Kornimate/medical-research-clean huggingface dataset:
platelet reactivity according to ticagrelor dose after transcatheter aorticvalve implantation

Conditions: Symptomatic Aortic Stenosis

Summary: the narrowing of the aortic valve, which prevents blood from reaching the entire body correctly is a common disease in our environment. to correct this problem, many patients undergo transcatheter aortic valve implantation (tavi) according to standard clinical practice. patients have to continue with a specific pharmacological treatment (antiplatelet agents) to avoid possible complications during the first months after the procedure. this treatment is not yet well established. current guidelines recommend dual antiplatelet therapy with aspirin and clopidogrel for 3-6 months after tavi to avoid thromboembolic complications. but the risk of bleeding events with dapt in this population is not negligible. this study aims to determine the degree of response to ticagrelor 60 mg every 12 hours as a single antiplatelet strategy in patients who do not achieve an adequate response with clopidogrel 75mg every 24 hours. the study will evaluate if patients have an adequate response to clopidogrel and if not, then patients will start treatment with ticagrelor 60 mg every 12 hours after tavi and until completing 3 months of treatment.


Eligibility criteria:
inclusion criteria: * diagnosed with severe symptomatic aortic stenosis * accepted for transfemoral tavi by a heart team decision * evaluation of platelet reactivity assessed by verifynow® assay prior tavi exclusion criteria: * contraindication to tavi * tavi performed by a different access route than transfemoral * ned for oral anticoagulation therapy * history of intracranial hemorrhage * ischemic stroke the 14 days before tavi * active pathological bleeding or diathesis * moderate to severe hepatic impairment * use of strong cyp34a inhibitors or inducers * contraindications to dapt for 3 months * contraindication to clopidogrel or ticagrelor * platelet count \<50,000 * pregnancy or breastfeeding

Keywords: transcatheter aortic valve implantation (tavi) transcatheter aortic valve replacement (tavr) antiplatelet therapy ticagrelor clopidogrel
autologous stem cell transplantation in chronic lymphocytic leukemia

Conditions: Chronic Lymphocytic Leukemia

Summary: phase iii trial evaluating the role of autologous stem cell transplantation in previously untreated patients under 65 years with stage b and c b-cell chronic lymphocytic leukemia. endpoints of the trial : * major : progression free survival at 3 years * secondary : overall survival, tolerance, prognostic factors according to baseline clinical stage and biological characteristics (ighv mutational status, expression of zap70 and cd38, cytogenetics).

all registered patients will be treated with 6 monthly courses of chemotherapy. first three ones will be a chop regimen with half dosage of adriamycin, as previously published (effectiveness of "chop" regimen in advanced untreated chronic lymphocytic leukemia. french cooperative group on chronic lymphocytic leukemia. lancet ; 1986, i : 1346-1349), followed by three subsequent courses with iv fludarabine (25 mg/sqm d1-5). patients in cr (nci, 1996, including cat scan evaluation) will be then randomized to surveillance without additional treatment or autologous stem cell transplantation using peripheral stem cells collected after the three first courses of chemotherapy, and/or after the completion of the six courses when necessary. for patients not in cr after the six courses, a rescue regimen with the dhap association ( cisplatin, 100 mg/sqm d1, cytarabine 2 g/sqm d2, dexamethasone 40 mg/sqm d1-4) will precede an additional stem cell collection if necessary, and patient will be randomized between autologous stem cell transplantation and three additional courses of an association of fludarabine (25 mg/sqm d1-3) and cyclophosphamide (300 mg/sqm d1-3). conditioning regimen will associate tbi (10 grays, d -3-1) and cyclophosphamide (60 mg/sqm d-5-4). evaluation for response wil be performed before randomisation and two months after completion of therapy in each arm. follow-up data will be registered and monitored every three month during the first year, and then every six month. criteria for evaluation of response will use the nci system (1996).

Eligibility criteria:
inclusion criteria: * patients with stage b \& c cll, 18- 65 years. * previously untreated * given written informed consent exclusion criteria: * childbearing women * oms performance status \> 2 * binet stage a * autoimmune hemolytic anemia * active or previous (\< 5 years) malignant disease, except cutaneous cell carcinoma. * previous cll treatment * hiv seropositivity * abnormal renal or liver function tests (creatinine \> 1,5n, transaminases \> 2n, bilirubin \> 1,5n) * cardiac failure (ejection fraction \< 50%) * lung disease or perturbed ventilation tests

Keywords: chronic lymphocytic leukemia, autologous stem cell transplantation
a prospective registry of pediatric cellular therapy patients at risk for endothelial dysfunction, sinusoidal obstruction syndrome and/or multi-organ dysfunction syndrome (mods).

Conditions: Hematopoietic Cell Transplantation

Summary: this is a prospective international multi-center registry and biorepository trial of children and adolescents/young adults (aya) undergoing hematopoietic cell transplantation (hct) to assess the impact of endotheliopathies in the hct setting as a contributor of significant morbidity and mortality.

primary: * to evaluate the proportion of pediatric patients undergoing hematopoietic cell transplant (hct) who develop endotheliopathies (sos, tma, dah and ips) and/or mods within 100 days of such therapies. * to evaluate the proportion of pediatric patients undergoing hematopoietic cell transplant (hct) who experience abnormal levels of circulating angiogenic, vascular permeability and inflammatory factors within 100 days post hct-ct in the setting of endotheliopathies. secondary/exploratory objective(s): * to determine the impact of endotheliopathies in the hct setting on the overall survival. * to assess the efficacy of specific prophylaxis and treatment strategies directed at endotheliopathies (sos, tma, dah and ips) post-hct among enrolled children on overall survival. * to assess whether exposure to immunotherapies (car-t, pd-1 inhibitors, bispecific t-cell engager (bite) antibodies and antibody drug conjugates) prior to hct affects post-hct outcomes (endotheliopathies and mods).

Eligibility criteria:
inclusion criteria: * children, adolescents and young adults (aya) 0-26 years of age undergoing hsct. * recipients of autologous and allogeneic hsct. * any preparative regimen. exclusion criteria: * any patient who does not consent/assent to participation. * any patient for whom 5 ml blood sample(s) drawn at specified intervals would pose any more than minimal risk, as defined by institutional guidelines and at discretion of treating physician will be ineligible for biorepository banking.
juvenile inflammatory rheumatism (jir) cohorte

Conditions: Arthritis, Juvenile Rheumatoid

Summary: the investigators created a cohort of patients with juvenile inflammatory rheumatisms with the purpose to follow them prospectively, and investigate the tolerance and efficacy of immunosuppresive and biological agents.

the jir-cohort has to be filled by an authorized investigator during or after the consultation. each patient much be followed at least once a year. different data are requested in the jir-cohort: diagnosis, treatment, adverse events and outcome.

Eligibility criteria:
inclusion criteria: * patients with juvenile inflammatory diseases * age at onset up to 18 years old * consent according national codes of ethics and current laws exclusion criteria: * non-consent from patients and/or legal representative

Keywords: juvenile inflammatory rheumatism pediatric-onset inflammatory diseases
efficacy of splinting, exercise and electrotherapy on hallux valgus

Conditions: Hallux Valgus

Summary: the aim of this study was to investigate the effects of splinting, exercise and electrotherapy on the hallux valgus (hv) angle, and foot-specific health-related quality of life. sixty women (120 feet) with bilateral hv deformity were randomly assigned to one of three groups - an hv night splint (sp) group, an exercise (ex) group, and a high-voltage galvanic stimulation (el) group. angular degrees (hallux interphalangeal, hv, and intermetatarsal angles expressed as angles a, b and c, respectively) were determined before enrollment (t0) and three months after treatment (t2). foot-specific quality of life was assessed using the manchester-oxford foot questionnaire (mofq) at t0, after one month (t1), and at t2. all groups exhibited significant changes in the a, b, and c angles and outcome measures (p ≤0.001). decreases in the a and c angles, and mofq-pain subscale scores, were higher in the sp group than in the other two groups (p\<0.05). c angle at t2, mofq-walking score at t1 and t2 and mofq-pain subscale score at t1 were lower in the sp group (p\<0.05).


Eligibility criteria:
inclusion criteria: * a diagnosis of hv confirmed by an orthopedist experienced in foot surgery * female gender * bilateral hv deformity * aged 18-60 years. * patients were then selected based on an hv deformity degree of '2' or '3' on the manchester scale before randomization exclusion criteria: * patients with hv deformity degrees less than '2' or more than '3' according to the manchester scale * patients with systemic disease, cognitive or mental disturbance, a history of surgery to the lower extremity, or previous use of any foot splints were excluded.

Keywords: hallux valgus night splint exercise high voltage galvanic stimulation radiographic angular degree foot-specific health-related quality of life
the association of maternal night-eating pattern with glucose tolerance during pregnancy

Conditions: Metabolic Disease

Summary: this study aims to assess the associations of maternal food timing with glucose levels during pregnancy.

a novel line of research has emerged, suggesting that synchronizing the timing of food intake with body's circadian rhythms or day-night cycle has metabolic implications. eating at the inappropriate time can disrupt circadian system which might induce metabolic perturbations, including glucose abnormalities. recent evidence showed that circadian timing of eating was associated with glucose regulation in pregnant women. however, little is known about night-eating pattern during pregnancy, particularly the influence of nocturnal snacking on glycaemic control. this cross-sectional study aims to recruit 400 pregnant women at 18-21 weeks' gestation. the investigators will assess maternal dietary intake, monitor 24-hour activity-rest pattern and light-dark exposure, and measure glucose and insulin profiles during the second trimester of pregnancy. maternal socio-demographic status, lifestyle characteristics, health conditions and pregnancy outcomes will be asked through interview or retrieved from medical notes. this study allows understanding the importance of circadian eating pattern, which is a modifiable behavior, in glycaemic control during pregnancy, and help to provide evidence for developing nutritional guidelines which can ameliorate metabolic health for mothers.

Eligibility criteria:
inclusion criteria: 1. 18-21 week's gestation 2. singapore citizens or singapore permanent residents 3. age 18-45 years 4. plan to follow-up for antenatal care in kk women's and children's hospital 5. intend to deliver in kk women's and children's hospital 6. provide written informed consent exclusion criteria: 1. type 1 or 2 diabetes 2. diabetes in pregnancy as confirmed by oral glucose tolerance test 3. use of medications such as anticonvulsant medications or oral steroids in the past 1 month 4. multiple pregnancy 5. on routine night-shift work for at least 3x/week over the past 1 month 6. known or suspected allergy to medical grade adhesives 7. chronic kidney diseases 8. preeclampsia 9. eventual miscarriage or undergo termination event

Keywords: food timing gestational diabetes mellitus glucose tolerance night-eating pregnancy outcomes snacking
the use of drugs to improve kidney function in patients with liver and kidney dysfunction

Conditions: Type 2 Hepatorenal Syndrome; Refractory Ascites

Summary: we will address the hypothesis that refractory ascites and type 2 hepatorenal syndrome are mediated in part by diminished circulatory volume and that treatment with midodrine, octreotide and albumin can improve renal and patient outcomes by restoring effective circulating volume and systemic perfusion. our primary objective is to assess change in creatinine clearance using inulin. we will enroll 15 patients with type 2 hepatorenal syndrome or refractory ascites once inclusion and exclusion criteria are satisfied. they will be treated for 1 month with octreotide lar, albumin and midodrine. renal, serum and neurohormonal parameters will be measured before, during, and after initiation of drug and compared.


Eligibility criteria:
inclusion criteria: * cirrhosis (biopsy or compatible clinical (ascites, varices), laboratory (low albumin, elevated bilirubin, elevated inr) and radiologic data (nodular appearing liver on ultrasound)). type 2 hepatorenal syndrome and/or refractory ascites exclusion criteria: * secondary causes of renal dysfunction (proteinuria \>500 mg/day, active urinary sediment, abnormal renal ultrasound, nephrotoxic medications) bacterial infection (positive blood, urine or ascites cultures) within the past 2 weeks gastrointestinal hemorrhage or encephalopathy within the past 2 weeks age \<18 transvenous intrahepatic portosystemic stent shunt (tips) hepatocellular carcinoma beyond the milan criteria

Keywords: hepatorenal syndrome refractory ascites midodrine octreotide albumin cirrhosis
non-interventional study (nis) in patients with advanced and/or metastatic renal cell carcinoma (mrcc) treated with sutent®

Conditions: Metastatic Renal Cell Carcinoma

Summary: primary objective: to increase knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of sutent®. secondary objectives: treatment response, hypothyroidism prevalence.the efficacy will be assessed using the objective response rate, time to progression based on the recist criteria and the ecog performance data.

180 patients will be enrolled at 20 key oncological centres, the sample size is sufficient for exploratory analysis.

Eligibility criteria:
inclusion criteria: * patients with advanced or metastatic renal cell carcinoma. exclusion criteria: * no previous cytokines therapy.

Keywords: safety and tolerability of sutent® in patients with metastatic or advanced renal cell carcinoma after failure of cytokines in real-life setting.
effects of nerchal exercises on lateral epicondylitis.

Conditions: Lateral Epicondylitis

Summary: painful condition of lateral epicondyle of the humerus characterized by the inflammation of the tendons during loading of the wrist extensor muscles is a common musculoskeletal presentation in men and women between 35 and 54 years of age. the above symptom is associated with a clinical diagnosis of lateral elbow tendinopathy (let), also known as tennis elbow or lateral epicondylalgia the two effective treatment approaches for lateral epicondylitis are nirschl exercises and mulligan taping. this study aims to evaluate the effectiveness of nirschl exercises with or without mulligan taping in treating lateral epicondylitis. the study design for this project employs a randomized controlled trial and a sample of individuals with lateral epicondylitis randomly assigned in one of the two groups i.e., nirschl exercises only and nirschl exercises with mulligan taping. nirschl exercises involve the eccentric strengthening of the wrist extensor muscles and forearm. the participants in both groups will receive nirschl exercises while the second group will also receive mulligan taping, which involves the application of tape to the lateral aspect of the elbow to offload stress during movement of the extensor tendons. different outcome measures including pain intensity, functional disability, grip strength, range of motion will be evaluated using, prtee scale, visual analogue scale (vas) and calibrated jammer hand held dynamometer. statistical analysis, including independent t-tests or chi-square tests, will be conducted to compare the outcomes between the two groups. the significance level will be set at p \< 0.05. this study will contribute to the evidence base regarding the efficacy of nirschl exercises and mulligan taping in managing lateral epicondylitis and will help the clinicians and patients in deciding the best treatment approach for lateral epicondylitis.


Eligibility criteria:
inclusion criteria: * pain and tenderness over lateral epicondyle * at least two out of three tests for the lateral epicondylitis including cozen's test, mill's maneuver, or resisted middle finger extension positive exclusion criteria: * individuals with a history of recent trauma of upper limbs * recent administration of platelet-rich plasma containing growth factors, * patients which had taken physical therapy of any sort in the past 6 months * occupation-related pain were ruled out.
observational longitudinal study in children affected by idiopathic growth hormone deficiency (ghd)

Conditions: Growth Hormone Deficiency

Summary: the aim of this study is to assess the developmental patterns of lung function in children affected by growth hormone deficiency after one year of gh therapy.the assessment by specific questionnaires of quality of life and of parental stress index.parameters will be evaluated at the time of the diagnosis and after 12 months of gh therapy.

observational longitudinal study in children affected by idiopathic growth hormone deficiency (ghd): lung function parameters assessment; quality of life assessment; stress parenting assessment (pneumo ghd). the aim of this study is to assess the developmental patterns of lung function in children affected by growth hormone deficiency after one year of gh therapy.the assessment by specific questionnaires of quality of life and of parental stress index.parameters will be evaluated at the time of the diagnosis and after 12 months of gh therapy.

Eligibility criteria:
inclusion criteria: * gh deficiency exclusion criteria: * respiratory infections 4 weeks before the recruitment * children with autoimmune diseases * therapy with drugs able to modify the lung function

Keywords: ghd
hypo-fractionated radiation therapy for localized prostate cancer

Conditions: Prostate Cancer

Summary: the aim of this study is to determine the maximum tolerated dose of hypo-fractionated radiation therapy and the toxicity of the treatment program. eligible patients with stage t1-2c prostate cancer who sign consent will be enrolled to this phase i dose escalation trial and be treated with hypo-fractionated radiation therapy (hrt). dose escalation will be as follows: there will be 3 cohorts consisting of 3 patients each.

dose escalation will be as follows: there will be 3 cohorts consisting of 3 patients each. all patients will receive 18 fractions of hrt over the course of 6 weeks (3 fractions per week). dose level i will be 54gy (3 gy per fraction), dose level ii will be 55.8 gy (3.1gy per fraction), dose level iii will be 57.6 gy (3.2 gy per fraction). after accrual of dose level i, all patients will be observed for a minimum of two weeks after completion of radiation treatments, for assessment of toxicity, before the dose can be escalated for the next cohort. after dose level ii, patients will be observed for 6 months before enrolling patients on dose level iii. all patients will be seen weekly by their radiation oncologist during radiation therapy. any observations regarding radiation reactions will be recorded.

Eligibility criteria:
inclusion criteria: * history/physical examination with digital rectal examination of the prostate within 8 weeks prior to registration * clinical stage t1-2c (ajcc 6th edition) * gleason \<6 and psa \<10 ng/ml * gleason =7 and/or psa 10-20 ng/ml provided \<34% of core biopsies are positive for carcinoma * psa \< 20 ng/ml within 180 days prior to registration. psa should not be obtained for at least 10 days after prostate biopsy. * zubrod performance status 0-1 * age ≥ 18 * patient must sign study specific informed consent prior to randomization. exclusion criteria: * prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years. (for example, carcinoma in situ of the bladder or oral cavity is permissible) * evidence of distant metastases * regional lymph node involvement * previous radical surgery (prostatectomy) or cryosurgery for prostate cancer * prior androgen deprivation therapy (adt) * previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy * previous or concurrent cytotoxic chemotherapy for prostate cancer

Keywords: localized prostate cancer radiation
a study evaluating the safety of elexacaftor/tezacaftor/ivacaftor in participants with cystic fibrosis (cf)

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to evaluate the safety and tolerability of elexacaftor (elx)/tezacaftor (tez)/ivacaftor (iva) in participants with cf who are 12 years of age or older.


Eligibility criteria:
key inclusion criteria: * completed study drug treatment in parent study (vx19-445-117 \[nct04599465\] or vx20-445-126 \[nct04969224\]), or had study drug interruption(s) in parent study but completed study visits up to the last scheduled visit of the treatment period in the parent study key exclusion criteria: * history of drug intolerance in a parent study other protocol defined inclusion/exclusion criteria may apply.
are audiovisual materials superior to printed materials in improving awareness among type 2 diabetic patients?

Conditions: Diabetes Mellitus

Summary: this research evaluates the effectiveness of video educations against patients fixed believes and knowledge that either not precise or overestimated, and compare with classic educational method such as brochure. as many researches indicates the difficulties to initiate insulin therapy for type 2 diabetic patients due to overestimated barriers such as needle anxiety, feelings of guilt and failure, concerns about hypoglycemia, sense of loss of control over one's life and reduced quality of life. this research will introduce different educational tools to evaluate their effectiveness in breaking psychological insulin barriers.

introduction this research evaluates the effectiveness of video educations against patients fixed believes and knowledge that either not precise or overestimated, and compare with classic educational method such as brochure. as many researches indicates the difficulties to initiate insulin therapy for type 2 diabetic patients due to overestimated barriers such as needle anxiety, feelings of guilt and failure, concerns about hypoglycemia, sense of loss of control over one's life and reduced quality of life. this research will introduce different educational tools to evaluate their effectiveness in breaking psychological insulin barriers. methodology it's a randomized controlled trial. validated questionnaire (itas) was used to evaluate the psychological insulin barriers, video and brochures were devolved as educational materials contain same contents and validated. study conducted in king abdulaziz city housing with total sample size of 126. they were divided into intervention group (video group) and controlled group (brochure group). both group filled the same questionnaire before the intervention. and then immediately after the intervention. six weeks later, both groups filled the same questionnaire to measure the long-term effects.

Eligibility criteria:
inclusion criteria: 1. type 2 diabetic patients 2. age group from 30 to 70 years 3. a1c = 8 mg/dl or above 4. both genders exclusion criteria: 1. pregnant women 2. blindness or profound vision loss 3. severe mental problems e.g. psychosis

Keywords: diabetic education audiovisual material manual material