Kornimate/medical-research-clean huggingface dataset:
prophylactic antibiotic treatment in hemodialysis

Conditions: Hemodialysis

Summary: the purpose of this study is to assess the efficacy of prophylactic antibiotic treatment on blood stream infections and severe culture negative infections, in patients on newly started hemodialysis(hd), with a central venous catheter as vascular access.

after being informed about the study and potential risks all eligible patients, giving written informed consent will be included in the study. at week 0 patients will be randomized in a single blinded manner (participants and care providers) in a 1:1 manner to receive 500/125mg amoxicillin/clavulanic acid 30-120 minutes before each hemodialysis with a central venous catheter (cvc) as vascular access, or corresponding placebo. the timing of antibiotic administration has been established in a pilot-study in order to secure a sufficient concentration of antibiotics during the dialysis session. in case of side effects to amoxicillin/clavulanic acid, the prophylactic antibiotic will be shifted to 600mg clindamycin. total treatment period with prophylactic antibiotics is 6 months, with a 1 year follow-up.

Eligibility criteria:
inclusion criteria: * end stage kidney disease (eskd) patients who receive an uncuffed or cuffed cvc for expected chronic hd, regardless of previous eskd treatment modality (pd or ktx) and hemodialysis access (av-fistula or av-graft)) * ≥18 years * ability to understand the study background, risk and benefit of treatment and to give written informed consent exclusion criteria: * unable to give informed consent * known intolerance to beta-lactam antibiotics and clindamycin * active infection treated with antibiotics * breastfeeding * pregnancy. in women of childbearing age, an approved birth control must be ensured at least 1 month before and during all the 6 months of antibiotic/placebo treatment. patients may be rescreened later i.e. within a time period of one month from start of hd, if exclusion criteria are reversible.

Keywords: blood stream infections severe culture negative infections central venous catheter prophylactic antibiotics
a study to learn about the study medicine sisunatovir in adults with respiratory syncytial virus (rsv) infection

Conditions: Respiratory Syncytial Virus Infection

Summary: the purpose of this study is to learn about the safety and effects of sisunatovir. sisunatovir is studied for the possible treatment of respiratory syncytial virus (rsv). rsv is a virus that causes lung infections with cold-like symptoms, but it can cause severe illness in some people. sisunatovir is studied in adults: * who are not admitted to the hospital and * who have high chances of having a severe illness from rsv infection. this study is seeking participants who: * are confirmed to have rsv. * have symptoms of a lung infection. * are 18 years of age or older. * have one or more of the following which increases the chances of rsv illness: * a long-term lung disease. * heart failure. * a condition that weakens the immune system. * are 65 years of age or older and do not have any of the conditions above half of the participants in this study will receive sisunatovir. the other half will receive a placebo for 5 days. placebo looks same like the study medicine but does not have any medication. both sisunatovir and placebo will be taken by mouth. the study will compare the experiences of people receiving sisunatovir to those of the people who do not. this will help decide if sisunatovir is safe and effective. participants will attend about 8-10 study visits over 5 weeks. during this time, they will have: * visits at the study clinic, * blood work, * swabs of the nose, * questionnaires, * a follow-up phone call.


Eligibility criteria:
inclusion criteria: * participants aged 18 years or older at screening. * diagnosis of rsv infection collected within 5 days prior to randomization. * new onset or worsening (if present chronically) of at least one of the following signs and/or symptoms consistent with a viral acute respiratory infection (ari), within 5 days prior to randomization: nasal congestion, nasal discharge, sore throat, cough, sputum production, shortness of breath, or wheezing. * has at least 1 of the following characteristics or underlying medical conditions: a) 65 years of age or older b) chronic lung disease, c) heart failure, d) immunosuppressive disease/condition or immune-weakening medications exclusion criteria: * any medical or psychiatric condition that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study or interfere with the evaluation of response to the study intervention. * diagnosis of viral respiratory infections other than rsv including influenza and sars-cov-2 * current need for hospitalization or anticipated need for hospitalization for any reason to provide inpatient/acute care within 24 hours after randomization * any clinically significant ecg abnormality in the pre-dose ecg that, per investigator judgement, may affect participant safety * has hypersensitivity to or other contraindication to any of the components of the study interventions, as determined by the investigator.
combined ketorolac bupivacaine versus bupivacaine alone for tap block in children undergoing lower abdominal surgeries

Conditions: Postoperative Pain, Acute

Summary: control of of pain in children is fundamental. tap block is associated with less side effects compared with other neuraxial techniques especially when done under ultrasound guidance. ketorolac has analgesic effect comparable to morphine. children were arranged randomly into two equal groups, forty-five children in each. group (k) (n= 45): received ultrasound guided tap block with bupivacaine 0.25% (0.5 ml/kg) and ketorolac (0.5 mg/kg). group (t) (n =45): received ultrasound guided tap block with bupivacaine 0.25% (0.5 ml/kg)

this prospective randomized controlled study were carried out in sohag university hospitals after getting approval from medical research ethics committee and written informed consents from the patients' parents or legal guardians. this study included 90 asa status i and ii children aged 6-12 years undergoing elective lower abdominal surgeries.preoperative assessment: * history taking from the parents. * complete physical examination. * laboratory investigations: complete blood picture and coagulation profile. preoperative preparation before starting, standard monitoring will be as follow: 1. non-invasive blood pressure (systolic and diastolic). 2. peripheral oxygen saturation (spo2%). after insertion of intravenous line, all children will receive atropine premedication (0.01-0.02 mg/kg). general anesthesia will be induced using propofol 1% (2 mg/kg), atracurium (0.5 mg/kg) to facilitate endotracheal intubation. anesthesia will be maintained using isoflurane (1-2%) with controlled ventilation.at the end of operation, muscle relaxant is reversed using neostigmine and atropine. intraoperative hemodynamic parameters will be recorded throughout the surgery at fixed intervals (at time of skin incision then after every 5 min till the end of surgery). then tap block were done under ultrasound guidance using either bupivacaine and ketorolac or bupivacaine alone

Eligibility criteria:
inclusion criteria: * asa status i and ii children age 6-12 years elective lower abdominal surgeries. exclusion criteria: * parents' or legal guardians' refusal. * a history of developmental delay or mental retardation. * asa iii and iv. * a known allergy to ketorolac or bupivacaine. * hemodynamic unstable patient * urgent surgeries

Keywords: tap ketorolac bupivacaine, ultrasound children
scheduled awakenings for the treatment of nocturnal enuresis

Conditions: Nocturnal Enuresis

Summary: this study is a simple effectiveness trial to determine if the lully sleep guardian has any effect on benign nocturnal enuresis.

primary monosymptomatic nocturnal enuresis (pmne) is defined by the diagnostic \& statistical manual of mental disorders (dsm- iv) as an involuntary voiding of urine during sleep, with a severity of at least twice a week, in children aged \>5 years in the absence of congenital or acquired defects of the central nervous system(1-3). pmne affects 10-20% kids at 5 years old (1, 4, 5). it does resolve spontaneously so that 5% of 10 year olds and 1% of 15 year olds are still affected (2-4). is more common in boys. while the disease its self is benign, and improves without intervention, it does pose a significant social and emotional burden on the child and their family. these include parental disapproval, sibling teasing, and inability to attend sleep overs with peers, all of which lead to families seeking treatment options (3, 4). current treatments start with conservative management. this includes appropriate fluid intake, scheduled toileting during the day, avoidance of bladder irritants and constipation (4, 5). if these fail to improve symptoms or families are looking for a more active form of treatment, first line therapy is either a bed wetting alarms or desmopressin (1, 4, 5). the lully sleep guardian was initially developed for use in night terrors. the device works by programing a vibrating disk that is placed under the child's bed to alter sleep patterns and prevent the onset of sleep terrors. the child is not woken up for the treatment of sleep terrors. the device has also been shown to anecdotally improve users' nocturnal enuresis. there have been no reports of safety concerns or hazards with the device (7, 8). the aim of this study is to determine the effectiveness of scheduled awakenings, with the lully sleep guardian, in patients with pmne, at reducing the frequency of bed-wetting.

Eligibility criteria:
inclusion criteria: * benign nocturnal enuresis * age: 5 - 17 * must have or have access to an apple iphone, ipad, or ipod touch exclusion criteria: * diurnal enuresis * constipation * neurogenic bladder * any serious underlying cardiopulmonary problems that require diuretics or antihypertensive medications to manage * any bladder active medications * age: \ 17 years of age * cerebral palsy * mental disorders, mood disorders, or autism-spectrum disorder * epilepsy or seizure history * restless leg syndrome * use of benzodiazepine/clonidine

Keywords: bedwetting
retinol equivalence of plant carotenoids in children

Conditions: Vitamin A Deficiency

Summary: to determine vitamin a value of beta-carotene in oil capsule, spinach, and golden rice. the experiments will be conducted in children (ages 7-9) with/without adequate vitamin a nutrition. as plant provitamin a carotenoids are a major and safe vitamin a source for a vast population in the world, it is essential to determine the efficiency of provitamin a carotenoid (mainly ß-c) conversion to vitamin a. by introducing ß-c into rice endosperm, golden rice may directly benefit consumers by providing vitamin a nutrition. our investigation uses hydroponically grown, deca-deuterium labeled spinach and golden rice, synthetic ß-c-d10 and a vitamin a isotope reference, deca-deuterated retinyl acetate (rac-d10), to evaluate the bioavailability and the bioconversion of plant provitamin a carotenes to retinol as compared with ß-c in oil capsules in vivo. our objectives will be to test the following hypotheses and to make the following determinations: (1) the absorption and bio-conversion of provitamin a carotenes taken by children are different between spinach, golden rice, and ß-c in oil capsules. (2) the absorption of provitamin a carotenes and their bioconversion to vitamin a are different in children with or without adequate vitamin a nutrition. (3) to define the vitamin a equivalence(s) of dietary spinach, golden rice, and a ß-c in oil dose by using an isotope reference method in children with or without adequate vitamin a nutrition and to compare those values with values derived from model based compartmental analysis. (4) to determine the number and time of blood samples needed for future studies in various field settings on the retinol equivalence of a large number of plant sources. this study will be of importance in planning vitamin a deficiency prevention strategies and also will provide useful information regarding the potential efficacy of a bioengineered crop to provide vitamin a nutrition.

seventy-two children each will take two meals, lunch and supper, containing equal amounts of ß-c in labeled spinach (along with white rice), or golden rice (along with light colored vegetables), or ß-c oil capsules (along with white rice and light colored vegetables), every day for 7 days. before the two meals, the volunteers will take a breakfast with a rac-d10 dose as a reference for 7 days. the enrichment of labeled ß-c and labeled retinol in human circulation will be determined using advanced liquid chromatography / mass spectrometry and gas chromatography / mass spectrometry. through the applications of these novel technologies, we will be able to determine the relative biological activities of endogenous carotenoids; that is, the vitamin a value of spinach, golden rice, and ß-c in oil capsules for children with/without vitamin a malnutrition.

Eligibility criteria:
inclusion criteria: * 7-9 years old exclusion criteria: * parasitic infection

Keywords: vitamin a malnutrition low vitamin a status
effect of phytosterols enriched products consumption on carotid artery artherosclerotic plaque

Conditions: Hypercholesterolemia

Summary: the objective of this exploratory study is to analyse in humans any qualitative changes of carotid artery atherosclerotic plaque under the influence of plant sterols consumption.


Eligibility criteria:
inclusion criteria: * patient, men and women, aged between 40 to 75 ans (limits included) willing to participate to the study and have signed informed consent for its participation in the study * displaying a non serious chirurgical indication of clinical asymptomatic carotid stenosis defined by: * atherosclerotic stenosis of 60 to 75% on one on the two carotid junction (external carotid excluded) according to criteria from nascet * without constituted or transitory recent cerebral vascular accident. the discovery of an ischaemic after-effect on a systematic scanner is not a criterion of exclusion * subject with normal body weight or in over weight (body mass index ranged between 19 and 30 kg/m2, \[limits included\]) * subject willing to follow dietary recommendations advised during hypercholesterolemia (according to afssaps' recommendations) * subject with social insurance or equivalent. exclusion criteria: * subject who, according to afssaps' recommendations, should received a hypocholesterolemic therapy before the end of the study. * subject with a history of diabetes * subject with cardiac disease such as unstable angina, myocardial infarction, coronary angioplasty, coronary artery bypass graft surgery, or moderate or severe congestive heart failure within the last 6 months. * subject with plasma triglyceride levels higher than 2,5 g/l \[limit included\], * subject taking any drugs known to affect the evaluation of studied parameters * subject with severe or acute disease that could affect the results of the study or subject safety * subject with regular consumption of phytosterol enriched foods products during the study. * subject with any other medical condition or laboratory abnormality prior to recruitment that in the opinion of the principal investigator could affect subject safety or render unlikely trial to be conducted to the end. * for women: pregnancy or breast feeding or subject likely to be pregnant during the study. * for women: subject likely to modify their hormonal therapy during the study * subject in exclusion period after its participation in an other clinical trial
the survey of ipragliflozin treatment in elderly type2 diabetes patients

Conditions: Type 2 Diabetes

Summary: the objective of this survey is to confirm the safety of suglat tablets when used in the elderly.

elderly patients (65 years or older at the time of first administration) with type 2 diabetes who used suglat tablets within 3 months from its launch are included in this study. followings are measured with the patients. 1. specify incidence rates of adverse drug reactions associated with a decrease in body fluids and their risk factors. 2. investigate the occurrence of urinary tract infection. 3. investigate the occurrence of adverse drug reactions in patients at a high risk (those who have poorly controlled blood sugar levels, concurrent organic abnormalities in the urinary system, advanced diabetic neuropathy, etc). 4. investigate the occurrence of adverse drug reactions other than the above. 5. factors that may possibly influence the safety of suglat tablets.

Eligibility criteria:
inclusion criteria: * type 2 diabetes who used suglat tablets within 3 months from its launch exclusion criteria: * off-label use patients

Keywords: sglt-2 inhibitor elderly patients asp1941
study to assess effectiveness and adverse events of foscarbidopa/ foslevodopa in adult participants with advanced parkinson disease in real life setting

Conditions: Advanced Parkinson Disease

Summary: parkinson's disease (pd) is a neurological condition, which affects the brain. pd gets worse over time, but how quickly it progresses varies a lot from person to person. some symptoms of pd are tremors, stiffness, and slowness of movement. this study will assess how effective foscarbidopa/ foslevodopa is in treating french adult participants with advanced parkinson disease under routine clinical practice. foslevodopa/foscarbidopa is an approved drug outside of us for the treatment of parkinson's disease. approximately 200 adult participants who are prescribed foslevodopa/foscarbidopa by their doctors will be enrolled across approximately 30 sites in france. participants will receive foscarbidopa/ foslevodopa subcutaneous infusion as prescribed by their physician. participants will be followed for up to 12 months. there is expected to be no additional burden for participants in this trial. participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.


Eligibility criteria:
inclusion criteria: * participants with advanced parkinson disease with motor complications insufficiently controlled by current therapy * participants eligible for foscarbidopa / foslevodopa according to french label \& regulation. * treatment initiation decision prior to and independently from study enrolment exclusion criteria: * participants with any contraindication to foscarbidopa / foslevodopa. * participants with mini mental state examination (mmse) score \< 24

Keywords: advanced parkinson disease foscarbidopa/ foslevodopa abbv-951 ldp/cdp
p3 long term safety study of once daily sb204 in acne

Conditions: Acne Vulgaris

Summary: this is a multi-center, open label long-term safety (lts) study to be conducted in approximately 600 subjects with acne vulgaris.

a phase 3 multi-center, open label study evaluating the long term safety of sb204 once daily in the treatment of acne vulgaris.

Eligibility criteria:
inclusion criteria: * have completed 12 weeks of treatment in ni-ac301 or ni-ac302 exclusion criteria: * terminated early from an sb204 phase 3 pivotal study for any reason * have an on-going adverse event at week 12 visit for ni-ac301 or ni-ac302 that warrants stopping study drug application * have used medications or vitamins during the 12 weeks immediately preceding this study which were reported to exacerbate acne.
dendritic cell vaccination with standard postoperative chemotherapy for the treatment of adult ovarian cancer

Conditions: Recurrent Ovarian Cancer

Summary: effective treatments are desperately needed for ovarian cancer patients. this phase i clinical trial assesses the safety of a novel personalized dendritic-cell vaccine administered to ovarian cancer patients. secondary outcomes will be evaluated such as patient pharmacodynamics， progression-free survival and overall survival.

this is a single arm, non-randomized phase i study to evaluate the safety and feasibility of delivering a novel dendritic cell vaccine in 6 to 12 (n=6-12) adult patients diagnosed with ovarian cancer after undergoing surgical resection. the vaccine contains both tumor-associated antigen and patient specific neoantigens. standard-of-care chemotherapy therapy will be followed as per routine,during which patients enrolled into this study will receive a personalized vaccine in addition to standard of care. effective adjuvant therapies are urgently needed for these patients given that high rate of recurrence still occurs after standard of care with poor prognosis among ovarian cancer patients. the study is constructed in a 3+3 algorithm for two steps of dose escalation with rigorous and mandatory safety monitoring.

Eligibility criteria:
inclusion criteria: 1. 18-75 years old female patients； 2. histopathologically diagnosed recurrent stage iii/iv epithelial ovarian cancer; 3. normal liver, heart as well as kidney functions and blood chemistry; 4. predicted survival for more than 6 months； 5. provision of signed and dated informed consent form. exclusion criteria: 1. allergic to human albumin, an excipient of the manufactured dendric cell vaccine； 2. predicted survival for less than 6 months； 3. diagnosed with brain metastasis and other diseases unsuitable for cell therapy including but not limited to myelodysplastic syndromes、acute myeloid leukemia and systemic lupus erythematosus; 4. diagnosed with viral diseases including but not limited to hiv, tp, hcv and hbv ； 5. female patients who are pregnant, breast feeding, or of childbearing potential without a negative pregnancy test prior to baseline; 6. other conditions deemed unsuitable for this study by the leading investigators.

Keywords: neoantigen dendritic cell vaccine
improving uptake and adherence to hiv prevention services with pre-exposure prophylaxis (prep), hiv self- testing and adherence support for very high risk hiv-negative young women aged 15-24 in kampala, uganda

Conditions: HIV/AIDS

Summary: the main aim is to develop and assess an intervention to enhance initiation and adherence to prep among hiv negative young women of high risk (ywhr). the specific aims are (1) to conduct formative research to enhance our understanding of the dynamics of the social and sexual networks, and context of young hiv-uninfected women (aged 15-24) engaged in high risk sexual behavior in kampala, uganda (2) document barriers and opportunities for prep uptake and adherence as well as repeat hiv testing by self test; (3) to develop and test a socially and culturally acceptable and feasible prevention intervention on uptake and adherence to prep and hiv self-testing for young women at high risk for hiv.


Eligibility criteria:
inclusion criteria: * female age 15- to 24-years old * engaging in high-risk sexual behavior having had sex at least once in last three months, --hlv-negative * agree to participate in a minimum of four interviews over a 12-month period; including baseline * willing to receive services at good health for women project (ghwp) * for those initiating prep (truvada): * participants should have immunity to hepatitis b infection and serum creatinine before * contra-indications for starting truvada to be considered include creatinine \> 1.2 ( (mgldl) or 0.106 (mmolil) and a weight below 35kg. exclusion criteria: * inability to consent to participation in the study * condition impeding participation in the study, including severe mental reason to the discretion of the principal investigator, cognitive impairment or illness; serious medical illness or developmental disability and any other reason to the discretion of the principal investigator.