Kornimate/medical-research-clean huggingface dataset:
evaluation of an implant free interatrial shunt to improve heart failure

Conditions: Heart Failure

Summary: this is a prospective, single arm feasibility study to establish safety and performance of the pas-c system in subjects with heart failure and elevated left atrial pressure.


Eligibility criteria:
key inclusion criteria: * documented chronic, symptomatic heart failure and nyha class ii, class iii or ambulatory class iv at the time of screening visit and receiving guideline directed medical therapy. * at least one hospitalization or emergency department visit with heart failure as the primary or secondary diagnosis or intravenous diuretic treatment for heart failure or documentation of elevated bnp. * lvef ≥ 40%. * echocardiographic evidence of diastolic dysfunction during the baseline echocardiography: * per baseline exercise right heart catheterization, site measured elevated left atrial pressure with a gradient compared to right atrial pressure. key exclusion criteria: * stroke or thromboembolic event in the past 6 months. * severe or advanced heart failure such as stage d heart failure, non-ambulatory nyha class iv, cardiac index less than 2.0 l/min/m2, lvedd \> 6 cm, or received inotropic therapy for lvef less than 40% within 6 months prior to enrollment. * any of the following within 3 months prior to enrollment: myocardial infarction, percutaneous cardiac intervention, cabg, cardiac resynchronization therapy, aicd, or indicated for coronary revascularization at the time of enrollment. * more than moderate valve disease (mitral, tricuspid, aortic) at the time of enrollment. * chronic pulmonary disease requiring continuous home oxygen or hospitalization within prior 12 months for pulmonary disease. * bmi \> 40. * 6-minute walk test distance less than 100 m or greater than 450 m performed during baseline screening, or unable to perform baseline bicycle exercise test. * any of the following at the time of baseline screening: moderate or worse right heart dysfunction, requires dialysis, atrial fibrillation with ventricular rate \> 100 bpm, systolic blood pressure greater than 170 mmhg (average of 3 measurements at baseline). * evidence of precapillary pulmonary hypertension defined as pvr \> 2 wood units at rest, tpg \> 15 at rest or with exercise, resting ra \> 15 mmhg, or ra to pcwp ratio \> 0.7 at rest and with exercise. * anatomic anomaly that precludes creation of interatrial shunt.
study in patients' with persistent asthma and chronic obstructive pulmonary disease

Conditions: Asthma; Chronic Obstructive Pulmonary Disease

Summary: the study is to evaluate the percentage of patients with asthma or copd achieving disease control

there are no treatment groups or interventions to which the patients can be randomly assigned. data will be collected in a routine setting on a single occasion during an otherwise normal visit at the physician's office or clinic. participating physicians will not perform any medical procedures that are outside of their normal daily clinical practice. all treatment decisions are at the sole discretion of the participating physicians and reflect their current standard of care

Eligibility criteria:
inclusion criteria: * patient ≥ 18 years of age who has been diagnosed with persistent asthma or patient ≥ 40 years of age and/or (ex)-smoker with more than 10 pack years of smoking who has been diagnosed with copd * treatment with a stable dose (no change in dose or change by less than 50% in the last 3 months) of a inhaled corticosteroid (ics), long-acting beta2-agonists (laba), fixed dose combination (fdc) administered twice daily by dry powder inhaler (dpi) for 3 months prior to enrollment in accordance with its approved indication * patient is willing and able to provide written informed consent; * patient agrees to participate in the study and to disclose any medical events to the treating physician; * patient is able to complete the questionnaires. exclusion criteria: • current enrolment or planned enrolment in an interventional study (patients are allowed to participate in other observational or case-control studies).
longitudinal surveillance registry

Conditions: Heart Failure; Sudden Cardiac Death

Summary: boston scientific crm's longitudinal surveillance registry (lsr) will serve as an active ongoing source of updated information on the long-term reliability and performance of bsc commercially available leads and latitude-enabled (wireless or wanded) pulse generators (pgs).

the lsr is an active, prospective, non-randomized, multi-center registry of patients implanted with bsc commercially available latitude-enabled products. the primary purpose of the lsr is to evaluate and report on the long-term reliability and clinical performance of bsc's commercially available pgs and leads using the latitude patient management system to augment information collected from in-clinic visits. the lsr is designed to enroll patients implanted with bsc latitude-enabled (wireless or wanded) commercially available pgs (lead systems may include other manufacturers' leads). the primary objective of the lsr is to prospectively evaluate market-released pgs and leads to verify long-term system performance. the secondary objectives of the lsr include: i. to compare pg- and lead-related reliability data collected via latitude with pg- and lead-related reliability data collected at in-clinic visits ii. to compare this active surveillance of bsc pg and lead reliability data to the current passive surveillance system iii. to enhance understanding of feature performance, patient management and clinical outcomes

Eligibility criteria:
inclusion criteria: * patient who is or is scheduled to be implanted within 30 days of signing the consent with a currently available bsc pg (lead systems may include other manufacturers' leads) that can be followed on the latitude patient management system * patient who plans to remain in the long-term care of his/her enrolling physician (must be followed in-clinic at least once every 24 months by his/her enrolling physician) * patient who confirms that s/he has a telephone line compatible with the latitude patient management system communicator * patient or appropriate legal representative who is willing and capable of providing authorization for participation in the lsr exclusion criteria: * patient who cannot be followed on the latitude patient management system * patient who is unable or unwilling to comply with the protocol requirements

Keywords: icd crt-d
open-label study to evaluate safety of multiple courses of im alefacept during treatment of chronic plaque psoriasis

Conditions: Psoriasis

Summary: an extension study to evaluate safety and tolerability of up to 3 additional courses of im alefacept in patients with chronic plaque psoriasis who have been previously treated with 1 or 2 courses of im alefacept.


Eligibility criteria:
inclusion criteria: * must have received at least 8 injections in the c99-717 study and completed the final follow-up visit or, * must have completed the c99-712 study and been in c99-717 interim visits at the time dosing in the c99-717 study was closed. a subject who completed c99-712 but did not participate in any part of c99-717, including interim visits, must have prior sponsor approval before admission into c-728 exclusion criteria: * nursing mothers, pregnant women, and women planning to become pregnant while on study are to be excluded. female patients who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study * clinically significant abnormal hematology values or history of an immunosuppressive disorder * serious local infection or systemic infection within 3 months prior to the first dose of alefacept * a significant change in the subject's medical history from their previous alefacept study * any subject who initiated alternative systemic therapy, phototherapy, or disallowed therapy prior to visit 8 in study c99-712 or c99-717 * current enrollment in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy (participation in registry-type studies is allowed)

Keywords: psoriasis alefacept intramuscular
a tetracycline drain reduces alveolar osteitis in third molar surgery

Conditions: Post-Operative Wound Infection

Summary: the aim of this study was to investigate the effect of an oxytetracycline impregnated gauze drain on the incidence of alveolar osteitis (ao) and postoperative pain during the first week after mandibular third molar surgery.

the study was designed as a single-blinded randomized controlled trial. patients were randomized in two groups by a sealed envelope system: a drain group and a control group. the study population comprised patients undergoing surgical removal of one or both mandibular third molars (3m) during january 2016 until march 2017. patients referred to our department, who fulfilled the inclusion criteria, were asked to participate in the study. patients were prospectively included after giving written informed consent. the inclusion criteria were: age \>18 years, indication for removal of one or both 3m, asa i-ii, no need for sedatives, possession of a smartphone with internet access (to be able to register pain score and use of analgesics, see "data collection methods and statistical analysis"), and being able to attend a postoperative examination after 1 week. exclusion criteria were: age \<18 years, no indication for removal of 3m, asa iii or higher, pregnancy or breastfeeding, need for sedatives or systemic antibiotics, not possessing a smartphone, and not being able to attend a postoperative examination after 1 week. the national institutes of health's consensus statement (1979) and the american association of oral and maxillofacial surgeons white paper on third molar data (2007) served as guidelines when evaluating indication for 3m removal (nih consensus statement 1979, aaoms white paper 2007). study population (n=200) and group size (n=100) were determined through power analysis: 90% power, 5% significance level and an expected difference of up to 10% between the two groups.

Eligibility criteria:
inclusion criteria: the inclusion criteria were: age \>18 years, indication for removal of one or both 3m, asa i-ii, no need for sedatives, possession of a smartphone with internet access (to be able to register pain score and use of analgesics, see "data collection methods and statistical analysis"), and being able to attend a postoperative examination after 1 week. exclusion criteria: exclusion criteria were: age \<18 years, no indication for removal of 3m, asa iii or higher, pregnancy or breastfeeding, need for sedatives or systemic antibiotics, not possessing a smartphone, and not being able to attend a postoperative examination after 1 week.
randomized trial of mosapride versus placebo in the treatment of constipation-predominant irritable bowel syndrome

Conditions: Constipation-Predominant Irritable Bowel Syndrome

Summary: the purpose of this study is to determine whether mosapride, an agent which acts on serotonin receptors in the gastrointestinal tract, is effective in the treatment of constipation-predominant irritable bowel syndrome (c-ibs).


Eligibility criteria:
inclusion criteria: * rome iii criteria for ibs: patients must have recurrent abdominal pain or discomfort at least 3 days per month during the previous 3 months that is associated with 2 or more of the following: * relieved by defecation * onset associated with a change in stool frequency * onset associated with a change in stool form or appearance in addition, patients have to experience at least two of the following symptoms for at least 25% of the time \[11\]: * altered stool frequency (\< 3 bowel movements per week) * altered stool form (lumpy/hard i.e. bristol type i-iii \[see appendix 1\]) * altered stool passage (straining, urgency, or a feeling of incomplete evacuation) * passage of mucus, bloating, or a feeling of abdominal distension exclusion criteria: * previous allergy to mosapride * nocturnal symptoms (pain in the middle of the night, or other nocturnal symptoms which suggest an organic disease) * age \< 18 years * history of bloody stools or melena * diarrhea (\>3 bowel movements per day) * constitutional symptoms (fever, weight loss) * severe constipation (\< 1 bm/week) * pregnancy or lactation * patients with history of cardiac arrhythmias * qt prolongation on baseline ecg * chronic laxative use and dependence * patients with previous history of congenital heart disease * patients with previous history of hypokalemia or hyperkalemia * patients taking the following classes of drugs: hiv antivirals, macrolides, anti-arrhythmics, and azole drugs.

Keywords: mosapride irritable bowel syndrome constipation
improvement of sti detection in adolescent emergency department patients

Conditions: Sexually Transmitted Infections

Summary: the goal of this trial is to test a novel means of collecting patient-entered sexual health information for the provision of clinical decision support to increase the testing and detection of sexually transmitted infections (sti) in adolescent emergency department (ed) patients at high risk for stis.

the investigators have developed a novel means of collecting sexual health information from adolescents in the emergency department (ed) through the use of an audio-computer assisted self-interview (acasi). this information can then be used to provide clinical decision support to clinicians for targeted sexually transmitted infection (sti) screening in the ed for adolescents. this randomized trial randomizes patients to whether or not the clinician receives the decision support and tests whether provision of decision support results in increased sti screening for patients who report high risk sexual activity. secondary outcomes include evaluation of whether the clinical decision support results in increased sti detection, and identifying factors associated with adapting the clinical decision support.

Eligibility criteria:
inclusion criteria: * aged 14-19 presenting to the emergency department. exclusion criteria: * history of developmental delay, * medical instability, * altered mental status, * unable to understand english
a clinical study to assess the effects of joyrise recovery powder on mitigating alcohol aftereffects.

Conditions: Alcohol Aftereffects; Anxiety; Cognitive Impairment

Summary: this study assesses the effectiveness of joyrise recovery powder in reducing alcohol aftereffects, cognitive impairment, and anxiousness among participants aged 35-54 who consume alcohol. participants will be randomly assigned to either the joyrise group or a placebo group. the study will measure hangover symptoms, cognitive function, and overall well-being through a series of questionnaires and cognitive tests at baseline, 30 minutes after product consumption, and 4 hours later.


Eligibility criteria:
inclusion criteria: * aged 35-54, male or female * regular alcohol consumption * event planned within one month that involves alcohol consumption * willingness to avoid new medications or supplements during the study period * must confirm that they will not drive while under the influence of alcohol. exclusion criteria: * anyone not in good health. * anyone who has any chronic health conditions such as oncological or psychiatric disorders. * anyone who has any known serious allergic reactions that require the use of an epi-pen. * anyone who is pregnant, breastfeeding, or trying to conceive. * anyone who cannot/ will not commit to the study protocol. * anyone with a history of substance abuse. * anyone who has undergone an invasive medical procedure in the six months prior to the study, or has a procedure planned during the study duration. * anyone currently using any medications that may affect their response to alcohol or impact hangover symptoms, such as diuretics (water pills) or medication for hypertension. * history of severe reactions or sensitivity to alcohol. * anyone currently taking glutathione.

Keywords: cognitive function hangover anxiety reduction
platelet rich plasma in corneal surface diseases

Conditions: Persistent Corneal Epithelial Defects; Dry Eye

Summary: the aim of the study is to evaluate the efficacy of platelet rich plasma eye drops in the management of different corneal surface disorders. prp is a blood sample with a concentrated platelet count, and numerous growth factors that are associated with conjunctival and corneal wound healing process. which is an important advantage over other products. prp eye drops recently are proving to be an effective and potent therapeutic approach to promote corneal wound re-epithelization and promote ocular surface regeneration in different pathological conditions.

there are many conditions in which the ocular surface is severely affected as keratoconjunctivitis sicca, persistent epithelial corneal defect, recurrent corneal erosion, neurotrophic keratopathy, post laser in-situ keratomileusis (lasik) ocular surface syndrome (oss), dormant corneal ulcer, graft-versus-host disease, ocular cicatricial pemphigoid, and neurotrophic changes. if corneal wound healing does not occur promptly, it can lead to visual loss, severe scarring, infection and even corneal perforation, the treatment of ocular surface disorders has a multifactorial approach and conventional therapy is often not enough to solve the problem. platelet-rich plasma (prp) is defined as a portion of the plasma fraction of autologous blood having a platelet concentration above baseline. they use a prp device, concentrate platelets using a double centrifugation technique and activate prp just when they are ready to use it. the final concentration is at least 1.000.000 platelets/ microliter. therefore, it is an autologous concentration of platelets and growth factors. an important reservoir of proteins and growth factors precipitating in haemostasis, tissue regeneration, immune response, and wound healing. alpha granules of the platelets include over 30 biologically active substances such as platelet-derived growth factor, transforming growth factor b1 and b2 and insulin-like growth factor 1, vascular endothelial growth factor, epidermal cell growth factor, fibroblast growth factor 2, and insulin-like growth factor. eye platelet-rich plasma has a lubricating effect and has been effective in regenerating the ocular surface in cases of micropunctate keratitis, decreasing inflammation in patients suffering from dry eye and stimulating wound-healing processes in dormant corneal ulcers.

Eligibility criteria:
inclusion criteria: 1. persistent epithelial defects (exposure keratopathy, post infectious keratitis). 2. dry eye disease. exclusion criteria: 1. active ocular infection or inflammation. 2. patients will be withdrawn if allergic or adverse side effects develop. 3. pregnancy or breast feeding. 4. the use of systemic antiplatelet or anticoagulant. 5. uncontrolled systemic diseases 6. non-compliance with the study protocol. 7. positive hiv, hbv, hcb or syphilis. 8. anemia (less than 10 g/dl of hgb, platelet count less than 105/ul).
effect of preoperative topical ketorolac on aqueous cytokine levels and macular thickness in cataract surgery patients

Conditions: Cystoid Macular Edema, Postoperative; Diabetes Mellitus

Summary: the purpose of this study is to determine whether there is a relationship between inflammatory cytokines in the aqueous of the eye and thickness of the macula after treatment of topical ketorolac for patients undergoing cataract surgery.

to compare aqueous levels of inflammatory cytokines in diabetic and non diabetic patients treated with preoperative topical ketorolac tromethamine 0.45%. to compare the macular thickness changes in diabetic and non diabetic patients treated with preoperative ketorolac tromethamine 0.45% and its correlation with the aqueous inflammatory cytokines.

Eligibility criteria:
inclusion criteria: diabetic patient group 1. type 2 diabetes mellitus with no diabetic retinopathy 2. if with co-morbid, controlled hypertension with no hypertensive crisis in recent six months 3. listed for phacoemulsification cataract surgery non diabetic patient group 1. no history of diabetes 2. if with co-morbid, controlled hypertension with no hypertensive crisis in recent six months 3. listed for phacoemulsification cataract surgery exclusion criteria: 1. smoker 2. presence of immune disease, local or systemic inflammation 3. presence of retinal diseases, glaucoma 4. previous surgical procedure on the eye 5. intra-operative complications

Keywords: diabetes mellitus aqueous humor inflammatory cytokines cystoid macular edema, postoperative nonsteroidal anti-inflammatory drugs
efficacy and safety of bcx7353 to prevent angioedema attacks in subjects with hereditary angioedema

Conditions: Hereditary Angioedema (HAE)

Summary: this 3-part study will evaluate the safety and efficacy of an oral treatment, bcx7353, in preventing angioedema attacks in subjects with hereditary angioedema (hae). in part 1 of the study, eligible subjects will be randomized to receive oral bcx7353 or placebo for 4 weeks. assuming successful completion of part 1, additional subjects will be randomized in part 2 to one of 2 lower doses of bcx7353 or placebo. part 3 will enroll additional subjects into one of three doses of bcx7353 or placebo. the study will compare the number of acute attacks in each treatment group, as well as a number of other clinical and pharmacologic outcomes, and the safety and tolerability of each dose of bcx7353 compared to placebo.


Eligibility criteria:
key inclusion criteria: * a clinical diagnosis of hae type i or ii * documented hae attacks within a defined calendar period * access to acute attack medications * sexually active women of child-bearing potential and sexually active men must utilize effective contraception key exclusion criteria: * women who are pregnant or breast-feeding * any clinical condition or medical history that would interfere with the subject's safety or ability to participate in the study * use of c1inh, androgens or tranexamic acid for prophylaxis of hae attacks * history of or current alcohol or drug abuse * infection with hepatitis b, hepatitis c or hiv * participation in any other investigational drug study currently or within the last 30 days
feasibility study of dialysis clinic semi-autonomous ultrasound scanning using the vexev ultrasound imaging system for arteriovenous fistula mapping examinations. the canscan trial.

Conditions: Feasibility Assessment of the VxWave Device for Vascular Access Imaging

Summary: study to assess the feasibility of dialysis clinic staff to perform upper limb mapping ultrasound scans using the vexev ultrasound imaging system.


Eligibility criteria:
inclusion criteria: 1. referred to a study site for chronic renal replacement therapy or referred to a study site for management of ckd. 2. able to understand the procedures and requirements of the study and provide written informed consent and authorization for protected health information disclosure. 3. greater than or equal to 21 years of age at the time of written informed consent. exclusion criteria: 1. patients' unable to load arm into scanning bed (due to upper limb medical co-morbidities/injury). 2. patient has evidence of open or incompletely healed wounds on both arms. patients with open or incompletely healed wounds on a single arm are not excluded - if the ipsilateral arm is not able to be scanned - contralateral arm may be scanned. 3. any acute or chronic condition that would limit the ability of the patient to participate in the study - in the opinion of the principal investigator. 4. previous vascular/vascular access surgery on both upper limbs. patients with previous vascular/vascular access surgery on a single arm are not excluded- contralateral arm may be scanned. -