Kornimate/medical-research-clean huggingface dataset:
evaluation of esthetic performance of resin infiltration technique on enamel lesions

Conditions: Tooth Demineralization

Summary: the purpose of this study is to evaluate the esthetic performance of resin infiltration technique on superficial hypo-mineralized and demineralized enamel lesions of anterior teeth

the teeth that meet the inclusion criteria will be cleaned from debris and clinical intra-oral photos of the lesions will be taken before and after the treatment. resin infiltration technique will be performed according to manufacturer's instructions under rubber-dam isolation. intra-oral photos will be taken directly after infiltration (1 day), and 1 week and 6 months later. the system of the commission internationale de l'eclairage (cie) involving 3 color parameters: lightness (l), red/ green chromaticity (a), and yellow/blue chromaticity (b), will be used to assess the extent and durability of color and lightness changes between lesion and sound enamel areas before and after resin infiltration. the extent of assimilation and durability of effect will be assessed by comparing cie l\*a\*b data collected before infiltration (baseline), directly after infiltration (1 day), and 1 week and 6 months later. the color assessments were standardized using a spectrophotometer (spectroshade, italy). lesion areas will be measured for each time point by using an image analysis toolkit (imagej, national institutes of health, bethesda, md.). multifactorial analysis of variance with repeated measures will be used for statistical analyses.

Eligibility criteria:
inclusion criteria: * patients and parents of patients who accept to participate and sign the informed consent. * at least one non-cavitated anterior teeth with a superficial discoloration on enamel due to demineralization or hypo mineralization * fully erupted anterior teeth with closed apices. exclusion criteria: * patients and parents of patients who accept to participate. * teeth having absence of active cavitated-caries lesions, root canal treatment or restorations * teeth with icdas code 3 lesions (localized enamel breakdown due to caries with no visible dentin) * teeth that have a previously esthetic procedure (e.g. bleaching) * patients who are not in cooperation with the procedure. * fully erupted teeth with open apices

Keywords: image analysis
effect of environment on the central and peripheral nervous system

Conditions: Rumination

Summary: the main goal of this study is to understand how different environments influence both mental responses, like overthinking (rumination), and physical reactions, such as heart rate and blood pressure, after a challenging task.

this study aims to explore the restorative effects of nature exposure on rumination- a mental process that affects attention-and cardiovascular responses to a challenging task. a total of 95 participants will be randomly assigned to either a built or natural environment. each participant will take part in a 2.5-hour session. initially, an electrocardiogram (ecg) will be attached to measure heart activity. participants will then engage in a 30-minute task designed to immerse them in their assigned environment (the abc engagement task). following this, they will have a 10-minute period of quiet relaxation to establish baseline cardiovascular measures. after baseline, participants will complete a challenging task (the remote associates test (rat)), which is designed to induce sympathetic arousal. afterward, they will rest quietly for another 10 minutes to monitor cardiovascular recovery. finally, participants will complete post-task surveys through qualtrics, assessing their state of rumination, perceived difficulty of the task, effort levels, and expectations of success.

Eligibility criteria:
inclusion criteria: * individuals 18 years of age or older. exclusion criteria: * individuals with a history of cardiovascular disease or disorders, those who are pregnant, or are taking medications which may alter/affect cardiovascular function.

Keywords: rumination, nature exposure, respiratory sinus arrhythmia, blood pressure
study of a jak3 inhibitor for the prevention of acute rejection in kidney transplant patients

Conditions: Kidney Transplantation

Summary: a new immunosuppressive drug, based on the inhibition of an important enzyme in the immune system called jak3, is being developed by pfizer to prevent transplant rejection. in this research study, a jak3 inhibitor or cyclosporine will be given to new kidney transplant patients for 12 months. patients will be assigned to one of three treatment groups after receiving a kidney transplant. two of the treatment groups will receive 2 different dosing regimens of the jak3 inhibitor that will be taken by mouth. the third treatment group will be a standard-of-care control arm. patients will continue to take the assigned study medication for 12 months as well as other standard transplant medications such as prednisone.


Eligibility criteria:
inclusion criteria: * recipient of a first-time kidney transplant * between the ages of 18 and 70 years, inclusive exclusion criteria: * recipient of any non-kidney transplant

Keywords: immunosuppression jak3 inhibitor kidney transplantation.
intraoperative lidocaine infusion as a sole analgesic versus morphine in laparoscopic gastric bypass surgery

Conditions: Pain, Postoperative

Summary: postoperative opioid-centric pain management strategies in obese patients are accompanied by the possible development of; opioid-induced ventilatory impairment (oivi) and hypoxemia. this presents as sedation and respiratory depression, combined with upper airway obstruction and hypercapnia. if it remains undetected and untreated, it can result in increased perioperative morbidity and mortality.thus, an increased interest in the use of non-opioid analgesic adjuncts has been prompted. intra-operative intravenous lidocaine infusion has analgesic, anti-inflammatory, anti-hyperalgesic, opioid-sparing effects with an enhanced recovery after surgery (eras) profile. its postoperative analgesia may last after reduction of its plasma concentration. so, lidocaine could be a good alternative in bariatric surgery. lidocaine has been studied as part of an opioid-free multimodal analgesia in morbidly obese patients. also, its use in bariatric surgery showed a decrease in postoperative opioid use and improvement in the quality of recovery.

compare the postoperative analgesic effect of intraoperative lidocaine infusion (study group) used as a sole analgesic agent, to the intraoperative intravenous morphine (control group) in laparoscopic gastric bypass surgery.

Eligibility criteria:
inclusion criteria: * asa physical status i- ii * body mass index (bmi) ˃ 35 * scheduled to undergo laparoscopic gastric bypass exclusion criteria: * patients' refusal * hypersensitivity to the study medications * patients with known history of; hepatic disease, renal dysfunction * severe renal impairment (egfr \<30ml/min/1.73m2) * heart failure; left ventricular ejection fraction than 35% * any cardiac dysrhythmias; adam-stokes syndrome; wolff- parkinson-white syndrome, atrio-ventricular block with heart rate below 50 bpm * chronic pain * concomitantly taking beta blocking drugs •substance abuse disorder * chronic opioid use.

Keywords: lidocaine morphine analgesia
study of wa-ng telescope prosthesis in patients with end-stage age-related macular degeneration

Conditions: Age Related Macular Degeneration

Summary: this is a pilot study to evaluate the safety of the model wa-ng telescope prosthesis in patients with bilateral moderate to profound central vision impairment due to end-stage age-related macular degeneration.

patients will be screened for eligibility and informed consent will be obtained from those who meet screening criteria and are interested in participating in the study. eligible patients will be examined preoperatively to obtain a medical history and to establish a baseline for ocular condition. baseline measurements will include successful use of an external telescope. postoperatively, patients will undergo ophthalmic evaluation at regular intervals as specified in this protocol and will be required to return for 6 to 10 additional visits for vision training with a low vision specialist.

Eligibility criteria:
inclusion criteria: * bi-lateral, stable, moderate to profound (20/80 to 20/800) central vision impairment due to bilateral scotoma associated with end-stage macular degeneration, defined as retinal finds of bilateral, geographic atrophy or disciform scar with foveal involvement. phakic in the operative eye. must achieve a 5 letter improved with external telescope simulator. more medical exclusion criteria: * evidence of active cnv or any ophthalmic pathology that compromises peripheral vision of fellow eye or predisposes eye rubbing. previous intraocular of corneal surgery of any kind in operative eye. retinal disease, optic nerve disease, diabetic retinopathy, retinal tears, or any intraocular tumor or medical or ophthalmic condition that in the opinion of the investigator renders the subject unsuitable for participation.

Keywords: macular degeneration visual impairment implantable telescope
e-vita: european-japanese virtual coach for smart ageing (wave ii)

Conditions: Older Adults; Quality of Life

Summary: the study is a multicentre proof-of-concept. the general objective of the e-vita project is to develop a personalized virtual coach capable of interacting with its elderly interlocutor. the experimentation will be carried out in 4 sites: italy, france, germany and japan.

the general objective of the e-vita project is to improve well-being for older adults and thereby promote active and healthy ageing, contribute to independent living, and reduce risks of social exclusion of older adults by making use a virtual coach by 240 healthy older adults recruited from europe (france, germany and italy) and japan. the study is a multicenter proof-of-concept study with a duration of the intervention of six months. the multidisciplinary consortium collaborating in this project will develop an innovative ict-based virtual coaching system to detect subtle changes in physical, cognitive, psychological and social domains of older adult's daily life. the e-vita virtual coach will thus provide personalized recommendations and interventions, for sustainable wellbeing in a smart living environment at home. the different components of the system are: * coaches, consisting of social robots, that will interact with the users and are guided by apps; * sensors (both wearable and domestic) to detect physiological parameters, physical activities, and behavior of the users; these sensors are: the huawei smart band (wearable), the neu device (wearable), and the deltadore system (domestic). * smartphones (the chatbot to provide insights, suggestion, and stimulation about healthy nutrition and physical exercise; the social platform to encourage users to share their interests). these components (coaches, sensors, chatbot and social platform) together with a main software named use cases configurator (ucc) constitute the virtual coach.

Eligibility criteria:
inclusion criteria: * able to stand and walk unaided; * no acute or untreated medical problems; * montreal cognitive assessement test (moca) ≥ 22; * geriatric depression scale (gds) \< 9; * short performance physical battery (sppb) ≥ 7 * clinical frailty scale score between 2 and 4. exclusion criteria: * use of active implant or not-implant medical devices; * allergy to nichel; * a myocardial infarction or stroke within 6 months; * painful arthritis, spinal stenosis, amputation, painful foot lesions or neuropathy limiting balance and mobility; * uncontrolled hypertension; * pacemaker or implantable cardioverter defibrillator;

Keywords: virtual coach older adults technological system quality of life usability well-being
a brentuximab vedotin trial for patients who have previously participated in a brentuximab vedotin study

Conditions: Disease, Hodgkin; Lymphoma, Large-Cell, Anaplastic; Lymphoma, Non-Hodgkin

Summary: this is a multicenter, open-label study to evaluate the safety and efficacy of treatment with brentuximab vedotin (sgn-35) in patients who have previously participated in an brentuximab vedotin study.

this is a multicenter, open-label study to evaluate single-agent brentuximab vedotin (sgn-35) treatment in patients who previously participated in a brentuximab vedotin study, including studies sgn35-005 (nct01100502), sgn35-007 (nct01026233), and sgn35-008 (nct01026415). patients treated on this study (sgn35-006) could re-enroll on study if eligible. the study consisted of 2 arms, as follows: * retreatment arm: patients with cd30-positive hematologic malignancies who experienced a complete remission (cr) or partial remission (pr) with previous brentuximab vedotin treatment on a clinical study and subsequently experienced disease progression or relapse. the purpose of this arm was to assess safety and efficacy of retreatment with brentuximab vedotin. * extension treatment arm: patients with either cd30-positive hematologic or nonhematologic malignancies who completed treatment in a prior brentuximab vedotin study without unacceptable toxicity and experienced clinical benefit as assessed by the investigator. the purpose of this arm was to enable patients who participated in certain prior brentuximab vedotin trials to receive extension treatment and to assess patient safety and survival in the extension treatment setting.

Eligibility criteria:
inclusion criteria: * participated in a previous brentuximab vedotin study. * cd30-positive hematologic malignancy. * at a minimum, experienced clinical benefit in the prior brentuximab vedotin study. for retreatment, patients must have previously achieved either complete or partial remission with brentuximab vedotin and experienced disease progression after discontinuing the prior brentuximab vedotin study. exclusion criteria: withdrew consent to participate in any prior brentuximab vedotin study.

Keywords: antibodies, monoclonal antibody-drug conjugate antigens, cd30 drug therapy hematologic diseases immunotherapy monomethylauristatin e
estimation study to assess the effect of severe renal impairment and end-stage renal disease hemodialysis on the pharmacokinetics of evolocumab

Conditions: Hyperlipidemia; Mixed Dyslipidemia

Summary: the primary objective of this study was to evaluate the pharmacokinetics of evolocumab after a single 140 mg subcutaneous (sc) dose in aduts with normal renal function or severe renal impairment or end-stage renal disease (esrd) receiving hemodialysis.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) of ≥ 18 and ≤ 35 kg/m² at screening. * subjects will have low-density lipoprotein cholesterol (ldl-c) of 70-190 mg/dl (inclusive) and on statin therapy. * other inclusion criteria may apply. exclusion criteria: * subject with current or prior history of statin intolerance * subject has previously received evolocumab (amg 145) or any other investigational therapy directed against pcsk9 * known substance abuse (eg, alcohol, licit or illicit drugs) within 12 months of day -1 * testing positive for alcohol and/or drugs-of-abuse at screening, day -1, or day 1 (alcohol only) * history of hypersensitivity or allergic reaction to mammalian-derived drug preparations * known sensitivity to any of the active substances or their excipients to be administered during dosing, eg, carboxymethylcellulose * other exclusion criteria may apply.

Keywords: subjects with normal renal function or severe renal impairment (ri) or end stage renal disease (esrd) receiving hemodialysis
dynamic preload dependence indices in laparoscopic surgery

Conditions: Laparoscopic Surgery

Summary: a goal-directed fluid management is definitely beneficial in high risk surgery. the fluid administration can be directed by cardiac output monitoring which evaluate the response to repeated fluid challenge or by preload dependence indices. these indices are not well validated in laparoscopic surgery while pneumoperitoneum can alter venous return or pulmonary compliance. the aim of the study is to study the validity of pulse pressure variation to predict fluid response under laparoscopic conditions and to describe the effect of the pneumoperitoneum on the dynamic preload indicators, i.e. the pulse pressure variation, the plethysmographic waveform of pulse oximetry variation and the stroke volume variation.


Eligibility criteria:
inclusion criteria: * need to laparoscopic colectomy or hepatic resection * written informed consent exclusion criteria: * cardiac arrhythmia * esophageal and cervical pathologies * radial artery allen test negative * allergy to anesthesic treatment, to egg or soja * severe kidney failure (estimated glomerular filtration rate \< 30 ml/min) * age \< 18 years old * pregnancy

Keywords: preload dependence indices pulse pressure variation plethysmographic waveform of pulse oximetry variation stroke volume variation laparoscopy pneumoperitoneum
prospective record of the use of dabigatran in patients with acute stroke or tia

Conditions: Brain Ischemia With Non-valvular Atrial Fibrillation; Transient Ischemic Attack With Non-valvular Atrial Fibrillation

Summary: the multi-center, prospective prodast study is investigating patients with non-valvular atrial fibrillation (af) who experienced an ischemic stroke or a transient ischemic attack (tia) recently (≤ 1 week) both with and without previous oral anticoagulation. it consists of a baseline visit and a 3 months central follow-up for patients who were discharged with dabigatran, vitamin k-antagonists, antiplatelets only, or no oral antithrombotic treatment at all. thus, data on the use of dabigatran and vitamin k-antagonists in routine clinical practice will be collected to describe how dabigatran is prescribed and used in the population of af patients with recent cerebrovascular events and how these factors influence important outcome and safety events. the utilization of dabigatran will be assessed with regards to treatment persistence, compliance, proportion of patients discontinuing treatment and reason for discontinuation as well clinical endpoints such as major bleeding, stroke or systemic embolism. due to the fact that patients will be treated according to local medical practice it is possible that medication will be changed during the observation period. in the follow-up, data from the first as well as from the second prescribed medication will be used in the study. to explore a long-term effect of anticoagulation, survival up to one year will be assessed.


Eligibility criteria:
inclusion criteria: * age ≥18 years at enrollment * male or female patient willing and able to provide written informed consent for data transmission. for patients who are not legally competent to sign this informed consent for data transmission exceptions/special cases are described in the protocol. * patient with ischemic stroke or tia within the last 7 days. * patient diagnosed with non-valvular af. documentation of af by 12 lead ecg, ecg rhythm strip, monitor print-out, pacemaker/icd electrocardiogram, holter ecg (duration of af episode at least 30 seconds) or written physician´s diagnosis prior to index event needed for all enrolled patients. exclusion criteria: * presence of any mechanical heart valve, or valve disease that is expected to require valve replacement intervention (surgical or non-surgical) during the next 3 months. * current participation in any randomized clinical trial of an experimental drug or device. * women of childbearing age without anamnestic exclusion of pregnancy or not using an effective contraception or nursing mothers.
safety and efficacy of albiglutide in type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to determine the safety, tolerability and efficacy of albiglutide in the treatment of type 2 diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * bmi 20-45kg/m2 exclusion criteria: * nyha class ii to iv heart failure * females who are pregnant, lactating, or less than 6 weeks post-partum

Keywords: diabetes
clinical trial to evaluate the efficacy and safety of yhp1701

Conditions: Hypertension and Hyperlipidemia

Summary: the purpose of this study is to determine superiority of yhp1701 comparing to each monotherapy in patient with hypertension and primary hypercholesterolemia.


Eligibility criteria:
inclusion criteria: * both man and woman who is over 19 years old * patient with dyslipidemia and hypertension exclusion criteria: * ssbp difference is ≥20 mmhg or sdbp difference is ≥10 mmhg * a history of cardiovascular disease * rhabdomyolysis, myopathy * hypertension or hypercholesterolemia due to secondary causes * uncontrolled diabetes * evidence of hepatic or renal disease
multidimensional individualized nutritional therapy for individuals with severe copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: individuals with severe chronic pulmonary disease often life isolated with a high burden of symptoms. nutritional risk and low quality of life are common, and both associated with increased societal cost and poor prognosis. copd is a complex and progressive disease with changing clinical states that influences nutritional status and quality of life in different ways. the primary aim is to improve quality of life for individuals with severe copd. 120 individuals are recruited from the outpatient clinic at nordsjællands hospital in denmark to a randomized controlled trial with two parallel groups (intervention and control). the intervention will last for 3 months comprising four elements including nutritional plan, regular contact, informal caregiver/friendly reminder and a weight dairy. we expect that the intervention will improve quality of life, nutritional status and prognosis.


Eligibility criteria:
inclusion criteria: * ≥ 35 years * severe copd defined as gold grade 2 group b or d or gold grade 3 and 4 group abcd * able to eat orally * live in own home * speak danish or english * undernourished or at risk of undernutrition defined as bmi ≤ 21 kg/m2 if \< 70 years and bmi \<22 kg/m2 if ≥70 years or bmi 21-25 kg/m2 plus nutritional risk (nutritional risk screening score ≥3) if \<70 years and bmi 22-25 kg/m2 plus nutritional risk if ≥70 years * stable phase change: undernourished or at risk of undernutrition (a maximum bmi of 25 kg/m2) determined by nutritional risk screening 2002 or mini nutritional assessment short form according to the protocol published in trials. exclusion criteria: * active solid cancer" defined as cancer diagnosed within the previous six months, recurrent, regionally advanced, or metastatic cancer, cancer for which treatment had been administered within six months or hematological cancer that is not in complete remission * unable to sign informed consent e.g. due to severe dementia. * severe chronic renal failure defined as estimated glomerular filtration rate \< 30 ml/min./1.73 m2 (icd-10 codes n18.4 and n18.5 * severe alcohol abuse (icd-10 codes f10.2 and k70.x).

Keywords: chronic obstructive pulmonary disease health-related quality of life nutrition mental health functional capacity anthropometry