Kornimate/medical-research-clean huggingface dataset:
navigating pregnancy and parenthood with lyme disease

Conditions: Lyme Disease; Post Treatment Lyme Disease; Chronic Lyme Disease; Tick-Borne Infections; Tick-Borne Diseases; Pregnancy Complications; Parenting

Summary: this is a mixed methods study exploring the experiences of pregnancy and parenting among participants with lyme disease. eligible participants will have been diagnosed with lyme disease (ld), post-treatment lyme disease syndrome (ptlds), and/or chronic lyme (cl) either during or before a prior pregnancy. participants will complete quantitative surveys on topics such as their medical history, their child(ren)'s development, and demographic information. they will then participate in a qualitative interview where they will be asked about their experiences with pregnancy and with parenting their child(ren) in the context of their condition.

patients with chronic conditions may experience the perinatal period and the experience of parenting differently than their healthy peers. the purpose of this study is to understand the lived experiences of pregnancy and parenting among gestational parents with lyme disease. participants may be included in this study if they report having received a diagnosis of lyme disease (ld), post-treatment lyme disease syndrome (ptlds), or chronic lyme (cl) and they have given birth to at least one liveborn child. the investigators hypothesize that patients with ld/ptlds/cl will experience unique challenges related to pregnancy, experiences in medical care settings, and their child's development. enrolled participants will complete a brief set of online quantitative questionnaires on topics such as their demographic characteristics, family information, lyme disease histories, and mental health. the investigators will report on these data to illustrate similarities and differences between participants in the study for potentially relevant factors (e.g., timing of lyme diagnosis relative to pregnancy, symptoms, mental health concerns). the questionnaires will be followed by an in-depth qualitative interview in english with each participant to learn about their experiences related to pregnancy and parenting with ld/ptlds/cl, including specific questions about navigating the health care system, information seeking behaviors, and their child's development.

Eligibility criteria:
inclusion criteria: * over 18 years of age and reside in the united states or canada * diagnosed with acute lyme disease, ptlds, and/or chronic lyme by a health care provider while they were pregnant or ptlds/cl prior to becoming pregnant with ongoing symptoms during pregnancy exclusion criteria: * under 18 years of age * live outside of the united states or canada * never been diagnosed with lyme disease by a medical provider * never been pregnant * never given birth to a liveborn infant * previously participated in a qualitative study about their experience with lyme disease * do not want to agree to having their interviews audio recorded
caregiver burden and distress in hematopoeitic stem cell transplant

Conditions: Depression; Anxiety; Fatigue; Distress

Summary: the purpose of this study is to examine the impact that serving as a caregiver for a patient undergoing hematopoietic stem cell transplant has on the caregiver. this will include looking at the caregiver's level of burden, depression, anxiety, somatic symptoms, fatigue and overall distress. it will also look at whether caregiver burden leads to an increase in hospitalization and overall outcome.


Eligibility criteria:
inclusion criteria: patient: * any patient undergoing autologous or allogeneic hsct at the blood and marrow transplant program at northside hospital * patients must have a single primary caregiver * patients must be willing to comply with all assessments as outlined in the protocol * patients must be willing to sign informed consent caregiver: * must be the primary caregiver for an autologous or allogenic hsct patient at the blood and marrow transplant program at northside hospital * caregiver must be willing to comply will all assessments as outlined in the protocol * caregiver must be willing to sign consent

Keywords: hsct caregiver caregiver burden allogeneic transplant autologous transplant hematopoietic stem cell transplantation
milk biofortification promotes health benefits in institutionalized elderly

Conditions: Nutrient Deficiency; Age-Related Immunodeficiency; Vitamin E Deficiency; Selenium Deficiency; Fatty Acid Deficiency; Institutionalization; Disinhibited Attachment

Summary: the project aims to study the effects of inclusion of sunflower oil, vitamin e and selenium in the diet of dairy cows on milk composition and the influence of modified milk on nutrition and health of elderly. to achieve those goals, two experiments will be conducted, both lasting 12 weeks. in the first one, 32 cows at the beginning of lactation will be allotted in a completely randomized block design with a 2 x 2 factorial arrangement of treatments, as follow: 1) control diet; 2) control diet plus selenium and vitamin e; 3) control diet plus sunflower oil diet; 4) control diet plus sunflower oil, selenium and vitamin e. this experiment seeks the development of modified milks through nutritional manipulation of cow's diet. concomitantly, in the second experiment, 132 elderly people will receive the four different kinds of milk produced in the first experiment in a completely randomized block (gender) design. the selection of the elderly for each group shall be composed clinical evaluations. will be conducted biochemical tests before and after supplementation of milk consumption (serum α-tocopherol, selenium, analysis of fatty acid profile). assessment of nutritional status will be made body mass index (bmi) with each participant before and after the experiment of 12 weeks, including body composition by multifrequency bioelectrical impedance analysis (bia), evaluating the strength of pressure of the hand portable dynamometer, demographics and food consumption. the study of human nutrition and health will be held in the form of a double-blind study. the second experiment aims to study nutrition and health of elderly people, as it is expected that milk produced with better fatty acid profile, vitamin and minerals can improve the inflammatory profile of markers of the elderly. this project is important for the human population in general, particularly elderly people, health workers, human and animal nutritionists, and especially for the milk chain, as it has a potential to develop new dairy products and boost milk consumption.


Eligibility criteria:
inclusion criteria: * any institution residents that use milk in their usual diet. exclusion criteria: * inability to drink * use of enteral diets * lactose intolerance * autoimmune disorders * infections, allergies or inflammation in the two weeks prior to blood collection.

Keywords: aging nutrients milk dietary supplementation
research on building and application of internet-based home pre-rehabilitation model for lung surgery patients.

Conditions: Lung Cancer

Summary: this study, based on the internet platform, involving family caregivers in preoperative management, not only promotes patient compliance with preoperative rehabilitation exercise, but also provides multi-way rehabilitation measures for elderly patients with limited mobility or medical difficulties, and also provides new ideas for other specialties。

this study using a randomized controlled trial, 100 patients that meet the inclusion criteria are divided into experimental group and control group, experimental group adopts routine nursing measures, intervention group for preoperative family rehabilitation training, intervention for 2 weeks, observe the first after surgery, lung function index, chest catheterization days, postoperative hospital stay and medical expenses.

Eligibility criteria:
inclusion criteria: 1. age ≥ 60 years old; 2. a preliminary diagnosis of pulmonary结节 or lung tumor by chest ct; 3. planning to undergo thoracoscopic lung resection surgery; 4. voluntary participation of patients. exclusion criteria: 1. patients with severe condition who cannot tolerate pre-rehabilitation training; 2. patients with consciousness disorder or mental abnormalities who cannot cooperate with pre-rehabilitation training; 3. patients who cannot complete questionnaire filling out due to visual, auditory, or intellectual impairment, etc.
effects of platelet-rich fibrin and kinesio taping on postoperative recovery in oral surgery

Conditions: Impacted Third Molar Tooth; Postoperative Pain; Postoperative Edema

Summary: this study investigates the effectiveness of platelet-rich fibrin (prf) and kinesio taping in reducing postoperative pain, edema, and improving recovery following impacted third molar surgery. a prospective, randomized clinical trial was conducted with 44 patients aged 18-35 years. patients were assigned to three groups: (1) prf applied locally to the extraction socket, (2) kinesio taping applied postoperatively and removed on the third day, and (3) a control group receiving standard postoperative care. postoperative outcomes were assessed on days 3 and 7, including pain levels, edema, and quality of life. this study aims to evaluate prf and kinesio taping as non-pharmacological adjuncts in oral and maxillofacial surgery.

this study investigates the effectiveness of platelet-rich fibrin (prf) and kinesio taping in postoperative management following impacted mandibular third molar surgery. postoperative complications, such as pain and edema, are commonly observed and may impact patient comfort and recovery. this study aims to evaluate the feasibility of two non-pharmacological approaches-prf and kinesio taping (elastic bandaging)-in postoperative care. a total of 44 patients aged 18-35 years participated in this prospective, randomized clinical trial. patients were assigned to one of three groups: prf group: platelet-rich fibrin (prf) was applied locally into the extraction socket. kinesio taping group: an elastic bandage was applied postoperatively to the surgical area and removed on the third day. control group: standard postoperative care was provided with no additional intervention. postoperative evaluations were conducted on the 3rd and 7th days. the measured parameters included: edema: measured using anthropometric techniques. pain: assessed with the numerical rating scale (nrs). quality of life: evaluated using the oral health impact profile-14 (ohip-14). this study aims to assess the feasibility of prf and kinesio taping in postoperative management.

Eligibility criteria:
inclusion criteria: * ages 18-35 years * systemically healthy individuals * non-smokers * no psychological disorders * preoperative pain level between 0-3 on the numerical rating scale (nrs) * no preoperative edema in the surgical area * impacted mandibular third molars classified as class 1 or 2, level b, and mesioangular according to the pell-gregory classification * signed an informed consent form exclusion criteria: * under 18 or over 35 years old * presence of chronic or systemic diseases * pregnant or breastfeeding patients * surgical duration exceeding 45 minutes * smokers * patients requiring prophylactic antibiotics due to systemic health conditions * patients who did not meet the study criteria or did not sign the informed consent form

Keywords: impacted third molar elastic bandage platelet-rich fibrin postoperative pain quality of life postoperative edema
efficacy of probiotics for parkinson disease (pd)

Conditions: Parkinson's Disease (PD); Movement Disorders; Depression; Anxiety

Summary: in previous clinical studies, ps128 has been reported to ameliorate motor deficits in parkinson's disease (pd). ps23 has been reported to delay some age-related disorders. on the basis of previous animal and clinical studies which hope that this study can support the theory of the gut-brain axis, and have the opportunity to realize the relationship between peripheral inflammation and neurodegeneration.

the gut microbiota plays important roles in gastrointestinal homeostasis, essential physiological processes and cns function, and affects the gut-brain axis via neural, immune and endocrine pathways giving rise to the microbiota-gut-brain-axis (mgba). combining the mgba concept and the theory that parkinson's disease (pd) is derived in the gut, researchers have studied the relationship between the gut microbiota and the pd neurodegenerative process. probiotics are live microorganisms that confer health benefits on the host and can improve host physical and mental health by affecting mgba homeostasis. lactobacillus plantarum ps128 (ps128) and lactobacillus paracasei ps23 (ps23) are specific probiotics, known as a psychobiotic, which has been demonstrated to alleviate depression- and anxiety-like behaviors in mouse model. furthermore, ps128 alleviated motor deficits, nigrostriatal dopaminergic neuronal cell death, and striatal dopamine reduction in the mptp mouse model of parkinson's disease. in previous clinical studies, ps128 has been reported to ameliorate motor deficits in pd. ps23 has been reported to delay some age-related disorders. on the basis of previous animal and clinical studies which hope that this study can support the theory of the gut-brain axis, and have the opportunity to realize the relationship between peripheral inflammation and neurodegeneration. the eligible participants will be administered with probiotics capsules for 12 weeks. symptoms of pd will be clinically evaluated before and after the treatment. blood and stool samples will be collected before and after the intervention for biochemical parameters.

Eligibility criteria:
inclusion criteria: * the age between 41-80 years old and at least the elementary education level. * diagnosed as a patient with parkinson's disease of modified hoehn and yahr stage between 1 and 3 as rated. exclusion criteria: * diagnosed before 40 years old. * used probiotic products in powder, capsule, or tablet form within four weeks. * have taken antibiotics within four weeks. * those who are not suitable to participate in the research are judged by pi.
mitraclip expand g4 study

Conditions: Mitral Valve Regurgitation; Mitral Regurgitation

Summary: this primary objective of the expand g4 study is to confirm the safety and performance of the mitraclip g4 system in a post-market setting.

this is a post-market, multi-center, single-arm, prospective study to assess the safety and performance of the next generation mitraclip g4 system. the current protocol describes the design of this post-market study. up to 1,100 post-market, consented patients will be treated with a mitraclip g4 device according to local guidelines and ifu from the europe and middle east, the united states, canada and japan, and will be included in the analysis for the mitraclip expand g4 study. follow-up echocardiograms will be collected at discharge, 30 days and 1 year and 5 year at post-procedure visits. additional clinical follow-up visits will be at 6 months (phone call), 2, 3, 4 year (office visits). cardiovascular adverse events will be reported through 5 years to confirm safety of the mitraclip g4 system. during the phase 1 of the study 100 subjects were enrolled at 15 sites in the united states with the goal of evaluating the early safety and procedural outcomes associated with the mitraclip g4. the follow up duration was 30 days. phase i was completed august 2020.

Eligibility criteria:
inclusion criteria: 1. subjects scheduled to receive the mitraclip per the current approved indications for use 2. subjects who give consent for their participation exclusion criteria: 1. subjects participating in another clinical study that may impact the follow-up or results of this study

Keywords: mitraclip mitraclip g4 mitral regurgitation
prospective controlled trial on surgical treatment of type 2 diabetes patients with bmi 25-30 by means of biliopancreatic diversion

Conditions: Type 2 Diabetes Mellitus; Bariatric Surgery; Biliopancreatic Diversion

Summary: a previous prospective study of bpd effect on type 2 diabetes patients with bmi 25-35 (dia-chir) showed that t2dm is less sensitive to bpd beneficial effect in the simply overweight patients. a new prospective study was then planned with the aim to gain insight in the mechanism of action of bpd in t2dm patients in the 25-30 bmi range. thirty patients will be submitted to bpd and compared with 10 nonoperated controls. euglycemic-hyperinsulinemic clamp, ogtt, and mixed meal test will be performed in all subjects preoperatively, and 1 month, 1 year, and 5 years after bpd. complete clinical and biochemical evaluations will be performed at 1, 4, 8, and 12 months, and every sixth month thereafter until the end of the fifth year.


Eligibility criteria:
inclusion criteria: * age: 35-70 years * diabetes duration: \>5 years * documented poor glycemic control (hba1c =\>8% despite medical treatment according to gcp) * presence of comorbidities or complications (e.g. dyslipidemia, arterial hypertension, neuropathy, retinopathy, cvd, previous stroke or tia, lower limb amputation) * availability to comply with the entire follow-up exclusion criteria: * general contraindications to bpd (applies also to medical controls) * presence of anti-islet or anti-gad antibodies or plasma c-peptide concentration \<0.5 mcg/l * blindness * severe concomitant medical conditions (e.g. liver cirrhosis, renal failure, collagen diseases, severe endocrinopathies) * heart failure * recent history (less than 12 months) of myocardial infarction, stroke or tia * unstable angina * pregnancy * previous or concomitant malignancy * severe active inflammatory, neurologic, or cardiovascular conditions * geographic inaccessibility * any condition which, in the opinion of the principal investigator, may make risky the participation in the study or bias the results
flicker app for minimal hepatic encephalopathy

Conditions: Hepatic Encephalopathy

Summary: there is a great unmet clinical need for improved screening for mhe in patients with cirrhosis. we will demonstrate that the flicker-app can be used in clinic as well as at home by patients with cirrhosis to measure cff, a proven screening test for mhe. we will optimize the protocol, software, and hardware of the flicker-app to create a product appropriate for production and distribution to patients

sa 1. determine whether cirrhotic patients (n=75) can self-administer the flicker-app in clinic supervised by a research assistant and calculate the level of agreement between the cff determined by the flicker-app, the cff determined by the "gold-standard" ffs device, and the test scores on the encephalapp stroop test. sa 2. determine whether cirrhotic patients (n=75) can self-administer the flicker-app at home, including daily measurements over 1 week and weekly measurements over 6 weeks, and calculate the adherence to this protocol and the variability of these cff measurements. sa3. make any necessary software or hardware adjustments to the flicker-app to facilitate and simplify its self-administration by patients based on structured interview-questionnaires with the study participants and with clinical gastroenterologists/hepatologists

Eligibility criteria:
inclusion criteria: * cirrhosis (standard criteria) * chronic liver disease exclusion criteria: * grade iii or iv hepatic encephalopathy * mini-mental state examination score ≤25 (suggestive of dementia) * alcohol or illicit drug use within 3 months * current use of benzodiazepines * antiepileptics or psychotropic drugs * color blindness * severe vision impairment (blindness, macular degeneration).
compliance an observational study of treatment compliance and quality of life in patients on antihypertensive medication

Conditions: High Blood Pressure

Summary: the aim of this multi-centre survey is to assess treatment adherence and quality of life in a jordanian and lebanese population newly diagnosed with hypertension or with uncontrolled essential hypertension being on antihypertensive treatment for at least 6 months.


Eligibility criteria:
inclusion criteria: * patients older than 21 years of age * patients newly diagnosis with essential hypertension or with hypertension that is uncontrolled after being under the same antihypertensive treatment for at least 6 months (based on the criteria established by the joint national committee vii) * patients capable of providing an informed consent exclusion criteria: * patients with secondary hypertension * pregnant women or nursing mothers * patients with acute illnesses or psychiatric diagnosis

Keywords: hypertension
treating pulmonary embolism with laguna thrombectomy system (trust)

Conditions: Pulmonary Embolism

Summary: this is a prospective, multi-center, pivotal study to demonstrate the safety and effectiveness of the laguna thrombectomy system for the treatment of pulmonary embolism. the laguna thrombectomy system is an investigational device which consists of the laguna clot retriever™ system and the malibu aspiration catheter™ system. these devices are manufactured by innova vascular, inc.


Eligibility criteria:
inclusion criteria: 1. ≥ 18 years of age; \< 85 years old 2. rv/lv ratio \> 0.9 as determined by cta 3. systolic blood pressure \> 90 mmhg 4. heart rate ≤ 120 5. patient is deemed eligible for procedure by the interventional investigator 6. cta evidence of proximal pe (filling defect in at least one main or lobar pulmonary artery) 7. pe symptom duration ≤ 14 days exclusion criteria: 1. systolic pulmonary artery pressure \> 70 mmhg on initial invasive hemodynamic assessments 2. life expectancy of \< 90 days in the opinion of investigator at the time of enrollment 3. subject pregnant or breast feeding 4. current participation in another drug or medical device treatment study 5. in active chemotherapy or radiation treatment for a malignancy during the course of the study 6. any intravascular administration of a fibrinolytic agent (such as alteplase or tenecteplase) within the last 30 days 7. presence of recently placed (\<8 weeks) intracardiac devices (such as pacemaker leads) in the right ventricle or right atrium 8. history of prior pe within the past 90 days 9. fio2 requirement: \> 40% (6 lpm) to keep oxygen saturation \> 90% 10. hematocrit: \< 28% 11. platelets: \< 100,000/microliter 12. serum creatinine: \> 2 mg/dl 13. international normalized ratio (inr): \> 3 14. major trauma injury severity score (iss): \> 15 15. cardiovascular or pulmonary surgery within the last 7 days 16. known bleeding diathesis or coagulation disorder that cannot be managed with anti-coagulation 17. history of known severe or chronic pulmonary arterial hypertension 18. history or chronic left heart disease with left ventricular ejection fraction \< 30% 19. history of underlying lung disease that is oxygen dependent 20. history of chest irradiation 21. known anaphylactic reaction to radiographic contrast agents that cannot be pretreated 22. any absolute contraindication to systemic or therapeutic dosage of heparin or anticoagulants 23. imaging or other evidence that suggests, in the opinion of the investigator, the subject is not appropriate for mechanical thrombectomy intervention (e.g., inability to navigate to target location, predominantly chronic clot or non-clot embolus) 24. known presence of clot in transit within right atrium or ventricle

Keywords: laguna thrombectomy system pulmonary embolism