Kornimate/medical-research-clean huggingface dataset:
optic nerve stimulation to prevent visual deficits after endoscopic cranial approaches

Conditions: Optic Nerve Injuries; Sellar Tumor; Skull Base Neoplasms

Summary: assessing the function of the optic nerve is paramount during various neurosurgical procedures. effective optic nerve monitoring has remained elusive as visual evoked potentials (the current existing tool) provides only diffuse and delayed assessment of nerve function. here, the investigators propose a prospective study involving adult patients (aged 18 years and older) undergoing endonasal or open cranial approaches around the optic nerves, who will receive pre- and post-operative visual evaluations. during surgery, the optic nerve and chiasm will be stimulated, and the response will be recorded in both eyes and the occipital cortex via skin electrodes. the investigators aim to utilize anterograde optic nerve microstimulation to assess the nerve's integrity during open and endoscopic cranial approaches. electrophysiological readings will be acquired, as is routine in the operating room, by our team of experts, and intraoperative findings will be correlated with post- surgical clinical outcomes. our objective is to utilize existing technology in the operating room to safely and effectively monitor optic nerve function during surgery.

our hypothesis is that utilizing anterograde optic nerve microstimulation during open and endoscopic cranial approaches will allow for more accurate and real-time assessment of optic nerve function compared to the current standard of visual evoked potentials. the investigators predict that this novel approach will lead to improved intraoperative monitoring and better correlation with post- surgical clinical outcomes. the study design proposed is interventional and prospective. it involves implementing a novel approach, anterograde optic nerve microstimulation, during surgical procedures to assess optic nerve integrity. this design entails actively intervening during the surgical process to stimulate the optic nerve and record responses, indicating an interventional approach.

Eligibility criteria:
inclusion criteria: * patients diagnosed with suprasellar tumors including meningiomas, craniopharyngiomas and pituitary adenomas. * must not present with any permanent or temporal visual deficit. * must receive an open or endoscopic endonasal procedure as part of their care. exclusion criteria: * preexisting visual impairments unrelated to the tumor. * history of prior cranial surgeries or radiation therapy. * significant cognitive impairment or inability to provide informed consent * contraindications to microstimulation procedures such as uncontrolled coagulopathy or active infection. * patients with tumors located outside the sellar region or those requiring emergent or urgent surgery due to life-threatening complications. * additionally, individuals with systemic conditions or comorbidities that may significantly impact visual function or surgical outcomes, such as uncontrolled diabetes mellitus or severe cardiovascular disease.
68ga-citrate pet/mr imaging for glioma

Conditions: Glioma

Summary: this is a prospective, single center, open-label study in adult patients with presumed world health organization (who) grade 3 or 4 glioma who will be undergoing surgical resection as standard of care. in some cases, patients will have had biopsy. study participants will undergo 68ga-citrate positron emission tomography / magnetic resonance (pet/mr) prior to surgery.


Eligibility criteria:
inclusion criteria: * world health organization (who) grade 3 or 4 glioma planning to undergo surgery * age \>= 18 yrs. * karnofsky performance status of \>= 60 * ability to understand a written informed consent document, and the willingness to sign it. cohort a: - positive for phosphatase and tensin homolog (pten) deletion, confirmed by immunohistochemistry of tissue biopsy cohort b: - negative for pten deletion, confirmed by immunohistochemistry of tissue biopsy exclusion criteria: * contraindications to positron emission tomography (pet) imaging (e.g. pregnant or breast-feeding woman) * contraindications to magnetic resonance (mr) imaging (e.g. pacemakers, metallic implants, etc.)
neuropsychobiology of brain theta-burst stimulation: a mind-body interface for depression

Conditions: Depression; Treatment

Summary: this is a sham-controlled, randomized trial for patients with mdd to identify the effects of tbs on depressive symptomatology, brain function, and peripheral biomarkers in mdd patients.

this is a sham-controlled, randomized trial for patients with mdd to identify the effects of tbs on depressive symptomatology, brain function (e.g. functional mri, pet, and qeeg), peripheral biomarkers (e.g. candidate genetic expression, neuroendocrine, inflammation, and neurotransmissions) in mdd patients.

Eligibility criteria:
inclusion criteria: * the diagnostic criteria of dsm-iv for mdd * the range of the age from 18 to 70-year-old * physically healthy on medical history, physical examination, and laboratory parameters within normal limits * competent for a full explanation of the study and written informed consent is obtained. exclusion criteria: * having other current axis i disorders (except nicotine dependence), patients with psychotic disorders, bipolar disorders, organic mental disorders, and a prevailing strong suicidal risk were excluded * pregnant * history or family history of seizure disorder * known neurological disorders or evidence of central nervous system disease based on baseline complete neurological examination, electroencephalography, and magnetic resonance imaging of the brain * having ferromagnetic material in the body or close to the head (implanted pacemaker or medication pump, metal plate in skull, or metal objects in the eye or skull)

Keywords: depression transcranial magnetic stimulation theta-burst stimulation
randomized phase iii trial comparing sequential administration of fe75c followed by docetaxel versus paclitaxel as adjuvant chemotherapy in axillary lymph node (+) breast cancer

Conditions: Breast Cancer

Summary: anthracycline-containing regimens are recommended as adjuvant treatment for women with node positive breast cancer. in at least three large randomized clinical trials the addition or sequential administration of a taxane (paclitaxel or docetaxel) to an antracycline-based regimen resulted in superior clinical outcome for women with node positive early breast cancer. in two large randomized studies the dose dense administration with g-csf support of anthracycline-based and paclitaxel combination was superior to the same regimen administered every three weeks without growth factors as adjuvant therapy in women with axillary node positive breast cancer. in one randomized trial, docetaxel was proved superior to paclitaxel in women with metastatic breast cancer

this trial will compare the dose dense, g-csf supported sequential administration of 4 cycles of 5-fluoruracil (f) plus epirubicin (e 75mg/m2) plus cyclofosfamide (c) followed by 4 cycles of docetaxel versus 4 cycles of paclitaxel as adjuvant chemotherapy in women with axillary lymph node positive breast cancer

Eligibility criteria:
inclusion criteria: * women with histologically-confirmed unilateral invasive ductal or lobular breast adenocarcinoma * within 60 days after the surgical excision of the primary tumor with tumor-free operation margins; at least 10 axillary lymph nodes have to be removed. * tumor involvement of at least one axillary lymph node * absence of any clinical or radiological evidence of local or metastatic disease * premenopausal or postmenopausal women aged 18-75 years old * adequate bone marrow function (absolute neutrophil count \>1500/mm3, platelet count \>100.000/mm3, hemoglobin \>10gr/mm3) * adequate liver (bilirubin \<1.0 times upper limit of normal and sgot/sgpt \<2.5 times upper limit of normal) and renal function (creatinine \<1.5mg/dl) * adequate cardiac function (lvef\>50%) * written informed consent exclusion criteria: * positive pregnancy test. * psychiatric illness or social situation that would preclude study compliance. * other concurrent uncontrolled illness. * prior or concurrent antineoplastic therapy e.g. hormonal therapy, radiation therapy, chemotherapy, biological agents. * previous history of other invasive malignancy other than non-melanomatous skin cancer.

Keywords: early breast cancer axillary node positive adjuvant chemotherapy dose dense docetaxel paclitaxel fec
learning management of open fractures on virtual patient

Conditions: Educational Problems; Simulation of Physical Illness; Fractures, Bone; Emergencies

Summary: * a novel virtual world programme with over 240 multiple choice questions was developed to assess the competencies in managing an open fracture of the lower limb according to the british orthopaedic association standards for trauma (boast) and advanced trauma life support (atls) guidelines. * a longitudinal, observational, multi-centre prospective cohort study was conducted at imperial college london. * primary objective consisted of objective scores calculated in real-time from the 240 multiple choice questions between novices, intermediates and experts. * participants who had either completed atls training, or had familiarised themselves with boast guidelines were also identified and correlated with objective scores.

this is a multi-centre prospective randomised controlled educational trial observing for validity and training effect of managing an orthopaedic emergency using a virtual patient within an online world. cohorts consist of junior, intermediate and expert surgeons being tested on 240 multiple choice questions to assess for competency as well as face, content and construct validity.

Eligibility criteria:
inclusion criteria: * postgraduate orthopaedic trainees and naïve to surgical simulation exclusion criteria: * undergraduates and previous exposure to surgical simulation involving cognitive task analysis

Keywords: virtual reality simulation resuscitation
internet-delivered cbt for nccp-patients - a pilot trial

Conditions: Chest Pain; Anxiety; Fear

Summary: this pilot randomized controlled trial (rct) aims to test the feasibility and effectiveness of a guided internet-delivered cognitive behavioural therapy intervention in the treatment of cardiac anxiety and fear of body sensations in patients with non-cardiac chest pain. the control group will receive care-as-usual.

despite reassurance, many patients with non-cardiac chest pain (nccp) think they have an undetected cardiac disease and avoid activities that they think might be harmful to their heart. these patients need help and support to evaluate the way they perceive and handle their chest pain. therefore, we have developed a 4 session guided intervention based on cognitive behavioural therapy that will be delivered via internet. the intervention consists of psychoeducation, exposure to physical activity, and a breathing-based relaxation exercise. the goal with the intervention is to help the participants modify their beliefs about chest pain, change their cognitive and behavioural strategies, and give them tools to handle chest pain to prevent them from relapse.

Eligibility criteria:
inclusion criteria: * recurrent chest pain that has been diagnosed as non-cardiac at least twice during last 6 months * patients screened positive for avoidance of physical activity due to cardiac anxiety and/or fear of body sensations exclusion criteria: * no regular access to a computer/tablet computer with internet connection * language difficulties * not able to perform physical activity/exercise test due to physical constraints * patients with severe depressive symptoms * patients with acute ischemic heart disease
study of anal cytologies in patients with high grade cervical intraepithelial neoplasia (cin ii and iii)

Conditions: Anal Carcinoma; Anal Condyloma

Summary: cervical cancer is the third most frequent neoplasm in brazilian women (estimated risk of 15.33 cases / 100,000 women by 2014), behind breast and colorectal cancer. this high incidence is explained by the pre-neoplastic lesions of the cervix being probably related to the practice of unsafe sex and to a poor local immune response against hpv. human papillomavirus (hpv) infection affects people of any age, although it is more common in young people, probably due to increased sexual activity in that period. the association between high-risk hpv and anus neoplasm in men and women with immunodeficiency or immunosuppression has been confirmed and measures related to surveillance are standardized. in patients without immunodeficiencies, this association is still unclear, which may contribute to the lack of adequate standards to diagnose hpv and prevent cancer of the anus. the frequency of the cancer of anus previously considered low, is currently in considerable elevation, mainly squamous cell carcinoma (scc). the causal relationship between this virus and cancer of the cervix and the anus is established. these facts have motivated the inclusion of this disease as std, which justifies the necessity of adopting surveillance measures in the clinics of sexual, gynecological and urological diseases. cancer of the anus, when diagnosed in the early stage, makes healing possible with less aggressive treatments, but in the advanced stage, abdominoperineal amputation is necessary. concerned about possible anal cancer, some gynecologists have referred patients with genital hpv to search for anal infection.


Eligibility criteria:
inclusion criteria: female patients aged 18-65 years with an anatomic pathology compatible with cin ii / cin iii, without restriction regarding skin color, race, ethnicity, religion; patients of the oncology gynecology service of the hcsl, registered in the hospital management system, in outpatient consultations; those who agree to participate in the study and sign the icf. patients attended at the general gynecological surgery outpatient clinic (control group) with no evidence of colpocitological alteration. - exclusion criteria: patients who withdraw the consent term. history of previous anal cancer / anal intraepithelial neoplasia. immunosuppressed: hiv, sle, users of immunosuppressive and transplanted drugs. -
impact of patient education on preoperative anxiety and postoperative psychosocial outcomes

Conditions: Preoperative Anxiety

Summary: the aim of the study is to investigate the effect of preoperative patient education on the level of properative anxiety and postoperative psychosocial outcomes. participants will be assigned to one of the 3 study groups: on-line education, contact education and control (no preoperative education). the investigators will evaluate preoperative anxiety level at different time points (baseline at 2 weeks before the surgery, at the evening before the surgery and postoperatively) and investigate dynamics of anxiety in the perioperative period. additional qualitative interview by psychologists will be performed to evaluate the potential causes of increased/decreased preoperative anxiety. impact on postoperative complications, well-being of the participant, quality of recovery and satisfaction with medical care will also be evaluated.


Eligibility criteria:
inclusion criteria: * agreement to participate in the study * elective cholecystectomy or colon surgery exclusion criteria: * refusal to participate in the study * do not speak lithuanian * do not pass the phq-2 depression screening test
impact of menstruation on glycemic response and exercise in females with type 1 diabetes

Conditions: Type 1 Diabetes; Hypoglycemia; Hyperglycaemia Due to Type 1 Diabetes Mellitus; Menstruation Disturbances

Summary: the objectives of this study are to examine how sex hormones (use of hormonal birth control, menstrual cycle phase) impact glycemic control among women with type 1 diabetes (t1d), and to test adjustments to insulin dosing and food intake to ameliorate cycle-related glycemic variability. a secondary aim is to examine how the menstrual cycle and use of hormonal birth control impact patient-reported outcomes and glycemic responses to physical activity.

the overall goal of this project is to further understand the impact of hormonal status on glycemic metrics and to test personalized changes to insulin dosing, through implementing the following specific aims: specific aim 1: using cgm, examine glucose levels among women with t1d by menstrual cycle phase over a three month period to establish baseline glycemic variability, to identify personalized patterns of glycemic control across the menstrual cycle phase, and to test glycemic responses to acute bouts of aerobic, interval and resistance training. specific aim 2: using the data from the observational period, examine patterns of glycemic variability by menstrual cycle phase in order to determine the appropriate alteration to insulin delivery needed to improve glycemic control across the menstrual cycle among women with t1d specific aim 3: test an intervention that includes up to four personalized adjustments to food intake, insulin dose and glycemic algorithms by menstrual cycle phase in a randomized intervention and control group. we will also examine responses to daily activity, planned exercise activities, and acute bouts of aerobic, interval and resistance exercise.

Eligibility criteria:
inclusion criteria: * women 18-45 who have had type 1 diabetes for at least 12 months * premenopausal with either menstrual cycles or currently using oral contraceptives exclusion criteria: * women who are postmenopausal, pregnant, trying to become pregnant, or have had a hysterectomy

Keywords: type 1 diabetes menstrual cycle exercise hypoglycemia hyperglycemia glucose control
predictive value of scoring system in neonates with disseminated intravascular coagulation

Conditions: Disseminated Intravascular Coagulation; Neonates

Summary: the aims of this study were to investigate underlying diseases associated with neonatal dic diagnosed on the first 28 days of life, and whether dic score could predict mortality in neonates.

disseminated intravascular coagulation (dic) is a syndrome caused by the activation of blood coagulation, in which systemic intravascular micro thromboses result in multiple organ failure and severe bleeding due to consumption of platelets and coagulation factors \[1\]. compared with adults, neonates have an immature coagulation-fibrinolysis system and are prone to complications that cause dic, such as hypoxia, acidosis, and infection \[2\]. additionally, preterm infants have a lower hemostatic profile than term infants, which increases their risk of dic \[3\]. however, gold standard interventions and treatments for dic are lacking in neonatal medicine, veldman et al. suggested that dic in neonates is caused by prenatal risk factors such as placental abruption (pa), pregnancy induced hypertension (pih), and neonatal factors such as sepsis, asphyxia, and interventricular hemorrhage (ivh), along with postnatal factors, such as necrotizing enterocolitis, gastrointestinal perforation, and infection \[4\]. the japan society of obstetrical, gynecological \& neonatal hematology (jsognh) revised its diagnostic guidelines for neonatal dic in 2016 and proposed a dic scoring system \[5\]. anticoagulant therapy, such as antithrombin administration and fresh frozen plasma (ffp), has been used to treat neonatal dic \[6\]. since 2008, recombinant human soluble thrombomodulin (rtm) has emerged as a novel anticoagulant for dic in japan \[7\]. reversal of the underlying condition is paramount in achieving treatment success in the newborn with dic. strategies such as early antibiotic therapy and identification and control of the source of disease in cases of necrotizing enterocolitis, sepsis, and septic shock should always precede interventions directed at normalizing the coagulation system \[8\]. reports are lacking about diseases associated with neonatal dic and whether anything predicts mortality in this context. we discuss the clinical andlaboratory criteria using (jsognh) scoring system to see if dic score could predict mortality in neonates.

Eligibility criteria:
inclusion criteria: 1. age at enrollment from the first day of life to 28 days of life. 2. neonates diagnosed as dic. exclusion criteria: 1. neonates born to mothers with itp. 2. autoimmune thrombocytopenic patients.
a gene transfer single dose study to evaluate the safety, tolerability and efficacy of srp-9003 in non-ambulatory and ambulatory participants with limb girdle muscular dystrophy, type 2e/r4 (beta-sarcoglycan [β-sg] deficiency)

Conditions: Limb Girdle Muscular Dystrophy

Summary: the primary purpose of this study is to evaluate the safety of srp-9003 and to quantify expression of β-sg in the skeletal muscle of participants with limb-girdle muscular dystrophy, type 2e/r4 (lgmd2e/r4). the study will include both ambulatory (cohort 1) and non-ambulatory (cohort 2) participants.


Eligibility criteria:
inclusion criteria: * cohort 1 only: ambulatory per protocol specified criteria. - cohort 2 only: non-ambulatory per protocol specified criteria and 4 to 50 years of age. * possesses 1 homozygous or 2 heterozygous pathogenic and/or likely pathogenic β-sarcoglycan gene deoxyribonucleic acid (dna) (sgcb) gene mutations based on documented clinical findings. * ability to cooperate with muscle testing. exclusion criteria: * presence of any other clinically significant illness or medical condition, including cardiac, pulmonary, hepatic, renal, hematologic, immunologic, neuromuscular (other than lgmd2e/r4), or behavioral disease, or infection or malignancy or concomitant illness or requirement for chronic drug treatment that in the opinion of the investigator creates unnecessary risks for gene transfer or a medical condition or extenuating circumstance that, in the opinion of the investigator, might compromise the participant's ability to comply with the protocol required testing or procedures or compromise the participant's wellbeing, safety, or clinical interpretability. * exposure to gene therapy, investigational medication, or other protocol-specified treatment within the protocol specified time limits. * any contraindication to use of corticosteroid. note: other inclusion or exclusion criteria could apply.

Keywords: ambulatory non-ambulatory gene-delivery lgmd2e/r4 β-sg deficiency lgmd performance of upper limb (pul)