Kornimate/medical-research-clean huggingface dataset:
japan post marketing surveillance of the gore® cardioform septal occluder

Conditions: Stroke; PFO - Patent Foramen Ovale; Cryptogenic Stroke; TIA

Summary: the purpose of this post-marketing surveillance is to evaluate the effectiveness and safety of gore® cardioform septal occluder under the post-marketing setting in japan.


Eligibility criteria:
inclusion criteria: * diagnosed with cryptogenic stroke (including transient ischemic attack with positive head imaging findings) * diagnosed with a pfo * note: additional inclusion criteria may apply exclusion criteria: * n/a
mhealth for psychosis help-seeking

Conditions: Psychosis

Summary: the proposed study research project aims to develop and test a mobile health intervention designed to improve the wellness of young people at risk for psychosis and facilitate users' engagement with treatment and thus reduce duration of untreated psychosis. this clinical trial will involve a remote pilot randomized controlled trial that will examine (1) the feasibility of the proposed research approach, (2) the acceptability and usability of the north intervention as well as (3) the specific additive value of help-seeking support in the context of self-guided mhealth for early psychosis. the full intervention, which includes psychoeducational lessons, cognitive-behavior therapy-based practices, a symptom tracking feature, and help-seeking resources will be compared to a "lite" version that will include the lessons, practices, and tracking but exclude the help-seeking resources.


Eligibility criteria:
inclusion criteria: * elevated risk for psychosis that warrants further evaluation (a distress score \>= 20 on the prodromal questionnaire, brief \[pq-b\], per savill et al., 2018; and a positive frequency average score \>= 1.47 on the community assessment of psychic experiences \[cape-p15\], per jaya et al., 2021 and bukenaite et al., 2017) and confirmation of symptoms consistent with online data collection checks (per moritz et al., 2013) * age 18-30 years old * lives in the united states * under five years since participant's first psychotic episode or awareness of symptom onset * owns an iphone * unengaged in specialty mental health treatment, in which the participant has not done either of the following in the previous three months: (1) taken a prescribed antipsychotic medication, (2) attended regular (i.e. more than one session of) psychotherapy. exclusion criteria: * failed to demonstrate understanding of study details in comprehension screening process. * engaged in specialty mental health treatment in the previous three months, defined as the following: (1) taken a prescribed antipsychotic medication, or (2) attended regular (i.e. more than one session of) psychotherapy. * unengaged in treatment, but only as a result of having completed or "graduated" from a specialty mental health program.

Keywords: early psychosis psychosis risk duration of untreated psychosis
lung cancer screening: a multilevel intervention

Conditions: Lung Cancer

Summary: the study will develop and test the feasibility of the lung cancer assessment of risk and education (lungcare) intervention to increase discussions about lung cancer screening between patients and physicians. this intervention will be designed to reach primary care patients and will be implemented at three levels of the healthcare structure: patient, physician, and system. the patient component includes a short lung cancer screening video and questions regarding screening preferences. patients will receive immediate feedback in a report (patient report) that summarizes their lung cancer screening preferences and a handout summarizing the educational video. at the physician level, primary care physicians (pcps) will receive a similar report (physician report), which will be delivered to them prior to the patient visit. the report contains additional information about documenting discussion related to risk, screening, and referrals in the electronic health record (ehr) system (system component). the investigators will develop the lungcare intervention and have a comparison group that will receive usual care. preliminary testing of lungcare will occur via a randomized controlled trial (rct) at the university of california, san francisco, general internal medicine and women's health primary care clinics. the rct will evaluate lungcare among 50 pcps and 120 high-risk current and former smoker patients. the investigators will determine whether the intervention is accepted by patients and physicians and whether patients who received lungcare are more likely to discuss lung cancer screening with their physicians when compared to patients and physicians in the comparison group. the investigators will also determine whether the intervention affects knowledge of lung cancer and low-dose computed tomography (ldct) screening, perception of risk, and worry about lung cancer in patients when compared to patients in the comparison group. the investigators expect their research to provide specific recommendations that will facilitate patient-physician discussions about ldct screening and promote shared decision-making among patients and physicians.


Eligibility criteria:
inclusion criteria: * age 55-80 * smoked at least 30 pack-years in lifetime * if former smoker, quit smoking within the last 15 years * english speaker * no prior history of lung cancer * did not have a lung cancer screening test within the last year * pcp does not object to patient's participation * have a scheduled visit at university of california, san francisco (ucsf) internal medicine clinics. exclusion criteria: * speaking a language other than english * has a history of lung cancer * had a lung cancer screening test within the last year * pcp objects to patient's participation.

Keywords: randomized control trial lung cancer risk assessment shared decision making
native t1 mapping by cardiovascular magnetic resonance imaging in rare diseases

Conditions: Fabry Disease

Summary: fabry disease (fd) is a rare, x-linked lysosomal storage disorder leading to left ventricular hypertrophy, myocardial fibrosis, arrhythmia and heart failure. cardiac involvement is the leading cause of death in fd. treatment with enzyme replacement therapy is expensive, may be poorly targeted and there are difficulties in early detection and disease monitoring. t1 mapping signal change is a potential remarkable biomarker for fd. fabry400 is a multicentre study aiming to understand the biology of fabry disease and its relationship to non-invasive multi parametric mapping by cmr.

our understanding of cardiac involvement in fd is limited because the myocyte storage cannot be assessed non-invasively. however with the development of cmr t1 mapping this maybe possible. t1 mapping demonstrated excellent discrimination between fd and other causes of lvh, and this property is highly suggestive of a direct but intricate relationship between t1 signals and abnormal fat storage. specifically, 50% of patients without lvh have low t1 values, suggesting that t1 is an early disease marker in fd. this property may prove particularly useful for assessing disease progression and treatment response in early disease. in cmr, lge in fd characteristically occurs in the basal inferolateral wall. lge is associated with a poor response to therapy and adverse outcomes. hybrid imaging with pet/mr has shown that some fd lge may be inflammation. t2 mapping may be useful as it is a sensitive detector of inflammation and oedema, for example discriminating acute from chronic myocardial infarction, and diagnosing myocarditis, particularly in the setting of chronic myocarditis or heart failure. the aims of this study are: 1. improve the diagnosis of cardiac involvement by recognition of early disease 2. detect early changes and responses to therapy 3. improve the understanding of the pathophysiology of cardiac involvement using multiparametric mapping by cmr study method: this is a cohort observational study of fd patients including children, patients starting ert, ert naïve patients and lvh positive patients. follow up scans at 6 months and 12 months will be done on patients starting ert. cmr scanning will use t1 and t2 mapping techniques against established gold-standard sequences. the patients will also have echo and ecg. blood biomarkers will be collected (serum, plasma and urine).

Eligibility criteria:
inclusion criteria: * gene-positive fabry disease * male or female * age at least 9 years exclusion criteria: * any absolute contraindication to cmr * pregnancy

Keywords: fabry disease t1 mapping cardiovascular magnetic resonance
the long-term safety and effectiveness evaluation of the qdot micro system use in conjunction with visitag surpoint module for the treatment of symptomatic drug refractory paroxysmal atrial fibrillation.

Conditions: Paroxysmal Atrial Fibrillation

Summary: observational, multi-center, non-randomized, post-market study. this is a nested sub-study of the real af registry. consecutive symptomatic drug refractory paroxysmal atrial fibrillation (paf) patients from the registry will be screened for enrollment to this sub-study per inclusion and exclusion criteria.

enrolled qdot pas subjects are defined as consented patients with symptomatic paroxysmal atrial fibrillation (paf) enrolled in the real af registry. these enrolled subjects will be treated with the commercially available qdot micro™ system (qdot micro™ catheter and ngen™ generator) in conjunction with visitag surpoint™ module. subjects are required to complete scheduled assessments within 12 months of the index procedure, and additional two assessments at 24 and 36-months post procedure.

Eligibility criteria:
inclusion criteria: 1. symptomatic drug refractory paroxysmal (af episode terminate spontaneously within 7 days) who, in the opinion of the investigator, are candidates for ablation for af 2. 18 years of age or older 3. able and willing to participate in baseline and follow up evaluations for the full length of the sub-study 4. willing and able to provide informed consent for this sub-study exclusion criteria: 1. patients who have undergone catheter ablation for atrial fibrillation (pvi, roof line, posterior wall ablation...) 2. enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan 3. persistent or long-standing persistent af 4. in the opinion of the investigator, any known contraindication to an ablation procedure
surgical vs percutaneous laao

Conditions: Atrial Fibrillation

Summary: atrial fibrillation is the most common cardiac arrythmia globally. its prevalence ranges between 2-4% worldwide. it is associated with significant morbidity and mortality. one of the main concerns of af is the risk of thromboembolism, which can result in debilitating or detrimental stroke. the gold standard for preventing af stroke is long term oral anticoagulation in the form of warfarin or noac1,2. around 50% of patients who need anticoagulation are not on any form tablets and about 5% of patients who are not anticoagulated developed stroke. some patients could not take anticoagulation because of high risk of bleeding, and this result in challenges within this cohort of patients. the left atrial appendage (laa) is believed to be the main source of embolic in atrial fibrillation. the laa is an anterolateral structure which is the smallest part of the left atrium. it originates anterior from the left pulmonary vein ostium. more than 90% of thromboembolic events happened in the laa of non-rheumatic patients whereas only 57% of thrombi in rheumatic mitral valve disease3. this suggests that occluding the laa is more beneficial in the non-valvular af patients. incomplete laa closure is associated with a higher occurrence of thromboembolism. the growing evidence of laa occlusion has been emerged. percutaneous laa occlusion (laao) has been suggested that it may be considered for stroke prevention in patients with atrial fibrillation and contraindication for long term anticoagulation (class iib, level b)1,2. this recommendation is based on the randomized controlled trials to show that percutaneous devices are non-inferior to oral anticoagulation in terms of preventing stroke in af patients. surgical laa clip occlusion (laac) has emerged as a potential method to isolate laa to prevent thromboembolism. the recent laaos iii trial shows that the risk of ischemic stroke or systemic embolism was lower with concomitant left atrial appendage occlusion performed during the surgery than without it, most of whom continued to receive ongoing anticoagulant therapy4. this reinforced the mechanistic value of occluding the laa in prevention of stroke. however, the efficacy of isolated laac without anticoagulation is uncertain. besides, as this surgical clip occlusion is frequently performed together with other concomitant cardiac surgery, post evaluation in the form of imaging is lacking. our study aims to study the imaging follow-up result and clinical efficacy of surgical and percutaneous left atrial appendage closure.


Eligibility criteria:
inclusion criteria: * atrial fibrillation diagnosis * underwent laa clip (atriclip) or left atrial appendage occlusion with chadvasc \>=2 exclusion criteria: * subject not required anticoagulation due to low chadvasc * mechanical valve replacement * tissue mitral valve replacement or tissue aortic valve replacement with underlying chronic rheumatic heart disease

Keywords: left atrial appendage closure left atrial appendage occlusion
diabetes education for patients with type 2 diabetes in turkmenistan

Conditions: Diabetes Mellitus, Type 2

Summary: the aim of the study is to investigate whether structured diabetes mellitus education leads to improved blood glucose control in turkmenistan.

diabetes education is not routinely carried out in turkmenistan. the aim of the study is to investigate whether patients with type 2 diabetes benefit from an international diabetes federation (idf) based education program. patients will be randomized into a education group and a control group. the education group will receive 4 - 5 hours of education and the control group will only receive general information about diabetes mellitus. after 6 months, it is checked whether the change in the hba1c value differs between the two groups. additinal paremeters such as blood pressure, diabetes knowledge and lipids will also be evaluated (secondary parameters).

Eligibility criteria:
inclusion criteria: * type 2 diabetes exclusion criteria: * type 1 diabetes * diabetes duration \< 1 year * severe comorbidities * abuse of alcohol or drugs * pregnancy
telerehabilitation exercise in older adults

Conditions: Pain; Elderly; Balance

Summary: the aim of this study was to investigate the effectiveness of chair-based exercises and cognitive exercises through synchronous telerehabilitation in older adults. older adults will be divided into two groups (intervention group n=16; control group n=11) .


Eligibility criteria:
inclusion criteria: * getting a score of 6 or above on the hodkinson mental test exclusion criteria: * -having another chronic disease that can cause pain having a neurological disease being blind having an orthopedic, neurological or mental disability
safety and efficacy of ckdb-501a in subjects with post-stroke upper limb spasticity

Conditions: Post-stroke Upper Limb Spasticity

Summary: multicenter, randomized, double-blind, active-controlled, parallel-design study to evaluate the safety and efficacy of ckdb-501a in subjects with post-stroke upper limb spasticity


Eligibility criteria:
inclusion criteria: * male or female patients ≥ 19 years * history of stroke more than 24 weeks prior to screening * ≥ 2 points in the focal spasticity of wrist flexor and ≥ 1 point at least one of finger flexor and elbow flexor as measured on mas(0 to 4) * ≥ 2 points in one of the targeted functional disability item (i.e. hand hygiene, clothing, upper extremity, or pain for evaluation on das exclusion criteria: * neuromuscular disorders such as lambert-eaton syndrome, myasthenia gravis, or amyotrophic lateral sclerosis * fixed joint/muscle contracture in the target limb * history(within 24 weeks of screening visit) or planned(during study period) treatment with phenol or alcohol injection(chemodenervation) or surgery in the target limb * history(within 4 months of screening visit) or planned(during study period) treatment with tendon lengthening in the target limb * history(within 12 weeks of screening visit) treatment with botulinum toxin * concurrent treatment with an intrathecal baclofen * known allergy or sensitivity to the study medication or its components (clostridium botulinum toxin type a, albumin, sodium chloride, etc.) * male and female who are not willing to take any appropriate means of contraception during the study period * patients who are not eligible for this study at the discretion of the investigator.
transient elastography to assess liver fibrosis and portal hypertension in hcv cirrhotic patients treated with new antiviral drugs (spleen-c)

Conditions: Chronic Hepatitis C; Cirrhosis; Portal Hypertension

Summary: the purpose of this study is to evaluate the effects of sustained virological response in liver and spleen stiffness in patients with hcv compensated advanced chronic liver disease treated with new all oral antiviral drugs in order to determine factors implicated in stiffness change and its implications for long-term follow-up.

prospective cohort study including consecutive patients (with baseline liver stiffness measurement ≥10 kpa who meet the baveno vi criteria for compensated advanced chronic liver disease) who initiate treatment with new all oral antiviral drugs following current recommendations in spain. in all these patients the following parameters will be assessed: * baseline liver and spleen stiffness and cap measurements at the time of starting therapy and then, during treatment in week 4 and week 12 (end of treatment). after finishing therapy, these measurements will be repeated at 6 and 12 months of follow-up. * routine lab tests, including liver enzymes and viral load, will be performed at baseline, 4 and 12 weeks of therapy, and at 3 and 6 months after finishing therapy according to standard clinical practice. * liver ultrasound will be performed every 6 months as a routine procedure in patients wiht liver cirrhosis. * patients who were known to have esophageal varices prior to therapy will be assessed with an upper endoscopy 12 months after finishing therapy if they achieve svr.

Eligibility criteria:
inclusion criteria: * age 18 to 90 years. * history of chronic hepatitis c infection. * compensated advanced chronic liver disease (baveno vi definition): * baseline liver stiffness ≥15 kpa or, * baseline liver stiffness 10-15 kpa and one of the following: platelet count \ 5 mmhg, upper gastrointestinal endoscopy showing gastroesophageal varices or previous liver biopsy showing bridging fibrosis or cirrhosis. * indication to start antiviral treatment with new oral drugs. * willingness to enter the study. * sign the informed consent. exclusion criteria: * chronic liver disease due to other etiology than hcv. * terminal illness. * treatment with interferon. * liver stiffness measurement \< 10 kpa at baseline.

Keywords: cirrhosis chronic hepatitis c clinically significant portal hypertension portal hypertension elastography antiviral therapy
dose-ranging study of skf7™ for obesity

Conditions: Obesity

Summary: this study has been designed as a randomized, double blinded, multi-centric, placebo controlled, and phase ii dose-ranging study. the herbal drug contains bioactive ingredients from labisia pumila plant and it is an aqueous ethanolic standardized extract (skf7™).

labisia pumila or kacip fatimah is a native malaysian and indonesian plant. it has been used as traditional medicine for over 400 years by both men and women for multiple treatments including toning and firming the abdominal area. as a water-ethanol dry extract, it has been reported to reduce body weight, cholesterol level and triglyceride level, and regulate blood glucose and sex hormones. in malaysia, this kacip fatimah extract has been used as a natural anti-obesity drug and dietary supplement for healthy weight loss and healthy body by the trade-name of labeesity® or skf7™. this extract has been shown to be pesticide / herbicide free and has branded halal ingredient identity and security.

Eligibility criteria:
inclusion criteria: 1. men aged 18 - 50 yrs or women aged 18 until before perimenopause, with obesity 2. willing to participate in the study by signing the informed consent 3. healthy by anamnesis 4. agreed to maintain their current lifestyles (no changes in their diet and physical exercise) during the clinical trial period. exclusion criteria: 1. positive result for rapid test for covid-19 at screening period. 2. known hypersensitivity to any herbal product. 3. pregnant or lactating women. 4. taking any other weight loss therapy and/or lipid lowering products. 5. participate in other interventional clinical study or have taken other investigational drug within 30 days prior to screening.

Keywords: dose-ranging kacip fatimah labisia pumila obesity
a prospective study of surgical treatment strategies for chordoma

Conditions: Chordoma of Spine; Surgery

Summary: chordoma is a rare but locally invasive cancer that arises from the embryonic notochord. total resection is challenging in mobile spine because of the complex anatomy and bone invasion.


Eligibility criteria:
inclusion criteria: * between the ages of 18 and 70 ys, * with a diagnosis of chordoma confirmed by pathology, * undergone surgical treatment in our hospital, * available for clinical follow-up and agree to long-term clinical follow-up and sign informed consent. exclusion criteria: * suffer from other tumors, * suffer from cardiovascular disease, cerebrovascular disease, or immune system disease.

Keywords: chordoma
parent navigator program (pnp) to improve outcomes in latino/x children and parents

Conditions: Congenital Heart Disease

Summary: the goal of this clinical trial is to see if a parent navigator program (pnp) is helpful for latino/x parents of babies with congenital heart disease (chd) to get connected to developmental follow-up services. the main question it aims to answer are: * do families assigned to the parent navigator program (pnp) have higher rates of connection to high-risk infant follow-up (hrif)/early intervention (ei) compared to the standard care group 6 months after randomization? * do children assigned to the parent navigator program (pnp) have better neurodevelopmental outcomes (ndos) compared to the standard care group 6 months after randomization? * do parents assigned to the parent navigator program (pnp) have decreased parental stress compared to the standard care group? researchers will compare the parent navigator group to the standard care group to see if parent navigator group is helpful in connecting families to high-risk infant follow-up (hrif)/early intervention (ei), improving neurodevelopmental outcomes (ndos), and lowering parental stress. participants will: * undergo developmental assessments and survey at newborn stage and at 6 months * participants randomly assigned to the parent navigator group will have weekly (at least) phone calls with the parent navigator * participants randomly assigned to the parent navigator group will complete a 30-minute phone interview about their experience with the parent navigator program 6 months after random assignment


Eligibility criteria:
latino/x infants: inclusion criteria: * infants born with chd requiring medical/surgical intervention at less than 30 days of age * identify as latino/x exclusion criteria: * presence of a major genetic syndrome * intraventricular hemorrhage or other major structural brain lesion * undergoing end of life care parents of latino/x infants: inclusion criteria: * identify as latino/x exclusion criteria: * not fluent in english or spanish

Keywords: congenital heart disease parent navigator program latino/x children high-risk infant follow-up (hrif) early intervention (ei) neurodevelopmental outcomes