Kornimate/medical-research-clean huggingface dataset:
implementing enhanced recovery after surgery (eras) protocol in patients undergoing minimal invasive esophagectomy

Conditions: Esophageal Diseases; Esophagostomy Complication

Summary: detect impact of enhanced recovery after surgery (eras) on the outcomes of oesophageal surgery .

esophagectomy for both malignant and benign disease has been identified as a particularly complex surgical procedure due to documented high levels of peri-operative morbidity and mortality. a comprehensive review of complications associated with the esophagectomies performed in high-volume esophageal units utilizing a standardized format for documenting complications and quality measures has confirmed an overall complication rate of 59 % with 17.2% of patients sustaining complications of iiib or greater utilizing the clavien-dindo severity grading system. post-operative complications include high rate of anastomotic leakage , pulmonary infection ,thoracic duct injury , voice changes , breathlessness ,long hospital stay. these outcomes accentuate the need for providing an enhanced recovery after surgery standardized format for esophagectomy which can be routinely applied and audited to improve international outcomes. though eras lacking randomized control trials

Eligibility criteria:
inclusion criteria: * 1) first detected and endoscopically confirmed esophageal cancer; 2)preoperative evaluation showed no distant metastases and suitable for mie; 3preoperative clinical stage of i to iii exclusion criteria: * 1) patients had a history of thoracic or abdominal surgery; 2)patients were iv to vi in the american society of anesthesiologists (asa) physical status classification system; 3)patients had other malignancies; 4)patients had missing clinical data
a placebo-controlled study of the safety of incb054707 in participants with hidradenitis suppurativa

Conditions: Hidradenitis Suppurativa

Summary: the purpose of this study is to evaluate the safety of incb054707 over an 8-week treatment period in men and women with moderate to severe hidradenitis suppurativa.


Eligibility criteria:
inclusion criteria: * diagnosis of hs (confirmed by a dermatologist) with a disease duration of at least 6 months before screening. * stable course of hs for at least 90 days before screening, as determined by the investigator. * hs lesions present in at least 2 distinct anatomic areas, 1 of which must be hurley stage ii or hurley stage iii at screening. * total an count of at least 3 at screening and baseline. * willingness to avoid pregnancy or fathering children. exclusion criteria: * women who are currently pregnant or lactating. * presence of \> 20 draining fistulas at screening and baseline. * participants with protocol-defined concurrent conditions or history of other diseases. * prolonged qt interval corrected for heart rate using fridericia's formula (qtcf), defined as ≥ 450 msec. * positive test result for tuberculosis from the quantiferon-tb gold test, or t-spot.tb test at screening. * a history of active tuberculosis (treated or untreated) or a history of untreated latent tuberculosis. * positive serology test results for hiv, hepatitis b surface antigen, hepatitis b virus core antibody, or hepatitis c virus (hcv antibody with positive hcv-rna) at screening. * decreased blood cell counts at screening per protocol-defined criteria. * severely impaired liver function (child-pugh class c) or alanine aminotransferase or aspartate aminotransferase levels ≥ 1.5 × upper limit of normal at screening. * impaired renal function with serum creatinine \> 1.5 mg/dl at screening. * use of protocol-prohibited medications. * known or suspected allergy to incb054707 or any component of the study drug. * known history of clinically significant drug or alcohol abuse in the last year before baseline.

Keywords: hidradenitis suppurativa janus kinase (jak) inhibitor skin disease
syndactyly versus closed reduction in 5th metacarpal neck fracture

Conditions: Metacarpal Fracture

Summary: this study aims to compare the functional results of two different therapeutic approaches in patients that present with a 5th metacarpal neck fracture. patients will be randomly assigned to be treated with either syndactyly or closed reduction plus inmovilization.

syndactyly, although limiting the activity of the patient, allows a quick mobilization and recovery, as well as a better management in daily activities compared with immobilization with splint. in addition, follow-up of these fractures is difficult due to poor compliance, since patient profile is young people who give little relevance to their pathology in the hand. the purpose of our study is to carry out a randomized clinical trial of good methodological quality to assess whether immobilization with syndactyly for 3 weeks does not imply loss of functionality or residual symptoms, avoiding rigidity, postinflammation arthritis or loss of grip strength, demonstrating that early mobilization of fractures of the fifth metacarpal provides clinically satisfactory results compared to prolonged immobilization provided that the volar fracture angle does not exceed 70 ° nor does it produce digital movement disruption.

Eligibility criteria:
* inclusion criteria: * men and women ≥ 18 years old. * admitted to the emergency department with fracture of 5th metacarpal neck, in acute phase (maximum 72 h of evolution) with a possibility of clinical and radiological follow-up of at least 6 months. * willing to participate in the study and give their consent in writing. * exclusion criteria: * patients younger than 18 years. * patients presenting with more than 72 h of evolution * patients with comminuted neck fractures. * patients with angulation greater than 70 in the lateral-oblique plane * patients with clinical-radiological disruption * patients with previous fractures in the metacarpal. * patients with open fracture grade ii-iii gustilo. * patients with bifocal fractures or fractures in another metacarpal-phalanx or carpal bones requiring different treatment. * polytraumatized patients requiring further care that prevents them from adjusting to the therapeutic regimen specific to the protocol of isolated metacarpal fractures. * patients with congenital anomalies on hand affect * patients with a psychic disability (dementia-psychiatric illness or mental disorder) that prevents their collaboration in the follow-up * patients with medical or surgical pathologies that at the discretion of the investigator do not allow their participation in the study. * patients with inability to understand the nature and purpose of the study and / or to accept written participation in the study. * unable to attend the pre-established clinical follow-up. * do not wish to participate or give their consent in writing.

Keywords: fifth metacarpal neck, fracture, syndactyly, inmobilization, rct
evaluation of contrast enhanced breast ct for diagnosis and staging of breast cancer

Conditions: Breast Cancer

Summary: contrast-enhanced breast ct is a novel high resolution and fully 3d imaging method to document abnormalities within the breast. i will establish its value for breast cancer staging and in monitoring therapy response.

breast ct is a novel modality that has not been largely evaluated in a clinical setting. only recently fda and ce marked bct machines have been released, and the number of installed bases internationally is below 10 (although rapidly rising). internationally only a few studies on contrast enhanced breast ct have been performed in small numbers of patients, albeit with excellent results. nevertheless, substantial evidence for this novel modality is still absent. in particular, the correlation of enhancement and histological grade of dcis, correlation of cebct findings with histopathology, and prediction and assessment of primary systemic treatment are open fields for which more substantial evaluation is clearly needed. in this study we want to establish the value of cebct in staging of women with breast cancer, particularly those with extensive carcinoma in situ (dcis), and in the evaluation of women treated with primary systemic therapy.

Eligibility criteria:
inclusion criteria: * diagnoses of breast cancer * scheduled for a pre-surgery staging contrast enhanced breast mri * eligible for primary systemic therapy exclusion criteria: * women with suspected or confirmed pregnancy * women with prior history of breast cancer * women who are breastfeeding * women who are very frail and unable to cooperate * women who cannot give informed consent * contra indication of iodine contrast (i.e. untreatable contrast allergy, renal function impairment (gfr \<60 ml/min/1.73m2)) * contra indication for irradiation (i.e. genetic mutation that predispose to breast cancer) * male subjects
validation of predictive scale of chronic postsurgical pain

Conditions: Chronic Postoperative Pain

Summary: to asses the precision of a score to predict chronic post surgical pain in patients undergoing inguinal hernia repair, abdominal hysterectomy, vaginal hysterectomy and thoracotomy. prospective multicenter cohort study in 21 hospital in spain.


Eligibility criteria:
inclusion criteria: * patients with given inform consent, aged mor than 18 years, who undergo scheduled surgery of one of the following types: inguinal hernia (men), abdominal hysterectomy, vaginal hysterectomy and thoracotomy (men) exclusion criteria: * patients aged less than 18 years, * patients requiring reoperation because of surgical complications.
evaluation of the efficacy of probiotics in chronic periodontitis patients

Conditions: Chronic Periodontitis

Summary: periodontitis is an infectious inflammatory disease. bacteria modulate the inflammatory response and alter the diversity of periodontal disease. in recent years, various host-response modulation therapies have been developed to block the pathways responsible for periodontal tissue breakdown. there have been significant changes with respect to the effectiveness of, and attitudes towards conventional antimicrobial therapy to combat disease. with the threat of widespread antibiotic resistance rendering many antibiotics useless against important diseases, there is an increased necessity not only to minimise antibiotic use and develop novel non-antibiotic-based treatments, but also to raise the profile of disease prevention. one approach that has gained interest over recent years is the use of probiotic bacteria for oral applications. the rationale for their use in oral health care stems from the increase in evidence that supports their claims for benefit for a range of diseases. lactobacilli play an important role in the maintenance of health by stimulating the natural immunity as well as by contributing to the balance of the microflora, by interacting with the other members of the flora. the application of health promoting bacteria for therapeutic purposes, is one of the strongest emerging fields. time has come to shift the paradigm of the treatment from specific bacteria elimination to alteration of the bacterial ecology by using probiotics. so the purpose of this study is to discover a more promising approach for the treatment of chronic periodontitis .


Eligibility criteria:
inclusion criteria: * clinically diagnosed chronic generalized periodontitis * need of phase 1 therapy * pocket probing depth (ppd) of ≥ 5 mm \< 7 mm at two and/or more sites * patients with no history of allergies to the drugs to be used exclusion criteria: * patients on antibiotics within 3 month prior to study * patients with any systemic diseases * patients with history of any periodontal therapy within 6 months to trial
early external cephalic version (ecv) 2 trial

Conditions: Breech Presentation

Summary: for women with a fetus in breech presentation, does early ecv (at 34 0/7 up to 35 weeks and 6/7 days) versus delayed ecv (not before 37 weeks and 0/7 days) increase or decrease the likelihood of cesarean section (cs)?

primary outcomes: rate of caesarean section secondary outcomes: rate of preterm birth other outcomes: admission to neonatal intensive care unit ≥ 24 hours, perinatal or neonatal mortality or serious neonatal morbidity, serious fetal complications, maternal death or serious maternal morbidity, non-cephalic presentation at birth, women's views, and health care costs. the data coordination for this study is being carried out at the maternal, infant reproductive health research unit at sunnybrook and women's college health sciences centre.

Eligibility criteria:
inclusion criteria: 1. women with any breech presentation 2. a live singleton fetus 3. gestational age of 33 weeks 0 days to 35 weeks 6 days exclusion criteria: 1. contraindications to ecv (e.g. fetal heart rate abnormalities, abruptio placenta, major life-threatening fetal anomalies, uterine anomalies, hyper-extended fetal head, rupture of membranes, severe oligohydramnios, severe polyhydramnios) 2. contraindications to early ecv (e.g. increased risk of preterm labour \[such as past history of preterm labour in this or previous pregnancies\], increased risk of abruptio placenta \[such as maternal hypertension\]) 3. contraindications to labour or vaginal delivery (e.g. placenta previa, previous classical cs) 4. women planning delivery by cs if the fetus turns to cephalic 5. women planning a vaginal delivery if the fetus remains breech 6. women at increased risk of unstable lie (eg. grand multiparity) 7. previous participation in eecv2 trial

Keywords: external cephalic version cesarean section pregnancy labour breech pregnancy
phase 1 study to assess the safety, tolerability, and pharmacokinetics of recombinant human c1 esterase inhibitor in healthy adult subjects

Conditions: Hereditary Angioedema (HAE)

Summary: this trial is looking to gain information about the safety and tolerability of an investigational treatment (shp623) in healthy adult volunteers. this study will also collect pharmacokinetic data (how the body absorbs and breaks down the study drug).


Eligibility criteria:
inclusion criteria: 1. must be considered healthy. healthy status is defined by absence of evidence of any active or chronic disease 2. male, or non-pregnant, non-lactating female, who agrees to comply with any applicable contraceptive requirements of the protocol, or females of non-child-bearing potential. 3. body mass index between 18.0 and 30.0 kg/m2 inclusive with a body weight \>50 kg (110 lbs.). this inclusion criterion will be assessed only at the first screening visit. 4. hemoglobin ≥12.0g/ld. exclusion criteria: 1. have a history of allergic reaction to c1 inh products (e.g. c1 inhibitor \[human\], berinert \[c1 estrace inhibitor (human)\] and c1 estrace \[recombinant\] 2. known history of alcohol or other substance abuse within the last year. 3. donation of blood or blood products within 60 days prior to receiving investigational product. 4. current use of any medication except hormonal replacement therapy, hormonal contraceptives and occasional use of any over-the-counter non-steroidal anti-inflammatory drug (nsaid) or acetaminophen. 5. have a history of hypercoagulability or other predisposition to thrombotic events.
screening non small cell lung cancer with bone metastasis and efficacy and safety research of receiving bisphosphonates

Conditions: Non-small Cell Lung Cancer; Bone Metastases

Summary: a multicenter prospective study to assess the screening methods, parameter of ntx and the efficacy and safety of zoledronic acid treatment in addition to anti-tumor therapy in patients of non-small cell cancer with bone metastasis in china.


Eligibility criteria:
inclusion criteria: 1. age \>18, either sex 2. histologically confirmed non-small cell cancer 3. one bone metastasis at least confirmed by image(x ray,ct or others) 4. without receiving zoledronic acid 5. life expectancy \> 6 m 6. ecog \<= 2 7. signed icf exclusion criteria: 1. women who are pregnant or in lactation 2. patients with hyperostosis 3. with brain metastasis(exception of those without symptom or with metastasis lesions under controlled 4. previous or current treatment with any other bisphosphonates, bone- protecting, cytotoxic or targeted therapy 5. severe co-morbidity of any type that may interfere with assessment of the patient for the study -
modification of pavlovian and instrumental learning in human addiction

Conditions: Healthy; Alcohol Use Disorder (Mild vs. Moderate to Heavy)

Summary: the project aims at investigating modifications of environmental factors (i.e. cues and stress) relevant for learning mechanisms in addictive disorders.

project c02 aims at investigating modifications of environmental factors (i.e. cues and stress) relevant for learning mechanisms in addictive disorders. the investigators will examine non-treatment seeking subjects with alcohol use disorder (aud; mild vs. moderate to heavy), and healthy controls with a focus on the impact of pavlovian conditioned stimuli (context-related cues) on instrumental behavior (so-called pavlovian-to-instrumental transfer (pit)) and whether the pit effect can be systematically modified by manipulating the approach/ avoidance propensities of pavlovian cues (work package (wp) 1). concerning stress as a major modulator of cue reactivity in addiction, the investigators further plan to assess whether acute, active stress reduction modifies such pit effects (i.e. decreasing transfer effects) as well as goal-directed vs. habitual behavior (i.e. strengthening goal-directed decisionmaking) (wp2). lastly, this project aims at contributing to the understanding of the underlying neurobiological correlates of manipulation of approach/ avoidance propensities of pavlovian cues and acute stress reduction by using functional magnetic resonance imaging (wp3) with a focus on amygdala-striatal activity (pit) and frontostriatal processes (goaldirected decision-making).

Eligibility criteria:
inclusion criteria: 1. men and women aged 16-32 years, 33-49 years, and aged 50-65 years 2. mild, moderate to heavy alcohol-use disorder (aud) according to dsm-5 criteria (mild: 2-3 aud criteria; moderate: 4-5 aud criteria; heavy: 6 or more aud criteria); not clinically requiring detoxification (as confirmed by an independent board-certified psychiatrist); aud patients can have mild to moderate cannabis use disorder as well as tobacco use disorder 3. ability to provide fully informed consent and to use self-rating scales 4. willingness to use an android phone 5. sufficient understanding of the german language exclusion criteria: 1. lifetime history of dsm-5 bipolar disorder, schizophrenia or schizophrenia spectrum disorder, or substance dependence other than alcohol or nicotine or cannabis dependence. severe alcohol and cannabis use disorder will be excluded. 2. current threshold dsm-5 diagnosis of major depressive disorder, or presence of suicidal intention 3. history of severe head trauma or other severe central nervous system disorder (e.g., dementia, parkinson's disease, multiple sclerosis) 4. pregnancy or nursing infants 5. current use of medications or drugs known to interact with the cns within at least four half-life post last intake

Keywords: approach / avoidance alcohol use disorder stress stress reduction goal-directed decision-making
guangzhou surveillance and clinical study in microcephaly (gscsm)

Conditions: Microcephaly

Summary: screening for microcephaly is important at birth and during early childhood. the guangzhou surveillance and clinical study in microcephaly (gscsm) aims to establish a multicentric surveillance system for microcephaly in newborns and infants, to develop a new head circumference reference and microcephaly criteria basing on the local population in guangzhou, to improve the prediction model of microcephaly, and to follow up the outcomes of the children diagnosed with microcephaly.

microcephaly is associated with neurological dysfunctions in infants and children. there is not a uniform diagnostic criteria for microcephaly. the world health organization (who) recommended a criteria of head circumference (hc) less than 2 standard deviations (sd) below the mean of the intergrowth-21 standard, which was found not applicable to the newborns and infants in guangzhou.in the gscsm, the hc measures of newborns are conducted by trained midwives using a standard tool, and extensive information including adverse perinatal outcomes are collected. longitudinal follow up of infants' neurodevelopment in cognitive, motor, emotional and other domains are also to be conducted. the gscsm intends to find out the infants who are 'real microcephaly' and most at risk of short-term or long-term adverse outcomes in guangzhou.

Eligibility criteria:
inclusion criteria: 1. newborns born after 24+0 weeks of gestation 2. newborns delivered at the study hospitals exclusion criteria: 1. with major congenital abnormalities 2. multiple births

Keywords: head circumference neurodevelopment newborn infant surveillance prediction
biological investigation of explanted endobronchial lung valves study

Conditions: Emphysema or COPD

Summary: rationale: copd is a severe, often progressive and currently incurable lung disease which affects both the upper airways (chronic bronchitis) as well as the lower airways (emphysema). in advanced stages of the disease air-trapping severely reduces the ability to breathe and subsequently the quality of life. a highly effective treatment for restoring lung mechanical functionality of these patients is the introduction of bronchoscopic lung volume reduction (blvr), e.g. implanting small silicone/nitinol valves (ebv) inside the airways to reduce air-trapping. although successfully investigated in a selected group of severe copd patients, the effectiveness of the treatment can sometimes be short-lived due to fibrotic and granulation responses and tissue-material interactions. objective: the main objective of this study is to study and understand the underlying biological principles of granulation and fibrotic responses limiting the effectiveness and longevity of belvr treatment with ebvs, this to investigate the mechanism of action of tissue-device interactions.


Eligibility criteria:
inclusion criteria: * elidgible for ebv treatment exclusion criteria: * anticoagulation which cannot be stopped prior to the procedure