Kornimate/medical-research-clean huggingface dataset:
a feasibility study to evaluate the performance of the harmony 1 sensors in adults and pediatrics

Conditions: Type 1 Diabetes

Summary: the purpose of this study is to demonstrate the performance of the harmony 1 sensor in subjects age 14 - 75 years.

the study is a multi-center, prospective single-sample correlational design without controls.

Eligibility criteria:
inclusion criteria: 1. subject is 14 - 75 years of age at time of screening 2. a clinical diagnosis of type 1 or 2 diabetes for a minimum of 6 months duration as determined via medical record or source documentation by an individual qualified to make a medical diagnosis 3. adequate venous access as assessed by investigator or appropriate staff exclusion criteria: 1. subject will not tolerate tape adhesive in the area of harmony 1 sensor placement as assessed by qualified individual. 2. subject has any unresolved adverse skin condition in the area of harmony 1 sensor or device placement (e.g., psoriasis, rash, staphylococcus infection) 3. subject is actively participating in an investigational study (drug or device) wherein they have received treatment from an investigational study (drug or device) in the last 2 weeks 4. subject is female and has a positive pregnancy screening test 5. females of child bearing age and who are sexually active should be excluded if they are not using a form of contraception deemed reliable by investigator 6. subject is female and plans to become pregnant during the course of the study 7. subject has had a hypoglycemic seizure within the past 6 months 8. subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to screening visit. 9. subject has had an episode of diabetic ketoacidosis (dka) within the past 6 months prior to screening visit. 10. subject has a history of a seizure disorder 11. subject has central nervous system or cardiac disorder resulting in syncope 12. subject has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (tia), cerebrovascular accident (cva), angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease 13. subject has a hematocrit (hct) lower than the normal reference range 14. subject has a history of adrenal insufficiency.

Keywords: type 1 diabetes type 2 diabetes harmony sensor continuous glucose monitoring cgm
to evaluate the efficacy and safety of levocetirizine versus loratadine for treatment of seasonal allergic rhinitis

Conditions: Rhinitis; Allergic; Seasonal

Summary: to evaluate the efficacy and safety of levocetirizine versus loratadine for treatment of seasonal allergic rhinitis


Eligibility criteria:
inclusion criteria: * male or female, 18 to 60 years old, inclusive * two-year history of allergic rhinitis due to tree, grass or weed pollen * sufficient histamine-dependent symptoms of rhinitis during the selection week (t5ss ≥ 5) exclusion criteria: * an ear, nose or throat (ent) infection * asthma requiring daily drug therapy other than ß2 inhaled agonists taken prn * atopic dermatitis or urticaria requiring an antihistamine or corticosteroid treatment * an associated ent disease * use of decongestants * nasal or ocular topical treatment

Keywords: levocetirizine dihydrochloride xyzal tablets
"family connections": a program for relatives of people with borderline personality disorder

Conditions: Relatives

Summary: the aim of this study is to validate an intervention for relatives of people with borderline personality disorder in spanish population in a randomized control trial.

family members of patients with borderline personality disorder (bpd) often experience high levels of suffering, anxiety, stress, burden and helplessness. the treatment program with the most empirical support is "family connections". it is one of the first programs specifically designed to help relatives of patients with bpd. the program is an adaptation of multiple strategies of dialectical behavioral therapy. it consists of 12 sessions with an approximate duration of two hours each. the results of these studies and their subsequent replications showed an improvement in family attitudes and perceived burden. the investigators have translated and adapted the program so that it could be applied to the spanish population. the aim of the present study is to evaluate the effectiveness of the adaptation of "family connections" in spanish population through a controlled clinical trial. the first hypothesis of the study is that "family connections" will be more effective (significant reduction in the primary outcome variables), compared with a treatment as usual (tau), in the posttest time and in the follow-ups of 3 and 6 months. in addition, a second hypothesis is that "family connections" will be more efficient (fewer abandonments, better opinion on the part of the patients) than tau.

Eligibility criteria:
inclusion criteria: * aged 18 years or older. * having a relative with dsm-5 diagnosis of personality disorder * understand spoken and written spanish. * grant informed consent. exclusion criteria: * diagnosis of severe mental disorder. * presence of medical illness that may interfere with psychological treatment. * suicide risk.

Keywords: borderline personality disorder family connections relatives dbt intervention program caregivers
impact of the pet in the diagnosis strategy of fuo or inflammatory syndrome in immunocompetent patients fuo-tep

Conditions: Fever

Summary: fever of unknown origin (fuo) and chronic inflammatory syndrome could be seen in many affections. the diagnostic process is still a challenge and could not be specified yet after several clinical studies performed by trained teams using two levels diagnostic procedures. for this reason, the diagnosis involves many additional and expensive tests such as computed tomography (ct scan), scintigraphic imaging, endoscopy, biopsy. there is no evidence-based recommendation for the diagnostic work-up of fuo or chronic inflammatory syndrome. positron emission tomography with 2-\[18f\] fluoro-2-deoxy-d-glucose combined with ct scan (fdg-pet/ct) is widely used in malignant diseases and seems to be promising for the diagnosis of inflammatory disorders. its role has not been yet clearly defined in the investigation of fuo and chronic inflammatory syndrome.

all patients with fuo and chronic inflammatory syndrome will undergo fdg-pet/ct and conventional morphologic imaging modalities. results of these two diagnostic procedures in identifying diagnostic clues will be compared. we assume fdg-pet/ct could be safer and more helpful to reach early final diagnosis in patients with fuo and chronic inflammatory syndrome than conventional morphologic imaging modalities

Eligibility criteria:
inclusion criteria: * patient with fuo criteria: fever since 3 weeks, temperature \> 38.3°c, no diagnostic after 3 days of hospitalization. * patient with periodic fever criteria: fever with criteria like fuo, fever-free intervals, and apparent remission of the underlying disease, at least 3 febrile episodes. * inflammatory syndrome without any clinical sign, important inflammatory syndrome: erythrocyte sedimentation rate ≥ 50 at the first hour, and elevation of at least one another inflammatory parameter (haptoglobin, orosomucoïd, fibrinogen or c-reactive protein), evolution since more than 3 weeks, no diagnostic orientation after clinical examination and history-taking, no diagnostic clue after 3 days of hospitalisation. * oral informed consent obtained. exclusion criteria: * demented patient or unable to receive information on the protocol and to give informed consent. * pregnant women, or without contraception. * contraindication to iodine examination, gallium scintigraphy or 18fdg tep-scan. * immunodeficient patient. * know hiv infection, neutropenic patient and nosocomial fever.

Keywords: fdg-pet/ct fuo chronic inflammatory syndrome fever of unknown origin
the effect of phone application supported nutrition education on weight loss

Conditions: Obesity

Summary: internet-based applications are potential supporters for individuals in weight loss programs due to their accessibility and wide access. these applications are aimed at changing the lifestyle of individuals. this study is a randomized controlled study aiming to evaluate the effect of phone application supported nutrition education on weight loss according to standard education. it has been assumed that the telephone application would increase the adaptation and motivation of the people on diet. anthropometric measurements and nutritional features of individuals, weight efficacy lifestyle (wel test), quality of life sf-36, rosenberg self-esteem, obese individuals specific quality of life, healthy life style behaviour scale-ii and healthy eating index score changes questioned as intermediate variables. between march and september 2018, 79 people aged between 18-64 years, whose bmi was 25 and more, who were admitted to the dietitian at ege university faculty of medicine hospital endocrine and metabolic diseases clinic and received routine nutrition education were included in the study. in the first interview, the data collection form of all individuals was filled out and anthropometric measurements of all individuals were made by the researcher. all individuals received a classic nutrition education by the clinical dietician and then written personal weight loss diets. afterwards, only a control appointment for 3 months later was given to the control group. phone application named motive designed by the researcher uploaded to only case group's phone. with the telephone application text, visual and video notifications were sent to case group for 3 months.


Eligibility criteria:
inclusion criteria: * body mass index is 25 or more. * capable of filling the data collection form * no visual-hearing problems * having a smart phone * having a internet connection * individuals who agreed to participate in the study and whose written consent was obtained exclusion criteria: * not having smart phone * not having a internet connection * those who have undergone bariatric surgery * pregnancy * thyroid patients that using drugs * individuals who require a special diet other than obesity treatment (celiac, gout, diabetes, kidney diseases, coumadin users, etc., diagnosed by a doctor)

Keywords: obesity phone application nutrition education
sub urethral sling with or with out anterior repair

Conditions: Urinary Incontinence

Summary: there is a concern about choosing adequate surgical options for stress urinary incontinence associated with vaginal prolapsed and still lack of evidence can be observed. in this study we compared primary and secondary outcomes of single or combine surgery for sui with pelvic organ prolapsed.


Eligibility criteria:
inclusion criteria: 1. patients must be female 2. subjective evidence of stress predominant symptoms on symptom specific questionnaire 3. stress incontinence on urodynamics 4. patients must be capable of filling in the symptom diary 5. prolapse beyond the introitus exclusion criteria: 1. patients who are medically unfit to undergo surgical intervention. 2. patients who have undergone previous continence surgery 3. patients with voiding dysfunction 4. patients with recurrent urinary tract infection 5. patients who are not sure that their family is complete
azelaic acid versus hydroquinone in melasma

Conditions: Melanosis

Summary: the purpose of this study is to compare the safety and effectiveness of azelaic acid gel to hydroquinone cream in the treatment of melasma.

melasma is a chronic condition in which dark areas appear on the forehead, cheeks, and upper lips. hydroquinone is a skin lightener (or fade cream) and is one of the most commonly used medications for the treatment of melasma. azelaic acid gel is currently used to treat acne and rosacea.

Eligibility criteria:
inclusion criteria: * must have stable moderate-severe epidermal or mixed melasma involving the face * all races * males and females * persons taking birth control medication, hormone replacement therapy or any other hormone altering medication may participate only if they have not started or stopped the medication within the last 3 months exclusion criteria: * if the person has only dermal melasma * pregnancy, breastfeeding, a positive pregnancy test in the office or plans to become pregnant * a known allergy or sensitivity ot azelaic acid or hydroquinone * the use of photosensitizing medications (ex. tetracycline) within 3 months of the study. * starting or stopping hormonal medication within 3 months * chemical peels, microdermabrasion, or laser treatment within 6 months * worsening or improving melasma

Keywords: melanosis melasma azelaic acid hydroquinone
pre-marketing feasibility evaluation of the uricap-rm - urine collection in hospitalized male patients

Conditions: Urinary Incontinence

Summary: the study will evaluate device performance and user satisfaction in the uricap-rm, an fda cleared non-invasive urine collection device for men.

following various disease conditions such as trauma, orthopedic surgery, and infections etc., patients may be bedridden and unable to void in a bedpan or to make their way to the toilet. others may be incontinent of urine. in such situations an indwelling catheter is often placed to relieve patients while they are incapacitated; in many cases a catheter is placed despite lack of urinary retention. indwelling catheters, although effective, are associated with discomfort, pain, and urinary tract infections. in other cases diapers or absorbent pads may be used, or a condom-type urine collection device. these may be associated with skin irritation and infection. the study will evaluate the uricap-rm non-invasive urine collection device in hospitalized men.

Eligibility criteria:
inclusion criteria: * male ≥ 18 years old. * empties the bladder completely on voiding * a clinical indication for an indwelling catheter, use of pads or diapers * subject has signed an informed consent form, is cooperative and willing to complete all study procedures * absence of localized disease at the site of device application - no discharge, itching, inflammation or skin condition - - on visual examination * subject has no hypersensitivity to silicon. exclusion criteria: * known allergy to silicon * dysuria * urinary retention - post-void residual urine more than 300cc * hematuria or pyuria (turbidity) on visual inspection, according to investigator judgement. * diagnosed with acute renal failure, according to investigator judgement. * serious or unstable psychological condition (e.g., eating disorders, clinical depression, anxiety, emotionally labile) which, in the opinion of the investigator, would compromise the subject's well-being or successful participation in the study * participating in another clinical study. * financial interest in the sponsor company or a competitor company by subject or a family member
renal sympathetic denervation for reduction of pain and improvement of insulin sensitivity in adult polycystic kidney disease

Conditions: Adult Polycystic Kidney Disease

Summary: in patients with polycystic kidney disease, pain may be resistant to drug therapy and may reduce quality of life. this study investigate the effect of renal denervation on this pain.


Eligibility criteria:
inclusion criteria: * pain limiting daily activities in spite of pain killers, adpkd exclusion criteria: * pregnancy

Keywords: adpkd denervation renal denervation
mindful yoga therapy for veterans with ptsd and pain

Conditions: PTSD; Chronic Pain

Summary: the primary objective of the current study is to establish the safety and acceptability of mindful yoga therapy as an adjunctive treatment for posttraumatic stress disorder (ptsd) and chronic pain among oef/oif/ond veterans. the current study also seeks to establish preliminary efficacy of myt for reduction of ptsd and chronic pain symptoms and explore anxiety sensitivity as a mechanism of therapeutic action.

ptsd is a chronic, debilitating anxiety disorder associated with disability, functional impairment, and a host of co-morbid physical and mental health conditions. although several treatments are successful in treating veterans with ptsd, many veterans fail to complete these treatments and many others complete treatment without significant relief from symptoms. yoga is one integrative treatment option that has shown promise for a number of physical and mental health conditions, including the treatment of depressive, and anxiety disorders in civilian samples, and chronic pain in veterans. yoga is widely offered in veterans affairs (va) ptsd treatment programs, yet there is a lack of research on its efficacy for ptsd in veterans. mindful yoga therapy (myt) is a 12-week treatment protocol incorporating meditation, breathing exercises, mindful movement practice, and guided rest (yoga nidra) that has been developed specifically for veterans with ptsd. this pilot clinical trial will examine the efficacy of myt with baseline, 12 week, and 24 week follow-up assessments that will include diagnostic, neurocognitive, and psychophysiological measures conducted by a research team member blinded to the study purpose.

Eligibility criteria:
inclusion criteria: * oif/oef/ond veteran * ages 18-45 * a willingness to participate in yoga and ability to commit to two 75-minute sessions per week for 12 weeks. * currently enrolled (under active care) at the ptsd firm or the mst group at vachs, west haven * participants will meet clinical criteria of ptsd (dsm-iv-tr) * comorbid conditions, including substance abuse/dependence will be allowed except as noted under exclusion criteria. * veteran with combat exposure or military sexual trauma during deployment(s). * non-cancer pain score (nrs pain score \> 4 on a 0-10 scale whereby 0=no pain and 10=worst pain imaginable) and presence of pain for \>3 consecutive months exclusion criteria: * any diagnosis of current comorbid psychotic disorders or bipolar disorder * active si/hi * primary and only pain complaint as headache disorder * a regular yoga or meditation practice in past month (more than twice weekly) * participants with significant limitations or injuries (potential participants with significant limitations or injuries will be evaluated on an individual basis by research team and the yoga therapists.) * inability to speak or read english

Keywords: ptsd yoga complementary and alternative medicine (cam) chronic pain
combined transcatheter aortic valve implantation and percutaneous closure of the left atrial appendage

Conditions: Aortic Valve Disorder

Summary: atrial fibrillation (af) is a common comorbidity of patients candidates to transcatheter aortic valve implantation (tavi). the management of chronic oral anticoagulation (oac) for the prevention of ischemic stroke is very challenging in this population of complex and frail subjects. since the percutaneous left atrial appendage (laa) closure with the watchman device proved promising safety and efficacy results in randomized comparisons with oac (current standard of care), the aim of the current study is to assess the feasibility and the early safety of performing tavi with the lotus system and percutaneous laa closure with the watchman device at the same session.


Eligibility criteria:
inclusion criteria: * tavi candidates * elderly patients with symptomatic, severe, calcific, native aortic valve stenosis, assessed by echocardiography ava up to 1.0 cm2 or avai up to 0.6 cm2m2 and mean pressure gradient 40 mmhg or jet velocity 4 ms * inoperable or at increased surgical risk (according to multidisciplinary heart team decision) * non-valvular af (paroxysmal, persistent or permanent) * cha2ds2-vasc ≥ score * has-bled score ≥ 2 * written informed consent * aortic annulus size ≥ 20 mm and ≤ 27 mm * adequate laa ostium diameter (17 31mm) exclusion criteria: * previous tavi * previous laa closure (surgical or percutaneous) * previous rf ablation of af * need for long-term oac (history of pulmonary embolism, mechanical heart valve) * contraindication to aspirin * relevant cad requiring revascularization * infective endocarditis * lv ejection fraction \< 20 percent * cardiogenic shock or hemodynamic instability * symptomatic carotid disease * life expectancy \< 1 year * severe renal failure (dialysis or serum creatinine level \> 3.0 mg/dl or 265 μmol/l) * cve within the past 3 months * acute complications occurring during tavi procedure * congenital unicuspid aortic valve * femoral artery lumen diameter \<6.0 mm or \<6.5 mm (for the 23-mm valve or the 25-mm and 27-mm valves, respectively) * documented laa and/or lv thrombi * severe mr * atrial septal defect

Keywords: aortic valve stenosis left atrial appendage
use of the visumax femtosecond laser lenticule removal procedure for the correction of hyperopia

Conditions: Hypermetropia

Summary: the correction of farsightedness using relex smile for hyperopia is focus of this investigation. the objective is to evaluate the safety and effectiveness.

the visumax laser keratome is an ophthalmic surgical femtosecond laser intended for use in patients requiring corneal incisions. the cutting action of the visumax laser keratome is achieved through precise individual micro-photodisruptions of tissue, created by tightly focused, ultra-short pulses, delivered through a disposable applanation lens while fixating the eye under a low vacuum. relex smile combines state-of-the-art femtosecond laser technology of the visumax with high-precision lenticule extraction to provide minimally invasive refractive correction. it is distinguished by its flapless, minimally invasive laser correction. a refractive lenticule is created in the intact cornea, but removed via a small incision. the changed form of the cornea corrects the refraction error. relex smile for myopia is a well-established treatment with extensive supporting published evidence for efficacy and safety. it is ce marked and available since 2011; more than 1 million procedures have been performed worldwide. the correction of farsightedness using relex smile for hyperopia is focus of this investigation and is therefore not yet ce marked.

Eligibility criteria:
inclusion criteria: * normal corneal topography; * predicted post-operative keratometry ≤51 d; * contact lens wearers must stop wearing their contact lenses before baseline measurements according to local requirements of the clinic; * patients should be able to understand the patient information and willing to sign an informed consent; * patients should be willing to comply with all follow-up visits and the respective examinations; * patients with hyperopia or hyperopia with astigmatism (attempted correction: sphere up to +6.00d, cylinder up to 5.00d and maximum hyperopic meridian up to +7.00d); * the corrected distance visual acuity should be 20/25 or better in each eye pre-operatively; * a difference between cycloplegic and manifest refractions of ≤1.00 d spherical equivalent in the eye to be treated; exclusion criteria: * the patients presenting at least one of the characteristics as described for exclusion criteria in the documentation set of the visumax laser keratome relex smile option. * mixed astigmatism * any impaired person (minors, pregnant or breast feeding women or persons incapable of giving consent) are definitely excluded from the study.

Keywords: relex smile hyperopia visumax small incision lenticule extraction lenticule farsightedness