Kornimate/medical-research-clean huggingface dataset:
daytime corneal swelling during wear of narafilcon b lenses

Conditions: Myopia

Summary: the purpose of this research is to measure daytime open-eye response to wearing of narafilcon b lenses.


Eligibility criteria:
inclusion criteria: * be of legal age (i.e. ≥ 18 years). * be mentally competent, willing and able to sign a written informed consent form. * have contact lens distance sphere requirement in the range -1.00d to -6.00d. * have spectacle astigmatism \<1.25d in each eye. * currently wear soft contact lenses (for at least 6 months prior to the trial) with documentation of current prescription. * have normal eyes with no evidence of abnormality or disease. for the purpose of this study a normal eye is defined as one having: i) no evidence of lid abnormality or infection; ii) no conjunctival abnormality or infection; iii) no clinically significant slit lamp findings (i.e, edema, staining, scarring, vascularization, infiltrates or abnormal opacities); iv) no other active ocular disease. exclusion criteria: * required concurrent ocular medication. * any systemic illness which would contra-indicate lens wear or the medical treatment of which would affect vision or successful lens wear. * eye injury or surgery within eight weeks immediately prior to enrollment for this study. * abnormal lacrimal secretions. * pre-existing ocular irritation that would preclude contact lens fitting. * keratoconus or other corneal irregularity. * pregnancy, lactating or planning a pregnancy at the time of enrollment. * participation in any concurrent clinical trial.
diagnosis and prognosis for aortic aneurysm and dissection in anzhen(dpanda) study

Conditions: Aortic Aneurysm; Aortic Dissection

Summary: the registry study aims to determine serial biomarkers to diagnosis and prognosis of aortic aneurysm/aortic dissection.

the study aims to investigate the role of candidate biomarkers in the diagnosis and prognosis of aa and ad. in the diagnosis part, we begin with a discovery phase where individually matched case-control study. patients within each disease outcomes (i.e. ad, ami, pe, aa without ad and healthy controls) are age and sex matched and retrospectively included.in the prognosis part of the study, patients with confirmed aa and ad are enrolled. the primary outcome is the all-cause mortality based on the death certificates. the secondary outcome is the in-hospital mortality according to the patients'medical records.

Eligibility criteria:
inclusion criteria: retrospective * all patients who were referred to the surgical service for evaluation and management of aortic dissection were included. perspective * patients with initial suspicion of having aad were perspectively enrolled. exclusion criteria: retrospective * patients who received packed red blood cells, whole blood, or platelets less than 10 days before the blood sample was taken; * patients with aortic trauma, pseudo aneurysm, history of heart failure, renal dysfunction, severe pulmonary diseases, or active cancer; * patients who entered the hospital for checkups after surgery. perspective * patients in whom there is little or no suspicion of a life-threatening disease; * patients with confirmed acute myocardial infarction,angina or pulmonary embolism * the symptoms were clearly not related to ad (e.g. pleurisy, pneumonia, acute abdominal diseases).
lumbar degenerative disc disease treated with anterior tension band system (atb) with alif/fra spacer

Conditions: Lumbar Degenerative Disc Disease

Summary: multi-center, prospective nonrandomized study of treatment for 1 and 2 level degenerative disc disease between l2 and s1. patients will be followed for a minimum of 2 years. the primary objective of this study to measure fusion success in patients with lumbar degenerative disc disease using the atb and alif/fra spacer. the secondary objective is evaluation of the patient's quality of life, pain and function.


Eligibility criteria:
inclusion criteria: 1. one or two level (consecutive) degenerative disc disease between l2 and s1. degenerative disc disease is defined as follows: chronic pain (confirmed by patient exams and history) of discogenic origin, confirmed by radiographic evidence (e.g. mri, discogram) two or more of the following: * modic type 2 endplate changes on t2 weighted mri * high intensity zone signal on t2 weighted mri * positive discogram with negative controls * dark disc (diminished t2 weighted signal) * decreased disc height 2. has experienced pain, functional deficit and/or neurological deficit for a minimum six month period of time prior to enrollment 3. has failed to respond to non-operative treatment modalities for a minimum three month period of time prior to enrollment 4. skeletally mature and at least 18 years of age 5. signs the approved informed consent document 6. is available for long term follow-up and interval visits exclusion criteria: 1. has more than 2 levels to be instrumented 2. has had a previous fusion attempt at the involved level(s) 3. has had more than two previous open, lumbar spine surgical procedures at the involved level(s) 4. currently implanted with anterior instrumentation at the involved level(s) 5. patient would be classified as morbidly obese bmi \> 35 6. active localized or systemic infection 7. presence of a disease entity or condition which significantly affects the possibility of bony fusion (e.g., osteoporosis, metastatic cancer, long-term use of steroids, etc.) 8. has an immunosuppressive disorder 9. pregnant or interested in becoming pregnant during the study. 10. has a known sensitivity to device materials 11. mentally incompetent or prisoner 12. currently a participant in another study for the same indications.
oxymorphone extended release (er) in opioid-naive patients with chronic pain

Conditions: Pain; Chronic Disease

Summary: the purpose of this study is to determine if oxymorphone er is effective and safe in treating chronic pain in opioid-naive patients.

the purpose of this study is to assess the effectiveness and tolerability of oxymorphone er for the treatment of moderate to severe chronic pain in opioid-naive patients. patients are gradually titrated from a 5mg dose of oxymorphone er (taken every 12 hours) until stabilized dose is achieved. the study design is an open-label, nonrandomized 6-month study with a titration/stabilization period of ≤ 1 month followed by a 5-month maintenance period.

Eligibility criteria:
inclusion criteria: * currently receive a stable non-opioid analgesic regimen * have an initial pain intensity score of greater than or equal to 40 mm on a 100-mm visual analogue scale (vas) and a categorical pain rating of moderate or severe on a categorical scale of none, mild, moderate, or severe * if female, must be practicing abstinence or using a medically acceptable form of contraception * understand written and spoken english * have been informed of the nature of the study and provided written informed consent. exclusion criteria: * positive pregnancy test (females only) * history of or active asthma or emphysema * clinically significant hepatic impairment * received any of the following medications within 48 hours prior to dosing: * dextromethorphan-containing medications (over-the-counter \[otc\] cough and cold preparations, such as vicks formula 44) * st. john's wort \>1000 mg/day * received monoamine oxidase inhibitor (maoi) drugs within 2 weeks prior to dosing * are not stabilized on the following medications for at least 4 weeks prior to dosing: * tricyclic antidepressant drugs * serotonin reuptake inhibitors * amphetamines used for attention-deficit/hyperactivity disorder (adhd) * history of alcohol or substance abuse within the last 3 years * history of opioid abuse within 6 months prior to study entry * have a known oxymorphone sensitivity or allergy * have scheduled an elective surgery or procedure during the study that would not permit continuation of study medication, and/ or require another analgesic not currently taken by the patient * have received an investigational drug or product or participated in an investigational drug study within a period of 30 days prior to receiving study medication * have a known allergy or significant reaction to opioids * have been a participant in a previous oxymorphone clinical trial * have a history of seizure (patients with a history of juvenile febrile seizures may be included if there has been no seizure history within the past 10 years).

Keywords: chronic pain extended release long-acting opioid opioid opioid-naive oxymorphone
a study to examine the safety, pharmacokinetics and pharmacodynamics of pf-03635659 in patients with chronic obstructive pulmonary disease

Conditions: Pulmonary Disease, Chronic Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Obstructive Airway Disease; COPD

Summary: pf-03635659 is being developed for the treatment of chronic obstructive pulmonary disease. this is a study to examine the safety, pharmacokinetics and pharmacodynamics of pf-03635659 in patients with chronic obstructive pulmonary disease (copd).


Eligibility criteria:
inclusion criteria: * male or female (women of non-childbearing potential) subjects between the ages of 40 and 80 years, inclusive with a diagnosis of moderate copd (gold, 2007 update) and who meet the following criteria for gold stage ii disease * body mass index (bmi) of less than 35.5 kg/m2; and a total body weight \>40 kg (88 lbs). * current smokers, or ex-smokers who have abstained from smoking for at least 6 months exclusion criteria: * subjects having more than 2 exacerbations requiring treatment with oral steroids or hospitalization for the treatment of copd in the previous year. * history of lower respiratory tract infection or significant disease instability during the month preceding screening or during the period between screening and randomization.

Keywords: safety pharmacokinetics pharmacodynamics pf-03635659 copd
venous leg ulcer and lymphedema registry

Conditions: Venous Stasis Ulcer; Quality of Patient Care

Summary: this is an observational, longitudinal real world registry of venous leg ulcers created from electronic health record data obtained in the course of clinical care. data from certified electronic health records transmit data as part of the requirement to share data with a specialty registry under objective 10 of meaningful use of an ehr.

this is an observational, longitudinal real world registry of venous leg ulcers created from electronic health record data obtained in the course of clinical care. data from certified electronic health records transmit data as part of the requirement to share data with a specialty registry under objective 10 of meaningful use of an ehr. no secondary data entry are required and all data are obtained via structured language from data entered in the ehr. data from quality measures designed as electronic clinical quality measures (ecqms) standardize the quality of care provided to patients and their clinical outcomes which are risk stratified using the wound healing index (whi). the ecqms enable standardized data collection and the ability to transmit data electronically obviates the possibility of transcription errors. national bench marking is possible since data are available from thousands of participants across the usa. while an independent irb oversees this project, the data are collected for the purpose of measuring and improving the quality of care delivered to diabetic patients with foot ulcers and understanding their outcomes in relation to level of risk. quality performance is reported as part of pqrs. these functions are exempt from the requirements of informed consent.

Eligibility criteria:
inclusion criteria: * all patients with venous leg ulcers seen by the practitioner. exclusion criteria: * none

Keywords: venous leg ulcer venous qcdr quality measure wound outcome lymphedema
cannabidiol as a different type of an antipsychotic: drug delivery and interaction study

Conditions: Schizophrenia

Summary: despite recent advances in the understanding and treatment of schizophrenia, this devastating disease still affects one percent of world's population. existing antipsychotics reduce psychotic symptoms but are generally not very effective in treating so called negative symptoms such as blunted affect and social withdrawal or cognitive disturbances due to the disease. furthermore, a significant portion of patients is refractory to all current treatments. therefore new treatment strategies are needed. several studies suggest a strong association between schizophrenia and the endocannabinoid system. this system mediates e.g. the pro-psychotic effects of the best-known ingredient of the cannabis plant - delta-tetrahydrocannabinol (δ9-thc). while the pro-psychotic δ9-thc is known to abet the onset of schizophrenia, another, non-psychotomimetic plant ingredient - cannabidiol - has recently been shown to exert antipsychotic effects similar to those of one of the most effective modern antipsychotics, amisulpride, but it induced significantly less side effects. in this phase i safety study, the investigators will evaluate the pharmacokinetics, pharmacoequivalence, and drug-drug interaction profile with current antipsychotics of a new tablet pharmaceutical preparation of cannabidiol in healthy volunteers.


Eligibility criteria:
inclusion criteria: * informed consent given by the subject * both, female and male subjects may participate * age between 18 and 45 * negative drug screening at the time of screening * non-smoking * in female participants in fertile age, reliable contraception, which means contraception's pearl-index is equal or smaller than 1. * body mass index between 18 and 30 exclusion criteria: * lack of accountability * any current psychiatric disorder through the structured clinical interview for dsm-iv (scid) at the time of screening * pregnancy or lactation phase in female at the time of screening * any known psychiatric or neurological illness in the participant's history. * known family history concerning psychiatric disorders * relevant use of cannabis (which is defined on the present state of knowledge as at the most five times lifetime-consumption and no consumption for at least one year) * severe physical (internal) or neurological illness, especially cardiovascular, renal, advanced respiratory, haematological or endocrinological failures or infectious diseases (acute hepatitis a, b or c or hiv) assessed at the time of the screening by the subject's history, clinical examination and laboratory testing, at the discretion of the investigator * consumption of any illicit drugs (except cannabis in history, see above)
pedi-cap co2 detector for face-mask ventilation in the delivery room

Conditions: Neonatal Resuscitation; Neonatal Disease

Summary: the goal of this study is to determine if using a pedi-cap (a type of colorimetric carbon dioxide detector) during face mask ventilation (ppv) for newborn infants in the delivery room will lower the time of ppv needed. a group of nurses, doctors, and respiratory therapists, called the neonatal resuscitation team, will either use or not use the pedi-cap during face mask ppv for infants born at ≥30 weeks' gestation. a randomization generator will assign each month to either use the pedi-cap or not use the pedi-cap. the researchers will collect information from the medical chart to find the infant and mother's information, medical interventions done in the delivery room, and lab values. in addition, resuscitation team members will fill out a survey of their experiences of using or not using the pedi-cap during delivery room facemask ppv.

this is an open, prospective, quasi-randomized, single center trial that will address the primary research question: does use of a colorimetric carbon dioxide (co2) detector (pedi-cap) decrease the duration of non-invasive positive pressure ventilation (ppv) in the delivery room? the neonatal resuscitation team, comprised of nurses, doctors, and respiratory therapists will include or omit the pedi-cap during noninvasive ppv for infants born at ≥30 weeks' gestation in the delivery room. the quasi-randomization scheme will be determined by a opening an opaque envelope each month. this will be revealed at the beginning of each month on whether to use the pedi-cap or not. other outcomes variables that will be assessed include initial heart rate (hr), time to hr \> 100 bpm, duration of bradycardia, time to start of ventilation corrective maneuvers (if needed), maximum peak inspiratory pressure used, maximum peek inspiratory pressure used, maximum fractionated inspired oxygen, time to gold color change on pedi-cap, need for intubation, need for delayed ppv, need for chest compressions/epinephrine, need for neonatal intensive care unit admission if infant ≥35 gestational age, occurrence of pneumothorax, length of mechanical ventilation in days, doses of surfactant given, and survival to discharge. infant and maternal characteristics will be obtained from the electronic medical record. association of outcomes with each study arm will be stratified by infant and maternal characteristics. in addition, a survey will be administered to the resuscitation team members at the completion of the study to assess their experience with each study arm.

Eligibility criteria:
inclusion criteria: * infants born at ≥30 weeks' gestation * presence of the resuscitation team prior to delivery * need for non-invasive positive pressure ventilation (ppv). exclusion criteria: * infants born at \<30 weeks' gestation * no non-invasive ppv needed in the delivery room * infants with conditions requiring immediate intubation such as congenital diaphragmatic hernia * resuscitation team not present prior to delivery/need for ppv * infants who have a prenatal plan of comfort care only
ultrasound-guidance for intraosseous access during earthquake

Conditions: Cardiac Arrest Due to Trauma (Disorder)

Summary: the aim of this field report is to describe as the use ultrasound guidance can facilitate the insertion of intraosseous access, during the resuscitation, in the victims of out-of hospital traumatic cardiac arrest

the aim of this field report is to describe as the use ultrasound guidance can facilitate the insertion of intraosseous access, decreasing the time for drug administration and providing some benefits during the resuscitation, in the victims of out-of hospital traumatic cardiac arrest.

Eligibility criteria:
inclusion criteria: * traumatic cardiac arrest exclusion criteria: * non traumatic cardiac arrest * beheading * post-mortem hypostasis * carbonized bodies * dismembered bodies
hernia repair in multiply morbid patients

Conditions: Ventral Hernia

Summary: support of a ventral hernia repair with a prosthetic mesh has been demonstrated to result in a diminished rate of hernia recurrence. the patient with co-morbidities undergoing hernia repair is at increased risk of wound related complications, which may be exacerbated by the choice of prosthetic mesh, and which are known to influence the ultimate rate of hernia recurrence. it is hypothesized that patients receiving a mesh of biologic origin may experience fewer wound related complications and hence at least an equal rate of hernia recurrence, compared to those receiving a synthetic mesh.


Eligibility criteria:
inclusion criteria: * adults of either gender * must have 2 or more co-morbidities exclusion criteria: * local or systemic infection * expected survival of \<24 months * non-ambulatory

Keywords: hernia repair, surgical mesh, co-morbidities
hypofractionated post mastectomy radiation with two-stage expander/implant reconstruction

Conditions: Breast Carcinoma

Summary: hypofractionated radiotherapy could provide more convenient treatment and had similar toxicities.however,reports of hypofractionated radiotherapy with two-stage expander/implant reconstruction are rare,some studies have shown that hypofractionated radiotherapy had similar toxicities to conventional fractionated radiotherapy in patients with breast reconstruction. so,investigators conducted a phase ii study to observe the reconstruction failure in hypofractionated radiotherapy with two-stage expander/implant reconstruction.

results from a phase iii randomized controlled study in china showed that postmastectomy hypofractionated radiotherapy was non-inferior to and had similar toxicities to conventional fractionated radiotherapy in patients with high-risk breast cancer.however,reports of hypofractionated radiotherapy with two-stage expander/implant reconstruction are rare. literatures report that reconstruction failure is a well-known complication of radiation therapy in breast cancer patients with reconstruction. results may vary based on rt timing and technique. some studies have shown that hypofractionated radiotherapy had similar reconstruction failure to conventional fractionated radiotherapy in patients with breast reconstruction. so,investigators conducted a phase ii study to observe the reconstruction failure in hypofractionated radiotherapy with two-stage expander/implant reconstruction.

Eligibility criteria:
inclusion criteria: * pathologic diagnosis of stage i-iiic invasive breast cancer (ductal, lobular, mammary, medullary, or ductal) ≤ t3 or n+ * negative surgery margins * positive postoperative pathologic axillary lymph nodes after neoadjuvant chemotherapy (ypn+). * undergo mastectomy+expander+rt（hypofractionated radiotherapy）+delayed prosthesis reconstruction * sign the informed consent form exclusion criteria: * t4, * axillary sentinel lymph node biopsy without axillary dissection * recurrent breast cancer or history of prior breast radiation therapy (neck, chest wall, axilla) * uncontrollable co-morbidities, including but not limited to active collagen vascular disease (e.g., systemic lupus erythematosus, scleroderma, or dermatomyositis), persistent or active infection, symptomatic congestive heart failure, unstable angina, mental illness incapacitating participation in this study * pregnancy or breastfeeding * history of malignancy other than the following： (at least 5 years of tumor free survival with a very low risk of recurrence, e.g., carcinoma in situ of the cervix and basal cell or squamous cell carcinoma of the skin） * requiring bilateral breast/chest wall radiation therapy

Keywords: hypofractionated radiotherapy two-stage expander/implant reconstruction breast cancer
two bedside ultrasound techniques and standard methods for confirmation of endotracheal tube insertion in intensive care patients

Conditions: Two Bedside; Ultrasound; Endotracheal Tube; Intensive Care Patients

Summary: this cross-sectional observational study aims to predict the sensitivity and specificity of ultrasonography using suprasternal and subxiphoid methods to confirm the correct placement of endotracheal tubes compared to standard methods in intensive care patients.

endotracheal intubation is the primary medical procedure used for securing the airway, confirmation of endotracheal tube (ett) placement is essential to prevent hypoxia and aspiration. the best primary approach to confirm endotracheal tube placement is observation of the tube passage through the vocal cords followed by assessment based on chest and epigastric auscultation. ultrasound machines are now increasingly available in emergency departments and intensive care units. it is a non-invasive, portable and serves as a real-time diagnostic tool with rapid and accurate results.

Eligibility criteria:
inclusion criteria: * patients \> 18 years old. * both sex. * all patients requiring prophylactic airway management e.g (patient with glasgow coma scale \<8) with endotracheal intubation in the intensive care unit. exclusion criteria: * an abnormal airway anatomy. * tracheal or endobronchial lesion. * significant cervical trauma. * cervical abnormality. * neck swelling. * patients who need cardiopulmonary resuscitation.