Kornimate/medical-research-clean huggingface dataset:
autophagy dysfunction in hidradenitis suppurativa

Conditions: Hidradenitis Suppurativa (HS)

Summary: the pathogenesis of hs is still poorly understood: the pilosebaceous tropism and the fact that patients respond to combinations of antibiotics and/or immunosuppressive treatments suggest the involvement of 3 factors that would be intimately linked: the presence of (i) a microbial dysbiosis, (ii) a dysfunction of the pilosebaceous apparatus and (iii) an inappropriate immune response. but how these 3 elements interact with each other remains unestablished, with few studies that have analyzed them from a kinetic point of view. beyond a possible dysfunction of the pilosebaceous apparatus, we hypothesize a bacterial dysbiosis in connection with abnormalities of autophagy function with secondary development of an inappropriate immune response. because of its functions of bacterial clearance and activation of local immune response, a defect in the autophagic process may be associated with the development of inflammatory pathologies related to microbial dysbiosis. crohn's disease (cd), an inflammatory pathology of the gastrointestinal tract associated with intestinal dysbiosis, has been associated with alterations in autophagy, with approximately 50% of patients having single nucleotide polymorphisms (snps) associated with autophagy deficiency (ellinghaus et al., 2013). the epidemiological association of cd/hs, the presence of skin dysbiosis and a chronic inflammatory response during hs, make us suspect a deficit of autophagic function in these patients, in a similar way to what is observed during crohn's disease. the aim of this study is to analyze the frequency of 100 snps, reported to be associated with autophagy deficiency, in a cohort of moderate-to-severe hs patients.


Eligibility criteria:
inclusion criteria: * subject aged 18 to 65 years (included) * subject diagnosed with hs for at least 1 year * subject diagnosed with moderate-to-severe hs defined by hs pga≥3 * subject presenting an hs with inflammatory phenotype defined by the presence of folliculitis, nodules and/or abcesses * subject suffering from at least 4 flares/year and presenting 5 active inflammatory lesions (nodules and/or abcesses) * subject able to read, understand and give documented informed consent * subject willing and able to comply with the protocol requirements for the duration of the study * subject with health insurance coverage according to local regulations exclusion criteria: * - pregnancy or breast-feeding women * subject currently experiencing or having a history of other concomitant skin or systemic inflammatory conditions that could constitute a bias (i.e. psoriasis, crohn's disease, etc.) * subject with any additional condition that, in the opinion of the investigator, may interfere with the assessment or put the subject at risk * linguistic or mentally incapacity to sign the consent form * subject protect by the law (adult under guardianship, or hospitalized in a public or private institution for a reason other than study, or incarcerated) * subject in an exclusion period from a previous study or who is participating in another clinical trial using a drug
reoxygenation for cyanotic pediatric chd

Conditions: Tetralogy of Fallot

Summary: evidence is emerging that those patients with cyanotic pathologies may be more vulnerable to end-organ injury during and after surgery than those patients without, because of compromised cardiopulmonary performances or the proinflammatory state that follows conventional hyperoxic cardiopulmonary bypass. several clinical and basic studies have identified that controlled oxygenation during the initiation of bypass significantly improved the cardiac adaptation and remodeling capacity than hyperoxic oxygenation strategy among cyanotic patients undergoing tetralogy of fallot repair, as evidenced by these reduced myocardial gene expression profiles associated with reoxygenation injury. the investigators designed the reoxygenation for pediatric cardiac surgery study to investigate the effect of reoxygenation during cardiopulmonary bypass on clinical outcomes in patients with cyanotic congenital heart disease .


Eligibility criteria:
inclusion criteria: * the operation-naive infants and young children aged 1 months to 18 years old were eligible for enrolment if they were indicated for undergoing anticipated radical repair of cyanotic congenital heart disease with cardiopulmonary bypass. exclusion criteria: * the chromosomal defects, airway and parenchymal lung disease, immunodeficiency, blood transfusion during the current admission, previous cardiac operation, or the opinion of the treating physician that randomization would not be in the best interest of the patient (lack of equipoise)

Keywords: tetralogy of fallot
effectiveness of standard exercises and wall angels exercise in young adults with kyphotic posture

Conditions: Kyphosis Thoracic; Exercise Therapy

Summary: kyphosis-oriented exercise programs consist of isolated stretching, strengthening, and breathing exercises. however, the literature emphasizes that the body is a kinetic chain in many musculoskeletal disorders and supports holistic exercise approaches. to our knowledge, the effects of a complex exercise such as the wall angels exercise have not been studied in the kyphotic population. the aim of our study is to investigate whether the wall angels exercise combined with standard kyphosis exercises performed at home has additional effects and to contribute to the optimization of kyphosis rehabilitation programs.

the study was planned as a randomized controlled double-blind study and will consist of two groups: intervention (wall angels exercise combined with kyphosis and breathing exercises) and control (only kyphosis and breathing exercises). the g-power version-3.1.9 power analysis measurement method was used to determine the sample size. according to the power analysis conducted by taking into account the results of the studies of elpeze and usgu (15), it was calculated that at least 38 volunteers would be included in the study for a p\<0.05 with an effect size of 0.5 and a power of 85%. the outcome measures of the study will be demographic characteristics, pain (visual analog scale), trunk flexibility assessment, thoracic range of motion assessment, kyphosis index, scapula protraction, upper extremity function, respiratory capacity, postural habit and postural awareness level, and quality of life assessment. statistical analyses will be performed using spss version 23.0 (ibm spss statistics; ibm corporation, armonk, ny, usa) software. descriptive statistics of the data will be given using mean and standard deviation for numerical variables; and percentages for qualitative variables. the kolmogorov-smirnov test will be used to examine the conformity of the data to normal distribution as a result of descriptive analyses. intra-group comparisons will be evaluated using the dependent groups t test for groups with normal distribution, and the wilcoxon signed ranks test for those not with normal distribution. in order to compare pre-post training values between groups, the independent groups t test for data with normal distribution, and the mann whitney-u test for data not with normal distribution will be used. the level of statistical significance will be accepted as p\<0.05.

Eligibility criteria:
inclusion criteria: 1. volunteering to participate in the study and giving written consent 2. being a woman/man between the ages of 18-25 3. having a kyphotic posture exclusion criteria: 1. having a musculoskeletal disorder (scoliosis, etc.) 2. having a neurological system disorder 3. having a cardiopulmonary system disorder 4. having a fracture or surgery related to the spine, rib cage, or upper extremity within the last year 5. participating in an exercise program for kyphosis within the last 6 months

Keywords: corrective exercise kyphosis posture thoracic mobility
aspirin vs clopidogrel after tavr

Conditions: Severe Aortic Stenosis

Summary: currently, the optimal antithrombotic therapy after transcatheter aortic valve replacement (tavr) remains still unknown., the purpose of the study is to compare aspirin versus clopidogrel monoantiplatelet therapy for preventive effect on leaflet thrombosis in patients undergoing tavr for severe aortic stenosis. this study is designed as a prospective, multicenter, open label, randomized controlled study. eligible patients will be randomized to aspirin or clopidogrel monotherapy after tavr. patients will have dual antiplatelet therapy of aspirin 100 mg and clopidogrel 75 mg for 4 weeks after tavr and then subsequent monoantiplatelet therapy of either aspirin 100 mg or clopidogrel 75 mg according to the randomization. leaflet thrombosis will be assessed with cardiac computed tomography (ct) and transthoracic echocardiography at 3 months after tavr. patients will be clinically followed for 6 months. the primary endpoint is the incidence of leaflet thrombosis on cardiac ct at 3 months.

1. prospective, multicenter, open label, randomized controlled study 2. eligible patients will be randomized to aspirin or clopidogrel monotherapy after tavr 3. all patients will have dual antiplatelet therapy of aspirin 100 mg and clopidogrel 75 mg for 4 weeks after tavr and then subsequent monoantiplatelet therapy of either aspirin 100 mg or clopidogrel 75 mg. 4. leaflet thrombosis will be assessed with cardiac computed tomography (ct) and transthoracic echocardiography at 3 months after tavr 5. clinical follow-up up to 6 months

Eligibility criteria:
inclusion criteria: 1. patients \>19 years old 2. patients who underwent tavr symptomatic severe as 3. provision of informed consent exclusion criteria: 1. patients requiring dual antiplatelet therapy longer than 4 weeks 2. any conditions requiring specific antiplatelet therapy aspirin or clopidogrel 3. history of stroke or transient ischemic attack (tia) within 6 months 4. planned major surgery 5. cardiogenic shock or hemodynamic instability 6. chronic kidney disease stage 4 or 5 (egfr \<30ml/min) 7. valve-in-valve tavr procedure 8. hypersensitivity or contraindication to aspirin or clopidogrel 9. indication for anticoagulation therapy
family connections

Conditions: Emotional Disturbance; Behavior Disorders in Children

Summary: the family connections study, is intended to disrupt disparities in mental health treatment access for children at-risk for childhood trauma (aces) and/or serious emotional disturbance (sed). "family connections" will use mobile clinical and family support teams to improve mental health outcomes. this clinical innovation, nested in an integrated system-of-care will be piloted for children, ages 3-18 yrs., with sed who receive primary care through cambridge health alliance.


Eligibility criteria:
inclusion criteria: * 3 through 18 years (17½ years maximum at time of enrollment) * referred by primary care physician's (pcp) from one of the three cambridge health alliance (cha) primary care intervention sites to the family connections team for an integrated child mental health and/or substance use disorder clinical assessment. * positive screen on cha's standard pediatric mental health and substance use screening instruments, and/or parental concern about possible mental health/substance use needs, and/or pcp concern about possible mental health/substance use needs * enrolled in masshealth exclusion criteria: * subjects over 17.5 years (samhsa data collection required at 6 and 12 months after enrollment which must occur before age 18 years.) * youth who are not enrolled in masshealth * cha patients with pcp located at cha primary care site other than the identified intervention sites
dual time point pet imaging in lymphoma

Conditions: Hodgkin's or Non-Hodgkin's Lymphoma

Summary: comparison of single time point with dual time point pet imaging in the accuracy of diagnosing active lymphoma. biopsy results or clinical/radiological progression will be used in conjunction with the pet data.


Eligibility criteria:
inclusion criteria: - age 16 and above diagnosis of hodgkin's or non-hodgkin's lymphoma pet scan scheduled as part of management exclusion criteria: * pregnant or lactating diabetes mellitus
carbon dioxide (co2) measurement with a co2/o2 guedel airway

Conditions: Breathing Stop

Summary: this trial compares capnographic signals using a modified co2/o2 guedel airway with a co2/o2 nasal cannula without and with oxygen supply in sedated children aged 4 - 24 months.

sedation of pediatric patients is frequently jeopardized by respiratory adverse events such as central and/or obstructive apnea resulting in hypoxemia. various factors such as patient comorbidities, medication and inconsistent physiologic monitoring are known to contribute to or facilitate adverse events during sedation. therefore, monitoring of breathing by capnography is recommended and has become common standard e.g. by the use of a co2/o2 nasal cannula. however, capnography derived from co2/o2 nasal cannulas may be impaired and these impairments are exaggerated in infants based on their physiologic characteristics (small tidal volumes, high respiratory rates). to overcome these impairments, the investigators developed a modified co2/o2 guedel airway including a co2 sampling port at the tip of the airway. in a previous study, significantly more accurate capnographic signals resulted compared with measurements derived from a nasal cannula when using a modified co2/o2 guedel airway in a model of a breathing 6-month-old manikin. the aim of the study is to examine the accuracy of capnographic measurements of the modified co2/o2 guedel airway in comparison with measurements from a co2/o2 nasal cannula in sedated children aged 4 - 24 months.

Eligibility criteria:
inclusion criteria: * term born infants aged 4 to 24 months * physical status according classification i or ii (american society of anaesthesiologists (asa)) * scheduled for elective diagnostic/therapeutic procedures or surgery under sedation/anaesthesia * informed consent as documented by signature of the parents or legal caregiver exclusion criteria: * syndrome that affects the airway anatomy * physical status according classification iii or iv (american society of anaesthesiologists (asa)) * upper respiratory tract infection at present or within the last two weeks before the study * previous enrolment into the current study * known hypersensitivity or allergic reactions to midazolam, nitrous oxide (n2o), propofol or sevoflurane. * positive family history for malignant hyperthermia, morbus pompe or ophthalmic operations with gas injection or sinus- or inner ear surgery.

Keywords: capnography pediatric nasal cannula guedel airway
effect of plant stanols on cholesterol absorption

Conditions: Hypercholesterolemia

Summary: this study aims to measure the effect of three different doses of plant stanols in margarine on the cholesterol absorption efficiency in subjects with mildly to moderately increased serum ldl cholesterol concentrations

serum cholesterol lowering effect of plant sterols is well established and it is also known that plant stanols inhibit the absorption of cholesterol. however, there is lack of dose-response studies directly measuring the cholesterol absorption efficiency during prolonged consumption of plant stanols. therefore this study aims to measure the cholesterol absorption efficiency at different plant stanol consumption levels using a stable isotope tracer method. subjects will be randomized in their study groups that consume 20 g of margarine with different doses of plants stanols (0.8, 1.6 and 2.0g) based on cholesterol absorption efficiency at screening (high and low absorbers randomised separately). cholesterol absorption test with cholesterol tracer will be conducted twice: at baseline and after 2-3 weeks margarine consumption period. cholesterol absorption efficiency will also be examined by indirect method i.e. by following the concentrations of serum cholesterol precursors and plant sterols in blood. in addition serum total, ldl and hdl cholesterol and triglycerides are followed.

Eligibility criteria:
inclusion criteria: * healthy adults with mild to moderate hypercholesterolemia exclusion criteria: * lipid lowering medication * pregnancy or lactation * severe diseases (inc. diabetes, unstable cvd, malignant diseases) * severe obesity * regular plant sterol consumption

Keywords: plant sterols plant stanols cholesterol absorption
clinical and histological evaluation of the picosure 755nm laser with cap array for facial rejuvenation

Conditions: Facial Rejuvenation

Summary: the purpose of this study is to assess treatment of facial rejuvenation using the standard hand piece and a lens array for the 755nm alexandrite laser.


Eligibility criteria:
inclusion criteria: 1. is a healthy male or female between 18 and 65 years old 2. is willing to consent to participate in the study. 3. is willing to comply with all requirements of the study including biopsies, being photographed, following post treatment care and attending all treatment and follow up visits. exclusion criteria: 1. the subject is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period. 2. the subject is hypersensitive to light exposure or takes photo sensitized medication. 3. the subject has active or localized systemic infections. 4. the subject has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy {greater than 81 mg per day}). 5. the subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study. 6. the subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 3 months prior to entering this study. 7. the subject has used accutane within 6 months prior to enrollment. 8. the subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial. 9. the subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate). 10. the subject has a history of keloids. 11. the subject has evidence of compromised wound healing. 12. the subject has a history of squamous cell carcinoma or melanoma. 13. the subject has a history of immunosuppression/immune deficiency disorders (including hiv infection or aids) or use of immunosuppressive medications. 14. the subject has an allergy to lidocaine and epinephrine.
study to evaluate efficacy and safety of prelipid® on subjects with higher than normal blood lipid levels

Conditions: Hyperlipidemia

Summary: study to evaluate efficacy and safety of prelipid® on subjects with higher than normal blood lipid levels

a prospective, double blind, placebo-controlled, randomized, multicentric, study to evaluate the safety, efficacy and tolerability of prelipid®, a twice-daily nutritional supplement in subjects with higher than normal blood lipid levels

Eligibility criteria:
inclusion criteria: newly diagnosed male or female participants with higher than normal cholesterol levels defined by the american heart association, national cholesterol education program (ncep) and atp-iii goals for ldl cholesterol and cut off points for therapeutic lifestyle changes (tlcs) and drug therapy in different risk categories: 1. age ≥ 18 years to ≤ 65 years 2. ldl cholesterol levels \>120mg/dl 3. ability to understand and willingness to sign and date a written informed consent document at the screening visit before any protocol- specific procedures are performed and willing to adhere to the protocol and entire trial procedures - exclusion criteria: 1. stroke, myocardial infarction, coronary artery bypass graft (cabg) percutaneous transluminal coronary angioplasty (ptca) or angina pectoris in the past. 2. cardiac status new york heart association class iii-iv 3. uncotrolled blood pressure \> 150 mmhg systolic and \> 100 mmhg diastolic 4. impaired renal function as shown by but not limited to serum creatinine ≥ 1.5 mg/dl for males and ≥ 1.4 mg/dl for female 5. clinically significant peripheral edema 6. clinical evidence of active liver disease or serum alenine aminotransferase (alt) or aspartate amino transferase (ast) 2.5 times the upper limit of the normal range (2.5 x uln) 7. participants on steroid 8. pregnancy or lactating women 9. known hypersensitivity to any of the study drugs 10. any malignancy within the last 5 years, with exception of adequately treated basal or squamous cell carcinoma of the skin or adequately treated carcinoma insitu. 11. current addiction or current alcohol abuse or history of substance or alcohol abuse within the last 2 years 12. subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol 13. mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study. 14. subject unlikely to comply with protocol e.g. uncooperative attitude, inability to return for follow up visits and unlikelihood completing of the study 15. any disease or condition that in the opinion of the investigator and/or sponsor may interfere with the completion of the studyevaluation. -

Keywords: dyslipidemia high cholesterol high ldl triglycerides
trial of 225ac-dotatate (ryz101) in subjects with er+, her2-negative unresectable or metastatic breast cancer expressing sstrs.

Conditions: Metastatic Breast Cancer; HER2-negative Breast Cancer; ER+ Breast Cancer; Advanced Breast Cancer

Summary: phase 1b/2 open-label trial of 225ac-dotatate (ryz101) in subjects with er+, her2-negative unresectable or metastatic breast cancer expressing sstrs.


Eligibility criteria:
inclusion criteria subjects must meet all the following criteria for enrollment in the study: * eastern cooperative oncology group performance status ≤2. * histologically confirmed, er+, her2-negative, locally advanced and unresectable or metastatic breast cancer not amenable to treatment with curative intent. * at least one recist v1.1-measurable tumor lesion that is sstr-pet positive (defined as maximum standard uptake value (suvmax) higher than liver mean standard uptake value (suvmean) on sstr-pet imaging) and at least 80% of recist v1.1measurable tumor lesions are sstr-pet positive * sufficient renal function, as evidenced by egfr ≥60 ml/min/1.73m2 calculated using the chronic kidney disease epidemiology collaboration (ckd-epi) equation * adequate hematologic and hepatic function exclusion criteria subjects who meet any of the following criteria will be excluded from the study: * prior radiopharmaceutical therapy, including radioembolization. * any toxicities from prior treatments that have not recovered to ctcae grade ≤1, except for alopecia. * significant cardiovascular disease * known active uncontrolled or symptomatic central nervous system (cns) metastases, carcinomatous meningitis, spinal cord compression, or leptomeningeal disease. * history of hypersensitivity or allergy to 225ac, 68ga, 64cu, octreotate, or any of the excipients of dotatate imaging agents. * prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the study safety or efficacy assessments. * pregnancy or lactation.

Keywords: actinium alpha-emitter sstr+ mbc er+, her2-, mbc ryz101 225ac targeted radiotherapy radiopharmaceutical sstr+ abc er+, her2-, abc