Kornimate/medical-research-clean huggingface dataset:
lipiflow treatment alone vs. lipiflow + dextenza treatment for dry eye disease

Conditions: Dry Eye Syndromes

Summary: to evaluate the benefit of treatment with a physician administered intracanalicular dexamethasone insert in evaporative dry eye disease (ded) patients with meibomian gland disfunction (mgd) and underlying inflammation undergoing lipiflow thermal pulsation.

this prospective, open-label, single-center, non-randomized, investigator-sponsored clinical study seeks to investigate the benefit of managing patients with ded secondary to mgd with a sustained release intracanalicular dexamethasone (0.4 mg) insert in addition to lipiflow thermal pulsation compared to lipiflow thermal pulsation alone. in addition, this study will evaluate the ease of dextenza insertion and the patient preference for therapy. after screening a given patient for inclusion and exclusion criteria, and gaining informed consent, each eye will undergo lipiflow thermal pulsation on the same day. the most symptomatic eye will be selected to receive dextenza® insertion on the day of the procedure (study eye), while the other eye will be assigned to a receive a sham punctum dilation (control eye). if there is no obvious symptomatic difference, the right eye will receive the intracanalicular insert. per patient, the study period will last for approximately 12 weeks after the lipiflow procedure, consisting of one screening visit, one treatment v4isit and 3 post-procedure follow-up visits (week 1, week 4 and week 12). at week 1, week 4 and week 12, primary and secondary endpoints will be assessed alongside standard-of-care procedures. adjusting for enrollment period, the study will last a total of approximately 4 months.

Eligibility criteria:
inclusion criteria: a patient's study eye must meet the following criteria to be eligible for inclusion in the study: * 18 years of age or older * evaporative ded with mgd and clinically significant inflammation * willing and able to comply with clinic visits and study related procedures * willing and able to sign the informed consent form exclusion criteria: a patient who meets any of the following criteria will be excluded from the study: * patients under the age of 18. * pregnancy (must be ruled out in women of child-bearing age with pregnancy test) * active infectious systemic disease * active infectious ocular or extraocular disease * altered nasolacrimal flow of either acquired, induced, or congenital origin * hypersensitivity to dexamethasone * patient being treated with either topical, oral, or intravenous steroids * patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
effect of aromatherapy on postoperative nausea, vomiting

Conditions: Postoperative Nausea and Vomiting

Summary: the aim of this study is to evaluate the effect of the aromatherapy with lavender, rose or ginger essential oils on nausea, vomiting and postoperative quality of recovery scores in patients with postoperative nausea and vomiting.

postoperative nausea and vomiting (ponv) relief is still challenge for the anesthesiologist. pharmacological therapies is also cornerstone for treatment of ponv. although future researches are needed, there is some proofs about the aromatherapy could provide an inexpensive, noninvasive and effective treatment for ponv.

Eligibility criteria:
inclusion criteria : * be scheduled for elective surgery * have a postoperative nausea and vomiting exclusion criteria: * age \> 65years or \<18 years * not accepted to inhale lavender, rose or ginger oil * preoperative predications with anti emetic drugs * pregnancy or breastfeeding * asthma, chronic obstructive pulmonary disease * poor sense of smell * allergy to the lavender, rose or ginger oil

Keywords: postoperative nausea and vomiting aromatherapy quality of health care
formoterol certihaler, tiotropium handihaler and tiotropium handihaler in combination with formoterol certihaler in patients with stable chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this study is not being conducted in the united states. this study is designed to provide efficacy and safety data for formoterol 10µg twice-a-day (b.i.d.) delivered by the certihaler in patients with chronic obstructive pulmonary disease (copd). this study is also designed to compare the efficacy and safety of therapy with formoterol (certihaler)10µg b.i.d. added to tiotropium (handihaler) 18µg once daily (o.d.) compared with tiotropium (handihaler) 18µg o.d. monotherapy, and to compare the safety and efficacy of formoterol 10µg b.i.d. (certihaler) with tiotropium 18µg o.d. (handihaler).


Eligibility criteria:
inclusion criteria: * co-operative males or females with a diagnosis of moderate copd as per the global initiative for chronic obstructive lung disease (gold) criteria with an age at onset ≥ 40 years. * current or previous smokers with a smoking history of ≥ 10 pack-years. ten pack-years is defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc. * pre-bronchodilator forced expiratory volume in one second (fev1) \< 70% of patient's predicted normal value and ≥ 1.00 l, with fev1/forced vital capacity (fvc) \< 70% at visit 2. * a total symptom score from the patient diary of more than 0 on at least 4 of the last 7 days prior to visit 3 exclusion criteria: * pregnant women, nursing mothers, and females of childbearing potential, regardless of whether or not sexually active, who do not use a reliable contraceptive method (oral, mechanical, subcutaneous or surgical contraception). * patients who have been hospitalized for an acute exacerbation of their airway diseases in the month prior to visit 1 or during screening. * patients who have had a respiratory tract infection within 1 month prior to visit 1. patients who develop a respiratory tract infection during the screening period must discontinue from the trial, but will be permitted to re-enroll at a later date (at least 1 month after the resolution of the respiratory tract infection). * patients with concomitant pulmonary disease including a history of cancer (all), pulmonary tuberculosis or congenital bronchiectasis. * history of asthma

Keywords: copd, formoterol,
evaluation of the conversion from peginesatide to epoetin alfa in patients receiving hemodialysis

Conditions: Anemia

Summary: the purpose of this study is to evaluate whether hemodialysis patients on peginesatide can be converted to epoetin alfa by using a predefined conversion table while achieving a stable hemoglobin.

this is a phase 4, multicenter, single-arm, open-label study designed to evaluate whether patients receiving hemodialysis and treated with peginesatide can be converted to epoetin alfa using a predefined conversion table while achieving stable hemoglobin. the study will be conducted in two phases. hemodialysis patients treated with epoetin alfa 3 times a week (tiw) will first be converted to peginesatide administered every 4 weeks (q4w). after 24 weeks, these participants will be converted back to epoetin alfa administered tiw for 32 weeks. the primary endpoint will be the mean hemoglobin during the last 8 weeks of the epoetin alfa period.

Eligibility criteria:
key inclusion criteria: * receiving hemodialysis 3 times a week * receiving epoetin alfa iv 3 times a week * hemoglobin concentration ≥ 9.0 and ≤ 12.0 g/dl within 8 weeks of or during screening key exclusion criteria: * systemic hematologic disease * changes in epoetin alfa dose by ≥ 50% within 8 weeks of or during screening

Keywords: anemia, chronic kidney disease, end stage renal disease, erythropoiesis-stimulating agents, hemodialysis, hemoglobin
an european multi-centre cohort study for unravelling pharmacokinetic and genetic factors underlying post-ercp pancreatitis

Conditions: Post-ERCP Acute Pancreatitis

Summary: endoscopic retrograde cholangiopancreatography (ercp) comes with a risk for post-ercp pancreatitis (pep), which accounts for considerable morbidity, high healthcare expenditure, and death. the pathophysiology of pep and the underpinnings of the preventive effect of rectal nsaid (rn) is poorly understood. guidelines advise to take preventive measures with a single dose of 100mg rn, peri-ercp. while nsaid administration reduces the risk with 40%, pep still occurs after ercp. in addition, patients with a pep history have a higher risk to develop recurrence after a subsequent ercp. this might suggest that an underlying genetic risk may contribute to increasing the incidence of pep in some patients.

this study is a hypothesis driven and hypothesis free analyses of pep risk variants. integrative analysis of nsaid pharmacokinetics and-genetics in pep patients.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * written informed consent * indication to undergo an ercp exclusion criteria: * pancreatic cancer * chronic pancreatitis * ongoing acute pancreatitis * altered anatomy, defined as anatomical variations in which gall and/or pancreatic juices (in case of pancreatic duct interventions) do not enter the duodenum by way of the ampulla of vater.
botox® prophylaxis in patients with chronic migraine

Conditions: Migraine Disorders

Summary: this is a post authorization observational study to monitor the utilization practices and describe the safety profile of botox® in clinical practice for the prophylactic treatment of headaches in adult patients with chronic migraine.


Eligibility criteria:
inclusion criteria: * diagnosis of chronic migraine * willing to use botox® as preventative treatment for migraine exclusion criteria: * none
the long term impact of initiating pramipexole versus levodopa in early parkinson's disease (calm-pd cohort study)

Conditions: Parkinson's Disease

Summary: to determine the long-term consequences (8 years) of initiating patients with parkinson's disease on either pramipexole or levodopa. we hypothesize that patients initiating therapy with pramipexole compared with levodopa will demonstrate less self-reported disability as measured by the modified schwab and england (s/e) scale 8 years after randomization.


Eligibility criteria:
inclusion criteria: * available 301 subjects enrolled in the calm-pd study. exclusion criteria: * those not enrolled in the calm-pd study.
a comparison of p53-induced genes activation in patients with and without acute myocardial infarction

Conditions: Acute Myocardial Infarction

Summary: the purpose of this study is to compare p53-induced genes activation as possible markers differentiating between patients presenting with acute myocardial infarction and controls.

the diagnosis of acute myocardial infarction is based on the rise of bio-markers for cardiac necrosis such as troponin. while troponin measurement is highly sensitive for myocardial necrosis it has several limitations that influence its clinical use. first, since the troponin test is reliable only after 4-6 hours from symptoms onset, it has only limited value in the assessment of patients presenting earlier. second, several clinical situations, most commonly renal dysfunction, are associated with increased troponin level and therefore may decrease the specificity of the test. third, since troponin rise indicates myocardial infarction it is not useful in the common situations where there is myocardial ischemia without necrosis. the p53 is a tumor suppressing gene activated in different stressful situations including hypoxia. this activation is associated with accelerated transcription (up to 30-50 folds from baseline) of different genes that are involved in apoptosis, dna repair and in stopping the cell cycle. a study on pregnant women demonstrated high levels of fetal mrna of these genes in maternal circulation. this gene expression correlated with other signs of fetal stress associated with hypoxia. myocardial ischemia is another stressful event associated with tissue hypoxia. nevertheless, the association of this gene expression with myocardial ischemia has not been investigated yet.

Eligibility criteria:
inclusion criteria: acute mi group: patient presenting with chest pain lasting for at leasy 1 hour and no more than 6 hours accompanied by 1 of the following ecg criteria: * st segment elevation of anterior or inferior wall (at least 2 consecutive leads) * new lbbb controls: * patients undergoing non-invasive evaluation of possible myocardial ischemia exclusion criteria: * chronic lung disease requiring chronic treatment * any malignancy in the 5 year prior to enrollment
placental perfusion in the entire placenta and with sonobiopsy by ultrasound

Conditions: Placenta Diseases

Summary: in this study is tested the validity of placental vascular indices obtained from placenta ultrasonographic sphere biopsy and entire placenta investigation.

although, to this date, there have been a number of human placental studies that concerned the evaluation of placental 3 dimensional power doppler vascularization with the use of vocal technique, but there was no one in which placental vasculature has been compared between the sonobiopsy and whole placental volume.

Eligibility criteria:
exclusion criteria: * multiple pregnancy, * abnormal (\> 3mm) nuchal translucency from 11+0 to 13+6 weeks of gestation, * the fetal or neonatal structural or chromosomal anomaly, * inadequate localization of the placenta (placenta praevia), * self-reported drugs, alcohol, caffeine or nicotine abuse, * exposed to circulatory medication (oxerutins, calcium dobesilate) * or not signing the consent form. * if the mother suffer from er systemic disease (e.g. diabetes, autoimmune disease, vasculitis, haemophilia, thrombophilia, hiv infection, etc) inclusion clriteria: * single pregnancy * healthy pregnant women * no anatomical alteration of fetus * no genetical abnormality of fetus

Keywords: 3-dimensional ultrasound ultrasound placenta investigation of placenta in-vivo
accessible hcv care intervention for people who inject illicit drugs (pwid)

Conditions: Hepatitis C; People Who Inject Drugs; PWID; HCV Coinfection

Summary: the proposed study will examine the feasibility, acceptability, safety, effectiveness, and cost of an accessible care intervention for engaging people who inject illicit drugs (pwid) in hepatitis c care. accessible care for pwid is low-threshold care provided in programs designed specifically for pwid where they can comfortably access care without fear of shame or stigma. accessible care will be provided by co-locating a hepatitis treatment provider, together with a hepatitis c care coordinator (hccc), on-site at a collaborating needle exchange program. the proposed study will compare the effectiveness of accessible care with usual care (referrals to existing services) in facilitating linkage, engagement, and retention of pwid in care for hepatitis c, addiction, and hiv prevention. the primary outcome is sustained virologic response, which constitutes virologic cure. substance use and hiv and hcv risk behaviors are secondary outcomes.


Eligibility criteria:
inclusion criteria: 1. 18 years or older, 2. injected heroin, cocaine, or other drugs in the past 90 days. 3. test hcv ab and rna positive 4. provide written consent (including consent for researchers to examine their hepatitis c medical records) exclusion criteria: persons already in care for hepatitis c, defined as having had at least 2 visits with a hepatitis treatment provider within the past 6 months, will be excluded. people with decompensated cirrhosis will be excluded.

Keywords: hepatitis c hcv people who inject drugs
a study of al2846 capsule combined with standard chemotherapy regimen in subjects with advanced colorectal cancer

Conditions: Advanced Colorectal Cancer

Summary: this is a study to explore the safety, tolerance and efficacy of al2846 capsules combined with mfolfolx6 or folfiri standard chemotherapy regimen in subjects with advanced metastatic colorectal cancer.


Eligibility criteria:
inclusion criteria: -1. histologically confirmed advanced metastatic colorectal cancer. 2. has received only first-line standard chemotherapy regimen for metastatic disease, and which was failed. 3. at least one measurable lesion. 4. has received systemic chemotherapy, palliative radiotherapy or other anti-tumor therapy before first dose at least 4 weeks. 5.18 and 75 years old; eastern cooperative oncology group (ecog) performance status of 0 to 1; life expectancy ≥ 3 months. 6. adequate laboratory indicators. 7. no pregnant or breastfeeding women, and a negative pregnancy test. 8. understood and signed an informed consent form. exclusion criteria: * 1. diagnosed and/or treated additional malignancy within 5 years with the exception of basal cell carcinoma of the skin and carcinoma in situ of the cervix. 2. has received radiotherapy, chemotherapy and surgery before and less than 4 weeks from the first administration and less than 5 half-lives of oral targeted drugs after the completion of treatment. 3. has multiple factors that affect oral medications. 4. has gastroduodenal ulcer, ulcerative colitis, intestinal obstruction and other gastrointestinal diseases or other conditions judged by the investigator that may cause gastrointestinal bleeding or perforation. 5. uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage. 6. has arterial or deep vein thrombosis events in 6 months. 7. hypersensitivity to al2846 or its excipient. 8. imaging (ct or mri) shows that tumor invades large blood vessels or the boundary with blood vessels is unclear. 9. has symptomatic brain metastases, spinal cord compression, and cancerous meningitis within 8 weeks,or brain or pia mater disease confirmed by ct or mri examination before the first dose. 10.has adverse events caused by previous therapy that did not recover to ≤ grade 1, with the exception of alopecia or ≥ grade 2 neurotoxicity caused by oxaliplatin. 11. subjects plan to receive folfiri chemotherapy regimen with uridine diphosphate glucuronyltransferase homozygous variant or double hybrid variant. 12. has drug abuse history that unable to abstain from or mental disorders. 13. has any serious and/or uncontrolled disease. 14. has received allogeneic organ transplants, hematopoietic stem cell transplants or bone marrow transplants. 15. has participated in other clinical trials within 4 weeks before the first dose. 16. according to the investigators' judgment.
pulmonary hypertension secondary to idiopathic pulmonary fibrosis and treatment with sildenafil

Conditions: Pulmonary Arterial Hypertension; Idiopathic Pulmonary Fibrosis; Interstitial Lung Disease; Pulmonary Hypertension

Summary: pulmonary arterial hypertension (pah) in the setting of idiopathic pulmonary fibrosis(ipf)is a risk factor for morbidity and mortality in the peri-lung transplant(lt) setting. currently there is no significant data to support the use of pulmonary vasodilators for pah in the setting of interstitial lung disease such as ipf. the majority of ipf patients have pah either at rest or during exercise. the study hypothesis is that sildenafil may improve morbidity and mortality in the peri-lt setting in both ipf cohorts with either resting or exercise pah.

the purpose of this study is to evaluate the use of sildenafil in patients with pulmonary fibrosis and ph being considered for lung transplantation. we hypothesize that not only will sildenafil improve functionality and qol in the pre-transplant setting but it may also improve primary graft dysfunction after lung transplantation.

Eligibility criteria:
inclusion criteria: * patients with idiopathic pulmonary fibrosis referred for lung transplantation at our medical center * minimal 6 minute walk distance of 50 meters; must be able to conduct supine exercise during heart catheterization exclusion criteria: * non ambulatory * prior adverse reaction/allergy to sildenafil or other pde-5 inhibitors * any other pulmonary vasodilator within one month of enrollment

Keywords: pulmonary hypertension pulmonary arterial hypertension interstitial lung disease idiopathic pulmonary fibrosis
study to evaluate safety, tolerability and drug levels of bms-986435/myk-224 in participants with heart failure with preserved ejection fraction (hfpef)

Conditions: Heart Failure

Summary: the purpose of this study is to evaluate the safety, tolerability, and exposure-response (e-r) of bms-986435/myk-224 in participants with symptomatic heart failure with preserved ejection fraction (hfpef).


Eligibility criteria:
inclusion criteria - adult participants with stable, symptomatic hfpef with a normal heart pumping ability. exclusion criteria * participants must not have a known diagnosis of obstructive or genetic hypertrophic cardiomyopathy or infiltrative/storage disorder such as cardiac amyloidosis, or any other acute or serious condition that could interfere with assessments during the study or may pose a risk to the participant. * other protocol-defined inclusion/exclusion criteria apply.

Keywords: bms-986435 myk-224 pharmacokinetics pharmacodynamics safety hfpef
prognostic value of estimated plasma volume in pulmonary hypertension

Conditions: Pulmonary Arterial Hypertension; Chronic Thromboembolic Pulmonary Hypertension; Acute Right Heart Failure

Summary: assessment of the prognostic value of the estimation of plasma volume or its variation in patients with pulmonary arterial hypertension (pah) or chronic thromboembolic pulmonary hypertension (cteph) after acute right heart failure.

the aim of the study is to show that a low plasma volume status, assessed by the strauss (estimated plasma volume variation) and the duarte (instantaneous estimated plasma volume) formulas evaluated during acute right heart failure in patients presenting with pah or cteph, is associated with better long-term outcomes. optimization of plasma volume is important for patients with pah and cteph and constitutes a prognostic factor. however, plasma volume status can be difficult to assess in clinical practice. different formulas have been developed and have shown interest in patients with congestive heart failure with an association between plasma volume estimation and long-term prognosis. acute right heart failure may occur in patients with pah and cteph. thus, the investigators plan to study the prognostic value of these formulas evaluating plasma volume, in patients with pah or cteph, after acute right heart failure.

Eligibility criteria:
inclusion criteria: 1. patients with confirmed diagnosis of pah or cteph, referred to the medical department of the investigators 2. patient with acute right heart failure defined by at least 2 of the following clinical features: worsening of peripheral oedema, development or increase of ascites, weight gain of more than 2.5 kg in 1 week preceding the visit and decline in one nyha functional class compared to the previous stable state exclusion criteria: 1) patients with another cause of pulmonary hypertension than pah or cteph, either groups 2, 3 or 5 of the current clinical classification of pulmonary hypertension