Kornimate/medical-research-clean huggingface dataset:
the "virtual" multicenter spontaneous coronary artery dissection (scad) registry

Conditions: Spontaneous Coronary Artery Dissection; SCAD

Summary: the primary goal of this project is to describe the clinical and physiologic characteristics of spontaneous coronary artery dissections (scad) in order to increase awareness, understanding, treatment and prevention of a potentially fatal cardiovascular event. this study will be a retrospective and prospective review of medical course and current health of men and women with scad.

spontaneous coronary artery dissection (scad) is a relatively rare and poorly understood condition that has been reported to affect more women than men. the coronary arteries consist of three layers, and dissection occurs when two of these layers separate, enabling blood to flow into the space between the layers. as the blood accumulates, this can cause obstruction to normal blood flow within the heart, leading to chest pain, heart attack and even sudden death. the medical community has much to learn about treatment and prevention of this potentially fatal cardiovascular event. mayo clinic is conducting two studies of scad. this study consists of building a database/registry of patients with scad (whether they have been patients at mayo clinic or not) to identify patterns of scad incidence, causes and associations that could guide future research. with participant consent, mayo clinic staff will request a copy of the original coronary angiogram when scad was diagnosed to confirm the diagnosis and determine eligibility. if eligible, study coordinators will contact the participant to provide more information about the studies and request a signed informed consent document.

Eligibility criteria:
inclusion criteria: * individuals who have been cared for at mayo clinic with a diagnosis of scad * scad in women who are pregnant or within 12 months postpartum at the time of scad * scad in individuals who self-identify as a member of a racial or ethnic group that is currently underrepresented in the registry. this would include anyone who identifies as: black/african american, asian, american indian or alaska native, native hawaiian or other pacific islander, and any race with hispanic ethnicity * scad in a man * scad in persons younger than 30 years of age * scad within the past 2 weeks (acute) * scad patient enrolling into any other mayo clinic scad research study * scad in individuals who have a relative that has had a scad event persons with history of scad who are interested in participating in the study but do not meet the updated inclusion criteria will not be enrolled at this time. however, they will be given the option to share their contact information in order to be invited to future mayo clinic scad studies.

Keywords: spontaneous coronary artery dissection scad coronary artery disease myocardial infarction coronary dissection
improved quality of the treatment and increased compliance in asthmatics through the dialog tool soren - between patient and caregiver

Conditions: Asthma

Summary: the purpose of the study is to assess if a dialog tool can improve compliance and asthma control in patients with asthma.


Eligibility criteria:
inclusion criteria: * diagnosis of asthma \>/= 3 months, * prescribed daily use of inhaled glucocorticosteroid exclusion criteria: * asthma exacerbation within the last month

Keywords: asthma dialog tool compliance
a pharmacokinetic study to evaluate the drug interaction between shr0302 and cyp substrates in healthy volunteers

Conditions: Rheumatoid Arthritis

Summary: this is a drug-drug interaction study conducted in healthy volunteers to evaluate the pharmacokinetic effect of shr0302 on cyp3a4, cyp2c9, cyp2c9, cyp2c19, using midazolam, s-warfarin, omeprazole, and repaglinide as probe drugs.


Eligibility criteria:
inclusion criteria: - 1.18 ≤ age ≤45, healthy male; 2.subjects with body weight ≥ 50 kg, and 19≤bmi ≤26 kg/m2 ； 3.subjects must agree to take effective contraceptive methods from signing informed consent to 6 months after the last administration. exclusion criteria: 1. subjects with known history or suspected of being allergic to the study drugs； 2. participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening 3. subjects with egfr less than 90 ml/min/1.73m2； 4. subjects with systolic blood pressure less than 90 mmhg or more than 140 mmhg, and/or diastolic blood pressure less than 60 mmhg or more than 90 mmhg; 5. subjects whoes12-lead ecg qtcf was more than 450 ms or there were other abnormalities determined by the investigator； 6. subjects with clinically significant abnormalities in coagulation function； 7. subjects with infectious disease； 8. subjects with positive of urine drug screen； 9. subjects with acute illness occurred within 4 weeks prior to the screening period; 10. subjects who required antimicrobial therapy within 4 weeks prior to the screening period; 11. subjects with medical history of systemic inflammatory disease, autoimmune disease, recurrent herpes zoster, disseminated herpes zoster, disseminated herpes simplex; 12. subjects with a history of tuberculosis (tb) within six months prior to the screening period; 13. subjects with a history of hypoglycemic episodes or fasting blood glucose less than 2.8 mmol/l during screening； 14. subjects who took inhibitors or inducers of cyp3a4, cyp2c8, cyp2c9, or cyp2c19 within 28 days before the study; 15. subjects with contraindications for midazolam, warfarin, omeprazole, and repaglinide.
alpha-1 carrier genomics study

Conditions: Alpha-1 Antitrypsin Deficiency; Emphysema; COPD; Smoking

Summary: the goal of this study is to better understand why some alpha-1 genotype mz (pimz) individuals develop chronic obstructive pulmonary disease (copd) while others do not. this study will examine portions of the alpha-1 gene that are not routinely tested to determine whether other changes in this gene correlate with development and progression of copd. participation involves responding to questionnaires about lung health and history, and performing an at-home finger stick to obtain blood spots using a test kit that is mailed. the blood provided will be used for genetic testing and correlation of results with copd history. participants will receive their results and access to genetic counseling at the conclusion of the study.

alpha-1 antitrypsin deficiency (aatd, alpha-1) is the best established genetic risk factor for chronic obstructive pulmonary disease (copd) and liver disease. clinical presentation is heterogeneous in most genotypic populations of alpha-1 antitrypsin deficiency (aatd) and genetic variation in the alpha-1 gene has been incompletely studied. rare gene alterations that predispose to copd risks of classic aatd in individuals without a classic homozygous deficiency genotype have not been studied and are important in understanding, testing and treating at-risk populations. investigators hypothesize that serpina1 gene sequencing will find important sequence variations in previously assessed mz individuals who have copd compared to age, race, sex, aat level and smoking status matched mz individuals who do not have copd. the alpha-1 carrier genomics study is a pilot study that will enroll up to 150 mz individuals. copd+ and copd- individuals will be matched on age, sex, race and smoking history. presence and severity of copd is assessed by a copd severity score on questionnaires. participants will be mailed a test kit to obtain and return a blood sample by finger stick for the purpose of serpina1 gene sequencing. gene sequencing will identify, if present, genomic signatures that may correlate with copd in this cohort. participants will receive their results and access to genetic counseling at the conclusion of this study.

Eligibility criteria:
inclusion criteria: 1. signed informed consent 2. pimz individuals who fall into the lower quartile of aat levels. exclusion criteria: 1. age \<18 years 2. known homozygous or compound heterozygous classic severe aatd (e.g. pisz, zz, znull)

Keywords: alpha-1 antitrypsin deficiency aatd alpha-1 serpina1 mz carrier heterozygote smoking copd emphysema sequencing
dextenza with ilux for treatment of mgd

Conditions: Meibomian Gland Dysfunction; Evaporative Dry Eye

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 ilux mgd treatment system.

this prospective study will use a fellow-eye design for 30 participants, (2 groups of 15) equating to 60 eyes. all eyes will receive bilateral ilux mgd treatment system. the most symptomatic eye will be selected to receive dextenza® insertion on the day of the procedure (study eye). in group 1, the other eye will be assigned to receive prednisolone acetate 1% on a 4,3,2,1 month taper schedule (active comparator). in group 2, the other eye will receive punctal "sham" dilation (control eye). if there is no obvious symptomatic difference, the right eye will receive the intracanalicular insert. the study group will consist of 30 eyes receiving dextenza® insertion. the control group will consist of 15 eyes receiving prednisolone acetate 1% and 15 eyes receiving sham punctum dilation. thus, for every eye in the study group, there will be a paired eye with similar baseline characteristics in the control group sourced from the same participant. this fellow-eye design allows for greater control of potential confounders tied to participants' systemic and ocular health.

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

Keywords: dry eye meibomian gland dysfunction
remifentanil in ventilated preterm infants

Conditions: Preterm Infants; Mechanical Ventilator Care

Summary: the purpose of this study is to evaluate efficacy of remifentanil in preterm infants during ventilator care with remifentanil and to analyze pharmacokinetics in preterm infants


Eligibility criteria:
inclusion criteria: * preterm infants (\<37weeks of gestational age) * requiring ventilator care * informed consent exclusion criteria: * major anomaly * 48hrs after birth * requiring operation during drug infusion * cord blood ph \< 7.0 * intraventricular hemorrhage grade iii or more * investigators decision
comparison of femtosecond laser assisted cataract surgery to conventional phacoemulsification cataract surgery

Conditions: Cataract

Summary: in this project, the investigators aim to compare the safety, efficacy, and predictability outcomes of conventional ceiol surgery to femtosecond-laser-assisted ceiol (flacs) in an effort to improve cataract surgery outcomes. the investigators hypothesis is that flacs may lead to preservation of endothelial cells compared to conventional ce iol.

this study will only include patients who are eligible to undergo cataract surgery. all patients will receive treatment that is fda approved for cataract surgery. because all study participants will have been scheduled for elective cataract extraction regardless of their participation in this study, there will be little or no additional surgical risk associated with participation. a total of 720 patients are expected to be enrolled in the study during a period of 2 years. the investigators will recruit patients with bilateral operable cataracts. one eye will undergo cataract surgery using conventional cataract extraction technique including phacoemulsification whereas the second eye will undergo flacs. no significant increased risk to the patient is expected in either arm of the study compared to routine cataract surgery. the patients will be examined as per previous post-operative cataract surgery guidelines on pod1, pow1, pom1, pom3, pom6, poy1 and poy2. the only treatment difference will take place at the time of the cataract surgery. post-operatively, endothelial cell count will be obtained by the no-touch technology of specular microscopy at baseline as well as three months after surgery. if the study ends prematurely, the investigators do not anticipate any significant change in the care of the patient.

Eligibility criteria:
inclusion criteria: 1. patients older than 18 years of age 2. ability to understand and sign an informed consent 3. visually significant cataract eligible to undergo cataract extraction by phacoemulsification with primary intraocular lens implantation in at least 1 eye 4. ability and commitment to follow up for 18 months after surgery 5. no other ocular pathology and no previous/concurrent surgery exclusion criteria: 1. any other ocular pathology that may affect best-corrected visual acuity 2. previous or concurrent ocular surgery 3. subjects who are pregnant, lactating, or planning to be pregnant during the course of the study. 4. patients with keratoconus or keratectasia 5. patients who are blind on one eye

Keywords: cataract, femtosecond laser, flacs
pharmacokinetics and relative bioavailability study of oxycodone in healthy volunteers

Conditions: Healthy

Summary: to estimate the pharmacokinetics and relative bioavailability of oxycodone after administration of 40 mg doses of pf-00345439 formulations taken whole under fed conditions and after chewing under fasted conditions in healthy volunteers

this study will estimate the pharmacokinetics and relative bioavailability of oxycodone following oral administration of single 40 mg doses of pf-00345439 formulations j and k compared with the reference pf-00345439 formulation a, all taken whole and under fed conditions in healthy volunteers. in addition, the study will estimate the pharmacokinetics and relative bioavailability of oxycodone followingoral administration of single 40 mg doses of pf-00345439 formulation j or k (to beselected based on periods 1-3) after chewing under fasted conditions compared to that taken whole in the fed state in healthy volunteers, and assess the single-dose safety and tolerability of oxycodone inpf-00345439 formulations in healthy volunteers when administered under a naltrexone block.

Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects between 18 and 55 years of age (inclusive). exclusion criteria: * evidence or history of clinically significant disease. * positive urine drug test

Keywords: pharmacokinetics bioavailability oxycodone management of moderate to severe pain
the impact of group commitment contracts on smoking cessation and weight loss

Conditions: Smoking Cessation; Weight Loss

Summary: we will conduct a randomized controlled trial to evaluate the effectiveness of group commitment contracts for smoking cessation and weight loss.

initial screening will be conducted online via the qualtrics survey platform. respondents meeting the inclusion/exclusion criteria will immediately be randomized into one of the intervention arms described below, and then take a baseline survey. this baseline survey will also be conducted online via the qualtrics survey platform. the initial screening, randomization, and baseline survey should take approximately 15 minutes total and can be completed anywhere the participant has an internet connection. intervention: respondents who meet the inclusion/exclusion criteria will be randomized into one of the following arms: 1. control arm (no intervention) 2. group contract arm 3. individual monetary rewards arm 4. individual commitment contract arm subjects in arms #2-4 will be cross-randomized into two subgroups: a. additional information treatments on the likelihood of success of the different incentives and contracts, with the goal of shifting "naives" to "sophisticates." b. no additional information treatments. follow-up survey: after the participants finish their contract, they will be emailed a link to the follow-up survey that will be administered online via the qualtrics survey platform. the survey should take approximately 5 minutes and can be completed anywhere the participant has an internet connection. participants will be directly prompted to answer whether they have been able to quit smoking or lose their target weight in the past six months. if a participant self-reports a claim of smoking cessation or successful weight loss, they will be asked to furnish at-home verification of their claim. in-person verification: a randomly selected subset of successful participants will be asked for in-person verification of their claim with a urine test (smoking cessation) or in-person weigh-in (weight loss) at a quest diagnostics location of their choice.

Eligibility criteria:
inclusion criteria: * aged 18 years or older * has smartphone with capability to reach internet daily and download app * able and willing to visit quest location or take an at-home verification test * willing to furnish a payment method for commitment contract stakes if completing a smoking cessation contract: * daily smoker if completing a weight loss contract: * has access to a functioning scale * interest in losing weight at a pace of 2 lb or fewer per week, with a target bmi at or above 18.5 exclusion criteria: * pregnancy * any terminal illness
the effect of green tea or cocoa extracts in endothelial dysfunction in patients with diabetes mellitus

Conditions: Diabetes Mellitus; Diabetic Nephropathy; Arterial Hypertension

Summary: the purpose of this study is to determine whether green tea or cocoa extracts are effective in improve endothelial dysfunction in patients with diabetes mellitus and nephropathy and arterial hypertension.


Eligibility criteria:
inclusion criteria: * type 1 or type 2 diabetes mellitus * diabetic nephropathy * hypertension exclusion criteria: * gfr \< 30 ml/min/1.73m2 * serum k \> 5.5 meq/l * age \< 18 y * pregnancy * breast feeding * cocoa or green tea intolerance * alcohol and drugs abuse * incapacity to understand the information related to the study

Keywords: diabetes mellitus diabetic nephropathy hypertension green tea cocoa polyphenol nitric oxide
the value of home chlorhexidine pre-surgical wash before spine surgery

Conditions: Infection; Spinal Injuries

Summary: the study team hypothesizes that at-home cleansing of the surgical site with chlorhexidine wipes provide no added benefit to decreasing microbial activity or preventing surgical site infections. patients will be randomized to the chlorhexidine or no additional intervention groups. patients will be randomized to use 4% chlorhexidine cloths, while the other half receive no additional intervention. those randomized into the chlorhexidine gluconate (chg) home-application group will be asked to shower the night before surgery, and to use a standardized pre-packaged chg wipe (that the patients would receive at their pre-surgical consultation) on their surgical site after thoroughly drying those areas. the patients will be asked to use a second wipe in each area the morning of surgery. the surgical sites will be analyzed in two groups: anterior cervical and posterior spine. each of these two groups will be randomized separately. all patients will undergo a standardized preoperative cleansing regimen. once positioned, they will be cleansed with an alcohol solution. then, the surgical site (either the anterior portion of the neck or the posterior area of the spine) will be scrubbed with chlorhexidine soaked brushes and then painted with chlorhexidine solution. perioperative antibiotics will be given per attending surgeon preference. cutaneous samples will be taken from the surgical site of each patient at each time point.

to the investigator's knowledge no prior study has evaluated the effects of cleaning the skin at home before surgery in patients undergoing spine surgery. this study will investigate whether patients who use a chlorhexidine cleansing wipe have decreased amounts of bacteria on their skin when they arrive for scheduled spine surgery. spine surgeons strive to decrease infections in their patients, so it is important to see if this intervention helps to do this.

Eligibility criteria:
inclusion criteria: * 18 years old or older * scheduled for elective spine surgery at columbia university medical center exclusion criteria: * unable to apply at-home chlorhexidine wipe by themselves * deemed "high risk" preoperatively by the treating surgeon * diagnosed with spine trauma * undergoing deformity correction surgery * unable to consent to the terms of the surgery * known infection at time of the index procedure * hospitalized within 1 week pre-operatively * allergic to chlorhexidine * immunocompromised * end stage renal disease on dialysis * local or systemic skin disease (such as psoriasis, eczema, etc.) * open skin wounds

Keywords: infection control preoperative care chlorhexidine pre-surgical wash spine surgery surgical site infections cutaneous bacterial load on skin
phase ii pilot study of octreotide, a somatostatin octapeptide analog, for gastrointestinal hemorrhage in hormone-refractory hereditary hemorrhagic telangiectasia and senile ectasia

Conditions: Hereditary Hemorrhagic Telangiectasia; Ectasia

Summary: objectives: i. evaluate the efficacy of octreotide, a somatostatin octapeptide analog, in decreasing gastrointestinal bleeding in patients with hormone-refractory hereditary hemorrhagic telangiectasia or senile ectasia.

protocol outline: patients are treated with subcutaneous injections of octreotide twice a day. the dose is adjusted based on response. if there is no requirement for transfusions or intravenous iron for 4 weeks and the hemoglobin is greater than 10 mg/dl, therapy is continued for 1 year. if there is no decrease in bleeding after 10 weeks, the patient is removed from study.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- hereditary hemorrhagic telangiectasia or senile ectasia refractory to or unable to tolerate hormonal therapy, i.e.: estrogen progesterone danazol gastrointestinal (gi) hemorrhage requiring transfusion within past 3 months recurrent gi bleeding over more than 1 year at least 4 units packed rbcs transfused within past year or intravenous iron required more than 4 times within past year no other likely source of hemorrhage determined within past year --prior/concurrent therapy-- disease hormone-refractory --patient characteristics-- no octreotide sensitivity

Keywords: genetic diseases and dysmorphic syndromes hematologic disorders hereditary hemorrhagic telangiectasia rare disease senile ectasia