Kornimate/medical-research-clean huggingface dataset:
a post-market registry to assess safety and performance of refluxstop™ in the treatment of gerd in general hospital practice

Conditions: Gastroesophageal Reflux Disease

Summary: a post-market retrospective and prospective, open label, multicenter, single-arm registry study using standard clinical procedures to record available and/or new data to evaluate the safety and performance of refluxstop™ for the treatment of subjects suffering from gerd. following surgery, patients will have follow-ups visits at 3 and 6 months and annually up to 7 years.


Eligibility criteria:
inclusion criteria: 1. willing and able to provide informed consent and to participate in the registry study; 2. age ≥ 18 years or according to local legal age of adulthood at the location of the test site if older; 3. documented gerd present for ≥ 6 months. typical symptoms are defined as heartburn; 4. 24-hour ph or impedance ph monitoring proven gerd with ph measurement, off ppi therapy for at least 7 days prior to testing. (total distal esophageal ph must be \ 55 or weekly acid \>26 for \> 5 seconds, all measured 5 cm above les); 5. suitable to undergo general anaesthesia and is a suitable laparoscopic surgery candidate as determined by the investigator. exclusion criteria: 1. hiatal hernia larger than 8 cm; 2. known presence of delayed gastric emptying, if no other cause for acid reflux could be diagnosed. patients with substantially weak peristalsis (manometry dci value 100-200) in esophagus measured during manometry would continue the simplified contrast swallow x-ray to perform a simplified two-hour gastric emptying contrast swallow 3. history of bariatric surgery wherein the stomach fundus has been extirpated; 4. female subjects who are pregnant; 5. known sensitivity or allergies to silicone materials; 6. intraoperative findings determined by the investigator that may result in unfavorable conduct of the registry procedure (as outlined in the ifu); 7. subjects that are unable to comply with the registry requirements (for example due to major psychiatric disorder or are considered otherwise unsuitable for participation in the clinical investigation according to the investigator's judgement).
cardiotoxicity of adjuvant trastuzumab

Conditions: Breast Neoplasms; Heart Failure

Summary: trastuzumab (herceptin®) increases the chances of cure in patients with her-2 overexpressing early breast cancer. unfortunately, both the chemotherapy drugs used in this setting (anthracyclines) and trastuzumab are known to cause cardiac dysfunction in a proportion of patients. patients who develop heart problems when taking trastuzumab might have to stop this treatment, which could jeopardise their chances of cure. n-terminal pro-b-type natriuretic peptide (nt pro-bnp) is a cardiac biomarker that is measured in the blood, the levels of which have been shown to indicate the presence of heart failure. some early research has suggested that there may be a correlation between elevated nt pro-bnp and heart damage due to cancer chemotherapy and also trastuzumab. troponin is another substance measured in the blood that can indicate heart damage. finally, certain variations in an individual's genetic makeup (called polymorphisms) could put them at increased risk of heart damage from trastuzumab. here we are studying whether any of these factors (nt pro-bnp levels, troponin levels, or certain genetic polymorphisms) can accurately predict who is at highest risk of trastuzumab-related cardiotoxicity. the principal aim of this study is to evaluate the utility of nt pro-bnp as a predictive biomarker for the development of trastuzumab related cardiotoxicity (trc). the investigators will also examine if single nucleotide polymorphisms in the her2 gene or fc-gamma-receptor genes predict for trc.


Eligibility criteria:
inclusion criteria: * female 18 years or older * histologically confirmed, completely excised invasive breast cancer with her-2 overexpression * primary surgery less than twelve weeks prior to registration * lvef\>50% as assessed by transthoracic echocardiogram or gated heart pool scan * eastern cooperative oncology group performance status 0-2 * adjuvant systemic treatment plan comprises at least three cycles of anthracycline chemotherapy and 52 weeks of trastuzumab * before patient registration, informed consent must be given according to local regulations. exclusion criteria: * pregnancy * distant metastases from breast cancer * any systemic chemotherapy prior to study entry
working memory training in adults with adhd

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the purpose of this study is to evaluate whether computerised working memory training improves cognitive performance, adhd symptoms, psychosocial functioning and quality of life in adults with adhd, from psychiatric outpatient clinics (n=100) as well as from a high-security prison facility (n=50).

the primary aim is to evaluate whether 5 weeks of computerised working memory training improves working memory capacity. secondary aims are to explore whether improvements in working memory capacity will be transferred to improvements in learning abilities and fluid intelligence. also, far transfer effects on executive functioning, adhd symptoms, psychosocial functioning and quality of life will be explored. finally, it will also be assessed to what extent improvements gained from 5 weeks of working memory training will be maintained 3 and 6 months post-study, respectively.

Eligibility criteria:
inclusion criteria: * confirmed adhd according to dsm-iv criteria; adhd combined type, adhd inattentive type or adhd uns, primarily inattentive type. * unmedicated for adhd during the course of the trial, or being under stable adhd medication for at least one month at baseline visit and without any planned changes in medication until post-study assessments have taken place. exclusion criteria: * previous participation in computerised working memory training (completed training). * any psychiatric disorder that in the judgment of the investigator, may interfere with study participation and/or study assessments, also including current substance abuse. * participation in psychological treatment addressing adhd during the course of the 5-week training period (psychoeducation is accepted). * initiation of psychological treatment for coexistent disorders during the course of the study (treatment already ongoing at baseline visit is accepted if there are no planned changes during the 5-week training period).

Keywords: adhd adults working memory training rct
early feasibility study of the nervive vitalflow stimulation for acute ischemic stroke patients

Conditions: Acute Stroke

Summary: this early feasibility study (efs) is a multi-center, open-label single-arm study in 10 acute ischemic stroke (ais) patients treated with vitalflow-is stimulation within 6 hours of symptom onset. the purpose of the efs is to evaluate initial clinical safety and device functionality in the clinical workflow setting for treatment of acute ischemic stroke patients that will inform design modifications and/or user interface in preparation for next steps consisting of (1) a full safety/feasibility clinical study and (2) randomized controlled pivotal trial with a surrogate endpoint (expedited premarket approval (pma) pathway).


Eligibility criteria:
inclusion criteria: * time last known normal within 4.5 hours of presentation for enrollment * allows 1.5 hours for pre-stimulation study procedures to maintain a 6-hour therapeutic window * iv rtpa and endovascular treatment (evt) permissible if not inappropriately delayed by study procedures * age 18-85 years * diagnosis of ischemic stroke in the anterior circulation * nihss at baseline 4-20 * creatinine \< 1.7 mg/dl * signed informed consent by patient/legally authorized representative (lar) exclusion criteria: * pre-stroke disability modified rankin score (mrs) between 2-6 * inability to communicate sufficiently to participate in study procedures * neuroimaging with intracranial hemorrhage, severe brain edema, or aspects \<5 * known or newly-discovered aneurysm or arteriovenous malformation (avm) * intracranial mass lesion, infection, or other reason to suspect increased intracranial pressure * metallic foreign bodies or implanted devices in the head or neck, including tattoos * cardiac, vagal nerve, or intracranial neural stimulation device * cochlear implant or implanted hearing aid * potential for delay in intravenous rtpa or endovascular therapy due to study procedures * intravenous (iv) rtpa: stimulation might be delivered during the rtpa infusion period * evt: stimulation might be performed while evt team is mobilized * seizure concurrent to stroke, or history of seizures, epilepsy, or recurrent syncopal events. * history of neuropathy (including facial nerve injury), carotid surgery, or vagotomy.
study of saxagliptin, 5-hydroxy saxagliptin, and metformin concentrations/levels in pediatric subjects with t2dm

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to evaluate the pharmacokinetics of saxagliptin, 5-hydroxy saxagliptin, and metformin in pediatric subjects with type 2 diabetes mellitus (t2dm) following oral administration of saxagliptin and metformin xr fixed dose combination tablet and co-administration of saxagliptin and glucophage® (metformin) ir tablets

the primary purpose is to assess the pharmacokinetics of saxagliptin, 5-hydroxy saxagliptin, and metformin in pediatric subjects aged 10 to 17 years with t2dm following oral administration of saxagliptin and metformin xr fixed dose combination tablet and co-administration of saxagliptin and glucophage® (metformin) ir tablets

Eligibility criteria:
inclusion criteria: * clinical diagnosis of t2dm * male and female subjects ages 10-17 * body weight ≥50 kg * glycosylated hemoglobin (hba1c) 6.5 to 10% exclusion criteria: * fasting plasma glucose (fpg) \> 240 mg/dl at screening * abnormal renal function * active liver disease and/or significant abnormal liver function
regional differences in indication for ventral hernia repair

Conditions: Ventral Hernia

Summary: the aim of the present study is to investigate whether there are differences in indication for ventral hernia repair and surgical approach among hernia surgeons from different geographical regions of denmark.

30 outpatient consultation will be taped and distributed among hernia surgeons in different regions of denmark. the surgeon will then be asked to answer a questionnaire regarding the treatment and surgical technique.

Eligibility criteria:
inclusion criteria: * patients referred to køge hospital surg. department with ventral hernia in december 2014

Keywords: indication differences
lime powder regimen in healthy volunteers

Conditions: Kidney Stone; Oxidative Stress

Summary: the study aims to investigate the pharmacokinetic parameters and its antioxidative effects in thai healthy men.


Eligibility criteria:
inclusion criteria: * thai healthy male or female aged 18-45 years old * bmi 18-25 kg/m2 * normal medical history, physical examination and vital signs * normal screening laboratories * no history of drug allergies * willingness to take part in the study and provide informed consent exclusion criteria: * history of gi, liver, kidney, allergic disease or any other disease that may interfere with the bioavailability of lime powder regimen * history of alcohol or drug abuse * heavy smoking * receive any medication within 14 days prior to the study day

Keywords: pharmacokinetic lime powder regimen kidney stone oxidative stress
the clinical trail of nafld treated by traditional chinese medicine

Conditions: NAFLD( Non-alcoholic Fatty Liver Disease )

Summary: to investigate in subjects with non-alcoholic fatty liver disease the direct effects of a chinese herb formula.

1) liver fat (measured by ct scan) and liver function assessed by liver enzymes levels; 2) insulin sensitivity measured by homa index, oral glucose tolerance test (ogtt) and a euglycaemic hyperinsulinaemic clamp (with stable isotopes) in a subset of the subjects; 3) plasma lipid profile and non esterified fatty acids (nefa) concentration; 4) circulating levels of adipokines.

Eligibility criteria:
inclusion criteria: * subjects with nafld(nonalcoholic fatty liver disease) (criteria of society of hepatology, chinese medical association, 2002.10), * aged 18-65 * alcohol consumption less than 40g/week; * liver/spleen (l/s) ratio no more than 1 by ct scan. exclusion criteria: * alt more than twice the upper end of the normal range * viral hepatitis * total parenteral alimentation or secondary liver disease such as hepatocirrhosis, autoimmune hepatitis, metabolic liver disease or drug induced liver disease * severe cardiovascular or renal dysfunction * subjects with diabetes (fasting glucose more than or equal to 7.0mmol/l or postprandial glucose more than or equal to 11.1mmol/l) * subjects treated with statins
promoting resilience in teens with asd

Conditions: Autism Spectrum Disorder

Summary: interventions for autism spectrum disorder (asd) are almost uniformly costly and time-intensive, blunting dissemination of intervention and stymying opportunities to make scalable impact. this study offers the first pilot randomized controlled trial (rct) of whether a single session intervention, shown to reduce internalizing problems in typically-developing youth, may improve core and co-occuring symptoms of asd.

interventions for core and co-occurring symptoms of autism spectrum disorders (asd) are almost uniformly costly and time-intensive, blunting dissemination of intervention and stymying opportunities to make scalable, population-level impact. one promising solution to this problem is a new class of evidence-based treatments, single-session interventions (ssis), which have shown remarkable efficacy in treating a range of other developmental psychopathologies. no study to date has examined ssis in youth with asd, which, if even marginally effective, could dramatically reduce the cost and expand the public health impact of accessible intervention options for asd. this study offers the first pilot randomized controlled trial (rct) of whether an ssi shown to reduce internalizing problems in typically-developing youth may improve core and co-occurring symptoms of asd.

Eligibility criteria:
inclusion criteria: * youth between the ages of 11-16 (inclusive) at the time of study participation; * youth with one parent or legal guardian willing to participate in the study (i.e. to be present for the lab visit and to complete questionnaires throughout the study period); * youth speaks english well enough to complete online or virtual based intervention activities; * youth with iq ≥ 70; * parent or legal guardian speaks english well enough to complete online questionnaires; * youth with scq \>10; * youth who meet criteria for autism or asd on the ados-2. exclusion criteria: * failure to meet the above inclusion criteria; * intellectual disability (iq\<70), as this may undermine comprehension of intervention materials; * adolescent is non-english speaking; * the presence of a known developmental disability aside from asd that would interfere with study participation; * the presence of a significant medical disability or disorder that would interfere with study participation.

Keywords: anxiety depression autism autism spectrum disorder single session intervention asd ssi
antioxidant supplementation in patients with kashin-beck disease

Conditions: Kashin-Beck Disease

Summary: the purpose of this study is to determine whether antioxidant supplementation can have a positive health effect on patients suffering from kashin-beck disease.

current research regarding kashin-beck disease, (kbd) have identified dramatic deficiencies of both selenium and iodine in patients with this disease. initial supplementation of these trace minerals provided no measurable benefit to the affected population. research conducted by innovative humanitarian solutions, suggests that such deficiencies may not be causal, but markers of an underlying condition of extreme oxidative stress brought on by the improper functioning of the glutathione peroxidase enzyme in synthesizing h202 during periods of critical cellular development, primarily in mesenchymal cell development. the purpose of this trial is to determine the efficacy of antioxidant supplementation in aiding the glutathione peroxidase enzyme in its proper function and thereby reducing oxidative stress and enabling the uptake of selenium and iodine which are necessary for proper bone growth and development.

Eligibility criteria:
inclusion criteria: * clinically diagnosed patients with kashin-beck disease exclusion criteria: * less than 24 hours from admission to icu * patients who are moribund * lack of commitment to program * absolute contraindication to enteral nutrients * severe acquired brain injury * pregnant or lactating patients * previous randomization in this study * enrollment in a related interventional study * child's class c liver disease metastatic cancer with life expectancy \< 6 months seizure disorder requiring anticonvulsant medication

Keywords: kashin-beck disease kashin-beck osteoarthropathy
dose adjusted chemoradiotherapy in hpv-associated oropharynx cancer of the elderly

Conditions: Oropharynx Cancer; Frailty

Summary: previous studies of this type of head and necl cancer have shown high rates of cancer control but result in many short and long term side effects when treated with high dose radiation and chemotherapy. recently, investigators have noticed similar high rates of cancer control in small numbers of patients who receive less intensive treatments using lower doses of radiation, smaller radiation fields with chemotherapy. it is expected that the side effects of treatment with lower doses of radiation would be less. for this reason this study is looking at a different regimen of reducing the intensity of the treatment. the purpose of this study is to compare any good and bad effects of using lower dose smaller fields radiation therapy and chemotherapy with published outcomes. this study will allow the researchers to know whether these different approaches are better, the same, or worse than the usual approach. to be better, the study approach should result in the same survival rate of the usual approach (about 85 out of 100 patients alive and free of cancer at 2 years) but with less long-term side effects.

there will be about 30 people taking part in this study. this study has one study group. all the people on the study will receive radiation therapy once a day, 5 days a week (for a total of 55 gy over 5 weeks) and chemotherapy, cisplatin, (given through the vein for about 30-60 minutes) once a week for 5 weeks. medications and saline solutions to prevent side effects of chemotherapy may also be given by vein and may prolong your time in the chemotherapy clinic to as much as 4-6 hours. standard regimen not delivered on this study pertains to radiation therapy and chemotherapy, cisplatin in a schedule of 5 treatments a week for a total of 69.96 gy over 6.5 weeks.

Eligibility criteria:
inclusion criteria: * pathologically proven diagnosis of squamous cell carcinoma of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls) * patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations. * p16-positive based on local site immunohistochemical tissue staining * clinical stage t1-3, n1-2, m0 (ajcc, 8th ed.) * age ≥ 65. * normal organ and marrow function within 14 days prior to registration defined as follows: * absolute neutrophil count ≥ 1,500/mcl * platelets ≥ 100,000/mcl * hemoglobin ≥ 8.0 g/dl * total bilirubin ≤ 1.5× institutional upper limit of normal (uln) * ast(sgot) or alt(sgpt) ≤ 3.0 × institutional uln * serum creatinine ≤ 1.5× uln exclusion criteria: * metastatic disease * recurrent disease after primary management cancers with center of mass is outside the oropharyngeal boundaries * synchronous double primaries * prior radiotherapy for lymphoma or other malignancy * prior systemic therapy including immunotherapy * severe active comorbidity where life expectancy is \<1 year. * autoimmune disease * uncontrolled hiv
antiplatelets and intramyocardial hemorrhage in stemi: incidence and outcomes

Conditions: STEMI; Acute Myocardial Infarction

Summary: the miron-platelet study is a retrospective, observational multi-center analysis assessing the impact of different antiplatelet therapies on hemorrhagic myocardial infarction (hmi) incidence and outcomes in stemi patients. key endpoints include hemorrhagic transformation, mace, bleeding complications, and 30-day mortality. findings will offer insights into the safety and clinical implications of antiplatelet therapy in high-risk patients.


Eligibility criteria:
inclusion criteria: 1. age ≥18-79 years at the time of stemi diagnosis 2. diagnosed with st-segment elevation myocardial infarction (stemi) based on standard clinical criteria 3. received antiplatelet therapy as part of stemi management 4. underwent primary percutaneous coronary intervention (pci) 5. evidence of hemorrhagic mi confirmed by cardiac magnetic resonance imaging or post-pci biomarker diagnostics 6. availability of comprehensive medical records documenting stemi presentation, treatment details, and clinical outcomes 7. minimum of 30-day follow-up data, with extended follow-up available for up to 10 years exclusion criteria: 1. diagnosis of non-stemi (nstemi), unstable angina, or other non-ischemic cardiomyopathies 2. history of prior hemorrhagic stroke or active intracranial bleeding before the index stemi event 3. known bleeding disorders (e.g., hemophilia, thrombocytopenia \<50,000/µl) 4. use of chronic antiplatelet therapy (aspirin, clopidogrel, ticagrelor, prasugrel) before stemi diagnosis 5. use of long-term anticoagulation therapy (warfarin, doacs such as apixaban, rivaroxaban, dabigatran) before stemi diagnosis 6. incomplete or missing medical records preventing outcome assessment 7. history of malignancy with life expectancy \<1 year at the time of stemi diagnosis 8. patients lost to follow-up before 30 days post-stemi

Keywords: hemorrhagic myocardial infarction antiplatelets mace
evaluation of electrocardiography performed with mobile ecg devices in cardiac patients and healthy volunteers

Conditions: Cardiac Arrhythmia

Summary: electrocardiography is one of most basic laboratory tests in cardiology. novel mobile ecg are becoming popular. the investigators aim to compare typical electrocardiographic measurements obtained with mobile ecg devices (alivecor kardia and alivecor cardia 6l) and 12-leads standard ecg (gold standard). the recordings will be compared by cardiologist paying special attention to heart rhythm disturbances, components of ecg curve and quality of recording.

electrocardiography is one of most basic laboratory tests in cardiology. novel mobile ecg are becoming popular. the investigators aim to compare typical electrocardiographic measurements obtained with mobile ecg devices (alivecor kardia and alivecor cardia 6l) and 12-leads standard ecg (gold standard). the recordings will be compared by cardiologist paying special attention to heart rhythm disturbances, components of ecg curve and quality of recording. ecg evaluation will include: rhythm description, measurements of mean rr, pr, qrs, qt, qtc and st-t description. additionally inter/intraventricular conduction abnormalities are to be determined from 12-leads ecg and approximate from mobile ecg recordings.

Eligibility criteria:
inclusion criteria: * patients with indication for electrocardiography * informed consent to participate in the study * the possibility of self-registration of a mobile ecg (no physical and mental restrictions) exclusion criteria: * not willing or incapable to give written informed consent. * lack of willingness to cooperate

Keywords: electrocardiogram mobile ecg