ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01297959
Conditions: Infections
Keywords: Surgical Wound Infection Therapeutic Enzyme System Singlet Oxygen Peroxidase Glucose Oxidase Colorectal surgery Incisional Surgical Site Infections (SSI) Anti-infective Agents, Local Clinical Trial, Phase III
Sponsor: Excited States, LLC
Start date: 2013-01-10; Completion date: 2015-10-14
Enrollment: 503 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is intended to determine the efficacy, safety and tolerability of topical application of E-101 Solution directly into the surgical incisional wound in the prevention of infection of superficial and deep surgical incisional wounds. E-101 Solution is an enzyme-based antiseptic that is being developed for direct application to a surgical incision.

Detailed description:
The purpose of this standard-of-care, pivotal Phase 3 study is to evaluate the efficacy and safety of topical E-101 Solution after direct application into the principal surgical incision in the prevention of superficial and deep incisional surgical site infections (SSI) within 30 days after elective colorectal surgery. The study is intended to support a target indication statement of: "E-101 Solution is indicated for the prophylaxis of incisional surgical site infections following elective colorectal surgery". E-101 Solution is comprised of the active ingredients of glucose oxidase (GO) and porcine myeloperoxidase (pMPO) that produce coupled reactions after the addition of glucose substrate. The hypothesis is that E-101 Solution topically applied directly into the principal incision is safe and significantly reduces the incidence of incisional SSI compared to placebo topical application. (The principal surgical incision is ≥ 5cm and \< 35 cm used as a hand port, colorectal specimen extraction port, or extracorporeal manipulation port depending on the specific colorectal surgical approach.)

Arms: arm 1: Participants will receive E-101 Solution at porcine myeloperoxidase (pMPO) concentration of 300 guaiacol units per milliliter (GU/mL) applied topically twice to surgical wound site. The first topical application will occur just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application will occur just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound. arm 2: Participants will receive placebo (saline solution) matched to E-101 Solution applied topically twice to surgical wound site. The first topical application will occur just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application will occur just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.
Interventions: intervention 1: E-101 Solution 300 GU/ml intervention 2: Saline solution
Intervention descriptions: intervention 1: 8 mL of E-101 Solution intervention 2: Saline solution matched to E-101

Protocol documents:
Clinical trial NCT01964378
Conditions: Pain Neoplasms Chronic Pain
Keywords: cancer pain neuropathic related cancer pain morphine cebranopadol (GRT6005) Numerical Rating Scale
Sponsor: Tris Pharma, Inc.
Start date: 2013-10-29; Completion date: 2015-10-16
Enrollment: 200 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Pain is one of the most common symptoms associated with malignant tumor. The purpose of this trial is to determine whether cebranopadol is as effective in patients with cancer related pain as morphine sulfate prolonged release (PR).

Detailed description:
The trial comprises an enrollment period, a treatment period (titration and maintenance), and a follow-up period. Participants will receive either cebranopadol or morphine PR for 44 days. Initially participants will be titrated after 2 and then every 4 days to a morphine PR or cebranopadol dose that provides adequate analgesia and is tolerated. The titration period is planned to last 16 days. Thereafter the dose of morphine PR or cebranopadol is to be kept stable for a further 28 days, i.e. no dose adjustments will be allowed during the maintenance period. This 28 day period is the maintenance period. The follow-up period is planned for up to 18 days after the end of last pain medication treatment intake.

Arms: arm 1: Once daily oral administration. 200, 400 or 600 µg film coated tablets. Dosage 200 µg to 1000 µg per day. arm 2: Twice daily oral administration. 15, 30 or 45 mg morphine sulfate capsules. Dosage 30 to 150 mg per day.
Interventions: intervention 1: Cebranopadol intervention 2: Morphine Prolonged Release
Intervention descriptions: intervention 1: Participant will take one or two tablet(s) of cebranopadol in the morning and one or two placebo double-dummy morphine-like capsule(s) in the morning and the evening. intervention 2: Participant will take one or two morphine capsule(s) in the morning and in the evening and one or two placebo double-dummy cebranopadol-like tablet(s) in the morning.

Protocol documents:
Clinical trial NCT03725085
Conditions: Healthy Subjects
Sponsor: Reckitt Benckiser LLC
Start date: 2015-01-24; Completion date: 2015-10-16
Enrollment: 552 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This was an open label, multicentric, non-comparative, single arm prospective post marketing surveillance (PMS) study to evaluate the safety and tolerability of Mucinex™ (GGE, 600 mg ER bi-layer tablets, taken as 1200 mg BID dose) in the treatment of otherwise healthy patients with symptoms of cough, thickened mucus and chest congestion due to URTI. Symptomatic patients who visited the outpatient department of hospitals and clinics or general physicians and had agreed to participate in this study were screened and enrolled into the study.

Detailed description:

Arms: arm 1: 2 tablets of Mucinex™ (GGE, 600 mg ER bi-layer tablets, taken as 1200 mg BID dose) every 12 hours (twice daily, in the morning and the evening) orally with a full glass of water for 7 days.

GGE = Guaifenesin

BID = Twice in a day
Interventions: intervention 1: Mucinex™ extended-release (SE)
Intervention descriptions: intervention 1: 2 tablets of Mucinex™ (GGE, 600 mg extended-release bi-layer tablets)

Protocol documents:
Clinical trial NCT01113515
Conditions: Diabetic Foot Ulcer
Keywords: Diabetic foot ulcer Diabetic wound chronic non healing ulcer
Sponsor: Novalead Pharma Private Limited
Start date: 2014-02-20; Completion date: 2015-10-17
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine safety and efficacy of a new gel formulation of Esmolol hydrochloride (Galnobax®) for the treatment of Diabetic Foot Ulcer (DFU). The study will compare number and types of adverse events occured, rates of wound closure and percentage of wounds closed in Galnobax treated groups versus placebo group.

Detailed description:
This is an interventional, placebo-controlled, randomized, double-blinded, dose comparison, phase I/II study of Galnobax® in subjects with diabetic foot ulcers. Additionally the effect of dosage and frequency of application will also be studied . The total trial duration per subject is 25 weeks which comprises of 1 week for screening, 12 weeks of treatment and 12 weeks of follow-up.

Arms: arm 1: Placebo gel arm 2: Esmolol Hydrochloride (Galnobax) 20% gel once daily arm 3: Esmolol Hydrochloride (Galnobax) 20% gel twice daily arm 4: Esmolol Hydrochloride (Galnobax) 14% gel twice daily
Interventions: intervention 1: Esmolol hydrochloride intervention 2: Esmolol hydrochloride intervention 3: Esmolol hydrochloride intervention 4: Placebo gel
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00978380
Conditions: Congenital Bleeding Disorder Congenital FXIII Deficiency
Sponsor: Novo Nordisk A/S
Start date: 2009-09-21; Completion date: 2015-10-20
Enrollment: 63 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This trial is conducted in Asia, Europe and North America. The aim of the trial is to investigate the safety of monthly replacement therapy of recombinant factor XIII in patients with congenital FXIII deficiency. The trial continues until the product is commercially available, but an interim assessment will take place when all subjects have completed 52 weeks in the trial.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: catridecacog
Intervention descriptions: intervention 1: Monthly administration of recombinant factor XIII as preventative treatment of bleeding episodes. Dose: 35 IU/kg body weight intravenous (into the vein)

Protocol documents:
Clinical trial NCT00183872
Conditions: Gastric Cancer Esophageal Neoplasms
Keywords: Gastroesophageal cancer Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma
Sponsor: University of Southern California
Start date: 2005-04-14; Completion date: 2015-10-20
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is for people with advanced gastric or gastroesophageal cancer. This study is being done to find out how long it takes tumors to grow after receiving treatment with the drugs irinotecan (also known as CPT-11) and docetaxel (also known as Taxotere). Irinotecan is a drug that has been approved by the Food and Drug Administration (FDA). Irinotecan has been approved for treatment of cancer of the colon and rectum. Docetaxel is another drug approved by the FDA. Docetaxel is approved for treatment of breast, prostate and lung cancer. However, the FDA has authorized the use of irinotecan and docetaxel in this study. This study will evaluate the effects of these drugs on participant's tumors. The side effects of the combination of irinotecan and docetaxel will also be evaluated. This study will also measure the levels of certain substances in participant's tumors. These substances, called genes (which are the cell's blueprint), affect how people's bodies react to the cancer drugs. Genes will also be measured in participant's blood. The researchers want to see if these substances can predict response to the study drugs.

Detailed description:

Arms: arm 1: Irinotecan given day 1 and 8 every 21 days Docetaxel given day 1 and 8 every 21 days
Interventions: intervention 1: irinotecan, docetaxel
Intervention descriptions: intervention 1: docetaxel 30 mg/m2 IV infusion days 1 and 8, with irinotecan 65 mg/m2 IV infusion on days 1 and 8.

Protocol documents:
Clinical trial NCT02296476
Conditions: Glioblastoma Multiforme
Sponsor: Oncoethix GmbH, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Start date: 2014-10-29; Completion date: 2015-10-20
Enrollment: 12 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study of single-agent birabresib (MK-8628) (formerly known as OTX015) in recurrent GBM after standard front-line therapy failure.

The first phase of the study (dose escalation) will determine the maximum tolerated dose (MTD). MTD assessment will be based using dose-limiting toxicities (DLTs) observed during the first 28 days of treatment.

The second phase of the study (expansion cohort) will assess efficacy as measured by the progression-free survival rate at 6 months (PFS-6) as determined by an independent central review committee.

Detailed description:

Arms: arm 1: Participants received 80 mg of oral birabresib administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles. arm 2: Participants received 120 mg of oral birabresib administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles. arm 3: Participants received 160 mg of oral birabresib administered once daily (in a fasted state) every day in a 28-day cycle for up to 6 cycles.
Interventions: intervention 1: Birabresib
Intervention descriptions: intervention 1: Administered orally in a fasted state once daily.

Protocol documents:
Clinical trial NCT01766778
Conditions: Type-2 Diabetes Mellitus
Keywords: type-2 diabetes mellitus, inadequately controlled Metformin
Sponsor: Novartis Pharmaceuticals
Start date: 2013-05-13; Completion date: 2015-10-22
Enrollment: 117 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to observe change of HbA1c over time from baseline to month 12. The ultimate goal of this study was to provide a local reference value to the physicians \& patients in the future when they consider initiating Vildagliptin and taking balance between efficacy, compliance, risk factors, convenience and medication cost.

Detailed description:

Arms: arm 1: Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin arm 2: Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin
Interventions: intervention 1: LAF237 (vildagliptin) intervention 2: Metformin
Intervention descriptions: intervention 1: Vildagliptin 50mg capsule intervention 2: Metformin maximum tolerance dose

Protocol documents:
Clinical trial NCT01972841
Conditions: Urinary Bladder Overactive Urinary Bladder Diseases\Urologic Diseases Overactive Bladder Urgency Incontinence
Keywords: Combination Therapy Mirabegron Overactive Bladder Urgency Urinary Incontinence Nocturia Solifenacin Succinate
Sponsor: Astellas Pharma Europe B.V.
Start date: 2013-11-05; Completion date: 2015-10-22
Enrollment: 3527 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to examine how well two medicines (solifenacin succinate and mirabegron) combined work compared to each medicine alone in the treatment of bladder problems.

Detailed description:

Arms: arm 1: Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks. arm 2: Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks. arm 3: Participants who received matching placebo once a day for 12 weeks. arm 4: Participants who received solifenacin 5 mg once a day for 12 weeks. arm 5: Participants who received mirabegron 25 mg once a day for 12 weeks. arm 6: Participants who received mirabegron 50 mg once a day for 12 weeks.
Interventions: intervention 1: Solifenacin succinate intervention 2: Mirabegron intervention 3: Placebo to match solifenacin succinate intervention 4: Placebo to match mirabegron
Intervention descriptions: intervention 1: Oral tablet intervention 2: Oral tablet intervention 3: Oral tablet intervention 4: Oral tablet

Protocol documents:
Clinical trial NCT02397954
Conditions: Idiopathic Polypoidal Choroidal Vasculopathy
Keywords: idiopathic polypoidal choroidal vasculopathy IPCV Zimura™ (previous name) Avastin® Eylea® Lucentis®
Sponsor: Ophthotech Corporation
Start date: 2015-03-12; Completion date: 2015-10-23
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objectives of this study are to evaluate the safety and tolerability of Zimura™ intravitreous injection in combination with anti-vascular endothelial growth factor (VEGF) therapy in subjects with Idiopathic Polypoidal Choroidal Vasculopathy (IPCV).

Detailed description:
Treatment experienced (Prior treatment with anti-VEGF monotherapy of ≥8 injections in the previous twelve (12) months) subjects of either gender aged 50 years or above with a diagnosis of IPCV, will receive 3 monthly (Q4W) intravitreal injections of Zimura™ (1 mg/eye) in combination with anti-VEGF therapy (Avastin® 1.25 mg/eye or Lucentis® 0.5 mg/eye or Eylea® 2 mg/eye).

Safety endpoints include visual acuity loss (proportion of subjects with \>15 letter loss at Month 3), ophthalmic adverse events (AEs), systemic adverse events (AEs), change in total retinal thickness (SD-OCT) at Month 3, regression and/or elimination of polyps at Month 3 compared to screening as measured by indocyanine green angiography (ICGA), and laboratory values.

Arms: arm 1: Subjects will receive monthly intravitreous injections of Avacincaptad Pegol in combination with either Lucentis, Avastin or Eylea.
Interventions: intervention 1: Avacincaptad Pegol
Intervention descriptions: intervention 1: Subjects will receive monthly intravitreous injections of Avacincaptad Pegol in combination with Lucentis, Avastin or Eylea.

Protocol documents:
Clinical trial NCT02520297
Conditions: Pain
Keywords: Pain Long bone Fracture
Sponsor: Trevena Inc.
Start date: 2015-10-20; Completion date: 2015-10-23
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective is to evaluate the analgesic efficacy of TRV130 for moderate to severe acute pain in patients presenting to the emergency department (ED) with a suspected/known, unilateral, closed long bone fracture.

Detailed description:
This study is designed to evaluate the analgesic efficacy of TRV130 for the treatment of moderate to severe acute pain associated with a long bone fracture in patients presenting to the ED. The safety and tolerability of TRV130 will also be evaluated in this open-label pilot study.

Arms: arm 1: Drug: TRV130
Interventions: intervention 1: TRV130
Intervention descriptions: intervention 1: Drug

Protocol documents:
Clinical trial NCT01462357
Conditions: Infections, Papillomavirus
Keywords: Human papillomavirus Safety HPV vaccine Immune response
Sponsor: GlaxoSmithKline
Start date: 2011-11-21; Completion date: 2015-10-27
Enrollment: 1079 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the immunogenicity and the safety of Cervarix administered according to a 2-dose schedule at 0, 6 months compared to Gardasil, administered according to a 2-dose schedule at 0, 6 months or the standard 3-dose schedule of 0, 2, 6 months in 9-14 years old healthy females.

Detailed description:

Arms: arm 1: Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm. arm 2: Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm. arm 3: Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
Interventions: intervention 1: Cervarix intervention 2: Gardasil intervention 3: Placebo
Intervention descriptions: intervention 1: 2 doses of 0.5 mL supplied as a liquid in individual pre-filled syringes to be administered intramuscularly in the deltoid muscle of the non-dominant arm at Day 0 and Month 6. intervention 2: 2 or 3 doses of 0.5 mL supplied as a liquid in individual pre-filled syringes or vials to be administered intramuscularly in the deltoid muscle of the non-dominant arm at Day 0 and Month 6 (Gardasil 2 dose Group) or at Day 0, Month 2 and Month 6 (Gardasil 3 dose Group), respectively. intervention 3: 2 doses of 0.5 mL supplied as a liquid in individual pre-filled syringes to be administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 2 to maintain blinding.

Protocol documents:
Clinical trial NCT01646762
Conditions: Refractory Plasma Cell Myeloma
Sponsor: Mayo Clinic
Start date: 2012-11-05; Completion date: 2015-10-27
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with multiple myeloma that has returned or did not respond to treatment. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate the efficacy (overall response rate) of single agent nab-paclitaxel (Abraxane) (paclitaxel albumin-stabilized nanoparticle formulation) in patients with relapsed or refractory multiple myeloma.

SECONDARY OBJECTIVES:

I. To evaluate the adverse events associated with use of single agent nab-paclitaxel (Abraxane) in patients with relapsed or refractory multiple myeloma.

II. To evaluate overall survival, time to progression, and duration of response among patients with relapsed or refractory multiple myeloma undergoing treatment with single agent nab-paclitaxel (Abraxane).

OUTLINE:

Patients receive paclitaxel albumin-stabilized nanoparticle formulation intravenously (IV) over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3-6 months for up to 3 years.

Arms: arm 1: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Paclitaxel Albumin-Stabilized Nanoparticle Formulation intervention 2: Laboratory Biomarker Analysis
Intervention descriptions: intervention 1: Given IV intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT02554799
Conditions: Malaria
Sponsor: Medicines for Malaria Venture
Start date: 2015-09-17; Completion date: 2015-10-28
Enrollment: 18 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will be conducted in a single centre, as an open single dose two parallel cohorts design with oral doses of MMV390048 administered in healthy male and female subjects between 18 to 55 years of age. Subjects will be screened within 28 days prior to entering the study. On Day 1 of the study each subject will receive one of the two MMV390048 prototype formulations, at a dose of 40 mg with 240 mL of water. Subjects will be discharged on Day 3 after 48h post-dose and they will attend the unit for follow-up visits on Days 5, 7, 10, 14, 19, 26 and 29.

Detailed description:
A Phase 1 exploratory study to evaluate the pharmacokinetics of selected oral formulations of MMV390048 administered in healthy volunteers. It is anticipated that eighteen (18) healthy male and female subjects are to be included in the study, however there is an option to include an additional cohort of 9 subjects. The optional cohort would receive a single dose of the formulation considered to have the least pharmacokinetic variability with a suitable safety and tolerability profile with food or milk. Timing of PK samples may be adjusted in accordance with evolving data and dosing schedule. Additional or fewer PK samples may be taken in accordance with evolving data and dosing schedule to establish full protocol specific PK profile. The study specific maximum blood volume taken will not be exceeded.

Arms: arm 1: 40 mg MMV390048 tablet formulation A, in fasted state arm 2: 40 mg MMV390048 tablet formulation B fasted arm 3: Optional cohort: 40 mg of MMV390048 in the formulation that has been shown to have the most favourable PK profile, taken with milk or in the fed state.
Interventions: intervention 1: MMV390048 formulation A intervention 2: MMV390048 formulation B
Intervention descriptions: intervention 1: MMV390048 formulation A, tablet intervention 2: MMV390048 formulation B, tablet

Protocol documents: