Kornimate/medical-research-clean huggingface dataset:
toripalimab combined with s1 and albumin paclitaxel in patients with advanced biliary tract cancer

Conditions: Advanced Biliary Tract Cancer

Summary: the investigator's study is a single armed phrase ii trial ,aiming to improve the effecacy of treatment for advanced billiary tract cancer by means of toripalimab combining with s1 and albumin paclitaxel as first line in patients with advanced biliary tract cancer. treatment continually until disease progression or intolerable toxicity or patients withdrawal of consent.and target sample is 30+ patients.

toripalimab: 240 mg , once every 2-3 weeks; s1: 80-120mg, bid; oral, day1-14; albumin paclitaxel: 120mg/m2 , administered on the first day and the eighth day of each cycle; 21 days for a treatment cycle

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old 2. patients with gallbladder and cholangiocarcinoma diagnosed by histology or cytology 3. liver function child-pugh grade a (5-6 points) or better grade b (≤ 7 points) 4. ecog score 0 or 1 point 5. at least one measurable lesion 6. no previous treatment exclusion criteria: 1. organs failure ,including liver ,heart ,kidney 2. have received a liver transplant in the past 3. active brain metastasis or spinal cord compression 4. ecog score 3 or 4 point 5. symptomatic peripheral neuropathy (ctcae ≥ 2)

Keywords: advanced biliary tract cancer albumin paclitaxel s1 toripalimab
clinical evaluation of the inflammadry device for detecting dry eye

Conditions: Dysfunctional Tear Syndrome

Summary: inflammadry is a rapid diagnostic test for the detection of elevated levels of matrix metalloproteinase-9 (mmp-9) protein in tear fluid.

the inflammadry test will be used to aid in the diagnosis of dry eye in conjunction with other methods of clinical evaluation.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * patient voluntarily reported at least 1 episode of any of the following ocular symptoms during the last month: 1. burning or stinging 2. sandy or gritty feeling 3. foreign body sensation 4. tearing 5. light sensitivity 6. intermittent or fluctuating vision 7. tired eyes exclusion criteria * allergy to cornstarch or dacron * allergy to topical anesthetic or fluorescein dye * prior eye injury, trauma, or ocular surgery within the last 3 months * known blockage of the lacrimal drainage system * contact lens wear in the last month * previous corneal refractive surgery including rk, lasik or prk surgery * have an active ocular infection or history of a recent ocular infection in the last month * have active intraocular inflammation or history of intraocular inflammation, e.g. uveitis * use of oral doxycycline, corticosteroids, or immunomodulators in the last month * have received topical ocular corticosteroids, topical nonsteroidal (nsaids) therapy, or topical ocular cyclosporine in the last month * pregnant or lactating * use of any topical ophthalmic medications, including artificial tears 2 hours prior to enrollment

Keywords: dry eye
float through anxiety: virtual reality application's efficacy as a tool to distract from negative emotions and thoughts

Conditions: Control; Experimental

Summary: the goal of this clinical trial is to examine the effectiveness and safety of the vr float application as a tool to reduce negative thoughts and feelings and anxiety symptoms in students with high levels of stress and anxiety. the main questions it aims to answer are: 1. will subjects with high levels of anxiety who will use the float application experience a more significant relief in feelings of anxiety compared to subjects in the control group? 2. will subjects who are used to using technology find greater comfort in using vr compared to subjects who are not used to it? 3. what is the degree of satisfaction with the use of vr and are there any reports of side effects?participants will \[describe the main tasks participants will be asked to do, treatments they'll be given and use bullets researchers will compare control group to see the comparison between using float as a regulation strategy after psychoeducation on emotional regulation and cognitive-behavioral use of a regulation strategy after the same psychoeducation


Eligibility criteria:
inclusion criteria: * 'moderate' or 'severe' levels of stress and/or anxiety according to the dass-21 questionnaire * student exclusion criteria: * under the age of 18 * diagnoses of schizophrenia or bipolar disorder, including past or present psychotic conditions * suicidality * pregnant women * do not speak or read hebrew fluently * a diagnosis of epilepsy.
emotional association bias modification training in individuals with igd

Conditions: Internet Gaming Disorder

Summary: this project aims to investigate (1) the efficacy of emotional association bias modification (eabm) training on internet gaming disorder (igd); (2) the underlying neural mechanisms of such efficacy

as with the efficacy, the experiment aims to test whether eabm training will reduce positive emotional association bias towards gaming, compulsive choice of gaming pictures, cue-induced craving for gaming, the severity of gaming behaviors in individuals with igd. as with the underlying neural mechanisms, the experiment aims to test whether eabm training will alter the activation of reward circuits in response to gaming pictures, the activation of executive control network (mainly refering to the prefrontal cortex) regarding regulation ability for craving and response inhibition ability.

Eligibility criteria:
inclusion criteria: 1. the 5th edition of diagnostic and statistical manual of mental disorders (dsm-5 ) recommended diagnosis of internet gaming disorder : the scores of the 9 items of dsm-5 recommended diagnosis for internet gaming disorder ≥ 5. engagement in popular internet games (e.g. arena of valor, league of legends and player unknown's battle grounds) for over 20 hours per week for a minimum of 12 months. 2. the scores of the young-internet addiction test ≥ 50 exclusion criteria: 1. current or history of use of illegal substances and other addictions; 2. current or history of psychiatric or neurological illness; 3. current use of psychotropic medications.
a clinical investigation to confirm the ability of mammowave in breast lesions detection

Conditions: Breast Cancer

Summary: this is a multicentric, single arm, prospective, stratified by breast density clinical investigation to confirm the ability of the microwave mammogram 'mammowave' to detect breast lesions. mammowave is a innovative medical device, class iia marked ce, which uses microwaves instead of ionazing radiation (x-ray) for breast lesions. specifically mammowave employs a novel technique wich generates images by processing very low power (\<1mw) microwave. the mammowave exam takes few minutes for breast and is performed with the patient lying in a confortable facing down position. mammowave is safe to be used at any age, in any condition (pregnancy, specific illness and for unlimited number of times.

the maximum number of participants to the clinical investigation will be 600 (for all the sites). the study will be composed of two phases: a preliminary phase to 'optimize the imaging algorithm for each apparatus installed at each centre', where 15 volunteers (in each centre) having breast with no lesions (nl) will be examined by mammowave. in the second phase, the remaining people will be enrolled (bl will be 50% of total) and examined by mammowave by the clinical investigator, and results will be compared with the effective diagnosis already obtained by standard clinical methods. bl includes malignant lesions (bc) and benign lesions, and may be palpable or non-palpable lesions. bl includes also isolated clustered microcalcifications. the primary gol of the clinical study is to assess mammowave's ability in bl detection. the study will involve investigational sites in italy, germany and spain.

Eligibility criteria:
inclusion criteria: * signed informed consent form * women * adult ≥ 18 years old * having a radiologist study output obtained using mammography within the last month. such radiologist study output may be integrated with ultrasound and /or magnetic resonance imaging output if deemed necessary by the responsible investigator and when available. the radiological output will be integrated with histological one if deemed necessary by the responsible investigator and when available. * patients willing to comply with study protocol and recommendations exclusion criteria: * patients who belong to any vulnerable group * patients with implanted electronic devices * patients who have undergone biopsy less than one week before mammowave scan * patients with nipple piercings (unless they are removed prior to examination) * pregnancy or breastfeeding
quality of life and patient-centered outcomes after icu admission for covid-19

Conditions: Quality of Life; Long-term Outcomes; Coronavirus Infection; Morality; Rehospitalization

Summary: patients suffering from pneumonia due to sars-cov-2 infection, after admission to the intensive care unit (icu), are susceptible to development of various functional sequelae, increased risk of chronic diseases, increased mortality rates and existence of relevant impacts on their quality of life in the months and years that follow the icu admission. the present study aims to assess the determinants of health-related quality of life and patient-centered long-term outcomes among patients recovered from sars-cov-2 pneumonia, after discharge from the icu, its determinants and predictors, in portugal. it is a multicenter prospective cohort study of adult patients admitted at the icu due to proven or suspected sars-cov-2 infection, included 90 days after discharge from the icu. the primary outcome is one-year health-related quality of life assessed by the eq-5d-3l. the secondary outcomes are all-cause mortality, rehospitalizations, return to work or study, the degree of dependence and functional capacity, symptoms of anxiety, depression and post-traumatic stress, level of physical activity and cognitive, renal and respiratory functions after icu discharge. investigators will collect data by means of structured telephone interviews, at a 12 months follow up period.


Eligibility criteria:
inclusion criteria: * men and women aged 18 years and older * admission to the intensive care unit (icu) * pneumonia due to proven or suspected sars-cov-2 infection exclusion criteria: * refusal to provide consent for the study by the patient or legal guardian * icu length of stay less than 24 hours * absence of telephone contact
usefulness of post-operative radiotherapy in high-grade cutaneous squamous cell carcinoma: an observational study

Conditions: Cutaneous Squamous Cell Carcinoma (CSCC)

Summary: post-operative radiotherapy (port) is currently considered as the second most important therapy to treat high-grade cutaneous squamous cell carcinoma. nonetheless, only few studies evaluate its impact on recurrence rate and the major part of those ones do not include a proper control group of patients. most recent guide lines from nccn, sidemast and british associations of dermatologists suggest clinicians to offer or consider port in selected patients but class nor level of evidence of those guide lines are provided. this project evaluates impact of post-operative radiotherapy on recurrence rate and overall survival by comparing two cohort of patients, the former who accepted port and the latter who, nonetheless its necessity, decided to not undergo it. the hypothesis which this project will answer concerns the effectiveness of post-operative radiotherapy in preventing local and regional recurrences. we expect a significant decrease of recurrence rate in patients who undergo this therapeutic option as compared to those with clinical indication but do not undergo port.


Eligibility criteria:
inclusion criteria: * diagnosis of high-grade cutaneous squamous cell carcinoma * patients eligible for post-operative radiotherapy * minimum follow-up of 24 months exclusion criteria: * lack of clinical of histological data * impossibility of a proper follow-up * occurrence of intermediate events (i.e., pregnancy)
impact of treatment with colistin on mortality bacteremia multiresistant acinetobacter baumannii sensitive colistin in patients critical

Conditions: Acinetobacter Infections

Summary: the present study was designed to study the impact of empirical treatment with colistin empirical monotherapy and combined treatment with tigecycline and vancomycin on mortality of bacteremia multiresistant acinetobacter baumannii . the main objective was to evaluate the efficacy of empirical treatment with colistin and combined targeted therapy. the different therapeutical interventions were administered following the routine clinical practice in the medical centre and the investigator did not assign specific interventions to the subjects of the study.


Eligibility criteria:
inclusion criteria: * critics included patients ≥ 16 years with monomicrobial bloodstream infections by multiresistant acinetobacter baumannii to carbapenems and sensitive to colistin accompanied by systemic inflammatory response syndrome, provided they have received targeted treatment with colistin.
sex or no sex: that is the question.

Conditions: Infertility, Female; Sexual Intercourse

Summary: this study aims to evaluate the impact of sexual intercourse and orgasm in the 72 hrs following embryo transfer of blastocysts on the clinical pregnancy rate. an impact on sexual activity and a decrease in the frequency of intercourse has been observed in infertile couples. in couples who undergo assisted reproductive technology (art), sexual relations have an additional component that can condition them, such as the fear of influencing the outcome of the cycle. the usual practice in art cycles has evolved towards a preference for blastocyst-stage embryo transfer, both in fresh in vitro fertilization (ivf) cycles and in frozen embryo transfer (fet) cycles. the investigators consider it important to elucidate whether coital intercourse after embryo transfer (et) has an impact on the clinical pregnancy rate after the transfer of blastocyst-stage embryos.

it is proposed to carry out an observational, prospective study, in which women with a heterosexual sexual relationship are included, who carry out an embryo transfer, in a fet cycle in the dexeus woman reproduction medicine service and who agree to participate in the same.

Eligibility criteria:
inclusion criteria: * women with a heterosexual sexual relationship * that they carry out an embryo transfer, in a fet cycle exclusion criteria: * exclusion criteria are not foreseen
exploring clinical study experiences of people with anorexia nervosa

Conditions: Anorexia Nervosa

Summary: the study seeks to delve into the firsthand experiences of patients diagnosed with anorexia nervosa who partake in a separate clinical trial featuring a specific medical intervention. the primary emphasis will be on meticulously tracking the rates of trial completion and withdrawal among these individuals. by joining this clinical trial, individuals have the unique opportunity to contribute to the betterment of future anorexia nervosa patients and play an active role in advancing medical research.


Eligibility criteria:
inclusion criteria: * patient has self-identified as planning to enroll in a clinical trial * patient has been diagnosed with anorexia nervosa * patient is a minimum of 18 years or older exclusion criteria: * patient does not understand, sign, and return consent form * inability to perform regular electronic reporting * patient is pregnant

Keywords: anorexia nervosa
airway scope and macintosh laryngoscope for tracheal intubation in patients lying on the ground

Conditions: Intubation

Summary: pre-hospital intubation is often required in sub-optimal conditions, such as in patients lying on the ground. direct laryngoscopy and intubation of a patient lying supine on the ground is difficult because the intubator's head is far above the head of the patient. it is thus tricky to align the intubator's visual axis with the patient's tracheal axis. the airway scope is a new laryngoscope designed to facilitate intubation without requiring alignment of the oral, pharyngeal, and tracheal axes. we thus tested the hypothesis that the intubation with the airway scope is faster than the macintosh laryngoscope in subjects lying on the ground.

adult surgical patients were enrolled. following anesthesia induction and muscle relaxation, direct laryngoscopy was performed as usual and airway characteristics noted. patients were randomly assigned to tracheal intubation by either the airway scope (n=50) or the macintosh laryngoscope (n=50). intubation was performed from a table positioned at the height as the operating table, thus simulating intubating on the ground. overall intubation success rate, time required for intubation, the number of attempts required for successful intubation, and airway complications related to intubation were recorded.

Eligibility criteria:
inclusion criteria: * patients scheduled for various surgeries requiring tracheal intubation as part of anesthesia and designated as american society of anesthesiologists (asa) physical status i, ii, or iii. exclusion criteria: * patients with an increased risk of pulmonary aspiration, cervical spine pathology, anticipated airway difficulties (i.e., mallampati grade iv or thyromental distance \ iii.

Keywords: supine emergency intubations emergency intubations
necklace-shaped sensor for non-invasive remote monitoring of vitals

Conditions: Heart Failure; Hypertension

Summary: this study is designed to validate the use of the cova monitoring system in subjects with implanted devices.

the study had the following objectives: 1. verify that the cova monitoring system does not interfere with implanted devices. 2. verify that implanted devices do not interfere with the functions of the cova monitoring system. 3. verify that the cova monitoring system fits on a wide variety of body types.

Eligibility criteria:
inclusion criteria: * subject is between 21 (twenty-one) and 95 (ninety-five) years of age at screening. * subject has a pacemaker, implanted cardioverter-defibrillator, or ventricular assist device. * subject and/or legally authorized person/representative is willing to undergo the informed consent process prior to enrollment in the study. * subject is a candidate for this study based on the pi's opinion and knowledge of the subject's condition. exclusion criteria: * subject is participating in another clinical study that may affect the results of either study. * subject is unable or not willing to wear electrode patches as required. * subject has skin sensitivity to adhesive or hydrogel materials used in electrode patches. * subject is considered by the pi to be medically unsuitable for study participation.

Keywords: hypertension heart failure fluids
patient-reported outcomes in preoperative immunochemotherapy/radiotherapy-treated esophageal cancer patients

Conditions: Esophageal Squamous Cell Carcinoma; Patient-reported Outcomes; Immunotherapy

Summary: preoperative immune checkpoint inhibitors combined with chemotherapy have revolutionized the treatment landscape of locally advanced esophageal squamous cell carcinoma. however, there are still a significant proportion of patients who could not benefit from such treatment modality. currently, no effective biomarkers were identified to stratify responders and non-responders. early dynamic and persistent relief of dysphagia may act as a predictive biomarker to reflect the on-treatment anti-tumor activity. in this prospective study, we aimed to explore the feasibility of using patient-reported outcomes (pros) to predict the pathological complete response of esophageal squamous cell carcinoma patients treated with neoadjuvant immunochemotherapy with or without short-term radiation as well as to assess the efficacy and safety of short-term radiotherapy in pros-insensitive patients after one cycle of neoadjuvant immunochemotherapy.


Eligibility criteria:
inclusion criteria: * pathologically confirmed esophageal squamous cell carcinoma * potentially resectable esophageal squamous cell carcinoma at first diagnosis (ct1-4an1-2m0, ct3-t4an0m0) * treatment-naive * expected life span \> 6 months * aged 18 - 75 years old * adequate organ functions * ps 0-2 * participants are fully informed about the whole study and are willing to sign the informed consent exclusion criteria: * previous history of thoracic surgery or radiation * cervical or multi-origin esophageal cancer * known or suspected experimental drug allergy * pregnant or lactating women * esophagomediastianl fistula * peripheral neuropathy * previous cancer history other than esophageal cancer * severe organ function deterioration that can not tolerate neoadjuvant therapy * previous autoimmune diseases * diabetic history \> 10 years * interstitial pulmonary disease, non-infectious pulmonitis * active type b hepatitis * any other conditions that may affect patients' safety and compliance

Keywords: pathological complete response efficacy safety dysphagia
durability and safety of en3835 in the treatment of efp (cellulite) in women

Conditions: Edematous Fibrosclerotic Panniculopathy

Summary: this is a phase 2b, rollover, long-term study to evaluate the safety and duration of efficacy of en3835 in the treatment of women with efp. subjects who participated in and completed studies en3835-201 and en3835-202 and had composite improvement of at least 2 levels on both the cr-pcss and pr-pcss in study en3835-201 will be eligible for this study.


Eligibility criteria:
inclusion criteria: * to qualify for the study a subject must: 1. be able to provide voluntary written informed consent prior to the initiation of any study-specific procedures per the policy of the governing institutional review board (irb)/independent ethics committee (iec). 2. have participated in and completed both studies en3835-201 and en3835-202 and had composite improvement of at least 2 levels on both the cr-pcss and pr-pcss in study en3835-201. 3. be willing and able to comply with all protocol required visits and assessments. exclusion criteria: * subjects will be ineligible for participation in this study if the subject: 1. has had retreatment with en3835 in the area initially treated during the en3835-201 study since the completion of study en3835-202. 2. has had liposuction on the body region treated during the en3835-201 study since the completion of that study. 3. has had any of the following in the area initially treated during the en3835-201 study since the completion of that study. 1. injections (eg, mesotherapy); radiofrequency device treatments; laser treatment; or surgery (including subcision and/or powered subcision). 2. any investigational treatment for efp/cellulite. 3. endermologie® or similar treatments. 4. massage therapy. 5. creams (eg, celluvera™, trilastin®). 4. any other condition(s) that, in the investigator's opinion, might indicate the subject is unsuitable for the study.

Keywords: edematous fibrosclerotic panniculopathy efp cellulite