Kornimate/medical-research-clean huggingface dataset:
efficacy of sternum guard in post cardiac surgery patient

Conditions: Coronary Artery Disease; Valvular Heart Disease; Congenital Heart Disease in Adolescence; Post Operative Wound Infection; Surgical Site Infection; Postoperative Hemorrhage

Summary: this is a single-center, single-blind, randomized parallel superiority trial comparing two groups; sternum guardtm as the treatment arm and bone wax as the active control group. both investigated modalities are materials used during sternotomy for covering the sewn sternal edge. the primary outcomes of this study comprised of four parameters; namely surgical site infection (superficial or deep infection), sternal dehiscence, hemostatic effect, and surgeon's satisfaction rate. the first three primary outcomes were assessed during the operation, at the end of the hospital stay, 14 days, and 30-days postoperative.

a single center randomized controlled clinical trial was conducted at harapan kita national cardiovascular center, jakarta, indonesia as the tertiary cardiovascular referral hospital. the rct was conducted from may 17th, 2020 until october 20th, 2021 (current status: completed). this study assessed the efficacy of sternum guardtm, a commercially-available nonwoven cellulose based, single use, sterile surgical drape used for covering the dissected sternal bone edge during median sternotomy for cardiac surgery. the active comparator/ control group in this study is the use of bone wax, a vaseline and beeswax-made materials widely used during sternotomy as a mean of bleeding control. the subjects were adults undergoing elective cardiac surgery with median sternotomy approach for any indication. both the patients and the principal investigators were blinded for the treatment-control allocation, but the surgeon were not blinded for the materials used. the patients were purposively selected and were randomly assigned to one of the arms with block randomization. the primary outcomes of this study comprised of four parameters; namely surgical site infection (superficial or deep infection), sternal dehiscence, hemostatic effect, and surgeon's satisfaction rate. the first three primary outcomes were assessed during the operation, at the end of the hospital stay, 14 days, and 30-days postoperative. the minimum sample size was 414 subjects.

Eligibility criteria:
inclusion criteria: * patients ages \> 18 years old * patients who are scheduled electively for cardiac surgery * cardiac surgery with the usage of cardiopulmonary bypass machine * patients who are agreed to participate in this study exclusion criteria: * patients who are scheduled for surgery in emergency or urgent manner * patients with the history of uncontrolled hypertension and uncontrolled diabetes mellitus. * patients with the history of past cardiac surgery drop - out criteria: * patients who are pronounced death on operation table * patients who are pronounced death within hospitalization * patients who are lost to follow up (day 30 post-operative) * patients who are not committed for the whole stage of the research

Keywords: sternum guard bone wax median sternotomy surgical site infection operative blood loss
respiratory functions response to tens acupoint stimulation post inhalation injury

Conditions: Inhalation Injury

Summary: this study designed to examine the effect of acu-tens applied bilaterally on ding chuan acupoint to boost pulmonary functions, improve diaphragmatic excursion and decrease dyspnea in patients with inhalation injuries.


Eligibility criteria:
inclusion criteria: * partial or full-thickness major burns * diagnosis of smoke inhalation based on the history of smoke exposure and chest computed tomography (ct) * have no systemic disease * body mass index less than 30. exclusion criteria: * patients with any other pulmonary condition * cardiac condition * rib fracture * systemic disease * local infection and cigarette or tobacco use
ciclosporin in the management of chronic or recurrent erythema nodosum leprosum

Conditions: Leprosy

Summary: study 2b: ciclosporin in the management of chronic or recurrent erythema nodosum leprosum aim: to assess the safety, tolerability and efficacy of ciclosporin in the treatment of patients whose enl is not controlled with standard prednisolone. objective: a pilot double blind controlled study randomizing patients whose enl is not controlled with standard prednisolone, and comparing a group treated with ciclosporin to a group treated with additional steroid only.

a pilot double blind controlled study randomizing patients whose enl is not controlled with standard prednisolone, and comparing a group treated with ciclosporin to a group treated with additional steroid only.

Eligibility criteria:
inclusion criteria: * individuals with clinical evidence of recurrent or chronic enl * aged 18-65 * weigh more than 30kg exclusion criteria: * unwillingness to give informed consent * patients with severe active infections such as tuberculosis * pregnant or breastfeeding women (see appendix ii) * those with renal failure, abnormal renal function, hypertensive * patients taking thalidomide currently or within the last 3 months * patients not willing to return for follow-up * women of reproductive age not willing to use contraception for the duration of the study ( see appendix ii) * hiv positive patients

Keywords: leprosy enl erythema nodosum leprosum prednisolone ciclosporin
the effects of baduanjin qigong exercise on ankylosing spondylitis: a randomized controlled study

Conditions: Ankylosing Spondylitis

Summary: the aim of this study is to examine the effectiveness of 12-week baduanjin qigong exercises in patients with ankylosing spondylitis. 59 volunteer individuals, ages 18-64, will be included in the study. they will be randomly divided into two groups (the intervention and the control). the intervention group will perform a qigong exercise program online (via zoom video conference) for 12 weeks under the supervision of two physiotherapists. the qigong exercise program had previously been videotaped by the researchers. the control group will perform the home exercise program at home for 12 weeks.

this study will be conducted to examine the effect of baduanjin qigong exercises on patients with ankylosing spondylitis. 29 individuals with ankylosing spondylitis (the intervention group) and 30 healthy individuals (the control group), totaling 59 volunteer individuals ages 18-64, will be included in the study. the intervention group will perform a qigong exercise program online (via zoom video conference) for 12 weeks under the supervision of two physiotherapists. the qigong exercise program had previously been videotaped by the researchers. the control group will perform the home exercise program at home for 12 weeks. the intervention group will perform qigong online exercise program, and the control group will perform home exercises for 45 minutes twice a week for 12 weeks. in this study the bath ankylosing spondylitis disease activity index, bath ankylosing spondylitis functional index, bath ankylosing spondylitis metrology index, chest expansion measurement, the pittsburgh sleep quality index, fatigue severity scale, hospital anxiety and depression scale, and ankylosing spondylitis quality of life questionnaire will be applied before and after the 12-week exercise program in the evaluation of patients.

Eligibility criteria:
inclusion criteria: * patients with ankylosing spondylitis diagnosis exclusion criteria: * patients with another rheumatological diseases or orthopedic, neurological, psychiatric, cardiovascular, oncological comorbidities

Keywords: qigong exercises ankylosing spondylitis pain quality of life fatigue
influence of depth of anesthesia on pupillary reactivity to a standardized stimulus

Conditions: Pain

Summary: a standardized tetanic stimulation is applied to patients under propofol-remifentanil tci, in a cross-over fashion, at two different levels of anesthesia monitored by the bis: bis 25 and bis 55. remifentanil target remains constant during the whole study period (1 ng/ml). pupillary reflex dilation is recorded after each stimulation.


Eligibility criteria:
inclusion criteria: * asa 1-2 * scheduled for an idiopathic scoliosis surgical correction exclusion criteria: * ophtalmologic pathology * neurologic or muscular pathology * metabolic pathology * chronic pain

Keywords: analgesia pupillometry general anesthesia
a study of single and multiple doses hrs9531 tablets in healthy subjects

Conditions: Overweight or Obesity; Type 2 Diabetes

Summary: the study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of hrs9531tablets in healthy subjects.


Eligibility criteria:
inclusion criteria: 1. ability to understand the trial procedures, be able and willing to provide a written informed consent. 2. 18-55 years of age at the time of signing informed consent. 3. sad stage: body weight ≥50 kg,19.0 ≤bmi≤ 35.0 kg/m2 at screening visit. mad stage: 24.0 ≤bmi≤ 35.0 kg/m2 at screening visit. 4. subjects with good general health, no clinically significant abnormalities. exclusion criteria: 1. known or suspected hypersensitivity to trial product(s) or related products. 2. with previous major organ diseases, including but not limited to neuropsychiatric, cardiovascular, digestive, respiratory, urinary, endocrine, blood, immune and other diseases, are judged by researchers to be unsuitable for the study. 3. abnormal and clinically significant blood pressure at screening. 4. blood donation within 1 month prior to screening, or blood donation ≥400 ml or blood loss ≥400 ml within 3 months prior to screening. 5. participation in other clinical trials. 6. presence of any clinically significant results in examination at screening visit. 7. hepatitis b surface antigen (hbsag), hiv antibody detection, treponema pallidum specific antibody detection, hepatitis c virus antibody (hcvab) positive. 8. presence of - clinically significant ecg results. 9. known or suspected history of drug abuse or drug abuse, or urine drug screening test during the screening periodthose who are positive. 10. addiction to tobacco and alcohol. 11. in the opinion of the investigator, there are any other conditions that interfere with the evaluation of the results of the trial or are not suitable for participation of this study.
can we improve the comfort of pelvic exams?

Conditions: Pain

Summary: the purpose of this study is to investigate patients self-reported comfort levels during each section of the pelvic exam.

the purpose of this randomized controlled trial is to investigate the sequence in which physicians perform the pelvic exam, describe and compare the self-reported comfort during each section of the pelvic exam and how comfort during the exam relates to quality of life, self-esteem, and sexual function in english speaking females at least 18 years of age in an outpatient setting.

Eligibility criteria:
inclusion criteria: * english-speaking, female patients * are able to can read and write english * are utilizing outpatient services at an obgyn outpatient office * are scheduled for a well-woman exam exclusion criteria: * non-english speaking patients * patients who cannot read or write * those who are pregnant * have an active vaginal infection * patients who, otherwise, do not require a speculum exam during their appointment
fall risk reduction in multiple sclerosis: exercise versus behavior

Conditions: Multiple Sclerosis; Adult Disease

Summary: falls are a serious health concern for persons with multiple sclerosis (ms). over 50% of persons with ms suffer a fall over a 6-month periodwith the majority of falls resulting in medical attention for injuries (i.e., lacerations, bone fractures, \& head injuries). the effects of a fall are often compounded as it can lead to activity curtailment, physiological deconditioning, and institutionalization. despite the importance of falls in persons with ms, the appropriate prevention strategies (i.e. rehabilitation approaches) are not clear. the purpose of this investigation is to determine whether exercise based or educational based interventions are more suited for fall prevention in older adults with ms.

falls are a serious health concern for persons with multiple sclerosis (ms). over 50% of persons with ms suffer a fall over a 6-month periodwith the majority of falls resulting in medical attention for injuries (i.e., lacerations, bone fractures, \& head injuries). the effects of a fall are often compounded as it can lead to activity curtailment, physiological deconditioning, and institutionalization. despite the importance of falls in persons with ms, the appropriate prevention strategies (i.e. rehabilitation approaches) are not clear. it is well known that causes of falls are multifactorial with over 400 risk factors identified. however, it is believed that these factors can be divided into two main classes: intrinsic (e.g. physiological factors) and extrinsic factors. for instance balance dysfunction, spasticity and muscle weakness are physiological risk factors for falls in ms . behavioral fall risk factors in ms include choosing appropriate footwear, lighting and utilizing appropriate assistive device. there is evidence that both types of risk factors can be minimized with appropriately designed interventions in persons with ms and have been shown to reduce fall risk and incidence in other clinical populations. this has led to calls for the combination of exercise training program that targets specific, modifiable physiological risk factors and educational interventions targeting modifiable behavioral risk factors in persons with ms. however, there is minimal evidence that these interventions in isolation or combination actually reduce fall incidence or risk in persons with ms. this proposal seeks to determine the effectiveness of a combined exercise and educational rehabilitation strategy to prevent falls in persons with ms.

Eligibility criteria:
inclusion criteria: * definite multiple sclerosis diagnosis * ambulatory * aged 50-75 years of age * fallen within 12 months exclusion criteria: * non-ambulatory * outside age range * no fall history
postoperative chemotherapy with/without radiotherapy and immunotherapy for colorectal liver metastases with high risk of locally recurrence

Conditions: Radiotherapy; Immunotherapy; Liver Metastases; Colorectal Cancer

Summary: this study is a randomized controlled phase ii trial to evaluate the efficacy of the combination of stereotactic body radiation therapy (sbrt) and immunotherapy with postoperative chemotherapy in colorectal cancer liver metastasis (crlm) patients with high risk of locally recurrence. researchers will compare the combination therapy with the postoperative chemotherapy alone to see if postoperative chemotherapy plus sbrt and immunotherapy can further reduce the risk of recurrence and metastasis after surgery.

40-50% of colorectal cancer patients have metastases at the time of diagnosis, of which liver metastases are the most common. surgical resection is the most likely cure for crlm patients, however, more than 50% of patients will experience recurrence within 2 years after resection of liver metastases. sbrt can be an effective and safe treatment modality, which can not only provide better local control of metastatic lesions, but also has a sensitizing immunotherapeutic effect. sbrt can effectively synergize with anti-pd-1/pd-l1 antibodies to activate the immune microenvironment of crlm patients and improve survival. however, in crlm patients after surgery, whether combining sbrt, immunotherapy and adjuvant chemotherapy results in better survival than chemotherapy alone, the evidence is insufficient.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old, female and male 2. pathological and imaging confirmed colorectal colorectal liver metastases (synchronous or heterochronous) 3. metastatic liver lesions \<= 5 4. primary colorectal cancer under control 5. absence of evidence of extra-hepatic diseases 6. metastatic liver lesions received resection with insufficient margin (\<0.5cm) or r1/r2 resection 7. karnofsky \>= 70 8. adequate organ function without contraindications to surgery, radiotherapy and immunotherapy 9. without previous antitumoral immunotherapy 10. with good compliance 11. signed the inform consent exclusion criteria: 1. pregnancy or breast-feeding women 2. history of other malignancies within 5 years (except cured skin cancer and cervical cancer in situ) 3. history of uncontrolled epilepsy, central nervous system disease, or psychiatric disorders 4. clinically serious heart disease, such as symptomatic coronary artery disease, new york heart association (nyha) class ii or worse congestive heart failure or severe arrhythmia requiring pharmacologic intervention, or history of myocardial infarction within the last 12 months 5. immunodeficiency disease, autoimmune diseases or long-term using of immunosuppressive agents 6. severe uncontrolled recurrent infections 7. baseline blood and biochemical indicator do not meet the following criteria: neutrophils \>=1.5×10\^9/l, hb \>=90g/l, plt \>=100×10\^9/l, alt/ast\<=2.5 uln, cr \<= 1uln 8. allergic to any component of the therapy
breathing relaxation exercise heart failure

Conditions: Congestive Heart Failure

Summary: the aim of the study is to determine the effect of breathing and relaxation exercises on dyspnea, fatigue and self-care level in heart failure patients.

the effect of breathing and relaxation exercise on dyspnea, fatigue and self-care level in patients with heart failure: a randomized controlled study it was planned according to consort rules as a randomized controlled study to determine its effect on self-care level. the hypotheses of the research are as follows: a: breathing exercise applied to hf patients has an effect on the mean dyspnea score. b: breathing exercise applied to hf patients has an effect on the mean fatigue score. c: breathing exercise applied to hf patients has an effect on self-care mean scores. d: relaxation exercise applied to hf patients has an effect on the mean dyspnea score. e: relaxation exercise applied to hf patients has an effect on the mean fatigue score. f: relaxation exercise applied to hf patients has an effect on self-care mean scores.

Eligibility criteria:
inclusion criteria: (a) 18 years of age or older; (b) patients with hf stage nyha ii-iii; (c) hospitalized for two weeks; (d) not pregnant; (e) not applying any integrated treatment; (f) patients who have been taking the same heart failure medication for at least three months. exclusion criteria: the exclusion criteria of patients are as follows: (a) not expected to participate in a breathing or progressive relaxation exercise study in expert opinion; (b) patients with copd, (d) patients with severe mental disorders. individuals' eligibility for inclusion and exclusion criteria will be evaluated through patient file records and interviews with the physician.

Keywords: heart failure, breathing exercise, relaxation exercise
prolectin-m in covid-19 patients having mild to moderate symptoms not requiring oxygen support.

Conditions: COVID-19

Summary: a randomised controlled trial of open label prolectin-m; a (1-6)-alpha-d-mannopyranose among patients with rt pcr positive covid-19 patients.

sarscov2 has infected over 20 million people worldwide. the virus has a unique protein structure enabling it to rapidly infect and spread among the population. covid19 is a global health emergency and has affected lives of all people irrespective of being infected. there are no proven therapies and a vaccine is yet to be approved for wide public usage. our study aims to test a hypothesis of physically blocking the spike protein from infecting the human cells, thus promoting its rapid excretion from the infected person. we will randomise 10 subjects in this proof of concept trial and test the hypothesis by measuring the effect of prolectin-m; a (1-6)-alpha-d-mannopyranose in reducing the viral copy numbers over 5 days of treatment. the absolute copy numbers will be measured on digital droplet pcr developed by biorad. a fall in copy numbers by 2-fold from baseline will be considered a positive treatment effect in this population. all standard care measures currently being practiced for these patients will be continued.

Eligibility criteria:
inclusion criteria: * symptomatic and laboratory-confirmed diagnosis of covid-19. * age ≥18 years and ≤45 years, male and non-pregnant female * identified within 72 hours of testing positive on rt pcr. * able to give informed consent to stay in institutional care and undergo 3 times collection of throat and nasal swabs over 7-day period; day 1, day 3 and day 5 since randomization. exclusion criteria: * oxygen saturation at admission ≤96%. * high temperature ≥100 deg f (≥37.5 deg c) not controlled on oral doses of acetaminophen. * known history of diabetes on oral medications or insulin. * il-6 levels ≥ 3times of laboratory reference range and / or significantly elevated levels of crp, serum ferritin or d-dimer. * lymphocyte / monocyte ratio ≤3 or neutrophil / lymphocyte ratio ≥5 or platelet count ≤150,000 cells per microliter * on any chronic medications for more than 4 weeks before randomization or active malignancy or having any co-morbidity that increases risk of rapid disease progression. * previously tested positive and recovered from covid-19

Keywords: ddpcr, sarscov2 copies
effect of reducing uric acid on insulin sensitivity and oxidative status

Conditions: Obesity; Metabolic Syndrome; Hyperuricemia

Summary: the purpose of this study is to learn more about what is the effect of uric acid on oxidative stress and on the way the body metabolizes sugar in obese people. understanding this may lead to better diseases such as diabetes.

it has been hypothesized that oxidative stress is involved in the pathogenesis of insulin resistance associated with obesity. circulating uric acid (ua) is the body's major endogenous plasma antioxidant. therefore, the investigators evaluated whether alterations in serum ua concentration affect: 1) systemic and skeletal muscle oxidative stress, 2) total antioxidant capacity, and 4) skeletal muscle insulin sensitivity during a hyperinsulinemic-euglycemic clamp.

Eligibility criteria:
inclusion criteria: * obese (bmi 30-45 kg/m²); * serum ua concentration either ≥5 mg/dl or ≤4.0 mg/dl (297 µmol/l)\], exclusion criteria: * renal dysfunction (serum creatinine \>1.5 mg/dl); * pregnancy or lactating; * take urate-lowering agents, thiazide diuretics, prednisone or medications containing aspirin or other salicylates; * history of xanthinuria, type 2 diabetes or other significant organ system dysfunction; * have g6pd deficiency; * use hormone-replacement or oral-contraceptive therapy; * smoke tobacco; * anemic (hb \<10 g/dl)

Keywords: obesity metabolic syndrome hyperuricemia
analog classroom study comparison of adderall xr with strattera in children aged 6-12 with adhd

Conditions: ADHD

Summary: evaluate the behavioral effects of adderall xr versus strattera under controlled conditions utilizing the skamp deportment scale.


Eligibility criteria:
inclusion criteria: * primary diagnosis of adhd combined subtype or predominantly hyperactive-impulsive subtype, based on psychiatric evaluation * capable of understanding and following classroom instructions * generally functioning academically at age-appropriate levels exclusion criteria: * adhd, predominantly inattentive subtype * controlled or uncontrolled comorbid psychiatric diagnosis (except odd) with significant symptoms such as ptsd, psychosis, bipolar disease, severe ocd, severe depressive or severe anxiety disorder * documented history of aggressive behavior serious enough to preclude participation in regular classroom activities * documented allergies or intolerance to either of the active treatments or tricyclic antidepressants