Kornimate/medical-research-clean huggingface dataset:
kinesiotape treatment for postoperative edema after joint replacement surgery of the knee- the kneetape study

Conditions: Postoperative Edema

Summary: postoperative edema is a common condition affecting wound healing and function. traditionally, manual lymphatic drainage and compressive bandages have been employed to reduce swelling. kinesiotaping might be an alternative approach. to analyse the efficacy, cost-effectiveness, satisfaction, quality of life, functional outcome and and morbidity of the use of kinesiotape for the treatment of postoperative edema after knee replacement surgery, compared to standard manual lymphatic drainage with compression (i.e. compressive stockings or bandages) or sham taping.


Eligibility criteria:
inclusion criteria: * joint replacement surgery of the knee including conversion from partial to total joint replacement or revision surgery * informed consent as documented by signature exclusion criteria: * isolated retropatellar replacement or revision surgery for infection * contraindications to manual lymphatic drainage and compression treatment (i.e. compressive stockings or bandages) e.g. heart failure * contraindication to kinesiotape treatment, e.g. hypersensitivity to medical glue * dermatoses at or around the surgical site * suspected or confirmed local infection * participation in another trial with investigational drug within the 30 days preceding and during the present trial * enrolment of the investigator, his/her family members, employees and other dependent persons * inability for consent or assent by the patient, or lack of proxy consent in assenting patients with signs of incapacity.

Keywords: total knee replacement kinesiotape treatment manual lymphatic drainage compressive bandages kinesiotaping
thermal imaging for evaluation of the cervix

Conditions: Cervical Neoplasia

Summary: when screening results for cervical premalignant lesions are positive, colposcopy is recommended. this is highly sensitive screening method. however, specificity of the test is of low. thus, a technology that improves the accuracy of the colposcopic exam is needed. this is a feasibility study with the goal of examining the performance of a thermal imaging camera in the detection of cervical malignant and premalignant lesions.


Eligibility criteria:
inclusion criteria: * age \> 18 * women with premalignant cervical lesions who are candidates for conization (group a) * women with a normal cervix who are candidates for hysterectomy (group b) * women with newly diagnosed cervical cancer exclusion criteria: * for group a and b - women that had conization in the past
prostate nutrition and exercise study (pronest)

Conditions: Metabolic Syndrome; Prostate Cancer; Diet Modification

Summary: the purpose of this study is to test the feasibility of nutrition and exercise counseling program for reducing the incidence of metabolic syndrome in prostate cancer patients on androgen deprivation therapy.

this is a pilot study to evaluate the role of dietary modifications and exercise in patients started on adt for preventing and or delaying metabolic syndrome in this aging population. the study will employ a randomized, 2-arm wait-control design. subjects will be randomized in a 1:1 ratio into two arms: dietary modifications and exercise counseling (arm a) or standard of care (arm b). the duration of intervention in arm a will be 24 months. at 12 months, participants in arm b will be offered the same intervention that arm a received during months 1-12. medical records will be accessed up to 5 years for standard of care visits. the goal of this project is to generate preliminary data on the feasibility of applying such an intervention on a much bigger population with approximately 100 subjects on each arm. for this pilot, we aim to randomize 20 patients to each arm. the principal investigator or co-investigators who are evaluating the patient will perform the randomization since this is an open-label, non-therapeutic study. the adt received by patients on both arms is considered standard of care therapy for their prostate cancer.

Eligibility criteria:
inclusion criteria: 1. patient has provided written, informed consent 2. 18 years of age or greater 3. histologically or biochemically confirmed hormone-naïve prostate adenocarcinoma 4. recently started or re-started adt within 4 months of starting the study 5. eastern oncology co-operative group (ecog) performance 0-1 6. patient who is on an antihypertensive medications with a blood pressure less than 130 systolic and 85 mm hg diastolic 7. patient who is on an antihyperlipidemic agents with tg ≤ 150 mg/dl, serum hdl ≥40 mg/dl exclusion criteria: 1. current use of taxane based chemotherapy for metastatic disease 2. clinically significant or active cardiovascular disease: 1. no previous mi within the past 12 months 2. no uncontrolled angina within 12 months 3. history of mobitz ii second degree or third degree heart block without a permanent pacemaker in place 4. uncontrolled hypertension (systolic bp \> 170 mmhg or diastolic bp \> 100 mmhg at screening) 5. chf with nyha class 3 or 4 3. structurally unstable bone lesions suggesting impending fracture 4. estimated life expectancy of \< 6 months 5. patients who meet criteria for metabolic syndrome that are uncontrolled based on the internal diabetes federation.
a study of bevacizumab (avastin) in combination with dacarbazine in participants with unresectable/metastatic melanoma

Conditions: Malignant Melanoma

Summary: this study will assess the preliminary anti-tumor activity and safety profile of a combination of bevacizumab and dacarbazine in participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed cutaneous malignant melanoma * clinical evidence of metastatic disease and/or unresectable regional lymphatic disease and/or extensive in transit recurrent disease * measurable and/or evaluable lesions according to recist exclusion criteria: * prior interferon alfa and/or cytokine therapy for metastatic disease * prior chemotherapy for metastatic disease * brain metastases * chronic daily treatment with high-dose aspirin (more than 325 milligrams per day) * other co-existing malignancies or malignancies diagnosed within the past 5 years with the exception of basal cell cancer or cervical cancer in situ
peripheral plasma micro-rna and proteomics mapping in depressive patients, treated with ssri medications

Conditions: Depression

Summary: a pilot study of mapping the peripheral plasma micro-rna and proteomics patterns in depressive patients, treated with ssri medications. it is an observational clinical bio-markers laboratory controlled research with no device. the research includes two groups; one for patients diagnosed of having depression, and will get a standard ssri medication regimen. second group is for control subjects without depression. an option for a third group is planned to include first degree relatives of the depressed patients. after giving their informed consents, subjects and patients will go through standard clinical psychiatric interview, and routine clinical lab tests. clinical standard, specific depression and anxiety questionnaires will be held at four follow-up meetings: at start; after 2 weeks; 4 weeks; and 10 weeks. subjects and patients will be asked to give blood samples at these points of time for the lab processing: complete plasma proteomics and specific micro-rna levels.


Eligibility criteria:
inclusion criteria: * depressed patients,over 18 yo * untreated with ssri, in the last 3 months exclusion criteria: * bipolar patients or another major psychopathology * depressive disorder clearly due to general medical condition, or drug related * bmi under 18.5 or above 40 * pregnant patients * active suicidality

Keywords: depression selective serotonin reuptake inhibitors micrornas proteome
adherence to mediterranean diet in type 1 diabetes initiating minimed 780g: glucose metrics vs insulin metrics, is there a difference

Conditions: Type1diabetes

Summary: in this observaltional study, 240 patients aged \>12 years old with t1dm who are on multiple daily injections or insulin pump and are scheduled to start using minimed 780g system will be included.we aim to compare patients' adherence to mediterranean diet (md) before and 12 weeks after initiation of minimed 780g and its association with cgm and insulin metrics, as well as anthropometric measurements, bmi, body composition, lipid levels, blood pressure and gut microbioma. moreover, at baseline, at six and 12 months, markers of endothelial and cardiovascular function will be also assessed and associated with the use of minimed 780g and the adherence to md.

this observational study will include 240 participants (80 participants per country) from igi region (italy, greece and israel), children adolescents and young adults (12\> years old) with t1d that are on multiple daily injections or insulin pump and are scheduled to start using minimed 780g system. after a 7-day run-in period, participants will be evaluated with food intake log and adherence to meditteranean diet (md) with predimed questionnaire. one hour session on md and healthy impact on diabetes will be provided to all participants and will be assigned to initiate minimed 780g and followed for 12 weeks. hba1c, cgm and insulin metrics, anthropometric measurements, body composition, blood pressure and lipid leves as well a gut microbioma will be performed at baseline and 12 weeks, after minimed 780g initiation. a 7-day food diary logbook will be collected to identify the amount and type of the food at baseline and at the end of the study. at baseline, at 6 and at 12 months, markers of endothelial and cardiovascular function will also be assessed. an extension phase will include additional 3 and 6, which concludes one year of follow-up.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of type 1 diabetes \>1 year prior to consent date. diagnosis of type 1 diabetes is based on the investigator's judgment; c peptide level and antibody determinations are not required. 2. hba1c \< 12.5% 3. age \>7years at the initiation of the system 4. multiple daily injections (basal bolus therapy) with total daily insulin use of great than 8.0 units per day over a 1-week period 5. clinically able to start the ahcl system 6. history of 3 clinic visits in the last year exclusion criteria: 1. diabetic ketoacidosis in the 6 months prior to screening visits -
a first-in-human study of men2312 in adults with advanced breast cancer

Conditions: Advanced Breast Cancer

Summary: this is a first-in-human study of men2312, a lysine acetyltransferase 6 (kat6) inhibitor, in adult participants with advanced breast cancer.


Eligibility criteria:
key inclusion criteria: * participants with advanced breast cancer that cannot be cured. * participant must have received at least one prior line of endocrine therapy for advanced/metastatic disease. progression on previous cyclin-dependent kinase 4/6 inhibitor treatment in combination with fulvestrant or aromatase inhibitor is required. * up to 6 prior lines of therapy are allowed. up to 2 prior chemotherapy and/or cytotoxic antibody-drug conjugates regimens in the advanced/metastatic setting is permitted. key exclusion criteria: * new or active brain metastasis. * severe internal organ spread that could cause immediate life-threatening problems, including large uncontrolled fluid build-up or severe lung or liver involvement. note: other inclusion/exclusion criteria may apply.

Keywords: first-in-human men2312 advanced breast cancer kat6
frailty intervention trial in end-stage patients on dialysis

Conditions: Hemodialysis Complication; Nutritional Deficiency; Physical Activity

Summary: the proposed investigation for this study aims to; 1) understand the prevalence and outcomes associated with frailty among haemodialysis patients; 2) ascertain the best frailty assessment tool for haemodialysis patients, and; 3) design a clinical study to explore the feasibility of facilitating, recruiting and executing a multi-disciplinary clinical and psychological intervention to improve frailty status among haemodialysis patients. work package 1: firstly, there is a need to understand the prevalence and spectrum of frailty in a uk haemodialysis cohort and what impact frailty has for haemodialysis patients. to investigate this, the investigators will approach every patient on haemodialysis within the local catchment of haemodialysis units and, after informed consent, clinically phenotype their frailty status (pre- and post-haemodialysis for calculation of variability). the frailty phenotyping will encompass a number of frailty assessments (including the edmonton frail scale, clinical frailty scale from rookwood score and fried frailty scale) to identify the ideal frailty assessment tool. all patients in this observational cohort study will be prospectively monitored for clinical/biochemical outcomes using an informatics-based approach for up to 60 months. work package 2: building upon the work conducted in work package 1, work package 2 will aim to recruit 50 patients clinically phenotyped with pre-frailty from work package 1 into a feasibility study exploring a multi-disciplinary intervention to improve frailty status. eligible patients, after informed consent, will be randomised into active or passive intervention. the active intervention will involve a dietitian and physiotherapist who have been trained and accredited with cognitive behavior intervention, utilising established behavioral intervention frameworks, to deliver a multi-disciplinary clinical intervention targeting multiple components of frailty. the fitness project will therefore answer some important unanswered questions regarding frailty among the haemodialysis population and help in the design of a large multi-disciplinary intervention study if deemed feasible.


Eligibility criteria:
inclusion criteria: * on hemodialysis exclusion criteria: * inability to give consent
rhprg4 for the treatment of ocular graft-versus-host disease (ogvhd)

Conditions: Ocular Graft-versus-host Disease

Summary: rhprg4-gvhd-001 is a prospective multi-center study conducted in australia to evaluate the safety and efficacy of topically-applied rhprg4 in subjects with moderate to severe dry eye secondary to chronic gvhd.


Eligibility criteria:
inclusion criteria: diagnosis and main criteria for inclusion: all to be queried and checked at the screening visit (v1): 1. subjects 18 years of age or older; 2. subjects diagnosed with ogvhd for at least 3 months (current use of artificial tears for the treatment of gvhd); 3. vas eye dryness (100-point scale) score ≥ 60 mm; 4. tear osmolarity ≥ 312 in either eye; 5. corneal staining score with fluorescein ≥ 2 using the oxford scale in the worst performing eye; staining must include quadrants beyond only inferior or superior staining; 6. only subjects who satisfy all informed consent requirements may be included in the study. exclusion criteria: diagnosis and main criteria for exclusion: 1. evidence of an active ocular infection in either eye; 2. history or presence of ocular surface disorders not related to ogvhd in either eye, including but not limited to significant conjunctivochalasis, superior limbic keratoconjunctivitis, limbal stem cell deficiency, allergic conjunctivitis, giant papillary conjunctivitis, atopic keratoconjunctivitis, anterior basement membrane dystrophies, neurotrophic keratitis, corneal dystrophy, exposure keratitis and moderate to severe blepharitis; 3. history of any ocular surgery (including laser or refractive surgical procedures) in either eye within 90 days before study enrollment. ocular surgery will not be allowed during the study treatment period and elective ocular surgery procedures should not be planned during the duration of the follow-up period; 4. initiation of new therapeutic modalities within 30 days of recruitment; 5. artificial rescue tears are allowed as long as they are recorded in a diary; 6. known hypersensitivity to one of the components of the study or procedural medications; 7. participation in another clinical study at the same time as the present study or within 60 days of screening/baseline visit; 8. history of drug, medication or alcohol abuse or addiction; 9. females of childbearing potential (those who are not surgically sterilized or post-menopausal for at least 1 year) are excluded from participation in the study if they meet any one of the following conditions: 1. are currently pregnant or, 2. have a positive result on the urine pregnancy test at the screening/baseline visit or, 3. intend to become pregnant during the entire course of and 30 days after the study treatment periods, or, 4. are breast-feeding or, 5. not willing to use highly effective birth control measures, such as: hormonal contraceptives - oral, implanted, transdermal, or injected and/or mechanical barrier methods, during the entire course of and 30 days after the study treatment periods.
the combination of terbutaline and danazol as the treatment of corticosteroid-resistant/relapse immune thrombocytopenia

Conditions: Immune Thrombocytopenia

Summary: a randomized, open-label, multicenter study to compare the efficacy and safety of terbutaline plus danazol compared to danazol monotherapy for the second-line treatment of adults with corticosteroid-resistant or relapsed primary immune thrombocytopenia (itp).

the investigators are undertaking a parallel group, multicenter, randomized controlled trial of 228 adults with itp in china. patients were randomized to terbutaline plus danazol compared to danazol monotherapy group. platelet count, bleeding and other symptoms were evaluated before and after treatment. adverse events are also recorded throughout the study.

Eligibility criteria:
inclusion criteria: patients \>18 years old with corticosteroid-resistant or relapsed itp who had either a platelet count of \<30×10\^9/l or a platelet count of \<50×10\^9/l and clinically significant bleeding. 1. not achieving a sustained response to therapy with full-dose corticosteroids for a duration of at least 4 weeks or relapsed during the process of corticosteroid tapering or discontinuation; 2. platelet counts \<30×10\^9/l or platelet counts \< 50×10\^9/l and significant bleeding symptoms (who bleeding scale 2 or above); 3. willing and able to sign written informed consent. exclusion criteria: 1. pregnant or lactating women; 2. secondary itp (have a known diagnosis of connective tissue diseases, malignancy, active infection, hiv infections or hepatitis b virus or hepatitis c virus infections); 3. received drugs affecting the platelet counts within 6 months before the screening visit (e.g., chemotherapy, anticoagulants, etc); 4. severe medical condition (lung, heart, hepatic or renal disorder); 5. patients who are deemed unsuitable for the study by the investigator. 6. patients who had hypertension, diabetes mellitus, hyperthyroidism or coronary heart disease.
study to assess adverse events, change in disease activity, and how oral upadacitinib moves through the body of pediatric participants with moderately to severely active ulcerative colitis.

Conditions: Ulcerative Colitis

Summary: ulcerative colitis (uc) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). this study will assess how safe and effective upadacitinib is in treating pediatric participants with uc. adverse events and change in disease activity will be assessed. upadacitinib (rinvoq) is a drug approved in adults for moderate- to severely active uc and is being developed for moderate- to severely active uc in pediatric participants. this study is conducted in 2 periods: period 1 is comprised of two phases: an 8-week open-label induction phase which means that the study doctor and patients know that participants will receive upa dose-a (or the adult equivalent based on body weight) followed by a 44-week double-blind maintenance phase meaning that neither the participants nor the study doctors will know which dose of upadacitinib will be given(upa dose b or dose c). period 2 is a 260 week open-label extension (ole) of period 1. approximately 110 pediatric participants with moderate to severely active uc will be enrolled at up to 100 sites worldwide. participants will receive upadacitinib oral tablets once daily or oral solution twice daily at approximately the same time each day, with or without food. participants will be followed up for 30 days after each phase (i.e. after induction, maintenance, ole) and only if a participant doesn't continue into the next phase. there may be higher treatment burden for participants in this trial compared to their standard of care. participants will attend regular visits during the study at a hospital or clinic. the effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility criteria:
inclusion criteria: * active uc with an ams of 5 to 9 points and endoscopic subscore of 2 to 3. * demonstrate an inadequate response, loss of response, intolerance, or medical contraindications to corticosteroids, immunosuppressants, and/or biologic therapy. exclusion criteria: * partcipants with previous exposure to jak inhibitors (e.g., tofacitinib, baricitinib, filgotinib, upadacitinib). * females who are pregnant, breastfeeding, or considering becoming pregnant during the study and for approximately 30 days after the last dose of study drug.

Keywords: upadacitinib rinvoq ulcerative colitis uc corticosteroids immunosuppressants biologic therapy
lactate levels correlates with ki-67 in brain tumor surgery

Conditions: Brain Tumor; Anesthesia

Summary: in neurosurgery, brain tumor patients show increased levels of lactate at the beginning of surgery. this has been related to malignancy. ki-67 is a cell proliferation index used as a marker of tumor mitotic activity. this research aims to describe the correlation between lactate levels and the ki-67 index in patients with brain tumor.

lactate levels are used in the evaluation of perfusion status in critical care. increases not related to a hypoperfusion state are observed in the patient with brain tumors. these increases have been related to type and tumor grade. this observation does not fully explain the variation within the same tumor grade. ki-67 label index is a marker of mitotic activity that can be used as proliferation index. it has been associated with histologic grade and survival rate. provides a quantitative measure of the tumor proliferation status. the investigators will perform a retrospective analysis of the clinical charts of patients after brain tumor resection. the study will address the relationship between baseline lactate levels and the proliferation index found in tissues biopsies.

Eligibility criteria:
inclusion criteria: * neurosurgical craniectomy cases * june 2017 - february 2018 * valid lactate information after anesthesia induction * ki-67 label index informed in biopsies * tumor type information confirmed in biopsies exclusion criteria: * incomplete lactate or ki-67 index information

Keywords: lactate ki-67 mitotic index brain tumor