Kornimate/medical-research-clean huggingface dataset:
efficacy of immunoglobulin plus prednisolone in reducing coronary artery lesion in patients with kawasaki disease

Conditions: Kawasaki Disease

Summary: this study evaluates the efficacy of the addition of prednisolone to conventional initial treatment (intravenous immunoglobulin \[ivig\] plus aspirin) in reducing coronary artery lesion in children with kawasaki disease (kd) .

this is a multicenter, open-label, blind-endpoints, randomized controlled trial at more than 10 hospitals in china. the investigators enrolled kd children diagnosed within 10 days of onset. participants will be randomly assigned in a 1:1 ratio to the control group (receiving 2g/kg ivig and 30 mg/kg aspirin) or the intervention group (receiving 2 g/kg ivig, 30 mg/kg aspirin and additional 2 mg/kg prednisolone). baseline characteristics of each participant will be collected, including sex, age of onset, height, body weight, subtype of kd, fever days before initial ivig, echocardiographic findings at enrolment, and a series of pre-ivig laboratory tests. two-dimensional echocardiography will be performed at admission, 2 weeks, 1 month, 3 months, 6 months，and 12 months after onset of kd to assess the coronary artery lesions.

Eligibility criteria:
inclusion criteria: * meeting diagnostic criteria for kawasaki disease (kd) released by american heart association (aha) in 2017 * diagnosed before the tenth day of illness (with the first day of illness defined as the first day of fever) * not treated with ivig yet * age ≥1 month exclusion criteria: * z score of any coronary artery before initial treatment ≥10 * receiving steroids or other immunosuppressive agents in the previous 30 days * with a previous history of kd * afebrile before enrolment * with suspected infectious diseases including sepsis, septic meningitis, peritonitis, bacterial pneumonia, varicella and influenza * with serious immune diseases such as immunodeficiency or chromosomal abnormalities

Keywords: kawasaki disease prednisolone coronary artery lesion
reliability and validity of urdu version of disabilities of the arm, shoulder and hand questionnaire

Conditions: Carpal Tunnel Syndrome

Summary: the goal of study is to convert disabilities of the arm, shoulder and hand questionnaire into urdu and test its reliability and validity among the pakistani citizens. also check its correlation with boston carpal tunnel syndrome questionnaire and visual analogue scale as well.

a cross-sectional study will be conducted after approval from ethical review committee of riphah international university of faisalabad. total of 90 participants will be included in this study from different community areas, hospitals and rehabilitation centers with carpal tunnel syndrome. 71 of them will be male and 19 will be female. disabilities of the arm, shoulder, and hand questionnaire will be correlated with boston carpal tunnel syndrome questionnaire and visual analogue scales. these questionnaires will be filled by participants firstly for baseline, secondly after treatment and third one week later as a follow up. written informed consents will be taken before filling questionnaires.

Eligibility criteria:
inclusion criteria: * age above 18 years. * subjects with phalen's and tinnel's test positive. exclusion criteria: participants who had following conditions: * diabetes mellitus, thyroid disease, rheumatoid arthritis, radiculopathy of cervical spine, cognitive impairment. * hand surgery within previous 3 months. * difficulty in understanding of language. * musculoskeletal disorder.

Keywords: disabilities of the arm, shoulder and hand questionnaire urdu version reliability validity carpal tunnel syndrome
flotation-rest for chronic pain, stress, and sleep

Conditions: Healthy; Chronic Pain; Musculoskeletal Pain

Summary: this randomized crossover trial aims to examine the effects of flotation-rest (reduced, environmental, stimulation, technique/therapy) compared to laying in a dark room (with reduced environmental stimulation) for those with chronic musculoskeletal pain. this design will allow for comparisons between the two interventions on daily diary assessments of pain, stress, and sleep, both between groups and within individuals.

chronic pain is a prevalent and significant health problem. previous research shows that flotation-rest may be an effective treatment for reducing pain but little is known about the short-term effects of a single session of flotation-rest on the day-to-day variability of pain, stress, and sleep. sleep, stress, and pain are all bidirectionally related to each other, and previous research shows that flotation-rest may positively influence all three of these outcomes. therefore, the primary aim of this study is to examine changes in pain, stress, and sleep following flotation-rest. the secondary aim is to investigate whether various subjective experiences during the intervention are associated with changes in pain, stress, and sleep following the interventions.

Eligibility criteria:
inclusion criteria: * chronic musculoskeletal pain (e.g., back pain or upper or lower extremity pain, arthritis, fibromyalgia) on more days than not for the past 3 months * psychologically healthy * adults between the ages of 18-75 years. exclusion criteria: * previous experience in a flotation-rest device. * diagnosed with neuropathic pain condition or endorsing more than 4 peripheral neuropathy symptoms. * diagnosed with any psychiatric condition (e.g., schizophrenia or bipolar disorder). * active suicidality with intent or plan. * currently taking ssri medication. * history of neurological conditions (e.g., epilepsy, stroke, severe traumatic brain injury, parkinson's disease, alzheimer's disease or other forms of dementia) * any skin conditions or open wounds that could cause pain when exposed to saltwater * inability to lay comfortably for 60 minutes * pregnant * started a new sleep or pain medication within the last 6 weeks

Keywords: healthy chronic pain floatation-rest floating
ai classifies multi-retinal diseases

Conditions: Deep Learning; Retinal Diseases

Summary: the objective of this study is to establish deep learning (dl) algorithm to automatically classify multi-diseases from fundus photography and differentiate major vision-threatening conditions and other retinal abnormalities. the effectiveness and accuracy of the established algorithm will be evaluated in community derived dataset.

retinal diseases seriously threaten vision and quality of life, but they often develop insidiously. to date, deep learning (dl) algorithms have shown high prospects in biomedical science, particularly in the diagnosis of ocular diseases, such as diabetic retinopathy, age-related macular degeneration, retinopathy of prematurity, glaucoma, and papilledema. however, there is still a lack of a single algorithm that can classify multi-diseases from fundus photography. this cross-sectional study will establish a dl algorithm to automatically classify multi-diseases from fundus photography and differentiate major vision-threatening conditions and other retinal abnormalities. we will use the receiver operating characteristic (roc) curve to examine the ability of recognition and classification of diseases. taken the results of the expert panel as the gold standard, we will use the evaluation indexes, such as sensitivity, specificity, accuracy, positive predictive value, negative predictive value, etc, to compare the diagnostic capacity between the ai recognition system and human ophthalmologist.

Eligibility criteria:
inclusion criteria: * fundus photography around 45° field which covers optic disc and macula * complete patient identification information; exclusion criteria: * incomplete patient identification information
comparison of postprandial inflammation in lean and obese subjects

Conditions: Nutritional Intervention; Nutritional and Metabolic Diseases; Obesity

Summary: the purpose of this study is to quantify the systemic inflammatory and metabolic response of lean subjects and obese subjects to the ingestion of three caloric doses of a high-fat meal.


Eligibility criteria:
inclusion criteria for lean subjects: * age 25-50 * 20\<bmi\<25 * waist circumference \<94cm inclusion criteria for obese subjects * age-matched to healthy subjects * 30\<bmi\<40 * waist circumference \>102cm exclusion criteria for lean and obese subjects: * physiological or psychological diseases * allergies to food or intolerance to high-fat meal * vegetarians * chronic intake of drugs * smokers * diabetes mellitus type i and ii * debilitating kidney diseases * debilitating liver diseases * clinically established coronary heart diseases * ingestion of vitamins or dietary supplements during the course of the study
treatment of wounds utilizing light

Conditions: Diabetic Ulcer

Summary: the qray device is emitting broad light energy that is intended for diabetic ulcer healing. the study is double blinded.


Eligibility criteria:
inclusion criteria: * patient has 8 weeks venus leg ulcer. * the ulcer was not better on prior treatment of various medical clinics. * the patient has diabetic ulcer grade 1 or 2 exclusion criteria: * patient has severe infection. * patient is taking antibiotic * patient has ankle brachial index less than 0.7 * patient is schedule to undergone revascularization surgery 10 weeks before the study * patient has photosensitive disease * patient has cancer * creatinine level is more than 2 mg% * patient is taking immunosuppressive medication. * pregnant women * dialysis patient * anaemic patients(less than 9 gr) * patient has albumin level less than 3 mg%

Keywords: ulcer wound diabetes
spectroscopic assessment of intramyocardial oxygen saturation feasibility during open-heart surgery

Conditions: Coronary Artery Disease; Heart Valve Diseases

Summary: this traditional feasibility study aims to capture preliminary safety and effectiveness information on a near-final investigational device design to adequately plan the forthcoming pivotal study.

the study design is based on measuring the depth of ischemia during the operation, which is compared to the intraoperative and postoperative morbidity of the patient, especially to the dysfunction of the heart. a qualified and experienced monitor is assigned for the study to oversee and document the progress of the trial. the monitor ensures the trial performance in accordance with the protocol and good clinical practice (gcp). the trial team conforms to iso 13485 quality standards and iso 14155 gcp. processes included in the monitoring activities are documented in the quality management system. below are described the summaries of all these activities. source data will be collected and transferred into the electronic crfs by site staff, and the collected data quality and the conformity to the good clinical practice will be assessed by monitoring. based on a risk assessment performed, a data monitoring committee shall not be established. clinical research associate (cra) is responsible for checking the accuracy and completeness of case report form (crf) entries, source documents, and other investigation-related records against each other. other responsibilities of cra, including detailed source data verification (sdv), are documented by the clinical project manager (cpm) or head of clinical research (hcr)(both are sponsor's representatives). sdvs will be performed and documented during monitoring visits. monitoring planning, reporting, and visits are pre-defined and documented with pre-made templates per the sponsor's quality management system. monitoring visits will be performed to cover data from all study participants, and according to qms and the standard operation procedures. the monitoring shall ensure that all source documentation is precise and document control is exercised in all relevant documentation. the monitoring ensures, that the adverse events are always reported and appropriate authorities or stakeholders are informed.

Eligibility criteria:
inclusion criteria: * any 18 to 90-year old patient scheduled for open-heart operation * the ability to understand the objective of the study and the risks involved. * informed consent obtained, including the agreement to authorization to use the protected personal patient records according to privacy legislation. exclusion criteria: * inability to obtain an informed consent form * patients included as vulnerable population according to finnish medical research act, including retarded, pregnant women, nursing mothers, prisoners, or forensic patients.

Keywords: monitoring, intraoperative heart surgery
cd19-car-t cells in patients with r/r b-all

Conditions: B-cell Acute Lymphoblastic Leukemia

Summary: this is a single center, single arm, open-lable phase 1 study to determine the safety and efficacy of autologous or donor-derived allogeneic t cells expressing cd19 chimeric antigen receptors (referred to as "cd19-car-t cells") in patients with relapsed or refractory acute b-cell lymphoblastic leukemia (r/r b-all).

primary objective: to investigate the safety and efficacy of autologous or hla-haploidentical allo-cd19-car-t cells in the treatment of patients with relapsed or refractory acute b-cell lymphoblastic leukemia. secondary objective: to assess the patient's quality of life after receiving the treatment.

Eligibility criteria:
inclusion criteria: 1. obtain informed consent form (icf) voluntarily signed by the patient; 2. age 3-70 years old; 3. primary resistant or relapsed b-cell line acute lymphoblastic leukemia; 4. b cells are positive for cd19 expression; 5. peripheral blood tumor cell load \ 50 points; 7. normal liver and kidney function; 8. normal heart function; 9. good follow-up compliance; 10. women of childbearing age (15-49 years old) must have a pregnancy test within 7 days before treatment and have a negative result; men and women with fertility should agree to use effective contraception to ensure that during the study period and following 3 months after treatment the women will not get pregnant. exclusion criteria: 1. patients with non-b cell acute leukemia; 2. organ failure: heart: grade iii and iv liver: class c with child-turcotte liver function classification kidney: renal failure and uremia lung: severe respiratory failure brain: disabilities 3. active infection; 4. human immunodeficiency virus (hiv) positive; 5. acute and chronic graft-versus-host disease (gvhd)\> level 1； 6. pregnant or lactating women; 7. patients do not agree to use effective contraception during the treatment period and following 3 months; 8. patients who participated in other clinical studies at the same time; 9. the researcher believes that there are other factors that are not suitable for inclusion in or influence the subject's participation in or completion of the study; 10. long-term use greater doses of hormones than physiological doses.
the efficacy of transversus abdominis plane block versus wound infiltration for analgesia after cesarean delivery:

Conditions: Cesarean Section Complications

Summary: this study aimed to compare bilateral ultrasound-guided tap block with single-shot local anesthetic wound infiltration for analgesia after cesarean delivery performed under spinal anesthesia

this double-blind, randomized controlled trial aimed to compare bilateral ultrasound-guided tap block to single-shot local anesthetic wound infiltration for analgesia after cesarean delivery performed under spinal anesthesia. this will be done by measuring vas (visual analogue score) for pain after ceserian section at2, 4, 6, 12, 24 hours .

Eligibility criteria:
inclusion criteria: * women undergoing cesarean section under spinal anesthesia * aged ≥19 years and \> 40 years . * gestational age ≥ 37 weeks . * informed consent from the patient . exclusion criteria: * body mass index (bmi) ≥40 kg/m2 .. * history of recent opioid exposure . * hypersensitivity to any of the drugs used in the study . * significant cardiovascular, renal, or hepatic disease.
apatinib dose titration in advanced or metastatic gastric cancer

Conditions: Gastric Cancer

Summary: apatinib dose titration in advanced or metastatic gastric cancer


Eligibility criteria:
inclusion criteria: 1. ≥ 18 and ≤ 70 years of age 2. histological confirmed advanced or metastatic adenocarcinoma of the stomach 3. have failed for at least 2 lines of chemotherapy 4. life expectancy of at least 12 weeks 5. eastern cooperative oncology group performance status of 0 or 1 6. at least one measurable lesion beyond stomach (larger than 10 mm in diameter by spiral ct scan) 7. duration from the last therapy is more than 6 weeks for nitroso or mitomycin 8. more than 4 weeks for operation or radiotherapy or cytotoxic agents 9. adequate hepatic, renal, heart, and hematologic functions exclusion criteria: 1. pregnant or lactating women 2. history of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix 3. hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents (systolic blood pressure \> 140 mmhg, diastolic blood pressure \> 90 mmhg) 4. any factors that influence the usage of oral administration 5. evidence of central nerves system metastasis 6. intercurrence with one of the following: coronary artery disease, arrhythmia ,heart failure 7. proteinuria ≥ (+) 8. international normalized ratio \> 1.5 and activated partial thromboplastin time \> 1.5 × upper limit of normal（uln） 9. certain possibility of gastric or intestine hemorrhage 10. less than 4 weeks from the last clinical trial 11. prior vegfr inhibitor treatment 12. disability of serious uncontrolled intercurrence infection objective evidence of previous or current pulmonary fibrosis history, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, pulmonary function damaged seriously etc

Keywords: gastric cancer pharmacokinetics dose titration
evaluation of proprioception in patients with total hip replacement

Conditions: Coxarthrosis; Primary

Summary: disturbances of balance and postural stability are frequent in patients with coxarthrosis due to the damage to the mechanoreceptors, characteristic of arthritic degeneration, and muscular hypotrophy of the affected limb. the aim of the study is to evaluate with adequate instrumentation the alterations of proprioception and postural control in patients with hip osteoarthrosis and the effectiveness of joint reconstruction in improving any deficit.


Eligibility criteria:
inclusion criteria: * primary osteoarthrosis * bmi \< 35 kg/m\^2 * able to stand in monopodalic support without aids / support exclusion criteria: * history of previous hip or knee replacement * orthopedic trauma within the previous 6 months * pathologies that can interfere with balance: neurological (of the central nervous system, neuropathies, movement disorders), vestibular, visual, cognitive disability, consumption of alcohol / drugs / psychoactive drugs in the 24 hours prior to the test
effect of different non-surgical treatment approaches of peri-implantitis

Conditions: Peri-implant Inflammation; Peri-Implantitis and Peri-implant Mucositis; Non-surgical Treatment

Summary: peri-implantitis is a biofilm-associated pathological condition characterized by inflammation within the peri-implant mucosa, which leads to the progressive loss of the surrounding supporting bone tissue. the primary goal of managing peri-implantitis is to control the peri-implant biofilm and resolve inflammation. nonsurgical treatment of peri-implantitis by submarginal mechanical instrumentation alone typically provides clinical improvements, particularly in non-advanced cases. however, to ensure surface decontamination and enhance treatment outcomes, alternative or adjunctive methods, such as systemic/local antibiotics, antiseptics, lasers, and air-abrasion systems, have been proposed. therefore, the null hypothesis (h0) of the present study is that no statistically significant difference would be detected in clinical inflammation signs among patients diagnosed with early-stage peri-implantitis after undergoing one of the following treatments: nonsurgical mechanical instrumentation alone, mechanical instrumentation plus chlorhexidine (chx), mechanical instrumentation plus gaseous ozone, mechanical instrumentation plus glycine air polishing, or glycine air polishing alone.


Eligibility criteria:
inclusion criteria: * the presence of at least one titanium implant with clinical and radiographic signs of initial to moderate peri-implantitis * single-unit or partial restorations without overhangings * absence of occlusal overload * the presence of at least 2 mm of keratinized attached peri-implant mucosa * periodontally healthy participants with a good level of oral hygiene exclusion criteria: * the presence of implant mobility * systemic diseases (i.e. diabetes (hba1c \<7), osteoporosis, bisphosphonate medication) which could affect the outcome of treatment * smoking * placement, and prosthetic loading of implants within the past year
correlation between the volume flow of the cfa after angioplasty of critical ischemic limb and wound healing

Conditions: Wound Heal, Duplex Volume Flow

Summary: in our study we are examining the volume flow of the common femoral artery before and after angigraphy of a critical ischemic limb, as a predictor for wound healing after the treatment

all patients with threatened limbs, that was decided upon to have angioplasty will be asked to sign consent form to participate in this study. before having the angioplasty, all participants will be examined with ultrasound duplex to determent their common femoral artery volume flow. day after the angioplasty, they will be reexamined (this is the usual practice) to detriment the new volume flow in the cfa. the participents examinations in the outpatient clinics will be documented and time for healing will be recorded.

Eligibility criteria:
inclusion criteria: * all patients with threatened limbs, that was decided upon to have angioplasty . exclusion criteria: * those who are not willing to sign a consent form to participate in this study