Kornimate/medical-research-clean huggingface dataset:
the reliability and validity of family report chewing evaluation

Conditions: Mastication Disorder

Summary: the family has a primary prescription in the identification of the chewing disorder in children to plan appropriate rehabilitation program and implementation of the training. therefore, it is very important to investigate the validity and reliability of classification systems that can be applied by parents. the purpose of this study is to determine the validity and reliability of the reliability and validity of family report chewing evaluation.

chewing is a function that is defined as the grinding of solid food and making them ready for swallowing. chewing begins with the acceptance of solid food with the lips. the rotational and lateral movements of the tongue is also necessary during grinding the solid food in the molar region. in the molar region, grinding is carried out with the help of salivary and salivary enzymes. chewing behavior is a learned function. the child begins to chew at 6 months and the coordinated movement to the 9th month continues to develop. together with experience, chewing activity continues to develop. the families have a primary role in chewing training. in some children, the chewing function does not develop as desired. many children with developmental, medical, or oral motor problems have difficulty in grinding and swallowing solid foods. therefore, it is very important to assess the ability of the child's chewing and determine the treatment goals. assessment of the child's ability to chew should begin by considering chewing as a function. for this reason, the karaduman chewing performance scale (kcps) was developed at the hacettepe university, faculty of health sciences department of physiotherapy and rehabilitation. the chewing performance of the child during chewing a biscuit is scored by the therapist between 0-4. 0 refers to normal chewing, 4 means no bite and chew. the family has a primary prescription in the identification of the chewing disorder in children to plan appropriate rehabilitation program and implementation of the training. therefore, it is very important to investigate the validity and reliability of classification systems that can be applied by parents. the purpose of this study is to determine the validity and reliability of the reliability and validity of family report chewing evaluation (karaduman chewing performance scale-family report).

Eligibility criteria:
inclusion criteria: * children above the age of 18 months * children with chewing disorders exclusion criteria: * children below the age of 18 months * children without chewing disorders

Keywords: mastication cerebral palsy family
safety study of remsima® (infliximab) in rheumatoid arthritis patients in jordan

Conditions: Rheumatoid Arthritis

Summary: the purpose of this observational study is to assess the safety and effectiveness of biosimilar infliximab in patients with rheumatoid arthritis(ra) in jordan where no visits or intervention(s) additional to the daily practice will be performed

a multi-center, observational, prospective, cohort study to assess the safety and effectiveness of biosimilar infliximab (remsima®) in patients with rheumatoid arthritis in jordan. biologic naïve patients will receive remsima® in accordance with standard medical care and the approved label and will be followed over a period of 34 weeks (8.5 months). outcomes including occurrence of adverse events (aes), mean changes in disease activity and health assessment in each cohort will be measured and compared

Eligibility criteria:
inclusion criteria: * adult patients (age ≥18 years) * biologic naïve patients with active ra diagnosed according to the revised 1987 american college of rheumatology (acr) (arnett et al. 1988) or 2010 acr / european league against rheumatism (eular) rheumatoid arthritis classification criteria (aletaha et al. 2010) * patients should be receiving a stable dose methotrexate (mtx) for at least 3 months prior to enrolment, and still have active disease defined as erythrocyte sedimentation rate (esr) ≥28 mm/h and swollen and tender joints ≥ 6 * absence of tuberculosis demonstrated by negative chest x-ray exclusion criteria: * patient \<18 years * previous treatment with biologics * patients who meet any of the contraindications to the administration of infliximab * previous or concurrent malignancies

Keywords: infliximab remsima biosimilar autoimmune disease rheumatoid arthritis cohort study disease modifying anti-rheumatic drugs tumor necrosis factor-alpha inhibitors
bloodstream absorption of avastin and lucentis after injection into the eye

Conditions: Diabetic Macular Edema

Summary: currently, two similar medications are available for injection into the eye to treat a variety of eye diseases. these medications are called ranibizumab (lucentis) and bevacizumab (avastin). they both have a similar mechanism of action and work equally well, however only ranibizumab was designed for use in the eye. it is significantly more expensive per injection than bevacizumab (by a factor of roughly 40x). in published studies trends have been noted towards an increased rate of systemic side effects such as heart attacks and strokes. this is presumably due to absorption of the drug(s) from the eye into the bloodstream, however this has never been shown before. the purpose of the investigators study was to compare the bloodstream levels of bevacizumab and ranibizumab at various time points after injection into the eye. this required the creation of a sophisticated assay to measure blood levels of the drugs.

see above

Eligibility criteria:
inclusion criteria: * patients in whom anti-vascular endothelial growth factor (vegf) therapy is indicated for the treatment of diabetic macular edema * able to return for extra clinic visits according to study schedule exclusion criteria: * active malignancy * previous retinal laser treatment * previous anti-vegf therapy * previous vitrectomy

Keywords: vascular endothelial growth factor macular edema diabetic retinopathy
research study examining nerve block for migraine

Conditions: Migraine

Summary: migraine and the skin sensitivity that accompanies it can go away in minutes after a nerve block, which is a procedure involving an injection of a small amount of a local anesthetic next to a nerve to the skin, causing an area of skin to become numb. we have also noticed that light sensitivity goes away quickly after a nerve block. we would like to see how quickly this happens and how long the benefit of nerve block lasts. we are interested to see if these effects are due to the injection itself or due to the lidocaine. a subject may be asked to participate in this study if a subjects physician has planned for a subject to receive an injection of botox® in the area of the greater occipital nerve (a spinal nerve located at the back of the head) as part of a subjects routine preventive treatment for migraine today.


Eligibility criteria:
inclusion criteria: * subjects with episodic or transformed migraine age 18to 80 years old. * subjects must have unilateral migraine headache and trigeminal distribution brush allodynia at the time of injection. * subjects must be able to consent or assent to the study. exclusion criteria: * subjects who in their own or in the investigator's opinion are unable to report the severity of four symptoms (pin sharpness to determine efficacy of nerve block, headache severity, photophobia severity and allodynia severity), every 30 seconds for 5 minutes post injection; * subjects with skull defect, or history of injury to the area of the gon. * subjects with prior adverse reaction to gon block, lidocaine or marcaine. * subjects who are pregnant or lactating
a clinical study evaluating the safety and efficacy of biottt001 in patients with malignant solid tumors

Conditions: Solid Tumor

Summary: this is a phase 1 open-label study to evaluate the safety, tolerability, and pharmacokinetics of recombinant human nsil12 oncolytic adenovirus injection (biottt001) at dose of 5×10∧9vp、5×10∧10vp、5×10∧11vp in patients with malignant solid tumors. subjects will be treated with a single dose of biottt001 injection after the screening period.

this study is a single arm, open label, single center dose escalation trial. three study drug dosage groups are pre-set, namely 5 × 10∧9vp、5 × 10∧10vp、 5 × 10∧11vp. according to the principle of dose escalation from low to high, the "3+3" dose escalation method is adopted. in theory, in order to protect the safety of the subjects, during the dlt observation phase of the same dose group, the first subject in each dose group can only be enrolled in the second subject after at least 2 weeks after administration. the dlt observation period for each subject is 28 days after the first administration, and the last subject in each dose group can only enter the next dose escalation after completing the dlt observation period. at least 3 subjects are enrolled in each dose group, and each subject only receives one corresponding dose.

Eligibility criteria:
inclusion criteria: 1. age range from 18 to 80 years old (including the threshold), no gender restrictions. 2. patients with histologically and/or cytologically confirmed malignant solid tumors, who have experienced at least one-line standard treatment failure or intolerance, or lack standard treatment options. focus on malignancies in the head and neck, colorectal cancer, skin malignancies, and cervical cancer. 3. at least one assessable lesion according to the response evaluation criteria in solid tumors (recist) 1.1. 4. assessed by the investigators to have lesions suitable for intratumoral injection (assessable lesions and intratumoral injection lesions can refer to the same lesion). exclusion criteria: 1. known allergy to the investigational drug or its components. 2. previous treatment with other adenovirus drugs. 3. patients with active autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, etc.), except type 1 diabetes, hypothyroidism that only needs hormone replacement therapy, and skin diseases that do not need systemic treatment (such as vitiligo, psoriasis or alopecia). 4. patients who have not recovered from the adverse reactions of previous treatments (the treatment-related toxicity ≤ grade 2, except for alopecia, pigmentation or other tolerable events judged by the investigator ).

Keywords: oncolytic virus il-12 adenovirus
evaluation of intestinal vascolarization with indocianine green angiography during rectal resection or left colectomy

Conditions: Rectal Disease; Sigmoid Disease

Summary: a randomized controlled multicenter trial on the usefulness of intraoperative angiography with indocyanine green to assess anastomosis perfusion in patients who undergo laparoscopic rectal resection or left colectomy.

anastomotic leakage after colorectal surgery is a severe complication. one possible cause of anastomotic leakage is insufficient vascular supply. the aim of this study is to evaluate the usefulness of intraoperative assessment of vascular anastomotic perfusion in laparoscopic colorectal surgery using indocyanine green (icg)-enhanced fluorescence, in order to assess if the information of the icg angiography could lead to change the site of resection and improving the anastomotic leak rate. two-hundred and eight patients, undergoing rectal resection or left colectomy, for benign or malignant disease, with high vessels ligation, will be randomized intro 2 arms: ich angiography (colonic perfusion is intraoperatively assed with icg angiography and level of resection is selected based on the fluorescence) and control (resection is performed with subjective judgment). the rate of postoperative leak in the two groups will be recorded.

Eligibility criteria:
inclusion criteria: * adult patiens * laparoscopic rectal resection or left colectomy exclusion criteria: * rectal amputation * no anastomosis * allergy to iodine or indocyanine green
study of prineo (dermabond protape) versus sutures in breast procedures

Conditions: Macromastia

Summary: this is a prospective, controlled, randomized, multi-center clinical study of up to 80 patients with full thickness surgical incisions associated with bi-lateral breast procedures. breast procedures where symmetrical incisions of at least 15cm in length are planned for both breast (bilateral procedure) will be randomised to receive final skin closure of one breast with prineo (dermabond protape) and the other with intradermal sutures (control). patients will be evaluated post-operatively at 24 hours (± 6 hours), 7 days (± 1 day), 12 - 25 days, and 90 days (± 10 days).


Eligibility criteria:
inclusion criteria: * be at least 18 years of age; * be in good general health in the opinion of the investigator with no conditions that would significantly impact wound healing as determined by medical history and review of recent concomitant medications; * require identical skin closure of full-thickness intersecting surgical incisions with a combined length of at least 15cm on each breast as part of elective breast procedures, requiring the placement of sutures in the superficial fascia and subcutaneous tissue to relieve skin tension prior to final skin closure; * be willing to follow instructions for incision care as instructed by the investigator, and refrain from swimming or soaking in a tub until suture removal occurs (during the first 12-25 days) of the study; * agree to return for all follow-up evaluations specified in this protocol \[7 days (± 1 day), 12 - 25 days, and 90 days (± 10 days)\], six (± 1 month) and twelve months (± 1 month)\]; * agree not to schedule any additional elective surgical procedures that involve an incision that is randomized for inclusion in this study, until their participation in this study is complete; and * sign the informed consent. exclusion criteria: * have peripheral vascular disease; * have insulin dependent diabetes mellitus; * be known to have a blood clotting disorder; * be receiving antibiotic therapy for pre-existing condition or infection; * be known to be hiv-positive or otherwise immunocompromised; * have known personal or family history of keloid formation or hypertrophy; * be currently taking systemic steroids; * have known or suspected allergy or sensitivity to cyanoacrylate, formaldehyde, tapes or adhesives * have incision type or location known to have an incidence of cyanosis or other healing abnormalities; and * be participating in any current clinical trial of an investigational product or have participated in any clinical trial of an investigational product within 30 days of enrolment in this study.

Keywords: breast lift breast reduction breast reconstruction plastic surgery skin closure wound healing dermabond
safety and tolerability study of mbs2320 in healthy subjects and subjects with rheumatoid arthritis

Conditions: Arthritis, Rheumatoid

Summary: rheumatoid arthritis (ra) affects 1 percent of the population worldwide and up to 40 percent of patients don't respond to current treatments. mbs2320, the drug being tested in this trial, represents a new approach to treating ra, with the potential not only to reduce levels of inflammation but to also directly inhibit bone damage.the aim of this study is to test the safety of mbs2320 in healthy volunteers, to find out how mbs2320 levels change in the blood with dose, and to test the safety and compatibility of giving mbs2320 to patients with ra in combination with an existing treatment, methotrexate.

the study will be conducted in 4 parts (parts a to d). the principal aim of this study is to obtain safety and tolerability data when mbs2320 is administered orally as single and multiple doses to healthy subjects (parts a to c). the effect of mbs2320 on the pharmacokinetics (pk) of the first-line rheumatoid arthritis (ra) therapy, methotrexate (mtx), and the effect of mtx on the pk of mbs2320, will also be evaluated in a cohort consisting of subjects with ra (part d).

Eligibility criteria:
principal inclusion criteria: parts a, b, and c. * healthy males or females between 18 and 60 years of age. * a body mass index (bmi) between 18.0 and 30.0 kg/m2. * female subjects will be of non-childbearing potential or postmenopausal as defined by the protocol. * female subjects must not be pregnant. part d * subjects will be otherwise healthy males or females with a diagnosis of ra between 18 and 70 years of age. * subjects will have a bmi between 18.0 and 30.0 kg/m2. * female subjects must not be pregnant. * subjects must have been treated with, and tolerated, oral or subcutaneous mtx for a minimum of 3 months prior to screening entry. principal exclusion criteria: parts a, b, and c. * male subjects who do not agree to use appropriate contraception. * female subjects who are receiving hrt who do not agree to use appropriate contraception. * subjects who have donated blood in the 3 months, plasma in the 7 days or platelets in the 6 weeks prior to screening. * subjects who consume more than the permitted alcohol requirement, who have a significant history of alcoholism or drug/chemical abuse. * subjects who are unwilling to abstain from alcohol as required. * a positive urine drug screen, alcohol breath test at screening or first admission. * subject has received a live virus vaccination within the 30 days prior to first dose administration. * subjects with a positive test for tuberculosis. additional part d exclusions * subjects who have received any medication (except mtx) known to chronically alter drug absorption or elimination processes within 30 days prior to the first dose administration. * subjects currently taking any medications other than those allowed per protocol guidelines.

Keywords: rheumatoid arthritis osteoclastogenesis inhibitor anti-inflammatory agent musculoskeletal diseases joint diseases
carotid artery intima-media thickness following exposure to raloxifene or placebo

Conditions: Osteoporosis, Post-Menopausal

Summary: the purpose of this study is to measure carotid artery imt at a single visit in a subset of women previously enrolled in the core (h3s-mc-ggjy) trial


Eligibility criteria:
inclusion criteria: * patients must have completed the eli lilly and company clinical trial core (h3s-mc-ggjy) inclusive of visit 5, in one of the 9 participating study sites in california. * patients must have been dispensed study drug in the core trial (h3s-mc-ggjy). exclusion criteria: * have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry * have previously withdrawn from this exploratory study or any other study investigating raloxifene * are employed by eli lilly and company (that is, employees, temporary contract workers, or designees responsible for the conduct the study). immediate family of eli lilly and company employees may participate in lilly-sponsored clinical trials, but are not permitted to participate at an eli lilly and company facility. immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted * are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
impaired preoperative nutritional status as a risk factor for postoperative clinical outcome

Conditions: Nutritional Status

Summary: the aim of this retrospective observational study is to determine the impact of preoperative nutritional status on postoperative outcome. elective surgical patients were screened with bio-impedance-analysis, malnutritional universal screening tool, and other variables for body composition. outcome parameters were collected by patient chart review.


Eligibility criteria:
inclusion criteria: 1. elective surgical intervention 2. patients must be 18 years or older 3. ambulation 4. asa-score i-iv 5. bioelectrical impedance analysis to determine the phase angle exclusion criteria: 1. emergency surgery 2. pregnancy 3. asa score v-vi 4. amputated limbs 5. pacemaker and defibrillators 6. cerebrovascular events 7. tattoos on the electrode locations

Keywords: malnutrition post-operative outcome phase angle must clavien dindo classification bioelectrical impedance analysis
imatinib as pre-operative anti-colon cancer targeted therapy

Conditions: Colonic Neoplasms

Summary: in this proof-of-concept trial the investigators will study the effects of imatinib treatment on the biology of mesenchymal-type colon cancers.

tumor biopsies from patients with newly diagnosed colon cancer will be pre-screened with an rt-qpcr test to identify tumors of the mesenchymal subtype. patients with mesenchymal-type tumors that meet the in- and exclusion criteria will be treated with imatinib during the "window period" that normally precedes surgery. immediately following tumor resection, biopsies will be taken from the surgical specimen. gene and protein expression of the pre- and post-treatments biopsies will be compared to assess the effects of imatinib therapy on pdgfr- and ckit-signalling and on the mesenchymal gene expression profile.

Eligibility criteria:
inclusion criteria: 1. male or female aged ≥18 years 2. histologically proven adenocarcinoma of the colon; 3. completed cancer staging with ct-abdomen and ct-thorax/x-thorax according to hospital's standard of care; 4. confirmed eligibility for surgery with curative intent as deemed by the hospital's multidisciplinary board (mdb) review; 5. an intratumoural gene expression profile of pdgfr-α, pdgfr-β, pdgf-c and kit, indicative of the mesenchymal phenotype, according to our diagnostic rt-qpcr test (i.e. more than 50% chance of having the mesenchymal phenotype); 6. minimum of four properly stored pre-treatment biopsies for gene expression analysis/elisa; 7. who performance status 0 or 1; 8. adequate haematology status and organ function, defined as: * normal creatinine clearance (≥60 ml/min (mrdr)) * alat within 2.5x upper limit of normal (uln) * pt-inr \< 1.5 * leukocytes \> 1,5\*10\^9/l; hb \> 6.0 mmol/l; platelets \> 100\*10\^9/l 9. willingness and ability to comply with scheduled visits, treatment plans and laboratory tests; 10. written informed consent. exclusion criteria: 1. the presence of synchronous distant metastases; 2. current hospital standard of care dictates that subject should undergo any neoadjuvant therapy; 3. concurrent participation in another clinical trial using any medicinal product, or participation in such a trial in the period of three months prior to the current trial; 4. women who are pregnant, plan to become pregnant or are lactating during the study or for up to 30 days after the last dose of imatinib; 5. known hiv or hepatitis b/c infection; 6. known symptomatic congestive heart failure; 7. co-morbidity requiring concomitant treatment with drugs that act as strong inducers of cyp3a4 or with drugs with a narrow therapeutic range influenced by imatinib
the vascularity changes of scars with laser therapy

Conditions: Hypertrophic Scar

Summary: the purpose of this study is to explore the effects of pulsed dye laser on managing scar vascularity and thickness.

the pulsed dye laser is increasingly used in clinical settings to manage scars and shows promising outcomes.the pulsed dye laser targets at micro-vascular structures in scar tissues. this study aims to explore the vascularity changes in scars with pulsed dye laser during the scar formation process.

Eligibility criteria:
inclusion criteria: * scars caused by burn injury or related trauma; * wound healing days over 3 weeks; * days post injury less than 1 year; * ability and willingness to comply with all the treatment and assessment procedures. exclusion criteria: * history of steroid injection or graft surgery; * history of keloid scarring; * open wound or active infection; * conditions that affect wound healing, such as diabetes mellitus.

Keywords: hypertrophic scar pulsed dye laser