Kornimate/medical-research-clean huggingface dataset:
confirm rx insertable cardiac monitor smart registry

Conditions: Cardiac Arrhythmias; Symptoms and Signs; Atrial Fibrillation

Summary: the purpose of the confirm rx smart registry is to collect real world data to assess the safety and performance of the confirm rx insertable cardiac monitor (icm) and system over a 12 month period. a sub-set of subjects enrolled in the confirm rx smart registry will meet the post market clinical follow-up (pmcf) requirement for ce mark.


Eligibility criteria:
inclusion criteria: * have an approved indication for continuous arrhythmia monitoring with an icm * have a cellular phone or the ability or willing to use a st. jude medical mobile transmitter that is compatible with the mymerlin app and able to communicate with the confirm rx icm device. * have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations. * are 18 years of age or older, or of legal age to give informed consent specific to state and national law. exclusion criteria: * subject is implanted with or indicated for implant with a pacemaker, implantable cardioverter defibrillator (icd), or cardiac resynchronization therapy (crt) device. * enrolled or intend to participate in a clinical drug and/or device study, which could confound the results of this trial as determined by the sponsor, during the course of this clinical study. * have a life expectancy of less than 1 year due to any condition. * have a previous icm placement.
systolic ankle arterial pressure and transcutaneous oximetry during a turtle test in athletes

Conditions: Iliac Kinking

Summary: aim of the study is to test the feasibility of transcutaneous oxygen pressure (tcpo2) recording in the diagnosis of iliac kinking in 20 patients with suspected of endofibrosisoriliackinking and 40 asymptomatic control heathy subjects

patients suspected of pes and healthy controls after detailled explanation of the protocol will have a recording of tcpo2 on both calves and will perform a series of thigh flexion in the standing position.

Eligibility criteria:
inclusion criteria: - age over 18 years insurance company affiliation symptoms consistent with iliac kinking (patients) or absence of symptoms (controls) exclusion criteria: * refuse to participate exclusion period from another protocole non affiliation to the french healthcare system

Keywords: diagnosis peripheral artery disease sports
sleep disorders pre and post liver transplantation

Conditions: Liver Cirrhosis

Summary: sleep disturbance and sexual dysfunction are common complaints of patients with cirrhosis . the term sleep disturbance describes insomnia, poor quality sleep, circadian rhythm disorders and obstructive sleep apnea and is associated with reduced health-related quality of life (hrqol) score indices. sleep and sexual disorders have only been formally evaluated in small studies in these patients and to date, no studies have objectively assessed these patients. in addition, no studies have been performed in these patients after liver transplantation. the investigators' hypothesis is that sleep and sexual disturbance is commonly seen in patients with advanced cirrhosis and improves after liver transplantation. however, despite this, hrqol remain impaired because of residual sleep disturbance.this study will be unique in providing cross-sectional follow-up of patients with cirrhosis at baseline and after liver transplantation (\> 6 months).


Eligibility criteria:
inclusion criteria: * liver cirrhosis * comprehend and read english * on liver transplantation list or post-liver transplantation exclusion criteria: * non-english speaking * \ 85 yrs
associations of plasma fatty acid patterns with gestational diabetes mellitus

Conditions: Gestational Diabetes

Summary: background: limited studies have explored the difference of fatty acid profile between women with and without gestational diabetes mellitus (gdm), and the results were inconsistent. individual fatty acids tend to be interrelated because of the shared food sources and metabolic pathways. thus, whether fatty acid patters during pregnancy were related to gdm odds needs further exploration. objective: we aim to identify plasma fatty acid patters during pregnancy and their associations with odds of gestational diabetes mellitus (gdm). design: a hospital-based case-control study was carried out in urban wuhan, china from august 2012 to april 2015. pregnant women who screened for gdm at the outpatient clinics of the department of endocrinology, tongji hospital were invited to participant in the study. the inclusion criteria were as follows: 1) age ≥ 20 years; 2) gestational age at gdm screening ≥ 24 weeks; 3) singleton pregnancy. we excluded women who met any of the following items: history of diabetes (including but not limited to gdm), cardiovascular disease, cancer or other systemic diseases; pharmacologic treatment or dietary supplement use that might influence glucose or lipids metabolism; accompanied by other pregnancy complications; blood sample hemolysis or insufficiency; incomplete basic information. the diagnosis of gdm can be made if one or more glucose values are above the cut points of 5.1, 10.0 and 8.5 mmol/l at fasting, 1 and 2 h during a 75-gram oral glucose tolerance test (ogtt). controls were randomly selected and individually matched to cases by age (± 2 years), gestational age (± 2 weeks) and parity. finally, 217 gdm cases and 217 matched controls were selected in this study. all participants gave written informed consent before enrolling in the study. fasting blood samples (≥ 8 h overnight fasting) were collected using anticoagulant tubes and centrifuged at 3000 rpm for 5 min. plasma were separated from blood cells and stored at -80 ℃ for further assay. we measured plasma concentrations of fatty acids by gas chromatography - mass spectrometry, and derived potential fatty acid patterns trough principle components analysis. conditional logistic regression and restricted cubic spline model were used to evaluate the associations between individual fatty acids or fatty acid patterns and odds of gdm.


Eligibility criteria:
inclusion criteria: * age ≥ 20 years; * gestational age at gdm screening ≥ 24 weeks; * singleton pregnancy; * with enough plasma collected for fatty acids detection. exclusion criteria: * history of diabetes (including but not limited to gdm), cardiovascular disease, cancer or other systemic diseases; * history of receiving pharmacological treatment known to affect glucose metabolism; * incomplete basic information.

Keywords: fatty acid pattern gestational diabetes mellitus
a trial of lifestyle interventions to control weight after bariatric surgery

Conditions: Obesity; Weight Gain

Summary: this randomized controlled trial is designed to test the feasibility and efficacy of a novel 10-week mindfulness-based intervention (mbi) on weight maintenance as well as behavioral and psychosocial outcomes in patients who have undergone bariatric surgery. primary hypothesis: bariatric patients who have stopped losing weight (\ 70%) and no issues with meeting recruitment goals. secondary hypotheses: patients assigned to the mbi will show greater improvement in a) weight control (defined by differences in body weight between baseline and follow-up); b) eating behaviors (binge eating, emotional eating); and c) psychosocial measures (quality of life, depression, perceived stress, eating self-efficacy, coping ability) than a standard lifestyle intervention (1 hr lifestyle counseling). patients assigned to the mbi intervention will show greater improvement in biomarkers of stress and inflammation \[salivary cortisol, high sensitivity c-reactive protein (hs-crp), interleukin-6 (il-6), and tumor necrosis factor-alpha (tnf-alpha)\] as compared with a standard lifestyle intervention. food-related attentional bias as measured by the food-related stroop task will be differentially affected among patients assigned to the mbi as compared with the intensive lifestyle intervention and standard lifestyle intervention.


Eligibility criteria:
inclusion criteria: 1. patients who have undergone bariatric surgery 1-5 years prior to study start (by medical record and/or self report) 2. weight loss plateau (\< 5 lbs weight loss in past month) (by medical report and/or self report) 3. ages 18-65 years (by medical record and/or self report) 4. able to complete outcome assessments exclusion criteria: 1. prior experience with meditation course (past 6 months), current mindfulness/meditation practice, or regular meditation or mindfulness practice in past year ("regular practice" defined as practicing formally 1 or more times a week for 2 months). 2. plans to leave the study area within next 12 months 3. serious psychiatric illness or personality disorder (by medical record and/or self-report) 4. current alcohol and/or substance abuse 5. pregnancy or plans to become pregnant in next year 6. non-english speaking 7. \> 1 prior weight loss surgery (by medical record and self-report) 8. gastric band removed prior to study contact.

Keywords: randomized controlled trial mindfulness obesity
quality of life in breast cancer patients and survivors

Conditions: Breast Neoplasms

Summary: the purpose of this study is to determine how physical activity, other lifestyle factors, and psychosocial factors are related to quality of life and other health outcomes across the breast cancer survival spectrum from diagnosis to long term survival in a nationally representative sample of breast cancer patients and survivors across a 6 month period of time.

participants in this study will be asked to sign an informed consent, wear an activity monitor (similar to a pedometer) for 7 consecutive days and complete a packet of questionnaires. the questionnaires will take about 45 minutes to complete. all materials will be sent to participants via the us postal service and will need to be mailed back in the provided self-addressed stamped envelopes within 2 weeks. participants will be asked to repeat these same assessments again in 6 months. no lab visits will be required for participation. women from all across the u.s. who have been diagnosed with breast cancer at any point in their lives are being sought. there is no limit on time since diagnosis or treatment status.

Eligibility criteria:
inclusion criteria: * female * have received a breast cancer diagnosis and consider self a breast cancer patient or survivor * aged 18 years and older * english speaking * no limit on time since diagnosis exclusion criteria: * under the age of 18 * male * have never been diagnosed with breast cancer
effect of acetazolamide on lung water content by ultrasound in patients with respiratory disease at altitude

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this trial will evaluate the effect of acetazolamide (375 mg per day) vs. placebo on lung water content by ultrasound at acute altitude exposure in patients with chronic obstructive pulmonary disease (copd).

this is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect of acetazolamide (375 mg per day) vs. placebo on lung water content by ultrasound in lowlanders with chronic obstructive pulmonary disease travelling to altitude. participants living in the bishkek area, kyrgyzstan (760m), will be transferred by car within 4h to the tuja ashu high altitude clinic (3100 m), and stay there for 2 days. acetazolamide 375mg/day (or placebo) will be administered 24 hours before departure at 760 m and during the stay at altitude. outcomes will be assessed during the stay at 3100 m.

Eligibility criteria:
inclusion criteria: * male and female patients, age 18-75 yrs. * copd diagnosed according to gold, fev1 40-80% predicted, oxygen saturation (spo2) ≥92% at 750 m. * born, raised and currently living at low altitude (\<800m). * written informed consent. exclusion criteria: * copd exacerbation, very severe copd with hypoxemia at low altitude (fev1/forced vital capacity \<0.7, fev1 \<40% predicted, oxygen saturation on room air \<92% at 750 m). * comorbidities such as uncontrolled cardiovascular disease, i.e., unstable systemic arterial hypertension, coronary artery disease; previous stroke; obstructive sleep apnea; pneumothorax in the last 2 months. * internal, neurologic, rheumatologic or psychiatric disease including current heavy smoking (\>20 cigarettes per day) * known renal failure or allergy to acetazolamide and other sulfonamides

Keywords: prevention acetazolamide obstructive airway disease lung water
chlorhexidine skin application for prevention of infection in infants weighing <1500 g at birth

Conditions: Neonatal Sepsis; Neonatal Mortality Rate

Summary: purpose of this study is determine if skin application of chlorhexidine at birth would reduce infection in infants weighing \<1500 g at birth.

background infants weighing \<1500 g at birth infants are more prone to acquire infections, often through their immature skin which serve as a portal of entry for invasive pathogens. skin application of antiseptics such as chlorhexidine may reduce infections in these infants. however, there is a paucity of data on the safety and efficacy of such intervention in these infants. hypothesis: among hospitalized very low birth weight (vlbw; \<1500 g) neonates, single whole body skin cleansing with 0.25% chlorhexidine within 6 hours after birth would reduce the incidence of sepsis in the first seven days of life from 25% to 17.5% (relative reduction of 30%) when compared to skin cleansing with sterile water objectives: primary- to evaluate the effect of whole body skin cleansing with 0.25% chlorhexidine (single application, at birth) on the incidence of sepsis (culture positive or culture negative) compared to sterile water cleansing in the first week of life in vlbw infants secondary- to compare following outcomes in this experiment: 1. culture-confirmed sepsis within the first week of life 2. need for repeat hospital admissions within first 28 days of life 3. mortality within first 28 days of life 4. cold stress/hypothermia at 0, 5, 15 and 30 minutes of intervention 5. skin condition at 24 h of life 6. colonization rates (subset) 7. serum levels of chlorhexidine (subset) methods: eligible infants would be randomized within 6 hours of birth to either whole body skin cleansing with chlorhexidine (specially prepared wipes releasing 0.25% chlorhexidine), or sterile water (placebo). the research staff would collect the baseline data, record the axillary temperature and assess the skin condition using the newborn skin condition scoring (nscs)score. the research team would follow the infants for development of sepsis and other outcomes. the infants would be subjected to detailed sepsis work up on clinical suspicion of sepsis, until 28 days of life. sepsis would be defined based on combination of clinical course, indirect markers, bacterial culture results and antibiotic treatment status.

Eligibility criteria:
inclusion criteria: * birth weight less than 1500 g exclusion criteria: * birth weight \<750 g * major congenital malformations * total duration of positive pressure ventilation (ppv) \> 3 mins or chest compressions * shock- requiring inotropes \>10 mic/kg/min

Keywords: chlorhexidine sepsis neonatal whole-body skin cleansing
postoperative analgesic effect of subcostal tapb for laparoscopic gastrectomy

Conditions: Postoperative Pain

Summary: this prospective, randomized, single blinded study is designed to evaluate the postoperative analgesic efficacy of the ultrasound-guided subcostal transversus abdominis plane block in gastric cancer patients undergoing laparoscopic gastrectomy. we hypothesize that us guided subcostal tap block with ropivacaine can significantly reduce postoperative opioid comparison in patients with laparoscopic gastrectomy.

adult patients undergoing elective laparoscopic gastrectomy are randomly allocated to receive subcostal tap block (n=56) or not (n=56), in addition to a standard postoperative analgesic regimen comprising of iv fentanyl-based patient-controlled analgesia (pca) and nsaids as required. at the end of surgery, the tap group patients will receive bilateral subcostal tap block under ultrasound guidance with 15ml of 0.375% ropivacaine bilaterally. each patient was assessed by a blinded investigator at 6, 12, 24, and 48 h postoperatively. the primary outcome is total fentanyl consumption at 24 h after surgery.

Eligibility criteria:
inclusion criteria: * patients scheduled to undergo elective laparoscopic gastrectomy under general anesthesia * american society of anesthesiologists (asa) physical classification i-iii * consent to iv-patient controlled analgesia use * willingness and ability to sign an informed consent document exclusion criteria: * do not understand our study * allergies to anesthetic or analgesic medications * wound infiltration analgesia for postoperative pain control * infection or anatomic abnormality at the needle insertion site * pregnancy/breast feeder * medical or psychological disease that can affect the treatment response

Keywords: postoperative pain stomach neoplasms nerve block
exercise in migraine and co-existing tension-type headache and neck pain

Conditions: Migraine; Tension-type Headache; Neck Pain

Summary: the purpose of this study is to study the effect of a physical exercise program on patients suffering from migraine and co-existing tension-type headache and neck pain. the investigators hypothesized that migraine patients are ofte physically inactive because of their headache and that they will benefit from a specific exercise program.

migraine and tension-type headache are among the most common neurological diseases and are causing reduced quality of life, private and socio-economic consequences in terms of medical consumption and work-related absenteeism. the clinical experience shows that physical activity, like cycling and brisk walking, can prevent migraine attacks, but the evidence of the efficacy is sparse. the primary aim of the study is to investigate the acute and the long term effect of exercise on patients suffering from migraine and co-existing tension-type headache and neck pain. the project will be the first of its kind that explores the effect of an exercise program on patients who both suffer from migraine, tension-type headache and neck pain. we expect that the participants from the exercise program will achieve a reduced pain impact on everyday life, an improved fitness and quality of life, and a decrease of absence days and medication use.

Eligibility criteria:
inclusion criteria: * migraine * tension-type headache * neck pain exclusion criteria: * whiplash injury or other significant neck trauma * nerve root compression * post traumatic headache * medication overuse headache * cluster headache * trigeminal neuralgia * pregnancy and breast feeding * severe physical and psychological illnesses * alcohol and or drug abuse * current insurance claim owing to headache * persons not able to speak or understand danish * persons deemed not to implement the program because of musculoskeletal pain or physical limitations
treatment of chronic leg ulcers with autologous stromal vascular fraction

Conditions: Leg Ulcer

Summary: chronic leg ulcers are associated with decreased quality of life and an increased mortality. in many cases these ulcers are treated conservatively and the healing time can be several months. in this open randomized clinical trial we will examine if we can accelerate wound healing when using autologous stromal vascular fraction as an adjunct to standard wound care.

chronic leg ulcers are associated with decreased quality of life and an increased mortality. in many cases these ulcers are treated conservatively and the healing time can be several months. in this open randomized clinical trial we will examine if we can accelerate wound healing when using autologous stromal vascular fraction (svf) as an adjunct to standard wound care. the plan is to include 30 patients with arterial or arteriovenous chronic leg ulcers and these are randomized in two groups of which one receives standard wound care only and the other group receives autologous stromal vascular fraction treatment in addition to standard wound care.

Eligibility criteria:
inclusion criteria: * arteriovenous chronic leg ulcer * present beyond 4 months * conservative treatment not leading to progress * wound size between 2-30cm2 * ankle-brachial index (abi) ( 50-90% and/or toe pressure 50-70% and where ankle pressure \> 60 mmhg or toe pressure \> 40 mmhg * written informed consent exclusion criteria: * uncontrolled wound infection * osteomyelitis * hemoglobin \<6.0mmol/l * hba1c \>80mmol/mol * underlying malignancy * pregnancy or lactating * renal insufficiency requiring dialysis * charcot foot * underlying malignancy
the molecular pathogenesis of late-onset fuchs' endothelial corneal dystrophy

Conditions: Fuchs' Endothelial Dystrophy

Summary: the purpose of this study is to gain further insights into the molecular pathogenesis of fuchs' endothelial corneal dystrophy (fecd), to identify targets for potential specific drug therapy.


Eligibility criteria:
inclusion criteria: * fecd * normal corneas (including enucleations for uveal melanoma) * non-fecd oedematous corneas exclusion criteria: * prior irradiation therapy for uveal melanoma * corneal extension of uveal melanoma

Keywords: pathophysiology
blood pressure lowering effect of transcutaneous electrical nerve stimulation

Conditions: Hypertension

Summary: the purpose of this study is to compare the blood pressure reducing property of transcutaneous electrical nerve stimulation with the blood pressure reducing drug felodipin.

hypertension is a major risk factor for development of several vascular complications and is common world wide. drug treatment is often necessary to achieve adequate blood pressure reduction but blood pressure control in studied countries is unsatisfactory low. reasons for failure in treatment are several. among others reasons intolerable side-effects may prevent successful treatment irrespective of the number of drugs. transcutaneous electrical nerve stimulation (tens) constitutes no risk of interaction with pharmacological agents and previous studies have reported blood pressure reduction.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of hypertension, untreated or currently treated with a maximum of one blood pressure (bp) lowering agent exclusion criteria: * systolic blood pressure \>170 mmhg and/or diastolic blood pressure of \>105 mmhg * second- or third-degree atrioventricular block * current use of opiates or other intoxicants * neurological disorders (such as parkinson's disease, multiple sclerosis or peripheral neuropathy) * need of treatment with tens, regardless the reason

Keywords: randomized cross-over transcutaneous electrical nerve stimulation felodipin hypertension blood pressure treatment