Kornimate/medical-research-clean huggingface dataset:
a study on the impact of online positive psychological intervention on the mental health and quality of life of crohn's disease patients

Conditions: Crohn Disease

Summary: crohn's disease (cd) is a chronic, nonspecific inflammatory disease that can affect the entire digestive tract. it is difficult to cure and often relapses, causing long-term suffering for patients. this persistent condition significantly impacts their mental and psychological well-being, leading to a noticeable decline in their quality of life. furthermore, these negative emotions can contribute to disease recurrence and the worsening of symptoms. positive psychological intervention (ppi) refers to the enhancement of positive emotions, cognition, and behaviors to increase well-being and alleviate symptoms. therefore, this study aims to use psychological methods to help cd patients better recognize and understand their positive experiences, thus aiding them in coping with stress and adversity more effectively.


Eligibility criteria:
inclusion criteria: * patients diagnosed with crohn's disease according to the 2018 diagnostic criteria established by the inflammatory bowel disease group of the chinese medical association's gastroenterology branch; * patients aged between 18 and 75 years; * patients with a score of 5-14 on the gad-7 (indicative of mild to moderate anxiety) or a score of 5-14 on the phq-9 (indicative of mild to moderate depression); * patients who understand and agree to comply with the study requirements and have signed informed consent; * patients who are able to read and access the internet, either independently or with assistance from a family member, and are capable of using wechat and mobile applications; * patients who are able to complete all course trainings and/or follow-up procedures. exclusion criteria: * individuals with a history or current diagnosis of psychiatric illness or cognitive impairment, or those currently taking psychiatric medications; individuals working in the field of psychology, or those who have previously studied or are currently studying positive psychology; * individuals with concurrent other intestinal diseases or malignancies; * individuals with severe primary diseases of the cardiovascular, cerebrovascular, hepatic, or renal systems. withdrawal criteria: * patients lost to follow-up due to withdrawal or other reasons during the intervention period; * patients who develop severe complications or experience significant changes in their condition that prevent them from continuing the study.
clinical trial to evaluate the effectiveness and safety of a remote automated ultrasound diagnostic system for automated ultrasound examinations: a prospective, multicenter study

Conditions: Ultrasound; Thyroid; Carotid Artery; Liver; Gallbladder; Spleen; Pancreas; Kidney

Summary: the purpose of this clinical trial is to verify the safety and effectiveness of the remote automatic ultrasound diagnosis system produced by wuhan cooper technology co., ltd. for automatic ultrasound examination. it aims to answer the main questions: can the robot complete automatic ultrasound scanning of multiple systems and organs such as liver, gallbladder, spleen, pancreas, kidney, thyroid, carotid artery, etc.? will there be medical safety issues during the robot\&#39;s scanning process?


Eligibility criteria:
inclusion criteria: * 1) aged ≥ 18 years old, regardless of gender; 2) those who need to undergo ultrasound examination; 3) those who voluntarily participate in this trial and sign the informed consent form. exclusion criteria: * 1) those who are allergic to ultrasound coupling agents; 2) those who are unable to undergo long-term ultrasound examinations due to physical or mental reasons (such as intellectual disability, mental illness, etc.); 3) those who have suffered severe trauma or burns within the past month; 4) pregnant or breastfeeding women; 5) those who have participated in other clinical trials within the past month; 6) other subjects deemed by the researchers to be unsuitable for participating in the trial.

Keywords: ultrasound intelligent robot multitasking automated ultrasound clinical application
dynamics and tracer distribution of tilmanocept in early stage breast cancer

Conditions: Breast Cancer; Sentinel Lymph Node

Summary: a sentinel node procedure is recommended for patients with early stages of breast cancer to exclude metastases to local lymph nodes. this procedure is done with a "tracer" which is injected near to the tumor and drains to these nearby lymph nodes. the first draining lymph node(s) are called "sentinel" node(s). these sentinel nodes are excised by the surgeon for microscopic investigation using a detection probe. this study aims to further document the distribution and dynamics of a recently approved new tracer called tilmanocept and comparing it with the standard used tracer (nanocolloid) to determine whether there is a significant difference between both products (which are both approved for clinical use in this scenario in the european union). this will be done by randomly assigning patients between injection of tilmanocept or nanocolloid and making scans on multiple (3) time points.


Eligibility criteria:
inclusion criteria: * early stage breast cancer (t1, t2) * clinically node negative (no enlarged axillary lymph nodes) exclusion criteria: * prior surgery in same breast * pregnancy or breastfeeding
phase 1 study of bpi-442096 in advanced solid tumor patients

Conditions: Solid Tumor; Non-small Cell Lung Cancer; Pancreatic Cancer; Colorectal Cancer

Summary: a first-in-human study to evaluate the safety, tolerability and maximum tolerated dose (mtd) and establish the recommended phase 2 dose (rp2d) of bpi-442096, a shp2 inhibitor, in patients with advanced solid tumors.

the first-in-human (fih) study of bpi-442096 will be an open-label, non-randomized, phase 1 study utilizing a modified "3+3" dose escalation followed by an expansion phase in patients with kras g12 mutation, class-3 braf mutation, nf1 lof mutation or rtk mutation, amplification or rearrangement advanced solid tumors. the primary objective is to determine safety and tolerability of bpi-442096, the mtd and rp2d. the secondary objectives are to assess the pharmacokinetic (pk) and pharmacodynamic (pd) profile, preliminary anti-tumor activity of bpi-442096.

Eligibility criteria:
inclusion criteria: * signed informed consent; * age ≥18 and ≤75 years, male and female patients; * eastern cooperative oncology group (ecog) performance status (ps) 0-1; * dose escalation phase: histologically or cytologically confirmed locally advanced or metastatic solid tumor patients (excluding hcc patients), who had disease progression after standard therapy, intolerable to standard therapy, refuse to standard therapy or for whom no standard therapy exists; * dose expansion phase: histologically or cytologically confirmed locally advanced non-small cell lung cancer, pancreatic cancer, colorectal cancer or other diagnosed solid tumor patients (excluding hcc patients), who had disease progression after standard therapy, intolerable to standard therapy, refuse to standard therapy or for whom no standard therapy exists; * evaluable lesion required for dose escalation phase and at least 1 measurable lesion as per recist v1.1 required for dose expansion phase; * dose expansion only: patients must have confirmation of tumour mutation status (including kras g12, class-3 braf, nf1 lof mutations, rtk mutations, amplifications or rearrangements). * adequate organ function; exclusion criteria: * patients who have previously received a shp2 inhibitor; * inadequate wash-out of prior therapies described per protocol, which may include anti-tumor therapies, tumor adjuvant drugs, organ or stem cell transplantation, moderate or strong cyp3a inhibitor or inducer; * patients with severe or unstable systemic disease, unstable/symptomatic cns metastasis, other malignant tumors, autoimmune disease, ild, cardiac disease, bleeding or embolic disease, infectious disease, conditions affecting drug swallow and absorption, medical history leading to chronic diarrhea, etc; * pregnancy or lactation; * other conditions considered not appropriate to participate in this trial by the investigators.
a study to assess the safety and efficacy of muc1 peptide vaccine and hgm-csf in patients with muc1-positive tumor malignancies

Conditions: Multiple Myeloma

Summary: the scientific approach behind this study is to develop novel anti-cancer therapeutic vaccine to induce a robust cellular immune response mediated via both cd4+ and cd8+ t lymphocytes populations and can be be applicable to the majority of the target population.


Eligibility criteria:
inclusion criteria: 1. all\* patients must have a histological or cytological diagnosis of metastatic disease or hematological malignancies expressing the muc1. patients must have metastatic disease, and have failed at least one regimen of standard based chemotherapy for metastatic disease as indicated in the following table. patients must have disease considered to be incurable by surgical or radiological intervention. 2. patients must be \> 18 years of age, consenting to participate in the study. 3. patients must have at least one site of measurable tumor or measurable tumor marker. 4. radiological and other relevant imaging studies, such as ct scans, must be performed within 4 weeks of the first treatment as a baseline to document extent of disease. 5. patients should be at least 4 weeks beyond any major surgery or chemoradiotherapy and have recovered from drug induced toxicity. 6. patients must have a performance status of 70% or greater on the karnofsky scale (ecog 0-2) and a minimal life expectancy of 12 months. 7. patients must sign an informed consent, and be mentally responsible. * in multiple myeloma, muc1 expression will be tested after confirming that all inclusion/exclusion criteria are met and within the screening period. exclusion criteria: 1. patients not fulfilling the above criteria. 2. patients with a significant concurrent medical complication that in the judgment of the principal investigator could affect the patient's ability to tolerate or complete this study. 3. patients receiving any immunosuppressive treatment that could negate development of an effective immune response to the vaccine. (first vaccination should be at least 30 days from end of immunosuppressive treatment) 4. subjects with prior irradiation to a field that includes more than 25% of their lymph nodes and bone marrow likely to be immunosuppressed will be excluded. however, patients who had standard pelvic field radiation as adjuvant therapy for rectal cancer are not excluded. 5. pregnant and breast feeding women will be excluded. premenopausal women who are not practicing or willing to practice adequate birth control methods for a period of 3 months after treatment will be excluded. 6. patients with brain metastasis. 7. patients with active infection. 8. patients with hiv hbsag and hcv positive.

Keywords: muc1 immucin vaccine multiple myeloma
swallowing training combined with game-based biofeedback in post-stroke dysphagia

Conditions: Dysphagia

Summary: the purpose of this study is to determine whether swallowing training combined with game-based biofeedback is effective in the treatment of dysphagia due to stroke.

swallowing maneuvers are very effective if done correctly, but to evaluate the use of force and the extent of laryngeal elevation is very difficult. the therapist often requests the patient to "swallow hard" or "maintain laryngeal elevation". however, it is difficult to provide appropriate feedback to the patient, because it's hard to see the throat muscle contraction and bone displacement,the real point of the force is not clear, only oral and tactile feedback is inadequate and when combined with sensory loss, fatigue or cognition impairment. biofeedback is defined as "the technique of using equipment (usually electronic) to reveal internal physiological events by visual and auditory signals, to teach patients to manipulate the intrinsic physiological activity (basmajian, 1989).the rationale is thus that if a patient sees his muscle activity, rather than just feels his muscles contract, he will be able to contract his muscles more fiercely and therefore he will be able to train his muscles faster. past studies have shown that biofeedback can help nerve injury patients control their physiological activities such as swallowing training. the purpose of this study is to determine whether swallowing training combined with game-based biofeedback is effective in the treatment of dysphagia due to stroke.

Eligibility criteria:
inclusion criteria: * stroke * above 18 years-old * pharyngeal stage dysphagia exclusion criteria: * on trachea * cannot follow one command

Keywords: stroke swallowing training game-based biofeedback
potential risk factors and predictive model construction of obl during smile

Conditions: Myopia; Small-incision Lenticule Extraction (SMILE) Surgery

Summary: to explore the prediction of obl by deep learning model in smile surgery

the dl model was used to predict the obl area during smile surgery by identifying the corneal full-view images before laser scanning. the dl model developed may assist surgeons to predict the possible obl area of patients in advance, so as to adjust some surgical parameters and reduce the formation of obl, which can avoid negative effects on surgeons' operation and patients' postoperative visual recovery, which has important practical significance.

Eligibility criteria:
inclusion criteria: * a condition in which the spherical equivalent refractive error of an eye is ≤ -0.50 d when ocular accommodation is relaxed; * age ≥18 years; * spherical equivalent (se) ≥ -10.0d; * corrected distance visual acuity (cdva) ≥ 16/20; * stable myopia for at least 2 years; * no contact lenses wearing for at least 2 weeks exclusion criteria: * the presence or history of eye conditions other than myopia and astigmatism, such as keratoconus or external eye injury; * a history of eye surgery; * the presence or history of systemic diseases.

Keywords: small-incision lenticule extraction (smile) artificial intelligence opaque bubble layer
recell® combined with meshed skin graft in the treatment of acute burn injuries

Conditions: Burns

Summary: this is a randomized, within-subject controlled study to compare the clinical performance of the recell device when used as an adjunct to meshed skin graft in subjects requiring skin grafts for closure of burn injuries. co-primary effectiveness endpoints include: (1) confirmed treatment area closure (i.e., healing) prior to or at 8 weeks as assessed by a blinded evaluator, and (2) a comparison of the actual expansion ratio, computed as the ratio of measured treated area to the measured donor site area, achieved for the recell-treated and control treatment areas. safety will be evaluated in terms of long-term durability, scar outcomes and treatment-related adverse events.


Eligibility criteria:
inclusion criteria: 1. the subject requires skin grafting as a result of an acute thermal burn injury (i.e. injuries caused by exposure of the skin to fire/flames, excessive heat, hot steam or water). 2. the area of total burn injury is 5-50% tbsa inclusive. 3. two areas requiring skin grafting, each at least 300cm2 (or 600cm2 contiguous), excluding hand/face and joints. 4. the subject is at least 5 years of age. 5. the subject (or family, for those under 18 years of age) is willing and able to complete all followup evaluations required by the study protocol. 6. the subject is to abstain from any other treatment of the wound(s) for the duration of the study unless medically necessary. 7. the subject agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study. 8. the subject and/or guardian are able to read and understand instructions and give informed, voluntary, written consent. exclusion criteria: 1. the subject's burn injuries were caused by chemicals, electricity, and/or radioactive substances. 2. the subject is unable to follow the protocol. 3. the subject has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives. 4. the subject has a known hypersensitivity to trypsin or compound sodium lactate for irrigation (hartmann's) solution. 5. life expectancy is less than 1 year.

Keywords: second degree burn injuries
applying a multidisciplinary intervention for drug adequacy in an intermediate care hospital (amida-ich)

Conditions: Poly Pharmacy; Frail Elderly

Summary: the goal of this clinical trial is to learn if a multi-professional (conducted by geriatricians, clinical pharmacists, nurses) medication revision, centered on patients' goals and characteristics, can improve treatment adequacy in older adults admitted to an intermediate care hospital. the main question it aims to answer is: does this approach reduce the average number of medications taken per patient? researchers will compare this multi-professional patient-centered revision to the usual standard of care (treatment revision conducted by a clinical pharmacist) to see if the patient-centered revision works in improving treatment adequacy. participants admitted to an intermediate care hospital will undergo a comprehensive assessment by a geriatrician, and a medication revision (conducted by a multidisciplinary team or a clinical-pharmacist alone). they will also be asked to fulfill some questionnaires on their health status and attitudes. any possible adverse events to the medications will be recorded at discharge. participants will be contacted again three months after discharge to check for any readmission or death.


Eligibility criteria:
inclusion criteria: * older adults (65+ years) * ≥ 3 or more chronic conditions requiring medical therapy * able to speak spanish * capacity to provide informed consent or have a surrogate able to consent on their behalf exclusion criteria: * unable to provide informed consent * anticipated length of hospital stay \< 72h * estimated life expectancy \< 3 months * homeless * already enrolled in a drug trial

Keywords: polypharmacy frailty adverse drug event deprescribing
safety and efficacy study of association between tretinoin and clindamycin on the treatment of acne mild and moderate

Conditions: Acne Vulgaris

Summary: the purpose of this study is to determine the safety and efficacy of association between tretinoin and clindamycin phosphate on the treatment of acne vulgaris mild and moderate.


Eligibility criteria:
inclusion criteria: * individuals of both sexes with age greater than or equal to 12 years * subjects diagnosed with acne vulgaris in the face, except for the nasal area, range from mild to moderate, with the following requirements. * mild acne = presence of fewer than 20 comedones or less than 15 lesions, inflammatory lesions or a total of less than 30 injuries. * moderate acne = presence of 20 the 100 comedones or of 15 the 50 inflamatory lesions or a total of 30 the 125 lesions, with not more than lesions small nodule until 5,0 mm. * ensure that the existing injuries were not submitted any treatment for acne, topical or systemic, within the last 30 days. * be able to properly follow the determinations of the protocol. * has provided a written voluntary consent to participate in the study, by signing the informed consent, before being subjected to any procedure. * under 18 years old, be accompanied by legal guardian in the process of obtaining the informed consent. * be mentally able to provide consent and be fulfilling all the requirements of the study. exclusion criteria: * pregnant women or in periods of lactation. * women of childbearing age and sexual activity with not using safe contraceptive method, such as oral contraceptives, implantable, injectable or intra-uterine, introduced for at least 120 days. * women who are using oral contraceptives containing the hormone combination for acetate ciprosterone and etinolestradiol, association of drospirenone and ethinyl estradiol, or desogestrel. * clinical evidence or history of immunodeficiency. * any use of immunosuppressive drug and/or immunomodulating over the past 3 months, topical or systemic. * concurrent use of fotossentetizadores, neuromuscular blockers, medications that exacerbate the acne, blockers (filters) with solar alcoholic vehicle, spironolactone, flutamide or zinc salts. * prior use of systemic retinoid. * presence of acne medication and/or cosmetic. * history of systemic metabolic disorder that can interfere with the integrity of the skin. * history of inflammatory disease, intestinal or regional enteritis and/or symptoms similar. * history of joy to any of the components of the formula (active principle or carrier). * history of abuse of alcohol and/or illegal drugs. * history of non-adherence to medical treatment earlier. * any clinical observation made by the investigator that prohibits participation in the study of the subject.

Keywords: clindamycin tretinoin acne vulgaris acne vulgaris mild to moderate
predictive value of drug sensitivity testing tumorspheres from patients with metastatic colorectal cancer

Conditions: Colorectal Cancer Metastatic

Summary: the purpose of the present study is to investigate the benefit of anti-cancer therapy administered on the basis of drug sensitivity testing. this concerns colorectal cancer patients who have previously received standard treatment.


Eligibility criteria:
inclusion criteria: * metastatic colorectal cancer * biopsy proven adenocarcinoma compatible with colorectal origin (primary tumor or metastasis) * if only biopsy from metastasis can be obtained, the patient must have a previously resected or image proven tumor of the colon or rectum (scanning or endoscopy) * non-resectable metastatic spread * previously exposed to or intolerance or contraindications to standard systemic therapy, defined as * oxaliplatin * irinotecan * 5-fluorouracil (or similar such as capecitabine, s1) * vegf inhibitor bevacizumab * egfr inhibitor panitumumab or cetuximab (if ras/raf wt) * progressive disease defined as progression according to recist 1.1 * ecog performance status 0-2 * age at least 18 years * adequate bone marrow, liver and renal function allowing systemic chemotherapy * absolute neutrophil count ≥1.5x10\^9/l and thrombocytes ≥ 100x10\^9/l. * bilirubin ≤ 1.5 x upper normal value and alanine aminotransferase ≤ 3 x upper normal value * calculated or measured renal glomerular filtration rate at least 30 ml/min * anticonception for fertile women and for male patients with a fertile partner. intrauterine device, vasectomy of a female subject's male partner or hormonal contraceptive are acceptable * written and orally informed consent exclusion criteria: * incapacity, frailty, disability, or comorbidity to a degree that according to the investigator is not compatible with participation in the protocol * other active malignant disease requiring therapy * other systemic anti-cancer therapy (palliative radiotherapy is allowed). * pregnant (positive pregnancy test) or breast feeding women