Kornimate/medical-research-clean huggingface dataset:
immunological senescence phenotype as a resistance profile to pembrolizumab in patients with relapsed/refractory hodgkin's lymphoma

Conditions: Hodgkin Lymphoma

Summary: this is a single-centre, observational, prospective and exploratory study, which involves the use of human tissues from patients affected by relapsed/refractory classic hodgkin lymphoma treated with pembrolizumab at the departmental diagnosis and therapy program for chronic lymphoproliferative syndromes of the irccs aou of bologna. peripheral blood samples will be used for the study and will be taken: * before starting treatment with pembrolizumab. * undergoing therapy with pembrolizumab (cycle 2 (c2), c3, c4, c8, c12).

this is a single-centre, observational, prospective and exploratory study using human tissues from chl r/r patients treated with pembrolizumab at the irccs aou of bologna's diagnosis and therapy of chronic lymphoproliferative syndromes departmental programme. peripheral blood samples will be used for the study * before starting treatment with pembrolizumab. * during pembrolizumab therapy (cycle 2 (c2), c3, c4, c8, c12). patients who have achieved complete metabolic remission will continue pembrolizumab for two years without any consolidation therapy, while those who have achieved a partial response (after about 14-16 doses) will receive allo-transplantation. withdrawals will be performed according to clinical practice in accordance with the doctor's judgement. the diagnostic-therapeutic course of the patients will in no way be influenced by the outcome of the tissue examinations that will be carried out for the purposes of the study. all patients with chl r/r who are candidates for treatment with pembrolizumab as part of the normal care pathway at the irccs aou of bologna's diagnosis and treatment of chronic lymphoproliferative syndromes departmental programme will be prospectively enrolled.

Eligibility criteria:
inclusion criteria: * patients of both sexes aged ≥ 18 years at enrollment * patients affected by chl r/r candidate to receive a treatment with pembrolizumab * signature of informed consent exclusion criteria: * none

Keywords: pembrolizumab
cryolipolysis induced gluteal fat change

Conditions: Body Weight Changes

Summary: there was no difference in efficacy in removal of local fat on thigh by cryolipolysis through zeltiq machine. cryolipolysis was found to be safe for 12 week clinical trial.

this study is conducted to investigate the clinical efficacy and safety of cryolipolysis on fat removal of thigh through cryolipolysis. healthy premenopausal volunteered women had been conducted to assess their anthropometrical, social, and cardio-metabolic, and femoral fat amount by computer tomography, and adverse events at initial, 4 week, 12 week visit.

Eligibility criteria:
inclusion criteria: * pre-menopausal healthy women * subjects with body mass index ≥ 18 * subjects with visible fat on both thigh * subjects to understand and agree to this study protocol exclusion criteria: * subjects with cryoglobulinemia, cold urticaria, or paroxysmal cold hemogobulinemia * subjects with pregnancy or lactation within 6 months or next 3 months * subjects with any laboratory, or metabolic abnormalities * uncooperative subjects to comply with the study protocol * women taking any medication/ over the counter/herbal supplements to regulate weight or fat mass over 6 months * subjects with menstrual irregularities * subjects to change over 10% of the former weight within the past 6 months - any procedure such as liposuction, or another surgical procedure or mesotherapy to reduce fat within 6 months * subjects with any dermatologic abnormalities on the target areas (thigh) * subjects with any injection into the area of intended treatment (e.g. cortisone) within 6 months

Keywords: fat cryolipolysis women femoral fat
screening for hypoglycemia in an institutionalized elderly diabetic population.

Conditions: Old Age; Institutionalized in EHPAD (French Nursing Home); Diabetes; Hypoglycemic Syndrome

Summary: diabetes is a major public health problem that has been growing steadily in recent years. its prevalence is very high in the elderly, in whom there is an increased risk of hypoglycemia. hypoglycaemia in elderly diabetics has serious consequences: * increased mortality, * increased cardiovascular morbidity, * increased risk of falling, * impairment of quality of life. * hypoglycaemia is also a risk factor for dementia in type 2 diabetes. the frequency of asymptomatic and atypical hypoglycemia has been shown to be greater in the elderly, but the exact prevalence of hypoglycemia in the elderly remains unknown. elderly diabetic patients in institutions are particularly fragile and have more frequent cognitive problems than non-diabetic subjects. a study conducted in this population of patients showed that a third of them had hba1c \<6.5%, which suggests a higher frequency of hypoglycemia though the figures were not available. we therefore decided to conduct a study to assess the frequency of hypoglycemia in order to better understand the contributing factors and to improve the management of this fragile population.


Eligibility criteria:
inclusion criteria: * written consent * diabetic patient receiving treatment which could result in hypoglycemia: insulin and/or sulfonamide and/or glinides * institutionalized patient in an ehpad * patient over 60 years of age exclusion criteria: - person not affiliated to a national health insurance
effect of different lining materials in stepwise excavation

Conditions: Dental Pulp Necrosis

Summary: deep carious lesions will encounter the dentist with the challenge of selecting a treatment method that could avoid the pulpal exposure and maintain the pulp vitality.conventional restorative treatments suggest complete removal of the caries in one visit which could cause pulpal exposure in 53% of the cases which in next step needs pulpotomy, pulpectomy or root canal therapy (rct). stepwise excavation(se)is an old concept but has been researched recently to reduce the possibility pulpal exposure during the removal of the lesion. contrary to indirect pulp capping (ipc), in this technique only the central infected part of the caries is removed in first visit and the rest of the caries will be lined by a suitable material to suppress the remained cariogenic biomass and seal the cavity. this will help the pulp to defend and survive. after a period, the cavity is re-opened and the rest of the caries which is darker, harder and with less bacteria will be removed and the tooth is restored permanently.the aim of this study was to compare the effect of different lining materials in clinical and radiographical symptoms in stepwise excavation without re-enter after one year.

in this randomized clinical trial of 4 lining materials have been applied in deep caries teeth in stepwise excavation. the common material which is applied as a liner over the remained caries in se is calcium hydroxide(ch). there are several reports of the solubility of this liner over time which could interact with sealing of the cavity in long term. it seems that a material with antibacterial activity, good sealing ability and suitable mechanical properties could cause se be done efficiently with good prognosis. mta is a biomaterial that has been introduced since 1993 with antibacterial property and good sealing ability. a new endodontic cement, calcium enriched mixture (cem) cement with good antibacterial effect like ch with sealing ability that is proposed to be similar to mta according to its double sealing property. cem cement has been suggested as a suitable material in pulp capping of permanent molars with irreversible pulpitis.

Eligibility criteria:
inclusion criteria: a tooth with deep caries lesion - tooth at risk of pulpal exposure - no pulpal , instantaneous , night pain exclusion criteria: unbearable pain of the involved tooth- apical radiolucency of the tooth- pdl widening

Keywords: stepwise excavation pulpal vitality deep caries lesions clinical symptoms radiographic evaluation
a safety and efficacy study of optive fusion™ with vismed® multi for the management of dry eye

Conditions: Dry Eye Syndromes; Keratoconjunctivitis Sicca

Summary: this study will evaluate the safety and efficacy of optive fusion™ compared to vismed® multi for the management of dry eye.


Eligibility criteria:
inclusion criteria: * use of artificial tears for dry eye in both eyes for at least 3 months * use of preservative-free artificial tears at least twice daily for 2 weeks; exclusion criteria: * cataract, laser-assisted in situ keratomileusis (lasik), photorefractive keratectomy (prk) surgery in the last 12 months * use of punctal plugs or contact lenses in the last month * active ocular allergy within last 2 years * best corrected visual acuity (bcva) less than 20/200 in either eye
adaptive optics retinal imaging

Conditions: Glaucoma, Primary Open Angle

Summary: the objective of the study is to collect and assess adaptive optics (ao) retinal images from human subjects in support of projects to demonstrate, advance, and enhance clinical use of ao technology.

objective: the objective of the study is to collect and assess adaptive optics (ao) retinal images from human subjects in support of projects to demonstrate, advance, and enhance clinical use of ao technology. study population: fifty (50) healthy volunteers without eye disease and thirty (30) subjects with primary open angle glaucoma (poag) will be enrolled. design: this is an interventional study protocol where participants will be imaged with investigational multimodal ao retinal imaging systems that include optical coherence tomography (oct) and scanning laser ophthalmoscopy (slo) channels. high resolution oct and slo videos will be collected while the instruments automatically detect and correct for image distortion caused by ocular aberrations. in general, videos of different retinal structures will be acquired from several retinal locations using various imaging modes. outcome measures: the primary outcomes for this protocol are qualitative and quantitative assessment of the ao images and investigation of the cellular morphological and physiological changes due to glaucoma.

Eligibility criteria:
inclusion criteria: 1. are 21 years of age or older. 2. have the ability to cooperate with instructions during adaptive optics imaging (similar to instructions given during a clinical eye exam). 3. have the ability to understand and sign an informed consent. 4. have been diagnosed with poag (cohort 2). exclusion criteria: 1. are under 21 years of age. 2. have a condition which prevents adequate images from being obtained (e.g. unstable fixation or media opacity). 3. have visual correction outside of the range +4 diopters (d) to -8 d. 4. have a history of adverse reaction to mydriatic drops. 5. have a predisposition to (i.e., narrow iridocorneal angle) or any history of acute angle closure glaucoma (aacg). 6. have any health conditions that would contraindicate oxygen supplementation, including chronic obstructive pulmonary disease (copd), emphysema, asthma, or any other obstructive or restrictive lung disease (oxygen challenge participants only). 7. have a dependency on oxygen support or a baseline oxygen saturation \<95% (oxygen challenge participants only). 8. have tested positive for covid-19 at initial enrollment or have acute or chronic photophobia as a result of contraction. 9. are working under the direct supervision of dr. hammer.
bpap in pediatric asthma pilot study

Conditions: Asthma in Children; Status Asthmaticus

Summary: the investigators aim to study the effect and safety of bilevel positive airway pressure (bpap) in children with moderate to severe asthma exacerbations - by examining the effects of early initiation of bpap in pediatric patients who present to the emergency room with a moderate to severe asthma exacerbation. the study is interested in how early initiation of bpap affects pram scores, vital signs, as well as the total duration of continuous albuterol in the patient population.

asthma is the most common chronic illness of childhood. bilevel positive airway pressure (bpap) has been suggested as an adjunct therapy in the setting of moderate to severe asthma exacerbations. it is a form of noninvasive positive pressure ventilation that provides both an inspiratory positive airway pressure (ipap) as well as an expiratory positive airway pressure (epap). the goal of this study is to determine the feasibility of enrolling, randomizing, and completing data collection in at least 30 participants over a one-year period. the investigators will enroll children 5 to 17 years of age presenting to the emergency department with a moderate to severe asthma exacerbation. eligible participants will be randomized into two groups: standard therapy (continuous albuterol) or standard therapy plus bpap. the following data will be collected: pediatric respiratory assessment measure (pram) score at 0, 2 and 4 hours, vital signs at 0, 2 and 4 hours, rate of adverse events and pediatric intensive care unit (picu) admissions, duration continuous albuterol, length of hospital stay, and rates of intubations or deaths.

Eligibility criteria:
inclusion criteria: * 5 to 17 years of age (inclusive) presenting to the emergency department (ed) with an asthma exacerbation * prior clinician diagnosis of asthma * pram score of 4 or greater after initial albuterol/atrovent back to backs, steroids, +/- oxygen * need for continuous nebulized albuterol therapy exclusion criteria: * hypercapneic respiratory failure (partial pressure of carbon dioxide \> 60 mmhg) * hypoxemic respiratory failure (sao2 \ 0.35) * presence of a tracheostomy or baseline noninvasive ventilation requirement * non-asthma causes of wheezing (foreign body, tracheomalacia, vocal cord dysfunction, pulmonary edema, uncorrected congenital heart disease, cystic fibrosis) * contra-indication to bpap (facial trauma, uncontrollable vomiting, hypotension for age, glasgow coma scale (gcs) 8 or less, drowsiness or confusion, known or clinical suspicion for pneumothorax, pneumomediastinum, or subcutaneous emphysema, pregnancy, current weight \< 20kg)

Keywords: non-invasive ventilation bpap continous albuterol pediatrics
smallpox vaccine for mpox post-exposure prophylaxis: a cluster rct

Conditions: Monkeypox

Summary: a cluster randomized controlled trial to determine if smallpox vaccine reduces secondary cases and symptom severity in persons exposed to mpox.

a pragmatic, adaptive, multi-site, cluster randomized trial where households with one or more persons confirmed to have mpox will be randomized to smallpox vaccine or control. the co-primary outcomes are rt-pcr confirmed mpox and symptom severity.

Eligibility criteria:
inclusion criteria: 1. household member of person with laboratory confirmed mpox 2. age ≥ 2 years 3. within 14 days of onset of illness in mpox index case exclusion criteria: 1. pregnancy 2. breastfeeding 3. past serious allergic reaction to study vaccine components 4. previous smallpox vaccination 5. current or planned use of another investigational drug at any point during study participation

Keywords: mpox
incidence and risk factors of acute kidney injury after thoracic aortic surgery due to dissection

Conditions: Dissection of Thoracic Aorta

Summary: acute kidney injury (aki) is one of the most frequently encountered and prognostically significant complications after cardiovascular surgery. however, there is no definitive treatment to intervene after development of aki, therefore, preventive strategy has been the major issue. by this time, incidence of aki after cardiovascular surgery has been reported 3-50% based on the studies with various definition of aki and different patient cohorts. development of unified definition for aki in the early 2000s opened a new era in aki study. according to the previous studies, aortic surgery, especially thoracic aortic surgery was known to be highly prevalent of aki, which was considered to be caused by use of total circulatory arrest (tca), relatively high number of emergency cases, combined malperfusion syndrome before surgery and relatively complicated surgical procedure. however, there has not been many studies of aki in thoracic aortic surgery because of its low incidence and urgent clinical presentation of aortic pathology, which hinder large randomized controlled study. moreover, there are conflicting reports of incidence and risk factors of aki after thoracic aortic surgery, no conclusive result has been made. therefore, this study was designed to investigate the incidence and risk factors after thoracic aortic surgery only due to dissection.


Eligibility criteria:
inclusion criteria: * thoracic aortic surgery due to dissection exclusion criteria: * chronic kidney disease on renal replacement therapy before surgery * death during or within 24 hours after surgery
amphotericin b to treat visceral leishmaniasis in brazilian children

Conditions: Visceral Leishmaniasis

Summary: the purpose of this study is to determine if amphotericin b is effective against visceral leishmaniasis in brazilian children. amphotericin b will be compared to meglumine antimoniate which is the current approved drug used for this disease in brazil.

despite their high toxicity, antimonials and amphotericin b deoxycholate are commonly used for treating visceral leishmaniasis (vl). few studies showing conflictive data about their efficacy and adverse events in pediatric population are available. this study aimed to evaluate efficacy and safety of amphotericin b deoxycholate vs. that of n-methylglucamine antimoniate in treating pediatric vl in brazil. this was a randomized, open-label, 2-arm and controlled pilot clinical trial. treatment naïve children and adolescents with vl without signs of severe illness were treated with n-methylglucamine antimoniate or amphotericin b deoxycholate. all patients were diagnosed with positive direct examination and/or positive pcr for leishmania spp. performed in bone marrow samples. the primary efficacy end-point was vl cure determined after 180 days of completion of treatment. the analysis was performed using intention-to-treat (itt) and per protocol (pp) analyses.

Eligibility criteria:
inclusion criteria: * clinical symptoms of visceral leishmaniasis: fever plus hepatomegaly or splenomegaly * diagnosis of visceral leishmaniasis confirmed through parasite visualization in bone marrow smears or positive serology (indirect immunofluorescent antibody test or rk39 rapid test)or positive kdna pcr test exclusion criteria: * any of the following laboratory findings * total serum bilirubin higher than 2,5 mg/dl * serum sgot higher than 5 times the upper normal level * serum sgpt higher than 5 times the upper normal level * prothrombin time concentration lower than 70% * abnormal serum creatinine * any of the following signs or symptoms * generalized edema * severe malnutrition * systemic inflammatory response syndrome * any of the following conditions * hiv infection/disease * diabetes * corticoid or immunosuppressive drugs use * symptomatic heart diseases * chronic hepatic or renal diseases * lupus erythematosus

Keywords: visceral leishmaniasis amphotericin b deoxycholate meglumine antimoniate children brazil
double abcx theory based cognitive psychotherapy combined progressive muscle relaxation intervention on women undergoing ivf-et

Conditions: Infertility

Summary: the in vitro fertilization and embryo transfer(ivf-et) is a therapy to help the infertile couples. the mental health status of couple under ivf-et, commonly seen in depression and anxiety, is found to be closely related to the success of ivf-et. this study aims to develop a intervention program combing cognitive psychotherapy and progressive muscle relaxation to ease the negative emotion and promote the success rate among couples undergoing ivf-et.


Eligibility criteria:
inclusion criteria: * the couple who are eligible for in vitro fertilization-embryo transfer (ivf-et) treatment; * junior high school and above; * voluntarily accepted for investigation and signed informed consent. exclusion criteria: * suffering from physical diseases such as severe heart, liver and kidney, and mental disorders; * experiencing major traumatic events in the past 2 years.

Keywords: cognitive psychotherapy progressive muscular relaxation in vitro fertilization and embryo transfer(ivf-et) couples therapy
alpha-1 antitrypsin (aat) enhances islet autograft survival in patients with chronic pancreatitis

Conditions: Chronic Pancreatitis

Summary: primary objective: to describe and compare the safety and efficacy of treatment with aat in chronic pancreatitis patients who undergo total pancreatectomy and islet autotransplantation (tp-iat).

the goal of this study is to assess whether infusion of prolastin-c during peri-transplant period can enhance islet autograft survival and function in chronic pancreatitis patients who have total pancreatectomy and islet autotransplantation. this is a prospective, controlled, double-blind study. the primary endpoint will be area under the curve for the serum c-peptide level during the first 4 hours of an mixed meal tolerance test (mmtt), normalized by the number of islet equivalents (ieq)/kg at day 365±14 after the transplant.

Eligibility criteria:
inclusion criteria: * patients scheduled for total pancreatectomy and islet auto-transplantation * age \> 18 years * diabetes free before surgery exclusion criteria: * patients who are under immunosuppression * patients who have had puestow or frey pancreatic surgery * patients who have immunoglobulin a (iga) deficiency, known antibodies against iga, or individuals with a history of severe immediate hypersensitivity reactions, including anaphylaxis to alpha1-proteinase inhibitor products (allergic to aat)

Keywords: islet autotransplantation alpha1 anti trypsin
renal recovery after peep weaning in ards (re2sdra)

Conditions: ARDS (Acute Respiratory Distress Syndrome); AKI - Acute Kidney Injury

Summary: the purpose of the study is to investigate renal recovery in ards after peep weaning. the primary outcome was the variation of the hourly urine output (huo), 48 h after peep weaning. secondary outcomes were the need for rrt and mortality. two groups were defined depending wether hourly urine output was greater or lower than 0.35 ml/kg/h.


Eligibility criteria:
inclusion criteria: * intubated for more than 48 hours, exposed to a peep≥ 8 cmh20 exclusion criteria: * chronic end-stage renal disease on admission * refusal to participate * non-opposition could not be obtained from themselves or their trusted support person in the event of incapacity * under legal protection.