ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02499952
Conditions: Germ Cell Neoplasms Testicular Neoplasms Non Seminomatous Germ Cell Tumors Mediastinal Neoplasms Genital Neoplasms, Male Genital Neoplasms, Female Ovarian Neoplasms
Keywords: Pembrolizumab MK-3475 PMNSGCT PD-L1 Non Seminomatous Germ Cell Tumors
Sponsor: Nasser Hanna, M.D.
Start date: 2016-01-01; Completion date: 2017-01-13
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open label, multi-institutional, single arm phase II trial of pembrolizumab in patients with incurable platinum refractory germ cell tumors. No randomization or blinding is involved.

Detailed description:
OUTLINE: This is a multi-center study.

Eligible subjects must have received initial cisplatin-based combination therapy, such as bleomycin-etoposide-cisplatin (BEP), cisplatin-etoposide (EP), etoposide-ifosfamide-cisplatin (VIP), or similar regimens AND demonstrated progression following the administration of at least one 'salvage' regimen for advanced germ cell neoplasm, such as high dose chemotherapy, paclitaxel-ifosfamide-cisplatin (TIP), or vinblastine-ifosfamide-cisplatin (VeIP).

INVESTIGATIONAL TREATMENT:

Pembrolizumab 200mg IV every 3 weeks until progression or toxicity. Treatment will continue for up to 52 weeks in the absence of prohibitive toxicities or disease progression.

The following screening labs to demonstrate adequate organ function must be performed within 10 days of treatment initiation:

Hematological:

* Absolute neutrophil count (ANC) ≥1,500 /mcL
* Platelets ≥100,000 / mcL
* Hemoglobin ≥9 g/dL or ≥5.6 mmol/L without transfusion or hematopoietin (EPO) dependency (within 7 days of assessment)

Renal:

* Serum creatinine ≤1.5 X upper limit of normal (ULN) OR
* Measured or calculated creatinine clearance ≥60 mL/min for subject with creatinine levels \>1.5 X institutional ULN
* Glomerular filtration rate (GFR) can also be used in place of creatinine or creatinine clearance (CrCl)

Hepatic:

* Serum total bilirubin ≤ 1.5 X ULN OR
* Direct bilirubin ≤ ULN for subjects with total bilirubin levels \> 1.5 ULN
* AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases
* Albumin \>2.5 mg/dL

Coagulation:

* International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
* Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants

Arms: arm 1: Pembrolizumab
Interventions: intervention 1: Pembrolizumab
Intervention descriptions: intervention 1: 200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or after 52 weeks of therapy.

Protocol documents:
Clinical trial NCT02770248
Conditions: Glaucoma
Sponsor: Alcon Research
Start date: 2016-05-23; Completion date: 2017-01-14
Enrollment: 162 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate differences between treatments in mean change from baseline in 24-hr intraocular pressure (IOP) at Week 4.

Detailed description:
Subjects will undergo washout of pre-study IOP-lowering medications for the appropriate duration, then undergo 2 eligibility visits. Eligible subjects will be randomized 1:1, to receive masked SIMBRINZA ® or Vehicle for 4 weeks. Two 24-hour visits will be conducted (Day 0 and Week 4) during which intraocular pressure will be collected every 2 hours. The expected duration of subject participation in the study is 10 weeks.

Arms: arm 1: Brinzolamide 1% / Brimonidine 0.2% tartrate ophthalmic suspension, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days arm 2: Vehicle, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
Interventions: intervention 1: Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension intervention 2: Vehicle
Intervention descriptions: intervention 1: None intervention 2: Inactive ingredients used as a placebo for masking purposes

Protocol documents:
Clinical trial NCT00423917
Conditions: Breast Cancer
Keywords: stage IV breast cancer male breast cancer recurrent breast cancer
Sponsor: Alliance for Clinical Trials in Oncology
Start date: 2007-08-01; Completion date: 2017-01-15
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Fulvestrant and bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Giving fulvestrant together with bevacizumab may be an effective treatment for metastatic breast cancer.

PURPOSE: This phase II trial is studying how well giving fulvestrant together with bevacizumab works in treating patients with metastatic breast cancer.

Detailed description:
OBJECTIVES:

Primary

* Assess the efficacy of fulvestrant and bevacizumab, in terms of 6-month progression-free survival (PFS), in patients with metastatic breast cancer previously treated with an aromatase inhibitor.

Secondary

* Assess the quality of life of patients treated with this regimen.
* Determine the adverse-event profile in these patients.
* Determine the PFS and overall survival of these patients.
* Determine the confirmed response rate, duration of response, time to treatment failure, and time to first cytotoxic agent in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive fulvestrant intramuscularly on day 1 and bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, prior to every other course, and at the completion of study treatment.

After completion of study treatment, patients are followed every 3-6 months for 5 years.

PROJECTED ACCRUAL: A total of 51 patients will be accrued for this study.

Arms: arm 1: Patients receive fulvestrant intramuscularly on day 1 and bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, prior to every other course, and at the completion of study treatment.

After completion of study treatment, patients are followed every 3-6 months for 5 years.
Interventions: intervention 1: bevacizumab intervention 2: fulvestrant
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02176837
Conditions: Subarachnoid Hemorrhage
Keywords: subarachnoid hemorrhage vasospasm nitrite sodium nitrite
Sponsor: Hope Pharmaceuticals
Start date: 2014-06-01; Completion date: 2017-01-15
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The hypothesis is that intravenous infusion of sodium nitrite is safe and effective for the reversal of cerebral vasospasm after subarachnoid hemorrhage in patients with a cerebral aneurysm.

Detailed description:
This is a pilot single center, open-labeled study. Patients with subarachnoid hemorrhage admitted to the hospital and who meet entry criteria will be offered enrollment into the study. The patients will be enrolled promptly after detection of the presence of cerebral vasospasm. Subjects will receive sodium nitrite infusion.

One dose cohort is planned, 64 nmol/min/kg sodium nitrite (0.1325 mg/hour/kg; 0.0442 ml/hour/kg at a concentration of 3mg/ml).

Arms: arm 1: One dose cohort is planned, 64 nmol/min/kg sodium nitrite (0.1325 mg/hour/kg; 0.0442 ml/hour/kg at a concentration of 3mg/ml).
Interventions: intervention 1: Sodium Nitrite
Intervention descriptions: intervention 1: Subjects will receive continuous intravenous infusion of study drug for 7 days at a dose of 64 nmol/min/kg. The infusion will begin shortly after angiographic demonstration of cerebral vasospasm and will be for 7 days unless side effects of the drug dictate stopping the infusion.

Protocol documents:
Clinical trial NCT02209610
Conditions: Heart Failure
Keywords: Heart Failure
Sponsor: VA Office of Research and Development
Start date: 2015-07-01; Completion date: 2017-01-15
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A hallmark of patients with heart failure (HF) is premature fatigue which impairs their quality of life and depicts a major source of morbidity. Premature fatigue may be attributed to a) contraction-induced transient changes within muscles (i.e. peripheral fatigue) and/or b) failure of the central nervous system to 'drive' / activate locomotor muscles (i.e. central fatigue). Both determinants of fatigue can lead to a reduction in a muscle's force and power generating capacity and to a compromised ability to perform whole body activities (e.g. walking). Recent findings in health have documented that group III/IV afferent fibers from the working muscle play a critical role in the development of both components of fatigue. Specifically, group III/IV muscle afferents limit central motor drive (CMD) during exercise and thereby exaggerate the development of central fatigue. In contrast, muscle afferents optimize muscle O2 delivery through the precise regulation of circulation and ventilation during exercise and thereby attenuate the development of peripheral fatigue.

Detailed description:
Recent findings in HF suggest an altered effect of group III/IV muscle afferents in this population. Although normal afferent feedback is crucial for adequate O2 delivery during exercise, excessive neural feedback has substantial negative consequences. HF patients are characterized by augmented neural feedback arising from overactive muscle afferents. It has been hypothesized that this abnormality compromises locomotor muscle O2 delivery in these patients. Therefore, the abnormally elevated muscle afferent feedback in HF might exacerbate, compared to healthy age- and activity matched individuals (CTRLs), the development of both peripheral (via limiting O2 delivery) and central (via restricting CMD) fatigue during exercise. Recent advances in non-invasive stimulation techniques offer a genuine opportunity to identify the sites and synaptic mechanisms that mediate central and peripheral fatigue including alterations in the responsiveness of the corticospinal tract (i.e. a determinant of central fatigue). Taken together, the proposed studies aim to determine the impact of HF on the precise development of central and peripheral fatigue during both whole body and single muscle exercise and evaluate the extent to which group III/IV muscle afferents contribute to this development.

Arms: arm 1: Patients with Heart Failure arm 2: Health Control Subjects
Interventions: intervention 1: Electrical and Magnetic Nerve Stimulators intervention 2: Intrathecal Fentanyl
Intervention descriptions: intervention 1: Stimulation of motor nerve and central nervous system intervention 2: Mu-opioid receptor agonist

Protocol documents:
Clinical trial NCT02105961
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Chronic Obstructive Pulmonary Disease exacerbations SB240563 mepolizumab eosinophils
Sponsor: GlaxoSmithKline
Start date: 2014-04-24; Completion date: 2017-01-16
Enrollment: 674 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-centered, randomized, placebo-controlled, double-blind, parallel group, trial evaluating 2 doses of mepolizumab against placebo given every 4 weeks through subcutaneous (SC) injection. In severe COPD subjects, sputum eosinophils levels are elevated to similar levels as those seen in severe asthmatics. It is hypothesized that the reduction of eosinophils with mepolizumab in COPD subjects would translate into a reduction of COPD exacerbations. The study will evaluate the efficacy and safety of mepolizumab, in subjects who are at or above the baseline blood eosinophil count of at least 150 cells/microliters who exacerbate despite regular use of maximal tolerated therapy, appropriate for severe COPD subjects, in the 12 months prior to study start. In total, 660 subjects will be randomized in 1:1:1 ratio to receive mepolizumab 300 mg, mepolizumab 100mg, or placebo administered SC. The total duration of subject participation will be approximately 62 weeks, consisting of a 1 to 2 week screening period, 52-week treatment period and 8-week follow-up period.

Detailed description:

Arms: arm 1: Each subject will receive 100 mg mepolizumab SC injection every 4 weeks (13 administrations during 52 week treatment period) along with their baseline standard of care COPD medication arm 2: Each subject will receive 300 mg mepolizumab SC injection every 4 weeks (13 administrations during 52 week treatment period) along with their baseline standard of care COPD medication arm 3: Each subject will receive placebo (0.9percent sodium chloride) SC injection every 4 weeks (13 administrations during 52 week treatment period) their baseline standard of care COPD medication
Interventions: intervention 1: Mepolizumab intervention 2: Placebo
Intervention descriptions: intervention 1: Humanised IgG antibody (IgG1, kappa) with human heavy and light chain frameworks, provided as a lyophilised cake in sterile vial. Vial to be reconstituted with Sterile Water for Injection, just prior to use. intervention 2: Sterile 0.9percent sodium chloride solution

Protocol documents:
Clinical trial NCT02666352
Conditions: Hepatitis C, Chronic
Sponsor: Merck Sharp & Dohme LLC
Start date: 2016-01-22; Completion date: 2017-01-16
Enrollment: 24 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a non-randomized, open-label, single-dose study to evaluate the pharmacokinetics (PK) of uprifosbuvir (MK-3682), the M5 and M6 metabolites of uprifosbuvir, and ruzasvir (MK-8408), in participants with moderate hepatic insufficiency (HI), participants with severe HI, and age-matched healthy control participants.

Detailed description:

Arms: arm 1: On Day 1, participants with moderate HI will receive a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. arm 2: On Day 1, participants with severe HI will receive a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast. arm 3: On Day 1, participants with normal hepatic function will receive a single oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast.
Interventions: intervention 1: Uprifosbuvir intervention 2: Ruzasvir
Intervention descriptions: intervention 1: A single dose of uprifosbuvir 450 mg (given as three 150-mg tablets) taken by mouth. intervention 2: A single dose of ruzasvir 60 mg (given as six 10-mg capsules) taken by mouth.

Protocol documents:
Clinical trial NCT01111019
Conditions: Hypochondroplasia
Keywords: Hypochondroplasia Skeletal dysplasia Growth Growth Hormone Recombinant-human Growth Hormone
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2006-03-21; Completion date: 2017-01-17
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is conducted to describe the efficacy and safety of recombinant human growth hormone (r-hGH) treatment Saizen® on children with hypochondroplasia.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Recombinant human growth hormone (r-hGH)
Intervention descriptions: intervention 1: Subjects will receive a single subcutaneous injection of recombinant human growth hormone (r-hGH) equivalent to a dose of 0.057 milligram per kilogram per day (mg/kg/day). The dose will be subsequently adjusted during the trial and subjects will be treated for at least 3 years or until near final height is reached.

Protocol documents:
Clinical trial NCT01346540
Conditions: Carcinoma, Non-Small-Cell Lung
Sponsor: Boehringer Ingelheim
Start date: 2011-04-14; Completion date: 2017-01-17
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The LUME-Lung3 study is in 2 parts:

Run-in Phase I - Open label study to identify the Maximum Tolerated Dose of BIBF 1120 that can be added to standard first-line treatment with 3 weekly schedules of gemcitabine and cisplatin.

Phase II - Placebo controlled efficacy study of BIBF 1120 added to standard 3 weekly cycles of gemcitabine and cisplatin therapy in patients with at least Stable Disease after 2 previous courses of the chemotherapy

Detailed description:

Arms: arm 1: VEGF inhibitor arm 2: BIBF 1120 placebo
Interventions: intervention 1: BIBF 1120 intervention 2: Placebo
Intervention descriptions: intervention 1: VEGF inhibitor intervention 2: BIBF 1120 placebo

Protocol documents:
Clinical trial NCT02016898
Conditions: Primary Open Angle Glaucoma
Keywords: Primary open angle glaucoma trabeculectomy mitomycin-C express mini-shunt
Sponsor: Duke University
Start date: 2014-03-01; Completion date: 2017-01-17
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary focus of this study is to assess intraocular pressure and complication rates between patients who receive mitomycin-C using a sponge versus no-sponge.

Detailed description:

Arms: arm 1: Randomization will be stratified by age (age ≥65 or age \< 65), baseline IOP (IOP ≥ 28 mmHg or IOP \< 28 mmHg), and concurrent cataract surgery. arm 2: Randomization will be stratified by age (age ≥65 or age \< 65), baseline IOP (IOP ≥ 28 mmHg or IOP \< 28 mmHg), and concurrent cataract surgery.
Interventions: intervention 1: Placement of the sponge intervention 2: Mitomycin-C
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02105948
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: eosinophils SB240563 exacerbations Chronic Obstructive Pulmonary Disease mepolizumab
Sponsor: GlaxoSmithKline
Start date: 2014-04-15; Completion date: 2017-01-17
Enrollment: 837 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-center, randomized, placebo-controlled, double-blind, parallel group trial evaluating mepolizumab 100 mg against placebo given every 4 weeks through subcutaneous (SC) injection.

In severe COPD patients, sputum eosinophils levels are elevated similar as those seen in severe asthmatics. It is hypothesized that the reduction of eosinophils with mepolizumab in COPD patients would translate into a reduction of COPD exacerbations. The study will determine the reduction in exacerbations in subjects who are above and below the baseline blood eosinophil count of at least 150 cells/microlitres. The study will evaluate the efficacy and safety of mepolizumab on the frequency of moderate and severe exacerbations in COPD subjects at high risk of exacerbations, despite the use of optimized standard of care background therapy.

Overall in this study, a total of 800 subjects will be randomised in 1:1 ratio to receive placebo or mepolizumab (100 milligram (mg)) administered SC. The total duration of this study will be approximately 62 weeks, consisting of a 1 to 2 week screening period, 52-week treatment period and 8-week follow-up period.

Detailed description:

Arms: arm 1: Each subject will receive 100 mg mepolizumab SC injection every 4 weeks (13 administrations during 52 week treatment period) along with optimized standard of care background therapy. arm 2: Each subject will receive placebo (0.9% sodium chloride) SC injection every 4 weeks (13 administrations during 52 week treatment period) along with optimized standard of care background therapy.
Interventions: intervention 1: Mepolizumab intervention 2: Placebo
Intervention descriptions: intervention 1: Humanised IgG antibody (IgG1, kappa) with human heavy and light chain frameworks, provided as a lyophilised cake in sterile vial. Vial to be reconstituted with Sterile Water for Injection, just prior to use. intervention 2: Sterile 0.9% sodium chloride solution

Protocol documents:
Clinical trial NCT02259088
Conditions: Diabetic Macular Edema Visual Impairment
Keywords: DME macular edema vision impairment Chinese diabetes
Sponsor: Novartis Pharmaceuticals
Start date: 2014-11-05; Completion date: 2017-01-17
Enrollment: 384 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study of efficacy and safety of 0.5 mg ranibizumab in Chinese patients with diabetic macular edema (DME)

Detailed description:
The purpose of this study was to provide efficacy and safety data on 0.5 mg ranibizumab intravitreal injections compared to laser photocoagulation in Chinese patients with visual impairment due to DME. Treatment was driven by achieving vision stabilization.

Arms: arm 1: 3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser arm 2: Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections
Interventions: intervention 1: Ranibizumab (RFB002) intervention 2: Laser intervention 3: Sham injection intervention 4: Sham laser
Intervention descriptions: intervention 1: Ranibizumab 0.5 mg/0.05 mL for intravitreal injection intervention 2: Laser photocoagulation according to Early Treatment Diabetic Retinopathy Study (ETDRS) guidelines intervention 3: Imitation of an intravitreal injection consisting of an empty vial and an injection syringe without a needle intervention 4: Imitation of an active laser

Protocol documents:
Clinical trial NCT01104155
Conditions: Non-small Cell Lung Cancer
Keywords: NSCLC Eribulin Mesylate Erlotinib
Sponsor: Eisai Inc.
Start date: 2010-02-22; Completion date: 2017-01-18
Enrollment: 123 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase 2, multicenter, randomized study of two different dose regimens of eribulin mesylate in combination with intermittent erlotinib in patients with previously treated, advanced non-small cell lung cancer.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: eribulin mesylate + erlotinib intervention 2: eribulin mesylate + erlotinib
Intervention descriptions: intervention 1: 21-day Regimen: Eribulin mesylate given at a dose of 2 mg/m2 as a 2-5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 2-16 of a 21-day cycle. intervention 2: 28-day Regimen: Eribulin mesylate given at a dose of 1.4 mg/m2 as a 2-5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15-28 of a 28-day cycle.

Protocol documents: