Kornimate/medical-research-clean huggingface dataset:
highflo study - highlife trans-septal mitral valve replacement (tsmvr) feasibility study of the open cell clarity valve

Conditions: Mitral Regurgitation

Summary: feasibility, safety and performance of the highlife clarity tsmv and its delivery system

study to assess the feasibility, safety, and performance of the highlife clarity tsmv, and its deliver systems, in nyha class ≥ ii-iv patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment according to the local multidisciplinary heart team decision, and who are at high risk for potential lvot obstruction(lvoto).

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. moderate-severe or severe mitral regurgitation (≥ 3+) 3. patient has new york heart association (nyha) functional class ii, iii or ambulatory iv 4. patient is under guideline directed medical therapy for at least one month, as reviewed and confirmed by the local multidisciplinary heart team 5. patient is high-risk for open-heart surgery based on the assessment of the multidisciplinary heart team using standard scoring systems and consideration of co-morbidities, frailty, and disability 6. patient meets the anatomical criteria for highlife valve 7. patient is willing to participate in the study and provides signed informed consent 8. patients with a high risk for lvoto exclusion criteria: 1. any stroke/tia within 30 days 2. severe symptomatic carotid stenosis (\> 70% by non-invasive imaging) 3. active infections requiring antibiotic therapy 4. active ulcer or gastro-intestinal bleeding in the past 3 months 5. history of bleeding diathesis, coagulopathy or refusal of future blood transfusion 6. patients in whom tee is not feasible 7. patients who are pregnant or lactating, or plan to get pregnant in the next 12 months. 8. patient is unable to comply with the follow-up schedule and assessments 9. participation in another clinical investigation at the time of inclusion 10. patient has known allergies to the device components or contrast medium 11. patient cannot tolerate anticoagulation or antiplatelet therapy 12. patients with a life expectancy of less than 12 months due to non-cardiac conditions 13. patient had permanent pacemaker, or similar device with implantable cardiac leads (i.e. resynchronization therapy) within the last 3 months -
muscle strength, muscle endurance, lower extremity function, aerobic capacity, pressure pain threshold and edema in women with lipedema

Conditions: Lipedema; Healthy

Summary: lipedema is a chronic progressive disease that causes disproportionate, painful extremities with abnormal fat distribution. lipedema is known to cause physical and psychosocial disorders in individuals, but there are very limited studies on this subject. the aim of this study is to evaluate muscle strength, muscle endurance, lower extremity function, aerobic capacity, pressure pain threshold and edema parameters in individuals diagnosed with lipedema and to compare them with individuals without lipedema. volunteer women aged 18 years and older with lipedema (study group) and without lipedema (control group) will be included in the study. after recording the demographic information of the patients, lower extremity muscle strength will be assessed with the k-force handheld dynamometer, lower extremity muscle endurance with the 30 second sit-to-stand test, lower extremity function with the lower extremity functional scale, aerobic capacity with the 6-minute walking test, pressure pain threshold with the baseline algometer, and edema with the moisturemeter. data from the study and control groups will be recorded in the spss program and compared using the appropriate statistical method.


Eligibility criteria:
inclusion criteria: * women over the age of 18 diagnosed with lipedema exclusion criteria: * having cardiovascular, orthopedic and/or neurological problems that may affect physical capacity * having diseases such as heart failure, kidney failure that may cause general or localized edema
clinical trial of multi-periscopic prism glasses for hemianopia

Conditions: Homonymous Hemianopia

Summary: this clinical trial will evaluate the efficacy of two types of high-power prism glasses that provide field of view expansion for patients with homonymous hemianopia (the complete loss of half the field of vision on the same side in both eyes).

patients with hemianopic field loss may be unaware of objects in their blind (non-seeing) hemi-field and often experience difficulties with hazards, such as walking into obstacles on the side of the field loss. prism glasses that provide field of view expansion may be helpful in detecting hazards on the blind side. in this clinical trial, two types of high power prism glasses will be evaluated. a new design of prisms, multi-periscopic prisms (mpp), will be compared to commercially-available permanent fresnel peripheral prism (fpp) glasses. the extent to which the prismatic devices improve detection of hazards on the side of the field loss and are helpful when walking will be evaluated. participants will try each type of prism glasses at home for 4 weeks in counterbalanced order. prism glasses will be fitted by low vision practitioners at vision rehabilitation clinics. participants will attend in-office study visits before and after wearing each type of prism glasses. at the in-office visits they will complete a test that involves detecting pedestrian hazards in a video simulating a walk through a busy shopping mall (virtual reality, vr, walking simulator test). in addition, they may be asked to complete questionnaires to record their experiences of using the prism glasses. after wearing the second pair of prism glasses, participants will be asked to complete a questionnaire comparing the two types of prism glasses and to select their preferred type. a clinical decision will be made as to whether the participant should continue to use either the first or second pair of prism glasses (e.g. if a participant finds one pair of prism glasses helpful for obstacle avoidance when walking). for participants who continue with the prism glasses, telephone follow-up interviews will be conducted after about 6 and 12 months.

Eligibility criteria:
inclusion criteria: * homonymous hemianopia with or without macular sparing for at least 3 months * visual acuity of at least 20/50 in each eye, with correction if needed * refractive error in the -12d to +5d range * able to walk independently, using a cane or walker if needed * able to communicate in english sufficiently to understand the study procedures and how to use the prisms exclusion criteria: * central visual field loss in the seeing hemifield of either eye (e.g. from macular degeneration, glaucoma, diabetic retinopathy or other maculopathies) * hemi-spatial neglect * significant cognitive impairment * dementia * any other physical or mental disabilities, or general health problems that could impair the ability to be independently mobile (i.e., walk ), participate in the vr walking simulator test or use the prism glasses
a study of the efficacy of subcutaneous phosphatidylcholine and deoxycholate injections for localized fat removal

Conditions: Obesity

Summary: the primary objective of this study is to determine the efficacy of phosphatidylcholine and deoxycholate subcutaneous injections for localized fat removal. subcutaneous injections of the study drug will be efficacious in decreasing localized fat deposits due to the known fat necrosis effects on fat tissue after study drug tissue incubation.

this study is a randomized, double-blind study of 21 subjects. participants in this study will be healthy, non-obese (bmi \<30) subjects over 25 with two localized, symmetrical, and contralateral areas of fat deposition on the abdomen or flanks and on the buttocks or thighs that have proven resistant to diet and exercise. each participant will be randomized to one of three groups and will receive 4 series of injections two weeks apart. multiple injections will be placed in the subdermal fat layer from 1-1.5 cm apart depending on the size of the treatment area. group a will serve as a control and will receive only injections of saline as a placebo. group b will receive saline injections on one side of the body and receive study drug injections on the contralateral side. group c will receive only study drug injections. the study sites will include a symmetric, contralateral area of localized fat deposit on both the upper and lower torso. clinical evaluations will be performed at each visit. hematologic and ultrasonographic evaluations will be performed at baseline, at the 3rd treatment (week 4), and at 6 month follow-up. histologic evaluations will be performed on select individuals at baseline and at the 3rd treatment (week 4) visit.

Eligibility criteria:
inclusion criteria: * age 25 and over * bmi of 18.5-29.99 * two localized areas of fat deposition on the upper and lower torso that have failed on self-reported diet and exercise * the subject is in good health * the subject has the willingness and the ability to understand and provide informed consent exclusion criteria: * under 25 years of age * pregnancy or lactation * bmi≥ 30 * subjects with known eating disorders or a history of weight loss/gain of 5 pounds or more within the past 6 months * subjects with hepatrophy, nephopathy, diabetes, hyperthyroidism, neoplasias, aids or other immuno-compromised illness, allergies to eggs or soy, poorly controlled hypertension, or autoimmune disease * subjects currently taking blood thinners or who have had chemotherapy or radiation within the last 6 months * subjects with an open, non-healing sore or infection near site of injection * subjects with active eczema or psoriasis * subjects who are unable to understand the protocol or to give informed consent * subjects with mental illness
efficacy and safety of imipenem+cilastatin/relebactam (mk-7655a) versus colistimethate sodium+imipenem+cilastatin in imipenem-resistant bacterial infection (mk-7655a-013)

Conditions: Bacterial Infections

Summary: the study will evaluate the efficacy and safety of imipenem+cilastatin/relebactam (mk-7655a) versus colistimethate sodium+imipenem+cilastatin in the treatment of imipenem-resistant bacterial infections. infections evaluated in the study will be hospital-acquired bacterial pneumonia (habp), ventilator-associated bacterial pneumonia (vabp), complicated intra-abdominal infection (ciai), and complicated urinary tract infection (cuti).


Eligibility criteria:
inclusion criteria: * hospitalization that requires treatment with iv antibiotic therapy for a new, persistent or progressing bacterial infection involving at least 1 of 3 primary infection types (habp, vabp, ciai, or cuti) * positive culture data from the primary infection-site specimen collected within 1 week of study entry. at least one of the suspected causative pathogens from the specimen meets all of the following: 1) identified as a gram-negative bacterium, 2) culture-confirmed imipenem resistance (and colistin resistance for group 3 only), 3) culture-confirmed susceptibility to imipenem/relebactam and to colistin (for groups 1 and 2 only) * not of reproductive potential, or of reproductive potential and agrees to avoid becoming pregnant or impregnating a partner by complying with one of the following: 1) practice abstinence, or 2) use of acceptable contraception during heterosexual activity exclusion criteria: * concurrent infection (endocarditis, osteomyelitis, meningitis, prosthetic joint infection, disseminated fungal infection, or active pulmonary tuberculosis) that would interfere with evaluation of the response to the study antibiotics * received treatment with any form of systemic colistin for \>24 hours within 72 hours before initiation of study drug (for groups 1 and 2 only) * habp or vabp caused by an obstructive process * cuti which meets any of the following: 1) complete obstruction of any portion of the urinary tract, 2) known ileal loop, 3) intractable vesico-ureteral reflux, 4) presence of an indwelling urinary catheter which cannot be removed at study entry * history of serious allergy, hypersensitivity, or any serious reaction to listed antibiotics (per-protocol) * female who is pregnant or is expecting to conceive (or a male partner of a female who is expecting to conceive), is breastfeeding, or plans to breastfeed before completion of the study * anticipated treatment with any of the following during the study: valproic acid or divalproex sodium, or concomitant systemic (e.g. iv, oral or inhaled) antimicrobial agents with known gram-negative bacterial coverage * currently undergoing hemodialysis or peritoneal dialysis * participated or anticipates participating in any other clinical study involving administration of investigational medication up to 30 days before screening or during the course of the trial
comparison of three management strategies for post cardiac surgery bleeding

Conditions: Heart Disease; Coagulopathy

Summary: open-heart surgery frequently results in abnormal clotting, which in turn results in excessive blood loss and the need for transfusion of multiple blood products to patients and leads to adverse outcomes. prompt identification of any clotting abnormalities after cardiac surgery reduces blood loss and blood product transfusion and may improve outcomes. currently, however, this monitoring is dependent on standard laboratory-based tests of clotting that have a long turnaround time (30-45 min) and do not measure some important aspect of clotting. there are now other monitoring options that are carried out at patients' bedside, providing results more quickly than standard laboratory tests (within 2-5 minutes for some), and measure more aspects of clotting, providing more information on possible causes of any abnormalities. in this study, we will compare the cost-effectiveness of two of these newer monitoring techniques with standard laboratory-based tests by assigning 150 patients who will be undergoing open-heart surgery to one of the three monitoring techniques (50 patients will be assigned by chance to each group). in each group, an explicit algorithm based on the monitoring technique of that group will be used to guide all transfusion decisions. between-group differences in number of units of blood products transfused (primary outcome), amount of blood loss, rate of adverse events, and cost of monitoring will be measured. the objective of the study is to determine which of the three methods is most cost-effective in terms of these outcomes.


Eligibility criteria:
inclusion criteria: * greater than 18 years * no emergent complex cardiac surgery exclusion criteria: * isolated cabg * single valve surgery * pre-existing coagulopathy ptt\>50's, inr\>1.3 * severe thrombocytopenia platelet \<100,000 * recent antiplatelet drugs(plavix within 7 days, integrilin within 24 hours)

Keywords: coagulopathy cardiac surgery point of care monitoring
tertiary prevention by exercise in colorectal cancer therapy

Conditions: Colorectal Cancer

Summary: the purpose of this study is to determine the feasibility of a one year exercise training program in post-surgical patients with colorectal cancer.

apart from a genetic predisposition lifestyle factors (low physical activity, nutrition, and obesity) increase the risk of colorectal cancer. furthermore, in observational studies increased physical activity has shown to improve the prognosis in patients after the diagnosis of colorectal cancer. however, there are currently no prospective randomized controlled trials which prove the causal relationship between exercise and prognosis in colorectal cancer patients. the long-term aim of this study is to evaluate whether physical activity of ≥ 18 met-h (metabolic equivalent task-hours) per week significantly improves disease free survival in colorectal cancer survivors (stage uicc ii/iii). in the first instance, structure-, process- as well as outcome-characteristics need to be investigated within a feasibility study (f-protect). essential aims are to establish collaborations with clinics and training centres, to achieve the required recruitment numbers, and to conduct the training intervention.

Eligibility criteria:
inclusion criteria: * histologically confirmed nonhereditary primary stage ii or iii colon cancer diagnosis or rectal cancer * written informed consent in german * histopathologically confirmed r0-resection * start of guideline conformed adjuvant chemotherapy within 12 weeks after r0-resection in stage iii colon cancer diagnosis (if necessary in stage iii colon cancer diagnosis) exclusion criteria: * hereditary colon cancer diagnosis * r1 and r2 resection * clinically relevant complications during recovery * secondary neoplasm * non-continuance of guideline conformed therapy * uncontrolled infection * manifest cardiac disease (e.g. unstable cad, heart failure (nyha iv), malignant hypertension) * clinical relevant respiratory disease (gold iv) * musculoskeletal disorders severely restricting the patients mobility (e.g. gonarthrosis, coxarthrosis) * cirrhosis of the liver (child b and c) * karnofsky performance status scale ≤ 60% * maximal exercise capacity ≤ 50 watt * clinically relevant lab factors (leukocyte count ≤ 3000/μl, thrombocyte count ≤ 20.000/μl, hemoglobin \< 8 g/dl) * physical activity level ≥ 18 met-h/ week at screening

Keywords: colon cancer prevention exercise physical activity rectal
value of functional anesthetic and provocative discography in the surgical treatment of discogenic pain

Conditions: Discogenic Pain; Low Back Pain

Summary: although discography and spinal imaging techniques, either alone or in combination, are commonly used to diagnose discogenic pain, their exact role in predicting surgical results are poorly defined. our aim in this study is to compare the ability of functional anesthetic discography (fad), and provocative discography (pd) to diagnose discogenic pain and to correctly identify the disc levels for the surgical treatment. proper identification for disc levels should improve the overall results of surgery for this condition. patients with discogenic pain have better outcomes if the disc levels for the fusion surgery are identified by using fad compared to similar disc level identification by pd.


Eligibility criteria:
inclusion criteria: 1. age between 21 to 65 years. 2. symptoms of at least 6 months duration. 3. primarily axial low back pain. 4. at least 6 months of conservative treatment, including, physical therapy, injections, chiropractic etc. 5. patients with overall pain scores of greater than 6/10 (nrs). 6. recent (within the past 6 months) lumbar spine mri showing: disc desiccation and loss of disc height of at least one disc level. exclusion criteria: 1. history of previous spine surgery. 2. mri changes at more than two disc levels on the recent (within the past 6 months) lumbar spine mri. 3. clinical or radiological evidence of significant: 1. disc herniation 2. spinal stenosis 3. spinal deformity 4. spondylolisthesis 5. spinal instability or pars-defect 6. facet syndrome 7. sacroiliac joint dysfunction 8. myofascial pain syndrome 9. fibromyalgia 4. current issues of: 1. litigation 2. disability 3. drug addiction or substance abuse 4. chronic pain medication abuse 5. current diagnosis of and medication use for unstable anxiety, depression, and/or behavioral disorders.

Keywords: low back pain spinal fusion primarily axial low back pain
observational real-world evidence (rwe) study to assess patient-reported wellbeing using tildrakizumab in live setting - positive study

Conditions: Plaque Psoriasis

Summary: this is an ethics-approved, multi-national, multi-site phase iv, 1-cohort prospective observational study. the main purpose of this study is to assess the effect of tildrakizumab on the overall wellbeing in patients with moderate-to-severe psoriasis using the 5-item world health organization wellbeing index (who-5) questionnaire.


Eligibility criteria:
inclusion criteria: * patient with diagnosis of moderate-to-severe chronic plaque psoriasis documented in the medical chart. * patient who need systemic biologic therapy and qualify for treatment with an il-23p19 inhibitor. tildrakizumab must be the anti-il-23p19 selected therapy before including the patient in the study. * patient aged 18 years or older at the time of patient recruitment. * patient who have provided written informed consent (if required by country regulations). exclusion criteria: * patients unable to comply with the requirements of the study (fulfilling of the study questionnaires) or who, in the opinion of the study physician, should not participate in the study. * patients included in a clinical trial.

Keywords: moderate-to-severe plaque psoriasis psoriasis tildrakizumab prospective
the effects of metformin on glycemic control and insulin sensitivity in adolescents with t1dm

Conditions: Diabetes Mellitus, Type 1

Summary: the investigators intends to carry out a randomized, cross-over, prospective study which will last 48 weeks in youth with t1dm followed up by the center. the purpose is to observe the effects of metformin on glycemic control and insulin sensitivity in adolescents with t1dm based on insulin therapy by using 72h cgms and hyperinsulinemic euglycemic clamps.


Eligibility criteria:
inclusion criteria: 1. type 1 diabetes mellitus; 2. age≥12 yr; 3. tanner sexual maturation rating 2-5; 4. hba1c levels: 7.5%-10%; 5. mdi or csii ≥6 months; 6. insulin dose ≥ 0.8u/kg before the enrollment，and the dosage is stable at least \>1 month（dosage change\<10%）. exclusion criteria: 1. serious acute and chronic complications associated with diabetes; 2. repeated and serious hypoglycemia episodes repeatedly; 3. hepatic function damage (alt≥2.5 times higher than the upper limit of the normal accepted range); 4. moderate to advanced renal impairment (calculated according to mdrd equation: egfr\<60ml/min/1.73m2); 5. clinically significant heart attacks: myocardial infarction, arrhythmia，ii-iii°avb，unstable angina，decompensated hf（nyha iii\~iv; 6. female patients who have a sex life and are not willing to use contraceptive methods; 7. pregnancy.
efficacy and safety of linagliptin in combination with insulin in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to placebo during long term treatment (52 weeks and longer) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.


Eligibility criteria:
inclusion criteria: 1. diabetes type 2, detectable c-peptide, hba1c 7-10% 2. pretreatment with basal insulin +/- metformin or/and +/- pioglitazone 3 age \> 18 years, bmi \<= 45 kg/m2 exclusion criteria: 1. uncontrolled hyperglycemia during run-in 2. myocardial infarction, stroke or tia within 3 months prior to informed consent 3. liver impairment; gastric surgery; medical history of cancer in last 5 years 4. other antidiabetic drugs, antiobesity drugs, systemic steroids, other investigational drug before randomisation 5. unsufficient birth control, pregnancy and nursing