Kornimate/medical-research-clean huggingface dataset:
masitinib in first line treatment of gastro-intestinal stromal tumor (gist)

Conditions: Gastrointestinal Stromal Tumors

Summary: masitinib in first line treatment of gastro-intestinal stromal tumor (gist)

masitinib is a selective tyrosine kinase inhibitor with potent activity against wild-type c-kit, the juxta membrane domain of c-kit, and pdgfr. in addition to its direct inhibitory action against these kinase targets, masitinib is also thought to promote survival via modulation of immunostimulation-mediated anticancer effects and modulation of the tumor microenvironment. the objective of this prospective, multicenter, randomized, open-label, active-controlled study is to compare the efficacy and safety of masitinib with respect to imatinib in the first line treatment of gastro-intestinal stromal tumor (gist). treatment will be given until disease progression, limiting toxicity or patient consent withdrawal.

Eligibility criteria:
main inclusion criteria include: * histologically proven, metastatic or locally advanced non resectable, or recurrent post-surgery gist * naïve patient or patient previously treated with imatinib as neoadjuvant/adjuvant who relapsed after imatinib discontinuation * c-kit (cd117) positive tumours detected by immuno-histochemically or pdgfr positive if c-kit negative main exclusion criteria include: * patient previously treated by tyrosine kinase inhibitors except imatinib in case of inclusion criteria * patient treated for a cancer other than gist within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in situ * patient with active central nervous system (cns) metastasis or with history of cns metastasis

Keywords: gastro-intestinal stromal tumor gist metastatic non resectable locally advanced
randomized trial of two ablation catheters in paroxysmal atrial fibrillation

Conditions: Atrial Fibrillation

Summary: atrial fibrillation (af) is a chaotic heart rhythm of the top chambers of the heart. af occurs in up to 10% of the population over the age of 60. it is associated with tiredness, impaired functional capacity and is the cause of up to 10% of strokes. ablation is a procedure performed with small tubes (catheters) that are introduced through the top of the leg. burns are made inside of the heart to treat af. this procedure has been shown to cure 90% of patients with intermittent (paroxysmal) af. the investigators currently use either one of two different catheters to create these burns inside the heart. the investigators do not know which is the best catheter to use in patients with paroxysmal atrial fibrillation. the investigators study will randomly allocate patients to have their ablation performed by either one of the catheters to give a fair comparison between the two. the investigators objective is to study the differences between these two catheters.


Eligibility criteria:
inclusion criteria: * patients with paroxysmal af with a planned ablation procedure exclusion criteria: * prior af ablation * la size greater than 60mm * mechanical prosthetic mvr * hypertrophic cardiomyopathy

Keywords: randomized controlled trial single-blind study catheter ablation
circulating regulatory lymphocytes and outcome of metastatic colorectal cancer patients

Conditions: Metastatic Colorectal Cancer

Summary: aim of the present study is to investigate whether baseline or early post-treatment (one month after treatment commencement) frequency of peripheral t regulatory lymphocytes (tregs or cd4+/cd25high/foxp3+ t cells), known to suppress antitumor immune response, may influence long-term clinical outcome (i.e. radiological response, progression-free survival or overall survival) in metastatic colorectal cancer patients treated with a standard first-line chemotherapy including fluorouracil, irinotecan and bevacizumab


Eligibility criteria:
inclusion criteria: * patients with histologically or cytologically confirmed diagnosis of metastatic colorectal cancer not amenable to surgery * adjuvant treatment ended ≥6 months before the study entry * no prior exposure to irinotecan and/or bevacizumab in the adjuvant treatment * no prior exposure to cytotoxic drugs for the metastatic disease * at least one measurable lesion according to the recist criteria * adequate laboratory parameters (hemoglobin level ≥ 9.0 g/dl; neutrophil count \> 1.5 x 109/l; platelets count \>100 x 109/l; total bilirubin \ 50 ml/min or serum creatinine \<1.5 x unl; urine dipstick of proteinuria \< 2+) * written informed consent. * patients must be accessible for treatment and follow up. exclusion criteria: * untreated brain metastases or spinal cord compression * history of inflammatory bowel disease and/or acute or subacute bowel occlusion. * serious, non-healing wound, ulcer, or bone fracture * evidence of bleeding diathesis or coagulopathy. * uncontrolled hypertension. * clinically significant cardiovascular disease(cerebrovascular accidents ≤ 6 months, myocardial infarction ≤ 6 months, unstable angina, new york heart association (nyha) grade ii or greater congestive heart failure, serious cardiac arrhythmia requiring medication) * current or recent (within 10 days prior to study treatment start) ongoing treatment with anticoagulants for therapeutic purposes. * chronic, daily treatment with high-dose aspirin (\>325 mg/day) or other medications known to predispose to gastrointestinal ulceration. * treatment with any investigational drug within 30 days prior to enrolment. * patients with known allergy to chinese hamster ovary cell proteins, or any of the components of the study medications * other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal and squamous cell carcinoma or cervical cancer in situ * major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study. * pregnant or lactating women. women of childbearing potential with either a positive or no pregnancy test at baseline * substance abuse, medical, psychological or social conditions that may interfere with the participation into the study or the evaluation of study results * patients unable to swallow oral medications
experimental research on deep carious lesion treatment of molars

Conditions: Dental Caries in Children

Summary: maintaining dental pulp vitality is crucial for tooth preservation and functionality. untreated dental caries may lead to pulp necrosis and infection, affecting children's growth and well-being. the first permanent teeth erupt around 6 years old. these are the first molars (fpm), which are frequently affected by caries, soon after their eruption. in the present application, our main goal is to determine whether two treatment groups (mta and theracal) are long-term effective in preserving pulp vitality among children' fpm affected by deep caries.

among the most frequently used materials for pulp capping are calcium hydroxide, mineral trioxide aggregate (mta), and, more recent, theracal. all of them are biocompatible and induce the formation of coronal hard tissue barriers (tertiary reparative dentin). calcium hydroxide, considered for a long time the gold standard of direct pulp capping materials, has excellent antibacterial and remineralisant properties; however, it lacks adhesion, especially at moist dentin, and reparative dentin is less homogenous. mta proved to stimulate protective dentin bridge formation without inflammatory changes and least necrosis. it is also moisture tolerant, but it is more expensive, has poor handling characteristics and slow setting time. theracal bonds to deep moist dentin, has strong physical properties, no solubility, high radioopacity and higher calcium releasing abilities than mta or calcium hydroxide.

Eligibility criteria:
inclusion criteria: * untreated deep uncomplicated carious lesions in first permanent molars (fpm) * absence of clinical diagnosis of pulp exposure * fistula * swelling of periodontal tissues * abnormal tooth mobility * history of spontaneous pain or sensitivity to percussion * healthy appearance of adjacent gingiva * normal tooth color * positive vitality to thermal and electric tests. exclusion criteria: * fpm with previous treatment * fpm with developmental abnormalities (such as enamel hypoplasia, dentinogenesis imperfecta etc.) * children with mental disabilities or systemic diseases.

Keywords: dental pulp deep carious lesions treatment effect
acute metabolic effects of carbohydrate restriction at varying energy levels

Conditions: Healthy

Summary: this study investigates how different low-carbohydrate diets affect metabolism and hunger in overweight adults. we will measure metabolic rates and blood metabolites.

participants will engage in three distinct eating plans: a standard diet with usual carbohydrate and calorie levels, a low-carb diet with typical calories, and a low-carb diet with reduced calories. each diet is followed for a single day, with subsequent monitoring to assess how the body processes food and manages hunger after a meal. the goal is to understand the potential metabolic benefits of reducing carbohydrate intake, either alone or in combination with calorie reduction. this research aims to identify simpler dietary strategies that could improve heart health and assist in weight management without the need for severe calorie restriction or fasting, offering valuable insights for enhancing health outcomes in overweight individuals.

Eligibility criteria:
inclusion criteria: * stable weight within ±3 kg over the past three months * no significant medical history. exclusion criteria: * pregnancy * breastfeeding, * using medications that could affect the study's outcomes * high intake of caffeine and alcohol * existing eating or psychiatric disorders * adherence to strict dietary regimens like veganism * high bmi resulting from significant muscle mass
social robotics for autism

Conditions: Autism; Autism Spectrum Disorder

Summary: socio-pragmatics focuses on the study of language in the context of social interactions. it explores how individuals use language to communicate effectively in specific social situations, taking into consideration the social, cultural and contextual factors that influence communication. socio-pragmatics analyzes linguistic and nonlinguistic behaviors, such as gestures, facial expressions, tone of voice, and posture, to understand intended meaning, social implications, and shared communicative norms. children with autism often present difficulties in social-pragmatic skills. the integration of advanced technologies can play a crucial role in innovative approaches to the development of this skill. in this experimental protocol, an attempt will be made to demonstrate the effectiveness of training through the use of social robots by comparing the performance of an asd group performing a treatment using social robots with a control group performing the same in a traditional manner.


Eligibility criteria:
inclusion criteria: * aged between 8 and 13 years * clinical diagnosis of asd according to dsm-5 criteria by a licensed child neuropsychiatrist * verbal and performance iq \> 75 and total iq \> 85, assessed with the wisc-iv * no current aggressive behavior or severe oppositional tendencies * no hearing, vision, or physical impairments that could interfere with participation * not currently taking any psychotropic medications exclusion criteria: * absence of a clinical diagnosis of asd based on dsm-5 criteria * verbal or performance iq ≤ 75, or total iq ≤ 85 as assessed by wisc-iv * presence of aggressive behavior or severe oppositional tendencies * hearing, vision, or physical impairments that could hinder participation in the intervention * current use of psychotropic medications

Keywords: autism social robot social pragmatic skills intervention social skills educational technologies
initial dosing of paricalcitol in secondary hyperparathyroidism

Conditions: Secondary Hyperparathyroidism

Summary: the purpose of this study was to compare two different initial dosing schemes for the administration of paricalcitol in hemodialysis patients with secondary hyperparathyroidism: the already in use ipth/80 scheme, and an ipth/120 scheme, which corresponds to the immediately lower dose, based on current instructions on paricalcitol dose adjustment. we studied the effectiveness of the two dosing schemes in achieving a target ipth level (150 - 300 pg/ml)

adjustment of the initial dose of paricalcitol, in hemodialysis patients with secondary hyperparathyroidism (shpt), on the basis of severity of shpt is generally preferred in current practice. whether the proposed dose, based on the formula baseline intact parathyroid hormone (ipth \[pg/ml\]) divided by 80, is the most appropriate has not been adequately assessed. a trial comparing the ipth/80 dose to the immediately lower ipth/120 dose was undertaken. we studied the ability of the two different dosing schemes to control ipth levels within a desired range between 150 and 300 pg/ml, as well as the frequency of ipth over-suppression (\< 150 pg/ml) in the two groups (ipth/80 and ipth/120).

Eligibility criteria:
inclusion criteria:-maintenance hemodialysis therapy (3 sessions per week) for at least 3 months; ipth between 300 and 900 pg/ml; age \> 18 years; normal serum calcium concentration (8.1 - 10.4 mg/dl); ca x p product less than 70; no vitamin d metabolite replacement therapy for at least one month prior to the enrollment; aluminum levels lower than 60 μg/l. - exclusion criteria:administration of calcitonin, disphosphonates or corticosteroids; presence of a clinically serious medical condition; previous parathyroidectomy; active malignancy. -

Keywords: hemodialysis; secondary hyperparathyroidism; hypercalcemia; hyperphosphatemia; vitamin d
at-home telehealth yoga for treating chronic pain in people with alzheimer's disease and their caregiver's

Conditions: Alzheimer Disease; Musculoskeletal Pain; Chronic Pain

Summary: this feasibility study will evaluate yoga as a treatment for chronic pain in people living with alzheimer's disease, and their caregivers. the experimental treatment is yoga delivered via a tablet computer to participants at home ("teleyoga").

the investigators will demonstrate the feasibility of conducting a trial involving teleyoga for people with alzheimer's disease and their caregivers. participants with alzheimer's disease and chronic pain (n=15) and their caregivers (n=15) will all participate in teleyoga classes. yoga classes will be given weekly for 12 weeks. at the end of treatment, participants will provide feedback by completing a satisfaction questionnaire.

Eligibility criteria:
inclusion criteria: ad patients inclusion criteria for ad patients (as determined by): * diagnosis of probable alzheimer's disease- baseline * mini-mental state examination (mmse) score 18-25 (mild ad)(screening interview) * ≥ 18 years old * has a primary care provider who can provide medical clearance for participation in the study * diagnosis of chronic musculoskeletal pain \> 6 months * minimum pain intensity at screening visit: pain rated ≥4 on a 0-10 numeric rating scale (nrs) * not begun new pain treatments or medications in the past month * if on a psychotropic medication regimen: stable regimen for at least 4 weeks prior to entry to the study; willingness to remain on a stable regimen during the 12-week acute treatment phase * english literacy * wireless internet connection at home (screening interview) * has a caregiver who is willing to accompany ad patient for treatment, and who can receive yoga treatment at the same time as ad patient. exclusion criteria for ad patients (as determined by): * participation in another concurrent clinical trial * back surgery within the last 12 months * back pain potentially attributed to a specific underlying cause, disease, or condition (va emr; screening interview) * baseline pain \<4 or ≥9 on a 0-10 numeric rating scale (nrs) inclusion criteria for caregivers of ad patients (as determined by): * are caring for a patient diagnosed with ad who will practice yoga together with them * has a primary care provider who can provide medical clearance for participation in the study (yoga medical clearance form) * exclusion criteria for caregiver * participation in another concurrent clinical trial * attended or practiced yoga ≥ 1 x in the past 12 months * attended or practiced yoga ≥ 1 x in the past 12 months

Keywords: alzheimer disease yoga telehealth caregiver
weight-bearing training in stroke patients.

Conditions: Stroke

Summary: 1. are there differences in weight-bearing (wb) and wb symmetry immediately following sts and stepping training with or without using external feedback in ambulatory patients with stroke? 1. are there differences in mobility immediately following sts and stepping training with or without using external feedback in ambulatory patients with stroke?

subjects are patients with stroke, the age of over 40 years to 74 years, both males and females who are able to walk independently at least 10 meters. most of them will be recruited from a tertiary rehabilitation center and communities. subjects have to participate in sts and stepping training with and without using the external feedback for 1 time/condition with a wash-out period for 2 weeks (crossover design). the outcomes will be measured in terms of wb ability during sts and stepping, walking speed, and balance ability. the primary outcomes were wb ability on the affected limb and wb symmetry. secondary outcomes were walking speed and balance ability.

Eligibility criteria:
inclusion criteria: * independent ambulatory patients with chronic stroke (post-stroke time more than 6 months) * age at least 40 years to 74 years * body mass index (bmi) between 18.5- 29.9 kg/m\^2 * ability of independent walking over at least 10 meters with or without a walking device * ability to rise from a chair with or without using their arms * ability to follow a command used in the study exclusion criteria: any conditions that may affect ambulatory ability or ability to participate in the study, such as * auditory or visual deficits that are unable to be corrected by a hearing aid, glasses or contact lens * musculoskeletal pain with a pain scale more than 5 out of 10 on a visual analog scale (vas) * deformity in the limbs or spine that affect ambulatory ability * modified ashworth scale (mas) more 2 score * unstable cardiovascular, orthopedics, musculoskeletal, or neurological disease other than stroke.

Keywords: cerebrovascular disease rehabilitation walking balance mobility
phase ii randomized study of the effects of growth hormone on children and adolescents on maintenance dialysis

Conditions: Renal Osteodystrophy; End Stage Renal Disease

Summary: objectives: i. evaluate the separate and combined skeletal effects of recombinant human growth hormone (gh) and calcitriol in patients with adynamic renal osteodystrophy. ii. assess whether calcium-regulated changes in parathyroid hormone secretion predict changes in bone formation. iii. characterize the response to gh in cancellous bone and in growth plate cartilage in patients with secondary hyperparathyroidism during calcitriol therapy.

protocol outline: this is a randomized study. patients are stratified by bone lesion turnover and secondary hyperparathyroidism. patients in the first group are treated with recombinant human growth hormone subcutaneously every day for 8 months. patients in the second group are treated with calcitriol for 8 months, administered as a daily oral dose or an intraperitoneal dose three times a week. patients in the third group are treated with growth hormone and calcitriol (same dosages as above). a control group does not receive any hormonal therapy.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * end-stage renal disease undergoing continuous cycling peritoneal dialysis at the university of california at los angeles --prior/concurrent therapy-- * no concurrent prednisone * no concurrent cytotoxic agents * at least 12 months since parathyroidectomy --patient characteristics-- * other: no documented history of poor compliance with medical treatment regimens

Keywords: end stage renal disease rare disease renal and genitourinary disorders renal osteodystrophy
ketamine versus low dose thiopental for induction of anesthesia in septic shock

Conditions: Septic Shock

Summary: the aim of this work is to compare two protocols (ketamine-fentanyl-midazolam versus thiopental-fentanyl-midazolam) for induction of anesthesia in patients with septic shock aiming to find the most safe protocol with regards to hemodynamic status of patients.

induction of anesthesia in hemodynamically compromised patients is a challenge for every anesthetist. most of the intravenous induction agents have a negative effect on arterial blood pressure and cardiac output. theoretically, the "ideal" emergency induction intravenous anesthetic should achieve rapid hypnosis and maintain the hemodynamic stability ketamine has been reported as an induction anesthetic with a sympathomimetic activity. in patients with intact autonomic nervous system ketamine increases heart rate, cardiac output, and arterial blood pressure (abp). despite its sympathomimetic activity in hemodynamically stable patients, the hemodynamic response to ketamine in unstable cardiovascular conditions is not clear no studies to the best of our knowledge compared ketamine and low dose thiopental in rapid sequence induction of anesthesia in hemodynamically unstable patients. in this study, patients with severe sepsis or septic shock scheduled for surgery will be assigned to receive either ketamine or thiopental for induction of anesthesia. after induction of anesthesia, endotracheal tube will be inserted aided by succinyl choline. invasive blood pressure will be monitored through a transducer connected to arterial catheter. electrical velocimetry (cardiometry) device will be used for non-invasive monitoring of cardiac output and stroke volume.

Eligibility criteria:
inclusion criteria: * sepsis patients with shock index (heart rate divided by systolic blood pressure) \>0.7. or sepsis patients with norepinephrine infusion. exclusion criteria: * traumatic brain injury * cerebrovascular disorders