Kornimate/medical-research-clean huggingface dataset:
proximal protection versus non-protection in carotid artery stenting

Conditions: Carotid Artery Stenosis

Summary: to compare the incidence of new ischemic brain injury detected with magnetic resonance imaging (mri) after carotid artery stenting in patients treated with and without proximal cerebral protection (gore flow reversal system).

primary objective: the purpose of this study is to compare the rate of new ischemic brain injury detectable on mri after carotid artery stenting between patients treated with proximal cerebral protection (gore flow reversal system) and without cerebral protection. secondary objective: impact of mri-morphology of atherosclerotic plaque to the rate of new hyperintense diffusion weighted imaging (dwi) lesion on the post-treatment scan and to the rate of ipsilateral stroke or death.

Eligibility criteria:
inclusion criteria: * male and female ≥ 18 years old; * suitable/eligible for carotid artery revascularization; * significant artery stenosis in symptomatic patients defined as ≥ 50% of the artery diameter (%ds) or asymptomatic ≥ 80 %ds by angiography. symptomatic is defined as a carotid artery stenosis associated with ipsilateral transient ischemic attack (tia), amaurosis fugax, ischemic stroke or retinal infarction within 6 months prior to enrollment. * adequate clinical conditions to perform dw-mri. * ability of the individual to understand the character and the consequences of clinical trial. * signed and dated informed consent provided before the beginning of any intervention. * negative pregnancy test (serum or urine) and contraception use for any woman of childbearing age. systematic contraceptives (oral, implant, injection) and dia-phragm or condoms with spermicidal are considered reliable. women who have undergone bilateral oophorectomy or/and hysterectomy or women status post-menopausal for at least two years are eligible for this trial. exclusion criteria: * intracranial hemorrhage, hemorrhagic stroke, or stroke with mass effect demonstrated on ct scan or mri within 30 days of the index procedure. * persisting ischemic stroke (defined as either a score \> 15 on the nih stroke scale, a rankin score \> 3 or a barthel score \< 60 measured within one week prior to study entry). * intracranial mass lesion (i.e., abscess, tumor, or other infection). * peripheral vascular, supra-aortic or internal carotid artery tortuosity precluding the use of catheter-based techniques required for successful results. * lactation. * arterio-venous malformation in the territory of the target carotid artery. * any disease or medication that affects local hemostasis, * participation in other clinical trials during the present clinical trial or within the last month. * medical or psychological condition that would not permit completion of the trial or signing of informed consent.

Keywords: carotid artery stenting cas proximal protection
sono-electro-magnetic therapy for refractory chronic pelvic pain syndrome

Conditions: Chronic Pelvic Pain Syndrome

Summary: treatment of chronic pelvic pain syndrome (cpps) is challenging for patients and physicians once conventional therapies fail. we hypothesize that combined sono-electro-magnetic therapy can improve refractory cpps in men.


Eligibility criteria:
inclusion criteria: * cpss iii * symptomatic \>3 months * nih-cpsi total score =/\>15 * nih-cpsi pain =/\>8 exclusion criteria: * post void residual \>100ml * urinary tract infection * urethral stricture * age \<18 years

Keywords: chronic pelvic pain syndrome neuromodulation
periodontitis and upper gi post-operative complications

Conditions: Periodontitis; Surgery--Complications

Summary: periodontitis is a infection of mouth gingival mucosa and connecting tissue. it has been shown in previous studies to have a effect on the risk of heart diseases getting worse and elevate risk in heart surgery. the investigators are studying periodontitis and how it affects upper gastrointestinal tract patients complication rates and the quality of complications.

before patricipating patients go to preop, the investigators have them take a mouth rinsing quick-test, periosafe(c), that tells specifically about periodontitis. participants go to surgery (upper gi) and have a normal operation following our clinics standards and normal follow up. after the investigators analyze the patient data concerning possible complications and do they have relations between the positive periodontitis results. participants are also given advice about seeing a dentist if positive results are seen, but the operating surgeons do not get to know the mouth rinsing test results.

Eligibility criteria:
inclusion criteria: * need for a upper gi surgery exclusion criteria: -
the professional values and ethical sensitivities during the covid-19 pandemic

Conditions: Professional Values; Ethical Sensitivities

Summary: this study was conducted to examine the professional values and ethical sensitivities of senior nursing students in distance education during the covid-19 pandemic. during the covid-19 process, senior nursing students continue their education with distance education practices. the sample consisted of 302 senior nursing students.


Eligibility criteria:
inclusion criteria: * being over the age of 18 * being a fourth level student * agreed to participate in the research exclusion criteria: * being diagnosed with a neuropsychiatric disease

Keywords: covid-19 ethical sensitivity nursing student professional value
4-point therapy response score with pet/ct for anal squamous cell cancer

Conditions: Anal Squamous Cell Carcinoma; Stage 0 Anal Cancer AJCC v8; Stage I Anal Cancer AJCC v8; Stage II Anal Cancer AJCC v8; Stage IIA Anal Cancer AJCC v8; Stage IIB Anal Cancer AJCC v8; Stage III Anal Cancer AJCC v8; Stage IIIA Anal Cancer AJCC v8; Stage IIIB Anal Cancer AJCC v8; Stage IIIC Anal Cancer AJCC v8

Summary: this study determines whether a positron emission tomography (pet)/computed tomography (ct) 4-point scoring system may predict overall survival for anal squamous cell cancer patients. a 4-point scoring system involving imaging scans may help to predict how patients with anal squamous cell cancer respond to chemoradiation therapy.

primary objective: i. to determine whether a pet/ct scoring system in invasive biopsy proven anal squamous cell carcinoma (scca) to be treated with chemoradiation with curative intent (any t any n) predicts for overall survival (os). secondary objectives: i. to determine whether a pet/ct scoring system in invasive biopsy proven scca to be treated with definitive chemoradiation with curative intent predicts for progression free survival (pfs). ii. to determine and validate inter-reader reliability. iii. to calculate c-index to evaluate the prognostic capacity of pet/ct scores for survival. iv. to determine the association between pre-treatment pet/ct scores after treatment and os. exploratory objective: i. to correlate level of standardized uptake value (suv) pre and post therapy and its correlation with overall survival. outline: patients undergo pet/ct at baseline and at 3 months post therapy completion. patients' medical records are received. patients are followed up for 5 years.

Eligibility criteria:
inclusion criteria: * histologically confirmed biopsy proven invasive scca (any t, any n) deemed a candidate to undergo standard of care definitive chemoradiation at md anderson cancer center (mdacc) with curative intent * age \> 18 years at time of study entry * ability to provide written informed consent exclusion criteria: * patients unwilling to participate in a pet/ct at baseline and at 3 months post completion of definitive chemoradiation * patients with an active second primary malignancy requiring chemotherapy or radiation treatment * stage iv scca
study to compare gi tolerability following oral administration of bafiertam™ or tecfidera to healthy volunteers

Conditions: Multiple Sclerosis

Summary: the primary objective of the study is to compare in healthy subjects, the gi tolerability of bioequivalent doses of bafiertam™(monomethyl fumarate) and its pro-drug tecfidera® (dimethyl fumarate). secondary objective of this study is to compare the safety and tolerability of bafiertam™ and tecfidera® when administered orally following bioequivalent dose regimens in healthy subjects.

subjects randomized (1:1) to either bafiertam (monomethyl fumarate) or tecfidera (dimethyl fumarate) will enter a double-blind titration period where they will receive either bafiertam 95 mg twice daily (bid) or tecfidera 120 mg bid for 7 days. following the titration period, they will enter a maintenance period in which they will receive bafiertam 190 mg bid or tecfidera 240 mg bid for 4 weeks.

Eligibility criteria:
inclusion criteria: 1. males or non-pregnant females. 2. healthy, according to the medical history, ecg, vital signs, laboratory results and physical examination as determined by the pi/sub-investigator. 3. body mass index within 18.0 - 34.0 kg/m2, inclusive exclusion criteria: 1. known history or presence of any clinically significant hepatic, renal/genitourinary, gastrointestinal (gi), cardiovascular, cerebrovascular, pulmonary, endocrine, immunological, musculoskeletal, neurological, psychiatric, dermatological or hematological disease or condition unless determined as not clinically significant by the pi/sub-investigator. 2. clinically significant history or presence of any clinically significant gi pathology unresolved gi symptoms, or other conditions known to interfere with the absorption, distribution, metabolism or excretion of the drug experienced within 7 days prior to first study drug administration, as determined by the pi/sub-investigator. 3. presence of any significant physical or organ abnormality as determined by the pi/sub-investigator. 4. subject with abnormal baseline laboratory values deemed to be clinically significant by the investigator. 5. lymphocyte count \<1.5x 10\^9/l. 6. known history or presence of: alcohol abuse or dependence within one year prior to first study drug administration; drug abuse or dependence; hypersensitivity or idiosyncratic reaction to dmf, its excipients, and/or related substances; progressive multifocal leukoencephalopathy (pml); fanconi syndrome; flushing (e.g., warmth, redness, itching, and burning sensation); low white blood cell count (lymphopenia);

Keywords: gastrointestinal
a study of ibi362 9 mg in chinese adults with obesity

Conditions: Obesity

Summary: this is a multicenter, randomized, double-blind, placebo-controlled phase 3 clinical study evaluating the efficacy and safety of ibi362 9 mg in obese subjects. subjects will be randomly assigned to ibi362 9 mg and placebo groups. all study treatment will be administered once-weekly and subcutaneously. the entire trial cycle includes a 2-week screening period, a 60-week double-blind treatment period, and a 12-week drug withdrawal follow-up period after the end of treatment.


Eligibility criteria:
inclusion criteria: * male or female, age 18 years or older at the time of signing informed consent * have a bmi ≥30 kg/m2 * have a history of at least one self-reported unsuccessful dietary effort to lose body weight for subjects with t2d at screening: * have a diagnosis of t2d according to the who classification above or equal to 3 months prior to the day of screening * treated with either diet and excercise alone or on stable treatment with up to 3 oral antidiabetic medications alone or in any combination (except glp-1r agonists or dpp-4 inhibitors) for at least 2 months prior to the day of screening * hba1c 7.0-10.0% (both inclusive) at screening * fasting blood glucose ≤11.1 mmol/l at screening exclusion criteria: • a self-reported change in body weight above 5% within 3 months before screening for subjects without t2d at screening: • hba1c ≥6.5% as measured by local laboratory at screening for subjects with t2d at screening: * have history of proliferative diabetic retinopathy, diabetic macular edema or non-proliferative diabetic retinopathy that required acute treatment * have had 2 or more episodes of ketoacidosis, hyperosmolar state or lactic acidosis within 6 months before screening;
rheos system for the treatment of hfpef heart failure

Conditions: Heart Failure

Summary: the purpose of this clinical investigation (nct00957073) is to continue long-term follow-up of device arm subjects enrolled in the hope4hf trial, utilizing the barostim neo™ legacy device for implantable pulse generator (ipg) replacements.

the initial trial design randomized subjects in a 2:1 ratio to receive a rheos system plus medical management (device arm) or to receive medical management alone (medical management arm). on march 24, 2011, the study closed to enrollment before adequate endpoint data was collected and before enrollment was completed; 19 subjects had been randomized, 10 device and 9 medical management. medical management subjects were withdrawn from the study and subjects who had been implanted with the device were given the opportunity to continue in the study under long-term follow-up; 8 of the 10 device subjects continued in the study. long-term follow-up visits occurred at 15 and 18 months post-randomization; visits occur semi-annually until study closure. the study was not stopped for safety or futility, but for business/strategic reasons due to production of a new generation of the device.

Eligibility criteria:
inclusion criteria: 1. currently implanted with the rheos device and actively participating in the hope4hf trial (g090001). 2. have signed a cvrx, fda and institutional review board (irb) approved informed consent form for participation in this study. exclusion criteria: 1. treating physician decision that the subject should not continue with therapy.

Keywords: heart failure diastolic dysfunction
comparison of two treatment regimens in asthmatic patients

Conditions: Asthma

Summary: the objective of the study was to compare in real life clinical practice two treatment regimens: inhaled glucocorticosteroid + salmeterol and inhaled glucocorticosteroid + montelukast.

48 month pre/post retrospective repeated measures design was used to compare the level of asthma control among patients continuously treated at the outpatient asthma and allergy treatment center, chair of clinical immunology and microbiology, medical university of lodz, poland.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of asthma according to the who/gina 2006 definition by the physicians of the centre, backed up by detailed medical history and physical examination as well as additional spirometry and bronchodilatation test or methacholine challenge where necessary * occurrence of an index event (intervention) defined as the first prescription for salmeterol or montelukast, establishing a 12-month pre-index and three consecutive 12-month post-index periods * at least one inhaled glucocorticosteroid prescription in the pre-index period, and at least one salmeterol/montelukast prescription depending on the arm in every post-index period exclusion criteria: * incomplete diagnostics

Keywords: asthma asthma control inhaled glucocorticosteroid ics leukotriene antagonist ltra montelukast fluticasone salmeterol observational study repeated measures retrospective
safety and tolerability of a novel malathion formulation in children age 6-24 months with head lice

Conditions: Pediculosis

Summary: in a previous phase ii study, the safety and efficacy of a novel formulation of malathion 0.5% was evaluated in patients 2 years of age and older. based on the results of that study, this formulation is currently in a phase iii study for that population. the current study will use blood markers and clinical evaluations to determine the safety and tolerability of this formulation when used in children 6-24 months of age.


Eligibility criteria:
inclusion criteria: * confirmed active head lice infestation exclusion criteria: * allergy to pediculicides or hair care products * scalp conditions other than head lice * previous head lice treatment within the past 4 weeks * current antibiotic treatment

Keywords: head lice
growth hormone in eb

Conditions: Epidermolysis Bullosa Dystrophica

Summary: growth is extremely affected in epidermolysis bullosa patients

studying the role of growth hormone and ilgf-1 in eb may pave the to new therapeutic modality that could improve the growth in those children and avoid the irreversible sequelae that affected subjects experience after adulthood

Eligibility criteria:
inclusion criteria: - children with eb dystrophica exclusion criteria: * adults with the same disease
the metabolic effects of intermittent fasting

Conditions: Normal and Overweight Individuals at High-risk of Diabetes

Summary: caloric restriction has beneficial metabolic effects in humans including weight loss and improvement in blood pressure and lipid levels. intermittent fasting has emerged as a popular alternative to caloric restriction as it does not require daily adherence to a dietary protocol, but whether the benefits of fasting protocols are dependent on weight loss is not known. in this study, the investigators will explore the metabolic effects of fasting and evaluate whether these effects, including negative effects on bone metabolism, are independent of weight loss.


Eligibility criteria:
inclusion criteria: 1. men and women, ages 25-45 years 2. bmi of at least 21 kg/m2 and up to and including bmi of 29 kg/m2 3. normal thyroid function 4. regular menses (women) 5. at least one first-degree relative with type 2 diabetes (t2d) and/or history of gestational diabetes exclusion criteria: 1. any chronic diseases including hypertension and type 2 diabetes mellitus 2. indication for lipid-lowering therapy in non-diabetics, using the more stringent aha guideline cutoff (ldl\>190 or an estimated 10-year ascvd risk of \>7.5%) 3. chronic medications, including oral contraceptive pills 4. pregnant and/or breastfeeding 5. history of an eating disorder 6. 25-oh vitamin d level \< 20 ng/ml 7. active substance abuse, including alcohol 8. subjects with a prior history of intermittent fasting 9. the study physician feels that the subject may not be able to safely complete the protocol or may place themselves at risk by undergoing the protocol
comparing transcranial direct current stimulation montages in stroke

Conditions: Acute Stroke

Summary: 40 acute subjects will be split into 5 groups. each group will receive one of the following tdcs montages : anodal, bilateral, cathodal, extracephalic or placebo. subjects will receive, in addition to conventional rehabilitation, 2ma for 20 mins of their attributed tdcs, 5 times a week. evaluations will take place before the first stimulation period (48h post stroke), after 1, 2, 3 and 4 weeks. evaluations consist of the wolf motor function test, the fugl meyer, and the semmes weinstein monofilament test

40 acute subjects will be randomized and split into 5 groups. each group will receive one of the following tdcs montages : anodal : anode placer over the affected primary motor cortex, cathode over contralateral supra orbital area bilateral : anode placer over the affected primary motor cortex, cathode over unaffected motor cortex cathodal : cathode placer over the unaffected primary motor cortex, anode over contralateral supra orbital area extracephalic : anode placer over the affected primary motor cortex, cathode over right shoulder placebo : anode montage but current is ramped up over 15 secondes, then ramped down. subjects will receive, in addition to conventional rehabilitation (±1.5h/weekday), 2ma for 20 mins of their attributed tdcs, 5 times a week. evaluations will take place before the first stimulation period (48h post stroke), after 1, 2, 3 and 4 weeks. evaluations consist of the wolf motor function test, the fugl meyer, and the semmes weinstein monofilament test all researchers, therapists, data analysis and patients are blinded by a code system implemented in the tdcs machine

Eligibility criteria:
inclusion criteria: * first ever stroke * motor or sensory deficit * understands and follows orders * signed inform consent exclusion criteria: * one yes on the medium and high risk sections of the tsst (bornheim et al.,2019)

Keywords: tdcs acute stroke wmft swmt fugl meyer
a multi-center, open-label study evaluate the efficacy and tolerability of a dual skincare regimen treatment for facial hyperpigmentation and photodamaged skin in patients exposed to extrinsic factors of aging

Conditions: Hyperpigmentation; Photodamaged Skin; Wrinkle; Fine Lines

Summary: this open-label, multi-center clinical trial was conducted to evaluate the dual skincare regimen of vitamin c serum and moisturizing sunscreen spf 45 to improve facial hyperpigmentation and photodamage after 12 weeks of twice daily use in healthy female subjects between 35 - 60 years old. a total of 33 subjects completed study participation.

this open-label, multi-center clinical trial was conducted to evaluate the dual skincare regimen of vitamin c serum and moisturizing sunscreen spf 45 to improve facial hyperpigmentation and photodamage when used twice daily over the course of 12 weeks by healthy women with fitzpatrick skin type i - v, moderate to severe global face hyperpigmentation and moderate global face photodamage. efficacy and tolerability will be assessed through clinical grading at baseline, weeks 4, 8 and 12. efficacy evaluation for hyperpigmentation (mottled), hyperpigmentation (discrete), overall photodamage, clarity/brightness, overall appearance, skin tone evenness (redness), fine lines and wrinkles. investigator and subject tolerability, self-assessment questionnaire and clinical visia photography will be completed at baseline, weeks 4, 8 and 12. subject testimonials will be completed at week 12. a total of 33 subjects completed study participation.

Eligibility criteria:
inclusion criteria: * women between the ages of 35 and 60 years old. * women with fitzpatrick skin type i-v. * subjects must have moderate to severe global face hyperpigmentation. * subjects must have moderate global face photodamage. * subjects must have no known medical conditions that, in the investigator's opinion, may interfere with study participation. * subjects must be willing to provide verbal understanding and written informed consent. exclusion criteria: * subjects which had a health condition and/or pre-existent dormant dermatological disease on the face. * subjects that are unwilling to comply with the protocol. * female subjects who are pregnant, breast feeding, or planning a pregnancy. * subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products. * subjects who have a history of skin cancer. * subjects who have observable suntan, sunburn, scars, nevi, tattoo, excess hair, etc. or other dermatological condition on the face that might influence the test results in the opinion of the investigator. * subjects who have routinely used any anti-aging, anti-wrinkles, antioxidants treatments and skin-firming products less than 30 days prior to the study entry.

Keywords: vitamin c sunscreen pollution solar radiation