Kornimate/medical-research-clean huggingface dataset:
efficacy of adding oral amisulpride to dual prophylaxis for postoperative nausea and vomiting in patients at high risk for nausea and vomiting undergoing gynecological surgery

Conditions: Post Operative Nausea and Vomiting (PONV)

Summary: amisulpride is a potent antagonist of dopamine d2 and d3 receptors, both implicated in the emetic response when activated. it is currently used intravenously for the prevention of chemotherapy-induced and postoperative nausea and vomiting (ponv), but this route has a short half-life time of 4 to 5 hours, could be expensive, causes infusion-related pain, and is not available in brazil. some of these limitations could be overcome by the preemptive use of an oral formulation. at present, there are no data regarding the use of oral amisulpride for ponv, which is an affordable and painless option with half-life time of 12 hours. we propose a quadruple-blind clinical trial involving patients undergoing gynecological surgery aged 18 years and older, and assessed as being at high risk for ponv according to the apfel score (score 3 or 4). the primary outcome of this study is to evaluate complete response to ponv up to 24h, comparing the efficacy of adding 50 mg oral amisulpride as a third antiemetic agent to the standard institutional protocol at the hospital da mulher of são paulo (iv dexamethasone 10 mg + iv ondansetron 4 mg) for laparoscopic surgeries. secondary outcomes will evaluate (1) nausea, (2) vomiting, (3) nausea and vomiting, (4) use of rescue treatment, (5) overall adverse events, and (6) adverse events.


Eligibility criteria:
inclusion criteria: * laparoscopic hysterectomy to treat benign conditions. * high risk for ponv according to the apfel score: scores 3 or 4. * american society of anesthesiology (asa) physical status: 1 or 2. exclusion criteria: * cognitive or psychiatric conditions impairing consent or compliance. * incapability of using the mobile app mycapp for data collection. * history of allergy or sensibility to any medication included in the protocol: amisulpride, dexamethasone, ondansetron, fentanyl, midazolam, bupivacaine, morphine, propofol, rocuronium, sevoflurane, ephedrine, metaraminol, remifentanil, metamizole, ketoprofen, sugammadex, dimenhydrinate, pyridoxine hydrochloride, tramadol, dimethicone. * inability to swallow medications. * current use of typical or atypical antipsychotic medications. * gestation or lactation. * clinically significant cardiac arrhythmia or long qt syndrome documented. * hypokalemia (k+ \< 3.5 mmol/l) * prolactin-dependent tumors. * pheochromocytoma. * parkinson's disease. * nausea or vomiting in the 24 hours before surgery. * therapeutic use of antiemetics, including corticosteroids. * emetogenic oncological therapy (above 10% probability of causing vomiting) in the 2 weeks before surgery. * persistent pre-operative hypotension on the day of surgery, defined as systolic blood pressure \< 100 mmhg on at least 2 consecutive measurements. * mechanical ventilation plan or need for a naso/orogastric tube after surgery. * intestinal endometriosis

Keywords: amisulpride postoperative nausea and vomiting laparoscopy gynecologic surgical procedures
a study of different doses of uk-453, 061 plus truvada compared to efavirenz plus truvada in patients who have not been previously treated for hiv-1

Conditions: HIV-1

Summary: this is a 96 week study to determine if uk- 453,061 in combination with truvada is as efficacious, safe and tolerable as efavirenz in combination with truvada in hiv-1 infected patients who have not been previously treated with antiretroviral drugs.


Eligibility criteria:
inclusion criteria: * male or female at least 18 years of age available for a follow-up period of at least 96 weeks. * hiv 1 rna viral load of greater then 1,000 copies/ml * negative urine pregnancy test. exclusion criteria: * suspected or documented active, untreated hiv-1 related opportunist infection or other condition requiring acute therapy at the time of randomization. * subjects with acute hepatitis b and/or c within 30 days of randomization. * absolute cd4 count \<200 cells/mm3.

Keywords: hiv-1. treatment naive hiv infections treatment naive
surpass flow diverter for intracranial aneurysms: surmount registry data collection

Conditions: Cerebral Aneurysm

Summary: the purpose of this observational post-marketing registry will be to collect and analyze safety, effectiveness, and quality of life outcomes, during and after treatment with the surpass flow diverter. health economics assessments (cost data) will also be collected and analyzed.

this will be a prospective, observational, multi-center, single-arm, post-marketing, international registry with consecutive enrollment of a minimum of 150 patients treated with the surpass flow diverter in accordance with the standard of care at up to 30 registry sites.

Eligibility criteria:
inclusion criteria: * patients who are to be treated with a surpass flow diverter(s) will be eligible to participate in this registry. patients will be enrolled on a consecutive basis. exclusion criteria: * this is a standard of care registry. patients should be excluded if standard of care at a given site is such that they are not eligible for treatment with a surpass flow diverter(s).
sages safe cholecystectomy program in polish reality - awareness, implementation and opinion on usefulness

Conditions: Cholelithiasis; Cholecystectomy, Laparoscopic

Summary: the study is designed to assess the awareness of the sages safe cholecystectomy program among polish surgeons, as well as the degree of implementation of this program during laparoscopic cholecystectomy performed in poland. it also gathers the opinion of polish surgeons on usefulness of each of the sages safe cholecystectomy rules

the study is based on an anonymous questionnaire that is distributed among polish surgeons across the country. the questionnaire focuses on the demographic data of the surgeon, their experience in years, a few questions regarding their experience in the field of cholecystectomy surgery and questions about whether or not they are familiar with the sages safe cholecystectomy program, teaching program for the culture of safety in cholecystectomy, as well as updated tokyo guidelines for the management of acute cholangitis and cholecystitis. the questionnaire is available as an appendix. it is then followed by the list of all the rules of sages safe cholecystectomy program with questions about the usefulness of each of the rule, evaluated in form of a 10-point numeric scale (0 - completely useless, 9 - critical). the collected data will be subject to statistical analysis, the result of which will form the base for creating the polish program for safe cholecystectomy that will serve to increase the safety of this very common surgical procedure.

Eligibility criteria:
inclusion criteria: * general surgery specialist or resident registered in polish national doctors' registry * filled questionnaire on sages safe cholecystectomy program exclusion criteria: * questionnaire not filled properly, missing answers * declaration of not being either general surgeon specialist of general surgery resident in poland
a study on evaluation of mental health index of patients with psychiatric disorders

Conditions: Psychiatric Disorders

Summary: psychiatric patients under the mental impaired influences, their living function were disabled, and their social lives were handicapped consequently. idea psychiatric treatment is to control the psychiatric symptoms in a better way, to develop efficient psychiatric adjustment, to manage living stress into a lower level, to gradually develop the meaning and value of the patients' lives, and to obtain the satisfaction and happiness in life for them. in order to investigate the satisfaction for psychiatric patients under the current treatment and to evaluate their psychiatric health, it is necessary to measure the mental health status for the psychiatric patients, and to ensure the ideological status of psychiatric treatment. if there is a mental health measurement for the psychiatric patients, we may precisely identify the mental health levels of the patients and their mental disturbances degrees. accordingly, we may develop efficient procedure to manage the mental health for the psychiatric patients, and to achieve the goal for the idea psychiatric treatment. in this study, we established the mental health assessment data sheet according to the clinical experiences. it includes mental health index data sheet, mental-and-physical stress response data sheet, mental sustentation data sheet, and supplemented with a general living satisfaction assessment data sheet. we will evaluate the reliability and validity of this study to ensure the usability of these data sheet in clinics. we will also recruit the continuous treated and mentally stabilized patients as subjects. after obtaining their written informed consents, we will go through these mental health assessments to discover the mental health status of these psychiatric patients, and use it as a reference to develop idea psychiatric treatment. we will use icc test for the repeated measurement validity, pearson r correlation coefficient within our data analyses to evaluate the validity of the same measurement, and independent t-test to assess the differences between the patient group and the society group (from previously established data files). this study result may evaluate the possible deficits existing in the traditional psychiatric treatment and may be used as a reference for the development of idea psychiatric medicine.


Eligibility criteria:
inclusion criteria: * psychiatric disorders exclusion criteria: -

Keywords: psychiatric disorders evaluation of mental health index
effectiveness of bifidobacteria in children affected by seasonal allergic rhinitis

Conditions: Seasonal Allergic Rhinitis

Summary: this study is aimed at assessing the efficacy of supplementation with a mixture of three bifidobacteria , on the allergic rhinitis..the rhinitis symptoms were assessed by validated score ( tss ) , for children aged between 4 and 17 years with allergic rhinitis parietaria , mild , moderate or severe , than children not supplemented . secondary objectives * the effectiveness of treatment by vas : * evaluation of the rescue medication consumption * evaluation of quality of life ( using structured questionnaire ) * evaluation of the frequency and school performance ( using structured questionnaire ) * assessment of sleep quality and attention (through structured questionnaire ) * satisfaction rating and satisfaction of parents * evaluation of asthma exacerbations in children susceptible

this is a randomized , double-blind , placebo - controlled , phase 3 , 2 arms , in which patients were selected to receive placebo or a mixture powder composed of three bifidobacteria : bifidobacterium longum bb536 ( 3 billion units ) + bifidobacterium infantis m - 63 ( 1 billion units ) bifidobacterium breve m + -16 v ( 1 billion units ) . the subjects included in our study are represented by children aged between 4 and 17 years , with seasonal allergic rhinitis moderate and presenting positive skin prick test against parietaria.the participation of each subject in the study was based on evaluation of its clinical history. the recruited patients were divided into two groups according to the drug used.the group a received placebo , while the group b mixture bifidobacteria. the treatment was performed for a period of two months. at the beginning and at the end of therapy several surveys have been carried out , so as to be able to compare results and to draw some preliminary conclusions about the effectiveness of treatment.

Eligibility criteria:
inclusion criteria: * children of both sexes , aged from 4 to 17 years * history seasonal allergic rhinitis mild , moderate or severe , according to the guidelines defined air 2013 , documented by recurrent episodes in the previous year and confirmed by skin prick test positive * written informed consent of one parent or a legal representative exclusion criteria: * lack of written informed consent by at least one parent or a legal representative * concurrent disorders such as infection of the upper or lower respiratory tract , nasal surgery in the past year , respiratory tract abnormalities , immune diseases * use of antihistamines , nasal or systemic corticosteroids , leukotriene modifiers , or cromolyn sodium , on an ongoing basis used in the last six weeks.
evaluation of an alternative injection paradigm for onabotulinumtoxina (botox®) in the treatment of overactive bladder in patients with urinary incontinence

Conditions: Urinary Bladder, Overactive; Urinary Incontinence

Summary: this study will evaluate the efficacy and safety of onabotulinumtoxina 100 u (botox®), compared to placebo, when injected into the bladder using an alternative injection paradigm in reducing the number of daily urinary incontinence episodes in patients with overactive bladder (oab) and urinary incontinence whose symptoms have not been adequately managed with an anticholinergic.


Eligibility criteria:
inclusion criteria: * participant weighs ≥ 40 kg (88 lb) * participant has symptoms of over active bladder (oab) (frequency and urgency) with urinary incontinence for a period of at least 6 months immediately prior to screening. exclusion criteria: * participant has symptoms of oab due to any known neurological reason (eg, spinal cord injury, multiple sclerosis, cerebrovascular accident, alzheimer's disease, parkinson's disease, etc.) * participant has received pharmacologic therapy to treat symptoms of oab, including nocturia, within 7 days of the start of the screening period procedures * participant uses clean intermittent catheterization (cic) or indwelling catheter to manage urinary incontinence * participant has been treated with any intravesical pharmacologic agent (eg, capsaicin, resiniferatoxin) within 12 months of day 1 * participant has had previous or current botulinum toxin therapy of any serotype for any urological condition * participant has had previous or current botulinum toxin therapy of any serotype for any non-urological condition within 12 weeks of day 1 * participant has been immunized for any botulinum toxin serotype * participant has history or evidence of any pelvic or urological abnormalities, bladder surgery or disease, other than oab, that may affect bladder function * participant has an active genital infection, other than genital warts, either concurrently or within 4 weeks prior to screening * participant has a history or current diagnosis of bladder cancer or other urothelial malignancy * participant is male with previous or current diagnosis of prostate cancer * participant has a history of 2 or more urinary tract infections (utis) within 6 months of day 1 or is taking prophylactic antibiotics to prevent chronic utis * participant has current or previous uninvestigated hematuria * participant has hemophilia, or other clotting factor deficiencies, or disorders that cause bleeding diathesis * participant cannot withhold any antiplatelet, anticoagulant therapy or medications with anticoagulant effects for 3 days prior to day 1 * participant has a known allergy or sensitivity to any botulinum toxin preparation * participant has any medical condition that may put him/her at increased risk with exposure to botox® including diagnosed myasthenia gravis, eaton-lambert syndrome, or amyotrophic lateral sclerosis * participant has current swallowing or breathing difficulties.
a study to evaluate the safety and efficacy of axatilimab in combination with ruxolitinib in participants with newly diagnosed chronic graft-versus-host disease

Conditions: Chronic Graft-versus-host-disease

Summary: this study will be conducted to determine the preliminary efficacy of axatilimab in combination with ruxolitinib and to assess the contribution of axatilimab to the combination treatment effect in participants with cgvhd.


Eligibility criteria:
inclusion criteria: * ≥ 12 years of age at the time of informed consent. * new-onset moderate or severe cgvhd, as defined by the 2014 nih consensus development project criteria for clinical trials in cgvhd, requiring systemic therapy. * history of 1 allo-sct (any type of stem cell donor, any conditioning regimen, and source of hematopoietic stem cells). * adequate hematologic function independent of platelet transfusion and growth factors for at least 7 days prior to study entry: anc ≥ 0.75 × 109/l and platelet count ≥ 20 × 109/l. * willingness to avoid pregnancy or fathering children. exclusion criteria: * received more than 1 prior allo-sct. prior autologous hct is allowed. * has overlap cgvhd, defined as simultaneous presence of features or characteristics of agvhd in a patient with cgvhd. * received previous systemic treatment for cgvhd, including systemic corticosteroids and extracorporeal photopheresis. * received systemic corticosteroids within 2 weeks prior to c1d1, regardless of indication. * initiated systemic treatment with cnis or mtor inhibitors within 2 weeks prior to c1d1. * prior treatment with a jak inhibitor within 8 weeks before randomization. participants who received a jak inhibitor for the treatment of agvhd are eligible only if they achieved a response (cr or pr) to jak inhibitor treatment and did not discontinue due to toxicity. * evidence of relapse of the primary hematologic disease or treatment for relapse after the allo-sct was performed, including dlis for the treatment of molecular relapse. * history of acute or chronic pancreatitis. * history of thromboembolic events (such as deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction) in the 6 months prior to study entry. * active symptomatic myositis. * severe renal impairment, that is, estimated crcl \< 30 ml/min measured or calculated by cockcroft-gault equation in adults and schwartz formula in pediatric participants, or end-stage renal disease on dialysis. participants with crcl of 30 to 59 ml/min on treatment with fluconazole are not eligible. * impaired liver function, defined as total bilirubin \> 1.5 × uln and/or alt and ast \> 3 × uln in participants with no evidence of liver cgvhd. * currently active significant cardiac disease, such as uncontrolled arrhythmias, uncontrolled hypertension, or class 3 or 4 congestive heart failure as defined by new york heart association, or a history of myocardial infarction or unstable angina within 6 months prior to randomization. * pregnant or breastfeeding. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: cgvhd
chronic alcohol and brain stress circuit response

Conditions: Stress; Alcoholism

Summary: alcoholism is among the top three causes of preventable death and disease in the us (mokdad et al., 2004; room et al., 2005). stress plays an important role in the development of alcoholism and in high vulnerability to alcohol relapse. this study will provide a greater understanding of the mechanism by which stress and alcohol consumption interacts to influence development of compulsive alcohol seeking and vulnerability to stress-induced drinking, and the results will have significant implications for the development of new prevention and treatment interventions for alcoholism.


Eligibility criteria:
inclusion criteria: * ages 21-50

Keywords: social drinkers
effects of an hiv intervention among sex workers in the philippines

Conditions: HIV/AIDS Prevention

Summary: this study will implement a socio-behavioral intervention in quezon city, the philippines, using a community-based participatory approach. the intervention involves 1-2 psychosocial and health education training workshops for the establishment managers and their workers, focusing on hiv/aids risk reduction information and condom use and condom negotiation skill-building. participants will also be invited to do dream-building activities that explore their personal goals and goals for their organization of peers.

this study will implement a socio-behavioral intervention in quezon city, the philippines, using a community-based participatory approach. the intervention involves 1-2 psychosocial and health education training workshops for the establishment managers and their workers, focusing on hiv/aids risk reduction information, condom use, and condom negotiation skill-building. participants will also be invited to do dream-building activities that explore their personal goals and goals for their organization of peers. the intervention involves targeted and tailored bio-psycho-educational interventions directed at organizational behavior change and social influence modeling through training peers and managers. the intervention site will receive peer and manager trainings consisting of specific information on stis along with standard care, held on a day convenient to the participants and at the establishment or neutral location. in addition to quick pre-post tests before and immediately after the intervention, participants will be interviewed 6-12 months after the intervention to evaluate the effects of the intervention on their sti/hiv knowledge, attitudes, beliefs, safer sex practices, and social support.

Eligibility criteria:
inclusion criteria: * self-identification as conducting sex work or working in a venue where sex work occurs. exclusion criteria: * those not actively engaging in sex work activities or working in a venue or area where sex work occurs.

Keywords: hiv/aids sex work reproductive health human rights ethics
sensory symptoms in active vitiligo

Conditions: Totest Sensory Symptoms in Active Vitiligo

Summary: this work aims to assess sensory symptoms in early active vitiligo patients (segmental, non-segmental, or mixed) and to measure 3 neuropeptides expression in their lesional skin \[neuropeptide y(npy), calcitonin gene-related peptide (cgrp), and nerve growth factors (ngf)\] to correlate neuropeptide levels, sensory symptoms, and functions, with criteria of disease activity and perceived stress scale.

study design: case-control study population: 45 patients with active vitiligo and 45 patients with stable vitiligo inclusion criteria: age: 18 years old and older sex: both sexes exclusion criteria: other hypopigmented diseases such as pityriasis alba, tinea versicolor, lichen sclerosis, post-inflammatory hyperpigmentation, and leprosy as excluded by lack of accentuation by wood's light examination. - cases who received treatment (systemic or topical) in the last 3 months before sampling. - neurological or other diseases that cause itching. - medical history of dm, htn, or other systemic diseases, history of associated autoimmune diseases. assessment will be carried as follows: • history of itching or other abnormal neurological sensations as paresthesia and numbness. aggravating factors (e.g. dryness, hot environment, sun exposure, ..etc), alleviating factors of itching type of vitiligo (segmental, unilateral, vulgaris). • assessment of activity by assessing: koebner's phenomenon, confetti depigmentation, trihypochrome areas, poorly defined borders, inflammatory signs (e.g eye inflammation and hearing loss), and leukotrichia. • assessment of sensory symptoms and signs (fine touch, crude touch, pain, and sweating by starch iodine test) in active vitiliginous patches. • clinical assessment: the vitiligo area score index (vasi), vitiligo extent scores (ves), vitiligo disease activity score (vida) (feily, 2014) will be assessed in every participant and demographic data

Eligibility criteria:
inclusion criteria: * active and stable vitiligo exclusion criteria: * diabetic or other associated disease