Kornimate/medical-research-clean huggingface dataset:
comparison the topical anesthesia and retrobulbar anesthesia for 27-gauge vitrectomy for vitreous floaters

Conditions: Perioperative Pain Experiences

Summary: routine anesthesia methods for vitrectomy surgery include retrobulbar and peribulbar anesthesia. however, both methods have potential complications that can vary from minor to severe. vitrectomy surgery for vitreous floaters is widely considered straighter forward than other vitreoretinal surgeries. hence, the investigators compared the effect of topical anesthesia (with eye drops) and retrobulbar anesthesia for 27-gauge par plana vitrectomy for symptomatic vitreous floaters.


Eligibility criteria:
inclusion criteria: 1. patients who is going to undergo vitrectomy surgery for vitreous floaters 2. age\>18 years 3. patients who are willing to participate in this study exclusion criteria: 1. patients who had vitrectomy surgery before 2. patients who had penetrating ocular trauma before
a study to assess persistence, adherence and changes in disease activity in the children population of juvenile arthritis patients treated with adalimumab (humira®)

Conditions: Polyarticular Juvenile Arthritis

Summary: the objective of this study is to assess persistence, adherence and changes in disease activity in the children population of juvenile arthritis patients treated with adalimumab (humira®) in the routine clinical settings in the russian federation.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of polyarticular juvenile idiopathic arthritis (jia) according to international league of associations for rheumatology (ilar) criteria . * planned treatment with humira according to the local product label and prescription guidelines. alternatively, subjects assigned to humira treatment not more than 1 month prior to inclusion can be enrolled. * negative result of tuberculosis (tb) screening procedure and tb specialist permission to start biologic therapy. * patient's informed consent form signed by the parent or guardian/and by the child, if applicable. exclusion criteria: * has contraindications for the treatment with humira according to the latest version of the locally approved label. * any biologic drugs taken prior to 3 months of enrolment in the study. * patients treated with any biosimilar version of humira * previous participation and dropout from this study. * patients participating in another clinical and/or observational study priory 3 months before the enrolment to this study.

Keywords: humira® polyarticular juvenile arthritis adalimumab
dietary analysis for caries prevention in children using a computer software

Conditions: Dental Caries

Summary: children will be recruited from the pediatric dentistry clinic of marquette university at their first or recall appointment and will be asked to fill a questionnaire regarding their dietary habits. afterwards a dietary analysis will be performed using a computer software, developed for this study and dietary instructions will be given to the children.


Eligibility criteria:
inclusion criteria: * free medical history * informed consent exclusion criteria: * general disease
aging, geriatric syndromes and clonal hematopoiesis

Conditions: Geriatrics; Aged; Geriatric Syndromes; Cardiovascular Diseases

Summary: in this study the investigators will incorporate a wide range of clinical variables associated with aging and cardiovascular disease to determine whether they are associated with mutation status independent of chronologic age. clinically, aging can be operationalized using geriatric assessment, which entails a comprehensive multi-dimensional assessment of the health of an older adult, including measures of comorbidity, polypharmacy, functional status, cognition, depression, falls, social activities and social support. given that aging is heterogeneous, geriatric assessment allows greater specificity for aging than chronological age alone.


Eligibility criteria:
inclusion criteria: * at least 50 years of age. * able to understand written and spoken english. * able to understand and willing to sign an irb-approved written informed consent document (or that of a legally authorized representative, if applicable for the trauma cohort) exclusion criteria: * inability or unwillingness to complete health questionnaire. * history of a recent (\<30 days) acute viral illness. * current cancer diagnosis and currently receiving chemotherapy or undergoing radiation therapy. a prior history of cancer is allowed if the participant completed therapy \> 1 year prior to enrollment; participants with a prior diagnosis of cancer will be asked to sign a release of information for the research team to obtain records regarding their prior cancer treatment. * current use of drugs that cause dna damage (e.g. cytoxan, azathioprine, etc.) for the treatment of a non-malignant disease. * vulnerable populations (e.g. prisoners). * known infection with hepatitis b or c, htlv, or hiv. * additional exclusion for optional bone marrow aspirate/biopsy substudy: * use of medications for anticoagulation or "blood thinning" including warfarin, low molecular weight heparins (enoxaparin, daltaparin) or direct-acting oral anticoagulants (dabigatran, rivaroxaban, apixaban, edoxaban or betrixaban) * allergy to lidocaine or other local anesthetics.
muscle fiber fragment treatment for urinary incontinence

Conditions: Urinary Incontinence

Summary: this study is designed to evaluate the safety of autologous muscle fiber fragments for the treatment of urinary incontinence due to incompetent outlet (bladder neck/urethra).

eligible subjects with a diagnosis of urinary incontinence who give consent to take part will undergo a biopsy of the muscle from the inner thigh under anesthesia. during the same procedure, muscle fiber fragments will be obtained from the sample and then immediately delivered via target injected into the bladder neck sphincter region using an endoscopic needle via cystoscope or under ultrasound guidance. all subjects will be followed at 1 week, 6 weeks, 3 months, 6 months and 12 months post-treatment injection.

Eligibility criteria:
inclusion criteria: * adult female patients who are not pregnant or lactating/breast-feeding and must be either not sexually active, surgically sterilized, or must be practicing an effective method of birth control as determined by the investigator * patients between the ages of 18 and 75 years * patients with positive diagnosis of urinary incontinence due to sphincter insufficiency caused by acquired (e.g., stress urinary incontinence) and/or congenital conditions. * patients with cystometric capacity of bladder \> 100 ml * patients with normal renal function * patients with a history of primary incontinence exclusion criteria: * patients with a history of hypercontractile bladder, non-compliant bladder, hydronephrosis or neurogenic bladder * patients with an active urinary tract infection as evidenced by positive urine culture * patients who are taking medication that affect urination such as prescription drugs, over-the-counter drugs, or dietary supplements, including herbal supplements and those taken with teas * patients requiring concomitant use of or treatment with immunosuppressive agents * patients with a history of systemic conditions, including but not limited to hiv, diabetes and chronic liver disease (including hepatitis b or c), that the investigator believes may jeopardize the safety of the patient to participate in the study * patients with evidence or diagnosis of any primary muscle disease or coagulation disorder (including concomitant anti-coagulation therapy) * patients who have been treated with any other investigational drug or participated in any investigational study within 30 days prior to enrollment in this study * patients who have been treated with any cellular therapy within 12 months prior to enrollment in this study * patients with urinary incontinence other than the categories being investigated * patients with significant (\>grade 2) pelvic organ prolapse * patients with vaginal prolapse beyond introitus * patients with neurological disorders * patients with abnormal bladder capacity (i.e., less than 100 cc) * patients with abnormal urologic conditions, including post-void residual, urethral stricture and bladder neck contracture, spastic bladder, vesicoureteral reflux, bladder stones, bladder tumors, hydronephrosis, other renal impairment

Keywords: urinary incontinence, muscle fibers
safety and efficacy study of a topical minocycline foam in patients with papulopustular rosacea

Conditions: Rosacea; Papulopustular Rosacea

Summary: the purpose of this study is to see if the study drug, fmx-103, is safe to give and if it helps people with moderate-to-severe papulopustular rosacea. the investigational product is fmx-103 minocycline foam. two concentrations of the investigational product, 1.5% and 3%, will be studied along with vehicle. the foam will be applied once daily to the face for the 12-week treatment duration of the study. approximately 210 patients will participate in this study.


Eligibility criteria:
inclusion criteria: 1. participants age is 18 years or older. 2. participants have a moderate-to-severe rosacea excluding lesions involving the eyes and scalp. 3. subject must have diagnosed rosacea for at least 6 months prior to screening. exclusion criteria: 1. history of hypersensitivity or allergy to minocycline, any other tetracycline or any other component of the formulation such as soybean oil or coconut oil. 2. women of child bearing potential who are pregnant, lactating (in the last 3 months) or planning to become pregnant during the study period. 3. moderate or severe rhinophyma, dense telangiectasis (score 3, severe), or plaque- like facial edema. 4. rosacea conglobata or fulminans, corticosteroid-induced rosacea or isolated pustulosis of the chin, facial erythrosis of known origin other than rosacea (e.g., known carcinoid syndrome). 5. ocular rosacea (e.g., conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical ophthalmic or systemic antibiotics, papulopustular rosacea that requires medically indicated systemic treatment. 6. bacterial folliculitis.
prevention of unmitigated chemotherapy-induced emesis

Conditions: Chemotherapy-induced Nausea and Vomiting; Nausea Post Chemotherapy

Summary: chemotherapy-induced nausea and vomiting (cinv) remains a major obstacle to patient care and continues to decrease quality of life. despite the addition of medications and antiemetic regimens, doctors' ability to control cinv is still inadequate: even moderately-emetogenic chemotherapy regimens cause roughly 20% of patients to have vomiting and over 40% to experience significant nausea. in this study, the investigators test a transcranial vibrating system that has shown great promise at reducing nausea and vomiting. .

chemotherapy-induced nausea and vomiting (cinv) remains a major obstacle to cancer patient care despite numerous medications being available to prevent and treat cinv. cinv decreases quality of life in roughly one third of patients receiving highly emetogenic chemotherapy. in addition, roughly half to two thirds of all patients receiving chemotherapy require rescue anti-emetic medications despite being given guideline-based prophylactic anti-emetics.the anti-emesis armamentarium continues to grow with new medications, including olanzapine and fosaprepitant, being studied in recent years. however, despite the addition of these medications and guideline-based antiemetic regimens, the ability to control cinv is still inadequate as even moderately-emetogenic chemotherapy regimens cause roughly 20% of patients to have vomiting and over 40% to experience significant nausea. in this study, the investigators aim to test a new transcranial vibrating system that has shown promise in phase i studies for treating dizziness, motion sickness and nausea.

Eligibility criteria:
inclusion criteria: * subject currently receiving chemotherapy known to be emetogenic (i.e subject has already received one round of chemotherapy) * mascc antiemesis tool score of \> 6 on the nausea severity scale and/or * one or more episodes of vomiting anytime in the 4 days following receipt of chemotherapy and/or * the need for three or more uses of rescue antiemetic medications within 4 days of chemotherapy during previous round. exclusion criteria: * pregnant women * individuals unable to provide informed consent * any preexisting condition causing significant nausea or vomiting, or causing reaction to the bone conduction system (e.g. superior canal dehiscence) * prisoners

Keywords: nausea chemotherapy cisplatin emesis
effect of clostridium butyricum in treating irritable bowel syndrome

Conditions: Effect of Clostridium Butyricum in Treating Irritable Bowel Syndrome

Summary: clostridium butyricum might be an effective drug in treating irritable bowel syndrome


Eligibility criteria:
inclusion criteria: * the presence of rome iii criteria for ibs ; * aged between 18 and 65 years old exclusion criteria: * antibiotic, probiotic or laxative usage within 4 weeks. * organic gastrointestinal diseases * severe systematic disease: diabetes mellitus, hepatic, renal or cardiac dysfunction, thyroid disease or tumor etc. * pregnancy or lactation. * previous major or complicated abdominal surgery. * severe endometriosis and dementia

Keywords: irritable bowel syndrome clostridium butyricum
a surgical approach to the management of type ii diabetes mellitus in patients with a bmi between 25-35 kg/m2

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of the study is to determine if by performing surgery we can cure type ii diabetes. the surgical procedures: 1. a sleeve gastrectomy, cutting out a portion of the stomach, which provides restriction of caloric intake and rapid gastric emptying. 2. ileal transposition which involves repositioning a 150cm segment of the ileum into the jejunum causing improved glucose homeostasis.


Eligibility criteria:
inclusion criteria: * age- 21-55 years. * body mass index between 25-35 kf/m2. * currently being treated for type 2 diabetes mellitus with oral hypoglycemic, insulin or both for the at least 3 years. * documented hba1c\>7.5% for at least 3 months. * stable weight for 3 months (+/-) * evidence of stable medical treatment for diabetes over the past 12 months. * able to provide informed consent -female subject agrees to participate in accepted birth control methods - exclusion criteria: * type i diabetes/juvenile onset * c-peptid levels below 1.0 ng/ml * previous major upper abdominal surgery --pregnant or plans to become pregnant with in the next 12 months * current malignancy * severe pulmonary, cardia, or renal disease * eating disorders such as bulimia or binge-eating * severe mental health disorders such as schizophrenia and bipolar disorder * obesity due to other metabolic disorders * taking appetite suppressants * currently abusing illicit drugs,alcohol or using tobacco products * unable to provide informed consent * unwillingness or unable to comply with study procedures * any condition that deems them unsuitable for the study in the opinion of the investigators

Keywords: type 2 diabetes mellitus
gaze contingent feedback for anxiety disorders in children

Conditions: Anxiety Disorders

Summary: the purpose of this study is to determine whether giving gaze-contingent feedback is an effective attention modification procedure, helping in the treatment of anxiety disorders in children.

attention biases in threat processing have been assigned a prominent role in the etiology and maintenance of anxiety disorders. the purpose of this study is to determine whether giving gaze-contingent feedback is an effective treatment for anxiety disorders in clinically anxious 6-10 year-olds children. participants will be assessed using clinical interviews and parent- and self-rated questionnaires before and after eight training sessions. outcome measures will be anxiety symptoms and depression as measured by gold standard questionnaires as well as structured clinical interviews with children and their parents. attentional threat bias and attentional control will also be measured to explore potential mediators of abmt's effect on anxiety.

Eligibility criteria:
inclusion criteria: * primary diagnosis of gad, sop, or sad. * co-morbid attention deficit hyperactivity disorder (adhd) or depressive disorders must be treated with medication and stable. * tics or impulse control problems must be treated with medication, stable and cause minimal or no impairment. exclusion criteria: to be excluded youth must: * meet diagnostic criteria for organic mental disorders, psychotic disorders, pervasive developmental disorders, or mental retardation. * show high likelihood of hurting themselves or others. * have not been living with a primary caregiver who is legally able to give consent for the child's participation. * be a victim of previously undisclosed abuse requiring investigation or ongoing supervision. * be involved currently in another psycho-social treatment. * have a serious vision problem that is not corrected with prescription lenses. * have a physical disability that interferes with their ability to click a mouse button rapidly and repeatedly.

Keywords: attention bias modification treatment anxiety disorders attention training
performance proof of the new norma-sense

Conditions: Vaginal Infection

Summary: this study was designed to validate the color appearance on the newly developed panty liner (norma-sense). the norma-sense liner changes color when worn by the user and comes into contact with vaginal secretion with an elevated ph level, without false positives due to urine remains or incontinence. the study will also asses the physical comfort in using norma-sense and the result reading clarity which includes the ability to visualize and interpret the norma-sense strip results.


Eligibility criteria:
inclusion criteria: 1. women, age 18 years or greater without symptoms of vaginal infection. 2. subject is ready to sign the informed consent form. exclusion criteria: 1. subject is unable or unwilling to cooperate with study procedures. 2. subject is currently participating in another clinical study. 3. subject suffers from vaginal bleeding or is menstruating. 4. subject that have had sexual relations within the last 12 hours. 5. subject that applied local antiseptic or antibiotic or vaginal treatment within the last 3 days. 6. subject that applied vaginal douching within 12 hours prior to the visit at the clinic.

Keywords: vaginal infection color appearance elevated ph
electrode placement in electrical velocimetry

Conditions: Cardiovascular Disease

Summary: electrical velocimetry (ev) is one of the latest adaptions of impedance cardiography showing diverging results. with electrode position being a suspected factor influencing measurement accuracy or reproducibility for impedance cardiography in general, no data is currently available on altering the gap of the two lower electrodes in ev. reference values were determined using the non-invasive gold-standard cardiac magnetic resonance imaging (cmr).


Eligibility criteria:
inclusion criteria: * indication for cmr exclusion criteria: * pregnancy
efficacy of antistax® in improving microcirculation of the skin in the leg in patients suffering from chronic venous insufficiency

Conditions: Venous Insufficiency

Summary: study to determine the efficacy and safety of antistax® film coated tablets in improving microcirculation of the skin in the leg of patients with chronic venous insufficiency (cvi)


Eligibility criteria:
inclusion criteria: * male or female * \>= 18 years of age * cvi i or cvi ii (without expanded trophic disturbances) * willing and able to give written informed consent in accordance to good clinical practice and local legislation prior to participation in the study exclusion criteria: concomitant disease(s) exclusion criteria: * decompensated cardiac insufficiency * edema not due to venous disease of the legs (e.g. latent cardiac insufficiency, renal insufficiency, lymph edema, etc) * peripheral arterial disease (ankle/arm pressure index \< 0.9) * current acute phlebitis or thrombosis * renal insufficiency (serum creatinine \> 1.5 mg/dl) * liver disease (sgpt (alat) \> 3x upper limit of normal) * other diseases: insulin-dependent diabetes mellitus, neuropathies, hyper- or hypocalcaemia, malignancies * anamnestic indications of diabetic microangiopathy or polyneuropathy * drug and/or alcohol abuse * pregnant or nursing women or inadequate birth control methods (this applies to females of childbearing potential only) * severe climacteric complaints or changes in, or initiation with post-menopausal hormone replacement therapy within the last 3 months * immobility * avalvulie * klippel-trénaunay-weber-syndrome (naevus varicosis osteohypertrophicus, haemangiectasia hypertrophicans) * state after pulmonary embolism * recognized hypersensitivity to the trial drug ingredients * current florid venous ulcus * clinical indication for a necessary, specific phlebologic acute treatment, e.g. compressive treatment, phlebectomy, etc. previous treatment(s) exclusion criteria: * treatment with venous drugs within the last 4 weeks * changes in, or initiation with, treatment with theophylline, diuretics, cardiac glycosides, ace inhibitors or calcium antagonists within the last 8 days concomitant treatment/non-drug therapy exclusion criteria: * other venous drugs apart from the trial medication * compression bandages * venous surgery of the leg used for the fluxmetry * extensive use (i.e. on more than a total of 6 days during the entire trial) of laxatives which affect fluid or electrolyte balance * major surgery requiring full anesthesia other exclusion criteria: * previously studied under this protocol * participation in another clinical trial within the previous 90 days or during the present study * patients considered as mentally ill as well as unable to work or with limited working ability, or unable (or only partially able) to follow the spoken or written explanations concerning the trial * patients in a bad general health state according to the investigator's judgment