Kornimate/medical-research-clean huggingface dataset:
transcatheter repair of tricuspid regurgitation with edwards pascal transcatheter valve repair system

Conditions: Tricuspid Valve Insufficiency

Summary: this is a postmarket clinical follow up study on the safety and effectiveness of the edwards pascal transcatheter valve repair system and the edwards pascal precision transcatheter valve repair system in transcatheter tricuspid valve repair.

the objectives of this clinical study are to collect data on the safety and effectiveness of the pascal system and pascal precision system in improving tr, functional status, and quality of life in a post-market setting.

Eligibility criteria:
inclusion criteria: 1. patient is a candidate for transcatheter tricuspid valve repair as determined by a heart team 2. tr grade ≥3+ (5 grade classification) 3. patient is eligible to receive the pascal device per the current approved indications for use exclusion criteria: 1. tricuspid valve anatomic contraindications, including previous tricuspid valve replacement 2. severe aortic, mitral, and/or pulmonic valve stenosis and/or regurgitation 3. concurrent medical condition with a life expectancy of less than 12 months in the judgment of the investigator 4. any patient considered to be part of a vulnerable population
non-invasive computer-aided phenotyping of vasculopathy

Conditions: Carotid Atherosclerosis; Peripheral Arterial Disease

Summary: the investigators use mri and/or ct to evaluate the extent, as well as, the structure, composition, and functional aspects of atherosclerotic plaques in human carotid and femoral arteries in patients scheduled to undergo an endarterectomy of the aforementioned vascular beds as part of their routine clinical care.

the investigators hypothesize that in vivo mri and/or ct examinations of patients, when suitably acquired and analyzed with the vascucap™ analysis software, can provide a sufficiently accurate profile of plaque characteristics to provide an objective basis for patient management. study subjects include patients undergoing endarterectomies to mitigate their clinical risk or symptoms for conditions including stroke, claudication, and critical limb ischemia. the endarterectomy specimens removed at surgery will allow a direct comparison between the mri information obtained prior to the surgery and the histopathological analyses of the arterial specimens. the vascucap™ measurements of structural and functional features of the arterial wall will be performed in patients undergoing endarterectomy. measured results will be compared in a blinded fashion with histology to assess performance of plaque profiling and build a pilot prediction model for risk scoring.

Eligibility criteria:
inclusion criteria: individuals must meet one of the following inclusion criteria in order to be eligible to participate in the study: * case subjects will be patients with documented carotid atherosclerosis, scheduled for magnetic resonance or ct angiography and subsequent elective endarterectomy with 30 days of enrollment in the study * case subjects will be patients with peripheral arterial disease (pad) with clinical symptoms, scheduled for magnetic resonance or ct angiography and indicated endarterectomy of diseased areas of femoral arteries within 30 days of enrollment in the study exclusion criteria: * subjects with claustrophobia or inability to tolerate prior mri studies. * subjects with metal implants that are not mri compatible (lsu detailed checklist to be attached) including: subjects with any type of bio-implant activated by mechanical, electronic, or magnetic means (e.g. cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.). subjects with any type of ferromagnetic bio-implant that could potentially be displaced or damaged, such as aneurysm clips, metallic skull plates, etc. * subjects with a history of kidney disease or dialysis that are unable to receive intravenous gadolinium contrast material. * female subjects. a urine pregnancy test will be required of all female subjects of childbearing potential prior to inclusion in this study. pregnant or nursing females will be excluded from the study. * subjects who cannot adhere to the experimental protocol. * subjects allergic to contrast material.
mesenchymal stem cells and amniotic membrane composite for supraspinatus tendon repair augmentation

Conditions: Supraspinatus Tear

Summary: this is a non-randomized clinical trial conducted in a single tertiary hospital which investigates the efficacy of allogeneic adipose-derived mesenchymal stem cells and human amniotic membrane (aadmsc-ham) composite for supraspinatus tendon repair augmentation

supraspinatus tendon tear is the most common factor causing shoulder pain, mainly resulting in discomfort and functional deficit in individuals over the age of 35. supraspinatus tendon repair surgery represents one of the most widely performed types of orthopedic operation. nevertheless, concerns persist regarding tendon-to-bone healing during the postoperative period. despite advancements in surgical technique, re-tear of a previously repaired supraspinatus tendon is a fairly common complication, especially in a larger size tear. such repair technique employing suture anchor devices alone has not yet produced functional results demonstrating both anatomical and biomechanical properties. therefore, tendon tissue engineering using a combination of scaffolds, cells, and growth factors stimulation offers a potential solution as a biological augmentation in tendon repair. human amniotic membrane (ham) has been widely used as a natural scaffold in tissue engineering due to many of its unique properties such as providing growth factors, cytokines and tissue inhibitors of metalloproteinases, adequate mechanical strength, and biocompatibility. whereas, mesenchymal stem cells (mscs) constitute one of the adult stem cells that promote replacement and repair of damaged tissue along with normal tissue turnover. these mscs are seeded to the ham scaffolds to biologically augment tendon repair, with mscs acting as cytokines/growth factors to stimulate tissue repair. this approach serves as the foundation to conduct the present study. the investigators aim to investigate the efficacy of using allogeneic adipose-derived mscs and human amniotic membrane (aadmsc-ham) composite for supraspinatus tendon repair augmentation.

Eligibility criteria:
inclusion criteria: * suffering from complete/total tear of supraspinatus tendon for a duration of fewer than 12 months * diagnosis is established based on clinical condition and ultrasonography or mri examination exclusion criteria: * patients with comorbid diseases: diabetes mellitus, rheumatoid arthritis, and other inflammatory diseases. * patients presenting with other related injuries, such as fractures or dislocation around the shoulder joint.

Keywords: supraspinatus rupture supraspinatus tear tendon repair tendon tissue engineering amniotic membrane mesenchymal stem cells
blood pressure and cardiac autonomic adaptations to isometric exercise training

Conditions: Hypertension

Summary: a randomized, sham-controlled intervention measuring the effects of isometric exercise training (iet) on blood pressure and cardiac autonomics. iet has been proven effective in a plethora of randomized trials, but very little research has employed a sham-controlled design. this researched involved the recruitment of 30 participants who completed a 4 week iet intervention, sham control of the iet intervention, or a non-intervention control period. pre and post blood pressure and cardiac autonomic measures were acquired and analysed. the hypothesis of this trial was a significant effect of iet on blood pressure, with no such effects following the sham control or normal control interventions.


Eligibility criteria:
inclusion criteria: * healthy with no significant health conditions contraindicating exercise * over 18 years of age * physically inactive exclusion criteria: * achieving current physical activity guidelines * abnormal resting ecg * under 18
swiss study of the impact of mayzent on spms patients in a long-term non-interventional study

Conditions: Secondary Progressive Multiple Sclerosis With Inflammatory Disease Activity

Summary: this study is a national, prospective, multicenter, non-interventional (observational) study with the aim to describe the impact of siponimod treatment in a real-world spms population in switzerland who are treated with siponimod as per swiss label.

primary data will be collected during an observational period of three years of siponimod treatment. additionally, medical history of participants will be collected including edss, mri outcomes, relapses and previous medication to allow the estimation of siponimod treatment effects on an individual basis. it is planned to include an optional blood draw for a later biomarker analysis.

Eligibility criteria:
inclusion criteria: 1. signed informed consent 2. adult patients with a documented diagnosis of spms with inflammatory disease activity who are going to be treated with siponimod under routine medical care and in accordance with the swiss label 3. patient willing and able to complete the questionnaires exclusion criteria: 1. patients treated outside of the approved swiss label for siponimod 2. prior treatment or already ongoing treatment with siponimod 3. use of investigational drugs during the study, or within 3 months before enrollment, or within 5 half-lives of investigational drug before enrollment, or until the expected pharmacodynamic effect has returned to baseline, whichever is longer 4. subjects who are not able to provide consent due to incapable judgement

Keywords: spms secondary progressive multiple sclerosis siponimod active disease inflammatory disease activity disability progression
restore in patients who had covid-19 and close others

Conditions: Mental Health; PTSD; Anxiety; Depressive Symptoms

Summary: there is considerable need for psychological intervention targeting stressor-related mental health symptoms related to covid-19. the investigators have developed an online self-directed transdiagnostic intervention to address this need called restore: recovering from extreme stressors through online resources and e-health. the specific aims of this project are to refine and investigate the initial safety, efficacy, and desirability of restore for addressing mental-health symptoms in individuals who have recovered from severe covid-19 and close others.

this uncontrolled pilot interventional study will examine the feasibility and preliminary efficacy of restore. restore is a guided self-directed online intervention to improve anxiety, depression, and posttraumatic stress disorder (ptsd) in individuals exposed to covid-19 related traumatic or extreme stressors. restore is based on evidence-based psychotherapies and has been designed to overcome many of the barriers associated with accessing evidence-based psychotherapies. the intervention will be iteratively refined over the course of the study. the guidance methods will also be refined over the course of the study the primary hypotheses are that restore will be safe, feasible, and desirable to participants, and will lead to improvements in mental health symptom severity from baseline to post-intervention. secondary hypotheses are that restore will lead to significant improvements in perceived health, quality of life, and functioning that will be maintained at one-month follow-up. participants will be assessed at baseline, pre-intervention, during the intervention (after module 4), immediately after the intervention, and 1 month after completion of the intervention.

Eligibility criteria:
inclusion criteria: * experienced a traumatic or extremely stressful experience related to being covid-19+ or having a close other who was covid-19+ * participants who were covid+ will be eligible once they are no longer exhibiting covid-19 symptoms and those who were hospitalized will be eligible post-discharge * close others will be eligible once their close other with covid-19 has recovered or if their loved one is deceased * ≥ 18 years of age * scores at above clinical threshold on at least one of: patient health questionnaire-9 (\[phq-9\] score ≥ 10), generalized anxiety disorder scale-7 (\[gad-7\] score ≥ 10), and/or posttraumatic stress disorder scale-5 (\[pcl-5\] score ≥ 33) * access to a computer or a tablet with high speed internet access, be able to clearly see the screen of a computer or tablet, and be fluent in english * ability to provide consent exclusion criteria: * elevated risk of suicide * currently enrolled in another intervention or treatment (e.g., cognitive behavioural therapy) for stress responses related to the covid-19 pandemic
non-invasive optical spectroscopic methods for dehydration identification in marathon trainees

Conditions: Dehydration

Summary: dehydration can result from exposure to harsh environments including hot and dry desert climates. soldiers and non-military workers are frequently required to work in hot, dry conditions, and dehydration can be productivity limiting and life threatening if unrecognized.

the research can use low power laser technology to take measurements of muscle tissue water content in volunteers before and after marathon training runs to detect dehydration. two slightly different devices can be used to detect dehydration. 1). diffuse optical spectroscopy and 2). spatial frequency domain imaging-modulated imaging the researchers can determined by use other methods to assess the level of dehydration status in runners. these methods will include taking weight and temperature before and after run, skin-fold measurements pre and post run, and obtaining saliva samples from before and after run. the researchers can determine the study use non-invasive, laser light technology measure tissue water concentrations, as an indicator of dehydration.

Eligibility criteria:
inclusion criteria: * male female ages of 18 and 60 * training for a marathon exclusion criteria: 1. poorly controlled diabetes mellitus 2. diabetes insipidus (excessive urination of water) as diagnosed by your physician 3. disorder of the intestine 4. irritable bowel syndrome with excessive diarrhea, as diagnosed by a physician 5. congestive heart failure and subsequent use of a diuretic "water pill" to remove excess water from the body 6. have poor kidney function 7. have been diagnosed with hyperthyroidism/hypothyroidism by your physician

Keywords: dehydration
an expanded access protocol for setmelanotide for treatment of bardet-biedl syndrome (bbs)

Conditions: Bardet-Biedl Syndrome (BBS); Obesity

Summary: an open-label, single-arm, multicenter, expanded access protocol \[eap\] designed to provide treatment access to setmelanotide (3 mg, administered subcutaneously \[sc\], once daily) for eligible patients with bbs who have no alternative treatment options. all patients will continue to receive setmelanotide at the discretion of the treating physician and while they are deriving clinical benefit.

this is an open-label, multicenter, eap, designed to provide treatment access to setmelanotide for eligible patients who have bbs and who have no alternative treatment options. patients will undergo clinical and safety assessments before setmelanotide initiation, and then at 3 monthly intervals - or more frequently if clinically indicated - following initiation of setmelanotide and until treatment is completed or discontinued. all patients must have a 4 week (30 day) follow up safety evaluation after treatment is stopped. the end of the program is defined as the last expected evaluation of the last patient or the date of reimbursement and commercialization of setmelanotide in these indications, whichever comes first.

Eligibility criteria:
patients who have not taken part in any previous setmelanotide clinical trial must fulfill all of the following study's eligibility criteria: inclusion criteria: 1. clinical diagnosis of bbs 2. males and females aged ≥6 years 3. obesity (≥30 kg/m2) for patients ≥18 years old or weight \>97th percentile for age and sex on growth chart assessment for patients aged 6 to 17 years 4. female participants of child-bearing potential must be confirmed as non-pregnant 5. patients with significant neuropsychiatric disorders such as depression should be carefully evaluated regarding the benefit/risk ratio for the use of setmelanotide 6. patients unable to enroll in another clinical trial with setmelanotide as determined by the treating physician exclusion criteria: 1. moderate to severe renal dysfunction defined as a glomerular filtration rate (gfr) \<60 ml/min/1.73m2 2. history or close family history (parents or siblings) of skin cancer (excluding non-invasive basal or squamous cell lesion) melanoma, or patient history of ocular cutaneous albinism 3. inability to comply with a daily injection regimen patients who have taken part in any previous setmelanotide clinical trial, have met all of the study's eligibility criteria, and have shown meaningful clinical benefit, defined as at least a 5% reduction in body weight for patients aged ≥18 years or a 5% reduction in bmi in patients aged \<18 years from baseline through the end of the preceding study, will be eligible.
a study of pembrolizumab (+) berahyaluronidase alfa (mk-3475a) (pembrolizumab formulated with berahyaluronidase alfa (mk-5180)) in japanese participants with recurrent or metastatic cutaneous squamous cell carcinoma (r/m cscc) or locally advanced (la) unresectable cscc (mk-3475a-e39)

Conditions: Squamous Cell Carcinoma

Summary: the purpose of this study is to evaluate the efficacy, safety, and tolerability of subcutaneous (sc) pembrolizumab (+) berahyaluronidase alfa in japanese participants with recurrent or metastatic cutaneous squamous cell carcinoma or locally advanced unresectable cscc. the primary hypothesis is that pembrolizumab (+) berahyaluronidase alfa will result in greater than 10% objective response rate (orr) per response evaluation criteria in solid tumors version 1.1 (recist 1.1) as assessed by blinded independent central review (bicr).


Eligibility criteria:
the key inclusion and exclusion criteria include but are not limited to the following: inclusion criteria: * has histologically confirmed cscc by the investigator as the primary site of malignancy * r/m cscc cohort only: has metastatic disease, defined as disseminated disease distant to the initial/primary site of diagnosis, and/or has locally recurrent disease that has been previously treated (with either surgery or radiotherapy) and is not curable by either surgery or radiotherapy * la unresectable cscc cohort only: is ineligible for surgical resection * la unresectable cscc cohort only: has received prior radiation therapy (rt) to index site or has been deemed to be not eligible for rt * la unresectable cscc cohort only: has received prior systemic therapy for curative intent are eligible regardless of regimen * has a life expectancy of greater than 3 months * must provide archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated exclusion criteria: * has cscc that can be cured with surgical resection, radiotherapy, or with a combination of surgery and radiotherapy. * has any other histologic type of skin cancer other than invasive squamous cell carcinoma as the primary disease under study * has received prior systemic anticancer therapy including investigation agents within 4 weeks before allocation * has not adequately recovered from major surgery or has ongoing surgical complications * received prior radiotherapy within 2 weeks of study intervention, or had radiation-related toxicities, requiring corticosteroids * received a live or live-attenuated vaccine within 30 days before the first dose of study intervention * known additional malignancy that is progressing or has required active treatment within the past 2 years * has an ongoing active infection requiring systemic therapy * has a history of human immunodeficiency virus (hiv) infection * has an active autoimmune disease that has required systemic treatment in past 2 years * has history of allogenic tissue/organ transplant

Keywords: programmed cell death-1 (pd1, pd-1) programmed cell death 1 ligand 1(pdl1, pd-l1) programmed cell death 1 ligand 2 (pdl2, pd-l2)
evaluation of the correlation between molecular phenotype and radiological signature (by pet-scanner and mri) of incident who ii and iii grade gliomas.

Conditions: Glioma

Summary: from the medical records of a series of patients operated on for incident grade ii and iii glioma, the primary objective is to evaluate the correlation between the molecular profile of tumours and preoperative imaging data (by fdg and fdopa pet-scan and multimodal mri).

a retrospective monocentre study of medical data (clinical, histological, molecular and imaging) contained in the medical records of patients operated on for grade ii or iii incident glioma.

Eligibility criteria:
inclusion criteria: * subject 18 years of age or older, having been informed of the research * subject operated on with an incident glioma of grade ii or iii, histologically confirmed (who 2016 classification) * subject for which all preoperative imaging data is available (mri, fdg and fdopa pet-scan) * subject for which molecular data of the lesion are available exclusion criteria: * subject having signified his opposition to the use of his medical data * subject under safeguard of justice, guardianship or trusteeship * subject with incomplete or missing part of the molecular and/or imaging data
study to evaluate the effect of renal impairment on the pharmacokinetics of pf-04991532

Conditions: Type 2 Diabetes Mellitus; Healthy

Summary: the primary purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of a single oral dose of pf-04991532 in subjects with renal impairment.


Eligibility criteria:
inclusion criteria: * stable renal function defined as \<20% difference between two measurements of serum creatinine obtained on two occasions separated by at least 72 hours to 14 days; the second determination must be obtained within the 28-day period prior to the start of study medication administration. crcl value at screening (average of two values obtained within two weeks apart before dosing) will be used for study enrollment. * body mass index (bmi) of 17.5 to 40 kg/m2; and a total body weight \>50 kg (110 lbs). * subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. exclusion criteria: * pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception as outlined in this protocol from at least 14 days prior to the first dose of study medication. * subjects with recent (within the last 6 months) history of myocardial infarction, unstable angina, coronary revascularization, stroke or transient ischemic attack (tia). * subjects with severe heart failure (new york heart association functional class iv) at screening. * subjects with acute renal disease.