Kornimate/medical-research-clean huggingface dataset:
an open-label extension study evaluating safety and tolerability of lcz696 in subjects who completed paragon-hf in japan.

Conditions: Heart Failure With Preserved Ejection Fraction (HFpEF)

Summary: this study evaluated the safety and tolerability of lcz696 treatment in japanese heart failure patients (nyha class ii-iv) with preserved ejection fraction after clcz696d2301 (paragon-hf).

this study was an open-label extension study following the paragon-hf. patients who have completed the paragon-hf were eligible to participate. during the study, open-label lcz696 was taken in addition to background treatments of comorbidities. all subjects were treated with lcz696 (sacubitril/valsartan) at maximally tolerated dosed with a target dose of 200 mg b.i.d (twice a day). the subject were to continue to receive lcz696 until it became commercially available, or for a period up to 24 months from the first patient enrolled in this study whichever came first. however, this study was terminated early based on the pre-defined early termination criteria of "the primary endpoint of paragonhf was not met" in the protocol.

Eligibility criteria:
inclusion criteria: * signed informed consent must be obtained before any assessment is performed. * patients who have completed lcz696d2301 and are able to be safely enrolled into this study as judged by the investigator. exclusion criteria: * patients who discontinued study drug treatment during lcz696d2301 due to an event or intercurrent illness. eligibility can be re-considered if the event has resolved and no longer represents a risk to the patient and the patient can safely tolerate the administration of lcz696 per the investigator's assessment. * any medical condition that in the opinion of the investigator is likely to prevent the patient from safely tolerating lcz696 or complying with the requirements of the study. * patients who have experience of angioedema event(s) which occurred and reported by the investigator during lcz696d2301. * pregnant or nursing (lactating) women. * women of childbearing potential unless they are using highly effective methods of contraception. other protocol-defined inclusion/exclusion may apply.

Keywords: heart failure with preserved ejection fraction, japanese patients, extension study, long-term safety and tolerability, open-label
shr-1210 combined with apatinib in treatment of ed-sclc after failure of first line standard therapy

Conditions: Small-cell Lung Cancer

Summary: this is a multi-center, open-label, phase ii study of intravenous (iv) shr-1210 at 200mg,q2w in combination with apatinib at one dose (375mg). comparison of 3 different dose schedules in subjects with extensive-stage disease small cell lung cancer. shr-1210 is a humanized monoclonal antibody against programmed death 1(pd-1). apatinib is a new kind of selective vascular endothelial growth factor receptor 2 (vegfr-2) tyrosine kinase inhibitor (tki). the study is composed of two parts. part 1 of the study will determine the safety and tolerability of shr-1210 in combination with apatinib in first 6 subjects of each arm. the second phase of treatment was carried out by selecting one group of administration mode and the tolerated dose of apatinib. part 2 of the study will determine the safety and efficacy of shr-1210 in combination with apatinib in 39 subjects.


Eligibility criteria:
inclusion criteria: 1. signed inform consent form. 2. age \>= 18 years and \<= 70 years. 3. histologically or cytologically confirmed small cell lung cancer. 4. ed-sclc according to veterans administration lung study group. 5. radiographically progression following a platinum-based standard prior chemotherapy regimen. 6. eastern cooperative oncology group performance status of 0 or 1. 7. measurable disease as defined by recist v1.1. 8. life expectancy \>= 8 weeks. 9. adequate hematologic and end organ function. exclusion criteria: 1. histologically or cytologically confirmed mixed non-small cell and small cell carcinoma. 2. prior exposure to therapeutic anticancer vaccines; prior exposure to any t cell co-stimulatory therapy or immune checkpoint inhibitors, including but not limited to other anti-ctla-4, anti-pd-1, anti-pd-l1 and anti-pd-l2 antibodies. 3. prior exposure to anti-vegf or anti-vegfr therapy. 4. active brain metastasis or meningeal metastasis. 5. clinically significant third space effusion (e.g., uncontrolled pericardial effusion, ascites or pleural effusion by extraction or other treatment). 6. known hypersensitivity to study drug or any of its excipients; known hypersensitivity to any antibody. 7. treatment with any other investigational agent or participation in another clinical trial within 4 weeks prior to screening. 8. other conditions that the investigator thinks unsuitable in this study.
clinical assessment of pidogrel® versus plavix® (capp)

Conditions: Coronary Disease

Summary: this study aims to demonstrate non-inferiority of pidogrel ® compared to plavix ® in patients with coronary disease: * primary outcome measures: measure of platelet reactivity by verifynow assay after 600 mg loading dose or after the last maintenance dose (75 mg). * secondary outcome measures: time to first occurrence of major cardio-vascular events (mace). * safety criteria: severe bleeding (gusto scale).

after randomization of patients in both groups (plavix or pidogrel), the measure of platelet activity by the verifynow assay, 4 to 12 hours after the loading dose of 600mg or after the last dose of clopidogrel for patients on maintenance dose. the verifynow assay will determine: - the pru:-p2y12 reaction units- -% of platelet inhibition it will be considered low responder or clopidogrel resistant patient with pru\> 235 or %inhibition \<15%. monitoring of patients included in the study will take place over a period of 12 months, mace will be notified and dated. mace criteria are: angina, myocardial infarction, coronary angioplasty, coronary artery bypass graft, and stroke. each hemorrhagic event will be notified and classified according to the gusto scale.

Eligibility criteria:
inclusion criteria: * male or female, * old (e) over 20 years * patients hospitalized for acute coronary syndrome (whatever the t and troponin) * patients with proven coronary candidates for treatment with clopidogrel (who received a loading dose of 600mg over 2 hours and treated with 75mg / d of clopidogrel for longer than 7 days) exclusion criteria: * patients unwilling. * patient participating in another study. * patients with cardiogenic shock * patient on anti gpiibiiia or stopped less than 72 hours before the test aggregability * patients scheduled for surgery in less than 6 months. * patients candidates for coronary angioplasty * patients who underwent tac + / - bare stent fewer than 30 days. * patients who underwent stenting with atc active there is less than 12 months. * ischemic stroke older than 6 weeks. * history of hemorrhagic stroke (any time) * patients on warfarin or candidates * patients with a different anti adp (ticlopidine, prasugrel) * patients with indication for clopidogrel-cons (side effects, bleeding ...) * thrombocytopenia \<100000/mm3 * anemia (ht \<30%) * thrombocythaemia (ht\> 52%) * patients seeking treatment for an elective forms of clopidogrel. * pregnancy

Keywords: platelet agregation clopidogrel major adverse cardiac events (mace)
a dual tandem study - sc vs. cad-eye vs. cad-eye with g-eye

Conditions: Adenoma; Colo-rectal Cancer

Summary: single-center, four-arm dual-tandem, randomized, open-label study involving the following devices: 1. the standard colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (bli) and linked color imaging (lci). 2. cad-eye is an artificial intelligence software, used in real-time during the colonoscopy procedure for aiding the identification and characterization of polyps and adenomas. 3. the g-eye® balloon is a reusable (reprocessable) balloon permanently installed on the distal tip of a standard colonoscope, and is also intended to assist in flattening colonic folds and control the colonoscope's field of view and tip positioning.

single-center, four-arm dual-tandem, randomized, open-label study involving the following devices: 1. the standard colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (bli) and linked color imaging (lci). 2. cad-eye is an artificial intelligence software, used in real-time during the colonoscopy procedure for aiding the identification and characterization of polyps and adenomas. 3. the g-eye® balloon is a reusable (reprocessable) balloon permanently installed on the distal tip of a standard colonoscope, and is also intended to assist in flattening colonic folds and control the colonoscope's field of view and tip positioning. total of up to 372 patients will be randomized,186 to each of the two tandems

Eligibility criteria:
inclusion criteria: 1. screening and surveillance population for adenoma and crc. 2. the patient must understand and sign a written informed consent for the procedure. exclusion criteria: 1. subjects with inflammatory bowel disease; 2. subjects with a personal history of hereditary polyposis syndrome; 3. subjects with suspected chronic stricture potentially precluding complete colonoscopy; 4. subjects with diverticulitis or toxic megacolon; 5. subjects with prior colonic surgery (exclusion appendectomy) 6. subjects with a history of radiation therapy to abdomen or pelvis; 7. pregnant or lactating female subjects; 8. subjects who are currently enrolled in another clinical investigation. 9. subjects with current oral or parenteral use of anticoagulants, not considered eligible by the investigator. 10. subjects with recent (within the last 3 mounts) coronary ischemia or cva (stroke) 11. any patient condition deemed too risky for the study by the investigator
pediatric normative movement analysis data collection

Conditions: Pediatric ALL

Summary: the objective of this project is to collect baseline data from a normative population of children that gender and age matches the population of patients expected to be treated by mary bridge children's therapy services and seen in the research and movement laboratory. this project seeks to recruit 25 male and 25 female typically developing children between the ages of 3 and 18 years of age. non-invasive measurements of movement patterns will be collected during common activities of daily living over a single data collection session.


Eligibility criteria:
inclusion criteria: * age between 3-18 years * ambulate independently and without the use of assistive devices * perform activities of daily living without physical assistance * tolerate adhesive markers placed on skin and clothing * willing and interested in participating exclusion criteria: * neuromuscular disorders such as cerebral palsy, muscular dystrophy, myotonic dystrophy, spinal muscular atrophy, peripheral neuropathy, or other generalized muscle and/or nerve issues * evidence of developmental delays, muscle weakness, decreased muscle tone, joint stiffness, muscle or bone deformity * currently using or has a history of using assistive technology devices, bracing/orthoses, manual or powered mobility equipment * was born pre-term * currently or has a history of taking medication or pharmaceutical treatment related to musculoskeletal side-effects/scenario/diagnosis
the effect of social relationships on psychological distress and disease progression in patients with diabetes

Conditions: Diabetes Mellitus, Type 2; Psychological Distress

Summary: this study will determine the feasibility and effectiveness of a monthly social support group along with a weekly peer-to-peer meeting in improving perceived level of social support, diabetes distress, and a1c profiles in patients with type ii diabetes mellitus, compared with standard care offered at british columbia diabetes (bc diabetes).

this is a prospective, randomized, non-blinded comparative group clinical trial of 48 participants receiving social interaction in addition to standard diabetes care or standard diabetes care alone. all participants will have a baseline and 6 month follow-up visit where assessment of their a1c, diabetes distress, and social support will be performed. participants randomized to the social interaction cohort will meet on a monthly basis for a two hour group session designed to build social connections. in addition, participants will be paired with another study participant in this group, and will be asked to meet on a monthly basis for a minimum of 45 minutes. all participants in the social support cohort will continue to receive best standard diabetes management. participants in the control group will be treated with standard diabetes care. at the end of the 6-month study, they will have the opportunity to engage in the same social interventions offered to the social interaction group.

Eligibility criteria:
inclusion criteria: * willingly provide your full informed consent to participate; * are at least 19 years of age; * have an established diagnosis of type 2 diabetes mellitus; * have a diabetes distress screening scale (a score of 2-3 is considered moderate distress, 3-4 is considered high) * have a social provisions scale score less than 60 (a score of 80-90 is considered high, 60-80 moderate and less than 60 sub-optimal) * have an a1c greater than 8.5% in the last 2 months (a score of 6-7 is considered optimal, 7-8 sub-optimal and \>8.0 inadequate) exclusion criteria: * are unable to easily communicate in oral and written english. * have a physical disability or psychiatric diagnosis which would limit the ability to participate in the study; * are a prisoner, or in pre-trial; * do not have a fixed address;

Keywords: social relationships vulnerable connections diabetes distress support group
high-intensity interval training on cardiorespiratory fitness in overweight women

Conditions: Healthy Volunteers

Summary: high-intensity interval training (hiit) is currently considered one of the most effective strategies to improved cardiorespiratory fitness, which is recognized as a protective factor for cardiovascular diseases and metabolic diseases such as overweight and obesity. however, current evidence is still limited and requires clarity (frequency, time per session and intensity) regarding to greater increases attributed to hiit. the aim of this study is to compare the effect of a low-volume high-intensity interval training versus a moderate-intensity continuous exercise on maximal oxygen consumption in overweight women 18 to 44 years old.

thirty-six women will be randomly assigned to one of two aerobic exercise on a real-life setting supervised for a physical activity instructor. the interventions will performed three times a week for ten-weeks (on alternate days). the first two weeks will correspond to the conditioning period (30 minutes between 55-65% of maximum heart rate (hrmax). from week three, 18 participants will perform 30 minutes of continuous exercise at an intensity between 65-75 % of hrmax, and the remaining 18 will complete 21.5 minutes of interval exercise at an intensity between 90-95% of hrmax, with recoveries between 50-55% of hrmax. all participants will be evaluated to measure their maximal oxygen consumption, total body fat, waist circumference, body mass index, systolic blood pressure, diastolic blood pressure, prior to start the interventions and at the end of the program (week 11).

Eligibility criteria:
inclusion criteria: * overweight (≥ 25 kg/m-2) women 18 to 44 years. * healthy volunteers. * perform ≤ 600 met/min/week. exclusion criteria: * perform high-intensity interval exercise in the last six month. * smoker. * history of asthma. * history of diabetes. * history of hypertension. * history of cardiovascular disease. * history of coronary heart disease. * arrhythmias. * personal history of surgical procedures in the last three months * uncontrolled non-communicable diseases * under medical treatment with anticoagulants, beta-blockers, calcium antagonists, bronchodilators, and/or steroids. * psychological, neuromotor and/or osteo-muscular conditions that may affect participation in an exercise program. * psychoactive drug abuse.
assessment of scan quality of sparse oct retina scanner (mimostudy01)

Conditions: Macular Degeneration

Summary: optical coherence tomography (oct) is an established non-invasive medical imaging technique ophthalmologists use to diagnose and monitor retinal diseases such as age-related macular degeneration (amd). this study assesses the scanning performance of a newly developed sparse oct retina scanner that is smaller and more compact than most commercially available medical oct systems. the prototype device was developed at artorg center bern and berner fachhochschule biel. in this study the device is first tested on human eyes. the scanning performance is compared to a reference device. additionally patient feedback during the examination is acquired. the findings of this study are used to improve the software and the ergonomics of the investigational device.

background optical coherence tomography (oct) is an established non-invasive medical imaging technique ophthalmologists use to diagnose and monitor retinal diseases such as age-related macular degeneration (amd). this study assesses the scanning performance of a newly developed sparse oct retina scanner that is smaller and more compact than most commercially available medical oct systems. the prototype device was developed at artorg center bern and berner fachhochschule biel. in this study the device is first tested on human eyes. the scanning performance is compared to a reference device. additionally patient feedback during the examination is acquired. the findings of this study are used to improve the software and the ergonomics of the investigational device. objective * comparing scan quality of investigational device to scan quality of reference device. * obtaining patient feedback on the examination with investigational device. methods comparison of oct scans made with standard device and investigational device.

Eligibility criteria:
inclusion criteria: * 18 years or older * german speaking * suffering from age-related macular degeneration * written informed consent exclusion criteria * epilepsy * parkinsonian syndrome * dementia * pregnant women * persons using electronic medical aids i.e. hearing aid, pacemaker..

Keywords: amd oct
famotidine in schizophrenia

Conditions: Schizophrenia

Summary: objective of the trial is to study if famotidine add-on treatment is more effective than placebo add-on in reducing symptoms of schizophrenia among patients receiving insufficient response to ongoing antipsychotic treatment.


Eligibility criteria:
inclusion criteria: * icd-10 diagnosis of schizophrenia (f20.00-20.39, f20.5, f20.9) who have had the disorder for at least 5 years and who are on disability pension. (this means that their treatment response is not satisfactory and for the purpose of this study, the subjects are potentially treatment resistant). * clinical global impression (cgi) severity score of at least 3. * no changes in schizophrenia treatment within 12 weeks before study inclusion. * written informed consent * the subjects must fulfil schizophrenia criteria both according to dsm- iv (295.10, .20, .30, .60, .90) (american psychiatric association) and the research diagnostic criteria for schizophrenia (rdc) \[40\]. they must also have at least mild residual symptoms (cgi 3 points). the dsm-iv diagnosis will be verified by use of the scid-i \[41\]. the dsm-iv is clearly the most commonly used in psychiatric research, so this is important to be able to generalize the findings. however, several previous studies have used the rdc, so to be able to compare the results, we will diagnose the patients according to both systems. * women of child-bearing age will be included only of they use adequate contraception, or if we can otherwise verify that the subject is not pregnant (s-hcg), the possibility of pregnancy is negligible (e.g. the personnel of the housing facility reports that the person has not had sexual relationships for years) and the subject approves to remain sexually abstinent for the duration of the study. exclusion criteria: * epilepsy or a history of unclear seizures, stroke, parkinson's disease, aids * history of substance addiction or abuse within 3 months prior to enrolment. * individuals who are deemed at risk for aggressive behaviour or suicide * if their laboratory tests, ekg or other clinical observation warrants exclusion, they will be excluded * women who are pregnant or breast-feeding subjects will not be included in the study. * patients with any serious unstable physical illness will also be excluded * patients who have been deemed to be legally incapacitated according to finnish or swedish law. * regular uuse of h2-antagonists as prescribed by a physician. * known allergy to famotidine or any other component of interventional drug will be excluded. * ongoing treatment with clozapine and dixyrazine. * clinical condition "very much improved" or "much improved", assessed by cgi, during the placebo lead-in * renal insufficiency (p-creatinine not within normal range. glomerular filtration rate \<30 ml/min according to the cockcroft-gault formula. ) * liver insufficiency (s-alat elevated more than 2-fold above the laboratory specific normal range)
increasing prep among african americans in louisville ky

Conditions: HIV/AIDS PREVENTION

Summary: this study evaluates the effectiveness of a multifaceted strategy to increase pre-exposure prophylaxis (prep; a medication regimen to reduce hiv risk) uptake among high risk african americans in louisville, ky. we will do this by 1) implementing a media campaign to raise awareness about prep, 2) providing prep education to medical personnel who can prescribe prep, and 3) partnering with aids service organizations to improve outreach and linkage to prep services.


Eligibility criteria:
inclusion criteria: * between ages 18-29 years old * self-identifies as african american or black * resident of louisville, ky * member of a priority group for prep hiv prevention (men who have sex with men, people who inject drugs, trans women, high risk heterosexuals, people in serodiscordant relationships). * not diagnosed with hiv exclusion criteria: * older than 29 and younger than 18 years old * does not identify as african american or black * does not reside in louisville, ky * not a member of a priority group * diagnosed with hiv
pioneering advancements in cardiocerebrovascular interactions in the asia pacfic - patent foramen ovale study

Conditions: Ischemic Stroke; Patent Foramen Ovale

Summary: a registry of patients from the asia-pacific region with pfo and ischemic stroke, designed to study the characteristics, investigations, treatment and outcomes using real-world data.

this is an observational, multi-center, non-randomized real-world registry including ischemic stroke and/or transient ischemic attack patients with pfo in the asia pacific region. the primary objective of this registry is to assess the clinical characteristics and outcomes of patients with pfo and stroke or tia using real-world data in the asia-pacific region, including patients who underwent pfo closure versus medical management only. patients who had ischemic stroke or tia within 5 years of inclusion into the registry, with follow up data of at least 1 year. patients with ais or tia within one year of inclusion into the registry will be part of the prospective cohort. the total duration of the registry will be approximately 3 years.

Eligibility criteria:
inclusion criteria 1. subject has experienced acute ischemic stroke or transient ischemic attack 2. subject is screened with presence of pfo (right-to-left shunt) on appropriate cardiac imaging (transthoracic echocardiography and/or transesophageal echocardiography) or transcranial doppler bubble study 3. age ≥18 years exclusion criteria 1. stroke mimics, haemorrhagic stroke or cerebral venous thrombosis 2. subjects with less than 3 months of follow up

Keywords: patent foramen ovale ischemic stroke