Kornimate/medical-research-clean huggingface dataset:
historical case record survey of visual acuity data from patients with leber's hereditary optic neuropathy (lhon)

Conditions: Leber's Hereditary Optic Neuropathy (LHON)

Summary: the purpose of this survey is to collect visual acuity data from patients with lhon in order to establish the clinical course (natural history) and visual acuity outcomes in patients with a genetically confirmed diagnosis of lhon. in addition, this survey will generate data that will serve as comparator for the open-label study snt-iv-006.


Eligibility criteria:
inclusion criteria: 1. age ≥ 12 years 2. the onset of symptoms is dated after 1999 and is well documented (at least month of onset of symptoms is known for each eye) 3. at least two va assessments are available within 5 years of onset of symptoms and prior to idebenone use 4. have a genetic diagnosis for lhon for one of the following mitochondrial dna (mtdna) mutations: g11778a, g3460a, t14484c exclusion criteria: 1. any participation in an interventional clinical trial after the onset of symptoms 2. any other cause of visual impairment (e.g. glaucoma, diabetic retinopathy, aids related visual impairment, cataract, macular degeneration, etc.) or any active ocular disorder (uveitis, infections, inflammatory retinal disease, thyroid eye disease, etc.) during the data collection period
clinical characteristics and discharge assessment of patients from palliative care

Conditions: Critical Illness

Summary: the number of people having chronic diseases and the demand for palliative care has increased. the factors that have an impact on length of stay and discharge of patient who were admitted to palliative care center will be investigated.

adult patients admitted to the diskapi yildirim beyazit teaching and research hospitals palliative care unit between august 2018 and september 2020 and discharged to their home will be retrospectively evaluated. patient's age, gender, diagnosis, conditions/comorbidities, karnofsky performance scale, discharge status (death, intensive care unit or at home), gastrostomy status, presence of tracheostomy and/or mechanical ventilation, nutritional status (total parenteral nutrition or enteral nutrition), pressure ulcers, the lowest and highest recorded hemoglobin concentration, white blood cell count and serum sodium concentration and the education level of the patient and the caregiver will be recorded. patients will be grouped according to length of stay (los) as group 1: discharged in equal or less than 21 days or group 2: prolonged discharged in longer than 21 days and analysed accordingly

Eligibility criteria:
inclusion criteria: • adult patients admitted to the palliative care unit exclusion criteria: • patients not consenting to participate the study

Keywords: critical illness palliative care length of stay
effect of pulsed electromagnetic stimulation on doms

Conditions: Electromagnetic Fields

Summary: the aim of our study is to investigate the effect of pulsed electro magnetic field application on delayed muscle soreness in healthy quadriceps femoris muscle.

participants will complete 100 consecutive fall jumps from a 0.60 m high platform to generate delayed muscle soreness. after landing, participants will be encouraged to jump vertically immediately with maximum force. five sets of 20 jumps will be performed with 10-second intervals between each jump, with a 2-minute rest between sets.immediately after the implementation of the exercise protocol that will cause delayed muscle soreness, the participants will be randomly divided into 2 groups. pulsed electromagnetic field or sham pulsed electromagnetic field application will be applied to the non-dominant extremities of the participants. the participants will be evaluated before (0), 24, 48 and 72 hours after the delayed muscle pain protocol. pain intensity of the participants will be evaluated with visual pain scale (vas), muscle fatigue will be evaluated with modified borg scale, muscle performance will be evaluated with one-leg jump test, and muscle tenderness will be evaluated with an algometer. in addition, serum creatine kinase and myoglabin values will be tested by laboratory analysis.

Eligibility criteria:
inclusion criteria: * not having any systemic disease * not having neuromuscular deficit * not having knee pathology * to be defined as inactive (less than 30 minutes of moderate physical activity five times a week) according to the minimum activity guidelines published by the american college of sports medicine exclusion criteria: * being actively involved in any sport * participating in a regular exercise program

Keywords: electromagnetic fields delayed onset muscle soreness
renal function among thalassemia patients treated by a oral chelator deferasirox

Conditions: Thalassemia; Iron Overload

Summary: thalassemia major patients developed iron overload due to blood transfusions and intestinal iron absorption. renal function caused by iron overload was studied in a previous study and shows principally tubular disfunction. in this previous study the iron chelator used was deferrioxamine. in the last five years an oral iron chelator was introduced and approved by the fda, deferasirox, (novartis, switzerland and usa). the purpose of this study is to assess the renal function in thalassemia major patients treated with this new oral iron chelator and compare the results with our previous study.

patients with thalassemia major. the laboratory tests that will be studied are: urine dip stick, urea, creatinine, na, k, uric acid, calcium, phosphorus in serum and urine, and n acetyl-b-d-glucosaminidase in urine.blood gases will be also taken in serum samples. the overall iron accumulation will also be calculated based in the amount of packed cells units transfused. the total iron burden will also assessed by measurement of transferrin saturation and serum ferritin.

Eligibility criteria:
inclusion criteria: * patients with thalassemia major or intermedia treated by iron chelators or by blood transfusions without treatment with iron chelators exclusion criteria: none relevant

Keywords: renal function
paramedic - norwegian acute stroke prehospital project

Conditions: Stroke; Triage; Paramedic; Mobile Application

Summary: the main aim of the study is to show that patients with suspected acute stroke met by the emergency medical service and assessed using the estroke model including prehospital nihss and a mobile application will identify a higher number of patients with stroke, than those who receive conventional prehospital care.

primary aims: in patients with suspected stroke 1. the proportion of patients hospitalized with a suspected acute stroke and discharged with a stroke diagnose is significantly increased using the paranaspp model compared with conventional prehospital care 2. time from onset to hospitalization is significantly reduced with the paranaspp model 3. the paranaspp model identifies patients eligible for direct transportation for comprehensive stroke center

Eligibility criteria:
inclusion criteria: * all patients with suspected acute stroke met by emergency medical services (ambulance and rapid response car)
exploring individual nutrition care elements and nutritional evaluation methods within dietetic practice in cancer care

Conditions: Cancer; Malnutrition

Summary: the purpose of the study is to explore and deepen the understanding of the dietitian's role and work related to individually tailored nutritional treatment in cancer care. the research questions focus on behavior change strategies, goal setting, the possibility of using calf circumference to assess changes in muscle mass, and mapping energy and protein intake, nutritional symptoms, and food-related quality of life during nutritional treatment for cancer patients. in the first part of the project, audio recordings of conversations between dietitians and patients with cancer will be conducted to investigate the dietitian's work with behavior change strategies and goal setting. data analysis will be performed using two different methods: content analysis and thematic analysis. the research subjects include both dietitians and cancer patients who engage in conversations. the second part of the project will include 100 patients with cancer at risk for or with malnutrition. data collection will involve measurements of weight, height, calf circumference, muscle mass, energy and protein intake, nutritional symptoms, and food-related quality of life.


Eligibility criteria:
inclusion criteria: inclusion criteria for the first part of the project involve encountering dietitians treating patients with cancer who have malnutrition or are at risk of malnutrition. for these patients, the inclusion criteria are as follows: * aged ≥18 years with a diagnosed cancer * ongoing nutrition therapy by a dietitian * malnutrition or risk of malnutrition according to the hospitals criteria where at least one of the following criteria must be met: low bmi, involuntary weight loss, and/or eating difficulties. patients can also be included if they are referred to a dietitian based on treatment guidelines due to a high risk of malnutrition associated with the cancer diagnosis or its medical therapy. for the second part of the project, the inclusion criteria are: * aged ≥18 years with a diagnosed cancer * undergoing or planned treatment, including surgical, oncological, or a combination of these * have been referred to a dietitian but have not yet had their initial contact with the dietitian, and * malnutrition or risk of malnutrition according to the hospital's criteria, where at least one of the following criteria must be met: low bmi, involuntary weight loss, and/or eating difficulties. patients can also be included if they are referred to a dietitian based on treatment guidelines due to a high risk of malnutrition associated with the cancer diagnosis or its medical therapy. exclusion criteria: for the first part of the project, the exclusion criteria regarding patients are: * known dementia or impaired cognitive function, and * not proficient in spoken and written swedish. for the second part of the project, the exclusion criteria are: * known dementia or impaired cognitive function, * ongoing nutrition therapy by a dietitian at inclusion, and * not proficient in spoken and written swedish.
evolution of functional gastrointestinal disorders in infants fed with a new infant formula

Conditions: Functional Gastrointestinal Disorders

Summary: this study aims to assess the evolution of functional gastrointestinal disorders (fgids) in infants fed with a new infant formula, using the gastrointestinal (gi) and gastroesophageal reflux (ger) (giger) scale through an interventional, open-label, non-comparative multicenter study.

the study comprises a first period of 30 days followed by an optional intervention period of 90 days.

Eligibility criteria:
inclusion criteria: 1. infants presenting with at least one of the fgids below, defined based on adapted rome iv criteria as follows: 1.1 regurgitations: 1.2 colic: 1.3 constipation: 2. infants born at 35 weeks or more of gestational age 3. infants up to 4 months of age exclusion criteria: 1. exclusively or partially breastfed infants (i.e. \&amp;gt; 2 breast feeds per day) with maternal willingness to continue breastfeeding 2. diversified infants or whose parents intend to start diversification within the first 2 weeks of the study 3. use of antibiotics at inclusion visit (v0) and within 7 days before the inclusion visit (v0) 4. the willingness to take additional pre-, probiotics or thickening agents during the study 5. known allergy/intolerance to any of the product ingredients or suspected allergy to cow's milk requiring an eviction diet 6. infants presenting with any other situation including the participation in another clinical trial, which, according to the investigator, may interfere with the study participation, or lead to a particular risk for the patient (non exhaustive list)

Keywords: regurgitations colic constipation infant formula giger scale nutrition infants
bowel preparation before hemorrhoidectomy

Conditions: HEMORRHOIDECTOMY

Summary: the purpose of this research; to evaluate the effect of preoperative bowel preparation on post-hemorrhoidectomy outcomes. bowel preparation is a routine practice before surgery in anorectal diseases. this study aims to evaluate the effect of bowel preparation using laxatives or enemas on the patient postoperative pain, analgesic consumption amount, comfort, first defecation time and satisfaction, and to evaluate the satisfaction of the surgical team.

the study is planned as a semi-experimental. the effect of bowel preparation using laxatives or enemas on postoperative pain, analgesic consumption, comfort and satisfaction will be evaluated. criteria for inclusion in the research; being a patient who will undergo hemorrhoidectomy with spinal anesthesia and agreeing to participate in the study are the exclusion criteria; refusal to participate in the research was determined as. following the admission of the patient, who is planned to undergo hemorrhoidectomy, to the clinic, the patient will be interviewed, the purpose of the study will be explained and he/she will be invited to participate in the study. written consent will be obtained from patients who agree to participate in the research.

Eligibility criteria:
inclusion criteria: * being a patient who will undergo hemorrhoidectomy surgery with spinal anesthesia * agreeing to participate in the study exclusion criteria: * not accepting participation in the study

Keywords: hemorrhoidectomy bowel preparation pain comfort
a study of rec-4881 in participants with cancers which have an axin1 or apc mutation

Conditions: AXIN1 Gene Mutation; APC Gene Mutation; Solid Tumor

Summary: this is a multi-center, open-label study to investigate the safety, efficacy and pharmacokinetics of rec-4881 (12 mg po daily doses) for the treatment of participants with unresectable locally advanced or metastatic solid tumors with axin1 or apc mutation.

approximately 60 individuals will be enrolled in this open-label phase 2 study, allocated 1:1 between the 2 cohorts - axin1 mutation or apc mutation. the purpose of the study is to investigate the safety, efficacy, and pharmacokinetics of rec-4881 for the treatment of participants with unresectable locally advanced or metastatic solid tumors with either mutation. participants will receive treatment with rec-4881 (12mg po daily) for up to 2 years.

Eligibility criteria:
inclusion criteria: 1. 55 years of age or older with histologically-confirmed unresectable, locally advanced, or metastatic solid tumor with axin1 or apc mutation. if a participant has colorectal cancer, then they must be ras / raf wild type to enroll into the apc mutant cohort 2. have experienced progressive disease, relapsed disease, or be intolerant to at least one established standard systemic anti-cancer treatment, or in the opinion of the investigator have been considered ineligible for standard therapy 3. measurable disease at baseline per recist 1.1 criteria 4. eastern cooperative oncology group (ecog) performance status ≤ 1 exclusion criteria: 1. received treatment with another mitogen-activated protein kinase (mek) inhibitor within two months of first dose of rec-4881 2. left ventricular ejection fraction (lvef) \<50% as measured by echocardiogram (echo) or multigated acquisition (muga) scan

Keywords: axin1 apc locally advanced or metastatic solid tumor
efficacy and safety study to evaluate vadadustat for the maintenance treatment of anemia in participants with non-dialysis-dependent chronic kidney disease (ndd-ckd)

Conditions: Anemia; Non-Dialysis-Dependent Chronic Kidney Disease

Summary: a multicenter, randomized, open-label, active-controlled phase 3 study for the maintenance treatment of anemia in participants with non-dialysis-dependent chronic kidney disease (ndd-ckd)

this is a multicenter, randomized, open-label, active-controlled phase 3 study of the efficacy and safety of vadadustat versus darbepoetin alfa for the maintenance treatment of anemia in participants with ndd-ckd

Eligibility criteria:
inclusion criteria: * ≥18 years of age * diagnosis of chronic kidney disease (ckd) with an estimated glomerular filtration rate ≤60 milliliters per minute per 1.73 square meter (ml/min/1.73 m\^2) at screening and not expected to start dialysis within 6 months of screening * currently maintained on erythropoiesis-stimulating agents therapy, with a dose received within 6 weeks prior to or during screening * mean screening hemoglobin between 8.0 and 11.0 grams per deciliter (g/dl) (inclusive) in the united states (us) and between 9.0 and 12.0 g/dl (inclusive) outside of the us * serum ferritin ≥100 nanograms per milliliter (ng/ml) and transferrin saturation (tsat) ≥20% during screening exclusion criteria: * anemia due to a cause other than ckd or participant with active bleeding or recent blood loss * red blood cell transfusion within 8 weeks prior to randomization * uncontrolled hypertension * severe heart failure at screening (new york heart association class iv) * acute coronary syndrome (hospitalization for unstable angina or myocardial infarction), surgical or percutaneous intervention for coronary, cerebrovascular, or peripheral artery disease (aortic or lower extremity), surgical or percutaneous valvular replacement or repair, sustained ventricular tachycardia, hospitalization for heart failure, or stroke within 12 weeks prior to or during screening * hypersensitivity to darbepoetin or vadadustat or to any of their excipients

Keywords: vadadustat akb-6548 chronic kidney disease anemia ckd chronic renal insufficiency renal impairment erythropoietin kidney renal oral anemia treatment hemoglobin hypoxia-inducible factor hif hypoxia-inducible factor prolyl-hydroxylase inhibitor hif-phi efficacy safety phase 3 cardiovascular ndd-ckd
efficacy and tolerability study of v501 in japanese males (v501-122)

Conditions: Anogenital Human Papilloma Virus Infection; Condyloma Acuminata

Summary: a study to evaluate the efficacy and tolerability of v501 (quadrivalent human papilloma virus \[hpv\] \[type 6, 11, 16 and 18\] l1 virus-like particle vaccine, gardasil™) in healthy, 16- to 26-year old japanese males. the hypotheses tested are: 1) v501 reduces the combined incidence of hpv 6-, 11-, 16-, or 18-related persistent infection compared with placebo, and 2) v501 reduces the combined incidence of hpv 6-, 11-, 16-, or 18-related persistent infection, condyloma acuminata, penile/perianal/perineal intraepithelial neoplasia, or penile, perianal, or perineal cancer compared with placebo.


Eligibility criteria:
inclusion criteria: * japanese * no clinical evidence of gross genital lesion suggesting sexually-transmitted disease and no clinically present external genital warts * other inclusion criteria will be discussed with the investigator during screening exclusion criteria: * history of known prior vaccination with an hpv vaccine or plans to receive one outside the study * history of external genital warts * history of severe allergic reaction that required medical intervention * received immune globulin or blood-derived products in the past 6 months or plan to receive any before month 7 of the study * history of splenectomy, is currently immunocompromised, or has been diagnosed with immunodeficiency, human immunodeficiency virus (hiv), lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition * received immunosuppressive therapy in the past year, excluding inhaled, nasal, or topical corticosteroids and certain regimens of systemic corticosteroids * known thrombocytopenia or coagulation disorder that would contraindicate intramuscular injections * ongoing alcohol or drug abuse within the past 12 months
a study of surufatinib plus sintilimab in patients with advanced solid tumor

Conditions: Advanced or Metastatic Solid Tumors

Summary: the purpose of this study is to evaluate the safety and efficacy of surufatinib plus sintilimab in patients with advanced solid tumor


Eligibility criteria:
inclusion criteria: 1. advanced or metastatic and recurrent cancer where an appropriate treatment option is not available 2. have measurable disease based on recist 1.1 3. life expectancy \> 12 weeks 4. eastern cooperative oncology group (ecog) performance status: 0 or 1 exclusion criteria: 1. any therapy with anti-pd-1, or anti-pd-l1/l2 antibodies or anti-cytotoxic t lymphocyte associated antigen-4 (ctla-4) antibody (or any other antibody acting on t cell costimulatory or checkpoint pathway) or fruquintinib treatment in previous; 2. prior receipt of surufatinib 3. history of any active autoimmune disease or autoimmune disease, including but not limited to interstitial pneumonia, uveitis, inflammatory bowel disease, hepatitis, pituitary inflammation, vasculitis, systemic lupus erythematosus, etc. (except patients with hypothyroidism that can be controlled only by hormone replacement therapy and patients with type i diabetes who only need insulin replacement therapy) 4. history of gastrointestinal perforation and/or fistula, ileus, inflammatory bowel disease, or extensive enterotomy (partial colectomy or extensive enterotomy with chronic diarrhea), crohn's disease, ulcerative colitis, or chronic diarrhea within 6 months prior to first dosing 5. any life-threatening bleeding event or grade 3 or 4 bleeding requiring blood transfusion, endoscopy, or surgery with 3 months prior to dosing.
effects of diacutaneous fibrolysis over neuromuscular response

Conditions: Myofascial Pain Syndrome; Contraction

Summary: the study consists in evaluating the neuromuscular response of the gastrocnemious muscles before and after a diacutaneous fibrolysis over the gastrocnemious muscles.


Eligibility criteria:
exclusion criteria: * muscle injury in the last two months * to not understand the study orders * suffer a musculoskeletal disorder that doesn't allow the subject to do the study protocol

Keywords: neuromuscular response diacutaneous fibrolysis
observational study to observe the safety of levemir® treatment in children and adolescents with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this observational study is conducted in europe. the trial aims to observe the incidence of serious adverse drug reactions in children and adolescents with type 1 diabetes during levemir® treatment.


Eligibility criteria:
inclusion criteria: * informed consent obtained prior to any trial-related activities * any patient with diabetes type 1 is eligible for the study, including newly * the selection of the patients will be at the discretion of the individual physician exclusion criteria: * type 2 diabetes * currently treated with levemir®