Kornimate/medical-research-clean huggingface dataset:
continuous versus intermittent cardiac electrical monitoring

Conditions: Torsades de Pointe Caused by Drug; Long QT Syndrome

Summary: the purpose of this study is to validate the continuous patch monitoring system to evaluate cardiac arrhythmias in patients receiving drugs that can cause cardiac complications and compare the continuous patch system with standard electrocardiograms (ecgs).


Eligibility criteria:
inclusion criteria: * diagnosis of acute promyelocytic leukemia (apl) and being initiated on standard of care arsenic trioxide or diagnosis of solid tumor and being initiated on standard of care capecitabine (alone or as part of combination treatment) or diagnosis of solid tumor and being initiated on standard of care ribociclib (alone or as part of combination treatment) * at least 18 years of age. * no allergy to adhesive patches. * able to understand and willing to sign an irb-approved written informed consent document. exclusion criteria: * younger than 18 years of age * allergy to adhesive patches
incidence of postoperative persistent diaphragmatic dysfunctions in cardiac surgery

Conditions: Surgery, Cardiac

Summary: postoperative respiratory complication is a common complication that occurs in 6% of patients after cardiac surgery and increases morbidity and mortality and hospital length of stay. diaphragmatic dysfunction (dd) is one of the main risk factors for post-operative respiratory distress syndrome. it alters the ventilatory mechanical function of patients and promotes pneumonia. in the literature, risk factors included older age, diabetes, harvesting of a mammary artery, intraoperative ice solution using, prolonged cardiopulmonary bypass and intra-operative phrenic nerve injury. ultrasonography using the two-dimensional (2d) mode is a diagnosis tool for dd. for patients with dd, ultrasound criteria are: 1) an excursion during quiet breathing \< 9 mm for woman and \< 10 mm for man, 2) an excursion after sniff test \< 16 mm for woman and \< 18 mm for man and 3) an excursion during deep breathing \< 37 mm for woman and \< 47 mm for man. a paradoxical diaphragmatic ascent may also be observed during inspiration. dd may be transient, linked to mechanical factors such as pain, the presence of pleural and mediastinal drains, lying down or sternotomy; with recovery from 5 postoperative days. it may be more prolonged (persistent after 7 days) in connection with a partial or complete phrenic nerve injury and / or diaphragmatic devascularization after mammary artery harvesting. the aim of this prospective study is to determine the incidence of persistent dd after cardiac surgery.

diaphragmatic amplitude will be assessed by ultrasonography during quiet breathing and after sniff test, before the surgery and at day 7 post-surgery in all patients. patients with persistent dd at day 7 post-surgery will have additional respiratory functional explorations.

Eligibility criteria:
inclusion criteria: * patients undergoing cardiac surgery requiring sternotomy * consent for participation * affiliation to the social security system exclusion criteria: * contraindication to preoperative respiratory functional explorations * pregnant or breastfeeding women * patients under protection of the adults (guardianship, curators or safeguard of justice) * communication difficulties or neuropsychiatric disorder

Keywords: diaphragmatic paralysis respiratory complications
interactive voice based administration of the gad 7

Conditions: General Anxiety Disorder

Summary: this study investigates a new delivery method for the general anxiety disorder - 7 (gad 7), a clinically accepted tool for diagnosing general anxiety disorder. the new tool records auditory responses to the assessment and the study will examine if the instrument is effective at capturing participant depression levels. if proven effective, future studies may investigate if the new format can be used to improve at home clinical care.

this study is an investigation of the construct validity and user experience of a new delivery system for the general anxiety disorder - 7 (gad 7), a clinically accepted tool for diagnosing general anxiety disorder. the purpose of the study is to examine if the new delivery system of the gad 7 is effective at capturing participant anxiety levels and to assess the differences of usability between the paper and voice administered versions. the voice administered version uses a mirror device, which is similar to a smart television with a mirror interface. the device records auditory responses to the gad 7 through amazon alexa. the investigators will be comparing the responses on the new device to those given on the clinically established paper format. if proven effective at capturing depression levels of patients, future studies may investigate if the new format can be used to improve at home clinical care.

Eligibility criteria:
inclusion criteria:: * newly admitted patients to the oklahoma state university behavioral medicine clinic exclusion criteria: * vulnerable populations, such as children (i.e., minors or individuals under the legal age of consent) and individuals who are incarcerated (i.e., prisoners), will be excluded. * individuals who are not their own guardian (i.e., those suffering from severe disabilities) will also be excluded.
ultrasound guided tapb vs surgical tapb with bupivacaine in cesarean section

Conditions: Cesarean Section; Ultrasound Guided Transversus Abdominis Plane Block; Surgical Transversus Abdominis Plane Block; Bupivacaine; Acute Pain

Summary: the aim of this study is to compare surgical transversus abdominis plane block and ultrasound guided transversus abdominis plane block (tapb) as a postoperative analgesic regimen in female patients undergoing elective cesarean delivery.

caesarean delivery rates have been increasing worldwide nowadays. at rate of \[52%\], egypt stands out among countries with the world's highest cesarean delivery percentages . within the arab region, rate of cesarean section far higher in egypt than other arab countries. a much simpler and theoretically superior means of establishing a tap block. when using a transcutaneous (conventional) approach there is always the risk of peritoneal puncture with its attendant complications. moreover, there are technical difficulties, especially in obese women and the procedure requires specialist equipment, a skilled operator and training in ultrasonography. our approach obviates these risks and difficulties because the procedure is carried out under direct vision, and it is much easier to perform by the surgeon during caesarean section.

Eligibility criteria:
inclusion criteria: * full term pregnant women * older than 21 years of age * had elective cesarean section with pfannenstiel incision. exclusion criteria: * patients with cesarean section using different surgical incision * history of addiction \[including opioids and benzodiazepines\] * allergy to the anesthetic analgesia * psychological disorders * coagulopathies * infection at the block injection site.
investigation of the interplay between local oral inflammation, microbiota and systemic immune responses.

Conditions: Gingival Inflammation

Summary: this is a clinical research study designed to measure changes in inflammation and the oral microbiome during a phase of good oral hygiene and the absence of oral hygiene. the goal of the study is to investigate the interplay between local oral inflammation, microbiota and systemic immune responses.

an experimental gingivitis model will be used to explore changes in inflammation and the oral microbiome during gingivitis induction and resolution phases. biological samples (blood, mucosal swabs, plaque biofilm, saliva, and gingival crevicular fluid) will be collected at each visit (pre-30 days, baseline (day 0), day 3, day 7, day 14, day 21, and day 28. plaque and gingivitis examinations will be taken at each visit.

Eligibility criteria:
inclusion criteria: 1. males and females, between 18-65 years of age; 2. availability for the duration of the study; 3. asa 1 good general health (absence of any self-reported systemic disease or condition that, in the opinion of the principal investigator, might constitute a risk to the subject while participating in the study. examples include heart problems, valve/hip replacements, etc); 4. willingness to provide information related to their medical history; 5. minimum of 20 uncrowned permanent natural teeth (excluding third molars and crowns); 6. informed consent form signed. exclusion criteria: 1. subjects with more that 2 sites with pocket depth of \> 4 mm and those presenting purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone; 2. oral pathology or a history of allergy to testing products; 3. subject using anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory medication or daily analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study; to be defined by the dental examiner; 4. subject participating in any other clinical study; 5. subject pregnant or breastfeeding; 6. subject allergic to oral care products and personal care consumer products 7. extended use of antibiotics or therapeutic mouthwash (eg: chlorhexidine) any time during the three months prior to entry into the study; 8. ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine) 9. current smokers (or users of tobacco and vaping products) and subjects with a history of alcohol or drug abuse; 10. an existing medical condition which prohibits eating or drinking for periods up to 4 hours. 11. individuals with orthodontic bands or removable partial dentures. 12. dental prophylaxis in the previous 3 months prior to the baseline examination

Keywords: induced gingivitis
exercise in men with prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this pilot study is to compare a walking exercise program (exercise group) to standard medical care (control group) in prostate cancer survivors receiving androgen depletion therapy (adt). the central hypothesis of the proposed research is that the walking exercise program will have a positive impact on the bone health, health-related quality of life, and physical function of men with prostate cancer receiving adt.


Eligibility criteria:
inclusion criteria: * men aged 50 years or older * diagnosed with adenocarcinoma prostate cancer * will initiate and receive continuous adt (luteinizing hormone releasing hormone agonist (lhrh) or combination of lhrh and anti-androgen) for at least 12 months after recruitment * patients will also consent to participating in the study. exclusion criteria: * severe cardiac disease (new york heart association class iii or greater) * angina * severe osteoporosis * uncontrolled hypertension (blood pressure \> 160/95mm hg) * orthostatic blood pressure drop \> 20mm hg * moderate to severe aortic stenosis * acute illness or fever * uncontrolled atrial or ventricular dysrhythmias * uncontrolled sinus tachycardia (\> 120 beats per minute) * uncontrolled congestive heart failure third-degree atrio-ventricular heart block, active pericarditis or myocarditis, recent embolism, thrombophlebitis, deep vein thrombosis, resting st displacement (\> 3mm), uncontrolled diabetes, uncontrolled pain, cognitive impairment, history of falls due to balance impairment or lost of consciousness, severe neuromusculoskeletal conditions that limit their ability to perform walking exercise (including ataxia, peripheral or sensory neuropathy, unstable bone lesion, severe arthritis, pathological lower limb fractures within 6 months, lower limb amputation).
nitazoxanide as adjuvant therapy in type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: diabetes mellitus (dm) is a complex metabolic disorder characterized by hyperglycemia and abnormalities in carbohydrate, fat, and protein metabolism. despite the advancement in anti-diabetic drug therapy, most patients fail to achieve optimal glycemic control. this highlights the need for more effective strategies to control type 2 diabetes mellitus. nitazoxanide (ntz), a broad-spectrum anti-infective drug with activity against various protozoa, helminthes, bacteria, and viruses, was identified as peroxisome proliferative activated receptor gamma (pparγ) agonist using one dimensional drug profile matching. additionally, it improved insulin sensitivity in insulin-resistant type 2 diabetic rats. therefore, this study is designed to evaluate the efficacy of nitazoxanide as adjunctive therapy in patients with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * glycated hemoglobin (hba1c) between 7% and 9%. * body mass index ≥ 25 kg/m2 exclusion criteria: * pregnant or nursing women. * type 1 diabetes mellitus. * liver disease (alanine aminotransferase \> 3 upper normal limit). * kidney disease (estimated glomerular filtration rate \< 60 ml/min/1.73 m2). * inflammatory bowel diseases. * history of allergy and/or adverse reactions to the drugs used in the study.
the effect of clopidogrel and ticagrelor with and without acetylsalicylic acid (asa) on hemostatic system activation at the site of plug formation in vivo in man

Conditions: Acute Coronary Syndrome

Summary: background: coronary heart disease is the most common cause of death in industrialized countries. revascularisation by percutaneous coronary angioplasty or thrombolysis is the main principle for treatment of the acute coronary syndrome. to inhibit platelet activity patients are routinely given acetylsalicylic acid (asa) and clopidogrel, a second-generation thienopyridine. recently, ticagrelor, a novel cyclopentyl-triazolo-pyrimidine with several pharmacological advantages, has demonstrated greater efficacy but a higher bleeding risk than clopidogrel. coronary thrombus formation is a complex process and the antithrombotic mechanisms of platelet function inhibitors are incompletely understood. studies in venous blood or in vitro do not truly reflect the in vivo circumstances as they often do not take into account flow conditions or the interaction between endothelium, blood cells and coagulation factors. results from animal models may not be relevant for the prothrombotic mechanisms in humans. we have developed a technique that allows investigating hemostatic system activation directly at the site of thrombus formation in vivo in humans. aim: to compare the inhibitory effects of clopidogrel and ticagrelor (with and without concomitant asa) on hemostatic system activation under circumstances close to the in vivo situation. design, patients and interventions: prospective, randomized, double-blind, placebo controlled parallel-group study with a 2x2 factorial design including 112 healthy volunteers who will be randomised to 4 treatment arms: ticagrelor or clopidogrel + placebo, ticagrelor or clopidogrel + asa. outcome variables: indicators of platelet and coagulation activation \[ß-thromboglobulin and thromboxane b2 as well as prothrombin fragment f1+2 and d-dimer, respectively\] will be measured before and at several time points during a 8 day period in venous blood and in blood emerging from a standardized injury of the microvasculature to determine bleeding time (shed blood). statistical considerations: sample size calculation is based on the percent change in the main outcome variable "β-tg in shed blood" from baseline to 2 hours after treatment start. statistical analysis is based on the full analysis set, including all randomized subjects who received at least the starting dose of the study medication and for whom blood collections at baseline and at 2 hours after treatment start have been performed.


Eligibility criteria:
inclusion criteria: * young, healthy males exclusion criteria: * history of bleeding * any medication * known intolerance to study drug(s)

Keywords: acs, acute coronary syndrome
evaluation and management for prostate oncology, wellness, and risk (empower)

Conditions: Prostate Cancer

Summary: the empower study is proposed as a cohort study with longitudinal follow-up to determine rates of genetic mutations among men with or at-risk for prostate cancer to address the various facets of genetic education and counseling for optimized genetic assessment and wellness of men. the results will inform practice guidelines and future studies for maximal impact of genetic evaluation of men for inherited prostate cancer.


Eligibility criteria:
inclusion criteria: * men with a personal history of prostate cancer * unaffected males who are at higher risk for prostate cancer (family history of prostate cancer or african american males) * men who previously tested positive for a mutation may be eligible for specific aims 2-7 * men with a known familial mutation * men who previously participated in the genetic evaluation of men (gem) study (irb#14s.546) will be offered participation in empower - exclusion criteria: * age \< 18 years * mental or cognitive impairment that interferes with ability to provide informed consent
gender, pain, and placebo analgesia

Conditions: Experimental Pain

Summary: the response to standard pain stimuli in males and females is investigated, together with the effect of informing participants about the effect of a painkiller. physiological response to pain is recorded.

the social context in which pain is reported has been found to modulate pain. specifically, male participants reporting pain to female observers report significantly lower pain levels compared to male participants reporting to male observers. female participants seem less affected by social context. this is a methodological problem in the study of pain and has consequences in the development of new drugs, and for pain research in general. the present study has two aims: to investigate whether social context affects also the placebo response to pain, i.e. the reduced pain often observed after administration of a an inert substance the participants believes to be a painkiller. it is hypothesized that placebo analgesia will be larger in males reporting pain to females. secondly, heart rate variability and skin conductance, measures of parasympathetic and sympathetic activity, will be recorded, to investigate if social context affects not only pain report, but also pain response.

Eligibility criteria:
inclusion criteria: * 18-40 years, healthy exclusion criteria: * pregnant, earlier serious disease or injury,

Keywords: experimental pain placebo analgesia heart rate variability skin conductance
resection of flexor digitorum superficialis tendon for severe trigger fingers

Conditions: Trigger Finger; Stenosing Tenosynovitis

Summary: the purpose of this study is to compare the effectiveness of resection of one or both slips of the flexor digitorum superficialis tendon versus the a1 pulley division.

the preoperative visit occurred a number of weeks or months prior to surgery. surgeons from the centre de la main at the chuv in lausanne recruited the subjects during their consultations. during this initial visit, the patient was asked about his problem, his general health and a clinical examination (including range of motion of finger joints, pulp-to-palm distance, pain evaluated with a vas) was performed. once the diagnosis of trigger finger was established, the inclusion and exclusion criteria were evaluated. if the eligibility criteria were fulfilled, the patients were offered to be part of the study. they received oral and written information about the study and the surgeons gave further explanation if needed. on the surgery day, the signed consent form was recovered. participants were randomized in two groups according to a computer-generated list ranging from 01 to 60 (www.randomization.com). surgery was then performed according to the method chosen by randomization. the possible occurrence of adverse effects during surgery was monitored. all information was recorded on the case report forms. the first postoperative visit occurred 1 week ± 3 days after surgery. the surgeons evaluated the wound to exclude the presence of postoperative complication (infection, hematoma, nerve or tendon injury) and answer any question the patient could have. range of motion and pain were recorded. all information was recorded on the case report forms. the second postoperative visit occurred 4 weeks ± 5 days after surgery. the appointment was conducted in the same way as the previous one. patients could choose to be withdrawn from the study at any point. the follow-up was similar to that of patients included in the study.

Eligibility criteria:
inclusion criteria: * adult patients (≥18 years old) with a flexor tendon tenosynovitis of a finger resulting in a decreased range of motion of the pip joint (defined with a palm-to-pulp distance ≥0mm and/or flexion contracture ≥15°). exclusion criteria: * minors (\<18 years old). * pip joint contracture resulting from another illness than stenosing flexor tenosynovitis (for example: rheumatoid arthritis) or caused by a traumatic event. * contraindications to any surgery: presence of a severe coagulation disorder, immunosuppression or decompensated psychiatric illness.

Keywords: trigger finger stenosing flexor tenosynovitis
time trend analysis of pe diagnosis with spect v/q: a single institution observational study

Conditions: Pulmonary Embolism

Summary: following the implementation of spect v/q imaging for pe diagnosis, the investigators previously conducted an observational study over the period 2011-2013 that showed the safety of a diagnostic management based on spect v/q to rule out pe. however, pe prevalence was high (28%), which may seem a bit high as compared with other recent studies. the hypothesis was that the use of spect v/q may be responsible for an overdiagnosis of pe, especially at the implementation phase of the test. the aim of this study was to perform a time trend analysis of the evolution over the years of pe diagnosis with spect v/q.


Eligibility criteria:
inclusion criteria: * patients who underwent a spect v/q scan performed for a suspected acute pe in the nuclear medicine department of brest university hospital from april 2011 to december 2016 exclusion criteria: * patient under legal or judicial protection * patient opposed to the use of his medical data for research.
thickness-varied soft surface on shoe-insoles based on in-shoe pressure measurement

Conditions: Diabetes Mellitus

Summary: the goal of this cross-sectional study is to evaluate a new shoe insole manufacturing method with the goal of further preventing foot ulceration for people with diabetes. this is achieved by decreasing pressure under risk areas of the foot, often on the insole; the interface between the shoe and the foot. the main question it aims to answer is: does a thickness-varied surface based on plantar pressure measurement decrease pressure at high risk areas compared to even thickness surfaces. researchers will compare three different pairs of insoles for each participant. participants will partake in two sessions. the first one being a pre-measurement and foot status for manufacturing the insoles. during the second session, three pairs of insoles will in a random order be tested for each participant. the pressure measurement of the insoles will be made using f-scan(tm), while participants walk.


Eligibility criteria:
inclusion criteria: * over 18 years of age at the date of signing consent. * diabetes mellitus 1 or 2 * diabetic foot risk group 2: signs of distal neuropathy and/or peripheral circulatory disorder. * able to walk 10 meters without walking aids * able to speak and understand swedish exclusion criteria: * diabetic foot risk group 3: distal neuropathy or peripheral circulatory disorder and foot ulcers, or amputation, foot deformity of clinical importance or skin pathology. * diabetic foot risk group 4: occuring foot ulcer, severe osteoarthropathy or chronic foot pain.

Keywords: plantar pressure shoe insert ulcer prevention