ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02643251
Conditions: Painful Diabetic Neuropathy Diabetic Neuropathy Neuropathy
Keywords: Diabetes Mellitus Pain Foot Pain Neuropathy
Sponsor: BioDelivery Sciences International
Start date: 2015-12-01; Completion date: 2016-11-01
Enrollment: 138 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will include three (3) phases: Screening Phase, Treatment Phase, and Follow-up Phase. Subjects who qualify to participate will apply study drug to their feet three times daily and will record their daily pain scores using an interactive voice response system (IVRS) during the Treatment Phase for 12 weeks. Approximately 100 adult subjects will be randomized to receive Clonidine Gel or Clonidine Gel Comparator.

Detailed description:
Study CLO-291 is a randomized, double-blind, comparator-controlled, parallel-group, multicenter study of 0.1% clonidine topical gel (Clonidine Gel) for the treatment of pain associated with painful diabetic neuropathy. The study will include three (3) phases: Screening Phase, Treatment Phase, and Follow-up Phase. Subjects who satisfy all eligibility criteria will apply Clonidine Gel Comparator to their feet three times daily and will record their daily pain scores using an interactive voice response system (IVRS). Approximately 100 adult subjects will be randomized to receive Clonidine Gel or Clonidine Gel Comparator during the 12 week Treatment Phase.

Arms: arm 1: Clonidine Hydrochloride Topical Gel,0.1% arm 2: Clonidine Hydrochloride Gel Comparator
Interventions: intervention 1: Clonidine Hydrochloride Topical Gel, 0.1% intervention 2: Clonidine Hydrochloride Gel Comparator
Intervention descriptions: intervention 1: Clonidine Gel is supplied as an aqueous gel formulation for topical use. intervention 2: Clonidine Gel Comparator is supplied as an aqueous gel formulation for topical use.

Protocol documents:
Clinical trial NCT02649920
Conditions: Delivery
Keywords: unfavorable cervix obese pregnant women
Sponsor: Centre Hospitalier Departemental Vendee
Start date: 2016-06-01; Completion date: 2016-11-01
Enrollment: 2 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
At the moment in France, one delivery on four is induced for a medical indication. In this context, the practitioners are exposed to an additional difficulty when the clinical examination of the patient reveals a unfavorable cervix because the main drug used for the releases cannot be used and the cervix must be previously mature.

There is a pharmacological method used and estimated in these indications of cervical maturation: the dinoprostone (Propess®).

Other methods using a mechanical process, are under development and of evaluation as it is the case of the probe of dilation with double balloon (Cook®).

The population of the obese women is a population in constant increase in France and presenting deliveries to higher risks of maternal and foetal complications. At these patients, the medicinal releases seem also more difficult and at greater risks of failures.

The investigators wish compared the efficiency of the cervical ripening balloon to the dinoprostone within the framework of a medical indication in a release with a unfavorable cervix in obese pregnant women.

Detailed description:

Arms: arm 1: Prospective arm 2: Retrospective
Interventions: intervention 1: Cervical ripening balloon intervention 2: Dinoprostone
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02678286
Conditions: Pain, Post-operative
Keywords: Abdominoplasty Pain Analgesia N1539 Phase 3
Sponsor: Baudax Bio
Start date: 2016-01-01; Completion date: 2016-11-01
Enrollment: 219 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the analgesic efficacy of N1539 in subjects with acute moderate to severe pain following abdominoplasty surgery.

Detailed description:

Arms: arm 1: N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses. arm 2: IV Placebo every 24 hours for up to 3 doses.
Interventions: intervention 1: N1539 intervention 2: Intravenous Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02680457
Conditions: Type 2 Diabetes Mellitus
Sponsor: University of Guadalajara
Start date: 2013-11-01; Completion date: 2016-11-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Type 2 diabetes mellitus (T2DM) is characterized by wide fluctuations of glucose. The long-acting insulin has showed to improve glycemic variability however the behavior of insulin glargine versus insulin degludec is unknown.

Detailed description:
Cross-over, double dummy, randomized, clinical trial was carried out. The sample size was calculated using the formula for clinical trials of mean differences with an "n" of 6 patients per group was obtained. Patients between 30 and 65 years of age will be included with T2DM, without hyperglycemic drugs, hemoglobin A1c (A1C) 6.5 to 11.0 % and with written signature consent. They were assigned randomly by sealed envelope either to received insulin Degludec (Novo Nordisk A/S. Bagsvaerd, Denmark) or insulin Glargine (Sanofi-Aventis Deutschland GmbH. Frankfurt, Germany) \[10 international units (IU) subcutaneous (SC) every 24 hours for six days\], patients who were administered initially insulin Degludec corresponded then insulin Glargine and vice versa, with a washout period of 14 days between each intervention.

The clinical findings and laboratory tests included a metabolic profile and biosafety, which will be made at baseline. Body weight, body mass index and blood pressure were performed during the initial visit, likewise, interstitial glucose concentrations by ambulatory continuous glucose monitoring system (Guardian®, Medtronic MiniMed, Northridge), through which the mean amplitude of glucose excursions (MAGE) and area under the curve of glucose were calculated, which served to assess the glycemic variability. Adverse events and adherence to treatment are documented. Statistical analysis: Mann-Whitney U test, Chi2, Fisher exact test. It is considered with significance at p \<0.05.

Arms: arm 1: Insulin Degludec 10 IU SC every 24 hours for 6 days Washout for 14 days Insulin Glargine 10 IU SC every 24 hours for 6 days arm 2: Insulin Glargine 10 IU SC every 24 hours for 6 days Washout for 14 days Insulin Degludec 10 IU SC every 24 hours for 6 days
Interventions: intervention 1: Insulin Degludec intervention 2: Insulin Glargine
Intervention descriptions: intervention 1: Insulin Degludec 10 IU SC every 24 hours for 6 days intervention 2: Insulin Glargine 10 IU SC every 24 hours for 6 days

Protocol documents:
Clinical trial NCT02681172
Conditions: Alzheimer's Disease (AD)
Keywords: CSF Alzheimer's Disease (AD) and related dementia HAS recommendations
Sponsor: Piramal Imaging Limited
Start date: 2015-10-01; Completion date: 2016-11-01
Enrollment: 218 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase 4 study will explore, in the context of the present French clinical practice, the impact of florbetaben 18F (FBB) in patients evaluated for AD who require a biomarker for etiologic determination of the cognitive and functional impairment, but in whom:

1. lumbar puncture was not feasible for medical conditions
2. results of cerebrospinal fluid (CSF) analysis were considered ambiguous by treating physicians
3. lumbar puncture (LP) was refused by the patient

Detailed description:
It will be conducted in an outpatient setting at the tertiary memory clinics (CMRR) in France in patients with a preliminary diagnosis based on the completion of a prior, full diagnostic workup, not more than 12 months previously - which could include, but will not be limited to brain imaging if needed (magnetic resonance imaging (MRI) or computed tomography (CT)), neuropsychological evaluation including a Mini-Mental Status Examination (MMSE), CSF examination and other examinations according to "Haute Autorité de santé" (HAS, National Authority of Health, France) Recommendations - and in whom:

1. lumbar puncture was not feasible for medical conditions
2. results of cerebrospinal fluid (CSF) analysis were considered ambiguous by treating physicians
3. lumbar puncture (LP) was refused by the patient

For all subjects the study will comprise 3 outpatient clinic visits to record information on previous work ups and to perform the FBB Positron Emission Tomography (PET) scan (Visit 1: screening/ baseline, Visit 2: PET scan, Visit 3: subject informed on the FBB PET scan result).

At Visit 1, the initial diagnosis based on previous work up will be collected and rated on a five-point Likert confidence scale by the Physician.

At Visit 2, the FBB PET scan will be performed. Adverse events will be reported during the exam and up to 7 days after the PET procedure.

At Visit 3, based on the amyloid PET scan results, change of diagnosis will be collected, in addition to physician confidence.

Arms: arm 1: A single dose of 300 Megabecquerels (8.1 millicuries) Neuraceq will be administered per subject.

The applied florbetaben radioactive dose will be ± 20%.
Interventions: intervention 1: Neuraceq (florbetaben 18F) intervention 2: PET
Intervention descriptions: intervention 1: Florbetaben 18F is given as an i.v. injection followed by a flush of sodium chloride solution to ensure full delivery of the dose. intervention 2: A brain PET scan is usually taken 90 minutes after the i.v. injection of florbetaben 18F.

Protocol documents:
Clinical trial NCT02693002
Conditions: Menopause
Sponsor: Gretchen Wells
Start date: 2016-02-01; Completion date: 2016-11-01
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Peri-menopausal women will be randomized to hormone replacement therapy or placebo for 12 weeks to determine if markers of systolic and diastolic function change by echocardiography as well as laboratory markers of heart failure, including b-type natriuretic peptide (BNP).

Detailed description:
This preliminary, feasibility study will randomize 28 peri-menopausal women to either hormone replacement therapy or placebo for 12 weeks. Prior to randomization, each participant will undergo echocardiography, measurements of activity using the Duke Activity Status Index, measurements of quality of life and laboratory data, including b-type natriuretic peptide (BNP) measurements. Following the intervention for 12 weeks, these measurements will all be repeated.

Arms: arm 1: Estradiol/norethindrone acetate 1mg/0.5 mg by mouth oral daily for 12 weeks arm 2: Inert ingredients by mouth oral daily for 12 weeks
Interventions: intervention 1: Estradiol/Norethindrone acetate intervention 2: Placebo
Intervention descriptions: intervention 1: Estradiol/Norethindrone acetate 1mg/0.5 mg intervention 2: inactive ingredient

Protocol documents:
Clinical trial NCT02714062
Conditions: Pediatric Obesity Childhood Obesity
Keywords: Adolescent Obesity Childhood Obesity Qsymia Pharmacokinetics VI-0521 Phentermine Topiramate
Sponsor: VIVUS LLC
Start date: 2016-03-01; Completion date: 2016-11-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to describe the pharmacokinetic profiles of VI-0521 in obese adolescents.

Detailed description:

Arms: arm 1: Days 1-56: Placebo arm 2: * Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg) arm 3: * Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
Interventions: intervention 1: Placebo intervention 2: VI-0521 Mid Dose intervention 3: VI-0521 Top Dose
Intervention descriptions: intervention 1: po once daily intervention 2: po once daily intervention 3: po once daily

Protocol documents:
Clinical trial NCT02762370
Conditions: Osteoarthritis of the Knee Type 2 Diabetes Mellitus
Keywords: osteoarthritis knee pain diabetes intra-articular injection corticosteroid
Sponsor: Pacira Pharmaceuticals, Inc
Start date: 2016-04-01; Completion date: 2016-11-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to compare the effects of FX006 and Triamcinolone Acetonide Injectable Suspension, United States Pharmacopeia (USP) (referred to as TCA IR in the protocol) on blood glucose (BG) in patients with osteoarthritis (OA) of the knee and Type 2 diabetes mellitus (DM).

Detailed description:
This study employed a double-blind, randomized, parallel group, single dose design to explore the pharmacodynamic effects on BG levels in type 2 diabetics following IA administration of 32 mg FX006 compared to 40 mg TCA IR. The study was conducted in male and female patients ≥40 years of age with OA of the knee and type 2 DM not managed by injectable agents. In order to be eligible for study participation, patients were to be treated with 1 or 2 oral agents and have hemoglobin A1c (HbA1c) levels between 6.5%-9.0%.

Approximately 36 patients were planned to be randomized and treated to ensure there were at least 30 evaluable patients (15 patients on FX006 and 15 patients on TCA IR). Patients were randomized to 1 of 2 treatment groups (1:1) and treated with a single IA injection of either:

* 32 mg FX006 (18 patients) or
* 40 mg TCA IR (18 patients)

BG levels in each patient were evaluated for a total of 3 weeks (1 week prior to IA injection and 2 weeks post IA injection). After a screening visit, patients' BG levels were measured using a Dexcom Z4 Platinum Professional™ continuous glucose monitor (CGM) device, set to blinded mode, for up to 1 week pre-injection and for 2 weeks post injection using the same blinded CGM device. Patients also were provided with a Bayer Contour™ standard glucose measuring meter in order to perform the necessary calibrations per the manufacturer's recommendations. A final safety visit was planned at 6 weeks post-injection.

Arms: arm 1: Single 5 mL intra-articular (IA) injection Extended-release Formulation arm 2: Single 1 mL intra-articular (IA) injection Immediate-release Formulation
Interventions: intervention 1: FX006 32 mg intervention 2: TCA IR 40 mg
Intervention descriptions: intervention 1: Single 5 mL IA injection intervention 2: Single 1 mL IA injection

Protocol documents:
Clinical trial NCT02786810
Conditions: Urinary Tract Infection Vesicoureteral Reflux
Sponsor: University of Tennessee
Start date: 2016-03-01; Completion date: 2016-11-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study will be evaluating the efficacy and safety of a contrast drug in pediatric renal ultrasound.

Detailed description:

Arms: arm 1: All subjects will be recruited into this arm. All subjects will receive 0.03 ml/kg IV sulfur hexafluoride type-a lipid microspheres one time, unless a second, adjusted dose is necessary.
Interventions: intervention 1: Sulfur hexafluoride type-a lipid microspheres
Intervention descriptions: intervention 1: Used as a contrast to enhance renal ultrasound

Protocol documents:
Clinical trial NCT02803307
Conditions: Osteoarthritis of the Knee
Keywords: osteoarthritis of the knee TLC599 Dexamethasone DSP
Sponsor: Taiwan Liposome Company
Start date: 2015-06-01; Completion date: 2016-11-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is a multi-site, randomized, open-label, parallel, and single-dose administration study to investigate the safety and efficacy of TLC599 in subjects with osteoarthritis of the knee.

Detailed description:
Protocol No: TLC599A1001

Name of Finished Product: TLC599

Title of Study:

A Randomized, Open-label, Parallel, Phase I/II Single-Dose Administration trial of TLC599 in Subjects with Osteoarthritis (OA) of the Knee

Methodology This trial is a multi-site, randomized, open-label, parallel, and single-dose administration study to investigate the safety and efficacy of TLC599 in subjects with osteoarthritis of the knee.

Study duration:

The trial will last 14 weeks including a 14-day screening period and a 12-week follow-up period.

Arms: arm 1: 6 mg DSP with 50 μmol PL arm 2: 12 mg DSP with 100 μmol PL
Interventions: intervention 1: TLC599
Intervention descriptions: intervention 1: Single dose via intra-articular injection

Protocol documents:
Clinical trial NCT02809183
Conditions: Acidosis
Keywords: metabolic acidosis serum bicarbonate kidney disease
Sponsor: Tricida, Inc.
Start date: 2016-03-01; Completion date: 2016-11-01
Enrollment: 135 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a double-blind, placebo-controlled, parallel-design, 6-arm, fixed dose study. The study enrolled 135 adult male and female subjects with Stage 3 or 4 chronic kidney disease and low serum bicarbonate levels. The study was conducted in two parts. In Part 1 study drug dosing (TRC101 or placebo) continued for 14 days twice daily (BID). In Part 2 study drug dosing (TRC101 or placebo) continued for 14 days once daily (QD).

The maximum study duration per subject was anticipated to be up to 42 days.

Detailed description:

Arms: arm 1: Administered twice daily (BID) for 14 days arm 2: Administered twice daily (BID) for 14 days arm 3: Administered twice daily (BID) for 14 days arm 4: Administered twice daily (BID) for 14 days arm 5: Administered once daily (QD) for 14 days arm 6: Administered once daily (QD) for 14 days
Interventions: intervention 1: Placebo intervention 2: TRC101
Intervention descriptions: intervention 1: oral suspension intervention 2: oral suspension

Protocol documents:
Clinical trial NCT02914379
Conditions: Healthy
Sponsor: Eli Lilly and Company
Start date: 2016-09-01; Completion date: 2016-11-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to measure how much LY3337641 gets into the bloodstream and how long it takes the body to get rid of it. In addition, the safety and tolerability of the study drug will be evaluated.

Participants will be admitted to a clinical research unit (CRU) the day before dosing. Participants remain confined to the CRU for at least 7 days. Participants may be discharged from the CRU any time after 7 days post-dose (Day 8), and up to a maximum of 21 days post-dose (Day 22).

This study will last approximately 30 days for each participant, not including screening. Screening is required within 28 days prior to the start of the study.

Detailed description:

Arms: arm 1: Participants received 20 milligrams (mg) oral dose of LY3337641 containing 120 microcuries of radioactivity.
Interventions: intervention 1: [¹⁴C]-LY3337641
Intervention descriptions: intervention 1: Administered orally

Protocol documents:
Clinical trial NCT02917733
Conditions: Healthy
Sponsor: Eli Lilly and Company
Start date: 2016-09-01; Completion date: 2016-11-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This type of study is called a radiolabeled study. For this study, LY3039478 (study drug) has been specially prepared to contain radiolabeled carbon \[¹⁴C\]. \[¹⁴C\] is a naturally occurring radioactive form of the element carbon. This study will help determine how the drug appears in the blood, urine, and stool after it is administered by mouth to healthy people. Information about any side effects that may occur will also be collected. This study will last about 10 weeks for each participant.

Detailed description:

Arms: arm 1: Single dose of radiolabelled LY3039478 administered orally.
Interventions: intervention 1: LY3039478
Intervention descriptions: intervention 1: Administered orally

Protocol documents:
Clinical trial NCT02992236
Conditions: Renal Function Impairment in Healthy Volunteers
Sponsor: veriNOS operations GmbH
Start date: 2015-08-01; Completion date: 2016-11-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Analysis of the effect of the NO-Synthase inhibitor VAS203 (6 hours infusion of 10 mg/kg) on renal function and perfusion in 16 healthy subjects.

Detailed description:
Analysis of the effect of i.v. VAS203 on renal function and perfusion in healthy subjects.

Primary objective:

Possible adverse effect of VAS203 on the Renal Plasma Flow (RPF) and the Glomerular Filtration Rate (GFR) during and after 6 hours of constant-rate iv. infusion of 10 mg/kg VAS203.

Secondary objective:

To analyse the effects of VAS203 on

* filtration fraction
* hemodynamics (afferent and efferent resistance, intraglomerular pressure)
* markers of kidney injury and renal function
* systolic, mean and diastolic brachial blood pressure
* Plasma Pharmacokinetic of VAS203 and its first metabolite.

Arms: arm 1: Infusion (6 hours) of Saline arm 2: Infusion (6 hours) of VAS203 (10 mg/kg)
Interventions: intervention 1: VAS203 intervention 2: Saline
Intervention descriptions: intervention 1: Infusion of NO-Synthase inhibitor VAS203 intervention 2: Infusion of saline

Protocol documents:
Clinical trial NCT00890825
Conditions: Non Small Cell Lung Cancer
Keywords: Non small cell lung cancer (NSCLC) KRAS mutation
Sponsor: AstraZeneca
Start date: 2009-04-20; Completion date: 2016-11-02
Enrollment: 88 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy of AZD6244 in combination with docetaxel versus docetaxel alone in patients with KRAS mutation positive locally advanced or metastatic non small cell lung cancer.

Detailed description:
The primary objective of this study was to assess the efficacy in terms of overall survival (OS) of AZD6244 in combination with docetaxel, compared with docetaxel alone, in second-line patients with KRAS mutation-positive locally advanced or metastatic NSCLC. Amendment 4 of the CSP altered the primary objective and outcome variable from progression-free survival (PFS) to OS, and the secondary outcome variable changed from OS to PFS.

The secondary objectives of the study were:

* To further assess the efficacy of AZD6244 in combination with docetaxel, compared with docetaxel alone, in second-line patients with KRAS mutation-positive locally advanced or metastatic NSCLC
* To assess the safety and tolerability profile of AZD6244 in combination with docetaxel
* To investigate the use of plasma and serum as a potential source of circulating free tumour DNA (cfDNA) for the analysis of KRAS mutation status
* To investigate the PK of AZD6244 and N-desmethyl AZD6244 and any other known metabolites when AZD6244 is administered in combination with docetaxel.

The exploratory objectives of the study were:

* To assess the prevalence, severity and change over time of advanced NSCLC cancer specific symptoms in patients receiving AZD6244 in combination with docetaxel and docetaxel alone
* To explore potential biomarkers in residual tumour, plasma and/or serum taken for KRAS mutational analysis which may influence development of NSCLC (and associated clinical characteristics) and/or response (optional)
* To investigate the relationship between AZD6244 and/or N-desmethyl AZD6244 and any other known metabolite plasma concentrations or exposure and clinical outcomes, efficacy, AEs, and/or safety parameters if deemed appropriate
* To collect and store deoxyribonucleic acid (DNA), derived from a blood sample, for future exploratory research into genes that may influence response, eg, distribution, safety, tolerability, and efficacy of AZD6244 and/or agents used in combination and/or as comparators (optional).

Arms: arm 1: AZD6244 75 mg bd + Docetaxel 75 mg/m\^2 arm 2: Placebo + Docetaxel 75 mg/m\^2
Interventions: intervention 1: AZD6244 intervention 2: docetaxel intervention 3: Placebo
Intervention descriptions: intervention 1: oral capsules, 75mg twice daily intervention 2: 75mg/m2 iv on day 1 of every 21 day cycle intervention 3: placebo

Protocol documents: