Kornimate/medical-research-clean huggingface dataset:
follow-up in gynecological cancer survivors

Conditions: Gynecologic Cancer

Summary: a cross-sectional prospective study of follow-up in gynecologic cancer patients after primary treatment

the objective of this study is to identify physical and psychosocial problems and needs after treatment for gynecological cancer. 1100 patients stratified by cancer sites and treatment - a minimum of 120 patients within each stratum - will be recruited. institutional data on follow-up policy, demographic and clinical data (related to treatment history and tumor characteristics) will be collected. patients will complete a set of 76 quality of life questions, at one single time point. descriptive analyses will be conducted to characterize the collected data. multivariate model building will be used to identify patterns of physical, psychological and social problems based on factors specific to the patient and to the disease. logistic multinomial or continuous regression analysis will be used to investigate which socio-demographic, clinical variables, or institutional are associated significantly with compromised quality of life and sexual health outcomes. exploratory factor analysis will be used to explore the factor structure of the various proms to identify issue clustering.

Eligibility criteria:
inclusion criteria: * histological proven gynecological cancer (cervical, endometrial, ovarian (including fallopian tube and peritoneal primary), vulva). * figo stage i-iv before completion of primary therapy. * disease-free without any evidence of relapse: no symptoms or signs potentially indicating recurrent disease (assessed according to standard clinical parameters using physical and gynecological examination, blood tests, ca 125 (ovarian cancer), or radiological imaging techniques). * at least 6 months but no more than 5 years since completion of primary treatment. * performance status 0, 1 or 2 (who scale). * age ≥ 18 years. * ability to understand and fill out questionnaires. * written informed consent according to ich/gcp, and national/local regulations. exclusion criteria: * other cancer diagnosis in the past 5 years. * patients participating in interventional clinical studies with quality of life as primary endpoint. * any psychological (including pre-existing psychiatric disorders), familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

Keywords: long-term survival gynecologic cancer quality of life
amoxicillin and metronidazole during periodontal treatment

Conditions: Chronic Periodontitis

Summary: the aim of this multicenter randomized clinical trial is to compare the clinical, microbiological and immunological effects of the adjunctive use of systemic metronidazole plus amoxicillin administered in different phases of the treatment of generalized chronic periodontitis.

the combination of systemic metronidazole (mtz) and amoxicillin (amx) to scaling and root planing (srp) has shown to be a promising periodontal treatment. however, some essential issues associated with the use of these antibiotics remain to be established. although these agents are often prescribed after the healing phase of the srp procedure, there is biological plausibility to support its use in conjunction with the mechanical treatment. however, to date, no placebo controlled randomized clinical trial (rct) has directly compared these two protocols. therefore, the aim of this multicentric rct is to compare the clinical, microbiological and immunological effects of adjunctive systemic mtz+amx administered in different phases of the treatment of generalized chronic periodontitis (gchp). 180 subjects with gchp will be randomly assigned into three groups (n=60/group) that will receive srp-only (control group) or in combination with 400 mg mtz+500 mg amx beginning at the first srp session (group test 1) or after 3 months of its completion (group test 2). all volunteers will receive clinical and microbiological evaluation at baseline, 3, 6 and 12 months, and immunological assessment (levels of 20 chemokines) at baseline and 12 months post-therapy. nine subgingival biofilm samples will be collected by subject and analyzed for counts and proportions of 40 bacterial species by checkerboard dna-dna hybridization. differences in clinical, microbiological and immunological parameters among groups and over time will be evaluated using the anova, ancova, chi-square and tukey tests. microbiological analyzes will be performed using adjustments for multiple comparisons. statistical significance will be set at 5%.

Eligibility criteria:
inclusion criteria: * ≥35 years of age; * at least 15 teeth (excluding third molars and teeth with advanced decay indicated for extraction); * a minimum of 6 teeth with at least one site each with probing depth (pd) and clinical attachment level (cal) ≥5 mm; * at least 30% of the sites with pd and cal ≥4 mm and bleeding on probing (bop). exclusion criteria: * pregnancy; * breastfeeding; * current smoking and former smoking within the past 5 years; * systemic diseases that could affect the progression of periodontitis (e.g. diabetes, immunological disorders, osteoporosis); * scaling and root planing an in the previous 6 months; * antibiotic therapy in the previous 6 months; * long-term intake of anti-inflammatory medications; * need for antibiotic pre-medication for routine dental therapy; * use of orthodontic appliances; * extensive dental prosthetic rehabilitation; * allergy to metronidazole and/or amoxicillin.

Keywords: periodontal disease metronidazole amoxicillin scaling and root planing healing phase
feasibility and safety of a dedicated biliary stent for transmural eus-guided hepatico-gastrostomy: the fit study

Conditions: Malignant Bilio-pancreatic Diseases

Summary: one of the major roles of interventional eus is biliary drainage (eus-bd) as an alternative to ercp-based biliary decompression. in fact, even when performed by expert endoscopists, ercp-based stenting fails in 5% of cases. in these cases, standard alternative approaches include surgical bypass and percutaneous transhepatic cholangiography and biliary drainage (ptbd). however, these procedures are associated with higher patient discomfort and prolonged hospital stay. the most diffuse approach for eus-bd are choledochoduodenostomy (cds) or hepaticogastrostomy (hgs). as a matter of fact, since dedicate devices as lumen apposing metal stents (lams), have been adopted for cds, we have been witnessing the escalation of such procedure. on the other hand, the diffusion of eus-hgs is still limited due to the complexity of the procedure and the lack of dedicated devices. however, recently a dedicated stent was conceived as asymmetrically covered and shaped in order to have its uncovered, tubular end into the intrahepatic ducts and the covered, flanged end into the gastric cavity, to reduce the risk of migration. the developement of such stent could further increase both the technical feasibility and the clinical outcomes of hgs in order to explore the whole potential of this procedure and to definitively find its role in biliary drainage algorithm.


Eligibility criteria:
inclusion criteria: • subjects with malignant bilio-pancreatic diseases with an indication to undergo biliary stent positioning for biliary drainage after ercp failure. exclusion criteria: * age \< 18 y * contra-indication for endoscopy or interventional radiology * unsigned informing consent form, icf * pregnancy
telerehabilitation for visually impaired

Conditions: Visual Impairment

Summary: the purpose of the study is to evaluate the software usability and patient's adherence from five vision rehabilitation centres. in addition, the effect and benefits of a customizable telerehabilitation program were tested.

the software is used in our practice for every day vision rehabilitation training. so it is part of our routine medical care, and a we are going to study studies the effect of the intervention in several different centers.

Eligibility criteria:
inclusion criteria: * all patients were eligible if they were over 18 years old and had a best corrected visual acuity (bcva) between 1.3 logmar and 0.4 logmar and/or a visual field of less than 60%, according to the who classification. exclusion criteria: * subjects were excluded if they had a cognitive/psychiatric impairment or a motor disability that prevents the use of a computer pointing device (mouse).
phase ii study with catumaxomab in patients with gastric cancer after neoadjuvant ctx and curative resection

Conditions: Gastric Cancer; Gastric Adenocarcinoma

Summary: primary evaluation of the safety, tolerability and feasibility regarding specific postoperative complications of an adjuvant treatment with catumaxomab administered after curative tumor resection subsequent to a neoadjuvant chemotherapy.

an open-label, multi-center phase ii study in surgically resectable patients after neoadjuvant ecx-chemotherapy, with confirmed diagnosis of gastric adenocarcinoma and with a high risk of disseminated tumor cells due to serosal infiltration or positive lymph nodes after curative gastrectomy. treatment with catumaxomab will consist of an initial dose of 10 µg given intraoperatively as an intraperitoneal bolus and of four postoperative ascending doses (10-20-50-150 µg)which will be administered as an i.p.-infusion using an installed abdominal i.p.-port on the postoperative days 7, 10, 13 and 16. catumaxomab is a trifunctional antibody targeting epcam on tumor cells and cd3 on t cells. trifunctional antibodies represent a new concept for targeted anticancer therapy. this new antibody class has the capability to redirect t cells and accessory cells (e.g. macrophages, dendritic cells \[dcs\] and natural killer \[nk\] cells) to the tumor site. according to preclinical data, trifunctional antibodies activate these different immune effector cells, which can trigger a complex anti-tumor immune response.

Eligibility criteria:
inclusion criteria: * signed and dated informed consent * male or female patient at an age of 18 years or older * patient has a primary diagnosis of a histologically confirmed gastric adenocarcinoma (including ge junction siewert-type 2 or 3) * tnm-staging at screening of t3/t4, n+/-, m0 or t2, n+, m0 * indication and eligibility for a neoadjuvant chemotherapeutic regimen featuring three cycles of ecx with 21 days per cycle * intended curative gastrectomy * karnofsky index \> 70 exclusion criteria: * exposure to prior cancer therapy or planned adjuvant chemo- or radiotherapy of the current gastric cancer * prior diagnosis of any malignancy not cured by surgery alone less than 5 years before study entry * previous use of non-humanized monoclonal mouse or rat antibodies * treatment with another investigational product during this study or during the last 30 days prior to study start * presence of distant metastases * presence of constant immunosuppressive therapy * history of pancreas resection (also partial) or thoracotomy * presence of any acute or chronic systemic infection * patient with a bowel obstruction within the last 30 days * known contraindications to any of the planned ecx chemotherapeutics

Keywords: gastric cancer catumaxomab neoadjuvant chemotherapy phase ii interoperative trifunctional antibody
pre-symptomatic screening of visual acuity in pre-school students

Conditions: Visual Acuity; Refractive Errors; Low Vision; Vision Disorders

Summary: the present research process is a prospective, non-interventional clinical study that will be conducted -under the auspices of the democritus university of thrace (duth)- in the pre-school students of the city of alexandroupolis, greece. * the study aims to assess the visual acuity of the kindergarten students. * the measurement of monocular best-spectacle corrected visual acuity will be performed using a web-based visual acuity chart

study protocol will adhere to the tenets of the declaration of helsinki and written informed consent will be obtained by the legal guardians of all participants. the measurement of the visual acuity (monocular and binocular) will be performed using ddart, a digital visual acuity tool that has been developed and validated by the democritus university of thrace and is also an approved category 1 medical device by the country's national organization for medicines, via a web-based digital chart in a high-resolution screen. the same environmental lighting conditions and the same screen brightness will be applied. the examination will be performed at the same predetermined viewing distance. finally, according to each participant's visual acuity, appropriate instructions will be given for further examinations directly to the legal guardians in order to comply with the gdpr.

Eligibility criteria:
inclusion criteria: * pre-school students aged 5-7 years old. exclusion criteria: * age \>7 years old * students with health conditions that do not allow the evaluation of the visual acuity .

Keywords: kindergarten distance visual acuity pre-school students reading capacity
p.vivax treatment trial

Conditions: Plasmodium Vivax

Summary: this study aims to determine whether a 14 day course of 0.5 mg/kg/day primaquine can eliminate subclinical p. vivax infections detected by high volume ultra-sensitive pcr (upcr).

this is a randomized, single blind trial in g6pd normal participants with subclinical p. vivax infections in laos. participants with subclinical p. vivax infections and those meeting the enrolment criteria will be randomly assigned to one of two treatment arms: * intervention: dihydroartemisinin-piperaquine (dp) therapy 3 days dosing plus 14 days of supervised primaquine (7mg/kg total dose) administered once per day (0.5 mg/kg/day). * control arm: dihydroartemisinin-piperaquine (dp) 3 days dosing therapy plus 14 days identical primaquine placebo. participants found to be g6pd deficient (g6pdd) will be treated with primaquine 0.75mg/kg/week for 8 weeks according to who recommendations. primaquine and placebo will be administered with food (biscuits), which has been shown to reduce gastrointestinal side effects. all doses of study drugs will be supervised. if participants cannot visit the study centre, or fail to attend during the 14 days of supervised therapy, team members will visit them in their homes, schools or work to ensure complete dosing. findings: the study showed that a 14-day course of primaquine added to mass drug administration with dihydroartemisinin-piperaquine prevented recurrent asymptomatic p. vivax infections (doi: 10.1186/s12936-019-3091-5)

Eligibility criteria:
inclusion criteria: * participants with subclinical mono- or mixed p. vivax infections (upcr) can be enrolled. * able to participate as decided by the investigators, and willing to comply with the study requirements and follow-up. * a participant (or parent/guardian of children below age of consent) is willing and able to give written informed consent to participate in the trial. exclusion criteria: * currently pregnant or breastfeeding (female of child-bearing age). * inability to tolerate oral treatment. * previous episode of haemolysis or severe haemoglobinuria following primaquine. * known hypersensitivity or allergy to the study drugs. * blood transfusion in last 90 days, since this can mask g6pd deficiency. * an acute malaria episode requiring treatment. * a febrile condition due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration). * anaemia (haemoglobin (hb) \< 9 g/dl * presence of any condition which in the judgment of the investigator would place the participant at undue risk or interfere with the results of the study (e.g. serious underlying cardiac, renal or hepatic disease; severe malnutrition; hiv/aids; or severe febrile condition other than malaria); co-administration of other medication known to cause haemolysis or that could interfere with the assessment of antimalarial regimens. * currently taking medication known to interfere significantly with the pharmacokinetics of primaquine and the schizontocidal study drugs

Keywords: single-blinded controlled trial primaquine
a neuropsychological characterization of social feedback processing in social anxiety

Conditions: Social Anxiety

Summary: the purpose of this study is to characterize neuropsychological mechanisms (positive affect, negative affect and self-evaluation) mediating processing of social feedback in people with different levels of social anxiety, by implementing functional and structural mri.

social anxiety (sa) disorder is a relatively widespread emotional disorder which is associated with considerable impairment in social, educational, and occupational functioning (kessler et al., 2005). this condition is characterized by a debilitating preoccupation with the evaluation of the self by others, ultimately leading to excessive fear and avoidance of interpersonal encounters. as opposed to healthy individuals who typically process social feedback in a positively biased manner, individuals with high levels of sa tend to evaluate the feedback conveyed by others negatively. such biases have a profound contribution to the maintenance of social-related concerns (clark \& wells, 1995). thus, the overreaching goal of this research is to provide a neuropsychological account of biased processing of social feedback evident in sa. to meet this goal, participants varying in their level of sa are asked to deliver a speech and evaluate it before and after receiving social feedback during an fmri scan. additional structural and resting-state fmri scans, as well as physiological and psychological measures, are obtained throughout the experiment in order to explain individual differences in processing of feedback. fmri tasks probing basic neuropsychological processes include a self-referential paradigm, wherein participants judge if different traits varying in valence and social domain (power vs. affiliation) are descriptive of them; a reward vs. punishment task, in which participants can win or lose money; and an emotional reactivity task, in which participants view faces with different emotional expressions. the long-term goal of this study is to better delineate both neurobiological and psychological models of sa, as well as to help in directing future neuromodulation-based treatments of mood and anxiety disorders.

Eligibility criteria:
inclusion criteria: * healthy participants * with different levels of social anxiety as measured by the liebowitz social anxiety scale-self-report (lsas-sr; fresco et al., 2001) * normal or corrected-to-normal vision * compatibility with general mri requirements exclusion criteria: - history of neurological or psychiatric diseases
a trial to learn more about an experimental gene therapy called bidridistrogene xeboparvovec (srp-9003) as a possible treatment for limb girdle muscular dystrophy 2e/r4

Conditions: Limb-girdle Muscular Dystrophy

Summary: this is a multicenter, global study of the effects of a single systemic dose of srp-9003 on beta-sarcoglycan (β-sg) gene expression in participants with limb-girdle muscular dystrophy, type 2e/r4 (lgmd2e/r4). this study will consist of both ambulatory participants (cohort 1) and non-ambulatory participants (cohort 2).


Eligibility criteria:
inclusion criteria: * cohort 1, only ambulatory participants: * able to walk without assistive aid * 10-meter walk test (10mwt) \<30 seconds * nsad ≥25 * cohort 2, only non-ambulatory participants: * 10mwt ≥30 seconds or unable to perform * pul 2.0 entry scale score ≥3 * participants must possess 1 homozygous or 2 heterozygous pathogenic and/or likely pathogenic β-sg dna gene mutations * able to cooperate with muscle testing * participants must have adeno-associated virus serotype rh74 (aavrh74) antibody titers \<1:400 (that is, not elevated) as determined by aavrh74 antibody enzyme-linked immunosorbent assay. exclusion criteria: * left ventricular ejection fraction \< 40% or clinical signs and/or symptoms of cardiomyopathy * forced vital capacity ≤40% of predicted value and/or requirement for nocturnal ventilation * diagnosis of (or ongoing treatment for) an autoimmune disease and on active immunosuppressant treatment * presence of any other clinically significant illness or medical condition (other than lgmd2e/r4) other inclusion/exclusion criteria apply.

Keywords: limb girdle muscular dystrophy type 2e/r4 lgmd2e/r4 pediatric srp-9003 scaavrh74.mhck7.hsgcb bidridistrogene xeboparvovec non-ambulatory ambulatory
effect of tdcs on cognition, symptoms in chronic schizophrenia patients with tardive dyskinesia

Conditions: Tardive Dyskinesia

Summary: the aim of the study was to evaluate the efficacy, safety, and cognitive function of transcranial direct current stimulation (tdcs) in chronic schizophrenia patients with tardive dyskinesia (td).

this study is a randomized, double-blind, sham-controlled clinical trial. 60 patients with td were randomly allocated to active (n=30) or sham tdcs groups (n=30). all patients received 2-ma anodal left/cathodal right prefrontal tdcs treatment (fifteen 30-minutes sessions: monday to friday once daily, every other week to do a group of treatment). abnormal involuntary movements scale (aims), tardive dyskinesia rating scale (tdrs), assessment of negative symptoms(sans), the positive and negative symptom scale(panss), and the cambridge neuropsychological test automatic battery (cantab) were assessed in patients. all evaluations were scored at baseline, the end of 3rd weeks, 5th weeks, and 7th weeks. side effects of tdcs were assessed with an experimenter-administered open-ended questionnaire during the whole experiment.

Eligibility criteria:
inclusion criteria: 1. right-handed; 2. meeting the diagnosis of schizophrania; 3. had been receiving antipsychotic drugs for at least 12 months; 4. at least one aims item rated(moderate) or at least two aims items rated ≥2(mild); 5. all patients volunteered to participate in this study. exclusion criteria: 1. organic disorder that could cause movement disorders, mental retardation,and a history of substance dependence(except nicotine); 2. with serious physical illness(e.g.severe cardiovascular diseases); 3. with color blindness/weakness, stuttering, deafness.

Keywords: transcranial direct current stimulation randomized controlled trial schizophrenia tardive dyskinesia abnormal involuntary movements scale tardive dyskinesia rating scale cognition