Kornimate/medical-research-clean huggingface dataset:
an open,single-centre pilot study of efficacy and safety of topical mob015b in the treatment of distal subungual onychomycosis (dso)

Conditions: Distal Subungual Onychomycosis

Summary: assess efficacy and safety of topical mob015b, applied daily during 48 weeks, in adults with fungal nail infection.


Eligibility criteria:
inclusion criteria: 1. male or female 2. 18 - 70 years 3. dso of at least one of the great toe(s) affecting 25 % to 75 % of the target nail. 4. positive culture for dermatophytes (i.e. trichophyton species; t. rubrum or t. mentagrophytes) 5. signed written informed consent exclusion criteria: 1. proximal subungual onychomycosis. 2. dso of both great toenails where involvement has extended into the proximal portion of the target nail (unaffected proximal nail is less than 2 mm) 3. "spike" of onychomycosis extending to eponychium of the target nail 4. presence of dermatophytoma (defined as demarcated and localised thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail 5. other conditions than dso known to cause abnormal nail appearance 6. topical antifungal treatment of the nails within 1 month before screening 7. systemic use of antifungal treatment within 3 months before screening 8. history or signs of peripheral circulatory insufficiency and/or diabetic neuropathy 9. immunosuppression 10. participation in another clinical trial with an investigational drug or device during the previous 4 weeks before screening 11. known allergy to any of the tested treatment products 12. a pregnancy test indicating pregnancy in a woman of childbearing potential at screening (visit 1) 13. pre-menopausal (last menstruation ≤ 1 year prior to screening) sexually active women who : * are pregnant or nursing * are not surgically sterile * are of child bearing potential and not practising an acceptable method of birth control, or does not plan to continue practising an acceptable method of birth control throughout the trial (acceptable methods include intrauterine devices (iud), oral, implantable or injectable contraceptives, diaphragm or cervical cap with intravaginal spermicide, condom with intravaginal spermicide or vasectomised partner)

Keywords: dso
self-compassion against burnout in dentistry

Conditions: Self Compassion; Mindfulness Meditation; Burn Out (Psychology)

Summary: although studies have highlighted the relationship between stress-related psychopathological symptoms and changes in biochemical parameters, no study in dentistry has concurrently evaluated the association of stress and relaxation with biochemical markers and psychological parameters. moreover, the impact of mindfulness-based self-compassion training programs on these variables has yet to be explored within this context. to enhance the well-being of dentists, an evaluation of a test group participating in an 8-week mindfulness-based compassionate living (mbcl) program was conducted. this assessment included daily cortisol curves, as well as salivary il-6, il-1β, and oxytocin levels. additionally, empathy, burnout, self-compassion, depression, and mindfulness levels were measured before and after the training. in this study, the main hypothesis was that, compared to the control group, the test group would exhibit lower il-1β, il-6, and cortisol levels, along with higher oxytocin levels. furthermore, as the secondary hypotheses was that the test group would demonstrate increased empathy, self-compassion, and mindfulness levels, accompanied by reductions in depression and burnout scores.


Eligibility criteria:
inclusion criteria: * dentists in their final year of specialty training at the faculty of dentistry, * systemicaly healthy exclusion criteria: * individuals who received a diagnosis of mood disorders based on dsm-5 criteria following a standard diagnostic assessment conducted by psychiatrists from the department of psychiatry
comparison of injections of botulinum toxin and topical nitroglycerin ointment for the treatment of chronic anal fissure

Conditions: Fissure in Ano

Summary: patients will be randomized to receive treatment with either a total of 20 u of botulinum toxin(diluted in saline to a concentration of 50 u per milliliter.

lateral internal sphincterotomy, the most common treatment for chronic anal fissure, may cause permanent injury to the anal sphincter, which can lead to fecal incontinence. we compared two nonsurgical treatments that avert the risk of fecal incontinence.treatment with either topical nitroglycerin or botulinum toxin is effective as an alternative to surgery

Eligibility criteria:
inclusion criteria: * clinical diagnosis: evidence of posterior circumscribed ulcer, with a large sentinel tag of skin, induration at the edges, and exposure of the horizontal fibers of the internal anal sphincter * symptoms (post-defecatory or nocturnal pain, bleeding, or both) lasting for more than two months. exclusion criteria: * patients with acute fissure * fissure associated with other conditions (i.e., inflammatory bowel diseases, hiv infection, hemorrhoids, fistula in ano, anal abscesses, or anal or perianal cancer) * those who had undergone previous surgical procedures in the anal canal. * known hypersensitivity to component of the formulations of type a btx * pregnant or breast-feeding women 6-refusal of consent

Keywords: fissure, botulinum toxin, gtn ointment
implementing physical activity guidelines for adults with ms

Conditions: Multiple Sclerosis

Summary: the proposed project will evaluate two methods of implementation of the new physical activity guidelines (pags) for adults with multiple sclerosis (ms) living in two ontario communities. the investigators will also determine if following the pags will improve aspects of fitness, function, quality of life and risk for cardiometabolic disease in this population. the investigators hypothesize that adherence to the pags will be higher in people who have been referred directly to a community-based exercise program, and that this greater adherence to physical activity will be associated with greater improvements in fitness, function and quality of life. this randomized controlled trial will provide important information on how best to implement physical activity recommendations within the community setting; this information will be translated to key stakeholders during the final stages of the project.


Eligibility criteria:
inclusion criteria: * diagnosis of ms with mild-moderate disability (edss 1-7) * aged 18-60 * medical clearance to participate in physical activity exclusion criteria: * current participation in regular physical activity (at least twice-weekly) * other serious medical condition that might impair ability to participate in strength or aerobic exercise

Keywords: physical activity exercise guidelines multiple sclerosis
effects of beta-blockade on platelet aggregation in acute coronary syndrome

Conditions: Acute Coronary Syndrome

Summary: the investigators will test the hypothesis that nonselective beta-blockers would have a more pronounced effect on platelet aggregation than selective beta-blockers in patients with acute coronary syndrome treated with dual anti platelet therapy.

in patients with acute coronary syndrome (acs) beta-blockers are recommended for secondary prevention. it is known that catecholamine levels can potentiate platelet reactivity and beta-blocking agents may also affect platelet aggregation. this effect is mainly mediated by adrenergic receptors on platelets. this suggests that nonselective beta-blockers would have a more pronounced effect on platelet aggregation than selective beta-blockers. however, little is known about the effect of beta-blockers on platelet aggregation in patients with cardiovascular disease and, to date, nothing is known in the setting of acs. the aim of the present study is to evaluate the effect of selective and nonselective beta-blockers on platelet aggregation in acs patients treated with dual anti platelet therapy.

Eligibility criteria:
inclusion criteria: * acute coronary syndrome * current dual anti platelet treatment with acetylsalicylic acid and ticagrelor exclusion criteria: * ongoing prasugrel, ticlopidine or clopidogrel therapy * creatinine clearance \< 30 ml/min/1.73mm2 * moderate to severe anemia hemoglobin \< 10 mg/dl * platelet count \>600000/mm3 or \ 50% or \<25% * concomitant neoplastic or immune-mediated pathologies * severe pulmonary pathologies * contraindication to beta blocker therapy.

Keywords: acs beta blockers platelet aggregation light transmission aggregometry beta-adrenergic blockers
development and needs assessment and efficiency of smart communication system for patients with als.

Conditions: ALS (Amyotrophic Lateral Sclerosis)

Summary: this project aims to develop a smart communication system for patients with amyotrophic lateral sclerosis (als), especially for stage 3 and stage 4 (late stage). patients with als will be able to communicate with outer environment by means of mental control or eye tracking control, which would increase their life quality. this integrated research project includes experts from different domains and proposes a solution for smart communication system.

a multi-function brain- computer interface (bci) communication system will be developed by combining a bci system (subproject 1) and a 3d electro-cap (subproject 3). then, this system and an eye-controlled device (subject 2) are further integrated to a smart communication system. the outputs of the system are presented with the original voice the als patients, which will be achieved by using the voice reconstruction technology (subproject 4) in this project. all the user-interfaces of the bci and eye tracking systems will be re-deigned by employing human factors engineering to increase the usability of the proposed smart communication system for als. finally, the validity of the system in improving the life quality of als will be assessed through clinical study.

Eligibility criteria:
part one: inclusion criteria: * als diagnostic criteria (brooks et al., 2000).must have the following characteristics: 1. degeneration of motor neurons (lmn) by clinical, electrophysiological or neuropathological evidence. 2. degeneration of upper motor neurons (umn) is demonstrated by clinical examination. 3. according to the medical history or examination, the symptoms or signs gradually disappear in a certain part. also, there are no features: 1. electrophysiological or pathological evidence of other diseases that may explain signs of lmn and/or umn degradation 2. neuroimaging evidence of other diseases that may explain the observed clinical electrophysiological signs. * use mandarin as the main language. * age limits minimum is 20 exclusion criteria: * concomitant other central nervous disorders that interfere with their cognitive function, such as dementia, severe depression, and psychosis. * the questionnaire cannot be completed without the assistance of others. part two: inclusion criteria: * als diagnostic criteria (brooks et al., 2000). * use mandarin as the main language. * age limits minimum is 20 * in everyday oral communication, people who are consciously difficult. * ability to perform equipment wear and system operators. exclusion criteria: * concomitant other central nervous disorders that interfere with their cognitive function, such as dementia, severe depression, and psychosis. * after correction, the visual acuity cannot see the communication board. * the scalp is sensitive or there is deep brain stimulation, etc. it is not applicable to brain wave measurement. * -the questionnaire cannot be completed without the assistance of others.
heat-sensitive moxibustion self-administration in patients in the community with primary hypertension: protocol for a multi-center, pragmatic, non-randomized trial

Conditions: Primary Hypertension

Summary: heat-sensitive moxibustion is considered to be effective for primary hypertension in hospital setting. this study aims to investigate whether heat-sensitive moxibustion self-administration is effective for lowering blood pressure and improving quality of life for patients with primary hypertension in community setting using a multicenter, prospective, non-randomized study design

primary hypertension is a global health issue with high incidence; it affected approximately 1.13 billion people worldwide and directly or indirectly causing an 10.4 million of death yearly. the routine drugs for primary hypertension are limited by adverse effects and expensive costs. therefore, complementary and alternative medicine with good efficacy and safety and low expenditure is still needed for primary hypertension, especially in poverty-stricken areas. heat-sensitive moxibustion is an innovative therapy developed on the basis of traditional moxibustion. compared with traditional moxibustion, heat-sensitive moxibustion advocates finding heat-sensitive acupoints where patients have special reactions to moxibustion heat, including diathermy, heat transfer, soreness, etc. the application of moxibustion on heat-sensitive acupoints (i.e., heat-sensitive moxibustion) has been shown to be more effective to traditional moxibustion for many diseases, including primary hypertension. moreover, compared with acupuncture, heat-sensitive moxibustion has a main advantage that moxibustion does not require professional qualifications and patients can self-administer moxibustion after professional training. however, the current evidence is generated only from hospital settings. therefore, this study is specifically designed to investigate whether heat-sensitive moxibustion self-administration is an effective intervention for lowering blood pressure and improving quality of life for patients with primary hypertension in community setting.

Eligibility criteria:
inclusion criteria: 1. meet the diagnostic criteria of primary hypertension 2. 18 to 70 years old 3. sign the informed consent exclusion criteria: 1. secondary hypertension caused by kidney disease, macrovascular disease, pregnancy, endocrine disease, brain disease, drug-induced factors, etc. 2. allergic to moxibustion equipment, moxa smoke or moxa 3. pregnancy or lactation 4. a history of serious cardiovascular and cerebrovascular events such as cerebrovascular accidents and myocardial infarction 5. complicated by liver and kidney dysfunction indicated by total bilirubin, alanine aminotransferase, aspartate aminotransferase, or blood creatinine are more than 2 times upper limit of normal value 6. complicated by malignant tumors 7. complicated by major mental disorders
extension study of prx-102 for up to 60 months

Conditions: Fabry Disease

Summary: to evaluate the ongoing safety, tolerability, and efficacy parameters of prx-102 in adult fabry patients who have successfully completed treatment with prx-102 in studies pb-102-f01 and pb-102-f02.

an open-label study to evaluate the ongoing safety, tolerability and efficacy parameters of prx-102 in adult fabry patients (≥18 years of age). patients enrolled received 1.0 mg/kg of prx-102 as an intravenous infusion every 2 weeks (+/- 3 days) for up to 60 months and no less than 36 months.

Eligibility criteria:
inclusion criteria: * completion of study pb-102-f02 * the patient signs informed consent * female patients and male patients whose co-partners were of child-bearing potential agree to use a medically acceptable method of contraception, not including the rhythm method. acceptable methods of contraception include hormonal products, intrauterine device, or male or female condoms. contraception should be used throughout the duration of the study and for 3 months after termination of treatment. exclusion criteria: * presence of any medical, emotional, behavioral or psychological condition that, in the judgment of the investigator and/or medical director, would interfere with the patient's compliance with the requirements of the study

Keywords: prx-102 pegunigalsidase alfa fabry disease
a phase ii study of moxidex ophthalmic solution for treatment of marginal corneal infiltrates

Conditions: Corneal Infiltrates

Summary: the purpose of the study is to determine whether moxidex ophthalmic solution is safe and effective in treating marginal corneal infiltrates.


Eligibility criteria:
inclusion criteria: * diagnosis of marginal corneal infiltrates of size equal to or less than 1.5mm in diameter, with mild, moderate or severe bulbar conjunctival injection in at least one eye. * other protocol-defined inclusion criteria may apply. exclusion criteria: * age related. * other protocol-defined exclusion criteria may apply.

Keywords: cornea inflammation blepharitis lid infection
clinical outcomes and cost of gram negative bacteremia

Conditions: Gram-negative Bacteremia; Bacteremia

Summary: this study examines the clinical outcomes and healthcare costs associated with gram negative bacteremia at duke university medical center from 2002-2015.

specific aim 1: define the clinical impact of gram negative bacterial (gnb) bloodstream infections (bsi). in this objective, the investigators will describe the prevalence, source of bacteremia, and location of acquisition (i.e., community-acquired, healthcare-associated, hospital-acquired) of gnb bsi. the investigators will also examine the outcomes associated with gnb bsi including length of hospital stay, length of icu stay, in-house mortality, and hospital costs. specific aim 2: describe antibiotic resistance patterns in gnb bsi, and explore associations between antibiotic resistance and clinical and economic outcomes. in this objective, the investigators will describe the prevalence and antibiotic susceptibility profiles of multidrug resistant phenotypes including mdr bacteria, which are defined by resistance to three or more drug classes, esbl-producers, and cre. the investigators will examine the differences in mortality, resource use (length of hospital stay, length of icu stay), and direct medical costs between cases with and without antibiotic resistance.

Eligibility criteria:
inclusion criteria: since january 2002, one investigator (vgf) has received daily reports from the clinical microbiology laboratory on all hospitalized patients at duke university medical center with one or more blood culture(s) positive for gram negative rods. patients were then evaluated within 36 hours of the detection of bacteremia for clinical evidence of infection exclusion criteria: patients were excluded from the study for the following reasons: age less than 18 years, polymicrobial infection (blood culture positive for more than one pathogen), neutropenia (white blood cell count less than 1.0 x 109/l), or death prior to the return of positive blood cultures. in order to preserve the independence of observations, only the initial episode of gram negative bacteremia was included in the analysis (e.g., patients were only included once). the study was approved by the duke university medical center institutional review board.
the effect of baby massage training given to pregnant women on maternal attachment and postpartum depression

Conditions: Baby Massage; Postpartum Depression

Summary: the research to be conducted within the scope of the project will be randomized controlled, and the population of the research will be primiparous pregnant women reached through social media. primiparous pregnant women in the 32nd - 40th weeks of pregnancy will be included in the study, and the sample size is determined by using the g\*power (3.1.9.2) program, considering a margin of error of 0.05 and data loss, with a power of 95% and a medium effect size; 27 people should be included in the experimental (baby massage) group and 27 people in the control group. in determining the groups, participants will be assigned to experimental and control groups using the "randomizer.org" program. pregnant women included in the research will be informed about the study and will be presented with an "informed consent form" and "voluntary consent form". baby massage training will be given to the experimental group, and a reminder training will be given 2 weeks later. "personal information form", "prenatal attachment inventory" and "beck depression inventory" will be applied to both groups at the beginning of the study, and postpartum 30-42 weeks. and 60-72. "maternal attachment scale" and "edinburg postpartum depression scale" will be administered between days.


Eligibility criteria:
inclusion criteria: being between the ages of 18-35, being primiparous and having a singleton pregnancy, * no high-risk pregnancy, * being in the 32nd to 40th week of pregnancy, * being literate and knowing and understanding turkish, * pregnant women who have internet access and knowledge of internet usage. exclusion criteria: * ● presence of chronic disease, * pregnancy with congenital malformation, * unwanted pregnancy, * having attended a pregnancy school, * women who become pregnant as a result of assisted reproductive technology, * those with hearing and vision problems, * having a known serious psychiatric disease diagnosis.

Keywords: postpartum depression baby massage attachment
bioequivalence study comparing calcium acetate oral solution versus calcium acetate gelcaps in healthy volunteers

Conditions: Hyperphosphatemia

Summary: to compare the bioequivalence of calcium acetate oral solution vs. calcium acetate gelcaps in healthy volunteers with calcium citrate as a positive control.


Eligibility criteria:
inclusion criteria: * signed and dated informed consent form * ages: 18-75 years * serum calcium level 8.6-10.2 mg/dl * 25 vitamin d level 20-100 ng/ml * 1, 25 dihydroxy vitamin d level 6-62 pg/ml * fasting glucose level of 65-99 mg/dl (min 8 hr fast) * ipth level of 10-65 pg/ml * serum phosphorous level of 2.5-4.5 mg/dl * albumin level of 3.6-5.1 g/dl * sodium level of 135-146 meq/l * potassium level of 3.5-5.3 meq/l * negative pregnancy test (at screening and prior to dosing) for women of childbearing potential and subjects must agree to use adequate contraception (hormonal or double barrier method) during the study * no clinically significant abnormalities on electrocardiogram (ecg) reading as determined by the investigator * no clinically significant abnormalities on liver function tests * no clinically significant abnormalities on cbc and coagulation studies * no clinically significant abnormalities on kidney function (egfr using serum creatinine) * bmi between 18.5-30 * subjects must agree not to consume alcohol while in the treatment phase of the study exclusion criteria: * women who are pregnant or breast feeding * malignancy except squamous cell carcinoma of the skin * documented current acute or chronic disease * positive for human immunodeficiency virus (hiv), hepatitis b or hepatitis c * myocardial infarction within 6 months of study day 0 * parathyroidectomy within 6 months of study day 0 * gastrointestinal disorder associated with impaired absorption of oral medications * inability to swallow tablets or tolerate calcium acetate oral solution * hormonal therapy (except for contraceptives), immunotherapy or corticoid therapy * concurrent antibiotic treatment * any concurrent investigational treatment within 30 days of screening * unable or unwilling to comply fully with the protocol * diuretic therapy such as thiazides, furosemide (inn) or frusemide (former ban) within one month before screening * subjects taking over-the-counter (otc) or prescribed phosphorous or calcium containing supplements * subjects testing positive for drugs of abuse

Keywords: bioequivalence