Kornimate/medical-research-clean huggingface dataset:
are post-operative antibiotics indicated in simple appendicitis?

Conditions: Appendicitis

Summary: hypothesis: a single dose of prophylactic antibiotics is as effective as a three dose regime in preventing post-operative complications in paediatric patients with simple appendicitis. this project will compare patients 16 years and under with simple appendicitis (appendicitis that is not perforated or gangrenous). patients will be randomly divided into two groups; * group one will receive a single pre-operative dose of antibiotics (metronidazole 12.5mg/kg up to 500mg and cefazolin 25mg/kg up to 1g) and two 'doses' of normal saline (placebo) eight and sixteen hours after the initial dose, respectively. * group two will receive one pre-operative dose of antibiotics (metronidazole 12.5mg/kg up to 500mg and cefazolin 25mg/kg up to 1g) and two post-operative doses, eight and sixteen hours after the first dose, respectively. group allocation will be concealed from the patient and their guardian, the treating surgical team and outcome assessors (triple blinded). a process to rapidly reveal group allocation if required will be in place. the aim of the study is to determine if a single dose of antibiotics is as effective as three doses in preventing post-operative infection. this will be assessed by comparing: * duration of hospital stay from operation until discharge, based on a standardised discharge criteria. * development of wound infection or requirement of antibiotics in the six weeks post-operation * need for re-admission. information will be collected prospectively from each patient's hospital notes and from a follow-up phone call six weeks after the operation.


Eligibility criteria:
inclusion criteria: * all patients who have their appendix removed and are found on operation to have 'simple appendicitis' as defined in the cochrane review\[7\]. that is an appendix that is non-inflamed, acutely inflamed, phlegmonous, suppurative or mildly inflamed. exclusion criteria: * patients who on operation are found to have 'complicated appendicitis' defined as an appendix that is gangrenous or perforated. * patients who pre-operatively appear to be acutely septic or for another reason require extended antibiotic therapy. * patients who, at operation, are found to have other pathology e.g. meckel's diverticulum, intussusception; requiring surgical or medical intervention. * any patient whose guardian does not wish for them to participate in the study. * patients who have additional co-morbidities, including diabetes, immuno-suppression, cardiac, renal or liver failure. * if the child continues to show sign of sepsis, in terms of fever, tachycardia, he/she will be discontinued from the study and be given additional doses of antibiotics, as clinically indicated.

Keywords: paediatric simple non-perforated
optimizing reperfusion to improve outcomes and neurologic function

Conditions: Acute Ischemic Stroke

Summary: the goal of this study is to evaluate the safety and efficacy of jx10 versus placebo in participants with acute ischemic stroke (ais) who present for care within 4.5 to 24 hours. the main question the study aims to answer are: 1. jx10 improves functional outcomes as measured by the modified rankin scale score when compared with placebo following ais. 2. risk of symptomatic intracranial hemorrhage of jx10 in participants with ais. during part 1, participants will be randomized to jx 10 (1mg/kg, 3 mg/kg) or placebo. during part 2, participants will receive jx10 (optimal dose chosen from part 1) or placebo.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 and ≤ 90 years old. 2. acute ischemic stroke with compatible clinical presentation and symptomatic high grade or complete occlusion of the intracranial internal carotid, m1, m2 or distal branches of the middle cerebral artery (mca), anterior cerebral artery (aca), or posterior cerebral artery (pca). 3. radiographic evidence of salvageable tissue. 4. pre-treatment score of nihss ≥ 5. exclusion criteria: 1. radiographic findings pre-randomization of any of the following: 1. large core infarction, or 2. occlusion in more than 1 vascular territory, or 3. significant mass effect or clinically significant cerebral edema, or 4. evidence of acute intracranial or extracranial hemorrhage, intracranial tumor (except small meningioma), neoplasm, or arteriovenous malformation), or 5. clinical history, past imaging, or clinical judgement suggests that the intracranial occlusion is chronic. 2. medical history or active clinically significant bleeding, lesions, or conditions (at the investigator's judgement) considered to be of significant risk for major bleeding. 3. severe, uncontrolled hypertension (systolic blood pressure ≥ 185 mmhg or diastolic blood pressure ≥ 110 mmhg) that cannot be controlled with antihypertensive therapy. 4. known bleeding diathesis (hereditary or acquired) or any significant coagulopathy. specifically, platelet count \ 1.7, aptt \> 40 seconds, or prothrombin time \> 15 seconds. 5. major trauma, surgery, or invasive procedures. 6. pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional evaluations of this study. 7. pre-treatment blood glucose \> 400 mg/dl (22.20 mmol/l) or pre-treatment blood glucose \< 50 mg/dl (2.78 mmol/l) unless it is corrected prior to study treatment administration. participants with subsequently normalized blood glucose levels may be considered for inclusion, per investigator judgement.

Keywords: reperfusion orion acute ischemic stroke late presentation jx10 thrombolytic
human factors study of methotrexate prefilled pen (50 mg/ml) in patients with juvenile idiopathic arthritis

Conditions: Juvenile Idiopathic Arthritis

Summary: this study is planned to evaluate the human factor (hf)/usability of pediatric or adolescent jia patients and the caregivers of juvenile idiopathic arthritis (jia) patients with the methotrexate prefilled pen (including a label comprehension assessment and a device robustness evaluation).


Eligibility criteria:
main inclusion criteria: * patient of either gender aged ≥2 to \<21 years of age * is a suitable candidate for treatment with injectable methotrexate for jia per the patient's primary rheumatologist, with the previous or current diagnosis of active polyarticular course jia main exclusion criteria: * is a female patient who is pregnant, trying to become pregnant, or breastfeeding, or of childbearing potential, sexually active but not practicing a highly reliable method of birth control during the study and at least 6 months thereafter * has contraindications for methotrexate * has a history of or current inflammatory arthritis or rheumatic autoimmune disease other than jia * is unable, or does not have a caregiver able to comprehend written labeling and training materials
homologous recombination deficiency status in epithelial ovarian cancer

Conditions: Epithelial Ovarian Cancer; Chinese; Homologous Recombination Deficiency; BRCA1 Mutation; BRCA2 Mutation; Prognosis

Summary: the homologous recombination deficiency (hrd) status in chinese population with epithelial ovarian cancer (eoc) is little known. this study would recruit 1300 chinese eoc patients. a multi-panel testing of 36 genes would be given for these patients in their peripheral blood and tumor tissues. these 36 genes include: brca1, brca2, abraxas1(fam175a）, atm, atr, bap1, bard1, brip1, c11orf30（emsy）, cdk12, chek1, chek2, fanca, fancc, fancd2, fanci, fancl, mre11a, nbn, palb2, ppp2r2a, pten, rad50, rad51b, rad51c, rad51d, rad54b, rad54, mlh1, msh2, msh6, pms2, epcam, stk11, tp53, cdh1. the study would select 150 patients with pathogenic or likely pathogenic mutations in brca1/2 and 150 patients without these mutations to further explore the hrd status. the hrd model is based on the loss of heterozygosity (loh), telomere allele imbalance (tai) and large-scale state transitions (lst). the mutated genes, hrd score model and their relationship with the prognosis, would provide a full description of for the chinese eoc patients.


Eligibility criteria:
inclusion criteria: * aged 18 years or older * pathological confirmation of epithelial ovarian cancer * with available tumor tissues * given consents to participate the study exclusion criteria: * not meeting all of the inclusion criteria
sentinel lymph node mapping with near infrared fluorescent markers

Conditions: Breast Cancer

Summary: surgery is the primary curative option for patients with cancer, with the overall objective of complete resection of all cancerous tissue while avoiding damage to healthy tissue. in addition, sentinel lymph node (sln) mapping and resection is an essential step in staging and managing the disease. even with the latest advancements in imaging technology, incomplete tumor resection in patients with breast cancer is at an alarming rate of 20-25%, with recurrence rates of up to 27%. the clinical need for imaging instruments that provide real-time feedback in the operating room is unmet, largely due to the use of imaging systems based on contemporary technological advances in the semiconductor and optical fields, which have bulky and costly designs with suboptimal sensitivity and co-registration accuracy between multimodal images. to address these challenges, the investigators have introduced an innovative design comprising a bio-inspired multispectral sensor which can significantly improve image-guided surgery. the objective of this clinical study is to determine the feasibility of using a bio-inspired multispectral imaging system to detect sentinel lymph nodes and cancerous tissue during intraoperative procedures in patients with breast cancer.

per current standard of care for patients with breast cancer, three different tracers will be injected in the participants: technetium radiocolloid, indocyanine green and methylene blue. initially, the surgeon will identify the location of the sentinel lymph node per standard of care by using a handheld gamma-probe and by visual inspection of the wound site. while the surgeon is locating the sentinel lymph nodes in the underarm surgical wound site, the investigators will be recording the fluorescent signals from the same site with the bio-inspired multispectral camera. all resected tissue from the patient will be imaged with the multispectral camera before sending samples for pathology analysis. results obtained from the multispectral cameras will not be presented to the surgeon during the surgery in order not to influence their surgical decision.

Eligibility criteria:
inclusion criteria: * early or progressive stage of breast cancer * able to understand and willing to sign a written informed consent document exclusion criteria: * inflammatory cancerous tissue * pregnant women * history of allergic reactions to iodide or seafood allergy * sentinel lymph nodes were not detected with radiocolloid and static gamma camera * patients have previous breast surgery * patients who were unwilling to enter the study

Keywords: breast cancer sentynel lymph node fluorescence imaging
efficacy of fractional carbon dioxide laser combined with platelet-rich plasma

Conditions: Striae Gravidarum

Summary: this study determined the efficacy of ablative fractional carbon dioxide laser combined with autologous platelet-rich plasma versus ablative fractional carbon dioxide laser with placebo in the treatment of striae gravidarum of postpartum filipino women.


Eligibility criteria:
inclusion criteria: * postpartum patients with ages 18 to 45 years * fitzpatrick skin type iii-v * having bilateral symmetrical sg of red, white or a combination of both types. exclusion criteria: * pregnancy * breastfeeding * heavy consumption of alcoholic beverages * dermatological conditions such as psoriasis, systemic lupus erythematosus and atopic dermatitis * uncontrolled hypertension, diabetes mellitus, heart disease, acute and chronic liver/kidney impairment/disease; * elevated liver function tests (sgpt, sgot), and serum creatinine; * intake of any medications that may influence the outcome of the study; * intake of any vitamins/minerals or any supplements in the past 6 months; and * application of any topical agents (e.g., whitening, anti-aging) in the past 6 months

Keywords: striae gravidarum carbon dioxide laser platelet-rich plasma
automated 3d (sonoavc) versus 2d ovarian follicles assessment in ivf cycles: a randomized controlled trial

Conditions: Infertility

Summary: accurate assessment of the size of follicles is important in ivf treatment.timing of oocyte maturation and subsequent egg collection is largely based on follicle size. an accurate assessment of follicle size and appropriate timing of hcg result in retrieval of more mature oocytes, improved fertilization and higher pregnancy rates. in 3d technology- fter the capturing of a 3d image of an ovary, sonoavc automatically analyzes the volume dataset, identifies the boundaries of hypoechoic follicles, and provides estimates of their absolute dimensions. these measurements include the largest diameters in three orthogonal planes, the mean follicular diameter (mfd), the volume of the follicle, and the volume-based diameter (d(v)) of the follicle. in the current study the investigators aim to evaluate the use of this automated technique of follicle measurement vs. standard 2d technology on the timing of oocyte maturation and subsequent oocyte retrieval. the investigators speculate that 3d assessment will increase the rate of mature oocyte collection, and eventually will improve other treatment outcomes such as fertilization rate.

not desired

Eligibility criteria:
inclusion criteria: * age:18-39, cycle number 1-4 exclusion criteria: * pcos * endometriosis * poor ovarian response * tesa sperm

Keywords: ivf 3d ultrasound sonoavc patients in ivf treatment
risk of infertility related to adjuvant chemotherapy for early breast cancer: oocyte/embryo cryopreservation

Conditions: Breast Cancer

Summary: the aim of the study is to perform a french multicenter prospective interventional study in order to assess the feasibility and safety of ovarian hyperstimulation for oocyte / embryo cryopreservation in young women with breast cancer. the oncologic and reproductive benefit / risk ratio will be investigated in the oncology and reproductive area.

medical oncology: * information and collection of consent, * imaging staging, * inclusion * physical examination * contraception advise given reproductive medicine center: * ovarian reserve assessment: serum anti-mullerian hormone (amh) measurement and antral follicle count (afc) by ultrasound. * serology syphilis, hepatitis b and c, hiv (human immunodeficiency virus). in case of embryo cryopreservation, same serology determination for the men. * infertility risk and fertility preservation techniques information. * in case of agreement, this technique will be done during the time-interval between surgery and chemotherapy * fertility preservation (coh stimulation, triggering and oocyte retrieval) adjuvant chemotherapy: * the chemotherapy regimen is 3 fec (fluorouracil epirubicin cyclophosphamide) 100 followed by standard chemotherapy (according to local practice) +/- trastuzumab. adjuvant chemotherapy may only begin after the oocyte retrieval. * usual adjuvant chemotherapy is not changed during chemotherapy: * clinical exam before each cycle of chemotherapy * amh, afc at cycle 6 after chemotherapy: * usual patient monitoring in expert center : physical examination at month 3 (m3), m6 m9 m12 m18 and m24 and mammography at m9 then annual * amh at month 3 (m3), m6 m9 m12 m18 and m24 * afc at month 12 (m12) and m24

Eligibility criteria:
inclusion criteria: * women with histologically proven breast cancer * aged 18 to 38 years old * planned adjuvant chemotherapy * no prior chemotherapy * affiliated to a public health insurance program * informed consent signed by the patient exclusion criteria: * metastatic breast cancer * planned neo-adjuvant chemotherapy * hysterectomy * exclusive adjuvant hormonotherapy * positive serology for syphilis, hepatitis b or c, or vih * contraindication related to use of r-fsh * pregnant or breastfeeding patients

Keywords: oocyte/embryo cryopreservation
compliance with dietary recommendations in children at risk for undernutrition

Conditions: Children; Under-nutrition

Summary: this study will assess compliance with dietary recommendations, in conjunction with a nutritional supplement to meet the nutritional requirements in children and the effects of the compliance on promoting growth in children who are at risk of under-nutrition.

this study will assess compliance with dietary recommendations, in conjunction with an oral nutritional supplement to meet the nutritional requirements in children older than 36 (\>36) to less than or equal 48 (≤48) months of age, and the effects of the compliance on promoting catch-up growth and normal healthy growth in children who are at risk of under-nutrition.

Eligibility criteria:
inclusion criteria: * child is between 36 and 48 months of age. * child has weight-for-height greater than or equal to 5th and less than or equal to the 25th percentile. * child is capable of oral feeding. * child's parent(s)or legal guardian is willing to abstain from giving additional non-study nutritional supplements to the child throughout the study period. exclusion criteria: * child whose either parent has bmi greater than or equal to 27.5 kg/m2. * child allergic or intolerant to any ingredient found in the study product. * child who was delivered pre-term. * child was born small for gestational * child had birth weight \ 4000 g. * child has current acute or chronic infections. * child demonstrates presence of severe gastrointestinal disorders. * child has a diagnosis of neoplastic diseases, renal, hepatic and cardiovascular diseases. * child has a diagnosis of hormonal or metabolic disorders. * child has a congenital disease or genetic disorder. * child is diagnosed with infantile anorexia nervosa. * child has a developmental disability or physical disorder. * child has disorders of hemoglobin structure, function or synthesis. * child is participating in another study that has not been approved as a concomitant study.
effectiveness of enhanced cognitive behavioral therapy (cbt-e) in the treatment of anorexia nervosa

Conditions: Anorexia Nervosa

Summary: the primary objective of this study is to gain knowledge about the effectiveness of enhanced cognitive behavioral therapy (cbt-e) for anorexia nervosa (an).

the study will assess the potency of outpatient cbt-e in a sample of patients suffering from an who are admitted to the section for eating disorders at the department for psychosomatic medicine, haukeland university hospital in bergen, norway. secondary objectives are to (1) prospectively identify baseline predictors of treatment outcome and dropout, (2) determine variables related to the treatment process and patient engagement as predictors of the outcome and/or treatment dropout, and (3) in a multidisciplinary approach, focus on selected pathophysiological mechanisms including changes in the gut microbiota as well as immunological measures in patients with severe an in different stages of the disease, and determine to what extent they are related to treatment outcome.

Eligibility criteria:
inclusion criteria: * patients aged \>16 years * suffering from an, as diagnosed based on the diagnostic and statistical manual of mental disorders, fifth edition (dsm-v) and confirmed with a clinical examination. * either at least one unsuccessful treatment attempt in a secondary health-care service unit or severe an that is evaluated as not manageable in a secondary health-care service unit. exclusion criteria: * deemed unsafe to manage on an outpatient basis * psychiatric comorbidity that precludes a focused eating-disorder treatment, such as psychosis or drug abuse. * not available to participate during the requested treatment period * for the analysis of the gut microbiota: patients suffering from inflammatory bowel disease, acute or chronic diarrhea or other bowel disease, treatment with antibiotics during the previous 3 months before stool sampling, or laxative abuse;
clinical pharmacology of 35/4 nexthaler® in children 5-11 years old

Conditions: Asthma

Summary: the study will be conducted in asthmatic children aged 5 to 11 years and is based on a single-dose, open-label, randomized, 2-way cross-over design where a dry powder inhaler (dpi) fixed combination of beclometasone dipropionate (bdp) 35 μg plus formoterol fumarate (ff) 4 μg is compared with the free combination of licensed bdp dpi and ff dpi

this is a pharmacokinetic comparison of nexthaler 35/4 μg versus the free combination of beclomethasone dpi and formoterol dpi in children (5 to 11 years old) of a formulation already approved in adults.

Eligibility criteria:
inclusion criteria: * male/female children with asthma stable enough, according to paediatrician opinion, to allow a wash out period from steroids of 3 days before study treatments. * male/female children with asthma on regular treatment with ics or using short-acting inhaled 2-agonist as reliever to control asthma symptoms. * age ≥ 5 \< 12 years (8 to 10 children in the age range 5-8 years old). * children with a forced expiratory volume in one second (fev1)\>70% of predicted values (% pred) after withholding 2-agonists treatment for a minimum of 4 h prior to screening and to each study treatment. * a cooperative attitude and ability to be trained about the proper use of dpi, ability to use correctly the medical devices and compliant to study procedures exclusion criteria: * past or present diagnosis of cardiovascular, renal or liver disease. * known hypersensitivity to the active treatmen * exacerbation of asthma symptoms within 4 weeks prior to screening. * inability to perform the required breathing technique and blood sampling. * hospitalization due to exacerbation of asthma within 1 month prior to screening (visit 1). * lower respiratory tract infection within 1 month prior to screening (visit 1). * disease (other than asthma) which might influence the outcome of the study. * obesity, i.e. \> 97% weight percentile by local standards
study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of sam-315 in healthy japanese males

Conditions: Alzheimer Disease

Summary: to assess the safety and tolerability of ascending single oral doses of sam-315, an investigational drug, in healthy japanese male subjects.to obtain preliminary pharmacokinetic (pk) and pharmacodynamic (pd) profiles of sam-315 in healthy japanese male subjects.


Eligibility criteria:
inclusion criteria: * men aged 20 to 45 years (inclusive) at the time of getting informed consent. * body mass index (bmi) in the range of 18.5 to 25.0 kg/m2 and body weight≥50 kg (bmi = \[weight (kg)\]/\[height (m)\]2). * healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and digital 12-lead electrocardiogram (ecg). alanine aminotransferase (alt), aspartate aminotransferase (ast) and creatinine levels must be within the upper limit of normal for eligibility. exclusion criteria * any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. * any clinically important deviation from normal limits in physical examination, vital signs, digital 12-lead ecgs, or clinical laboratory test results. * consumption of any caffeine-containing products (eg, coffee, tea, chocolate, or cola) or alcoholic beverages is prohibited from 48 hours and consumption of grapefruit or a grapefruit-containing products is prohibited from 72 hours before study day 1.