Kornimate/medical-research-clean huggingface dataset:
effect of combination of non-slip element balloon (nse) and drug-coated balloon (dcb) for in-stent restenosis lesions

Conditions: Coronary Restenosis

Summary: use of sequent® please drug coated balloon (dcb) is effective to treat patients with in-stent restenosis (isr). however, whether the type of pre-dilatation balloon prior to dcb dilatation impacts on clinical and angiographic outcomes or not is unknown. lacrosse® non-slip element balloon (nse) is a balloon catheter with 3 longitudinal plastic elements which are attached to proximal and distal balloon edges. nse is developed to incise neointimal tissue and avoid balloon slippage without vitiating balloon derivability and crossability. we investigated angiographic and clinical outcomes following normal non-compliant balloon or nse dilatation prior to dcb dilatation in isr lesions.this study is a single blinded, multicenter, randomized trial. total 200 patients with isr are randomly assigned to treat with non-compliant balloon or nse before dcb dilatation. optical coherence tomographic (oct) analysis are performed before pre-dilatation and after dcb dilatation follow-up angiography analysis are planned at 8 months in all patients. clinical follow-up is planned at 8 and 24 months.primary endpoint is angiographic in-segment late loss at 8 months.


Eligibility criteria:
inclusion criteria: * patients with in-stent restenosis lesions who are planned to be treated with drug coating balloon exclusion criteria: * st elevation myocardial infarction * stent thrombosis * severe renal dysfunction (egfr \<30 ml/min) except dialysis * pregnancy * planned surgery within 3 months * shock vital

Keywords: in-stent restenosis percutaneous coronary intervention balloon
the efficacy of three months-prednisolone therapy for chronic eosinophilic pneumonia

Conditions: Eosinophilic Pneumonia; Chronic Disease

Summary: a comparison of 3 months-prednisolone administration with 6 months-prednisolone therapy in the treatment of chronic eosinophilic pneumonia. three months-prednisolone administration may be as effective as 6 months-therapy.


Eligibility criteria:
inclusion criteria: * biopsy-proven chronic eosinophilic pneumonia exclusion criteria: * patients who received oral glucocorticosteroid (more than 10 mg) * immunosuppressive drug
comparison of outcomes between open wedge high tibial osteotomy and double level osteotomy in antromedial knee arthritis with extra articular deformity

Conditions: Knee Osteoarthritis

Summary: to compare the radiographic and clinical outcomes of varus osteoarthritic knees treated with an open-wedge high tibial osteotomy (owhto) alone or with a double-level osteotomy (dlo). it was hypothesized that treatment with dlo would prevent the joint line obliquity (jlo) , optimize post-operative limb alignment and provide better clinical and radiological outcomes after surgery than medial opening-wedge high tibial osteotomy (owhto) alone for patients with medial compartment osteoarthritis.

osteoarthritis is a degenerative joint disease characterized by erosion of the articular cartilage, hypertrophy of the bone at the margins and subchondral sclerosis(1). osteoarthritis of the knee is a common problem causing significant knee pain and disability. medial compartment osteoarthritis is predisposed to be varus deformity of the knee(2). high tibial osteotomy (hto) is a well-established method for treatment of medial uni compartmental-knee osteoarthritis and correction of varus deformity(3).double level osteotomy recently used as another method for treatment this problem to improve outcomes and decrease complication(4).

Eligibility criteria:
inclusion criteria: * patients that are indicated for surgery for medial compartment osteoarthritis only (medial joint line tenderness, varus tibiofemoral malalignment) with classification of kellgren lawrence grade (1/2/3) * age between 40 _ 60 years * no associated bony fractures or deformities * no associated ligamentous functional instability * varus more than or equal 15 degrees exclusion criteria: * age younger than 40 or older than 60 years * secondary arthritis (inflammatory arthritis, post-traumatic osteoarthritis, active knee infection) * lateral compartment oa or patellofemoral oa
influence of weight-bearing mechanical axis on foot and ankle in patients following total knee arthroplasty

Conditions: Total Knee Artroplasty

Summary: this comprehensive scientific research will investigate the influence of the weight-bearing mechanical axis on foot and ankle following total knee arthroplasty. few studies have monitored the outcome of surgical treatment using similair methods, and consequently the aim of this study was to evaluate the change in upper and lower leg load by analyzing radiographic recordings and pedobarographic measurements after the implantation of total knee endoprosthesis. in addition to objective instruments, knee and foot questionnaires will be used to describe the functional outcome of the operation of the subjects. the practical contribution of this research lies in the prediction of possible changes in the joints of the feet depending on the type of knee deformity (varus / valgus). our research will consist of: analysis of postero-anterior radiographs of the lower extremity (weight-bearing) preoperatively and at the follow-up three months postoperatively, pedobarographic analyzes preoperatively and at the control examination three months postoperatively, analysis of personal data (age, gender, weight and height, operated side) and completion of functional standardized questionnaires (aofas, koos) preoperatively, and at the screening three months postoperatively.


Eligibility criteria:
inclusion criteria: * knee varus or valgus deformity 5 degrees or more exclusion criteria: * previous surgery which included corrective osteotomies, osteosynthesis or arthrodesis of the knee, ankle and foot.

Keywords: weight-bearing mechanical axis total knee arthroplasty
capsaicin patch 8 % for the treatment of persistent pain after inguinal herniotomy

Conditions: Persistent Pain After Inguinal Herniotomy

Summary: in the present study the investigators intend to investigate analgesic and sensory effects of a capsaicin patch 8 %(qutenza) in patients with severe post-herniotomy pain and sensory abnormalities in the skin.


Eligibility criteria:
inclusion criteria: * patients asa (american society´s of anesthesiology´s classification) scores i-iii * severe post-herniotomy pain for more than six months and with severe pain (numerical rating scale \[nrs\] 0-10 points) during rest or during movement \> 5. exclusion criteria: * history of an allergic reaction or intolerance to capsaicin or vehicle ingredients in the patches * severe cardiac impairment, e.g., nyha (new york heart association) class ≥ iii * inflamed or injured skin at the application site * signs of cognitive impairment * known drug or ethanol abuse
local infiltration analgesia during total knee arthroplasty

Conditions: Pain

Summary: the primary objective is to evaluate whether local infiltration analgesia (lia) will reduce oxycodone consumption during the first 48 postoperative hours in patients undergoing total knee arthroplasty (tka).

the goal of lia is to gain an effective and safe pain control during the first postoperative days. the study is a single-center, randomized controlled trial, which will be performed in coxa hospital for joint replacement in tampere, finland. the injectant mixture consists of 150 mg levobupivacaine mixed with 30 mg ketorolac and 0.5 mg adrenaline with occasional variations if the patient is unusually small, very elderly, infirm or has a history of significant intolerance to analgesics or anesthetic agents. the rka mixture is diluted with normal saline. total volume of the solution is 100 ml depending on the size of the wound. the normal saline injection are used in the control group in the same manner than in the rka group.

Eligibility criteria:
inclusion criteria: * patients requiring primary tka for primary oa * patients aged 75 years or less * patients suitable for all applicable devices exclusion criteria: * rheumatoid arthritis or other inflammatory diseases * patients requiring bone grafting during surgery * unwilling to provide informed consent * bmi \> 35 * asa \> 3 * renal dysfunction * allergic to asa * previous high tibial osteotomy or previous osteosynthesis * \> 15 degrees varus / valgus malalignment * physical, emotional or neurological conditions which would comprise the patient´s compliance with postoperative rehabilitation and follow-up (e.g. drug or alcohol abuse, serious mental illness, general neurological conditions such as parkinson, ms, etc.) * known sensitivity to materials in the devices

Keywords: pain relief
the immunodynamic effect of radiotherapy in prostate cancer patients.

Conditions: Prostatic Neoplasm

Summary: radiotherapy has an important role in the treatment of prostate cancer both as curative treatment and postoperative or salvage ones. several studies demonstrated a significant reduction of lymphocytes during rt but there are only a few studies monitoring these cells in the treatment of prostate cancer. this study will enroll 50 patients with hystologically proven prostate cancer who will undergo to radiotherapy according to institutional protocols. this study aims to evaluate the effect of rt on immuno-regulatory b, nk, t, b and t lymphocyte subpopulations (breg and treg) and plasma cells, quantitative / qualitative changes,their correlations with the clinical course of the disease and acute and late toxicity. in parallel, using multicolor panels (12 colors) we will evaluate the expression of inhibitory checkpoints and tgfβ signaling. the final objective is to identify new therapeutic targets to be combined with rt.


Eligibility criteria:
inclusion criteria: * histologically documented prostatic cancer * indication to perform radiotherapy treatment * age over 18 years * informed consent exclusion criteria: * hematological diseases * autoimmune diseases * previous neoplasias * prior chemotherapy or other therapies that may have violated the hematopoietic organs * patient's refusal to undergo periodic blood samples
efficacy study of iferanserin to treat hemorrhoids

Conditions: Hemorrhoids

Summary: to evaluate the safety and efficacy of topical 0.5% s-mpec cream vs. placebo cream (applied twice daily for 14 days) in the treatment of grade i - iii hemorrhoids.


Eligibility criteria:
inclusion criteria: * age 18 years or older * diagnosis of grade i - iii hemorrhoids with bleeding episodes of at least every other day during the last two weeks before enrollment in the study. * patients signing the informed consent form. exclusion criteria: * patients with protruding or irreducible hemorrhoids (grade iv). * patients with anal fistulas, periproctitis or hemorrhagic diathesis * patients with current history of type i or type ii diabetes mellitus. * patients with severe hepatic, renal or cardiovascular disorders. * patients with any type of infectious disease. * patients who have been involved with another experimental drug trial within the past 30 days. * patients presently diagnosed with cancer. * patients who have known alcohol and drug abuse. * patients who require the use of suppositories. * patients with blood or urine laboratory values outside the normal limits or those with values considered abnormal in the opinion of the investigator.
azelaic acid as a novel treatment for central centrifugal cicatricial alopecia (ccca)

Conditions: Central Centrifugal Cicatricial Alopecia

Summary: the purpose of this pilot study is to determine if azelaic acid shows potential to be an effective treatment for central centrifugal cicatricial alopecia (ccca). in this study, the aim is to compare azelaic acid vs placebo since azelaic acid may increase anti-inflammatory effects that affect the hair growth cycle.

the management of central centrifugal cicatricial alopecia (ccca) is challenging due to limited current treatments and a lack of randomized controlled trials. management focuses on behavioral and styling modifications, in addition to symptomatic relief. any potentially damaging hair care practices such as chemical relaxers, heat application to the scalp, and the use of hardening gels and sprays are discouraged. many commonly used therapies are anti-inflammatory in nature, including intralesional steroids, topical steroids, oral antibiotics and increased frequency of hair washing with antidandruff shampoos. these treatments not only lead to improvement in pruritus and tenderness, but in some cases result in increased hair density. currently, comparison studies of different treatments for ccca subjects is limited. the aim is to determine if there is an advantage in using one particular anti-inflammatory therapy over another for relieving symptoms and promoting hair follicle regrowth.

Eligibility criteria:
inclusion criteria: * women eighteen years of age or older * biopsy-proven and /or clinical diagnosis of ccca stage ii-iv * on stable treatment without changes for at least three months * recruited from outpatient dermatology clinics at the wake forest baptist health department of dermatology exclusion criteria: * males

Keywords: hair growth hair follicle regrowth hair loss regression
cangrelor neonatal pk/pd and safety study

Conditions: Partial Obstruction of Systemic to Pulmonary Artery Shunt; Complete Obstruction of Systemic to Pulmonary Artery Shunt

Summary: the purpose of this study is to assess the pk/pd and safety profile of cangrelor in neonatal participants at risk of thrombosis.


Eligibility criteria:
inclusion criteria: 1. males and females with congenital heart disease, and ranging in age from birth through 28 days of life 2. postoperative neonatal cardiac participants with placement of systemic-to-pulmonary artery palliative shunts, right ventricle to pulmonary artery palliative shunts, or ductus arteriosus stents who are at risk of thrombotic events after repair for structural congenital heart disease. 3. written informed consent from a parent/legal guardian 4. life expectancy of at least 15 days at study entry participants will be excluded from the study if any of the following exclusion criteria apply: 1. history of intracerebral bleed (confirmed by a ultrasound (us) of the head prior to surgery), or cerebral arteriovenous malformation, or any prior bleed with neurological deficit 2. gastrointestinal or urinary bleeding 3. cerebrovascular accident or any cerebrovascular accident with a residual neurological deficit 4. known congenital or acquired bleeding or clotting disorder 5. weight less than 2.5 kilograms (kg) 6. adjusted gestational age less than 37 weeks 7. platelet count less than 100,000 cells/microliter (µl) 8. chest and/or mediastinal tube blood output of greater than 3 milliliters (ml)/kg/hour (hr) at the time of cangrelor administration 9. participants with evidence of severe hepatic or renal failure \[aspartate aminotransferase (ast) or alanine aminotransferase (alt) greater than three times normal for age or total bilirubin greater than 20 milligrams (mg)/deciliter (dl); creatinine greater than 2 times the normal upper limit\] 10. known allergy to cangrelor or known sensitivity to any component of cangrelor 11. any condition that in the investigator's opinion would constitute a contraindication to participation in the study or cause inability to comply with the study requirements 12. participation in another investigational therapeutic drug or investigational therapeutic device trial within 30 days of starting study 13. participants who have been receiving warfarin (coumadin®) therapy
the ronnie gardiner method effectiveness study

Conditions: Psychiatric Disorder

Summary: the investigators want to investigate the feasibility and transdiagnostic effectiveness of the ronnie gardiner method (rgm) in a sample of flemish psychogeriatric residential patients (≥60 years old) admitted to the psychiatric clinic of alexianen zorggroep tienen. no control group will be used in this study, as every patient in the clinic is entitled to receive treatment. the investigators expect to observe significant improvements in the core executive functions (core efs) by rgm participation. the investigators expect that the more sessions participants follow, the larger the effects will be. given the strong connection between executive functions and emotion regulation, the investigators anticipate that strengthening the core efs will in turn contribute to better emotion regulation. more specifically, the mediating role of core efs in the relationship between the number of rgm sessions attended and improvement in emotion regulation is investigated. given rgms previously reported effects on quality of life, the investigators also expect to observe improved well-being. additionally, the investigators want to examine to what extent positive experiences with rgm and temperament based personality types influence the effectiveness of the rgm training. the rgm training will be organised twice a week for a period of 12 weeks. the training sessions will be provided by trained rgm-practitioners in the psychiatric clinic of the alexianen zorggroep tienen. each session will last at least 45 minutes. core efs, emotion regulation and well-being are evaluated pre-, mid- and post-rgm (at 6-week intervals) using a number of relevant instruments (i.e. questionnaires and neuropsychological tests). at baseline, the information and consent forms will be delivered to the patient and exclusion criteria will be checked using the mmse and the patient file. experiences with rgm training will be evaluated midway and post-intervention by means of a brief questionnaire developed by the research team. personality type questionnaires (the behavioural inhibition system (bis)/behavioural activation system (bas) scales and the effortful control (ec) scale), which allow us to study whether a particular temperament based personality type is predictive of rgms success, are routinely administered in the psychiatric clinic upon admission.


Eligibility criteria:
inclusion criteria: * psychogeriatric inpatients aged 60+ exclusion criteria: * checking for moderate to severe cognitive impairments (exclusion criterion) using the mini-mental state examination (mmse; folstein, folstein, \& mchugh, 1975; dutch version: kok and verhey, 2002), following exclusion criterion applies: a score of less than 21 on the mmse (excluding dementia or other moderate to severe cognitive impairment) * not fluent in dutch * having undergone surgery and/or chemotherapy in the last three months.
study to assess monoclonal b-cell lymphocytosis in individuals with chronic hepatitis c

Conditions: Chronic Viral Hepatitis C; Monoclonal B-Cell Lymphocytosis

Summary: this study evaluates the incidence of monoclonal b-cell lymphocytosis mbl) in patients with chronic hepatitis c and to determine if monoclonal b-cell lymphocytosis is affected by treatment for hepatitis c.

primary objectives: i. to determine the prevalence of mbl in patients with chronic hepatitis c who are to begin therapy with directly acting antiviral (daa), and compare with clinic controls who are seen in the general medicine clinic at mayo clinic. ii. to determine the correlation between the specific subtype of mbl (cd5- mbl, atypical cll-phenotype mbl and cll-phenotype mbl) relative to the hepatitis c virus (hcv) genotype. iii. to assess the proportion of individuals with mbl who have an improvement in the circulating monoclonal b-cell population following therapy with daa. outline: this is an observational study. patients undergo blood sample collection and have medical records reviewed throughout study.

Eligibility criteria:
inclusion criteria: * individuals with chronic hepatitis c who are to begin therapy with daa * willing to submit a peripheral blood sample at baseline, end of therapy, 12 weeks after the end of therapy, and 52 weeks from baseline exclusion criteria: * individuals with chronic hepatitis c who have cirrhosis * individuals with chronic hepatitis c who have a past history of a lymphoproliferative disorder and for which they received chemotherapy
patient's preference between conventional oral olanzapine tablet vs olanzapine orodispersible tablet

Conditions: Schizophrenia

Summary: the purpose of the study is to estimate drug preference of stable schizophrenic patients who will be treated with olanzapine orodispersible tablets for 6 weeks then with olanzapine tablets for 6 weeks and vice-versa.


Eligibility criteria:
inclusion criteria: * you are an outpatient diagnosed with stable schizophrenia. * you are a male or female in the age of 18 to 65 years old. * you are retrospectively judged by investigators, based on clinical interview and impression, to have been stable for at least 4 weeks. * you must be able to take olanzapine orodispersible in a single daily dose. * you are treated with conventional oral olanzapine tablet (as monotherapy) for at least 1 month. exclusion criteria: * you have used olanzapine in the past and are no longer using it because of a bad reaction. * you have known human immunodeficiency virus positive (hiv+) status. * you have known uncorrected, narrow angle glaucoma. * you have known leukopenia, (abnormally low white blood cell count). * you have a serious or uncontrolled illness (for example: liver disease, history of heart disease, or inadequately controlled diabetes.) * you have parkinson's disease. * you are a female patient who is either pregnant or nursing * you are taking medications that are not allowed in the study.
ipl and meibomian gland expression to treat ocular rosacea ocular gvhd

Conditions: GVHD; Ocular Rosacea; Dry Eye Syndrome

Summary: the purpose of this study was to see if intense pulsed light (ipl) can be used safely and effectively to help treat dry eyes from ocular rosacea after chronic graft-versus-host disease (gvhd). current treatment options for this disease are limited.

ocular rosacea and meibomian gland disease are major contributors to keratoconjunctivitis sicca after chronic gvhd. rosacea exacerbates the aqueous deficiency caused by damage to lacrimal and accessory lacrimal glands similar to cholestasis damage in the biliary system. subjects who had inactive chronic gvhd after allogeneic bone marrow transplantation and severe dry eye symptoms related to ocular rosacea were recruited and treated with 4 monthly sessions of ipl and meibomian gland expression. their charts were reviewed prior to treatment to confirm quiescence of active systemic disease. symptom scores were quantified with ocular surface disease index (osdi) and standard patient evaluation of eye dryness questionnaire (speed2). baseline complete eye exam was performed, and subjects received an eyes assessment score based on the chronic graft-versus-host disease (gvhd) assessment and scoring form. symptoms, exam, and diagnostic data were obtained at baseline (month 0, month 1, month 2, month 3, month 4, month 5, month 6, month 9 and month 12). ipl treatment and meibomian gland expression was performed at baseline (month 0), month 1, month 2, and month 3.

Eligibility criteria:
inclusion criteria: * ocular rosacea with inactive gvhd exclusion criteria: * active gvhd * facial laser treatment * accutane exposure * inability to wear sun protection factor (spf) 30 sunscreen and avoid sun exposure * inability to meet study requirements