Kornimate/medical-research-clean huggingface dataset:
subject´s preference regarding hearing performance and functionality using a new sound processor

Conditions: Deafness; Sensoneural Single Sided; Conductive Hearing Loss; Mixed Hearing Loss

Summary: the aim of this clinical investigation is to investigate the subject´s overall preference, hearing performance and self-reported assessments with the investigational device and its precursor sound processor (comparator) after 6 weeks in subjects with conductive/mixed hearing loss or single sided deafness, (ssd).


Eligibility criteria:
inclusion criteria: * completed clinical investigation cbas5539, and an active user of the osia system. * signed informed consent. * subject with conductive or mixed hearing loss in the implanted ear. bone conduction thresholds with pure tone average (pta4; mean of 0.5, 1, 2 and 4 khz) of ≤ 55 db hl. or subject with single-sided sensorineural deafness. air conduction thresholds with a pure tone average pta4 of ≤ 20 db (decibel) hl (hearing level) (mean of 0.5, 1, 2 and 3 khz) in the good ear. - optimally fitted with osia sound processor, according to subject's experience prior to inclusion. exclusion criteria: * any ongoing soft tissue complication that could significantly affect the use of the osia 2 sound processor during the 6 weeks period * use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator * unable to follow investigational procedures and instructions, e.g. inability to complete quality of life scales or audiological testing as described in the clinical investigation plan (cip). * participation in another clinical investigation with pharmaceutical and/or device.
uf-bmt-hsct-001: a non-interventional study evaluating diet in hsct survivors

Conditions: Hematopoietic Neoplasm

Summary: this is a single center, cross-sectional, non-interventional study aimed at the nutritional intake of long-term health of allogeneic or autologous hematopoietic stem cell transplant (hsct) survivors.

higher rates of comorbidity among hematopoietic stem cell transplant (hsct) survivors support the need for lifestyle interventions that target this vulnerable population. comprehensive evaluation of the nutrient intake will provide adequate information necessary for develop of a targeted nutritional intervention in order to achieve specific nutritional need and improve long-term health of hsct survivors. the cross-sectional design of this study has been selected for the timely collection of subject reported nutrient intake data. the intended study is strictly observational.

Eligibility criteria:
inclusion criteria: * written informed consent obtained from the subject and the ability for the subject to comply with all the study-related procedures for subjects enrolled from the cancer registry. * both males and females ≥ 18 years of age. * a medical history of allogeneic or autologous hematopoietic stem cell transplant (hsct), irrespective of the disease. for the purpose of this study, hsct survivor is defined as subjects one or more years after allogeneic or autologous hsct without disease relapse, active graft-versus-host disease, or active infection. subjects with chronic graft versus host disease who are on stable dose of immunosuppressant (or being tapered off of immunosuppressant) over the past 3 months will be eligible. * study participants must have the ability to complete the questionnaires through one of the previously stated mechanisms. * english speaking due to the logistics of the questionnaires and phone contact included in this study. exclusion criteria: * subjects demonstrating an inability to comply with the study procedures.
serum anti-mullerian hormone and polycystic ovarian syndrome

Conditions: Polycystic Ovary Syndrome

Summary: in 1935 the polycystic ovary syndrome was a clinical diagnosis made on the morphological appearance of the ovaries in association with amenorrhoea, hirsutism and frequently obesity. at that time wedge resection of the ovaries was introduced on an empirical basis and proved a successful treatment for the associated anovulation and infertility. in the ensuing fifty years the limitations of a purely surgical approach to therapy have become recognized and the importance of the biochemical abnormalities appreciated. prevalence of polycystic ovary syndrome: the prevalence of polycystic ovary syndrome in any specified population is dependent upon the diagnostic criteria used, but does have some regional and ethnic variation. while most reports on the prevalence of polycystic ovary syndrome range between 2 and 20%, the chosen diagnostic criteria are recognized to influence the determined prevalence. anti-mullerian hormone which is a predictor of ovarian reserve is known to decrease after laparoscopic ovarian drilling. on the best of our knowledge no study had been done to use the level of anti-mullerian hormone as a factor for planning the number of ovarian drills in each ovary.


Eligibility criteria:
inclusion criteria: 1. infertility more than 2 years. 2. age between 20-35 years. 3. clomiphene resistant patients: patients received clomiphene 150 mg from day 3 to 7 of the menstrual cycle for 6 months and non-ovulatory (with failure of conception). they were followed up in the outpatient clinic. 4. no contraindications for laparoscopy. 5. normal hysterosalpingography exclusion criteria: 1. contraindications for laparoscopy e.g cardiac diseases, bad scared abdomen ect.... 2. women's age less than 20 years or more than 35 years. 3. previous laparoscopic surgery. 4. previous ovarian surgery. 5. women with antimullerian hormone level less than 4 ng/ml. 6. tubal factor infertility as diagnosed by hysterosalpingography .
resin salve versus honey treatment in wound care

Conditions: Wound Healing; Wound Infection

Summary: in recent years, salve prepared from norway spruce (picea abies) resin and refined honey from manuka myrtle (leptospermum scoparium), has successfully been used in medical context to treat both acute and chronic surgical wounds. the objective of this prospective, randomized and controlled clinical trial is to investigate healing rate and healing time of surgical wounds in patients, who have undergone peripheral vascular surgery, and whose complicated wounds are candidate for topical treatment with the resin or honey. in addition, factors contributing with delayed wound healing, antimicrobial properties, safety and cost-effectiveness of the resin salve and medical honey will be analyzed.


Eligibility criteria:
inclusion criteria: * infected of non-infected acute or chronic wound after vascular surgery. * need for topical wound care. * need for wound healing follow-up at the surgical outpatient department. exclusion criteria: * life expectancy less than 6 months. * advanced malignant disease. * need for extensive surgical wound revision or skin transplantation.

Keywords: wound healing wound infection resin salve medical honey
artificial intelligence system for the detection and prediction of kidney diseases using ocular information

Conditions: Artificial Intelligence; Ophthalmology; Kidney Diseases

Summary: this is an retrospective and prospective multicenter study to develop and validate an artificial intelligent (ai) aided diagnosis, therapeutic effect assessment model including chronic kidney disease (ckd) and dialysis patients starting from april 2009, which is based on ophthalmic examinations (e.g. retinal fundus photography, slit-lamp images, octa, etc.) and ckd diagnostic and therapeutic data (routine clinical evaluations and laboratory data), to provide a reliable basis and guideline for clinical diagnosis and treatment.


Eligibility criteria:
inclusion criteria: * patients previously received kidney biopsy, ophthalmic examinations and routine examinations of the department of nephrology during in-hospital period with bcva\>0.5. exclusion criteria: * patients without retinal fundus images or kidney diseases. * the quality of the retinal fundus images can not meet the requirement for furthur analysis. * severe loss of results of routine examinations of the department of nephrology.

Keywords: kidney diseases artificial intelligence eye information
prostaglandin e2 in migraine suffers without aura.

Conditions: "Migraine-like" Headache

Summary: the hypothesis of this study is that prostaglandin e2 (pge2) induces headache and dilatation of brain vessels in migraine patients without aura.


Eligibility criteria:
inclusion criteria: * patients with migraine without aura exclusion criteria: * tension type headache more than x 3 per month * other forms for primary headache * headache 24 h before the day of the investigation * migraine 48 h before the day of the investigation * hypertension * hypotension * pregnant/nursing * daily intake of medication (except oral contraceptives and migraine rescue medicine during migraine attack) * cardiovascular or central nervous system (cns) disease * drug/alcohol abuse * psychiatric disease * asthma or any other lung diseases
a long-term, placebo-controlled x-ray study investigating the safety and efficacy of sd-6010 in subjects with osteoarthritis of the knee

Conditions: Osteoarthritis

Summary: the objective of this 2-year study is to evaluate the safety, tolerability and disease modifying efficacy of sd 6010, an inhibitor of inducible nitric oxide synthase (inos), in overweight and obese subjects with knee osteoarthritis. the efficacy of sd-6010 will be evaluated by radiography using joint space narrowing in the medial tibiofemoral compartment of the study knee as the primary endpoint.


Eligibility criteria:
inclusion criteria: * subjects aged \>= 40 years with a bmi \>= 25 and \<= 40 kg/m2 * in the past, has been diagnosed with knee oa * radiographic evidence of oa in the study knee exclusion criteria: * a diagnosis of any other rheumatic disease * current conditions in the study knee that would confound efficacy * selected, traditional clinical safety and laboratory parameters

Keywords: knee osteoarthritis disease modifying osteoarthritis drug
a real life evaluation of the performance of a large volume nebulizer

Conditions: Asthma

Summary: continuous albuterol has become the standard of care for patients in status asthmaticus. we have previously performed an in-vitro study comparing 4 different brands of continuous nebulizers. we now want to compare the in-vitro with the in-vivo performance of the brand we use. we hypothesize that there will be no difference between in-vivo and in-vitro results.

there will be no intervention to the patients. nebulizers will be used as per current policies and procedures. they will only be marked on the outside at the water level every 2 hours for the first 6 hours. once ready to be discarded will be collected for laboratory testing once in the laboratory, nebulizers will be weight on a precision scale without liquid, then they will be filled with normal saline to the first mark (6th hour) and re-weight. the nebulizers will be filled to next mark and re-weight until 200 mls. of total volume are achieved. solution output will be calculated as the weight difference between the 2 hour periods.

Eligibility criteria:
inclusion criteria: * pediatric patients admitted to pediatric intensive care unit due to status asthmaticus, requiring continuous albuterol nebulization. exclusion criteria: * patients requiring invasive or non-invasive ventilation.

Keywords: large volume nebulizer
qol in incarcerated inguinal hernias: tapp vs open repair

Conditions: Inguinal Hernia

Summary: to determine if there is a difference in the quality of life in between patients who undergoes laparoscopic transabdominal pre-peritoneal (tapp) or modified lichtenstein hernioplasty

patients presenting with incarcerated inguinal hernias will be randomized between open or laparoscopic repair groups. the primary outcome will be the quality of life scores. patients will be followed-up for 12 months.

Eligibility criteria:
inclusion criteria: * 18 years of age and older * both genders * unilateral inguinal hernias * incarcerated inguinal hernias * elective setting exclusion criteria: * anaesthesiologists) grade \> 2 * recurrence * inguinal-scrotal hernias * prostatectomy, pfannenstiel incision, previous pre-peritoneal surgery * pregnancy * refusal for general anaesthesia
using tms to understand neural processes of social motivation

Conditions: Social Avoidant Behavior; Major Depressive Disorder; Social Anxiety Disorder

Summary: the purpose of this study is to use transcranial magnetic stimulation (tms) to better understand the neural circuits associated with social motivation. participant includes four study visits each that range from 1.5 - 3.0 hours in duration over approximately a one month period. the first study visit involves answering survey questions, a clinical interview, and computer tasks. the second study visit involves a magnetic resonance imaging (mri) scan, computer tasks, and a brief tms protocol. the second and third study visits involve a full session of tms followed by an mri scan and computer tasks. adults in the auburn/apelika area who avoid social situations, experience symptoms of depression or social anxiety, and are between 25 years old and 50 years old are eligible to participate.


Eligibility criteria:
inclusion criteria: * a diagnosis of major depressive disorder or a diagnosis of social anxiety disorder (assessed/confirmed at screening visit). * scoring above clinical threshold on a measure of social avoidant behavior (assessed/confirmed at screening visit). exclusion criteria: * unstable medication regimen (i.e., changes in medication or dosage in past 3 months). * current or lifetime diagnosis of bipolar disorder. * a diagnosis of substance use disorder within past 12 months. * a diagnosis of psychotic-spectrum disorder such as schizophrenia. * pregnancy or probable pregnancy. * medical illness or medical treatment that would preclude or inhibit study participation. * neurological disorder or prior neurosurgical procedure. * history of seizures or head trauma. * metal implants or objects within body (e.g., pacemaker).
comparison of screening tests in detecting cervical neoplasia

Conditions: Cervical Cancer

Summary: rationale: screening tests may help doctors detect abnormal cells in the cervix early and plan effective treatment. purpose: screening trial to compare different types of screening tests used to detect cervical neoplasia.

objectives: * compare the sensitivity and specificity of primary screening strategies for the detection of cervical intraepithelial or invasive neoplasia. * compare the positive and negative predictive values of these strategies. outline: this is a multicenter study. patients are stratified according to the reason for the visit (general gynecological screening vs colposcopy referral). * stratum 1 (general gynecological screening): patients undergo pap smear, visual inspection aided by acetic acid (via), a colposcopy, and finally a visual inspection aided by toluidine blue (vit) followed by an acetic acid wash. a biopsy may be performed at this initial visit. within 2-3 weeks, patients are notified of results. * stratum 2 (colposcopy referral): patients undergo pap smear, via, colposcopy, vit, and possible biopsy as in stratum 1. during the same visit, patients receive histologic evaluation and treatment with see-and-treat loop electrosurgical excision procedure and/or endocervical curettage. projected accrual: a total of 600-1,000 patients (300-500 per stratum) will be accrued for this study.

Eligibility criteria:
inclusion criteria:: * history of cervical neoplasia * presenting for a well-woman visit, annual pap smear, or family planning * other gynecological or non-gynecological complaints allowed or * referred for colposcopy secondary to an abnormal pap smear * planned screening for cervical cancer * over 18 years of age * prior laser surgery, cryotherapy, or conization or loop electrosurgical excision procedure for cervical neoplasia allowed exclusion criteria: * bleeding diathesis * pregnant * prior hysterectomy * concurrent anticoagulants

Keywords: cervical cancer
comparison of prasugrel and clopidogrel in very elderly and non-elderly patients with stable coronary artery disease

Conditions: Coronary Artery Disease

Summary: the 5-milligram (mg) maintenance dose (md) of prasugrel in very elderly patients with coronary artery disease produces a pharmacodynamic response within the same therapeutic range as 10-mg md in non-elderly patients.


Eligibility criteria:
inclusion criteria: * participants (either: at least 45 years of age, but less than 65 years of age or 75 years of age or older) with a history of stable coronary artery disease who are not currently indicated for treatment with a thienopyridine (that is, prasugrel, clopidogrel, or ticlopidine) * provision of written informed consent * body weight greater than or equal to 60 kilograms (kg) * for women of child-bearing potential only (that is, women who are not surgically or chemically sterilised and who are between menarche and 1 year post menopause), test negative for pregnancy (based on a urine or serum pregnancy test to be performed before randomisation) and agree to use a reliable method of birth control during the study exclusion criteria: * unstable coronary artery disease * myocardial infarction (mi) within the previous 30 days * percutaneous coronary intervention (pci) or coronary artery bypass graft surgery (cabg) within the previous 90 days * history of refractory ventricular arrhythmias within the last 6 months; an implanted defibrillator device; congestive heart failure within 6 months prior to screening; major surgery, or severe trauma, fracture or organ biopsy within 3 months prior to enrollment * any planned surgical procedure or any coronary revascularisation (surgical or percutaneous) planned within 60 days following randomisation * any known contraindication to treatment with an antiplatelet agent * significant hypertension at the time of screening or randomisation * clinically significant out-of-range values for platelet count or haemoglobin at screening, in the investigator's opinion, or results of clinical laboratory tests at the time of screening that are judged to be clinically significant for the study population, as determined by the investigator * prior history or presence of significant bleeding disorders, abnormal bleeding tendency, or personal history of coagulation or bleeding disorders * prior history or clinical suspicion of cerebral vascular malformations, intracranial neoplasm, transient ischemic attack (tia) or stroke * prior history of thrombocytopenia or thrombocytosis * use of antiplatelet agents (besides aspirin) within 10 days prior to screening; the use (or planned use) of heparin, oral anticoagulants, or fibrinolytic agents within 30 days of screening; or participants receiving daily treatment with nonsteroidal anti-inflammatory drugs (nsaids) or cyclooxygenase-2 (cox-2) inhibitors that cannot be discontinued for the duration of the study

Keywords: platelet function
evaluation of gut permeability in patients affected by obesity and nafld: influence of ketogenic diet.

Conditions: Permeability; Increased; NAFLD; Obesity

Summary: this study is open label, with one arm only. in this study will be enrolled patients with obesity (bmi more than 30). aim of the study is to determine the influence (if any) of a very low calorie ketogenic diet (vlckd) on gut permeability and liver steatosis. the first objective is to examine the influence of obesity on the prevalence and severity of impaired intestinal permeability and hepatic steatosis. intestinal permeability means the ability of the intestinal barrier to block the passage of substances potentially harmful to our body. the second objective is to evaluate whether a low-calorie and ketogenic dietary intervention, lasting 6 weeks, can change intestinal permeability and hepatic steatosis


Eligibility criteria:
inclusion criteria: 1. bmi ≥ 30 kg/m2 or abdominal circumference (waist) \>94 cm in men and \>80 cm in women (idf criteria for the definition of abdominal obesity) with or without the features that characterize the metabolic syndrome 2. age range between 18 and 70 years, both sexes 3. diagnosis of hepatic steatosis, formulated on the basis of fibroscan \[cap (controlled attenuation parameter) \> 238 db/m(decibel/meter)\], and other recognized criteria (fli - fatty liver index , fib-4 - fibrosis-4 index, nfs - nafld fibrosis score). exclusion criteria: 1. normal and underweight subjects 2. presence of any pathology that may affect the presence of altered intestinal permeability or steatosis, apart from pathologies that represent inclusion criteria 3. treatment with any device, pharmacological or not, that can affect intestinal permeability and liver metabolism and, therefore, the presence of steatosis 4. pregnancy or lactation

Keywords: obesity gut permeability nafld ketogenic diet
aesthetic outcome of complex linear closure vs second intention healing: below the knee

Conditions: Wound Heal; Wound of Skin

Summary: the purpose of this study is to determine whether complex linear closure vs second intention healing for cutaneous wounds below the knee affects esthetic outcomes (primary outcome). as secondary outcome, the study team plans to look at patient quality of life measures and complications. this will be a prospective, 2-arm, randomized, evaluator-blinded clinical trial. one half of the patients will receive repair by complex linear closure and the other half of the patients will undergo second intention healing. three-months post-surgery, the scar will be evaluated via the patient observer scar assessment scale (posas), a validated scar instrument, as well as the trace-to-tape method, an objective outcome measure for linear postoperative scars. in addition, patients will be provided a validated quality of life survey to complete. any adverse events will also be recorded.

when a cutaneous wound is created following mohs micrographic surgery and standard excisions, a decision is made to either allow the wound to heal by second intention ("leave open") or repair the wound ("close"). the decision may depend on patient characteristics, wound location, wound size or wound characteristics. when the decision is made to repair the wound, the majority of wounds are reconstructed using two layers of sutures: a deep (subcutaneous) layer and a top (cutaneous) layer. this study aims to investigate whether complex linear closure versus second intention healing for cutaneous surgical procedures performed below the knee affects wound cosmesis. in other words, the study team would like to determine which of the following yields a more cosmetically appealing scar: below the knee wound that is closed in a linear fashion or below the knee wound that is left open to heal on its own. the study team also plans to look at quality of life measures via validated surveys and complications. randomized control trials comparing these two methods appear to be lacking. a randomized trial looked at second intention healing vs primary simple closure following 4mm or 8mm punch biopsies on the arm, back or thigh1. besides this study, no other information could be found in the literature on randomized trials comparing linear closure vs second intent for cutaneous wounds below the knee. the study team hopes that this study will provide new insight in cutaneous surgery.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * able to give informed consent themselves * patient scheduled for cutaneous surgical procedure below the knee with a lesion excision diameter of at least 1 cm. * willing to return for follow up visit exclusion criteria: * incarceration * under 18 years of age * pregnant women