Kornimate/medical-research-clean huggingface dataset:
thermomechanical distraction and social anesthesia in interventional radiology to improve patient satisfaction

Conditions: Pain; Analgesia; Anxiety

Summary: the study will prospectively analyze the analgesic and anxiolytic effects of thermomechanical stimulation (cold and vibration effects) with or without patient selected music preference during non-sedating interventional radiology procedures.

there are wide ranging influences on the perception of human pain. the perception of pain is shaped by physiology, genetic factors, prior experiences, and external ameliorating factors. extensive research has been performed in the pediatric population utilizing distraction as a means of reducing pain, particularly during venipuncture. these methods include medications (i.e. creams, anxiolytics), behavioral distraction (i.e. music, games), cold anesthesia, and thermomechanical stimulation via a cooling/vibrating device; however, fear and anxiety associated with needle procedures does not always resolve with time or age and can result in avoidance of treatment and delays in care. few studies have focused on the impact of non-pharmacologic anxiolytics using thermomechanical stimulation and social anesthesia (i.e. music as a form of distraction) in the adult population. utilizing non-pharmacologic measures is one of the first steps in procedural pain management. a thermomechanical device used in the pediatric population called buzzy (mmj labs, atlanta ga) employs a battery operated, handheld plastic device with a vibrating motor and a mechanism to attach an ice pack. this is used either independently or in combination. most reports of the device demonstrate significant pain relief, but the majority of these completed studies focused on children undergoing venous cannulation. there have been a few cited uses in adult podiatry, dermatology, and pain management. in addition, passive music based intervention have been used in cancer patients undergoing biopsy and surgery, revealing a significant pain reduction effect. the study will prospectively analyze the analgesic and anxiolytic effects of thermomechanical stimulation (cold and vibration effects) with or without patient selected music preference during non-sedating interventional radiology procedures.

Eligibility criteria:
inclusion criteria: * 18-90 years of age exclusion criteria: * prisoners, elderly, minors, pregnant women

Keywords: distraction thermomechanical analgesia music anxiety pain analgesia buzzy interventional radiology ir picc paracentesis
pre-meal protein drink improve glycemic regulation

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to investigate if a pre-meal drink containing proteins can positively influence glycaemic control in patients with type 2 diabetes mellitus. comparison with a placebo is included.


Eligibility criteria:
inclusion criteria: * diagnosed type 2 diabetes mellitus according to who criteria (1999) * age between 30-80 years * non well controlled diabetes with hba1c-levels above 62 mmol/mol exclusion criteria: * pregnant or risk of becoming pregnant * severe disease * psychological disease, dementia or mental disability that makes it impossible to retrieve informed consent of participation * liver disease * kidney malfunction (gfr \<60 or aspartate transaminase (asat)/alanine transaminase (alt) two times higher than the normal interval
fibrates in pediatric cholestasis

Conditions: Chronic Cholestasis

Summary: a study conducted to assess the effect of fibrates on pruritus and biochemical picture in pediatric patients with cholestatic liver diseases.

cholestatic liver disorders include a spectrum of hepatobiliary diseases of diverse etiologies that are characterized by impaired hepatocellular secretion of bile, resulting in accumulation of bile acids, bilirubin and cholesterol.this could result in different clinical features including pruritus, malabsorption and vitamin deficiencies with subsequent coagulation disorders and bone disease. persistence of cholestasis leads to biliary fibrosis which can progress to liver cirrhosis and end-stage liver disease. nuclear receptors (nrs) regulate ligand-activated transcription factor networks of genes for the elimination and detoxification of potentially toxic biliary constituents accumulating in cholestasis. activation of several nrs also modulates fibrogenesis, inflammation, and carcinogenesis as sequelae of cholestasis. hence, it represent attractive targets for pharmacotherapy of cholestatic disorders. several already available drugs may exert their beneficial effects in cholestasis via nr activation eg, ursodeoxycholic acid via glucocorticoid receptor and pregnane x receptor, and rifampicin via pregnane x receptor. unfortunately, some patients may not respond to these medications. fibrates, serum lipid lowering medication, has a stimulation action on proliferator activated receptor alpha. it is a nuclear receptor with an integral role in bile homeostasis. several case reports and pilot studies have demonstrated the efficacy of fibrates in reducing serum biomarkers of cholestasis and liver function abnormalities in patients with incomplete response to ursodeoxycholic acid monotherapy. these results are of interest, because fibrates are attracting increased attention as adjunct therapy for chronic cholestatic liver diseases.

Eligibility criteria:
inclusion criteria: * patient with chronic cholestatic liver disease defined as any condition in which substances normally excreted into bile are retained for more than 6 months. exclusion criteria: * patients with anatomical or mechanical obstructive causes for cholestasis. * cholestatic patients who were suffering from another liver disease. * cholestatic patients who were receiving drugs affecting lipid profile. * patients receiving drugs that interact with fenofibrate (ff) e.g statins and warfarin * patients with non obstructive gall bladder stones were excluded from t gp.

Keywords: pediatric cholestasis, fibrate
hec73543 versus salvage chemotherapy in r/r flt3-itd aml

Conditions: Leukemia, Acute Myeloid (AML)

Summary: a randomized，multicenter, open-label phase iii, clinical study is conducted to evaluate the clinical benefit clifutinib in chinese patients with relapsed/ refractory (r/r) flt3-mutated aml as shown with overall survival compared to salvage chemotherapy, and also to investigate the efficacy of clifutinib as assessed by cr/crh rate in these subjects.

subjects who are at least 18 years and above at the time of signing informed consent may participate in this study. subjects will be randomized in a 2:1 ratio to receive clifutinib or salvage chemotherapy. subjects will enter the screening period up to 28 days prior to the start of treatment. prior to randomization, a salvage chemotherapy regimen will be pre-selected for each subjects; options will include low-dose cytarabine (lodac), azacitidine, decitabine, ara-c±ida or flag±ida. the randomization will be stratified by response to first-line therapy and pre-selected salvage chemotherapy. participants will be administered treatment over continuous 28-day cycles. after treatment discontinuation, participants will have a end-of-treatment visit within 7 days after treatment discontinuation, followed by a 30-day follow-up for safety. after that, long term follow-up will be done every 90 days.

Eligibility criteria:
inclusion criteria: * subject is ≥ 18 years of age at the time of obtaining informed consent. * subject has a diagnosis of primary acute myeloid leukemia (aml) or aml secondary to myelodysplastic syndrome (mds) according to who classification; * subject is refractory to or relapsed after first-line aml therapy (with or without hematopoietic stem cell transplant ) * subject is positive for flt3 mutation in bone marrow or whole blood as determined by the central lab * subject has an eastern cooperative oncology group (ecog) performance status of 0-2 * subject is eligible for pre-selected salvage chemotherapy at the investigator's discretion exclusion criteria: * subject has received prior treatment with other flt3 inhibitors * subject has aml that has relapsed after or is refractory to more than 1 line of therapy * subject has an active uncontrolled infection * subject is known to have human immunodeficiency virus infection * subject has any condition which, in the investigator's opinion, makes the subject unsuitable for study participation
effect of bile acids on satiety, cell function and body weight in patients with obesity and abnormal satiety phenotype

Conditions: Obesity; Healthy

Summary: the purpose of this research is to study the effect of the study drug (a conjugated bile acid dietary supplement) or placebo on cell function, hormones and body weight.


Eligibility criteria:
inclusion criteria: i. patients with obesity bmi\> 30 kg/m2 and hungry gut phenotype. ii. age: 18-65 years. iii. gender: men or women. women of childbearing potential will have a negative pregnancy test before initiation of medication and within 48 hours of receiving radioisotope for the gastric emptying study. iv. otherwise healthy individuals or with controlled chronic medical conditions such as type 2 diabetes. exclusion criteria: i. structural or metabolic diseases/conditions that affect the gastrointestinal system, or functional gastrointestinal disorders. for screening the bowel disease questionnaire will be used to exclude subjects with irritable bowel syndrome. ii. subjects with stool type bristol classification 6-7 per bowel disease questionnaire. iii. female subjects who are pregnant or breast-feeding. iv. use of anti-obesity medications upon screening (ie., orlistat, phentermine-topiramate, liraglutide, semaglutide, bupropion-naltrexone), metformin or glp-1 analogs. v. individuals who are currently on treatment for unstable cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, endocrine, and psychiatric disease. vi. any acute or chronic condition or other disease that, in the opinion of the investigator, would limit the subject's ability to complete and/or participate in this clinical study. vii. significant untreated psychiatric dysfunction based upon screening. hospital anxiety and depression inventory (had) score \>11 on depression scale, a self-administered alcoholism screening test (audit-c) score \>4 in men or \>3 in women, and difficulties with substance or eating disorders determined by the questionnaire on eating and weight patterns (binge eating disorders and bulimia); will mean the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up. the provider will review the patient's alcohol intake over the past few months to confirm accuracy and determine study eligibility. vii. principal investigator discretion.

Keywords: bmi of 30 or greater
clinical and functional outcomes 2 years after acl repair and internalbrace ligament augmentation in comparison with acl reconstruction

Conditions: Injury of the Anterior Cruciate Ligament (ACL)

Summary: the aim of this study is to assess the clinical, biomechanical and functional outcome 2 years after anterior cruciate ligament (acl) repair and internalbracetm augmentation now in direct comparison to acl reconstruction and to identify potential deficits compared to the contralateral healthy side as well as with a knee-healthy age-matched collective. in addition, socio-economic aspects such as return to work and sports and treatment cost will be compared between both techniques.

injury of the anterior cruciate ligament (acl) is one of the most common injuries of the knee. since may 2016, patients with proximal ruptures of the acl have been treated with direct repair and internalbracetm ligament augmentation at the university hospital of basel. the remodelling of hamstring grafts used for acl reconstruction is completed at the earliest 2 years after the surgery. the aim of this study is to assess the clinical, biomechanical and functional outcome 2 years after anterior cruciate ligament (acl) repair and internalbracetm augmentation now in direct comparison to acl reconstruction and to identify potential deficits compared to the contralateral healthy side as well as with a knee-healthy age-matched collective. in addition, socio-economic aspects such as return to work and sports and treatment cost will be compared between both techniques.

Eligibility criteria:
inclusion criteria: * patients: 2 years since acl reconstruction with autologous hamstring tendon * control subjects: no previous injury to the meniscus or the ligament apparatus of the knee exclusion criteria: * bmi \> 35 kg / m2 * neuromuscular diseases that affect lower limb movement * inability to give informed consent * patients: previous injury or surgical treatment of the opposite side within the past 2 years and the injured leg within the past 6 months; other pathologies that affect the mobility of the knee

Keywords: acl rupture primary acl repair acl reconstruction using autologous hamstring tendons internalbracetm ligament augmentation
study of cadonilimab combined with bevacizumab and standard chemotherapy as first line therapy in unresectable pleural mesothelioma

Conditions: Pleural Mesothelioma

Summary: cadonilimab, a tetravalent bispecific antibody targeting pd-1 and ctla-4, is designed to retain the efficacy benefit of combination of pd-1 and ctla-4 and improve on the safety profile of the combination therapy. the aim of this study is to evaluate the efficacy and safety of cadonilimab in combination with bevacizumab and standard chemotherapy as first line therapy in unresectable pleural mesothelioma.


Eligibility criteria:
key inclusion criteria: 1. histologically confirmed pleural malignant mesothelioma not eligible for curative surgery 2. eastern cooperative oncology group (ecog) performance status of 0 or 1. 3. no previous systemic anti-tumor treatment for advanced/metastatic disease 4. measurable disease as per mrecist v1.1 for assessment of response in malignant pleural mesothelioma. 5. adequate haematological, renal and liver function. key exclusion criteria: 1. primitive peritoneal, pericardial and tunica vaginalis testis mesothelioma. 2. active, untreated central nervous system (cns) metastasis. 3. use of chinese herbal medicine or immunomodulatory agents with anti-tumor indications within 14 days prior to the first dose of study treatment. 4. known active autoimmune diseases. 5. presence of other uncontrolled serious medical conditions.

Keywords: bispecific antibody
evaluation of irdye800cw-nimotuzumab in lung cancer surgery

Conditions: Lung Cancer

Summary: the purpose of this study is to determine the safety, optimal dose and imaging time of the investigational product, irdye800cw-nimotuzumab for use as a near infrared imaging probe for image-guided surgery during lung cancer resection. irdye800cw-nimotuzumab targets cancer cells over-expressing egfr, allowing tumors to be visualized and may help surgeons better identify cancer during surgery.


Eligibility criteria:
inclusion criteria: * surgically resectable stage i and ii non-small cell lung cancer * able to give informed consent * age ≥ 18 and ≤ 80 years old * adequate cardiopulmonary reserve to undergo lung resection as determined by operating surgeon * no prior history of malignancy * no neoadjuvant therapy * karnofsky performance status of at least 70% or eastern cooperative oncology group (ecog)/zubrod level 0-2 * hemoglobin (hgb) ≥ 90 g/l * white blood cell count (wbc) \> 3 x 109/l * platelet count (plt) ≥ 100 x 109/l * serum creatinine ≤ 1.5 times upper reference range exclusion criteria: * received anti-egfr antibody therapy (cetuximab, panitumumab, necitumumab) within 60 days prior to trial drug * pregnant or nursing * known history of hypersensitivities or allergic reactions to antibodies or nso derived products * myocardial infarction (mi); cerebrovascular accident (cva); uncontrolled congestive heart failure (chf); significant liver disease; or unstable angina within 6 months prior to enrollment * subjects receiving class ia (quinidine, procainamide) or class iii (dofetilide, amiodarone, sotalol) antiarrhythmic agents * subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis * any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug

Keywords: irdye800cw nimotuzumab lung cancer egfr near infrared image guided surgery optical imaging
efficacy of proprioceptive neuromuscular facilitation in older women with gonarthrosis

Conditions: Osteoarthritis Knee

Summary: to evaluate the effectiveness of the method proprioceptive neuromuscular facilitation (pnf) as physical therapy approach to the reduction of pain and improvement in functional performance and quality of life in women with knee osteoarthritis.

patients will be divided into two groups: group perform proprioceptive neuromuscular facilitation and other group submit performing resistance exercises.

Eligibility criteria:
inclusion criteria: * women; * age between 50 and 80 years; * clinical diagnosis of osteoarthritis of knees ; * patients with presence of at least 90 ° range of motion of knee flexion ; * do not practitioners of physical exercise and physical therapy during the period of participation in the survey exclusion criteria: * diagnosis of other rheumatological and neurological diseases ; * orthopedic surgery history in the lower limbs ; * individuals with muscle strength of the lower limbs \<3 ; * cognitive impairment or neurological disease that compromises the understanding and implementation of the protocol (mini mental state examination \<18 for the illiterate and \<24 for others); * body mass index ≥ 30.0 (obesity , according to the world health organization ) . * individuals classified as physical activity level "very active" by the ipaq (international physical activity questionnaire ) .

Keywords: proprioceptive neuromuscular facilitation (pnf ) resistance exercise
llif plus posterior decompression for severe lumbar spinal stenosis

Conditions: Lumbar Spine Degeneration; Lumbar Spinal Stenosis

Summary: lateral lumbar interbody fusion (llif), as a minimally invasive technique, is an indirect decompression technique, and its decompression effect is not as thorough as traditional posterior decompression surgery. for certain patients with severe lumbar stenosis, additional posterior decompression is required. however, whether additional posterior decompression is necessary for these patients is unknown. radiographic predictors of failed indirect decompression via llif is unknown. in current randomized, controlled trial , the investigators compare the clinical outcomes of patients with severe lumbar stenosis who received llif plus posterior decompression and those without posterior decompression.

the current randomized controlled trial consists of two groups. patients included in the study are with schizas's stenosis grades c. patients in one group received transpsoas lateral lumbar interbody fusion. patients in the other group received transpsoas lateral lumbar interbody fusion plus posterior decompression. patients will be followed for one year. clinical outcomes of the two groups will be compared. and radiographic predictors of failed indirect decompression via llif will be analyzed.

Eligibility criteria:
inclusion criteria: * male and female patients who are 50 - 80 years of age. * patients who present with symptomatic grade i or ii degenerative spondylolisthesis at one or two contiguous lumbar levels between l1 and l5 and who are surgical candidates for interbody lumbar fusion surgery; symptoms should include radiculopathy and/or neurogenic claudication with or without back pain. * patients who have been unresponsive to at least 6 months of conservative treatments or who exhibit progressive neurological symptoms in the face of conservative treatment. * patients who understand the conditions of enrollment and are willing to sign an informed consent to participate in the study. exclusion criteria: * patients with lumbar pathologies requiring treatment at more than two levels. * patients who have had previous lumbar fusion surgery. * patients with congenital lumbar stenosis. * patients with radiographic confirmation of grade iv facet joint disease or degeneration. * patients with noncontained or extruded herniated nucleus pulposus. * patients with active local or systemic infection. * patients with rheumatoid arthritis or other autoimmune disease. * patients who cannot undergo magnetic resonance imaging (mri). * patients who are mentally incompetent. * patients with bmi over 30kg/m2 or less than 18 kg/m2.

Keywords: indirect decompression lateral interbody fusion lumbar direct decompression
genetic epidemiology of responses to antihypertensives

Conditions: Cardiovascular Diseases; Heart Diseases; Hypertension

Summary: to determine whether measured variation in genes coding for components of vasoconstriction and volume regulating systems predict interindividual differences in blood pressure response to therapy with a thiazide diuretic, hydrochlorothiazide, or an angiotensin ii receptor blocker, candesartan, in hypertensive african-americans (n=300 treated with each drug) and in hypertensive european americans (n=300 treated with each drug).

background: essential hypertension is a common disorder that contributes to morbidity, mortality, and cost of health care, especially among african-americans. although a single-drug therapy is commonly prescribed for treatment of hypertension, blood pressure levels are controlled in some individuals but not in others. the study has the potential to identify genes contributing to the etiology of interindividual differences in blood pressure response to diuretic therapy in african-americans and european americans. design narrative: hypertensive adults were treated with the diuretic hydrochlorothiazide, 25 mg/day, for four weeks; or with the angiotensin ii receptor blocker candesartan, 16 mg/day for 2 weeks followed by 32 mg/day for 4 weeks. interindividual variations in blood pressure responses and in candidate genes coding for components of systems regulating vasoconstriction and volume were measured. in addition, a panel of 500,000 single nucleotide polymorphisms genome-wide was measured in subsets of the most extreme responders and nonresponders to each drug for genome-wide association of analyses.

Eligibility criteria:
primary (essential) hypertension

Keywords: hypertension pharmacogenetics hydrochlorothiazide candesartan