Kornimate/medical-research-clean huggingface dataset:
a study of epacadostat in combination with pembrolizumab and chemotherapy in participants with advanced or metastatic solid tumors (echo-207/keynote-723)

Conditions: Solid Tumor

Summary: this was an open-label, nonrandomized, phase 1/2 study designed to determine the safety, tolerability, and efficacy of epacadostat when given in combination with pembrolizumab and 7 different chemotherapy regimens described as treatment groups a through g below (see study drug and background therapies, dose, and mode of administration). phase 1 consisted of a 3 + 3 + 3 design intended to determine the mtd or pad of epacadostat when given in combination with pembrolizumab and chemotherapy; efficacy was also explored. phase 2 was designed to enroll efficacy expansion cohorts to further evaluate the safety, tolerability, and efficacy of epacadostat at the mtd or pad (as selected in phase 1) when given in combination with pembrolizumab and chemotherapy. each efficacy expansion cohort was to enroll participants with 1 specific type of advanced or metastatic solid tumor. additional cohorts (ie, the mandatory biopsy cohorts) were designed to evaluate changes in the tumor microenvironment in participants with any advanced or metastatic solid tumor who had progressed on previous therapy with a pd-1 or a pd-l1 inhibitor. no participants were enrolled in any phase 2 efficacy expansion cohort, or in any phase 2 mandatory biopsy cohort receiving treatment a, b, f, or g. phase 2 mandatory biopsy cohort participants received treatments c, d, or e (ie, were included in treatment groups c, d, or e). participants were assigned to a treatment group based on the chemotherapy regimen most appropriate for their tumor type.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of selected advanced or metastatic solid tumors. * presence of measurable disease per recist v1.1. * eastern cooperative oncology group (ecog) performance status of 0 or 1. exclusion criteria: * laboratory and medical history parameters not within the protocol-defined range. * receipt of anticancer medications or investigational drugs within the protocol-defined intervals before the first administration of study drug. * previous radiotherapy within 2 weeks of starting study therapy. * known active central nervous system (cns) metastases and/or carcinomatous meningitis. * has not recovered to ≤ grade 1 from toxic effects of previous therapy and/or complications from previous surgical intervention before starting study therapy. * receipt of a live vaccine within 30 days of planned start of study therapy. * active infection requiring systemic therapy. * subjects who have any active or inactive autoimmune disease or syndrome. * women who are pregnant or breastfeeding.

Keywords: solid tumors colorectal cancer pancreatic ductal adenocarcinoma non-small cell lung cancer pd-1 pd-l1 epacadostat ido inhibitor
effects of sublingual immunotherapy on grasspollen allergy

Conditions: Hayfever

Summary: the objective of the study is to document the objective immunological effects of slit on the nasal mucosa. better understanding of these immunological pathways, in which this widely practised clinical therapy is likely to work, can only benefit the overall outcome of this, more patient friendly, therapy and it will demonstrate the effects of slit on the allergic reaction, with objective parameters, in the nasal tissues showing it to be a true etiological treatment of allergy.

double blind placebo controlled evaluation of the immunological effects (decrease of ige specific cells and the decrease of th2 mediator release, respectively increase of th1 mediator release) of slit on the nasal mucosal tissue of adult humans with severe rhinocunjunctivitis due to grass pollen allergy.

Eligibility criteria:
inclusion criteria: 1. age 18 and older. 2. patients known in general practice with documented clinical history of grass pollen allergy with moderate disease intensity as retrospectively derived from the use of symptomatic allergy medication during the previous grass pollen season, i.e. regular use of cromoglycates as nasal spray and/or eye drops, and/or regular use of anti histamine tablets or sprays and/or limited use of local acting or systemically administered corticosteroids. 3. positive (artu) grass pollen specific skin prick test (despite negative rast). exclusion criteria: 1. clinical history of severe asthmatic symptoms requiring inhalant therapy with daily pulmonary steroids during at least 3 months a year. 2. symptomatic perennial allergic rhinitis. meaning perennial allergy is allowed if the allergen is not present in patients' daily life (especially one month prior to provocation) and if they have no apparent symptoms of this perennial allergy. 3. other seasonal allergic rhinitis are not allowed unless it is asymptomatic during the period of provocation. 4. the intention to subject the patient to surgery of the nasal cavity in the course of the study. 5. previous immunotherapy. 6. negative (artu) grass pollen specific skin prick test (despite positive rast). 7. contraindications to sublingual immunotherapy, i.e.: * malignancies and serious disorders of the oral cavity * history of status asthmaticus and anaphylactic shock * aggressively developing asthmatic symptoms * serious chronic inflammations, chronic disorders associated with fever, particularly of the bronchial tubes * irreversible, secondary changes in reactive organs (emphysema, bronchiectasis) * auto immune diseases and immunodeficiency * concurrent therapy involving immunosuppressives * systemic and collagen diseases * tuberculosis of the lung and tuberculosis * serious psychological disorders * documented hypersensitivity to glycerol * pregnancy * serious cardiovascular disease * usage of b -blockers

Keywords: nasal biopsy grasspollen sublingual immunotherapy
an investigational immuno-therapy study to test combination treatments in patients with advanced non-small cell lung cancer

Conditions: Advanced Cancer

Summary: the purpose of this study is to determine whether nivolumab, in combination with other therapies, is effective in patients with advanced non-small cell lung cancer


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * advanced non small cell lung cancer (nsclc) * eastern cooperative oncology group (ecog) performance status of ≤ 1 * life expectancy of at least 3 months from most recent chemotherapy or immunotherapy treatment * must have at least 1 lesion with measurable disease exclusion criteria: * subjects with certain mutations that have not been treated with a targeted therapy prior to enrollment * subjects who need daily oxygen therapy * people with autoimmune disease other protocol defined inclusion/exclusion criteria could apply
special survey on parkinson's disease patients treated long-term use of pramipexole

Conditions: Parkinson Disease

Summary: the survey is conducted to collect safety and effectiveness information on the use of pramipexole for long time of period in daily clinical settings in japan.


Eligibility criteria:
inclusion criteria: patients with parkinson's disease exclusion criteria: patients should have been treated according to the japanese insert slip
biomarker-guided implementation of the aki bundle

Conditions: Acute Kidney Injury (Nontraumatic)

Summary: there is no specific therapy for acute kidney injury. it is presumed that supportive measures improve the care and outcome of patients with acute kidney injury. the investigators hypothesize that the implementation of a bundle of supportive measures adapted to patients undergoing cardiovascular surgery reduces the occurence of aki. a randomized prospective multicenter trial is needed to investigate whether the implementation of the bundle of measures is effective to prevent aki in high risk patients undergoing cardiac surgery. in this feasibility trial the investigators will analyze the compliance rate to the trial protocol in a multicenter, multinational cohort in preparation for a large randomized controlled trial.


Eligibility criteria:
inclusion criteria: * adult patients undergoing cardiac surgery with cardiopulmonary bypass (cpb) * urinary \[timp-2\] \* \[igfbp7\] \>= 0.3 4h after cpb * written informed consent exclusion criteria: * preexisting aki (stage 1 and higher) * patients with cardiac assist devices (ecmo, lvad, rvad, iabp) * pregnancy, breastfeeding * known (glomerulo-)-nephritis, intersstitial nephritis or vasculitis * ckd with egfr \< 20 ml/min * dialyses dependent ckd * prior kidney transplant within the last 12 months

Keywords: cardiac surgery kdigo-guideline
symphion® system in-office study

Conditions: Uterine Leiomyomas; Endometrial Polyps

Summary: the purpose of this study is to determine the safety and feasibility of using the symphion system in an office setting.

the purpose is to determine the safety and feasibility of using an intrauterine tissue resection system in the office setting, as well as to expand the national discussion regarding in-office hysteroscopic procedures as it relates to the highest standards of care and cost containment.

Eligibility criteria:
inclusion criteria: * subjects must meet the approved instructions for use for the symphion® bipolar hysteroscopic tissue resection system * confirmation hysteroscopic evaluation to access appropriate pathology type and size meets the protocol guidelines for inclusion * subject has signed written informed consent exclusion criteria: * subjects who are pregnant * subjects who have an active genital tract infection (as assessed by the physician) * subjects who have cervical malignancies * subjects who have previously been diagnosed with endometrial cancer * subjects who have type 2 intracavitary myomas * type 0 or 1 intracavitary myoma greater than 3.0 cm
feasibility of enchroma use in the emergency department setting

Conditions: Color Vision Defects

Summary: this study addresses whether the use of enchroma products are feasible for use in the emergency department by color vision deficient providers.

this study addresses whether it is feasible for color vision deficient (cvd) physicians and other healthcare providers to wear enchroma products in the clinical setting. it is known that color vision is important to the practice of medicine. identifying red skin or red ear drums, noticing whether lips have turned blue or a patient is pale, and identifying colors under a microscope all are aided by or dependent upon color vision. while color vision deficiency does not preclude a person from becoming and succeeding as a physician, it may be appropriate and desired to utilize devices to improve color vision during patient care.

Eligibility criteria:
inclusion criteria: * age 18-65 * red-green color deficiency exclusion criteria: * achromatopsia * cataracts * glaucoma * legal blindness * macular degeneration * retinitis pigmentosa

Keywords: cvd color vision deficiency healthcare providers emergency department enchroma glasses
effects of an early rehabilitation program during hospitalization in patients with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: studies demonstrate that exercise increases the maximal oxygen uptake, peak oxygen consumption, reduce effort-induced lactic acid production, and increase skeletal muscle oxidative capacity, as well as psychological aspects such as increased self-esteem and improvement of the quality of life. in the literature there is only one study involving rehabilitation in hospitalized pediatric patients with cystic fibrosis. thus, more information on in-hospital rehabilitation is required in adult cystic fibrosis patients. the present study aims to evaluate the effects of an early rehabilitation program, based on aerobic training and muscle strength training, in adolescent and adult patients with cystic fibrosis hospitalized at hospital de clinicas de porto alegre for exacerbation of lung disease.

after completing the study inclusion criteria, the individual will be invited to participate and will receive the consent form for signature. the patient will be submitted to the following evaluations: quality of life questionnaire for cystic fibrosis, spirometry, shwachman-kulczycki score, modified dyspnea questionnaire (modified medical research council), maximum repetition test, six minute walk test and blood sample for the determination of inflammatory markers. these evaluations should be performed within the first 48 hours of hospitalization, and will be repeated on the last day of hospitalization. in the period up to 48 hours after hospital admission, patients will be randomized to either the intervention group or the control group.

Eligibility criteria:
inclusion criteria: * patients aged 16 years and older, * regularly followed up in the hospital de clinicas de porto alegre program for adolescents and adults with cystic fibrosis with a diagnosis of cystic fibrosis confirmed according to the consensus criteria, * admitted to hospital admission due to exacerbation of lung disease. * hospital stay will be defined as the stay equal to or greater than 24 hours in any hospital de clinicas de porto alegre unit. exclusion criteria: * patients with cardiac, orthopedic or trauma complications that make it impossible to perform the proposed exercises; * pregnant patients; * patients with hemodynamic instability, massive hemoptysis, pneumothorax, and continuous use of noninvasive ventilation.
shockwave™ vs surgical endarterectomy for calcified severe common femoral artery stenosis: comparison of efficacy, safety and long-term outcomes

Conditions: Common Femoral Artery Stenosis; Calcification; Heart

Summary: the investigators hypothesize that shockwave with dcb is non-inferior to surgical endarterectomy for common femoral artery (cfa) stenosis with regard to primary efficacy and safety endpoints. the study will challenge the current guideline that recommends common femoral endarterectomy (cfe) as the primary treatment for symptomatic cfa stenosis.

this is a pilot, prospective, randomized clinical trial. this trial compares patients with severe symptomatic moderate to severe calcified cfa stenosis undergoing traditional gold standard cfa endarterectomy to innovative technique of endovascular treatment using shockwave™ intra vascular lithotripsy (ivl) using m5+ balloon with drug coated balloon to achieve removal and debulking of plaque and achieve luminal gain. patients who meet inclusion criteria will be informed and consented by a clinical coordinator if they wish to participate in the trial. if participants are candidates for surgery, they will then be randomized into one of two cohorts, receiving either shockwave™ ivl + dcb (drug-coated balloon) procedure or a standard surgical endarterectomy. the study compares the 1-year efficacy and 6-month safety outcomes post-procedure for patients with severe, symptomatic cfa stenosis receiving shockwave™ ivl with dcb versus surgical endarterectomy.

Eligibility criteria:
inclusion criteria: a patient will be eligible for inclusion in this study if he or she meets all of the following criteria (confirmed by core lab): 1. cfa atherosclerotic stenosis 60-100% 2. moderate to severe calcification reported on imaging 3. lifestyle-limiting intermittent claudication (ic) or chronic limb-threatening ischemia (clti) as described by rutherford chronic limb ischemia (cli) category 2-5 4. failing conservative therapy 5. operative candidate for cfe prior to enrollment 6. ≥18 years of age exclusion criteria: a patient will be ineligible for inclusion in this study if he or she meets any of the following criteria: 1. history of cfe or bypass in affected limb 2. thrombosis of affected cfa 3. aneurysm in the common femoral artery of target limb 4. known target lesion restenosis (re-narrowing of the artery to ≥50% following the alleviation of a previous narrowing within 3 months) 5. any preceding percutaneous cardiovascular intervention within 2 weeks 6. inability to tolerate dapt 7. known coagulopathy or bleeding diathesis, thrombocytopenia with platelet count \<100,000/µl 8. uncontrolled diabetes (hba1c ≥10.0%) 9. non-ambulatory 10. extensive tissue loss requiring amputation or salvageable only with complex foot reconstruction or non-traditional transmetatarsal amputations 11. mi within 6 weeks (defined as presumed ischemic symptoms (chest pain, st-segment deviation and troponin higher than 2 times the upper limit of normal)) 12. stroke within 3 months (defined as sudden transient or irreversible focal neurological deficit resulting from a cerebrovascular cause) 13. pregnant
post extraction wound healing evaluation of immediate complete denture using ipr scale

Conditions: Complete Edentulism Due to Periodontal Disease (Disorder)

Summary: in the first part, after a brief introduction, the advantages and disadvantages of immediate dentures are compared. there is a detailed discussion on assessment and treatment planning which includes history taking, examination of the soft and hard tissues, current prostheses, occlusion as well as discussion on investigations required and formulating a diagnosis. the first part ends with a summary of types of immediate dentures and denture designs.

an immediate denture is a complete or partial removable prosthesis that is fitted immediately after extraction or modification of teeth. the prosthesis replaces the missing/modified teeth and where required, the adjacent hard and soft tissues. it is constructed prior to the extraction of teeth and is used immediately to provide function and aesthetics which are lost as a result of tooth removal and avoid the embarrassment patients may have with living without teeth, while waiting for the tissues to heal prior to definitive tooth replacement.1 (see image 1) some clinicians take impressions on the day of the extractions and fit the dentures a few days later. these dentures are fraught with challenges as the alveolar ridge begins to resorb soon after. therefore an immediate denture is only truly an immediate denture when fitted on the day of the extractions. the use of a removable prosthesis within the uk is currently around 19% of adults in the general population 2 and in spite of this decreasing trend, as patients retain their natural dentition into older age,2 there is still a need for prosthodontic replacement as teeth are lost as a result of caries, periodontal disease, tooth wear or trauma. 3,4,5 the provision of an immediate denture can be challenging and close co-operation between patient, technician, and clinician is required.

Eligibility criteria:
inclusion criteria: * good physical and mental health * willing to give informed consent * normal maxilla-mandibular relationship angle class i * adequate bone quality and quantity in terms of width and height in the anterior maxillary and mandibular ridges verified by preoperative cone beam ct * adequate inter-arch space to accommodate maxillary and mandibular implant prostheses exclusion criteria: * uncontrolled diabetes * smoking habits * radiotherapy * clinical or radiographic signs of pathologic conditions, osteoporosis * patients on corticosteroids * bruxism
safety study of continuous positive airway pressure via a nasal mask

Conditions: Upper Airway Obstruction

Summary: upper airway obstruction (uao) is common complication during induction of general anesthesia. the mechanism of uao during anesthesia has not been well understood. posterior displacement of soft palate are believed to be the primary contributing factors. the mechanism of uao during anesthesia share many similarities with obstructive sleep apnea (osa). since nasal continuous positive airway pressure (ncpap) can maintain the airway patent in patients with osa, the investigators hypothesize that ncpap during induction of anesthesia will reduce the incidence and severity of uao.


Eligibility criteria:
inclusion criteria: patients,between 18-65 years of age meeting asa physical status classification i-ii requiring general anesthesia for elective surgery who are able to breathe through both their nose and mouth while awake. exclusion criteria: 1. patients with major cardiovascular disease, respiratory disease, cerebral vascular disease or american society of anesthesiologists physical status class iii or greater. 2. abnormal vital signs on the day of admission for surgery \[heart rate (hr, \> 100 bpm or \ 180/100 mmhg or \< 90/60 mmhg), room air transcutaneous oxyhemoglobin saturation (spo2) \< 96%\] that are not correctable with his or her routine medication or commonly used pre-operative medication. 3. unable to open mouth (\< 2.5 cm) or unable to breathe through their mouth or nose. 4. subjects with a beard, an abnormal facial structure or other factors precluding obtaining a viable face mask fit without air leak. also, subjects having claustrophobia that can not tolerate the mask. 5. any person with an anticipated difficult airway. this will include subjects who require or may require either a fiberoptic intubation or intubation while awake and subjects with known osa or body mass index (bmi) greater than 35 km/m2. 6. gastric-esophageal reflex or a full stomach. 7. the subject has remained in bed for more than 24 hours. 8. neurological symptoms associated with neck extension, a neurological deficit from a previous stroke or spinal cord injury, a recent stroke or transient ischemic attack (tia) within 2 weeks. 9. pregnant women and women less than one month post-partum. ruling out pregnancy will be conducted by careful history and physical examination as performed routinely prior to surgery. if the history is believed to be unreliable, the patient will be excluded unless a pregnancy test is performed and the result of the test is negative. 10. emergency cases and subjects who have not adhered to the asa npo (nil per os) guidelines.

Keywords: continuous positive airway pressure nasal mask upper airway obstruction
pd-1 inhibitor tislelizumab maintenance therapy in r/r dlbcl patients after asct

Conditions: Lymphoma, Large B-Cell, Diffuse; Transplantation; Chemotherapy

Summary: this is a multicenter, randomized controlled, prospective clinical trial. the objective is to investigate the efficacy and safety of tislelizumab maintenance therapy in newly diagnosed diffuse large b-cell lymphoma (dlbcl) patients after autologous hematopoietic stem cell transplantation (asct).

this is a multicenter, randomized controlled, prospective clinical trial. the objective is to investigate the efficacy and safety of tislelizumab maintenance therapy in newly diagnosed diffuse large b-cell lymphoma (dlbcl) patients after autologous hematopoietic stem cell transplantation (asct). 94 patients were randomly divided into two groups according to the ratio of 1:1. the whole trial included screening period (day-28 to day-1), treatment period (tislelizumab, 200mg every 8 weeks, 12 times) and follow-up period (2 years after the enrollment).

Eligibility criteria:
inclusion criteria: 1. male and female, aged 18-65; 2. relapsed/refractory dlbcl patients after autologous stem cell transplantation; 3. laboratory tests (blood tests, liver and renal function) meet the following requirements: 1. blood tests: white blood cell count ≥ 3.0 × 109 / l, absolute neutrophil count ≥ 1.5 × 109 / l, hemoglobin ≥ 90g / l, platelet ≥ 75 × 109 / l 2. liver function: transaminase ≤ 2.5 × upper limit of normal value, bilirubin ≤ 1.5 × upper limit of normal value; 3. renal function: serum creatinine 44-133 mmol / l; 4. the score of ecog was 0-2; 5. the subject or his legal representative must provide written informed consent before the special examination or procedure of the study. exclusion criteria: 1. pregnant or lactating women; 2. severe complications or infection; 3. lymphoma involving central nervous system; 4. participate in other clinical trials at the same time; 5. according to the judgment of the researcher, the patients who are not suitable for this study were selected.