Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of emodepside in adults infected with strongyloidiasis stercoralis

Conditions: Strongyloides Stercoralis Infection; Strongyloidiasis

Summary: efficacy, safety and pharmacokinetics of ascending dosages of emodepside and in comparison to ivermectin against strongyloidiasis stercoralis in adults: randomized stage ii seamless adaptive controlled trials


Eligibility criteria:
inclusion criteria: * written informed consent signed by the participant him/herself * males and females of age 18 or older * infected with s. stercoralis (positive by at least two baermann assays on two different days and infection intensities of at least 0.75 lpg in the two stool samples. * agree to comply with the study procedures, including to be examined by a study physician at the beginning of the study and to provide three stool samples during the screening period (within a maximum of 10 days) and approximately three weeks after treatment (follow-up). * female participants of childbearing potential to ensure adequate contraception during the study period. exclusion criteria: * no written informed consent by individual. * presence of acute or uncontrolled systemic illnesses (e.g. severe anemia, clinical malaria) as assessed by a medical doctor, upon initial clinical assessment. * recent history of acute or severe chronic disease, as assessed by a medical doctor or reported by the participant: type 1 and/or 2 diabetes; psychiatric disorders; chronic heart, liver, or renal disease * prior treatment with anthelmintics (eg, diethylcarbamazine \[dec\], suramin, ivermectin, mebendazole or albendazole) within 4 weeks before planned study drug administration. * actively participating in other clinical trials during the study. * positive pregnancy test or breastfeeding women and planning to become pregnant within three months of study drug administration. * received strong cyp3a4 inducers or inhibitors as well as concomitant treatments that are relevant substrate for cyp3a4 such as clarithromycin, erythromycin and rifampicin within 4 weeks before planned study drug administration. * received strong p-gp inhibitors as well as concomitant treatments that are relevant substrates for p-gp such as clotrimazole and ritonavir. * known allergy to study drugs or any of the ingredients
effects of ginst on human semen

Conditions: Infertility

Summary: the purpose of the study is to evaluate the effect of ginst on human semen. the study is a pilot study, designed as open-label, prospective randomized clinical trial using ginst either 500mg/capsule (panax ginseng 0.96g/day) or 1000mg/capsule (panax ginseng 1.92g/day), two capsules at once, three times a day for 12 weeks. ginst(ilhwa, republic of korea) is a dietary supplement capsule, which is made with 6 year-old korean red ginseng (panax ginseng). expected participants are to be male partners of female patients who visit infertility clinic at severance hospital, whose total motile sperm count is more than 0.5x106 by semen analysis using computer aided sperm analyzer (casa). semen analysis, blood test, questionaires are planned to be performed 2 times, on the initial visit and after 12weeks of ginst treatment. semen analysis will reveal ejaculated volume, sperm count, motility, morphology, total leukocyte count, total motile sperm count, further analysis including sperm chromatin assessment to examine the quality of sperm and malondialdehyde (mda) analysis of seminal fluid to assess oxidative stress will be performed. blood test will be done including serum follicle stimulating hormone (fsh), luteinizing hormone (lh), total and free testosterone. quality of life, sexual performance before and after taking ginst will be evaluated using questionaires.


Eligibility criteria:
inclusion criteria: 1. partner of female patient who visit infertility clinic with chief complaint of infertility. 2. ≥0.5x106 of total motile sperm count on screening semen analysis. exclusion criteria: 1. those who have chronic, systemic disease or endocrinologic disorder. 2. patients with hypertension (systolic blood pressure ≥ 140mmhg, diastolic blood pressure ≥ 90mmhg) 3. patients who have undergone chemotherapy due to malignancy 4. patient who has history of taking testosterone or anti androgen agents within 1 month. 5. patient who has retrieved sperm surgically
epigenetic regulation of human adipose tissue distribution

Conditions: Obesity

Summary: the purpose of this study is to collect data to help researchers better understand the different ways that women or men store fat (apple shape versus pear shape).


Eligibility criteria:
inclusion criteria: * age 18-45 years inclusive; * bmi 23-35 kg/m2 inclusive; * hba1c \<6.0%; * weight stable (± 3 kg) during the 3 months prior to enrollment; * women must be \> 9 months post-partum; * able to provide written, informed consent. exclusion criteria: * postmenopausal women * women with an oophorectomy * fasting plasma glucose \> 126 mg/dl, or diagnosis with type 2 diabetes (t2dm) * untreated or symptomatic thyroid disease. * aminotransferase or aspartate aminotransferase \> 3x upper limit of laboratory reference range, or known diagnosis of liver disease. * creatinine \> 2x upper limit of laboratory reference range, or known diagnosis of kidney disease. * uncontrolled hypertension (bp \> 140 systolic or \> 90 diastolic) * new onset (\<3 months on a stable regime) use of oral contraceptives or hormone replacement therapy. * history of drug or alcohol abuse (\> 3 drinks per day) within the last 5 years, or psychiatric disease prohibiting adherence to study protocol. current drug use may be determine by plasma or urine drug screens. * history of cancer within the last 5 years (skin cancers, with the exception of melanoma, may be acceptable). * history of organ transplant. * myocardial infarction within the last 6 months. * current treatment with blood thinners or antiplatelet medications that cannot be safely stopped for biopsy and testing procedures. * history of hiv, active hepatitis b or c or tuberculosis * presence of clinically significant abnormalities on ekg. * current smokers (smoking within the past 3 months). * use of any medications known to influence glucose, fat and/or energy metabolism within the last 3 months (eg. growth hormone therapy, glucocorticoids \[steroids\], etc.) * other chronic or acute illness that might affect study results / interpretation in the opinion of the clinical * other items related to procedural risk (outlined below) such as bleeding disorder, claustrophobia, etc. * elevated high sensitivity c-reactive protein or known active infection. * there are some implants which are mr compatible (safe) but would cause artifacts which could obscure our ability to measure an organ, e.g. full braces may negate the ability to measure brain size.

Keywords: adipose tissue, epigenetic, abdominal gluteal fat
gastric ultrasound in elective surgical diabetic patients

Conditions: Gastric Ultrasound; Elective Surgery; Diabetes Mellitus

Summary: the aim of this study is to evaluate the role of gastric ultrasound in elective surgical diabetic patients.

aspiration of gastric contents during perioperative period is a grave complication with significant morbidity and mortality. the overall incidence of gastric content aspiration ranges between \<0.1% and 19% and aspiration pneumonia account for 9% of all anesthesia-related mortality. mendelson described the pathophysiological mechanisms of pulmonary aspiration, which led to the development of strategies to prevent pulmonary aspiration. consequently, american society of anesthesiologists (asa) released preoperative fasting guidelines for healthy patients undergoing elective surgery, in order to reduce gastric content volume and minimize the risk of aspiration. however, there are still many situations where the asa fasting guidelines may be not suitable, including urgent or emergency situations and medical conditions such as diabetes mellitus. ultrasound is widely available and has been proven to be a reliable, bedside assessment tool for real-time evaluation of gastric contents. as diabetic patients are prone to have an inadequately empty stomach even after an adequate fasting, ultrasound can be used prior to induction for screening the fasting gastric volume (gv) of diabetic patients and see if it is more than the recommended safe limit. as a novel point-of-care application, ultrasound sonography allows anesthesiologists to evaluate a patient's gastric content and volume at the bedside and helps guide anesthetic and airway management.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * both sexes. * undergoing elective surgery. exclusion criteria: * american society of anesthesiology (asa) physical status \>iii. * body mass index (bmi) outside the range of 18.5-40 kg/m2. * history of upper gastrointestinal disease or previous surgery on the esophagus, stomach, or upper abdomen. * abnormalities of the upper gastrointestinal tract, such as gastric tumors and recent upper gastrointestinal bleeding (within the preceding 1 month). * taking preoperative medicines that may delay gastric emptying (e.g., anticholinergic agents, opioids). * hypothyroidism. * current smoking history. * pregnancy.
liver transplantation in patients with hepatitis c virus (hcv) and human immunodeficiency virus (hiv) coinfection

Conditions: HIV Infections; Hepatitis C

Summary: to show the feasibility of liver transplantation in hcv-hiv coinfected patients. to study the two-year survival after transplantation, the interaction between hcv and hiv after transplantation, the influence of hiv on hcv recurrence after transplantation, the interaction between immunosuppressive and antiretroviral drugs in particular anti-proteases, immunological follow-up and quality of life of these patients

until recently, hiv infection was considered as a contraindication for liver transplantation. a dramatic improvement in survival of hiv patients have been observed since the advent of new antiviral treatments against hiv including antiproteases. however an important proportion of patients with hcv-hiv coinfection are suffering from life-threatening liver disease due to hcv infection. liver transplantation may be considered in this particular group of patients. the ideal timing for the indication of liver transplantation during hiv disease and during the course of hcv liver disease needs to be defined. liver transplantation in this particular group of patients raised several questions : a) the role of hiv infection on prevalence and severity of hcv recurrence after transplantation ; b) the role of liver transplantation and immunosuppression on hiv disease ; c) drug interactions between immunosuppressive agents and antiproteases ; d) immunological follow-up and quality of life of these patients.

Eligibility criteria:
inclusion criteria: * coinfection hiv-hvc * indication of liver transplantation for severe hepatopathy with life threatening:repetitive ascitis or infection of ascitis or icterus or decreased of prothrombin index under 50 percent or digestive haemorrhage by portal hypertension uncontrolled exclusion criteria: * toxicomania * alcohol consumer (over 30g per day) * aghbs positive * hepatocarcinoma over 5 cm or 3 nodules * cd4 below 200/mm3 * viral load below 400 cp * hiv stade c

Keywords: liver transplantation hepatitis c hiv infections
efficacy and safety of apsctc for the treatment of postsurgical pain due to third molar extraction

Conditions: Postsurgical Pain; Third Molar Extraction

Summary: the purpose of this study is to evaluate the efficacy of apsctc compared to two active drugs in acute pain relief.


Eligibility criteria:
main inclusion criteria: * males and females aged 18 to 40 years; * ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms; * participants who require extraction of impacted mandibular third molar. main exclusion criteria: * known hypersensitivity to the formula components used during the clinical trial; * previous history of alcohol or drugs abuse diagnosed by dsm-v; * previous history of renal failure from moderate to severe; * women who are pregnant, lactating, or positive for β - hcg urine test.
saving brain in uganda and burkina faso

Conditions: Poor Performance Status; Neurologic Deficits; Mixed Behavior and Emotional Disorder; Malnutrition; Infections, Hospital

Summary: the study will estimate the effect of peer-counseling for exclusive breast feeding (ebf) in the first 6 months of life on cognition and other determinants of human capital formation including behavioral and emotional status; school readiness and attainment; health status; fine and gross motor skills; physical growth; and household economic status.

between 2006 and 2008 we carried out a cluster randomized study (promise-ebf) to establish the effect of individual home based peer counselling on exclusive breast feeding (ebf). the results, published in the lancet in 2011 were remarkable(tylleskar t, et al). the promise-ebf trial which compared mothers in the intervention arm that were offered at least 5 peer-visits promoting ebf to mothers in the control arm, that received the standard of care showed a doubling in the prevalence of ebf in the intervention arm. community-based peer counsellors increased the ebf rate in uganda and burkina faso from about 40% to 80%. the current study will trace and re-enrol at least 70% of the children involved in the promise-ebf study. these children are now aged between 5 and 7 years. the primary objective of the current study is to evaluate the effect of peer-counselling for ebf in the first six months of life on human capital formation among children in uganda and burkina faso. this study will contribute to a crucial wider discussion on external validity regarding the relationship between ebf and intellectual performance and mental health. in the social area, this study will identify solutions to potential barriers that limit scale up for peer-counselling for ebf. from the business perspective, the study will identify the best business model for affordable, acceptable and cost effective ways of delivering peer counselling for ebf in burkina faso and uganda. if this intervention is found effective, and is adopted, it could improve productivity in adulthood and work towards breaking the cycle of poverty.

Eligibility criteria:
inclusion criteria: * children whose mothers participated in the original intervention of peer support for exclusive breastfeeding (ebf). * informed caregiver consent exclusion criteria:

Keywords: human capital formation
safety and feasibility of early discharge for transfemoral transcatheter aortic valve replacement

Conditions: Aortic Valve Stenosis

Summary: the primary objective of this study is to determine the efficacy, safety and feasibility of next day discharge home in patients undergoing self-expandable transfemoral tavr utilizing the vancouver 3m clinical pathway.


Eligibility criteria:
inclusion criteria: patients with severe symptomatic aortic stenosis undergoing elective transfemoral tavr with a self-expanding transcatheter heart valve 1. considered at increased surgical risk by the multidisciplinary heart team 2. informed written consent exclusion criteria: 1. non-cardiovascular co-morbidity reducing life expectancy to \<3 years 2. any factor precluding 1 year follow-up 3. inadequate ct image acquisition to perform area-based annular ct sizing, exclude adverse root features, and determine a coaxial valve deployment angle (ct is not required for valve-in-valve procedures) 4. predicted inability to perform uncomplicated percutaneous vascular access and closure 5. illiofemoral diameter \<6 mm (for 23 and 25 mm valves) and \<6.5 mm (for 27 and 29 mm valves) measured at or below the femoral head 6. surgical prosthesis \<23 mm (labelled size) for valve-in-valve procedure 7. in-patient (unless clinically stable, mobilizing at baseline, and primarily in hospital for logistical reasons) 8. language barriers (inability to understand peri-procedural and discharge instructions) 9. insufficient social support post procedure to allow next day discharge 10. airway unfavourable for emergent intubation 11. inability to lay supine without conscious sedation or general anaesthetic

Keywords: transcatheter aortic valve replacement
application of changyanning granule in endoscopic resection of colorectal polyps

Conditions: Colorectal Polyps

Summary: this study aims to evaluate the efficacy of chanyanning granules in patients undergoing endoscopic resection of colorectal polyps with a basal diameter of 5-30 mm. from one day before the procedure to five days postoperatively, patients will be administered chanyanning granules. the study will observe intraoperative and postoperative bleeding, perforation, and digestive system-related clinical symptoms such as postoperative abdominal pain, bloating, diarrhea, constipation, hematochezia, and fatigue, as well as related inflammatory markers, to determine the therapeutic effect of chanyanning granules.


Eligibility criteria:
inclusion criteria: * patients diagnosed with colorectal polyps through endoscopic examination and who received corresponding endoscopic treatments (emr, hybrid esd, esd). exclusion criteria: * concurrent infectious diseases or malignant tumors; accompanied by severe cardiopulmonary diseases (such as severe heart failure, copd, etc.)

Keywords: colorectal polyps
a long-term extension study of wa22762 and na25220 of subcutaneous (sc) tocilizumab (tcz) in moderate to severe rheumatoid arthritis (ra)

Conditions: Rheumatoid Arthritis

Summary: this open-label extension study will evaluate the long-term safety and efficacy of sc tcz in participants with moderate to severe ra who have completed the 97-week wa22762 (nct01194414) or 96-week na25220 (nct01232569) core studies on sc or intravenous (iv) tcz. participants will receive tcz 162 milligrams (mg) sc every week (qw) or every 2 weeks (q2w) for up to 96 weeks.


Eligibility criteria:
inclusion criteria: * completed the 97-week wa22762 (nct01194414) or 96-week na25220 (nct01232569) core study on sc or iv tcz and, based on the investigator's judgment, may continue to benefit from tcz treatment in this study investigating the sc formulation * receiving treatment on an outpatient basis * females of childbearing potential and males with female partners of childbearing potential must agree to use reliable means of contraception as defined by protocol exclusion criteria: * premature withdrawal from wa22762 (nct01194414) or na25220 (nct01232569) core studies for any reason * history of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies * evidence of serious uncontrolled concomitant disease or disorder * known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections * any major episode of infection requiring hospitalization or treatment with iv antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks of screening * history of or currently active primary or secondary immunodeficiency * oral corticosteroids at greater than (\>) 10 mg per day prednisone or equivalent, or non-steroidal anti-inflammatory drugs (nsaids) above the maximum recommended dose * intra-articular or parenteral corticosteroids within 4 weeks prior to baseline * treatment with any investigational or commercially available biologic disease-modifying anti-rheumatic drug (dmard) other than tcz at any time between completion of the core study wa22762 (nct01194414) or na25220 (nct01232569) and enrollment in the long-term extension study * pregnant or breastfeeding women * history of alcohol, drug, or chemical abuse within 1 year prior to screening
effect of nns on metformin/gdf15, pilot

Conditions: Obesity, Adolescent; Pre Diabetes

Summary: metformin use for diabetes has the benefit of causing weight loss in some. the investigators in a preclinical trial, demonstrated that mice consuming non-nutritive sweetened (nns) drinks had worse glucose improvements and weight loss than mice consuming sugar drinks or water. this study will conduct a pilot to determine if this translates into pediatric clinical practice. the hypothesis is that nns drinks impair metformin-induced satiation, weight loss, and glucose tolerance.

this study will enroll 40 children ages 10-21 years (will be recruited from the university of florida (uf) pediatric obesity\& metabolic clinic in gainesville) and randomize eligible participants into a 2-arm, 12-week metformin (500mg bid) intervention (n=20/group) in which one arm will be randomized to receive education and counseling to avoid all sweetened drinks (drink water only) and the other to avoid drinks sweetened with sugar (can have diet drinks sweetened with nns). participants will be asked to consume minimum of 3 drinks/day in the initial visit (baseline visit) the investigators will do a complete evaluations of physical health and eating behaviors. the investigators will draw lab work including a1c and gdf15 levels. the investigators will also get anthropometric measurements of height and weight to calculate body mass index (bmi). for assessment of beverage intake, the investigators reviewed questionnaires validated in children and adolescents in the past 10 years to better reflect currently available beverages. the investigators combined data from bevq-15 (that was validated in children aged 6-18 years) and bfq(17 items questionnaire validated in young adults, aged 16-30 years),and edited further to make the important distinction between unsweetened and artificially sweetened drinks while adding several examples to each category to help improve correct selection. the investigators will also limit to weekly intake assessments. data will be collected biweekly. following completion of the 12-week intervention, participants will return fasting to assess the effectiveness of the metformin treatment on the following: hemoglobin a1c (a1c), growth differentiation factor 15 (gdf15), with bmi and 24-hour dietary recall, including questions about change in hunger while on metformin. the investigators predict that metformin-induced gdf15 levels will be blunted in participants consuming nns beverages. to improve compliance and decrease attrition, the investigators will provide performance feedback and interpretation of physiological parameters.

Eligibility criteria:
inclusion criteria: * eligible patients will have already been prescribed metformin as part of their normal clinical care * must also be aged 10-21 years * have a diagnosis of obesity (bmi \> 95th%ile or \>30 kg/m2 - whichever is lower) and pre-diabetes (a1c between 5.7 and 6.4%) exclusion criteria: * previous treatment with oral hypoglycemic medications, (2) resting systolic blood pressure (sbp)\>180 mm/hg or diastolic blood pressure (dbp)\>100mm/hg, (3) self-reported pregnancy