Kornimate/medical-research-clean huggingface dataset:
prophylactic treatment of episodic cluster headache

Conditions: Cluster Headache

Summary: the purpose of this study is to determine whether candesartan cilexetil are effective prophylactic treatment of episodic cluster headache

cluster headache is an unilateral headache with periodic attacks, that usually lasts for 6 to 12 weeks. the pain is usually unbearable. the attacks are treated with injections of sumatriptan (migraine medication)and inhalation of oxygen. the most common prophylactics today has limited effect and a risk of side effects. candesartan has in one study shown a clinically significant effect in migraine prophylaxis. the angiotensin ii receptor blocker, candesartan is well tolerated with side-effects not significantly different from placebo and with few drug interactions. we therefore wish to investigate the prophylactic effect in treatment of cluster in headache patients. this will be a multicenter, double-blind, randomized, parallel study where the prophylactic effect of candesartan is compared to placebo in a period of 3 weeks. first week 16 mg and the following 2 weeks 32 mg.

Eligibility criteria:
inclusion criteria: * the episodic cluster headache must be diagnosed according to the ihs classification. had at least one episode with cluster headache before inclusion. previously had at least one cluster headache episode lasting one month or more. at the time of inclusion, the cluster headache period shall not have lasted more than 3 weeks exclusion criteria: * pregnancy, nursing, decreased hepatic og renal function, psychiatric illness, cardiac problems, hypersensitivity to candesartan, previous serious allergic reaction to medication, chronic cluster headache, drug/alcohol abuse, use of antipsychotic,antidepressants, lithium or other prophylactic treatment less than one month prior to inclusion, systolic blood pressure below 110 mmhg, use of other hypertensive medication, use og other specific attack medication than sumatriptan injection or oxygen 7-10l/min and inability to change medication, use of other triptans than sumatriptan during the study

Keywords: prophylactic episodic cluster candesartan angiotensin ii receptor blocker randomized placebo controlled parallel study headache diary
autologous serum efficacy study in patients with severe dry eye

Conditions: Dry Eye

Summary: the purpose of this study is to compare the reduction in symptomatology of patients with severe dry eye treated with autologous serum and conventional artificial tears.

severe dry eye remains an important and frequent eye disease, that reflects in a severe impairment of the patient´s life quality. up to date there is no ideal therapy for this condition. few studies have reported some kind of improvement in different parameters related to dry eye with the use of autologous serum, but no one has considered the patient´s symptoms with a systematic and validated evaluation method.

Eligibility criteria:
inclusion criteria: * age \> 18 years * severe dry eye, as defined by a osdi score \> or = 40 plus: * tear break up time (tbut) \< 5 seconds * cornea-conjunctival epithelial defects measured by fluorescein staining and evaluation using the oxford score. exclusion criteria: * no dry eye associated ocular disease * unable to comply protocol * severe anemia * previous use of autologous serum * concomitant use of other topical ocular drug * hypersensibility to any proposed interventions

Keywords: dry eye autologous serum ocular surface disease index
zilebesiran as add-on therapy in patients with high cardiovascular risk and hypertension not adequately controlled by standard of care antihypertensive medications (kardia-3)

Conditions: High Cardiovascular Risk; Hypertension

Summary: the purpose of this study is to evaluate the effect of zilebesiran as add-on therapy in patients with high cardiovascular risk and hypertension not adequately controlled by standard of care antihypertensive medications.


Eligibility criteria:
inclusion criteria: * history of cardiovascular (cv) disease, high cv risk, or estimated glomerular filtration rate (egfr) ≥30 to \<60 ml/min/1.73m\^2 * mean seated office sbp ≥140 mmhg and ≤170 mmhg * 24-hour mean sbp ≥130 mmhg and ≤170 mmhg assessed by abpm * must be on stable therapy with 2 to 4 classes of antihypertensive medications exclusion criteria: * secondary hypertension * orthostatic hypotension * proteinuria \>3 g/day * serum potassium \>4.8 milliequivalents per liter (meq/l)

Keywords: high blood pressure hypertension sirna angiotensinogen agt cardiovascular disease chronic kidney disease uncontrolled hypertension
study to evaluate the effect of improving systolic bp and ldl-c compared to conventional treatments and the convenience of taking medication of olostar tab

Conditions: Hyperlipidemias; Hypertension

Summary: the purpose of this study is to evaluate the effectiveness of olostar tablet on blood pressure and lipid profiles, obtain safety-related information for subgroups that failed to participate in the clinical trials, and to evaluate variables that affect treatment effectiveness.


Eligibility criteria:
inclusion criteria: 1. men and women over the age of 19 2. patients who signed a written consent form to participate in the study 3. patients who are eligible for olostar tablet prescription according to domestic permission exclusion criteria: 1. a person who falls under "2. do not administer to the following patients" among the precautions for use in the user manual 2. patients in hospital (hospitals only; nursing care facilities can be recruited) 3. a person who has been administered the study target drug or is being administered at the time of recruitment within 6 months based on the date of the study contract
characterization of suicidal depression

Conditions: Depression

Summary: antidepressants are widely used to prevent suicidal risk. however, even though the use of antidepressants has been associated with a 40-60% decrease in suicidal risk, they do not seem to be sufficient and appropriate. indeed recent studies have shown that patients with a history of suicide attempt and/or with current suicidal ideation (si) respond less well to antidepressant treatments. this suggests that patients with depression with si may be different from those with depression without si, thus requiring specific treatments for both si reduction and depressive remission. in other words, suicidal depression may be a specific subtype of depression. the study aims to characterize the clinical phenotype of patients with suicidal depression vs. those without suicidal depression, and to assess the occurrence of suicidal events at one year in patients with suicidal depression vs. without suicidal depression. all data having already been collected during the particpation of patients in various clinical research studies of the department


Eligibility criteria:
inclusion criteria: * over 18 years old * hospitalization in the department of emergency psychiatry and acute care (montpellier university hospital) between 2012 and 2019 * having being enrolled in one the department's clinical studies between 2012 and 2019 * moderate to severe characterized depressive episode according to dsm-5 diagnostic criteria (severity assessed with bdi, idsc-30 and qids) exclusion criteria: * protection by law (guardianship or curatorship) * deprivation of liberty (by judicial or administrative decision) * bipolar disorder

Keywords: suicide suicidal ideation suicidal depression
developing and testing mobile health question prompt list in gastroesophageal reflux disease

Conditions: Gastroesophageal Reflux; Patient Activation

Summary: more than 40% of patients with gastroesophageal reflux disease (gerd) experience uncontrolled, chronic symptoms. this proposal aims to improve symptom control for patients with gerd, by developing a mobile health (mhealth) question prompt list (qpl) intervention that helps patient ask questions with his/her physician about gerd. the first aim is to gather feedback about daily challenges of living with gerd. the second aim is to gather feedback on the prototype app. the third (primary) aim of this project is to develop the mhealth application and measure differences in patient activation when used compared to standard of care.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of gerd * gerdq score of \>=8 * documented ppi use for gerd * internet access at home or computer/mobile device * ability to provide written or e-consent. exclusion criteria: * established diagnosis that mimic gerd symptoms (e.g. achalasia by prior esophageal manometry) * non-english speaking patients
inverted t-shape free gingival graft for treatment of rt2 / rt3 gingival recession defects

Conditions: Gingival Recession

Summary: the aim of this study is to compare the use of t-inverted shape free gingival graft with free gingival graft for improving the clinical attachment, gain partial root coverage, and improve keratinized tissue width in recession type 2 /recession type 3 gingival recession defects . research question : in patients with rt2 / rt3 mandibular defects will the use of inverted t-shape free gingival graft differ from free gingival graft in recession depth?


Eligibility criteria:
inclusion criteria: * patients with rt2/rt3 gingival recession. * indication for fgg treatment at mandibular incisor area (i.e., difficulty or discomfort during oral hygiene; gingival margin mobility; high muscle attachment and/or frenum pull; shallow vestibule and gingival recession. * kt width (ktw) \&amp;lt; 2 mm. * ages 18-40 years old. * patients with healthy systemic condition (brightman. 1994). * gingival and plaque index \&amp;lt;10. * good oral hygiene (wiesner et al. 2010). * accepts 6 months follow-up period (cooperative patients) exclusion criteria: * smokers. * poor oral hygiene. * patient with a physical disability that hinders the upkeep of good oral hygiene measures. * intake of any medications known to affect gingival homeostasis or to interfere with wound healing. * pregnant or lactating women. * rt1 gingival recession. * caries or non-carious cervical lesions at recipient sites. * severely malpositioned teeth. * teeth with residual probing depth ≥ 4 mm. * mobility ≥ 1 mm. * pervious periodontal surgery within the last 6 months before the start of the trial. * patients with active periodontal disease. -

Keywords: inverted t-shape free gingival graft gingival recession free gingival graft
sms: substrate modification study in patients getting an implantable cardioverter defibrillator (icd)

Conditions: Tachycardia, Ventricular

Summary: the present standard of care for the management of unstable ventricular tachycardia (vt) in the setting of chronic coronary artery disease is the placement of an implantable cardioverter defibrillator (icd) after the initial episode, and radiofrequency ablation and/or antiarrhythmic medication in the event of recurrences causing frequent icd interventions. the primary purpose of this randomized study is the assessment of recurrences of unstable vt in patients who undergo icd implantation plus substrate ablation after the initial episode compared to patients who only undergo icd implantation. thus the primary purpose is an improvement in the quality of life. a decrease in mortality is not a primary purpose of this study.


Eligibility criteria:
inclusion criteria: * coronary artery disease documented by coronary angiography. for the purpose of this study, coronary artery disease will be defined as the presence of a 50% or more diameter stenosis of the left main or of a 75% or more diameter stenosis of the left anterior descending, circumflex or right coronary arteries, or the history of a surgical or percutaneous revascularization procedure. * left ventricular ejection fraction \< 40% as estimated by echocardiography or contrast ventriculography within the previous 30 days. * clinical unstable vt without reversible factors (acute ischemia or antiarrhythmic medications as defined below). unstable vt can have one of the following clinical presentations: * hypotensive vt without major neurologic dysfunction; * syncope; or * cardiac arrest. exclusion criteria: * age \ 80 years * protruding left ventricular (lv) thrombus on pre-ablation echocardiogram * acute myocardial infarction within the preceding 2 months * class iv new york heart association (nyha) heart failure * valvular heart disease or mechanical heart valve precluding access to the left ventricle * unstable angina * cardiac surgery within the past 2 months * serum creatinine \> 220 mmol/l (2.5 mg/dl) * thrombocytopenia or coagulopathy * contraindication to heparin * pregnancy * acute illness or active systemic infection * other disease process likely to limit survival to less than 12 months * significant medical problem that, in the opinion of the principal investigator, would preclude enrollment into the study * participation in another investigational study * unwillingness to participate or lack of availability for follow-up

Keywords: unstable ventricular tachycardia
measures of respiratory health registry

Conditions: Respiratory Disease; Cystic Fibrosis

Summary: there are many techniques that can allow for the quantification of lung function in children; some are being used clinically and others are under development. many of these tools are available at bc children's hospital. this registry study will act as a central repository for the results of traditional and novel pulmonary function tests done at bc children's hospital to allow for future analysis.

the scope of the registry is to collect data on small airways function in healthy children, children with cystic fibrosis (cf) and children with non-cf respiratory disease using the multiple breath washout (mbw) system. these data will be stored along with demographic data, clinical data, and traditional pulmonary function testing (pft) data. the mbw data will be collected with concurrent with clinically indicated pft testing. the purpose of the registry is to 1/ establish a locally collected normal range of small airways function across the paediatric age range and 2/ to collect these measurements in cf and non-cf respiratory disease. ultimately, the objective of this registry is to validate mbw technology as a tool that can be utilized in clinical care.

Eligibility criteria:
participants with cf inclusion criteria: -diagnosis of cf as evidenced by one or more clinical feature consistent with the cf phenotype or positive cf newborn screen and one or more of the following criteria: i. a documented sweat chloride ≥ 60 meq/l by quantitative pilocarpine iontophoresis (qpit). ii. a documented genotype with two disease-causing mutations in the cftr gene. - in the opinion of the investigator, the participant will likely have the ability to perform the lung function test of interest on the day of testing exclusion criteria: * physical findings at the screening that would compromise the safety of the participant or the quality of the data (e.g. respiratory distress or work of breathing) * requirement of supplementary oxygen to maintain oxygen saturation above 95% participants with other respiratory disease inclusion criteria: * physician-diagnosed lung disease * informed consent by participant, parent, or legal guardian * in the opinion of the investigator, the participant will likely have the ability to perform the lung function test of interest on the day of testing exclusion criteria * physical findings at screening that would compromise the safety of the participant or the quality of the research data * requirement of supplementary oxygen to maintain oxygen saturation above 95% healthy participants * inclusion criteria * informed consent by participant, parent, or legal guardian * in the opinion of the investigator, the participant will likely have the ability to perform the lung function test of interest on the day of testing exclusion criteria * physical findings at screening that would compromise the safety of the participant or the quality of the research data * evidence of lung disease
effect of nebivolol on oxidative stress and endothelial progenitor cells

Conditions: Hypertension

Summary: hypertension, or high blood pressure, is a common disease that affects many americans, and can lead to devastating consequences such as heart attack, stroke, and death if not treated. nebivolol is a medication that has been recently approved by the fda for the treatment of hypertension. nebivolol has an unusual profile compared to other medications, in that its effects may be related to release of a substance called nitric oxide. nitric oxide is released from the cells lining the blood vessels, and nebivolol may stimulate these cells to release more nitric oxide. our study will investigate whether treatment with nebivolol, as compared to another medication called metoprolol, in hypertensive subjects will be more effective in protecting blood vessels against the harmful effects of high blood pressure. the mechanisms we will investigate include oxidative stress markers and circulating levels of endothelial progenitor cells.


Eligibility criteria:
inclusion criteria: 1. males or post-menopausal females aged 21-80 years. 2. hypertensive patients (bp \>135/85) will be eligible to participate. 3. patients on current anti-hypertensive therapy that does not include beta blockade should have bp \>135/85. 4. patients on anti-hypertensive therapy including beta blockade will have their beta blockers discontinued gradually over 2 weeks before enrolment. 5. concomitant therapy: patients will be allowed to be on comcomitant therapy with aspirin, statins, thiazide diuretics, calcium antagonists (for treatment of hypertension), clonidine, vasodilators, or angiotensin antagonists. patients will be on stable medical therapy for at least 2 months before recruitment. patients with previous treatment with beta adrenergic blockers (metoprolol, propranolol, atenolol, and labetalol) will also be eligible to participate, but will be randomized to the study beta blocker. exclusion criteria: 1. age \ 80 years 2. initiation or change in dose of statin or anti-hypertensive therapy within 2 months before the study 3. premenopausal females with potential for pregnancy 4. acute infection in previous 2 weeks 5. history of substance abuse 6. current neoplasm 7. chronic renal failure \[creatinine \> 2.5 mg/dl\] or liver failure (liver enzymes \>2x normal) 8. acute coronary syndrome, class iv heart failure, cva, coronary intervention within 2 months 9. known aortic stenosis, hypertrophic cardiomyopathy. 10. inability to give informed consent 11. inability to return to emory for follow-up testing
apatinib in treating patients with recurrent or metastatic nasopharyngeal carcinoma (npc)

Conditions: Nasopharyngeal Carcinoma

Summary: to evaluate the efficacy and safety of apatinib in treating patients with recurrent or metastatic nasopharyngeal carcinoma who failed prior platinum based chemotherapy


Eligibility criteria:
inclusion criteria: 1. histologically or cytologic confirmed recurrent and/or metastatic nasopharyngeal carcinoma( npc ) 2. have failed for ≥1 lines of platinum based chemotherapy 3. at least one measurable lesion according to the recist 1.1 4. ≥ 18 and ≤ 65 years of age 5. ecog performance scale 0-2 6. life expectancy of more than 3 months 7. adequate hepatic, renal and hematologic functions (hemoglobin ≥ 90g/l, platelets ≥ 100×10\^9/l, neutrophils ≥ 1.5×10\^9/l, serum transaminase \ 60ml/min. 8. signed and dated informed consent. exclusion criteria: 1. prior therapy with tyrosine kinase -inhibitor agent targeting at vegfr and pdgfr 2. before or at the same time any, second malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix 3. any factors that influence the usage of oral administration 4. known spinal cord compression or diseases of brain or pia mater by ct /mri screening 5. within 6 months before the first treatment occurs artery / venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism, etc. 6. within 3 months before the first treatment occurs myocardial infarction, unstable angina pectoris, cardiac angioplasty or stent implantation 7. within 1 months before the first treatment received surgical operation and the wounds were not healed 8. application of anticoagulants or vitamin k antagonists such as warfarin, heparin or its analogues; if the prothrombin time international normalized ratio (inr) ≤ 1.5, with the purpose of prevention, the use of small doses of warfarin (1mg orally, once daily) or low-dose aspirin (between 80mg to 100mg daily) is allowed 9. blood coagulation abnormal, having hemorrhagic tendency (eg. active peptic ulcer disease) or receiving the therapy of thrombolysis or anticoagulation. 10. preexisting serious accompanying disease which may bring great risk or influence the patient's compliance( uncontrolled hypertension, grade iii - iv cardiac insufficiency, severe arrhythmia -qtc duration between 500 m/s, severe liver and kidney insufficiency :urine protein+ +, 24 hours urinary protein \> 1.0 g, mental illness.) 11. history of organ transplants 12. evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study. -
clinical feasibility and efficacy of intermittent use of a fasting mimicking diet in the treatment of type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: in this randomized, controlled, assessor blinded and prospective intervention study the investigators will evaluate the clinical feasibility and effectiveness of intermittent use of a fasting mimicking diet in patients with type 2 diabetes mellitus compared to usual care.

100 individuals (men or women, ethnicity not specified) with type 2 diabetes and a bmi≥ 27, who are treated with diet only and have a hba1c \> 48, or who are treated with diet and a dose of metformin can participate in the study. participants will use a fasting-mimicking diet for 5 consecutive days per month. for the other days, there are no regulations. during follow-up of one year, several study parameters will be measured including hba1c and antidiabetic medication dosage.

Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes * age \> 17 years and \<75 years * treatment with diet only and have a hba1c \> 48, or treatment with diet and metformin * bmi ≥ 27 exclusion criteria: * recent myocardial infarction (\< 6 months) * creatinine clearance \< 30 ml/min/1,73m2 (mdrd) * pregnancy * contraindications for mri * allergy for nuts, sesame, soya or another ingredient of the diet * history of syncope with calorie restriction in the past * any significant other disease (at the discretion of the investigator)

Keywords: diet fasting