Kornimate/medical-research-clean huggingface dataset:
advance: an observational study to determine bortezomib safety and effectiveness at first relapse after participation in first line hovon-49/50 clinical studies.

Conditions: Multiple Myeloma; Hematological Neoplasms

Summary: the primary aim of this observational study is to collect safety and effectiveness data for bortezomib used at first relapse in a group of multiple myeloma patients who received specific and well defined first line treatments within previous clinical studies.

there is a need by physicians to evaluate the results of bortezomib treatment in a homogenous patient population with regard to the multiple myeloma treatments in first line. for that reason the current study, advance, is designed to structurally collect data on the daily practice use of bortezomib as treatment after first relapse in patients with specific and well defined first line treatments (i.e. patients who participated in the hovon-49 or hovon-50 study). in both hovon studies patients were randomized to either receiving thalidomide or not, as a part of the first line treatment. therefore, the effect of pre-treatment with thalidomide on duration, effectiveness and safety of the bortezomib treatment after first relapse can be studied specifically. the analysis of this particular type of data will, however, be descriptive. all adverse events, regardless of seriousness, severity, or presumed relationship to bortezomib therapy will be recorded on the case report form, i.e., a form for each patient in the study on which all needed data are recorded, and reported to the sponsor within current timelines. the sponsor assumes responsibility for appropriate reporting of adverse events to the regulatory authorities. this project is a 'post authorization study (pas)'. this means that only routinely available medical data are collected, with the patients' permission, and no additional interventions or diagnostic procedures should be done specifically for this study. because the study is observational, dosage, administration and duration of treatment is at discretion of the treating physician

Eligibility criteria:
inclusion criteria: * patients have to sign a statement that they agree with collection of their clinical data for this project * patients had a first relapse or progressive disease after treatment in the hovon-49 or hovon-50 study and will be treated with bortezomib. exclusion criteria: * prior enrollment in hovon-54 study

Keywords: multiple myeloma hematological neoplasms chemotherapy efficacy safety bortezomib proteasome inhibitor
laryngeal view with videolaryngoscopy

Conditions: Respiratory Aspiration; Hypoxemia

Summary: to prevent bronchial aspiration during induction of anaesthesia it has been a common procedure to perform a cricoid pressure, called sellicks maneuver, to occlude esophagus, and thereby prevent aspiration. during the last ten years the efficiency of this maneuver has been discussed, since it probably prolong the intubation time and do not significantly reduces the risk of aspiration. the hypothesis is that sellicks maneuver prolong the time of intubation and reduces the view of the laryngeal inlet, during intubation with a videolaryngoscopy. the hypothesis is tested by a double-blinded randomized study where patients is intubated twice, with and without sellicks maneuver, in a randomized order. the specific cricoid pressure is blinded to the personal performing the intubation.


Eligibility criteria:
inclusion criteria: * asa 1-2, bmi \< 35, * no indication for rapid sequence induction, * age \> 18, * able to give consent. exclusion criteria: * asa \> 2, * bmi \> 35, * rsi

Keywords: videolaryngoscopy bronchial aspiration hypoxia
metformin for antipsychotic-induced weight gain in adults with intellectual disability

Conditions: Intellectual Disability; Developmental Disability; Obesity

Summary: people with idd (intellectual and developmental disability) have very high rates of obesity and die prematurely from cardiometabolic disease. while antipsychotics contribute to this problem, their use is necessary and appropriate in a significant subgroup of individuals with idd. exercise and diet interventions have limitations and may not be sufficient, requiring effective adjunctive pharmacological approaches to target obesity and related comorbidities in idd. however, persons with idd treated with antipsychotics are systematically excluded from clinical trials hindering development of evidence to help guide safe and effective treatment of these comorbidities. moreover, evidence from other disorders cannot be extrapolated to idd given inherent biological differences between disorders. this trial will address the identified gaps, which extend beyond cardiovascular morbidity and negatively impact psychosocial outcomes, in a hugely underserviced population.this is the the first rct (randomized control trial) to examine the efficacy of metformin in overweight or obese adults with idd who have experienced antipsychotic-induced weight gain. by generating efficacy data for a very accessible and scalable intervention, allows for guideline and implementation strategies to address a recalcitrant health problem.


Eligibility criteria:
inclusion criteria: * stable outpatients * age 18-65 years * diagnosed with idd * on maintenance treatment with an antipsychotic (stable dose for ≥3 months). * bmi must be ≥30 kg/m2, or ≥27 kg/m2 with at least one weight-related comorbidity (treated or untreated) such as: hypertension, dyslipidaemia, obstructive sleep apnea, or impaired fasting glucose. * females of child-bearing age must be on one of the following regular contraceptives: 1. agree to abstain from sex for the duration of the trial or 2. a barrier method of a diaphragm with spermicide and/or latex condom or 3. an oral contraceptive agent, implantable contraceptive or an injectable contraceptive for at least six months prior to entering the study and will continue its use throughout the study, or 4. an intrauterine device, or 5. partner has had a vasectomy at least 3 months prior to study start exclusion criteria: * females who are nursing, currently pregnant, or have a positive pregnancy test * clinical or laboratory evidence of uncompensated cardiovascular, endocrine, haematological, hepatic, renal, or pulmonary disease * previous treatment and lack of efficacy or tolerability with metformin * history or diagnosis of type 1 diabetes (t1d) or type 2 diabetes (td2) or fasting blood work, hba1c \> 6.5% * history of metabolic acidosis or lactic acidosis * treatment with weight-lowering agents * medications with significant renal impact * major medical or surgical event in the preceding 3 months * acute suicidal risk. * moderate to severe substance use disorder, other than caffein or nicotine use disorder

Keywords: intellectual disability developmental disability obesity metformin
effects of celecoxib on restenosis after coronary intervention and evolution of atherosclerosis trial

Conditions: Angioplasty, Transluminal, Percutaneous Coronary; Coronary Restenosis

Summary: to evaluate the effect of celecoxib use for 3 month after drug-eluting stent implantation * on restenosis * on clinical outcome such as target lesion revascularization, thrombotic event, myocardial infarction, death * on inflammatory biomarkers

restenosis is the major adverse effect of coronary stent implantation. drug-eluting stent has markedly reduced restenosis as compared with bare-metal stent, but restenosis is still the main cause of repeat coronary intervention after drug-eluting stent implantation. after coronary stent implantation, inflammatory reaction occurs in vessel wall and vascular smooth muscle cells proliferate. celecoxib is well known to have anti-proliferative effect as well as anti-inflammatory effect, and safety of this drug is well-established. celecoxib use for 6 month after paclitaxel-eluting stent implantation significantly reduced neointimal growth and repeat intervention without increase in adverse effect. because inflammatory reaction seems to occur in very early period after vessel injury, reduced use of celecoxib may also be effective.

Eligibility criteria:
inclusion criteria: * angina pectoris or a positive stress test with native coronary artery lesions feasible for drug-eluting stent implantation exclusion criteria: * acute or recent st segment elevation myocardial infarction (within four weeks) * left main coronary artery disease * hepatic dysfunction (ast or alt \> 120 iu/l ) * renal dysfunction (serum creatinine \> 2.0 mg/dl) * severe congestive heart failure (nyha class \> 2) * left ventricular ejection fraction \< 30% * hemodynamically unstable condition * definite intracoronary thrombus * contraindication or history of allergy to aspirin, clopidogrel, or celecoxib * warfarin use * expected survival less than two years due to other medical conditions * patients already taking any cox-3 inhibitor or nasids

Keywords: drug-eluting stent restenosis celecoxib
efficacy and safety of tripterygium wilfordii in patients with rheumatoid arthritis

Conditions: Arthritis, Rheumatoid

Summary: evaluation of oral t2 (chloroform/methanol extract of tripterygium wilfordii hook f) in the treatment of ra patients with clinical efficacy and safety.open-labeled, randomized, prospective multi-center clinical trial. observation period of 24 weeks.


Eligibility criteria:
inclusion criteria: * age 18-65 years with informed consent * diagnosed with rheumatoid arthritis as determined by meeting the 2010 acr/eular classification criteria and has had rheumatoid arthritis for at least 6 weeks * swollen joint (sjc)≥3 and tender joint count(tjc)≥5 * esr \>28 mm/hr or c-reactive protein \> 20 mg/l exclusion criteria: * pregnant, lactating or further fertility requirements * previous treated with methotrexate or biologic dmard. * active or chronic infection, including hiv, hcv, hbv, tuberculosis * patient with cancer

Keywords: rheumatoid arthritis methotrexate tripterygium
protective effect of electroacupuncture on lung in patients undergoing general anesthesia

Conditions: Electroacupuncture; Lung Injury, Ventilator Induced

Summary: objective to investigate the protective effect of preoperative electroacupuncture on lung function in patients with mechanical ventilation for more than 2 hours under general anesthesia

randomized parallel control study. from september 1, 2021 to december 31, 2022, patients with mechanical ventilation time more than 2 hours will be randomly divided into electroacupuncture pretreatment group and blank control group. the blood gas index, ventilator parameters and serum inflammatory factor concentration of patients will be evaluated to evaluate whether electroacupuncture has protective effect on lung function of patients with mechanical ventilation.

Eligibility criteria:
inclusion criteria: * patients undergoing general anesthesia in our hospital; * ages 18-60; * american society of anesthesiologists (asa) grade ⅱ \~ iii , no severe respiratory, circulation, liver, kidney, coagulation function abnormalities; * expected duration of operation \>2h; * surgical grade 2-4; * no serious lung infection and lung disease; * body mass index (bmi) 18\~30 kg/m2; there are no contraindications for electroacupuncture stimulation. exclusion criteria: * patients with severe circulatory or other system dysfunction; * patients with pulmonary and one-lung ventilation; * unwilling to cooperate with the patient; * patients with low compliance.

Keywords: electroacupuncture lung protection ventilator induced lung injury
does occlusive hydrocolloid silver-containing wound dressing after sternotomy reduce surgical side infection after cardiac surgery?

Conditions: Surgical Site Infection; Cardiac Surgery; Advanced Dressing; Postoperative Care

Summary: wound healing disorders are a major problem in cardiac surgery. they prolong the inpatient stay and are associated with a high health and, above all, psychological burden for patients. they also represent a major organizational, medical and financial challenge for the treatment team. there is therefore still a great need for effective prevention of wound healing disorders. it goes without saying that wound management plays a major role in the development of wound healing disorders. nowadays, there are a large number of products from various manufacturers and studies for efficient wound healing disorder prophylaxis. one point of criticism is that most of the existing studies are financed by the manufacturer. due to the otherwise broad range of applications for all wounds in various specialist areas, it remains to be clarified whether such products can achieve a reduction in the rate of wound healing disorders, especially in cardiac surgery. after extensive literature research, we are of the opinion that the aquacel surgical ag dressing, a new silver-coated hydrocolloid dressing, can be offered to cardiac surgery patients at our clinic as an effective prophylaxis against wound healing disorders.the study is a randomized prospective clinical trial. it is being conducted at the clinic for cardiothoracic and vascular surgery and has already been approved by the rhineland-palatinate ethics committee. the study should include 440 heart patients and last for 12 months. it will compare the aquacel surgical ag bandage against our conventional methods. this study is being conducted independently of the industry. we want to prove that an intelligent investment in the prophylaxis of wound healing disorders is worthwhile for both patients and the clinic. if the outcome of the study is positive, this dressing will be be used regularly in our cardiac surgery clinic.


Eligibility criteria:
inclusion criteria: 1. coronary artery bypass surgery 2. elective and primary surgery (no reoperations) 3. complete median sternotomy 4. age under 90 years 5. weight in the range of 50-140kg 6. no known allergy to silver or other wound dressings 7. no immunosuppressive therapy or hormonal substitution therapy, except for thyroid hormone 8. capacity to consent exclusion criteria: 1. failure of medical personnel to adhere to study protocol, e.g., not applying the right wound dressing according to study protocol 2. patients own decision 3. lack of harvesting of at least one internal thoracic artery 4. peri- and post-operative ventilation for \>48h 5. re-thoracotomy for reasons other than ssi, e.g., bleeding 6. mortality within the first 30 days
mri following stereotactic radiosurgery (srs) for brain metastases

Conditions: Brain Metastases

Summary: the purpose of this study is to test whether an additional magnetic resonance image (mri) sequence can improve the ability to distinguish radiation damage from tumor recurrence in participants with brain metastasis who have previously been treated with stereotactic radiosurgery (srs).


Eligibility criteria:
inclusion criteria: * adult patients, age ≥18 * metastatic malignancy with at least 1 brain metastasis previously treated with srs * patients may have also received whole brain radiation therapy (wbrt) for management of brain metastatic disease but this is not required for study participation * patients must have been diagnosed with a metastatic solid tumor of any histological type except small cell lung cancer (sclc), or lymphoma. * radiographic progression on post-srs imaging at previously treated srs site(s) * must be a candidate for brain surgery as determined by treating neurosurgeon and/or anesthesia team * patients must sign study-specific informed consent prior to study entry exclusion criteria: * poor surgical candidate as determined by treating neurosurgeon and/or anesthesia team * unable to undergo contrasted mri (e.g. incompatible medical device, inadequate renal function per standard institutional clinical protocol, contrast allergy) * small cell lung cancer (sclc) or lymphoma histology

Keywords: laser interstitial thermal therapy (litt) stereotactic radiosurgery (srs) magnetic resonance image (mri)
evaluation of the effectiveness of the nebulization bronchodilators under high nasal flow humidified

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the principal objective is to show noninferiority of nebulized salbutamol through the high flow nasal system moistened airvo ™ 2 in terms of reversibility of airflow obstruction compared to nebulization by the usual method (spray mask).

randomized, comparative, non inferiority study between two nebulization strategies bronchodilators, one according to the method tested namely the spray - in across the top humidified nasal flow system and the other according to a customary procedure, through a mask. a third arm will be evaluated (control arm) to overcome a possible own bronchodilator effect of high flow nasal humidified.

Eligibility criteria:
inclusion criteria: * adults * patient with chronic obstructive pulmonary disease * patients, when performing lung function tests performed outside of the study : 1. a report fev / fvc less than 60% prior to bronchodilator treatment and 2. a positive reversal test defined by fev variation of over 12 % and 200 ml after administration of inhaled salbutamol * patients affiliated to social security scheme * informed consent signed by the patient exclusion criteria: * exacerbation of chronic obstructive pulmonary disease during * uncontrolled asthma * pneumothorax current or recent ( \< 2 months) * pleural aspiration or biopsy , trans - bronchial biopsies and / or bronchoalveolar lavage in the preceding 48h * hemoptysis in progress * patient under guardianship or trusteeship safeguard justice * pregnant or breastfeeding women or parturient woman * known allergy or intolerance to salbutamol
diagnostic utility of exercise cardiac magnetic resonance in the assessment of cardiac dyspnea.

Conditions: Shortness of Breath; Cardiac; Dyspnea

Summary: researchers are examining the diagnostic utility of an exercise cardiac mri (ecmr) in the assessment of cardiac dyspnea (shortness of breath).


Eligibility criteria:
inclusion criteria: * consecutive patients aged ≥18 years years with suspected cardiac dyspnea who are scheduled to undergo right heart catheterization as dictated by a comprehensive examination and echocardiography will be included for enrollment. exclusion criteria: * age \<18 years * pregnancy * mechanical ventilation * acute or chronic renal failure (creatinine clearance \<30 ml/min or requiring renal replacement therapy) * inability to perform mri (i.e. claustrophobia, severe obesity (\>150 kg), device incompatible with mri) * inability to exercise * significant arrhythmia that precludes adequate ecg-gating for the mri (i.e. atrial fibrillation with highly variable cycle lengths) * prior heart or lung transplantation * left ventricular systolic (ejection fraction \<50%) or diastolic failure (based on framingham criteria for heart failure with preserved ejection fraction) * significant left-sided valvular disease (≥moderate aortic stenosis, mitral stenosis, aortic regurgitation, mitral regurgitation) or prior valve surgery
left atrial isolation by catheter ablation in persistent atrial fibrillation with severe atrial fibrosis

Conditions: Persistent Atrial Fibrillation

Summary: this is a single-arm clinical trial evaluating the efficacy and safety of left atrial isolation achieved by catheter ablation in patients with persistent atrial fibrillation with severe atrial fibrosis.

this is a single-arm clinical trial. patients with persistent atrial fibrillation with severe atrial fibrosis are enrolled as subjects to conduct left atrial isolation by catheter ablation. postoperative recurrence rate and other indicators are analyzed to evaluate the efficacy and safety of left atrial isolation achieved by catheter ablation in patients with persistent atrial fibrillation with severe atrial fibrosis.

Eligibility criteria:
inclusion criteria: 1. aged 18 to 80 years old 2. persistent af with severe atrial fibrosis and left atrial anterioposterior diameter \> 50mm 3. nonresponse or intolerance to ≥1 antiarrhythmic drug 4. cha2ds2-vasc ≥ 3 and has-bled \< 3 exclusion criteria: 1. with uncontrolled congestive heart failure; 2. having significant valvular disease; 3. having moderate-to-severe pulmonary hypertension; 4. with myocardial infarction or stroke within 6 months of screening; 5. with significant congenital heart disease; 6. ejection fraction was \<40% measured by echocardiography; 7. allergic to contrast media; 8. contraindication to anticoagulation medications; 9. severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (copd); 10. left atrial thrombus; 11. having any contraindication to right or left sided heart catheterization

Keywords: persistent atrial fibrillation severe atrial fibrosis left atrial isolation catheter ablation
subzero and scorpion trial

Conditions: Ductal Carcinoma in Situ

Summary: this is a prospective single-institution pilot study examining the feasibility of performing ultrasound-guided cryoablation to completely ablate breast ductal carcinoma in situ (dcis). the study is designed such that patients meeting selection criteria will undergo cryoablation followed by surgical resection. the pathology of the surgical specimen will be used to determine the rate of complete tumor ablation. standard adjuvant therapies otherwise remained unchanged.


Eligibility criteria:
inclusion criteria: 1. age \>= 18 2. pre-registration core biopsy: unifocal primary ductal carcinoma in situ (dcis) or atypical ductal hyperplasia (adh) bordering on dcis or dcis with microinvasion diagnosed by core needle biopsy. note: patients with lobular carcinoma, multifocal and/or multicentric ipsilateral breast cancer are not eligible. patients with contralateral disease will remain eligible. 3. tumor size \< 1.5 cm in greatest diameter. specifically, the tumor must measure \< 1.5 cm in the axis parallel to the treatment probe and \< 1.5 cm in the axis anti-parallel to the treatment probe. largest size measured by required pre-treatment scans (mammogram, ultrasound and mri) will be used to determine eligibility. 4. an ultrasound visible target for cryoablation: ultrasound-visible mass or nonmass finding corresponding to the tumor or an ultrasound-visible biopsy marker placed within 1cm of the biopsied tumor. 5. no prior or planned neoadjuvant chemotherapy for breast cancer. 6. adequate breast size for safe cryoablation. this will be determined by the interventional radiologist using a combination of clinical exam and imaging. site of target for cryoablation must be greater than 1 cm from the nipple and greater than 1cm from the closest skin surface. exclusion criteria: 1. multifocal of multicentric carcinoma. 2. pre-registration core biopsy with diagnosis of frank invasive carcinoma (not microinvasion) or lobular carcinoma. 3. prior or planned neoadjuvant chemotherapy for breast cancer. 4. retroglandular breast implants. (please note that patients with retropectoral implants are allowed to enroll if they meet all other inclusion criteria.)