Kornimate/medical-research-clean huggingface dataset:
the efficacy and safety of aracmyn in patients with systemic latrodectism

Conditions: Arachnidism; Latrodectism

Summary: the purpose of this study is to compare the safety and effectiveness of an investigational antivenom and the current standard of care (pain management with opioid analgesics) for treating patients with a widow spider bite. the working hypotheses are as follows: 1. the investigational antivenom is more promptly effective at alleviating the pain associated with a widow spider bite than routine management with opioid pain medication 2. the investigational antivenom is as safe a treatment as opioid pain medication in treating patients with a widow spider bite.

the purpose of this randomized, double-blind, multi-center phase ii trial is to examine the safety and efficacy of aracmyn® \[antivenin latrodectus (black widow) equine immune f(ab)2\], a new antivenom, for treatment of patients envenomed by the widow spider. twenty-four subjects will be randomized to receive either the study drug or control (normal saline) through intravenous (iv) infusion. following infusion, subjects will be monitored for changes in pain and clinical signs during a two-hour observation period. a standard dose of iv fentanyl will be offered to all subjects as pain medication at specific intervals following treatment. vital signs, blood samples, and pain intensity scores (using a visual analog scale, vas) will be collected before and after the infusion, as well as during the observation period. this study uses a treatment failure protocol, which involves administration of merck antivenin to subjects who do not obtain adequate pain relief from the study drug or control. primary efficacy and safety endpoints for this 12-month trial will be improvement in pain intensity and clinical signs and incidence of adverse events, respectively.

Eligibility criteria:
inclusion criteria: * patient presents for treatment within 72 hours from time of symptoms onset * clinical diagnosis of widow spider envenomation * patient has moderate to severe pain intensity exclusion criteria: * history of significant cardiac, respiratory, hepatic, or renal disease * distracting injury or chronic pain syndrome that would obscure pain intensity assessment * history of asthma or known sensitivity to fentanyl, morphine, diazepam, or equine serum * pregnant or lactating

Keywords: black widow spider antivenom
relationship of ebv-positive gastric cancer and multiple genes associated with gastric carcinogenesis

Conditions: Gastric Cancer; EBV Infection; MSI

Summary: the data of 460 gastric cancer patients who underwent curative gastrectomy with d2 lymph node dissection between january 2017 and february 2022 were analyzed. the clinicopathological features and prognosis of the patients with ebv-positive gastric cancers were compared with those of ebv-negative gastric cancers. immunohistochemistry for epidermal growth factor receptor (egfr), c-erb b2, ki-67, and p53 was performed. additionally, in situ hybridization was conducted to detect ebv, and microsatellite instability (msi) analysis was used to assess the deficiency in mismatch repair (mmr) genes.

this study collected consecutively the data of 463 patients with gastric adenocarcinomas who underwent curative gastrectomy with lymphadenectomy at our institution between january 2017 and february 2022. the institutional review board of st. vincent's hospital, the catholic university of korea approved this study (vc22risi0177). informed consent of the patients was waived because of the retrospective nature of the study. the inclusion criteria were: (1) gastric adenocarcinoma; (2) r0 resection; (3) formalin-fixed paraffin-embedded tissue (ffpe) blocks available for analysis. patients who had undergone previous surgery, palliative resection, chemotherapy, or radiation therapy were excluded. all patients underwent gastrectomy with lymphadenectomy based on the korean practice guideline for gastric cancer 2018 \[18\]. after the surgery, clinical follow-up data were collected every 6 months during the first year and then every year thereafter. disease-free survival (dfs) was defined as the length of time from curative surgery to the first tumor recurrence or distant metastasis. overall survival (os) was defined as the time from curative surgery to death from any cause.

Eligibility criteria:
inclusion criteria: * (1) gastric adenocarcinoma; (2) r0 resection; (3) formalin-fixed paraffin-embedded tissue (ffpe) blocks available for analysis. exclusion criteria: * patients who had undergone previous surgery, palliative resection, chemotherapy, or radiation therapy were excluded.

Keywords: gastric cancer ebv msi prognosis
a relative bioavailability study of nicotine delivery from selected oral nicotine products

Conditions: Healthy Volunteers

Summary: this will be a randomised, cross-over, single-blind, confinement study conducted in 27 male or female snus or nicotine pouch users. the study will investigate 4 different nicotine containing products in a cross-over design, incorporating pharmacokinetic (pk) evaluation, nicotine extraction evaluation, subjective questionnaire assessments as well as safety and tolerability evaluation. during the study participation, subjects will come for 2 visits to the clinic, including a screening visit and a 4-day confinement period. a final follow up end-of-study telephone call will be performed within a week of last product use.


Eligibility criteria:
inclusion criteria: * bmi ≥ 18.0 and ≤ 30.0 kg/m2 * clinically normal medical history * user of snus or nicotine pouches for ≥1 year, with a minimum weekly use of 2 or more snus or nicotine pouch cans and who is willing and considered able to use brands with nicotine content in the range of 14 to 20 mg nicotine/pouch exclusion criteria: * history of any clinically significant disease or disorder * any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first use of ip. * any positive result on screening for serum hepatitis b surface antigen, hepatitis c antibody and hiv * female subjects who are pregnant or breastfeeding * presence or history of drug or alcohol abuse * excessive caffeine consumption defined by a daily intake of \>5 cups of caffeine containing beverages * intend to change nicotine-use habit or make a quit attempt within the next 3 months from the screening visit.
efficacy and safety of f-18 fpcit pet in parkinson's disease and essential tremor patients

Conditions: Parkinson's Disease

Summary: the purpose of this study is to determine whether f-18 fpcit is effective and safe radiopharmaceutical for the objective diagnosis of parkinson's disease.

parkinson's disease is a common neurodegenerative disorder with loss of dopaminergic terminals in the striatum. essential tremor is one of the conditions most commonly misdiagnosed as parkinsonism, and early clinical differentiation between these conditions can be difficult. f-18 fpcit is a promising radiopharmaceutical for pet imaging to assess the dopamine transporter in the striatum.

Eligibility criteria:
inclusion criteria: parkinson's disease * male or female with age over 40 years * clinical diagnosis of parkinson's disease * ability to give informed consent essential tremor * male or female with age over 40 years * clinical diagnosis of essential tremor * ability to give informed consent healthy volunteers * male or female with age over 40 years * no any symptoms or sign suggesting parkinson's disease or essential tremor * ability to give informed consent exclusion criteria: parkinson's disease and essential tremor * current pregnancy and breast feeding * current or past medical history of cardiac and neuropsychiatric disease * clinical evidence of dementia * inability to hold antiparkinsonian medication * history of surgical therapy for tremor * severe or unstable medical or psychiatric condition * medication affecting cns in last 6 months(e.g. cns stimulants, sympathomimetics) * prior participation in other research protocol within 30 days healthy volunteers * current pregnancy and breast feeding * current or past medical history of cardiac and neuropsychiatric disease * severe or unstable medical or psychiatric condition * drug abuse or medication affecting cns (e.g. cns stimulants, sympathomimetics) within 6 months * prior participation in other research protocol within 30 days

Keywords: parkinson's disease essential tremor f-18 fpcit pet
pilot study evaluating broccoli sprouts in advanced pancreatic cancer [pouder trial]

Conditions: Pancreatic Ductal Adenocarcinoma

Summary: the goal of the pouder trial is to determine the feasibility of a randomized controlled trial regarding the application of freeze-dried broccoli sprouts rich in sulforaphane and quercetin in patients with advanced pancreatic ductal adenocarcinoma that receive palliative chemotherapy.

patients will be randomly classified into two groups - verum and placebo. the patients in the experimental arm will receive capsules with broccoli sprout grain containing a total of 90mg sulforaphane active substance per day over one year as nutrition supplement whereas patients assigned to the placebo group will receive inactive substance (methylcellulose) with identical capsule and portion distribution.

Eligibility criteria:
inclusion criteria: * advanced, surgically non-treatable pancreatic ductal adenocarcinoma (surgical exploration, intraoperative biopsy but also palliative bypass interventions (bileodigestive anastomosis and/or gastroenterostomy because of preoperative cholestasis or impaired gastric emptying due to tumor-mass effect) * intact gastric emptying * written informed consent * patients ≥18 years of age * palliative chemotherapy exclusion criteria: * intolerance to broccoli or its ingredients * impaired mental status or language problems / barriers

Keywords: pancreatic adenocarcinoma broccoli sprouts sulforaphane palliative chemotherapy cancer stem cells
combination chemotherapy with or without dexrazoxane in treating children with hodgkin's disease

Conditions: Cardiac Toxicity; Lymphoma

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. chemoprotective drugs, such as dexrazoxane, may protect normal cells from the side effects of chemotherapy. purpose: randomized phase iii trial to compare the effectiveness of combination chemotherapy with or without dexrazoxane in treating children who have hodgkin's disease.

objectives: i. determine the efficacy of doxorubicin, bleomycin, vincristine, etoposide, prednisone and cyclophosphamide (dbve-pc) with filgrastim (g-csf) followed by consolidative radiotherapy in children with advanced stage hodgkin's disease. ii. tailor therapy based on rapidity of response in order to minimize cumulative drug dosages. iii. compare the efficacy of dexrazoxane in reducing pulmonary and cardiac toxicity of dbve-based therapy without compromising response. outline: this is a randomized study. patients are randomized to one of two treatment arms. all patients receive 3 courses of chemotherapy consisting of doxorubicin and etoposide on days 0 and 1, bleomycin and vincristine on days 0 and 7, cyclophosphamide on day 0, and prednisone on days 0-6. filgrastim (g-csf) is administered on days 5-6 and 8-19. each course is 21 days in length. patients assigned to arm i receive only these drugs. patients assigned to arm ii receive dexrazoxane on days 0, 1, and 7 in addition to therapy as in arm i. patients who exhibit a complete remission (cr) or provisional cr then receive radiotherapy to the regional field 5 days a week for 2.8 weeks. if the disease is not responsive, 2 more courses of chemotherapy are given. patients whose disease remains nonresponsive or progresses go off the study. radiotherapy may follow for others. patients are followed every 3 months for the first year, every 4 months for the second year, every 6 months for the third year, and then annually thereafter. projected accrual: a total of 277 patients will be accrued for this study within 3 years.

Eligibility criteria:
disease characteristics: histologically proven hodgkin's disease of the following stages: stages iib, iiib or iv patient characteristics: age: 21 or under performance status: not specified life expectancy: not specified hematopoietic: not specified hepatic: bilirubin less than 2 times upper normal limit renal: not specified other: not pregnant prior concurrent therapy: biologic therapy: no prior biologic therapy chemotherapy: no prior chemotherapy endocrine therapy: less than one week of steroids for management of airway complications radiotherapy: no prior radiotherapy except emergency radiation to the mediastinum surgery: not specified

Keywords: stage ii childhood hodgkin lymphoma stage i childhood hodgkin lymphoma stage iii childhood hodgkin lymphoma stage iv childhood hodgkin lymphoma cardiac toxicity
sbrt for hepatocellular carcinoma patients with partial response to tace

Conditions: Carcinoma, Hepatocellular

Summary: this is a pilot study where patients with hepatocellular carcinoma (hcc) that have failed transarterial chemoembolization (tace) will be treated with stereotactic body radiation therapy (sbrt). the focus of the study will be to evaluate safety and efficacy in our population of patients.


Eligibility criteria:
inclusion criteria: * hcc diagnosis according to the american association for the study of liver diseases (aasld) 2010 criteria * tumor stage * liver only disease * tumor thrombus at segment is allowed * no extra hepatic metastases * tumor encompassing less than 50% of hepatic volume * previous treatment with transarterial chemo embolization (tace) - patient must have performed at least 2 sessions of tace and have signs of viable tumor in ct or mri performed 30-40 days after last tace * presence of measurable lesion (at least one lesion that can be measured equal or more than 1 cm in ct or mri). * maximum lesion size of 10 cm. * liver residual volume equal or more than 700cc or 40% of total liver volume * child-pugh a or absence of hepatic cirrhosis * absence of encephalopathy or ascitis on clinical exam * eastern cooperative oncology group (ecog) performance status 0-1 * lab exams: * hemoglobin \> or equal 8 mg/dl * neutrophils \> or equal 1.200/mm³ * platelets \> or equal 45.000/mm³ * alanine aminotransferase (alt) and aspartate aminotransferase (ast) less than 6 times the upper normal limit * bilirubin equal or \< 2 mg/dl * international normalized ratio (inr) \< 1.7 * serum creatinine equal or \ or equal 60 ml/min * albumin \>2.8 mg/dl * not being pregnant - a negative pregnancy test is required (for women). patients in fertile age should use a contraceptive method during treatment and 4 months after. exclusion criteria: * patients with more than 5 discrete lesions in the liver * main or common biliary duct invasion * patients with main portal vein tumor thrombus or more than 2 portal branch thrombus * patients in systemic treatment (sorafenib, chemotherapy). there should be an interval of at least 4 weeks between any medication for treatment of hcc and the current study treatment * previous radiation to upper abdomen * patients with other malignant neoplasms or previous malignant neoplasms will be accepted in the study if hcc prognosis is worse * patients with ischemic myocardial infarction within the last 6 months * patients with large esophageal varices with red color sign or bleeding within the last 3 months * patients with symptoms of colitis, enteritis, esophagitis, fistula, ileus, necrosis, stenosis or ulcer * patients with severe anorexy, constipation, dehydration, diarrhea or vomiting * patients unable to understand and sign written informed consent

Keywords: carcinoma, hepatocellular sbrt
internet-delivered cbt for children with functional abdominal pain disorders

Conditions: Functional Abdominal Pain Disorders

Summary: this randomized controlled study aims to evaluate the efficacy of exposure-based internet-delivered cognitive behavior therapy for children 8-12 years with functional abdominal pain disorders. the children participate along with their parents, who will also receive specific modules with information on how to support their children in the treatment. predictors and mediators for treatment effects will be studied as well as the cost effectiveness of the intervention.


Eligibility criteria:
inclusion criteria: * children 8-12 years with either irritable bowel syndrome, functional dyspepsia or functional abdominal pain - not otherwise specified diagnosed according to rome-iii or rome-iv criteria. * psychopharmacological medication stable for at least a month if medicating. * child and at least one parent speaking and writing swedish. * access to computer with internet connection. exclusion criteria: * severe somatic disorder and/or if the child fulfills criteria of other disorder that better explains the abdominal symptoms. * severe psychiatric or social problems that needs other care. * ongoing psychological treatment. * school absenteeism more than 40 %.
cancer of the upper aero-digestive tract and socio-professional future

Conditions: Upper Aerodigestive Tract Neoplasms

Summary: the aim of this study is to explore the main factors associated with the return to work of patients presenting an upper aero-digestive tract cancer.

socio-professional, medical, psychological, demographic, economic, and educational data collection in patients within the care pathway of upper aero-digestive tract cancer. a series of questionnaires will be presented at the initial consultation and then at 6 months, at 12 months and at 18 months during follow-up visits. medical data will be collected via the crf.

Eligibility criteria:
inclusion criteria: * age at diagnosis ≥ 18 to ≤ 55 years * employed at the entry into the care pathway * presenting an upper aero-digestive tract cancer (excluding nasal cavities), stage i, ii and iii, under a first anti-tumor treatment (surgery, radiotherapy, or chemotherapy) * patient mastering the french language * affiliated to the social security system * consent signed by the patient before the implementation of any specific study procedure exclusion criteria: * having been treated for another cancer before (except skin cancer and / or prostate) * metastatic disease from the outset * patient unable to submit to a regular follow-up * presenting psychiatric disorders

Keywords: socio-professional future
comparison of aesthetic techniques for rejuvenation of genital region: a randomized clinical trial

Conditions: Laxity; Skin; Skin Hyperpigmentation; Needlestick Puncture

Summary: the microneedle is a minimally invasive technique, consists of the application of a roller surrounded by small and thin needles that pierce the skin and generate a mechanical stimulus with no ablative effect on the skin. the study aims to test the hypothesis that the technique of microneedle in the treatment of tissue flaccidity and hyperchromia of female external genitalia is safe and with a more effective result in clinical improvement through genital rejuvenation and unification of skin tone when compared to non-ablative radiofrequency technique.

dissatisfaction with the genital image has been receiving more attention in recent years and is influenced by mediation and the methods of waxing modernity. in the face of this, the number of women in search for aesthetic female genital surgeries. since the year 2015, the implementation of the labiaplasty surgery had a growth of 45% worldwide. brazil is a leader in the procedure, with a total of 23,155 procedures in the year 2016 (isaps data). however, the most genital surgical cases are performed unnecessarily, without long-term term, according to a conflict of interest arising from financial gain, generating ethical complications the search for aesthetic non-invasive genital treatments, in its majority, is related to sagging big lips and genital hyperchromia. in the literature, the non-invasive therapeutic resource and with fewer adverse effects described for aesthetics of the genital region is the use of the radiofrequency apparatus ablative, considered to be a safe and effective technique for flaccidity of the cutaneous tissue. it is not described in the literature treatments used for genital hyperchromia, however, several formulations for clearings using kojic acid and niacinamide, already described as effective for other regions, are available for marketing primarily for genital year whitening. minimally invasive technique, consists of the application of a roller surrounded by small and thin needles that pierce the skin and generate a mechanical stimulus with no ablative effect on the skin.

Eligibility criteria:
inclusion criteria: • women aged 18-65 years with skin flaccidity and genital hyperchromia exclusion criteria: * patients who use cosmetics in the genital region * use of anticoagulant medication * use of pacemakers * pregnancy * dermatoses in the region to be treated and / or local inflammatory condition, without diagnosis of infection * difficulty in understanding the proposed instruments

Keywords: microneedling laxity skin hyperpigmentation
comparing fluoride varnish and sealant to prevent white spots in orthodontic patients

Conditions: White Spot Lesion

Summary: the purpose of the study is o compare the efficacy of cpp-acp mi varnish and proseal sealant in preventing white spot lesion (wsl) formation in orthodontic patients.

this prospective randomized clinical trial included 40 orthodontic patients between the ages of 12-17 who were randomly allocated to two groups. group 1 (sealant group) received sealant on the maxillary anterior canines, lateral incisors, and central incisors, with reapplication of the sealant every 3 months. group 2 (varnish group) had mi varnish applied every 4-6 weeks, without sealant placed on the maxillary anterior teeth. white spot lesion formation was evaluated with standardized digital photographs at two timepoints, t1 (initial appointment before bonding), and t2 (12 months later, with brackets removed). the brackets were removed in order to facilitate an adequate photographic exam. photographs were analyzed side-by-side at the conclusion of the study with the enamel decalcification index (edi). the location of wsls were recorded by tooth type and by region. oral hygiene was evaluated at t1 and t2.

Eligibility criteria:
inclusion criteria: * no significant medical history * no underlying medical problems such as sjogren's syndrome or conditions requiring more than 2 medications (to prevent bias of possible dry mouth) * less than 17 years old at the start of orthodontic treatment, * fully erupted permanent maxillary canines and incisors, starting fixed orthodontic treatment * ability to come to appointments every 4-6 weeks. exclusion criteria: * professional fluoride application in the last 3 months * allergy to milk * untreated cavitated lesions * heavy initial fluorosis * dry mouth * pregnancy * any illness/condition that the investigators felt would affect the study outcome.

Keywords: oral hygiene orthodontics white spot lesion enamel decalcification