Kornimate/medical-research-clean huggingface dataset:
study of clinical features of patients with autoimmune liver disease complicated with covid-19 and the immune mechanism affecting prognosis

Conditions: Autoimmune Liver Disease, COVID-19

Summary: with the decreasing virulence of omicrons strain, the current domestic epidemic prevention policy has been changed based on the health of the people and the development needs of the country. at present, the infection rate of the novel coronavirus in china is rising rapidly. previous studies have found that patients with chronic liver disease are more likely to be co-infected with coronavirus disease 2019 and have a worse prognosis. based on its unique immune mechanism and therapeutic drugs, patients with autoimmune liver disease also have very different manifestations after infection with the novel coronavirus. by observing the clinical characteristics and prognosis of patients with autoimmune liver disease complicated with coronavirus disease 2019, this study analyzed the roles of vaccines, immunosuppressive agents and ursodeoxycholic acid , and explored the immune mechanism behind them, so as to seek new anti-coronavirus disease 2019 drugs and provide new strategies for clinical prevention and treatment.


Eligibility criteria:
group a: 1) aged 18-75; 2) aih patients diagnosed by aih comprehensive scoring diagnosis system; 3) no history of other malignant tumors; 4) no metabolic diseases such as hypertension and diabetes; 5) no serious circulatory and respiratory diseases; 6) non-alcoholic liver disease, drug-induced hepatitis, viral hepatitis and other liver diseases; 7) exclude pregnant and lactating women. group b: 1) aged 18-75 years; 2) patients with pbc diagnosis; 3) no history of other malignant tumors; 4) no metabolic diseases such as hypertension and diabetes; 5) no serious circulatory and respiratory diseases; 6) non-alcoholic liver disease, drug-induced hepatitis, viral hepatitis and other liver diseases; 7) exclude pregnant and lactating women. group b: 1) aged 18-75 years; 2) patients with pbc diagnosis; 3) no history of other malignant tumors; 4) no metabolic diseases such as hypertension and diabetes; 5) no serious circulatory and respiratory diseases; 6) non-alcoholic liver disease, drug-induced hepatitis, viral hepatitis and other liver diseases; 7) exclude pregnant and lactating women. group b: 1) aged 18-75 years; 2) patients with pbc diagnosis; 3) no history of other malignant tumors; 4) no metabolic diseases such as hypertension and diabetes; 5) no serious circulatory and respiratory diseases; 6) non-alcoholic liver disease, drug-induced hepatitis, viral hepatitis and other liver diseases; 7) exclude pregnant and lactating women. group e: those who had no previous history of covid-19 infection and had been vaccinated against covid-19. - -
newpromri-pathway - a new prostate magnetic resonance imaging (mri) pathway

Conditions: Prostate Cancer; MRI

Summary: prostate cancer is the second most common cancer in men worldwide. the demand for magnetic resonance imaging (mri) to diagnose and manage prostate cancer is continually growing. there is, however, a severe global shortage of radiologists who review and make decisions on prostate scans. this shortage causes compromises that are inefficient and negatively affect care provision, patient outcomes, and patient experiences. two key examples of these compromises are that every patient receives a gadolinium contrast injection during a prostate mri scan and patients often require multiple imaging appointments. if radiologists' knowledge of making prostate mri decisions around these compromises could be harnessed and passed to radiographers (who are trained to acquire the mris but currently do not review them) with a computerised system to support clinical decision-making, this would have enormous potential to improve the diagnosing and managing prostate cancer.


Eligibility criteria:
inclusion criteria: * mri radiographers in university hospitals of north midlands (uhnm) and or university hospitals of derby and burton (uhdb) with over 5 years' experience in mri of the prostate. * radiographers from uhnm or uhdb who have completed an online and hands on study specific training materials before the testing phase. * retrospective data of 800 patients each from uhnm and uhdb who have had mpmri and went on to have a biopsy. exclusion criteria: * non-mri radiographers. * radiographers who did not completed an online and hands on study specific training materials before the testing phase. * non-mpmri.
hypofractionation with simultaneous integrated boost for early breast cancer

Conditions: Breast Cancer After Breast Conserving Surgery Indicating Postoperative Radiotherapy With Boost

Summary: hypofractionation with simultaneous integrated boost has been investigated in a few trials and appears to be safe and feasible with less lung toxicity in smaller studies. investigators initiated this multicenter phase ii prospective trial to analyse acute toxicity of hypofractionation with simultaneous integrated boost in patients with early breast cancer under the hypothesis that the ratio of patients with acute radiogenic toxicity grad ii according nci-ctcae amounts maximum 20%.

hypofractionated radiotherapy of the breast 16 × 2.50 gy with simultaneous integrated boost to the tumor bed (total dose within the boost volume 16 × 3.00 gy).

Eligibility criteria:
inclusion criteria: * histopathologically confirmed breast cancer operated by breast conserving surgery with clear margins * indication to adjuvant radiotherapy including boost radiotherapy * clearly identified primary tumor region preferably by radiopaque clips * primary wound healing after breast conserving therapy without signs of infection * pre- and/or postoperative chemotherapy and endocrine therapy were permitted when indicated * written informed consent exclusion criteria: * patients operated by mastectomy * no indication for boost radiation * resection margins positive for disease or insufficient identification of the boost volume * indication for radiotherapy of the regional lymph nodes * history of prior breast or thoracic radiotherapy * extended postoperative seroma at the beginning of radiotherapy * psychiatric disorders or psychological disabilities thought to adversely affect treatment compliance * pregnant or lactating patients and woman of child bearing potential, who lacked effective contraception

Keywords: breast cancer hypofractionation simultaneous integrated boost toxicity
short-term starvation vs. normal diet before chemotherapy of solid tumors

Conditions: Cholangiocarcinoma; Pancreatic Ductal Adenocarcinoma; Colorectal Cancer; Gastric Cancer; Adenocarcinoma of the Esophagogastreal Junction; Esophagus Cancer

Summary: recent pre-clinical data provide strong evidence that short-term starvation before the administration of cytostatic drugs for the chemotherapy of solid tumors leads to significantly higher efficacy and lower toxicity levels. however, these findings have so far not been validated in patients. the aim of this trial is to provide first clinical evidence regarding the impact of pre-chemotherapeutic short-term starvation on response to therapy (primary endpoint). additionally, progression-free survival, adverse events, and overall survival will be monitored (secondary endpoints). in perspective, short-term starvation before chemotherapy could represent a simple and secure way to improve both efficacy and tolerance of chemotherapies at low cost.


Eligibility criteria:
inclusion criteria: 1. patient (male/female) ≥ 18 years of age 2. written informed consent obtained prior to any trial specific procedure 3. patient suffering from gastrointestinal tumors: cholangiocarcinoma (cc), pancreatic ductal adenocarcinoma (pdac), colorectal cancer (crc), gastric cancer (gc)/ adenocarcinoma of the esophagogastreal junction (aeg) / esophagus cancer (ec). 4. planned to receive palliative chemotherapy 5. no prior palliative chemotherapy 6. ecog performance status of 0 or 1 7. life expectancy of 12 weeks or more 8. adequate hematological parameters, as demonstrated by: * hemoglobin \> 9.0 g/dl (5.6 mmol/l) * wbc ≥ 3.0 x 109/l * anc ≥ 1500/mm³ * platelets ≥ 75 x 109/l * s-creatinine ≤ 1.5 mg/dl (132 µmol/l) exclusion criteria: 1. underweight (bmi \< 18.5) 2. dysphagia 3. insulin-dependent diabetes mellitus 4. renal failure requiring hemo- or peritoneal dialysis 5. pregnant or breast-feeding women 6. drug/alcohol abuse
leg heat therapy in heart failure with preserved ejection fraction

Conditions: Heart Failure With Preserved Ejection Fraction

Summary: the objective of this pilot study is to establish evidence to support the validity of ht in improving skeletal muscle function and physical capacity of patients with hfpef. our central hypothesis is that ht treatment will lead to improvements in skeletal muscle and microvascular function compared to a control intervention. as a result, we anticipate that patients treated with ht will demonstrate improved skeletal muscle microvascular blood flow and oxygenation resulting in enhanced exercise tolerance. to explore this hypothesis, we propose the following specific aim: explore the effects of home-based ht on exercise tolerance in patients with hfpef.


Eligibility criteria:
inclusion criteria: * men and women older than 18 years * established diagnosis of heart failure with preserved ejection fraction (hfpef) including left ventricular ejection fraction (lvef) ≥50% as evidenced by doppler echocardiography and/or ratio of the early mitral inflow velocity (e) to septal tissue doppler velocity (e') \>8 and at least 1 other sign of chronically elevated filling pressures, including an enlarged left atrium (left atrial volume index \>34 ml/m2), an elevated n-terminal pro-brain natriuretic peptide (nt-pro-bnp) level within the past year, long-term loop diuretic use for control of symptoms, or elevated filling pressures (mean pulmonary capillary wedge pressure \>12 mmhg) on prior cardiac catheterization * stable medical treatment exclusion criteria: * recent hospitalization (within the previous 1 month) * unstable angina and/or uncontrolled cardiac arrhythmia causing symptoms or hemodynamic compromise (including severe bradycardia or tachycardia, sick sinus syndrome, or multifocal premature ventricular contractions) * presence of any clinical condition that makes the patient unsuitable to participate in the trial, e.g., significant ischemic or valvular heart disease, cor pulmonale, unstable coronary artery disease, primary renal (e.g., estimated glomerular filtration rate (egfr) \ 3.0 times the upper limit of the normal range), pulmonary, neuromuscular, orthopedic disorders, among others * inability to exercise on the treadmill * inability to provide informed consent * concern for inability of the patient to comply with study procedures and/or follow up (e.g., alcohol or drug abuse) * any contraindication to heat therapy and/or inability to fit into water-circulating trousers * impaired thermal sensation in the leg
computer-based tutorial as supportive means to enhance the informed consent process for cataract surgery

Conditions: Cataract

Summary: to assess whether a computer-based tutorial as supportive means enhances quality and efficiency of the informed consent process for cataract surgery focussing on the patients' attitude before and after surgery.

informing the patient and obtaining informed consent is one of the major duties physicians perform before starting a medical treatment. the requirements concerning the informed consent process are high. the amount of information needed to be explained to the patient is growing, as procedures get more complex and the number of treatment options increase. the catinfo tool is a computer-based tutorial about cataract and cataract surgery run on a handheld device with headphones and presented in an audio-visual fashion. the patient gives feedback after each chapter using a traffic light system to ensure that the content has been understood (green - content understood, ready to continue; yellow - questions that require discussion with the physician and red - repetition of the module required). a printout that summarizes what the patient has selected after each chapter immediately tells the physician which topics have been poorly understood or were unclear. it has been shown in a randomized triple-masked study that patients using the catinfo tool were significantly better informed than patients only having a face-to-face interview. satisfaction with the tool was high. this present study has the goal to assess the patients' attitude before and after surgery using validated questionnaires (decisional conflict scale, decision regret scale) as well as knowledge. patients scheduled for their first eye cataract surgery are randomly allocated to two groups, receiving standard face-to-face informed consent (control group) or additionally using the interactive catinfo tool (study group). scores between the groups are compared.

Eligibility criteria:
inclusion criteria: * cataract * age 18 and older * first eye to be operated * no previous ophthalmic surgery * written informed consent to participation in the study exclusion criteria: * visual acuity of less than 0.1 snellen in the worse eye * severe hearing loss * inability to use touch screen device (e.g. severe tremor, etc.)

Keywords: cataract surgery informed consent process patient education
effect of 'parentbot - a digital healthcare assistant (pda)' in improving parenting outcomes during the perinatal period

Conditions: Perinatal Depression; Parents; Self Efficacy; Anxiety; Stress; Parenting Satisfaction

Summary: the parentbot - a digital healthcare assistant (pda) is a mobile application-based psychosocial parenting intervention with integrated chatbot features, intended for couples to use during the perinatal period. it provides parents with multimedia educational materials (text files, audio files and videos), discussion forum, guided mindfulness-based meditation videos, guided reflection and gratitude journals and a chatbot to answer their queries related to perinatal care in real-time. this study aims to: 1. develop a theory-based perinatal intervention with integrated chatbot features for both first-time and experienced parents 2. examine the effectiveness of the pda intervention in improving parenting self-efficacy (primary outcome), stress, depression, anxiety, social support, parent-child bonding and parenting satisfaction (secondary outcomes) among parents during the perinatal period 3. examine the perceptions of parents from both the intervention and control group after the intervention 4. collate suggestions for further improvement from the participants and members of the research team the hypotheses of this study are: the pda intervention group will have significantly higher scores for parenting self-efficacy, social support, parent-child bonding and parenting satisfaction, as well as lower scores for stress, depression and anxiety compared to the control group receiving standard care after the intervention at one-month postpartum (post-test 1) and three-months postpartum (post-test 2).


Eligibility criteria:
inclusion criteria: heterosexual married couples who are first-time parents or experienced parents are included if they: * are at least 21 years old * are fluent in english * own a smartphone with internet access * intend to stay in singapore until three months postpartum * are having a low-risk singleton or multiple pregnancy at \> 24 gestational weeks (age of viability). exclusion criteria: couples will be excluded if either parent has: * any self-reported psychiatric disorders, visual, auditory, cognitive impairment and/or any major medical condition that can affect their abilities to participate in the trial * high-risk pregnancy including placenta previa major, pre-eclampsia, intrauterine growth restriction etc * suffer from a miscarriage or made the decision to abort their child * give birth to still-birth newborn * give birth to a newborn with congenital anomalies or medical complications (require intensive care, severe jaundice, down's syndrome) single parents will also be excluded. if either the mother or father declines to participate in the study while their partner agrees, the couple will not be allowed to participate in the study.
analysis of ca-mrsa transmission: an ed population sampling strategy

Conditions: Methicillin-Resistant Staphylococcus Aureus

Summary: given that the emergency department (ed) has become the entry way for large populations of patients into the health care system, a strategy of sampling mrsa isolates in ed populations and merging this information with patient-level data may present a window to hypothesize and investigate ca-mrsa transmission within the community and its impact on hospital-acquired infections.

prospective cross-sectional study involving 500 patients enrolled over a one year period at the ufhealth shands hospital's adult and pediatric emergency department. the collected information will serve as pilot data for a future large comprehensive multi-site study. patients will have a wound culture and a nasal swab obtained as part of the study, which will be assessed for mrsa isolates using next-generation whole genome sequencing. the principal investigator or pi designee will also survey participants and review hospital records.

Eligibility criteria:
inclusion criteria: * patient or legally authorized representative (lar) must have voluntarily signed an institutional review board-approved informed consent form before initiation of any study procedures * patient presents with an acute abscess or a non-post-operative skin/soft tissue infection * patient presents through the ufhealth shands emergency department exclusion criteria: * patients who are employed by ufhealth and provide direct patient care * patients who have previously been enrolled in the study * patients who are not suitable for the study in the opinion of the investigator
antipsychotic and motor effects of acp-103 when administered in combination with haloperidol and risperidone

Conditions: Schizophrenia

Summary: the primary purpose of this study is to determine whether a combination of acp-103 (the study medication) with either haloperidol or risperidone will show antipsychotic efficacy and that it is safe and well tolerated. further purposes of this study are to determine whether acp-103, in combination with either haloperidol or risperidone, will enhance their antipsychotic effectiveness, demonstrate effectiveness against the negative symptoms, improve motoric tolerability, and is safe and well tolerated. this is a seven-week study (one week screening and six weeks of study medication) where a total of 400 patients who meet entrance criteria will randomly be assigned to receive one of five groups of study treatments of either low dose haloperidol plus acp-103, low dose haloperidol plus placebo (a substance similar to a sugar pill), low dose risperidone plus acp-103, low dose risperidone plus placebo, or high dose risperidone plus placebo. the study will begin with with a three to seven day drug-free period followed by six weeks of a stable daily dosage of study medication. study subjects will be treated as hospital in-patients during screening and for the first 14 days of the study. study subjects will be closely monitored throughout the study.


Eligibility criteria:
inclusion criteria: * male or female subjects ages 18-65 diagnosed with schizophrenia * experiencing an acute exacerbation of psychosis * has had prior response to antipsychotic therapy within the previous 3 years * female subjects must be of non-childbearing potential or must comply with double-barrier protection methods against conception * ability of subject or caregiver or legally authorized representative to provide informed consent * subjects must be hospitalized at screening and must be willing to remain in the hospital at least 14 days after baseline and must comply with all study events through completion of the study exclusion criteria: * inability of the subject or caregiver or legally authorized representative to provide consent * any female subject who is pregnant or breast feeding * any subject with concurrent mental illness or disability * any subject considered to be a danger to themselves or others * recent use of certain antipsychotics or other medications that might interfere with this study's medication * abnormal clinical laboratory values * presence, or recent history, of serious medical conditions or drug abuse * likely allergy or sensitivity to acp-103, haloperidol, or risperidone, based on known allergies to drugs of the same class * any subject who has participated in a prior clinical trial of acp-103 * any subject judged by the principal investigator to be inappropriate for the study

Keywords: schizophrenia psychosis delusions hallucination
a study to evaluate the safety and effectiveness of the tops™ sp system

Conditions: Lower Back Pain

Summary: the tops™ sp system is intended to provide stabilization in skeletally mature patients. the system is designed to afford motion of the spine segment without fusion. the pur0pose of this prospective clinical study is to establish the safety and effectiveness of the tops™ system, when used following decompression, in the treatment of lower back and sciatic pain.


Eligibility criteria:
inclusion criteria: * patients with symptomatic monosegmental lumbar spinal stenosis or facet arthrosis * patients with degenerative spondylolisthesis * patients with at least 3 months failed conservative treatment * narrowing of the lumbar spinal canal * patients with lower back pain or sciatica exclusion criteria: * discogenic back pain at tops system level * back or non-radicular leg pain of unknown etiology at tops system level * lytic spondylolisthesis at tops system level * more than one motion segment involved in degenerative pathology to the extent that justifies its inclusion in the surgical procedure * known allergy to titanium and/or polyurethane