Kornimate/medical-research-clean huggingface dataset:
evaluate safety/tolerability in portuguese participants with rrms transitioning from current therapy

Conditions: Relapsing Remitting Multiple Sclerosis

Summary: the primary objective of the study is to evaluate safety and tolerability as defined by the frequency of the adverse events (aes) of flu-like symptoms (fls) \[chills, pyrexia, myalgia, and asthenia\], injection site reactions (isrs), and injection site reaction pain (isr-p), over 24 weeks of treatment (the active comparator period) with plegridy 125 microgram (μg) subcutaneous (sc) every 2 weeks versus current sc ifn-β therapy in participants with relapsing remitting multiple sclerosis (rrms).


Eligibility criteria:
key inclusion criteria: * a confirmed diagnosis of rrms, as defined by mcdonald criteria (2017). * an edss score between 0 and 5.0. * all female participants of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 3 months after their last dose of study treatment. * on continual treatment for ≥6 months with a single current sc ifn-β therapy, including ifn-β-1b 0.25 mg sc every other day or ifn-β-1a 22 μg or 44 μg sc 3 times weekly key exclusion criteria: * known history of human immunodeficiency virus. * known history of or positive test result for antibodies to hepatitis c, or current hepatitis b infection (defined as positive for hepatitis b surface antigen \[hbsag\] and/or positive for hepatitis b core antibody \[hbcab\]) at screening. participants with immunity to hepatitis b from either active vaccination (defined as negative hbsag, positive hepatitis b surface antibody \[hbsab\], and negative hbcab) or from previous natural infection (defined as negative hbsag, positive hbsab immunoglobulin g, and positive hbcab) are eligible to participate in the study (definitions are based on the centers for disease control and prevention's interpretation of the hepatitis b serology panel \[cdc 2007\]). * an ms relapse that has occurred within the 50 days prior to randomization and/or lack of stabilization from a previous relapse prior to randomization (day 1). * any previous treatment with plegridy. note: other protocol defined inclusion/exclusion may apply
study to learn more about the onset of effect of iberogast in patients suffering from abnormal stomach and intestine function

Conditions: Functional Gastrointestinal Disorders

Summary: several studies have been done on the efficacy of the herbal medicine iberogast. in this study researcher want to learn more about the time needed for iberogast to start to work after the patient took the drug. this study plans to enroll 300 adult male and female patients suffering from disturbance of stomach and intestine normal function and treated by their doctor with iberogast drops. patients will be asked to document on a diary card the changes of symptom severity of the stomach and intestine complaints and the time needed for the symptoms to improve after drug intake. at the end of the study the treating doctor and the patients will be asked about the overall changes of symptoms. in addition information on the safety of the drug and how well the drug is tolerated by the patients will be collected


Eligibility criteria:
inclusion criteria: at the discretion of physician under the instructions of rome iii criteria concerning functional gastrointestinal symptoms as well as the summary of product characteristics of iberogast exclusion criteria: therapeutic necessity
protocol for postmenopausal women at increased risk of developing breast cancer

Conditions: Breast Cancer

Summary: to examine nipple aspirate fluid for secretions that may be identified as a high risk indicator for development of breast cancer, and compare those to serum analysis.

to examine nipple aspirate fluid analysis in lactating women for local concentration of estrogen, prolactin, glucocorticoids, insulin, parity, prior lactation and age. naf secretors have been reported to have modest increase in breast cancer risk compared to non-secretors . estrogen levels have been found to be markedly higher in naf samples than in the serum collected from the same women. estradiol and estrone concentrations in premenopausal women are 10x and 20x greater in naf samples than in serum and 50x and 35x greater in post-menopausal women not on hrt. it has been suggested that the disparity between serum and naf levels may be due to local estrogen production via aromatase and sulfatase.

Eligibility criteria:
inclusion criteria: * women with high a high risk of breast cancer * older than 18 exclusion criteria: * anticoagulants * marked breast tenderness * pregnant or within twelve months of breast feeding/childbirth

Keywords: naf nipple aspirate fluid breast atypia high risk for breast cancer breast epithelial hyperplasia ki-67 hormones plus chemoprevention chemoprevention
the safety, immunogenicity and immune effect research of the varicella vaccine after the 2nd dose vaccination

Conditions: Varicella

Summary: to investigate the safety, immunogenicity and immune effect of the varicella vaccine after the 2nd dose vaccination in chao yang district, bei jing, since the 2nd varicella vaccination was promoted by beijing center for disease control and prevention in november, 2012.

"breakthrough" varicella cases and varicella cases were monitored to evaluate the protective effective in a large population. make the basic evaluation of safety for the two dose of varicella vaccination monitoring the varicella virus origin and virus types from illness cases in chao yang district make the evaluation of healthy costs reduce for the varicella emergency vaccination after large number of varicella cases occurred.

Eligibility criteria:
inclusion criteria: * participants were between 4-12 years old * participants were in good healthy determined through medical history, physical examination, clinical judgment of the investor exclusion criteria: * having a fever (axillary temperature \>37.0℃) before enrollment; * having a disease history of seizures, brain and mental disease and the vaccination history of allergies and convulsions; * antibiotics allergy; * having a problem of intramuscular injection because thrombocytopenia or other blood coagulation disorder; * having immunodeficiency or under immunosuppression therapy, radiation therapy; * having respiratory diseases, acute infection, chronic disease and hiv infection; * having systemic skin rash, skin tinea, herpes; * chronic liver and kidney disease; * heart disease, and severe hypertension; * have received whole blood, plasma or immunoglobulin therapy 3 months before enrollment; * have not received other vaccination in 7 days before enrollment
safety and efficacy study of adjunctive rosiglitazone in the treatment of uncomplicated falciparum malaria

Conditions: Falciparum Malaria

Summary: the purpose of this study is to examine the safety, tolerability, and efficacy of adjunctive rosiglitazone in the treatment of uncomplicated p.falciparum malaria.

study rationale: evidence suggests that if ppar-rxr agonists (such as rosiglitazone) are used as adjunctive therapy in p. falciparum malaria infections they may increase phagocytic clearance of p. falciparum malaria, modulate deleterious inflammatory responses and decrease sequestration of malaria parasites in vital organs. they may therefore represent a novel immunomodulatory treatment approach for p. falciparum malaria. study objectives: 1) to examine the in vivo effect of rosiglitazone on the rapidity of clearance of p. falciparum parasitemia and fever in patients with non-severe p. falciparum infections 2) to assess the safety and tolerability of adjunctive rosiglitazone treatment in non-severe cases of p. falciparum infection. primary outcomes: time to clearance of p. falciparum parasitemia study design: randomized double blind placebo-controlled trial. intervention: standard antimalarial treatment (atovaquone/proguanil) to all patients combined with adjuvant rosiglitazone treatment (8mg per day) or placebo. setting: hospital for tropical diseases at mahidol university, thailand. participants: 140 patients with non-severe p. falciparum infection. follow-up: 28 days

Eligibility criteria:
inclusion criteria: * microscopically confirmed p.falciparum infection * age \>18 years * able to tolerate oral therapy * able to give informed consent exclusion criteria: * fulfillment of who criteria for severe/cerebral malaria * prior treatment with any thiazolidinedione * allergy to rosiglitazone * history of diabetes mellitus * history of severe/decompensated liver disease * alt level \>2.5 times normal * current treatment for congestive heart failure * pregnancy or breastfeeding

Keywords: randomized controlled trial malaria plasmodium falciparum thiazolidinediones rosiglitazone atovaquone-proguanil
potential predictive biological markers of major depression response to citalopram therapy in anorexia nervosa.

Conditions: Anorexia Nervosa

Summary: in patients suffering from anorexia nervosa associated with severe major depression, serotonin reuptake inhibitor drugs have shown little efficacy in significantly reducing depressive symptoms. a possible explanation for this poor efficacy could be that people with anorexia nervosa have a deficiency in amino acids such as tryptophan, which is necessary for the production of the neurotransmitter serotonin. therefore, tryptophan supplementation has been suggested as a means of increasing the pharmacological response to serotonin reuptake inhibitor drugs in patients with anorexia nervosa. furthermore, malnutrition present in patients suffering from anorexia nervosa is in some cases associated with problems of intestinal absorption of nutrients, with possible implications on the pharmacokinetics of the drugs administered, including selective serotonin reuptake inhibitors (ssris). the present observational study aims to evaluate the correlations between the clinical response to citalopram therapy (in different o.s. and i.v. formulations) and some nutritional, neurotransmitter and inflammatory biomarkers, in order to identify potential predictive markers of response to therapy for severe major depression in patients with anorexia nervosa. the following parameters will be evaluated in patients enrolled in all 3 observation times described above: * plasma concentration of citalopram * serum concentration of serotonin * plasma concentration of dopamine * serum concentration of tryptophan * serum concentration of bdnf * hamilton scale 17 items and other clinical scales (edi-3, scl-90, but).


Eligibility criteria:
inclusion criteria: * anorexia nervosa * severe depression (hamilton score 25 or higher) * written informed consent exclusion criteria: * other psychiatric disorders * acute infectious diseases * chronic inflammatory diseases * disorders of central nervous system * pregnancy ore breastfeeding

Keywords: major depression citalopram biological markers
dextrose containing fluid and the postoperative nausea and vomiting in the gynecologic laparoscopic surgery

Conditions: Postoperative Nausea and Vomiting

Summary: the investigators tested the hypothesis that administration of intravenous dextrose as a maintenance fluid in gynecologic laparoscopic surgery would reduce the incidence and severity of postoperative nausea and vomiting (ponv) compared with normal saline solution in the same dose. a prospective randomized double blinded controlled study was conducted. eighty six participants were randomized to dextrose solution (n= 42) or normal saline solution (n= 44). the bellville postoperative nausea and vomiting scores were recorded until 24 hours after surgery.

postoperative nausea and vomiting (ponv) is a major complication in laparoscopic gynecologic surgery. there are limited data and conflicting results from previous studies related to the types of intravenous fluid and a reduction in ponv. the incidence of nausea is slightly greater than the incidence of vomiting (50% vs. 30%). general anesthesia increased the likelihood of ponv 11 times compared with other types of anesthesia. laparoscopic surgery can further increase the incidence of ponv to 80%.identified risk factors of ponv included female, history of motion sickness, nonsmoking, younger age, general anesthesia, use of volatile anesthetics and nitrous oxide, opioids, duration of anesthesia, and types of surgery (cholecystectomy, laparoscopic, gynecological). adequate intravenous fluid hydration is another effective strategy for reducing the baseline risk for ponv (evidence a2). previous studies showed that there was no difference in efficacy between crystalloids and colloids when similar volumes were used in surgeries associated with minimal fluid shifts. while liberal intravenous fluid administration, such as 30 ml/ kg of sodium lactate solution, reduced the incidence of ponv after gynecologic laparoscopy compared to another group receiving 10 ml/kg of sodium lactate solution, this strategy did not reduce the ponv in other surgical procedures such as thyroidectomy. among crystalloid solutions, results from previous studies were conflicting regarding the benefit of intravenous dextrose administration to reducing the ponv. hypovolemia with and without hypoglycemia after overnight fasting were believed to exacerbate ponv. the investigators hypothesized that intraoperative infusion of dextrose solution could reduce the incidence and severity of ponv. the investigators proposed to determine the relationship between types of fluid administration and antiemetic requirement and serum glucose in paricipants scheduled for the gynecologic laparoscopy.

Eligibility criteria:
inclusion criteria: * asa i-ii * elective surgery * gynecologic laparoscopic surgery * give informed consent exclusion criteria: * pregnancy * dm * congestive heart failure

Keywords: postoperative nausea postoperative vomiting gynecologic laparoscopic surgery
study to test the efficacy and safety of padsevonil as adjunctive treatment of focal-onset seizures in adults with drug-resistant epilepsy

Conditions: Drug-resistant Epilepsy; Focal-Onset Seizures

Summary: the purpose of the study is to characterize the dose-response relationship with respect to efficacy of padsevonil administered concomitantly with up to 3 anti-epileptic drugs (aeds) for treatment of observable focal-onset seizures in subjects with drug-resistant epilepsy.


Eligibility criteria:
inclusion criteria: * diagnosis of focal epilepsy per 1989 international league against epilepsy (ilae) criteria at least 3 years before study entry * subject has failed to achieve seizure control with 4 tolerated and appropriately chosen prior antiepileptic drugs (aed), including past and ongoing treatment, that were individually optimized for adequate dose and duration. prior discontinued aed treatment would need to be assessed by the investigator considering the patient medical records and patient and/or caregiver interview. 'prior aed' is defined as all past and ongoing aed treatments with a start date before the screening visit (visit 1) * average of \>= 4 spontaneous and observable focal seizures (type ia1 (i.e. focal aware), ib (i.e. focal impaired awareness), ic (i.e. focal to bilateral tonic-clonic)) per month * current treatment with an individually optimized and stable dose of at least 1 and up to 3 aeds for the 8 weeks prior to the screening visit with or without additional vagus nerve stimulation (vns) or other neurostimulation treatments exclusion criteria: * subject has a history of or signs of generalized or combined generalized and focal epilepsy * cluster seizures which are uncountable in the previous 8 weeks before study entry and during 4 weeks prospective baseline * current treatment with carbamazepine, phenytoin, primidone, phenobarbital * current treatment/ use of (non-aed) prescription, nonprescription, dietary (eg, grapefruit or passion fruit), or herbal products that are potent inducers or inhibitors of the cyp3a4 or 2c19 pathway for 2 weeks (or 5 half-lives, whichever is longer) prior to the baseline visit * subjects taking sensitive substrates of cyp2c19 for 2 weeks (or 5 half-lives, whichever is longer) prior to the baseline visit * subject has been taking vigabatrin less than 2 years at study entry * subject has been taking felbamate for less than 12 months * subject taking retigabine for less than 4 years * current treatment with benzodiazepines (i.e. gaba-a-ergic drugs like zolpidem, zaleplon, or zopiclone, excluding gaba-a-ergic aeds) \<3 times per week for emergencies * subject has a current medical condition that occurred within the last 12 months which, in the opinion of the investigator, could compromise his/her safety or ability to participate in this study

Keywords: epilepsy padsevonil
therapy of radiation enteritis with glutamine

Conditions: Radiation Enteritis

Summary: objective: to evaluate the effects of perioperative glutamine supplemented total parenteral nutrition support on nutritional status, immunologic function and intestinal permeability of patients with chronic radiation intestinal injury. methods: the 40 patients with crii were randomized into two groups, the standard tpn group and glutamine-enriched tpn group. the patients were administered total parenteral nutrition for at least four weeks (two weeks pre-operation and two weeks post-operation). the nutritional status, immunologic function, plasma concentration of glutamine and intestinal permeability were measured at 1 day, 1 week and 2 weeks pre-operation, 3 day, 1 week and 2 weeks post-operation. nutrition status was determined the plasma concentrations of hemoglobin, albumin, prealbumin, transferrin and triglyceride. immunologic function were measured by the percentages of cd4+t cells and cd8+t cells, the ratio of cd4 +t cells to cd8+t cells ( cd4 +/cd8 +) was calculated， and serum iga, igm and igg．the intestinal permeability was detected by the urinal ratio of lactulose and mannitol.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of chronic radiation enteritis * need the operation * malnutrition exclusion criteria: * hepatic failure * kidney failure * neoplasm recurrence * serious cardiovascular/metabolic disease * pregnancy and lactation
long-term safety of idp-118 lotion in the treatment of plaque psoriasis

Conditions: Plaque Psoriasis

Summary: the objective of this study is to evaluate the long-term safety of idp-118 lotion.

this is a multicenter, open-label study of the long-term safety of idp-118 lotion in participants with plaque psoriasis.

Eligibility criteria:
key inclusion criteria: * male or female, of any race, at least 18 years of age (inclusive). * freely provides both verbal and written informed consent. * has an area of plaque psoriasis appropriate for topical treatment that covers a body surface area (bsa) of at least 3 percent (%), but no more than 12%. the face, scalp, palms, soles, axillae and intertriginous areas are to be excluded in this calculation. * is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study. * has a clinical diagnosis of psoriasis at the baseline visit with an investigators global assessment (iga) score of 3 or 4 (the face, scalp, palms, soles, axillae and intertriginous areas are to be excluded in this assessment). key exclusion criteria: * has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular psoriasis, as determined by the investigator. * presents with psoriasis that was treated with prescription medication and failed to respond to treatment, even partially or temporarily, as determined by the investigator. * presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the investigator. * is pregnant, nursing an infant, or planning a pregnancy during the study period. * has received treatment with any investigational drug or device within 60 days or 5 drug half lives (whichever is longer) prior to the baseline visit, or is concurrently participating in another clinical study with an investigational drug or device.
oral candida in infants and dietary type

Conditions: Oral Candida; Breastfeeding; Bottle Feeding

Summary: this is an observational, non-randomised trial to evaluate the effect of dietary type on infants oral candida colonization the investigators evaluated 90 infants in 1-24 months (45 breastfeeding and 45 bottle feeding infants) who attended to yazd clinic for regular pediatric appointment. infants with unremarkable health histories, normal weight, free of sign or symptom of oral candidiasis or other mucosal disease. their mothers were also healthy and without sign or symptom of vagina or mammary candidiasis. pacifier usage, use of antibiotics in last months, sign or symptom of oral candidiasis in infants or vagina and mammary candidiasis in mothers were exclusion criteria.

after filling in a questionnaire about infants dietary intake, age and sex and their mothers education level and health condition, a pre-moistened sterile cotton swab was taken from dorsal surface of tongue and mid-plate. the swabs were cultured in agar plate containing sabourauds dextrose agar medium with chloramphenicol, and kept in 37 c for 48 hours. the number of candida colonies was counted and germ tube test performed to separate candida albicans from other types. the data was collected and analyzed by spss software and chi-square, logistic regression and mann-whitney test. study hypothesis: feeding by mothers milk reduces oral candida colonization.

Eligibility criteria:
inclusion criteria: * healthy infants * healthy mothers exclusion criteria: * pacifier usage * use of antibiotics in last month * sign or symptom of oral candidiasis in infants * vagina and mammary candidiasis in mothers
habitat escalated adaptive therapy (heat), with neoadjuvant radiation for soft tissue sarcoma

Conditions: High Grade Sarcoma

Summary: the purpose of the study is to utilize radiomic images to precisely locate areas of tumor that can be treated with dose escalation radiation therapy.


Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form * stated willingness to comply with all study procedures and availability for the duration of the study * for women of childbearing potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 52 weeks after the end of radiation. * for males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner 52 weeks after radiation. * agreement to adhere to lifestyle considerations (as outlined in protocol) throughout study duration. * pathologically (histologically or cytologically) proven diagnosis of high-grade (grade 2 or 3) soft tissue sarcoma (sts) of the deep trunk and/or extremity. clinical evidence should be documented, and may consist of pathology or imaging, and should be sufficient to estimate the size of the primary (for t stage) * primary site deemed resectable prior to the start of trial * american joint committee on cancer (ajcc) 8th edition staging t1-4 n0 m0, no evidence of distant metastases * patients must have clinically or radiographically evident measurable disease at the primary site. * pre-radiation therapy (rt) mri within 4 weeks of the start of rt. * eastern cooperative oncology group (ecog) performance status 0 to 3. * deemed a surgical candidate * participant agrees to blood and plasma preservation for future analysis. exclusion criteria: * contraindications to an mri * positive urine pregnancy test * gross total excision of primary sts, including an unplanned excision * superficial sarcoma located primarily in the subcutaneous or cutaneous tissue * prior radiation to the region of the study cancer that would result in overlap of radiation therapy fields. * participants with a medical condition or social situation that, at the discretion of the principal investigator, would preclude them from completion of the trial.