cyrilzakka/clinical-trials huggingface dataset:
Post-Discharge Opioid Reduction Intervention for Open, Laparoscopic, and Endoscopic Surgery

ORIOLES is a non-randomized, pre-post intervention study designed to improve quality of opioid prescribing and use after discharge for patients undergoing urologic surgery. The study will initially focus on a pre-defined cohort of patients undergoing radical prostatectomy. After the predefined study period for the pre-intervention arm, a three-part intervention is employed to assess the effect on opioid prescribing and use in the post-intervention arm. Pending results, the intervention may be applied to all surgeries in the department for routine clinical care.

The goal of the study is to reduce the amount of opioid analgesia prescribed after urologic surgery in the Department of Urology at Johns Hopkins. The initiative focuses on patients undergoing surgery for prostate cancer with radical prostatectomy including patients enrolled in IRB00123618/NCT03006562. The pre-intervention arm will consist of patients enrolled August 2017 to January 2018. The intervention arm will consist of patient enrolled January 2018 to completion of the study.

The intervention consists of a information discharge sheet, a standardized prescribing guideline at discharge, and nurses providing improved education for patients at discharge about appropriate use of opioid medication, routes for disposal, and potential side effects. Data on prescriptions written (amount and type of mediation) and use of opioid and other pain medication after surgery will be compared before and after the quality improvement initiative is started. Outcomes are assessed via 30-day phone call follow-up with data on perioperative outcomes, postoperative medication use, and symptoms already assessed in IRB00123618/NCT03006562. At the completion of the pre-intervention arm, providers in the urology department are informed about the average and distribution of usage of post-discharge opioids. Education and standardized prescribing (allowing for provider judgment) may help reduce/personalize the amount of opioids prescribed at discharge to reduce wasted medication entering circulation. The initiative may then be expanded to encompass all surgeries in the department to reduce opioid prescribing and use for routine clinical care.

Eligibility Criteria:
Inclusion Criteria:

* All patients diagnosed with prostate cancer and enrolled in NCT03006562

Exclusion Criteria:

* Patients not undergoing radical prostatectomy (for the primary pre-post ORIOLES study)
A Retrospective Study to Evaluate the Clinical Outcome According to Treatment in aHUS Patients in South Korea

Primary objective

- To determine the clinical prognosis by identifying the disease course and severity by treatment with or without eculizumab in patients with aHUS in Korea.

Secondary objectives

* To determine the clinical prognosis of the disease in all patients with aHUS in Korea.
* To determine the clinical prognosis of the disease in patients diagnosed with aHUS prior to the initiation of eculizumab reimbursement system in Korea.
* To determine the treatment responses by treatment options in patients with aHUS in Korea.
* To identify risk factors that affect mortality in all patients with aHUS in Korea.
* To investigate the recurrence and clinical prognosis in patients with aHUS in Korea when eculizumab is discontinued

As a retrospective, non-interventional, multi-center study

Eligibility Criteria:
Inclusion Criteria:

* Patients who are clinically diagnosed with the aHUS

Exclusion Criteria:

* Patients who are diagnosed with Shiga toxin-producing E. coli hemolytic-uremic syndrome (STEC-HUS).
* Patients with less than 10% in a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13 (ADAMTS-13) activity test
The Effect of Music by Mozart on Energy Expenditure in Growing Preterm Infants

Music has been consistently shown to reduce stress and increase weight gain in premature infants. The mechanism of this presumed improved metabolic efficiency is unknown. We aim to test the hypothesis that music by Mozart reduces energy expenditure in growing healthy preterm infants.


Eligibility Criteria:
Inclusion Criteria:

* appropriate weight for gestational age
* postmenstrual age of 30-37 weeks
* gavage fed
* tolerating full enteral feedings without significant gastric residuals (\>5% of total feed)
* no electrolyte imbalance

Exclusion Criteria:

* congenital anomalies
* dysmorphism
* intracranial hemorrhage of any grade
* periventricular leukomalacia
* necrotizing enterocolitis
* supplemental oxygen requirements by 28 days of age or by 36 weeks of postmenstrual age and at least 1 week prior to measurement
* active infection
* patent ductus arteriosus
* apnea of prematurity
Golf, Physical Rehabilitation, and Movement Disorders

The importance of physical activity for individuals with movement disorders, including Parkinson disease and Essential tremor, has been established. Barriers including patient engagement continue to limit effectiveness. Golf requires skills found challenging to individuals with movement disorders. This study seeks to assess the feasibility and effectiveness of an outpatient-based rehabilitation program incorporating golf skills and activities on functional measures and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of either PD, Parkinsonism, or ET. Subjects must also demonstrate functional deficits in at least one of the three categories (gait, transfers, balance) to be further assessed by the evaluating PT

Exclusion Criteria:

* Subjects will be excluded if they are unable to maintain standing balance with an assistive device, if they are non-ambulatory even with a device, if pain does not allow for subject participation, and if they are unable to follow instructions due to an underlying attentional or cognitive deficit.
Effect of Fenofibrate on Kidney Function: a Six-week Randomized Cross-over Trial in Healthy People

The purpose of this study was to test the effect of fenofibrate treatment on glomerular filtration rate (GFR), kidney hemodynamics and tubular function in middle-aged subjects with normal kidney function to further investigate the increase in creatinine levels observed in fenofibrate-treated subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male and female
* Age: 30-60 years old
* Subjects with normal renal function as documented by: Plasma creatinine \< 130 µmol/L, AND Cockcroft \& Gault creatinine clearance (Co Cr CL) \>80 ml/min
* Certified as normal by a comprehensive medical assessment and laboratory investigations the results of which are within the normal range /or clinically acceptable for the present subjects and who have a negative urinary screen for drugs of abuse.
* Written informed consent

Exclusion Criteria:

* Body Mass Index (BMI) ≥ 30 kg/m² or \<18 kg/m².
* Pregnant, breast-feeding, or woman with child bearing potential without a reliable method of contraception.
* Having received an investigational drug in the last 90 days before date of inclusion.
* With known hypersensitivity to fibrates.
* Unable or unwilling to comply with the protocol, or likely to leave the study before its completion.
* Who would undertake important change in physical exercise or vigorous sport competitions during the study period.
* Drug therapies are not permitted during the study, except contraceptive pill when applicable, with the exception of occasional use of paracetamol.
* Any administration of treatment, which could bring about induction or inhibition of hepatic microsomal enzymes within 3 months of the study start.
* Diabetes mellitus, Heart diseases, Kidney diseases, hypertension, asthma, Liver diseases, Chronic pancreatitis, or identified risk or known history of acute pancreatitis, Known cholelithiasis without cholecystectomy, ASAT and/or ALAT \> 1.3 times ULN, Gastric or peptic ulcer or intestinal diseases, Musculoskeletal diseases or increased CK \> 1.0 times ULN, History of neoplasm, Mental illness, Regular user of sedatives, hypnotics, tranquillisers or any other addictive agents or who are known to be prone to alcohol abuse (i.e. history or evidence of acute abuse), or alcohol intake \>14 units per week (unit = ½ pint of beer, 1 glass of wine, 2,5 cl standard spirits), or heavy smokers (\>10 cigarettes/day), or excessive drinker of tea, coffee and/or beverages containing caffeine (\>8 cups/day), Blood donor with recent donation (in the three months preceding the initiation of the study) or would make blood donations during the study, Blood transfusion or administration of blood-derived products, in the year preceding the study.
The SENTRY Clinical Study

The SENTRY Bioconvertible Inferior Vena Cava (IVC) Filter has been developed to provide temporary protection against pulmonary embolism (PE).

Pulmonary embolism (PE) is a prevalent disease with a significant morbidity and mortality. The estimated annual incidence is 1.45 per 1,000 patients, which translates to 1,350,000 cases per year in the United States. It is estimated that PE results in more than 200,000 deaths per year.

Currently there are two types of commercially available IVC filters utilized to prevent PE; permanent and retrievable. Both types of filters have documented limitations, such as tilting, migration, fracture, embolization and late deep vein thrombosis (DVT). Retrievable filters were developed to avert some of the late consequences of permanent filter, but in practice there is low success with eventual removal. In a series of 37 clinical studies, with a total of 6,834 patients the mean retrieval rate was 34%.

There are numerous design features of the SENTRY IVC Filter that are intended to improve on the limitations of available IVC filters and obviate the need for retrieval.

Eligibility Criteria:
Inclusion Criteria:

1. \> 18 years of age
2. fully informed subject who has executed an Institutional Review Board (IRB) or Ethics Committee (EC) approved informed consent
3. willing and able to comply with follow-up visit requirements
4. requirement of transient PE protection of \< 60 days
5. documented or high risk of PE or DVT
6. inability to use anti-coagulation due to contraindication, failure, complication or risk of injury from pharmacotherapy
7. IVC diameter compatible with filter diameter
8. IVC length adequate for filter placement

Exclusion Criteria:

1. intellectual impairment preventing understanding involvement in a clinical study
2. hypersensitivity to device components
3. impaired renal function defined as a serum creatinine level of \> 2.0 mg/dL
4. active systemic infection
5. life expectancy \< 12 months
6. malignancy extending PE risk \> 60 days
7. pregnant or plans to become pregnant during study follow-up period
8. participating in another investigational trial that has not reached its primary endpoint
9. known hypercoaguable state
10. inherited or acquired hemostatic disorder
11. history or presence of a caval stent or filter
12. inability to gain femoral or jugular access
13. duplicated or left sided IVC
14. renal vein thrombosis or IVC thrombosis extending to the renal veins
15. jugular and femoral vein irregularity, stenosis or aneurysm that would interfere with successful device delivery
16. spinal irregularity that may interfere with successful device delivery
17. occlusive or free-floating thrombus in the IVC
18. contrast allergy that cannot be adequately pre-medicated
Sunitinib, Tamoxifen, and Cisplatin in Treating Patients With High-Risk Ocular Melanoma

RATIONALE: Sunitinib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as tamoxifen and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sunitinib together with tamoxifen and cisplatin may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects and how well giving sunitinib together with tamoxifen and cisplatin works in treating patients with high-risk ocular melanoma.

OBJECTIVES:

* Determine the effect of adjuvant sunitinib malate, tamoxifen citrate, and cisplatin on disease-free survival and overall survival of patients with high-risk ocular melanoma who have undergone primary therapy.
* Determine the toxicity of this regimen in these patients.

OUTLINE: This is a pilot study.

Patients receive oral sunitinib malate once daily on days 1-21, oral tamoxifen citrate twice daily on days 1-7, and cisplatin IV on days 2 and 3. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 2 months for 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of ocular melanoma

  * High-risk disease, defined by any of the following:

    * Large choroidal tumors with a basal diameter ≥ 16 mm and/or tumor thickness ≥ 10 mm (T3)
    * Extrascleral extension (T4)
    * Ciliary body involvement
    * Epithelioid cell type only
* Have undergone appropriate primary treatment for ocular melanoma
* No measurable metastatic disease

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* ANC ≥ 1,200/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 9.0 g/dL
* Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 50 mL/min
* AST and ALT ≤ 3 times upper limit of normal
* Pancreatic enzymes normal
* Thyroid function normal or stable on replacement therapy
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Cardiac ejection fraction ≥ 50% by MUGA or ECHO
* No myocardial infarction within the past 6 months
* No congestive heart failure requiring medication
* No history of pulmonary disease requiring supplemental oxygen
* No dyspnea at rest
* No active infection
* No chronic underlying immunodeficiency disease
* No other serious illness that would preclude patient safety, in the opinion of the investigator
* No other cancer within the past 5 years except nonmelanoma skin cancer or cervical cancer
* No thromboembolic disease within the past 6 months

PRIOR CONCURRENT THERAPY:

* No prior sunitinib malate, tamoxifen citrate, or cisplatin
* No other concurrent chemotherapy, radiotherapy, or surgery
A Study of DMOT4039A in Participants With Unresectable Pancreatic or Platinum-Resistant Ovarian Cancer

This multicenter, open-label, dose-escalating study will assess the safety, tolerability, and pharmacokinetics of DMOT4039A in participants with unresectable pancreatic or platinum-resistant ovarian cancer. Cohorts of participants will receive multiple ascending intravenous doses of DMOT4039A.


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Histologically documented, incurable, locally advanced or metastatic disease for which no standard therapy exists, consisting of one of the following: Unresectable pancreatic ductal adenocarcinoma or platinum-resistant ovarian cancer
* Measureable disease, defined as at least one bi-dimensionally measurable non-lymph node lesion greater than or equal to (\>/=) 1 centimeter (cm) in long-axis diameter on spiral computed tomography (CT) scan or at least one bi-dimensionally measurable lymph node measuring \>/= 1.5 cm in short-axis diameter on spiral CT scan
* Adequate hematological, renal and liver function

Exclusion Criteria:

* Treatment with anti-tumor therapy, including chemotherapy, biologic, experimental or hormonal therapy, within 4 weeks prior to Day 1
* Known active infection
* Current Grade \>/= 2 toxicity (except for alopecia, anorexia and fatigue) from prior therapy or Grade \>/= 2 neuropathy
* Untreated or active cerebral nervous system metastases
* Pregnant or breastfeeding women
The CEDiD Study (COVID-19 Early Diagnosis in Doctors and Healthcare Workers)

This is a prospective observational cohort study of healthcare workers working in high-risk COVID-19 clinical areas, monitoring heart rate, sleep and temperature, correlating with daily self-reported symptoms, oxygen saturations and PCR Swabs. It will provide information about how many healthcare workers develop COVID-19, what their clinical observations and symptoms are.

During the COVID-19 Pandemic, doctors and other healthcare workers who work in COVID+ wards, intensive care unit and the accident and emergency department are at high risk of developing COVID-19 infection.

In April 2020, 14.6% of doctors were off sick with suspected or confirmed COVID-19 infection. Meanwhile, 17.9% of COVID+ patients are thought to be asymptomatic. Therefore, healthcare workers are also high-risk of spreading infection to patients, colleagues and their families.

This is a prospective observational cohort study that leverages wearable medical device technology and data analytics to develop an algorithm for early detection of COVID-19 infection in healthcare workers.

A total of 60 healthy healthcare workers working within high-risk COVID-19 clinical areas will be asked to wear a wearable medical device that measures their heart rate, skin temperature and sleep during non-working hours. They will take daily swabs for COVID-19 from themselves, measure their oxygen levels daily, and answer a survey of self-reported symptoms daily for the 30 day study period.

These will then be analyzed to develop an algorithm for early detection of COVID-19 in healthcare workers, and help to inform future workforce decisions, to promote welfare and prevent the spread of COVID-19.

Eligibility Criteria:
Inclusion Criteria

* Healthy healthcare professionals of any age

Exclusion Criteria

* Previous PCR/Antibody positive test for COVID-19
* Not working in high-risk COVID-19 area (ICU, A\&E, COVID positive wards)
* Involved in COVID-19 Vaccine Trial
Ultrasound Imaging of Subarachnoidal Space in Newborn Infants

Based on the ultrasound measurement of CSF/spinal cord ratio in neonates the investigators plan to define a normal range of CSF volume for 0-7 day old newborns. The investigators hypothise to be able to create an ultrasound measurement index/number to predict unsuccessful neonatalal LPs.

Based on the available literature the success rate of neonatal lumbar puncture (LP) is quite low (some articles reporting as low as 50% (unsuccessful LPs including dry taps and traumatic taps)).

Firstly, the investigators would like to set a normal range of CSF:spine ratio (representing the amount of CSF at the expected level of LP) based on the measurements in neonates of different gestational age and postnatal age with assessing ventricular index (VI) on cranial US.

In the next phase of the study the investigators plan to assess the subarachnoidal space/amount of CSF of those neonates whom need LP performed. The investigators hypothise to be able to create an ultrasound measurement index/number that would be able to predict unsuccessful LPs.

Eligibility Criteria:
Inclusion Criteria: All neonates born at the Obstretrics and Gynecology Department, University of Szeged and all treated neonates at the Neonatal Unit, Pediatric Department, University of Szeged

Exclusion Criteria: Hemidynamical instability, Strict minimal handling (eg Pulmonary Hypertension, MAS etc), Total Body Coooling for HIE (Hypoxic Ischemic Encephalopathy)
Subcutaneous CINRYZE With Recombinant Human Hyaluronidase for Prevention of Angioedema Attacks

The primary objectives of the study are to evaluate the safety, tolerability, and efficacy of two doses of CINRYZE with recombinant human hyaluronidase (rHuPH20) administered by subcutaneous (SC) injection to prevent angioedema attacks.


Eligibility Criteria:
Inclusion Criteria:

* Be ≥12 years of age.
* Have a confirmed diagnosis of Hereditary Angioedema.

Exclusion Criteria:

* Receipt of any C1 inhibitor (C1 INH) therapy or any blood products for treatment or prevention of an angioedema attack within 7 days before the first dose of study drug.
* Be receiving prophylactic intravenous CINRYZE that exceeds 1000 units every 3 or 4 days (maximum weekly dose 2000 units).
* Have received any androgen therapy (e.g., danazol, oxandrolone, stanozolol, testosterone) within 7 days prior to the first dose of study drug.
* If female, have started taking or changed the dose of any hormonal contraceptive regimen or hormone replacement therapy (i.e., estrogen/progestin containing products) within 3 months prior to the first dose of study drug.
* History of allergic reaction to C1 INH products, including CINRYZE or other blood products.
* History of abnormal blood clotting.
* Have a known allergy to hyaluronidase or any other ingredient in the study formulation.
Macular Ganglion Cell Analysis (GCA) of the Cirrus HD-OCT in Glaucoma

To determine the area under the Receiver Operator Characteristic Curve (AUC) for the Ganglion Cell Analysis (GCA) average thickness.

To determine the area under the Receiver Operator Characteristic Curve (AUC) for the following GCA parameters:

1. Minimum thickness
2. Supero-temporal thickness
3. Superior thickness
4. Supero-nasal thickness
5. Infero-temporal thickness
6. Inferior thickness
7. Infero-nasal thickness

Eligibility Criteria:
Inclusion Criteria:

* Age of 40 years or older
* Diagnosed to have glaucoma by the Principal Investigator or co-investigator
* Able and willing to make the required study visits
* Able and willing to give consent and follow study instructions

Exclusion Criteria:

Ophthalmic:

* Best corrected visual acuity in either eye worse than 20/40 on a Snellen chart or on a Snellen equivalent acuity chart.
* Refractive error outside -12.00D to +8.00D spherical range or \>-3.00D cylinder.
* Previous vitreoretinal surgery in study eye.
* Vitreoretinal traction or epiretinal membrane in the study eye.
* Any active infection of anterior or posterior segments.
* Evidence of diabetic retinopathy, diabetic macular edema, or other vitreoretinal disease in the study eye upon dilated examination, or upon evaluation of retinal photos.

Systemic:

* History of diabetes, leukemia, AIDS, uncontrolled systemic hypertension, dementia or multiple sclerosis.
* A life threatening or debilitating disease.
* Participation in any study involving a non-FDA approved investigational drug (IND) within the past month, or ongoing participation in a study with a non-FDA approved or cleared investigational device (IDE).
* Current or recent (within the past 14 days) use of an agent with photosensitizing properties by any route (e.g., Visudyne®, ciprofloxacin, Bactrim®, doxycycline, etc.).
* Concomitant use of hydrochloroquine and/or chloroquine.