved with pre-operative administration of gabapentin.

Detailed description:
The purpose of this study is to prospectively determine the influence of immediate pre-operative gabapentin administration on acute postoperative pain. We hypothesize that immediate post-operative pain will be improved with pre-operative administration of gabapentin.

We plan to conduct a prospective randomized trial to assess the effect of a single immediate pre-operative dose of gabapentin 300mg on immediate post-operative pain in patients undergoing laparoscopy for gynecologic indications. This concept has been studied in patients undergoing abdominal hysterectomy. We aim to study the effect on patients undergoing laparoscopy.

Arms: arm 1: Patients will receive Gabapentin 300mg tab less than 1 hour before surgery. arm 2: Patients will receive Methylcellulose based placebo tab less than 1 hour before surgery.
Interventions: intervention 1: Gabapentin intervention 2: Placebo
Intervention descriptions: intervention 1: Patients will receive Gabapentin 300mg tab less than 1 hour before surgery. intervention 2: Patient will receive placebo tab less than 1 hour before surgery

Protocol documents:
Clinical trial NCT02373865
Conditions: Diabetes Mellitus Type 2
Keywords: Diabetes mellitus type 2 nocturnal hypoglycemia metformin monotherapy
Sponsor: GWT-TUD GmbH
Start date: 2015-09-01; Completion date: 2017-01-01
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This exploratory double blind randomized active controlled study is designed to assess the effects of a treatment with therapeutical dosage of sitagliptin versus therapeutical dosage of glimepiride as add on therapy in patients with diabetes mellitus type 2 (T2DM) patients inadequately controlled on metformin monotherapy.

Detailed description:
Type 2 Diabetes is associated with an increased cardiovascular morbidity and mortality. Among patients insufficiently controlled with metformin multimorbidity and polypharmacy is common that makes the patients frail for cardiovascular complications related to hypoglycemic events.

This exploratory double blind randomized active controlled study is designed to assess the effects of a treatment with therapeutical dosage of sitagliptin versus therapeutical dosage of glimepiride as add on therapy in patients with T2DM patients inadequately controlled on metformin monotherapy.

Examinations will be performed as a 5 day recording of subcutaneous glucose concentration (CGMS) and holder ECG (AMEDTEC) at baseline and after a 12 weeks treatment with sitagliptin or glimepiride as active comparators used in combination with metformin.

With recording of nocturnal hypoglycemia and arrhythmias it is aimed to evaluate favorable glycemic profile under treatment with sitagliptin compared to glimepiride. The primary objective is risk of serious HE for both drugs.

The glycemic profile of sitagliptin as add-on therapy to metformin seems to be favorable compared to sulfonylureass such as glimepiride. Treatment with sitagliptin as add-on to metformin therapy causes less glycemic fluctuations and may be associated with lower oxidative stress and down regulation of low grade inflammation. This hypothesis will be tested as an explorative double blind study.

Arms: arm 1: Patients receiving Sitagliptin 100 mg+ Glimepiride-placebo (adapted dosage) arm 2: Glimepiride (adapted dosage) + Sitagliptin 100 mg Placebo
Interventions: intervention 1: Sitagliptin intervention 2: Glimepiride intervention 3: Sitagliptin-Placebo intervention 4: Glimepiride-Placebo
Intervention descriptions: intervention 1: Sitagliptin will be given in a daily dosage of 100 mg intervention 2: Glimepiride will be given in a starting daily dosage of 1 mg which will be adapted up to 6 mg intervention 3: Sitagliptin-Placebo will be given additional to Glimepiride (blinded). It will be given in a daily dosage of 100 mg intervention 4: Glimepiride-Placebo will be given additional to Sitagliptin (blinded). It will be given in a starting daily dosage of 1 mg which will be adapted up to 6 mg

Protocol documents:
Clinical trial NCT02387957
Conditions: Age-Related Macular Degeneration
Keywords: Wet AMD subfoveal choroidal neovascularization Fovista® Avastin® Lucentis® Eylea®
Sponsor: Ophthotech Corporation
Start date: 2016-04-26; Completion date: 2017-01-01
Enrollment: 63 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the safety of intravitreal (IVT) Fovista® administered in combination with anti-VEGF therapy.

Detailed description:
60 subjects randomized 1:1:1 and treated with IVT Fovista® 1.5 mg/eye in combination with anti-VEGF therapy as follows:

* Avastin® 1.25 mg/eye (20 subjects)
* Lucentis® 0.5 mg/eye (20 subjects)
* Eylea® 2.0 mg/eye (20 subjects)

Subjects will be stratified by lesion size (≤2 DA vs. \>2 DA).

Subjects will be treated with "combination therapy" of IVT Fovista® and IVT anti-VEGF therapy every month for the first 5 months (Day 1, Months 1,2,3,4), followed by Q12W (every 12 weeks) administration (Months 7,10, 13,16, 19 and 22), for a total of 24 months.

When administered, IVT Fovista® will be given first, followed by IVT anti-VEGF (same day).

Arms: arm 1: Fovista® 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection arm 2: Fovista® 1.5 mg intravitreal injection + 0.5 mg ranibizumab intravitreal injection arm 3: Fovista® 1.5 mg intravitreal injection + 2.0 mg aflibercept intravitreal injection
Interventions: intervention 1: Fovista® intervention 2: bevacizumab intervention 3: ranibizumab intervention 4: aflibercept
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT02401022
Conditions: Tobacco Use Disorder
Keywords: smoking smoking cessation cigarette
Sponsor: National Institute on Drug Abuse (NIDA)
Start date: 2015-07-01; Completion date: 2017-01-01
Enrollment: 214 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy and safety of AZD8529 for smoking cessation in female smokers.

Detailed description:
This is a 19-week, multi-center, randomized, Phase 2 clinical study comparing the efficacy of two different doses of AZD8529 (1.5 and 40 mg) in smoking cessation. Up to 2 weeks will be allowed for the Screening Period, followed by a 1-week, single-blind run-in period. At the end of Study Week 1 (on Study Day 8), medication compliance will be one of the factors used in a predictive enrichment strategy.

Arms: arm 1: 1.5 mg arm 2: 40mg
Interventions: intervention 1: AZD8529
Intervention descriptions: intervention 1: comparison of different dosages of drug

Protocol documents:
Clinical trial NCT02406443
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes, DPP-4 inhibitors, renal sodium excretion
Sponsor: University Health Network, Toronto
Start date: 2015-03-01; Completion date: 2017-01-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Background: Dedicated renal hemodynamic and renal function studies are lacking for DPP-4 inhibitors in patients with Type 2 diabetes; accordingly little is known regarding the mechanisms mediating the renal effects of DPP-4 inhibitors in humans.

Objectives: To evaluate the effect of DPP-4 inhibition acutely (single dose) and following short-term therapy (28 days) on renal sodium handling and renal hemodynamics and function in patients with type 2 diabetes and systolic hypertension.

Design: double-blind, randomized, placebo-controlled trial, Phase IV.

Patient population: 32 patients with Type 2 diabetes, HbA1c (6.5%-9%), with systolic blood pressure ranging from 120-160 mmHg.

Intervention: subjects will be randomized (1:1) to either sitagliptin (100 mg daily) or to placebo (1 tablet daily) for 28 days.

Endpoints: Fractional excretion of sodium, renal function, and renal hemodynamics.

Detailed description:
Background: DPP-4 inhibition improves glycemic control, modestly reduces blood pressure and may also reduce albuminuria in patients with Type 2 diabetes; effects which occur without significantly modifying heart rate or body weight. While preclinical studies have demonstrated that DPP-4 inhibition acutely increases urinary sodium excretion in addition to other favorable renal effects (anti-inflammatory, anti-proteinuric), few studies have examined the renal effects of DPP-4 inhibition either acutely or following short-term therapy in humans with type 2 diabetes. Considering the world-wide prevalence of Type 2 diabetes and the increasing use of DPP-4 inhibitors amongst patients, it is important to ascertain potential non-glycemic effects of DPP-4 inhibitors including those within the kidney.

Study Objectives: To determine effect(s) of DPP-4 inhibition on tubular sodium handling, renal hemodynamics, and renal function.

Study Design: double-blind, randomized, placebo-controlled trial, Phase IV.

Study Patients: 32 patients with Type 2 Diabetes and Systolic Hypertension (SBP 120-160 mmHg).

Endpoints: Fractional excretion of sodium, renal function (measured GFR), renal hemodynamics (effective renal plasma flow, filtration fraction, renal blood flow, renal vascular resistance), systemic hemodynamics (non-invasive cardiac monitoring), plasma neurohormones, urinary vasoactive mediators, markers of free radical stress.

Arms: arm 1: sitagliptin (DPP-4 inhibitor) oral tablet (100 mg); Januvia; administered once daily for 28 days arm 2: placebo (no medicinal ingredients) oral tablet (100 mg); administered once daily for 28 days
Interventions: intervention 1: Sitaglitpin intervention 2: Placebo
Intervention descriptions: intervention 1: Oral DPP-4 inhibitor, 100 mg tablet administered once daily for 28 days intervention 2: Oral tablet (no medicinal ingredients) administered once daily for 28 days

Protocol documents:
Clinical trial NCT02422940
Conditions: Post-ischemic Stroke
Sponsor: Acorda Therapeutics
Start date: 2015-04-01; Completion date: 2017-01-01
Enrollment: 294 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an extension study to evaluate the long-term safety, tolerability, and efficacy of two dose strengths of dalfampridine-ER.

Detailed description:
This is an extension study to evaluate the long-term safety, tolerability, and efficacy of two dose strengths of dalfampridine-ER twice daily tablets when administered for at least 12 months to subjects with chronic post-ischemic stroke walking deficits who have completed the controlled, double-blind Study DALF-PS-1016.

Arms: arm 1: Dalfampridine-ER 7.5 mg tablets taken orally twice daily, approximately 12 hours apart.

Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study. arm 2: Dalfampridine-ER 10 mg tablets taken orally twice daily, approximately 12 hours apart.

Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study.
Interventions: intervention 1: dalfampridine-ER 7.5 mg intervention 2: dalfampridine-ER 10 mg
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02446717
Conditions: Chronic Hepatitis C Hepatitis C Virus HCV Direct-Acting Antiviral Agent (DAA)-Experienced
Keywords: Hepatitis C HCV Genotype 6 HCV GT1 Interferon (IFN) free HCV Genotype 5 HCV HCV GT4 HCV Genotype 4 Chronic Hepatitis C Chronic HCV Hepatitis C Genotype 1 HCV GT5 HCV Genotype 1
Sponsor: AbbVie
Start date: 2015-04-01; Completion date: 2017-01-01
Enrollment: 141 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy and safety of ABT-493 and ABT-530 with or without ribavirin (RBV) in participants with chronic hepatitis C virus, (HCV)-infection who previously failed treatment with a direct acting antiviral (DAA)-containing regimen.

Detailed description:

Arms: arm 1: ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis. arm 2: ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD plus ribavirin (RBV) for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis. arm 3: ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis. arm 4: ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks in HCV genotypes 1- or 4-6- infected participants with or without cirrhosis. arm 5: ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 16 weeks in HCV genotype 1- or 4-6- infected participants with or without cirrhosis.
Interventions: intervention 1: ABT-493, ABT-530 intervention 2: ribavirin (RBV) intervention 3: ABT-493/ABT-530
Intervention descriptions: intervention 1: ABT-493 (tablet) dosed with ABT-530 (tablet) intervention 2: Tablet intervention 3: Tablet; ABT-493 coformulated with ABT-530

Protocol documents:
Clinical trial NCT02484911
Conditions: Chemotherapy-induced Nausea and Vomiting
Keywords: chemotherapy nausea vomiting
Sponsor: First Affiliated Hospital of Harbin Medical University
Start date: 2015-05-01; Completion date: 2017-01-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to mainly evaluate the efficacy and safety of aprepitant in combination with olanzapine ,palonosetron and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly or moderately emetogenic chemotherapy.

Detailed description:
Eligible patients will be randomized to receive different antiemetic regimens . In the experimental group,patients will receive aprepitant,olanzapine ,palonosetron and dexamethasone .In the other group,patients will accept the same dose of aprepitant ,palonosetron and dexamethasone .During the treatment, any grade of nausea and vomiting should be recorded in order to evaluate the complete response rate of CINV,nausea patients will be measured by a visual analogue scale (VAS) ,other adverse events should be recorded as well.

Arms: arm 1: Olanzapine in combination with aprepitant ,palonosetron and dexamethasone. arm 2: Aprepitant in combination with palonosetron and dexamethasone
Interventions: intervention 1: Olanzapine intervention 2: Aprepitant intervention 3: Palonosetron intervention 4: Dexamethasone
Intervention descriptions: intervention 1: 5mg,twice a day orally on day 1 to day 4 intervention 2: 125 mg capsule per oral, 1 hour before chemotherapy on day 1, 80 mg capsule daily in the morning during days 2 to 3. intervention 3: 0.25mg IV 30-60min before chemotherapy on day 1 intervention 4: 6mg IV on day 1 ，3.75mg IV on day 2 to 4

Protocol documents:
Clinical trial NCT02587143
Conditions: Anesthesia Pain
Sponsor: Bionorte
Start date: 2016-02-01; Completion date: 2017-01-01
Enrollment: 126 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Ethyl chloride vapocoolant sprays provide transient skin anesthesia within seconds of application. The current investigation aim is to compare the effect of ethyl chloride based vapocoolant spray to placebo in reducing pain associated with arterial puncture for gasometry determinations.

The investigators will conduce a double-blind randomized placebo-controlled trial at Emergency Department.

We will enroll patients who come to Emergency Department who need an arterial gasometry determination. Patients will be randomized to intervention-group (ethyl chloride vapocoolant sprays will be usad before arterial puncture) or to placebo-group (alcohol spray as placebo will be used before arterial puncture.) and after the puncture they will rate their pain using a 10 points visual analogue scale.

Detailed description:
Single-blind, randomized placebo-controlled trial in an emergency department of Hospital de Basurto in Bilbao, Spain. Patients for whom arterial blood gas analysis had been ordered will be included. They will be randomly assigned to receive application of the experimental ethyl chloride spray or a placebo aerosol spray of a solution of alcohol in water. The assigned spray will be applied just before arterial puncture. The main outcome variable is pain intensity reported on an 11-point numeric rating scale.

Arms: arm 1: Alcohol -based spray as placebo will be administrated before arterial puncture. arm 2: Ethyl choride will be administrated before arterial puncture.
Interventions: intervention 1: Ethyl chloride intervention 2: Alcohol
Intervention descriptions: intervention 1: Nurses will administrate ethyl chloride vapocoolant spray on patient's skin a few seconds before arterial puncture (of cubital arteria). intervention 2: Nurses will use an alcohol-based spray as placebo on patient's skin a few seconds before arterial puncture (of cubital arteria).

Protocol documents: