Kornimate/medical-research-clean huggingface dataset:
neoadjuvant docetaxel plus cisplatin and 5-fluorouracil (tpf) followed by concomitant chemoradiotherapy and chemoradiotherapy alone in locally advanced squamous cell carcinoma of the head and neck patients (scchns)

Conditions: Head and Neck Neoplasms

Summary: to evaluate the rate of clinical complete response 6-8 weeks after treatment with docetaxel plus cisplatin and 5-fluorouracil followed by chemoradiotherapy and after chemoradiotherapy alone in patients with locally advanced squamous cell carcinoma of the head and neck.


Eligibility criteria:
inclusion criteria: * histologically or cytologically proven squamous cell carcinoma of the head and neck. * primary tumor sites eligible: oral cavity, oropharynx, hypopharynx. although they are admittedly of squamous cell types, the following tumors will be excluded because of they responsiveness to chemotherapy: tumors of the nasal and paranasal cavities, larynx and of the nasopharynx. * stage iii or iv disease without evidence of distant metastases verified by chest x ray and/or lung ct scan, abdominal ultrasound, or ct (liver function test abnormalities); bone scan in case of local symptoms. * at least one measurable lesion. * tumor considered inoperable after evaluation by a multidisciplinary team (i.e. a surgeon, a medical oncologist and a radiation oncologist). * no previous chemotherapy or radiotherapy for any reason and no previous surgery for squamous cell carcinoma of the head and neck patients (other than biopsy) are allowed at time of study entry. * karnofsky performance status ≥ 70. * no active alcohol addiction. * adequate bone marrow, hepatic and renal functions * patients must be available for treatment and follow-up. exclusion criteria * pregnant or lactating women or women of childbearing potential not using adequate contraception. * previous or current malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma of the skin, or other cancer curatively treated by surgery and with no evidence of disease for at least 5 years. * symptomatic peripheral neuropathy ≥ grade 2 * symptomatic altered hearing ≥ grade 2 * other serious illnesses or medical conditions including:a) unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry.b) history of significant neurologic or psychiatric disorders including dementia or seizures.c) active uncontrolled infection.d) active peptic ulcer.e) hypercalcemia.f) chronic obstructive pulmonary disease requiring hospitalization during the year preceding study entry * history of hypersensitivity reaction to polysorbate 80 * patients requiring intravenous alimentation. * patients who experienced a weight loss of more than 20% of their body weight in the 3 months preceding study entry. * concomitant treatment with any other anticancer therapy. * participation in a therapeutic clinical trial within 30 days of study entry the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
cardiovascular and psychological consequences of covid-19

Conditions: Post-COVID Conditions

Summary: the study will assess cardiac and psychological profile at 2-3 months after recovery from covid-19 infection.

a significant proportion of patients hospitalized for covid-19 showed laboratory signs of myocardial damage, detected by elevated troponin levels, and these were associated with more severe clinical course and higher mortality. moreover, it is unknown how the health emergency and the associated conditions may have influenced and still influence the psychological experience of the affected people. thus, in order to promote continuity of care, post-covid-19 disease clinics have therefore been activated dedicated to a specific follow-up program for monitoring long-term alterations and for the early identification of patients requiring rehabilitation. the program includes a first follow-up visit (2-3 months after recovery) including cardiac (2d-echocardiography, six-minute walking test, autonomic function evaluation) and psychological (patient health questionnaire-9 (phq-9) generalized anxiety disorder-7 (gad) national stressful events survey ptsd short scale (nsesss)) evaluation. a second follow-up visit will be performed at 12 months in the form of structured interview,

Eligibility criteria:
inclusion criteria: * recent discharge (≤ 3 months) from a covid+ ward for sars-cov-2 disease exclusion criteria: * serious clinical conditions (severe chronic inflammatory diseases, neoplasms, neurological pathologies). * non-italian education, illiteracy, or return to illiteracy. * severe visual-perceptual deficits. * low motivation/interest or refusal to undergo the assessment.
patient's management receiving eplerenone therapy

Conditions: Left Ventricular Dysfunction Post Myocardial Infarction

Summary: on a population of patients followed by an office-based cardiologist and treated with eplerenone, the objectives of the survey are: * to describe the characteristics of the population treated. * to describe the methods of use of eplerenone (posology, duration of treatment, medicinal combinations). * to describe the follow-up methods of the treatment. * to describe the possible interruptions of the treatment

a sample size in the region of n = 400 patients will allow this accuracy of estimation, as for this size, the half-width would be equal to 5% for a frequency of 50% corresponding to a confidence interval of maximum width. in view of the type of survey and the need for 12 months of monitoring in the context of standard practice, it may be anticipated that the drop-off rate will be about 20%. a sample size of n = 500 patients was therefore chosen.

Eligibility criteria:
inclusion criteria: the following patients may be selected to participate in the survey: * those undergoing treatment with eplerenone in accordance with the ma or not, with a known start date. * those likely to be followed by the same physician for a minimal period of twelve months. exclusion criteria: * severe kidney disease * hyperkamiemia more than 5.5

Keywords: patients with mi- on top of treatment add eplerenone - assess lvef and bp
the neuroprotective effect of remote ischemic preconditioning on ischemic cerebral vascular disease

Conditions: Cerebrovascular Disease

Summary: this study is a prospective, randomized, single-center trial, designed to observe the effect of remote limb ischemic preconditioning on ischemic cerebral vascular disease.


Eligibility criteria:
inclusion criteria: 1. patients with stroke or transient ischemic attack (tia) within 180 days and the neurologic deficits were well matched to the territory of the stenosed artery, with intracranial arterial stenosis of at least 50% by angiography, at least 70% by ultrasound, or at least 70% by computed tomographic angiography (cta) or magnetic resonance angiography (mra) 2. age between 18 to 80 years old 3. trial of org 10172 in acute stroke treatment-1 (toast-1) subtype 4. national institutes of health stroke scale (nihss) score 0-15, and modified rankin scale (mrs) score 0-4. 5. abcd2 score between 6 to 7 6. stable vital signs, normal hepatic and renal functions, 7. no hemorrhagic tendencies. exclusion criteria: 1. within 72 hrs of intra-artery or intravenous thrombolysis 2. intracranial hemorrhage or large area of cerebral infarction (more than 1/3 middle cerebral artery perfusion territory) 3. any soft tissue, orthopedic, or vascular injury, wounds or fractures in extremities which may pose a contraindication for application of the preconditioning cuffs 4. acute myocardial infarction 5. systolic blood pressure more than 200 mmhg after drug control 6. peripheral blood vessel disease 7. hematologic disease 8. severe hepatic and renal dysfunction 9. severe or unstable concomitant disease 10. cannot tolerate blipc or without informed consent 11. patients who did not complete the whole treatment procedure.

Keywords: ischemic cerebral vascular disease stroke secondary prevention remote ischemic preconditioning
study to investigate the added value of a rehabilitation brace in the treatment at home after a fracture of the ankle

Conditions: Fracture of the Ankle

Summary: comparison between immobilisation by a plaster and a rehabilitation brace for the treatment of a fracture of the ankle


Eligibility criteria:
inclusion criteria: * fracture of the ankle exclusion criteria: -
lletz with videocolposcopy versus lletz with binocular colposcopy

Conditions: Uterine Cervical Dysplasia

Summary: to assess the benefits of performing large loop excision of the transformation zone (lletz) using videocolposcopy compared to binocular colposcopy.


Eligibility criteria:
inclusion criteria: * histologically proven cervical dysplasia * colposcopy prior to conization * informed consent exclusion criteria: * significant language barrier * a personal history of conization * pregnancy * the use of blood thinner * unwillingness to participate

Keywords: conization lletz randomized controlled trial colposcopy binocular colposcopy intraoperative colposcopy videocolposcopy loop excision
cohort of patients with inflammatory bowel disease during covid-19 pandemic

Conditions: IBD; COVID

Summary: multicenter cohort of patients followed for 6 months during the pandemic in france with biocollection of sera and peripheral blood mononuclear cells

multicenter cohort of patients followed for 6 months during the pandemic in france with biocollection of sera and peripheral blood mononuclear cellsno data has been published concerning the incidence and prevalence of sars-cov-2 infection in patients with ibd and treated by iv infusion of infliximab or vedolizumab. it seems that biotherapies have a minimal impact on the severity of the viral infection but data are scarce. the objectives of the cohort are to quantify the incidence and the prevalence of sars-cov-2 in this population of patients, to determine clinical, demographic and biological factors associated with the risk of infection and the severity of the disease with a multicenter cohort of patients followed for 6 months during the pandemic in france with biocollection of sera and peripheral blood mononuclear cells.

Eligibility criteria:
inclusion criteria: * adult patients (\>18 years), know crohn's disease or ulcerative colitis, treated by infliximab or vedolizumab exclusion criteria: * not affiliated to a sanitary social insurance

Keywords: ibd ulcerative colitis sars-cov-2 infliximab vedolizumab crohn's disease
telephone-coached "graphic narrative" bibliotherapy for dementia caregivers

Conditions: Dementia Caregiver; Depressive Symptoms; Caregiving Appraisal

Summary: this study aims to assess the efficacy of telephone-coached graphic narrative bibliotherapy in improving dementia caregiver depressive symptoms compared with the booklet group.

this is a two-arm cluster randomized controlled trial using a repeated-measures design to examine the effects of telephone-coached graphic narrative bibliotherapy on 128 (64 per group) informal caregivers of people with dementia. participants in the intervention group will receive eight weekly telephone-coached graphic narrative bibliotherapy sessions, plus two face-to-face booster sessions and two follow-up sessions. the control group will receive an education booklet and check-in calls. caregiver depressive symptoms, stress and anxiety, caregiving appraisal, care-recipient neuropsychiatric symptoms, and quality of life will be measured to test the intervention's effects immediately after completion and at a 6-month follow-up.

Eligibility criteria:
inclusion criteria: * provide unpaid care to a person diagnosed with early to moderate stage dementia; * provide at least 14 hours of care a week for at least 3 months * aged 18 years or above * able to read * have depressive symptoms * use a message application exclusion criteria: * with an unstable physical or mental condition * with cognitive impairment * receiving medical, psychological, or psychiatric treatment for depression * have been included in another interventional study
magnetic resonance imaging and ultrasonography in evaluation of muscle diseases

Conditions: Congenital Myopathy; Acquired Myopathy; Myositis

Summary: this study aims to determine the association between the pathological changes detected by ultrasound and those detected in mri in muscle diseases of different etiologies.

enrolled patients will be subjected to the following: neuro-imaging studies: 1. skeletal muscle ultrasound: the muscle group(s) to be assessed will be determined based on the category of the muscle disease for which the patient is being evaluated. a linear probe of 5-12 megahertz will be used. 2. mri of the suspected (affected) muscle group by ultrasound. image acquisition: selective regional mri imaging will be done based on the results of muscle ultrasound mri cuts included are the axial section of conventional t1- and t2-weighted sequences, for the evaluation of muscles' signal intensity and bulk. patients will be subjected to both imaging studies to compare their accuracy. neurophysiological studies: 1. nerve conduction study 2. electromyogram the interpretation of the neurophysiological studies will be performed by a neuropsychiatry specialist, department of neurology, assiut university hospital.

Eligibility criteria:
inclusion criteria: 1. a clinical diagnosis of muscle diseases; irrespective of different etiologies 2. age \> 3 years exclusion criteria: 1. patients with altered muscle anatomy due to severe trauma, tumor or surgery. 2. severe deformity preventing examination. 3. age \< 3years. 4. patients with contraindications to mri as patients with pacemaker, aneurysmal clipping, retained metallic

Keywords: muscle disease
prophylactic cranial irradiation in patients with lung adenocarcinoma with high risk of brain metastasis

Conditions: Lung Cancer

Summary: lung cancer is the first cause of death among cancer patients. non small cell lung cancer (nscls) represents about 80-85% of the cases. of this, about 80% presents with locally advanced or metastatic disease. important to mention the number of patients that progress or recur in central nervous system (cns). it has been reported that patients with adenocarcinoma, who are under 60 years and with elevated carcinoembryonic antigen (cea) are in the highest risk to develop brain metastasis. in small cell lung cancer, treatment with prophylactic cranial irradiation (pci) is the standard of care in patients without progression after locoregional or systemic treatment because the proven benefit in overall survival (os) and progression free survival (pfs). however, in nsclc pci has not been able to prove any survival benefit, only in cns pfs, probably because there is no trial, to our knowledge, of pci in nsclc that include only the specific group of patients considered in high risk of developing brain metastasis.

objectives: 1. to obtain a greater pfs and cns pfs in patients with nsclc treated with pci after locoregional or systemic treatment. 2. evaluate the benefit in os in the specific group of patients who are at increased risk of developing brain metastasis 3. evaluate quality of life and mental function before and after treatment with pci and compare it with patients in the observation group. methods: one hundred and twenty eight patients with locally advanced or metastatic (except cns metastasis) nsclc will be included and randomized to receive either observation or pci 25 gy in 10 fractions whole brain radiotherapy (wbrt) once the initial treatment has been completed and progression of the disease ruled out.

Eligibility criteria:
inclusion criteria: * patients with histologically proven advanced nsclc (stage iiib or iv) including wild-type, egfr-mutated or alk-rearrangements who received treatment and were without progression at the end. * above 18 years * general status with a karnofsky \>80% * eastern cooperative group (ecog) ≤2 * negative cns mri at the beginning of any treatment * carcinoembryonic antigen \> 20 pg * hepatic and hematic cytology test within normal range * adequate renal function * those who accepted to participate in the study and who sign the letter of informed consent. exclusion criteria: * patients with another type of cancer * patients who refuse participate in the protocol * general status with a karnofsky \<80% * eastern cooperative group (ecog) \>2 * previous treatment with wbrt * previous treatment with chemotherapy * disease progression after initial treatment, either chemotherapy or chemoradiotherapy depending the case. * cns metastasis at diagnosis * abnormal laboratory test that interfere with chemotherapy or tki administration

Keywords: prophylactic cranial irradiation lung cancer non small cell lung cancer carcinoembryonic antigen
dbt skills groups for veterans at high risk for suicide attempt

Conditions: Suicide, Attempted

Summary: veteran suicide death is a national crisis. risk factors include emotion dysregulation, which occurs across mental health disorders. dialectical behavior therapy (dbt) is an evidence-based suicide intervention that targets emotion dysregulation but is resource-intensive and not widely available at vha. a more efficient evidence-based dbt skills group (dbt-sg) is associated with reduced suicidal ideation and emotion dysregulation and likely more feasible to implement at vha. this is a randomized controlled trial to test whether dbt-sg in addition to vha treatment-as-usual, compared to only vha treatment-as-usual, reduces veteran emotion dysregulation.

this is a randomized controlled trial at four vha medical centers. veterans will be randomized to vha treatment-as-usual or vha treatment-as-usual plus dbt-sg.

Eligibility criteria:
inclusion criteria: * veteran eligible for vha care at participating site * two or more suicide attempts in lifetime, with one in past 12 months, on columbia-suicide severity rating scale (c-ssrs) * current suicidal ideation (endorsing a suicidal ideation scale of at least 1 \[passive ideation\] on c-ssrs * emotion dysregulation (score 95 or greater on ders) * can attend group sessions * willing to provide contact information for at least one person who can help locate the participant if study staff are unable to contact them (information for three contact persons will be requested; a participant must provide at least one contact person's information to be included in the study) * access to telephone; if insufficient access to videoteleconference and local facility is using remote procedures for study, willing to request access to va-provided device exclusion criteria: * significant cognitive impairment (score \< 28 on modified telephone interview for cognitive status (mtics) * inability to read english or communicate in spoken and written english * plan to move away or be unavailable in the next 18 months

Keywords: suicide, attempted dialectical behavior therapy suicide attempt emotion regulation
steam inhalations in covid-19 patients

Conditions: Covid19; Coronavirus Infection; Coronavirus

Summary: the new coronavirus (sars-cov-2) causing covid-19 is an rna virus coated with a capsid and a peri-capsid crossed by glycoprotein structures. the external proteic structure, which attacks human cells, is a potential target to therapeutic interventions against virus replication in airways. since high temperature can cause irreversible denaturation of proteins and loss of sars cov and sars cov-2 infectivity was obtained after heating at 56 ◦c for 15 and 30 min in liquid environments respectively, we designed a protocol aimed at damaging sars-cov-2 capsid through steam inhalation cycles. although the ominous consequences of covid 19 infections has directed medical attention toward solidly established medical approaches, the european pharmacopoeia vi edition also quotes steam inhalations as a procedure to treat of respiratory diseases. based on these suggestions we established a quasi-randomized clinical trial enrolling 200 asymptomatic or paucisymptomatic patients in whom rhino-pharyngeal-swab revealed a sars-cov-2 infection. the study protocol consisted of exposure of airway mucosae to humidified steam (ph 8 per nahco3 and hypertonic 15 g/l nacl) through steam inhalation for at least 20 min (4 cycles of 5 min) daily, for 10 days. the objective of the study is to reduce the viral shedding using steam inhalations.


Eligibility criteria:
inclusion criteria: * adults with a sars-cov-2 positive molecular swab carried out in the previous 48 hours before the enrollement * adults with mild infection * adults with symptoms such as fever above 37 ° c, feeling bad, cold symptoms (cough, pharyngodynia, nasal congestion), headache, myalgia, diarrhea, anosmia, dysgeusia * adults without the above symptoms exclusion criteria: * adults with dyspnea and/or dehydration and/or alterations in consciousness and/or sepsis. * subjects with severe asthma * subjects and with contraindications to treatment with steam inhalations * multi-allergic subjects * subjects unable to complete the protocol
adjuvant therapy omission for resected nsclc patients with longitudinal undetectable mrd

Conditions: Non Small Cell Lung Cancer

Summary: molecular residual disease (mrd) has strong relationship with clinical outcome in multiple solid tumors. here, the investigators try to verify the negative predictive value of undetectable mrd, which is considered as a superior prognostic factor for resected nsclc patients, and not requiring excessive adjuvant therapy. stage ib-iiia resected nsclc patients with landmark and longitudinal undetectable mrd are enrolled and under close surveillance in this study.

stage ib-iiia resected nsclc patients will undergo two-round mrd tests after operation, first in 3-7 days and second in 1 month after operation. and patients who confirm two-round landmark undetectable mrd will be enrolled. enrolled patients will be under close mrd and imaging monitoring without any adjuvant therapy.

Eligibility criteria:
inclusion criteria: * stage ib-iiia non-small cell cancer patients who after complete resection. * ≥18 years. * two-round mrd tests confirm landmark undetectable mrd. * expected survival ≥12 weeks. * expected survival ≥12 weeks. * ecog ps 1-2. * willing to accept mrd monitoring every 3 months for a total of 2 years after operation. exclusion criteria: * patients who had previously undergone radiotherapy or chemotherapy or any other anti-tumor therapy. * patients with a history of other malignancies in the past 5 years. * any unstable systemic disease (eg, active infection, high-risk hypertension, unstable angina, congestive heart failure, etc.).

Keywords: molecular residual disease adjuvant therapy