Kornimate/medical-research-clean huggingface dataset:
oral tafenoquine plus standard of care versus placebo plus standard of care for babesiosis

Conditions: Babesiosis

Summary: this study is a double-blind, randomized, multisite, placebo-controlled trial comparing the safety and efficacy of tq versus placebo in patients hospitalized for babesiosis with low risk for relapsing disease who will also be administered a standard-of-care antimicrobial regimen (a/a) that is recommended in the 2020 idsa guideline on the diagnosis and management of babesiosis.

this study is a double-blind, randomized, multisite, placebo-controlled trial comparing the safety and efficacy of tq versus placebo in patients hospitalized for babesiosis with low risk for relapsing disease who will also be administered a standard-of-care antimicrobial regimen (a/a) that is recommended in the 2020 idsa guideline on the diagnosis and management of babesiosis. patients hospitalized for a diagnosis of babesiosis, who have received a/a for \<48 hours (h) prior to randomization or are about to receive a/a, will be asked to provide written informed consent and will undergo eligibility screening including medical history, physical examination, prior and concomitant medications, blood chemistry and hematology, glucose-6-phosphate dehydrogenase (g6pd) deficiency testing, blood smear for diagnostic confirmation of babesiosis, pregnancy testing for females of child-bearing potential, and assessment of risk factors for relapsing babesiosis. the screening period will last a maximum of two days. the first day of dosing with tq or placebo will be day 1 and will be done while the patient is still hospitalized.

Eligibility criteria:
inclusion criteria: * male or female, aged ≥ 18 years. * laboratory confirmed infection with babesia. * exhibiting at least one self-reported clinical symptoms of babesiosis. * able and willing to give written informed consent. * expected to be hospitalized at the time of or following informed consent and still hospitalized on the day of randomization and start of investigational products. * willing to complete the study activities and assessments. * must agree not to enroll in another study of an investigational agent prior to completion of the study. * able to take oral medications. * if female of reproductive age, must agree to use an acceptable method of birth control. * adequate venous access. * blood hemoglobin ≥ 7 g/dl. exclusion criteria: * have any contraindications to tq. * have any contraindication for azithromycin or atovaquone. * any concomitant significant illness unrelated to babesiosis. * receipt of any experimental treatment for babesiosis. * taking any excluded concomitant medication. * current or planned treatment with quinine while participating in the study. * positive pregnancy test. * if a/a was initiated more than 48h prior to randomization and parasitemia is not \>1%. * azithromycin or atovaquone administered in the last 12 months to treat babesiosis, and, in the opinion of the investigator, high likelihood that current infection represents a relapse or continuation of disease.

Keywords: babesiosis
impact of weight loss surgery in adolescents with nafld

Conditions: NAFLD; Obesity, Adolescent

Summary: this study will assess the impact of weight loss surgery (wls) on non-alcoholic fatty liver disease (nafld) in adolescents as well as the interaction between nafld and cardiometabolic risk.

while the impact of wls has been studied in adults, little is known about nafld in adolescents undergoing wls. at present, only a small number of adolescents undergo wls each year and thus this area has not been well studied. however, as the prevalence of severe obesity continues to rise the investigators anticipate that so will wls in adolescents. this study will establish the impact of wls on nafld in adolescents. currently, it is assumed that adolescents with nafld diagnosed at the time of wls have universal resolution of their disease with appropriate weight loss, and no further evaluation is conducted. our group has shown that up to 40% of adolescents who undergo wls have persistently abnormal aminotransferase levels, suggesting that many may have persistent nash and are at risk of progressive liver disease. the study will elucidate the history of nafld following wls. such data have not been previously published and will represent a significant contribution to this field.

Eligibility criteria:
inclusion criteria: * obese * meets institutional requirements for weight loss surgery exclusion criteria: * alcohol consumption or other causes of chronic liver disease * intolerance to mri * weight \>435 lbs
telemonitoring among patients with multiple myeloma

Conditions: Multiple Myeloma

Summary: a two-arm open-label parallel-group randomized controlled trial will be conducted to compare the telemonitoring (mm e-coach) with standard mm care. this study aimed to recruit 150 patients with recently diagnosed multiple myeloma (rdmm), starting first or second line of treatment. blinded primary outcome is adherence by pill count after start of treatment at 1-3 months. secondary outcomes are patient reported outcomes: groninger frailty index (gfi), quality of life (eq-5d-5l, eortc-qlq-c30), shared decision making (sdm-q-9), self-reported adherence (mars-5), single item questions, patient experiences (prems), adverse events, overall survival (os) and progression free survival (pfs). patient reported outcomes were developed and integrated in the e-coach mm to regularly measure digitized outcomes of mm patients from time of rdmm until 12 months post-diagnosis. online measurements will be performed at baseline (0), 3, 6, 9 and 12 months.


Eligibility criteria:
inclusion criteria: in order to be eligible to participate in this study, a participant (patient) must meet all of the -following criteria: * signed informed consent * \>18 years * recently diagnosed mm patients with first-line or second-line treatment * able to complete patient-reported outcome measures and experiences * have minimal digital skills to check if they are able to interact with an e-coach * can read and understand dutch. participants who meet any of the following criteria will be excluded from participation in this study * psychiatric illness requiring secondary-care intervention * too ill to engage with the intervention in the opinion of the clinical care team * no perspective of \>12 months survival.

Keywords: value-base health care e-coach adherence
efficacy and patient satisfaction with aquacel® ag surgical dressing compared to standard surgical dressing

Conditions: Wound Healing

Summary: the objective of this study is to determine the safety and effectiveness of the aquacel® ag surgical dressing (treatment group) as compared to prepackaged island wound dressings consisting of traditional tape and gauze (control group) for total hip and total knee arthroplasty.


Eligibility criteria:
inclusion criteria: 1. patients presenting for primary total hip performed through a posterior or posterior-lateral surgical approach or primary total knee arthroplasty 2. patients between the ages of 18 and 90 3. the subject is willing and able to understand, sign and date the study specific patient informed consent, to volunteer participation in the study 4. the subject is having surgery at a carolinas healthcare system facility 5. the subject is psychosocially, mentally and physically able to comply with the requirements of the study exclusion criteria: 1. patients presenting for revision total hip or total knee arthroplasty 2. patients with topical hypersensitivity or allergy to any disposable components of the dressing system such as: ionic silver, polyurethane film 3. any systemic or local active dermatological disease that might interfere with the evaluation of the surgical site such as eczema, psoriasis, skin cancer, scleroderma, chronic urticaria 4. patients currently participating in another clinical trial that may affect your participation in this trial 5. patients with insurance coverage not included in gentiva list of payers 6. patients residing outside of gentiva's geographical coverage area 7. patients having surgery at a non-carolinas healthcare system facility
the effect of prematurity and hypertensive disorders of pregnancy on offspring cardiovascular health

Conditions: Preeclampsia; Preterm Birth

Summary: the purpose of this study is to investigate whether exposure to hypertensive disorders of pregnancy and/or a preterm birth results in alterations in the cardiovascular system during infancy.

while the incidence of cardiovascular disease has reduced dramatically, coinciding with favourable changes in risk factors, cardiovascular disease remains the single largest cause of mortality and premature mortality in the united kingdom. identification of novel biological pathways that underlie disease susceptibility raises the potential for new early primary prevention strategies to complement classical management. there is particular interest in the role of early environment in 'programming' risk of cardiovascular disease in later life and growing evidence that various early life exposures impact cardiovascular health in the longer term. the investigators have therefore designed the epoch study to investigate whether those individuals born to hypertensive pregnancies and/or to a preterm birth demonstrate differences in the cardiovascular phenotype at birth, or whether they develop any differences over the first three months of life and whether this varies with other perinatal factors. this study also allows investigation of the short term impact of perinatal interventions used in this cohort. comprehensive multi-modality non-invasive imaging measures of cardiovascular structure and function allow precise quantification of cardiovascular phenotype in this population.

Eligibility criteria:
inclusion criteria: * available for assessment within the neonatal period, * parent is willing and able to give informed consent for participation in the study, * physical condition is suitable to allow non-invasive vascular testing, * mother meets criteria for inclusion in the study and is willing to participate in the study. (aged \>/= 16 years and is able and willing to give informed consent for participation in the study, and is able and willing to give informed consent for her infants participation in the study. ) * cases: diagnosed during pregnancy with preeclampsia or gestational hypertension and/or delivered preterm (\<37 weeks gestation) * controls: no history of gestational hypertension or preeclampsia during this pregnancy and delivered at term (\>37 weeks gestation) exclusion criteria: * parent is unwilling to give consent, * unavailable for assessment of cardiovascular system, * physical condition unsuitable to allow for non-invasive testing of cardiovascular system, * evidence of congenital cardiovascular disease (with the exception of persistent patent ductus arterious (pda) and atrial septal defect (asd)), * cardiorespiratory instability at time of proposed measures, * active infection at time of proposed study measures, * mother of infant is excluded from the study. (aged \<16 years, unable or unwilling to consent to study or physical condition post delivery such that it would preclude participation in the study)
impact of different brca1/2 gene variants on response to therapy and prognosis of ovarian cancer

Conditions: Ovarian Cancer

Summary: identify any significant differences in terms of drug response and survival between the different possible alterations in the brca1/2 genes, in order to stratify ovarian cancer patients with a view to increasingly personalised and thus effective therapy.

ovarian carcinoma (oc) is the leading cause of death among gynaecological neoplasms. it is, in fact, a neoplasm that is not very frequent but highly lethal: in emilia-romagna, the incidence is about 17 cases per 100,000 inhabitants and the mortality rate is around 15 cases per 100,000, with a very high mortality/incidence ratio (0.83). the high mortality rate is mainly due to the fact that, due to the non-specific and late symptoms, 75-80% of patients arrive at the diagnosis at an advanced stage of the disease (iii-iv), characterised by a 5-year survival of less than 25%. the primary therapeutic approach for this tumour is a combination of debulking surgery and platinum-based chemotherapy generally associated with taxanes, while as far as maintenance therapies are concerned, parp inhibitors (parpi), drugs capable of blocking a dna repair mechanism alternative to that of homologous recombination, have been gaining in importance in recent years. they have proved particularly effective in tumours that present alterations in the brca1 and brca2 genes, which are key players in homologous recombination. for this reason, the detection of mutations in the brca1 and brca2 genes is predictive of the efficacy of parpi maintenance therapy and, consequently, as of 2015, the brca test has been indicated in all women newly diagnosed with ovarian cancer (excluding borderline and mucinous forms), possibly from tumour tissue, given the evidence that in addition to constitutional (inherited) variants, somatic variants (acquired and tumour-confined), present in about 9%, are also associated with a parpi benefit. recent data, however, have challenged the assumption that functionally significant variants for which a predisposing role has been demonstrated for hereditary breast and ovarian cancers are necessarily predictive of drug response. furthermore, the fact that somatic mutations are present in only a limited fraction of the dna copies analysed in a tumour suggests that there may be residual brca activity that compromises effective parpi activity.

Eligibility criteria:
inclusion criteria: * ovarian cancer diagnosis by 31/12/2021; * brca test at the uoc of medical genetics of the irccs aou of bologna policlinico s.orsola by 31/12/2021; * follow-up and/or treatment at medical oncology and/or gynaecological oncology of the irccs azienda ospedaliero-universitaria (aou) of bologna for a period of time of at least 1 year and by 31/12/2021 and for a minimum period of 6 months exclusion criteria: * ovarian carcinoma of 'mucinous' or 'borderline' histotype.

Keywords: brca1 brca2 parp
early oral feeding versus traditional postoperative care in emergency abdominal surgery

Conditions: Postoperative Care

Summary: the traditional postoperative care after abdominal surgery included the need of nasogastric tube, fasting until resumed bowel function and progressive reinstitution of oral intake from liquid to solid diet. recent studies have shown no benefits of this traditional management over early oral feeding. nevertheless, the researches in emergency surgery are scarce.


Eligibility criteria:
inclusion criteria: * patients over 14 years after abdominal emergency surgery. exclusion criteria: * lack of consensus of the patient * concurrent extra-abdominal surgery * short bowel or other clear indication of parenteral nutrition * inability to feed orally (eg, decreased level of consciousness) * interventional procedure * esophageal surgery * reoperations * pancreatitis

Keywords: early feeding postoperative care emergency surgery
safety of rabivax-s for pre-exposure prophylaxis

Conditions: Rabies Vaccine Adverse Reaction

Summary: people who are at frequent or continuous risk of exposure to rabies virus should be vaccinated against the disease (pre-exposure prophylaxis). this includes people who work with rabies virus in research or diagnostic laboratories or vaccine production facilities, veterinarians, staff, animal-control and wildlife workers in areas where rabies is endemic. veterinary students in clinical placements and externships are included in this category. currently, dvm students at ross university school of veterinary medicine (rusvm) are vaccinated against rabies in their 7th semester (final pre-clinical semester). vaccinations are done by rusvm health services using rabivax-s, produced by the serum institute of india (study co-sponsors). previously-unvaccinated students receive three injections of vaccine, on day 0, 7 and 21-28. the aim of the study is to generate additional data on safety and tolerability of rabivax-s administered as pre-exposure prophylaxis to this population.


Eligibility criteria:
inclusion criteria: a dvm student registered at rusvm will be eligible for inclusion in the study if the student is: 1. in the 7th semester of the dvm program, or 2. is in the 5th or 6th semester of the dvm program and is planning to undertake a veterinary externship in the following semester break that would require pre-exposure prophylaxis to rabies. exclusion criteria: a dvm student who meets the inclusion criteria will be excluded from the study if the student: 1. has previously received a dose of rabies vaccine, or 2. has any condition for which rabies vaccination is contra-indicated, or 3. does not provide informed consent for participation.
single-ascending dose study with a food-effect cohort to evaluate amg 581

Conditions: Schizophrenia or Schizoaffective Disorder

Summary: the purpose of this study is to find out the time it takes to absorb, distribute, breakdown and remove the drug from the body, safety and tolerability of amg 581 in healthy participants and subjects with schizophrenia.

the purpose of this study is to evaluate the safety, tolerability, and pharmacokinetic profile of single-ascending oral doses of amg 581 in healthy subjects and subjects diagnosed with schizophrenia or schizoaffective disorder receiving antipsychotic treatment. this will be a placebo-controlled, single-ascending oral-dose study of amg 581 with a food-effect cohort. approximately 70 subjects will be enrolled. this study will enroll healthy subjects into 8 cohorts (cohorts 1,2,3,4,5,6,8 and 9), and subjects with schizophrenia or schizoaffective disorder receiving antipsychotic medication into a single cohort (cohort 7).

Eligibility criteria:
inclusion criteria: * provide informed consent prior to initiation of any study-related procedure * male and female subjects ≥ 18 to ≤ 45 years of age at the time of screening * non-nicotine or non-tobacco for healthy subjects * no history of relevant medical disorders * bmi ≥ 18.0 and ≤ 30.0 * non-reproductive females * males practicing effect birth control * avoid tanning/direct sunlight * willing to consume high-fat meal * schizophrenia or schizoaffective disorder * panss score ≤ 4 points on a few items (i.e. conceptual disorganization, hallucinatory behavior, excitement, suspiciousness/persecution, hostility, depression, anxiety, disorientation, uncooperativeness, disturbance of volition, and poor impulse control) / total score ≤ 80 points exclusion criteria: * females lactating/breastfeeding * pregnant partners of male subjects * tremor or gait disturbance * history of hereditary shorten qt syndrome * malignancy or tumor (other than skin cancers) * history of gi disease * qtc ≥ 450 msec or ≤ 380 msec * creatinine clearance \< 80 ml/min at screening

Keywords: schizophrenia or schizoaffective disorder
effect of the consumption of a probiotic strain on the prevention of post-operative recurrence in crohn's disease

Conditions: Crohn's Disease

Summary: a double-blind, multicentre, stratified by centre, randomised, parallel study with two groups of adult patients operated on for crohn's disease, to determine if oral ingestion of probiotics could prevent the appearance of crohn's disease recurrent endoscopic ileo-colonic lesions 12 months after surgery. patients will consume 900 mg/day of active product (n=56) or control product (n=56) during one year.


Eligibility criteria:
inclusion criteria: * male/female at least 18 years old * diagnosis of crohn's disease defined by the criteria usually adopted (gower-rousseau, 1994) * crohn's disease mainly limited to the terminal ileum and/or the ascending and transverse colon * diagnosis of crohn's disease in agreement with surgical specimen analysis * patient having given its written consent to take part in the study * complete resection of all main macroscopic ileo-colonic lesions, as shown by inspection at surgery * to have an ileo-colic resection (right, transverse, left) with an anastomosis that can be inspected by endoscopy * ability to start oral nutrition and therefore the consumption of the study product within 21 days of surgery * patient receiving no antibiotics at the beginning of the product consumption exclusion criteria: * one or more intestinal resection during the 5 last years before the last surgery * presence of any severe additional disease * for female patient : pregnancy or breast feeding * for pre-menopausal female patient : no effective contraceptive methods used (combined oestrogen-progestogen pill or intrauterine device) * patient currently in an exclusion period following participation in another clinical trial * patient in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the patient * significant presence of crohn's disease in other intestinal tracts * small bowel cumulative resection exceeding 1 meter * patient with ileostomy * subtotal colectomy with ileo-rectal anastomosis * severe post-operative septic complications (fistula, peritonitis), leading to administration of more than 15 days of post-operative antibiotherapy) * intake of unauthorised treatments (mesalazine, olsalazine or sulfasalazine, 5-aminosalicylates (5-asa) or 4-aminosalicylates (4-asa)) ; corticoïds and immunosuppressors) after surgery except corticoids which will have to be stopped within 6 weeks after surgery according to standardised stepwise dose reductions * patient under artificial nutrition * subject with a loss of personal liberty, by administrative or judicial decision, or major with a legal guardian

Keywords: probiotic capsules crohn's disease recurrent endoscopic ileo-colonic lesions
acupuncture for insomnia: a randomized controlled trial

Conditions: Sleep Initiation and Maintenance Disorders

Summary: selecting different acupoints as an combination of acupoints is a key factor to clinical efficacy of acupuncture. different combinations of acupoints will generate different clinical efficacy. so,the purpose of this study is to determine the different clinical efficacy among three types of combinations of acupoints in the treatment of primary insomnia.


Eligibility criteria:
inclusion criteria: * diagnosed as insomnia based on the diagnostic and statistical manual of mental disorders, fifth edition,2013, american psychiatric association * psqi score \>7 * ais score ≥6 * sds ≤60 * sas ≤60 * age between 18 and 65 years old * not involved in other clinical trial in the lasted 6 months before screening * have the ability to write the informed consent. exclusion criteria: * breathing-related sleep disorders * circadian rhythm sleep-wake disorders * medication-induced sleep disorder * substance induced sleep disorders,such as alcohol, coffee, strong tea * secondary insomnia caused by systemic diseases or caused by external environment disturbance * pregnant or lactating women * combined with serious cardiovascular, lung, liver, kidney, hematopoietic system, and mental diseases * advanced malignant tumor or other serious debilitating diseases * location of acupoints combined with infection and bleeding * declined to acupuncture * couldn't provide the written informed consent.

Keywords: acupoints insomnia acupuncture randomized controlled trial