Kornimate/medical-research-clean huggingface dataset:
a real world evaluation of the eluvia stent in subjects with lesions located in the femoropopliteal arteries

Conditions: Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Arteriosclerosis

Summary: the regal study is a european, prospective, multi-center post-market clinical follow-up (pmcf) trial providing additional data including health economics data to support the use of the eluvia stent in the treatment of lesions located in the femoropopliteal arteries.

a european, prospective, multi-center post-market clinical follow-up (pmcf) trial providing additional data including health economics data to support the use of the eluvia stent in the treatment of lesions located in the femoropopliteal arteries. the objective of the study is to collect additional data including health economics data to support the use of the eluvia drug-eluting vascular stent system (eluvia stent) for treating superficial femoral artery (sfa) and/or proximal popliteal artery (ppa) lesions.

Eligibility criteria:
inclusion criteria: 1. subjects age 18 and older 2. subject is willing and able to provide written consent before any study-specific test or procedure is performed and agrees to attend all follow-up visits 3. de novo, restenotic or (re)occluded lesions in the native femoro-popliteal arteries, with reference vessel diameter (rvd) ranging from 4.0-6.0 mm, suitable for endovascular treatment exclusion criteria: 1. subject is pregnant or planning to become pregnant during the course of the study 2. life expectancy of less than 1 year (which is defined as documented life expectancy less than 12 months due to other medical co-morbid condition(s) that could limit the subject's ability to participate in the clinical follow-up, limit the subject's compliance with the standard of care follow-up, or impact the scientific integrity of the trial) 3. known allergy to the eluvia stent system or any of its components, concomitant medication, contrast agents (that cannot be medically managed) 4. subject enrolled in an investigational study that has not reached primary endpoint at the time of enrollment or that clinically interferes with the current study assessments (note: studies requiring extended follow-up for products that were investigational, but have become commercially available since then are not considered investigational studies)

Keywords: atherosclerosis superficial femoral artery (sfa) proximal popliteal artery (ppa) stenting paclitaxel health economics
compare d961h 20 mg bid and 20 mg qd in patients with refractory reflux esophagitis (inflammation of lower esophagus)

Conditions: Refractory Reflux Esophagitis

Summary: this is a phase 3 multicentre, randomised, double-blind, parallel-group, comparative study to evaluate the efficacy of esomeprazole (d961h) 20 mg twice daily and esomeprazole (d961h) 20 mg once daily in patients (in the form of esomeprazole magnesium salt) with refractory reflux esophagitis after 8 weeks of standard proton-pump inhibitor (ppi) therapy by assessment of presence/absence of inflammation (esophagitis) at week 8 according to the los angeles (la) classification

a multicentre, randomised, double-blind, parallel-group, comparative study to compare the efficacy and safety of d961h 20 mg twice daily oral administration and d961h 20 mg once daily oral administration in patients with refractory reflux esophagitis

Eligibility criteria:
inclusion criteria: 1. provision of informed consent prior to any study specific procedures. 2. patients with re classified into la classification grade a, b, c or d by endoscopy despite of at least 8-week treatment using standard doses of ppis. 3. patients must fulfill at least one of the following criteria such as (i) re with la grade c/d at endoscopy on visit 1 and/or history of re with la grade c/d, (ii) re was diagnosed more than 1 year before visit 1. 4. patients who are able to complete the patient diary exclusion criteria: 1. male or female aged less than 20 years at the time of informed consent. 2. patients with current evidence of the gastrointestinal diseases/conditions such as esophageal stricture to interfere with the evaluation of the study etc 3. gastric or duodenal ulcer verified by endoscopy within 12 weeks before randomisation. 4. previous esophageal, gastric or duodenal surgery except simple closure of perforated ulcer, simple endoscopic treatment with simple operation etc 5. current or historical evidence (within 12 weeks prior to randomisation) of the diseases/conditions as judged to interfere with the evaluation of the study.

Keywords: refractory reflux esophagitis, japanese, nexium, twice daily, oral administration
safety and efficacy study of herbal supplements in prediabetic and mild to moderate hyperlipidemic patients

Conditions: Prediabetes; Hyperlipidemia

Summary: objective of this study is to determine the safety and efficacy of administration of herbal supplements (salacia leaf extract, salacia root extract and sesame seed extract) for 6 weeks in the management of prediabetes and mild to moderate hyperlipidemia.


Eligibility criteria:
inclusion criteria: 1. as per atp iii guidelines: baseline ldl ranging 160-189 mg/dl, tc \>200 mg/dl and with no or one of the below risk factors * current cigarette smoking * family history of premature coronary heart disease(chd); in male first degree relative \<55 years; in female first degree relative \<65 years) * hypertension (bp \>140/90 mmhg or on antihypertensive medication) * low hdl-c (\<40 mg/dl) * age (men \> 40 years) 2. impaired glucose tolerance (2-hour post 75 g ogtt glucose levels in the range of ≥140 to ≤ 200 mg/dl) 3. impaired fasting sugar (fasting blood sugar levels in the range of ≥ 100 to ≤125 mg/dl) 4. being mentally competent and able to understand all study requirements and sign the informed consent form. exclusion criteria: 1. patients with severe liver, renal, cardiac or brain diseases. 2. pregnant or lactating women or women of child bearing potential whom are not practicing a reliable form of birth control (either with iud or with stable usage of oral contraceptives). 3. unable to complete follow up. 4. subjects on any medication that would affect evaluation like statins.

Keywords: blood sugar, lipoproteins, salacia, sesame, prediabetes, hyperlipidemia, herbal supplement
a study to evaluate the efficacy and safety of pf-06480605 in adults with moderate to severe ulcerative colitis

Conditions: Moderate to Severe Ulcerative Colitis

Summary: this phase 2b study is designed to have all subjects go into a 12 week induction period to compare different doses of study drug against placebo. after induction is complete all subjects will receive active therapy for 40 weeks, followed by a 12 week follow up period.


Eligibility criteria:
inclusion criteria:- * a diagnosis of uc for ≥3 months. * participants with moderate to severe active uc as defined by a total mayo score of ≥6, and an endoscopic subscore of ≥2. * active disease beyond the rectum (\>15 cm of active disease from the anal verge at the screening endoscopy). * must have failed or been intolerant to at least one of the following class of medications: steroids, immunosuppressants, anti-tnfs, anti-integrin inhibitors, anti- il-12/23 inhibitors, or jak inhibitors. exclusion criteria: * participants with a diagnosis of ischemic colitis, infectious colitis, radiation colitis, microscopic colitis, indeterminate colitis, or findings suggestive of crohn's disease (eg, skip lesions, fistulae/perianal disease, non-necrotizing granulomas, etc.). * participants with an imminent need for surgery or with elective surgery scheduled to occur during the study * chest radiograph showing abnormalities: the study will accept a chest x-ray or computed tomography scan of the chest examination performed up to 12 weeks prior to screening if available. * 12-lead electrocardiogram (ecg) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results * infected with tuberculosis, (tb): any evidence of untreated latent or active tb infection. * infected with human immunodeficiency virus, (hiv), hepatitis b or c viruses
a multicenter study on atrioventricular regurgitation in transthyretin amyloid cardiomyopathy: definition, prevalence, and prognostic impact.

Conditions: ATTR Amyloidosis With Cardiomyopathy; ATTR-CM; ATTR Amyloidosis Wild Type; Mitral Regurgitation; Tricuspid Regurgitation

Summary: the objective of this prospective registry study is to comprehensively characterize the prevalence, (semi-) quantitative parameters, and associated clinical outcomes of mitral (mr) and tricuspid regurgitation (tr) in patients diagnosed with transthyretin amyloid cardiomyopathy (attr-cm). the study further aims to develop and implement new grading standards for the quantitative assessment of regurgitation severity, tailored to the distinct hemodynamic profile of attr-cm. this approach seeks to address the limitations of current regurgitation severity classifications, which do not adequately reflect the unique pathophysiology of a restrictive phenotype as seen in attr-cm.


Eligibility criteria:
inclusion criteria: * diagnosis of attr-cm according to current diagnostic criteria * comprehensive baseline echocardiographic assessment, including (semi-)quantitative mitral and tricuspid regurgitation (mr/tr) parameters, performed within ±6 months of diagnosis * age ≥ 18 years * willingness to participate in the study and provide informed consent exclusion criteria: * severe aortic valve disease requiring intervention * inability to provide informed consent or participate in study follow-up

Keywords: attr-cm attr amyloidosis tricuspid regurgitation mitral regurgitation
optimizing postoperative nutrition in colorectal surgery

Conditions: Colorectal Cancer; Inflammatory Bowel Diseases; Bowel Ischemia; Malnutrition; Parenteral Nutrition

Summary: major surgical operations of the gastrointestinal tract, such as colorectal resections due to several diseases, lead to significant burden on the human body, which is expressed during the first postoperative hours with an intense inflammatory reaction and consumption of a large amount of energy, increasing nutritional requirements of the patients. therefore, specific protocols have been implemented for the early initiation of oral feeding in patients undergoing colorectal resections. however, it is not feasible for every patient to meet them due to several reasons, such as old age and associated pathophysiological changes, use of opioid drugs for the management of postoperative pain, which is associated with postoperative ileus or nausea, as well as open resection which lead to gastrointestinal impairment during the first postoperative days. the energy deficit that occurs during the early postoperative period, which appears to be associated with adverse clinical outcomes, can be counterbalanced by the administration of parenteral nutrition. however, the conventional way of administration through central venous lines is associated with significant complications. for this reason, administration of parenteral nutrition through a peripheral venous catheter could be used alternatively, which avoids morbidity and has been also effective in maintaining the patients' energy balance, even during the first postoperative hours. therefore, the main purpose of the present study is to investigate the efficacy of the administration of peripheral parenteral nutrition on the postoperative outcomes of patients undergoing colorectal resections. moreover, the correlation of the administration of peripheral parenteral nutrition with the reaction to post-operative stress and with the nutritional status of the patients post-operatively, which are determining factors for the clinical course of these patients, will be investigated.


Eligibility criteria:
inclusion criteria: * colorectal resection surgery * open or laparoscopic procedures * anastomosis, end-stoma or defunctioning stoma formation after colorectal resection * elective or emergent procedures * diagnosis of colorectal cancer, inflammatory bowel disease, diverticular disease and bowel ischemia * small bowel resection combined with colorectal resection * age \> 18 years old * informed consent exclusion criteria: * small bowel resection without colorectal resection * end-stoma or defunctioning stoma formation without colorectal resection * preoperative parenteral nutrition administration * administration of parenteral nutrition after the 4th postoperative day * peripheral parenteral nutrition initiation after the 1st postoperative day * contraindication for peripheral parenteral nutrition administration * age \< 18 years old * no informed consent

Keywords: peripheral parenteral nutrition postoperative outcomes colorectal surgery colorectal cancer inflammatory bowel disease bowel ischemia
a study of ly3022855 in combination with durvalumab or tremelimumab in participants with advanced solid tumors

Conditions: Solid Tumor

Summary: the main purpose of this study is to evaluate the safety of the colony-stimulating factor 1 receptor (csf-1r) inhibitor ly3022855 in combination with durvalumab or tremelimumab in participants with advanced solid tumors.


Eligibility criteria:
inclusion criteria: * must have histological or cytological evidence of a diagnosis of cancer that is not amenable to curative therapy. * part b: must have a type of malignancy that is being studied. * part a and part b (ovarian cancer cohort only): must be willing to undergo pretreatment and on-treatment core needle or excisional tumor biopsies. * part a (all cohorts): have the presence of measureable and /or nonmeasurable disease as defined by the response evaluation criteria in solid tumors (recist) 1.1. * part b (all cohorts): have the presence of measurable disease as defined by the recist 1.1. * have adequate normal organ and marrow function, including the following: * absolute neutrophil count ≥ 1.5 x 10⁹/liters (l) (1500/cubic millimeters) * platelet count ≥ 100 x 10⁹/l (≥100,000/cubic millimeters) * hemoglobin ≥9 grams per deciliter or ≥5.6 millimoles per liter * serum creatinine ≤1.5 × institutional upper limit of normal (uln) * total bilirubin ≤1.5 × institutional uln * aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤2.5 × institutional uln or ≤5 × institutional uln for participants with liver metastases * international normalized ratio (inr) or prothrombin time (pt) inr ≤1.5 × institutional uln or pt ≤5 seconds above institutional uln * ptt or activated partial thromboplastin time (aptt) ≤5 seconds above institutional uln * thyroid stimulating hormone (tsh) or free thyroxine (t4) within the normal limits * have a performance status of 0 or 1 on the eastern cooperative oncology group (ecog) scale. exclusion criteria: * are currently receiving or have had prior use of immunosuppressive medication within 28 days before the first dose of study drug, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 milligrams/day of prednisone, or an equivalent corticosteroid. * have symptomatic central nervous system (cns) malignancy or metastasis. * have had any prior grade ≥3 immune-related adverse event (irae) while receiving any previous immunotherapy agent, have any unresolved irae grade \>1, or any irae that led to the permanent discontinuation of prior immunotherapy. * have experienced a grade ≥3 ae or a neurologic or ocular ae of any grade while receiving prior immunotherapy.
mandibular muscle energy technique in patients with mandibular joint pathology and bruxism

Conditions: Temporomandibular Joint Disorders; Bruxism; Pain Threshold; Kinesiophobia

Summary: this is a randomized, controlled, double-blind clinical trial. the main objective is to evaluate the immediate effect of the mandibular muscle-energy technique on pain, functionality and kinesiophobia in subjects suffering from temporomandibular dysfunction and bruxism. in the experimental group the jaw muscle-energy technique will be applied and in the control group a placebo technique will be applied. the intention is to see the immediate effects of the intervention and two evaluations of the pre- and post-intervention outcome variables and a follow-up of kinesiophobia one week later will be performed.


Eligibility criteria:
inclusion criteria: * patients who agree to participate in the study by signing the informed consent form. * patients attending maxillofacial consultation with pain, temporomandibular dysfunction and bruxism. * pain of at least 3 months of evolution. exclusion criteria: * patients with congenital malformations or cervical spine pathology. * infectious or inflammatory disease in its acute phase. * patients with vertigo or vestibular alterations. * if there is a contraindication to the technique or phobia on the part of the patient. * physiotherapy treatment (manual therapy or electrotherapy) in the last month before their incorporation in the study. * pharmacological treatment (analgesics, relaxants and anti-inflammatory drugs) in the last 24 hours before the initial evaluation.
comparison of different volume of steroid hydrodilatation in treating patients with adhesive capsulitis

Conditions: Adhesive Capsulitis

Summary: this study was conducted to compare the efficacy of low volume steroid hydrodilatation with high volume steroid hydrodilatation under ultrasonographic guidance for treating adhesive capsulitis

adhesive capsulitis is a common cause of shoulder pain, and the efficacy of most interventions is limited. this study was conducted to compare the efficacy of low volume steroid hydrodilatation with high volume steroid hydrodilatation under ultrasonographic guidance for treating adhesive capsulitis design: a prospective, double-blinded, randomized, clinical trial patient and methods: patients with adhesive capsulitis for at least 3 months were enrolled and randomly allocated into group 1 (10cc steroid hydrodilatation under ultrasonographic guidance ) and group 2 (20cc steroid hydrodilatation). the patients were evaluated before treatment and were reevaluated 0, 6, and 12 weeks after the beginning of the treatment. outcomes measures included a pain scale (visual analog scale), range of motion, shoulder pain and disability index

Eligibility criteria:
inclusion criteria: 1) age 35-65 years (to prevent the inclusion of patients with secondary ac), 2) onset of shoulder stiffness since over a month, and 3) limitation in the passive range of motion (rom) over 30° when compared with the contralateral side in at least two of these three movements: forward flexion, abduction, or external rotation. exclusion criteria: 1. ultrasound findings of rotator cuff tears, 2) plain radiography findings of significant glenohumeral joint arthritis, 3) accompanying cervical radiculopathy, 4) systemic inflammatory joint disease, 5) intraarticular injection into the glenohumeral joint within the past 3 months, 6) history of surgery on the affected shoulders, 7) regular use of systemic non-steroidal anti-inflammatory drugs or corticosteroids, and 8) allergy to corticosteroid or lidocaine.

Keywords: adhesive capsulitis
clinical study of perioperative sleep disorders in cardiac surgery

Conditions: Sleep Wake Disorders; Esketamine and the Quality of Recovery; Dexmedetomidine

Summary: the aim of this clinical trial is to understand the effects of dexmedetomidine and esketamine on postoperative sleep in patients undergoing cardiac surgery. the main questions it aims to answer are: does dexmedetomidine or esketamine prevent the development of postoperative sleep disturbances? which one works better? the researchers compared dexmedetomidine and esketamine with saline (a drug-free solvent) to see if dexmedetomidine and esketamine prevented the development of postoperative sleep disturbances. participants will: 1. intraoperative continuous infusion of dexmedetomidine, esketamine or saline until the end of surgery 2. postoperative sleep was assessed on the first and third postoperative days using a sleep rating scale


Eligibility criteria:
inclusion criteria: 1. asa class ii-iii, nyha class i-iii, ef ≥ 50% 2. intended to perform cardiac surgery under extracorporeal circulation exclusion criteria: 1. patients undergoing second heart surgery 2. patients with mental retardation, deafness, or other conditions that interfere with normal communication 3. previous neurological or psychiatric disorders 4. patients with a history of sleep disorders 5. alcoholics, drug addicts, or psychotropic substance abusers 6. significant hepatic or renal dysfunction affecting drug metabolism 7. contraindication to the use of dexmedetomidine or esketamine.
phase 1/1b study of mgcd516 in patients with advanced cancer

Conditions: Advanced Cancer

Summary: mgcd516 is a receptor tyrosine kinase (rtk) inhibitor shown in preclinical models to inhibit a closely related spectrum of rtks including met, axl, mer, and members of the vegfr, pdgfr, ddr2, trk and eph families. in this study, mgcd516 is orally administered to patients with advanced solid tumor malignancies to evaluate its safety, pharmacokinetic, metabolism, pharmacodynamic and clinical activity profiles. during the phase 1 segment, the dose and regimen of mgcd516 will be assessed; during the phase 1b segment, the clinical activity of mgcd516 will be evaluated in selected patient populations. patients anticipated to be enrolled in phase 1b will be selected based upon having a tumor type, including but not limited to, non small cell lung cancer and head and neck cancer positive for specific activating met, ntrk2, ntrk3, or ddr2 mutations, met or kit/pdgfra/kdr gene amplification, selected gene rearrangements involving the met, ret, axl, ntrk1, or ntrk3 gene loci, or having loss of function mutations in the cbl gene. in addition patients with clear cell renal cell carcinoma refractory to angiogenesis inhibitors or metastatic prostate cancer with bone metastasis will be enrolled.

during the phase 1 segment, the dose and regimen of mgcd516 will be assessed. during the phase 1b segment, the clinical activity of mgcd516 will be evaluated in selected patient populations. patients anticipated to be enrolled in phase 1b will be selected based upon the following cancer diagnosis: non-small cell lung cancer with genetic alterations in met, axl, ret, trk, ddr2, kdr, pdgfra, kit or cbl. head and neck squamous cell carcinoma with genetic alterations in met. clear cell renal cell carcinoma refractory to angiogenesis inhibitors. metastatic prostate cancer with bone metastases. other cancer diagnosis having a selected genetic alteration in mgcd516 target rtks.

Eligibility criteria:
inclusion criteria: * metastatic or unresectable solid tumor malignancy * standard treatment is not available * adequate bone marrow and organ function exclusion criteria: * history of a significant cardiovascular illness * prolonged corrected qt (qtc) interval * left ventricular ejection fraction \< 40% * symptomatic or uncontrolled brain metastases * other active cancer

Keywords: mgcd516 met axl ret trk ntrk ddr2 kdr vegfr pdgfra kit tyrosine kinase inhibitor nsclc non-small cell lung cancer head and neck cancer renal cell carcinoma prostate cancer phase 1 cbl sitravatinib