Kornimate/medical-research-clean huggingface dataset:
adjuvant dynamic marker-adjusted personalized therapy trial optimizing risk assessment and therapy response prediction in early breast cancer

Conditions: Breast Cancer

Summary: trial for the optimization of risk assessment and therapy success prediction in patients with early breast cancer by the use of biomarkers in advance to therapy decision-making to personalize therapies.


Eligibility criteria:
inclusion criteria: * female patients, age at diagnosis 18 years and above (consider patients at 70 years and above for adapt elderly) * histologically confirmed unilateral primary invasive carcinoma of the breast * clinical t1 - t4 (except inflammatory breast cancer) * all clinical n (cn) * no clinical evidence for distant metastasis (m0) * known hr status and her2 status (local pathology) * tumor block available for central pathology review * performance status ecog \ = 80% * negative pregnancy test (urine or serum) within 7 days prior to start of induction treatment in premenopausal patients * written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements * the patient must be accessible for treatment and follow-up exclusion criteria: * known hypersensitivity reaction to the compounds or incorporated substances * prior malignancy with a disease-free survival of \< 10 years, except curatively treated basalioma of the skin or ptis of the cervix uteri * non-operable breast cancer including inflammatory breast cancer * previous or concurrent treatment with cytotoxic agents for any reason after consultation with the sponsor * concurrent treatment with other experimental drugs. participation in another interventional clinical trial with or without any investigational not marketed drug within 30 days prior to study entry * male breast cancer * concurrent pregnancy; patients of childbearing potential must implement a highly effective (less than 1% failure rate) non-hormonal contraceptive measures during the study treatment * breast feeding woman * sequential breast cancer * reasons indicating risk of poor compliance * patients not able to consent
acceptability and tolerance study of a new oral nutritional supplement (ons)

Conditions: Malnutrition

Summary: tolerance and acceptability of new oral nutritional supplement - aymes paris

to evaluate tolerance and acceptability of aymes paris in patients requiring supplementary oral nutritional support compared with currently available alternatives, measuring outcomes of gi effects, compliance, product preference,convenience etc. to obtain data to support an acbs submissions for aymes paris (to allow for prescription in the community at nhs expense).

Eligibility criteria:
inclusion criteria: * adult patients (≥18 years) who are able to communicate their views regarding acceptability. * patients established on an oral nutritional supplement, being prescribed 1-2 ons providing approximately 300kcal/day * patients expected to require oral nutritional supplementation for at least 2 further weeks. * informed consent obtained. exclusion criteria: * participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study * patients requiring a milk-free diet * patients with medical or dietary contraindication to any feed ingredients (see appendix 2 of protocol for full list) * patients with significant renal or hepatic impairment * patients with swallowing impairment requiring thickened fluids * patients with inflammatory bowel disease or previous bowel resection.
the impact of storage techniques on platelets number and function after acute normovolemic hemodilution (anh)

Conditions: Cardiac Surgical Procedures

Summary: acute normovolemic hemodilution (anh) is part of our current protocol to decrease post-operative bleeding and homologous blood transfusions post cardiopulmonary bypass. blood is drawn from our patients pre-bypass after obtaining the arterial line and administered back to the patient after separation from cardiopulmonary bypass (cpb) and reversal of heparin with protamine. in our practice we noticed some variability in the impact of anh on postoperative bleeding; with some patients appearing to show more hemostasis after separation from cpb than others. this is a prospective study to find out if there is an optimal time period that guarantees the largest amount of functioning platelets and what is the best practice for drawing and storing of anh to guarantee the largest amount of functioning platelets.


Eligibility criteria:
inclusion criteria: * all patients undergoing cardiac surgery on cpb and are determined to be suitable for anh by the cardiac team during the huddle process per our standard protocol. exclusion criteria: * patients who are undergoing cardiac surgery on cpb who are determined not to be suitable candidates for anh by the cardiac team during the huddle process per our standard protocol.
neuromuscular mechanisms underlying poor recovery from whiplash injuries

Conditions: Whiplash Associated Disorders; WAD; Whiplash

Summary: this study is investigating whether changes in the shape and size of bodily muscles and spinal cord anatomy can influence recovery rates following a motor vehicle collision (mvc). the objective is to demonstrate that the presence of muscle and spinal cord degeneration and associated muscle weakness is the consequence of a mild mvc-related injury involving the cervical spinal cord.

whiplash is a condition that consists of patients that display varying degrees of pain and disability. most patients should expect full-recovery within the first 2-3 months post injury. at the other end of the spectrum is a group of patients (\~ 25%) who continue to have moderate-severe pain-related disability in the long-term. reasons for this transition to chronicity are largely unknown. the situation would benefit if there were radiological findings of the disorder. however, clear and consistent findings of injured tissues on standard radiological exams remain elusive. as part of this study, the investigators will innovatively investigate measures to 1) quantify the temporal development of widespread muscle degeneration, 2) identify quantifiable markers of altered cervical spinal cord physiology, 3) quantify reductions in central activation and fatigue 4) evaluate potential genetic variants that may be associated with chronic pain after a mvc and 5) determine the mediational influence of psychosocial factors on recovery rates following whiplash injury, as a potential mechanism underlying the transition to chronic pain.

Eligibility criteria:
inclusion criteria: * males and females (18 - 65 years of age) * individuals less than one week post mva with a primary complaint of neck pain. * able to give written informed consent and complete interviews in english exclusion criteria: * individuals with a spinal fracture from the mva, or spinal surgeries * history of one or more mvas or previous diagnosis of cervical or lumbar radiculopathy * history of neurological disorders (e.g. multiple sclerosis, previous stroke, myelopathy), inflammatory diseases (e.g. hepatitis, systemic lupus erythematosus, rheumatoid arthritis or osteoarthritis, alzheimers, ankylosing spondylitis, crohn's disease, fibromyalgia) or metabolic disorders (e.g. diabetes, hyper- and hypo-thyroidism) * standard contraindications to mri: claustrophobia, metallic implants, pacemaker and pregnancy.

Keywords: whiplash neck pain chronic pain motor vehicle accident car accident mri dna rna
safety and efficacy of the addition of alanyl-glutamine-dipeptide to dialysis solution in peritoneal dialysis

Conditions: End Stage Renal Disease

Summary: peritoneal dialysis (pd) is a cost effective and safe form of renal replacement therapy in patients suffering from end stage renal disease. however currently available pdf (peritoneal dialysis fluids) are not biocompatible for the peritoneal cavity and its cells. acute cytotoxic effects of the majority of the current glucose-based pdf are caused by low ph, lactate, high glucose and its degradation products (gdp). toxic effects of pdf can thus be extended to suppression of mesothelial hsr (heat shock reactions) following pdf exposure resulting in increased susceptibility of mesothelial cells against pdf exposure: pdf inherent stress factors fail to adequately induce hsp as effectors of the cellular stress response - the adequate hrs rather seems to be blocked. hence, therapeutic approaches to activate and enhance the hsr will reduce peritoneal damage and organ failure and improve the survival of organisms. preclinical results demonstrated that supplementation of pdf with pharmacological doses of alanyl-glutamine restored hsp expression and increased the resistance of mesothelial cells in in-vitro models of pd and preserved peritoneal integrity in in-vivo models of pd. after these positive preclinical results, this study shall now clarify, whether the addition of alanyl-glutamine to the most commonly used glucose-based pdf is safe and tolerable. therefore pdfs will be drained in a randomized cross-over study. main outcomes measures will be total hsp expression in peritoneal cells and changes of the peritoneal transport kinetics and the presence/absence/severity of side effects.


Eligibility criteria:
inclusion criteria: * signed informed consent prior to any study-mandated procedure * male and female patients aged ≥ 19 years old * chronic renal failure; 2 months stable on pd * no peritonitis within the previous 2 months * without severe concomitant disease * negative pregnancy test in female patients of childbearing potential and adequate contraception in female patients of childbearing age exclusion criteria: * known hypersensitivity to study medication * treatment with another investigational drug within 1 month prior to start of study medication * malignancy requiring chemotherapy or radiation * pregnancy or nursing, * presumed non-compliance * limited efficacy of peritoneal dialysis due to anatomical anomalies or severe intra-abdominal adhesions * clinical significant inflammatory parameters * less than 50 kg body weight * immunosuppressive therapy

Keywords: peritoneal dialysis alanyl-glutamine-dipeptide heat shock protein peritoneal cells functional maintenance of the peritoneal membrane
fmf and atheroscelerosis

Conditions: FMF

Summary: the aim of this study is to search for subclinical atherosclerosis in children diagnosed as fmf in assiut university children's hospital, and to correlate the risk to develop atherosclerosis to the different characters and genetic variants of fmf.

* to describe the clinical characteristics of patients diagnosed as fmf in upper egypt, and to find the most common presenting symptoms. * to mention the most common genetic variants reported in fmf patients in upper egypt, and to correlate the genetic variant with the risk to develop atherosclerosis. * to assess the growth parameters in patients with fmf and compare it with the control group. * to estimate the differences in complete blood count (cbc) parameters, lipid profile, cit in patients with fmf and control group. * to search for subclinical atherosclerosis in patients with fmf based on their lipid profile and cit.

Eligibility criteria:
inclusion criteria: 1. age at enrollment less than18 years. 2. both sexes. 3. diagnosed as familial mediterranean fever according to tel hashomer criteria. \[10\] exclusion criteria: 1. patients with acute or chronic active infections. 2. patients with pre-existing illness as chronic lung, liver or renal diseases. 3. patients with diabetes mellitus, atherosclerotic vascular disease. 4. patients with malignancy
investigation of clinical relevance of β-d-glucan tests in patients with invasive fungal infection (ifi)

Conditions: Fungal Infection

Summary: invasive fungal infection (ifi) is a disease usually occurred in the patients with compromised immune condition, such as acute leukemia, allogeneic stem cell transplantation or long term immune suppression treatment with the incidence increasing over last decades. given the introduction of numerous anti-fungal agents and great advance has been made in recent years, ifi is still a dangerous disease with high mortality. early diagnosis of ifi is still a problem challenging the physicians. serum tests of β-d-glucan are introduced to the diagnosis of ifi, which have the advantage of easy application. however, the value of this test in the monitoring of antifungal treatment remains unclear. the investigators perform this study to evaluate the correlation of the serum test results of β-d-glucan test with the treatment response during the anti-fungal treatment, and hope to see that the results of serial serum tests are good predictive markers for treatment response.

this is a single center, open-label study. the duration of the study will be 2 years. the number of targeted subjects will be 50 (in 2 years). we estimate that on average, the treatment duration is 4-8 weeks. serum glucan levels will be measured 2 times per week until the recovery of the infection or treatment end.

Eligibility criteria:
inclusion criteria: patients with proven or probable ifi and immunocompromised because of hematopoietic-cell transplantation (hsct) or chemotherapy, and have positive results for serum glucan tests will be included in the study. patients must satisfy all the following criteria before entering the study : 1. episode of proven or probable ifi, diagnosed according to the eortc/msg definitions; 2. immunocompromised because of hsct or chemotherapy for malignant hematopathy; 3. ≥ 2 consecutive positive serum glucan level, using a threshold for positivity of ≥ 60 ng/l, at the start of antifungal therapy. exclusion criteria: if the fungal infection of the patient is excluded or confirmed to be a specific pathogen other than fungi before the enrollment/during the study period, he or she will be excluded/withdrew from the study.

Keywords: β-d-glucan test ifi
effects of post isometric relaxation and post facilitation stretching on young fast bowlers

Conditions: Sports Physical Therapy

Summary: the quadratus lumborum muscle exhibited the highest degree of asymmetry in fast bowlers with low back pain, the identification and correction of this asymmetry is always of interest. fast bowlers in cricket are more likely to experience non-contact lbp if they use improper technique, prepare less physically, ball too hard, or take on an excessive workload. the quadratus lumborum muscle exhibited the highest degree of asymmetry in fast bowlers with low back pain due to extreme side flexion at non-dominant side and hence results in ql tightness at that side. the study design will be a randomized controlled trial. this study will be conducted in pakistan sports board (psb) lahore. the study will be completed within the time duration of eight to ten months after the approval of the synopsis. the sample size will be 34 subjects. non-probability convenient sampling technique will be used to recruit the individuals for the study. then randomization will be done by lottery method to divide the individuals into 2 treatment groups. the experimental group a will be given post isometric relaxation for 20 minutes for 4 weeks (four times per week) on the other hand experimental group b will receive post facilitation stretching and after that measure their pre-post values on spss. pain will be measured with vas, range of motion with inclinometer and functional disability with athlete's disability index questionnaire. in this study, it will be aimed to examine the comparative effects of both techniques that affect pain, range of motion and functional disability with quadratus lumborum tightness in young fast bowlers.

the main objective of this study is to apply post isometric relaxation and post facilitation stretching techniques and to compare the results to identify their influence on pain, range of motion and functional disability on quadratus lumborum tightness in young fast bowlers.

Eligibility criteria:
inclusion criteria: * age15-19years * both male and female fast bowlers * passive pelvic transverse gliding test for quadratus lumborum tightness +ve * low back pain \> 6 weeks * training sessions of at least 3 days/week exclusion criteria: 1. congenital causes (spina bifida, scoliosis, spondylosis, spondylolisthesis) 2. traumatic cause * prolapsed intervertebral disc * fracture of vertebral column 3. inflammatory cause * ankylosing spondylosis * pott's spine 4. neoplastic cause * benign * malignant 5. radiculopathy 6. any spinal surgery 7. gynecological cause

Keywords: back pain muscle energy technique quadratus lumborum visual analogue pain scale disability
phytosterol supplementation and cardiovascular risk

Conditions: Hypercholesteremia

Summary: this study examined the effects of 2.6 g/d of phytosterol ingestion on ldl cholesterol metabolism. it is expected that this dose will significantly reduce ldl cholesterol after 12 weeks of supplementation.

this study examined the effects of 2.6 g/d of phytosterol ingestion on ldl cholesterol metabolism. it is expected that this dose will significantly reduce ldl cholesterol after 12 weeks of supplementation. the study recruited 72 men and women 20-70 years of age with mild hypercholesteremia (\>130 mg/dl ldl-c). they were assigned to 1 of 2 groups. participants ingested the supplement or a placebo for 12 weeks, with an interim assessment at 6 weeks. participants agreed to maintain current diet, medication, and exercise habits and to not donate blood during the trial.

Eligibility criteria:
inclusion criteria: * mild hypercholesteremia, sign informed consent, not donate blood, maintain diet and exercise habits exclusion criteria: * bmi \ 34.9, recent blood donation, serious or life-threatening disease

Keywords: ldl-c, phytosterol
serum level of bioactive mediators and urinary biopyrins in psoriasis

Conditions: Psoriasis

Summary: 1. assess the level of lipid mediators in patients with psoriasis 2. assess the urinary level of biopyrins as new marker of oxidative stress in patients with psoriasis 3. correlate the serum level of bioactive lipid mediators and urinary level of biopyrins with psoriasis area and severity index

psoriasis is acommon immune mediated inflammatory skin disorder of complex pathomechanisms which is generically conditioned and influenced by environmental factors

Eligibility criteria:
inclusion criteria: * age from12 to 80 and both sex exclusion criteria: * patients with other dermatological disorders
outcome study to evaluate klaricid xl® (clarithromycin modified release) in patients with acute exacerbation of chronic bronchitis

Conditions: Bronchitis

Summary: the objective of this study was to evaluate the role of klaricid xl (clarithromycin modified release) in the treatment of acute exacerbation of chronic bronchitis (aecb) and its impact on improving the quality of life.

participants in this observational study had a diagnosis of chronic bronchitis and signs and symptoms of an acute exacerbation, clinically diagnosed by the sudden worsening of symptoms characterized by extreme breathlessness and increased chest tightness, wheezing, cough, or sputum changes. a sequential non-systematic sample of patients with aecb from may 2011 until january 04, 2012 is included in this observational study. the observation period for each individual patient started with the diagnosis of the acute exacerbation of chronic bronchitis and prescription of antimicrobial medication per routine clinical care. this observational period continued during the treatment period and ended on at least one follow-up visit at the end of the treatment. duration of treatment was based on physician's judgment of severity of the patient's condition. the usual treatment period ranges from 5 to 14 days.

Eligibility criteria:
inclusion criteria: * patients with acute exacerbation of chronic bronchitis who required antimicrobial therapy and treated with klaricid xl (clarithromycin modified release) * male and female patients age 35 years and older exclusion criteria: * patients with clinical signs and symptoms suggesting pneumonia * patients with asthma * patients with any concomitant illness that may confound the interpretation of the effect of study medication (e.g., pulmonary malignancy, congestive heart failure, bronchiectasis, pneumothorax) * immunocompromised patients; however, patients receiving systemic steroids at baseline for the treatment of chronic obstructive pulmonary disease can be enrolled * pregnant females * nursing mothers * patients who are allergic to clarithromycin

Keywords: bronchitis
myocardialbridge bypass graft surgery efficacy verification

Conditions: Myocardial Bridge of Coronary Artery; Myocardial Bridge; Myocardial Bridging; Myocardial Infarction; Myocardial Ischemia; Pectoris, Stable Angina; Sudden Cardiac Death; Bypass Graft Stenosis; Bypass Graft Occlusion; Bypass Graft Thrombosis

Summary: myocardial bridge bypass graft surgery is introduced to relieve the unmedical symptoms of patients with long-segment or deep myocardial bridge, clinical outcomes will be collected to verify the effectiveness of the surgery.


Eligibility criteria:
inclusion criteria: * patients with myocardialbridge requiring drug therapy or surgical intervention. exclusion criteria: * patients with myocardialbridge not requiring drug therapy or surgical intervention, or unwilling to be enrolled for any reason
broadband vs narrowband phototherapy for eczema trial nested in the cacti cohort

Conditions: Atopic Dermatitis; Skin Diseases; Eczema

Summary: atopic dermatitis (eczema) is a complicated skin condition. in fact, it represents many different underlying problems. these include abnormalities in the skin barrier, the immune system and the ability to handle different bacteria. despite many recent gains in the understanding of eczema, a lot needs to be learned. there is little evidence to select between some of the older treatments that are available now. even the newest targeted therapy does not clear most patients' skin. in order to improve the understanding of eczema, how to treat it now, and to enable discovery of new treatments, the investigators plan to enroll patients into a large study at three centres in canada (university of toronto, mcgill university and university of british columbia). the study is called the canadian atopic dermatitis cohort for translational immunology and imaging (cacti). in this study, the investigators will collect data on how severe participants' eczema is and what treatments they use. for participants who give permission, the investigators will collect blood and skin biopsy samples to study the mechanisms underlying their disease. the investigators will test to see which form of phototherapy (broadband or narrowband ultraviolet b phototherapy) works best for eczema in a randomized clinical trial. the investigators will also use advanced imaging techniques to visualize the skin. this trial registry entry, including the description of the treatment arms and outcomes, refer to the nested broadband vs narrowband phototherapy for eczema clinical trial.


Eligibility criteria:
inclusion criteria: 1. atopic dermatitis according to the hanifin and rajka criteria. 2. validated investigator global assessment score of 3 or 4 out of 4 3. eczema area and severity index (easi) score ≥7.1 4. moderate to severe disease as above despite an adequate trial of topical therapy. exclusion criteria: 1. treatment with phototherapy or oral systemic immune-modulating agents (cyclosporine, methotrexate, azathioprine, mycophenolate) less than 30 days before baseline. 2. treatment with systemic biologic (dupilumab) or experimental therapeutic less than 90 days before baseline. 3. current treatment with oral or intramuscular corticosteroids within 30 days prior to baseline. topical, intralesional or inhaled corticosteroids are allowed. 4. participating in a clinical trial assessing an investigational agent for atopic dermatitis (topical, systemic or device) within 90 days prior to enrollment.