Kornimate/medical-research-clean huggingface dataset:
project ev minus regulatory clinical evaluation - system accuracy, user performance and system use evaluation

Conditions: Diabetes Mellitus

Summary: clinical evaluation including system accuracy, user performance and system use evaluation of a new blood glucose monitoring system.


Eligibility criteria:
summary of inclusion criteria: * able to voluntarily provide written informed consent to participate in the study. * user performance accuracy testing only: self-monitoring - subject is currently performing unassisted self-monitoring of blood glucose. exclusion criteria: * female subjects who are pregnant or lactating. * subjects who, in the opinion of the investigator, are unsuitable for participation in the study. * user performance accuracy testing only -prior involvement with the investigational bgms being used in this study.
scot sweet study (interaction of a non-nutritive sweetener with a high-fibre weight loss diet)

Conditions: Appetitive Behavior

Summary: the investigators present a weight loss diet intervention study, to be conducted as a within-subject design, with all food and beverages provided, to assess interaction of non-nutritive sweetener (sucralose) with a high-fibre weight loss diet, on markers of gut health in humans. this study will allow assessment of the effects of a non-nutritive sweetener (sucralose) with a high-fibre (soluble fibre, fructo-oligosaccharides, fos) diet on metabolic health and activity and composition of gut microbiota, by a controlled human diet intervention study. the investigators propose to recruit participants living with obesity, with a poor diet quality (moderate habitual fibre intake) to additionally address diet inequalities in the research approach, and this will also allow examine the time-course of adaptation of the gut microbiome (measured in faecal samples). the investigators will also assess changes in free-living glycaemic control with addition of dietary fibre and bio-markers of health.


Eligibility criteria:
inclusion criteria: * healthy but overweight/obese (bmi 28-40kg/m2) males and females (postmenopausal, using the oral contraceptive pill or some form of hormonal contraceptive) * moderate habitual fibre intake (18-23g/day) exclusion criteria: medication exclusion criteria: * antibiotic use (within the past 3 months due to impact on gut microbiota) * anti-depressants (current) * smoking or vaping * weight loss medication medical exclusion criteria: * females who are planning to be pregnant, are pregnant or are breastfeeding * anyone with food allergies, self-reported food sensitivity or intolerance * anyone with coeliac disease or gluten intolerance * anyone taking medication which may affect their appetite * anyone with an eating disorder * anyone with diabetes * anyone with a gastrointestinal disorder, kidney disease, liver disease or gout * anyone suffering from a psychiatric disorder or any type of substance abuse * anyone suffering from unregulated thyroid disease other exclusion criteria: * anyone following a vegetarian or vegan diet * anyone following a current weight loss programme (that may be affecting lifestyle, physical activity \& diet) or undergone gastric band/reduction surgery * anyone with unsuitable veins for blood sampling * anyone who is unable to fluently speak, read and understand english * anyone who is unable to comply to an alcohol-free diet for 6 weeks current sweetener consumption will not be an exclusion criteria as the phase 1 - ctrl and phase 2 - hf wl diets will provide enough of a washout (4 weeks) before the phase 3 diets containing sucralose are consumed. participants who do habitually consume sweeteners will be asked not to use them during the study.

Keywords: fibre non-nutritive sweetener weight loss gut microbiome glycaemic control
a non-interventional implementation study to evaluate treatment with inclisiran (leqvio®) and other lipid lowering treatments in a real-world setting

Conditions: Hypercholesterolemia

Summary: this is a multicenter, non-randomized, non-interventional three-cohort study with prospective collection of primary data of treatment with newly initiated oral lipid lowering treatment on top of a statin (oral llt cohort), newly initiated inclisiran (inclisiran cohort) and newly initiated inclisiran on top of lipid apheresis (apheresis plus inclisiran cohort) in routine clinical care. all procedures, treatment adaptions and laboratory assessments are part of clinicla routine and conducted independent of this study.


Eligibility criteria:
inclusion criteria: 1. patients who provide written informed consent to participate in the study 2. male or female patients ≥ 18 years of age 3. oral llt cohort: patients with documented ascvd newly initiated on an oral lipid lowering treatment on top of a statin (e.g. ezetimibe, bempedoic acid, cholestyraimin) 4. inclisiran cohort: patients newly initiated on inclisiran fulfilling the restricted reimbursement criteria or individual access requirements who are not at ldl-c goal as per their cv risk as recommended in the 2019 eas/esc guidelines (mach et al., 2020). at least 60% of the documented patients must be pcsk9-inhibitor naive 5. apheresis plus inclisiran cohort: patients with inclisiran on top of regular weekly or bi-weekly lipoprotein apheresis (ldl-c or lp(a)). exclusion criteria: 1. oral llt cohort: patients who receive a pcsk9-mab or other pcsk9-targeted therapy 2. inclisiran 1 cohort: current or previous pcsk9-targeted treatment 3. contraindication for inclisiran according to the smpc 4. patients who have received inclisiran previously 5. patients with homozygous fh 6. any underlying known disease, or surgical, physical, or medical condition that, in the opinion of the investigator (or delegate) might interfere with interpretation of the clinical study results. 7. simultaneous or planned participation in an interventional research study

Keywords: hypercholesterolemia inclisiran atherosclerotic cardiovascular disease ascvd
chronic and acute effects of resistance exercise on older subjects' blood pressure

Conditions: Blood Pressure

Summary: the study aimed to evaluate the chronic and acute effects of high-intensity resistance training on blood pressure and its hemodynamic and neural determinators in healthy normotensive older subjects.

to investigate the chronic and acute effects of resistance training on blood pressure and its hemodynamic and neural determinators in elderly, 24 healthy normotensive older subjects were randomly divided into 2 groups: trained and control. the trained group was submitted a progressive high-intensity resistance training. before and after 16 weeks, as well as, before and after the one training session, blood pressure (clinic and ambulatory), cardiac output (co2 rebreathing), and autonomic modulation (spectral analysis of heart rate and blood pressure variabilities) were measured

Eligibility criteria:
inclusion criteria: * age 60 to 80 years * normotensives * nonactive exclusion criteria: * cardiovascular disease * cardiovascular medication * orthopedic problems

Keywords: resistance training blood pressure hemodynamics autonomic elderly subjects
pregabalin compared to gabapentin for pain control in lumbar disc surgery

Conditions: Intervertebral Disc Prolapse

Summary: pregabalin is claimed to have superior analgesic effect at lower doses and better pharmacological profile as compared to gabapentin esp. in perioperative pain control after major surgeries like intervertebral disc surgery. the investigators found that pregabalin is equivalent to gabapentin for relief of post-operative pain at a lower dose in patients undergoing intervertebral disc surgery.


Eligibility criteria:
inclusion criteria: * 30-60 years age * any gender * elective micro discectomy for intervertebral disc prolapse exclusion criteria: 1. micro discectomy at two or more vertebral levels, 2. instrumentation i.e. pedicle screw fixation, hooks etc., 3. history of steroids or alcohol use, 4. multiple co-morbids i.e. renal failure, chronic liver disease, 5. use of anticonvulsant drugs, 6. spinal deformity, 7. obesity (bmi \>30), 8) inability to understand and respond vas and 9) patients with known allergy to gaba analogues.

Keywords: pregabalin gabapentin microdiscectomy pain
effects of kinesio taping application in women with overactive bladder

Conditions: Overactive Bladder Syndrome

Summary: the aim of this study is to compare the effects of kinesio tape application on bladder symptoms and quality of life in women with overactive bladder (oab).


Eligibility criteria:
inclusion criteria: * 20 to 65 years of age, * having overactive bladder * being volunteer exclusion criteria: * pregnancy, * only stress incontinence, * the presence of a malignant condition with a history of acute infection, * having a mental problem to prevent co-morbidity, evaluation and cooperative
different treatment modalities for myofascial pain

Conditions: Myofascial Pain; Splints; Low-Level Laser Therapy

Summary: myofascial pain dysfunction syndrome (mpds) is the most common reason for pain and limited function of the masticatory system. the low-level laser therapy (lllt) and occlusal splint therapy (ost) are therapeutic options for mpds. this study aims to evaluate the effect of lllt and ost on pain relief and mandibular movement improvement in patients with myofascial pain.

myofascial pain dysfunction syndrome in the masticatory muscles is the most common temporomandibular disorder. patients suffer from pain and muscle tenderness and may present with or without restricted mouth opening. the etiology of myofascial pain dysfunction syndrome is multifactorial including psychological factors, occlusion imbalance, and parafunctional habits. treatments for myofascial pain dysfunction syndrome include education, self-care, physical therapy, use of intra-oral appliances, short-term pharmacotherapy, behavioral therapy, and relaxation techniques. temporomandibular disorder is most often treated using occlusal splints safely to reduce temporomandibular joint load, and subsequently, clinical symptoms, as a reversible therapy. occlusal splints need to be used for at least three months to eliminate temporomandibular disorders. one of physical therapy is laser treatment. laser treatment on tissues provides a clinical effect called biostimulation, where the basic mechanism occurs at the molecular level. the low-level laser has non-invasive and inoffensive characteristics at appropriate parameters.

Eligibility criteria:
inclusion criteria: * diagnosis of myofascial pain syndrome according to the research diagnostic criteria for temporomandibular disorder. * individuals between the ages of 18-60 * occlusion of individuals with posterior teeth * forms of individuals who do not have any systemic disease exclusion criteria: * disc displacement with or without reduction, with or without limited mouth opening, arthralgia, arthritis, arthrosis * inflammatory connective tissue disease (such as rheumatoid arthritis) * psychiatric diseases * tumor * heart diseases * pregnancy * diseases that may cause pain symptoms in other orofacial regions (toothache, neuralgia, migraine) * having received any treatment for headache or bruxism in the last 2 years * skin infections on the masseter and temporal muscles

Keywords: myofacial pain occlusal splint low-level laser therapy
pharmacokinetic/pharmacodynamic drug-drug interaction of evogliptin 5 mg and pioglitazone 30 mg

Conditions: Type 2 Diabetes

Summary: a randomized, open-label, multiple dosing, three-way crossover clinical trial to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of evogliptin 5 mg and pioglitazone 30 mg after oral administration in healthy male subjects

a randomized, open-label, multiple-dose, three-treatment, three-period, six-sequence, crossover study

Eligibility criteria:
inclusion criteria: * healthy male volunteers (age: 19\~45years) * 55\<body weight\<90, 18\<bmi\<27 * fpg: 70-125 mg/dl exclusion criteria: * galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption * clinically significant medical history * allergy or drug hypersensitivity * ast(sgot), alt(sgpt) \> upper normal range\*1.5, egfr\<80 ml/min * drink during clinical trial period * smoking during clinical trial period * grapefruit/caffeine intake during clinical trial period * no contraception
behavioral effects of drugs: inpatient (36) (alcohol, duloxetine, and methylphenidate)

Conditions: Alcohol Use Disorder

Summary: this study will evaluate the behavioral effects of alcohol during maintenance on placebo, duloxetine, methylphenidate and duloxetine combined with methylphenidate using sophisticated human laboratory methods.

prior to the outbreak of the covid-19 virus and subsequent work-from-home orders from the state of kentucky government, participants completed five overnight sessions at theuniversity of kentucky inpatient research unit in the medical center. the protocol was then changed to have five sessions scheduled to be completed on an outpatient basis in the late afternoon/early evening. this protocol change was enacted following the resumption of research in the fall of 2020. for both the inpatient and outpatient portions of this protocol, the first of these sessions was a practice session to familiarize participants with experimental procedures. the subsequent four experimental sessions were conducted following one-week maintenance on a methylphenidate dose (0, 20, 40, and 60 mg/day; within-subjects factor) over the span of four weeks. participants were assigned to either an active duloxetine arm (60 mg/day) or placebo arm (between-subjects factor) also for the span of four weeks. the outcome measures collected were the same for both the inpatient and outpatient aspects of the study. subjects received 30 mg of oral duloxetine one time daily. note: only 2 subjects were enrolled in this arm prior to the arm being removed in the summer of 2020. data from this arm will not be reported in order to avoid any hipaa violation due to the small number of subjects in this arm. please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. two participants received 30 mg/day. however, visual inspection of their data revealed that their data was not appreciably different from participants in the 60 mg/day duloxetine arm. therefore, we have added the data from these two participants to the 60 mg/day duloxetine arm for all reported data.

Eligibility criteria:
inclusion criteria: * able to speak/read english * not seeking treatment at the time of the study * one binge drinking episode (5+/4+ standard alcoholic drinks per drinking session for men and women, respectively) in the past 30 days * recent alcohol use verified by ethyl glucuronide positive urine, as well as fulfillment of dsm-5 diagnostic criteria for alcohol use disorder * ecg within normal limits * otherwise healthy * body mass index of 19-35 * females using an effective form of birth control and not pregnant or breast feeding * judged by the medical staff to be psychiatrically and physically healthy * able to abstain from alcohol for 12 hours prior to session exclusion criteria * not under 21 years of age or over 55 years of age * no contraindications/allergies to alcohol, duloxetine, or methylphenidate
lesser tuberosity osteotomy for subscapularis repair

Conditions: Osteoarthritis

Summary: the primary objective of this study is to assess the clinical effectiveness of two different techniques used for subscapularis tendon repair during total shoulder replacement. the investigators hypothesize that participants who receive a newer repair technique called a lesser tuberosity osteotomy will have lower rates of postoperative subscapularis muscle dysfunction and rupture as compared to those who receive the traditional tenotomy repair.

the subscapularis tendon is mobilized during total shoulder arthroplasty in order to gain anterior access to the glenohumeral joint. postoperative subscapularis dysfunction is being recognized more frequently and has been reported in \>65% of patients following shoulder arthroplasty with a soft-tissue repair. subscapularis dysfunction has been associated with poor functional outcomes including tendon rupture and anterior instability, a major indication for revision surgery. recent studies suggest that a standard subscapularis tenotomy with primary tendon repair may lead to failure of the repair and decreased functional outcomes as compared to a more novel lesser tuberosity osteotomy technique. the investigators study aims to validate the results of the current literature in a prospective randomized controlled trial, which to their knowledge has not been reported on this topic.investigators will compare clinical outcomes following these two techniques during total shoulder arthroplasty. participants undergoing total shoulder replacement will be randomized to receive either a lesser tuberosity osteotomy or tenotomy with primary subscapularis tendon repair. all other procedures conducted in this study are considered standard of care except for ultrasounds, which are conducted for research purposes in the subscapularis tenotomy group. postoperative outcomes will be monitored objectively and subjectively at routine postoperative office visits using physical exam, imaging (x-rays and ultrasounds), and questionnaires. if the hypothesis is proven to be true, the investigators will establish gold-standard evidence for the use of the newer osteotomy technique to improve patient satisfaction and mobility following shoulder arthroplasty.

Eligibility criteria:
inclusion criteria: * patients already scheduled for total shoulder arthroplasty exclusion criteria: * unable to provide information throughout postoperative recovery and attend subsequent office visits thereafter (a minimum of one year).

Keywords: shoulder arthroplasty lesser tuberosity osteotomy subscapularis tenotomy
sexual dysfunction and anorexia nervosa

Conditions: Anorexia Nervosa

Summary: the objective of this observational study is to investigate the potential influence of anorexia nervosa on the sexual health of women. the primary focus is to determine the presence of sexual dysfunction in individuals with anorexia nervosa and explore any potential correlation between eating disorders and sexual dysfunction. to facilitate comparison, data from a control group comprising healthy women is incorporated alongside the clinical group data.

numerous studies indicate that women diagnosed with anorexia nervosa experience a discernible impact on their sexual well-being, often accompanied by symptoms of sexual dysfunction (sd). such dysfunction may manifest as a diminished libido, reduced sexual desire, and challenges in achieving orgasm

Eligibility criteria:
inclusion criteria: clinic group : * adult * women * diagnosis of anorexia nervosa * from slovakia and czech republic control group: * health women * adult * from slovakia and czech republic exclusion criteria: clinic group: * health women * other diagnosis or disorder * other country control group: * presence of some mental illness * other country

Keywords: sexual dysfunction, anorexia nervosa, women, libido
multicentric evaluation of two telematics systems in type 2 diabetic patients in failure of oral treatment and having to start treatment by basal insulin

Conditions: TYPE 2 DIABETES

Summary: telediab-2 is a national, multicenter, controlled, randomised trial. the primary objective of the study is to show that during the initiation of a basal insulin treatment , a computerized decision-making system of adaptation of the insulin, coupled to a distance follow-up (thanks to pdaphone or an interactive vocal server (ivs)), is able to improve metabolic control at the end of 4 mouths as compared with conventional care. main judgment criteria: comparison of hba1c means of the 2 groups profiting from a telemonitoring system compared to the reference group at 4 months.

secondary objectives : 1. - to compare the 2 methods of telemonitoring employed. 2. - to evaluate the speed of the glycemic attack of the objective to the rising, according to the method of follow-up employed. 3. - to evaluate the satisfaction of the patients and the doctors with respect to systems of telemonitoring, and improvement of the quality of life (dqol).

Eligibility criteria:
inclusion criteria: * type 2 diabetes since more than 3 years and claiming a strict balance glycemic; * patients treated since at least 3 months, by metformin and secreting insulinic (known or glinide); * patients uncontrolled with hba1c ≥ 7.5% and \< 10% at the inclusion. * bmi \< 40 ; * patients requiring a insulin treatment * patients agree to start a slow insulin treatment * patients already practising the glycemic self-monitoring or agree to learn it and practise it; * patients able to include/understand operation and to use the pda-phone and/or the svi; * patient not taking part in another biomedical research study * patients agree to carry out at least 2 finger sticks per day; * more than 18 years, there is no higher age limit. exclusion criteria: * patients introducing any evolutionary pathology associated and not stabilized, exhibitor with an uncontrolled diabetes during the year to come; * patients in a situation which justifies of a clinical follow-up diabetologic more frequent than that (quarterly) envisaged by the study * patients requiring a transitory passage to insulin; * patients needing a hospitalization for the adaptation of insulin doses; * patients presenting a cardiologic event * patients presenting a hemoglobinopathy interfering with the proportioning of hba1c; * patients suffering from drug-addiction, alcoholism or psychological troubles * type 1 or secondary diabetes * patients who don't need strict metabolic objectives; * pregnant or parturient patients * person with no freedom.