Kornimate/medical-research-clean huggingface dataset:
efficacy of animation, buzzy, and multiple interventions on pain in children

Conditions: Pain, Procedural; Child; Phlebotomy; Venipuncture

Summary: the aim of the study was to determine the effects of providing procedural informational animation, buzzy application during the procedure, the combination of both interventions (animated video and buzzy), and standard care on pain management during venipuncture in children aged 6-12 years.

a prospective randomized controlled trial design was used to determine the effects of buzzy, procedural informational animation, multiple interventions (buzzy and animated video), and standard care on the pain level of 6-12 years aged children during venıpunctrue. the study was conducted in the territory hospital pediatric blood collection unit the sample size was determined by power analysis and 45 child-parent pairs were included in each group. the patients who met the sample selection criteria were randomly and equally assigned into 4 groups using a computer-based program. as a data collection tools, data collection form and wong-baker have been used. venipuncture-related pain was self-reported by each child, as well as through parents and nurse. children in the multiple interventions group were shown procedural informative animation and the venipunctıre procedure was performed with buzzy®. standard care was applied to the control group, in which no local anesthetic was used and families could accompany the bloodletting process. the pain responses of the children were evaluated twice, immediately after the procedure (while the child was sitting in the blood collection chair) and 2-3 minutes after the procedure, both by the children's self-reports and by the parents and the nurse.

Eligibility criteria:
inclusion criteria: * being between the ages of 6 and 12 years, * admitted to the hospital as an outpatient, * having complete skin integrity at the place where the buzzy device will be inserted * having the ability to verbally communicate * parents being literate. exclusion criteria: * having any acute pain at the time of the procedure * having any audiovisual, cognitive sensitivity, or physical disability and having a chronic or life-threatening disease * being under the influence of any sedative/anticonvulsant/analgesic drug, * getting blood drawn in the last month * failure to phlebotomy at the first attempt * having nerve damage or peripheral neuropathy.

Keywords: procedural pain child phlebotomy venipunctur animation nursing practice non-pharmacological method
efficacy of albendazole to treat intestinal helminths and its effect on gut microflora

Conditions: Intestinal Diseases; Helminthiasis

Summary: albendazole is a main anti-helminth, however there is a lack of data regarding its efficacy in the school children population. the aim of this study is to evaluate the efficacy of the albendazole one versus two and three doses, in school children infected with intestinal helminth.


Eligibility criteria:
inclusion criteria: * presence of intestinal helminths eggs in the stool exclusion criteria: * allergy to imidazole derivate * no intestinal helminths

Keywords: albendazole ascaris trichiurus hookworms
arrow chloragard peripherally-inserted central catheters (picc) study

Conditions: Vascular Access Complication; Vascular Access Related Infection

Summary: a prospective study evaluating the timing, incidence and relationship of commonly occurring complications related to the use of peripherally-inserted central catheters. all subjects will receive picc access using the arrow picc with chloragard technology.


Eligibility criteria:
inclusion criteria: * patients age ≥ 18 years requiring a picc for a period of fourteen days or greater (note: maximum study period is 90 days) * ability to comply with study requirements inclusive of the follow-up duplex ultrasound procedures and, as applicable, recording of picc management, interventions and related treatments in the inpatient and outpatient setting in the daily subject diary * patients cognitively and physically able to give written consent to participate in the study or patient has a legally authorized representative (lar) who may give written consent to participate in the study exclusion criteria: * previous history of (within 3 months) or current diagnosis of venous thrombosis within the venous tract of the proposed catheter * history or diagnosis of peripheral or central vein stenosis (on proposed insertion side) * history or diagnosis of veno-occlusive disease * history or diagnosis of superior vena cava syndrome * known, pre-existing diagnosis of hypercoagulation disorder unrelated to underlying disease * previous enrollment in this study * currently pregnant or breast feeding * previous axillary lymph node dissection on the same side as intended catheter insertion site unless cleared by physician and patient consent * skin condition at or within 15 cm of the proposed catheter insertion site, including signs and symptoms of inflammation, rash, crusts, wounds with drainage, sites of intravenous infusion infiltration or extravasation, hematoma, phlebitis and or thrombophlebitis * medical, social, and/or psychological problems precluding subject from study participation * stage 2, 3 or 4 chronic kidney disease or serum creatinine \> 3 mg/dl or glomerular filtration rate (gfr) less than 60 ml per minute per 1.73 m2 unless cleared by a nephrologist for participation * known allergy or sensitivity to chlorhexidine
a ccta guided management strategy versus a standard of care strategy in type 2 nstemi

Conditions: Myocardial Injury

Summary: this study design is a prospective randomized control trial to compare outcomes between the utilization of coronary computed tomography angiography (ccta) vs conservative treatment in type 2 nstemi. the targeted population is expectedly heterogeneous and inpatient setting who are admitted and diagnosed with type 2 nstemi.

this study design is a prospective randomized control trial to compare outcomes between the utilization of coronary computed tomography angiography (ccta) vs conservative treatment in type 2 nstemi. the targeted population is expectedly heterogeneous and inpatient setting who are admitted and diagnosed with type 2 nstemi. patients are randomized into 2 groups. group 1 undergoes coronary 64-detector row computed tomography angiography (ccta) and group 2 receives conservative management and treatment for underlying conditions. the investigators will evaluate cross-sectional and time-varying clinical, laboratory, and imaging characteristics in association with clinical events. the exclusion criteria are an absence of information for follow-up of clinical events, and patients who have absolute and relative contraindications for ccta. absolute contraindications are a patient history of severe or anaphylactic reaction to iodinated contrast, inability to cooperate with scan protocols, hemodynamic instability, decompensated heart failure, acute myocardial infarction, and renal impairment with gfr \< 30. relative contraindications include pregnancy, inability to tolerate heart rate-slowing medications or nitroglycerin, recent phosphodiesterase inhibitor use, severe aortic stenosis, bronchospastic disease, and patient's weight and height.

Eligibility criteria:
inclusion criteria: * inpatient with type 2 nstemi * aged 18-70 years old * at the university of louisville and jewish hospitals exclusion criteria: * history of severe or anaphylactic reaction to iodinated contrast * inability to cooperate with scan protocols * hemodynamic instability * decompensated heart failure * acute myocardial infarction * renal impairment with gfr \< 30 * pregnancy * inability to tolerate heart rate-slowing medications or nitroglycerin * recent phosphodiesterase inhibitor use * severe aortic stenosis * bronchospastic disease * patient's weight and height
efficacy and safety of mfolfirinox as postoperative chemotherapy for pancreatic cancer in chinese patients.

Conditions: Pancreatic Cancer Resectable

Summary: this prospective and open-label study evaluates the efficacy and safety of mfolfirinox as postoperative chemotherapy in treating chinese patients with pancreatic cancer after r0/r1 resection.

the patients will be treated with systemic folfirinox chemotherapy of adjusted dosage.

Eligibility criteria:
inclusion criteria: 1. patients should be voluntary to the trial and provide with signed informed consent. 2. histologically confirmed diagnosis of pancreatic cancer 3. male or female, age: 18-79 years old. 4. no recurrence or metastasis was observed from a follow-up of 4 to 8 weeks by ct scan after radical surgery. 5. the value of carbohydrate antigen19-9(ca19-9) \< 180u/ml within 12 weeks after surgery. 6. no previous chemotherapy 7. eastern cooperative oncology group(ecog) performance status of 0-1 8. normal function of organ system including the followings. * no hematologic dysfunction(platelets ≥90×10\^9/l; neutrophil ≥2×109/l;hemoglobin ≥90g/l). * serum bilirubin ≤ 1.2 × upper limits of normal(uln); aminotransferase ≤ 5 × uln. * serum creatinine ≤ 1.25× uln, or creatinine clearance rate(ccr) ≥60ml/min(calculated by cockcroft-gault formula). 9. ecog scored as 0-1. 10. life expectancy \> 3 months. exclusion criteria: 1. patient is concurrently using other antineoplastic agent. 2. known severe hypersensitivity to drugs in the regimen. 3. patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment(with the exception of nonmelanoma skin cancer or cervical carcinoma in situ). 4. evidence of serious heart disease, including recorded history of congestive heart-failure, uncontrolled serious arrhythmia, angina that needs treatment of drugs, clinical diagnosed cardiac valve disease, history of serious myocardial infarction and intractable hypertension. 5. evidence of chronic diarrhea(≥4 times/day) or renal dysfunction. 6. evidence of active infection or active epidemic disease. 7. psychiatric illness that would prevent the patient from giving informed consent 8. pregnant or lactating women.
dexamethasone or clonidine as adjuncts to ropivacaine for caudal analgesia on analgesia duration in children

Conditions: Postoperative Pain

Summary: comparing the duration of pain relief from caudal analgesia when adjuncts like dexamethasone, clonidine, or saline (salt water) are added to ropivacaine.

the local anesthetic, which is currently used for caudal analgesia, is called ropivacaine. it works well and is safe in infants and children. doctors commonly add small amounts of other medication to ropivacaine to prolong the duration of pain relief provided by a single injection of caudal analgesia. in this study, the length of duration of pain relief the child receives from caudal analgesia will be examined when different medications are added to ropivacaine. specifically, dexamethasone, clonidine, or saline (salt water) will be added to ropivicaine and the length of time it takes before the child needs more pain medication will be determined. clonidine has been added to caudal analgesia for infants and children for many years. it increases the duration of pain relieving effect of ropivicaine by itself, however, it may lead to prolonged sedation following the surgical procedure (an undesired effect) and it is expensive. dexamethasone has been used for adult epidurals and nerve blocks and in spine surgeries. it prolongs the duration of pain relief and causes less sedation. it is commonly administered to children during surgery to help decrease nausea and vomiting after surgery. it is also much cheaper than clonidine.

Eligibility criteria:
inclusion criteria: * the subject will receive presurgical caudal block * american society of anesthesiologists (asa) 1 or 2 * day surgery unit * weight 30 kg or less exclusion criteria: * neuromuscular disease * back problem * caudal area skin infection * mental retardation * developmental delay * bleeding disorder

Keywords: analgesia caudal analgesia ropivacaine clonidine dexamethasone
biotronik 4french for ambulatory peripheral intervention

Conditions: Peripheral Artery Disease; Access Site Complication; Outpatient Treatment

Summary: biotronik 4french for ambulatory peripheral intervention. a multicenter, controlled trial comparing 4french versus 6french femoral access for endovascular treatment of lower-extremity peripheral artery disease in an ambulatory setting: bio4amb

controlled, multicenter, non-inferiority trial to compare the rate of access site complications (asc) in 4french (4f) vs. 6french (6f) femoral access endovascular interventions.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years or minimum age as required by local regulations * ability to walk * subject must be willing to sign patient informed consent (pic) * patient with infrainguinal arteries lesion(s) suitable to be treated during an ambulatory endovascular intervention exclusion criteria: * no possibility of an ambulatory management * physical fitness classified as asa ≥ 4 (american society of anaesthesiologists) * coagulation disorders * acute ischemia * less than 1month live expectancy * pregnant or breast feeding females or females who intend to become pregnant during the time of the study (pregnancy test required for all women with child bearing potential) * subject currently enrolled in other medical or drug study and has not reached the primary outcome measures * patient contraindicated for antiplatelet therapy, anticoagulants and antithrombotics * other access than common femoral * home alone the first night
a study on the impact of intelligent nutrition management on clinical outcomes in chemotherapy patients with gastrointestinal malignancies

Conditions: Gastric (Stomach) Cancer; Esophageal Cancer

Summary: an increasing body of evidence suggests that nutritional status is a key factor in determining the quality of life of cancer patients. the sensitivity of cancer patients to anti-tumor treatments, the occurrence of side effects, and their quality of life are closely related to their nutritional status. data show that about 50% of cancer patients experience a weight loss of more than 10% at the time of diagnosis and treatment, and once patients enter a cachexia state, the weight loss becomes difficult to reverse. therefore, the extent to which nutritional interventions can impact clinical outcomes in these patients needs to be answered through clinical research. currently, there are few studies using randomized controlled trials (rcts) to explore how nutritional interventions can improve patients' quality of life, particularly in terms of prolonging survival. a recent rct in a smaller sample population found that long-term, intensive, individualized nutritional counseling and support not only improved malnutrition in cancer patients, reduced treatment complications, and enhanced quality of life but also significantly extended survival time. this study is a prospective, randomized controlled clinical trial aimed at investigating the effect of full-scale intelligent nutrition management in gastrointestinal malignancy patients (esophageal cancer, gastric cancer) undergoing chemotherapy. the study attempts to confirm that full-scale intelligent nutrition management can benefit these patients by maintaining or improving their nutritional status, and that the clinical effectiveness of intelligent nutrition management is comparable to that of professional nutritionists. this research will also provide clinical evidence for the intelligent and standardized nutritional treatment of cancer patients during the chemotherapy period.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years; 2. voluntarily agree to participate and sign the informed consent form; 3. diagnosed with gastrointestinal malignancy (esophageal cancer, gastric cancer) and planned to undergo chemotherapy; 4. physical activity is acceptable, and capable of undergoing body composition analysis. exclusion criteria: 1. uncontrolled or severe heart, liver, lung, and kidney diseases; 2. history of stroke, epilepsy, or primary brain cancer, or patients with brain metastases from cancer; 3. pregnant individuals; 4. individuals allergic to milk, whey protein, etc.
treatment of buccal ginvigal recessions with the tunnel technique in conjunction with cross-linked hyaluronic acid and subepithelial connective tissue graft. a randomized clinical trial

Conditions: Cross-linked Hyaluronic Acid

Summary: to evaluate the outcomes of buccal gengival recession type 1 (rt1) treated with the tunnel technique in conjunction with a cross-linked hyaluronic acid and subepithelial palatal connective tissue grafts.

to evaluate the outcomes of buccal gengival recession type 1 (rt1) treated with the tunnel technique in conjunction with a cross-linked hyaluronic acid and subepithelial palatal connective tissue grafts. to evaluate the esthetic outcome as perceived by periodontists, using the root coverage esthetic score (res). test group - tunnel technique in conjunction with a cross-linked hyaluronic acid and subepithelial palatal connective tissue grafts. control group - tunnel technique and subepithelial palatal connective tissue grafts.

Eligibility criteria:
inclusion criteria: * none of the patients were smokers and all were systemically healthy without any signs of periodontal disease. * each patient had to display at least one ginvigal recession (rt1) of a depth of ≥ 2 mm. * patients exhibited an adequate level of oral hygiene evidenced by a full- mouth plaque score (fmps) \< 25%39 and full-mouth bleeding score (fmbs) \< 25%. exclusion criteria: * smokers * gingival recesstion rt 2 or rt 3 (cairo 2011).

Keywords: cross-linked hyaluronic acid tunnel technique gingival recession
respond post market study

Conditions: Aortic Valve Stenosis

Summary: the purpose of the respond post market study is to collect real world clinical and device performance outcomes data with the lotus valve system used in routine clinical practice to demonstrate that the commercially available lotus valve system is a safe and effective treatment for patients with severe calcific aortic stenosis.

the respond study is a prospective, open label, single arm, multi-center, observational post market study designed to collect real world clinical and device performance outcomes data of the commercially available lotus valve used in routine clinical practice for the treatment of severe calcific aortic stenosis. approximately 1000 real-world, consecutive subjects will be enrolled at up to 50 study centers in europe, asia pacific and central/south america. all enrolled subjects will be contacted for follow-up at 30 days, 1, 2, 3, 4 and 5 years post index valve implantation. follow-up visit at 1 year post valve implantation should be conducted via outpatient clinic visit. follow-up visits at 30 days and 2 through 5 years may be conducted in person (preferred) and via telephone interview. subjects who are not implanted with a lotus valve will be followed for safety through 30 days after the initial attempted index procedure. collection of safety events will include any serious adverse event (sae) that led to death, serious adverse device effect (sade), adverse device effect (ade), unanticipated serious adverse device effect (usade), and all valve academic research consortium (varc) events regardless of seriousness and device relationship through 5 year follow-up. the respond study will be conducted in accordance with the international organization for standardization (iso) 14155: 2011; ethical principles that have their origins in the declaration of helsinki; the relevant parts of the international conference on harmonization (ich) guidelines for good clinical practices (gcp); and pertinent individual country/state/local laws and regulations. an additional cohort of approximately 50 subjects will be enrolled at up to 6 study centers in europe after enrollment in the main cohort is completed to assess center-driven implantation technique with the commercially available lotus valve with depth guard technology.

Eligibility criteria:
subjects will be evaluated for eligibility by the clinical center's heart team per the local standard of practice in accordance with the directions for use.

Keywords: lotus valve real world aortic stenosis high risk
patient-centered advance care planning

Conditions: Heart Failure; Renal Failure

Summary: based on theories regarding decision-making and patient education the investigators have developed patient-centered advance care planning (pc-acp). this intervention is designed to improve patient and surrogate knowledge of acp, increase the congruence between patient and surrogate in treatment decisions, decrease the patient's and surrogate's conflict in making such decisions, and increase the consistency between patient preferences and the actual care they receive. the acp intervention is conducted with the patient in the presence of the surrogate.


Eligibility criteria:
inclusion criteria: * at high risk for impending death in the next 12 months exclusion criteria: * patient not having decision-making capacity
refitting somofilcon a sphere contact lens wearers into fanfilcon a sphere lenses for 4-weeks of wear

Conditions: Myopia

Summary: the aim of this subject-masked prospective study is to evaluate the clinical performance of habitual wearers of clariti elite sphere lenses after a refit with avaira vitality sphere lenses.

the aim of this subject-masked prospective study is to evaluate the clinical performance of habitual wearers of clariti elite sphere lenses after a refit with avaira vitality sphere lenses for 4 weeks of daily wear.

Eligibility criteria:
inclusion criteria: * is between 18 and 40 years of age (inclusive) * has had a self-reported visual exam in the last two years * is an adapted soft contact lens wearer * has a contact lens spherical prescription between - 0.25 to - 8.00 (inclusive) * have no less than -0.75d of astigmatism in both eyes. * can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logmar) or better in each eye. * can achieve a distance visual acuity of 20/30 (0.18 logmar) or better in each eye with the study contact lenses. * has clear corneas and no active ocular disease * has read, understood and signed the information consent letter. * patient contact lens refraction should fit within the available parameters of the study lenses. * is willing to comply with the wear schedule (at least 5 days per week, \> 8 hours/day assuming there are no contraindications for doing so). * is willing to comply with the visit schedule exclusion criteria: * has a cl prescription outside the range of the available parameters of the study lenses. * has a spectacle cylinder of ≥ 1.00d in either eye. * has a history of not achieving comfortable cl wear (5 days per week; \> 8 hours/day) * has contact lens best corrected distance vision worse than 20/25 (0.10 logmar) in either eye. * presence of clinically significant (grade 2-4) anterior segment abnormalities * presence of ocular or systemic disease or need of medications which might interfere with contact lens wear. * slit lamp findings that would contraindicate contact lens wear such as: * pathological dry eye or associated findings * pterygium, pinguecula, or corneal scars within the visual axis * neovascularization \> 0.75 mm in from of the limbus * giant papillary conjunctivitis (gcp) worse than grade 1 * anterior uveitis or iritis (past or present) * seborrheic eczema, seborrheic conjunctivitis * history of corneal ulcers or fungal infections * poor personal hygiene * has a known history of corneal hypoesthesia (reduced corneal sensitivity) * has aphakia, keratoconus or a highly irregular cornea. * has presbyopia or has dependence on spectacles for near work over the contact lenses. * has undergone corneal refractive surgery. * is participating in any other type of eye related clinical or research study.