Kornimate/medical-research-clean huggingface dataset:
adjuvant imrt with concommitant raltitrexed chemotherapy for locally advanced gastric cancer after d0/d1 radical resection

Conditions: Gastric Cancer

Summary: the purpose of this study is to determine whether raltitrexed concurrent with imrt is safe, tolerable and effective in the treatment for patients with local-advanced gastric cancer after d0/d1 radical resection.


Eligibility criteria:
inclusion criteria: 1. informed consent signed.; 2. age: 18-70 years old, sex is not restricted; 3. pathologically diagnosed as gastric adenocarcinoma or gastroesophageal junction adenocarcinoma; did not receive neoadjuvant chemotherapy or radiotherapy before surgery;received the 2-3 cycles of chemotherapy of folfox regimens or 1-2 cycles of xelox or sox regimens after operation; 4. received d0 or d1 operation, no tumor residual (r0); 5. postoperative pathological stage of pt3n0, pt4n0 or any t, n1-2, without distant metastatic disease; 6. ecog 0-2; 7. normal blood analysis: wbc≥3.5 x 109/l, gran≥2.0 x 109/l = 2, hb≥90g/l, plt≥100 x 109/l; 8. liver function: alt or ast is less than or equal to 2.5 times of the normal high value (uln); bilirubin is less than 1.5\*uln, serum apk is less than 2.5 \* uln; 9. renal function: serum creatinine is less than 1.5 \* uln, and creatinine clearance rate is more than 60ml/min; 10. no previous chemotherapy or radiation therapy history; 11. no organ transplant history; 12. urine pregnancy test results are negative for women of childbearing age in the first 7 days and not in lactation before treatment; 13. men and women of childbearing age agreed to adopt reliable methods of contraception for 30 days before , during and after the course of the study exclusion criteria: 1. received d2 radical operation; 2. tumor residual (r1/r2); 3. there was found evidence of distant metastasis (m1) or suspicious metastasis after examination; 4. other cancer history, except skin basal cell carcinoma or cervix in-situ carcinoma; 5. previously received chemotherapy or other systemic anticancer therapy, including cytotoxic drugs, targeted drugs; or had received abdominal radiotherapy; 6. anticipate other clinical trials in four weeks before enrollment. 7. severe complication, such as acute myocardial infarction in 6 months, uncontrolled diabetes, severe cardiac arrhythmia, etc. 8. drug abuse history or alcohol addiction; 9. active infection existed. 10. with severe malnutrition or severe anemia; 11. human immunodeficiency virus (hiv) infection; 12. pregnancy (confirmed by serum or urine beta -hcg test) or during lactation; 13. can not tolerate this study or may be allergic to the drug used in this study; 14. persons who have no or restricted capacity for civil conduct; or have mental illness, whom the researchers believe can not fully understand the possible complications of this study.

Keywords: raltitrexed imrt
to investigate the therapeutic effect of aculife magnetic therapist on carpal tunnel syndrome

Conditions: Carpal Tunnel Syndrome

Summary: carpal tunnel syndrome (cts) is the most common compressive focal mononeuropathy seen in clinical practice. patients commonly experience a constellation of symptom complex brought on by compression of the median nerve as it traverse through the carpal tunnel. when compression of the nerve occurs, ischemia and mechanical disruption of nerve function may result. pathological analysis shows a constellation of nerve injuries. until now, no satisfactory conservative treatment method. local steroid injections or oral steroids may result in initial relief, but relapses are frequent and have much side effects, which preclude their routine use for cts. full time wrist splints are claimed effective, but compromise hand function and daily activities. there are reasonable studies showing relief of pain with acupuncture on diverse pain conditions. however the therapeutic efficacy of acupuncture in cts was less convincing in the past. until recent decade, some case reports and few prospective studies reported the therapeutic effect of acupuncture in cts. other study also reported that low-level laser and microamperes transcutaneous electrical nerve stimulation (tens) are effective in improvement of clinical outcome of patients with cts. another report suggested that tens should be considered for the treatment of painful diabetic peripheral neuropathy. therefore, the investigators perform this study to evaluate the effect of aculife magnetic wave therapist (a battery operated device with a probe electrode which contains magnetic elements that transform the oscillating current into an electromagnetic wave to stimulate the acupuncture points, simulate the effect of electroacupuncture ) on cts and compared with that of transcutaneous electrical nerve stimulation(tens). after at least 4 weeks treatment ( at least 16 treatment sessions) the therapeutic effects will be evaluated by comparison of symptom severity score, electrophysiological study, sonographic morphology study or magnetic resonance imaging study, before and after treatment, and between the different groups.


Eligibility criteria:
inclusion criteria: * electrodiagnostic study confirmed with carpal tunnel syndrome * clinical symptom related to carpal tunnel syndrome exclusion criteria: * hypothyroidism, gout, systemic lupus erythematosus, rheumatoid arthritis, diabetes mellitus, chronic renal failure, acromegaly, polyneuropathy, brachial plexopathy, proximal median nerve entrapment, deficiency neuropathy (vitamine 2, b12, ect.), drug usage that may cause neuropathy, any surgery for peripheral nerve in the upper limb such as carpal tunnel surgical release, history of trauma in the upper limb such as wrist fracture, or having pregnancy.
whole grain, gluten-containing cereal and probiotics to evaluate digestive toleraance and immuno-inflammatory response

Conditions: Gastrointestinal Disorder; Immunologic Diseases in Children

Summary: this study will assess the development of gastrointestinal health in terms of digestive tolerability and immune-inflammatory response at the intestinal level comparing a conventional gluten-free cereal with a new cereal with prebiotics, probiotics and a very moderate amount of gluten. these are products adapted to infant feeding since 4 months.

in 2008 the espghan recommended not to give gluten cereals before 4 months but not after 7 months. although the introduction of gluten in this window was linked to a posible preventive effect on celiac disease, the truth is that it has not been demonstrated. in any case, high exposures to gluten since the 4 months have been associated with a higher incidence of celiac disease and current recommendations propose moderate and progressive exposure to gluten between 4 and 6 months old.

Eligibility criteria:
inclusion criteria: * healthy term infants (\>37 weeks) vaginal delivery * adequate birth weight for gestational age (10-90 percentile) * infants with normal growth curve (10-90 percentile) * infants who were breastfeeding for at least 4 weeks, and at least half of the takes have been by breastfeeding. * infants aged 4 months (+/- 1 week) at the time of study inclusion no longer following breastfeeding, or mixed breastfeeding and if they are breast-feeding, no more than one shot a day. * availability to continue throughout the study period. * signature of informed consent by partents/guardians. exclusion criteria: * infants who were born by cesarean section * infants born from preconception obese mothers * infants born from diabetic mothers or mothers with gestational diabetes * infants with a family history of celiac disease (parents or siblings) * infants who have had or have some type of allergic manifestation or allergic pathology * infants who have needed antibiotic treatment or have received some type of probiotic (the week before inclusion) * infants with malformations, diseases or conditions and physical disabilities that cause changes in growth and/or nutritional status * infants diagnosed with any immune system-related disease (primary immunodeficiency) * infants with a known allergy and/or intolerance to cow's milk protein * parents' inability to follow study (at the discretion of the researcher)

Keywords: gluten probiotic prebiotic
comparative effects of copenhagen and holmich exercises in hip adductor

Conditions: Groin Strain

Summary: groin pain that relates to the adductor muscle usually represents in the groin region specifically in superior internal thigh. tears or strains may happen within the muscles itself, tears or strains mainly occurs at musculotendinous junctions or within the tendons. adductor strain is a familiar but mostly ignored cause of groin injury and pain among athletes. risk factors include past hip or groin injury, age, weak adductors, muscle fatigue, lessen range of motion, and deficient stretching of the adductor muscle complex.

this study will be a randomized clinical trial and will be conducted in pakistan sports board and coaching center. non-probability consecutive sampling will be used to collect the data. sample size of this research is 46 subjects with age group between 18-30 years will be taken. data will be collected from the patients of adductor strain that causes groin pain by using tools numeric pain rating scale for pain, adductor muscle strength test by hand held dynamometer, the copenhagen hip and groin outcome score (hago's) questionnaire and lower extremity functional scale (lefs). an informed consent will be taken. squeeze test will be performed to evaluate the adductor related groin pain. the subjects will be divided into two groups i.e. group a and group b. group a will receive the copenhagen exercise, also known as the adductor strengthening protocol, is a dynamic and high-intensity exercise. it doesn't require any special equipment and can be done in any training center. group b will receive holmich continues to provide the strongest evidence for the efficacy of exercise as an argp treatment. both groups will perform their routine warm ups and cool downs the total duration of the protocol is 6 weeks, 3 times a week the duration of each session 3 sets of 10 repetitions with 15 sec recovery period keywords groin pain, holmich protocol, copenhagen exercise, adductor strain.

Eligibility criteria:
inclusion criteria: * • male soccer player age group 18-30 years * groin pain during or after game * persistent groin pain over 2-3 weeks * pain at palpation of groin * positive pain with adductor squeeze test exclusion criteria: * • low back pain * infection (uti) * malignancy * recent fractures or injuries * hip osteoarthritis * inguinal hernia

Keywords: holmich protocol copenhagen exercises groin pain adductor strain
bioequivalency study of torsemide tablets under fasting conditions

Conditions: Edema

Summary: the objective of this study was the bioequivalence of a roxane laboratories' torsemide tablets, 20 mg, to demadex® tablets, 20 mg (roche) under fasting conditions using a single-dose, 2-treatment, 2-period, crossover design.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to torsemide or any comparable or similar product.
study to assess the safety and tolerability of medi5117 in rheumatoid arthritis patients

Conditions: Rheumatoid Arthritis

Summary: study to assess the safety and tolerability of medi5117 in rheumatoid arthritis patients

a double-blind, placebo-controlled, randomized study in rheumatoid arthritis subjects to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of medi5117 (anti-il-6)

Eligibility criteria:
inclusion criteria: * active rheumatoid arthritis (ra) for 6 months or more. * males or nonpregnant, nonlactating femails aged 20 to 75 years, inclusive. * body mass index (bmi) between 19 and 36 kg/m2 and weight between 50 and 145 kg, inclusive. * males, unless surgically sterile, must use 2 effective methods of birth control from day 1 through follow-up. exclusion criteria: * history or presence of any clinically significant disease or disorder which has not been stable over the previous 3 months. * history of liver disease, bilirubin elevations, or gilbert's syndrome. * any systematic inflammatory condition in addition to ra (polymyalgia rheumatica, giant cell arthritis, systemic lupus, gout, pyrophosphate arthropathy). * current, chronic pain disorders including fibromyalgia and chronic regional pain syndromes or chronic fatigue syndromes. * intramuscular steroid injection or intraarticular steroid injection within 1 month of enrollment.

Keywords: rheumatoid arthritis phase i biologic
the effect of umbilical vein catheterization on splanchnic oxygenation in preterm infants

Conditions: Feeding Intolerance; Necrotising Enterocolitis Neonatal

Summary: objectives: this study aimed to assess the impact of umbilical vein catheter (uvc) placement on splanchnic oxygenation in preterm infants. methods: in our single-center, prospective, observational cohort study, near-infrared spectroscopy probes were placed to monitor regional splanchnic oxygen saturation (rso2s) and calculate fractional tissue oxygen extraction (foe) in preterm infants (ga \< 34 weeks, bw 1000-2000 g) for one week post-stabilization. gestational age-matched uvc (+) and (-) groups were clinically and physiologically compared, before and after uvc placement/removal.

the purpose of this study was to evaluate how the insertion of an umbilical vein catheter (uvc) affected the splanchnic oxygenation of preterm newborns..

Eligibility criteria:
inclusion criteria: * parents agreed to participate in the study * infants born in our hospital, who were followed up in the nicu, with a gestational age of \<34 weeks and a birth weight of 1000-2000 grams * infants who indicated uvc placement, and for whom nirs measurements were taken both before and after uvc placement were included in the uvc (+) study group * infants who did not have a uvc but matched the study group regarding gestational age and birth weight constituted the uvc (-) control group exclusion criteria: * infants who died during the first week of life * transferred to another hospital * chromosomal anomalies * major congenital anomalies affecting splanchnic bed monitoring (such as congenital heart disease, abdominal wall defects, or congenital diaphragmatic hernia) * inherited metabolic disorders * hydrops fetalis * torch infections * multiple organ failure * spontaneous intestinal perforation * lesions in the area where the nirs sensor was placed * if uvc was removed for any reason before 24 hours * severe anemia or polycythemia (infants with a birth hemoglobin (hb) level of 10 g/dl or below were considered severe anemic, and those with a hb level of 22 g/dl or above were considered polycythemic)

Keywords: umbilical venous catheter splanchnic oxygenation near-infrared spectroscopy small for gestational age feeding intolerance
impact of acute ittp therapies on long term neurologic and cognitive outcomes in ittp survivors

Conditions: Immune Thrombotic Thrombocytopenia

Summary: 1. we expect to find that the silent cerebral infarct (sci) rate is two fold higher in patients treated without caplacizumab. we also expect to find that the rate of mild and major cognitive impairment in patients treated with caplacizumab within 3 days of starting plasma exchange will be lower than patients treated without caplacizumab. 2. we expect that the differences in cognitive impairment in cases (caplacizumab) versus controls (no caplacizumab) will persist on serial evaluation 1 year later. we also expect that there will be differences in these groups even after adjusting for time since episode and severity of presentation. 3. we expect to find that sci and cognitive impairment is associated with worse scores on the health related quality of life instrument (sf-36) 4. based on studies in non-ttp populations, we expect to find that the rate of incident stroke over the period of follow up is at least 2 fold higher in patients that have sci compared with patients who do not have sci


Eligibility criteria:
inclusion criteria: 1. age \>= 18 years 2. confirmed ittp based on adams13 activity \< 10 % (or 10-20% with positive inhibitor or antibody) during an acute ittp episode 3. only 1 episode of ittp that was treated with plasma exchange and caplacizumab started within 3 days of diagnosis (or if more than 1 episode, then all episodes treated with plasma exchange and caplacizumab started within 3 days of diagnosis) exclusion criteria: 1. any contraindication for mri (metallic implants, shrapnel, mri incompatible stents, etc) 2. unable to speak, read or understand instructions in english (for nih toolbox) 3. combination of ittp episodes treated without caplacizumab or with caplacizumab. 4. caplacizumab started at \>= 4 days from diagnosis or for refractory ittp

Keywords: ttp ittp attp cognitive impairment
study to evaluate the abuse liability, pharmacokinetics, safety and tolerability of an abuse-deterrent d-amphetamine sulfate immediate release formulation (adair)

Conditions: ADHD; Narcolepsy

Summary: this is a randomized, double-blind, double-dummy, placebo- and active-controlled 4 period, 4 way crossover study to assess the intranasal abuse potential of manipulated adair formulation in nondependent, recreational stimulant users. the study will consist of an outpatient screening visit, an in clinic qualification phase, an in-clinic treatment phase, and an outpatient follow-up visit.

val-104 is a phase 1, randomized, double-blind, double-dummy, placebo- and active-controlled 4 period, 4 way crossover study to assess the intranasal abuse potential of manipulated adair formulation in nondependent, recreational stimulant users. the study objectives include assessing the pharmacodynamics (pd), pharmacokinetics (pk), safety and tolerability of manipulated adair 30mg when compared to crushed d-amphetamine sulfate and placebo. the primary pd endpoint is mean maximum drug liking (emax) on a bipolar 100mm visual analog scale. a total of 64 subjects demonstrating a confirmed positive response to stimulants will enter the treatment phase. safety will be assess via adverse events, vital signs, ecgs, clinical laboratory tests and columbia suicide severity rating scale (c-ssrs).

Eligibility criteria:
inclusion criteria: * healthy male or female volunteers, 18 to 55 years of age inclusive * recreational drug abuse experience (\>/= 10 times lifetime abuse of a cns stimulant, \>/= 1 abuse of cns stimulant in the previous 3 months) * prior intranasal recreational drug abuse experience * body mass index (bmi) 18 to 33 kg/m2 inclusive exclusion criteria: * history of any significant disease or disorder * history or current diagnosis of substance dependence (excluding caffeine and nicotine) * any confirmed significant allergic reactions against any drug, or multiple allergies in the judgement of the investigator * positive for hepatitis b, hepatitis c or hiv infection * pregnant or lactating women * participation in an investigational drug or device study within the last 30 days prior to day 1 of the study * confirmed positive drug screening * positive alcohol breath test at screening / any day -1 * heavy smoker (\> 20 cigarettes, \> 8 pipefuls or \> 8 cigars per day)
a study of tocilizumab added to dmards in patients with moderate to severe rheumatoid arthritis and an inadequate response to dmards.

Conditions: Rheumatoid Arthritis

Summary: this open-label single arm study will evaluate the efficacy and safety of tocilizumab added to traditional disease-modifying antirheumatic drugs (dmards) in patients with moderate to severe active rheumatoid arthritis and an inadequate response to dmards. patients will receive tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 24 weeks, in addition to their current non-biologic dmards at stable doses. anticipated time on study treatment is 24 weeks, and the target sample size is 200.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * moderate to severe active rheumatoid arthritis of \>/=6 months duration * inadequate clinical response to current non-biologic dmards * current dmards must be at stable dose for 8 weeks prior to study entry * oral corticosteroids (\ /=4 weeks prior to screening exclusion criteria: * rheumatic autoimmune disease other than ra * history of or current inflammatory joint disease other than ra * previous treatment with any biologic dmard * functional class iv as defined by the acr classification * intra-articular or parenteral corticosteroids within 6 weeks prior to screening
il-4 and insulin resistance for treatment of patients with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the purpose of this study is to better understand the interactions between the innate immune system, in particular eosinophils, their secreted cytokines (interleukin-4), and metabolism in human health and disease states such as obesity and insulin resistance.

patients with a body mass index (bmi) less than 30 kg/m2 and a history of atopic dermatitis on long-term (greater than 6 months) treatment with dupilumab. researchers will compare in vivo evaluations of insulin sensitivity in subjects on dupilumab vs subjects matched for similar weight and bmi, with atopic dermatitis, but without dupilumab therapy (phototherapy).

Eligibility criteria:
inclusion criteria: * ability to sign informed consent form. * body mass index (bmi), 22-29 kg/m\^2. * diagnosis of atopic dermatitis treated with dupilumab for longer than 6 months. * diagnosis of atopic dermatitis treated with topical steroids or phototherapy. exclusion criteria: * any prescription for systemic glucocorticoid, immunosuppressant, antidiabetic medications in the past 6 months. * evidence of diabetes mellitus. * morning cortisol \< 5 mg/dl (collected before 10.30 am). * presence of acute illness. * low hemoglobin or hematocrit. * current participation in a weight-loss regimen, with a weight loss \> 10% total body weight in the last 6 months). * smoking history in the last 6 months (tobacco, nicotine-containing products including e-cigarettes). * pregnant or breastfeeding. * personal history of gastric bypass surgery. * previous participation in a clinical trial with an investigational product in the past 30 days, or 5 half-lives, or twice the duration of the biological effect of the investigational drug (whichever is longest). * exposed to more than 4 new chemical entities within 12 months before study enrollment. * any other condition or event considered exclusionary by the pi and the study physician.