Kornimate/medical-research-clean huggingface dataset:
multi-center prospective randomized trial comparing standard esophagectomy against chemo-radiotherapy for treatment of squamous esophageal cancer - early results from the chinese university research group for esophageal cancer (cure)

Conditions: Esophageal Cancer

Summary: a multicenter randomized comparison of primary esophagectomy against definitive chemoradiotherapy for the treatment of squamous esophageal cancer.

cancer of the oesophagus is notorious for its grave prognosis with an overall 5-year survival rate of 10-20%. surgical resection with curative intent remains the most effective treatment for this disease. to improve the survival, a better treatment approach is in need to manage patients with oesophageal cancer. unfortunately, the use of preoperative adjuvant chemotherapy or adjuvant radiotherapy does not confer any survival benefit to patients with localized oesophageal cancer as proven in most randomized studies. however, the combination of chemotherapy and radiotherapy has greater clinical efficacy in achieving complete pathological regression of the tumour as well as the response rate as shown in our preliminary results. in fact, treatment of squamous oesophageal cancer by primary chemo-irradiation without surgery is now feasible. we propose to conduct a multi-center randomized trial to evaluate the efficacy and the patients' survival by comparing primary chemo-irradiation without surgery versus standard surgical resection as the treatment for squamous oesophageal cancer. those patients with residual cancer after primary chemo-irradiation will have salvage oesophagectomy to control the disease. over a 3-year period, a total of 80 patients will be recruited from 4 different hospitals with 100 patients being randomized into each treatment arm. treatment outcomes will be compared on an intention-to-treat analysis basis.

Eligibility criteria:
inclusion criteria: * mid or lower thoracic esophageal cancers that were confirmed on histology to be a squamous cell carcinoma deemed to be resectable exclusion criteria: * distant metastasis to solid visceral organs * local invasion into trachea, descending aorta or recurrent laryngeal nerve. * patients \> 75 years * serious premorbid condition * poor physical status that compromised a thoracotomy * compromised cardiac function * creatinine clearance less than 50 ml/min were not eligible.
value of whole-body spect-ct czt-based camera (veriton-ct) in the assessment of chronic inflammatory rheumatism with axial involvement

Conditions: Spondyloarthritis

Summary: the diagnosis of chronic inflammatory rheumatism with axial involvement is not always easy, and is fraught with difficulties : radiological sacroiliitis is not an early sign of spondyloarthritis and the delay in detecting radiological signs contributes to the delay in diagnosis. nevertheless, spondyloarthritis is now the second most common chronic inflammatory rheumatic disease, affecting 0.43% of the french population. the aim of this retrospective study is to evaluate the diagnostic performance of whole-body spect-ct czt-based camera (veriton-ct) in the assessment of chronic inflammatory rheumatism with axial involvement mri of the sacroiliac joints and thoracolumbar spine were used as a gold standard.

the present study was conducted by the department of rheumatology and nuclear medicine of the university hospital centre of nancy (france). an initial number of 51 hospitalised patients (35 females, 16 males) who underwent spect-ct czt-based camera for polyarthralgia or spinal pain between november 2021 and february 2023 and initial suspicion of chronic inflammatory rheumatism were included in the study. the investigators retrospectively reviewed the electronic medical records of the consecutive patients using medical softwares (dxcare or vna philips). the investigators collected demographic data (age, gender), clinical data (anamnesis, pain level (eva) and location, standardized clinical activity scores like ankylosing spondylitis disease activity score (asdas), widespread pain index (wpi), symptom severity scale (sss)), biological data (protein chain reaction in milligrams per litre), and medical imaging data (x-rays, mri and ct scans). the data collected was entered into an excel spreadsheet protected by a security code. for medical imaging data, the investigators performed a reading of the sacroiliac and thoracolumbar spine medical imaging under the supervision of an experienced rheumatologist specialising in chronic inflammatory rheumatism. the investigators assessed the diagnostic performance of veriton-ct (sensitivity, specificity), using mri of the sacroiliac joints and thoracolumbar spine as the gold standard.

Eligibility criteria:
inclusion criteria: * hospitalised patients (hospitalisation sector or day hospital) * patients who underwent spect-ct czt-based camera for polyarthralgia or spinal pain between november 2021 and february 2023 * patients who underwent axial mri * initial suspicion of chronic inflammatory rheumatism exclusion criteria: * patients who did not give their consent * patients with extravasation of contrast agent at the injection site * patients with a missing phase on spect-ct (blood-pool phase or delayed phase)

Keywords: spondyloarthritis sacroiliitis sacroiliac joints veriton-ct spect-ct thoracolumbar spine
behavioral activation for major depression with and without mindfulness

Conditions: Major Depressive Disorder

Summary: the objective of the study is to compare, in individuals who meet the diagnostic criteria for major depression, the effects of behavioral activation (ba) strictly behavioral with a ba protocol that includes mindfulness practices. the secondary objectives are: a) to verify if the changes in the level of depressive symptoms found after the treatment will be kept during the follow-up in both groups; b) evaluate the possible moderating role of baseline depression levels on the effectiveness of interventions; c) evaluate relapse rates after treatment; and d) test a ba protocol as a single treatment. the primary hypothesis is that ba protocol with mindfulness practices is superior to ba without mindfulness practices.

depression, according to the word health organization, is the leading cause of disability in the world, often leading to a decrease in productivity and the departure from work activities, which generates economic impacts to the own health system. between 2005 and 2015, an increase of almost 20% was identified in cases of depression worldwide. the impact of the disease on the world economy between 2011 and 2030 is expected at us $ 5,36 billion. behavioral activation (ba) and interventions with mindfulness are recognized as effective for depression. on the other hand, as currently the ba is complemented with strategies of the third generation therapies, including mindfulness, no study has compared a protocol strictly behavioral with any treatment and there is also insufficient data to affirm if the ba has better benefits than interventions that include or are based on mindfulness or vice versa. the aim of this study is is to compare, in individuals who meet the diagnostic criteria for major depression, the effects of ba strictly behavioral with a ba protocol that includes mindfulness practices. the two intervention are face to face, in group (8 weeks), by a randomized controlled trial (rct). our main hypothesis is that la intervencion ba with mindfulness practices will be more efficacious to improve the symptomatology depressive, compared to a group with only ba the end of treatment. 150 participants diagnosed with depression will participate in the rct.

Eligibility criteria:
inclusion criteria: * be older than 18 years of age, * to meet current dsm-5 criteria for major depression * be willing to participate in the study * be able to understand and read spanish. exclusion criteria: * not being able to read and write; * psychiatric conditions present that may affect study participation: schizophrenia, substance abuse, bipolar disorder, eating disorders, obsessive-compulsive disorder, social phobia, self-injurious behavior without suicidal intent; * be in psychotherapy; * have participated in three sessions of behavioral therapy and / or cognitive therapy; * have regular practice in any type of meditation; * disagreement in maintaining the dose of psychotropic medications without changes during the session period, if in use.

Keywords: behavioral activation mindfulness major depressive disorder
registry of huaier granule for prevention of recurrence and metastasis of gastrointestinal cancer after radical surgery

Conditions: Gastrointestinal Cancer

Summary: registration of patients after gastrointestinal cancer radical surgery, including the information of treatments, recurrence \& metastasis, adverse events,etc.

this study adopts a multicenter, open, and registered research method, and plans to include 840 cases, including 360 cases in the huaier granule test group, 360 cases in the radiotherapy and chemotherapy control group, and 120 cases in the blank group. using natural grouping, the registered objects are not pre grouped or queue divided, and the diagnosis, treatment, efficacy, and safety of gastrointestinal malignant tumor patients are accurately recorded under real conditions.

Eligibility criteria:
inclusion criteria: 1. patients with gastrointestinal cancer (stomach, colon or rectum); 2. patients who have received gastrointestinal cancer radical surgery within a month; 3. patients between 18 and 70 years old,no gender restriction; 4. patients volunteer to participate this study and have signed the informed consent form. exclusion criteria: 1. no chemotherapy or combined radiation and chemotherapy indications； 2. unable to cooperate to complete related information collection; 3. participation in any other clinical trial within three months; 4. conditions that are considered not suitable for this study investigators.
the characteristic of airway microbiome profiling of copd-bronchiectasis overlap patients and its association with acute exacerbation

Conditions: Bronchiectasis Adult; Chronic Obstructive Pulmonary Disease; Overlap; Microbiome

Summary: the overlap between chronic obstructive pulmonary disease (copd) and bronchiectasis is a neglected area of research, and it is not covered by guidelines for clinical practice. copd and bronchiectasis share common symptoms of cough with sputum production and susceptibility to recurrent exacerbations driven by new or persistent infection. physiological criteria for the diagnosis of copd and structural criteria for the diagnosis of bronchiectasis create the possibility for individual patients to fulfil both, resulting conceptually in either co-diagnosis or an overlap syndrome between the two conditions. the prevalence of this overlap will vary depending on the respective prevalence of copd and bronchiectasis in the population under consideration. a recent study of 201 copd patients with airway wall abnormalities typical of bronchiectasis confirmed an association with exacerbations and was predictive of mortality over 48 months. a further, single-centre study demonstrated a near three-fold increased mortality rate, with patients with bronchiectasis and associated copd having a 5-year mortality of 55%, compared with 20% in those with bronchiectasis without copd. airflow obstruction is perhaps best considered one marker of disease severity in bronchiectasis. disease-associated exacerbations have a major effect on patient healthcare costs as well as quality of life due to increased lung damage and mortality risk. microorganisms such as pseudomonas aeruginosa and, to a lesser extent, other gram-negative and gram-positive microorganisms identified in culture, have been linked to disease progression, poor clinical outcomes in bronchiectasis and driving airway neutrophil-mediated inflammation. the microbiome has the potential to provide valuable information regarding disease phenotype/endotype, treatment responses and targets for future therapy.


Eligibility criteria:
inclusion criteria: * diagnosed as copd, bronchiectasis or overlap based on hrct and lung function test. * aged between 18 and 80 years. exclusion criteria: * patients with active tuberculosis, traction bronchiectasis, malignancy, and severe systemic diseases.

Keywords: bronchiectasis chronic obstructive pulmonary disease overlap microbiome exacerbation
pleth variability and asthma severity in children

Conditions: Status Asthmaticus

Summary: research has shown that pleth variability can be used to assess asthma severity in children with status asthmaticus. the investigators would like to use an fda-cleared monitor (masimo radical 7) which measures pleth variability index (pvi) to see if the degree of pvi can be used to help triage patients who present to the pediatric ed in status asthmaticus.

patients with asthma have obstruction to exhalation resulting in hyperinflation of their lungs. this hyperinflation results in a phenomenon known as pulsus paradoxus in which the physiologic drop in blood pressure normally seen with inhalation is exaggerated. studies have shown that patients with more severe asthma exacerbations (i.e. more hyperinflation) have a greater degree of pulsus paradoxus. typically, pulsus paradoxus is measured using a sphygmomanometer, however, researchers have demonstrated that it can also accurately be measured using plethysmography, a term known as pleth variability index (pvi). using this concept, arnold et al (2008, 2010) showed that a greater degree of pulsus paradoxus correlates with asthma severity. the investigators' study aims to simplify the association between pvi and asthma severity. the investigators hypothesize the following: 1. patients with a higher admission pvi will have a higher likelihood of being admitted to the hospital. 2. patients admitted to the intensive care unit (picu) will have a higher pvi than patients admitted to a floor. 3. pvi can be accurately used to gauge response to bronchodilator/anti-inflammatory therapy. 4. pvi is as effective as respiratory severity score in predicting asthma severity and in gauging response to bronchodilator therapy. to do this the investigators will recruit children who present to the pediatric ed in status asthmaticus. they will be connected to a masimo radical 7 monitor upon admission to the ed and then again 4 hours later. in addition the investigators will calculate respiratory severity scores at those same time intervals. the investigators will then look at the disposition of the patient upon leaving the ed: discharge to home, admission to an inpatient floor or admission to the icu.

Eligibility criteria:
inclusion criteria: * diagnosis of asthma or reactive airway disease upon leaving the ed * greater than 10 kg exclusion criteria: * patients in whom effective pulse oximetry tracings cannot be obtained * patients who are diagnosed with conditions other than asthma/reactive airway disease that are known to cause pulsus paradoxus

Keywords: pulsus paradoxus
local wound infiltration for tracheal reconstruction

Conditions: Upper Tracheal Resection; Tracheal Reconstruction Surgery

Summary: tracheal resection and reconstruction (trr) is the treatment of choice for most patients with tracheal stenosis or tracheal tumors .the postintubation tracheal stenosis is the common indication for (trr).the immediate postoperative period can be anxiety provoking for some reasons such as requirement to maintain a flexed neck, oxygen mask, and surgical pain which inadequately treated. bilateral superficial cervical plexus block (bscpb) is a popular regional anesthesia technique for its feasibility and efficacy. the use of regional anesthesia in combination with general anesthesia may lighten the level of general anesthesia required , provide prolonged postoperative analgesia and reduce the requirements for opioid analgesics local anesthetic infiltration into the surgical incision can relieve pain at the wound site after surgery, as part of multimodal analgesic approach. levobupivacaine, is "s"-enantiomer of bupivacaine, has strongly emerged as a safer alternative for regional anesthesia than bupivacaine . levobupivacaine has been found to be equally efficacious as bupivacaine, but with a superior pharmacokinetic profile. clinically, levobupivacaine has been observed to be well tolerated in regional anesthesia techniques both after bolus administration and continuous post-operative infusion.

the aim of this study is to evaluate the intra- and postoperative efficacy of local wound infiltration versus bilateral superficial cervical plexus block with levobupivacaine for upper tracheal resection and reconstruction surgery.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists physical class status i or ii * undergoing elective upper tracheal resection and reconstruction surgery exclusion criteria: * age less than18 years * patients with preoperative medication included opioid * history of allergy to the drugs used * coagulation disorders * pregnancy * patient refusal * local sepsis * inability to understand the study protocol or pain scale.
school-based asthma care for teens (sb-act)

Conditions: Asthma

Summary: the goal of this study is to evaluate the widespread implementation of a developmentally appropriate preventive asthma care intervention for urban teens. the school based asthma care for teens (sb-act) program includes two core components: 1) a trial of directly observed therapy (dot) to allow the teen to experience the potential benefits from adhering to guideline-based asthma treatment, and 2) a developmentally appropriate motivational interviewing (mi) counseling intervention to help the teen transition to independent long-term medication adherence. the investigators hypothesize that teens receiving the sb-act program will 1) experience less asthma-related morbidity than an asthma education (ae) attention-control comparison group, and 2) have improved adherence, less urgent healthcare use, less absenteeism, improved quality of life, and reduced feno compared to ae. the investigators also hypothesize that participants receiving dot-only will have improved asthma-related outcomes immediately following their dot trial vs. teens receiving ae, but will not have sustained, clinically significant improvement in outcomes once the dot phase is complete. this represents a unique opportunity to build upon existing community relationships with an innovative and developmentally focused program to improve asthma outcomes for urban teens.


Eligibility criteria:
inclusion criteria: * physician-diagnosed asthma * persistent asthma or poor asthma control (based on nhlbi guidelines). * attending secondary school in rochester city school district exclusion criteria: * inability to speak and understand english * no access to a phone for follow-up surveys * diagnosed developmental or intellectual disability * other significant medical conditions, including congenital heart disease, cystic fibrosis, or other chronic lung disease, that could interfere with the assessment of asthma-related measures. * teens in foster care or other situations in which consent cannot be obtained from a guardian.
methylphenidate and driving ability in adult patients with attention-deficit hyperactivity disorder

Conditions: ADHD

Summary: the primary purpose of this study is to determine the effects of methylphenidate versus placebo on driving ability of adult adhd patients.

this study was set-up to examine the controversial issue whether or not it is safe to drive a car or not when treated with methylphenidate. on-the-road driving tests during normal traffic are conducted to determine the effects of methylphenidate versus placebo on driving ability of adult adhd patients.in addition, two laboratory tests are conducted to examine memory functioning and inhibitory control.

Eligibility criteria:
inclusion criteria: * adult adhd patient over 21 years old * valid driver's license for at least 3 years * treated with methylphenidate * written informed consent exclusion criteria: * use of illicit drugs * use of drugs or having medical conditions known to affect driving ability

Keywords: adult
differential effects of bacteria colonising venous leg ulcers on pain and healing rates

Conditions: Venous Leg Ulcer

Summary: this study aims to identify whether venous leg ulcers which are colonised by pseudomonas aeruginosa cause more pain than those which are not and if this bacteria affects healing time. this may determine how venous ulcer infections are treated in order to improve symtomatology and quality of life for patients with these chronic wounds.

pseudomonas is a gram-negative bacillus which commonly colonises lower limb venous ulcers. it produces exotoxins and elastase as well as forming biofilms within chronic wounds. its effects on venous ulcer healing are debated. the objective of this study is to examine the effects on pseudomonas aeruginosa colonisation on the pain expereinces and healing rates of venous leg ulcers.

Eligibility criteria:
inclusion criteria: 1. all patients age 18+ with lower limb venous ulcers as diagnosed on clinical history and examination. 2. are willing and capable to voluntarily sign a statement of informed consent to take part in this study. 3. with an abpi of \>/= 0.8 and/or palpable pedal pulses on clinical exam. 4. without evidence (either clinical or diagnostic) of other causes of lower limb ulceration, namely vasculitis, local dermopathology, congenital syndromes or arterial insufficiency (see above). 5. if equipoise or disagreement between two independent clinicians exist, the ultimate decision as to inclusion/exclusion will be made by the p.i exclusion criteria: 1. patients unable to provide informed consent. 2. patients under the age of 18 3. patients with arterial insufficiency manifesting as abpi's of \<0.8 4. known or suspected alternate likely primary cause of lower limb ulceration (vasculitis, dermatological disease, underlying congenital syndrome). 5. patients who are deemed unsuitable due to any circumstances as deemed appropriate by the p.i.