Kornimate/medical-research-clean huggingface dataset:
efficacy of chemoradiotherapy after neoadjuvant cisplatin and docetaxel in the nasopharynx carcinoma

Conditions: Head and Neck Neoplasms

Summary: * to assess the efficacy of docetaxel, cisplatin combination in terms of disease free survival. * time to progression of the disease in terms of local and distant failure; assess the survival time, and assess the objective (clinical and radiological) response rate and the safety of the treatment.


Eligibility criteria:
inclusion criteria: * histologically/cytologically confirmed, patients with stage t2b-t4n1 or tanyn2-3 undifferentiated or nonkeratinized squamous cell carcinoma of nasopharynx who are candidate for curative radiotherapy. * ecog performance status is 0-1 * weight loss within last 6 months \<10% of body weight * acceptable haematological profile (as defined by a leukocyte count ≥ 4000/mm3, a platelet count ≥ 100.000mm3 and hb ≥ 9g/100ml), and adequate renal function (as defined by serum creatinine ≤ 1.5mg/dl), and hepatic function (as defined by bilirubin ≤ 1.5 x maximum normal value even with hepatic metastasis; transaminases (alt, ast) ≤ 1.5 x maximum normal value; alkaline phosphatase ≤ 2.5 x maximum normal value, except in case of a bone metastasis) exclusion criteria: * patients with stage ivc or metastatic disease * patients treated with chemotherapy for nasopharyngeal cancer * patients treated with radiotherapy to head and neck region * concomitant use of another anti-cancer therapy * patients treated with amifostine or pilocarpine during protocol treatment. * unstable medical condition that makes the patient unable to take part in a clinical study (congestive heart failure, serious arrhythmia, uncontrolled diabetes mellitus), history of myocardial infarction within last 6 months, massive pleural, peritoneal or pericardial effusion; or presence of serious uncontrolled infection. * presence of other tumours different from carcinoma of the skin except melanoma and carcinoma in situ of the breast and cervix with disease free survival less than 5 years. * pregnancy or breastfeeding. in women of childbearing potential and in men, an adequate contraceptive method must be used * social or psychological condition that render the patient inadequate for the follow-up of the study * contraindication for any of the study drugs (e.g. history of hypersensitivity to any of the ingredients of the study drugs) the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
collection of human metabolic tissues

Conditions: Obesity; Insulin Resistance; Diabetes Mellitus, Type 2

Summary: this project aims at identifying new determinants of type 2 diabetes in severe obesity. to do so, a biological collection, including tissues of interest in the field of metabolism, will be collected during bariatric surgery in obese patients. three different groups of metabolic status of patients, corresponding to different stages of evolution of the disease, will be constituted: type 2 diabetes, insulin resistance, insulin sensitivity. the main objective is to compare, between these 3 groups of patients, several biological processes that may be involved in the pathophysiology of type 2 diabetes and disorders associated with obesity, including: * abnormalities of the transcriptome, proteome, metabolome in all target tissues (plasma, serum, muscle, subcutaneous and visceral adipose tissue, omental artery, liver) * identification of metabolic signatures, protein and mirna in plasma * immunoinflammatory response in adipose tissue * polymorphisms snp from whole blood * histological analysis of tissue sections this main objective will be studied on samples taken at the time of surgery secondary objectives will be to study the changes in metabolites, proteins and mirna in plasma level 3 and 12 months after the completion of surgery, according to the initial metabolic state.


Eligibility criteria:
inclusion criteria: 1. written informed consent 2. age 18 - 65 years inclusive at surgery 3. imc \> 35 4. subject qualified for bariatric surgery (sleeve gastrectomy or gastric bypass) 5. specific criteria : * type 2 diabetes group (d) (90 patients) : type 2 diabetes according to ada criteria * insulin resistance non diabetes group (ir) (80 patients) : homa-ir criteria ≥ 3 * insulin sensitivity non diabetes group (n) (100 patients) : n1.homa-ir criteria \< 3 non inclusion criteria: 1. vulnerability according to article l1121-6 of the public health code 2. protected adult or unability to give consent according to article l1121-8 of the public health code 3. unability to understand the design and aims of the study or to communicate with the investigator 4. non affiliation to a social security system 5. prior bariatric surgery (except lap-band procedure) 6. serologic profile indicating hepatitis b, hepatitis c or hiv infection 7. inflammatory, infectious or autoimmune disease (current or in the previous 3 month) 8. malignancies within 5 years prior to inclusion or not considered as treated curatively 9. concomitant use of steroids or nsai or use in the 8 days before surgery 10. alcohol abuse/addiction 11. anticipated poor compliance to study procedures 12. other type of diabetes than type 2 exclusion criteria : 1. cancelled bariatric surgery 2. tissue collection not possible during the bariatric surgery

Keywords: bariatric surgery
management of infants born to group b streptococcus positive mothers.

Conditions: Group B Streptococcus; Sepsis; Infant, Newborn

Summary: intrapartum antibiotic prophylaxis has greatly decreased but not abolished early-onset neonatal sepsis caused by gbs. according to current recommendations, the evaluation of infants at risk for gbs sepsis should include a complete blood count (cbc), wbc differential, a blood culture (bc) and a period of observation. the usefulness of cbc and bc in the evaluation process is not firmly established.

after implementation of appropriate guidelines, early-onset gbs sepsis has become a low incidence disease (cdc). recent rates are as low as 0.34 cases /1000 live births. according to cdc recommendations, the evaluation of infants at risk for gbs sepsis should include a complete blood count (cbc), wbc differential, a blood culture (bc) and a period of observation. the usefulness of cbc and bc in the evaluation process is not firmly established. there are several reviews on the predictive value of cbc and putative markers of early onset neonatal sepsis, but there seems to be no ideal laboratory test to assist the clinician in the diagnosis (fowlie 1998, malik 2003, ottolini 2003). given the continuing concerns about the reliability of laboratory tests, one may ask the question of whether physical examination might be at least as good as haematological indices. we are not aware of studies assessing the value of physical examination vs cbc, in the evaluation of asymptomatic at risk newborns. the aim of this study was to compare two approaches in the management of infants at risk for gbs sepsis: laboratory tests (cbc, differential and bc) with observation vs clinical observation alone.

Eligibility criteria:
inclusion criteria: * all newborns born in friuli venezia giulia region (italy)

Keywords: group b streptococcus sepsis infants diagnosis physical examination laboratory tests
is intraoperative pth monitoring obsolete in times of choline pet/ct? a prospective multicenter cohort study to determine whether the regular preoperative use of choline-pet/ct scan obviate the need for intraoperative pth-measurement in patients with primary hyperparathyreoidism

Conditions: Primary Hyperparathyroidism

Summary: in patients with primary hyperparathyreoidism (phpt) in 80-90% only one of the four parathyroid glands has developed an autonomy and is causative for the disease. localisation diagnostics are used to help identify the affected gland or glands in order to enable more focused surgical approaches and reduce morbidity of the surgery, as well as operative time. the gold standard for imaging in germany and austria are sonography and scintigraphy. if imaging is not conclusive, choline-pet/ct, which has been shown to have a higher specificity than the scintigraphy, especially for multiglandular disease, is performed mostly in austria, but only on special indications in germany. in switzerland, as of 2023 the choline-pet/ct has replaced the scintigraphy and is routinely performed in patients with indication for parathyroidectomy in many hospitals. the current s2k guideline recommends to perform an intraoperative pth measurement before and 10 minutes after removal of the parathyroid gland in order to assess the success of the surgery. due to the short half-life of pth of around three minutes, a pth drop of 50% or into the normal range within 10 minutes of removal of the suspected gland has a high sensitivity and specificity for cure. if pth drop is inadequate, further gland exploration is performed. the intraoperative measurement of pth is associated with waiting time in the or and uncertainty if the next patient can be anesthetized, prolonging surgeries by 30-60 minutes depending on the local facilities. if the choline-pet/ct is sufficiently sensitive and specific in detecting both uni- and multiglandular disease, surgery according to choline-pet/ct findings could make waiting for intraoperative pth drop unnecessary. the aim of the study is to determine whether the regular use of choline-pet/ct can obviate the need for intraoperative pth-measurement with the potential to shorten the length of parathyroid surgeries. this could save considerable costs and justify the regular use of choline-pet/ct.


Eligibility criteria:
inclusion criteria: * phpt, preoperative choline-pet, intraoperative pth exclusion criteria: * no consent
a study to test how new long-acting insulin (insulin icodec) works in the body of children and teenagers

Conditions: Diabetes Mellitus, Type 2

Summary: insulin icodec is a new medicine which is under development for use in humans and is not yet available at the pharmacy. it is being developed for the treatment of diabetes, a condition that causes high blood sugar levels. insulin icodec will be investigated in participants with type 2 diabetes. participant will get one dose of insulin icodec, which will be administered in the afternoon or evening of the day of dosing. the study will last for about 8 weeks. insulin icodec will be injected into a skin fold with a small needle (subcutaneous application) using a pen injector prefilled with a volume of 3 milliliter (ml) (a little less than a quarter of a teaspoonful). the amount of insulin icodec participant will receive depends on participant's body weight. participant must not participate if participant meets certain conditions called exclusion criteria, such as an age of above 18 years when the informed consent is signed or has serious health conditions. female participant cannot take part if she is pregnant, breast-feeding or planning to become pregnant during the study period.


Eligibility criteria:
inclusion criteria: * male or female * aged 10 to less than (\<) 18 years at the time of signing informed consent * diagnosed with type 2 diabetes mellitus greater than or equal to (\>=) 30 days prior to the day of screening * glycated haemoglobin (hba1c) less than or equal to (\<=) 10% (86 millimoles per mole \[mmol/mol\]) at screening * treated with basal insulin, premix insulin or continuous subcutaneous insulin infusion (csii) with or without bolus insulin or additional anti-diabetic drug(s). * current daily basal insulin treatment \>= 0.2 (i) units per kilogram per day (u/kg/day) with stable doses \>=30 days prior to the day of screening exclusion criteria: * known or suspected hypersensitivity to study interventions or related products * female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method
assess efficacy, immune response & safety of 2 doses of oral live attenuated hrv vaccine at different viral concentrations in healthy infants

Conditions: Hepatitis B

Summary: to assess the efficacy, immune response and safety of 2 doses of hrv vaccine (at different concentrations) in healthy infants aged approximately 3 months previously uninfected with human rotavirus.


Eligibility criteria:
inclusion criteria: * healthy infants 11 and 17 weeks of age at the time of the first vaccination, born after a normal gestation period (between 36 and 42 weeks). * written informed consent obtained from the parents or guardians of the subject. exclusion criteria: * use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * previous vaccination against or history of or intercurrent diphtheria, tetanus, pertussis, polio and/or hib. * chronic administration of immunosuppressants or other immune-modifying drugs since birth. (topical steroids are allowed.) * use of antibiotics during the period starting from 7 days before each dose of vaccine(s) and ending 7 days after. * any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gi tract or other serious medical condition as determined by the investigator. * any confirmed or suspected immunosuppressive or immunodeficient condition, including hiv infection. * history of allergic disease or reaction likely to be exacerbated by any component of the vaccine. * ge within 7 days preceding the study vaccine administration (warrants deferral of the vaccination). * household contact with an immunosuppressed individual or pregnant woman. * administration of immunoglobulins and/or blood products since birth or planned administration during the study period. * previous confirmed occurrence of rv ge.

Keywords: oral live attenuated human rotavirus vaccine gastroenteritis vomiting
a comparison of cpap with and without humidification: a pilot study

Conditions: Obstructive Sleep Apnea

Summary: to compare a group of patients with our standard treatment of continuous positive airway pressure (cpap) and another group of patients with cpap and a humidifier attached. the therapy cost and the successfulness of the treatment will be measured. a humidifier is a water chamber that is currently added to cpap only if the patients needs it.


Eligibility criteria:
inclusion criteria: * older than 18 years of age * diagnosed with osa (obstructive sleep apnea) and eligible for cpap treatment under local requirements (nice guidelines: ahi (apnea hypopnea index) ≥ 15, or ahi \> 5 with significant daytime sleepiness) * naïve to cpap therapy, i.e. have not been prescribed, or used cpap in the last 5 years. * fluent in spoken and written english exclusion criteria: * significant uncontrolled cardiac disease, as per the principal investigator's discretion * co-existing lung disease, as per the principal investigator's discretion * co-existing sleep disorder, such a predominant central sleep apnoea * pregnancy * participants that are unable or unwilling to give informed consent.
the effectiveness of kinesio taping in violin players

Conditions: Pain, Neck; Pain, Joint; Pain, Shoulder; Occupational Diseases; Musculoskeletal Pain

Summary: this study aimed to investigate the effectiveness of kinesio taping (kt) on playing-related pain, upper extremity and hand function, grip and pinch strength in violin players. one hundred seventeen participants who were professional violinists for at least two years were randomized to receive either therapeutic tape application (kt group), a sham tape application (placebo group) or no application (control group) for one week. the primary outcome was the disabilities of the arm, shoulder and hand (dash) in one week. the secondary outcomes were the visual analogue scale (vas), the purdue pegboard test, grip and pinch strength. outcome measures were performed at baseline, immediately after the intervention, and one week later (follow-up). participants were asked to play the "violin concerto no.2, op.35", and pre-and post-performance pain and grip and pinch strength were assessed.

kinesio tape (kt), an alternative taping technique, is a method consisting of a tape with elastic properties and stretching capabilities used to treat pain or prevent injuries in conjunction with exercise.it has been concluded that kt intervention might not be helpful to reduce dystonic patterns or improve playing ability in musicians with focal hand dystonia. however, there is no enough study to conclude the effectiveness of kt application in playing-related musculoskeletal disorders. therefore, this study aimed to investigate the effect of kt on playing-related pain, upper extremity and hand function, grip and pinch strength in violin players compared to placebo kt application and control. as a secondary outcome, the investigators explored whether the pre-and post-performance effect of the kt on playing-related pain and grip and pinch strength.

Eligibility criteria:
inclusion criteria: 1. aged between 18 and 35 years; 2. professionally playing violin at least for two years; 3. having playing-related musculoskeletal pain at neck and upper extremity \[visual analogue scale (vas) ≥3\] 4. ability to read and write in turkish; and 5. able to follow simple instructions. exclusion criteria: 1. having significant musculoskeletal, neurologic, or cardiovascular disorders; 2. a history of surgery on the upper limbs in the previous six months; 3. the initiation of any analgesic intervention for musculoskeletal pain within the previous six weeks; 4. known allergies to tape; and 5. participation in physiotherapy and rehabilitation program in the last six months.
effects of progressive elastic band resistance training

Conditions: Prader-Willi Syndrome; Resistance Training

Summary: abnormal body composition with increased body fat mass and decreased lean body mass has been found in adults with prader-willi syndrome (pws), contributing to reduced physical capacity and impairment. the aim of this study was to investigate whether progressive elastic band resistance training can improve physical motor performance and regional body composition in adults with pws.

six participants were enrolled in this pilot study. following 24 weeks of progressive elastic band resistance exercise training, significant reduction was observed in their body weight, bmi, and regional extremities fat mass and percentage. regarding the functional performances, there were also significant improvements in their hand grip strength, 3 meter timed up and go, 30 seconds sit to stand, and 2-min step up tests, as early as the 8th week of training. balance function achieved significant improvements after 16 weeks of training.

Eligibility criteria:
inclusion criteria: * pws individuals who can cooperate with motor performances exclusion criteria: * arthritis, fracture, or severe musculoskeletal deformities that would interfere with exercise training or motor performance * severe cognitive impairment or parents who cannot read nor write.

Keywords: prader-willi syndrome resistance training body composition
balloon pump assisted coronary intervention study

Conditions: Coronary Artery Disease; Left Ventricular Dysfunction

Summary: this study will test the hypothesis that elective use of the intra-aortic balloon pump (iabp) in patients undergoing high-risk percutaneous coronary intervention (pci) will reduce the rate of in-hospital major adverse cardiac and cerebrovascular events compared to patients who are managed without planned insertion of iabp.


Eligibility criteria:
inclusion criteria: * impaired left ventricular function (ejection fraction \< 30%) * large area of myocardium at risk (bcis-1 myocardial jeopardy score ≥ 8/12) exclusion criteria: * cardiogenic shock * acute stemi within previous 48 hours * complications of recent ami (including ventricular septal defect, severe mitral regurgitation, intractable ventricular arrhythmias) * contraindications to iabp use (including significant iliac or femoral arterial disease and more than mild aortic regurgitation)

Keywords: coronary artery disease percutaneous transluminal coronary angioplasty intraaortic balloon pumping left ventricular dysfunction high risk
prp and pbd-vsel stem cell therapy for parkinson's disease

Conditions: Regenerative Medicine

Summary: an experimental study will be conducted at iffat anwar medical complex conducted to evaluate the effectiveness of prp and stem cell therapy in the treatment of pd. after the initial cognitive and laboratory testing, the first infusion appointment will be planned within 2 weeks. * the treatment began with the administration of three prp sessions, where the patients received intravenous injections at four acupuncture points (stomach 36 and gb 34 on both sides) at the 1st, 2nd, and 3rd month. * after three months of treatment, patients were sent back to the neurophysician for evaluation. they will be given a booster dose of prp during the 1-year follow-up, and then monitored every six months for the next two years. the primary outcomes of the study will beto see the improvement in the unified parkinson's disease rating scale (updrs), hospital anxiety and depression scale (hads) and self-report parkinson's disease questionnaire-39 (pdq-39).

parkinson's disease the second most common neurological disease worldwide is a progressive disorder that affects movement and can cause tremors, stiffness, and difficulty with coordination and balance caused by dopamine deficiency and progressive degeneration of dopaminergic neurons (dan). autologous platelet rich plasma (prp) and stem cell therapy is new and practical treatment option that aims to decrease neuroinflammation, modulate immune system and stimulate, replace or repair lost or damaged dopamine-producing cells in the brain lost in parkinson's disease. methods: total 30 patients aged 30 - 50 years will enrolled in the study. after the initial cognitive and laboratory testing, the patients will be infused prp in the autologous blood, once a month for 2 months. after three monthly sessions of prp treatments, peripheral blood derived very small embryonic like (pbd-vsel) stem cells therapy will be done on the 90th day. all the patients will be sent to neuro physicians for evaluation and improvement after 3 months, 6 months and 12 months. the primary outcomes of the study will be to see the improvement in the unified parkinson's disease rating scale (updrs), hospital anxiety and depression scale (hads) and self-report parkinson's disease questionnaire-39 (pdq-39). all the data will be entered and analyzed by spss 25.0. before and after difference outcome variables will compared before and after difference will be observed by paired sample t test. p-value \<0.05 will be considered as significant.

Eligibility criteria:
inclusion criteria: * the diagnosis of clinically established pd for at least 1-3 years, * both genders aged between 30 to 50 years * on stable therapy (dopaminergic medication and/or deep brain stimulation parameters) exclusion criteria: * gout, congestive heart failure, renal failure * uncontrolled atrial fibrillation, stroke, anaphylaxis, blood clotting problem, * clinical suspicion or diagnosis of atypical forms of parkinsonism or essential tremor

Keywords: parkinson's disease prp stem cells safety